You are here


Exercise and Memory

Science Based Medicine - 11 hours 3 min ago

There is no escaping the evidence that regular moderate exercise is associated with a host of medical benefits. Among those benefits are perhaps improved memory and cognition, and questionably a decreased risk of developing dementia.

The latest study to show this correlation involved younger and older adults who wore a step-monitor. The number of steps they took during the study interval was then correlated with their performance on neuropsychological testing. The researchers found that for the older adults, but not younger adults, more physical activity correlated with better overall cognitive performance, but especially for face-name recognition.

This is a small study, with 60 subjects total. Also, the study is correlational only. It is possible that healthier older adults are both more physically active and cognitively nimble, because of underlying biological fitness. More cognitively active older adults may also be more physically active – the lines of cause and effect are plausible in multiple ways.

However, we do have a fairly large literature to draw upon to explore this question further. For example, studies looking at the acute effects of aerobic exercise find that it improves some types of cognitive function immediately.

There is complexity in interpreting the research due to the fact that there are many subquestions to sort through. Studies can look at all adults, only older adults, healthy adults, adults with minimal cognitive impairment or with dementia. They can look at any exercise, or at aerobic fitness. And there are a large number of cognitive outcomes they can measure.

A Literature Review

A 2008 Cochrane review concluded:

There is evidence that aerobic physical activities which improve cardiorespiratory fitness are beneficial for cognitive function in healthy older adults, with effects observed for motor function, cognitive speed, delayed memory functions and auditory and visual attention. However, the majority of comparisons yielded no significant results.

They go on to recommend greater standardization among researchers, focusing on a few cognitive tests so results can be more comparable.

A more recent 2015 review found:

Results indicated that physical exercise may benefit cognitive function among older adults who have MCI, including improvements in global cognition, executive function, memory, attention, and processing speed. Physical exercise may also positively impact the physiology of the aging brain. However, evidence surrounding the characteristics of effective physical exercise interventions in terms of exercise type, intensity, duration, and frequency remains limited.

Newer studies continue to find a correlation, and even causation with intervention trials, in which some type of physical activity improves some cognitive measures.

A 2014 review concluded:

The studies on older subjects with MCI reported some positive effects of physical exercise on cognition, mainly on global cognition, executive function, attention and delayed recall.

They also call for more rigorous trials with prospective intervention designs to better establish cause and effect.

The consensus of the reviews make several consistent points:

– There does appear to be a consistent association between physical activity and some kinds of improved cognitive function in older adults who are either healthy or who have minimal cognitive impairment. The data for adults with Alzheimer’s disease is trending negative.

– Because of the large number of variables, the literature is a bit challenging to interpret, and everyone agrees that more rigorous trials are needed to clarify which types of exercise yield benefit (if the benefits are specific to any types of exercise).

The Bigger Picture

The meta-lesson here is understanding how challenging it is to answer a specific clinical question with high quality research. Even a question that seems rather straightforward at first – does exercise improve memory or cognitive function? – turns out to be very complex and difficult to answer.

We also see a very familiar pattern emerge: the preliminary literature shows results that are highly variable, but are trending in one direction. This preliminary literature is most useful for indicating if more rigorous research is worth the effort, and also helps clarify how to design more rigorous studies.

Eventually, over years and many studies looking at the question in different ways, a clearer picture begins to emerge. Still, the results need to be interpreted with caution and with an understanding of the limitations of clinical research.

Even with a highly plausible and uncontroversial putative effect, such as the effects of exercise on cognition, we can see this familiar pattern. These lessons need to be remembered with more controversial, ideological, and emotional medical questions.

Conclusion – Current Recommendations

At this point I would say that there is probably a beneficial effect from physical activity for cognitive function in older adults who are either healthy or have mild cognitive symptoms. Benefits for full-blown dementia are less clear, but have not been ruled out.

Given that a benefit is highly plausible given what we know about exercise physiology, and that the risks of getting regular moderate exercise are low, while there are a host of well-established other benefits, it seems obvious to recommend regular exercise for overall and mental fitness.

Further research may or may not clarify which types of exercise have the most benefit. It may not make a significant difference – it may just turn out that any exercise is better than being sedentary.

Finally, for those interested in science-based medicine in general, it is a good practice to pick a very narrow and uncontroversial question and then carefully examine the research to see how the experts address a question, how the literature evolves over time, and the strengths and weaknesses of different kinds of studies.

These are basic critical thinking skills to have, and may be easier to learn when not clouded with the emotional blur of a highly charged issue.



Categories: Medicine, Skepticism

Scientific Consensus and Corporate Influence

Neurologica Blog - Tue, 11/24/2015 - 08:09

A new study published in PNAS explores the messaging of organizations commenting on climate change and their relationship to corporate funding. The sole author, Justin Farrell, finds that those organizations who received corporate funding were likely to network their messaging together, and to engage in a campaign of casting doubt on the scientific consensus. There was no such network among those organizations not receiving corporate funding.

Farrell notes:

“This counter-movement produced messages aimed, at the very least, at creating ideological polarization through politicized tactics, and at the very most, at overtly refuting current scientific consensus with scientific findings of their own.”

As further evidence of corporate influence, the Washington Post notes:

The publication of the report comes two weeks after New York prosecutors announced an investigation into whether Exxon Mobil misled the public and investors about the risks of climate change. The probe was prompted in part by reports in the Los Angeles Times and the online publication Inside Climate News, alleging that Exxon researchers expressed concerned about climate change from fossil fuel emissions decades ago, even as the company publicly raised doubts about whether climate-change was scientifically valid.

This should come as no surprise to those following the climate change debate. Climate change and other issues, in fact, challenge the very notion of scientific consensus and what it means, but also demonstrate why we should listen to a robust consensus.

Those who are at odds with a particular scientific consensus will often argue that the scientific consensus can be comfortably ignored. Reasons given are often: the scientific consensus has been wrong in the past, the current consensus is the result of external or internal ideological, political, or financial influence, or there isn’t really a scientific consensus.

Ironically, these campaigns of denial demonstrate that it is not easy to manipulate the scientific consensus.

The Nature of Consensus

I have written about scientific consensus previously. The consensus is often dismissed as an argument from authority, but this is not a valid application of that fallacy. The power of science is that conclusions are crowd-sourced among experts, and are self-correcting with new evidence. Individual quirky opinions average out, and ideas have to go through the meat-grinder of peer-review and the scientific community.

The scientific process, as imperfect as it is because it is executed by humans, is the closest thing we have to a pure meritocracy. Logic and evidence are what matter. That argument has been used to dismiss the consensus, but ironically that is why the consensus should not be blithely dismissed.

Of course reality is complex, and not every scientific consensus is created equal. The questions you have to ask yourself are – how robust is the consensus, how mature is the science, are there any serious minority opinions or differences among various fields, and how legitimate is the scientific discipline and relevant areas of expertise.

I really don’t care what the consensus of opinion among homeopaths is, for example. I listen to my colleagues who are studying string theory, but I don’t think the science is mature enough for any particular opinions to dominate. There are many valid opinions about the true ultimate cause of the various neurodegenerative conditions, without a strong consensus behind any one. Finally, while there is a strong consensus that an asteroid strike wiped out the dinosaurs, many paleontologists feel the data does not fit one sudden extinction event and look to other causes, like volcanism.

Of course it is true that the scientific consensus has changed on many questions over time. But again you have to ask – how solid was that consensus? Does it really say anything about a current consensus under question? Scientific consensus is not black and white, it is not a seal of approval that gets stamped on scientific ideas. It is a continuum.

Let’s take, for example, the current scientific consensus on the fact that life on Earth came to its current state through a process of organic evolution. If you are going to claim that this scientific consensus is wrong, you cannot simply point to a previous example of a scientific consensus being wrong, you have to point to one that was as solid as the consensus behind evolution. I would argue that there isn’t a single example of a robust consensus of the magnitude of the fact of evolution being overturned in the modern scientific era. I am open to any counter-examples.

Climate Change

Climate change contrarians often try to argue that there is no real scientific consensus, but there clearly is. Multiple analyses of the scientific literature demonstrate a clear and robust consensus that climate change is happening.

There are two ways to measure the robustness of a consensus – what percentage of relevant experts accept the consensus, and how certain are they? With respect to climate change we actually have some hard numbers. Evaluations of the literature and of climate scientists find that 97% agree that the planet is warming mostly through human activity. Deniers have tried to refute this number, but they have been unable to put forward a persuasive argument.

How certain are those 97% of climate scientists? Well, the IPCC in its latest report indicated that there is a 95% chance that anthropogenic global warming is real. While that is pretty good, 95% means they think there is a 1 in 20 chance they are wrong. I would consider this a robust consensus, enough on which to base policy, but this is nowhere near the strength of the consensus on evolution. While I have never encountered anyone trying to put a number on it, I would say the probability that evolution is true approaches 100%. Nothing in science can ever be 100%, but it is so close it would be absurd to treat it as anything else.

The challenge with the climate change issue is that we are faced with immediate decisions about how to run our civilization. Like a physician and patient facing a life-and-death decision based on imperfect information, we need to make choices based on a 97% consensus with a 95% confidence. I think this is robust enough to make some reasonable choices, like pushing for renewable energy sources and improved energy efficiency.

Corporate Influence

What does the recent study on the climate change issue say about corporate influence? Combining this study with experience in other areas, like evolution, vaccines, and genetically modified organisms, I think we can make some generalizations.

First, it is interesting to note that the oil industry is perhaps the most wealthy and powerful industry of any of the industries involved in the above public debates. They have more resources and influence than Big Pharma, Big Agro, or Big Evolution (whatever that is). It also seems clear that they were actively trying to influence the scientific consensus.

Despite their motivation, influence, and resources they were unable to affect the scientific consensus on climate change. They could not manufacture a consensus. All they could do is sow doubt in the real scientific consensus, and even then only among those ideologically aligned, not with the public at large, and not within scientific circles.

This fact is often given as a direct refutation of the claim that Monsanto and Big Agro have manufactured a scientific consensus on the safety of GMOs. At the same time they argue there is no consensus. First – yes there is. There is an international scientific consensus on the overall safety of GMO technology and the current GMO products. This consensus is at least as strong, and I would argue stronger, than the consensus on climate change.

Biotechnology companies have nowhere near the resources as the fossil fuel industry, and it is frankly absurd to argue that they were somehow able to use their money and influence to manufacture a fake scientific consensus on GMO safety. They would have to have secretly controlled the outcome of hundreds of apparently independent studies.

The same is true of vaccine safety.


What an examination of climate change, vaccine safety, and GMO safety show us is that ideological and corporate influence in science is real, but has serious limits. If the science itself is legitimate and robust, the best corporate influence can do is sow doubt and confusion. They cannot manufacture an apparently robust consensus by simply buying the science they want.

Buying science can be done on the fringe, or in areas largely ignored by academic science. Industry can have undue influence when it is poorly regulated. In such situations, however, they are not buying off academics, they are simply doing their own biased research. They are not creating a robust consensus of legitimate experts, they are simply bypassing legitimate experts and presenting their corporate flawed science directly to the public.

With vaccine safety and efficacy, GMO safety, climate change, and evolution we have a robust scientific consensus of legitimate academic experts. You cannot dismiss the consensus on these issues with a convenient narrative about corporate influence. The science is simply too strong.

Categories: Medicine

American Academy of Family Physicians Home Study Course Recommends Non-Science-Based Treatments

Science Based Medicine - Tue, 11/24/2015 - 03:00

Strong medicine… along with a little nonsense


Since passing my board exams in family practice in 1979 I have relied heavily on the American Academy of Family Physicians for continuing medical education via the American Family Physician and the AAFP home study programs. The AAFP prides itself on its evidence-based approach to medicine. In general, it delivers. But the recent FP Essentials Number 432 on “Chronic Pain Management” fell short. It recommended treating chronic pain with acupuncture, chiropractic, touch therapy, and S-adenosyl methionine (SAM-e), presenting them in a way that misled readers into thinking that the recommendations were based on good scientific evidence. They were not.

With 6500 peer reviewed journals and over 2 million papers published every year, it is easy to find a study to support pretty much any point of view. John Ioannidis taught us that most published research findings are false, with preliminary studies frequently being overturned by larger, better follow-up studies. When evaluating the evidence for a treatment, it is not enough to find one or two positive studies. It is essential to also look for negative studies and for systematic analyses that weigh all the published evidence, and to put all the available evidence into perspective. The authors failed to do that.


 First, let me point out that the lead author incorporates acupuncture into her practice. This could be considered a conflict of interest. She obviously believes in it, which is bound to interfere with an objective interpretation of the published evidence. The personal experience of seeing patients improve after a treatment can be very compelling, but it is notoriously misleading. Medieval blood-letters saw patients recover after their treatments and never realized they were doing more harm than good. Surgeons who performed internal mammary artery ligations for heart disease had a 90% success rate, and it took a sham surgery experiment to convince them that the operation was actually useless. Only controlled studies can determine whether a treatment is more effective than placebo. As Mark Crislip says, “In my experience” are the three most dangerous words in medicine.

“Acupuncture” is not a single well-defined treatment. The authors themselves point out that it may refer to needles, acupressure, electrical stimulation, moxibustion, cupping, or herb placement; and it can actually refer to many more varieties such as esogetic colorpuncture (with colored light) and Tong Ren (tapping meridians on acupuncture dolls with a metal hammer). The references they cite are for more than one form of acupuncture, so their claim that “acupuncture” has been shown to relieve pain is so imprecise that it is virtually meaningless. They say it involves stimulation of specific points, but the highest quality research has shown that it doesn’t matter where you put the needles; stimulation of non-acupuncture points works just as well. It doesn’t even matter whether you use needles; one study showed that touching the skin with toothpicks worked just as well. They say that acupuncture points are thought to be associated with unique electrical measurements, and that their stimulation results in a release of neuromodulators that can affect the central nervous system locally and systematically. Those claims are not supported by credible evidence. There have been many studies attempting to define a mechanism by which acupuncture might work, but those studies are flawed and inconclusive. They contradict each other instead of building on each other to develop a coherent body of evidence. Acupuncture has been shown to cause release of endorphins, but the same thing happens when you give patients a placebo sugar pill or when you throw a stick for a dog to fetch. There is no evidence that any effects of acupuncture are specific to acupoints, so it is premature to look for a mechanism to explain acupoints.

Edzard Ernst was the world’s first professor of complementary medicine. A former user of many kinds of alternative medicine, he set out to test which ones really worked. In Trick or Treatment: The Undeniable Facts about Alternative Medicine, the book he co-authored with Simon Singh, they concluded: “While there is tentative evidence that acupuncture might be effective for some forms of pain relief and nausea, it fails to deliver any medical benefit in any other situations and its underlying concepts are meaningless.” [emphasis added]

The FP Essentials authors cherry-picked studies showing that acupuncture is effective; they omitted other studies showing that it isn’t. When the results of studies conflict, the next step is to do a systematic review. In the case of acupuncture, the systematic reviews also conflicted. So Edzard Ernst and two Chinese colleagues did what was obviously the next step: a systematic review of systematic reviews of acupuncture for pain. They found that there were only four conditions for which more than one systematic review agreed: in three cases they agreed that acupuncture didn’t work; in the fourth, they agreed that it worked for neck pain. I ask you: if studies of a pain pill gave similarly heterogeneous results and indicated that it worked for pain in the neck but not for pain anywhere else in the body, would you choose to take that pill for pain, or would you suspect that something might have gone wrong with the positive studies?

When the Medical Letter reviewed acupuncture in 2006, they concluded:

Acupuncture alone has not been shown in rigorous, duplicated studies to benefit any defined medical condition.

The Center for Inquiry issued a policy statement on acupuncture in 2010.  It said,

It is becoming increasingly clear that the placebo effect accounts for much of the optimistic research on acupuncture published between the 1970s and 1990s. With the development of sham needles during the past decade – needles which retract like stage knives – researchers have since been able to more accurately assess the therapeutic effects of acupuncture. The result has been a complete unraveling of nearly all acupuncture claims….The bulk of recent research strongly tends towards the hypothesis that acupuncture’s positive effects are mainly due to a built-in expectation…

In June 2013, David Colquhoun and Steven Novella reviewed the history and the evidence for acupuncture for the treatment of pain in the journal Anesthesia and Analgesia. After thousands of trials and hundreds of systematic reviews, the evidence remains controversial, weak and unconvincing. All the evidence is consistent with exactly what one would expect to find if an elaborate placebo were tested. They concluded

 that the benefits of acupuncture are likely nonexistent, or at best are too small and too transient to be of any clinical significance. It seems that acupuncture is little or no more than a theatrical placebo.


 The authors said that weak evidence supports manipulation alone to relieve chronic neck pain. It is “weak” indeed! A Cochrane review showed that manipulation was no more effective than gentle mobilization, and that neither was effective alone, but only in combination with exercise. Any discussion of neck manipulation should include a warning that neck manipulation can result in a rare but deadly complication: stroke. These authors didn’t mention that.

Touch therapy

 The authors describe touch therapy (including healing touch, therapeutic touch, noncontact therapeutic touch, and Reiki) as “a type of energy treatment in which practitioners place their hands on or above patients to manipulate their energy.” What energy? The only reference they provide is a Cochrane review that has been withdrawn from publication because it is out of date.

Touch therapies claim to manipulate a “human energy field.” Science can measure tiny energies down to the subatomic level, but it has never been able to measure a “human energy field” and we can only conclude that it is a myth and that practitioners who claim they can sense it and manipulate it are only fooling themselves. Studies of energy treatments are what I call Tooth Fairy Science. We can study how much money the Tooth Fairy leaves under the pillow in varying circumstances (family income level, birth order, whether the tooth is placed in a plastic bag or wrapped in tissue) and we can get reproducible data that is statistically significant. We can fool ourselves into thinking we have learned something about the Tooth Fairy, but we haven’t, because there’s no such thing.

The human energy field is no more real than the Tooth Fairy. Emily Rosa did a grade school science fair project to test experienced therapeutic touch practitioners to see if they could really sense the energy field they claimed to feel emanating from Emily’s hand. They could “sense” it reliably as long as they could see her hand, but when their vision was blocked by a screen, their guesses were no better than chance. Emily’s research was eventually published in the Journal of the American Medical Association. It took a child to show that the emperor had no clothes. It is ludicrous to study something before it has been shown to exist: clinical studies of energy medicine are inherently flawed and any positive results can be assumed to be false positives attributable to placebo effects and/or to the pitfalls of experimental design.


 For SAMe, the authors cited an article from the NCCAM (now NCCIH)  that showed only mixed results for SAM-e in osteoarthritis and said there was insufficient evidence for its use in other pain conditions. It even recommended “do not use SAM-e to replace conventional care.” They also cited a single positive clinical study from 2004, but didn’t mention a later Cochrane review from 2009 that concluded

The current systematic review is inconclusive, hampered by the inclusion of mainly small trials of questionable quality. The effects of SAMe on both pain and function may be potentially clinically relevant and, although effects are expected to be small, deserve further clinical evaluation in adequately sized randomised, parallel-group trials in patients with knee or hip osteoarthritis. Meanwhile, routine use of SAM-e should not be advised.” [emphasis added]

The Natural Medicines Comprehensive Database interprets the evidence as insufficient to establish effectiveness. Instead of rating SAM-e “Effective” for osteoarthritis, it rates it as only “Likely effective.” For fibromyalgia it rates it “Possibly effective.” It didn’t find any evidence to support its use in other pain conditions. There is no justification for recommending SAM-e for treatment of chronic pain in general.


 The FP Essentials edition on Chronic Pain Management includes recommendations to treat chronic pain with acupuncture, chiropractic, touch therapy, and SAM-e. Those recommendations are not based on acceptable evidence. It is disappointing to see those alternative treatments misrepresented as evidence-based and recommended right along with conventional treatments that really are based on good quality evidence. I expected better of the AAFP.


Categories: Medicine, Skepticism

Health Advice from the 1950s

Neurologica Blog - Mon, 11/23/2015 - 08:19

One of the pillars of alternative medicine propaganda is historical revisionism. Proponents often claim that they were ahead of the curve on diet and exercise advice, while the medical establishment lagged behind. They go as far as to take credit for the entire field of nutrition by labeling it “alternative.”

The fact is, the disparity between mainstream and alternative advice has not changed much for the pat 60+ years. There are even some elements that are literally centuries old – using “natural” as a marketing angle, for example.

The alternative narrative is not based on reality, however. Fortunately we have records from the first half of the 20th century that document exactly what the scientific mainstream and alternative culture were saying. It is a good idea to frequently question your own narrative and check the actual facts. I sought to find some historical documents that would demonstrate what the medical mainstream were saying in the 1950s.

Obviously we have learned a great deal in the last 60 years, but it is perhaps surprising how little basic nutritional advice has changed. By the 1950s we had already worked out the basics of nutrition, identified all the vitamins, their role in the body, and their source in common foods. The benefits of exercise were also already being recognized, as well as maintaining a lean body mass. Everything we have learned since then, in terms of its bottom line effect on health advice, has been a small tweak, not a fundamental change.

This is perhaps the best 1950s eating advice video I came across. The video gives the following information:

1 – Identifies 5 groups of nutrients, carbohydrates, fats, proteins, vitamins, and minerals, and advises getting enough of each group every day
2 – Emphasizes eating a varied diet and plenty of fruits and vegetables
3 – Advises against faddish or narrow diets
4 – Mentions that if you eat a healthy diet, taking extra vitamins in unnecessary.

This is all sound advice today. That above video is British, here is an American version.  The advice is essentially the same, adding the need to eat a “vitamin C food” every day. \

These videos are focused on getting enough nutrition, although they do caution against too many calories. One difference between these historical recommendations and current advice is the 1950′s emphasis on dairy. Dairy food is a good source of many nutrients, and is still part of a varied and healthful diet, but is not emphasized as much today because it is also calorie dense.

The videos do mention eating “lean” meat, but do not spend sufficient time discussing the difference between red and lean meat or warning against eating excessive red meat.

Overall that is the big difference between these 1950s PSAs and current advice – the emphasis in the past was on getting sufficient nutrients and not as much on avoiding excess. Now, post obesity epidemic, there is more attention being pain to avoiding excess. Still, it was recognized that being overweight was a health risk and people should avoid excess calories and remain trim, as this cheesy cartoon illustrates.

What about exercise? Here is a quick overview of scientific exercise recommendations by the medical community. As evidence began to emerge in the 1950s on the importance of exercise to overall health, the medical community focused initially on researching specific exercises for specific health and fitness outcomes. There was some concern initially about the safety of certain rigorous exercises.

Specific exercise advice from the US government began to emerge in the 1970s, and Official US dietary guidelines recommending routine moderate exercise for overall health began in 1990. This timeline is often used to argue that medical advice adopting exercise was late to the game, but it misses the actual history of exercise within medicine, not just in official government guidelines.

Here is a thorough historical overview, showing that mainstream medicine was researching and recommending exercise even in the 1800s. But if we look at 1910, when the scientific revolution really occurred in the medical profession, at that time physical medicine was already a specialty, and scientific research into exercise physiology and the effects of exercise on health began in earnest.

By the 1960s exercise science was firmly established within medicine, as the paper reports:

The new exercise science research in the 1960s was built upon the unique and groundbreaking studies of exercise at the Harvard Fatigue Laboratory in the 1930s and _40s and T.K. Cureton_s Fitness Laboratory at the University of Illinois in the late 1940s and _50s (4,5), among a few others, along with the findings of epidemiologists Jeremy Morris and Ralph Paffenbarger, who linked physical inactivity with a variety of chronic diseases.

What the historical record shows is that mainstream medicine was interested in and researching exercise the same way it was researching other medical specialties, throughout the history of western medicine. That research drove medical advice.

Alternative practitioners did not invent advice about exercise, nor were they the first to recognize the relationship between diet, exercise, and health. Diet and exercise have been part of scientific research and modern medicine from the beginning.

Historical documents also show what the “alternative health” community was recommending in the past. One example I found was a site referencing a 1971 article in The Health Seeker, an alternative health magazine published by Rodale.

For those who don’t know, Rodale is considered the granddaddy of the modern natural living/alternative health movement.

The author is impressed that by the 1960s Rodale was recommending exercise for physical fitness. He was about three decades behind Jack Lalanne, but also was behind the medical community, not in front of it.

The article also emphasized eating organic (which has no health benefits) and avoiding chemicals (ala the Food Babe). Interestingly, it does mention that not all things “natural” are harmless, and mentions a liver fluke contamination of water cress. He felt the need to add this warning because of the well-documented obsession with being “natural” in the alternative community.


The historical record clearly indicates that mainstream scientific medicine was and continues to conduct research into diet and nutrition, following the history of scientific research in medicine in general. Specific advice flowed from this research.

Meanwhile, the alternative health community has historically been obsessed with eating organic, avoiding chemicals, and being “natural.” Their exercise and nutrition advice was in no way ahead of the medical community, but they happily take credit for it anyway.


Categories: Medicine

Stanislaw Burzynski and Robert O. Young: How two quacks of a feather illustrate how poorly states regulate medical practice

Science Based Medicine - Mon, 11/23/2015 - 03:00

Stanislaw Burzynski (upper panel) and Robert O. Young (lower panel), two quacks whose activities reveal the weaknesses in how the practice of medicine is regulated.


One of the weaknesses in our system of regulating the practice of medicine in the United States is that, unlike most countries, we don’t have one system. We have 50 systems. That’s because the functions of licensing physicians and regulating the practice of medicine are not federal functions, but state functions. Each state sets its own laws and regulations governing the practice of medicine, making for wide variability from state to state. Some states are lax in their regulation (cough, cough, I’m talking to you, Texas), others are not so lax.

Given how often state medical boards and the other enforcement bodies states use to protect the public from professional misconduct and quackery, I thought I’d take this opportunity to update our readers on two men who have been frequent topics of discussion on this blog, Stanislaw Burzynski and Robert O. Young. The reason is that, through some bizarre confluence of events, both of them faced justice last week, in the form of a hearing due to action against Burzynski by the Texas Medical Board and in the form of the trial of Robert O. Young in southern California.

What these two quacks share in common is that they’ve gotten away with their cancer quackery for a very long time, two decades in the case of Robert O. Young and nearly four decades in the case of Stanislaw Burzynski, with attempts by the law to bring them to heal having been largely ineffective. They are different in that one is a physician (Dr. Burzynski) and one is not (Young) and therefore different legal considerations come into play. Young, for instance, is a self-proclaimed naturopath known for his “pH Miracle Living” cure, which, he claims, can be used to cure basically any disease by “alkalinizing” the body. After two decades of running being tried for practicing medicine without a license, and, of course, fraud. Burzynski, although not an oncologist, is a licensed physician in Texas and has been administering an unproven and almost certainly ineffective “natural” treatment consisting of substances derived from blood and urine that he dubbed “antineoplastons” (ANPs) back in the 1970s. He is also different in that he’s gotten away with this largely through abuse of the clinical trial process, which is regulated at the federal level through the FDA and the HHS. It is not, however, the federal government that is pursuing action against Burzynski, but rather the Texas Medical Board (TMB). Thus, while Young is on trial and could go to jail if he loses, if Burzynski loses he will only lose his license to practice medicine in the state of Texas.

Despite their differences, both Stanislaw Burzynski and Robert O. Young illuminate major shortcomings in how the legal system deals with quacks.

The Texas Medical Board Versus Stanislaw Burzynski, Round 4 (at least)

Last week as I contemplated what to write about this week, realized that it’s been a long time since I’ve written about Stanislaw Burzynski, the expat doctor who fled Poland in 1970 and for six years actually did legitimate cancer research at the Baylor College of Medicine. Convinced that he had made a major breakthrough in cancer treatment with his discovery of antineoplastons and apparently frustrated with the difficulties involved in doing legitimate clinical trials, Burzynski left Baylor and started treating patients with his home brew concoction in a private clinic. Since then, despite the fact that he has no training in medical oncology, Burzynski has treated thousands of cancer patients with ANPs beginning around the time he left Baylor and established over the intervening decades a reputation as a “miracle” cancer doctor who can cure deadly brain tumors that current conventional medicine cannot. He has managed this feat despite the fact that he’s never even come close to showing that ANPs are effective and safe against the cancers for which he uses it. Even so, the FDA has, with a brief interruption two years ago, continued to let him do his clinical trials, and the Texas Medical Board, despite at least three attempts since the early 1980s, has failed to strip Burzynski of his medical license. The best it managed to do was to put him on probation between 1994 and 2004.

It’s not because there hasn’t been a lot happening, either. Over a year ago, the Texas Medical Board decided to have another go at Burzynski. Over the last 16 months, what a long, strange trip it’s been. This week, the beginning of the climax of this effort was upon us. Indeed, what reminded me that the climax of this struggle is approaching was an e-mail from one of the several quack email lists to which I subscribe (in this case, The Truth About Cancer), which urged its members to support Burzynski:

In the Weekly Digest that was sent this past Saturday, I mentioned that Dr. Burzynski’s trial was on Tuesday, November 19th, when in fact it’s actually Thursday, November 19th.

Here are all the details again…

As we’ve shared many times before, actually curing cancer would be detrimental to the pharmaceutical industry. So much so that they’re willing to do whatever it takes to silence the doctors as to keep their poisons as the only solutions.

They’re trying to do that now with Dr. Burzynski by revoking his medical license and we need your help.

We’re asking for volunteers in the Austin area to go to the State Office of Administrative Hearings on the morning of Nov 19th and exercise their right to protest these absurd charges and hearings.

It’s 9:00am on Thursday, November 19, 2015, at 300 West 15th Street, Fourth Floor, Austin, Texas. Hearings will continue through November 25, 2015, before recessing until January 19, 2016, when it will reconvene at 9:00am and continue through January 29, 2016, if necessary.

There will be a lot of media attention and we need to show how powerful our voices are and that we will NOT be silenced.

Please arrive at 8:30am and bring signs that read “Dr. Burzynski saves lives” or “Stop persecuting Dr. Burzynski” or whatever else you’re inspired to write.

Unfortunately, I personally will not be able to travel and be in Austin but I’m doing my best to tell everyone I can and I’m hoping you will too. Even if you can’t make it in person, please tell everyone you can on Facebook and other social media sites.

Hopefully, if you’re in Austin (or inspired to travel there) you can go and represent our movement in a powerful way.

Thank you for your consideration.

Ty Bollinger

Meanwhile, other Burzynski supporters were also rallying. Eric Merola, the film maker who made two massively deceptive “documentaries” (which I like to call Burzynski I and Burzynski II: Electric Boogaloo, because those are far less awkward titles than the multiple subtitled ones Merola actually gave the movies) that amounted to the equivalent of hagiographies portraying Burzynski as the “brave maverick doctor” persecuted by the medical profession because he doesn’t play by its rules and can cure cancer where conventional oncologists cannot. Truly, it is not for nothing that I like to refer to Eric Merola as Stanislaw Burzynski’s own personal Leni Reifenstahl, even at the risk of going Godwin and even though Reifenstahl herself, were she still alive today, would recognize Merola for what he is: A talentless hack. Not surprisingly, the Alliance for Natural Health USA has also been trying to drum up support.

The whole situation is like a replay of the 1990s. If there’s one way Burzynski is very predictable it’s in his response to investigation and criticism. Whenever Burzynski is in trouble or the law actually threatens his practice, he cynically uses desperate cancer patients as “human shields” against government investigation. He did it in the 1990s, when Burzynski was being prosecuted for 75 counts of insurance fraud and violations of the Food, Drug, and Cosmetics Act. It was cynical political theater featuring media appearances of the weeping parents of children with deadly brain tumors, national press stories about demonstrations by patients chanting, “FDA go away! Let me live another day!” It worked back then, although I note that at the time Rep. Joe Barton (R-Dallas) was also putting intense pressure on the FDA, dragging then-FDA Director David Kessler in front of his committee multiple times to harangue him about his “persecution” of Burzynski. The FDA told Burzynski that he could administer ANPs, but only under the auspices of an approved clinical trial. So, urged by his lawyer Richard Jaffe, Burzynski cynically submitted 72 clinical trial protocols to use ANPs to treat pretty much any cancer he wanted to treat, and the FDA approved them all. In the intervening 16 years from 1997 to 2013, Burzynski enrolled patients on his clinical trials and charged them enormous “case management” fees for the privilege, even though doing so is completely unethical.

Of course, two years ago, Burzynski’s clinical trials were placed on partial clinical hold after the death of Josia Cotto of hypernatremia (very high sodium levels in the blood, a known complication of ANP treatment). In the wake of that decision, Burzynski went back to the tactic that had served him so well, mobilizing his patient base to do the same thing it did in the 1990s. Not long after that, the FDA gave in and let him begin his clinical trials again, albeit with conditions. Specifically, Burzynski had to provide ANPs for free, and he couldn’t be the one administering the cocktail. Then, last year, the FDA lifted all restrictions on Burzynski’s clinical trials. Burzynski had won again, but not long after that, the Texas Medical Board acted to strip Burzynski of his license.

The TMB’s 200 page complaint documents the charges that Burzynski misled patients by:

  • By making patients pay a retainer before receiving any diagnosis or treatment.
  • By performing unnecessary tests and “non-therapeutic treatment” with no potential to help them.
  • By imposing “exorbitant charges” for drugs and lab tests, without telling patients that he also owned the pharmacy and lab being used.
  • By allowing unlicensed staff to treat patients, while describing the staff as doctors.

Burzynski was also charged with prescribing unapproved combinations of toxic chemotherapy, which is quite ironic. Burzynski has been treating patients with an unapproved cancer drug (antineoplastons) for nearly four decades, but that’s not the heart of the case. Rather, the heart of the case appears to be Burzynski’s off-label use of what I like to call Burzynski’s “make it up as you go along” cocktails of expensive targeted therapies that he touted as “personalized, gene-targeted therapy” and I more accurately described as “personalized, gene-targeted therapy for dummies.”

A nice (and, unlike one of my typical posts, brief) summary of what’s been happening in the case over the last several months can be found here. Basically, as is commonly the situation in cases like this, there have been a number of motions and countermotions. In March, the judge rejected a large number of Burzynski’s motions to suppress evidence brought by the TMB, including testimony by FDA inspectors, FDA inspection documents, and the testimony of a former employee, the last of which looked to be particularly damaging to his defense.

Perhaps the most interesting and unexpected aspect of this whole case occurred over the summer, and when I say “unexpected,” I really mean it. Remember Richard Jaffe, whom I mentioned earlier and who was the architect of Burzynski’s wildly successful strategy of submitting over 70 clinical trials to the FDA, a strategy that served as the basis for Burzynski’s reputation and increasing wealth over the better part of the last 20 years. It was a strategy that didn’t start to fall apart until the partial clinical hold was placed on his clinical trials and Burzynski was forced to substitute his far less popular “personalized gene-targeted therapy.” The reason it was far less popular is because ANPs, for whatever reason, were viewed among the alternative cancer cure crowd as being a “natural” treatment for cancer (presumably because they were originally isolated from urine and blood) while Burzynski’s “personalized gene-targeted therapy” consisted of cocktails of expensive targeted therapies made by pharmaceutical companies. It turns out that Jaffe is no longer Burzynski’s lawyer, even though he had been working for Burzynski for decades. As Skeptics for the Protection of Cancer Patients drolly noted, those of us trying to expose Burzynski’s quackery all thought that Jaffe would be buried in the Burzynski family crypt, so tight had Burzynski and Jaffe been for so many years.

Apparently not any more.

How this shocking situation came about is not entirely clear, but it appears to involve—gasp!—enormous unpaid legal bills. Basically, a new lawyer, Dan Cogdell, started filing motions for Burzynski. It turns out that Cogdell was part of Burzynski’s legal team before. In any caes, the judge became concerned that it was late in the game to be switching lawyers; so another administrative law judge heard Jaffe’s explanation in private and ruled that Jaffe had to withdraw from the case. Per Judge Suzanne Marshall’s finding, Jaffe’s continued representation would violate the mandatory withdrawal provision of Rule 1.15. This provision reads:

A lawyer ordinarily must decline employment if the employment will cause the lawyer to engage in conduct that the lawyer knows is illegal or that violates the Texas Disciplinary Rules of Professional Conduct. Rule 1.15(a)(1); cf. Rules 1.02(c), 3.01, 3.02, 3.03, 3.04, 3.08, 4.01, and 8.04. Similarly, paragraph (a)(1) of this Rule requires a lawyer to withdraw from employment when the lawyer knows that the employment will result in a violation of a rule of professional conduct or other law. The lawyer is not obliged to decline or withdraw simply because the client suggests such a course of conduct; a client may have made such a suggestion in the ill-founded hope that a lawyer will not be constrained by a professional obligation. Cf. Rule 1.02(c) and (d).

So apparently Jaffe withdrew because he was concerned that his continue representation of Burzynski would somehow result in his violating a rule of professional conduct or other law. What could this mean? The explanation came when Jaffe withdrew from representing Stanislaw Burzynski’s son, Greg Burzynski and gave the following reason:

Respondent is a vice president and an employed physician at the Burzynski cancer clinic in Houston. The clinic is owned by Respondent’s father, Stanislaw R. Burzynski. Undersigned counsel had represented Stanislaw Burzynski in a related SOAH board case.

Undersigned counsel is taking legal action against Respondent’s employer which might have a material adverse effect on Respondent’s interests as an officer and employed physician at the clinic. As a result of such action, undersigned counsel will likely have a conflict of interest with Respondent, at least until the anticipated legal action is resolved.

In other words, Jaffe is suing Burzynski. But why? It turns out that Burzynski owes Jaffe nearly a quarter of a million dollars, and Burzynski hasn’t paid. In fact, Jaffe appears to be suing to force Burzynski into involuntary chapter 7 bankruptcy.

I tried not to go into too much detail in this post (which, as regular readers know, is hard for me) because a lot of the legal wrangling and back-and-forth comes across too much as “inside baseball.” It doesn’t help that I’m not a lawyer and don’t understand a lot of it. What I do understand is that, this week and in January, the TMB is doing its best to finally put an end to Stanislaw Burzynski’s cancer quackery, and I wish them the best in this endeavor.

To me, it’s a good sign that, for whatever reason, this time around the political theater that surrounded Burzynski’s 1997 trial is minimal to nonexistent, although there are some rather laughable letters being sent to the TMB. I have yet to see photos of terminally ill cancer patients with signs trying to shame the TMB, although there is a petition with over 13,000 signatures petitioning the TMB to “Save Doctor Burzynski’s Life-Saving Cancer Treatment,” complete with a video showing Hannah Bradley as one of Burzynski’s “success stories,” even though she was almost certainly saved by conventional treatment, not Burzynski. Thus far, news coverage of the disciplinary hearing has been minimal outside of local news media. I also hope that, with the rift between Burzynski and his former consigliere and architect of the strategy that has allowed Burzynski to abuse the clinical trial process for so many years to charge patients exorbitant sums to enroll in his clinical trials, Burzynski will finally fall.

Robert O. Young finally faces justice

Robert O. Young is a quack whom I’ve written about more on my not-so-super-secret other blog than here. Basically, Young is a naturopath (or claims to be one), two of whose seemingly impressive degrees came from diploma mills and whose degree in naturopathy came from Clayton College of Natural Health, a nonaccredited correspondence school that taught a panoply of quackery. For twenty years he’s been plying his cancer quackery (and quackery for HIV and other serious diseases) at Rancho del Sol, an avocado and grapefruit ranch in Valley Center, California that he’s turned into a plush quack retreat called the pH Miracle Center, complete with juicing, cleanses, and all manner of quack treatments. He even has a coaching program in which he trains other quacks in his method and offers “group cleanses.” (Eewww!)

When I took note of Robert O. Young’s arrest in January 2014, I experienced not a small amount of schadenfreude, for which I felt no guilt in this case. Seeing quacks hauled before a judge makes me happy. Even so, as much as I enjoyed the site of Young in a prison jumpsuit—if only it were orange instead of blue!—I nonetheless asked at the time: Will it stop him? During the nearly two years since his arrest, his arrest and impending trial for practicing medicine without a license and fraud seemed not to deter him in the least. He still did his “pH Miracle” cruises. (What is it with cranks and cruises these days? Is this a thing?) He still has his “pH Miracle” retreats planned in Como, Italy in December and January. (I wonder what will happen if he’s convicted.) He still runs his pH Miracle Center at the Rancho del Sol. He’s been promoting the “world’s first functionally structured alkaline water kiosk” and accepting awards from International Association of Colon Hydrotherapy. His blog, Twitter feed, and Facebook page have remained active this week promoting his activities, with nary a mention of his trial. Indeed, when I was first made aware that Young’s trial had begun last week, it caught me completely by surprise, given how little I had heard about what was going on since early 2014:

The author of a popular series of books espousing an alkaline diet as a way to improve health began standing trial this week in a Vista courtroom on charges that he practiced medicine without a license and took money under false pretenses.

In opening arguments Wednesday, prosecutor Gina Darvas described the defendant, Robert O. Young, as the proverbial “man behind the curtain,” making money peddling pseudoscience to desperate, dying people. Defense attorney Paul Pfingst said Young is under attack for espousing alternative views to traditional medicine.

Young, 53, faces nine charges linked to his work at his posh Valley Center compound, The pH Miracle Living Center, where people came for $2,000-a-day retreats. He is charged with seven counts of practicing medicine without a license — including inserting intravenous lines into people — and two counts of grand theft.

The trial is slated to last approximately four weeks, and thus far it hasn’t seemed to stop Young’s social media activity, although he makes no mention of his trial. No doubt he’d love to, in order to paint himself as the victim being persecuted by The Man (and Big Pharma) to keep his natural medicines from the people (which is always good for quack business), but I’m guessing his lawyer probably nixed that idea.

For those of you not familiar with Robert O. Young, a brief recap is in order. For this, a picture (or in this case, a PowerPoint slide that I’ve used before in various talks about cancer quackery) is worth a thousand words (not that that’ll stop me from using a thousand words to describe Young if I deem it necessary).

Basically, to Young, acid is the cause of all disease, to the point that he states that “overacidification” is the cause of all disease, an overarching theory of all disease that he has dubbed The New Biology, and about which he frequently states that “the pH Miracle Lifestyle and Diet is a program focuses on the foundational principal that the body is alkaline by design and yet acidic by function. This make this program the ultimate program for preventing and reversing aging and the onset of sickness and dis-ease. I would say that the pH Miracle Lifestyle and Diet is the diet for immortality.” (Note that another of Gorski’s rules, besides the rule that health practitioner who invokes Béchamp over Pasteur is to be avoided like the plague, is that anyone who uses the term “dis-ease” instead of “disease” is to be similarly shunned.)

For example, after a beautiful aspiring young Brazilian model named Mariana Bridi da Costa died of sepsis after a urinary tract infection so severe that she had had to have her hands and feet amputated in a desperate bid to save her life, Young wrote a post entitled Ignorance Caused Sepsis or Systemic Acidosis That Took The Life of a Young Brazilian Woman, in which he blamed “acidic lifestyle choices, including acidic food, drink, and drugs” and proclaimed, “Most people believe that sepsis or acidosis is an infection. It is not!” He explicitly denies germ theory to the point where he has written posts like The Illusion of Germ Theory, in which he refers dismissively to “Pasteurian scientific dogma,” challenges “everything in the modern construct of immunology and what is said to be the immune system,” and characterizes viruses as “molecular acids.”

Oh, and so is cancer. Well, not exactly. Cancer is…well, let me just quote Young to give you an idea:

The following is a summary of understanding cancerous tissues:

Cancer is not a cell but a poisonous acidic liquid.

A cancer cell, is a cell that has been spoiled or poisoned by metabolic or gastrointestinal acids.

A tumor is the body’s protective mechanism to encapsulate spoiled or poisoned cells from excess acid that has not been properly eliminated through urination, perspiration, defecation or respiration.

The tumor is the body’s solution to protect healthy cells and tissues.

Cancer is a systemic acidic condition that settles at the weakest parts of the body – not a localized problem that metastases.

Metastases is localized acids spoiling other cells much like a rotten apple spoiling a bushel of healthy apples.

There is no such thing as a cancer cell. A cancer cell was once a healthy cell that has been spoiled by acid.

The tumor is not the problem but the solution to protect healthy cells and tissues from being spoiled from other rotting cells and tissues.

The only solution to the acidic liquids that poison body cells causing the effects that medical savants call cancer is to alkalize and energize the body.

In conclusion, the human body is alkaline by design and acidic by function! If we desire a healthy body we must maintain that alkaline design.

This is, as they say, so wrong it’s not even wrong. Worse, as I described before when Young was arrested, his quackery can be blamed for at least one preventable death, that of Kim Tinkham, the woman who became briefly famous when she went on television with Oprah Winfrey, shocking even Oprah with her assertion that she was so inspired by The Secret that she had decided to go her own way and treat her stage III breast cancer with Robert Young’s “alkaline diet.” She didn’t reveal that it was Young until later, when she did testimonial for Young and appeared in an interview that was on YouTube but has since vanished down the memory hole. (True fact: I happened to have saved that video from YouTube and was therefore more than happy to provide a copy to the San Diego County District Attorney’s office last year.) Ultimately, Tinkham died of what was almost certainly metastatic breast cancer.

Based on his “alkaline diet,” Young ran a very lucrative quack spa business, both at Rancho del Sol and “on the road,” so to speak, as far away as Italy. Add to that his numerous courses and speaking engagements, and Young did quite well. Ironically, what tripped him up was not his claim that he could treat patients with diet alone, but, as is the case with many quacks, overreach. Basically, he started offering other treatments. Investigators basically ran a sting operation on him using officers posing as cancer patients, and Young made bogus diagnoses and offered bogus treatments. Two years later, we will see if Young is convicted.

The problem with state medical regulation

Whenever I come across egregious cases of misconduct by physicians, be they quacks like Robert O. Young or incompetent surgeons like Christopher Dunstch, I note the problems with how state medical boards function. First and foremost most state medical boards are understaffed and have too few resources for the tasks that they are charged to carry out. They are also made up of physicians, which means that (1) they tend to be reluctant to question another physician’s judgment unless the case is so far beyond the pale that no physician would fail to consider it a gross violation of the standard of care and (2) physicians tend to sympathize with other physicians and not to want to deprive them of their means to earn a living by taking their licenses away. This problem is magnified in Texas, where the TMB, by design and statute, is weak and doctors’ rights are strongly protected in their interactions with the TMB. Consequently, they tend to stick to the most egregious, easily provable cases, such as physicians who are substance-impaired, commit fraud, or diddle patients. Outside of that, it is enormously difficult in Texas to take away a physician’s license to practice. In other states, the situation is not as bad, but the same considerations apply. Add to that how expensive it is to prosecute a case like the one against Burzynski, who has up until now been able to afford the best lawyers and who has significant political pull, and it’s a wonder that the TMB decided to act. The current TMB is to be commended for this. Even though the outcome is nowhere near certain and the disciplinary proceeding might well fail, the TMB is doing the right thing at significant cost.

The bigger failure in the Burzynski case is that of the FDA. Burzynski has been running his bogus clinical trials for more than 17 years now, and it took the death of a six-year-old before the FDA shut him down, even though the FDA had investigated him multiple times before that. Worse, the shutdown was temporary. All Burzynski had to do was to file a remediation plan sufficiently convincing to the FDA that he was cleaning up his act, and he was free to enroll patients again. Whenever I see quacks ranting about the “fascistic” FDA, I roll my eyes, given how the FDA suffers from many of the same problems as state medical boards. It’s chronically underfunded, and given the current antiregulatory bent of Congress that situation is unlikely to change any time soon, even as legislators try to weaken the FDA in the name of “innovation” with misguided bills like the 21st Century Cures Act. One day, the story of why the FDA failed so monumentally in the Burzynski case will come out. I just hope I’m alive to see it, because it’s the biggest question I have remaining about him.

The law has nearly as much difficulty stopping non-physician quacks like Robert O. Young from taking advantage of desperate patients. Notice how Young could have gotten away with practically anything as long as he only recommended dietary changes to treat cancer, and it took him hiring physicians to prescribe dubious treatments to trip him up. It also doesn’t help that so many states are licensing quack specialties like naturopathy, where there is no standard of care and, let’s face it, even treatments and ideas like those advocated by Young are not beyond the pale.

Then there are even more misguided “health freedom laws” and far too much deference shown to quackery. For example, in her opening statement, prosecutor Gina Darvas said that Young’s trial “is not an attack on alternative medicine.” When I read that, my first thought was: Why the hell not? Alternative medicine for cancer costs patients’ lives!

It won’t be, though. In California, for instance, there is SB 577. This bill was passed and signed into law back in 2002 and was designed to regulate alternative medicine practitioners. Basically, it allows the practice of medicine without a license, as long as the practitioner provides clients with a clear statement that he is not a licensed physician, a list of services provided, and a description of training. Because of this, I feel for Darvas. I don’t know what her evidence includes, but based on SB 577, my guess is that her best bet will be to get Young on the fraud charges because convicting him for practicing medicine without a license is going to be difficult. The California legislature intentionally made it that way 13 years ago.

California is by no means alone, either. Jann Bellamy has pointed out to bills and laws that she refers to as the quack full employment act (Colorado) and “quack protection law” (Nevada). Such are the fruits of the “health freedom” movement and the increasing acceptance of pseudoscience that prosecutors, state medical boards, and the police have a hard time prosecuting and convicting even the most egregious and long-practiced quacks, like Robert O. Young. Add to that an insufficiently rigorous and well-funded regulatory structure in most states, coupled with excessive deference to the prerogatives of physicians, and you have physician-quacks like Stanislaw Burzynski getting away with administering unproven cancer treatments since the 1970s. Worse, even if the TMB is successful in its action, the worst that Burzynski will suffer is the loss of his medical license.

Let the patient beware!

Categories: Medicine, Skepticism

Separating Fact from Fiction in Pediatric Medicine: Ear Infections

Science Based Medicine - Fri, 11/20/2015 - 09:00

Please don’t try chiropractic first, or at all, for any pediatric condition

As discussed numerous times on the pages of Science-Based Medicine, children are increasingly a target of chiropractors, with some even pushing for recognition as primary care practitioners. Despite a thoroughly inadequate training, and a lack of experience with ill pediatric patients, they believe that they have what it takes to recognize and manage common pediatric conditions or refer to an actual pediatric medical professional when they deem it appropriate.  While a significant percentage of pediatric illness is self-limited, and thus might appear to respond to chiropractic manipulation, I have seen many deteriorate quickly and with little warning. The idea of an ill child suffering at the hands of a charlatan is terrifying.

Many chiropractors are of course more than happy to see pediatric patients without acting as their PCP. They love to claim that children are at risk of developing misalignment of the bones of the skull and spine, chiropractic subluxations, and numerous other conditions unique to alternative medical reality, particularly during the first few years of life. They tell caregivers that these insults can be subtle, or even silent for years, and that regular maintenance care is required to prevent severe problems, even going so far as to blame SIDS and “shaken baby syndrome” on these fictional entities.

Many chiropractors are also quick to claim that they can prevent or cure some of the most common conditions seen by pediatricians and family healthcare providers, such as viral infections of the upper respiratory tract, asthma, bedwetting, and ear infections to name just a few. By simply improving the function of the nervous system, chiropractors believe that they can “boost” the immune system’s ability to fight infections, improve control over bladder function, and even reduce airway inflammation and bronchoconstriction. If you think that sounds like nonsense, you’re right!

I’d like to focus on ear infections in the pediatric population in this post, and to contrast a science-based understanding and approach to treatment, warts and all, with that of the chiropractic profession. As you’ll see, the chiropractic understanding is overly simplistic, and its management makes no sense. And the research base is a house of cards toppled by the slightest breeze of skeptical evaluation.

Ear Infections in Kids

Infection of the middle ear, commonly referred to as “acute otitis media” or simply as an ear infection by physicians (and some chiropractors), is the most common reason for a parent to seek urgent medical care for their child. In fact, by the age of three years, roughly 90% of children will have had at least one ear infection. Many children suffer through multiple acute episodes with some even developing chronic infections that are managed with long courses of antibiotics and surgical drainage of the middle ear via the tympanic membrane or “ear drum.”

Ear infections are considerably more common in younger children, with the highest incidence in the first two years of life. It isn’t entirely clear why there is such a drop off in incidence after the early school age years. As with most pediatric conditions, it is likely highly multifactorial and the true answer is a combination of changes in the anatomy and physiology of the middle ear and its ability to drain as well as an improved response of the immune system to pathogenic bacteria. Other factors that influence the incidence of ear infections in children are family history, day care attendance, breastfeeding, exposure to cigarette smoke, pacifier use, and numerous other minor factors.

Not surprisingly, ear infections are also the most common reason why children receive a prescription for a course of antibiotics. This is problematic for a number of reasons. Historically, doctors have been too quick to diagnose ear infections, which has resulted in large numbers of unnecessary prescriptions for antibiotics. This has almost certainly played a role in the development of resistance to common antibiotics and has caused more harm than benefit considering expense and adverse events like allergic reactions and colitis caused by overgrowth of Clostridium difficile in the gut.

How are ear infections diagnosed and treated?

Physicians diagnose acute otitis media (AOM) based on direct visualization of the tympanic membrane using an otoscope, with some versions even providing a magnified view to aid recognition. In general, we look for the presence of purulent fluid in the middle ear that is causing a bulging outward of the drum. Just as important however is the clinical assessment of the signs and symptoms of the child’s illness and an understanding of the caregivers perception of the them.

Ear infections have been misdiagnosed and overtreated for a variety of reasons. Looking at the ear drum of a squirming child with an ear full of wax is extremely difficult. And even with a cooperative child it isn’t always easy to get a great look. Pediatricians are also human and we sometimes see what we want or expect to see, especially when the pressures of time, nervous parents, and a genuine desire to help children get better are added to the mix.

Until 2004, when the AAP released a new set of guidelines for the diagnosis and treatment of AOM, the criteria were fairly subjective and there weren’t strong recommendations for a wait-and-see approach. In 2013, the AAP further refined diagnostic criteria, making them considerably more simple and objective. Unfortunately, evidence from 2010 suggested that pediatricians largely ignored the 2004 update. We continued to give out antibiotics like candy on Halloween and to increase our use of newer and broader agents that don’t improve outcomes. I look forward to seeing if the 2013 update leads to better care but I’m not exactly holding my breath.

Don’t get me wrong. I’m not saying that antibiotics don’t play an important role in the treatment of ear infections in kids. When used appropriately, they work amazingly well. They reduce pain associated with ear infections, which can be severe, speed recovery tremendously, and reduce the risk of potentially severe complications such as spread of infection to surrounding tissue of the head and neck, even meningitis.

There is a bit of a myth out there that the vast majority of ear infections will resolve without antibiotics because they are viral in nature. As with most complex medical concepts, this is partially true and partially completely wrong. It’s nuanced. Based on the studies using the latest and most sensitive techniques, only about 5% of ear infections are caused by viruses alone. Most are caused by a combination of viral and bacterial pathogens, which makes sense because most ear infections occur in the setting of a viral upper respiratory infection.

Based on old criteria and the studies using them, it is true that 80-90% of ear infection will resolve on their own however. But this number falls to about 50% when more stringent criteria are in place. In the real world outside of a study, many kids diagnosed with ear infections simply have a cold and perhaps just some fluid behind their ear drums rather than a true infection of the middle ear.

Because of this, it is challenging to determine whether or not a treatment actually works or just appears to work when the outcome being looked at is simply that the patient gets better. When strict objective otoscopic criteria are used to determine resolution of the infection, the number needed to treat drops from the double digits down to 3-4. This doesn’t mean that observation isn’t often a reasonable approach, as delineated in the AAP guidelines, when the patient is older than 6 months and the infection is mild. This group makes up a large percentage of ear infections. But for younger children and kids of any age with significant symptoms, assuming that the newer diagnostic criteria are used, antibiotics are absolutely appropriate.

Vaccines, is there anything they can’t do?

The overall incidence of ear infections does at least appear to be on the decline, perhaps because of attempts by the American Academy of Pediatrics to tighten up the diagnostic criteria but more likely because of the success of the 13-valent penumococcal vaccine (PCV13). Introduced in 2010 as an improvement over PCV7, PCV13 is given during early childhood to prevent infection with the 13 strains of pneumococcus most likely to cause severe illness in kids. Pneumococcus, notorious as a cause of meningitis and severe pneumonia, also happens to be the most common bacterial pathogen associated with ear infections.

For a nice science-based discussion of the diagnosis and management of ear infections in the pediatric population, here is the 2013 updated AAP clinical practic guideline.

What role does chiropractic play in managing ear infections in kids?

Despite numerous claims to the contrary, chiropractic manipulation plays absolutely no role in the management of ear infections in kids. The American Association of Chiropractic disagrees, claiming that adjustments of the back of the skull and the first cervical vertebra can improve drainage of the middle ear. If true, this would be helpful, but it is utter nonsense as no chiropractic manipulation can move the bones of the skull around without causing pain or injury, and there is no proven link between the position of the first cervical vertebra and the drainage of the middle ear.

While many chiropractors believe that their manipulations “boost the immune system,” the bulk of their claims regarding ear infections focus on drainage of the middle ear via the Eustachian tube, and for very good reason. The Eustachian tube connects the middle ear with the back of the throat and allows drainage of normal secretions and potential pathogens, but it is a two way street. When inflammation and swelling, usually caused by a viral upper respiratory infection, interfere with the function of the tube, viruses and bacteria which get into the middle ear have no way of getting out. Infection and accumulation of pus lead to symptoms and eventually diagnosis.

Young children are more at risk for infection of the middle ear partly because of their unique anatomy, specifically that the Eustachian tube is horizontal and thus does not drain efficiently. As we grow, the tube takes on a path closer to vertical. Manipulation of the spine or skull cannot change the orientation of the Eustachian tube. Other factors, such as exposure to cigarette smoke and nasal allergies, can also play a role in poor drainage.

Information from the International Chiropractic Pediatric Association, which offers certification and diplomate programs in pediatric chiropractic, is even worse. They claim that the pneumococcal vaccine is dangerous and ineffective, and that antibiotics and surgery are never necessary. The article also contains several links to articles written by Joseph Mercola, a friend of SBM.

Is there any evidence in favor of chiropractic?

Is there evidence that can be held up by chiropractors to support their claims? Of course there is, and lots of it. But it is evidence of the lowest order, primarily anecdotes, case series, and trials that fail to take into account the difficulty in making the diagnosis and the natural course of the infection.

As expected, the better designed the trial the smaller the effect. A perfect example is the study most commonly cited on chiropractic websites. It is a retrospective nonrandomized study of 46 children treated with adjustments and “the doctor’s own modified applied kinesiology.” 90% of the children got better without antibiotics, which is exactly what would be expected considering the difficulty in diagnosis and the fact that children with severe symptoms more consistent with a true ear infection would be less likely to go to a chiropractor as opposed to a medical doctor. The report even states that children with only isolated ear discomfort were more likely to get better sooner than those with more significant symptoms.

Why are children with isolated ear discomfort even included in a study looking at the treatment of ear infections? More importantly, how are chiropractors even diagnosing ear infections in the first place? Pediatricians with years of training and experience looking in the ears of thousands of children of various ages and sizes find it difficult. How can a chiropractor, whose educational experience typically involves interaction with very few if any ill children, hope to become even remotely proficient? It isn’t any wonder why so many of them believe that their intervention works because any intervention, even no intervention, would appear to be effective when the symptoms resolve on their own. These patients are getting better despite the chiropractic, not because of it.


Ear infections in kids are extremely common and are the leading reason for antibiotic prescriptions in young children. Science-based research has revealed that although they will often resolve without specific treatment, simple observation isn’t always the best approach and there must always be a plan in place if symptoms fail to improve or they worsen. Severe complications, although uncommon, do occur in observed and treated patients although to a lesser degree.

As in their approach to most other medical conditions, chiropractors who treat pediatric patients generally have a simplistic if not an outright inaccurate understanding of the pathophysiology of ear infections. And although it may be somewhat understandable given the difficulty in determining if a treatment actually works for ear infections diagnosed in the real world, it is still inexcusable that they even try. At best the patient gets better on their own, but a delay in appropriate care will unnecessarily prolong a child’s pain and suffering, and increase the likelihood of a complication. Parents who bring their child to a chiropractor will also likely be exposed to other forms of pseudomedical nonsense, bogus nutritional advice, and vaccine misinformation.

And then there’s this.

Categories: Medicine, Skepticism

Vitastiq – Indiegogo Pseudoscience

Neurologica Blog - Fri, 11/20/2015 - 07:40

Crowdfunding is an excellent application of social media and the web. Anyone with a great idea, who can sell their idea, can get funding from the public. You don’t necessarily need big investors.

But of course, any tool or application that can be used for good can also be used for ill. Crowdfunding sites have been used to fund pure pseudoscience. A recently example was sent to me by a reader – Vitastiq. The campaign was 185% funded, for over $210,000.

What the product claims to do is measure vitamin and mineral levels non-invasively by simply touching a small probe against a specific location on the skin. I was immediately skeptical of these claims – how can the blood level of vitamin B12, for example, be measured on the skin? Further, the probe just has a simple electrical conductor. At best it is measuring skin conductance, which can be used to measure sweat levels but not much else.

Exploring further, the company claims that there are specific locations on the body to measure specific vitamin and mineral levels: Vitamin C on the thumb, Copper on the left abdomen, etc. This is starting to sound like acupuncture – and there is a good reason for that. It is based on acupuncture.

It is further based on “Electroacupuncture according to Voll” or EAV. The company claims:

Vitastiq is a single innovative concept that connects EAV methodology to your smartphone. Expensive tests and specialist check-ups are not needed anymore.

EAV devices essentially measure the galvanic skin response. This is a common target of quack devices, because it can look superficially impressive. It is used for devices like lie detectors, in order to measure sweating. It cannot detect medical conditions or measure blood levels of anything, however.

The galvanic skin response pseudoscience is then combined with acupuncture pseudoscience, leading to the claim that the conductance at a particular point on the body relates to a specific condition or physiological parameter. Such claims are completely devoid of scientific backing, however. In short, this is complete and utter quackery.

It is a sad commentary that enough people bought into this nonsense that the campaign was fully funded. Even the slightest curiosity about how such a device could possibly work should raise serious doubts about the claims being made.

Where is the vast body of scientific research that would be necessary to establish first the basic technology and then the specific application, namely the locations on the body that correspond to each vitamin and mineral? Vitastiq does not even pretend to link to any supporting research.

Think about what would need to be true if chromium levels in the blood could be detected specifically in the big toe. What would this say about human physiology?

Further, the FDA might have something to say about such devices. According to Quackwatch:

The FDA classifies “devices that use resistance measurements to diagnose and treat various diseases” as Class III devices, which require FDA approval prior to marketing. In 1986, an FDA official informed me that the FDA Center for Devices and Radiological Health had determined that the Dermatron and Accupath 1000 were diagnostic devices that posed a “significant risk.” [11] No such device can be legally marketed in the United States for diagnostic or treatment purposes. A few companies have obtained 510(k) clearance (not approval) by telling the FDA that their devices will be used for biofeedback or to measure skin resistance, but this does not entitle them to market the devices for other purposes.

Vitastiq does not mention FDA listing or approval of any kind, and I cannot find it listed under approved devices. I sent a notice to the FDA, we’ll see how they respond.


Vitastiq makes extraordinary medical claims without the slightest bit of plausibility or evidence. The only way to characterize such a device, in my opinion, is as medical quackery. Anyone relying upon this device to monitor their health and make decisions about diet and supplements is at risk.

Indiegogo should not only be ashamed of facilitating this quackery, they should be partly liable for it. At the very least they should not allow campaigns for unapproved medical devices.

Categories: Medicine

Australian review finds no benefit to 17 natural therapies

Science Based Medicine - Thu, 11/19/2015 - 10:40

Health care systems around the world are being pressured to “do more and spend less”, to make healthcare more cost effective. Owing to aging populations and the growing cost of providing health services, there’s more scrutiny than ever on the value of different health treatments, with the goal of reducing the use of treatments that don’t help. The Choosing Wisely initiative was establishing expressly for this purpose. Regrettably, while well-intentioned, Choosing Wisely hasn’t had as much of an effect as you might expect. Medicine can be slow to change, as David Gorski discussed earlier this week. Unless we ruthlessly scrutinize what we do for effectiveness, and are willing to act on what we learn, self-driven change is unlikely. One way that governments (and insurers) can dramatically reduce the use of a health service or treatment is to simply stop offering it, or paying for it. Yet stopping funding is something that is relatively uncommon in health care. It seems to be much more difficult to stop a practice, possibly owing to inertia, a reluctance to change, and the sometimes-vociferous protests that can emerge from patients or physicians that may feel that their preferred therapy is effective. The formidable challenge of stopping health care funding, once it has started, is one reason why this blog has been very critical of the expanding scope of practice being granted to alternative medicine purveyors – the legislative alchemy that is the first step towards insurance coverage. Because once that’s in place, it will be far more difficult to stop it. So it’s essential to understand the evidence.

Yet sometimes, which the evidence is so stark, insurers and governments face facts and start cutting benefits. Economic circumstances can strengthen that resolve. The most politically-acceptable approach, not surprisingly, is to conduct ruthlessly rigorous scientific reviews. When done effectively, these reviews can lead to solid, science-based decision making. Consider the slow death we are witnessing of homeopathy on the UK’s National Health Service (NHS). The NHS is a comprehensive public insurance system that maintains a “blacklist” of services that won’t be reimbursed if prescribed by a physician. It would seem self-evident that sugar pills should fall into this category, and that’s exactly what we may soon see.

Australia is another country with a fairly comprehensive public healthcare system that is also facing economic challenges and the desire to use its resources more efficiently. It also has a complex system in which the public insurance program (Medicare) is supplemented by private insurance which covers the cost of treatments and service that are not publicly funded. The risk to good care (and choosing wisely) is that there are often fewer incentives to reduce inappropriate costs from private plans, because those costs can be passed right back to the insured, typically in the form of higher premiums.

The Australian government recently undertook a review of natural products covered by private health insurance. It did this for two main reasons: The first was to ensure that private insurance plans were paying for “clinically proven” treatment. The second was based on concerns about tax dollars being used to subsidize ineffective treatments. The government provides a rebate on private insurance, and questions were raised about the extent to which the government was effectively subsidizing “natural” therapies that were not supported by good evidence yet were still being paid for through insurance. So in 2012 the government announced a review of natural treatments to determine if these therapies were effective, safe, and provided good value for money. Perhaps not surprisingly, the report has concluded:

The Private Health Insurance Rebate will be paid for insurance products that cover natural therapy services only where the Chief Medical Officer finds there is clear evidence they are clinically effective.

Such clear evidence has not been found.

The Review of the Australian Government Rebate on Natural Therapies for Private Health Insurance

The reality with many “natural” remedies is that there is often a lack of good evidence with which to evaluate them. Consequently, we’re often left with an “absence of evidence” rather than evidence that points clearly in one direction or another. (This gets to the distinction of evidence-based medicine from science-based medicine). In this review, the authors did not consider plausibility (a problem I will come back to), but looked only for direct evidence, drawing a very strict definition:

  • The data set was limited to systematic reviews (i.e., reviews of trials) published in the last 5 years. However, the authors noted that most reviews searched for all potentially relevant primary studies, without date limitations. They also considered literature submitted by stakeholders. Upon examination, both were felt to be low-quality evidence.
  • Searches were limited to the English language (which might limit the evidence base for some therapies).

The major problem with this approach was summarized by the authors as part of the quality assessment, and they noted the following:

  • A lack of randomized controlled trials. Even trials reported as RCTs didn’t contain enough information to demonstrate that they were truly randomized.
  • Poor comparators. Often trials were designed to make the assessment of a particular “natural therapy” impossible.
  • Lack of power. Studies were underpowered and not designed to actually answer the question being asked.
  • Lack of blinding. With most trials measuring subjective effects, blinding the investigator and the patient was critical. This was rarely observed. It was also observed that some therapies are very difficult, if not impossible, to truly blind (e.g., massage).
What was reviewed?

In three cases, the review had to modify its approach. Multi-modality therapies, like herbalism or naturopathy, needed to be studied differently. One topic, Ayurveda (natural medicine with Indian roots) was dropped owing to the diversity of the treatments and the requirement to translate data. Four others (hypnotherapy, biochemistry, nutrition and psychotherapy) were also dropped as it wasn’t clear which aspects of these therapies were “natural therapies”.

I’ve been blogging for years, but some of these therapies were new to me:

The evidence Alexander technique

Alexander technique is a type of physical therapy that aims to improve movement and correct posture, with the goal of improving health and reducing pain. Invented by Frederick Matthias Alexander, the process seems to encompass elements of mindfulness in the practice. Nine systematic reviews were identified, but the overall evidence base was poor. The reviewers concluded that the Alexander technique may be effective in improving pain and disability of low back pain in the short term (up to 3 months) but the long-term effectiveness of Alexander technique was unclear. There was insufficient evidence for other conditions to draw any conclusions.


Aromatherapy uses essential oils with the intent of delivering a medicinal effect. It’s used as part of massage therapy, but also on its own. The main uses are to treat stress and anxiety, but the oils are also thought to help reduce pain and nausea. Proponents make very wild claims about the effectiveness of aromatherapy of essential oils, but the actual evidence is lacking. There was limited, low-quality evidence to suggest aromatherapy may be effective in reducing anxiety and agitation in patients with dementia, and possibly in reducing generalised anxiety in some other situations, such as before health-care procedures. However, this observation emerged from data that was judged to be of poor quality. The overall effectiveness and relevance of aromatherapy for these uses felt to be unclear. The effect of aromatherapy on health outcomes with other conditions remains uncertain.

Bowen therapy

Bowen therapy is a form of physical manipulation/massage/bodywork that is described as a soft-tissue remedial therapy or a form of bodywork that primarily focuses on the myofascia. Therapists use their fingers and thumbs to apply gentle rolling movements over muscles, tendons, and connective tissues. Invented by Australian Thomas Ambrose Bowen which he described as a “gift from god”, you can learn to offer Bowen therapy over a weekend. When the limited data were considered, it was concluded that there was insufficient evidence to make any conclusions about the safety or efficacy of Bowen therapy.


Buteyko (the Buteyko method) is a breathing technique developed in Russia for the treatment of asthma. It involves shallow breathing, through the nose, with breath-holding at the end of the exhalation. It is promoted as a treatment for respiratory disorders. It was invented by Konstantin Buteyko in a moment of inspiration when he was dazzled by a bright light (I’m starting to see a pattern here). The quality of the evidence for Buteyko is low. None of the evidence reviewed demonstrated that the Buteyko breathing technique improves pulmonary function, asthma symptoms or quality of life in adults. There is weak evidence that it may decrease bronchodilator use compared with inactive controls, however.


The Feldenkrais method was invented by Moshe Feldenkrais. It is a gentle form physical therapy that focuses on breath, posture, and movement. What the Feldenkrais technique promises is vague and seems to revolve around nonspecific “wellness” rather than any objective effects. While several systematic reviews were found, few contained any RCTs. Data quality, again, was poor. Overall, the effectiveness of Feldenkrais for the improvement of health outcomes in people with any clinical condition was felt to be uncertain.

Herbalism/western herbalism

Herbalism was the basis of modern pharmacology and involves the use of plants and plant-derived substances as medicine. The report identified three main types of herbalism: Chinese, Ayurvedic and “western”. Herbals treatments can be administered in many ways – not just orally. This review looked at the overall effectiveness of herbalism – not just herbal remedies, as the question facing the review was the funding of herbalists as an insured service. Chinese and Ayurvedic medicine were excluded from the review as they were determined to be out of scope. No systematic reviews were found. While there is considerable research on individual plants and products, there was no data on the overall effects of herbalism, and the process of “individualized” treatments as provided by herbalists. Given herbalism is effectively the provision of impure drugs and chemical combinations, the authors noted the significant potential for adverse events with herbalism, particularly when herbal remedies are combined with drug products.


Homeopathy is an elaborate system of placebos where most homeopathic “remedies” contain no active ingredients at all, invented 200 years ago by German physician Samuel Hahnemann. Based on the idea that “like cures like” (which is a form of sympathetic magic) and the belief that sequentially diluting a substance will increase its effect (because the water has a “memory” of the substance), most remedies are inert. The authors looked at the National Health and Medical Research Council report as part of this review. They noted that there is little high-quality evidence, the available evidence is not compelling, and overall fails to demonstrate that homeopathy is an effective treatment for any condition.


Iridology is an alternative health practice that is based on the belief that medical conditions manifest in the iris. Examining the iris is thought to bring insights about overall health as well as specific organs and body functions. Iridology is prescientific pseudoscience, yet is used by iridologists, naturopaths and homeopaths for diagnostic purposes. No systematic reviews were identified that have studied iridology, signaling there is a lack of evidence to demonstrate any effectiveness for the practice.


Kinesiology is the study of body movement that identifies factors that block the body’s “natural healing process”. It is more commonly referred to as “applied kinesiology (AK) or specialized kinesiology, which should be distinguished from the science-based use of the term kinesiology, which refers to studies of mechanics and anatomy. (This portion of the review was poorly done and confusing to parse, as it did not distinguish clearly between the different practices that may be called kinesiology.) AK was invented by chiropractor George Goodheart and is a combination of chiropractic, acupuncture and western biomechanics. Applied kinesiology is pure pseudoscience. Dysfunctions found in AK are addressed by focusing on acupressure points and other specific body movements. The literature search found only a single systematic review on the topic of applied or specialised kinesiology. Not surprisingly, it was observed that there is a lack of evidence showing AK is effective for any condition.

Massage therapy

The term massage therapy or myotherapy encompasses a number of different manual therapies, and this review included remedial massage, sports therapy massage, deep tissue massage, myofascial release, therapeutic massage, myotherapy, lymphatic drainage, traditional Thai massage and Swedish massage. Systematic reviews were sought for any form of massage therapy. This was an extensive review and the data search results for each type of massage therapy are outlined in detail. Overall, the data was found to be of low quality. It’s important to acknowledge that like other manual therapies, blinding for providers and patients is difficult, as is data collection, as most outcomes are patient-reported, subjective measures.

The reviewers noted that there is a lack of good-quality evidence that examines the effectiveness of massage therapy for many conditions, and is actually inconclusive/uncertain for 29 clinical conditions it assessed. There is mixed but promising evidence for low back pain, and for reducing the length of stay in pre-term infants. There were some specific recommendations made about future research which I think are worth noting, as they point to the number of variables that may affect the effectiveness of massage therapy, and our ability to assess it:

In practice, massage therapists often combine various treatment modalities or techniques within a single session, and may also treat patients over longer periods of time than those assessed in an RCT. To allow for more firm and conclusive statements about the effectiveness of massage therapy for a particular clinical condition, more rigorous, multicentre, and well-designed clinical studies assessing the effectiveness of massage therapy for a particular patient population are required. RCTs need to combine treatment approaches so as to properly reflect the way that massage therapy is applied in practice. Also, there is little data about what constitutes an effective massage therapy session. Further research is required regarding optimal treatment parameters such as number of sessions or duration of sessions required, combined with longer-term follow-up of patients to assess the long-term effectiveness of massage therapy. Similarly, further high-quality research is required that reflects the way that myotherapists use various touch and equipment-based interventions in practice, to enable the effectiveness of this therapy to be assessed.


As has been noted many times on this blog, naturopathy is an alternative medicine practice that encompasses a variety of modalities including homeopathy, herbal medicine, and Traditional Chinese Medicine. “Vitalism” is the belief that living beings have a “life force” not found in inanimate objects; as a concept vitalism was disproved by Wöhler in 1828. Despite this, the idea remains the central dogma of naturopathy and informs much of its practice. Naturopathic treatment ideas are all grounded in the idea of restoring this “energy”, rather than being based on objective science. Naturopaths can use conventional medicine as part of their practice, but this tends to occur only when its use aligns with the naturopathic belief system. This review focused on the overall effectiveness of naturopathy and naturopathic practitioners, rather than individual remedies or treatments, some of which are covered separately in the report (e.g., homeopathy, which is a “clinical science” in naturopathy). The reviewers found a single systematic review as an unpublished abstract. Conditions studied included cardiovascular disease, multiple sclerosis, anxiety and various types of musculoskeletal pain. There was no data on acute conditions. The overall quality of the evidence was rated as low. It wasn’t clear if this data was generalizable, as the studies were North American, where many states (and Canadian provinces) licence naturopaths. Naturopathy is unregulated in Australia. While the reviewers concluded that there is some evidence to suggest that naturopathy as a service is effective in improving patient health for a range of chronic conditions, there were numerous limitations noted with that data. And as regular readers to the blog will know, the evidence demonstrating that naturopathy is effective is lacking.


Pilates is an exercise practice that is said to benefit health through improvements in strength, coordination, balance, flexibility, proprioception, range of motion, body definition, and muscle symmetry. It focuses on the body’s core muscles, as well as posture. Invented by Joe Pilates, there are over 500 exercises that may be done on the floor or using specialized equipment. Despite the popularity of Pilates, there is little published evidence that examines its efficacy. A search found 10 systematic reviews that included 18 unique RCTs. Conditions studied included obesity, breast cancer, strength/balance and falls prevention, low back pain, and stress urinary incontinence. Overall the data was quite limited, even for the conditions studied. The authors concluded that the effectiveness of Pilates for the conditions studied was uncertain. The most favourable interpretation was that Pilates may offer some benefit for low back pain, but even this tentative conclusion was limited by poor data quality.


Reflexology is the practice of applying pressure to the feet in the belief that points on the soles correspond to different organs and locations in the body overall. This type of massage is believed to release “blockages” and stimulate healing. Reflexology is another alternative medicine practice that is pure pseudoscience. Like iridology above, reflexology is a homonculus, or mapping-based system. Not surprisingly, this review found a lack of data and concluded that the effectiveness of reflexology was uncertain for all conditions that were assessed.


Rolfing is another form of manual therapy (sometimes referred to as structural integration) that is used to treat different health conditions, both musculoskeletal and non-musculoskeletal in nature. It seems to have elements of massage, yet focuses on the fascia and seems to veer more into beliefs about “energy medicine”. Rolfing was invented in the 1950s by Ida Pauline Rolf who claimed to identify a correlation between muscular tension and emotions. While anecdotal claims of effectiveness exist, there is a lack of published evidence that has critically examined Rolfing. The review concluded that there is a lack of evidence effectiveness of Rolfing for any clinical condition. Consequently, the safety, quality and/or cost-effectiveness of Rolfing could not be determined.


Shiatsu is a form of massage therapy that incorporates acupressure, with origins in Japan. Shiatsu is considered a gentle massage (unlike Rolfing) where pressure is applied to over 150 pressure points on the body. Its aim is to restore and “balance” “energy flows” in the body. Practitioners may also use other treatments, such as moxibustion, cupping, food as medicine and judo therapy/tai chi/qi gong. The researchers found no systematic reviews for shiatsu for any condition, so were unable to draw any conclusions about its effectiveness or safety. They noted that the lack of evidence makes it difficult for consumers and others to make informed assessments of this therapy.

Tai chi

Tai chi, taiji or taijiquan is a mind/body exercise that involves slow, flowing movements. It has origins in China as a martial art and is based on Confucian and Buddhist philosophies. It is thought that tai chi can balance the body’s yin and yang and the overall “life force” or “qi”. While there are several variants of tai chi, all use slow movements and focused breathing techniques. There is a substantial evidence base for tai chi: The authors found 37 systematic reviews that included 117 unique RCTs, and almost 9,000 participants across 16 clinical conditions. Overall, the quality of the evidence was not good however. The reviewers concluded that there was low-quality evidence to suggest that tai chi may have some beneficial health effects compared to control for some conditions. However, owing to the dearth of good data, the magnitude of any benefit was not clear. Tai chi is well tolerated, and the reviewers concluded it could be considered a safe treatment in the populations studied.


Yoga is a traditional Indian mind and body practice that involves a combination of physical postures, breathing techniques and meditation or relaxation. Depending on the form of yoga, there may be elements of stretching, strengthening and mediation. While spiritual elements are important components of traditional yoga, it is more popular as a form of exercise that ignores many of these elements. The reviewers found 67 reviews, 59 of which contained a total of 111 unique RCTs of yoga. The evidence base is limited by small, poor-quality studies that were poorly reported, making interpretation difficult. Consequently, the reviewers could only identify that there is weak evidence that yoga improves symptoms in people with depression compared with control. There was insufficient information available for other conditions.

Conclusion: Absence of evidence and plausibility

A comprehensive Australian review has found that there is a uniform lack of good quality clinical evidence to support the use of 17 different “natural” treatments. While absence of evidence is not the same as evidence of absence, the lack of good data to demonstrate efficacy suggests that these practices cannot be considered evidence-based. While this report gives a comprehensive summary of the current evidence, it is not without its problems. These therapies vary widely in their plausibility. On one end, iridology and homeopathy are pure pseudoscience. Pilates, yoga, and tai chi, however, are physical exercise which are admittedly difficult to evaluate in RCTs, yet are much more likely to have the potential to be beneficial. It’s here that a more clear science-based medicine filter would have been useful, something that the authors seem to acknowledge in their comments on the report, where plausibility is mentioned as a potential guide for future research. Given the very rigorous evidence bar it established, it is likely that insurance subsidies for these 17 treatments may end as a consequence of this review.


Photo via flickr user Joe Crawford used under a CC licence.



Categories: Medicine, Skepticism

Gene Editing Humans

Neurologica Blog - Thu, 11/19/2015 - 08:11

A Chinese team of researchers recently announced that they attempted to edit the genes in human embryos with the genetic disease beta-thalassemia. They used the CRISPR-Cas9 technology, which they said was not successful enough in this application to be used. Some of the embryos resulted in mosaics, with only some of the cells being fixed, and other resulted in unwanted mutations.

While the attempt to fix the genetic disease in embryos was unsuccessful, the announcement has prompted discussion over the ethics of gene editing in humans.


First for some background, because I have not yet written about the CRISPR technology, this is an exciting gene-editing technology that allows for rapid, accurate, and inexpensive gene editing.

CRISPR stands for Clustered Regularly Interspaced Short Pallindromic Repeats, which refers to a sequence of base pairs found on the DNA of bacteria that have this feature. Some bacteria and archaea use CRISPR for adaptive immunity, in order to incorporate bits of DNA from invading viruses into segments of their own DNA in order to target their immune system at those sequences.

Cas refers to CRISPR associated genes. Cas9 is for an endonuclease that can cleave DNA. It can be combined with specific RNA in a system that can either insert or delete genetic sequences into the target DNA.

What all of this means is that the CRISPR system can be used for highly specific and convenient gene editing, either deleting or inserting sequences into target genes. There is an overwhelming consensus that this technology will usher in an age of cheap and easy genetic manipulation.

One private company, for example, offers CRISPR systems to researchers, boasting:

Introducing the only complete genome editing solution designed to expedite your research. Our easy-to-use optimized and validated solutions span the entire cell engineering workflow, making genome editing accessible to anyone at any level.

Gene Editing Human Embryos

Given the controversy over genetically engineering corn, it is no surprise that the prospect of genetically modifying humans will be highly controversial. Despite the fact that the Chinese researchers concluded that the technology is not quite there yet, their announcement has sparked the predictable conversation.

The Huffpo Interview shows two basic attitudes toward this prospect. Dr. Marcy Darnovsky, executive director of the Center for Genetics and Society, is concerned about the implications of the technology. She raises several points, all of which we have heard before with other technologies, including IVF itself. There are safety concerns. The technology can go beyond treating disease to creating new humans and “designer babies.”  She also warns that this technology could lead to those with money creating a superior race, creating a world we would not want to live in. She equates the technology to eugenics.

Antonio Regalado from MIT Technology Review argues that the same objections were raised for IVF, and that the eugenic analogy is not apt since this technology will be voluntary and won’t harm anyone.

I tend to agree with Regalado. Raising safety concerns is a false issue. There are always safety concerns with a new technology, but they can be dealt with. They aren’t a reason to stop the technology. We can evaluate the precision and consequences of using CRISPR on human embryos, and only approve applications when the techniques are sufficiently safe. The same was true of IVF and pretty much any new medical technology.

Before we get to the issue of using CRISPR (or any genetic modification technology) to create enhanced embryos, let’s not forget that the application currently being studied is to correct a genetic illness. Regardless of ethical considerations about the former, we should not let that interfere with a technology that can cure genetic diseases at the embryo stage.

There are actually two approaches here. You can select embryos that lack a harmful mutation, without doing any editing. This is not possible, however, if every embryo is a carrier. Then gene editing is required.

I see no ethical reason to hamper any technology that can treat genetic diseases, which can be devastating and costly, resulting in a lifetime of medical bills. We cannot afford to eschew a potentially cost effective medical intervention given rising health care costs.

I don’t buy the slippery slope argument that such technology will necessarily lead to designer babies. We can use regulations to approve some applications and not others.

The thorny ethical issues, in my opinion, only revolved around creating genetically enhanced people. The argument that such technology would be unethical, or at least a bad idea for society, was articulated by Darnovsky – this can create a truly stratified society in which one race of humans, the offspring of those with money, is perceived to be superior to another.

The primary argument against this objection is that you can say the same thing about iPhones. Almost every technology is more accessible to the wealthy than the poor, and widens the gap between the haves and have nots. We are now dealing with a “digital divide,” where access to computer technology and the internet is yet another social advantage of those with resources over the poor.

I acknowledge that one meaningful difference here is that we are talking about changes to the people themselves, not just the technology to which they have access.

One might argue that the solution to such technology gaps is not to ban the technology so no one can take advantage of it, but to address the underlying social issues themselves. There are also social safety nets in place to provide at least some resources to the poor. Sure, the wealthy can afford organ transplants without having to worry, but poor people still get transplants through Medicaid.

These social systems are not perfect, and they probably never will be. In any society where people are allowed to benefit from their talent, skill, hard work, and even luck, there will be those who have more than others. Historically, this fact does tend to lead to increasing social disparity, but there are many mechanisms to mitigate stratification, allow for social mobility, and to distribute resources equitably.

Exactly how and how much to do this is a huge ideological debate, and pretty much drives the division between liberals and conservatives. I get the feeling that the same liberal/libertarian ideological divide is coloring the debate over gene editing and other similar technologies.

My position is essentially not to bring that ideological fight to medical technology that can be used not only to cure disease but to make humans smarter and healthier. Deal with the underlying social issues. We should no more ban gene editing than we should shut down the internet in order to eliminate the digital divide.

To be clear, we need to regulate genetic manipulation of humans, just like any powerful medical technology. Those regulations should be appropriate to the technology, to ensure safety, informed consent, and appropriate ethical use. We have similar regulations and systems in place for organ donation, for example. It can work.

Categories: Medicine

US Department of Justice Goes After Supplements

Science Based Medicine - Wed, 11/18/2015 - 07:59

It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The FDA (Food and Drug Administration) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The FTC (Federal Trade Commission) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.

Now the US Department of Justice (DOJ) is getting in on the fun.

USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.

This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.

As an aside, homeopathy is different because legally it is regulated as a drug, meaning the FDA has much more regulatory power and could effectively shut down the industry if they wanted. All they have to do is require evidence of efficacy for any homeopathic product and the entire industry would evaporate.

Some Background on Supplements

Supplements are regulated under DSHEA – the Dietary Supplement Health and Education Act of 1996. This was essentially a gift to the supplement industry, effectively removing it from FDA regulation by creating massive loop holes. The legislation (thanks to senators Orin Hatch and Tom Harkin) is blatantly pro-industry and anti-consumer, even though it was sold to the public as being pro-consumer freedom.

The predictable result was that the supplement industry exploded. We now no longer need to speculate about what an ineffectively regulated health care product industry would look like – we have almost 20 years of the supplement industry as an example.

The idea of DSHEA is that market forces and consumer choice will lead to better products, with the FDA and FTC looking over industry’s shoulder and helping them self-regulate. That’s not what happened.

What did happen was that the industry realized it could put almost anything in a bottle (as long as it didn’t contain an actual drug), and make whatever claims they wanted for it. They didn’t have to do any research or provide any evidence, just put a small disclaimer at the bottom saying the FDA has not reviewed the claims, a disclaimer the public was certain to ignore.

Even though the lax regulations created a formula for essentially making millions off of the placebo effect, the supplement industry pushed the limits even further. It has recently come to light that many supplements on the market don’t contain what’s on the label, and contain fillers, substitutions, and contaminants.

Sometimes they even contain banned drugs – put a little Viagra in your male enhancement supplement, or a stimulant in your weight loss supplement, to get an edge on the competition. The FDA issues warning letters to companies who do this, but most fail to comply.

All of this is justified by those making millions off supplements, and those in the public who have been receptive to their advertising, by the assumption that supplements are “natural” and therefore magically safe and effective. This is not true. Herbs are drugs and can have drug side effects, toxicity, and interactions. This is why the FDA is now targeting regulation of the term “natural.”

Now the DOJ is involved

While the FDA and FTC struggle to contain this avalanche of what are essentially fake products defrauding the public, without really having the teeth or resources to do so effectively, now they are getting some help from the justice sector.

At the state level, earlier this year New York State attorney general’s office, after an investigation, filed a cease-and-desist order against GNC, Target, Walgreens and Wal-Mart, ordering them to stop selling a number of herbal supplements that were found not to contain the ingredients on the label, and some of which contained unlisted fillers that were potential allergens.

Now at the federal level, the DOJ is getting involved, and with good reason. Here is perhaps the worse offense alleged in the indictment:

The indictment also said there were a rash of liver injuries associated with the product OxyElite Pro Advanced Formula in late 2013, and several users needed liver transplants.

USPlabs, when told of this, informed the U.S. Food and Drug Administration that it would stop marketing the supplement but instead tried to sell off inventories as quickly as possible even as executives ordered that two offending substances be removed from the formula, the indictment said.

Let that sink in – the executives were apparently told that their product was causing liver failure, so they sold off their inventory as fast as they could.

Conclusion – Now What?

We can think of the regulation and behavior of the supplement industry on three levels. The first level is where the supplement industry fully complies with current regulations. Even then, the industry is allowed to essentially sell unregulated drugs (herbs) with “structure function” health claims, testimonials, and endorsements without any burden of proof to back up their claims.

We now have a two-decade experiment on this regulation, and it is the utter failure that its critics said it would be. The net result was the public wasting billions of dollars a year on worthless supplements – and this is the best case scenario.

Level two is where the industry violates even these lax regulations, with poor quality control, inaccurate labeling, adulteration with regulated drugs, contamination, and making prohibited claims.

Now we are seeing level three – criminal corporate malfeasance. No one should be surprised that when lax regulations allow an industry to be dishonest, it attracts dishonest people.

What we need now is a complete overhaul of how the supplement industry is regulated. DSHEA should be repealed, or at least updated to fix its myriad problems (effectively repealed).

I have nothing against the free market, it can be a powerful tool to drive innovation and quality. In our current economic system companies can invest in research and product development, and then make a huge profit off of that development.

But the free market is a construct of regulations – there have to be rules or else you don’t have a free market, you have chaos. Especially with a vital industry like health care, thoughtful regulations are necessary to allow innovation while protecting the public health.

There is also a unique challenge for health care products in the free market – it is very difficult for consumers to evaluate long term effects of products and services. All product effects are obscured by placebo effects. Consumers cannot reasonably rely on their own anecdotal experience – they need to be informed by scientific evidence. That evidence will not be created and evaluated unless regulations demand it. Private consumer information companies also don’t have the resources to do this.

What we need is a system in which drugs are regulated as drugs, not food or vitamins. All health claims should be backed by adequate evidence. The industry needs to be carefully regulated for quality control, transparency, and accuracy in labeling.

Ironically, the public thinks this is what they already have. Most people have no idea that they are at the mercy of the supplement industry’s self-regulation.

Perhaps, however, we are reaching a tipping point where the political will exists to make some effective changes. Let’s hope so.



Categories: Medicine, Skepticism

Autonomous Cars and Ethics

Neurologica Blog - Tue, 11/17/2015 - 08:14

In the last few years autonomous cars have seemed to turn a corner – suddenly the technology is here. This is one of those technologies that was long anticipated, and then quickly arrived. They are not yet in mass production, but it feels like we are on the steep part of the curve.

Google car is the most in the news. The company has been testing their autonomous vehicle for years. Some use the term “driverless” but there still needs to be a human in the driver’s seat. The success of the vehicle is measured in how often the driver needs to intervene. At first they measured interventions per mile, and now they measure miles per intervention.

The autonomous car is certain to be a transformative technology. I can’t see how it won’t. It will transform the way we get around, could spawn new industries, and may also transform our infrastructure. For example, imagine a fleet of truly driverless cars you can summon with an app, Uber-style. Insert your credit card, and you’re off. For some people this may obviate the need to own a car.

Right now we are trying to adapt autonomous cars to our existing infrastructure. Eventually we will adapt our infrastructure to autonomous cars. At present the goal is to get the cars to drive more like humans. For example, recently a Google car was pulled over for driving too slowly. The algorithm called for the car to drive very cautiously (never more than 25 mph). This resulted in a back-up of traffic. Google now says they endeavor to make the cars drive more like people (at least in some ways).

Driving and Ethics

One interesting question that has arisen is how to program the cars to react to situations in which the actions of the car will affect who is likely to die in an accident. Should the car swerve to miss one person, even if they will plow into many people? Should the safety of the passengers or a pedestrian be prioritized? What if there are four people in the car, should they swerve into a tree to miss one pedestrian?

Often such questions are framed in a way similar to the classic trolley set of ethical problems. Trolley dilemmas are used to think about both the philosophy of ethics and human psychology. In the classic version you are a switch operator on a railroad. A train or trolley is out of control coming down the tracks, and is currently on course to kill 5 people crossing the track. You have only time to execute one decision – you can switch the track to save those 5 people, but the trolley will then hit and kill one person on the other track. Do you do it? Most people say yes.

What if instead, however, you were on the trolley when it is about to hit and likely kill 5 people. You are standing in the front, next to a large person. If you push them off their body will likely stop the trolley saving the 5 people. (Ignore how contrived the situation is, and just focus on the ethical decision.) Do you push them off? Most people say no.

In both cases you are sacrificing one person to save five. The math makes sense. But in the first case your actions are less directly connected to the death of the one person, and that matters to us emotionally.

How do we apply all of this to the programming of autonomous cars? Essentially, will we have to include in their programs a way of prioritizing such decisions?

I think the answer is yes and no. An article at addresses this question, and argues that it is a non-issue. I don’t quite buy their arguments, however. Here are their arguments:

a) No good solutions to these dilemma exist or can exist. Humans are not able to make a ‘right’ choice when faced with such situations either.

This is the Nirvana fallacy – because there is no perfect choice, it doesn’t matter. I disagree with this. The cars will still need to make the best choice, even if that choice is horrible.

b) These dilemmas assume certainty and knowledge that does not exist in such situations.

Again, this is the Nirvana fallacy. Perfect knowledge is not required. Health care professionals make decisions every day in the absence of certainty or perfect knowledge. What is likely to develop are algorithms that are statistically driven – cars will be programmed to make choices that result in the statistically best outcome overall, even if it cannot optimize the decision to each individual case.

This means that the autonomous car behavior will evolve over time, as we gather data on accidents, their causes and their outcomes.

c) These dilemmas are always incredibly contrived. The probability that a car faces such a situation is extremely low.

This is their best point, but I think a little over stated. Yes, the classic trolley dilemmas are very contrived. They are contrived to present a pure ethical choice, because that is their focus. With autonomous cars the focus is not to explore ethics or human psychology, but to make practical choices for the behavior of a machine.

There are many non-contrived situations that will still require those who program the autonomous cars to make decisions about how the reaction of the car will affect the probability of harm coming to how many people. Even just to swerve or not to swerve to avoid a pedestrian walking in front of the car is such a decision, and hardly contrived. Should the car brake only? How quickly? Should it break and swerve, and in which direction?

d) The question is wrong.

They argue that the real question is not what is ethical right, but how to avoid what is ethically (and legally) wrong. I agree that the question posed is often the wrong question, but I don’t think the article authors replaced it with the correct question. Avoiding legal liability is not the real issue either.

As I stated above, the goal is to minimize harm to people. Autonomous car behavior will be driven by statistical models operating on data, probably experimental at first, but then eventually informed by real-world data.

I do agree that the ethical/legal issues are likely not relevant. What I suspect will happen is that regulations will evolve that determine the behavior of the vehicles, based on best practices to minimize harm and maximize safety. As long as everyone follows the regulations, no one will be liable, even if bad stuff happens.

I do agree with the authors that it is possible such issues will be rare. One of the possible advantages of autonomous cars is that they can be programmed to be very safe, that computer drivers are less likely to make mistakes than humans, they never lose focus, and they can even communicate with each other and the infrastructure in order to avoid accidents.

There will likely be a transition phase where the cars do a little better than people, but still might be prone to accidents. The cars still find snowy or icy conditions challenging, for example. What appears to be happening is that the cars are approved for limited routes and conditions, and those routes and conditions will expand as the technology progresses.

Mature autonomous car technology will likely, however, be very safe, with only rare accidents due to technical failure or truly unlikely situations. Still, there will be people in the system (even if only as passengers and pedestrians) and people always introduce an unpredictable element.

I am curious how the technology will play out over the next 20-30 years. It is a transformative technology, but it has proven very difficult to predict exactly how such technology will transform our lives. We’ll have to wait and see.

Categories: Medicine

“The Truth About Cancer” Series Is Untruthful About Cancer

Science Based Medicine - Tue, 11/17/2015 - 03:00

“The Truth About  Cancer: A Global Quest” is billed as “the documentary series the mainstream media refused to air.” It consists of eleven episodes and is produced by Ty Bollinger, an outspoken supporter of natural treatments for cancer. Episodes 1 and 2 are currently available online.

Ty Bollinger started his quest because several of his family members had died of cancer despite conventional cancer treatment. He believed they had died not of the cancer but of the cancer’s “so-called treatments” and “false treatments.” He doesn’t explain which cancers they had, what the treatments were, or why he calls them “false.” He was angry, and he wanted his relatives’ lives to matter; he thought he could give their deaths meaning by seeking out alternative treatments that would have saved them and could save others. He was a CPA and bodybuilder, untrained in science or medicine. He started out with the conviction that conventional cancer treatment was a fraud, and confirmation bias had a field day. Instead of learning about cancer from reliable sources, he avoided mainstream cancer experts and researchers and only interviewed alternative practitioners from all over the world who agreed with his premise. He eagerly swallowed everything they told him.

He says “You are about to learn the best treatments and preventions to cancer, protocols that won’t harm your body, from the world leading doctors across the globe.” He promises to show viewers science and documented evidence. He promises to expose the lies of conventional cancer treatment. He thinks he has information that will eradicate cancer once and for all. He couldn’t be more wrong.A hopelessly biased sample

The people he interviewed are not the world’s leading doctors, but infamous characters whose non-science-based views are notorious. I was only too familiar with many of the names: Matthias Rath,  “Health Ranger” Mike Adams,  Joseph Mercola, Jonathan Wright, Rashid Buttar Russell Blaylock,  Stanislaw Burzynski, and Tullio Simoncini.  I will restrain myself and simply say these individuals are not reliable sources of health information. Others I was not familiar with, but they included “cancer conquerors” (patients with testimonials), journalists, chiropractors, naturopaths, integrative medicine practitioners, and operators of cancer clinics in Tijuana. He couldn’t have picked a more biased sample. He didn’t interview people like Siddhartha Mukherjee (the author of The Emperor of All Maladies), oncologists, or cancer researchers.

I have a rule, the SkepDoc’s Rule: before you believe a claim, make sure you understand who disagrees with it and why. Bollinger fails to do that. His mind is made up, and he is only willing to listen to people who agree with him. He asks questions like “Why would anyone prescribe poisons like chemotherapy?” but doesn’t consult the people who could answer and help him understand. He interviews patients who survived treatment with alternative medicine but doesn’t interview the families of patients who died.

False claims

He voices unsupported opinions and makes claims that can be easily refuted by a little research or even by common sense. Here are some of them:

  • The only thing that doctors are taught in medical school is how to prescribe drugs.
  • Professors are being paid by drug companies.
  • The Flexner Report, which reformed medical education in America, was a plot by Rockefeller and Carnegie to create a medical monopoly and eliminate all competition so they could sell more drugs.
  • “Anything coming from nature is excluded.”
  • The medical profession is a lap dog of the pharmaceutical industry.
  • Conventional medical has a monopoly on treatment: they make sure that insurance doesn’t cover CAM
  • The number one goal of health care is to make money.
  • Saying they are making progress in any disease is only a propaganda war.
  • Business thrives on the continuation of existing diseases.
  • By 2020 more than half of cancers will be medically induced by drugs or radiation.
  • Nobody dies from the cancer, they die from consequences of the treatment.
  • Surgery spills cancer cells, radiation enhances them.
  • “It’s against the law in California for oncologists to recommend integrative.”

Lies about chemotherapy

He says chemo is incredibly ineffective and is such a hazardous material that nurses who administer it have to take precautions. If it’s hazardous to medical personnel, why give it to people who are sick? (There is a simple answer: because it  has been proven to benefit those sick people.)

Chemo started with mustard gas. Yes, that’s true, but so what? The American Cancer Society explains the history of how observations of soldiers exposed to mustard gas led to an effective treatment for lymphoma.

He asks “Why is modern medicine so drug-intensive?” My answer: because drugs have been proven to work. And because efforts to get patients to improve their health by lifestyle modifications are so often fruitless.

He claims that 97% of people who undergo chemo are dead in 5 years. That is absolutely not true.  The study that claim is based on omitted all the types of cancer that chemo is most effective for, and it lumped chemo intended to cure with chemo used as an adjuvant or for palliation.

He perpetuates the lie that 90% of oncologists wouldn’t take chemotherapy themselves. That myth was based on an old study where oncologists were asked about an experimental chemotherapy regimen for one specific type of incurable lung cancer. The majority of them thought that the evidence available at that time showed that cisplatin and other experimental chemo drugs were ineffective and toxic. Keep in mind that lung cancer is not particularly amenable to chemo. A 1991 study in the British Journal of Cancer found that the majority of oncologists would take their own medicine; for instance, 98% of oncologists would take chemotherapy if they had stage IV Hodgkins disease, a cancer for which chemotherapy has been proven effective.

He claims that chemotherapy stimulates cancer stem cells. He interviews Blaylock, who seems to confuse embryonic stem cells with cancer stem cells. He says chemo has no effect on stem cells, only on daughter cells. After killing daughter cells it comes back “infinitely more aggressive.” When asked to explain, he says it’s complicated but has to do with chemistry and the micro-environment of the stem cell, producing cytokines that cause more DNA damage which makes the cancer more aggressive and more likely to metastasize. He can’t explain it because it isn’t true. Sayer Ji says chemo “enriches” cancer stem cells; there’s no evidence for that.

They claim that chemo harms every patient; it is referred to as “a suffering instead of a treatment.” They say that doctors who won’t prescribe it stand to lose their license. The tentacles of the medical cartel reach everywhere. Chemo causes side effects, which gives doctors a reason to prescribe more drugs and multiplies their business.

Matthias Rath says chemo is unethical and deceptive because it destroys the immune system and the immune system is needed to combat the cancer. He says doctors may not know better, but every scientist knows that chemo is a fraud, and if they say they don’t they should quit. (I know of doctors who think certain chemotherapies are sometimes used inappropriately, but I don’t know of a single reputable doctor or scientist who thinks chemo is “a fraud.”)

Breakthroughs in immunotherapy are misrepresented: immunologist and inventor A.J. Lanigan says “I don’t know that chemo has been successful at any level” except for making money. He sure doesn’t know much!

Rashid Buttar asks, “How is mandating chemo for children any different from Nazi Germany?” (Godwin’s Law strikes again! ) It is trivially easy to answer that question, and it is grossly unfair of Bollinger not to interview anyone who knows the answer.

They say the FDA should be protecting us from chemotherapy drugs and other toxic substances but instead they are protecting the very industries that they were supposed to protect us from. FDA approval means proven safe and effective. Side effects discovered after marketing constitute fraud. (No, they constitute more information that becomes available when a drug is used by more people and people who are not as highly selected as the subjects in the clinical studies.)

The natural fallacy

Sayer Ji says studies show that turmeric, resveratrol, and green tea are superior to chemo. (Not true.) The drug companies supposedly ignore the evidence because they can’t patent a natural substance and prefer to make money by creating artificial ones. That’s just silly. The same companies that manufacture pharmaceuticals make plenty of money from vitamins and supplements. And they can take a natural medicine, isolate the active ingredient, improve on it, and patent their discovery; in fact, about half of our drugs were developed from plants through that process.

They cite problems with Big Pharma like ghost-written articles, studies where data were made up or manipulated, and corporate malfeasance of various sorts. These are things the medical establishment is well aware of and is trying to fix. But they go much further to demonize Big Pharma. Matthias Rath says Big Pharma companies were directly responsible for creating concentration camps and for the death of 60 million people. They wanted slave labor and put profits over lives. They created the system; later the Nazis decided to use it to kill Jews. Godwin’s Law again!

They say patent medicines do not belong in human bodies and that pharmaceutical medicine fails 97% of the time (demonstrably not true; every drug has to show evidence that it works before it can be marketed). Plant medicine is holistic, safer, more effective, and less expensive. Big Pharma can’t patent nature, so it tweaks molecule and it never works as well. “Can we, as mortal men, improve on nature?” (Emphatically YES, we can, and we do. Their ignorance is appalling.)

War on nonconventional doctors?

Burzynski says the real war is being waged not on cancer but on nonconventional doctors like him. He and Wright complain of being persecuted. They cite the Fitzgerald Report to congress in 1953 that supposedly revealed a conspiracy to close and destroy clinics, hospitals, and scientific research facilities that do not conform to the viewpoint of medical associations. It documented suppression of natural treatments, “and it’s in the Congressional Record!” Mercola claims information about laetrile was suppressed. It wasn’t. Laetrile was extensively investigated and shown not to work, so it was not approved by the FDA. This was no conspiracy: it was science in action, working to protect the public as the FDA was mandated to do.

They claim there is a conspiracy of the FDA, Big Pharma, and the AMA to suppress unconventional treatments. For instance, Royal Rife “knew there were microbes inside the cancer cells” and developed a machine that he claimed cured cancer by attacking the vibratory frequency of microbes. It wasn’t accepted by mainstream medicine (for very good reason!). Burzynski says there is merciless harassment of doctors who are inventors. He says he is saving people who would have died. He accuses the mainstream of obeying orders like Nazis. (Godwin’s law strikes yet again!) Buttar says it’s considered OK if patients die with chemo, but it’s not politically correct if they use CAM and survive. Tullio Simoncini says all new discoveries are shut down. “If you withhold treatment that can save someone’s life, isn’t that the same as murder?” Jonathan Wright claims a doctor in Alabama was treating cancer successfully with intravenous hydrochloric acid. He supposedly was visited by AMA and asked to sell his treatment and told if he didn’t he’d never be published again. He didn’t and he wasn’t. Harry Hoxsey’s cancer treatment allegedly worked. The AMA supposedly wanted to buy it and bury it. Hoxsey went to jail. Patients were loyal. The Hoxsey treatment is still available in Mexico. They use a formula that targets only the malignant cells, plus diet, vitamins, herbs, etc. The whole regimen takes one day.

The truth is that there is no conspiracy. The establishment would gladly accept any of those unconventional treatments if there were credible evidence that they did more good than harm.

Cancer survivor testimonials

Bollinger interviews a number of cancer survivors who have used alternative treatments. He doesn’t understand that the plural of anecdote is not data. He only looks at a few who survived; he doesn’t tell us about the many, many people who have died because they trusted unconventional treatments over proven treatments that would have saved their lives. For example, he interviews Chris Wark, “cancer conqueror.” David Gorski has put the record straight; Wark had curative surgery. He refused adjuvant chemotherapy that was not intended to cure but only as insurance to decrease the already small chance of recurrence; he was fortunate, and the cancer did not recur. He thinks he healed himself with diet and natural therapies. He didn’t.

The myths

Bollinger and the people he interviews subscribe to a number of unsubstantiated beliefs:

  • Natural is always best.
  • It is possible to prevent and cure cancer by lifestyle changes and natural remedies.
  • A healthy immune system can eliminate cancer.
  • Detoxification is necessary for health
  • Conspiracy theories: the medical establishment is a totalitarian system that forces harmful treatment on its victims and is only interested in profits. “The so-called science, which is really just corporate driven fraudulent science, the so-called science-driven medicine is being forced on you in absolute violation of the AMA code of ethics, which says the patient must be informed and give consent.”

Episode 2

 I started watching episode 2, about breast cancer and epigenetics, but I quit in disgust after only a few minutes. Angelina Jolie is criticized for letting “irrational fear” persuade her to get a prophylactic double mastectomy. She should have known that our genes do not control life. She could have deactivated her BRCA gene by diet and lifestyle. A chiropractor tells us that the BRCA genes actually prevent cancer and repair DNA damage, and they only mutate to cause cancer when people don’t live right. This amounts to genetics denial and blaming the victim. David Gorski is a breast cancer surgeon and researcher who knows far more about the subject than any chiropractor and he has explained the BRCA genes and Jolie’s case.

Dangerous misinformation

 “The Truth About Cancer” is billed as a documentary series. It is not a documentary that tries to honestly present the facts, but a one-sided polemic, a vicious attack on conventional medicine based on misinformation, emotion, mistrust, and opinions that are not based on credible scientific evidence. It omits vital information, presents untruths and distorted partial truths, promotes natural treatments that have never been properly tested or have been tested and proven not to work, and it doesn’t give conventional medicine even the slightest chance to explain itself.

Conventional cancer treatment has cured some patients, prolonged the lives of others, and improved the quality of life for some of the ones who can’t be cured. It is ridiculous to talk about “cancer” as if it were one disease. There are many kinds of cancer, and the success rate varies. It is ridiculous to talk about chemotherapy without considering the type of cancer and the evidence for effectiveness, and without distinguishing between chemotherapies that are intended to cure and those that are prescribed as adjuvants, debulkers, or palliatives. We have seen incredible successes for many children’s cancers, and some adult cancers have been changed from a death sentences to a manageable chronic disease.

Bollinger doesn’t tell us about the patients who almost certainly could have been cured of cancer but who died because they rejected proven conventional treatments in favor of unproven natural treatments and outright quackery. He presents unconventional treatments as having been proven to work; they haven’t. If they had, they would be mainstream treatments and every oncologist would be using them.

Bollinger’s approach is as unfair as a trial where the prosecution is given carte blanche and no defense is allowed. This is a very unfortunate series, filled with misinformation, slickly produced, appealing to emotion, and likely to mislead scientifically naive viewers and even some scientists who ought to know better. I predict that Bollinger will have blood on his hands: people will die because they believed this was “the truth about cancer” and were persuaded to reject lifesaving treatment.









Categories: Medicine, Skepticism

David Katz Does Not Understand Science-Based Medicine

Neurologica Blog - Mon, 11/16/2015 - 08:12

David Katz is a prominent proponent of integrative medicine. We in the science-based medicine (SBM) community have on several occasions over the last seven years critically addressed some of his claims, for the purpose of public intellectual discourse on topics of vital interest to the public, namely health care. When Katz has responded, he has typically done so by attacking a strawman rather than the actual SBM position.

He has now done so again, in a transparent fashion. I suspect he is responding to our criticism of him from a couple of week ago. He has now written an article in the HuffPo in which he makes specific claims about SBM that are demonstrably false. When criticizing some one or group who advocates a position with which you disagree, it is critical to be fair, even charitable, to their position. At the very least you should endeavor to properly understand the position you are criticizing. Failing to do so falls somewhere on the spectrum from intellectually dishonest to lazy. Usually the pre-existing narrative holds sway and runs rough shod over the evidence, even when in plain sight.

Katz in his recent article is responding to an article in JAMA that reviews 10 standard practices the authors believe are not supported by evidence and should be questioned. This is exactly the kind of process that we support at SBM – examining all practices from a science-based point of view. The first half of Katz’s article is also quite reasonable, and in fact is something that could easily be found on the pages of SBM.

He did not stop there, however, and used the opportunity to go on a tare against SBM and in defense of his beloved Integrative Medicine. Here is where he goes south:

At the same time, and equally important, a certain sanctimony about evidence-based medicine results in contemptuous disregard for the “unconventional.” This broad designation may, at times, refer to so-called “alternative” medicine, where detractors will suggest one is headed toward voodoo. But it also refers to lifestyle interventions that are very far from the worrisome realm of “woo.”

Katz repeats the common CAM (complementary and alternative medicine) fiction that lifestyle factors are unconventional. This is nonsense, easily debunked by simply looking at historical evidence. Scientific conventional medicine identified the relationship between specific lifestyle factors and disease risk. Lifestyle recommendations have been slowly phased into convention medicine as the evidence has come to light. Sure, this has happened slower than we would have liked – in general the medical profession is slow to adapt to the evidence. They come around eventually, but we do need to explore ways to make this process happen more quickly. In any case, CAM does not own lifestyle factors. They have simply appropriated them to have some legitimate footing to their entire endeavor.

The rest of his statement needs to be put into the context of what he also says in the article:

If evidence matters, it matters equitably, and universally.

This has been a persistent theme of David Katz – accusing critics of CAM of having a double standard. The opposite is the truth. SBM specifically calls for one universal science-based standard of care. That is our very publicly and frequently stated position.

It is the proponents of CAM who are explicitly calling for a double standard. Health care freedom laws are about creating a double standard for CAM therapies. The National Center for Complementary and Integrative Health is about creating a double standard for CAM research funding. Dr. Katz himself has called for “a more fluid concept of evidence” when considering CAM.

The fact is, when held to the light of science, CAM therapies do not hold up well. That is precisely why they are alternative. Proponents don’t acknowledge this, so they have to create the fiction that CAM therapies are being treated unfairly. Katz repeats that accusation here:

In other words, the prevailing pattern is that “we” (i.e., conventional medicine) are innocent until proven guilty, but everyone else is guilty until proven innocent. No special olfactory acuity is required to discern how bad that smells.

What Katz is referring to here is not a double standard but simply considering scientific plausibility or prior probability. Katz has directly criticized the use of scientific plausibility in evaluating medical treatments. He is wrong, but at least here he is discussing the actual issue at hand.

It is true that conventional medicine will often use a treatment because it seems plausible before there is adequate evidence to show that it actually works. That, more than anything, is the central criticism put forth by the evidence-based medicine movement. EBM specifically eliminates considerations of plausibility in order to avoid this error.

SBM recognizes the problem but does not take that approach. Rather, we argue that treatments should be based on both scientific plausibility and rigorous clinical evidence. At the very least the clinical evidence needs to be put into the context of scientific plausibility.

Another way to look at the difference between SBM and EBM is that EBM tends to follow more of a frequentist statistical approach (with its over-reliance on p-values) while we prefer more of a Bayesian approach. The latter begins with prior probability and then evaluates the effect that any new clinical evidence has on that probability. In this way SBM advocates looking at all the scientific evidence to come to one overall conclusion about the likelihood that a treatment has benefits in excess of risks.

We advocate applying this standard to all of medicine.

I honestly don’t mind that Katz disagrees with us and advocates a different approach. Let’s have it out in open discussion. That is how better ideas prevail. I do mind when he mischaracterizes what SBM does and stands for. This is what he does here:

To the best of my knowledge, a rather boisterous group in cyberspace calling itself “science based medicine” is silent on all of this. They preferentially malign all alternatives to conventional medicine, implying that problems of evidence and its application lie entirely without, and not within. This, in turn, makes it clear that such protest is itself unconcerned with the underlying evidence, and born instead of ideological zealotry. If evidence matters, it matters equitably, and universally.

The link on SBM is not to SBM but to the recent article he wrote essentially calling us fools and fanatics (to which David Gorski and I responded two weeks ago).

Prefacing his claim with “to the best of my knowledge” does not save Katz from criticism for making a blatantly untrue statement. He is saying that SBM is silent when it comes to criticism of mainstream medicine. I am not saying that Katz should be highly familiar with the thousands of articles we have published on SBM. But even a casual perusal shows this claim to be false.

He could have also plugged something like “cancer screening” into the search window on SBM. He would have been greeted with 190 articles, most of which are discussing mainstream cancer screening practice. This was one of the actual topics of the JAMA article, and ironically David Gorski has addressed the very issue on SBM.

Just for fun I looked at the most recent 60 articles on SBM. Forty of them dealt with CAM, pseudoscience, science denial, a fringe treatment, or the regulation of fringe treatments or professions. That is undoubtedly our expertise and focus at SBM. However, 10 articles dealt with criticism of mainstream practice, 3 dealt with the nature of medical evidence itself, and 6 were about other topics. That is 10 articles in the last couple of months that Katz says “to the best of my knowledge” don’t exist. Often “to the best of my knowledge” means “I never bothered to look.”

In addition to being demonstrably factually wrong, Katz draws the wrong conclusion from his confirmation bias. He thinks it is “clear” that our focus on alternative treatments is due to “ideological zealotry.” This is a common tactic of CAM proponents – they try to depict the defenders of a reasonable standard of evidence as the zealots, while those trying to sell treatments based on magic and pseudoscience are just being “open-minded.”

We are actually quite open about our editorial policy. We focus on pseudoscience, unconventional treatments, and fringe claims for very good reasons.

1 – In establishing what the standard of science and evidence in medicine should be, it is useful to shine the light on the most egregious violators.

2 – The mainstream media does a generally poor job of reporting on fringe topics, falling for false balance, citing outliers as experts, and hyping sensational claims. We are filling a gap and correcting a great deal of bad science reporting.

3 – Understanding pseudscience is a specialty unto itself that requires specified knowledge. This knowledge is generally lacking in mainstream science and academia. That is our specialty, so of course we focus on it.

4 – Mainstream medicine already has an infrastructure of experts examining and commenting on practice and evidence. Our efforts there would largely be redundant. When we feel they aren’t, we comment.

The core of SBM, however, is an examination of the nature of scientific and clinical evidence, and the relationship between that evidence and the practice of medicine. We feel we have a very solid position, and Katz has failed to criticize it in any meaningful way. Instead he and others attack predictable and rather tired straw men.

In fact Katz’s entire article is just another iteration of the tu quoque logical fallacy common in CAM circles – trying to avoid criticism of CAM practice by saying that mainstream medicine has problems of it’s own.

In fact this is where Katz gets it most wrong – in his musings about how to fix the shortcomings of mainstream medical practice. He writes:

The cleanup will certainly not come courtesy of those calling themselves “science-based,” who live within its glass walls, tossing stones outward. They produce nothing more useful than shards of glass.

It will come courtesy of those who concede, with suitable humility, that no single domain of influence has a monopoly on dirty boots. It will come courtesy of those who like a level playing field, and respect the potential for baby and bathwater in any given tub.

This is a massive exercise in rewriting history and missing the point.  SBM is, in fact, the solution to the problems he discusses. SBM is about being humble before the evidence. What I call “neuropsychological humility” is a major theme of scientific skepticism, of which SBM is a part.

I and my colleagues have written many articles on SBM about how we need to increase the standard of evidence across the board. There are too many published false-positive studies, there is publication bias and citation bias, exploitation of researcher degrees of freedom, a problem with open-access journals, a reluctance to publish exact replications, a need for greater transparency, perhaps a rethinking of peer-review, and an overall problem of prematurely adopting new treatments with later reversals. These are all criticisms of mainstream medicine. To claim we do not address this issue is astounding.

Even more astounding is the fact that within CAM all of these problems are exacerbated, by orders of magnitude. The problems with conventional medicine that Katz criticizes are far worse in the world of CAM. It is difficult to take him seriously about “cleaning house” in mainstream medicine while he is simultaneously trying to give a free pass to his “integrative medicine.” He decries a double standard, while trying to create one. He calls for humility, while CAM at its very core is based on the hubris that personal experience and wisdom trump scientific evidence.


David Katz has his narrative – he believes in ancient wisdom and natural therapies, and would like for them to be integrated into mainstream medicine. The problem with this position is that there is no particular reason to suspect that ancient practices were based in reality, and there is no reason to think that the very vaguely defined “natural” is an advantageous property to have.

Unsurprisingly, when actually subjected to rigorous clinical study, treatments that are not based on scientific plausibility but instead on romantic notions of ancient wisdom and benign nature, turn out to be largely worthless. They don’t work.

Faced with this stark reality, proponents of integrative medicine have been doing a furious dance, trying to distract from the facts. They have attacked the messenger, and applied an impressive array of distractions and logical fallacies. Katz has become quite adept at this dance.

His criticisms all miss the mark, and in some cases are factually incorrect.

We could have a meaningful discussion of the optimal relationship between basic science, clinical science, and best medical practice. First, however, he would need to dispense with his obvious straw men positions, and acknowledge his factual errors.


Categories: Medicine

On “integrative medicine” and walking and chewing gum at the same time

Science Based Medicine - Mon, 11/16/2015 - 03:00

I didn’t think I’d be discussing Dr. David Katz again so soon. In fact, when Mark Crislip (who clearly hates me, given how often he sends me links to articles like this) sent me a link to Dr. Katz’s latest article Cleaning the House of Medicine, published—where else?—in The Huffington Post, that home for “reputable” quack-friendly bloviation since 2005. Indeed, when I first read the article, my first reaction was that Katz must surely be trolling us here at SBM. At first, I wasn’t going to respond to him again. However, Katz’s article represents a very common misconception about science-based medicine that is worth refuting. It is not my intention to be arguing back and forth with Dr. Katz every couple of weeks, but I did think it worth one more round. I think you’ll understand why by the end of this post.

First, however, a brief recap is in order for readers who might not have been following the discussion over the last couple of weeks. It all started a couple of weeks ago, when Jann Bellamy, in response to a special issue of the American Journal of Preventative Medicine edited by Katz and dedicated to making the case for integrative medicine in preventive medicine training, quite correctly discussed how “integrative medicine” is always all about the “potential.” Indeed, after having spent considerable sums of federal grant money studying the “integration” of pseudoscience into medicine with respect to preventive care, couldn’t come up with any concrete examples how integrative medicine adds anything (other than quackery) to medicine. Dr. Katz, who is well-known in the world of quackademic medicine for his infamous 2008 speech in which he asserted that physicians need to use a “more fluid concept of evidence” in evaluating treatments, particularly “complementary and alternative medicine” (CAM), responded with another HuffPo article entitled Science and Medicine, Fools and Fanatics: The ‘Fluidity’ of Woo. In lieu of reasonable, science-based arguments, Dr. Katz’ article was little more than a rant that consisted mainly of outrage that mere mortals lacking his awesome academic credentials had had the temerity to question his awesomeness and dedication to science coupled with an accusation that we are just too rigid and simplistic in our thinking to understand the subtle complexities of how different standards of evidence must be applied to complex patients. Steve Novella and I both responded that we understand just fine, explained how doctors do this all the time without using quackery like naturopathy and homeopathy (both of which Katz has advocated), and pointed out his argumentum ad ignorantiam with respect to energy medicine.

There’s where I thought it would end. Unfortunately, I was mistaken. On Friday, Katz launched another broadside at us, couched in the form of an argument that medicine must “clean its own house” before worrying about his quackademic medicine. It’s something I hear often enough that I thought it would be worth responding to, even if Dr. Katz was indeed trolling us.

Worry about what I think you should worry about

A frequent attack on science-based medicine (both the blog and the concept) goes something like this: There are so many problems in medicine when it comes to the rigorous application of evidence to medical treatments, such as the distortion of evidence by big pharma, the overuse of various treatments, and the use of treatments without a good basis in evidence, that we really shouldn’t worry so much about things like CAM or integrative medicine because there are far bigger fish to fry. In other words, worry and write about what I think you should worry and write about! If you don’t, clearly I can discount you as ideologically blinded. Indeed, Katz makes exactly this argument near the end of his article, with the further implication that because we here at SBM focus mostly on integrative medicine and CAM it must be due to ideology, not science (or, of course, as implied elsewhere, because we are in the thrall of big pharma):

To the best of my knowledge, a rather boisterous group in cyberspace calling itself “science based medicine” is silent on all of this. They preferentially malign all alternatives to conventional medicine, implying that problems of evidence and its application lie entirely without, and not within. This, in turn, makes it clear that such protest is itself unconcerned with the underlying evidence, and born instead of ideological zealotry. If evidence matters, it matters equitably, and universally.

Of course, we at SBM agree that evidence and science must matter equitably and universally. Indeed, our fearless founder Steve Novella wrote in the very first post ever on this blog, in which he laid out this blog’s manifesto:

This is why the authors of this blog strongly advocate for science-based medicine – the use of the best scientific evidence available, in the light of our cumulative scientific knowledge from all relevant disciplines, in evaluating health claims, practices, and products. The authors are all medically trained and have spent years writing for the public about science and medicine, tirelessly advocating for high scientific standards in health care. Together, and with contributions from other medical science writers, they will turn a critical eye toward all issues relating to science and medicine. They hope to make the Science-Based Medicine blog a vital resource for consumers, providers, regulators, the media, and anyone interested in quality health care.

That was the beginning. Over the years, I’ve lost track of how many times I (and other bloggers here) have pointed out that we advocate applying a single science-based standard to all of medicine. Dr. Katz also clearly has only ever read our posts here about him, because he sets up a rather massive straw man argument by characterizing us as claiming that we are saying that the problems of evidence and its application lie “entirely without, and not within.” What? No, the problems with application of evidence are indeed within medicine. The reason we discuss CAM so frequently is because the reason it is becoming more “respectable” is not because it’s being forced on medicine from without, but rather because certain, well-respected members of the medical profession (like Dr. Katz) are misapplying evidence from within, so to speak. After all, this is the physician who thinks naturopathy is a valid medical specialty and is willing to use homeopathy.

It was also at this point that I wanted to make like Ygritte in Game of Thrones and retort, “You know nothing Jon Snow David Katz.” Clearly, Dr. Katz knows nothing (or next to nothing other than our occasional criticism of his statements) about what we do here.

Because we at SBM argue for the rigorous application of science to medicine, over the years we have written posts questioning all manner of “conventional” medical interventions. I’ll start by mentioning just a few of my own posts questioning various conventional medical interventions, such as vertebroplasty for osteoporotic compression fractures, which I referred to as “placebo medicine.” Then there’s mammography, which has been a frequent topic on this blog ever since the USPSTF issued screening guidelines in 2009 that involved not starting screening until age 50 and then screening only every other year rather than every year and continuing to the publication last month of new guidelines by the American Cancer Society guidelines, which also backed off, albeit not as much, from starting mammographic screening at age 40. In the context of screening, I’ve discussed overdiagnosis in cancer screening and criticized a certain eminent radiologist who defends mammography at all costs, to the point where he wrote an e-mail complaining to me that reminded me of Dr. Katz’s displeasure with us. I’ve discussed how surgical procedures are often adopted too rapidly, before there is adequate evidence that they are as good or better than the procedures they supplant. That doesn’t even count the times I discussed some downright abusive and criminal conventional doctors and spectacular failures of state medical boards.

That’s just me writing about science in medicine, particularly one of my areas of interest, overdiagnosis due to screening.

It would be unfair to discuss only my writings, though; so I will “cherry pick” some recent high points from other SBM reglars. Over the last few weeks, Steve Novella, for instance, has discussed concepts like the number needed to treat, low energy sweeteners and weight control, whether placebos are getting stronger, open versus blinded peer review, and a lot of other topics that have nothing to do with integrative medicine. Harriet, for her part, has written about breast milk testing, immunity, misleading headlines about “female viagra,” and the horror of conventional medicine gone wrong when frontal lobotomy became widely popular. (Come to think of it, so did I once when discussing medical history and how procedures were portrayed in radio shows of the 1950s.) Meanwhile, Scott Gavura wrote about whether an aspirin a day decreases your risk of cancer.

I could go on, but got tired after finding just this much. You get the idea. Yes, we do write a lot about CAM and “integrative medicine.” We make no apologies for that. If I’m sounding a little defensive as editor of SBM, I make no apologies for that, either. Attacks based on ignorance of what we do irritate me. We write about plenty of other medical topics that have nothing to do with CAM. What they do have to do with is exactly what Dr. Katz accuses us of ignoring: Calling out areas of medicine where the application of scientific evidence is not so rigorous. He ought to love us for that, but he doesn’t. I wonder why.

The flying carpet problem

Dr. Katz uses a recent systematic review published in JAMA Internal Medicine presenting evidence against certain medical practices that should be reconsidered in 2015 as his jumping off point:

A recent report in JAMA Internal Medicine highlights prevailing medical practices that should be “reconsidered” in 2015 based on the weight of evidence. The paper, appropriately, is written in the matter-of-fact style customary for the peer-reviewed literature. To some extent, that semblance of analytical calm belies the storm swirling between the lines of the report, and the mess it has long been making in the House of Medicine.

The authors, for instance, note that excessive zeal for cancer screening results in “unnecessary surgery and complications.” As a statement, that is rather bland, and even when statistics are attached to show scale, as the authors do, it likely fails to evoke any deep impression. But consider any time you have been through surgery yourself, either as the patient, or as a family member. Unless you are the rare individual who has avoided the OR entirely, even by proxy, those occasions are likely indelible in your memory, and easy to recall.

Of course, this is nothing that we (myself in particular) haven’t been discussing quite frankly on SBM since at least 2008 (which, not coincidentally, is the year SBM was founded). Just type the words “overdiagnosis” and “mammography” or “overdiagnosis” and “screening” into the search box of this. Heck, I even just recently co-authored an article in the New England Journal of Medicine discussing this very issue and how widespread mammographic screening programs appear not to have decreased the incidence of metastatic breast cancer at diagnosis. I note that this NEJM article came about because H. Gilbert Welch has read SBM. Liking my posts on mammography, he invited me to co-author the article with him, and I jumped at the opportunity. In fact, I can’t help pointing out to Dr. Katz that this NEJM article, as well as my Nature Reviews Cancer article about integrative oncology and Steve’s an my article on clinical trials of highly implausible treatments are extension into the peer-reviewed medical literature of what we’ve been doing here at SBM since the beginning. We hope to do more.

But back to the study. Let’s summarize its findings briefly. Basically, the authors, from Yale University, the University of Maryland, Johns Hopkins, and the Memorial-Sloan Kettering Cancer Center, did a structured review of studies published in 2014 selected for use of the following words in the title: overuse, overtreatment, overdiagnosis, inappropriate, and unnecessary. Studies were limited to human studies and the English language and reviewed by authors for relevance to overuse. The ten most relevant studies were selected, highlighted, and organized into the categories of overdiagnosis, overtreatment, and methods to avoid overuse. Here are the findings:

  1. There Is No Benefit to Screening for Asymptomatic Carotid Stenosis. The authors cited the USPSTF review that showed that screening for asymptomatic carotid artery stenosis leads to false-positive results. There is no evidence that it reduces stroke on the side where carotid blockage is found.
  2. Screening Pelvic Examinations Are Inaccurate in Asymptomatic Women and Are Associated With Harms That Exceed Clinical Benefits. The authors cite a review from the American College of Physicians that failed to demonstrate benefit of routine pelvic examinations in women who are asymptomatic.
  3. Head Computed Tomography Is Often Ordered but Is Rarely Helpful. If you’ve ever done trauma (as I did during residency and as a part-time trauma attending back in the late 1990s), you know that we order too many head CTs. The study cited didn’t necessarily show that ordering the first CT is not indicated, but rather questioned the use of serial CTs, leading the authors to conclude that a second head CT scan “rarely affects patient management” and that “clinicians should be judicious in ordering multiple CT scans in the same patient,” as only 4% of these CTs showed clinically significant findings that changed the medical or surgical management of the patient.
  4. Thyroid Cancer Is Massively Overdiagnosed, Leading to Concrete Harms. I discussed the overdiagnosis of thyroid cancer as part of a post about screening for cancer in general way back in 2008. Harriet has discussed overdiagnosis of thyroid cancer herself. This is not a new topic.
  5. There Is No Benefit to Paracetamol or Acetaminophen for Acute Low Back Pain. A large, double-blind, placebo-controlled clinical trial tells us so.
  6. Postoperative Opioid Use Continues Past the Postoperative Period. This one’s less clear-cut. Basically, the authors cite a cohort study that showed that 3% of patients given a prescription for opioids after surgery are still taking them 90 days later. To be honest, I’m not sure I buy this one; undertreatment of pain appears to me to be more of a problem than overtreatment, at least in cancer patients.
  7. The Harms of Perioperative Aspirin Outweigh the Benefits in Patients Undergoing Noncardiac Surgery. The Perioperative Ischemic Evaluation-2 [POISE-2] trial tells us so.
  8. Renal Artery Revascularization for Renal Artery Stenosis Has No Clinical Benefit. There are several randomized trials that show that medical management does as well as stenting for blood pressure control and preventing deterioration of kidney function.
  9. Medications to Raise High-Density Lipoprotein Cholesterol Level Do Not Improve Cardiovascular Outcomes. A recent systematic review and meta-analysis supports this conclusion.

Another systematic review from earlier this year suggests that testing doesn’t reassure patients; testosterone supplementation might harm patients (as Peter Lipson, Harriet Hall, David Kroll, and I have pointed out); inappropriate antibiotics use can cause C. difficile colitis (well, duh!); and that dramatic regional variations in surgical practice is driven largely by physicians.

So, yes, medicine has a lot of “housecleaning” to do. Here’s the problem. His implication is that because medicine has problems with treatments that are not as rigorously evidence-based as they should be our focus on CAM is misguided and based on ideology rather than science. To this, I respond: Nonsense! I also like to quote Ben Goldacre at this point:

Quacks citing problems in pharma make me laugh. FLAWS IN AIRCRAFT DESIGN DO NOT PROVE THE EXISTENCE OF MAGIC CARPETS.

— ben goldacre (@bengoldacre) January 31, 2013

Similarly, just because big pharma misbehaves and conventional medicine practitioners don’t always use the most rigorous evidence does not mean that, for example, homeopathy or energy medicine works, as Dr. Katz seems to believe they might. In addition, contrary to what Dr. Katz thinks, we at SBM can walk and chew gum at the same time. We can call out the pseudoscience of CAM and integrative medicine while we advocate for more rigorous science in all areas of conventional medicine. Let’s see an example of how we do this.

In which I walk and chew gum at the same time

At this point, I feel as though I’ve flipped the script and, to an extent, changed roles with Dr. Katz. Last time, I criticized him for referring to his own medical authority (and awesome CV) over and over again in comparison, presumably, to us mere medical mortals and Jann Bellamy, who is not a physician. Here, I am about to assert my authority on this issue, because, well, you know nothing, Dr. Katz, about what we here at SBM do aside from criticizing pseudoscience in medicine. Also, doing so serves the purpose of demonstrating that it is indeed possible to walk and chew gum at the same time, as hard as it seems for Dr. Katz to believe.

Near the end of his article, Dr. Katz pontificates:

Were I tasked with rebutting the very case I am making in this column, I would say: Well, the articles cited here are evidence that conventional medicine is policing itself, seeking ever more evidence and a higher standard. That is just what we would hope to see.

That is the best, and perhaps only argument for the defense, and might matter if it managed to thrive, but alas, it is stillborn. The simple fact is that the products of conventional medicine — Big Pharma, Big Tech, and the associated patents — are routinely promulgated, widely practiced, and massively reimbursed, often for years, before there is evidence to support them. Evidence to repudiate them comes after, and this despite our prime directive: first, do no harm. In stark contrast, the often kinder, gentler, but unpatented offerings of other domains are repudiated for years until or unless evidence comes in to exonerate them, and sometimes, even then.

In other words, the prevailing pattern is that “we” (i.e., conventional medicine) are innocent until proven guilty, but everyone else is guilty until proven innocent. No special olfactory acuity is required to discern how bad that smells.

One can’t help but note that I discussed that bit of CAM allegedly “repudiated for years.” Let’s just say that Dr. Katz’s take on the matter is…exaggerated.

And, yes, it is rather amusing that Dr. Katz writes so bitterly about medical practices that lack rigorous evidence using an article from a peer-reviewed journal that is about as mainstream as there is, JAMA Internal Medicine, pointing out that those very practices should be questioned in light of new evidence. Heck, I’ll even concede that if Dr. Katz had written this article ten years ago, he would have had a point about medicine not being sufficiently vigorous at calling out and abandoning practices for which the scientific evidence is not sufficiently strong. Apparently, though, Dr. Katz is unaware that over the last several years there really has been a movement to do exactly what he says he wants done: To subject conventional medical practices to heavier scientific scrutiny and discard the ones that don’t make the cut.

My example of this movement in medicine is an initiative from the Foundation of the American Board of Internal Medicine (ABIM) called Choosing Wisely, whose goal is to advance “a national dialogue on avoiding wasteful or unnecessary medical tests, treatments and procedures.” It did this by working with Consumer Reports to challenge medical specialty societies in 2012 to come up with lists of medical practices that should be questioned in light of evidence. Thus far, over 70 medical specialty societies have done so. We at SBM like the Choosing Wisely initiative so much that we’ve written about it several times, most recently my post from three weeks ago pointing out how thus far Choosing Wisely hasn’t had much of an effect on medical practice because changing entrenched practices is very hard.

In fact, I’ll let Dr. Katz—and you—in on a little secret. (Well, it’s not a secret, given that I’ve mentioned it before.) I spend a lot of my time doing exactly what Dr. Katz says we as physicians should be doing and working to improve the quality of care by making it more evidence-based. In fact, I am the co-director of a statewide collaborative quality initiative (CQI) known as the Michigan Breast Oncology Quality Initiative (MiBOQI). We are 25 hospitals strong and looking to expand to more. Our mission is “to collect accurate data on women diagnosed with breast cancer in Michigan. We will collect demographic, diagnostic, treatment, and outcome data, and use this information to evaluate current standards of care and to initiate quality improvement efforts that will advance breast cancer treatments in order to improve patient outcomes.”

Indeed, one of our quality initiatives is based on Choosing Wisely, specifically the American Society of Clinical Oncology (ASCO) guideline not to do advanced imaging (PET, CT, or bone scans) in patients with early stage breast cancer without symptoms suggestive of metastasis. The reason, of course, is that in this group of patients metastasis is so uncommon at the time of presentation that the false positives far outstrip the true positives, leading to the sorts of additional interventions that Dr. Katz is so concerned about, and rightly so.

Isn’t this exactly what Dr. Katz says we at SBM don’t do in our ideological hatred of all things CAM? Near the end, he sneeringly writes:

The cleanup will certainly not come courtesy of those calling themselves “science-based,” who live within its glass walls, tossing stones outward. They produce nothing more useful than shards of glass.

It will come courtesy of those who concede, with suitable humility, that no single domain of influence has a monopoly on dirty boots. It will come courtesy of those who like a level playing field, and respect the potential for baby and bathwater in any given tub.

It will come courtesy of those who acknowledge that the blank in “_____ based medicine” has a long and rather unsavory list of applicants: profit; pharmaceutical; habit; preference; patent; turf; privilege; and status quo, to name a few. It is up to us to fill in that blank with a designation that is both desired, and deserved; both what we want, and what we actually do. That requires a much harder task than calling out the dirt on everyone else’s boots. It requires a serious devotion to cleaning our own house.

Which is exactly what I am involved in doing. It is possible to walk and chew gum at the same time. What, I wonder, is Dr. Katz doing to make the actual medicine more science-based? In fact, I’ll take it one step further. I have yet to see a single “CAM” organization or advocate like Dr. Katz take any serious, concrete steps to make their practice more science-based by abandoning treatments unsupported by evidence. The reason, of course, is that if they were to do that they would have to abandon most of the practices they want to “integrate” into medicine.

Dr. Katz’s double standard

Dr. Katz’s latest screed is very much of a piece with his previous screeds. Although I didn’t want to at first, I ultimately considered it necessary to counter his criticism, even though I suspected Dr. Katz was trolling us, because his criticism is one that is directed at us all too frequently. Basically, he is accusing us of hypocrisy because we write so much about the pseudoscience and quackery that is being “integrated” into medicine in the specialty known as “integrative medicine” but, from his perspective, do not write about problems with the evidence base of conventional medicine. He is wrong on both counts, and I suspect that, even if 95% of our output was about conventional medicine and 5% about CAM pseudoscience and quackery, Dr. Katz would still focus like a laser beam on that 5%. As I’ve shown above, we do write about issues with evidence in conventional medicine—and not infrequently, either. Also, unlike Dr. Katz, outside of our blogging and other activism, some of us do far more to promote what Dr. Katz claims he wants to promote than Dr. Katz himself does.

As I and the other bloggers here have said time and time again, enshrining this principle in our mission, the best medicine is medicine that has a firm basis in science. It doesn’t matter whether we are referring to conventional, big pharma-produced drugs, surgery, or diagnostic tests or whether we are referring to anything that is considered “alternative,” CAM, or “integrative medicine.” We here at SBM always advocate for a single, science-based standard of evidence for evaluating medical practices. Yes, we concentrate more on CAM and “integrative medicine.” We make no apologies for that. The integration of quackery into medicine in the form of what we like to call “quackademic medicine” is in itself a double standard, allowing into medicine treatments that someone like Dr. Katz would never approve of if they had been developed by big pharma or medical device companies. Just look at his conspiracy mongering about “big food” and “big pharma” conspiring for big food to profit by making people sick and then to have big pharma profit by treating those sicknesses, if you don’t believe me.

Dr. Katz is correct that “if evidence matters, it matters equitably, and universally.” We don’t argue with that at all. In fact, we not only agree with that statement, but we champion it in word and deed. If only Dr. Katz would do the same, instead of advocating a double standard whereby pseudoscience and quackery can be integrated into medicine using a standard of evidence that he would never accept for any other medical treatment.

Categories: Medicine, Skepticism

Homeopathy on the Ropes

Neurologica Blog - Fri, 11/13/2015 - 07:38

The British National Health Service (NHS) is considering blacklisting homeopathy prescriptions from general practitioners. While this would have an overall small effect on the homeopathy market, it is politically potentially very significant.

The NHS currently spends about £4m on homeopathy each year, of which only £110,000 is from GP prescriptions. The rest is from homeopathic hospitals (yes, hospitals). The real market, however, is in over the counter homeopathic products.

In the UK, Europe and the US homeopathy has ballooned into a multi-billion dollar industry. It is now potentially, it seems, the victim of its own success. When it was smaller it essentially flew under the radar – regulators and politicians didn’t think it was worth spending political capital to reign in a fringe treatment that people either wanted or did not know or care about.

In the US the FDA specifically decided to let the homeopathic industry regulate itself, because it was simply too small for them to spend their resources on. That has now changed.

The NHS has a blacklist, called Schedule 1, of drugs that cannot be prescribed by GPs, because either there is a cheaper or better alternative, or because the treatment simply does not work. That is the question they will take up in 2016 – should all homeopathic products be placed on Schedule 1?

Meanwhile, the FDA is reconsidering its regulation of homeopathy. The FTC (Federal Trade Commission) is doing the same. Both organizations have taken public comments, and we were sure to express our opinion.

As regular readers here know (but much of the public does not) homeopathy is pure snake oil. Homeopathic potions are based on prescientific magical ideas, like sympathetic magic, and are often diluted to the point that no active ingredients remain behind.

Five year ago the UK Parliament prepared a detailed report on homeopathy, concluding that it was essentially witchcraft. There is no possible mechanism by which it can work, and the clinical evidence shows that it does not work. They recommended it essentially be abolished in the UK, but politicians have mostly ignored the recommendations.

A similar review in Australia concluded that there is no evidence that homeopathy works for anything. The Swiss did their own review, coming to the same conclusion, but then proponents were unhappy so they created a follow up panel packed with homeopaths and sympathizers, who put a positive spin on the review and declared victory.

As homeopathy is coming under fire again, it is instructive to see how proponents defend it. You will notice that they rarely try to cite published scientific evidence to defend homeopathy because in the arena of published evidence, they lose. They may be able to cherry pick their studies and fool a naive audience, but once they acknowledge that published evidence is an appropriate criterion to use, they have essentially lost.

In this case at least the published quotes in the BBC article are typical of the strategies used. They begin with the argument, “Hey, look over there.”

But Dr Helen Beaumont, a GP and the president of the Faculty of Homeopathy, said other drugs such as SSRIs (selective serotonin reuptake inhibitors) for depression would be a better target for saving money, as homeopathic pills had a “profound effect” on patients.

This, of course, is a non-sequitur. Because other treatments may be on thin ice when it comes to the evidence (just for the record, the case against SSRIs is massively overstated) does not in any way let homeopathy off the hook.

She finishes with a naked assertion – as if saying something enough times makes it true. If homeopathy had a “profound effect” on patients it would be a simple matter to show this profound effect in clinical trials. But clinical trials show there is no profound effect, in fact there is no effect at all.

Next up is appeal to patient freedom and anecdotal evidence:

Patient choice is important; homeopathy works, it’s widely used by doctors in Europe, and patients who are treated by homeopathy are really convinced of its benefits, as am I.”

This is not about patient choice – this is about quality control in the health care profession. Patients do not want the choice to choose worthless treatments. Most patients don’t know what homeopathy actually is, and scandalized when they find out they have been ripped off. Others are convinced by the placebo effect, which does not justify a treatment. Placebo effects can convince patients that anything has benefits, that does not make it true.

In desperation, some homeopaths and defenders of alternative treatments try to argue that placebo effects are powerful and sufficient to justify a treatment. The evidence simply does not support this position. Placebo effects are small, transient, and subjective. They are mostly artifacts and illusions, not a real benefit.

We may now be at a historic moment when the political will is sufficient to get rid of or at least marginalize homeopathy. There is certainly sufficient evidence to conclude that homeopathy can’t and doesn’t work. There is no scientific debate. This is a solid conclusion based upon way more evidence than is necessary.

That fact, unfortunately, was not enough to kill homeopathy. Now, however, two other facts are conspiring against this pseudoscience. The first, as I stated, is its own success. The industry has grown large enough to get the attention of regulatory agencies, and that attention is not favorable.

Further, rising health care costs are providing the political motivation to weed useless treatments out of the health care system. For example:

Minister for Life Sciences, George Freeman, told the BBC: “With rising health demands, we have a duty to make sure we spend NHS funds on the most effective treatments.”

It is sad that simply making a rational and science-based argument is insufficient for regulators and politicians to do the right thing. The case against homeopathy is as strong as it can be. It is open and shut. If this is insufficient to get rid of it, then no amount of evidence will ever be enough.

The political will to do the right thing has to be based on something else, apparently. Now we may be seeing that political will, fueled by a desire to contain rising health care costs. Worthless treatments are never cost effective, no matter how cheap they are. Further, the homeopathic industry is now big enough to be seen in the light of corporate greed and excess. Big Homeopathy is in the cross hairs.

Still, this will be an uphill battle. The “health care freedom” movement has made political inroads, and they have their rhetoric down (as you can see above). The perception of “freedom” is a difficult hurdle to get over. We have to make it clear that this is not about the freedom of patients to choose which legitimate treatment they want, but the freedom of snake oil salesmen to con the public with worthless potions, dressed up like real medicine, and aided by a complicit regulatory regime.

Categories: Medicine

Acupuncture/TCPM Crapfest

Science Based Medicine - Fri, 11/13/2015 - 03:31

As I get older I get more grumpy. Issues that at one time I was rather sanguine about irritate the hell out of me. It is not like it was when I started practice. Information was hard to come by. Going through the Index Medicus, with the worlds tiniest font, wandering the stacks looking for papers, sending off for reprints, getting a precious xerox (or even a mimeograph) of a classic paper from an attending.

You understood the value of eminence based medicine as it took a career to acquire and master the literature. You relied on the wisdom of old geezers like me who had decades of experience and reading.

That was then. Now? The worlds information is available almost instantaneously. You may not be able to master a new topic spending a day on Google and Pubmed, but you can acquire a reasonable understanding especially of you have some background.

Because of Google and Pubmed the only reasons for ignorance of your area of expertise in medicine are time, laziness, or stupidity. As a specialist, only time is an excuse. It is my job to keep up with infectious diseases, although with over 10,000 articles a year in ID, it is impossible to read everything. But if I have a question concerning patient care, I need to look it up. I have another blog whose raison d’etre is looking up answers to the daily questions that arise in practice.

So the characteristics of a useful clinical trial are not hard to determine:  Randomized, double blind, placebo controlled, adequately powered. Because you want to avoid spending time and money on a study only to end up with no useful conclusions. This is especially important with acupuncture where it not does matter what kind of acupuncture is used, if needles are used, where the needles are placed or even it you mime acupuncture or perform acupuncture on a rubber hand. The key features for success in acupuncture are belief that the patient is receiving acupuncture and that the patient believes the acupuncture will be effective. And the stronger the belief, the better the subjective response.

Those characteristics of acupuncture and clinical trials are not hard to discover. It you want a rigorous study of acupuncture it has to be placebo controlled, double blind and you need to assess both the belief in acupuncture and the adequacy of blinding.

They never do that. Probably because deep in their heart of hearts they know that quality studies will not support their particular SCAM. The current buzzword is pragmatic, which the OED defines as ’not wishing to do a quality study that will not support my pseudo-scientific belief.’

There have been a gaggle of bad acupuncture studies the last few months, well, few years, well few decades. It is apparent that those who do acupuncture research have zero interest in doing a quality study.  Lets look at a few. Prepare for an acupuncture crapfest.

Acupuncture is theatrical placebo. Specifically Peter Pan.

Acupuncture, as has mentioned so many times, is a theatrical placebo. But what theatrical performance? I tend towards tragedy, mostly Macbeth

It is a tale

Told by an acupuncturist, full of sound and fury,

Signifying nothing.

But perhaps I should consider Peter Pan as a more apt metaphor.

Remember when Tinker Bell had chronic wing pain and was getting acupuncture and it didn’t appear to be effective? And Peter turns to the audience

“Do you believe in acupuncture? … If you believe,” Peter shouted, “clap your hands; don’t let Tink hurt.”

And Tinks pain went away for a while? You don’t?  I do.

There is a Tinker Bell effect, where

things that are thought to exist only because people believe in them.

That describes the effect of acupuncture perfectly. There are multiple studies that have demonstrated that patients who believe in the efficacy of acupuncture are those most likely to have an effect and the stronger the belief, the stronger the effect. And that placebo effect is significant:

When compared to waitlist, standard care, or no treatment, the effect size of acupuncture is moderate, around 0.50, meaning that a large part of the acupuncture effect is due to placebo elements.

There is now another study to show the theater that is acupuncture is Peter Pan: Response to placebo acupuncture in insomnia: a secondary analysis of three randomized controlled trials.

The study

conducted a post-hoc analysis of three randomized, double- blind, placebo-controlled trials of acupuncture for primary insomnia and residual insomnia in depressed patients. The aim of the exploratory analysis is to determine patient characteristics that are predictive of a response to noninvasive placebo acupuncture for insomnia.

And it was the belief in acupuncture that was important in responding to placebo acupuncture:

higher expectation toward acupuncture were associated with greater placebo response.

Belief is why it doesn’t matter where the needles are placed, it the needles are placebo, if toothpicks are used, it acupuncture is mimed or if acupuncture is done on a rubber hand. The effects are the same as long as you believe you are getting acupuncture and you believe it will work.

It is also why any acupuncture study is a waste of time if it does not include a sham/placebo intervention, reporting if blinding was successful and reporting of the belief of the patients in the intervention.  

Otherwise you will not know why Tink got better.

The Ongoing Decline of Quality in the Annals of Internal Medicine

Not like the annals is paying any attention. As an example there is Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial.

Patient with chronic neck pain were randomized to

12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone.

Sham comparison for acupuncture? Nope. Belief in the interventions determined? Nope. So you would expect patients to get better with the intervention when compared to usual care.   That is what ALWAYS occurs. Spend extra time, in this case an extra 10 hours,  and energy with a patient with a subjective problem and you would expect them to report improvement,  compared to usual care.

And given that the authors are members of the British Acupuncture Society, the results are obviously part of Big Acupuncture conspiracy.  Or potentially subject to significant bias.  Go to Midas, get a muffler.

And so much for wholistic care. Neck pain is a symptom of some underling process; we have no idea what these patient had. It was like a study that evaluated antibiotic for fever.

And what kind of acupuncture?   The methods state

Acupuncture practice was based on traditional Chinese medical theory, encompassing acupuncture-specific diagnostic explanations and related lifestyle advice.

That is quite a nonspecific intervention. You need to look in the table in the appendix, the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying beware of the leopard of medical papers,  you find they used between 5 and 35 needles per session (average of 14) with 259 acupuncture points used that were left in between 1 and 60 minutes (average of 20).


they could use moxibustion, electroacupuncture, ear seeds, cupping, acupressure, and heat lamps.


give advise relating to exercise, relation, diet and rest.

And you say it was acupuncture that led to improvement? Really? Color me skeptical. This is what passes for peer review these days at the Annals. Peer review with peer as in ‘to look at’. I imagine an old person, peering over the top of their glasses, saying ‘that ‘peers to be an acupuncture paper. Lets publish it. Or, in this case, publishit ( ™,©,®), my new neologism for the production of SCAM papers. Email me for volume discounts.

So the results of the study are what we would expect and consistent with every acupuncture study that does not control for bias. It is, like all such studies, a waste of time and resources.

The summary for patients says

Both acupuncture and Alexander Technique lessons may provide long-term relief from chronic neck pain and associated disability.

I have come to the conclusion that when it comes to SCAM papers, those who review them never really read them with anything that approaches a critical eye.

Dr. Edzard Ernst said in response to this article

I am truly surprised that a top journal like the Annals of Internal Medicine decided to publish it.

Sorry I must disagree. As a practicing Internist I have to say that the Annals has been slipping for years, with a long history of publishing gullible studies on pseudo-medicine. So much so they have lost at least one ’n’ in my mind.


It has often been noted that pseudo-medicines are immune to data. Practices are never abandoned or changed because of information that suggests lack of safety or efficacy.

Pseudo-medicines, as a recent US News article suggests, does not really require data to support it, which is good for its proponents, since such data does not exist. They can be satisfied with anecdote, knowing that it works.

However, when a study is done that fails to show efficacy of a pseudo-medicine such as acupuncture, it is always interesting to watch the authors squirm and try and rationalize their negative results.

No one has never said after a negative study ‘looks like acupuncture is useless for this condition.  Stop using it’. That would require a bit of honesty about what is probably a wasted career in acupuncture.

As two recent examples, there is Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

In reality-based medicine, there is no reason to think laser acupuncture would do anything. And it doesn’t. When compared to sham laser acupuncture,

…there was no significant difference in outcomes between the two groups…

When an intervention is equal to placebo, in reality-based medicine we conclude that it has no efficacy. It is why, as an example, we abandoned internal mammary ligation for angina.

But in the non-falsifiable world of pseudo-medicine?

the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain.

Or take  No Effect of Acupuncture in the Relief of Delayed-Onset Muscle Soreness: Results of a Randomized Controlled Trial. People received needle, laser, sham needle, sham laser acupuncture, and no intervention after exercise to see if there was efficacy in treating muscle soreness.

Nope. Didn’t work. And why would it? The authors suggest

From a mechanistic point of view, these results have implications for further studies:…the traditional acupuncture regimen, targeting muscle pain, might have been inappropriate as the DOMS mechanisms seem limited to the muscular unit and its innervation.

Or maybe acupuncture does nothing and is inappropriate for any intervention.

And as always negative studies mean bigger, better studies need to be done.

Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

Almost 50 years of clinical trials and still more studies need to be done.Only in the world of pseudo-medicine are the results of yet another negative study used as indication for further studies.

No Acupuncture on Infants and Children for China

If you have been a parent you probably remember just how vulnerable newborns and young children are. I remain amazed we survived as a species before the advent of civilization; crying babies at night must have been the signal for all you can eat for predators on the veldt.

Acupuncture has long been popular in China but there are differences between its practice in the West and East, as ‘Big needles, small bodies’—the absence of acupuncture treatment for infants in contemporary Shanghai: a qualitativestudy makes clear.

At the Longhau Hospital acupuncture clinic it was noted there were no infants and very few children were seen in the acupuncture clinic. They wondered why and did

Formal interviews and informal conversations with acupuncturists and other TCM professionals (which) revealed that acupuncture was neither routinely practiced nor recommended for infants and small children.

There were a variety of reasons for the lack of acupuncture in kids.

  • ‘Nobody does paediatric acupuncture’. Lack of experience
  • ‘Not convenient’. Lack of recommendations
  • ‘No classic, no modern’. Lack of textbooks and training
  • ‘For now, zero’. The lack of a strong research base
  • ‘Of course it is painful’. The possibility of pain
  • ‘Eighty percent of acupuncture on children is CP or other neurology’. Indications for acupuncture. “Acupuncturists and other TCM clinicians expressed the clear opinion that needle acupuncture was indicated for very few paediatric conditions in general.”
  • ‘TCM paediatrics is herbs’. The availability of TCM alternatives: Herbal medicine and Tui na
  • ‘The whole TCM world is shrinking in China, or at least in Shanghai’. The money and the system
  • It is a vicious cycle’. The slipping confidence

and most interesting

  • ‘Now parents take children to the Western Children Hospitals’. Trust in Western paediatrics.”  The vast majority of paediatric cases in Shanghai, particularly infants and toddlers, are treated at these hospitals. These hospitals provide treatment for a range of illnesses, from minor ailments to chronic or life-threatening conditions. Western medical hospitals are widely regarded as the first choice by Shanghainese parents seeking assessment, consultation and treatment for their children.”

When it comes to their children, parents in Shanghai appear know that science-based, or Western as they call it, medicine, delivers. This, unfortunately, is not always recognized by parents in the US.

And, as they note, not only is acupuncture not used in children, its use in the West is not based on either data or tradition in China:

This study adds to the ongoing discussion on the evidence, utility and limitations of acupuncture in children, as well as in medicine in general. Contrary to our observations in Shanghai, acupuncturists in the Western world encourage acupuncture for children, including infants. One rationale underpinning this trend is that acupuncture is widely considered in the West to be an integral part of TCM tradition, for patients of all ages. According to our study, Western beliefs that acupuncture is routinely indicated and recommended for infants and small children within TCM are unfounded. Such beliefs may appear to be a Western interpretation, and are not based on actual Chinese modern-day practices or therapeutic recommendations. Recent controlled trials investigating the efficacy of acupuncture treatment in the infant population yield conflicting results, and little clear empirical evidence is available to support the use of acupuncture. As such, it appears that the rise of infant acupuncture in the West could be partly attributable to Western acupuncturists’ own clinical observations and theoretical beliefs. In line with the principles of biomedical ethics, however, this study underscores that this rationale is insufficient to recommend a potentially painful treatment for infants and small children who lack the competence to provide informed consent.

No data for efficacy, no rationale within the context of TCM, potentially harmful, and unethical. That sums up acupuncture in children for China. Now if only doctors in the US would pay attention.  For example.

When IRBs Fail, Babies Suffer

I have been practicing medicine for 30 years. I spent most of my time in acute care hospitals, so I am well acquainted with the many ways people can suffer. Being 58 I have also had my share of medical problems that have caused a reasonable amount of pain and suffering.

As a result I have a list of processes that I do not want to experience. At the top of the list is kidney stones, followed by a disk infection. Another disease on the list is opiate withdrawal.   I always have a heroin addict or two under my care with one infection or another from injection drug use and going cold turkey looks really miserable.  The worst I am likely to experience is caffeine withdrawal.

There are children who are born to addicted mothers and after birth will go through withdrawal unless treated. Poor little things, their first experiences in life the misery of withdrawal and unable to really ask for help.

There is a horrible, unconvincing literature on using ear acupuncture for withdrawal in adults; the literature for children is even worse

This study, a painfully unnecessary attempt to determine the feasibility and efficacy of acupuncture in neonatal and pediatric intensive care unit patients at risk of withdrawal, was a complete waste of time. You cannot determine efficacy at all based on it and the question of feasibility was answered a long time ago. This study added nothing to our understanding of withdrawal or even of acupuncture.

Considering the reams of research showing that there are no benefits associated with the insertion of needles into, or pressing on, particular points on the body beyond placebo, it never should have happened.

The preponderance of the literature suggests that acupuncture is a theatrical placebo and that it is belief in acupuncture that is the main predictor of a response. Newborns, of course, can’t have a belief in the efficacy of acupuncture nor can they complain if they are suffering. So why would you try acupuncture on babies with withdrawal? Or laser acupuncture?  Every time I see the phrase laser acupuncture, I think really? You think that laser acupuncture will do something?  It just so flabbers my gaster than anyone with with even a modicum of understanding laser acupuncture would think it effective.

It didn’t stop Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial.

So here is the reasoning: ear acupuncture may help withdrawal in adults so we will use laser acupuncture on 5 ear and 4 body acupuncture points, bilaterally on babies.   All men die. Socrates was a man. All dead men are Socrates.

Why, oh why, would anyone would who lives in reality would think that shining a red light on the skin would do anything for drug withdrawal? I wouldn’t. And the reason the authors think it would help?

There isn’t any. None. They best they can offer is that it would safe. That is the level of reasoning behind the study.  And the editors of Pediatrics accepted it as reasonable.  More ‘peer’ review.

But there is zero plausible reason offered by the authors that laser acupuncture, an intervention even more worthless and implausible than needle acupuncture, would help babies with addiction symptoms.

It did not stop the Ethics Committee of the Medical University of Graz from approving it.

So children in withdrawal were assigned to laser acupuncture or control.

There was no blinding or sham procedure, except that the whole study was a sham in the more conventional use of the word.

The kids who received laser acupuncture had fewer drug treatment days although they had the same Finnegan score, an objective and subjective measurement of withdrawal symptoms in children.

So I read the study as newborns with equal amounts of withdrawal symptoms and suffering had less medication for their withdrawal as the staff thought they were being treated with the laser acupuncture. The laser treated kids were simply detoxed faster than their non laser controls. And probably suffered more. My wife, who worked for years in addictions, thinks it is a reasonable explanation that the laser treated were detoxed more rapidly.

Every time I read a pediatric acupuncture study I realize just how broken the IRB system is when it come to protecting vulnerable populations from being abused by pseudo-medical providers.   

Children and Mice Do Not Have a Chance

There are 385 hits searching the PubMed for ‘acupuncture mice’. Assume 40 mice per study.  I would wager that is a marked underestimate that does not include all the mice used in establishing models and failed studies.

I am not a PETA person but that is 15,400 mice essentially being abused trying to prove TCPM (Traditional Chinese Pseudo-Medicine) is effective.

Guidelines for ethical animal research state

…there should be a reasonable expectation that the research will:

…Provide results that benefit the health or welfare of humans or other animals. 

…The scientific purpose of the research should be of sufficient potential significance to justify the use of nonhuman animals.

Given that in humans acupuncture is a theatrical placebo based on concepts divorced from reality, I would say that any acupuncture research in animals is unethical.

The animal welfare committees do not seem to be doing their job at numerous facilities.

But then, why would you expect ethical treatment of animals when we can’t even protect our own newborns from jaw dropingly stupid studies?

Take Laser acupuncture before heel lancing for pain management in healthy term newborns: a randomised controlled trial.


From the Baskent University in Turkey.

Academic physicians actually thinking that

Acupuncture is a new non-pharmacological method for preventing pain in newborns

But not just acupuncture, laser acupuncture.

A laser

was applied to the Yintang point using a Laser PREMIO–30 unit for 30 s

The Yintang point is

Midway between the medial ends of the eyebrows


They actually thought that shooting a child between the eyes with a low level laser (at least the laser does have wobulation) would help decrease the pain from a needle stick. 

Surprise. Low level lasers and acupuncture, two interventions totally divorced from reality was judged

less effective than oral sucrose for reducing the discomfort of this procedure.

Who would have thought? I mean besides anyone with even the barest understanding of medicine, physiology, and physics ? Certainly not those whose responsibility it was to review the research.

This nonsense was approved by an Institutional Review Board whose ostensible task is to look out for the well being of research subjects.  I suppose IRB should now stand for Ineffective Review Board? Incompetent Review Board? Inadequate Review Board?

Mice and children. They don’t have a chance of being protected from the investigation of magical pseudo-medicine. 

BS (Blood Stasis) Syndrome

I receive a lot of push notifications from Google and Pubmed covering a variety of pseudo-medical topics.

There is a phenomenal amount of research coming out of China that I would perhaps classify as basic pseudo-science, not unlike the basic science of reality-based medicine.

What they do is apply modern techniques and measurements to Traditional Chinese Pseudo-Medicine, TCPM,  trying to validate their ancient pseudo-science. I am sure the recent Nobel prize will only lead to further encouragement of this process. Like blood stagnation.

Today I saw in one of my pateints chart the diagnosis qi deficiency and blood stagnation as a reason for acupuncture. Don’t get me started. It was so very dispiriting to see ancient nonsense in an EMR as if it were actually meaningful. I knew that it was really a problem with too much phlegm and the patient needed to be bled with leeches, but would they listen to me? No.

At least qi and blood stagnation don’t have ICD codes, even if acupuncture does.

The theory of TCPM, including qi and meridians, with diagnosis based on tongue and pulse evaluation, was developed without the benefit of understanding anatomy, physiology, microbiology etc, the basic sciences that are the foundations of medicine. Because of that TCPM is not grounded in reality and this results in a most peculiar literature such as Practical Diagnostic Criterion of Blood Stasis Syndrome: Introduction, Reliability, and Validity.

What, you may ask, is BS?  I mean blood stagnation?  The other question is way to open ended with directed at TCPM.

My first hit on Google says

Simply put, it means the flow of Blood is slowed down and brought to a static state.

We call that clot in medicine. 

Normally, Blood is stored in the Liver


and propelled by the Heart Qi to flow through the body.

And here I thought it was the ventricular contractions of the heart.

If Blood circulation is Stagnant or slowed down by certain factors, it will lead to retention of Blood in any part of the body or overflow of blood out of the vessels, resulting in Blood Stasis.

Huh?  There are nouns and verbs and all the other parts of grammar but there no content that maps to reality. As another author writes

Note for students: “The Liver stores Blood … when a person moves, Blood goes to the channels, when at rest it goes to the Liver.” (Maciocia, Foundations, p. 78) When you’re asleep or resting, the Blood collects and is stored in the Liver. When you’re active, the Blood is sent out to nourish and moisten the muscles.

Students of what I do not know (gibberish?), but I would hope they are not involved with patient care. I don’t think they are speaking metaphorically, which is really sad and nicely demonstrates how removed from reality the BS in TCPM is.

In TCPM, BS is bad:

If blood stasis occurs within the body, known as “blood stasis syndrome (BSS),” characteristic symptoms such as pain in a fixed position, nyctalgia, dark-purple coloring of the tongue or face, infraorbital darkness, sublingual varicosis, blood spots under the skin or tongue, or an astringent pulse can manifest. In clinical practice, many diseases include these signs and symptoms, such as ischemic heart disease, cerebral vascular accident, diabetes mellitus, chronic gastritis, chronic renal failure, chronic hepatitis, trauma, and dysmenorrhea

Almost total nonsense.  The manifestation of blood stasis are numerous. BS can involve any organ. Just check out this diagram.

BS is disease as metaphor, although practitioners of BS do not think so although even its practitioners evidently do not know what BS is

Of the 678 respondents, more than half (53%) had difficulties with the diagnosis of BSS because objective measurement methods were not readily available. Most respondents (88%) thought that the development of an objective diagnostic method for BSS was necessary.

Many researchers are trying to shoehorn BS into vascular diseases such as angina and lipid disorders.

It is too bad that I only have access to the abstracts as the original are in Chinese, because I really want to know more about phlegm-stasis cementation syndrome in mini-swine. Who knew that

The interaction of phlegm, blood stasis and toxin syndromes helps promote the progress and development of AS plaques, which is the key pathogenesis of phlegm-stasis cementation syndrome in coronary heart disease.

Like so much of the TCPM  research, time and money being devoted to validate with modernity BS concepts that are fundamentally grounded in fantasy.

Tongue Acupuncture Reigns Supreme

There are innumerable forms of acupuncture, perhaps as many as there are practitioners.  Which acupuncture is best?  Now there is a hint in the treatment of post-stroke dysphagia.

The patients were assigned into 2 groups: 90 in the Tongue acupuncture group received tongue acupuncture on the basis of conventional medication, 90 in the conventional acupuncture group received acupuncture on the neck and wrist.

and tongue is better!

On the basis of the conventional medication, tongue acupuncture would effectively improve the swallow functions, decrease the neurological deficit and reduce the incidence of pneumonia in patients with post-stroke dysphagia.

Which one would expect as

Traditional Chinese medicine holds: post-stroke dysphagia is pathogenesis of blocking meridians by the wind, fire, phlegm, blood stasis. Diseases in brain are related to the spleen, kidney and the heart. Tongue is closely related to zang-fu organs through the channels and collaterals directly or indirectly… By needling tongue, the heart, spleen, kidney meridian awake brain, dredge the bullishness and finally improve the swallowing functions.

Dredge the bullishess.   They are dredging up something with acupuncture studies.  It isn’t bullishess.  Close though. I think that was a slight misspelling during translation.


Categories: Medicine, Skepticism

Nutrient Density of Crops Over Time

Neurologica Blog - Thu, 11/12/2015 - 08:11

A new video is making the rounds on social media making the incredible claim that you would have to eat five grocery store apples today to equal the nutrient density (not calories, but other nutrients) of a grocery store apple from 1936. The video makes a second claim, that the decrease in nutrient density is due to poor soil. The video is little more that pro-organic propaganda, and neither claim is sourced – because they are not true.

However, the story of nutrient density of fruits and vegetables is a complex and interesting one. It is interesting to compare food plants from thousands of years ago (prior to any cultivation), 100 years ago, and today. First we need to ask – what are the differences? Then we can try to explain them.

Let’s compare first fruits and vegetable from today to 50 and 100 years ago.  A systematic review by Donald David found:

Recent studies of historical nutrient content data for fruits and vegetables spanning 50 to 70 years show apparent median declines of 5% to 40% or more in minerals, vitamins, and protein in groups of foods, especially in vegetables.

So there does appear to be a real decline, although not the 80% across the board suggested by the pro-organic video. The declines are significant for vegetables, and less so in fruits (so apples was a poor example to use). Averaging out all the declines, you get about a 20% decline in nutrient density for produce.

That decline is significant, and something we definitely need to pay attention to, but may not be having any health effect on the average consumer in an industrialized nation. It is more than offset by the increased availability of fruits and vegetables year round.

There appear to be two processes leading to this modest decline in nutrient density, a production dilution effect and a genetic dilution effect. The Davis review also concludes that the evidence suggests higher yields result in lower nutrient density – the production dilution effect. This makes sense – if you get more yield out of the same land, micronutrient density will tend to be diluted in the larger yield. This is the trade-off for producing more fruits and vegetables without dramatically increasing land use.

This dilution effect can likely be compensated for, the evidence also suggests. Differences in nutrient density differ from year to year, suggesting an environmental effect. Also, historically, when specific minerals were supplemented into the soil those minerals increase in the produce. While this is not a problem of degrading soil quality, if we are going to demand more from the soil with higher yields we will need to put more into it.

The second factor is perhaps more significant – genetic dilution. Essentially breeders have mainly selected crops for yield and properties that make them more marketable, such as shelf-appeal and durability for shipping. They have largely ignored nutrient density and have even sacrificed flavor in some cases in favor of yield or visual appeal.

This is almost certainly why people find that garden-grown vegetables taste better, because they are growing heirloom varieties that inherently taste better than the mass produced varieties in the store.

There is also reason to believe that this process is not new, but has been occurring for thousands of years. Many micronutrients are bitter, and when our ancestors cultivated plants that were sweet, tender, with high yields and high caloric content, they also reduced the bitter phytonutrients in the wild cultivars.

I don’t buy arguments, however, that there has been a net negative health effect from this trade off. We are taller, healthier, and have greater longevity today partly because of overall better nutrition.

It does mean, however, that for optimal nutrition you should eat plenty of fruits and vegetables. They may not be as nutrient dense as wild or heirloom varieties, but they still contain plenty of vitamins, minerals, and other micronutrients. You could also eat plants that are closer to their wild origins, like arugula. These tend to be bitter, and some people have a hard time tolerating the bitter taste.

The evidence clearly shows that eating fruits and vegetables regularly has a health benefit. There is no evidence, however, that eating “super foods” with especially high nutrient density is necessary or beneficial. It may simply be overkill without a specific health benefit, but more data is needed to say definitively.

In any case, if we want to maintain or improve the overall nutrient density of our produce there are two things that can be done. Optimizing soil treatments to replace micronutrients does seem to have an effect. For efficiency, this can be targeted to specific minerals that are especially low.

The more intriguing intervention, however, is to reverse some of the trends in cultivation. If plant breeders measured and prioritized nutrients and flavor we could possibly develop cultivars that have the best of both worlds – good yield and great flavor with preserved nutrient density.

However, sometimes these trade offs were unavoidable, or at least difficult to avoid with standard hybrids and cultivation. Scientists are studying plants genetically to identify what specific genetic changes occurred between wild or heirloom varieties and the modern grocery store varieties, and how these genetic changes resulted in the desire traits as well as the undesired traits.

One goal of this research is to be able to make specific genetic changes that will undo the damage while maintaining the increased yield and other desirable properties – to put the flavor and nutrient density back into produce.


The evidence shows that there has been a modest overall decrease in nutrient density, mostly in vegetables and less so in fruits, both over the last century and compared to the wild ancestors of our modern crops. For the individual consumer, this is probably not something you need to worry about. Fruits and vegetables are still plenty nutritious, and if you eat enough of them you will be fine.

However, systemically this is a trend we should pay attention to, and hopefully reverse. As we push the limits of our ability to mass produce food without dedicating the entire planet to farming, we obviously need to continue to tweak and advance our farming technology. This is nothing new, and farmers already know they need to treat their soil to keep it producing, but we are pushing the limits of production.

Perhaps more significant is the possibility of breeding or genetically modifying plants specifically to increase their flavor and nutrient density. We might be able to reverse some of the accidental negative effects of plant breeding, or even exceed wild varieties. Golden rice is an example of this, fortifying rice with beta carotene, a precursor of vitamin A. It seems likely that over the next century our produce will become more nutritious, not less.

Categories: Medicine

The DC as PCP: the battle resumes

Science Based Medicine - Thu, 11/12/2015 - 01:00

Daniel David Palmer, creator of the nebulous subluxation and father of chiropractic.

It has been almost five years to the day since I wrote my first post in “The DC as PCP” series. These posts (listed here) chronicle the continuing battles among various factions within the chiropractic profession over the subluxation and its many iterations, educational requirements for chiropractic colleges, legal scope of practice, and whether chiropractors are – or are not—primary care physicians (PCPs). At its heart, the controversy boils down to this essential issue: what is “chiropractic” and what is it that chiropractors do? Or, perhaps, should do.

At one end of the spectrum is the straight chiropractor, who wants to make his living detecting and correcting subluxations for all manner of problems. These are the chiropractors who claim newborns need adjustments for “birth trauma” and maintenance care is necessary to good health. At the other end are those promoting the idea that chiropractors are primary care physicians capable of seeing the undifferentiated patient, form a differential diagnosis, and either treat the patient or coordinate the patient’s care with other health care professionals.

Neither has any basis in reality. The subluxation is a chiropractic fiction. And the notion that chiropractors have the necessary education and training to act as primary care physicians is no less a fiction.

Apparently unrepresented in this battle is the chiropractor who wants to see the profession as evidence-based spine care specialists based on a model of specialty care like podiatry and dentistry.

The causus belli in the current skirmish is the Council on Chiropractic Education’s (CCE) second draft of a revision of the 2013 Accreditation Standards for chiropractic colleges. The CCE is the sole agency with the authority, granted by the U.S. Department of Education, to accredit chiropractic colleges and to monitor their activities for compliance with its standards for chiropractic education. Getting and keeping accreditation is extremely important for the colleges – without it, their students would not have access to federal student loans and their graduates would not be eligible for state licensing. The CCE’s educational standards for accreditation have become a battleground on which various chiropractic factions duke it out over their competing philosophies.

A contentious history

Back in 2010,  the CCE tried to eliminate the phrase “without the use of drugs or surgery” from its definition of chiropractic, as well as the word “subluxation,” and any requirement that students learn to “adjust” the putative chiropractic subluxation. The more conservative element smelled a nefarious plot to turn chiropractic away from its roots and set it on a path toward chiropractors practicing as some version of an MD/DO primary care physician.

This proposed revision of CCE educational standards was part of a larger effort to rebrand chiropractors as PCPs by expansion of the chiropractic practice acts and chiropractic regulatory board rulemaking, not always successfully. Chiropractors’ attempts to transform themselves via legal fiat into PCPs (or, at least, move in that direction) have been beaten back by a strange-bedfellows combination of straight chiropractors, medical doctors and pharmacists in New Mexico, Colorado and Texas.

The American Chiropractic Association (ACA) jumped on the PCP bandwagon by simply announcing that chiropractors are, indeed, PCPs, in the ACA News, an effort promptly demolished by Harriet Hall   The Journal of Chiropractic Education weighed in with and article claiming that the National University of Health Sciences, an accredited chiropractic college, was ready to train chiropractors as PCPs. Dr. Hall took a dim view of that as well:

The data they collected don’t even begin to support that assertion. The study is not only meaningless, it demonstrates a gross misunderstanding of the education required to practice competent primary care.

The ACA’s American Board of Chiropractic Specialties, a pseudo-American Board of Medical Specialties, approved a specialty called “Chiropractic Diagnosis and Management of Internal Disorders” practiced by “chiropractic internists.” One can become a “diplomate” of the American Board of Chiropractic Internists by taking a series of 26 weekend courses in hotel conference rooms and taking a test.

The straights weren’t satisfied with simply having input into the 3 drafts that it took to reach a final version of the CCE’s educational standards. They took their fight to the U.S. Department of Education to challenge the very authority of the CCE to accredit chiropractic colleges. A beleaguered CCE ended up getting itself put on a probation of sorts by the Department for one year while it set its house in order, finally gaining recognition for another 3 years in 2013.

As part of its effort to paper over the considerable differences between the straight and the PCP factions, and all sub-factions in between, the CCE spent considerable effort on the subluxation and its place in chiropractic education in redrafting its educational standards. Its solution was to create yet another name for this nebulous chiropractic creation. As the CCE explained in a “open letter:”

Despite its historical legacy in the profession, a number of educational programs and practitioners have opted to use other terms, such as joint fixation or joint dysfunction. Even the Association of Chiropractic Colleges (ACC) has not reached a unified definition or specific criteria for subluxation, despite its own task force addressing this issue. The 2012 Standards opted to use a combination phrase, ‘subluxation/neuro-biomechnical dysfunction.’

We’ll return to that term — “subluxation/neuro-biomechnical dysfunction” – in a moment, as it plays a role in the current controversy.

More recently, the ACA announced the establishment of a “College of Pharmacology and Toxicology,” yet another effort that upset the International Chiropractors Association (ICA), which represents the straights, who saw it as a suspicious move toward lobbying for prescription privileges. The ACA’s wholly unconvincing response to this criticism was to try to distinguish the word “pharmacology,” which, to them, is simply understanding drugs, from “pharmacotherapy,” which is actually prescribing drugs. The ACA argued that this semantic distinction meant they absolutely did not intend to move in the direction of chiropractic prescribing rights.  (It’s all about semantics again.)  Unfortunately for them, the ACA’s own proposed model scope of practice act includes “Full . . . Prescription Authority” for chiropractors, which makes their explanation even more unconvincing. On top of that is the fact that the “College” will operate under the jurisdiction of the Council on Diagnosis and Internal Disorders, whose avowed purpose is to create chiropractic “internists.” Really, one must admire the ACA’s temerity in even attempting to tackle this one.

The current draft of CCE standards for chiropractic colleges

With that background, we’ll march forward into the current skirmish surrounding the second draft of the CCE’s proposed accreditation standards, an attempt to revise the 2013 standards that were the subject of previous battles. Apparently, CCE accreditation standards have a very short shelf life.

Two chiropractic organizations have filed their objections to this draft. Not unexpectedly, one of them is the ICA. (The ICA’s summary of objections was in an email, so I can’t link to it.)

The ICA’s first gripe relates to patient management. The CCE draft standards require that the student be able to develop a “management plan” for the patient that includes “specific therapeutic goals and prognoses.” The ICA has a bone to pick with this – they want to delete the term “therapeutic,” because clinical goals are not always ‘therapeutic.’”

ICA is was especially concerned to see that the standards language was sufficient to support all appropriate forms of chiropractic case management and not just ‘therapeutic’ care based on episodic symptomatology.

Why? Well, unstated here is the ICA’s devotion to “maintenance” or “wellness” care – the notion that all patients require regular “spinal checkups” to detect subluxations and, if subluxations are found, to “correct” them with “adjustments.” (One does wonder if there was ever a chiropractic maintenance care exam that didn’t uncover a subluxation.) Which brings us to another ICA objection.

For the first time, apparently, the CCE has included what they call a  “meta-competency” requirement in adjusting/manipulation, which pleases the ICA. The fly in this ointment is that the skill required is not just “adjustment” but “adjustment/manipulation.” According to the ICA, they are not the same thing. The ICA is correct. “Adjustment” has always referred to a method of “correcting” the phantom subluxation. Other professions perform manipulation, or, as the ICA would prefer to call it, “other forms of manual care,” but, as the ICA says, “only doctors of chiropractic administer chiropractic adjustments.” The reason is that no other profession believes the chiropractic subluxation exists or, obviously, that it can be “adjusted,” but they don’t bring this up.

One suspects the CCE is trying to gloss over this difference by pretending adjustment is just another term for manipulation, a perfectly legitimate form of manual therapy, and not a method to correct the subluxation, which they would love to get rid of, at least in its straight chiropractic iteration.

And speaking of the subluxation, another organization, the International Federation of Chiropractors and Organizations (IFCO) also has a quarrel with the CCE regarding terminology. (IFCO motto: “Vertebral Subluxation . . . Nothing More . . . Nothing Less . . . Nothing Else.”) In the current draft standards, as part of the requirement that the student learn how to adjust/manipulate, he must know how to “employ methods to identify subluxations/segmental dysfunction of the spine and/or other articulations.” (Emphasis added.) Thus, we find that a mere 2 years after the CCE thought up the term subluxation/neuro-biomechical dysfunction in its continuing quest to define the subluxation by creating new names for it, “neuro-biomechanical dysfunction” is tossed aside in favor of “segmental dysfunction.” The CCE also uses the terms joint fixation and joint dysfunction.

The IFCO thinks the CCE needs to clean up this semantic mess.

There are significant operational and epistemological differences. Implicit in the term vertebral subluxation are both biomechanical and neurological elements. A fixated or tender joint might represent one manifestation of vertebral subluxation, not synonym for vertebral subluxation. The implication that they are the same leads to confusion and ambiguity.

No kidding on the confusion and ambiguity. But I’d venture to say that it’s the chiropractors’ failure, after 120 years, to define the subluxation, validate methods for finding one, determine the clinical significance of the subluxation and demonstrate convincingly that treating it improves patient outcomes, leads to the confusion and ambiguity. Not what to call it.

A few years ago, the cart-before-the-horse futility of trying to settle on a name for the subluxation was called out by the authors of “Subluxation: Dogma or Science.”

The subluxation is identified by a great many names, but neither the abundance of labels nor efforts to reach consensus on terminology tell us anything about the validity of the construct. Nelson points out that “…framing the subluxation debate as a semantic issue, resolvable by consensus, is precisely the same as asking whether we should refer to the spaceships used by aliens as flying saucers or UFOs.” Neither adoption nor rejection of the term subluxation or any of its myriad synonyms will resolve the problem created by assuming a priori that subluxation is clinically meaningful. If and when we demonstrate that there are alien spaceships hovering over us, we suspect an appropriate terminology will develop on its own.

Unfortunately, no one paid any attention, and the semantic shenanigans continue.

“Primary Care Chiropractic Physicians”

Both the ICA and the IFCO object to the CCE’s use of the terms “primary care” and “primary care chiropractic physician.” Here again, there is disagreement over just what those terms mean.

The new draft of the CCE standards require that all accredited educational programs produce graduates who are able to function as “primary care chiropractic physicians.” In defining what it calls “meta-competencies,” which must be taught to every student, there is little indication that the chiropractor’s skill set should be limited to musculoskeletal issues. Although students must learn to detect a “subluxation/segmental dysfunction,” and perform an “adjustment/manipulation,” the requirements are otherwise described in terms that are quite broad.

For example, in achieving a “meta-competency” in “assessment and diagnosis,” a student must demonstrate the ability to:

1) Develop a list of differential diagnosis/es and corresponding exams from a case-appropriate health history and review of external health records.

2) Identify significant physical findings and follow-up through a physical examination, application of diagnostic and/or confirmatory tests and tools, and any consultations.

3) Generate a problem list with diagnosis/es after synthesizing and correlating data from the history, examinations, diagnostic tests, and any consultations.

Students must also be able to “develop an evidence-informed management plan appropriate to the diagnosis” and “refer for emergency care and/or collaborative care as appropriate.” This doesn’t seem to contemplate that the chiropractor might step out of the picture once the referral is made, which is suspiciously like the role of the primary care physician in serving as a medical home and care coordinator.

For comparison, here’s how the American Academy of Family Physicians, quite similarly, describes primary care:

[A] generalist physician who provides definitive care to the undifferentiated patient at the point of first contact and takes continuing responsibility for providing the patient’s care . . . . [T]he personal primary care physician serves as the entry point for substantially all of the patient’s medical and health care needs – not limited by problem origin, organ system, or diagnosis. Primary care physicians are advocates for the patient in coordinating the use of the entire health car system to benefit the patient.

However, the CCE is taking a “big-tent” approach to teaching the required skills. It does not “define or support any specific philosophy regarding the principles and practice of chiropractic” nor do its educational standards “support or accommodate any philosophical or political position.” Each school, it says, is “free to determine its own method of meta-competency delivery and assessment.” So, cleverly, or perhaps as a survival strategy, the CCE allows each school to superimpose its own philosophy onto this educational template. If the straights want to read the requirements as allowing them to teach the overarching significance of the subluxation and how to detect and correct it with adjustments, so be it. If schools with more expansive agendas want to rebrand chiropractors as primary care physicians or chiropractic internists, that’s ok too.

Even with the implied promise that the straight schools will be left alone, the ICA doesn’t like the CCE’s expansive definition of primary care. It thinks “primary care” is simply synonymous with “portal of entry,” and that a “primary care chiropractic physician” is

A direct access, doctor level health care professional qualified to serve as the patient’s first point of contact within the health care system, without referral from any other professional.

According the Chair of the ICA’s committee on accreditation issues, this will “help avoid misrepresentation of what is actually meant and limit expansiveness and inappropriate interpretations in the direction of medicine and medical procedures.” But “expansiveness” is just what some chiropractic factions are after and it’s doubtful the ICA will convince the CCE to redefine primary care as a synonym for portal of entry.

However one defines the chiropractor’s role in health care, the ICA doesn’t want students forced into “interprofessional education” either, another new CCE-required meta-competency, including multi-disciplinary clinical practice settings for students. I have to agree with the ICA that this is a difficult goal to achieve. It would require the cooperation of the medical community, which may be reluctant to allow chiropractic students into their clinical training settings, such as teaching hospitals, private physicians’ offices and health care clinics. One can well imagine that this prospect will seem even less appealing to medical educators if chiropractors are trying to pass themselves off as PCPs.

The IFCO objects to the whole notion that chiropractors are primary care practitioners as well, and points out that

Many, if not most procedures termed “primary care” as commonly defined, are not within the scope of chiropractic practice in any jurisdiction. These include, by example, family planning; immunization against the major infectious diseases; prevention and control of locally endemic diseases; appropriate treatment of common diseases and injuries; and provision of essential drugs.

Which is absolutely true. Whatever you might otherwise think of the IFCO, it has put together a compilation of accepted definitions of primary care that nicely demonstrates its point. It’s solution is to use the term “doctor of chiropractic” instead of “primary care chiropractic physician” and eliminate the CCE’s definition of “primary care” from the standards altogether. Seems reasonable.

The danger here, of course, is that the scope of chiropractic practice can be changed by the legislature in any state. As we have discussed many times on SBM, the legal scope of practice of CAM providers is often at odds with their actual education and training. Especially disturbing are chiropractors’ attempts to push for a scope of practice that defines what they can do by reference to what they are taught in chiropractic school. This is why the CCE’s standards are so important. Left with plenty of room to improvise, all manner of things can be loaded into the chiropractic practice acts by default to whatever the chiropractic schools choose to teach.  Kansas, North Dakota and Oklahoma already reference chiropractic education as a metric for determining chiropractic scope of practice. In the last two legislative sessions (2013-14 session here), bills to define chiropractic in similar terms were defeated in New Mexico and Hawaii.

No doubt the battle will continue.

Categories: Medicine, Skepticism
Subscribe to aggregator - Medicine
buy viagra online paypal vipps
buy cheap viagra online now
purchase levitra
buy real viagra online pharmacy
cheap deal pill pill viagra
cheap viagra at online pharmacy
order viagra canada
viagra by mail order
Broken Arrow Watch Online
buy crestor
buy viagra safeway pharmacy
buy cheapest online place viagra
Bully Watch Online
buy viagra ups
buy caverta
buy viagra from brazil
buy viagra alternative
buy generic viagra buy
buy plavix
buy free viagra on internet
viagra buy do nu
order viagra now
buy depakote
buy viagra onlines
buy online pharmacy viagra
order viagra softtabs
buy cheap viagra uk
buy viagra prescription
buy avandia
cheap levitra online
buy cheap viagra online uk
cialis no prescription
buy cheap viagra cheap viagra online
cheap generic online viagra
buy viagra online in
cheap uk viagra
buy file viagra
cheap cheap viagra viagra
order viagra online
cheap levitra
cheap viagra in uk
buy viagra online pharmacy
buy pfizer viagra
buy cymbalta
buy price viagra
cheapest viagra in the uk
cheap man viagra
buy viagra pharmacy online
buy discount cialis
viagra buy general
buy deal deal price viagra
generic levitra
buy viagra viagra online
cheap viagra india
buy viagra in amsterdam
buy now online viagra
buy viagra cialis
buy online us viagra
order viagra uk
buy line viagra
cheap discount viagra
order viagra 1
order viagra now viagra money order
Cast Away Watch Online
buy discount generic viagra
order viagra online consumer rx
cheap cialis online
buy diflucan
cheap viagra online
order viagra buying viagr
buy viagra cheapest best prices online
buy viagra online now buy viagra
buy discount price sale viagra viagra
buy cost low viagra
buy viagra online at cheap price
cialis 20mg
buy viagra in great britain
cheap no prescription viagra
order viagra here
buy claritin
cheap pharmaceutical viagra
buy viagra securely online
cheap phizer viagra
cheap mexico viagra
buy viagra london
buy viagra cheap online
viagra buy uk
viagra by the pill
buy nolvadex
viagra buy australia
buy viagra us pharmacy low prices
buy viagra online
buy viagra next day delivery
buy viagra vaniqa prescription
buy online viagra viagra
buy internet viagra
cheap meltabs viagra
order viagra cialis levitra pharmacy
cheap online generic viagra
cheapest viagra on line
buy viagra with discount
cheap cheap viagra
discount viagra prescription drug
buy get online prescription viagra
cheap deal pill viagra viagra
cheapest uk supplier viagra
buy line viagra where
buy viagra pill online
cheapest viagra online pharmacy
cheap discount viagra viagra
cheap viagra discount
buy cheap viagra in uk
buy free viagra viagra
viagra buying
viagra brands
order viagra visit your doctor online
cheap viagra credit
viagra buy viagra
buy generic viagra usa
buy viagra online india
order viagra without a prescription
buy viagra over the counter us
order viagra without prescription
discount levitra
cheap generic overnight viagra
cheap molde ticket viagra
cheap viagra direct
viagra canada online pharmacy
buy pharmaceutical viagra
cheep generic viagra
buy viagra onli
order viagra online a href
Bug Watch Online
cheap generic india viagra
cheapest viagra online plus zenegra
viagra buy ionline
buy celebrex
discount viagra mastercard
discount viagra sales online
buy cheap generic viagra online
cialis 30
cheapest cheap viagra
cheap viagra buy pharmacy online now
order viagra prescription
cheap drug viagra
cheapest price on viagra
order cheap viagra
buy viagra prescription america
buy viagra by pill
Chicago Watch Online
cheap price viagra
order levitra
buy lexapro
buy discount viagra viagra viagra
cheap source viagra
buy viagra online no prescription
buy viagra online in uk
viagra and cialas
Bridge to Terabithia Watch Online
buy online online viagra viagra
buy cheap viagra online
buy deal viagra
buy evista
discount viagra uk
order viagra viagra
buy viagra without prescription online pharmacy
buy viagra for cheap
cheap viagra online order viagra now
cheapest generic viagra
buy cheap levitra
buy viagra here in the uk
viagra brazil
buy cialis online
buy cheap deal viagra viagra viagra
cheap viagra cialis india
discount viagra in the usa
buy online online pill viagra viagra
buy overseas viagra
order cialis
order mexican viagra
cheap online price price viagra
cheap generic viagra from usa
buy diovan
buy cheap p viagra
order prescription viagra
buy viagra low cost
viagra by mail canada
cheap free price viagra
buy viagra uk
viagra buy generic
viagra brand
buy buy sale viagra viagra
buy 100 mg viagra
cheap generic viagra online
order viagra online in wisconsin
Casanova Watch Online
buy viagra powered by phpbb
buy cheapest viagra
buy online viagra in the uk
order order viagra
buy viagra woman
buy online pill viagra
cheap viagra in the uk
Bride Wars Watch Online
viagra canada price
buy neurontin
buy viagra australian
cheap free viagra viagra
cheap generic viagra no script
buy viagra online in australia
buy viagra on the internet
buy cheap online viagra
cheap generic viagra uk
buy viagra from canada
buy flomax
buy cheap viagra online u
order generic viagra
buy viagra new york
iscount viagra europe
cheap viagra online uk
order viagra usa
buy viagra in mexico
cheapest brand viagra
Canadian Bacon Buy Online
buy p viagra
viagra buy now pay later
buy viagra online at lowest price
cheap viagra generic
order cheap viagra fas
buy now cialis
buy online sale viagra
discount viagra viagra
buy cozaar
buy viagra 1
buy viagra in australia
buy viagra now online
cheap soft tab viagra
cheaper viagra
buy viagra pill
buy and purchase viagra online
buy viagra online uk
buy viagra from safeway
cheap canadian viagra
buy viagra online off pharmacy prices
buy viagra where
buy viagra online without prescription
cheapest generic silagra viagra
cheapest viagra on the internet
cheap viagra bi
discount viagra sale
buy viagra cheap prices
viagra buy it online now
buy viagra online au
Brief Encounter Watch Online
cipro 20
viagra by mail catalog
levitra online
Bullitt Watch Online
order viagra buying viagra uk
buy diet viagra online
viagra canada online
cheapest prescription viagra
buy viagra no prescription
buy cheap viagra online now uk
cheap site viagra
buy kamagra viagra
buy viagra canada
buy viagra bradenton
cheapest prices for viagra online
buy viagra online discount
cheapest regalis viagra
buy now viagra
discount viagra pills
viagra by money order
cheapest viagra uk
buy pharmacy pill viagra
cheapest generic substitute viagra
Carlitos Way Buy Online
order forms for buying viagra
cheapest line viagra
cheap sale viagra
buy viagra contact us page
buy fosamax
cialis 1
buy coumadin
buy locally viagra
buy clomid
discount viagra brand drug
discount viagra sales
buy lexapro
buy viagra online alternative viagra
buy viagra over the counter
cheapest viagra online
buy buying sale viagra
order site viagra
cheap viagra uks
buy viagra cialis levitra
cheap prescription viagra without
cheap pill viagra
cheap discount levitra online
buy cheapest viagra online
cheap generic viagra substitutes
buy viagra in canada
viagra calgary
buy cheap discount levitra
buy real viagra
cheapest generic viagra and canada
Carrie Buy Online
buy viagra viagra
cialis 2005
cheapest price for generic viagra
discount viagra cialis
buy viagra online order generic viagra
buy viagra in toronto
buy viagra australia
buy levitra canada
buy viagra softtabs
buy viagra online order
buy viagra in malaysia
discount cialis
buy viagra locally
buy online uk viagra
buy canada viagra
cheapest price viagra
order cialis online
buy buy cheap viagra
buy nexium
cheap levitra online
buy viagra free on internet
buy viagra in spain
cheap online viagra viagra
cheap order site viagra
cheap discount cialis
cheap generic viagra
buy viagra toronto
buy viagra 50mg
Casino Watch Online
discount viagra generic
buy in spain viagra
buy lipitor
buy cheap deal online viagra viagra
cheapest viagra world
cheapest viagra in uk che
order generic viagra online
Cleaner Watch Online
cheap inexpensive viagra
cheap viagra 25mg
buy discount soma
buy real viagra online
viagra and cialis and
Evil Dead II
viagra canada generic
buy viagra without prescription
buy generic viagra
buy viagra and overseas
buy discount levitra
buy cialis no prescription
buy in online usa viagra
buy real viagra pharmacy online
Butch Cassidy and the Sundance teen Watch Online
buy cheap purchase uk viagra
cheap overnight viagra
cheapest price for viagra and cialis
buy viagra in london
buy later now pay viagra
order pfizer viagra with mastercard
buy generic viagra img
buy deal online sale viagra viagra
buy kamagra
buy viagra in uk
buy cheap tamiflu
order levitra online
buy levitra online
cheap drugs viagra cialas
buy generic viagra viagra
cheap cialis viagra
viagra canada prescription
cheap online sales viagra
buy female viagra
viagra canada pharmacy
buy viagra cheap
cheap viagra st
cheapest generic price viagra
cialis 30mg
Click Watch Online
buy viagra on-line
buy low price viagra
viagra buy in uk online
Cape Fear Buy Online
buy no online prescription viagra
buy generic no online prescription viagra
buy viagra online cheapest
City of Ember Watch Online
buy viagra online paypal
buy cheap generic viagra
buy levitra
cheapest in uk viagra