When a baby is born, parents are often awed and alarmed to find themselves responsible for this tiny new person, and they desperately want to do their very best to keep their infant safe and healthy. New mothers worry about everything from SIDS to vaccines, from feeding practices to sleep hygiene, and they are bombarded with conflicting advice about caring for their babies. Myths and misinformation abound. Finally someone has written a truly science-based guide to the first year of life: The Science of Mom. The author is a research scientist with a PhD in nutritional biology. When her first child was born, she had a lot of questions, and thanks to her background she knew how to look for reliable answers in the scientific literature. She started writing the Science of Mom blog and eventually turned her findings into a book.
Her first chapter covers the important concepts for understanding how to think about scientific studies:
In subsequent chapters she delves into what science has to say about various topics. She finds that there is seldom a simple yes-or-no answer to these questions, and she presents the evidence on both sides fairly, adding a common-sense perspective.
When to cut the umbilical cord
There are clear benefits of delaying cord clamping, but there are also risks. We don’t know how long a delay is optimal. And there are practical problems like the logistics of resuscitating a baby in distress and of banking cord blood.
Vitamin K shots and eye goop
She explains why newborns are given vitamin K injections, illustrating the danger of vitamin K deficiency bleeding (VKDB) with a horror story about a baby who nearly died from a brain bleed after the shot was inadvertently omitted. The evidence shows that oral supplements are not as effective, and that the injections are safe.
Antibiotic eye ointment is routinely used to prevent blindness and other complications of gonorrhea and chlamydia, but the incidence of gonorrhea in the population has declined. If a woman is at very low risk of sexually transmitted diseases, eye prophylaxis might reasonably be omitted; but when European countries tried doing it selectively instead of universally, the number of gonococcal infections in newborns rose. And the risks of treatment are minimal.
Breast is best
For some families, breast-feeding is clearly the best choice, but for others it isn’t. The benefits of breast-feeding have been hyped beyond the actual evidence. It is definitely beneficial; but the advantages are not huge, and formula feeding is a perfectly good option for mothers who can’t breastfeed or prefer not to. There are even some benefits to formula: it is fortified with iron, so bottle-fed babies are less likely to become anemic than breast-fed babies.
There are benefits to keeping your baby close, but sleeping in the same bed is dangerous. She covers the published evidence, cultural differences, SIDS, factors that might have influenced study findings, and how to minimize the risks if you choose to co-sleep.
One of the biggest problems for parents of newborns is chronic sleep deprivation. She covers the research on normal infant sleep patterns, arousability, and how infants learn self-soothing behaviors to fall asleep without help. Sleep training works, but not for all infants. It doesn’t harm babies, and it can help stressed parents get the sleep they need to be good parents.
This chapter starts with an affecting personal story. One of the author’s uncles died at age 6 of encephalitis caused by measles. What had appeared to be a typically benign, uncomplicated case of measles suddenly turned deadly. The benefits of vaccines are undeniable. She shows the statistics for lives saved and she debunks many of the common anti-vaccine myths. She gives a lucid explanation of herd immunity. She recognizes that vaccines are not without risk, but the evidence shows that the risk is very small and the risks of not vaccinating are much greater. She explains how vaccines are rigorously tested and monitored for safety. She tells how the first rotavirus vaccine caused intussusception in a few recipients and how the system responded to create a safer vaccine. The new vaccine has prevented thousands of hospitalizations for rotavirus infection, and has even decreased the incidence of the disease in the unvaccinated through herd immunity.
When to start solid foods?
When I started practicing medicine we used to recommend starting rice cereal at 1 month so the solid food in the tummy would help the baby sleep through the night; it didn’t work. The evidence for when to start solid foods is conflicting, and there are confounding factors like varying hygiene practices and resources in different cultures. Starting between 4 and 6 months reduces the risk of anemia in breastfed babies and may reduce the risk of allergies, celiac disease, and type I diabetes. Starting at 6 months may lower the risk of diarrhea and the baby is more developmentally ready, making feeding easier. Waiting longer than 6 months is not advisable.
She says, “Take the focus off the calendar and put it where it belongs, with the little one doing the eating.” Babies develop at different rates and have different preferences. A baby is ready for solid food when he can be positioned upright for feeding, has lost the tongue thrust reflex that pushes the food right back out in younger babies, shows an interest in solid food, and can communicate when he doesn’t want something by closing his mouth or turning his head away.
Breast milk is the perfect food for newborns, but it becomes inadequate in later infancy. It fails to provide the iron that babies need to prevent anemia, and it is lacking in a number of nutrients like vitamins A, C, and E and micronutrients like zinc and manganese. Our ancestors probably overcame this by feeding older infants meat and other foods, and the evidence shows that meat, egg yolks, and fish are good for babies. Vegetarian diets, especially vegan and macrobiotic diets, have been shown to result in nutrient deficiencies, stunted growth, muscle and fat wasting, and slower psychomotor development.
The risk of anemia can be counteracted by feeding infant cereals fortified with iron. Whole grains may be more nutritious, but refined grain cereals are a better source of iron. She recommends feeding babies a varied diet, avoiding sugar, and not adding salt. She found no evidence that organic food benefited children’s health. She emphasizes that the most important part of feeding isn’t the food: parents should relax and enjoy feeding and interacting with their babies.
Babies are amazing
She includes a chapter that amounts to a love letter to babies, urging parents to observe how their newborns explore, communicate, and learn. Newborns have special reflexes and are capable of more than most people realize. And they are unique individuals; parents need to learn to interpret their cues and respond appropriately.
In eight appendixes, she offers reassuring evidence-based answers to these questions:
This is science-based medicine writing at its best. Callahan doesn’t cherry-pick. She knows how to evaluate the entire body of research and put it into perspective along with practical parenting considerations. She enhances her message with a personal touch, including anecdotes about her own experiences as a new mother and about the experiences of her friends and family. If I had three thumbs, I would give this book a 3-thumbs-up recommendation. If every new parent could read this book, it would go a long way towards immunizing them against the misinformation they will inevitably encounter, misinformation that so often clouds their judgment and worries them unnecessarily.
A recent massive study attempting to replicate 100 published studies in psychology has been getting a lot of attention, deservedly so. Much of the coverage has been fairly good, actually – probably because the results are rather wonky. Many have been quick to point out that “science isn’t broken” while others ask, “is science broken?”
While many, including the authors, express surprise at the results of the study, I was not surprised at all. The results support what I have been saying in this blog and at SBM for years – we need to take replication more seriously.
Here are the results of the study:
We conducted replications of 100 experimental and correlational studies published in three psychology journals using high-powered designs and original materials when available. Replication effects (Mr = .197, SD = .257) were half the magnitude of original effects (Mr = .403, SD = .188), representing a substantial decline. Ninety-seven percent of original studies had significant results (p < .05). Thirty-six percent of replications had significant results; 47% of original effect sizes were in the 95% confidence interval of the replication effect size; 39% of effects were subjectively rated to have replicated the original result; and, if no bias in original results is assumed, combining original and replication results left 68% with significant effects. Correlational tests suggest that replication success was better predicted by the strength of original evidence than by characteristics of the original and replication teams.
Let’s unpack this. The big result is that while 97% of the original 100 studies had statistically significant results, only 36% of the replications did. If you look at effect sizes rather that significance, 47% of the original studies were replicated within the 95% confidence interval. If you combine these two, then the authors concluded that 39% of the replication studies confirmed the results of the original studies.
Using a threshold for statistical significance of p=0.05, you might think that there should be a 95% chance that the results are “real” and therefore most of the replications should also be positive. This is a misinterpretation of p-values, however.
I have discussed many reasons why a single study, even with high levels of statistical significance, may not be reliable. One is that p-values themselves don’t reliably replicate. Watch this video, dance of the p-values, to see what I mean. Even when you use a computer program with a fixed effect size and then generate random data, the resulting p-values are all over the place. P-values were never meant to be a solitary indication of if the results of an experiment are real – only a first approximation of whether or not the results are interesting.
So, even with iron-clad experimental design and execution, we would not expect 95% of studies with a p-value of 0.05 to replicate. But most studies do not have iron-clad experimental design and execution. I have discussed before experimenter degrees of freedom and p-hacking. Essentially, this is the practice (whether intentional, innocently, or with a bit of a wink – cutting corners but thinking it doesn’t really matter) of tweaking the execution of an experiment as one looks at the data in order to get across the magical line of statistical significance. You could, for example, keep collecting data until the drunken walk wanders over the line of significance, then stop and publish.
Exact replications take away researcher degrees of freedom, and therefore p-hacking, and therefore expose many false positive studies. Another way to reduce degrees of freedom, which I also discussed recently, is registering trials prior to execution. Simply doing this, in a recent analysis, reduced positive studies from 57% to 8%.
This new study supports another remedy to the apparent abundance of false-positive studies in the scientific literature – valuing replications more. The journal Psychology Today, infamously refused to publish an exact replication by Richard Wiseman of Bem’s ESP research. The journal simply said that they do not publish exact replications as a matter of policy.
The reason for this is that replications are boring while publishing new exciting research increases a journal’s prestige and impact factor. Of course, new exciting research is more likely to be wrong, precisely because it is new and because of what makes it exciting – it goes against the grain.
One aspect of this study often overlooked in popular reporting is the impact of effect sizes. First, the authors found that effect sizes in the replicated studies were about half that of the original studies. This is a well-known phenomenon known as the decline effect – the tendency of effect sizes to decrease as new studies of the same question are published. Sometimes effect sizes decline to zero, sometimes to a positive but diminished result.
ESP researchers, grappling with their own decline effect (consistently to zero) actually proposed that ESP as a phenomenon tends to decline over time as researchers pay attention to it. This is not only absurd, it is completely unnecessary. The far simpler explanation is that as researchers address a scientific question they get better and better at designing studies, learning from the previous studies. As study design and execution gets more rigorous over time, researcher bias is constrained, and effect sizes diminish.
What do we do now?
Every discipline of science has its own culture, journals, and practice, and some are more rigorous than others. But across the board it seems we need to shift the emphasis towards replications. Everywhere along the line of research replications need to have more academic and scientific value. If you talk to researchers, they know the value of replications. That is how we know what it real and what isn’t. But the incentives are all toward doing new and exciting research, and the rewards for doing exact replications are slight.
Journal editors hold a large amount of the blame. They need to start publishing more replications. There is probably an optimal balance in there somewhere – the perfect mix of new exploratory science with replications and confirmatory science. This is like getting the proper amount of oxygen and fuel in an engine. If the mix is not right, the engine is inefficient.
All of these problems with science does not mean science is broken. It means it is inefficient. In the long run, replications are done, and the science sorts itself out. Only real effects will persist over time. But I don’t think we have the mix right. Perverse incentives have pushed the system too far in the exploratory direction, resulting in a flood of false positive studies and a deficit of replications to tell which ones are real.
We know what the problem is and how to fix it.
Putting it All Together
There are also implications from this study for the average person in informing them how to evaluate scientific studies and scientific knowledge. The question is – what scientific results are compelling and where should we set the threshold for accepting that a claim is probably true.
From my experience it seems that many people believe that if a single study shows something, then they can treat the results as real – especially if it confirms what they want to believe. I am often challenged with single studies, as if they support a position against which I am arguing.
I have laid out exactly what kind of evidence I find compelling. Research evidence is compelling when it has all of the following features simultaneously:
1- Rigorous study design
2 – Statistically significant results
3 – Effect sizes that are substantially above noise levels
4 – Independent replication
Many people focus only on criterion #2 – if the results are significant, then the phenomenon is real. But #2 is perhaps the least important of these four. The current study of replications showed that effect sizes were a better predictor of replicability than statistical significance.
For example, I am not convinced of the reality of ESP, homeopathy, acupuncture, or astrology because with these disciplines you never see a specific effect that shows a significant and large effect size with a rigorous study design that is reliably independently replicated. Either effects sizes are razor thin, or the study design is loose, or a one-off study cannot be replicated.
All of this is also only looking at the evidence itself. In addition, you have to consider scientific plausibility. There is always the subjective question of – how significant, how large an effect size, how many times does it have to be replicated? The answer to these questions is – it depends on how plausible or implausible the alleged effect is. The threshold for something like homeopathy is very high, because the plausibility is close to zero. (But to be clear, the evidence for homeopathy does not even reach the minimal threshold for a highly plausible effect, let alone the magic that is homeopathy.)
Keep all this in mind the next time a new exciting study is being shared around social media. Put the study through the filter I outlined above.
I am fortunate to have become a physician in a time of great scientific progress. Back when I was in college and medical school, the thought that we would one day be able to sequence the human genome (and now sequence hundreds of cancer genomes), to measure the expression of every gene in the genome simultaneously on a single “gene chip,” and to assess the relative abundance of every RNA transcript, coding and noncoding (such as microRNAs) simultaneously through next generation sequencing (NGS) techniques was considered, if not science fiction, so far off in the future as to be unlikely to impact medicine in my career. Yet here I am, mid-career, and all of these are a reality. The cost of rapidly sequencing a genome has plummeted. Basically, the first human genome cost nearly $3 billion to sequence, while recent developments in sequencing technology have brought that cost down to the point where the “$1,000 genome” is within sight, if not already here, as illustrated in the graph above published by the National Human Genome Research Institute. Whether the “$1,000 genome” is truly here or not, the price is down to a few thousand dollars. Compare that to the cost of, for instance, the OncoType DX 21-gene assay for estrogen receptor-positive breast cancer, which costs nearly $4,000 and is paid for by insurance because its results can spare many women from even more expensive chemotherapy.
So, ready or not, genomic medicine is here, whether we know enough or not to interpret the results in individual patients and use it to benefit them, so much so that President Obama announced a $215 million plan for research in genomic mapping and precision medicine known as the Precision Medicine Initiative. Meanwhile, the deeply flawed yet popular 21st Century Cures bill, which passed the House of Representatives, bets heavily on genomic research and precision medicine. As I mentioned when I discussed the bill, it’s not so much the genomic medicine funding that is the major flaw in the bill but rather its underlying assumption that encouraging the FDA to decrease the burden of evidence to approve new drugs and devices will magically lead to an explosion in “21st century cures,” the same old antiregulatory wine in a slightly new bottle. Be that as it may, one way or the other, the federal government is poised to spend lots of money on precision medicine.
Because I’m a cancer doctor, and, if there’s one area in medicine in which precision medicine is being hyped the hardest, it’s hard for me not to think that the sea change that is going on in medicine really hit the national consciousness four years ago. That was when Walter Isaacson’s biography of Steve Jobs revealed that after his cancer had recurred as metastatic disease in 2010 Jobs had consulted with research teams at Stanford, Johns Hopkins, and the Broad Institute to have the genome of his cancer and normal tissue sequenced, one of the first twenty people in the world to have this information. At the time (2010-2011), each genome sequence cost $100,000, which Jobs could easily afford. Scientists and oncologists looked at this information and used it to choose various targeted therapies for Jobs throughout the remainder of his life, and Jobs met with all his doctors and researchers from the three institutions working on the DNA from his cancer at the Four Seasons Hotel in Palo Alto to discuss the genetic signatures found in Jobs’ cancer and how best to target them. Jobs’ case, as we now know a failure. However much Jobs’ team tried to stay one step ahead of his cancer, the cancer caught up and passed whatever they could do.
That’s not to say that there haven’t been successes. For instance, in 2012 I wrote about Dr. Lukas Wartman, a then recently minted oncologist who had been diagnosed with acute lymphoblastic leukemia as a medical student, was successfully treated, but relapsed five years later. He underwent an apparently successful bone marrow transplant, but recurred again. At that point, there appeared to be little that could be done. However, Dr. Timothy Ley at the Genome Institute at George Washington University decided to do something radical. He sequenced the genes of Wartman’s cancer cells and normal cells:
The researchers on the project put other work aside for weeks, running one of the university’s 26 sequencing machines and supercomputer around the clock. And they found a culprit — a normal gene that was in overdrive, churning out huge amounts of a protein that appeared to be spurring the cancer’s growth.
That was 2011 as well. Today, the sequence could have been done much more rapidly. In any case, Ley identified a gene that was overactive and could be targeted by a new drug for kidney cancer. His cancer went into remission. Wartman is now the assistant director of cancer genomics at Washington University.
The technology now, both in terms of sequencing and bioinformatics, has advanced enormously even since 2011. With it has advanced the hype. But how much is hype and how much is really hope? Let’s take a look. Also, don’t get me wrong. I do believe there is considerable promise in precision medicine. However, having personally begun my research career in the 1990s, when angiogenesis inhibitors were being touted as the cure to all cancer (and we know what happened there), I am also skeptical that the benefits can ever live up to the hype.The origin of “precision” medicine
“Precision medicine” is now the preferred term for what used to be called “personalized medicine.” From my perspective, it is a more accurate description of what “personalized medicine” meant, given that many doctors objected to the term because they felt that every good doctor practices personalized medicine. Even so, “precision medicine” is no less a marketing term than was “personalized medicine.” If you don’t believe this, look at the hype on the White House website:
Today, most medical treatments have been designed for the “average patient.” In too many cases, this “one-size-fits-all” approach isn’t effective, as treatments can be very successful for some patients but not for others. Precision medicine is an emerging approach to promoting health and treating disease that takes into account individual differences in people’s genes, environments, and lifestyles, making it possible to design highly effective, targeted treatments for cancer and other diseases. In short, precision medicine gives clinicians new tools, knowledge, and therapies to select which treatments will work best for which patients.
If you think this sounds like what alternative medicine quacks (but I repeat myself) routinely say about “conventional medicine,” you’d be right. It’s not that precision medicine advocates don’t have a germ of a point, but they fail to put it this criticism into historical context. Medicine has always been personalized or “precision.” Its just that in the past the only tools we had to personalize our care were things like family history, comorbid conditions, patient preferences, and aspects of the patient’s history that might impact which treatment would be most appropriate. In other words, our tools to personalize care weren’t that “precise,” making our precision far less than we as physicians might have liked. Genomics and other new sciences offer the opportunity to change that, but at the cost of peril that too much information will paralyze decision making. Still, at its best, precision medicine offers the opportunity to “personalize” medicine in a science-based manner, rather in the “make it up as you go along” and “pull it out of my nether regions” method of so many alternative medicine practitioners, as well as the clinical trials tools to do it, such as NCI-MATCH. At its worst, precision medicine is companies jumping the gun and selling genomic tests direct to the consumer without having an adequate scientific basis to know what they mean or what should be done with the results.
In any case, up until 2011, the term “personalized” medicine tended to be used to describe a form of medicine not yet in existence in which the each patients’ unique genomic makeup would serve as the basis to guide therapies. Then, the National Academy of Sciences Committee issued a report, Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease, which advocated the term “precision medicine” and differentiated it from “personalized medicine” thusly:
“Personalized medicine” refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Preventive or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not.” (PCAST 2008) This term is now widely used, including in advertisements for commercial products, and it is sometimes misinterpreted as implying that unique treatments can be designed for each individual. For this reason, the Committee thinks that the term “Precision Medicine” is preferable to “Personalized Medicine” to convey the meaning intended in this report.
As I said, “precision medicine” is a marketing term, but it’s actually a better marketing term than “personalized medicine” because it is closer to what is really going on. That’s why I actually prefer it to “personalized medicine,” even though I wish there were a better term. Whatever it is called, however, the overarching belief that precision medicine is the future of medicine has led to what has been called an “arms race” or “gold rush” among academic medical centers to develop precision medicine initiatives, complete with banks of NGS machines, new departments of bioinformatics and genomics, and, of course, big, fancy computers to analyze the many petabytes of data produced, so much data that it’s hard to have enough media upon which to store it and we don’t know what to do with it. Genomic sequencing is producing so much data that IBM’s Watson is being used to analyze cancer genetics. It’s not for nothing that precision medicine is being likened to biology’s “moon shot“—and not always in a flattering way.
So what is the real potential of precision medicine?Complexity intrudes
I discussed some of the criticism of precision medicine when I discussed the 21st Century Cures Act three weeks ago. I’ll try to build on that, but after a brief recap. Basically, I mentioned that I was of a mixed mind on the bill’s emphasis on precision medicine, bemoaning how now, at arguably the most exciting time in the history of biomedical research, the dearth of funding means that, although we’ve developed all these fantastically powerful tools to probe the deepest mysteries of the genome and use the information to design better treatments, scientists lack the money to do so. I even likened the situation to owning a brand new Maserati but there being no gasoline to be found to drive it, or maybe having the biggest, baddest car of all in the world of Mad Max but having to fight for precious gasoline to run it. I also noted that I thought precision medicine was overhyped (as I am noting again in this post), referencing skeptical takes on precision medicine in recent op-eds by Michael Joyner in the New York Times, Rita Rubin in JAMA declaring precision medicine to be more about politics, Cynthia Graber in The New Yorker, and Ronald Bayer and Sandro Galea in the New England Journal of Medicine. Basically, the number of conditions whose outcome can be greatly affected by targeting specific mutations is relatively small, far smaller than the impact likely would be from duller, less “sexy” interventions, such as figuring out how to get people to lose weight, exercise more, and drink and smoke less. The question is whether focusing in the genetic underpinnings of disease will provide the “most bang for the buck,” given how difficult and expensive targeted drugs are to develop.
Over the weekend, there was a great article in the Boston Globe by Sharon Begley entitled Precision medicine, linked to DNA, still too often misses that gives an idea of just how difficult reaching this new world of precision medicine will be. It’s the story of a man named John Moore, who lives in Apple Valley, UT. Moore has advanced melanoma and participated in a trial of precision medicine for melanoma. His outcome shows the promise and limitations of such approaches:
Back in January, when President Obama proposed a precision medicine initiative with a goal of “matching a cancer cure to our genetic code,” John Moore could have been its poster child. His main tumors were shrinking, and his cancer seemed to have stopped spreading because of a drug matched to the cancer’s DNA, just as Obama described.
This summer, however, after a year’s reprieve, Moore, 54, feels sick every day. The cancer — advanced melanoma like former president Jimmy Carter’s — has spread to his lungs, and he talks about “dying in a couple of months.”
The return and spread of Moore’s cancer in a form that seems impervious to treatment shows that precision medicine is more complicated than portrayed by politicians and even some top health officials. Contrary to its name, precision medicine is often inexact, which means that for some patients, it will offer false hope rather than a cure.
On the other hand, in the Intermountain study, after two years, progression-free survival in the group with advanced cancer treated using precision medicine techniques was nearly twice what it was in those who underwent standard chemotherapy, 23 months versus 12 months. Moore himself reports that with a pill he had one year of improved health and quality of life before his cancer started progressing again. It’s not yet clear in this trial whether this will translate into ain improvement in overall survival, the gold standard endpoint, but it’s a very promising start. It is, however, not a miraculous start.
Here’s the problem. I’ve alluded to it before. Cancer genomes are messed up. Really messed up. And, as they progress, thanks to evolution they become even more messed up, and messed up in different ways, so that the tumor cells in one part of a tumor are messed up in a different way than the tumor cells in another part of the tumor, which are messed up in a different way than the metastases. It’s called tumor heterogeneity.
Now enter the problem in determining which mutations are significant (commonly called “driver” mutations) and which are secondary or “just along for the ride” (commonly called “passenger” mutations):
But setbacks like Moore’s show that genetic profiling of tumors is, at this point, no more a cure for every cancer than angiogenesis inhibitors, which cut off a tumor’s blood supply, or other much-hyped treatments have been.
A big reason is that cancer cells are genetically unstable as they accumulate mutations. As a result, a biopsy might turn up dozens of mutations, but it is not always clear which ones are along for the ride and which are driving the cancer. Only targeting the latter can stop a tumor’s growth or spread.
Knowing which mutation is the driver and which are passenger mutations is so complicated that the Intermountain researchers established a “molecular tumor board” to help.
Composed of six outside experts in cancer genomics, the board meets by conference call to examine the list of a patient’s tumor mutations and reach a consensus about which to target with drugs. Tumor profiling typically finds up to three driver mutations for which there are known drugs, and the board reviews data on how well these drugs have worked in other patients with similar tumors.
The next difficulty, Nadauld said, is that “the mutations may be different at different places in a tumor.” But oncologists are reluctant to perform multiple biopsies. The procedures can cause pain and complications such as infection, and there is no rigorous research indicating how many biopsies are necessary to snare every actionable mutation.
But a cancer-driving mutation that happens to lie in cells a mere millimeter away from those that were biopsied can be missed. Similarly, cancer cells’ propensity to amass mutations means that metastases, the far-flung descendants of the primary tumor, might be driven by different mutations and therefore need different drugs.
Or, as I like to say: Cancer is complicated. Really complicated. You just won’t believe how vastly, hugely, mind-bogglingly complicated it is. I mean, you may think it was tough to put a man on the moon, but that’s just peanuts to curing cancer, especially metastatic cancer. (Apologies to Douglas Adams.) Because of this, precision medicine as it exists now can lead to what Dr. Don S. Dizon calls a new kind of disappointment when genomic testing fails to identify any driver mutations for which targeted drugs exist because “discovery is an ongoing process and for many, we have not yet discovered the keys that drive all cancers, the therapies to address those mutations, and the tools to predict which treatment will afford the best response and outcome—an outcome our patients (and we) hope will mean a lifetime of living, despite cancer.”
None of this is to say that precision medicine can’t be highly effective in cancer. I’ve already described one patient for whom it was. It’s also important to consider that even extra year of life taking a pill with few side effects is “not too shabby,” either, if the alternative is death a year sooner. Prolonging life with good quality is a favorable outcome, even if the patient can’t be saved in the end.What is precision medicine, anyway?
As I thought about precision medicine during the writing of this post, one thing that stood out to me is that, although precision medicine is rather broadly defined, in the public eye (and, indeed, in the eyes of most physicians and scientists) its definition is much narrower. This narrower definition of precision medicine is the sequencing of patient genomes in order to find genetic changes that can be targeted for treatment, predict the response to therapy of various pharmaceuticals or dietary interventions, or predict disease susceptibility. In other words, it’s all genomics, genomics, genomics, much of it heavily concentrated in oncology. (I know I concentrated in oncology for this post because it is what I know best.) If you reread the definition from the National Academy of Sciences Committee report, you’ll see that precision medicine is defined much more broadly. Other similar definitions include metabolomics, environmental factors and susceptibilities, immunological factors, our microbiome, and many more, although even a recent editorial in Science Translational Medicine emphasized genomica more than other factors.
In fact, in the most recent JAMA Oncology, there are two articles, a study and a commentary, examining the effect of precision medicine in breast cancer. What is that “precision medicine”? It’s the OncoType DX assay, which is generically referred to as the 21 Gene Recurrence Score Assay.
Basically, this assay is used for estrogen receptor-positive (i.e., hormone-responsive) breast cancer that has not yet spread to the axillary lymph nodes. Twenty-one different genes related to proliferation, invasion, and other functions are measured, and an empirically derived formula used to calculate a “recurrence score.” Scores below 18 indicate low risk of recurrence as metastatic disease and insensitivity to chemotherapy. Patients with low scores generally receive hormonal therapy but not chemotherapy. Scores over 30 indicate high risk and greater sensitivity to chemotherapy. For such patients, chemotherapy and hormonal therapy are recommended. Patients who score in the “gray” area from 18-30 remain a conundrum, but clinical trials are under way to better define the cutoff point for a chemo/no chemo recommendation. In any case, this study indicates that the use of OncoType DX is associated with decreased use of chemotherapy but because of limitations in the Surveillance, Epidemiology, and End Results (SEER) data set with linked Medicare claims, it wasn’t clear whether this decline was in appropriate patients. In any case, there’s no reason why genomic tests (like the Oncotype DX test) that are rapidly proliferating shouldn’t be considered “precision medicine,” and they are in practice already. Contrary to the image of oncologists wanting to push that poisonous chemotherapy, OncoType DX was designed with the intent of decreasing chemotherapy use in patients who will not benefit. Imagine that.
In the end, I don’t really like the term “precision medicine” that much. It seems to be a term that reminds me, more than anything, of Humpty Dumpty’s famously scornful boast, “When I use a word, it means just what I choose it to mean—neither more nor less.” It’s a sentiment that definitely seems to apply to the term “precision medicine.” To me, when new tests or factors that predict prognosis or response to therapy or suggest which therapies are likely to be most effective are developed and validated, it’s an artificial distinction to link them to genomics, proteomics, or whatever, as well as “big data” and refer to them as “precision medicine.” To me, medicine that works is just “medicine.”
Editors’ note: Britt Marie Hermies of NaturopathicDiaries.com returns to SBM to continue her series on naturopathy from the point of view of someone who has left that profession. If you missed it, the first post was “ND Confession, Part 1: Clinical training inside and out“. She has also contributed “The Wild West: Tales of a Naturopathic Ethical Review Board“.
Prior to renouncing naturopathic medicine and starting NaturopathicDiaries.com, I knew very little about the accreditation of higher education in the United States. I had the impression that accreditation signified that a program or school had the endorsement of the federal government for quality standards. When I first looked into attending naturopathic programs, I remember learning that they are accredited by the U.S. Department of Education.
For me, and I assume for many others, accreditation of naturopathic doctoral programs stood for a medical education of high quality that delivered career prospects similar to those available to primary care physicians who earn an MD or DO. Accreditation also meant I could take out federally-subsidized loans to pay tuition and cover living expenses. Because the $40,000 annual tuition at naturopathic programs was (and still is) comparable to regular medical school, my perception of the validity of naturopathic education at accredited programs made me feel that I was investing in a secure career.
It wasn’t until I graduated from Bastyr University and had been in private practice for several years that I learned the truth about accreditation. Naturopathic programs are accredited by an organization dominated by naturopaths; this authority has been granted to them by the U.S. Department of Education, and they make up their own standards. Leaders in the naturopathic profession can then use the accreditation status of naturopathic programs to convince the public that naturopathic medicine is safe and effective and convince students that they are matriculating into a bonafide medical school.Using the term accreditation to cultivate false credibility
When I was a naturopathic “medical” student at Bastyr, I was under the impression that my peers and I would be able to earn a salary similar to a primary care physician. Naturopathic medicine seemed to be on the up-and-up. I thought I would be eligible for jobs working right alongside physicians in hospitals, medical clinics, and other non-clinical organizations. One of my dreams was to bring naturopathic medicine to institutions involved with health policy, like the World Health Organization and U.S. Centers for Disease Control and Prevention. I thought my credentials from Bastyr would be accepted as forward-thinking medical training, which would give me a cutting-edge advantage over others who seemed stuck in some sort of old medical paradigm.
Why did I believe this fantasy?
I believed I was going to medical school. Printed on numerous pages of Bastyr’s website and over its promotional material are phrases that attractively support this outrageous story:
Just by focusing on this marketing language, Bastyr makes it exceedingly clear that its graduates will become top-notch medical professionals. In fact, Bastyr claims to be “the Harvard of naturopathic medicine” and boasts that the Princeton Review ranked its naturopathic medicine program as “one of the 168 best medical schools” in the U.S. (At the time that edition of Princeton Review was published in 2011, there may have been less than 168 “conventional” medical schools in the U.S., which would likely put Bastyr dead last.)
The fact that naturopathic programs, like Bastyr, are actually accredited through the U.S. Department of Education makes other selling points about naturopathic medicine more believable.
In reality, career prospects for naturopathic doctors are poor. According to an alumni survey [PDF] conducted by the National College of Natural Medicine (NCNM) in 2010, the median net income of NCNM graduates who completed a naturopathic residency and used their ND degree was $60,000 (n=43). These 43 respondents were in practice between 29 years and less than one year. The financial potential is slightly worse for NCNM graduates who did not complete a residency: median income of $50,000 (n=141). These earnings are dismal for any career requiring a doctorate, which in the case for an ND student, results in a punishing financial situation to pay off huge student loans.
I just don’t understand how the naturopathic schools, like Bastyr, can tell students they will get such great medical training, while naturopathic doctors are earning so little money using their degree.“Accreditation” associated rhetoric from the AANP and AANMC
Naturopathic professional organizations seem to rely on the U.S. Department of Education accreditation of ND programs to rationalize naturopathic medicine to public audiences. Usually, the rhetoric is focused on the following concepts: science-based, rigorous, and on-par with conventional medical school. There are two organizations responsible for broadcasting this information: the American Association of Naturopathic Physicians (AANP) and the Association of Accredited Naturopathic Medical Colleges (AANMC).
The AANP is the professional society of licensed naturopaths. One of the society’s main goals is to increase public awareness of naturopathic medicine, which includes promoting the notion that “naturopathic medicine is safe, effective, and cost-effective.” The AANP also states that it seeks to gain licensure for NDs in every state, so they “will be integrated into the nation’s health care system and be a part of all state and federal health care programs.” The AANP is responsible for major lobbying efforts at the federal and state levels.
The AANMC is an organization representing the seven approved naturopathic medicine programs in North America. This organization is different from the American Association of Medical Colleges (AAMC), which administers the MCAT and manages applications to medical schools and residencies. The AANMC appears to be more of a marketing and outreach organization for the naturopathic colleges. From its website, the AANMC’s mission is to “enhance the individual and collective success of member organizations in delivering high quality, innovative, and accessible naturopathic medical education and research.” The AANMC is located in Washington, D.C., and I can only assume this location helps them lobby for naturopathic issues at the federal government.
While each organization has a distinct purview, they are both active stakeholders in the naturopathic profession and lead the dissemination of information about naturopathic education and practice. I find their descriptions of naturopathic medicine misleading and often blatantly false.
In a 2011 lobbying document, the AANP describes the naturopathic degree as recognized by the U.S. Department of Education and Carnegie Institute as a “First-Professional Degree under Doctorate-Profession (Clinical), on par with MD and DO.” This document was used by naturopaths, including by myself as a student, to lobby for access to the same loans, scholarships, and residencies as MDs and DOs. I have seen recent lobbying material reproduce this description.
The Carnegie Institute, now called The Carnegie Classification of Institutions of Higher Education, is a group that categorizes schools and programs by the conferral of various post-secondary degrees. According to its website, the Carnegie Classification considers “degrees [to be] reliable artifacts of instructional activity” and works to categorize degrees for comparative purposes. If the AANP states that the Carnegie Classification of a naturopathic doctoral degree is in the same category as an MD or DO, one may very well believe that an ND degree is earned by learning a standard medical curriculum.
However, the ND degree is not classified as a first-professional degree by Carnegie Classification. Instead, it is classified as coming from a “special focus institution.” Institutions that also are classified as such include acupuncture schools, traditional Chinese medicine schools, theology programs, midwifery programs, and ITT Technical Institute.
First-professional degrees are considered comprehensive doctoral and professional programs that offer doctorates in the fields of humanities, social sciences, and Science, Technology, Engineering and Mathematics (STEM) fields, plus graduate degrees in professional fields such as business, engineering, law, and medicine. A doctoral degree in naturopathic medicine is not one of the first-professional degree categories classified by the Carnegie group.
As far as I can tell, the AANP has been lying to lawmakers about this supposed credential by the Carnegie Classification.
The AANMC is also complicit in putting out misinformation about naturopathic medicine. One of the most widely-disseminated bits of its propaganda is a chart showing a comparison [PDF] between the coursework hours of an MD student and an ND student in an “accredited” program in their first two years of training. One can make the following observations from the chart:
One could conclude from this chart that MD and ND programs have about the same number of coursework hours, and that differences in course categories shown on the chart might be explained by the different foci of the programs: natural medicine versus Western medicine.
Because the naturopathic programs are “accredited,” naturopathic medicine as a whole appears credible. Government accreditation can serve as a useful fact from which arguments against naturopathic medicine can be discredited and arguments in favor can be reinforced.Facts about naturopathic education
In reality, naturopathic education at accredited programs is not rigorous nor science-based. In my first post on SBM, “ND Confession, Part 1: Clinical training inside and out“, I detailed the clinical training I received and showed that naturopathic students are trained in a whole bunch of pseudoscience and very little actual medicine.
The American Academy of Family Physicians (AAFP) nicely summarizes the drastic difference between medical physician training from that of a naturopath’s in this PDF document. In my opinion, the AAFP was being overly generous in their comparison by using numbers that appear to be falsely inflated by the AANP and AANMC. The breakdown of my naturopathic training hours were not available to the AAFP when this document was made. If it had been, naturopathic training would look even more deficient.
The 1,200 clinical training hours in primary care medicine that the AANP, AANMC, and naturopathic programs claim are received by ND students are nothing of the sort. The patients seen are often the worried well, who present with nonspecific and elusive symptoms with no real health consequences. If an ND student didn’t get a chance to train on a patient with a heart condition, for example, he or she could just make a short presentation to their peers and supervisor on said disease.
Using my transcript and student handbook, I calculated that I received less than 600 hours in “direct patient contact”; I was required to observe [PDF] a minimum of 350 patients and be the primary student clinician for only 175 of them! (The Council on Naturopathic Medical Education (CNME) now requires programs to provide at least 450 contacts and 225 of those as primary.)
Pre-clinical coursework at accredited naturopathic programs is also not so rigorous or science-based, though on paper ND credit hours match an MD or DO program. Indeed, naturopathic programs teach classes with the same titles as those in medical schools. Naturopathic classes, including basic sciences courses, are almost entirely taught by other naturopaths or other practitioners of alternative medicine, such as doctors of naprapathy. The pediatrics courses assign reading from anti-vaccine authors, like Bob Sears, and overall the reading load seems quite low for what would be expected from MD and DO students.
The accredited naturopathic curriculum also includes a large amount of pure pseudoscience, with the most glaring examples being three quarters spent on homeopathy, but also many quarters in old-timey hydrotherapy and “naturopathic” manipulation, which is essentially old-school osteopathic manipulation mixed with chiropractic.
I think it is worth noting the incredibly low entrance requirements for naturopathic students at Bastyr University. There is no required minimum GPA and there is no medical or graduate school entrance exam, such as the MCAT which is required for medical schools or the GRE which is required for most graduate programs. I even knew one ND student who never completed his bachelor’s degree!
While naturopathic organizations say what they do about the credibility of naturopathic education and clinical training, students are taking out huge amounts of debt to learn pseudoscience as though it is real medicine. If naturopathic programs were not accredited by the U.S. Department of Education, students would not be eligible for subsidized loans, and the schools would likely not remain financially sound. Without accreditation, the sea of false information would seem a lot more unmistakeable to the general public.What is U.S. Department of Education accreditation?
The United States government has little authority over post-secondary institutions (colleges and universities). Individual states oversee some aspects of the education provided in post-secondary schools, but for the most part, schools maintain a large degree of autonomy. As a result, the quality of education provided at such institutions may vary.
The U.S. Department of Education does not directly accredit schools or programs. Instead, it delegates this task to private accrediting agencies.
Private accrediting agencies are educational associations that oversee the accreditation of institutions or programs. They have adopted criteria they deem appropriate for evaluating whether or not post-secondary institutions and programs can provide a decent education.
After the Secretary’s approval, the private accrediting agency is responsible for setting the standards for the institution or program seeking accreditation.
The CNME is the accrediting agency for naturopathic programs in North America. The CNME functions like the Liaison Committee for Medical Education (LCME), which accredits medical schools in North America. According to its website, the CNME “advocates for high standards in naturopathic education and its grant of accreditation to a program indicates prospective students and the public may have confidence in the educational quality of the program.” The CNME accreditation standards are described in the 2014 edition of the Handbook for Accreditation of Naturopathic Medicine Programs.Accreditation reflects good organization, not good academics
Eligibility for accreditation has more to do with the administration, organization, and operation of an institution or program than education quality. A few requirements do directly impact curricula, but most do not.
The U.S. Department of Education states the purpose of accreditation is to help students and the public by:
In other words, accreditation means prospective students and the public should be able to trust the institution’s description of its academic programs. The accredited agencies, like the CNME, are granted a great deal of responsibility because they are considered to be “reliable authorities as to the quality of education or training” offered by programs they accredit.
Because the U.S. Department of Education gives all of the accreditation standard-setting responsibility to private agencies, the standards that affect the educational curricula can be biased, possibly reflecting only the accrediting agency’s interests. Naturopathic medical programs are accredited by other naturopaths who run the CNME, which means that the curricula they pass meets only their own standards, and not widely-accepted, science-based standards of medical curricula.
Basically, naturopathic education is internally accredited.Accredited conflict of interest?
The CNME was founded in 1978 by a naturopath Joseph Pizzorno. Pizzorno also founded Bastyr University in the same year and then served as the university’s president for the next 22 years. (He is also the co-author of the Textbook of Natural Medicine, which is widely used in accredited programs.)
Bastyr University’s founders were determined that their naturopathic program would be accredited. To achieve this goal, Pizzorno helped write the CNME standards for naturopathic programs [PDF] that would eventually be used to accredit Bastyr’s naturopathic program in 1987. (It is not clear from my research what the CNME was up to between 1978 and 1987.)
It seems to me, the CNME was formed purely out of aspirations for program accreditation and all that comes with that label, and not to ensure a high-quality medical education for naturopathic students.
Had accreditation been about guaranteeing a quality medical education, there was already an approved accrediting agency capable of assessing Bastyr’s medical program: the Liaison Committee for Medical Education (LCME, formed in 1942). But since Bastyr’s accrediting agency was formed by Pizzorno and the other founders in order to establish the standards for its own accreditation and its own brand of pseudomedicine, one can believe that Bastyr’s founders may have had something to hide from the LCME or other external scrutiny.
I find the CNME’s history rife with conflicts of interests. To be fair, the board of the CNME is currently composed of 11 members of which three are public members who are not naturopaths. However, when I looked into these public members, I found it fascinating that they all worked as administrators at chiropractic schools; two of them served on the Chiropractic Council of Education (CCE), the accrediting agency for chiropractic programs; one of them worked as an administrator for the University of Bridgeport, an accredited naturopathic program:
Why is it that the CNME has chosen only public members who had high-level administration positions at chiropractic institutions? Even though there are non-naturopathic, public members on the CNME board, these folks are currently or have been affiliated with yet another pseudoscientific, alternative medicine profession. This means that the entire CNME board comprises people who have vested interests in pseudoscience. Would the CNME board function differently if it had three non-woo woo medical doctors? I think, yes, but that scenario may very well be impossible.
The CNME has already run into trouble with the U.S. Department of Education. In January 2001, the CNME’s accreditation status was revoked due to a failure to respond appropriately to violations of standards at the Southwest College of Natural Medicine in Arizona. The CNME was not allowed to appeal the decision, but could reapply. In 2003, the CNME was once again approved by the Secretary as an accreditation agency for naturopathic medicine programs. In 2011, CNME was re-approved by the Secretary for the maximum term of five years. At the end of 2015, the CNME is coming up once again for review.Naturopathic medicine is the fox guarding the hen house
Naturopathic program accreditation is a self-serving process that seems to be hiding something. As Jann Bellamy describes, this system results in the naturopathic curricula existing in a self-contained loop, divorced from mainstream medical standards. Naturopaths teach other naturopaths and unilaterally control the content of the program. There is no outside evaluation of course content taught at these schools, other than by its own accrediting agency. Although the CNME deems their accreditation review of the schools as external, they make a point to mention in the handbook [PDF] that:
The Council limits access to the evaluation team report to team members, Council members, the Council’s executive direction, and the chief administrative officer of the naturopathic medicine program, who is encouraged to distribute the report among the program’s community as the program considers appropriate.
Indeed, Bastyr’s webpage on accreditation provides PDFs of their regional accreditation self-study reports, but does not provide the reports prepared for CNME’s accreditation.
The sole purpose of the CNME, it seems to me, is to keep naturopathic schools accredited, rather than ensure a quality education for students who are under the impression that they are in a medical program to become real primary care physicians.What’s to gain by becoming accredited?
Accreditation by an approved agency entitles the institution to establish eligibility to participate in Title IV programs. Programs authorized under Title IV of the Higher Education Act allow students in those programs to utilize federal aid services, such as loans, grants, and federal work study programs to pay for school. This is very important for institutions offering expensive degrees.
All accredited institutions and programs are entitled to Title IV programs, unless it is specifically noted otherwise. The CNME accreditation has such a note, stating:
Title IV Note: Accreditation by this agency does not enable the entities it accredits to establish eligibility to participate in Title IV programs.
Despite this note, naturopathic students at accredited schools are allowed to borrow absurdly large sums of money with unsubsidized student loans, Perkins loans, graduate PLUS, and private loans. I am still researching how this works, but I believe this is a more recent option for ND students.
According to the AANMC website:
ND students may qualify for up to $40,500 per three-term award period. The ND aggregate is $224,000.
It has been my understanding that these figures are based on what medical students typically need to borrow to attend medical school. The Yale School of Medicine website page on financial aid confirms how much its medical students can borrow:
Depending on your need…medical students may borrow $40,500 [per year].
The total amount Federal Direct Loan you may borrow as a graduate or professional student is $138,500 (medical students may borrow up to $189,125).
Although Bastyr calls itself an internationally-recognized school with a world-leading reputation in natural medicine and research, Bastyr is not Yale nor Harvard. It has no business charging students this much tuition for an education that consists of homeopathy, chiropractic techniques, botany, Chinese and Ayurvedic medicine, counseling, nutrition, and then a little medicine. Most of these other modalities, as NDs like to call them, are not shown to be efficacious and many can be harmful.
But even with high tuition fees, there is no way Bastyr can afford to provide a “standard medical curriculum” to its students. Using data from 2009, Jann Bellamy determined the following financial conundrum:
It takes between $75 and $150 million dollars to start a medical school. Average annual instructional costs per U.S. medical student is $73,544.41 (2009 cost). According to Bastyr’s website, it has 1,108 students currently enrolled in 22 degree-granting programs, including Ayurvedic (ancient Hindu medicine), acupuncture and oriental medicine. There are 462 students currently enrolled in Bastyr’s N.D. program. If these were medical students, the total annual instructional cost should be just under $33 million. Yet Bastyr’s total expenditures for educating over 1,000 students enrolled in 22 degree programs are just under $30 million per year.
Providing a rigorous, standard medical curriculum to students at Bastyr is not financially feasible, and it is clearly not happening. Students, like me, have been taking out hundreds of thousands of dollars in student loans to pay for an education that is masquerading as a credible medical degree. The public should be aware that this situation is not sustainable, and at some point, the cat will be let out of the bag.The naturopathic profession needs to choose an identity
In my opinion, naturopathic schools and professional organizations are misleading the public, students, and politicians. They are capitalizing on misconceptions about accreditation status and using this term to suggest similarity to real medical programs. Accreditation through the auspices of the U.S. Department of Education enables naturopathic programs to stretch the truth on how they represent their medical curricula. On the one hand, the naturopathic profession claims they are a distinct form of primary care medicine, which can reduce costs and make us all healthier. On the other hand, it claims that naturopathic medicine is on-par with the standard medical curriculum and that NDs are trained just like medical doctors. Who are naturopathic doctors from accredited programs trying to be?
Rhetoric coming from the naturopathic profession is sticking. Naturopaths have been able to steadily gain licensure in the United States and Canada. In many states where they are already licensed, naturopaths are expanding their scopes of practice to include prescribing drugs and performing minor surgeries. Even mainstream medical and media sources online reproduce false information about naturopathic medicine:
a licensed naturopathic doctor (ND) attends a 4-year, graduate-level naturopathic medical school. He or she studies the same basic sciences as a medical doctor (MD).
Naturopathic practitioners have a Doctor of Naturopathic Medicine (ND) degree from a four-year graduate medical college with admission requirements comparable to conventional medical schools. The ND degree requires graduate-level study in conventional medical sciences, such as cardiology, biochemistry, gynecology, immunology, pathology, pharmacology, pediatrics, and neurology.
Applicants to accredited naturopathic medical colleges need a bachelor’s degree and a competitive GPA in scientific prerequisites, just like applicants to “conventional” medical schools.
The Department of Education classifies the Naturopathic Doctor degree (ND) from CNME schools as a Doctor’s degree – Professional practice, along with MD and DO degrees.
These statements are just not true.
(Also, why does the AMSA have an ND advisory board? I know from my experience with outreach at Bastyr, that naturopathic students thought if they could get in with medical students who tend to be more open minded about CAM than practicing physicians, we would establish relations that would foster into stronger professional ties. I hope leaders at the AMSA read more about naturopathic medicine and reevaluate their openness to NDs.)
If naturopathic schools aim to convince politicians and the public that their medical programs are as good as standard medical schools, then naturopathic schools need to achieve accreditation from the Liaison Committee on Medical Education or invite external review from a special task force composed of real medical doctors and scientists. Nothing short of these options will convince me that Bastyr’s naturopathic program is on to some cutting-edge fusion of science and traditional medical wisdom.
One thing’s for sure. Naturopathy can’t be both real medicine and naturopathic medicine. Naturopaths need to stop confusing the public with misrepresentations and lies about naturopathic doctoral degrees and unanimously decide exactly who they are—medical doctors (MD) or not doctors (ND).
Britt Marie Hermes is a naturopathy apostate: she practiced as a licensed naturopathic doctor in the United States for about three years, but then left the profession to pursue a science-based career. She is now a Master’s of Science student in Medical Life Sciences at the University of Kiel. Her research interests include inflammatory and genetic diseases, like psoriasis and Crohn’s. She lives in Kiel, Germany, with her husband, who is a doctoral candidate in archaeology, and their two dogs. She recently started the blog Naturopathic Diaries: Confessions of a Former Naturopath.
The great philosopher Deepak Chopra wrote: “I do not believe in meaningless coincidences. I believe every coincidence is a message, a clue about a particular facet of our lives that requires our attention.” So when SBM author extraordinaire Jann Bellamy emailed me last week with an article about so-called “Functional Dentistry” with the comment “Blog fodder?”, I looked it over with interest and then promptly filed it away in my brain along with other things that I might get around to doing but probably won’t. The very next day, Dr. Clay Jones – also an SBM bloggist extraordinaire – asked me if I’d mind pinch-hitting and write a blog post for his upcoming Friday morning time slot while he was away on vacation.
Personally, I find it more plausible that Jann and Clay secretly conspired to have me write this article in order to lure me into a rage spiral, than the notion that The Universe was sending me a message about a particular facet of my life that required my attention. But we are at Point B now, are we not? Regardless of whether the first domino was pushed by The Universe or by Jann and Clay, I suppose it is now incumbent upon me to share with the SBM readership yet another way where pseudo-scientific practices and deceptive branding and marketing tactics have trickled down from medicine into dentistry.
In this blog post, I will review what Functional Medicine (FM) is, what is wrong about it and what is right about it (yes, there are aspects of FM that are legitimate, if not admirable), and how it has infiltrated (some say contaminated) the field of dentistry. I think you’ll find that, when you pull back the curtains, the reality of FM as a “new and improved” medical/dental paradigm is vastly embellished and overstated, and the Great and Powerful Functional Medicine Oz is really just an old geezer pulling the levers of spin and hyperbole and pushing the buttons of pseudo-science.What is Functional Medicine?
Functional Medicine, according to the Institute for Functional Medicine’s website:
addresses the underlying causes of disease, using a systems-oriented approach and engaging both patient and practitioner in a therapeutic partnership. It is an evolution in the practice of medicine that better addresses the healthcare needs of the 21st century. By shifting the traditional disease-centered focus of medical practice to a more patient-centered approach, functional medicine addresses the whole person, not just an isolated set of symptoms. Functional medicine practitioners spend time with their patients, listening to their histories and looking at the interactions among genetic, environmental, and lifestyle factors that can influence long-term health and complex, chronic disease.
Functional Medicine has been covered thoroughly in SBM by the late Wally Sampson, and the not yet late David Gorski and Steve Novella, among others; consequently, I need not delve too deeply into it here. However, a cursory unpacking of the above definition reveals a recurring logical fallacy, namely the Unstated Major Premise or Unstated Assumption. When it is claimed that FM “…addresses the underlying causes of disease,” or “Functional medicine practitioners spend time with their patients, listening to their histories and looking at the interactions among genetic, environmental, and lifestyle factors that can influence long-term health and complex, chronic disease,” the unstated premise is that “regular” doctors don’t do any of these things; they must be only symptom-oriented, not preventive in their outlook, and don’t take all of a patient’s personal, medical, and social factors into consideration before arriving at an invidualized course of action. This, of course, is false, and is what any good physician will do. I know mine does, and he does not identify as a Functional Medicine physician. This dubious technique is employed by most if not all CAM providers in an attempt to set themselves apart from the crowd.Where does FM get it right?
Where FM gets it right is that, from all appearances, FM physicians as a whole tend to leave more appointment time for the history and physical exams, and claim to do a more thorough genetic, environmental, and lifestyle evaluation of their patients than a typical primary care physician. Functional Medicine practitioners emphasize healthy lifestyles, good nutrition, exercise, good sleep habits, smoking cessation, and so on, in addition to the normal comprehensive physical examination and lab tests, which is a good thing. This, of course, typically comes at a cost, as FM patients often (but not always) have higher out of pocket co-payments due to some tests and fees not being covered by medical insurance. However, patients state that they feel they are heard by their FM health care team, and the chances of some illness or condition being overlooked potentially could be reduced with the extra time spent and tests performed (although this hasn’t been demonstrated). Patients don’t want to wait hours in their “regular” doctor’s reception room, only to feel as though they are herded like cattle into cold examination rooms, then to wait another eternity until their nurse or physician gives them the proverbial seven minutes of their time before scribbling out a prescription that treats a symptom only. And while I hope you see through my above Straw Man scenario, you can see where the perception of individualized, caring medicine would be appealing to a significant percentage of the population, particularly those who are proactive and preventive in their health care decisions, those who may have a mistrust of “mainstream” medicine, and the worried well.
They are also right when they point out that the incidences of chronic diseases (such as cancer, heart disease, diabetes) have risen and that the health care costs associated with these diseases are burdening health care systems in many nations. Further, many if not most of these chronic disease are lifestyle related (smoking, poor sleep hygiene, sedentary habits, poor diet, etc.) and are thus preventable. Again, this is just good medical practice, and not a recent innovation of Functional Doctors.
Another area where FM is winning in the marketplace of perception and image is that they have branded themselves as progressive, a new paradigm in medicine. They throw around such enticing buzz- words and phrases as “powerful new operating system”, “empowerment”, “biochemical individuality”, “high touch/high tech”, et. al. while demonizing “conventional” medicine by describing it as “doctor centered”, “disease oriented”, “expensive”, and an “acute care model.” This message is indeed powerful, and has resulted in the integration (pardon the pun) of FM into such esteemed institutions as The Cleveland Clinic and George Washington University, and others. Even in my neck of the woods, The University of Kansas Medical Center has an Integrative Medicine department, where they boast of such quackery as vitamin C infusions and neurofeedback, the latter of which promises to “rebalance your brain.” Yes, those exact words are on the official University of Kansas Medical Center website. Sigh. Well, at least my alma mater still has the best college basketball program in the world.What is wrong with Functional Medicine?
What is wrong with Functional Medicine is that it often promotes many CAM practices which have been shown to be of questionable therapeutic value, or outright ineffective. Reiki, acupuncture, chiropractic adjustments, “detoxification” programs, the aforementioned vitamin C infusions (unless you’re a bescurvied 18th century sailor fresh off the boat), and many other CAM modalities are offered as “holistic patient centered” options (again, at a significant cost and not without risk). Individualized care based on biochemical and genetic markers have some merit in some situations, and I’ve no doubt that this will become more prevalent in the future as techniques improve and applications are demonstrated scientifically. For now, however, it is an idea whose time has not yet come on a broad scale, and it is disingenuous to state or imply otherwise.
The other area where FM is a bit misleading is in how they frame their message. As stated earlier, the concepts of treating the cause of disease instead of just the symptoms is the foundational basis of all health care. I’m sure that Mark Crislip, an infectious disease doc, actually tries to kill the bugs that cause his patients’ diseases; he doesn’t just treat the symptoms. Often, however, treating the cause isn’t possible. For example, with many auto-immune diseases, there is no cure for the underlying pathophysiology, therefore managing the patient symptomatically is the best modern medicine can do at the present time. Using deceptive rhetoric and logical fallacies to their advantage, they frame FM as cutting edge and (ironically) science based, while portraying the mainstream medical community as closed minded, archaic, and behind the times.Functional Dentistry – Coming to a theatre near you
Not wanting to feel left out, some dentists who have for years called themselves “biologic” or “holistic” dentists decided that a cool new word would really help separate themselves from the “ordinary” dentists who recommend such poisons as fluoride and amalgam fillings. Originally, “alternative” was the word of choice, but over time it grew stale and was subsequently replaced by “complementary”, a kinder and gentler term that implied a sort of truce between science based medicine/dentistry and non-traditional practices. After a while, the term “integrative” became fashionable, as complementary and alternative medicine attempted to insert itself into mainstream medicine. Thanks to promoters like Mehmet Oz, Andrew Weil, Deepak Chopra, and Joltin’ Joe Mercola, integrate it did. Not only into university-based medical centers, as mentioned above, but into private medical and dental practices worldwide. Within the past couple of years, some dentists have seized upon the “Functional” moniker and have co-opted it for their own use. Mind you, for these dentists, there has been no change in philosophy or standard of care from when they were only bioholisticompleternative dentists, it is a marketing/branding term only, which they presumably hope will help their websites’ Search Engine Optimization.
To date there are no “official” Functional Dentistry organizations, although I wouldn’t be surprised if one was founded in the near future. However, many individual dentists’ websites blatantly ride FM’s coattails. One dentist’s website states:
Functional Medicine Based Dentistry is the application of the principles and practices of Functional Medicine with the practice of the art and science of Dentistry. Philosophical differences exist today between traditional Evidence-Based Dentistry and Biological Dentistry, which have an impact on all patients and their oral and systemic health. Functional Medicine believes that a patient’s history, physiology, and lifestyle are fundamental factors when evaluating a patient’s health. Examination and interpretation of a patient’s individual biochemistry and genetics can give clues and hence better understanding of a patient’s chronic disease.
When we apply these concepts in the course of dental examination, diagnosis and treatment, the “one size fits all” philosophy of standard American dentistry becomes outdated and dentists transform from “molar mechanics” to true “physicians of the mouth.”
(emphases in the original)
Just like in Functional Medicine, statements like the above are disingenuous and fairly drip with the Unstated Assumption fallacy. As a non-Functional dentist, I can honestly say that I too believe that a patient’s history, physiology, and lifestyle are fundamental factors when evaluating their oral health. In fact, I know of no dentist who believes otherwise. Further, “examination and interpretation of a patient’s individual biochemistry” is a bit vague; while there are some useful genetic and salivary tests (when indicated) that are available in dentistry, they shouldn’t necessarily be utilized routinely and indiscriminately as screening tools until the evidence justifies it. And last, there is no such thing as a “one size fits all” approach to dentistry. Every person, every mouth, every situation is unique, and every prudent dentist takes all of these factors into consideration when determining a course of action for a patient, involving them in their treatment decisions. This is in our code of ethics and is not the domain of any one particular brand of dentistry.Conclusion: Choose substance over marketing
All that said, most “alternative” or “functional” dentists are very conscientious dentists who sincerely want the best for their patients. If your dentist claims to be “holistic” or “functional” or “biologic”, you may want to put your antennae up if you are a science-based consumer of health care, but don’t throw the baby out with the bath water and summarily reject him/her. He or she may be a fantastic, science based dentist who is merely adapting the cloak of Functional Medicine Based Dentistry because they believe they are indeed “whole person” centered, want to appear to be cutting edge and progressive, and to gain a marketing advantage on their competition. There’s nothing wrong with that per se. To that end however, never hesitate to ask for good evidence if your dentist recommends something that seems “non-traditional.” The Center for Evidence Based Dentistry is a great resource for patients and health care providers alike. By being aware of what labels are being employed by physicians and dentists, what these labels mean, and why they are being used will help health care consumers make sound, science based decisions for themselves and their loved ones.
A French court recently awarded a disability allowance ($912 per month for three years) to Marine Richard based upon her claim that she has EHS (electromagnetic hypersensitivity). This is a concerning development because EHS is likely not a real disease. The situation, however, is a bit more nuanced than it may at first appear.
EHS and Non-Specific Symptoms
First for some background on EHS (or Idiopathic Environmental Intolerance attributed to electromagnetic fields, IEI-EMF, as it is now called in the scientific literature) - sufferers claim that they are sensitive to electromagnetic fields and that these fields cause symptoms such as headaches, dizziness, nausea, fatigue, tingling sensation, or palpitations. In one case series of EHS specifically subjects reported:
The most frequently reported symptoms from exposure to smart meters were (1) insomnia, (2) headaches, (3) tinnitus, (4) fatigue, (5) cognitive disturbances, (6) dysesthesias (abnormal sensation), and (7) dizziness. The effects of these symptoms on people’s lives were significant.
This list of symptoms may seem familiar to anyone with a medical background. They are all considered to be common, subjective, and non-specific symptoms. Sometimes we refer to such symptoms as the “symptoms of life,” because most people will have them at some point, even if they are completely healthy.
Vague and/or nonspecific symptoms such as these are often a challenge for both patients and medical professionals. Because they are non-specific they don’t point to any one disease or even one category of disease. They can be caused by a long list of actual diseases. They can also be lifestyle symptoms, associated with things like poor sleep, being overweight or inactive, or overusing caffeine.
They can also be a manifestation of an underlying mood disorder, such as anxiety or depression. Sometimes a mood disorder might exaggerate baseline symptoms of life, or cause what is called hypervigilance – paying attention to every little daily symptom. These everyday symptoms then provoke further anxiety and depression, resulting in a vicious cycle.
The challenge for the healthcare professional is to ferret out any significant underlying medical condition. Because the symptoms are non-specific this can involve a fairly thorough medical workup. At some point, though, it is reasonable to conclude that any serious underlying condition has been ruled out. Then the challenge becomes shifting focus to addressing the symptoms and improving the quality of life, rather than continuing on an endless hunt for an elusive diagnosis that may not exist.
This is all challenging enough, but in addition there are an increasing number of “alternative” practitioners whose livelihood consists mainly of throwing a monkey wrench into this whole process. They are like sirens luring vulnerable patients who are struggling to deal with non-specific symptoms toward the rocky shores of the fake diagnosis.
Imagine if after a thorough workup your physician is trying to convince you that any serious disease has been ruled out and perhaps we need to focus on your sleep and your anxiety, then a naturopath or fringe doctor tells you that they have magically diagnosed your problem as being something very specific and treatable (what you have been looking for the whole time). The allure of that fake diagnosis would be great.
Often patients in this situation are diagnosed with chronic Lyme disease, something called “Wilson’s syndrome,” low thyroid, candida hypersensitivity, multiple chemical sensitivity, food allergies, non-celiac gluten sensitivity, or electromagnetic hypersensitivity.
Whatever is going on with patients who claim to suffer from EHS we can say with a high degree of scientific confidence that it is not being caused by electromagnetic fields. A 2010 systematic review of provocative studies found:
An extensive literature search identified 15 new experiments. Including studies reported in our earlier review, 46 blind or double-blind provocation studies in all, involving 1175 IEI-EMF volunteers, have tested whether exposure to electromagnetic fields is responsible for triggering symptoms in IEI-EMF. No robust evidence could be found to support this theory. However, the studies included in the review did support the role of the nocebo effect in triggering acute symptoms in IEI-EMF sufferers. Despite the conviction of IEI-EMF sufferers that their symptoms are triggered by exposure to electromagnetic fields, repeated experiments have been unable to replicate this phenomenon under controlled conditions.
This is a consistent and robust result. People who self-identify as having EHS cannot actually tell when they are exposed to an EMF – the electromagnetic field itself is not causing the symptoms.
The French Court Decision
Does all this mean that the judge who ruled to give Marine Richard a disability allowance based upon her EHS diagnosis was wrong? Perhaps, but there is a nuance here I would like to explore.
According to reports, the court “stopped short of recognising EHS as an illness.” What I think this means is that the court recognized that Richard is disabled by her symptoms, and that is sufficient to treat her as disabled, even while it remains agnostic toward the cause of her symptoms.
This is actually not unreasonable and is common practice. Courts are not the place to sort out complex medical science. The challenge that courts face is that they are often tasked to dispense justice in the absence of a clear scientific answer or in the face on an ongoing controversy.
Often courts will err on the side of perceived victims or those in need, while not explicitly endorsing their claims. The vaccine court in the US operates this way. They grant compensation to families of children who may have had a vaccine side effect. They give a wide benefit of the doubt to the families, and essentially grant compensation even with the acknowledged lack of a scientific conclusion that vaccines can cause the alleged injury.
In other words, if you happen to have a seizure following a vaccine, the court is not going to spend its time trying to sort out whether or not the vaccine actually caused the seizure. They will just grant you compensation.
The downside of this policy is that people will often interpret the court’s action as if it is endorsing the causative claim, even when it explicitly is not.
A more troubling situation I won’t get into extensively here is when the issue is not one of public compensation but one of liability. For example, when companies are sued because their product allegedly caused an illness, even before the science is in. Here I do not think that courts are justified in simply erring on the side of the alleged victim, even though they will often do that.
There are many examples of this, including the alleged association of silicone implants and autoimmune disease. While the data was still preliminary courts awarded a multi-billion dollar class action settlement against Dow Corning, forcing them into bankruptcy protection for nine years and the removal of silicone breast implants from the market. However, when the science was finally in, it turns out there is no increased risk of autoimmune disease from silicone implants.
In the end it is important to have the science right so that we can best approach difficult situations such as those who feel their life is being destroyed by EHS. It is extremely helpful to know scientifically that electromagnetic fields are not causing their symptoms.
This, however, does not mean that they are not sick or at least have a disorder. It’s just probably not what they think it is. In some cases it is possible that patients who become convinced they have EHS have another identifiable illness, which is being missed because they are pursuing a false diagnosis.
In many cases, however, the cause(s) may be as vague as the symptoms. There may be a number of lifestyle and mood factors contributing to the symptoms in a self-reinforcing manner. We don’t really have a good non-judgmental name for this situation, which is unfortunate. We need a label that describes the syndrome without implying a cause, especially one that is probably not true.
In any case, it is important to recognize that these non-specific symptoms, when severe, can be debilitating. As physicians we take this approach all the time, and then try to address the debility. I have no problems with courts taking the same approach, if that is how their laws are construed.
It is important to recognize, however, that concluding that “compensation is appropriate” (often the wording used by the vaccine court) is not the same as endorsing an alleged cause.
Unfortunately, however, that is how it is often taken, especially by proponents.
“Why do you bother blogging?” asked a colleague. “You take hours of your personal time to write, and you do it for free. You’re not even getting any citations for all that work.” I admit I found the questions a bit surprising. True, you won’t find SBM posts abstracted in PubMed. But I’m writing for an entirely different audience. I blog for the same reason that I became a pharmacist: To help people use medicines more effectively. Practicing as a pharmacist is one way to do that. In that setting, you’re helping one patient at a time. And seeing how your advice and support can enhance someone’s care is tremendously gratifying. I see blogging as another form of pharmacy practice, hopefully with similar effects. Yes I do get regular hate mail, and the occasional legal threat, but there’s also gratitude for a post that resonated with someone, or helped them make better decisions about their health. When Google searches don’t give answers, I get questions – too many to answer. Today’s post is based on a request for help from someone seeking advice on natural supplements to treat ringing in their ears. They have tinnitus, and they’re frustrated at the limits of what their physician (and medicine) can do. They sent me an advertisement for a supplement called Ear Tone, a natural health product which is advertised (and approved) to provide tinnitus relief. Can natural supplements do what conventional medicine cannot?When buying supplements, the deck is stacked against consumers
One of my recurring (and favourite) blog topics is evaluating the evidence supporting dietary supplements. Not only is it an opportunity to look at a specific medical condition, it’s a tool to illustrate how to use a science-based approach to answer medical questions. Supplements are also the perfect subject to illustrate the consequences of weak, ineffective health regulation, and how this approach harms consumers. Nowhere else in medicine is there an area that’s in such need of consumer advocacy and patient protection. While regulations will differ between countries, supplements tend to get a “pass” by most governments. This pass (which is usually in the form of special regulations), usually excludes supplements from the licensing requirements (and evidence standards) that applies to conventional drug products. It will vary somewhat depending on what country you live in, but in countries like the USA and Canada, this is what you’ll find:
The result is a marketplace that is a boon to supplement makers, but put consumers at a considerable disadvantage. What is worse, many health professionals also give supplements a pass, failing to hold them to the same evidence standards as drug products. Pharmacy shelves are becoming the “Wild West” of healthcare, where evidence-supported products are sold alongside those that are either unproven, or even worse, completely ineffective (e.g., homeopathy).Supplement manufacturers exploit difficult-to-treat conditions, like tinnitus
When medicine can’t deliver an obvious cure, or where a medical condition is poorly understood, you create the breeding ground for alternative medicine remedies. Steven Novella described their characteristics in a past post:
Tinnitus is one of those conditions.Tinnitus is not just a ringing in the ears
Tinnitus is the perception of noise when there is no external cause. While it’s typically thought of as ringing, it can also be perceived as buzzing or hissing. Tinnitus is common, affecting up to 15% of individuals, depending on your age. While rarely serious, tinnitus can significantly interfere with quality of life. Tinnitus can be caused by age, loud noise (from construction equipment to loud music), ear wax blockage, and ear bone changes. (Sixties rock icon Pete Townsend is a famous tinnitus sufferer, which he attributes to years of listening to headphones.) Many medications are associated with tinnitus, as can other medical conditions, such as cardiovascular disease. Consequently, every tinnitus case needs to be medically evaluated, to search for any underlying causes and to rule out more serious medical conditions. In some cases a clear cause for tinnitus cannot be found, and it becomes a chronic condition. Reducing the impact and effects becomes the treatment goal.
The management of tinnitus focuses first on any underlying causes or conditions. While there is no cure, there are medical treatments that can be effective, including:
Overall, these therapies are only modestly effective. There is no magic bullet. While numerous vitamins, minerals and supplements have also been tested, there are no studies that suggest that any supplement provides a meaningful improvement.What is Ear Tone?
Ear Tone is a combination herbal remedy that’s advertised widely and sold in many pharmacies for the treatment of tinnitus. It’s manufactured by New Nordic, a Swedish supplement manufacturer that has been criticized in the past for making misleading claims about its product. The manufacturer makes the following claim:
Ear Tone is a new product that is based on new research, showing significant results in treating tinnitus naturally. Ear Tone works by supplying the ear with the right nutrients while promoting peripheral blood circulation.
According to the manufacturer’s website, each Ear Tone tablet contains:
The recommended dose is two tablets per day, which gives a monthly cost of about $30.
The first ingredient, ginkgo, has a long history of use as a natural medicine, but there’s no clear evidence that ginkgo is effective for any medical condition. Presumably included here to enhance blood circulation in the area, studies have shown mixed results for the treatment of vascular disease and while it has been studied specifically for tinnitus, results have been mixed. Overall, there’s no convincing evidence it actually has any meaningful benefit with tinnitus. A Cochrane review concluded the same, noting:
The limited evidence does not demonstrate that Ginkgo biloba is effective for tinnitus when this is the primary complaint.
The second ingredient is magnesium, supplied as magnesium oxide, and according to the manufacturer is included because it “protects the nerves in the inner ear and promotes an electrolyte balance in its hair cells.” While magnesium is an abundant ion in the body, there is no published evidence with magnesium supplements to suggest it protects nerves or promotes electrolyte balance in hair cells. I found a single open-label study of magnesium supplementation and tinnitus published in 2011 that suggested a modest beneficial effect. Given it was neither randomized nor blinded, it’s hard to see this as evidence as efficacy.
The third ingredient is literally the bark from a pine tree, in this case, the Maritime pine. There’s one study with a branded version of pine bark (“Pycnogenol”) that was evaluated in a pilot study for effectiveness against tinnitus. Over four weeks, patients on the supplement were noted to experience an improvement in symptoms as well as cochlear blood flow. It’s not clear if the study was blinded or randomized, however, and the authors note:
More studies should be planned to better evaluate the pathology and potential applications of Pycnogenol in a larger number of patients who are currently without a real therapeutic solution.
There’s also a 2014 study with Pycnogenol which was a registry – a real-world evaluation that observed its alleged benefit in Meniere’s disease and tinnitus. This was nonrandomized, uncontrolled data so it’s difficult to see this as convincing. Before we can conclude this product offers actual benefits, it needs to be evaluated in prospective, blinded and controlled trials.
So there’s little evidence Ear Tone works. What about risks? There are few case reports of serious harms with ginkgo or with pine bark, but that’s complicated by poor data collection – since there are few trials and only limited real-world surveillance, the long-term safety is unclear. There is the risk that this combination of products could magnify or interfere with the action of drugs that affect blood coagulation. Its possible effects on other drugs is not well understood.
I don’t see enough evidence of effectiveness here to recommend Ear Tone, but ultimately this is a personal decision. Given what we know (and don’t know) about the efficacy and safety, some may decide it’s worth a try, especially if they’re experiencing poor quality of life from tinnitus. If that was my patient’s choice, I’d want to ensure that their other medications had been reviewed for any possible interactions. I’d also encourage any user to try to objectively measure whether or not they experience any relief. From reports online, many have not found it helpful.Is Ear Tone safe and effective?
Despite the limited evidence suggesting that Ear Tone has any beneficial effects, Health Canada has approved Ear Tone with the following wording:
Recommended Use or Purpose:
Helps to reduce the perception of tinnitus in the ears. Helps to support peripheral circulation.
Health Canada has concluded the product is effective despite the fact that there is no published evidence suggesting this particular combination of ingredients has even been formally tested. This is the double-standard for supplements at work – approval from the regulator without the requirement to actually test your product for safety or effectiveness.What’s the bottom line for consumers with tinnitus?
Tinnitus is an often-chronic condition for which we lack a good understanding of the causes and treatments. While there are some therapies that can help minimize symptoms, there are no cures.
Despite the hype, the anecdotes, and the marketing, there are no supplements for tinnitus that have been shown to offer any meaningful benefit. It would be wonderful if there really were a magic herb (or combination of herbs and minerals, like Ear Tone) that you could grind up, put in capsules or tablets, and expect relief. But that’s not realistic. This doesn’t stop manufacturers from making claims, or regulators like Health Canada from agreeing, that products like Ear Tone as “effective” because of a lowered evidence bar for natural health products.
Learning there are no easy solutions or cures for tinnitus can be difficult to accept, especially when tinnitus significantly impairs your quality of life. Supplement marketers know this all too well, and will likely continue to market unproven supplements for tinnitus that lack good evidence of efficacy.
The FDA (Food and Drug Administration) recently asked for public comment on its regulatory policies regarding homeopathy. They probably didn’t figure that a fellow federal agency, the FTC (Federal Trade Commission) would respond.
The FTC also recently asked for public comment on how it can better regulate homeopathic product advertising. While the FDA regulates food and drugs (including supplements), the FTC regulates claims that sellers can make about those foods and drugs. The FTC is now complaining to the FDA that their policies are in inherent conflict. They write:
The staff comment notes that the FDA’s regulatory framework for homeopathic drugs, set forth in a 1988 Compliance Policy Guide, does not require that over-the-counter (OTC) homeopathic drugs be approved by FDA as safe and effective if they satisfy certain conditions, including that the product’s label contains an indication for use. Yet the policy guide does not require sellers to have competent and reliable scientific evidence to support the indication for use.
The comment states that given the FTC’s long-standing advertising substantiation policy that health claims must be substantiated by such evidence the FDA’s current regulatory framework may harm consumers and confuse advertisers.
The FTC requires scientific evidence to support health claims for products, while the FDA does not require scientific evidence to support health claims made for homeopathic products.
The FTC cites complaints they have received by consumers who were under the false impression that “homeopathic” simply meant “natural” or that the product was an herbal supplement. Those consumers were surprised to find that homeopathic products are complete frauds that are literally nothing but sugar pills.
For anyone not aware, homeopathy is a 200 year old system of medicine that predates scientific understanding of things like biology, health, and disease. It is founded on two main principles. The first is “like cures like” – which is a belief in essence or sympathetic magic and not based on any scientific principles. The notion is that a substance that causes a symptom will cure that symptom in extremely low (even non-existent) doses.
The second homeopathic principle is that dilution potentiates a remedy and makes it stronger. Many homeopathic preparations are diluted to such a degree that no original substance is left behind. Homeopaths claims that the substance leaves behind its magical “essence.” Some modern homeopaths have tried to rescue this idea by claiming that the water “remembers” the signature of the substance, but this is implausible pseudoscience without scientific support.
Unsurprisingly, homeopaths have been unable to demonstrate, given 200 years, that any homeopathic preparation is effective in treating any indication. Systematic reviews of modern scientific studies of homeopathy show it is indistinguishable from placebo.
Why, then, does the FDA allow it to be marketed as a medicine at all? That’s a good question. Homeopathy might be considered a “legacy” product, written into FDA regulations by senator Royal Copeland, who was a homeopath.
Interestingly, the law only indicates that the FDA must regulate homeopathic products as if they were drugs. Jann Bellamy, our legal expert at SBM, reviewed the FDA regulations and found that the FDA is required by its own laws to regulate homeopathy. In the words of one federal judge, the FDA has:
largely abdicated any role it might have had in creating standards for homeopathic OTC [over-the-counter] drugs, and has instead attempted to delegate this authority to the non-governmental organization that determines whether homeopathic substances should be included in the HPUS. In addition, the FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs even if they meet the unknown standards for inclusion in the HPUS.
Jann believes that the FDA is violating its own rules and that it is acting outside of the statutory framework established for it by congress. In other words – it does not have the authority to neglect homeopathy regulation the way it has been for the last half century.
Likely, the FDA decided that the homeopathy market was simply too small to allocate resources to properly regulate, so they let the homeopathy industry regulate themselves – really, that is what’s happening. Now the FDA is responding to the exploding homeopathy market and reconsidering this position, which is a good thing.
It is really good to see the FTC get involved, and put pressure on the FDA to do the job that the law requires that they do. The FTC is essentially saying that they cannot properly do their job with respect to homeopathy unless the FDA does their’s.
The FDA recently announced it will reopen its comment period for another 60 days. I urge all consumers to demand that the FDA do its job, and require at least a minimal amount of scientific evidence that any homeopathic product is safe and effective prior to allowing that product onto pharmacy shelves with health claims, sitting beside real medicine.
The comments are currently full of anecdotes supporting homeopathy that completely miss the point, and also from homeopaths defending their turf. The Society for Science Based Medicine has commented, and there are other scientific comments as well. It would be nice to shift the balance a little, and let the FDA know there are consumers who want scientific regulation of health products.
Even more interesting to me than the question of whether or not acupuncture is effective for any particular symptom is the meta-question of how acupuncture proponents have managed to promote a treatment with systematically terrible scientific data. A new study provides a fresh example of this, which I will discuss below.
I think the behavior of acupuncturists reflects the fact that there are subcultures within science, where each community has its own standards, culture, and typical practices. You see this reflected in how they conduct their research and support their claims. Chiropractors, for example, have what is in my opinion a very unscientific culture. Their treatments are not science-based; science is an afterthought cherry-picked to support what is ultimately their philosophy.The culture of acupuncture
The world of acupuncture has its own culture as well. Within this world there are special, very permissive rules of science that allow acupuncture to work for almost anything. One trend is to look for anything that happens locally in the skin when you stick a needle into it and then declare that a “mechanism for acupuncture.” The rules of the acupuncture culture also allow for a shifting definition of what acupuncture actually is, allowing the definition to conform to whatever the evidence shows. It’s a neat and subtle trick that allows acupuncture proponents to completely subvert the purpose of science.
The most common definition of acupuncture given, even in the very studies that then violate that definition, is the practice of sticking acupuncture needles into acupuncture points. The definition may also include eliciting the “de qi,” which is a sensation perceived when the needle achieves the proper depth or is manipulated. The site “evidencebasedacupuncture.org,” for example, gives this definition:
Acupuncture is the method of treatment based on influencing the body by inserting needles in the specific points of human body, called acupoints.
The problem (for acupuncturists) with this definition is that carefully controlled scientific studies consistently show that it does not matter where you stick the needles or even if you insert needles (as opposed to just poking the skin with dull needles, or retracting needles, or even tooth picks). To further support this conclusion, the perceived effectiveness of acupuncture does not depend on the degree of training or experience of the acupuncturist (so whatever they are learning has no effect), but only upon how warm and nice they are to the patient. In short, acupuncture is an elaborate placebo.
One strategy to get around this pesky scientific evidence is to redefine acupuncture as needed. Depending on the results of any particular study, sham acupuncture (at the “wrong” positions) or placebo acupuncture (without needle penetration) may count as acupuncture.
Further, it is common practice now to rebrand transcutaneous electrical nerve stimulation (TENS) as acupuncture. TENS is a treatment that involves, as the name suggests, providing small non-painful current of electricity to modulate pain and other subjective symptoms. TENS is probably effective for pain (I could not find any studies with hot flashes, the topic of the next section).
What the acupuncture community has does is magically transform TENS into acupuncture and call it electroacupuncture, by delivering TENS through needles that they call acupuncture needles (which are just thin needles). Again, acupuncture points do not matter – because they do not exist.Acupuncture for hot flashes
The new study falls squarely into the bait-and-switch strategy that is now very popular among acupuncture proponents. They looked at women breast cancer survivors with hot flashes and compare four groups: “electroacupuncture” (EA), sham acupuncture (SA), gabapentin, and placebo pill (PP). They found:
By week 8, SA produced significantly greater reduction in HFCS [hot flash composite score] than did PP (-2.39; 95% CI, -4.60 to -0.17). Among all treatment groups, the mean reduction in HFCS was greatest in the EA group, followed by SA, GP, and PP (-7.4 v -5.9 v -5.2 v -3.4; P = < .001). The pill groups had more treatment-related adverse events than did the acupuncture groups: GP (39.3%), PP (20.0%), EA (16.7%), and SA (3.1%), with P = .005. By week 24, HFCS reduction was greatest in the EA group, followed by SA, PP, and GP (-8.5 v -6.1 v -4.6 v -2.8; P = .002).
The p-values are for the primary outcome, which was SA vs. PP. I thought that was an odd choice for primary outcome – essentially a competition between two placebos. In the end what this study shows is that sticking needles into someone has a larger placebo effect than taking a pill. This is something we already knew. Overall, the more invasive the procedure the larger the placebo effect. I should also point out that you cannot blind allocation to acupuncture vs pill – subjects know if they are getting stuck or taking a pill.
The comparison between EA and SA was not significant. So yet again, whenever you control for the variables that actually define acupuncture (acupoints and needle insertion) there is no significant effect.
A 2013 systematic review of acupuncture for hot flashes shows essentially the same thing:
We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT (hormone therapy). These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
That conclusion is very common in the acupuncture literature. You could almost cut and paste that in to the conclusion of any systematic review of acupuncture and just replace the name of the condition being treated. There is no difference between acupuncture and sham acupuncture. When comparing acupuncture to no acupuncture there is a difference, because that comparison is unblinded and needle insertion has a known placebo effect. Overall the data quality is poor with high heterogeneity.
Again, what is most interesting is why the authors decided to spend the resources on the current study given the status of the literature.Conclusion: Why indeed?
Medical science progresses by designing and performing more and more rigorous studies, controlling for specific variables, until we can say with a high degree of confidence what the risks and benefits are for a specific intervention in a specific subset of patients. The operative word there is “specific.”
The acupuncture literature does include the occasional well-designed study that follows this trend. The Archives of Internal Medicine acupuncture study in back pain published in 2009 was one such study – excellent control groups isolating specific variables. But then the authors blew it by completely misinterpreting their own data, confusing sham and placebo acupuncture for acupuncture.
More commonly we see a study similar to the current one – not designed to actually answer the question of whether or not there is any specific efficacy to acupuncture. We already have a pile of low quality studies, and now we have one more to throw onto the pile.
It seems almost that these types of studies are designed not to ask if acupuncture works, but to show that it works. The studies seem rigged to be positive – of course there is going to be a difference in an unblinded comparison between needle insertion and taking a pill.
There is a role for preliminary studies in medicine. They tell us where to focus our resources and how to design safer and better trials. They don’t answer the question of whether or not a treatment works.
There are now thousands of acupuncture studies looking at every indication you can imagine (which stretches credulity that there is any common underlying mechanism). We are well past the time for preliminary studies. Despite thousands of studies, there isn’t a single indication for which real acupuncture has been shown to work to a high degree of confidence. At this point I would say that acupuncture should be abandoned as a scientific concept. It is a failed hypothesis that has added no real knowledge to our understanding of health and disease.
If, however, you are going to spend the resources to do an acupuncture study, make sure it is rigorous enough to add new information, and isn’t just another preliminary study to throw on the pile and get another round of misleading headlines about how “acupuncture” works. Of course a cynical person might suspect that this is the real goal of these studies.
A recent commentary published in the New England Journal of Medicine (NEJM) by Philip J. Landrigan and Charles Benbrook has sparked some controversy. Landrigan and Benbrook are publishing in a medical journal because they claim the issue of genetically modified organisms (GMOs) is a public health issue. They use extremely strained logic and misrepresentation to make their point, however.
Equating GMOs with Herbicides.
The primary logical flaw in their argument is their attempt to equate GMOs with the use of herbicides. They write:
Herbicide resistance is the main characteristic that the biotechnology industry has chosen to introduce into plants.
The first of the two developments that raise fresh concerns about the safety of GM crops is a 2014 decision by the Environmental Protection Agency (EPA) to approve Enlist Duo, a new combination herbicide comprising glyphosate plus 2,4-D. Enlist Duo was formulated to combat herbicide resistance.
The authors also acknowledge that:
“ genetically engineered crops can increase yields, thrive when irrigated with salty water, or produce fruits and vegetables resistant to mold and rot.”
That is actually a short list – there are also genetic traits to resist crop viruses, to enhance nutrition, and reduce toxins. GM technology is a technique that can be used to introduce a variety of traits. It is not inherently tied to herbicide resistance.
And yet Landrigan and Benbrook want to paint all GMOs with the broad brush of herbicides, as if they are the same thing. And again, they even acknowledge the facts that render their entire premise absurd:
The National Academy of Sciences has twice reviewed the safety of GM crops — in 2000 and 2004. Those reviews, which focused almost entirely on the genetic aspects of biotechnology, concluded that GM crops pose no unique hazards to human health.
Questions about GM technology should focus on GM technology, not the consequences of one particular application of the technology. Their argument is the equivalent of opposing metallurgy because the technology is used to make bullets, or all of pharmacology because some antibiotics have been overused resulting in bacterial resistance.
They do this because they cannot argue that the technology itself is not safe. No specific health issues have arisen.
The NAS did mention that introducing novel proteins into food has the potential to introduce new allergens and toxins and recommended appropriate testing and monitoring, to which Landrigan and Benbrook write:
Both reports recommended development of new risk-assessment tools and postmarketing surveillance. Those recommendations have largely gone unheeded.
This is not a fair assessment. The process of creating GMOs specifically filters out new potential toxins and allergens. Toxins and allergenic proteins tends to have peptide sequences in common that allow them to survive stomach acid and digestive enzymes sufficiently intact to get absorbed and cause allergy or toxicity. Any genes added to GMO will produce known peptide sequences which are systematically checked against known toxins and allergens.
This system works, at least so far. There has not been a single case of allergy to a GMO crop. This is a better safety record than crops produced through traditional breeding, hybrids or mutation farming.
Kevin Bonham, responding to the claim that GMOs pose an allergy risk, writes in the Scientific American:
This is patently false – genetic engineering techniques allow us to precisely add genesof known structure and function to crops. It would in principle be possible to engineer corn that expresses anthrax toxin, or introduce peanut allergens into soybeans, but this would have to be by malicious intent of the scientists, not some accident. We know how genes work, and we know what kind of protein an individual gene will make.
What are the risks of herbicides?
Landrigan and Benbrook falsely equate GMOs with herbicides, and falsely create alarm about non-existent risks of GMO, while downplaying the fact that there is no specific risk to the technology itself. Are their concerns about herbicides legitimate, however? Yes and no.
Certainly we need to be cautious about agricultural technology, especially any substances used in farming that will end up on our food. Landrigan and Benbrook claim that use of herbicide resistant GM crops has lead to an increase in herbicide use, specifically of herbicides (glyphosate and now 2,4-D) that are listed as a probable and possible carcinogen respectively. This, however, is misleading.
Check out the reaction from scientists at the Science Media Center. This is a good neutral source that gets reactions from experts in the field to items in the news. They include great criticism of the NEJM article, including this:
Prof. Anthony Trewavas FRS, Emeritus Professor of Cell Biology at the University of Edinburgh, said:
“This latter organisation points out that the WHO cancer committee claims are based on very few documents, mainly on animals and with limited evidence in humans and of course ignore the importance of dose. This same WHO cancer committee also placed hairdressing, art glass, night shifts, tea bag manufacturing and grapefruit juice in the same ‘probably carcinogenic’ class along with emissions from frying food but not those from grilled food.”
The bigger point here is that Landrigan and Benbrook exaggerate the risks of glyphosate and 2,4,D, and they ignore the fact that glyphosate replaced far more toxic herbicides and therefore glyphosate resistant crops reduced the overall toxic potential of herbicides in farming. Further, toxicity data must be put into the context of real world exposures, which is what the EPA does. Careful monitoring by the EPA indicates that herbicide residues are orders of magnitude below toxic levels, even for children, despite the false claims of the authors.
Further still, they compare herbicide use today with five years ago, because recent glyphosate resistance has resulted in increased applications. But they ignore the fact that total herbicide use has not increased compared to pre-GMO level. Farmers were using herbicides (and more toxic herbicides) long before GMOs – another reason that conflating GMO technology and herbicide use if fallacious.
There is a legitimate concern with weeds developing herbicide resistance, just as there is a legitimate concern with bacteria developing antibiotic resistance. This gets to how herbicides (and antibiotics) are used. Over-reliance on a single method of pest control in massive farming is always going to be problematic. This is why there is a push for integrated pest management, to use a variety of methods that limit resistance. None of this has anything directly to do with the safety of GM technology.
Conflicts of Interest
Many commenters were upset at the fact that Benbrook disclosed no conflicts of interest. Meanwhile:
Benbrook was formerly the research director of The Organic Center, which is funded by the organic industry and is now officially part of the Organic Trade Association. His three year affiliation with the Center for Sustaining Agriculture and Natural Resources (CSANR) at Washington State University (WSU), which was funded entirely by organic industry contributions, ended on May 15, 2015 when his contract was not extended.
In the anti-GMO narrative, having a connection (no matter how tenuous) to a biotech company is a fatal conflict of interest, while have a connection to the organic food industry, no matter how close, is not a conflict at all.
Benbrook is pro-organic (an industry insider) and anti-GMO. This is a conflict of interest. This does not mean that his arguments are wrong, but it is now considered acceptable practice to disclose any such conflicts for the sake of transparency so that the reader can decide.
Landrigan and Benbrook conclude:
Finally, we believe the time has come to revisit the United States’ reluctance to label GM foods. Labeling will deliver multiple benefits. It is essential for tracking emergence of novel food allergies and assessing effects of chemical herbicides applied to GM crops. It would respect the wishes of a growing number of consumers who insist they have a right to know what foods they are buying and how they were produced. And the argument that there is nothing new about genetic rearrangement misses the point that GM crops are now the agricultural products most heavily treated with herbicides and that two of these herbicides may pose risks of cancer. We hope, in light of this new information, that the FDA will reconsider labeling of GM foods and couple it with adequately funded, long-term postmarketing surveillance.
Each one of their claims here is wrong or highly problematic. Labeling all GMOs will have no benefit, but instead will produce consumer confusion. Ironically the authors specifically contribute to that confusion and demonstrate exactly why it will happen.
They desperately try to conflate GM technology with herbicide use, and then hype the health risk of those herbicides. A “GMO” label, however, will tell the consumer precisely nothing about the risks of the food they are buying. A GM potato that produces less acrylamide (which may actually be carcinogenic) would receive the same GMO label as herbicide resistant soy. If the authors have their way, the average consumer would see the “GMO” label as if it means “laced with toxic herbicides.”
Many GMO traits have nothing to do with herbicides, and crops that are not GMOs may still have been treated with herbicides. The label does not actually tell the consumer anything about risk.
In their misleading piece, Landrigan and Benbrook actually inadvertently make a strong argument against labeling by demonstrating how it will be used to confuse and misinform.
The “Hubbard Protocol” is Scientology’s religion-based, pseudoscientific “detoxification” treatment used in its Narconon program to treat drug addiction. It was dreamed up by a science fiction writer with no medical training. Now it is being studied as a treatment for veterans suffering from Gulf War illness. Our limited public money for research is being wasted on a study with no scientific merit. Whether or not you consider this a church/state conflict, the study is clearly ill-advised.
A description of the study is available online in the government’s clinical trials registry. The DOD funded this study to the tune of $633,677. The subjects are veterans with Gulf War illness characterized by persistent memory and concentration problems, headaches, fatigue, and muscle and joint pain. The illness has not been well defined, and its cause has not been determined; but the researchers are working on the assumption that toxins are the cause and that the treatment will relieve symptoms by removing toxins from the body.
The control group will get only “usual care.” The experimental group will get:
A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140’F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
Subjects are randomized to the treatment or control group but are not a random sample of veterans with Gulf War illness. They are a “convenience sample” of veterans who reside in the local area and “show interest in the study,” whatever that means.
The outcomes they measure are quality of life, symptoms as reported on questionnaires, performance on neurocognitive tests, and physical health as measured by standard medical examination and blood tests (metabolic panel, lipid profile, hormones).
Toxins? What toxins?
They describe the intervention they are testing as a detoxification program; but they have no way of knowing whether toxins are responsible for the patients’ symptoms, they don’t identify the toxins, and they don’t demonstrate that any toxins have actually been removed.
One of the participants said, ““I was going to be done today, but… I had some more junk come out of my legs. Some black stuff. So I’m going to do one more day and see if I can clean it all out.” The program director, Dr. Crystal Grant, shows off towels with various colored stains (pink, blue, brown, purple, orange, light yellow) that she calls evidence that the program rids the body of nasty toxins. It is no such thing! It is reminiscent of the bogus claims for those detoxification foot baths. It is evidence that something colored the towels, not evidence that the program removes toxins.
One of the participants said by the end of the study she was taking two large canning jars of vitamins a day (!) along with a few spoonfuls of peanut oil.
Scientology’s Purification Rundown
The Hubbard protocol is also known as the “Purification Rundown,” and is based on the belief that toxins affect both the body and the soul, and that they can be eliminated from the body by exercise, saunas, and supplements. L. Ron Hubbard believed the regimen would take humans to a higher plane of existence, improve their IQ, and allow them to survive nuclear fallout in World War III.
Scientology’s Narconon program uses this regimen to treat drug addiction. Numerous deaths have been attributed to it. The Wikipedia article provides a handy summary with links to original sources.
The lead investigator, David Carpenter, is a professor of environmental health at the University of Albany who has been embroiled in controversy because of his research on the questionable diagnosis of electromagnetic sensitivity. He was approached by Scientologists and asked to do this study. A Scientology group is providing the therapy; it charges $2000 per participant, a discount from the usual rate of $3000. The vitamins they dispense are labeled with a picture of Scientology leader David Miscavage’s personal chiropractor, who has now gone into the supplement business.
The lead investigator, David Carpenter, was unaware of her conflict of interest until he read about it in The Daily Beast.
Scientology is behind organizations that purport to give impartial advice about drug rehabilitation programs but that actually use detailed scripts to inveigle prospective customers into paying exorbitant amounts for Narconon treatment and subject them to Scientology influence.
Sure, the treatment seems to work
Patients report feeling better, but that could be from a combination of exercise, enjoyment of saunas, and suggestion. They are subjected to an elaborate, time-consuming regimen and have to work at it. The Hawthorne effect of just being in a study may come into play. There is a natural resistance to thinking one’s time and effort have been wasted. It is only natural that participants will believe it has helped them. They are suffering. They want it to work. They expect it to work. They need it to work. A “usual care” group is not a valid control group; it does not control for confounding factors.
When used as a treatment for hyperlipidemia, niacin causes a number of side effects in 92% of patients. It must be started slowly to minimize problems like “niacin flush,” an uncomfortable warmness and redness of the skin. Study participants may interpret these side effects of niacin as a sign that the detoxification is working. It’s not just a matter of innocuous flushing. High dose niacin in the amounts used in the Hubbard protocol can sometimes cause liver failure and death.
Proponents have claimed that niacin releases fat stores into the blood stream to remove toxins stored in fat. In reality, niacin is used clinically to treat hyperlipidemia by decreasing blood lipid levels.
Public funds have been used for this before
Utah has used public funds to “detoxify” cops with the Scientology protocol after they raided meth labs. Public funds have also been spent on “detoxifying” 9/11 workers with the Scientology protocol. This effort has been severely criticized by scientists.
The sins of Scientology
I have written previously about Scientology’s war on medicine. They discourage medical treatment, although medicinal doses of vitamins are part of the Hubbard protocol. Scientology is a religious cult invented by L. Ron Hubbard, a science fiction writer. There is a Deadly Devotions episode that provides insight into how people become attracted to Scientology’s promises of a better life and how they are gradually indoctrinated into bizarre beliefs, persuaded to spend their money on a series of self-improvement courses, and let the church take over their life. It tells the true story of a woman who reached a high place in the church hierarchy, refused medical treatment for her paranoid schizophrenic son, was misled by a doctor who was a fellow Scientologist who told her her son only had a yeast infection and needed treatment with vitamins and isolation. The story ends in tragedy and then attempted cover-up to protect Scientology’s reputation.
In my opinion, this study is ill-advised from a scientific standpoint. It will do nothing to elucidate the cause of Gulf War symptoms or to credibly test the effectiveness of the Hubbard protocol. We can predict that more subjects will report improvement with the treatment than with usual care. That will not be strong enough evidence of its effectiveness to convince scientists; but it will be enough to bolster Scientology propaganda, to provide pseudoscientific support for their lucrative drug rehab business, and to help entrap suffering people in a dangerous cult.
The Center for Inquiry (CFI) has issued a strongly worded protest against spending public money on a pseudoscientific/religious practice and using our veterans as guinea pigs in a treatment that does nothing to address their plight. They went so far as to call this study obscene. They wrote a letter to the Secretary of Defense urging him to immediately halt the study and open an investigation into how it came about. I would love to see him do just that, but I am not optimistic.
Here we go again with the whole “CDC Whistleblower” thing, this time with a book about the recorded conversations between Brian J. Hooker and William Thompson. Well, not the whole conversations, of course. If they were to release the whole conversations, we might get the truth, and the truth always gets in the way of the antivax crowd. Instead, we get an edited transcript of the conversations between those two in which, according to them and the book’s editors and authors, there is some sort of massive cover-up at all levels of science, government, and public health. What’s the cover-up? As usual, vaccines are evil and whatnot.
I’m not going to review the whole book for you because Dr. Gorski has already done so, and Dorit Reiss has discussed the legal aspects of what is discussed in the book. You can go read his review and/or Prof. Reiss’ analysis and then come back, or stay here and read what I have to say about the failed attempts at epidemiology from both BJ Hooker and Thompson.
Let’s start by reviewing BJ Hooker’s credentials. He is a bioengineer and chemical engineer, not an epidemiologist, despite what the author of the book wants you to believe:
With the publication of Kevin Barry’s Vaccine Whistleblower: Exposing Autism Research Fraud at the CDC, any claims of credibility for the CDC’s science has collapsed. Barry built his book upon four legally taped conversations between CDC senior vaccine safety scientist Dr. William Thompson and Simpson College professor and epidemiologist, Dr. Brian Hooker.
Later in the book, in the transcript of one of the conversations between BJ Hooker and Thompson, BJ gets a list of things he needs to do to earn an “honorary” degree in epidemiology. Among those things was to look at some of the earlier studies that Thompson had coauthored. And BJ did. He would go on to write a flawed paper that I critiqued here and ended up being retracted, as I told you about here. That paper alone should tell you everything you need to know about BJ Hooker’s epidemiological understanding, but the transcripts given to us by his camp in the form of the book really reveal his ignorance.
So let’s go through the calls and pick at the epidemiological and biostatistical missteps that Thompson suggests for BJ Hooker.The first call
In the first call, Thompson tells BJ to look at a study from Italy — and a reanalysis of that study — and see that there is an association between thimerosal in vaccines and tics. No, not autism, but tics. And both studies caution against concluding that it was the thimerosal because of the methodology and biologic plausibility of this. Also, the Italian study invited subjects to participate, leading to a 70% participation rate. What the other 30% would have contributed is unknown. This is a huge source of bias and something that we should all watch out for.
Still, BJ Hooker agrees to look at those studies and use them for his court case:
Dr. Thompson: The only thing I know for sure, is that I can say that pretty confidently, vaccines cause tics. We replicated that. The Barile article replicated that and showed that once you took into account the number of tests and reduced them down to constructs, the one thing you couldn’t get to go away was the tic effect.
Dr. hooker: Was the tic effect, right. I agree. And I’m even using that in my son’s vaccine court case, because he has tics and so, we have that. It’s been confirmed in several studies, not to mention your study and then the Barile study that was the reanalysis from 2012. And I’ll go back and look at those means on Tozzi as well.
Dr. Thompson: Look at the means. Look at the means, they’re very close. You could do a simple t-test and see they’re very close to significance. The other thing I wanted to ask you.
Yeah, they may be “very close to significance,” but that means nothing when you look at the entirety of the evidence. The authors tells in those papers that there is bias, and that we must not jump to conclusions based on other factors, like biological plausibility. Still, Thompson and Hooker want to latch onto these studies and make something of them. Pretty par for the course for a couple of antivaxers.
Later in the first call, they discuss the numbers that led BJ Hooker and his followers to cry out that African American males were more likely to get autism from vaccines than others in the group analyzed in the DeStefano paper. What is funny to me is that they discuss how drilling down on the data and splitting the cases and controls like they were doing leads to small numbers of cases and controls being compared:
Dr. Hooker: Okay, and one of the things I did find in this weird um, when I use the thirty-six-month cut-off for African American males, I only had seven cases in the after thirty-six months. Okay, so the cohort was getting small. So, I had like seven cases and I can’t remember how many controls. Obviously, the lion’s share of the cases were for individuals who got the MMR before thirty-six months. Now I, when I, I wanted to correct for low birthweight. So I threw out low birthweight. But what I found was that in my cases after, in the cases of individuals that got the MMR after thirty-six months, I wasn’t throwing out low birthweight, I was throwing out individuals that didn’t have birthweight reported at all. So you basically look at that and it is essentially saying it is the birth certificate cohort. Does that make sense? Let me, I can explain it one other way. When you look at the data and you look at African American male cases of autism, there are seven cases. There are four cases that did have a birth certificate and were normal birth weight and the remaining three cases didn’t have a birth certificate so they didn’t have birth weight at all.
That right there is a huge source of bias. When you compare five people here and six people there, even if you pick them at random, you’re going to find some differences that are big between the two groups. You need larger sample sizes to make sure that what you are seeing continues to be true on average and in the long run. It’s basic epidemiology, but Thompson and Hooker continued down that path, even as they recognized that these low numbers could be criticized and could be a problem.
As BJ Hooker said:
Bill, I am not an epidemiologist by training.
And it shows.The second call
In the second call, Thompson seems horrified at the idea that no research group within and outside CDC wants to do an autism-vaccine study. Perhaps because that horse is dead and needs no more beatings?
Dr. Thompson: We’re going to have twelve hundred kids with autism as part of this uh study, um, with all their medical records and all their vaccine records abstracted. So, um, what’s amazing, now this is what’s going to be shocking to you, it shocked the crap out of me. They have ya know six different sites interviewing data and um they all put in proposals to do studies. So far there is about sixty proposals in, um, for people ready to do studies. Not a single one of them looks at vaccines, not one!
They probably don’t want to do a study like Thompson wants because the issue has been settled every which way before, because it is a huge waste of resources to look at autism and vaccines again.
In that same second call, there is a discussion about confidence intervals that needs to be noted. Thompson says this:
Dr. Thompson: You see that the strongest association is with those without mental retardation. The non-isolated, the non-mentally retarded, the effect is where you would think that it would happen. It is with the kids without other conditions, without the comorbid conditions. And the, ya know, honestly, I looked at those results, I had not gone through these hard copy papers, I don’t think I have ever gone through them since 2004 and I came across them, and I’m like “Oh my God” and this is 0.97 to 16 and it’s not statistically significant but odds ratio is 8 and if we would have added one more subject it probably would have been significant. I’m just looking that and I’m like. “Oh my God. I cannot believe we did what we did.” But we did. It’s all there. It’s all there. I have handwritten notes.
A confidence interval is the range of results that you will see 95 times out of 100 if you repeat the study many times. If your value includes 1.0, then there is a better than 5% chance that you will see no effect. Generally, you want confidence intervals to be nice and tight and not include 1.0. When you get a confidence interval that includes 1.0, you cannot rely on the results as being statistically significant. Now, did you catch that part about adding one more subject? Was Dr. Thompson suggesting that the results be manipulated some way? Or was he wishing that there were more subjects in the study so the confidence interval wouldn’t be as wide and include 1.0?
Either way, the confidence interval could have shifted the other way to include 1.0 and more values under 1 than seen here. Then what? But, again, true to the antivax way, Dr. Thompson seems to wish that the results show what he wants them to show.The third call
The third call is mostly about wishing that data had gone the other way and confirmed the biases that BJ Hooker and Thompson have about vaccines. They wish that non-Blacks had an association like the one seen in African American kids (when not adjusted for other factors). And then BJ Hooker basically says that autism equals mental retardation, and that those who are autistic but not mentally retarded are the result of an “in vogue” diagnosis:
Dr. Thompson: Well, if you … The kids with mental retardation. …
Dr. Hooker: Right.
Dr. Thompson: … it’s probably, it’s probably unlikely that mercury exposure causes mental retardation.
Dr. Hooker: How well though … If you’ve got … You know, and you, like you said before, you’re not really the person to answer this but, how well do you have those records? Because a lot of times if you have an isolated autism case, you’re going to have mental retardation. I don’t … You know, I don’t know; I’m out in the community; I don’t really know many autistic kids that aren’t mentally retarded.
Dr. Thompson: Oh, I don’t know. I actually don’t know that for sure, but my reading of our own papers, the recent papers, is there’s a huge increase in the number of kids who don’t have mental retardation. That number is going, proportionately is going up.
Dr. Hooker: Right.
Dr. Thompson: So, I still … I still say …
Dr. Hooker: But that could be … Part of that could be a health-care-seeking behavior, because if it’s in vogue to get an autism diagnosis … And I deal with this as a parent all the time. You know, some genius walks up and tries to have a conversation with my kid, and I’ll look at the parent and say, “Oh, my son has autism. He’s non-verbal; he doesn’t speak.” And they’ll look at me and they’ll say, “Yeah, my kid has autism too.” And I’m just like, “What the fuck! Really?” We should be so lucky to have that kind of autism.
Later in the conversation, they try to compare thimerosal exposure to mercury exposure from fish and to lead poisoning… Do these guys even science? And they then dive into the antivaccine conspiracy theories about conflicts of interests (ignoring BJ Hooker’s own, of course), hidden agendas, and Big Pharma interference.
In the last conversation in the book, there is more discussion about the papers that pointed to an increased chance of tics in children who got exposed to thimerosal. They try to explain away the lack of statistical significance in the findings and the recommendations to not look too much into the findings because there is an issue with biological plausibility. Yet again, they try to make sense of a world of science that they seem to not understand.
Again, check out the writers on other blogs who are reviewing the book and all of the discrepancies within it. Remember that you’re reading an edited version of conversations between two anti-vaccine people who have a lot to lose if it turns out that vaccines do not cause autism. Read carefully at the parts where they throw associates under the bus, and use some harsh language to describe those with whom they disagree. In essence, read the transcripts critically.
See, if you read the book with a total lack of understanding of what is going on, you might be tempted to think that a researcher at CDC is actually revealing some pretty messed-up — perhaps even criminal — activities with regards to studies on vaccines and autism. But you know better, you’re more of a critical thinker than the hundreds of people who will read the book and be even more convinced of their own biases about vaccines. If you do end up reading the book, keep in mind the following things:
René F. Najera was born and raised in Mexico. Came to the US at age of ten. Attended the University of Texas at El Paso for a BS in Medical Technology. Worked seven years as a medical technologist at a clinical laboratory while working part-time toward a Master of Public Health in Epidemiology and Biostatistics from the George Washington University. Then worked for six years as an infectious disease epidemiologist at the Maryland Department of Health and Mental Hygiene, doing disease surveillance and outbreak response. Started the Doctor of Public Health program at Johns Hopkins University Bloomberg School of Public Health in 2013, and my thesis will be on the use of epidemiological methods to address social inequities.
I gave a talk on the vaccine controversy over the weekend. I was not surprised that a couple of audience members had a lot of questions taken directly from anti-vaccine propaganda sites. What was interesting was that they were still pushing the idea that thimerosal, a mercury-based vaccine preservative, is linked to autism.
The reason this is interesting and illuminating is that the thimerosal hypothesis is not just mostly dead, it is most sincerely dead. It is pushing up the proverbial daisies.
A Brief History of Thimerosal
Thimerosal was developed as an organomercurial anti-microbial agent shortly after World War I. It was soon discovered that it has great anti-microbial properties and was well tolerated when injected into rabbits or rats even at high doses. This made it superior to anything else available at the time.
Bacterial contamination was a serious problem for vaccines in the first half of the 20th century. Thimerosal in tiny doses, well below safety limits, proved to be an effective agent for preventing contamination. By the 1940s thimerosal was being added to several vaccines for this purpose.
It should be noted that thimerosal can only be used in inactivated vaccines or those that contain just proteins, not in live attenuated virus or bacterial vaccines. Thimerosal would inactivate any live vaccines.
Safety concerns about thimerosal were first raised in the 1970s with increased awareness of the neurotoxicity of mercury. However the dose of mercury in vaccines was orders of magnitude below the levels showing any clinical effect. No safety concerns were raised with thimerosal and vaccines until the late 1990s. At this time Wakefield was raising alarms over the MMR vaccine (which never contained thimerosal) and autism. His research was later revealed to be flawed and even fraudulent, and independent studies showed convincingly that there was no connection between MMR and autism. So anti-vaxxers moved on to their next target, thimerosal.
Anti-vaxxer focus on thimerosal was given a huge boost by David Kirby and his book, Evidence of Harm. Robert Kennedy also jumped on the anti-thimerosal bandwagon, mainly coming from an environmental perspective.
A History of Dose and Thimerosal
The core of the anti-vaccine claim against thimerosal was that as the cumulative dose of thimerosal increased so did the incidence of autism. This claim was never scientifically validated. Correlation by itself is weak evidence for caustion, and the correlation itself really didn’t hold up. But the vague correlation of – both thimerosal and autism were increasing in the 1990s – was enough for the anti-vaxxers. Of course I have to show this graphic indicating that the correlation between autism and organic food is even better.
Despite the lack of any convincing scientific evidence, the CDC decided “out of an abundance of caution” to remove thimerosal from the routine vaccine schedule by 2002. This provided an opportunity for a mega-experiment. If the increasing dose of thimerosal caused increasing autism diagnoses, then a decreasing overall dose of thimerosal should cause the incidence of autism diagnoses to fall to pre-1990s levels.
David Kirby directly predicted a drop in autism incidence and correctly noted that if the rates do not drop that would call into question the role of thimerosal. In 2007 he was writing that the rates were starting to drop – extrapolating wrongly from short term fluctuations in the data.
The other game that anti-vaxxers were playing was that thimerosal was not really removed by 2002. There were still some vaccines with thimerosal. As autism rates continued to rise, they kept pushing back the date of when thimerosal was removed. Apparently doctors were holding onto their vaccines with thimerosal to the bitter end.
Vaccine manufacturers stopped making vaccines with thimerosal (except for some flu vaccines, more on that later) between 1999 and 2001. Vaccines have a two-year shelf life. Even if you take the latest estimates, the thimerosal-containing vaccines were gone by 2004. However, anti-vaxxers take the 2004 date then tack on two more years and claim that vaccines contained thimerosal as late as 2006. This is nonsense, however; 2004 is really the latest date that some doctor in the US might have given the last vaccine with thimerosal right before its expiration date. Even then the total dose of thimerosal given to the pediatric population was steadily declining between 1999 and 2004.
I can see why in 2007 anti-vaxxers were dickering about the exact date of thimerosal removal. But now we are in 2015 – 8 years later. We are a full 11 years after the latest realistic date of any lingering thimerosal in the vaccine schedule. Certainly anti-vaxxers cannot still be holding onto their thimerosal delusions. Well, of course they are.
Let’s review the historical dose of thimerosal in vaccines. In the 1970s, one vaccine contained thimerosal, diphtheria-tetanus-pertussis combination. One vaccine dose typically contains 25 micrograms of thimerosal. By the early 1980s, before the autism diagnosis increase, the total dose of thimerosal in the routine vaccine schedule was up to 100 micrograms. Total thimerosal dose to infants and young children peaked at 187.5 micrograms of thimerosal. This dose was by 6 months of age, and did not include any additional thimerosal from the flu vaccine, which is recommended but optional and not considered part of the routine schedule.
After around 2002 the 187.5 micrograms of thimerosal was completely removed. However, anti-vaxxers are now claiming that increased use of the flu vaccine has replaced this missing thimerosal. Simple math shows that they are wrong.
Multi-dose flu vaccines contain 25 micrograms of thimerosal. Even if a child gets the flu vaccine at six months, one year, and then every year after that they are still not getting anywhere near the total dose of thimerosal in the schedule prior to removal. Even if you include the shot their pregnant mother received (which the anti-vaxxers do) you are still not near the total dose.
Further still – in 2012 the CDC reported that only 1/3 of the flu vaccines produced in the US were mutli-dose vials. The single dose vials and the live virus vaccines do not contain thimerosal. So only one third of those flu vaccine doses in 2012 contained thimerosal, with similar numbers projected for this year.
So if we are considering the population dose of thimerosal, we have to drop the average dose from the flu vaccine to one third. That means that children who get all their flu vaccines by age six are getting about 50 micrograms of thimerosal total on average over six years, compared to at least 187.5 micrograms plus flu vaccines in 1999.
In addition to all this, some states, like California, have banned flu vaccines with thimerosal. So children in California get a total thimerosal dose of zero.
The CDC has statistics on autism incidence through 2010, which includes the birth cohort for 2002 – which is clearly after the total thimerosal dose had plummeted.
The CDC has also published data for 2011-2012, showing the autism rate has continued to increase, from 1 in 68 to 1 in 50 – that’s the 2003-2004 birth cohort. The rates in California are no different.
I should note that the evidence shows that the increasing rate of autism diagnoses is largely an artifact of expanding diagnosis, diagnostic substitution, and increased surveillance. There may not be any real increase in autism itself. A small real increase is possible, but unproven.
There is only one reasonable interpretation of this data – the removal of thimerosal from the vaccine schedule resulted in a dramatic decrease in the total thimerosal dose given to the pediatric population in the US, starting in 1999, completed by any reasonable estimate by 2004. Only one third of flu vaccines still contain a small dose of thimerosal, and some states, like California, have banned even those.
Despite this dramatic overall reduction in thimerosal, there has been no change in the rate of increase of autism diagnoses. The plummeting of autism diagnoses predicted by David Kirby and others never materialized.
Attempts to keep their thimerosal delusions alive are getting increasingly desperate and ridiculous. Antivaxxers are now at the point where they have to deny simple math.
Life’s but a walking shadow, a poor player
That struts and frets his hour upon the stage
And then is heard no more: it is a tale
Told by an idiot, full of sound and fury,
I don’t review books that often. The reason is simple. My posts for this blog sometimes take as much as a several hours to write (particularly my more “epic” ones that surpass 5,000 words), and I usually don’t have the time to add several more hours to the task by reading an entire book. Also, by the time I’ve read a book I might want to review, weeks—or even months—have often passed, and a review is no longer of much interest to our readers anyway. Fortunately, Harriet does an admirable job of reviewing books for us.
Today, I’m making an exception for a book hot off the presses. The main reason is curiosity, because the book is about a topic that I’ve blogged about three times here and several times for my not-so-super-secret other blog, and I really wanted to find out more about what was going on. I didn’t expect to find out what really happened, because I knew from the beginning that the book, Vaccine Whistleblower: Exposing Research Fraud at the CDC by an antivaccine lawyer named Kevin Barry, would be highly biased. However, as we found out a few weeks ago, the book promised four complete transcripts of telephone conversations between the “CDC whistleblower,” a Centers for Disease Control and Prevention (CDC) psychologist named William W. Thompson who has been a co-investigator on important CDC studies since the late 1990s.
Given my rather public skepticism about the particular’s of Thompson’s story, I was quite surprised when my request to Barry’s publicist for a review copy of Vaccine Whistleblower was enthusiastically answered in the affirmative, thus giving me time to read the e-book before it was released. I also sent a copy of the book to a law professor familiar with the saga, Dorit Reiss, to write a legal perspective, which is also being published on SBM today, which is why I will say little about this aspect of the book in my discussion.
Thompson’s rather implausible “revelations” that the CDC covered up data showing a link between the (measles-mumps-rubella) MMR vaccine and autism in African American boys birthed the whole “CDC whistleblower” phenomenon almost exactly a year ago. Before I review the book, let me briefly describe the “scandal” that spawned the book.
Thompson was an author on several pivotal papers examining whether vaccines cause autism. All of the studies were negative, of course, but to antivaccine activists that just adds to the conspiracy. Basically, almost exactly a year ago, Thompson was featured in a short film by Andrew Wakefield as a “whistleblower” who had “confessed” to a biochemical engineer named Brian Hooker that for one of the studies for which he had been a coauthor in 2004 (Destefano et al) investigators had “covered up” a correlation between MMR vaccination and autism in African-American males and had not followed the protocol as written. He based his claim of a coverup on a truly incompetently done “reanalysis” of Destefano et al, which he later touted for its “simplicity,” apparently not realizing that simplicity in statistical analyses of epidemiological data is not a virtue. Suffice to say, the original correlation was based on small numbers and disappeared when proper corrections for confounders were made. Not surprisingly, Hooker’s reanalysis was ultimately retracted.
None of this has stopped Hooker and Wakefield from trying to make hay about this “CDC Whistleblower” scandal or antivaccinationists from swarming Twitter on the #CDCWhistleblower hashtag. Just last month, Rep. Bill Posey (R-Florida), who appears to be taking up the antivaccine mantle left behind when Rep. Dan Burton retired, got up on the floor of the House to speak during the Morning Hour, a time when Representatives can basically say what they want for a few short minutes, and demanded an investigation into the CDC. He even went so far as to quote Thompson thusly:
All the authors and I met and decided sometime between August and September ’02 not to report any race effects for the paper. Sometime soon after the meeting, we decided to exclude reporting any race effects, the co-authors scheduled a meeting to destroy documents related to the study. The remaining four co-authors all met and brought a big garbage can into the meeting room and reviewed and went through all the hard copy documents that we had thought we should discard and put them in a huge garbage can. However, because I assumed it was illegal and would violate both FOIA and DOJ requests, I kept hard copies of all documents in my office and I retained all associated computer files. I believe we intentionally withheld controversial findings from the final draft of the Pediatrics paper.
It was the first statement, albeit unverified, from Thompson in quite some time, and it was also a serious accusation of major scientific misconduct on the part of his co-authors and former coworkers at the CDC. If this statement were to be verified as having come from Thompson (oddly enough, it appears nowhere in Vaccine Whistleblower) and I were one of his co-authors, I’d consider myself as having been defamed. Thompson himself has been silent—at least publicly—since last summer, when this whole kerfuffle erupted, and probably wisely so. Whatever his motivation, he has caused considerable damage with his foolishness in having trusted Brian Hooker. Or so I had thought. It turns out, if Vaccine Whistleblower is any indication, that Thompson was actually an enthusiastic participant in bringing about this scandal. Indeed, he appears to have turned antivaccine in such a way that he distinctly reminds me now of Andrew Wakefield, albeit without the charisma and hunger for the spotlight but with at least as much anger, resentment, and narcissism. You’ll see what I mean.The setup
Vaccine Whistleblower is a rather short book designed to showcase the transcripts of four telephone conversations recorded—legally, Barry is quick to point out multiple times—between Brian Hooker and William Thompson on May 8 (Transcript #1), May 24 (Transcript #1), June 12 (Transcript #3), and July 28, 2014 (Transcript #4). The first two conversations are rather brief (around 5,000 words each), while the last two are quite long (over 8,000 words each).
Barry begins with a Foreword by, of all people, Robert F. Kennedy, Jr. Right away, all I can say is: Way to go, Mr. Barry! If you want to portray yourself as being “not antivaccine,” as you say in the book so many times, there’s no better foreword writer to pick than RFK, Jr.! Hilariously, RFK, Jr. begins his Foreword by declaring again, as he did on The Dr. Oz Show, that he is “fiercely pro-vaccine”:
I have always been fiercely pro-vaccine. I had all six of my children vaccinated. I believe that vaccines have saved millions of lives and that broad vaccine coverage is desirable. To achieve those goals, we need safe vaccines, transparent and reliable science, and an independent regulatory agency. The extraordinary revelations in this book by CDC insider and whistleblower Dr. William Thompson prove that, unfortunately, we have none of these.
RFK, Jr.’s declaration is risible in the extreme.
It’s also apparent that these four transcripts were carefully selected. I base this conclusion on two observations. First, in the transcripts, Hooker and Thompson pal around as though they’ve been buddies a long time. For example, in Transcript #4, before anything of substance is recorded, the reader is treated to three and a half painful pages of Hooker and Thompson bantering about Hooker’s new iPhone 5s, Thompson’s family vacation in Chicago (where his kids played drum and guitar in a blues camp), and Hooker’s vacation near Mt. Shasta and the drum and bugle corps he enjoyed watching, which ended with his tale of hitting a deer, complete with a description of the gore flying back at them as semis hit the deer again and again. Clearly these passages are included to emphasize that Thompson and Hooker had become best buds, and it works. I’ve changed my opinion of Thompson. He wasn’t duped; Hooker was duped after he told Wakefield about the transcripts of his phone conversations. Thompson himself was all in.
The other observation is that Hooker’s and Thompson’s first contact was in November 2013, earlier than I thought. It’s not clear who reached out first, but it’s clear from the gist of the transcripts that Thompson had been planning long before that to “go rogue” for a long time and that his colleagues didn’t trust him—with good reason, it turns out. Also, RFK, Jr. states in his foreword that there were “over thirty conversations with Hooker” in which “Thompson disclosed in great detail the CDC’s tricks for executing the fraud.” So why were just these four chosen for publication in Vaccine Whistleblower? Inquiring minds want to know, particularly given that these four conversations actually don’t reveal that much. If, as is presumably the case, these are the best Hooker could come up with, I wonder about the rest. It’s not as though the book was so long that he couldn’t have included a couple of more or omitted the pointless hundreds of words’ worth of dull pleasantries between Hooker and Thompson to make room.
Be that as it may, May 2014 is, according to the May 24 transcript, when Thompson was becoming concerned enough about his situation at the CDC that he engaged Frederick M. Morgan, Jr. of Morgan Verkamp, a lawyer specializing in whistleblower claims, who is representing him pro bono and issued the last known public communication by Thompson in the form of his statement dated August 27, 2014. It thus appears that, even if Andrew Wakefield hadn’t “outed” Thompson a year ago, it probably wouldn’t have been too long before he went public, particularly given that Hooker wanted him to and news of his existence had begun to percolate through the antivaccine underground. Indeed, at the time of the phone conversations documented in Vaccine Whistleblower, he had already long been in contact with Rep. Posey, pushing him to investigate and providing him with “100,000 pages” of…it’s not exactly clear what.
Predictably RFK, Jr. links Thompson’s “revelations” with his claims of CDC malfeasance and conspiracy mongering about a study looking at thimerosal-containing vaccines and autism and the CDC conference in which the data were discussed that ten years ago formed the basis of his abysmally antivaccine pseudoscience article, Deadly Immunity. It’s a lot of the same ol’, same ol’, as RFK, Jr. seems incapable of thinking up a new antivaccine schtick. Similarly, disgraced antivaccine chemist Boyd Haley shows up to write a preface in which he touts his “extensive study of this issue over many years” to claim that thimerosal-containing vaccines are dangerous.Revisionist scientific history I: Thimerosal, vaccines, and tics, oh, my!
The first time through the book, I wondered why on earth the preface and the foreword both featured antivaccine activists who are all about mercury in vaccines. After all, what originally vaulted Thompson into the “CDC whistleblower” status were his accusations of scientific malfeasance against his former colleagues over a study from 2004 examining whether the MMR vaccine was associated with autism in African American boys, which, I noted, was the only subgroup where an effect was found. That’s why I originally characterized Hooker’s “reanalysis” of the DeStefano et al data, purged of all those pesky statistical techniques designed to correct for confounders, as proving Andrew Wakefield wrong in his assertion that the MMR vaccine was correlated with an increased risk of developing autism. Getting a “positive” result in African-American boys required small numbers of this subgroup (which the study had) and ditching corrections for confounders that produce a spurious correlation, as I’ve discussed before. Even so, I was surprised at how little emphasis, relatively speaking, was given to DeStefano et al in the transcripts chosen to be included in Vaccine Whistleblower. Maybe it’s because, as Jim Frost described, there’s just no there there. Emily Willingham agrees, and Matt Carey sees creative editing in Posey’s quoting of Thompson.
Far more discussion occurred between Thompson and Hooker over a study on which Thompson was the first author. Even more astonishingly, these transcripts show that Thompson doesn’t even know how to interpret his own data, which were quite clear. The study I’m referring to is a 2007 study published in the New England Journal of Medicine (NEJM) by Thompson et al entitled Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years. It’s a study that, as RFK, Jr. takes pains to point out, Dr. Paul Offit characterized as “wonderful” and “definitive.” And so it is, but that doesn’t stop Thompson from now reinterpreting it in the wrong way.
It also doesn’t take long for the first inkling to appear in the transcripts that Thompson has gone antivaccine. This exchange occurs in Transcript #1 early on:
Dr. Thompson: I just think there has to be a mantra. The mantra should be, “We know thimerosal causes tics.” That’s been demonstrated. That’s been demonstrated in the big studies. And just keep saying that, “We know thimerosal causes tics.” ’Cause the CDC never said that thimerosal doesn’t cause tics. The CDC always says thimerosal doesn’t cause autism. You have to take it off that. You have to take it off that. And I really do think it’s a public relations campaign. But I also have to say these drug companies and their promoters, they’re making such a big deal of these measles outbreaks and they are now, they’re making a big deal that polio is coming back and polio comes back all the time in third world countries. It’s like a never- ending thing where the press loves to hype it and it scares people. It scares the crap out of people when they hype those two types of outbreaks. I think as they teach you at the CDC, you have to stay on message. And the message I think to start getting out and then you wouldn’t have the press jumping on you saying, “Well vaccines don’t cause autism.” If you said, “Yeah, that’s true, but vaccines do cause tics.” And then eventually, eventually you could get the message over to oh tics are like five times as common among kids with autism.
Dr. Hooker: Right, it’s about four times, but, yes, absolutely.
Dr. Thompson: I do think that it’s staying on message with something different than autism because the press and everyone, you know, Jenny McCarthy, all those people. You bring up autism and vaccines you just get hammered. Who’s the company that, who sponsored one of your groups?
Dr. Hooker: Oh, Chili’s.
Dr. Thompson: Yeah, Chili’s just got fried. They just completely got fried.
Yes, you read that right. Immediately after the “Hello, how are you?” pleasantries, we see Thompson coaching a biochemical engineer turned antivaccine warrior on how to properly sell an antivaccine message. Forget about autism (for now), Thompson says. That’s too toxic, too associated with kooks like Jenny McCarthy. Instead, say that vaccines cause tics and go from there! It’s rather ironic how Thompson, after complaining how people working for the CDC “have to stay on message,” immediately provides Hooker a message to counter what he dismisses as the CDC message. Then Thompson complains about how Chili’s got “fried.” Most readers probably don’t remember this event, but in 2014 Chili’s came under fire for having scheduled a day to donate 10% of the day’s proceeds to the National Autism Association, which is, of course an antivaccine group posing as an “autism advocacy” group. Indeed, the NAA has explicitly stated on its website that one of its core beliefs is that vaccines can cause autism.
But is Thompson correct about thimerosal-containing vaccines acting as a cause of tics? The answer is no. However, before I get to how Thompson is now misinterpreting his own study, let me briefly touch on other articles that Thompson cited as evidence that thimerosal-containing vaccines cause tics. The first is what is commonly referred to as the Italian study:
Dr. Thompson: …And you can point to that Italy study (Tozzi et al. 2009) and just look at the means and the means are quite different in that study for tics. I really do think that study actually supports the idea. And then the other thing about the Italy study, the Italy study was the only randomly assigned study and it was a much smaller exposure so if you find something in there and they found two positive effects, right, if I’m recalling correctly, so again, ya know, a study that is randomly assigned, it’s the only study I know where there was random assignment and you found two negative associations where it was increased likelihood of maternal, I mean, verbal IQ and I can’t remember the other one. But tics, I’m telling you, if my recollection is correct, tics were significant in earlier drafts of the paper.
Really? Let’s go to the tape, so to speak and see what Tozzi et al really concluded. This particular study was clever in that it took advantage of an existing randomized study of two different diptheria-tetanus-acellular-pertuss (DTaP) vaccines, one that contained thimerosal and one that did not. This produced two groups of children who had been randomized, one whose vaccine schedule contained a cumulative intake of ethylmercury, the mercury metabolite of thimerosal, of 137.5 μg for the children who were assigned randomly to receive the DTaP vaccine that contained thimerosal (“higher intake group”) and 62.5 μg for those who received the thimerosal- free DTaP vaccine (“lower intake group”).
Ten years later, the children from this study living in the Veneto Region were studied. 1,403 children (697 belonging to the high thimerosal group and 706 belonging to the low thimerosal group) were recruited and subjected to a battery of eleven neurodevelopmental tests that produced a total of 24 neuropsychological outcomes to assess their development. The results were unsurprising. Most outcome measures showed no difference between the low and high thimerosal group, and the ones that did were small and entirely compatible with random chance due to multiple comparisons.
Oddly enough, the investigators did not control for multiple comparisons in their statistical analysis. I have no idea why they didn’t (they didn’t really explain), but they didn’t. They did, however, point out that for 78 different univariate statistical tests between all the outcome measures of all the tests (some outcome measures were tested by more than one test, and separate tests were done for males, females, and the entire sample), by random chance alone they would expect four “statistically significant” associations by univariate analysis. They found two. Girls had slightly lower scores in a measure of motor function, the finger-tapping test with the dominant hand, and a language test, the Boston naming test. As the authors described it, the differences were very small and of doubtful clinical relevance. My guess is that these apparent associations would probably disappear if a correction for multiple comparisons were applied. Moreover, only one case of autism was found, and that was in the group with the lower thimerosal dose. As for tics, the study reported that motor tics were observed for 2.56% of patients in the lower thimerosal intake group and 2.91% of patients in the higher intake group (RR: 1.13; 95% CI: 0.60–2.13; p = .744, Fisher’s exact probability test) and that phonic tics were detected for 0.43% of patients in the lower intake group and 0.87% of patients in the higher intake group (RR: 2.04; 95% CI: 0.51–8.13; P = .338, Fisher’s exact probability test). In other words, it was not statistically significant; so Thompson is reduced to insinuating that the effect was statistically significant in earlier drafts of the paper. This reminds me very much of David Kirby’s distortions about how another study exonerating thimerosal, Verstraeten et al, started out with a positive association between thimerosal and autism but that it disappeared in later drafts.
The Tozzi study is not without weaknesses. For instance, there was no control group who received no thimerosal. However, if thimerosal in vaccines were associated with autism, one would not expect that it would be different than any other toxin associated with an abnormality or condition. One would expect that the chance of autism or neurodevelopmental disorders would increase with increasing dose. Another criticism that antivaccine advocates made was to claim that the thimerosal dose-response curve has a plateau, and that plateau is below 62.5 μg, hence the lack of difference between the two groups. There’s just one problem with that argument. An exposure to 62.5 μg, to which the low exposure group was exposed, corresponds to roughly the total amount of mercury in vaccines to which American infants were exposed in 1989–before the alleged “autism epidemic.” Even if mercury caused autism and there was a plateau in the dose-response below a dose of 62.5 μg, that would not be consistent with antivacinationists’ other pet claim, that an autism epidemic started in the 1990s because of the increasing amount of thimerosal exposure due to vaccines. That couldn’t have happened if a dose of thimerosal less than 62.5 μg maxed out the risk of autism, because 62.5 μg is below the baseline exposure before the alleged “autism epidemic” started.Revisionist scientific history II: Thompson misinterprets his own study
The other study that Thompson harps on in the transcripts is one by John Barile at the CDC published in 2012. Here’s what he says about it:
Dr. Thompson: It’s going to take two or three years, right. They tell me, they’re two and a half years behind, and they actually said with Posey thing treat it as a FOIA because he’s not the head of a committee. So, I just, again, you gotta come up with a different message where you won’t get hammered and they can’t deny it. Right? The only thing I know for sure, is that I can say that pretty confidently, vaccines cause tics. We replicated that. The Barile article replicated that and showed that once you took into account the number of tests and reduced them down to constructs, the one thing you couldn’t get to go away was the tic effect.
Dr. Hooker: Was the tic effect, right. I agree. And I’m even using that in my son’s vaccine court case, because he has tics and so, we have that. It’s been confirmed in several studies, not to mention your study and then the Barile study that was the reanalysis from 2012. And I’ll go back and look at those means on Tozzi as well.
Thompson is also listed as a co-author on Barile’s study. A word of explanation regarding authorship is in order here. Thompson is last author, which usually signifies the corresponding author, the senior author who was the one overseeing the research. However, the article lists John Barile as the corresponding author, which means that Thompson, listed last, was deemed the author who contributed the least to the study. The study itself is a reanalysis of Thompson’s own 2007 NEJM study that he is now misinterpreting. So it’s not unreasonable here to discuss the Thompson 2007 study. This is a study that pointedly did not look at autism but rather at other neurodevelopmental outcomes. Basically, it was a cohort study that studied children from four HMOs that participate in the CDC’s Vaccine Safety Datalink. A total of 1,047 children between the ages of 7 and 10 were evaluated with a battery of standardized tests assessing 42 different neuropsychological outcomes and these outcomes correlated with exposure to mercury, estimated from prenatal maternal exposures to thimerosal-containing vaccines and exposures after birth.
As Steve Novella and a friend of the blog explained at the time, for some reason the investigators chose not to adjust for multiple comparisons. It is thus not surprising that they found some statistically “significant” exposures. One of these adverse associations was between thimerosal and tics in one HMO population and between thimerosal and language delay in another. Here’s where Thompson goes off the rails, taking a page from antivaccine activists like Sallie Bernard and David Kirby, Thompson cherry picks the negative association and ignores the positive. Why does this matter? Simple. By examining 42 neurodevelopmental outcomes and not correcting for multiple comparisons, Thompson made it virtually certain that a handful of the outcomes would be “statistically significantly positive.” Consistent with random chance, some of these were positive (as in mercury is protective against an adverse neurodevelopmental outcome) and some were negative. As a blogger other than Steve or me put it so aptly at the time:
The CDC study looked at 42 different outcomes, and determined multiple confidence intervals in each case, since different levels of exposure were tested. In total, I understand there were over 300 confidence intervals. Consequently, assuming the null hypothesis is correct, you should expect that an RR of 1.0 will be outside the 95% confidence interval in over 15 measures. What the study found was that in 12 measures there was an apparent protective factor, and in 8 measures there was an apparent risk factor. This is completely consistent with the null hypothesis. Therefore, the conclusion of the study, namely that the results of the same do not support a causal association between thimerosal-containing vaccines and neurological outcomes, is absolutely the correct conclusion.
Exactly. If you accept that thimerosal “causes” tics, then you have to accept that it also increases IQ. There is no basis to accept one correlation and reject the other. The most parsimonious explanation is that this study found no differences not attributable to random chance.
So what did Thompson do? He reanalyzed the data, with the help of John Barile, and published it in a pediatric psychology journal using “measurement models to assess more efficiently the associations between thimerosal exposure and theoretically meaningful neuropsychological constructs using a subset of the outcomes from the original study” and items “primarily based on the previous studies that found significant associations between methylmercury exposure and neuropsychological outcomes.” In other words, they got rid of all the other comparisons by organizing “25 of the measures into the following theoretical constructs based on expert opinion and previous literature: general intellectual functioning, verbal memory, fine motor coordination, executive functioning, behavior regulation, tics, and language.” By torturing the data this way, they found one statistically significant association between exposure to thimerosal-containing vaccines and the presence of tics among boys but not among girls. They concluded that “given that the association between thimerosal and tics has been replicated across several different studies, it may be informative to consider additional studies examining these associations using more reliable and valid measures of tics.” The problem is that those previous studies were not particularly convincing, and neither is this one, particularly given that the effect was only seen in boys. In the transcript, Thompson is even quite blatant when he explains why he chose to publish his reanalysis in a psychology journal:
Dr. Thompson: …And here is the other thing, is you gotta get it out of the medical journals, you gotta move it to the psychology journals. I don’t know if you saw but the Barile article got published in a psychology journal. It wasn’t actually, it was like Pediatric Psychology.
Dr. Hooker: It was the Journal of Pediatric Psychology, I saw that.
Dr. Thompson: Right, but if you get it out of the medical world and into the psychology world, you are not going to get as much bias from the medical establishment that has such a strong hold over these medical journals.
Dr. Hooker: Yeah, that makes a lot of sense. I’m not as well traveled in that realm. Is the Journal of Pediatric Psychology a good one to look at?
Dr. Thompson: It’s a great journal. It is a very good journal. We got great reviews from that journal. I’ll tell you. They actually made us [unintelligible] our discussion. They actually said, why are you downplaying the association with tics? So, actually made [UI] . . .
In other words, he looked for a sympathetic journal with a relatively low impact factor (2.472). Next, I predict, he’ll be publishing in bottom-feeding pay-to-publish journals.Inside politics and “persecution” at the CDC
One thing that becomes apparent reading this book is that Thompson, like Barry, has a definite agenda. He also doesn’t think very much of his colleagues at the CDC. Interestingly, despite Rep. Posey’s use of an alleged quote by Thompson accusing his co-authors on DeStefano et al of destroying data, no such statement is found in the book. Instead, however, on many occasions, Thompson expresses concerns that he’ll be labeled as “mentally ill” or “crazy” by the higher-ups at the CDC. For example, in Transcript #2, there is this exchange:
Dr. Thompson: Well I [laughing], Brian, this is where you and I don’t know each other very well and I . . . Here’s what I struggle with, is I struggle with saying anything that isn’t in writing that can’t be backed up. Here’s my fear okay? Let’s say you go public with anything okay? Whatever and then it becomes clear that you got information from call me. And then people will immediately say, “Well, he’s mentally ill and why would you believe anything that he says, it’s just hearsay.”
Dr. Hooker: How do people know about your business? Why do they know about ya know . . . It’s really none of their business your mental state or whether you’re quote-unquote mentally ill or not.
Dr. Thompson: I know but it will become, it will become, that will be the way they undermine me.
It’s hard for me not to point out here that Thompson’s “allies” Brian Hooker and Andrew Wakefield have already basically thrown him under the bus with respect to whether he suffers from any form of mental illness. They even alluded to this when they wrote a letter to the CDC demanding an investigation of Thompson’s allegations, quoting Thompson as saying that he had become “delusional” in a conversation dated May 24, 2014. When I went back to look at their letter, I noticed that that’s the same date as Transcript #2 in Vaccine Whistleblower, and there is no mention of that transcript. There are, however, two notations of “edited due to sensitive personal information” in this transcript, specifically:
Dr. Thompson: I know, maybe, maybe not, but I’m saying what he [Thompson’s whistleblower lawyer] and I agreed to. This is a lawyer that was reading through these documents that had never seen them before. And I basically was telling this guy I was complicit, and I went along with this, we did not report significant findings. Ya know, I’m not proud of that and uh, it’s probably, it’s the lowest point in my career that I went along with that paper. [Edited due to sensitive personal information.]
Thompson was quoted in Hooker and Wakefield’s letter as saying:
Ya know, I’m not proud of that and uh, it’s probably the lowest point in my career that I went along with that paper and I also paid a huge price for it because I became delusional
The match between the last sentence of the first quote and the first sentence of the last quote tell me I found the right place. There is another example as well.
As I said at the time, how low can Wakefield and Hooker go? In order to imply that the magnitude of the “crime” Thompson was being forced to be party to was so massive that it led him to some sort of mental breakdown, Hooker betrayed Thompson’s confidences about a very personal health issue. Barry, at least, left this part and another quote about Thompson’s having been delusional out of his book. I have no idea what Thompson’s mental state was or is (and deem it irrelevant for the purpose of assessing his veracity and credibility), but it’s odd that he fears that the CDC might paint him as mentally ill to discredit him but willingly cozied up to people who have already painted him as mentally ill when it suited their purpose.
Be that as it may, what comes through loud and clear in all of the transcripts is Thompson’s utter contempt for and fear of his former co-authors and colleagues. Time and time again, he unloads to Hooker about how he fears that they will collude to deny anything he claims and turn it into his word against theirs, the presumption being that their word will be what is believed. He claims that the CDC “watered down” DeStefano et al and his own NEJM study when, even by his own account, what happened sounds like the normal give and take that goes on in the multiple layers of approval that any study done by a government agency has to go through before it is approved for submission for publication. He even brings up Poul Thorsen suspected of committing fraud with CDC research grants, a man that antivaccinationists like to portray as being somehow “central” to the CDC’s studies that failed to find a link between vaccines and autism, when in reality he is anything but and those of us who oppose antivaccinationists would be more than happy to see him face justice. It’s just another place where Thompson sounds just like an antivaccine activist. He and Hooker even talk about how Mark and David Geier tried to do what needed to be done when they tried to go beyond the IRB and merge Vaccine Safety Datalink datasets and lamenting how it’s not possible any more to do what they tried to do. Amusingly, though, Hooker points out that ” it doesn’t really do me any favors to publish with the Geiers.” Given the Geiers’ history of atrociously unethical science in the name of blaming thimerosal for autism and Mark Geier’s history of having his medical license revoked, that has to be the understatement of the year!
Perhaps the most telling part of this whole exchange is here:
Dr. Thompson: Yeah, it’s all there. Um, but I’ve never looked at it yet. But I could actually go into the database right now and do a frequency count on things. But, I’m not going to do anything like that right now. I’m just really trying to sort this all out. I’m trying to, ya know I’m being in trouble because I’m blowing up and stuff like that and I’m getting really agitated and I just have to settle down.
Dr. Hooker: Right, you had mentioned on I think on a previous voicemail something about maybe taking a leave of absence or um or uh putting in for a new assignment.
Dr. Thompson: Yeah, I was considering getting detailed out of the branch. The downside to that is I would no longer have access to this type of information that I am sharing with you. I’m learning more and more. As I ask more and more, I’m learning more and more. I am, these people are like in one big bubble, they uh and their bubble is getting smaller and smaller.
So, on May 24, 2014, Thompson admitted to Hooker that the only reason he’s sticking around his branch of the CDC even though everybody there had come to distrust him (as well they should!) was to have access to information that he could funnel to Hooker, such as the existence of the SEED project, a dataset that contains the health records of 1,200 children, 800 of whom are confirmed autistic, with complete vaccination records. Thompson was also royally ticked off about the lack of use of this resource:
Dr. Thompson: So, um, what’s amazing, now this is what’s going to be shocking to you, it shocked the crap out of me. They have ya know six different sites interviewing data and um they all put in proposals to do studies. So far there is about sixty proposals in, um, for people ready to do studies. Not a single one of them looks at vaccines, not one! [laughing] So, I, well, I ripped into these people this week. And I’m like, “These vaccine studies have to be done. This is the largest case-control study you could ever do. They’re all objectively identified as kids with autism. You have the vaccine records.”
So, assuming this is true, Thompson is outraged that, of all the sixty proposals for studies using SEED project data thus far submitted, none of them looks at vaccines? If that’s not an indication that he’s become antivaccine, I don’t know what is! Let’s just put it this way: Did it ever occur to Thompson that the reason there are no proposals for studies using the SEED data that examine vaccines is because, from a strictly scientific standpoint, there is no interest in vaccines as a cause of autism or other neurodevelopmental disorders. The reason for that is simple. It’s been studied to death, and there is no credible evidence to support the hypothesis that vaccines (or just thimerosal-containing vaccines) cause autism. Like any good antivaccinationist, William Thompson cannot accept the science.
In fact, so antivaccine has William Thompson become that he and Brian Hooker gleefully trash other antivaccine groups for betraying the cause. Sallie Bernard, for instance, comes in for particularly harsh criticism, with Hooker dismissing her as a “double agent.” Mady Hornig, who produced the widely derided “autistic mouse” is derided by Hooker as “shacking up” with Ian Lipkin, whom Thompson chimes in to dismiss as an “arrogant dick,” even though they were married at the time. Of course, Hornig later did a study that tried to replicate Andrew Wakefield’s case series in The Lancet and failed to find a correlation between MMR and autism. How fast antivaccine heros fall when they embrace science!Kevin Barry’s agenda
I see little reason to write extensively about the rest of the book, the chapters that Kevin Barry wrote to fill it out to a measly 172 pages, counting the foreword by RFK, Jr., the preface by Boyd Haley, and Barry’s “executive summary” of the four transcripts. However, these still must be briefly discussed. This book is, if nothing else, intended as antivaccine propaganda, in which a former member of the hated “other side” recants and changes sides. Barry clearly wants to use Thompson to attack the vaccine program and to use Thompson as a motivator to prod antivaccinationists to agitate for political action and investigations into vaccine safety. That’s why the last three chapters of the book are dedicated to using Thompson’s betrayal of the CDC and science to demand that the President act:
The entire vaccine program is under the Executive Branch. It’s long past time for presidential leadership to take the issue of vaccine safety seriously. If President Obama won’t do it, then the next president must clean out the Immunization Safety Office and replace everyone but Dr. Thompson. Ideally, the replacements should do their best to resist unethical behavior, resist omitting significant data, and not lying in the first place.
Barry also demands that Congress “schedule hearings, issue subpoenas, and compel testimony under oath” and asserts:
As Dr. Thompson indicates, the lack of accountability must end. The White House, Congress, and the press need to hold CDC accountable for the lies and deception regarding vaccine safety over the past fifteen years. The same applies to the American Academy of Pediatrics—the nation’s pediatricians have also been deceived.
The funny thing is, nothing in Vaccine Whistleblower actually demonstrates this. All we have are the words of a very angry man, William Thompson, who clearly has been nursing a grudge against his former colleagues since at least 2003 and is willing to make accusations without significant evidence at them. All we have from this very angry man are a highly select number of transcripts, only four out of over 30, in which this bitter man makes his accusations. It’s all very one-sided, and unfortunately the CDC, probably because Thompson has lawyered up with one of the best whistleblower attorneys in the country, is being painfully vague and discreet in its response:
CDC is aware that employee Dr. William Thompson has raised concerns regarding an article he co-authored that was published in 2004 in Pediatrics. Consistent with CDC’s existing policies and procedures, the agency, through its Office of the Associate Director for Science (ADS), and in coordination with the HHS Office of Research Integrity, is reviewing these concerns. The agency will provide further information once the review is completed.
The bottom line is that this book is nothing more than propaganda, and deceptive propaganda at that. The sad thing is that a formerly reputable scientist, William Thompson, provided the grist for the propaganda because he apparently has an ax to grind against his former co-investigators. In any other organization besides a government organization, Thompson would have been fired a long time ago for incompetence and being a troublemaker, and he would have deserved it. Instead, Thompson has kept his job and is, of necessity, treated with kid gloves.
As for Barry’s book, it is propaganda, nothing more. What’s worse is that it isn’t even very good propaganda. It’s hard to read, and hits the reader over the head with its message, which isn’t even earned based on the thin gruel that the four transcripts provide. Indeed, if there was one impression of Thompson that I got from reading all the transcripts, it was of narcissism. Therein lies the comparison to Andrew Wakefield. As I read Thompson’s complaint, what came through loudest was his unshakable belief that he is right and everyone else at the CDC is wrong, that the only reason anyone could disagree with him is because they’re indoctrinated or bought off. To him his colleagues are not just wrong but incompetent, ideologically blinded boobs who are out to destroy him.
In fact, I can’t help but wonder if we are seeing a new Andrew Wakefield being born and if his name is William Thompson. I’m just thankful that, unlike the real Andrew Wakefield, the “CDC whistleblower” appears to be retiring and publicity-shy, preferring to act behind the scenes. Unfortunately, he can do a lot of damage to the vaccine program just the same.
This post addresses some legal issues raised in the Vaccine Whistleblower book. The first part explains whistleblower protections and how Dr. Thompson’s allegations fit into them. The second part addresses Dr. Thompson’s suggestion of an independent research agency. The third part explains why the book’s claim that school mandates violate international human rights is incorrect.
A note on the book: Chapters 1 is an executive summary of Chapters 2-5, the interview transcripts; Chapters 6-12 are the author Kevin Barry’s thoughts on what should be done. (Note that Dr. Gorski has also discussed this book from the perspective of the science.)Prologue: to set the scene
The “Vaccine Whistleblower Book” has four transcripts of telephone conversations between William Thompson and Brian Hooker, recorded between May 1, 2014 and July 28, 2014.
Hooker has elsewhere stated that these conversations were only four of over thirty conversations between Thompson and Hooker. Hooker asserts these conversations began in November, 2013, and that Thompson initiated the conversations. It is not clear if these four recorded conversations were the only ones during that time frame, or what was discussed in the non-recorded conversations.
William Thompson was a co-author on a number of vaccine-safety studies published by the CDC. The most salient one for this discussion is (hereinafter DeStefano 2004):
DeStefano F, Bhasin TK, Thompson WW, Yeargin-Allsopp M, Boyle C. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta. Pediatrics. 2004 Feb;113(2):259-66.
It is not clear why Thompson became concerned enough to reach out in 2013 about a paper that had been published almost a decade previously.Part I: Whistleblower Protections in the United States:
When a federal employee discloses wrongdoing that he or she has a “reasonable belief” falls into certain categories in the United States, the law protects the employee from retaliation by the agency he or she exposed (or tried to expose). That’s the heart of whistleblower protections. It’s important to remember that both the Whistleblower Protection Act and the Whistleblower Protection Enhancement Act seek to provide broad and strong protections to employees disclosing wrongdoing, and Congress clearly signaled a desire to interpret doubts in the disclosing employee’s favor — though that does not translate into automatic protection.
It’s also important to point out that these protections only come into play if there was alleged retaliation by the agency in response to a disclosure.
An employee does not claim whistleblower status in abstract. An employee discloses information about wrongdoing; then, if the agency retaliates, whistleblower protections provide a remedy to the employee (there are a number of other contexts in which we use the term whistleblower that are less relevant here).How do these whistleblower protections apply to Dr. Thompson?
Disclose to whom?
Dr. Thompson did not go higher up in CDC, to another agency, to the administration, to Congress or the press directly. What he did do is have a long series of phone conversations with a private citizen — Dr. Brian Hooker — in which he complained about his colleagues’ conduct. But that does not negate the protections: they come in to force, with some exceptions that don’t apply here, regardless of to whom the disclosure were made (5 U.S.C. § 2302(b)(8)(A)).
That said, if Dr. Thompson’s goal was to correct wrongdoing, his choice of channel to correct it was strange, to say the least. According to the transcripts, Dr. Thompson only hired legal representation in May 2014, when the possibility of his involvement becoming public was raised (p. 24, chapter 3). So he didn’t have the benefit of legal counsel when he decided to call Dr. Hooker initially. But if you think there is serious wrongdoing in your agency and you want to effectively redress it, is calling an individual that is not only part of the administration but is in many ways an outsider the best way to do so? Dr. Thompson could have hired legal counsel in 2013, or done a Google search on, for example, whistleblower, government and wrongdoing — the first result of which is the Office of Special Counsel whose mandate includes protecting whistleblowers. He could have gone to the press. He could have tried a number of things that would be more effective than calling Dr. Hooker, even if he thought Dr. Hooker had some connections to members of Congress. It may be unfair to criticize Dr. Thompson in hindsight — he may not have thought of this or been well informed on how to report alleged government misconduct — but it is still a strange choice.Do his allegations fall into protected categories?
In 2012, to broaden protection for whistleblowers, Congress passed the Whistleblower Protection Enhancement Act (WPEA). Relevant to us, section 110 of the act applies whistleblower protections to scientists that seek to disclose acts they reasonably believe consist of “censorship related to research, analysis, or technical information that cause, or will cause, gross government waste or mismanagement, an abuse of authority, a substantial and specific danger to public health or safety, or any violation of law.” Censorship is defined as: “any effort to distort, misrepresent, or suppress research, analysis, or technical information.” Dr. Thompson claims he saw acts of suppressing research and analysis that could be directly related to the public health, to harm to children. If his belief is reasonable, whistleblower protections would apply to him.What is Reasonable Belief, and Did Dr. Thompson have it?
Reasonable belief asks
whether, given the information available to the whistleblower, a person standing in his shoes could reasonably believe that the disclosed information evidences one of the identified conditions in the statute.
from The U.S. Office of Special Counsel’s Role in Protecting Whistleblowers and Serving as a Safe Channel for Government Employees to Disclose Wrongdoing, drawing on these cases: Fitches v. Dep’t of the Air Force, 82 M.S.P.R. 68 (1999); Gores v. Dep’t of Veterans Affairs, 68 M.S.P.R. 100 (1995)
The information does not have to be true, and the focus is on the whistleblower’s state of mind, not the listener. The whistleblower’s motives — for example, a desire to get even with a co-worker — do not negate the protection and are not directly connected to the reasonableness of the belief.
Given the holes in the facts in the book and my lack of familiarity with the day to day realities of the scientific process, I cannot really assess whether Dr. Thompson had reasonable belief that his co-authors engaged in “any effort to distort, misrepresent, or suppress research, analysis, or technical information.” I would assume his belief was sincere, but I don’t know if it was reasonable. All I can say is that there is a good chance that an administrative official or judge that does not have a background in science will, given the intent to make whistleblower protections broad, give Dr. Thompson the benefit of the doubt — if his agency acted against him and whistleblower protections were needed.
So far, there is no indication the CDC acted against Dr. Thompson, so there was no retaliation to trigger the protections in the act. It’s important to note that if there is reasonable belief by the employee that he is disclosing something that falls under the headings in the act, the agency has a heavy burden to support any action against him. If there is evidence that the disclosure was a contributing factor in the act against the employee, and knowing about the disclosure and the action being close in time to the disclosure can create such a case (as can other types of evidence), the agency
can avoid liability only if it demonstrates by clear and convincing evidence that it would have taken the same action in the absence of the whistleblowing.
It makes sense, therefore, that the CDC will be very careful not to take actions that could be seen as retaliation against Thompson if they believe his claims could possibly meet the standards in the whistleblower protection acts.
One more point on this deserves addressing. On page 111 Mr. Barry, the book’s author, claims that Dr. Thompson needs to be subpoenaed to testify before Congress because “it is unlikely that his attorney, an expert in whistleblower cases, would allow him to testify unless compelled.” It’s not quite clear why Mr. Barry thinks that. First, Dr. Thompson is an adult; he doesn’t need permission to testify, though he would be wise to listen to the experienced legal counsel he hired. Second, if his goal, as suggested in the transcripts, is to achieve meaningful reform, why wait for a subpoena? As his lawyer, who specializes in these areas, could have pointed out, OSC can require an investigation by the agency and then make recommendations to Congress and the CDC. Neither is bound by OSC’s recommendations, but recommendations by a specialized agency focusing on whistleblowing will almost certainly have an impact. And if Congress decided to investigate before OSC is done, it could. If CDC wanted to retaliate, whistleblower protection would come into play with or without a subpoena.
The only explanation I can think of is that Dr. Thompson thinks he may be criminally liable for something, and thinks a subpoena would guarantee immunity. It won’t, however. The only situation in which a subpoena would mean immunity is if Dr. Thompson was forced to testify after asserting a Fifth Amendment claim before Congress. Congress can grant immunity, or partial immunity (meaning Dr. Thompson can still be prosecuted, but not using his own testimony), but doesn’t have to, and it’s not an automatic part of a subpoena. These are two separate things.Part II: Thompson’s Suggestions for Reform of Vaccine Safety Oversight.
On page 69 to the book, Dr. Thompson explains his suggestion for solving the problems he identifies in CDC’s decision making. He says:
It would end this way. That you would end up with an agency like the National Transportation Safety Board. You know, the FAA; then there’d be NTSB. The FAA is responsible for regulating all sorts of things, but then when an accident happens, you bring in the NTSB. So, you would have the equivalent of an NTSB-like organization that would do vaccine safety studies independently.
Dr. Thompson suggests an institutional solution to the problem he identified. Institutional design is a well-accepted — and heavily studied — part of public administration. But both Dr. Thompson’s problem definition and his proposed solution seem simplistic. Dr. Thompson — and the authors of the book — seem to think the problem is that the CDC has complete control over studying and monitoring vaccine safety, which enables the agency to rig results, and that there is a lack of independence (from industry, presumably?) that motivates it to actually do so. Thompson also seems to think a separate agency will solve the independence problem. Neither part is correct.
Vaccine Safety Monitoring is Done by Multiple Actors
Even in the United States alone, vaccine safety is handled by more than one body, with a complex interaction both at the federal and state level. To give a simplified and partial picture, the FDA regulates licensing of vaccines, including governing clinical trials, pre and post licensure safety and effectiveness studies, labeling, manufacturing quality, and so forth. A CDC advisory committee recommends vaccines that are then approved by the CDC Director for specific populations. Even there, it’s not the CDC staff, but an advisory committee made of experts and a consumer representative, that makes recommendations which the head of the CDC confirms, and recommendations are also made, on that issue, by the American Academy of Pediatrics and the American Academy of Family Physicians. Federal advisory committee are heavily regulated by the Federal Advisory Committees ACT, which among other things imposes requirements of transparency. The Advisory Committee on Immunization Practices debates in public and provides detailed, heavily referenced recommendations that are then published (though often a while after they are made): nothing is hidden. The recommendations draw on studies not only from the United States but from the entire world. And those are recommendations: they do not automatically translate into mandates in any state, though they certainly influence the mandates.
In other words, the CDC is not a classic regulatory agency at all. It certainly has an influence on vaccine usage; but it’s not the CDC that can fine manufacturers for wrongdoing or oversees clinical trials. The CDC has additional roles — vaccine distributor; information provision to the public; a role in programs funding vaccines for certain populations; monitoring vaccine usage; and a responsibility for preventing diseases beyond vaccinating alone, for example, via monitoring cases. None of these make it a regulatory agency in the classic sense, and it has not been treated or studied as one.
A large part of the CDC’s role in vaccine regulation is close to NTSB’s role in air safety — research and investigate and recommend after the fact, though Dr. Thompson is right that it is more involved in actually handling vaccines and their influence than NTSB is. But the CDC is still probably closer to NTSB than FAA in this comparison. FDA is the main regulatory agency.
The CDC has a role in monitoring vaccine safety. Part of that role is doing studies. Another is that the Vaccine Adverse Reporting System is partly managed by the CDC. But the CDC is not alone in handling vaccine safety: the FDA has a part in that, as does the Institute of Medicine, a private body. Vaccine safety studies post-licensure (which are massive) are done through the Vaccine Safety DataLink. And the studies and results are collected and analyzed primarily by academic researchers independent of the CDC. Researchers in other countries also do studies, and other governments also monitor vaccine, with the information coming from multiple directions.
The diffusion of responsibility between several acturs prevents each one actor from completely controlling the information on vaccine safety. The fact that many studies are done abroad also limits the ability of CDC to control the information. Why would creating one specialized agency guarantee more accountability than a variety of actors that can check each other?Independence and its Feasibility
The second concern those promoting the CDC whistleblower story have is that the CDC’s personnel is too involved with industry in some way — a claim certainly made by Mr. Kennedy in his forward (p. xix) and by Mr. Barry himself (p. xxi and 6). It may be that this is part of Dr. Thompson’s concern.
If that’s what is on his mind, Dr. Thompson should ask himself where members of NTSB come from. According to the board’s website there are currently four members of the board. One previously served with the FAA, one has served with both the CDC and the American Automobile Association; the third was a professional pilot for three decades and worked in regulatory affairs in US Airways; and the fourth had a long career with an airplane manufacturer. The last two, in other words, came from industry, and the Chair came from FAA.
Reality check: in a specialized area, the majority of people involved in regulation and policy would often have served in more than one role and moved between the players. That’s because their expertise will be sought out. Specialized training takes a long time and is then often sought out by different actors. And often experts have to get hands-on experience somewhere, and in a specialized field the options are limited. And you often want the people regulating to have a mixture of theoretical knowledge and hands-on experience in the area.
You do not want people with no background in air safety having the major say in regulating it or investigating accidents, because lack of expertise, however good the intentions, can easily lead to bad results in a technical area that has real safety implications. For exactly the same reason you do not want people who do not understand infectious diseases and the vaccines that prevent them having the main say on regulating or monitoring them, because they will get it wrong, potentially with very, very bad results. Experts can get it wrong too — but hopefully, much less often. Is there a risk of corruption? Of course. That’s why we want multiple actors and divisions of labor, as well as mechanisms of accountability in place. That’s why you want to think about designing incentives. But you will not be able to get rid of interconnections between the players in a specialized field. Not going to happen, not without sacrificing expertise and knowledge, again, with potentially much, much worse consequences.
Thinking that you can create a magically independent agency to regulate vaccine safety and populate it with people that know what they are doing but do not have connections to industry or other government agencies involved with vaccines is simply unrealistic.
Even if there was extensive evidence of corruption and wrongdoing of the CDC — and the book has not provided that — creating another agency is no panacea, and has very real costs, monetary and in terms of the coordination that will need to happen with that agency. Some more sophisticated thought would be needed to truly analyze what, if any, are the problems with CDC and how to solve them.Part III: School Mandates and Human Rights
On pp. 128-129 (Chapter 1,1 First Principles and Moral Courage), Barry argues that freedom from vaccination — and in that case explicitly the freedom of a parent to refuse vaccination for her child — is a human right. This is not the first time we have heard that argument — it was made by Ms. Holland in her article in the book Vaccine Epidemic, chapter 1. Here, as there, it’s used as an attack on school mandates, claiming they violate informed consent. The twist added in Vaccine Whistleblower is to base the opposition on what Barry interprets Dr. Thompson to have disclosed. The passage reads:
If a state is going to force its judgment on a citizen or a parent regarding vaccination (a preventative medical intervention), the safety studies supporting those vaccines must be rock solid. According to Dr. Thompson, the studies are anything but rock solid. The quality of vaccine safety studies is insufficient to support mandatory vaccination.
Given what Dr. Thompson has disclosed, parents should not be removed from the decision-making regarding the health of their children. Parents know their own children’s and their own family’s health history better than their pediatricians and their elected representatives. Parents also know their religious beliefs and their personal relationships with God better than pediatricians, their elected representatives, and employees of their school districts.
The initial premise is incorrect in several ways; and the additional claim also doesn’t hold water.Whose Rights?
First, while I would agree that generally an adult of sound mind should not be forced physically to undergo any medical procedure, including vaccination, though there may be consequences to such refusal (such as quarantine or limiting access to some jobs), the protections do not apply in the same way to children — who do not have a choice either way. This discussion is not about bodily autonomy — which is why the comparison to rape made by anti-vaccine activists is not just reprehensible but incorrect. The question here is the extent of parental rights to make medical decisions for their child.
The view that parents have a human right to refuse vaccination for their children is problematic. Parents usually have a right to make medical decisions for their child — but that right is not, and for some time has not been, absolute — and that’s a good thing. Children are no longer property of their parents, to break and use as the parents will. Modern thinking raises three reasons to support the rights of parents to make those decisions (for a more complete discussion, see The Rights of the Unvaccinated Child: The Legal Framework).
First and most important, a child is — generally correctly — considered cognitively unable to make those decisions. Someone has to make them for the child, and in most circumstances it’s the parent who stands as the child’s agent, and makes decisions for the child, since usually the parent can be trusted to represent the child’s best interests.
Second, the parent usually has the responsibility to cover costs of treatment and to deal with the child in many ways. With such responsibility should come the power to make decisions that fit the family’s means and abilities.
Third, we respect privacy of the family and its autonomy, and want to minimize government interference in it. Most iterations of the “my child, my choice” argument seem to emphasize the third reason — but that is, clearly, much weaker than the first.
The main reason to give parents rights is because we hope and believe that usually parents will be the best person to protect the child’s interests. The child is an autonomous being, and children have rights. Parental rights are already limited and regulated by the state. Parents cannot starve or abuse the child. Parents cannot, in California, leave a young child unattended in a car. There are already clear limits on parental powers over a child’s welfare. Given the dramatic imbalance between the risks of vaccinating and the risks of not vaccinating, the state has the authority to step in in this area, too.
If anything, the human right at issue here is the child’s right to health, the right to be protected against preventable diseases via the simple, safe precaution of vaccinating. Not the right of the parent to deprive their child from such protection because they subscribe to anti-vaccine misinformation.
Indeed, in Prince v. Massachusetts, the seminal case about the limits of religious rights when it comes to children’s welfare, the Supreme Court, in a statement that wasn’t part of the ruling but has been incredibly influential, based its support of force vaccination in part on that:
[a parent] “cannot claim freedom from compulsory vaccination for the child more than for himself on religious grounds. The right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death.
Prince v. Massachusetts, 321 U.S. 158, 166–67 (1944)
And in another case from New York, a court found not vaccinating against measles, during an outbreak, can amount to medical neglect. (In re Christine M., 595 N.Y.S.2d 606, 616 (N.Y. Fam. Ct. 1992)).
To be clear, my view is that as long as dangerous diseases are reasonably under control in the United States, as long as the threat is not immediate, the state usually should not intervene and force vaccinating. But that’s not because the state does not have authority to intervene. It’s because parental rights, for the reasons above, matter, and where we can respect them without irreversible harm to the child, we should. We have other ways to increase immunization rates besides forcing unwilling parents to vaccinate, and as long as rates of non-vaccination are kept low, herd immunity can protect children. We should avoid the most extreme step unless the child is at immediate risk.
But the state can and should use other means to increase rates, to protect all children and others who may be harmed by disease — including, perhaps especially, children whose parents deny them vaccines.School Mandates are not Force Vaccinating
Furthermore, school mandates are not “force vaccinating”. Yes, it can seem intrusive and hard to parents who find homeschooling very difficult. But there is a difference in the degree of state intervention and the level of coerciveness. Contrary to some of the language we have heard, school immunization mandates do not mean anyone will be coming to the house of parents with a gun and force vaccinating, or throwing parents in jail. It’s just not direct coercion.
Even if we acknowledge parental rights to refuse vaccination in most circumstances, that does not mean they have a corresponding right to send that child to school unvaccinated and risk other students’ health. School immunization mandates are a traditional public health policy in the United States, dating back to the 19th century, and they have been upheld by every court, state or federal, that ruled on them, because even the strongest formulation of parental rights does not give a parent a right to impose the risk of disease they choose for their own child on others or their children. Your child is not the only one at school; low vaccination rates make schools less safe for others; and a parent does not have a right to make that choice for other parents and their children.School Mandates and Dr. Thompson’s Claims
As to the claim that Dr. Thompson’s allegation are an argument against mandates — first, it’s not clear that Dr. Thompson’s claims undermine even the 2004 paper, as Dr. Gorski’s review of the book demonstrates. Second, the 2004 paper is not the only one on MMR, and is not actually a “principal” one, in spite of the book’s claims; even for MMR, it’s one of many studies — and a small, localized study, with substantially less power than, for example, the large scale Danish or Finnish studies. Third, even if the alleged connection had power, and if the 2004 paper was the only or principal paper on MMR, they would do so, at most, for African American boys who received MMR between 18-36 months: so if an African American boy was not vaccinated on time, the solution is simple: vaccinate after the age of 36 months, where no correlation was found. It certainly does not support wholesale exemption of children from immunization mandates, something that would increase the risk of disease in schools.
Contrary to the author’s claims, the transcripts do not negate the science examining if there’s a link between MMR and autism, or vaccines and autism generally. They are not an argument against school immunization mandates — a traditional policy, aimed at making schools safer.
Dorit Reiss is a law professor in UC Hastings College of the Law. She received her LLB from the Hebrew University and her Ph.D. from the Jurisprudence and Social Policy program in UC Berkeley. She first became interested in vaccine related issues after her first son’s birth when she discovered through parenting blogs that there was an anti-vaccine movement. Over the last few years she has become more involved in activism and writing related to vaccine law and policy.
I’ve written more times than I can remember about the phenomenon of overdiagnosis and the phenomenon that is linked at the hip with it, overtreatment. Overdiagnosis is a problem that arises when large populations of asymptomatic, apparently healthy people are screened for a disease or a condition, the idea being that catching the disease at an earlier stage in its progression will allow for more successful treatment. Two prominent examples include—of course—screening for breast cancer with mammography and screening for prostate cancer with prostate-specific antigen (PSA) testing, and I’ve written about the problem of overdiagnosis with each of them on many occasion. Basically, overdiagnosis occurs when the screening test picks up what we call “preclinical” disease (i.e., disease that hasn’t become symptomatic) that, if left untreated, would never become symptomatic or endanger the health or life of the patient). Although intuitively, it seems to the lay public (and, truth be told, most doctors) that detecting cancer earlier must be inherently better, it turns out that it’s way more complicated than you think. There is a price to be paid for early diagnosis in the form of overtreatment of disease that doesn’t need treatment and for disease that is destined to threaten the life of the patient earlier treatment doesn’t always result in better outcomes. Also, whenever you screen for a condition in asymptomatic people, you will always—always—find much more of it, and the significance of those added diagnoses is not always clear, as a new study in JAMA Oncology shows.
Before I get to the meat of the study, from my perspective, nowhere is the problem of overdiagnosis and overtreatment in cancer screening as pronounced than in the condition known as ductal carcinoma in situ (DCIS). DCIS is commonly referred to as “stage 0″ breast cancer and is characterized by milk duct cells that appear malignant but remain confined to the milk ducts. In other words, they haven’t invaded the tissue surrounding the ducts. In general, DCIS is treated similarly to breast cancer, with surgical excision, either by mastectomy or breast conserving surgery, followed by radiation therapy if breast conserving surgery is used. Then, depending on its hormone receptor status, adjuvant treatment consists of blocking estrogen for five years. The rationale for this treatment is the view of DCIS as being a precursor to fully invasive breast cancer and that treating the DCIS will prevent the development of breast cancer. Over the last couple of decades, however, it has become clear that not all DCIS is created equal. Much of it will never progress to breast cancer in the lifetime of the woman (particularly if the woman is older, which means less time for fully malignant transformation to occur). Evidence suggesting this includes studies showing an increase in DCIS incidence by 16-fold since the 1970s, when mammography started to be introduced on a large scale, with little change in the incidence of invasive cancer. Today, 20-25% of mammography-detected breast cancer diagnoses are DCIS; forty years ago, DCIS was an uncommon diagnosis, except associated with an invasive cancer.
Screening for breast cancer tends to be based on the concept that progression from normal duct cells to invasive cancer follows more or less a linear progression, and then invasive cancer grows in the primary organ and eventually spreads, either through lymph vessels or the blood, to distant sites. By this paradigm, effective screening should result in finding disease earlier and thus preventing patients destined to develop metastatic disease from progressing to that point because the disease is removed before it can metastasize. This should result in what is referred to as a “stage shift,” in which the incidence of metastatic disease at diagnosis and of locally advanced disease declines, “shifting” the stage lower, to smaller, more localized disease. Unfortunately, although there is evidence of a small stage shift for breast cancer, the decline in incidence of advanced disease is far lower than the amount of DCIS diagnosed, meaning that most DCIS is almost certainly overdiagnosed. Indeed, in the accompanying editorial to this study, Laura Esserman and Christina Yau note that long-term epidemiology studies have demonstrated that the removal of 50,000 to 60,000 DCIS lesions annually has not been accompanied by a reduction in the incidence of invasive breast cancers. The problem, of course, is that we don’t know which cases of DCIS are destined to progress and which are not; so we have to treat them all the same.
This new study introduces a new wrinkle into the situation. You’ve probably seen the stories about it, such as one in the New York Times entitled Doubt Is Raised Over Value of Surgery for Breast Lesion at Earliest Stage. The reason is that the study questions whether treatment of DCIS actually decreases a woman’s risk of dying of breast cancer, based on an analysis of the Surveillance, Epidemiology, and End Results (SEER) database, a massive database maintained by the National Cancer Institute of cancer cases and outcomes. Specifically, the investigators (Narod et al) from the Women’s College Research Institute, Women’s College Hospital, and the Dalla Lana School of Public Health at the University of Toronto looked at the SEER18 database, which covers approximately 28% of the U.S. population. (The SEER database is maintained by a number of local registries; so it is basically a database of multiple local cancer registries.) From the SEER database, Narod et al identified 108,196 patients with DCIS diagnosed from 1988 to 2011 who formed the cohort studied. Patients with microinvasion (a tiny area of invasive cells) were excluded because that is generally considered invasive cancer. They then calculated a standardized mortality ratio (SMR), which is the ratio of the risk of dying in the study cohort compared to the risk of death in all women in the US population.
The first finding of the study is that the breast cancer–specific mortality over 20 years was 3.3% (95% CI, 3.0%-3.6%), which is similar to the lifetime risk of all women of dying of breast cancer, according to the American Cancer Society (2.7%). Next, the risk of death from breast cancer among all women with DCIS was 1.8 times greater than that of the US population (SMR, 1.8 [95% CI, 1.7-1.9]). Not surprisingly, the SMR decreased with increasing age at diagnosis, from 17.0 for women with DCIS before age 35 years to 1.4 for women older than 65 years. This is not surprising, given that younger women have a much longer time to live during which breast cancer can develop than older women. It makes intuitive sense. Indeed, as Esserman and Yau observe, DCIS in women under 40 is likely biologically different, because it would not in most cases be detected by mammographic screening and would thus be first noticed as a lump or other symptom. For these women, continuing current treatment protocols is probably appropriate.
There were other risk factors besides age at diagnosis of DCIS that predicted breast cancer mortality. For example, black women had a higher risk of death from DCIS than white, non-Hispanic women (HR 2.42 [95% CI, 2.05-2.87]; p < 0.001). Other factors were related to the tumor itself and included tumor size, grade, and the presence of a characteristic of DCIS called comedonecrosis, which has long been known to be a marker of more aggressive DCIS. The results of this analysis were robust and did not change substantially when patients with microinvasion or patients with a breast cancer death or recurrence within 6 months of the DCIS diagnosis were included.
Another result of the study is that aggressive treatment of nearly all DCIS does not appear to lead to a reduction in breast cancer mortality, which is consistent with an analysis of the NSABP B-17 and B-24 trials published four years ago. Basically, adding radiation therapy after lumpectomy also appears to have no effect on the risk of breast cancer mortality and might even be slightly higher. What this result suggests is that radiation therapy might not be necessary for the majority of DCIS cases.
The last finding is one that will be harder for doctors and patients to wrap their brains around, which is that DCIS might be more of a risk factor for ultimately developing breast cancer than a precursor to breast cancer. The reason is how similar ipsilateral (same side) and contralateral (opposite side) recurrence rates were, 5.9% and 6.2%, respectively, at 20 years. Recurrence of DCIS was not associated with increased risk of death for breast cancer, but an invasive recurrence was, hazard ratio 18.1 for ipsilateral recurrences, 13.8 for contralateral recurrences. As the authors put it:
The finding of greatest clinical importance was that prevention of ipsilateral invasive recurrence did not prevent death from breast cancer. Women with DCIS who developed an ipsilateral invasive in-breast recurrence were 18.1 times more likely to die of breast cancer than women who did not. For patients who had a lumpectomy, the use of radiotherapy reduced the risk of developing an ipsilateral invasive recurrence from 4.9% to 2.5% but did not reduce breast cancer–specific mortality at 10 years (0.9% vs 0.8%). Similarly, patients who underwent unilateral mastectomy had a lower risk of ipsilateral invasive recurrence at 10 years than patients who underwent lumpectomy (1.3% vs 3.3%) but had a higher breast cancer–specific mortality (1.3% vs 0.8%). Patients who had a mastectomy had cancers with a larger mean size and higher grade than patients who had a lumpectomy (eTable 5 in the Supplement). After adjustment for tumor size, grade, and other factors, the difference in survival for mastectomy vs lumpectomy was not significant (HR, 1.20 [95% CI, 0.96-1.50]; P = .11).
In other words, the type of treatment for DCIS didn’t matter. The risk of death from breast cancer was the same regardless, and very low. Moreover, these data challenge the existing paradigm of DCIS as a precursor of breast cancer:
Only a fraction of treated DCIS lesions progress to invasive breast cancer,13 but in the absence of treatment, the risk of invasive cancer is much higher.14 Also, mortality from breast cancer in women with DCIS increases substantially following the development of an invasive local recurrence.4,5 However, if DCIS were truly a (noninvasive) precursor of breast cancer, then a woman with DCIS should not die of breast cancer without first experiencing an invasive breast cancer (ipsilateral or contralateral), and the prevention of an invasive recurrence should prevent her death from breast cancer. Surprisingly, the majority of women with DCIS in the cohort who died of breast cancer did not experience an invasive in-breast recurrence (ipsilateral or contralateral) prior to death (54.1%). Furthermore, preventing the invasive in-breast recurrence (with mastectomy or radiotherapy) does not reduce mortality from breast cancer. This is in keeping with the findings of other studies.
This study is, of course, not without weaknesses. Any study that relies on the SEER database will have the weaknesses inherent in how the SEER database is put together. The database has been in existence many years and undergone multiple revisions. It’s also a bit slow to add data elements considered important to breast cancer treatment, such as HER2 status, as I discovered in 2009 when I wanted to do a project involving the SEER database. For instance, it’s possible that some cases of DCIS actually had microinvasion. Also, the authors didn’t have data on which DCIS cases were detected by mammography and which were symptomatic, although it’s likely that a small minority were symptomatic given that the vast majority of DCIS is detected by mammography. There were also no data on margin status. A positive margin (a margin in which tumor cells actually reach the surgical margin) is associated with a higher risk of recurrence. There are also vagaries of how multiple recurrences are coded.
So where to go from here? In an very rare occurrence, I cannot agree with Monica Morrow about this:
Dr. Monica Morrow, chief breast cancer surgeon at Memorial Sloan Kettering Cancer Center, said it made more sense to view D.C.I.S. as a cancer precursor that should be treated the way it is now, with a lumpectomy or mastectomy. She questioned whether those women who were treated and ended up dying of breast cancer anyway had been misdiagnosed.
In some cases, pathologists look at only a small amount of tumor, Dr. Morrow said, and could have missed areas of invasive cancer. Even the best mastectomy leaves cells behind, she added, which could explain why a small number of women with D.C.I.S. who had mastectomies, even double mastectomies, died of breast cancer.
Given the large numbers, I find it to be bordering on wishful thinking to speculate that so many of these women had been misdiagnosed that it significantly affected the results of this study. Yes, pathologists only look at a relatively small sampling of tumor, because to look at the whole thing for every patient would be so labor-intensive and expensive as to be impractical. The same could be said of any operations we do, and we’ve accepted this limitation since pathologists started looking at tissues under the microscope. It’s highly unlikely that rates of misdiagnosis are so high as to have made a difference.
What I think this study really means is that there is an urgent need for better molecular markers to determine which cases of DCIS are dangerous and which are not, something someone well known to readers of this blog has joined with others in arguing before in the medical literature. Until we have such prognostic markers, we will have this dilemma. Esserman and Yau suggest:
Narod and colleagues4 have assembled an impressive analysis on the basis of SEER data. There are limitations of SEER, but the large numbers and long-term follow-up provide a compelling case that it is time for change. The community of radiologists and surgeons needs to be part of the call for change. Given the low breast cancer mortality risk, we should stop telling women that DCIS is an emergency and that they should schedule definitive surgery within 2 weeks of diagnosis. The sum total of the data on DCIS to date now suggest that:
Of these, I think #4 is the most important, but unfortunately this approach will take years to bear fruit. In the meantime physicians and patients are left to struggle through as best we can with incomplete data. Nothing should yet change in the near term in our approach to DCIS in young women and with unfavorable characteristics, but it’s becoming increasingly clear that something needs to change is in our approach to lower risk forms of DCIS, such as low and intermediate grade DCIS.
A new meta-analysis of 323 studies looks at 93 possible factors associated with the risk of developing Alzheimer’s disease (AD). AD is a neurodegenerative disorder affecting the entire brain that causes a slowly progressive dementia over years.
Dementia is a generic term for a chronic disorder of memory and cognition. AD is a specific disease that causes dementia. It is the most common cause of dementia, responsible for about half of all cases. There are 5.2 million people with AD in the US, most over the age of 65. About one-third of people 85 years or older have AD.
AD, therefore, is a significant cause of a common condition that causes extreme disability and death in the older population. There is currently no cure for AD. Available treatments are considered symptomatic – they improve memory and function modestly but do not alter the course of the disease. Preventing AD, therefore, is very important.
The current meta-analysis looked at cohort studies and case-control studies. These are two different types of observational studies, meaning that they are observing what happens or has happened to people but does not randomize people to different groups. It is difficult to draw conclusion about cause and effect from observational studies because of possible confounding factors. The advantage, however, is that they can observe large populations. In the current analysis the researchers looked at 93 factors with >5,000 subjects in the pooled studies.
This is what they found (summary from the abstract):
Among factors with relatively strong evidence (pooled population >5000) in our meta-analysis, we found grade I evidence for 4 medical exposures (oestrogen, statin, antihypertensive medications and non-steroidal anti-inflammatory drugs therapy) as well as 4 dietary exposures (folate, vitamin E/C and coffee) as protective factors of AD. We found grade I evidence showing that one biochemical exposure (hyperhomocysteine) and one psychological condition (depression) significantly increase risk of developing AD. We also found grade I evidence indicative of complex roles of pre-existing disease (frailty, carotid atherosclerosis, hypertension, low diastolic blood pressure, type 2 diabetes mellitus (Asian population) increasing risk whereas history of arthritis, heart disease, metabolic syndrome and cancer decreasing risk) and lifestyle (low education, high body mass index (BMI) in mid-life and low BMI increasing the risk whereas cognitive activity, current smoking (Western population), light-to-moderate drinking, stress, high BMI in late-life decreasing the risk) in influencing AD risk. We identified no evidence suggestive of significant association with occupational exposures.
The authors suggest that if the nine largest factors were optimized in the population the incidence of AD could be reduced by 2/3.
Again – this is observational data, so these conclusions have to be taken with a huge grain of salt. Some of these factors are also likely related. For example, folate reduces homocysteine, so perhaps the protective effect of folate is essentially the same factor as the risk of increased homocysteine.
The second most common cause of dementia is vascular, and there is a large overlap of AD and vascular dementia. Therefore it is not surprising to see some vascular risk factors on the list – carotid stenosis, hypertension, and diabetes. Vascular treatments also lower risk of AD – anti-hypertensives, statin drugs, and non-steroidal anti-inflammatories (aspirin-like drugs).
Many of the factors are nutritional. There is evidence that overall poor nutrition, and low levels of specific micronutrients, are linked to AD. I say “linked” because we don’t know for sure the cause and effect. Patient with AD do not eat as well, or the disease itself may lower micronutrient levels due to increased demand. Either way optimizing nutrient levels is potentially beneficial.
Some of the identified factors are complex, and given observational data only I don’t think lead to any strong recommendations. For example, I would not recommend drinking, taking up smoking, or drinking coffee with the idea it will reduce your AD risk. These are complex factors likely obscured by confounding factors, and also with other risks not associated with AD.
What should the average person do with this information? First, let’s look at the low-hanging fruit or the win-wins. If you have high blood pressure, diabetes, high cholesterol, or metabolic syndrome then follow up closely with your doctor and make sure these conditions are being adequately treated. You should be doing that anyway, and here is possibly another benefit.
Stay mentally and physically active. Engage specifically in novel mental activities.
Maintain a healthy weight – which means not being obese when middle-aged and not being underweight when older.
What about vitamins and supplements? Most physicians will routinely test folate, B12, and homocysteine levels, especially in older patients, and supplement accordingly. That is better, in my opinion, than blind supplementation. I see many patients with high, and even toxic, levels of certain vitamins. At the very least you can avoid paying for and taking vitamins you don’t need.
Taking daily aspirin has risks and benefits, so again it is best to consult your primary care doctor. Reducing risk of AD is possibly another benefit to throw into the calculation and an additional motivation to be compliant.
This latest meta-analysis is helpful in reviewing the last 50 years of research into risk factors for AD and shows that there is the potential to reduce the incidence of this disease. In the end, however, most of the advice that flows from this data are thing we already knew.
For the average person the resulting advice is simple.
- See your primary care doctor and treat chronic health conditions and risk factors.
- Have an overall healthful diet and maintain a healthy weight.
- Stay mentally and physically active.
- Talk to your doctor about the risks and benefits of daily aspirin and also doing blood work for nutritional factors, like folate and B12.
They have their exits and their entrances,
And one man in his time plays many parts,
His acts being seven ages. At first, the infant,
Mewling and puking in the nurse’s arms.
Then the whining schoolboy, with his satchel
And shining morning face, creeping like snail
Unwillingly to school. And then the lover,
Sighing like furnace, with a woeful ballad
Made to his mistress’ eyebrow. Then a soldier,
Full of strange oaths and bearded like the pard,
Jealous in honor, sudden and quick in quarrel,
Seeking the bubble reputation
Even in the cannon’s mouth. And then the justice,
In fair round belly with good capon lined,
With eyes severe and beard of formal cut,
Full of wise saws and modern instances;
And so he plays his part. The sixth age shifts
Into the lean and slippered pantaloon,
With spectacles on nose and pouch on side;
His youthful hose, well saved, a world too wide
For his shrunk shank, and his big manly voice,
Turning again toward childish treble, pipes
And whistles in his sound. Last scene of all,
That ends this strange eventful history,
Is second childishness and mere oblivion,
Sans teeth, sans eyes, sans taste, sans everything.
As You Like It, Act II, Scene VII
This summer my wife and I have been transitioning somewhere between stage 5 and 6. My eldest left Tuesday for law school in Boston and my youngest leaves for college next week in LA. So we will soon be empty nesters. As part of the change we have been making a point of going out, to dinners, bars, concerts and theater.
We saw MacBeth performed in a pioneer cemetery, sitting on an old grave as Lady MacBeth practiced aggressive hand hygiene:
Doctor: What is it she does now? Look how she rubs her hands.
Gentlewoman: It is an accustom’d action with her, to seem thus
washing her hands. I have known her continue in this a quarter of an hour.
Lady Macbeth: Yet here’s a spot.
Doctor: Hark, she speaks. I will set down what comes from her, to
satisfy my remembrance the more strongly.
Lady Macbeth: Out, damn’d spot! out, I say! —One; two: why, then ’tis time to do’t.—Hell is murky.—Fie, my lord, fie, a soldier, and afeard? What need we fear who knows it, when none can call our pow’r to accompt?—Yet who would have thought the old man to have had so much blood in him?
No blood borne infections in Scotland.
We saw one of the best productions I have witnessed of Much Ado About Nothing (I enjoyed it more than the Whedon movie)as well as The Complete Works of William Shakespeare, abridged and revised. The latter I highly recommend if it comes your way: Three actors, one dead playwright, and all 37 plays, in under two hours.Medical Theater
CAM Provider: Therein the patient
Must minister to himself.
SBM: Throw physic to the dogs; I’ll none of it.
Theater is odd since it is artifice in a way that movies are not. If they do the play well, you get lost in the moment of the actors, the language, the plot and the play becomes the thing. You forget that it is all fake. And it can be truly moving. During the Complete Works they briefly abandoned the broad comedy and parody to slide into Act II Scene of Hamlet with a straight rendition, demonstrating the power and beauty of language of Shakespeare in the hands of skilled actor.
I have of late,—but wherefore I know not,—lost all my mirth, forgone all custom of exercises; and indeed it goes so heavily with my disposition that this goodly frame, the earth, seems to me a sterile promontory; this most excellent canopy, the air, look you, this brave o’erhanging firmament, this majestical roof fretted with golden fire, why, it appears no other thing to me but a foul and pestilent congregation of vapours. What a piece of work is a man! How noble in reason! how infinite in faculty! in form, in moving, how express and admirable! in action how like an angel! in apprehension how like a god! the beauty of the world! the paragon of animals! And yet, to me, what is this quintessence of dust? man delights not me; no, nor woman neither, though, by your smiling, you seem to say so.
Doctors Colquhoun and Novella have referred to acupuncture as theatrical placebo, but as I have watched plays this summer it occurred to me that large swaths of SCAM are Medical Theater. Everyone playing a part, for the moment suspending reason, strutting and fretting their hour upon the stage, believing that the SCAM is the thing, when in fact
Told by a naturopath, full of sound and fury,
Most of the practice of alternative medicine is delivered to make patients feel like something is happening when in reality it is nothing occurs. Theater. It will probably stay that way, immune from reality, till Birnam wood. Do come to Dunsinane.
I am in a Bardly mood this week.
Not that theater is without benefit.Vaccine Theater
Sometimes medical theater is understandable. When they took thimerosal out the vaccines, it was not because they needed to for medical reasons. It was medical theater, and necessary medical theater. It was also an interesting experiment, since removing thimerosal from most vaccines has not led to a decline in autism. Not that everyone seems to realize it.
And part of professionalism is participating in medical theater. You have to behave like a medical professional and that behavior is acting like a doctor, whatever that might be. The only time I really feel like a doctor is when I fill a syringe then squirt a little into the air to clear out the syringe. And the powers that be like to mention the theater that increases patient satisfaction. Sitting instead of standing when making rounds, etc, all part of making the patient feel comfortable. As I like to note, when you can fake sincerity you have it made.Ebola Theater
Some aspects of medical theater vex me with inconstant mind. Ebola for example. As infectious diseases go, ebola is just not that infectious. There are about 23,000,000 people in the three affected countries with 17,000 cases and 6000 deaths in a year. As epidemics go, it is a slow and small, albeit awful disease and devastating for the countries involved.
We have spent a lot of time and money in preparing for Ebola in our hospital system, and as a general approach to potential infectious diseases I am glad we have invested the resources. Who knows what the next plague will be, but outside of a HCW who spent time in an African ebola ward, there very little chance an ebola patient will ever show up in Portland
That being said, it has been suggested we train quarterly just in case. That is worthless medical theater and akin to planning your retirement on the lottery.
And the powers that be have a program where if a person enters the US from an ebola country they are ‘assigned’ to one of the hospital systems as an ebola person of interest, although for what reason I cannot figure out. These are not people who have ebola risks, just people from ebola countries. We are supposed to be the contact person should they show up in an ER or have a problem. But the few times a person of interest has visited an ER, have the power that be have said don’t worry about ebola, they are not at risk. So why bother to follow them if they are not a real ebola risk? Medical theater.Influenza Theater
More theater is having HCW’s who refuse the flu vaccine be required to wear a mask.
Don’t get me wrong. If you are a health care provider who refuses to get the flu vaccine I think you are an incompetent dumb ass and should not be allowed in my hospital. Not that I can enforce that opinion.
There has been an initiative to encourage patients to ask if their HCW’s have washed their hands. It is a morally bankrupt idea, since if you are so incompetent at core competencies such as hand hygiene that patients have to remind you to wash your dam hands, you have no business in health care. It is to my mind akin to airlines having an “it’s ok to ask if the wheels are down when landing’ policy.
And patients do not want to ask us to wash our hands. Oddly they expect us to know what the hell we are doing and protect them when they are at their most vulnerable.
Still, I dream of a similar program for influenza vaccination. Patients should ask their HCW’s if they have been flu vaccinated and if the answer is no, request another provider, one who is not a dumb ass. It will never happen.
But the question is: will a patient be protected from acquiring influenza from an asymptomatic unvaccinated health care worker if that worker wears a mask (one hopes if they are ill they will not be at work)? No data. The data t support use of masks to prevent flu in the hospital is at best marginal, probably in large part as the main source of influenza exposure is outside the hospital where most people do not wear a mask. If the mask is is used to prevent acquisition of influnzaflu from infected patient to HCW, during flu season any positive effect mask is likely to be lost once the HCW leaves the mask at work and heads out into the flu infested community
But think about it. Say, as we do, that 80% of your employes are vaccinated against the flu. So 20 are at risk. But at best the vaccine is 50% for preventing flu. So 40 of the vaccinated are at risk for flu transmission. So if you really wanted to stop the spread the of flu (assuming that masks worked), you would get the most bang for your buck by having the vaccinated workers wear a mask.
I can’t see that an unvaccinated HCW wearing a mask is really going to prevent the of spread of flu. It is too narrow an intervention. Wearing the mask is more of a scarlet ‘I’, a form of shaming that I do not think belongs in the workplace. Prevent them from working in the hospital? You bet. Since the data does point to vaccination of HCW’s decreasing patient mortality. But if the point of wearing a mask is prevention of influenza spread from HCW to patient, then the only science-based approach would be to mask everyone who walks into the hospital. Otherwise, it is all medical theater and stupid medical theater at that.
Vandana Shiva is one of the loudest voices speaking out against GM (genetic modification) technology and modern agriculture. She is an ideologue and a crusader, which unfortunately means that she feels free to play lose with the facts and the science as long as it serves her narrative. Michael Specter did an excellent article about Shiva a year ago for The New Yorker. This quote puts much of Shiva’s propaganda into perspective:
“There are two trends,” she told the crowd that had gathered in Piazza Santissima Annunziata, in Florence, for the seed fair. “One: a trend of diversity, democracy, freedom, joy, culture—people celebrating their lives.” She paused to let silence fill the square. “And the other: monocultures, deadness. Everyone depressed. Everyone on Prozac. More and more young people unemployed. We don’t want that world of death.”
To her, GMOs are part of a world of death, while opposing GMOs is all about joy and freedom. She is anti-corporate, anti-West, anti-globalization, and anti-technology. Her campaign is largely one of lies and misinformation. She would also apparently rather have people starve than eat GMOs.
Ten thousand people were killed and 10 to 15 million left homeless when a cyclone slammed into India’s eastern coastal state of Orissa in October 1999. In the aftermath, CARE and the Catholic Relief Society distributed a high-nutrition mixture of corn and soy meal provided by the U.S. Agency for International Development to thousands of hungry storm victims. Oddly, this humanitarian act elicited cries of outrage.
Shiva called on India to reject the donated food. She wanted to take food away from the hungry and homeless cyclone victims, rather than have them “poisoned” with GMOs. This motivated Ronald Bailey from reason.com to call Shiva, “One of the World’s Worst People.”
By the way, this anti-corporate crusader for the poor makes $40,000 per speaking engagement.
Recently Shiva wrote an article titled: 5 GMO Myths Debunked by Vandana Shiva. What she is actually doing is “rebunking” her own myths. Here we can see a huge red flag for an ideologue – they need to have every fact align with their narrative, rather than admitting that complex topics are complex. For example, anti-vaxers could admit that vaccines work but still oppose them because of alleged side effects. Global warming deniers could admit humans are warming the planet but oppose certain proposed solutions, and Shiva could admit that industrial farming is efficient, even if she opposes the methods for other reasons.
Myth #1: The Green Revolution
Right off, however, with myth #1 she makes the extraordinary claim that the green revolution actually decreased crop yields in India.
The Green Revolution did not save India from famine, as the proponents of Industrial Agriculture and GMO technology would argue, in fact the Green Revolution reduced India’s production. For more information about the Green Revolution read, Nothing Green in the Green Revolution in India Today.
Even looking at the data she cites, however, reveals her shenanigans. She writes:
His study comparing pre and post Green Revolution performance showed that the rate of growth of aggregate crop production was higher in the years before the Green Revolution was introduced (1967-68) than after it.
The comparison is not between yield but the rate of increase in yield. Yield still increased after the Green Revolution, but (she claims) for some crops not as fast. However if you look at the table on her article you will notice a couple of things. The period before the Green Revolution is 15 years, while after is 10 years. I don’t see that an adjustment was made for this difference. Further, you can see that the land area increased more before the Green revolution than after – so yield increases prior to the Green Revolution were due to planting more land.
Land scarcity and increasing land costs, however, were a major limiting factor – increasing food production by increasing land use was simply not keeping up with population growth. As a recent review of the actual evidence claims, the Green Revolution had a dramatic impact.
Although populations had more than doubled, the production of cereal crops tripled during this period, with only a 30% increase in land area cultivated.
Myth #2: Golden Rice
Anti-GMO activists hate golden rice, a GMO rice with added beta carotene, because it breaks just about every aspect of their narrative. The rice is not owned by any corporation, but is a humanitarian project. It has nothing to do with pesticides. There is no issue with cross-contamination. The crop is not for the benefit of western corporations. The sole purpose of golden rice is to reduce vitamin A deficiency in the developing world, which currently causes 80,000 deaths a year and half a million children to go blind.
Here is Shiva’s pathetic attempt to oppose this potentially very useful technology:
Here is our analysis establishing that our indigenous biodiversity and knowledge is far superior than Golden Rice to address malnutrition. Syngenta owns Golden Rice. It’s promotion as the fruits of public sector research are a blatant lie and an attempt to mislead people across the world.
Further, the Golden Rice paper had to be retracted, any fabricated claims made based on the paper do not stand.
First, vitamin A deficiency is a problem for more than just India. Further, the idea that planting gardens is going to solve the problem is ridiculous. There are plenty of poor people in developing regions of the world who do not have the land for even a small garden. Attempts to address vitamin A deficiency by providing fruits and vegetable and distributing vitamin A supplements have been ongoing. While they are helpful, they are nowhere near addressing the problem. Vitamin A enriched rice would be another tool to address this issue.
This type of argument is similar to the anti-fluoride crowd arguing that we don’t need fluoride in water because people can just brush their teeth.
Regarding Syngenta and golden rice, Syngenta has this to say:
Although Syngenta has a significant interest in seeing the humanitarian benefits from this technology become reality, we have no commercial interest in Golden Rice whatsoever. Golden Rice is an exclusively humanitarian project.
Seed from these plants and performance data were donated to the Golden Rice Humanitarian Board.
Shiva has absolutely no information to contradict these facts – Syngenta donated their expertise and has no commercial stake. If she did have evidence she would have linked to it.
Finally, she repeats the claim of the anti-GMO crowd that the recent study showing that golden rice has the potential to provide clinically relevant amounts of vitamin A is not valid because of ethical concerns. This is nonsense, however. Ethical concerns were raised by anti-GMO activists in an attempt to discredit the study because they did not like the results. A thorough review found, however:
The reviews found no evidence of health or safety problems in the children fed golden rice; they also concluded that the study’s data were scientifically accurate and valid. Indeed, Souvaine’s letter to the USDA stresses that the results “have important public health and nutrition implications, for China and other parts of the world.”
There were issues with the consent form, which is unfortunate, but they don’t invalidate the results.
Myth #3: Cancer and Suicide
She next writes:
The epidemic of cancer has affected the farmers of Punjab because of pesticides. It has affected farmers of West UP. In a single village, our recent field survey revealed that there were 100 cancer victims. The farmers are getting into debt and committing suicide buying the pesticides and the citizens are dying of cancer because of the same poisons.
The issue of cancer and pesticides is a complex one, but there is no evidence for an “epidemic of cancer.” Animal data shows that some pesticides are potentially carcinogenic, but this does not prove that they actually cause cancer in people. Causing cancer in rats in high doses is a pretty low threshold.
Epidemiological data is mixed but mostly negative. There are now five pesticides classified as possibly or probably carcinogenic. However, experts disagree about the evidence and some are highly critical of these designations.
If we take a very cautious approach, which is what the industry does, it is prudent to protect farm workers from exposure to pesticides with protective gear and good practice. The amounts that consumers are exposed to in food is negligible and there is no evidence of any negative health effects (and if you’re worried, just thoroughly wash your food).
Further, organic farming allows for pesticide use, just “natural” pesticides with the completely unwarranted assumption that natural pesticides are safe. In fact, organic pesticides may be more toxic and worse for the environment than synthetic ones, but they are given a regulatory pass because they are “natural.”
The claim that GMOs are linked to increased farmer indebtedness and suicide is a complete myth manufactured by Vandana Shiva. I address the claim here.
Myth #4: Safety
While the literature on biosafety is vast and I was appointed as a member of the expert group on biosafety by UNEP to create the framework for the International Law on Biosafety, two recent publications show that the assumption of safety and “substantial equivalence” is false.
One study is from the Norwegian Government, another by an Indian scientist from MIT who invented email.
We have been using GMOs for over 20 years now and no health issues have arisen. There is also no reason to suspect that the many different types of genetic changes broadly contained under GMO have any inherent health risk. GMOs are actually the most studied and regulated foods we have. Science and health organizations from the AAAS to the WHO have reviewed the evidence and found current GMOs and GM technology to be safe.
Further, we have a 19 year GMO animal feeding study, looking at data from literally billions of animals, showing no negative health effects from consuming GMOs.
Against this mountain of safety data, Shiva cherry picks two studies. One is from Shiva Ayyadurai, the “Indian Scientist from MIT” who, it turns out, didn’t invent e-mail (but that’s another story). His “study” was actually a computer model which he says predicts GMO soy will contain high levels of formaldehyde. This claim has already been thoroughly debunked as utter nonsense. I would also point out that genetic scientist Kevin Folta has offered to actually test Ayyadurai’s model by measuring formaldehyde levels in GMO soy, and the response from the MIT scientist has been deafening silence.
The review (not new research) commissioned by the Norwegian government is interesting. First, it is not a review of GMOs in general or GM technology but specifically of herbicide tolerant GMOs. It also does not conclude that they are not safe, only that we currently do not have sufficient evidence. Of course, what is “sufficient” evidence is completely subjective. Norway, to put it bluntly, is toward the extreme anti-GMO end of the spectrum. Their policy is:
Norway is one of the most restrictive countries with regard to the importation of genetically modified organisms (GMOs) and does not allow for GMO production. It has yet to approve an application for the import of foodstuffs that include GMOs. Norway applies the precautionary principle when vetting GMOs and in addition requires any user or importer of a GMO to show that the use is ethically and socially justifiable, requiring proof both that the GMO is not harmful and that its use will benefit society.
So they set the bar very high. There are many flaws with their review. For example, they cite as a criticism the fact that GMO studies often compare GMOs to standard farming practice, and not to organic farming or other methods. This is not an actual criticism, in my opinion. If you are trying to control for the GM trait as an isolated variable then that is the exact comparison you want to make. You don’t want to compare it to farming practices that differ in a variety of ways.
The report also relies upon discredited research, such as the infamous Seralini study.
The Norwegian review is therefore an outlier from an anti-GMO country with serious flaws, and is also limited in scope, and really can only cite the precautionary principle for justification in the end. This is the best that Shiva can do.
Myth #5: GMO and Science
Here we get a short naked assertion from Shiva:
The GMO story is not one of science, but of an unscientific and illegal takeover of our seeds and food.
She links only to her own documentary, not any actual evidence. She is not even making an argument here, just an assertion – restating her narrative.
The facts do not paint a flattering picture of Vandana Shiva. She is a fanatical ideologue who appears to have no problem spreading misinformation, making up stories to suit her needs, cherry picking data, and weaving conspiracy theories.
Her latest article is clearly nothing but sloppy propaganda. She makes no attempt to look fairly at the evidence and the arguments. She fails to cite evidence that substantiates her claims. And yet she remains the darling of the anti-GMO movement, which speaks volumes about that movement.
The Integrative Addiction Conference 2015 (“A New Era in Natural Treatment”) starts tomorrow in Myrtle Beach, SC. Medical doctors, doctors of osteopathy, naturopaths and other health care providers will hear lectures on such subjects as “IV Therapies and Addiction Solutions,” given by Kenneth Proefrock, a naturopath whose Arizona Stem Cell Center specializes in autologous stem cell transplants derived from adipose tissue. Proefrock, who was disciplined for using prolotherapy in the cervical spine without proper credentialing in 2008, claims that stem cells treatments are an “incredibly versatile therapy” and uses them for variety of conditions, such as MS and viral diseases. At the same time, he admits that they are not FDA approved and he is not claiming they are effective for anything, which leads one to wonder why he employs them.
Proefrock also offers a typical naturopathic mish-mash of services, from oncology to urology to “naturopathic endocrinology,” and claims he specializes in treating influenza, high blood pressure and kidney stones, as well as addiction. In other words, he doesn’t seem to be the sort of expert you’d find speaking at a science-based conference on addiction medicine.
You’ll find similarly troubling bios of some of the other speakers, as well as dubious treatments for addiction, on the conference website. Here, for example, are speaker Giordano’s and Eidelman’s websites.
Dalal Akoury, MD, is the “Title Sponsor” of the conference and appears to be running the show. Although she is listed by the S.C. Board of Medicine as board certified in pediatrics, she is founder of the “Integrative Addiction Institute” and runs the “AwareMed Health and Wellness Resource Center” in Myrtle Beach. Like the Arizona Stem Cell Center, it offers a range of treatments that defy categorization as any particular specialty: addiction recovery, “adrenal fatigue” treatment, stem cells, “anti-aging,” weight loss, “functional medicine” and “integrative cancer” care. Yet, only Akoury and one licensed practical nurse are on the staff of the Center. Again, it is questionable whether she is has sufficient qualifications in addiction medicine to run a conference on the subject.
Regular readers of this blog won’t be shocked that this sort of conference goes on. But what we should find disturbing is that a medical doctor can get continuing medical education credit for conference attendance. Why? Because it is sponsored jointly by Continuing Education, Inc. and the Southwest College of Naturopathic Medicine (no surprise there). Continuing Education, Inc. is accredited by the Accreditation Council for Continuing Medical Education (ACCME) as a provider of continuing education for physicians. Continuing Education, Inc., has designated this conference for a maximum of 19.75 hours of AMA (yes, that AMA) PRA (Physicians Recognition Award) Category 1 Credits, a decision it is empowered to make because of its ACCME accreditation.The American Council for Continuing Medical Education
A bit of background (bear with me here): Like other professionals, such as lawyers and accountants, medical doctors must earn a certain number of continuing education hours to keep their state licenses current and to retain a specialty board certification. State medical boards and specialty boards (such as the American Academy of Family Physicians and the American Board of Internal Medicine) set the number of hours and sometimes the subject matter of these courses. They also decide which courses they will accept as valid CME hours. Some of these accept courses offered by CME providers accredited by the American Council for Continuing Medical Education (ACCME). Others may not accept ACCME-accredited providers directly, but will accept hours approved by other entities that do. For example, my state, Florida, will accept courses approved for the AMA Physician Recognition Award.
Putting this all together, the Integrative Addiction Conference is presented by an organization accredited by the ACCME and qualifies for AMA PRA credit. In turn, because it is eligible for AMA PRA credit, it will be accepted by the Florida Board of Medicine.
The ACCME accredits organizations, not individual courses, based on set criteria. Once the organization is accredited to provide CME, it must maintain recognition through a continuing compliance process. ACCME member organizations include the AMA, the American Hospital Association, the American Board of Medical Specialties and the Federation of State Medical Boards of the U.S. There are a total of 2100 organizations accredited by the ACCME, conducting 125,000 events annually. In other words, if you take a CME course in the U.S., your getting credit for it likely involved the ACCME.
Here’s how the ACCME explains its work:
The Accreditation Council for Continuing Medical Education (ACCME®), a nonprofit corporation based in Chicago, is responsible for accrediting institutions that offer continuing medical education (CME) to physicians and other health care professionals. . . . The ACCME’s mission is to identify, develop, and promote rigorous national standards for quality CME that improves physician performance and medical care for patients and their communities. [Emphasis added.]
According to ACCME policy:
Accredited providers are responsible for validating the clinical content of CME activities that they provide. Specifically,
I’m not a physician, but I think the Integrative Addiction Conference 2015 falls a bit short of these standards, don’t you?Boning up on pseudoscience
Let’s look at a few other courses from ACCME-accredited CME providers and see how they measure up.
The Institute for Functional Medicine (IFM) is an ACCME-accredited CME provider as well. For those of you who aren’t familiar with Functional Medicine, we’re not sure we can explain it either. As David Gorski said
what constitutes functional medicine has never been clear to me, although it’s clear that a lot of it is pseudoscience. . . . It postulates “imbalances” in hormones and neurotransmitters, oxidation-reduction, detoxification and biotransformation, immune function, inflammation, and cell structure. It’s all so vague that these “imbalances” could mean almost anything, and when practitioners of “functional medicine” refer to them, they usually do. Arguably the most famous practitioner of “functional medicine” is Mark Hyman, known for creating “Ultrawellness,” the very name of which should tell you pretty much all you need to know about functional medicine. Indeed, it just seems to be a label used to encompass a whole lot of alternative medicine practices being “integrated” with real medicine.
The theme for IFM’s Annual International Conference, held this past May, was “The Omics Revolution: Nature and Nurture,” for 19 hours of CME. I’ll wager this is the type of “omics” that could be categorized as “Woo-Omics.”
On the faculty were:
Jeffrey Bland, PhD, the “father of functional medicine,” whose outsized claims for his nutritional products got him into trouble with the FTC in the early 1990s.
Paul Anderson, a naturopath whose clinic in Seattle offers hyperbaric oxygen therapy and IV therapy delivering “micronutrients and pharmaceuticals” for, among other things, “support for detoxification” and “heavy metal chelation.”
Yousef Elyaman, MD, a Florida functional medicine practitioner and author of the upcoming book, Your Healing Power, “a guide to mastering one’s genes to reverse disease.” (Who knew?)
If you missed the May conference, there are several other opportunities on the horizon to earn CME credits from IFM. In November, IFM will be presenting “Energy: Illuminating the Energy Spectrum: Evidence and Emerging Clinical Solutions for Managing Pain, Fatigue, and Cognitive Dysfunction,” for which the physician can earn 20 CME credits. The descriptions of the program and its presentations are so full of word salads you could open a restaurant with them.
Energy drives all biologic activity—within individual atoms and molecules, as part of cellular physiology, up through organ-system and whole-person functioning, and, ultimately, the entire biosphere. The last 20 years have brought us dramatic breakthroughs in understanding about how mitochondria work and what they require for enduring optimal function. Genetic and epigenetic vulnerabilities have been discovered; the effects of toxic environmental exposures on energy production have been revealed; and connections between dysregulation in energy production and many clinical conditions have been described.
Physiology is one side of the coin, but we are also learning about the larger energy landscape, including the mechanisms underlying the clinical effects of magnetic fields and microcurrent, hands-on therapies such as manipulation and craniosacral, acupuncture, and the profound power of the therapeutic partnership.
As for those “clinical effects of magnetic fields,” a “post-module activity” includes “Identifying Clinical Manifestations of EMF/RF: Adverse Impacts Including Electromagnetic Hypersensitivity Syndrome,” (a fabricated condition), by Devra Davis, PhD, a cell phone radiation alarmist who warns against keeping your cell phone in your bra due to an increased risk of breast cancer (another fabrication).
IFM is big into “detox.” Just this past July, it offered 19 CME credits for a sold-out conference styled “Detox: Understanding Biotransformation and Recognizing Toxicity: Evaluation and Treatment in the Functional Medicine Model.” And who better to teach MDs about detoxification than naturopaths, of which there were several on the faculty.
Also on the faculty is a chiropractor, Richard Mayfield, who lectured on “Ensuring a Safe Detox Program: Applying Oral Chelation Therapy to Reduce an Elevated Heavy Metal Burden with Case Studies,” one of 6 courses he teaches at the IFM “Detox” conference.
Mayfield’s own practice reveals a truly impressive array of such quackery, including chiropractic “adjustments” to remove “nerve interference,” bioidentical hormones, something called BioCranial treatments, and screening for “undiagnosed gluten intolerance,” among others. He treats autism spectrum disorder with a “biomedical approach” and is a former DAN! practitioner.
To be fair, the pseudoscience was not confined to ND and DC presenters. There were MDs and a dentist as well. The latter was Mary Ellen Chalmers, DMD, whose practice offers removal of mercury amalgam fillings, a totally unnecessary and expensive dental procedure that is based on the unproven “theory” that they are “toxic” to everyone.
One would be hard pressed to find better exemplars of CME courses “devoted to advocacy of unscientific modalities of diagnosis or therapy,” as the ACCME puts it, than these IFC conferences.
Or, maybe not.
If, unlike IFM, your organization does not have its own ACCME accreditation, you can glom onto one that does to present your pseudoscience for CME credit. For example, the American Academy of Integrative Health & Medicine offered CME for its 2015 conference under the auspices of Scripps, in the form of the pretentiously titled “People, Planet and Purpose: Global Practitioners United in Health and Healing.” (Interestingly, for all of its chumminess with DCs and NDs, there doesn’t seem to be either on the Scripps staff.) Here the speakers include:
I know people who ascribe to this philosophy. They are called “toddlers.”
John Weeks, a relentless promoter of integrative medicine, who believes that chiropractors and naturopaths are capable of practicing as primary care physicians.
Bill Wolfe, a speaker on “biological dentistry,” another dentist who advocates the removal of mercury fillings and believes “any degenerative condition in the mouth is a potential energetic disruption of the associated energy meridian.” And apparently believes that having two different metals in the mouth (e.g., gold and mercury) can generate electric currents, another disruptor of “energy meridians.”
Bill Reddy, an acupuncturist, who lectured on “Leaky gut.” (It must be awfully easy to master the understanding and treatment of “leaky gut” if your education as an acupuncturist is sufficient to lecture on it.)
Joseph Pizzorno ND, talked about “Assessing Body Burden” and “Detoxification.” There is not a detailed description of these courses available, so I’m not sure what he will say about “assessing body burden,” but I found a hint in The Encyclopedia of Natural Medicine, of which Pizzorno is co-editor. This Encyclopedia tells us that 25% of the US population suffers from heavy metal poisoning. The preferred method of assessing this mythical burden is provoked urine testing.
Amy Rothenberg, ND, spoke on “Clinical Applications of Homeopathy.” She memorably testified at the FDA recent hearing that homeopathy’s mechanism of action (of which there is none) can be explained by hormesis (a “theory” shot down here). She also said she uses homeopathy to treat autistic children.
I note that the listed conference speakers recommend all of the Five Things Patients and Physicians Should Question, according to the American College of Medical Toxicology and the American Academy of Clinical Toxicology. Doesn’t sound like “recommendations involving clinical medicine . . . based on evidence that is accepted within the profession of medicine,” per ACCME policy.
Integrative Practitioner, John Weeks’s organization, is also able to offer CME course by attaching itself to a medical school. In 2015, it teamed up with Mount Sinai/Beth Israel, to present the Integrative Healthcare Symposium Annual Conference, at which the physician could earn 17.75 CME credit hours. The keynote speaker was Nick Ortner, CEO of the Tapping Solution, LLC, a company with a mission to bring “simple, effective, natural healing into the mainstream through Emotional Freedom Techniques (EFT)” or “tapping.” According to Ortner, tapping is a healing modality that combines ancient Chinese acupressure and modern psychology which
utilizes the body’s energy meridian points by stimulating them with your fingertips – literally tapping into your body’s own energy and healing power.
No, not “literally,” Mr. Ortner. Ortner is also the author of a “revolutionary” book about tapping. As well, he
created and produced the breakthrough documentary film, The Tapping Solution, which follows ten people who used tapping to overcome tremendous challenges, including 30 years of chronic back pain, fibromyalgia, insomnia, devastating grief and more.
No shortage of superlatives in his bio.
Sadly for the integrative MD, someone thought to exercise some discretion here and Ortner’s talk could not be included in the attendee’s CME credits. Also not approved for credit was Dr. Devra’s talk: “Experimental and Clinical Observations on the Impact on Reproductive Health of Wireless Radiation from Cell Phones and Other Devices.” It was, however, approved CE for chiropractors, naturopaths acupunturists and (unfortunately) nurses.
There were a lot of functional medicine presentations, including a naturopath’s discussion of how foods can “reduce our toxic body burden” and another presentation by a naturopath who claims that a simple urine test can find two different markers reflective of both the amount of hydroxyl radical damage to the DNA, and the ability of the DNA to repair this damage as well as indicate whether a person is under “oxidative stress.”
Another Integrative Healthcare Symposium, “Focus On: the Microbiome,” teams up with the University of Miami medical school and “has been reviewed and is acceptable for up to 12.00 Prescribed credit(s) by the American Academy of Family Physicians” (AAFP).
Conference chair is David Perlmutter, MD, author of “Grain Brain.” Here, attendees, among other things:
Appreciate how leading edge novel techniques to restore a healthy microbiome may pave the way for meaningful treatment of autism, autoimmune conditions and inflammatory disorders
Perlmutter got his equivalent of an Oz takedown in a recent New York Magazine article by Alan Levinovitz, author of The Gluten Lie (a book highly recommended by SBM’s own Clay Jones.) It’s an excellent expose and well worth reading.
On its website, The AAFP offers this disclaimer regarding CME for integrative medicine courses.
[The AAFP] maintains there is value in providing information about integrative medicine (also referred to as complementary and alternatve practices and other terms) to help family physicians respond to patients who use these therapies and who would consider using them. Family physicians need to understand new medical practices and products including integrative approaches to effectively counsel patients, understand potential drug or treatment interactions, and better evaluate patient outcomes.
Continuing Medical Education (CME) activities that include information about integrative medicine must meet all existing AAFP CME Credit Eligibility Requirements. Among these is the requirement that clinical content that is not considered to be evidence-based or customary and generally accepted medical practice must be deemed neither dangerous nor proven ineffective by the Commission on Continuing Professional Development (COCPD). The COCPD relies on its collective clinical expertise, as well as findings (meta-analyses or systematic reviews) reported by sources it deems acceptable. The COCPD considers diagnostic and therapeutic interventions in which the risks substantially outweigh the benefits to patients to meet the definition of “dangerous.”
Yes, of course family physicians need to know about integrative, complementary and alternative medicine, but there are better ways than sending them to conferences that teach them how to practice sub-par medicine. And there are more risks than a treatment being “dangerous” or proven ineffective. Does it not matter that the patient is being ripped off by a physician who fails to use “evidence-based or customary and generally accepted medical practice.”But wait, there’s more . . . quackery!
Before we end, here are a few more questionable, but CME-approved, courses:
“Aromatherapy & Health: An Introduction” (4 hours CME credits), from the University of Arizona Center for Integrative Medicine.
“Bioidentical Hormone Replacement Therapy Symposium,” sponsored by the American Academy of Anti-Aging Medicine, which seems to fit nicely into Kimball Atwood’s Pseudomedical Pseudoprofessional Organization category. (27 hours CME credits)
Auricular Acupuncture , from the University of Miami Miller School of Medicine; (14 hours CME credit):
Auriculotherapy is effective for a wide range of health problems, including musculoskeletal pain, addiction, respiratory and gastrointestinal issues, skin problems, eye-ear-nose-throat disorders, control of blood pressure & many others.
“And many others?” Somehow I doubt that these claims of effectiveness are based on research that, again quoting the ACCME, “conform[s] to the generally accepted standards of experimental design, data collection and analysis.”
It is unfortunate to see the continued normalization of quackery as accepted medical practice. And it is unfortunate that the AMA and state medical boards, with the help of the ACCME, are facilitating that process by allowing CME credit for courses in pseudoscience. If these courses are “based on evidence that is accepted within the profession of medicine as adequate justification” for their use in patient care, then that standard has no meaning.