I always find it disturbing to see people, especially in large crowds, apparently acting according to primitive emotions rather than enlightened thinking. It makes it seem like the veneer of civilization is paper thin, and we are not far removed from apes huddled around the monolith and hitting each other over the head with bones.
We can get on top of it, but that is a high energy state. Entropy is forever dragging us down to the lowest common denominator of tribalism, fear, disgust, and paranoia. As Sagan wrote in the Demon-Haunted World:
Whenever our ethnic or national prejudices are aroused, in times of scarcity, during challenges to national self-esteem or nerve, when we agonize about our diminished cosmic place and purpose, or when fanaticism is bubbling up around us – then, habits of thought familiar from ages past reach for the controls.It does seem, based upon a century of psychological research, that all that basic programming is still there in our brains.
The candle flame gutters. Its little pool of light trembles. Darkness gathers. The demons begin to stir.”
A recent editorial about GMOs (genetically modified organisms) reminded me of that quote from Sagan. In the article McWilliams correctly, in my opinion, notes that much of the anti-GMO movement is built upon the emotion of disgust. This is any observation I have made before myself. Disgust is an interesting emotion. It has obvious survival advantages, but like many emotions is errs on the side of the false positive and is not very discriminating.
GMO rhetoric often takes the form of provoking disgust – talking about fish genes in tomatoes, “frankenfood,” emphasizing the use of pesticides (which is incidental to GMO technology), emphasizing that it is “unnatural,” or stating that it is not “real food.” These negative terms are contrasted with the language of wholesomeness for non-GMO foods – whole, natural, organic, and raw.
The Foodbabe is essentially basing her entire career on provoking the disgust reflex.
While disgust, just like fear and anxiety, is a protective reflex that serves a purpose, it is also a button that can easily be pushed and exploited. Part of the problem also is that the instincts we evolved in our pre-technological environment did not necessarily prepare us for the modern world. That is why we need things like science and evidence to help us figure out what is safe and what isn’t.
We are also interested in more than just what will make us instantly drop dead. We want to know what foods will be healthful to eat over our currently extended lifetimes. This is a more subtle effect, and a basic sniff test will simply not do. We need careful observation and rigorous data.
This is partly why popular campaigns to provoke disgust are so often anti-scientific. If the science were on your side, you wouldn’t need to push primitive emotional buttons.
The “fishmato” is perhaps my favorite example when it comes to GMOs. The example is meant to conjure images of fishy parts mixing with a tomato. Such images, however, are pure nonsense. All life on earth shares a common ancestry. Fish and tomatoes already share most of their genes (it’s hard to put a single number on it, but estimates hover around 60%). Also, genes shuffle around the kingdoms of life all the time, through viral vectors, for example.
In fact, you have to ask what is meant by “fish genes” and “tomato genes,” as if there is some fundamental difference between the two. There isn’t. They are just genes. Proteins are just proteins. There is nothing inherently “unnatural” about fish and tomatoes sharing genes.
The anti-GMO movement pushes other emotional buttons as well, specifically invoking the imagery of a villain and paranoia about the powers that be. Monsanto, of course, is the iconic boogeyman of the anti-GMO movement. They have created a demon almost entirely out of whole cloth. It is a modern day mythology. In fact, watching the anti-GMO movement unfold over the last two decades is an excellent example of how mythology forms and evolves. It is easy to see how the ancient world was populated with gods and demons, heroes and villains.
We are not yet free (if we ever will be) of the primitive circuits in our brains that helped us navigate the Serengeti but are not adapted to a modern technological world. For that we need science and critical thinking. The anti-GMO movement, along with many other social movements, provides ample examples of the various ways in which emotion trumps reason.
Understanding this aspect of human nature is critical, and it at least gives us the opportunity to use critical thinking to transcend our primitive instincts.
I had a dickens of a time writing this entry. The last week has been spent in New York for NECSS. It is safe to say that New York has plenty of distractions for us Dug the Dog types. Reality may be a honey badger, but New York is a squirrel. I say that when I travel I usually do not come across food better than I can find in Portland. Nope. Not true of New York. It joins Paris and New Orleans in the holy trinity of good eats, although I will stick with Pacific Northwest beer. And the rule is that for every day you are gone, three days worth of work piles up. I really need to stop taking time off.
I spoke at NECSS on a favorite topic of mine, how acupuncture works. It doesn’t. But I discussed a few studies that I found interesting. Like all studies, no single paper is definitive. The third law of the medical literature states that for every study, there is an equal and opposite study. A bit of an exaggeration perhaps but I do find the direction that the following studies point interesting both as to acupuncture’s mechanism of inaction and how the mind functions and are worth collecting in an essay.
In a weird way, the Secret is true. Expectations can influence the outcomes of an intervention such as acupuncture. If you have confidence in the procedure and believe you are going to have a salubrious effect, acupuncture will work. In The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain they took
864 patients (who) received either 12 sessions of acupuncture or minimal (i.e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent.
The patients had 4 kinds of pain: migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee, (one each; no one suffered from all four) and had 12 sessions of acupuncture or sham acupuncture, in this case superficial needling of non-acupuncture points. Since the only places on the body that do not have acupuncture points (depending on the acupuncture style) are the eyes, under the nails and the genitals, this must have been a very unhappy control group.
If the patient had the expectation that acupuncture was going to be effective in relieving pain, then they were better off than their long suffering skeptical compatriots with a decrease in pain, and the response lasted for 6 months.
This is not the only study to show that the expectation that acupuncture will be effective is important in causing a beneficial effect. Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture found that fake acupuncture was equal to real acupuncture but it was the
beliefs about treatment veracity (that) shape how patients self-report outcome.
It is not just the patients belief,
The individual practitioner and the patient’s belief had a significant effect on outcome
Eight trials analyzed the association between pre-randomisation expectations for assigned treatment and outcomes, and six the effect of pre-randomisation expectations across all patients independent of treatment allocation. Some showed associations but others did not.
There is some evidence that response expectancies interact with outcomes in acupuncture trials however the variety of question phrasing and analysis methods precludes drawing a firm conclusion about for whom and under which circumstance.
Adequate blinding of patient and practitioner and patient expectations need to be controlled for and reported in any future acupuncture trial in order for the study to be properly performed and interpreted. Although I would suggest that based on the data to date, no further acupuncture studies need be done nor are such studies ethically justified.
Also, if a patient is told that a needle is being used to cause pain instead of to relieve pain they will have a different response to the same jab. A needle perceived as beneficial activates different parts of the brain than a needle perceived as painful, but it is the same needle stuck in the same place,
Although the applied stimuli were physically identical in both groups, the verbal instructions differed: participants in the AS group were primed to consider the acupuncture as a painful stimulus, whereas the participants in the AT group were told that the acupuncture was part of therapeutic treatment. Acupuncture yielded greater brain activation in reward-related brain areas (ventral striatum) of the brain in the AT group when compared to the AS group. Brain activation in response to pain stimuli was significantly attenuated in the bilateral secondary somatosensory cortex and the right dorsolateral prefrontal cortex after prior acupuncture needle stimulation in the AT group but not in the AS group. Inserting needles into the body in the context of treatment activated reward circuitries in the brain and modulated pain responses in the pain matrix.
Except for a masochist I suppose. And people can be conditioned to have the ‘right’ response to being jabbed with a therapeutic needle. Pain relief from acupuncture is a learned response, probably not unlike ‘heat’ from hot sauce added to food to ‘enhance’ it.
If I had no ethics I would train our phlebotomy techs to tell patients that when they were searching for a good vein from which to draw blood they were also looking for acupoints and that they were going to draw the blood using an acupuncture needle technique to decrease pain and discomfort. I bet it would work and it would make for an interesting study in placebo effects.
But it gets even weirder. All the above studies involve touching people, albeit with needles. There is a spooky literature of inducing the same effects as acupuncture but not even touching the person.
There is this curious effect called the rubber hand illusion. First you place a rubber hand in such a manner that it is positioned as if it is part of a persons body and hide their real hand. Then you simultaneously stroke the real and rubber hand with a brush. By doing this you trick the brain into thinking that the rubber hand is the real hand. If you touch the rubber hand with an ice cube, or even a fake ice cube, the brain will feel cold. Or hit the hand and the brain will feel pain. Weird.
If you do acupuncture on the rubber hand? Meridians and chi spontaneously form in the rubber hand and the patient will experience some of the effects of acupuncture. They will have some of the same physiologic effects of acupuncture to a real hand if sham or real acupuncture is done to the rubber hand. And acupuncture on a rubber hand will induce the same fMRI changes in the brain as real acupuncture on a real hand.
Weird yes, but it gets even weirder.
Someone (probably a former mime, doing acupuncture against the wind or some such) developed phantom acupuncture, where the therapist goes through the motions of acupuncture but does not actually touch the patient. Some people find the phantom credible even having the Deqi sensation. The result is the same: some of the physiologic responses of real acupuncture occur with phantom acupuncture. And the physiologic response to the phantom intervention varied depending on whether the subject was convinced by the phantom acupuncture.
So real acupuncture has the same effects as sham acupuncture such as twirled toothpicks. It never matters where the needles are placed, or even if needles are used. Effects depend on large part on expectancy and belief that can conditioned in the patients. And the effect of acupuncture can, in part, be induced in a rubber hand or even thin air.
Steve Novella refers to acupuncture as a theatrical placebo, or as one author stated,
a complex, ritualistic somatosensory intervention,
but these studies would suggest that all the effects of acupuncture are manufactured in the mind, with no cause or effect in external reality. We create our own acupuncture reality from the quantum…man…oh…hell. Chopra was right.
Just kidding. He is still full of shit.
Acupuncture Doesn’t Work. The definitive review.
Mars is an interesting place. The more we study the surface of the planet with our various robot labs, the more interesting it becomes. This is one of the reasons that it is very enticing to send people to Mars, but there is debate about the feasibility of any mission to Mars over the next few decades.
Life on Mars
Recently the Curiosity rover found evidence that suggests there might be briny liquid water just under the surface of Mars. When the temperature and humidity are just right, salts in the Martian soil could absorb moisture from the air creating a subsurface briny liquid water. This water would then evaporate again when temperatures rise during the day, creating a water cycle.
This would be a harsh environment for life, perhaps not compatible with life as we know it, but extremophiles have surprised us before. It is perhaps more likely that deeper down in the Martial dirt there is more permanent liquid water and more protection from cosmic rays, meaning that life could endure in slightly less extreme conditions.
There are also geological features that suggest recent flowing something, perhaps water bubbling up temporarily from below the ground, and flowing briefly before it evaporates in the thin Martian atmosphere.
The possibility of finding life on Mars is one of the most exciting scientific questions of our time. Even evidence of past life would be amazing. Our best chance of finding this evidence might be through more and more sophisticated rovers. Having actual scientists on Mars, however, wouldn’t hurt.
A private group (Mars One) has received some attention recently by announcing its plans to send permanent settlers to Mars by the 2020s. We recently interviewed Chris Patil, one of the final 100 contestants for the Mars One missions, on the SGU. He was enthusiastic but realistic. The topic also came up recently at NECSS. Bill Nye, CEO of the Planetary Society and an exuberant proponent of space exploration and popularizer of science, was highly skeptical of the Mars One approach.
Mars One intends to raise 4 billion dollars, and claims that we have the current technology to send people to Mars and establish a permanent settlement. We don’t have the actual applications necessary – we will have to create the combinations of current technology that will be necessary.
Nye feels that there is no way to pull off this mission with 4 billion dollars. The challenges are just too great. Let me review some of them:
The trip to Mars will be long, at least several months, during which time the crew will have to survive in a cramped capsule. The capsule will have to be shielded from cosmic rays. The crew will need enough space to exercise, and to store sufficient food and water. Unlike the ISS, there will be no resupply missions.
Once they get to Mars they will have to land. As Nye pointed out – the atmosphere is too thin to be of any help, but too thick to ignore. We have landed equipment on Mars, but not people. There is more gravity than the moon, and the wispy atmosphere can still kick up killer dust storms. It is not thick enough for parachutes, however. We will need to develop a landing system optimized for Mars. This does not seem like a deal-killer, but is just one more challenge.
Once on Mars they will find a distinct lack of oxygen, water, and protein. There is also a lack of a magnetic field, which means there is an excess of cosmic rays. What this means is that any colony on Mars, in order to be self-sustaining, will need the ability to extract oxygen and water from the environment, and to grow sufficient food. They will need a habitat that will protect them from the cosmic rays. To make all this work they will also need a reliable source of energy.
While all of this is not impossible, it will take a substantial infrastructure. This gives us a bit of a chicken and egg problem. Do we build some or all of the infrastructure with robots then send people, or do we send people to build the infrastructure? Likely there will be some combination – it would be nice to have at least lots of supplies, a source of energy, and some prefab components waiting for the first Martian settlers.
Patil made the point that it will always be easier to go to Mars (or do anything huge) in the future, but at some point we just have to bite the bullet.
Nye and others feel that other Mars missions would be a better idea. First lets just get people into Mars orbit. From there they could control rovers in real time, do a few weeks or even months of science, then return home. We could also land people on Mars for a brief stay, and then return them home. While doing these temporary missions we will be developing the technology and experience that will enable a future permanent settlement on Mars.
There are also those who argue that sending people to Mars at all is a waste of resources. For the same money we could send many robotic missions. It’s dangerous and expensive to send people to space. Robots don’t need things like food or air, and they can tolerate the radiation.
I tend to agree mostly with Bill Nye. I do think it is worthwhile to send people into space, and to eventually colonize the Moon, Mars, and elsewhere in the solar system.
But we need to recognize that colonizing any place off the Earth is really difficult, and will take tremendous resources. I don’t think we need to wait until robots have built a luxury infrastructure for humans to stroll into, but neither should our first human mission to Mars have the goal of a permanent settlement. Let’s slowly build our infrastructure, for Earth orbit, the Earth-Moon system, and eventually Mars and elsewhere. The effort should be international, will collaboration between private and public institutions.
Ultimately I think that Mars One is a useful idea. At the very least it is an interesting thought experiment, and could increase enthusiasm for space exploration and science in general. As currently planned, however, it will also almost certainly fail. Its timeline is way too optimistic, the task is harder than imagined, and the project will need far greater resources than planned. Mars One may evolve into a project that can succeed, but not as currently conceived.
Opioids are widely available as prescription drugs for pain: hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), and codeine. Heroin, which has no medically approved use, is also an opioid. Unfortunately, opioids are also widely abused.
How enticing it is to imagine a magic bullet for opioid drug addiction. Addiction causes huge social problems. Yet it is hard to treat and suffers from a stigma that does not attach to other chronic diseases, like diabetes. Drugs like Naltrexone, Methadone and Buprenorphine, as well as behavioral therapies, are common opioid addiction treatments, although the relapse rate for addiction treatment is high.
One of the barriers to treatment is the addict’s fear of the side effects of withdrawal, which can be extremely uncomfortable, including nausea, cramping and vomiting. It is no wonder, then, that the opioid addict and his family would be drawn to a detoxification procedure advertised as both rapid, to speed up the initiation of relapse-prevention therapy, and relatively painless: anesthesia-assisted rapid opioid detox (AAROD), sometimes called ultra-rapid detox, or even just plain rapid detox, although the latter also refers to detox under lighter sedation.
Several clinics in the U.S. offer AAROD, claiming it is safe and effective. A more sober analysis by responsible medical authorities doesn’t agree. In fact, AAROD can be extremely dangerous and appears to be universally rejected by experts who actually waited to see what they evidence would say before coming to a decision.The overwhelming evidence against AAROD
Concerns about the procedure were published in the medical literature as early as 1997. As reported in JAMA, clinics were advertising AAROD as virtually painless opiate detoxification achieved in hours rather than days or weeks, even though
many addiction experts say that until claims of superior relapse rates for the ultrarapid detoxification methods are proven and concerns about the potential risks are allayed, the procedure should be considered experimental.
A Cochrane Review, in 2001, concluded that managing withdrawal by administration of opioid antagonists under anesthesia should be regarded as “experimental with both risks and benefits remaining uncertain.”
The California Society of Addiction Medicine was asked by an insurance company to evaluate AAROD. (Their report is undated, but appears to have been issued between 2001 and 2006). Their conclusion:
Until its safety and efficacy have been proven, and the procedure has been standardized, AAROD should only be used under research conditions . . . Two components of this procedure, precipitated withdrawal and anesthesia, are known to have risks that are not present in the more commonly used detoxification and withdrawal treatments. Any benefits of the procedure have not yet been shown to be worth these added risks.
“Precipitated withdrawal” refers to reports from clinicians that patients doing well in drug treatment had been targeted by AAROD clinics. They went through the procedure, lured by the idea that they could go to sleep and “wake up clean,” yet subsequently relapsed.
Based on the available evidence, the American Society of Addiction Medicine issued a policy statement in 2005, finding AAROD “not supportable until a clearly positive risk-benefit relationship can be demonstrated.” (Oddly, the procedure was approved, under certain conditions, by the ASAM as late as 2000, according to an Los Angeles Times story, even though it had not been adequately studied at that point.)
In 2006, two reports were published in the medical literature that should have sealed AAROD’s fate. A Cochrane Review updated previous Reviews (2001 and 2002). This time, it said, flat out, that
Given that the adverse events are potentially life-threatening, the value of antagonist-induced withdrawal under heavy sedation or anaesthesia is not supported. The high cost of anaesthesia-based approaches, both in monetary terms and use of scarce intensive care resources, suggest that this form of treatment should not be pursued.
Researchers at Columbia University Medical Center’s Clinical Research Center conducted a randomized clinical trial (blinding wasn’t possible), funded by the National Institute of Drug Abuse (NIDA), comparing AAROD for heroin detox with traditional detox approaches. The researchers concluded, as reported in JAMA, that AAROD patients suffer withdrawal symptoms as severe as those of patients treated with traditional methods. Post-detox treatment outcomes were no better for AAROD.
Three patients receiving AAROD suffered serious adverse events related preexisting medical conditions the patients failed to disclose to researchers. This gave rise to a concern that AAROD patients would conceal medical conditions that might disqualify them for treatment due to the allure of painless, yet effective, detox.
After the study was released, Dr. Ivan Montoya of NIDA’s Division of Pharmacotherapies and Medical Consequences of Drug Abuse, concluded
We now have several rigorous studies indicating that anesthesia-assisted detox— a costly and risky approach—offers no advantage over other methods.
Even if you weren’t convinced in 2006, warnings about AAROD continued to pile on. The U.K.’s National Institute for Healthcare and Excellence 2007 Guidelines warned against AAROD as well. Yet another Cochrane Review, in 2010, reached the same conclusion as in 2006.
Based on a serious adverse event rate of 9.3% at one New York City clinic offering AAROD, in 2012, the New York State Department of Health, the New York Office of Alcoholism and Substance Abuse Services, and New York City Department of Health and Mental Hygiene jointly issued a Health Alert informing New York health-care providers of AAROD-associated serious adverse events and recommending that they avoid use of AAROD in favor of evidence-based options for opioid dependence treatment. All adverse events required hospitalization and there were two deaths. There is no standardized AAROD procedure, but that used by the clinic was consistent with AAROD offered at other clinics: general anesthesia with intubation continued for a median duration of 8.3 hours, and the median time for administration of the opioid antagonist was 3.9 hours.
This, in turn, resulted in a CDC Morbidity and Mortality Weekly Report (September 27, 2013) warning that AAROD should be avoided.
So, as early as 1997 there were concerns in the medical literature. By 2006, the evidence was clear that AAROD carried serious risks and offered no benefit over other methods. As of 2015, the jury is in: don’t use AAROD. In fact, it is hard to imagine who else might be left to come out against it.Evidence v. money
But never let the evidence get in the way of making money. Several clinics around the country still offer it.
For example, Houston Rapid Detox, in Texas, administers Naltrexone while the patient is under anesthesia lasting 4-6 hours. The results? According to their website:
Once patients wake up, they are no longer physically dependent on opiates and they are unaware of the withdrawal that occurred during the procedure.
Although the website mentions complications at “other” clinics, they say this was due to improper procedure. While they say that “thousands” have benefitted, no research is cited in support of their claims for the safety and efficacy of their services. They even claim that traditional drug addiction treatment is itself unscientific and that they are among the few who understand addiction’s true nature. Again, they offer no research to support their allegedly novel theories. The website, as far as I can tell, doesn’t even say who is on the medical staff.
Midwest Rapid Opiate Detoxification Specialists, in Illinois (there is an affiliated center in Dallas as well) makes similar claims of safety and efficacy, without citing any supporting evidence. (Testimonials , yes; evidence, no.) It is as if the information discussed above doesn’t exist.
Anesthesia Assisted Rapid Opiate Detoxification (AAROD) is a safe and effective method to rapidly detoxify the body at the receptor level of active opiates. AAROD detoxifies the body of active opiates in 6 hours or less under the medical care of an anesthesiologist and skilled nurses. The AAROD procedure is safely conducted in a clinically equipped medical/surgical area by staff trained and experienced in the AAROD procedure.
This claim – that offering AAROD in a properly staffed and equipped facility is safe – is common among AAROD clinics. It may be true that it is safer, but that doesn’t mean it is safe and doesn’t address effectiveness. The 2006 JAMA study employed AAROD in a “safe” facility, but it made no difference in the study’s recommendations.
Interestingly, Midwest claims that
Our ASAM (American Society of Addiction Medicine) trained physicians are directly involved in the individual care of each patient.
They either don’t realize, or don’t want to admit, that ASAM’s own policy statement advises against the use of AAROD.
A Beverly Hills rapid detox facility uses the “Waismann Method,” which is
a pioneering opiate treatment based on a safe and proven protocol that utilizes the most advanced medical techniques available.
Again, no research is cited. I did find Dr. Waismann, who has treatment centers in Israel and Switzerland, and his claims that his
ANR Method (Accelerated Neuroregulation) reverses both the opiate dependency and its symptoms. ANR reverses dependency on Heroin, Methadone, Suboxone, Subutex, and prescription opiate medications using an effective, safe, and humane treatment.
I cannot find anything in PubMed about him or his treatment and he doesn’t help me out by citing any research.
My state, Florida, has, or maybe had, an AAROD clinic as well. In fact, it was through an article about Dr. Rick Spanaugle, of Florida Detox and Wellness in the Cleveland Plain Dealer that I first heard of AAROD. Unlike the Plain Dealer’s more thorough article, Dr. Spanaugle was the subject of some credulous media coverage, including a story by Anderson Cooper (sadly, featuring Dr. Sanjay Gupta’s report, which was less than satisfactory. Dr. Gupta has somewhat redeemed himself since.) Dr. Phil actually sent patients to Florida Detox.(The Plain Dealer story contains links, if you can bear it.) The clinic still offers detox, although it is not clear that he is still offering this particular procedure.
Dr. Sanaugle does, however, claim that he successfully treated Cleveland Browns player Bernie Kosar’s brain trauma, a service he is now offering to others, as well as treatments for “chronic Lyme disease” and “mold toxicity,” if you get my drift.
If you Google “rapid detox” you’ll find other treatment centers, but we’ll leave it at that.Why is this even legal?
The question of whether AAROD is safe and effective is settled: it isn’t. Yet, physicians continue to offer it. How can they do this?
Part of the problem, perhaps a large part, is the way we regulate medical practice in the U.S. Each state issues medical licenses under its own terms, which vary from state to state. Generally, once a license is issued, the medical doctor doesn’t have to stop using a diagnostic procedure or treatment until the state board of medicine makes him. And for the medical board to act, someone must file a complaint against the physician. No complaint, no action against the physicians’ license. A malpractice suit might result in a monetary judgment, but it won’t cause the medical board to act unless a complaint is filed, although physicians must generally report malpractice settlements or awards over a certain amount, as well as other disciplinary actions, to the board.
There is always the possibility of a ruling that results in a fine, the requirement of additional education, temporary suspension, or other sanctions that fall short of losing a license. (Two rapid detox doctors were suspended in New Jersey. One of them was also suspended in Pennsylvania and had his DEA registration revoked. He is now back in addiction medicine practice.)
Even falling below the medical standard of care isn’t always a cause for discipline. Some states have “healthcare freedom” laws that provide physicians with wiggle room when they want to offer unconventional treatment.
The current system allows physicians to engage in unproven, and sometimes dangerous, practices for too long. There needs to be a way to stop the problem before it starts. I’m not sure what that system would look like, but if you have any suggestions, please post them in the comments.
The World Health Organization (WHO) has recently released a new position statement on mandatory reporting of all interventional clinical trials. This is a positive step in the trend towards higher quality and greater transparency in clinical trials.
The underlying ethical concept here is that the public has a right to data that results from experimentation on humans. The researchers do not ethically own that data. They have been granted the privilege of performing research on humans as part of a social contract that includes the timely public reporting of the data.
The WHO statement calls for all registered clinical trial results to be made public in a open-access public forum in a searchable format within 12 months, and publication in the peer-reviewed literature within 24 months. They urge more rapid dissemination, but state that the 12/24 month time frame is the upper limit of when results should be reported.
The WHO statement is part of a larger trend toward greater transparency but also quality in scientific research. It is part of a recognition that we cannot understand how to best practice medicine and allocate resources based upon individual studies. We need to look at the entire scientific literature as a whole. Even when individual studies may be of high quality, there are many potential factors that can distort the scientific literature and therefore misinform doctors, scientists, and regulatory agencies.
Dissemination bias is one such factor. In the past certain pharmaceutical companies have even argued that they own the data from clinical trials they funded. This argument has been soundly rejected. The debate resulted in the formation of clinicaltrials.gov, a site where all human clinical trials must be registered. This registration has allowed for tracking of how clinical trials are reported.
“Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013.”
Corporate funded studies with FDA oversight were more likely to be reported than those funded by the government or academic institutions – so this is not a problem isolated to the pharmaceutical industry.
A 2014 study in the Annals of Internal Medicine also found many discrepancies between the trials registered in clinicaltrials.gov and what ultimately is reported. These discrepancies included reporting of secondary outcomes, reporting of adverse events, and even reports of deaths.
One of the missions of Science-Based Medicine is to explore the relationship between scientific evidence and the practice and regulation of medicine. We have learned a great deal over the last couple of decades about this relationship, which is complex and evolving.
It is important to understand how to evaluate the quality of individual studies and how the type of information provided relates to the practice of medicine.
Perhaps even more complex, however, is the relationship between the body of scientific evidence and our ultimate conclusions about practice and regulation. We now know that most individual published studies are wrong. You have to look at the overall pattern in the published literature to make a reliable conclusion.
Often we rely upon systematic reviews to assess the overall pattern in the literature. However, such reviews are likely to reflect any biases in the publication and dissemination of research results. There is a remarkable bias toward publishing positive studies – among researchers, funders, and journal editors. There also appears to be a bias toward provocative studies, which are the very ones that are most likely to be false positives. Exact replications, perhaps the most important type of study, are seen as uninteresting. Some journals, as Richard Wiseman discovered, may even have a policy of not publishing boring exact replications.
What is clear is that we need a global effort to improve the technology of tracking and disseminating clinical trial results to minimize any biases. Fortunately we have a relatively new technology, the internet, to help with this effort. There is no longer any excuse of the pages of a print journal being a limited resource. An unlimited amount of data can be published online.
Ideally we would have a situation in which all human clinical trials are registered before they begin, including details about methods, outcome measures, number of subjects, and comparisons (to reduce researcher degrees of freedom). Once registered, trial progress and results will be tracked and reported in a timely fashion. All this data will exist in a public, open-access, and searchable database so that researchers can easily access the information. Negative results will not be swept under the rug. Exact replications will be encouraged and enthusiastically reported.
As a result systematic reviews addressing a specific medical question will be much more likely to capture the true answer free of systematic biases. Ethics demand nothing less.
Without thorough and transparent reporting, the rights of subjects in clinical trials are violated. They allow themselves to be experimented on for the advancement of science, and if their results are not reported in a timely fashion then that trust is betrayed. Further, any subject in a future clinical trial that may have been unnecessary if only previous trials were properly reported are also being treated unethically. Dissemination bias wastes resources, distorts the practice of medicine, and is a disservice to patients, research subjects, and physicians and regulators who rely upon published data.
The WHO statement is a step in the right direction, although it needs to be backed up with more teeth. We now have the technology to make all clinical trial results transparent and accessible. This has the power to dramatically improve the science of medicine. The ethical imperative to do so seems clear.
The skeptical community is abuzz with the announcement by the FDA’s announcement that they are reviewing the “regulatory framework” of homeopathic products and are open to public input. We have written about this at Science-Based Medicine, and as you can imagine, this is a serious topic of discussion among the editors.
The FDA regulates food, drugs, medical devices, supplements, and cosmetics for the purpose of protecting the public health and safety. Congress created the FDA and determines its powers. In the 1938 FDA act, one Senator, Royal Copeland, who was a physician and homeopath, included in the bill that the provision that the Homeopathic Pharmacopeia of the United States (HPUS) would be included in the list of official drugs.
What this means exactly is that homeopathic products are automatically considered drugs by the FDA. Further, any new homeopathic product added to the HPUS in a supplement also counts. All homeopaths have to do, therefore, to get a homeopathic product listed as a drug by the FDA is write it down in one of their supplements to the HPUS. That’s it. No research is necessary, no assurance of safety or efficacy.
However, that does not mean that the FDA has to approve the homeopathic remedy. They have the authority to require evidence for safety and efficacy, just like they do with real drugs. They simply chose not to enforce this authority. Apparently they thought it wasn’t worth the trouble 70 years ago so they simply outsourced the regulation of homeopathy to the homeopaths.
I can see the logic behind this. At the time homeopathy was such a small industry, and their products are literally just water or sugar pills, so why waste limited FDA resources?
However, homeopathy has grown into a multi-billion dollar industry. I would argue it is a multi-billion dollar scam. Pharmacies sell homeopathic potions on the shelf right next to real medicines, with claims that they treat specific diseases. Most people don’t even know what homeopathy means, and may not look for the small print indicating that the cold remedy they are buying is homeopathic.
Better Late than Never
Now, finally (I hope), the FDA has apparently realized that they are completely neglecting their mandate to protect the public from harmful or worthless medical products when it comes to homeopathy. If I would guess, I think the FDA understands that homeopathic products are utterly worthless pseudoscientific nonsense. They can’t possibly work, and when studied they don’t work.
If they couldn’t figure this out by themselves, the UK government recently did a massive review and concluded that homeopathy is nothing more than witchcraft. More recently the Australian government did a similar review and found that homeopathy does not work for anything.
There are indications that the FDA is serious about reform. They actually contacted the Committee for Scientific Investigation (CSI) and asked them to send an expert skeptic to their public hearing. There is also a period for written public commentary, and we at SBM are preparing a statement (which we will publish as an open letter also, so stay tuned).
Here’s the preview, however – it seems to me that the simplest thing for the FDA to do is to simply do their job. They have the authority to regulate homeopathic products like drugs, so do it. Don’t outsource to the homeopaths. Require evidence for safety and efficacy for all homeopathic products. It that’s simple. If they did that, homeopathic products would disappear overnight.
Well, I suspect they would give manufacturers a grace period of 1-2 years to provide such evidence, and if they didn’t provide adequate evidence by the deadline their products would be removed from the pharmacy shelves.
The homeopaths, of course, are going to fight back. What, however, are they going to say? Up to now they have been claiming that homeopathy works, and many even claim that the evidence shows that it works. Now they either have to admit that there isn’t evidence showing that it works, or that the FDA requiring evidence is OK.
Their only other option is to make some sort of conspiracy claim, that some nefarious force is using the FDA to shut down homeopathy. So, of course, I suspect that is what they are going to do. They will complain that homeopathy can’t be studied like regular drugs, and existing studies are not fair or adequate.
The thing is – they actually make the case for the FDA properly regulating homeopathic products. Homeopaths argue that you need a homeopath to individualize a remedy for each patient. While this is BS, if it were true that would be an argument against the over-the-counter homeopathic industry. In fact homeopaths routinely throw the homeopathic product industry under the bus to explain away the negative clinical trials of homeopathy.
Therefore, by their own logic, the OTC homeopathic industry is unscientific and is selling ineffective nostrums. So let the FDA regulate them away. The FDA does not have the power to regulate the practice of medicine, just the sale of medical products.
I hope that this move by the FDA is the historic opportunity it appears to be – meaning that the FDA is sincere and will listen to reason. Homeopathy is a scam that has been operating under the nose of the FDA for decades. They can end it with a stroke of the pen.
Now is the time to put the pressure on.
FDA – do the right thing.
You have probably seen the TV commercials or other ads for Cancer Treatment Centers of America. They make it sound like “the place to go” if you have cancer. They claim to be “different,” to combine the best cancer technologies with natural therapies in a humane, patient-centered approach that helps you fight the disease and maintain your quality of life. They offer a kinder, gentler, more effective oncology. Those ads are misleading.
Dr. Gorski has written about the practices of Cancer Treatment Centers of America here and here. He has shown how they “integrate” real medicine with nonsense like homeopathy and how they misrepresent components of science-based medicine like exercise and diet, re-branding them as “alternative.”
A recent study by Vater et al. published in the Annals of Internal Medicine asked “What are cancer centers advertising to the public?” They found that the ads appealed to emotion, failed to provide important information, falsely portrayed testimonials as typical, and should be viewed as critically as any other advertising.History and ethics
There is an excellent article by N.D. Tomycz in the Journal of Medical Ethics titled “A profession selling out: lamenting the paradigm shift in physician advertising.” It covers the history of the relationship between doctors and advertising and the ethical issues involved.
From the first American Medical Association (AMA) Code of Ethics in 1847 to 1975 any advertising by doctors was strictly forbidden. Advertising was a commercial business practice; medicine was a profession, not a business. Only quacks and snake oil salesmen advertised. Advertising was considered incompatible with ethical patient care, and publishing testimonials or promises of cures was grounds for ostracism. Other professions followed suit; the American Bar Association prohibited advertising in the early 20th century. A U.S. Supreme Court decision in Goldfarb v. Virginia State Bar determined that lawyers were “engaged in trade or commerce” and therefore were not exempt from antitrust laws. In 1975 the Federal Trade Commission (FTC) accused the AMA of exercising “restraint of trade” in violation of antitrust laws and persuaded the medical profession to allow advertising. This led to what we have today: prescription drugs widely advertised in the media, doctors advertising their practices, and advertisements for cancer treatment centers. This commercialization may well have diminished public trust in the medical profession. In other countries, the ban on advertising persists.
Tomycz offers these ethical arguments:
Patients are not consumers in search of a commodity. There is a unique vulnerability that comes for want of relief from disability and disease, and patients are unlikely therefore to be capable of defending themselves with the incredulousness they may normally bring to other forms of advertising.
Physician advertising manipulates choice by presenting limited and biased information that aims to entice rather than inform. Advertisements often fail to cite complications and rarely present treatment alternatives not offered by the physician. The fleeting medium of advertisement—billboards, short radio segments, fliers, rapid television infomercials—is not appropriate for initiating the informed and often complex decision making process that should underlie all health interventions.
Now that medical quackery has returned with unprecedented sophistication, annually draining billions from the population with unproven treatments and supplements, physicians may be more tempted than ever to advertise and secure some piece of the healthcare pie. Yet no matter what the law permits, advertisement in medicine should remain a taboo that unifies doctors in the defence of professionalism and the unique covenant they share with patients.Cancer center advertising study
Vater et al. did a systematic content analysis of cancer center ads in top consumer magazines and on television networks in the US in 2012. After excluding duplicates, employment opportunities, fundraising ads, etc. they found 409 unique advertisements promoting clinical services at 102 cancer centers. They most commonly promoted cancer treatments (88%) rather than cancer screening (18%) or supportive services (13%). They frequently made vague claims like “Our team has saved lives through groundbreaking technology, personalized treatments, and research.” The type of cancer treatment was not specified, and very few mentioned palliative care or symptom management services. Less than 2% mentioned the possibility of risks from treatment. Only 5% mentioned costs or insurance coverage.
85% included emotional appeals relating to survival or potential cure. 61% used language that evoked hope (“your last hope,” etc.). 31% mentioned that treatments would be tailored to the individual. Nearly half of the ads included endorsements from patients, testimonials that emphasized survival or cure. Only 15% included a disclaimer that these results were not typical, and no ads described the outcome that a typical patient could expect. The FTC has recently mandated that testimonials include disclaimers and a description of results that a typical patient may expect to see. Most of these advertisers were not in compliance.
The ads failed to provide crucial information that patients need to make an informed decision about where to seek cancer treatment. They seldom mentioned risks and failed to quantify benefits.
The authors mentioned the limitations of their study. They did not include other media such as the Internet, newspapers or radio. Their sample may have been incomplete. Most importantly, they did not examine the effect of advertising content on patients.
An accompanying editorial praised the rigor of the study but expressed some caveats about its potential implications. It said it would be unreasonable for such ads to present quantified survival data because that data is easily manipulated and difficult for consumers to evaluate. It pointed out that advertising has potential benefits such as destigmatizing cancer. It mentioned a survey that asked whether these ads should be banned; only 11% of respondents supported a complete ban, 33% favored limited restrictions, and 56% believed no changes should be made. It concluded:
If marketing increases or decreases that burden for patients with cancer, it behooves us to know how. Vater and colleagues should be commended for taking an essential first step toward that goal.Conclusion
The advertising by cancer centers is frequently misleading, but we don’t yet have any data on how those ads actually impact patients. It would be a mistake for consumers to base their decisions about where to go for treatment only on the incomplete information in the ads.
Australia Prime Minister Tony Abbott has just announced a new policy that will go into effect January 2016 – the “no jab, no pay” policy. Under this policy parents who refuse to vaccinate their children will lose tax exemptions for children. This could cost them up to $11,000 per year (I have also seen estimates of up to $15,000) per child.
This new policy is reported to have bipartisan support and is supported by the Australian Medical Association.
The new policy would not apply to medical exemptions or religious exemptions, but the latter is enforced as a very narrow exemption.
Antivax parents are, of course, protesting, arguing that the new policy infringes on their rights as parents. But does it? The antvax community often makes the argument that they have the right as parents to make medical decisions for their children and the government cannot force them to vaccinate.
In the broader context of parental rights, it is clearly established that the state has a right and a responsibility to protect children from neglect and abuse at the hands of their parents. Parents cannot, ethically or legally, medically neglect their children, and not protecting them against communicable diseases can reasonably be considered medical neglect. There is an overwhelming scientific and medical consensus that vaccines are safe and effective – in the absence of any genuine controversy, antivax parents don’t have an ethical leg upon which to stand.
There is a further issue with vaccines as well – they protect the community, including vulnerable members of that community who cannot be vaccinated for various reasons. We don’t give people the freedom to speed on the highway, and we don’t give restaurant owners the right to raise chickens in their kitchen. There are numerous restrictions on personal freedom in the name of public health and safety.
The important ethical point is this: how does the restriction in freedom compare to the benefit to individual and public safety? Does the government have a compelling interest? In the context of vaccines I think the answer is clearly that the government and the public do have a compelling interest, and the restriction in freedom is justified by the safety concerns.
Further, no country (as far as I am aware – correct me if I am wrong) forces vaccines on children. No child is taken by government agents and force-vaccinated against the will of their parents. Countries that “mandate” vaccines, like the US, simply require them to access some public service or have some penalty for not vaccinating. In the US, for example, vaccines are required to enter public school. Parents, however, can refuse to vaccinate and still home school or enter certain private schools.
Australia is now taking a more aggressive approach, but this still falls within the same paradigm. They are withholding a benefit from parents who refuse to vaccinate their children. Parents can still choose not to vaccinate their kids, but they will lose certain tax exemptions if they do. The government is perfectly within its rights to use tax exemptions to encourage or discourage certain behaviors, as long as they are not discriminatory. In this case they are encouraging a behavior which is in the interest of public health.
This is similar to charging people higher health care premiums if they smoke. You are free to engage in this unhealthy behavior, but your bad behavior will not be subsidized by others. You will have to pay for the consequences of your own choices. At the same time you cannot smoke in certain public areas, so you are not free to impose your bad health choices onto other people.
It is a reasonable premise that parents who choose not to vaccinate put other children at risk and cost society money. Society therefore has a right to respond to their bad choices (and we have sufficient evidence and consensus to call them bad) by restricting access to certain public services and benefits.
I therefore think that Australia is on solid ethical and legal ground. I applaud them for having the political courage to take such a bold action. Hopefully their actions will set an example for other countries to follow suit. I would support a similar law in the US.
The Disneyland Measles outbreak has seemed to shift the balance of public opinion against the anti-vaccine movement, and so the time is ripe to lobby for laws to protect the public against anti-vaxxers.
Note: With Dr. Gorski busy at the NECSS, naturopathy apostate Britt Hermes has generously stepped in to provide her second contribution to ScienceBasedMedicine.org. Enjoy!
Right before I left the naturopathic profession, an Arizona naturopath told me that “all NDs are doing something borderline illegal.” Alarmed, I began looking around me.
Arizona naturopathic cancer clinics promote illegal substances, advertise results that are too good to be true, and use compounds that have yet to be proven effective in humans. Many clinics focus on intravenous therapies using ozone, hydrogen peroxide, sodium bicarbonate, vitamin C, and blood UV irradiation; some drugs and herbal preparations for injection are claimed to be imported from Europe.
In Arizona, current regulation enables naturopaths to craft hollow research projects under the cover of a private naturopathic institutional review board (an IRB, also often called an ethical review board). This allows them to legitimize experimentation on patients in private clinics and expand the naturopathic scope of practice in the name of so-called research. The IRB appears to influence the state’s naturopathic board, which seems reluctant to do its job properly.
Naturopathic regulation in Arizona may be the worst-case scenario of any state licensing pseudoscience as medicine. The ramifications are grave. Patients, especially those with cancer or other serious conditions, are easily duped and can be severely harmed by medical practitioners who seem kind, charismatic, and confident, but are actually inept and experimenting without the oversight of an ethical review board.Arizona’s unusually broad scope of practice for naturopathy
In Arizona, licensed naturopaths benefit from the broadest naturopathic scope of practice in the United States. Arizona law treats naturopaths like primary care physicians qualified to diagnose and treat diseases, administer vaccinations, and perform sports physicals (also chiropractors too) on young athletes. They are legally permitted to:
In the United States, naturopathic scopes of practice vary wildly across 16 states and jurisdictions. In some states, like Alaska, licensed naturopaths have very narrow scopes: they cannot diagnose disease, prescribe pharmaceuticals, or call themselves “physicians.” (Oddly, insurance reimbursement is mandated for their services.)
In California, naturopaths appear more like physician assistants: naturopaths require supervision by a physician (MD/DO) to prescribe from a limited formulary, but they can independently perform physical exams (including gynecological exams), order labs and imaging, and propose diagnoses. They can call themselves “doctors” but not “physicians,” and insurance coverage is not guaranteed. For more information see Dr. Stephen Barrett’s page on naturopathic regulation from 2005, useful even if somewhat outdated.
But the scope of practice is broadest of all in Arizona. This would be a problem even if it was regulated properly. But it’s not.Arizona’s sketchy regulation of naturopathy
Like other states with naturopathic licensure, Arizona has a naturopathic board of physicians tasked with licensing and regulating the practice of naturopathy. In my opinion, this board has done an unusually poor job of regulating naturopathic medicine to protect the public. A quick look at its disciplinary actions shows a chronic pattern of weak regulation and inadequate sanctions for what appear to be serious instances of professional misconduct. The Arizona naturopathic board also has a history of scandals:
The Arizona Auditor General’s office condemned the board in 2000 for severe shortcomings in how licensees are examined, how quickly complaints are resolved, and how the board is managed. Most appalling, the naturopathic board was found to have inflated exam scores so every applicant would pass.
Fourteen years later, things hadn’t improved much.
In 2014, the Auditor General reported that the naturopathic board still needed to strengthen examination and licensing requirements, improve complaint processing, develop consistent policies for serving disciplinary actions, and provide timely and accurate licensing and complaint information to the public.
As I explained last month in my first post for SBM, the education and practice of naturopathic medicine is so uncritically diverse that nearly any kind of treatment of patients is considered acceptable. Thus, it follows that naturopathic regulation must be weak for such practices to be lawful. In a state with a scope of practice as broad as Arizona’s, patients face considerable risks as naturopaths are permitted to treat patients however they like without regard for evidence or science.
This regulatory environment also creates a strange opportunity for hijacking the system.A naturopathic ethics committee?
A group of Arizona naturopaths established an Institutional Review Board and research group to direct, approve and monitor “naturopathic research” conducted by its members and other naturopaths in private practice. In my opinion, they are not conducting any legitimate medical research. Rather, they are using the group to establish flimsy standards of care and conduct dangerous experiments on patients.
A real IRB is an ethics committee designated to scrutinize research involving human subjects. An IRB ensures that research on people meets reasonable ethical standards for patient privacy, informed consent, and (most importantly) protection from physical and psychological harm. IRBs are crucial components of enforcing ethical standards in human research. Any medical IRB in the United States must be registered with the Food and Drug Administration.
The Arizona naturopathic IRB was founded in 2010 by licensed and practicing naturopaths and has three names:
ANRI/NORI/IRB states on NaturopathicStandards.org that the group strives to protect Arizona’s naturopaths against regulatory and malpractice insurance liability that could “erode and restrict the scope of naturopathic practice.” I think it’s striking that an ostensible ethics committee takes an adversarial stance against institutions that serve to protect patients, which is what an IRB is meant to do — not protect the naturopathic profession. I am concerned that the ANRI/NORI/IRB defines valid treatments for study and practice as anything taught in naturopathy school or done by two or more naturopaths. So, it seems, anything goes.
The main goal of ANRI/NORI/IRB is to “explore and conduct research” using naturopathic treatments that embrace “diverse practice modalities in a non-judgemental way” that will hopefully lead to “the greatest possible [number of] treatment choices” for patients with serious health conditions, like cancer and autoimmune diseases. (I spliced up the summary and quotations to provide an accurate gist, but you can read their whole mission statement, which actually seems more damning than my abridged version.)
The ANRI/NORI/IRB’s priorities are suspicious.IRB shenanigans
Let’s review an example of how ANRI/NORI/IRB’s board members consider approving naturopathic research from their board meeting minutes dated February 13, 2015.
Cast of characters:
Kenneth Proefrock, NMD, President of ANRI/ NORI/ IRB, vice-president of the North American Board of Naturopathic Examiners and founder of the Arizona Stem Cell Center.
Debbie Rogalla, NMD at Simply Ageless Nation.
Mary Ellen O’Brien, NMD with her own private practice.
Andrew Dickens, NMD at Healing Pathways Medical Clinic.
Cheryl Hamilton, NMD at the Women’s Health and Healing Center.
Bob Waters, PhD, professor at the Southwest College of Naturopathic Medicine; board member of the Aviratek Biomedical Solutions which develops botanical medicines; board member of Relief Blue which develops botanical cold sore treatments; a researcher at LiquidCMO which makes botanical medicines for fibromyalgia and osteoarthritis patients; he is also a former adjunct professor at Arizona State University’s Biodesign Institute.
This is the full text of the IRB minutes discussing Dr. Rogalla’s “research”:
Dr. Rogalla said: I want to start a brain center, and I want to compete with the largest neurological centers and distinguish myself for offering integrative-type therapies. I feel working under an IRB would give me some credibility. I feel it would help me protect myself from those who say it would be crazy to give fish oil, for example, to a patient with a neurological condition. Also if I work with others in my office, I would want them to be protected under my IRB umbrella.
Dr. Proefrock asked: Do you have a protocol for how to interview patients and how treatments would be chosen?
Dr. Rogalla said that there are many categories of patients: MS, ALS, Alzheimers [sic], sleep problems.
Dr. Proefrock asked: Do you provide the diagnosis, or do they come in with that?
Dr. Rogalla said: They’ve already been diagnosed. I feel like I don’t want to put a powerful label on a person. Also, I don’t want to do invasive procedures. Those should already have been done in the conventional medical community prior to coming in. Now there are wellness programs for various conditions and optimizing programs – like for kids who want to do better in school, or seniors who want to prevent cognitive deterioration.
Dr. Hamilton asked: Is this like doctors who do brain scans?
Dr. Rogalla responded: I want to stay away from SPECT scans, because of all the radiation. I would like to do QEEGs, etc. There are gentle and non-invasive ways to diagnose and to treat people. But I would require the labs and imaging to back up the diagnosis.
Dr. O’Brien asked: Do you have an evaluation plan, so that every few months you can reassess?
Dr. Rogalla responded: So if they’re coming in for the wellness side or the optimizing side, I want to track that, based on condition and the therapies.
Dr. Proefrock asked: Can you bring us case studies as this unfolds, so that we can know what happened after this remedy or that?
Dr. Rogalla agreed to do so.
Dr. Hamilton asked, so if you work with other doctors, who are giving other prescriptions, are you coordinating?
Dr. Rogalla replied: In my HIPAA form I ask permission to share. If a patient chooses not to, I would honor that. Most of the patients will be on hard-core drugs. So I would be heavily invested in homeopathics and frequency specific micro-current.
Dr. Dickens asked: Would you do any testing, such as Neuroscience or something like that?
Dr. Rogalla responded: I may order baseline organic acids or neurotransmitters, depending on their condition. But a lot of what they do would be based on their existing treatment programs. I would like them to work with a PCP, neurologist and other team members.
I added low dose naltrexone (LDN) on the list, because it’s a controversial area, technically off-label. But I’d like to err on the side of caution, have it on the IRB. In Europe, research has shown LDN can be compatible with a lot of the Rx’s out there. It can be compatible to wean them off their current Rx’s.
Dr. Proefrock said: I think it’s exciting; I think you have a good idea. From an IRB perspective, it’s broad, but that’s okay. In principle, I have no disagreement with it.
Dr. Dickens said: I make a motion to accept Dr. Rogalla’s research for review by the IRB. Dr. Huber said: I second it.
Dr. Proefrock said: All in favor aye; opposed nay.
[The motion was approved unanimously.]
I missed it: what is the research project under review?
Dr. Rogalla tells the board that she wants to setup a private clinic for patients with severe neurological diseases and have “IRB credibility” so she will be “protected.” She seems to anticipate that her naturopathic clinic would treat patients in a way that regulatory or consumer groups might find inappropriate or illegal. One wonders if her motivation is to protect herself, not her research subjects, particularly since she doesn’t say anything about research subjects. She identifies no research population other than her own patients, and doesn’t present any information about her research design. Her methodology seems to be to treat neurology patients in her naturopathic clinic with fish oil, low-dose naltrexone, homeopathy, and frequency-specific microcurrent (also a mystery to me).
I am deeply troubled that she discusses her plans to experiment with weaning patients off of “hard-core drugs” — and I don’t think she means heroin or crystal meth. Her attitude towards prescription medications indicates she might not understand or respect the medical treatments she hopes to usurp.
She fails to mention how she will do anything ethical for her patients in her study, except to “honor” their preference for privacy. There is no mention of informed consent, how the data will be disseminated and published, or how the research is funded. She will not even be confirming the diagnoses of her patients! (Perhaps she doesn’t know how.) Most troubling, the IRB board members ask her irrelevant questions and simply encourage Dr. Rogalla’s extremely insufficient research design. The board members do not scrutinize any aspect of her proposal, as a proper IRB would certainly do.
Read the whole text: there’s a lot more questionable content and interesting dialog that paints a dark picture of this group of naturopaths.Naturopathic “research” versus ethics
The purpose of a medical IRB is to ensure the safety and protection of research subjects. In the above exchange, there appears to be a complete lack of concern shown for the welfare of Dr. Rogalla’s patients. Instead, it seems like the other naturopaths on the board are rubber stamping a naturopathic business plan and passing it off as medical research, to deflect outside scrutiny.
Here’s another important excerpt from the meeting:
Dr. Proefrock: I’m not painting the picture that we are saving the profession by having an IRB, but rather, it is a way to strengthen the breadth of our scope of practice.
Dr. Waters said: I use this IRB for a different purpose. We use is commercially, and we brought in a 92-page IRB, and we got it approved very quickly. If we went through big bureaucracies, it would take months. I don’t want this IRB to go away any time [sic] soon. It is a Godsend.
Dr. Hamilton said, so then we should mentor and help newer graduates and people in other states, and we should join the big leagues and stop hiding in our offices and pretend nothing is going on.
I get the impression they have an agenda. They admit to using the IRB to protect and expand their scope of practice, make money, and teach their methods across the country. It seems to me like this naturopathic IRB does not have the purpose or ethical standards of a real IRB.
Dr. Waters goes on to voice concern that this naturopathic IRB may get shut down if outsiders are allowed to partake: “If you go out and invite scrutiny, you can get hammered.”
Ironically, Waters then goes on to say: “We have contacts that have a lot of weight in the governor’s office. So we have friends in high places.”
He’s got some true grit.
Indeed, the ANRI/NORI/IRB is registered by the FDA. Follow this link to the FDA and search “naturopathic” to find its records. The ANRI/NORI/IRB posts their meeting minutes online per FDA rules. I encourage you to take a look.The Arizona naturopathic board gets involved
In early 2015, the ANRI/NORI/IRB successfully petitioned the Arizona Naturopathic Physicians Board to expand the naturopathic intravenous formulary to include previously banned substances. The board then issued a request for an emergency rule change to the Secretary of State to permit naturopaths to administer “silver protein, or any substance that contains silver, Cesium chloride, Hydrazine sulfate, and Lipid replacement as used in total parenteral nutrition.” In the rule change, the ANRI/NORI/IRB is cited as “currently conducting an IRB (ID # IORG0007953), in which one or more of the excluded nutrients had been used.”
The rule change document clearly states that the board did not review or rely upon any study in its decision. The board solely relied on the word of the naturopaths wielding their dubious IRB.
The order of events indicate that naturopaths were administering these substances to their patients despite Arizona law having explicitly banned them. Then they scrambled to get the law changed.
The brazen attitudes of these naturopaths makes me fearful for the safety of Arizona residents. They could be misled into seeking bogus medical care as if it was part of legitimate research or a proven clinical regimen. When I practiced in Arizona, I witnessed patients being duped, but prior to finding this naturopathic IRB I had no idea that the deceit runs so deep in the profession. I am disgusted.Pulling back the curtain on naturopathic
On NaturopathicDiaries.com, I plan to write a series of posts about the malfeasance found in the IRB’s minutes, in the claims made by its participants, and in publicly-available documents at the FDA. I hope that these tales of a naturopathic IRB will communicate the real threat that is the practice of naturopathy in Arizona. I feel terrible for the patients who are at the hands of these naturopathic “doctors” and “physicians.” Those titles should always be reserved for the best-educated medical practitioners.
Arizona may not be the only problem jurisdiction. There may be more examples in the US and around the world of dangerously blurred lines between patient safety and the headstrong naturopathic ideology. Please be vigilant. If you suspect any wrongdoing, please report the activity to the relevant, non-naturopathic authorities.
For now, it appears, Arizona is the Wild, Wild West of naturopathic medicine.
Britt Marie Hermes is a naturopathy apostate: she practiced as a licensed naturopathic doctor in the United States for about three years, but then left the profession to pursue a science-based career. She is now a Master’s of Science student in Medical Life Sciences at the University of Kiel. Her research interests include inflammatory and genetic diseases, like psoriasis and Crohn’s. She lives in Kiel, Germany, with her husband, who is a doctoral candidate in archaeology, and their two dogs. She recently started the blog Naturopathic Diaries: Confessions of a Former Naturopath.
In 2011, psychologist Daryl Bem published a highly controversial series of nine experiments designed to tease out the potential existence of precognition, the ability to experience future events. In order to isolate the potential influence of future events on the present, Bem’s experimental design reversed the standard order of psychological investigations. In one experiment, for example, subjects were allowed to practice with random words after having already taken a memory test comprised of some of them.
Bem’s results were controversial for many reasons, mostly because they were positive. But the question of whether or not they should have even been published in the first place, regardless of the results, was raised by many in the scientific and skeptical community. As history has shown us repeatedly, the risk of falsely legitimizing nonsense by publishing positive but typically poorly-designed studies is very real. And negative studies tend to be ignored by believers and policy makers.
Bem’s experimental design was made available from the beginning of his research in 2002, and he encouraged others to perform their own studies. Unfortunately for Bem, attempts at replicating his findings were largely reported, if not always published, as negative. Apparently this was not enough to discourage the intrepid believer. In fact, he currently has a meta-analysis of 90 experiments using the same protocols as his original research under editorial review.
The conclusions of his new analysis [PDF] are, not surprisingly, supportive of the existence of precognition, and in his manuscript he attempts to address all of the skepticism regarding his findings. He even quotes Feynman and implies that physicists are taking the possibility of quantum-based explanations of psi seriously. It’s an interesting read to say the least.What does NCAA basketball have to do with the topic of psi research?
A new name in the field of parapsychology research has been making headlines since going public with his efforts on the 1st of the month, and not surprisingly the media coverage is increasing now that his findings have been announced. Dr. Mort Fishman, a psychologist and paranormal researcher out of Tuono di Legno University in Florence, has ingeniously incorporated one of the world’s most popular sporting events, the NCAA Men’s Basketball Tournament, into a study of precognitive abilities. The results, if they are to be believed, may change the minds of even the hardiest psi skeptics.
In anticipation of March Madness each year, millions of basketball fans around the world fill out tournament brackets in an attempt to correctly predict which teams will win, and ultimately who will emerge victorious from the championship game. Many make a contest out of it, with office pools now a nearly ubiquitous aspect of life this time of year. ESPN even holds a Tournament Challenge, the winner of which is given a chance for $20,000 and a trip to Hawaii. It might even be Mitt Romney this year, leading some to regret their vote in the 2012 Presidential election.
The reasons people give for their choices are myriad, ranging from a thorough evaluation of the various teams’ stats to something as primitive and powerful as a gut feeling or how cute the mascot is. Fishman, an avid basketball fan who played three seasons for the European Basketball Federation’s Florence Nightingales, set out at the beginning of the NCAA college basketball season to determine if there might be a precognitive component to these choices. Inspired by Bem’s study designs, he also incorporated a reversal of standard protocols into his research.
The typical approach to filling out a bracket is to do so before the first game of the tournament. In fact, most official contests require it in order to avoid any unfair advantage. Fishman, who had a league record foul-to-rebound ratio of 2.5 during his stint on the Nightingales, instead asked study participants to fill out their bracket after the completion of the championship game, which was won by beloved perennial tournament underdogs, the Duke Blue Devils. According to Fishman, the most challenging aspect of the study was preventing participants from being exposed to any potential contamination with information about the teams during the season.
We went to great expense to protect subjects from potential bias or even outright cheating by basing their bracket picks on outside information. They were sequestered in a reasonably priced hotel, without access to the internet, television, or radio from November 1st of last year through Monday night. They were not allowed to speak to anyone outside of each other and us. No family. No friends. I think there were a few old Reader’s Digests and maybe a Redbook in the room. Progress requires sacrifice.
Once the brackets were completed and turned over to the research team, the real science began. Each subject entered a sensory deprivation tank and was randomly exposed to the results of 25 of the tournament’s 67 total games. The brackets were analyzed using math to see if subject picks were retroactively impacted by knowing the result of games after the fact. Choosing to courageously forego the stifling process of peer review, Fishman announced the positive findings at a press conference held in the parking lot of a Buffalo Wild Wings eight minutes from Lucas Oil Stadium on East Washington Street in Indianapolis.Conclusion
As believers in Science-Based Medicine, we must have open minds when it comes to fringe or even highly implausible claims because you never know when seemingly-incontrovertible assumptions about the natural world will be proven wrong. Science is imperfect and historically has been very wrong on many occasions. Experts used to believe that the Earth was flat and we still don’t know how Tylenol even works.
Intellectual humility is a key component of scientific skepticism. Sometimes ideas which were ridiculed turn out to be true. Having a closed mind might help prevent any untrue new idea from being accepted, but some of them are pretty interesting and already very popular with the public. Who are we to judge truth from fiction?
Though the existence of psi has now been proven by the Fishman study, it doesn’t mean that more studies aren’t needed. In fact, the hard part lies ahead. We need to figure out how best to harness its potential in order to improve patient outcomes, and only science can lead the way in that regard. But we must not be afraid of the unknown or of different approaches to discovery. As Endocrinologist Dr. Deepak Chopra said, “All great changes are preceded by chaos.”
Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain labelled ingredients. Using a testing method called “DNA barcoding”, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.
When the recall occurred, I noted that the AG may not have had an airtight case: Manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They claimed that DNA may not survive the processing applied to herbal products is inappropriate and insufficient to detect ingredients. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity.
Before describing what happened next, it’s important to understand how we got here. While the US Food and Drug Administration (FDA) is respected worldwide for ensuring its pharmaceutical drug quality, the same cannot be said for its regulation of supplements. Today, the overall quality of supplements sold in the United States is unclear. Audits and recalls suggest that there is a small but persistent trend of poor manufacturing standards. Adulteration, virtually unheard of with drug products, seems to be a regular complaint with supplements. This shouldn’t surprise, as it’s likely a consequence of legislation deliberately designed to weaken the FDA from regulating and providing oversight of supplements. The Dietary Supplement Health and Education Act of 1994 (DSHEA) was an amendment to the U.S. Federal Food, Drug and Cosmetic Act that established the American regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from many of the requirements that are in place for prescription and over-the-counter drugs. Amazingly, it puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective. A weak regulatory framework, which doesn’t require pre-sale testing of product quality and finished product specifications, might be expected to result in a weaker commitment to quality. And that might result in more erratic product quality. And that’s exactly what we find when you look at supplement sales today.
There’s an additional twist with herbal remedies, which gets to the criticism of the AG’s analysis and claims. This problem isn’t exclusive to the FDA, but is a a challenge to manufacturers and regulators alike. With a herb, what should we be testing for? With a pharmaceutical product, there’s an active ingredient that is manufactured into a tablet or capsule to be predictably and consistently absorbed. We can easily measure the tablet’s contents by assay, or or measure how completely it is absorbed by drawing blood levels after ingestion. The same cannot be said for herbal remedies, which are essentially unpurified, unstandardized, drugs. A single plant species may have dozens, or even hundreds of biologically active compounds. The relative proportions of all of these ingredients may vary based on growth, harvesting and storage conditions. Now add in the fact that there’s little evidence to demonstrate that herbal products have any meaningful, beneficial effects. If there was a positive effect, we could try to determine what ingredient (or ingredients) were the cause. With that in mind, we could test for it in supplements for sale. But because there’s a lack of evidence to establish that herbal remedies have any useful effects, we don’t even know what we should test for. Without knowing if there is an “active” chemical component, we can’t test for it. So the AG’s test of DNA barcoding represented a minimum testing standard of sorts. It was simply a test to see if the labelled herb was in the tablet or capsule. And the testing showed that even that basic assumption about herbal quality may have been premature.
Supplement vendors, industry backers, and even some industry critics were quick to point out that DNA barcoding wouldn’t detect any herb present if the herb had been processed so extensively that DNA traces had been destroyed or removed. This could be expected with herbal extracts, which are not raw herbs but rather the result of combining a herb with a solvent, in a process where some components of the herb are removed or “extracted”. The process of extraction brings with it a huge number of variables that can affect the finished product’s chemical composition.
Rather than responding to criticisms about the herbal testing the AG conducted, the AG decided to double down. In mid-February, it issued subpoenas to GNC, Walgreens, Target and Walmart, demanding that they substantiate their “structure/function claims” for their supplements. Manufacturers of supplements cannot claim that their product can prevent or treat a disease. But they are allowed to make claims that describe how their product can benefit the structure of the body, or some aspect of how it functions. A structure/function claim might be “calcium builds strong bones,” or “antioxidants maintain cell integrity” which tell you nothing about the effectiveness of the product in question. Structure-function claims don’t give consumers adequate information to determine if supplements are useful or effective, but they do allow manufacturer to imply efficacy without the requirement to provide any proof. The FDA notes:
These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.
The disclaimer is the infamous Quack Miranda warning that in a few sentences tells you that what you’re holding is a product that hasn’t been tested or evaluated for effectiveness by the FDA.
The AG didn’t stop there, either. It subsequently demanded that four supplement manufacturers (Nature’s Way, NBTY (Sundown Naturals, Nature’s Bounty, Met-Rx, Solgar, Vitamin World and other brands) Nutraceutical Corp (Herbs for Kids brand), and Pharmavite (Nature Made brand) provide detailed information on their manufacturing and quality control practices. The AG noted:
The scientific community, public health officials, and others have raised serious doubt about the steps taken to ensure the safety and efficacy of the herbal dietary supplements taken daily by millions of Americans. As part of a broader investigation, NYAG is reviewing the sufficiency of the measures manufacturers and retailers are taking to independently assess the validity of their representations and advertising in connection with the sale of herbal supplements. We seek your company’s cooperation as an herbal dietary supplement manufacturer to address these issues and, ultimately, to resolve any deficiencies.
As you may know, NYAG recently commissioned an analysis that used DNA barcoding technology to test several popular herbal dietary supplements sold at four retailers in New York State. The results were shocking to many consumers and raise troubling legal questions. In addition to the frequent absence of genetic material associated with the plant depicted on the label from the tested supplements, more than one in three samples tested positive for the DNA of an unlisted plant species, potentially constituting a contaminated or substituted product. The contamination, substitution, or false labeling of herbal products would constitute a deceptive business practice and, even more troublingly, could expose consumers to unacceptable health risks. Of particular concern, companies selling herbal products may have inadequate proof that the substances come from the plant species they claim, not be able to easily identify the source of the ingredients, or have failed to put proper controls in place or conduct proper testing or measurement to prevent contamination.
The decision by the AG to go directly after manufacturers has brought considerable criticism from the supplement industry, with most of the criticism being centred on the fact that regulation of supplements felt to be a matter for the FDA, and not for local (state) action. In other words, they prefer the FDA’s light touch. The president of the United Natural Products Alliance complained:
This is a massive fishing expedition and highly disruptive to these companies’ daily operations that are all part of the clearly defined federal regulatory structure for dietary supplements. We continue to be mystified as to why the NY AG has chosen to do FDA’s job. We regret to see this misplaced use of the AG’s time, taxpayer money and red tape for reputable supplement companies that are simply trying to do the right thing.
Perhaps not unexpectedly, one of the supplement’s industry’s biggest supporters has weighed in as well. Senator Orin Hatch and Senator Martin Heinrich have written a letter [PDF] to the FDA Commissioner, asking the FDA to comment on the AG’s methodology and the appropriateness of the AG’s demands. They note:
Attorney General Schneiderman has refused to make the test results and the details of the study methodology public, and questions about the appropriateness of DNA testing for herbal extracts have been raised that merit consideration. The question at the heart of this matter is whether DNA barcoding methodology is fit for the purpose of identifying DNA in botanical extracts found in dietary supplements. It is our understanding that the process of extracting an herb’s phytochemicals for use in finished products can either damage, destroy or simply leave behind the DNA this testing protocol is designed to find, which has left many scientists – both inside and outside the industry – to question whether DNA barcoding technology is an appropriate or validated method for determining the presence of herbal ingredients in finished botanical products.
Hatch and Heinrich’s letter raises questions in four areas:
The AG’s prosecution has already had an effect that’s disrupting and angering the industry. GNC and the AG have already reached an agreement to put GNC’s products back on the the shelves in New York stores. While noting that the products that were pulled do in fact meet FDA requirement for sale, GNC has agreed to implement additional testing of their products that go beyond FDA requirements and will be implemented nation-wide. As per the AG:
Under today’s agreement, GNC will perform DNA barcoding on the “active” plant ingredients used in its products; implement testing for contamination with allergens, both before and after production; and post prominent signage advising consumers of the processed, chemical nature of extracts. GNC will be required to implement these new procedures in all of its more than 6,000 stores nationwide, making this agreement the first in the nation to require testing standards for herbal supplements that exceed current FDA requirements.
The supplement industry seems to have mixed feelings. While this deal may have been necessary for GNC to allow its sales to resume, it raises the expectations of quality for all manufacturers, a move that is being likened to California’s move to tighten crash standards and emissions standards for vehicles. Moreover, it seems to reinforce what the AG’s message has been all along – that supplement product quality is dubious, and the AG is getting results. One industry magazine noted:
The agreement also serves to make the case in the mainstream media and the world of social media that Schneiderman was right: The marketers of dietary supplements and the companies that make the products don’t have their customers’ best interests at heart and can’t be trusted to mind their own store.
“The extensive media coverage of the NY AG’s actions has caused a profound shift in consumer attitudes, far beyond anything I’ve observed before. I’ve closely monitored reader comments to negative media coverage for years, and what I am seeing now indicates an overwhelming loss of confidence in all dietary supplements, not just herbs. Comments in the past could be summed up as ‘I don’t believe this article: I’m healthier and feel better when I take my supplements.’ Now I’m seeing, ‘Those people should be in jail, those products are useless / dangerous so I will never buy them again.’ ” Shelton said.
The story doesn’t stop there. Now the AG has teamed up with 13 other State AG’s asking Congress to launch an inquiry into the herbal supplements industry. The letter notes:
The current investigation in New York and subsequent interest by other states, and the outstanding request to FDA, represent only the most recent indication of serious problems in the herbal supplements industry. The scientific community and the media have issued a series of troubling reports that suggest broader problems. Researchers, for example, measured high levels of heavy metals like lead, mercury, and arsenic in certain supplements. Products falsely identified as black cohosh—an herb commonly taken to reduce menopause symptoms—may have caused severe liver damage in certain women. And media reports have uncovered over-the-counter supplements, including those purporting to build muscle, aid weight loss, and reduce anxiety, that were secretly laced with dangerous prescription medications.
Additionally, if the producers of herbal supplements fail to identify all the ingredients on a product’s label, a consumer with food allergies, or who is taking medication for an unrelated illness, is taking a potentially serious health risk every time a contaminated herbal supplement is ingested.
The FDA has long been aware of problems in the dietary and herbal supplement supply chain, from dubious ingredient sourcing to a failure to carry out proper testing on finished products. In FY 2013, FDA inspectors cited two out of every three supplement manufacturers for allegedly violating current good manufacturing practices or “cGMPs.” More than one in five of those citations—called Form 483s—observed that the manufacturer failed to verify that a finished supplements batch met product specifications as to identity, purity, strength, or composition. A similar proportion was cited for failing to employ an appropriate test or examination to verify the identity of a dietary ingredient before incorporating it in the final product.
It’s good to see the New York AG recognizing the serious concerns that have been identified with the supplement industry in the United States. However, for its actions to be truly effective, it needs to build a careful case. In the interests of transparency, the AG should be releasing the results of its own testing – just as it is asking manufacturers to do. And it needs to address the criticisms of its testing methods. On balance, however, these moves should be seen as beneficial to consumers, particularly if the FDA’s role is re-evaluated. Until consumers and health professionals alike have confidence that supplements are of uniform and consistent quality, it’s not possible to use them safely, or to expect that they will deliver any predictable effects. The marketplace has been overly friendly to manufacturers for years. Now it seems the tide has a chance of turning, with the focus on consumer protection. If we want to avoid playing health roulette when we shop the supplement aisle, we should strongly support efforts to strengthen the quality and safety of herbal supplements.
Wikipedia, an online open-source encyclopedia, can boast 470 million visitors each month, making it one of the most popular websites on the internet. It is an incredibly useful resource – I think it’s fair to say it is the online reference of record. For that reason people care how topics important to them are represented in Wikipedia.
Wikipedia, in fact, has become no less than a battleground over certain controversial topics. In essence people generally want Wikipedia to reflect their opinions on controversial topics, and if it doesn’t then there must be something wrong with Wikipedia (rather than there being something wrong with their opinions). I don’t mean to imply that Wikipedia always gets it right – it is a crowdsourced reference and the content is only as good as the editors. But at least they make honest efforts to be neutral and to have standards.
Those standards are the real conflict here, and it is part of a broader conflict over standards. In medicine there is a standard of care, which in turn is based on an underlying system of professional and scientific standards. Medical education is standardized, students have to pass standardized exams, post-graduate clinical training is standardized, there are standardized exams for specialty certification, there are ethical standards enforced by institutions, hospitals, professional organizations, and the state boards of health, and peer-reviewed journals have standards.
This is all meant to ensure that individual patients receive the highest quality of care.
There is a movement, however, specifically designed to erode the standard of care and to replace it with a “wild west” system in which there are no standards. This may seem like an extraordinary claim, but the evidence is unequivocal. The elimination of the standard of care is packaged and sold as “health care freedom.” A number of states have already passed health care freedom laws which specifically eliminate the standard of care. What they say, in essence, is that the state board of health cannot act against a health care professional’s license simply because they are engaging in a practice which is deemed below the standard of care. All the practitioner has to do is proclaim their practice “alternative.”
The same is happening in medical education. Special courses are being carved out to teach medical students “complementary and alternative medicine,” and these courses are often not being held to the usual academic standard. Our colleague in the UK, David Colquhoun, has been successful in getting certain CAM programs removed from universities just by using freedom of information requests for their curricula, and then showing them to the board of trustees. This reflects the lack of effective oversight of CAM courses in medical school. I have had this same experience myself – no one is looking, and forcing them to look at what is actually being taught is often enough to embarrass them into action.
There has been an erosion of standards in government regulation as well. The 1994 Dietary Supplement Health and Education Act created a separate non-standard for supplements – since then sellers can make pseudo-health claims for their supplements without providing any evidence of safety or effectiveness.
I would argue that pressure to license naturopaths in every state also represents part of this war on standards. Naturopaths do not appear to follow any science-based standard, and they are lobbying for the right to essentially regulate themselves, to be a licensed profession not held to any external science-based standard.
This war on standards, sold in the name of freedom, has encompassed medical practice, licensure, regulation of products, academia, and publishing. Wikipedia is just the latest battle ground – the erosion of standards in public reference material.
I admire Wikipedia for holding the line. They have stated that on scientific issues Wikipedia will reflect the scientific consensus. If you want the content of Wikipedia to reflect a different point of view, then you better be prepared to back it up with science. Their policy states:
When writing about ideas around which scientific consensus has coalesced, Wikipedia editors should strive to describe those ideas as plainly as possible.
It may be that there are certain parties which dispute the consensus view. It is up to the editors of articles to determine, through careful examination of the sources, how notable the views of these parties are and whether they are relevant to articles on scientific matters. It is important to note that in forming its consensus it is the members of a particular scientific discipline who determine what is scientific and what is questionable science or pseudoscience. Public opinion or promoters of what is considered pseudoscience by the scientific consensus hold no sway in that determination.
Promoters of unscientific views don’t like that policy. When a fair and neutral referee disagrees with their pseudoscience, they cry conspiracy and censorship. Take, for example, this recent article on Natural News: “Unbiased: Help support a writer as he exposes the truth about Wikipedia’s censorship of alternative medicine.” In it the author claims:
As a matter of policy, Wikipedia actively denies the existence of science with which it disagrees.
No – it ignores pseudoscience with which the consensus of scientific opinion disagrees. Read their policy. The writers at Natural News are upset that Wikipedia does not reflect their pseudoscience, specifically discussing alternative medicine and GMOs.Conclusion
Standards matter. Establishing and enforcing quality standards is not censorship or a violation of anyone’s freedom, as long as the process of determining standards is transparent and fair.
The people whose job it is to establish, enforce, and maintain high quality standards within medicine have largely been failing in the last few decades, at every level. They have allowed pseudoscience to infiltrate and erode the standards. It is not clear to me how this has happened. Specifically I don’t understand how so many academics and professionals have allowed themselves to be quelled by the rhetoric of charlatans.
It is disturbing that all it took was some platitudes about freedom, “holistic” care, “patient-centered” care, and other fairly empty slogans to get the defenders of academic and scientific standards to drop their guards. It is ironic that the editors of Wikipedia are the ones holding the line for scientific standards.
Wikipedia, in this sense, is putting academic institutions to shame. It is not too late, however, for the academic and scientific communities to come to their senses when it comes to pseudoscience in medicine.
In November 2014 Rolling Stone magazine published an article called, “A Rape on Campus.” If you click on the link to that article today you are directed to another article on Rolling Stone: “A Rape on Campus,” What Went Wrong?
This one article may have triggered two important conversations in our society. The first was to push forward the conversation on the problem of rape on college campuses. This is a real and serious issue, but as is often the case when a new social issue comes to prominence the basic facts have not been fully vetted and worked through. There are many claims on all sides of the issue, and a lot of new data to sort through. For example, there is ongoing debate over the true incidence of rape on college campuses.
The article also unintentionally sparked a discussion of best journalistic practices. As the editor of Rolling Stone describes:
Last November, we published a story, ‘A Rape on Campus’ [RS 1223], that centered around a University of Virginia student’s horrifying account of her alleged gang rape at a campus fraternity house. Within days, commentators started to question the veracity of our narrative. Then, when The Washington Post uncovered details suggesting that the assault could not have taken place the way we described it, the truth of the story became a subject of national controversy.
Rolling Stone commissioned an independent journalistic investigation, which has now been published. The Columbia Report is a harsh indictment of the failures of the magazine, and a cautionary tale for all journalists.
So, what did go wrong? A New York Times editorial characterizes what went wrong as a failure of skepticism.
The author of the article, Sabrina Rubin Erdely, apparently was caught up in the narrative of a story she wanted to tell. The rape on campus story is big news, and Erdely wanted to tell that story with the most dramatic example she could find to illustrate it. She found the alleged victim, who goes by the shortened name Jackie, through an advocacy group. Jackie told a story which was horrifying and vivid.
There were problems with Joackie’s story, however. She never reported the rape, so there was no paper trail. She did not want Erdely to talk to any of her friends, or anyone who could contradict the details of her story. The mistake of Erdely and her editors was to give too much deference to a sympathetic victim. The horror of the alleged crimes was used to justify a suspension of the usual skeptical rules of good journalism.
In other contexts we call this phenomenon a “witch hunt.”
Erdely could have chosen other rape stories that were perhaps more nuanced and less dramatic, but which had a clear paper trail to verify the account. Erdely or her editors could have insisted on talking to others who could verify some of the supporting details of the rape story. If they had spoken to those people, it is now known, they would have contradicted Jackie’s account. It was therefore left to others do this investigation which eventually debunked the story.
The final nail came when a police investigation, exhausting all leads, could not verify any aspects of the story. The described perpetrator was unknown. The targeted frat house did not have a party on the weekend of the alleged rape. In short – the story unraveled.
The editors of Rolling Stone now acknowledge that giving too much deference to an alleged victim does the victim (and others) a disservice. The fear now is that women who have truly been abused will fear coming forward because the Rolling Stone piece has made everyone more skeptical of rape stories. The story that was meant to highlight the problem of rape may now be having a chilling effect on the very conversation it hoped to move forward.
Read the full report linked to above for all the details. What I want to highlight here is what I feel is the core lesson of this story – do not suspend necessary skepticism because of the righteousness of the cause. In fact, if anything you need to be more skeptical when telling a story you want to tell, one that reinforces your biases or ideology.
Don’t suspend skepticism or best journalistic practices because of the sensitivity of a story, or the sympathetic nature of a victim. The best thing you can do for a victim is skeptical due diligence, to remove any doubt about the veracity of their story because you were a skeptical journalist.
In fact, I can broaden this principle further. It is always a good idea to engage in skeptical due diligence, especially if you believe in the facts being asserted. If you think you have a dramatic new treatment for a horrible disease, that is all the more reason to do rigorous testing to prove that it actually works. If you think you have invented a free energy device, then you should be your own harshest skeptic.
Don’t suspend skepticism because your claims are so important. That is a reason to be more skeptical.
When my husband was helping a friend with a project at the house of someone he didn’t know, the lady of the house gave him an earful about the health benefits of the coffee sold by Healthy Habits Global (HHG), a multilevel marketing (MLM) enterprise for which she is a distributor. She sent him home with samples and a brochure with a long list of health claims. She told him she could provide lots of testimonials, and there was a wealth of evidence for her products in PubMed.
Before believing any health claims, especially from an unknown source, it is only prudent to examine the evidence. I consulted the company website, PubMed, and other sources; and I learned that the company’s advertising was full of false information and the whole rationale of the products was questionable. I am not persuaded that HHG coffee has any health benefits. It appears to be just another in a long line of gimmicks used by MLM businesses to sell untested, usually ineffective “health” products to gullible consumers who have little knowledge of science.
What is it?
It’s a whole line of beverages provided as single-serving packets of powder to be mixed with water: coffee, tea, hot chocolate, and energy drinks. The products contain TAGG, a combination of tongkat ali, ginseng panax, and ganoderma (Reishi mushroom). How much of each? The amount is not disclosed on the website, and the distributor didn’t know, but she was able to get the information for me from her corporate office:
The idea is to change everyday unhealthy habits such as drinking coffee, hot cocoa, tea, and energy drinks into healthy habits by enriching those beverages with beneficial nutrients. The underlying assumption is wrongheaded: drinking coffee in moderation is not an unhealthy habit. In fact, there are numerous documented health benefits of plain old coffee. Can those health benefits be augmented by the diet supplements added by HHG?
A video on the website starts by comparing HHG coffee to orange juice. They say HHG coffee contains 154 anti-oxidants and 200 phytonutrients vs. 8 and 4 in orange juice. (With 354 components, we can assume there must not be clinically effective amounts of all of them, perhaps not of any of them; and orange juice contains other important nutrients like vitamin C. So it’s not a fair comparison.)
Because the coffee is enriched with TAGG (tongkat ali, ginseng and ganoderma extracts), it “promotes the body’s ability to function in an optimal state in a single serving.” Here are the specific benefits they claim for the three components:
Ganoderma (Reiki mushroom)
They say it is “The most studied herb on the face of the planet.” They invite you to see for yourself on PubMed, and they provide this handy link to a PubMed search that produced 634 hits, many of which are irrelevant or are preclinical, uncontrolled, or poor quality studies. Some of those hits are actually evidence for harm, not benefit, such as a recent case report of Reishi ingestion being mistaken for a persistent parasitic infection. In fact, the very first study listed is a Cochrane systematic review that directly refutes some of the company’s claims. It found no evidence that ganoderma improves blood pressure, blood sugar, or cholesterol levels. And the typical doses used in the studies were between 1.4 and 3 grams daily. That’s 1400 and 3000 mg, compared to the 24-30 mg in HHG products.
They provide a long list of alleged effects including benefits for chronic fatigue syndrome and erectil [sic] dysfunction. Ginseng studies supporting those claims are largely in vitro or animal studies with only a few small, poor quality studies in humans. For erectile dysfunction there have been a total of six randomized controlled studies (RCTs) in humans; four showed benefit and two didn’t. In the ones that showed benefit, the dosage ranged from 600 mg to 1000 mg taken three times a day. Compare that to the 12 mg of ginseng in HHG products.
They say this triggers the body’s ability to produce testosterone, combating “the negative health risk revolved around Low Testosterone in both men and women.” The same webpage lists 10 benefits including “burns fat” and increases libido. They don’t provide any links to studies, and most of the claims seem to be for therapeutic doses of testosterone rather than for tongkat ali. They don’t say how much more testosterone is produced by the body with the amount of tongkat ali in their coffee, so any claims based on the benefits of testosterone are irrelevant. And the RCTs of tongkat ali that showed positive results in humans used doses on the order of 200-300 mg compared to the 12 mg in HHG products.
Arguments for the superiority of their products
They supply endorsements from the media and cite their high quality production standards. (Neither of these can be taken as evidence that the products are effective).
They claim that regular coffee:
In contrast, they claim that their coffee:
They say their (unspecified) competitor’s coffee has mediocre taste and aroma (but how does the taste and aroma compare to brewed coffee?). And they say the competitor’s coffee is more expensive. HHG is as low as 80 cents per cup (cheap if it offers real health benefits, but expensive if all it offers is false hopes and the chance of a placebo response).
Compared to the competitor’s coffee, HHG says its products contain 4 times the ganoderma, but they don’t tell you that still isn’t enough to produce any health effects. And they say there is no aluminum in the non-dairy creamer HHG puts in some of its products. They say, “Aluminum may cause Alzheimer’s or other diseases.” They cite a CDC website to supports that claim. But that website actually says pretty much the exact opposite, even for large occupational exposures:
Three studies have examined the possible association between occupational exposure to aluminum and the risk of Alzheimer’s disease. Two case-control studies did not find a significant association between occupational exposure to aluminum dust or fumes and the risk of Alzheimer’s disease (Graves et al. 1998; Salib and Hillier 1996). Another study of former aluminum dust-exposed workers (retired for at least 10 years) found some impairment in some tests of cognitive function; the investigators raised the possibility that cognitive impairment may be a pre-clinical indicator of Alzheimer’s disease (Polizzi et al. 2002)… The possible association between aluminum and Alzheimer’s disease was proposed over 40 years ago; however, the evidence that aluminum may or may not be a risk factor is inconsistent and inconclusive…In conclusion, the available data suggest that aluminum is not likely the causative agent in the development of Alzheimer’s disease [emphasis added].
Incidentally, that same source says that aluminum levels in tea are 10-50 times higher than the typical levels found in drinking water, so if they are so concerned about aluminum, why are they selling tea?
Do you want antioxidants?
Coffee is the number one source of antioxidants in the American diet. Green coffee beans contain 1000 antioxidants and brewing adds another 300. So the additional 154 antioxidants in ganoderma represent only a 12% increase over the number antioxidants already in coffee. Would you expect 1454 antioxidants (in trace amounts) to be significantly better than 1300 antioxidants?
Anyway, there is growing evidence that more antioxidants may not mean better health and in some cases may actually be harmful.
I consider the Natural Medicines Comprehensive Database (NMCD) to be the most reliable source of information about natural medicines. It is compiled by an unbiased group of experts in various fields who have combed PubMed, herbal medicine texts, and other sources and have summarized all available evidence about the remedies. They rate natural remedies for safety and effectiveness. They rate all three of the TAGG ingredients as only “possibly” safe, below their ratings of “safe” and “likely safe.” Here’s what they have to say about their effectiveness, side effects, interactions, and precautions:
The rationale for adding these supplements to coffee is far from clear. This specific combination and dosage of ingredients has not been shown clinically effective; in fact, it has never been tested. If you are convinced by some of the favorable studies in PubMed and decide to take ginseng, ganoderma, or tongkat ali to get a possible health benefit, it would make a lot more sense to take the amount that had been shown in those studies to provide that benefit, not a minuscule amount that is entire orders of magnitude smaller. These substances have potential harms, and it is doubtful whether distributors know about them. Do they warn their customers to stop using HHG beverages if they might be pregnant or if they have uterine fibroids? Do they warn them to stop using them two weeks before surgery? I doubt it.
There is no good evidence that adding TAGG to coffee will make it any healthier. You could arguably make coffee healthier by adding red rice yeast containing therapeutic amounts of natural statin drugs known to be effective, but I can’t imagine anyone would want to do that. Admittedly, the TAGG additives have fewer adverse effects than statins, but they are not entirely innocuous. Although in this case they are present in such small amounts that we needn’t worry.
The claims for HHG products range from the unsubstantiated through the misleading to the demonstrably false. Both the customers and the lower-level distributors are being duped by those at the top of the MLM pyramid who are the only ones likely to make money. They hype the income opportunities and even offer a luxury car club bonus, but the sad fact is that 99% of MLM distributors end up not only not making a profit but losing money. The mission statement of the company is all about creating income opportunities, not about improving the health of their customers. Caveat emptor.
I remain endlessly fascinated with the incredible social experiment we have all been living through over the last decade (and I can say, if you are reading this, you are part of the experiment). The internet and social media have changed the way we access information and communicate. The traditional top-down systems of information and opinion dispersion are eroding, being replaced by a largely bottom-up free-for-all.
I think we’re still figuring out all the consequences of these changes, both intended and unintended. One effect that has been casually observed is that many people believe they have expertise they do not have because they have been able to do “research” online. The democratization of information has lead to a false sense of democratization of expertise.
While free access to information is great, there is no systematic way in which the public is taught how to use this information to maximal benefit, and avoid the most common pitfalls. Schools are generally behind the curve in terms of teaching students how to manage their online information access. Most adults were done with their formal education before the wave of social media.
The result is the “Jenny McCarthy Effect.” She is a celebrity who feels that she can substitute her own non-expert opinion for the strong consensus of expert opinion on the safety and effectiveness of vaccines because she “did her own research.” She is an obvious example of how searching for information online can give someone a false confidence in an unscientific opinion, illustrating the fact that relying on “Google University” can be extremely misleading. There are some specific pitfalls at work here.
The first pitfall is the subject of a recently published series of experiments by Matthew Fisher, a doctoral student in cognitive psychology at Yale University. He looked specifically at the effect of searching online for information and confidence in one’s knowledge on that topic. Of course it makes sense that if we search for and read information on a topic this will increase our confidence in our knowledge about that topic. Fisher, however, tried to control for as many variables as he could to see if there was an independent effect of just searching, regardless of how it affected our actual knowledge.
He found that people had higher confidence in their knowledge even when they searched for a subject vs being taken there directly, when the topic had no relevant information online, when their searches were filtered for relevant information, and when they read the information online vs in print. So even when the actual information was controlled for, the act of searching online itself seemed to raise confidence in one’s knowledge.
These types of experiments are obviously complex and we’ll need to see this replicated from different angles, but so far it does seem that having access to a vast store of knowledge that one can sift through raises our assessment of our own knowledge (beyond access to relevant information itself).
It seems to me that there are likely other effects at work as well – chief among them is confirmation bias on steroids. Searching online gives us the opportunity to mine a vast amount of information and select (even if unconsciously) that information which confirms what we already believe or want to believe. Search online for information about vaccines and you can find plenty of information that supports the safety and effectiveness of vaccines, and plenty of information that vilifies vaccines. Choose any controversial topic and the results will be the same.
Confirmation bias is powerful and dangerous specifically because it creates the illusion that the data supports our beliefs, because we are unaware of the degree to which we have filtered and biased that information. The internet is a setup for confirmation bias.
The extreme version of this phenomenon is what we call “echochambers.” Filtering information can be formalized into online communities where only one perspective is expressed, and information that supports that perspective is shared, while opposing information is filtered out or directly contradicted. This is a pervasive effect, and is true of scientific and skeptical sites as well as pseudoscientific ones.
Another potential problem is the confusion of knowledge with expertise. This is often what leads to cranks – people who may be very smart and have a great deal of factual knowledge, but come to absurd conclusions in which they have high confidence. One problem with cranks is that they do not properly engage with the relevant intellectual community.
It is critically important to engage with the community, especially in highly complex and technical areas of knowledge. It can be very difficult for any individual to see a complex issue from every angle, and to consider all perspectives. Left alone we will tend to create a neat narrative, and become increasingly convinced in the truth of that narrative. Engaging with the community will tend to challenge that narrative, leading to a deeper and more nuanced understanding of the topic. This is the heart of true expertise.
Studying a subject alone by searching online can be a crank factory – giving factual knowledge without really engaging with the ideas. Then the echochamber effect can give the illusion of engaging, but only with a biased community rather than the broader community. The result are people who falsely believe they have sufficient knowledge in areas they do not truly understand. The Dunning Kruger effect kicks in as well, and they likely do not appreciate the gulf between their Google University understanding of a topic and the depth of understanding of true experts.
The internet may be creating an army of overconfident pseudoexperts. There are a number of fixes to this problem on the individual level:
- Be humble. Do not think a little knowledge makes you an expert. Respect the opinions of actual experts. (You don’t have to agree, but at least take them very seriously.)
- Understand the inherent advantage of a consensus of expert opinion over the opinions of any individual.
- When searching online, go out of your way to search for information which goes against your current belief or conclusion. Try to find what both or all sides are saying, and reserve your personal judgement until you think you have heard all sides.
- Understand how online searching is a setup for confirmation bias. Google itself can bias the results of your search. You can turn this feature off.
- Understand that, in addition to confirmation bias, there is organized bias on the internet – echochambers, astroturf campaigns, and deliberately biased ideological information. Be on the lookout for false information, and carefully vet a source before you rely upon it.
- As always, there is no substitute for skepticism and critical thinking.
Dr. David Katz is undoubtedly a heavy hitter in the brave new world of “integrative medicine,” a specialty that seeks to “integrate” pseudoscience with science, nonsense, with sense, and quackery with real medicine. In fairness, that’s not the way physicians like Dr. Katz see it. Rather, they see it as “integrating” the “best of both worlds” to the benefit of patients. However, as we’ve documented extensively here, on our personal blogs, and even in the biomedical literature (plug, plug), what “integrative” medicine means in practices is indeed what I characterized, the infiltration of woo into medicine. This infiltration seems to have started mainly in academia—hence the term “quackademic medicine” and “quackademia”—with the steady infiltration of nonsense into medical schools and academic medical centers, but has since metastasized to the world of community hospitals. This “integration” (or, as I like to refer to it, “infiltration”) has become so pronounced that a few years ago The Atlantic published an article entitled The Triumph of New Age Medicine, and just last December the Journal of the National Cancer Institute (JNCI) published a monograph full of articles touting “integrative oncology,” including guidelines recommended by the Society of Integrative Oncology (SIO) for the “integrative” treatment of breast cancer symptoms.
I mention Dr. Katz for two reasons. First, he’s taken another broadside at us at Science-Based Medicine in blog entry at the Huffington Post—where else?—entitled Holism, Holes and Poles that I’ve been meaning to address for a while. But before I address Dr. Katz’s most recent complaint against science-based medicine (SBM), it’s necessary to step back and look at some history.
Longtime readers might recall that Dr. Katz is on faculty at Steve Novella’s institution, Yale. More importantly he is (in)famous for making a statement that utterly blew me away seven years ago when I first encountered it, courtesy of David Colquhoun, portrayed in this video, specifically beginning at around 6:05:
Unfortunately, the original video I cited was taken down due to a copyright claim from Yale, but this one remains. The problem is that it is missing bits that were discussed when the talk was widely discussed in the medical blogosphere. However, the money quotes are still there, such as:
I think we have to move beyond the results of RCTs in order to address patient needs, and to do that I’ve arrived at the use of a more fluid concept of evidence than many of us have imbibed from our medical educations…[Referring to an anecdote of a patient with chronic pain Dr. Katz went on.]…Now, we don’t want you on narcotics anymore than you want to be on narcotics. We initicated a course of acupuncture and over the next two to three months weaned him off narcotics. He was pain-free on acupuncture and subsequently transitioned into homeopathy. Now, I don’t care to get into a discussion of how or even whether homeopathy even works, but this guy had tried everything.
And the anecdotal evidence that homeopathy might be effective was brought up by the naturopaths. We tried it. It worked.
Later in the talk, he mentions an NIH consensus statement about the use of multivitamins that concluded that there was insufficient evidence to determine if they work and says:
And so I would argue that here, too, is an invitation to think more fluidly about evidence. Absence of evidence is not evidence of absence.
Whether or not absence of evidence is not evidence of absence depends, of course, on how hard scientists have looked for evidence. Of course, the proper retort to such seemingly sensible nonsense is to suggest that maybe—just maybe—you shouldn’t be making such confident recommendations until there is actually some convincing supportive evidence. Moreover, in the context of discussing a bunch of negative clinical trials that Dr. Katz apparently doesn’t believe, it is fairly clear that he’s implying that negative clinical trials are an “absence of evidence.” They are not. They are evidence. While from a frequentist perspective, it is true that a negative clinical trial does not necessarily mean that a treatment does not work (it just means that the results observed in the treatment and control groups were statistically indistinguishable, to put it in simple form), when negative clinical trials, particularly if they are well-designed, pile up, that absence of positive evidence that a treatment works becomes fairly powerful evidence that it doesn’t. In any case, this “more fluid concept of evidence” clearly involves patient anecdotes, which are, for the many reasons explained here over the years, often unreliable and even misleading. That is why they are relegated to a much lower rung on the ladder of evidence than clinical trials.
As you might imagine, several of the longtime bloggers at SBM have discussed Dr. Katz’s idea of “a more fluid concept of evidence,” including Steve Novella, Kimball Atwood, and myself. More recently, Dr. Katz was very unhappy over how Steve Novella and I had criticized the Cleveland Clinic for opening a traditional Chinese medicine clinic run by a naturopath. I have characterized David Katz’s attitude as a false dilemma: Abandon patients or abandon science. And so it is. Unfortunately, it is a false dilemma that lies at the very heart of the very concept of “integrative medicine,” as you will see.Dr. Katz lashes out again
Dr. Katz is once again very unhappy with us over here at SBM. One can’t help but notice right away how he refers to us (without naming us, although he does at least link to us) as the “self-proclaimed guardians of the true definition of evidence-based medicine” (EBM). Ouch. He sure makes us sound as though we are uptight, doesn’t he? Except that we don’t really do that. Rather, we advocate changing the definition of EBM to be more like SBM because of the obvious defects in the definition of EBM that allow pseudoscience to infiltrate medicine. It’s not as though we haven’t discussed this more times than I can remember.
I get it, though. No one likes being criticized or having his favorite ox gored. I can even sort of understand why Dr. Katz seems to think that we are a bunch of peons unworthy to criticize him, as once again he has to lay down his bona fides in a rather obvious appeal to authority:
I opened an Integrative Medicine Center some 15 years ago, and have directed it, and seen patients in that context, since. I did so not because of any long suppressed desire to practice medicine under that banner, and certainly not because of any inclination to don Birkenstocks.
In fact, I was — as I remain- a card carrying member of the evidence-based medicine club. I was already running then, as I still am, a federally funded clinical research lab. I was already then, as I am now, routinely publishing studies in the peer-reviewed literature. I was teaching then, as I did for roughly ten years, biostatistics and clinical epidemiology to Yale medical students. And while back then I had co-authored a textbook on epidemiology and biostatistics, I have since co-authored four editions of that textbook, and a textbook on evidence-based medicine as well.
In other words: How dare you nothings criticize me? Yes, Dr. Katz has been using variants of this same whine since he dismissed David Colquhoun, Steve Novella, Dr. R. W. Donnell, and myself as not having “earned the right to express an opinion” on these issues and of “simply having an opinion, an Internet connection, and some time to kill.” He even referred to us as “health hazards of the blogosphere” and quacks.
Although not to the extent that Dr. Katz has, I, too, have been federally funded and I, too, routinely publish in the peer-reviewed literature. Unfortunately, I probably stuck too closely to basic science too long before transitioning it into the realm of clinical research, given that a surgeon will always have a great deal of difficulty directly competing with basic scientists at basic science, hence my difficulties retaining external funding more recently. In retrospect, I’m amazed I did as well as I did for as long as I did competing with basic scientists and am hopeful that my recent forays into much more directly clinically relevant areas are not too late, given priority score on a recent grant that just missed the draconian cutoff for funding in today’s—shall we say?—highly constrained funding environment.
Of course, Dr. Katz’s impressive qualifications, which I concede are more impressive than mine, do not matter much when he routinely spouts nonsense such as his justification of the use of homeopathy, naturopathy, and traditional Chinese medicine, as he has unfortunately done so often in the past. Only the quality of his arguments for the “integration” of various alternative medicine practices into conventional medicine, and these arguments have been uniformly of very poor quality, as we have documented for over seven years now. This time around is no different.
I’ll start with his third complaint, because it is a complaint so frequently used by advocates of quackery (whom, whether Dr. Katz realizes it or not, he is emulating by repeating that complaint), which is all about the money:
And third, there is the thorny little issue of money.
The horses that pull toward “evidence” pull a cart full of money. The average cost of bringing a new FDA-approved drug to market now approximates a billion dollars. Spending millions, tens of millions, or even hundreds of millions on clinical trials makes sense if a return in the billions is the offing. It’s pretty much a non-starter otherwise, and a problem even a budget the size of the NIH’s cannot solve. In fact, the price tag for one, new FDA-approved drug is nearly ten times the annual operating budget of the National Center for Complementary and Integrative Health.
Hmmm. Where have we heard this one before? I wonder…
Oh, yes. It becomes clear when Dr. Katz proceeds to use his favorite tale to illustrate how money supposedly rules everything in medicine. Basically, it’s a tale of co-enzyme Q10 (CoQ10), a tale he’s told many times before going back to his original “more fluid concept of evidence” talk in 2008 to periodic repetitions, up to and including Katz’s current post. CoQ10 is also known as ubiquinol and is found widely in plants. It acts at the level of the electron transport chain to facilitate the production of chemical energy through oxidative metabolism in our mitochondria. We tend to get most of what we need from our diet because our bodies don’t make CoQ10 very efficiently.
In any case, it was thought that CoQ10 would be a good adjunct in heart failure, in order to improve the function of the heart. In 2000, there was a small randomized double-blind placebo-controlled clinical trial that concluded that CoQ10 “does not affect ejection fraction, peak oxygen consumption, or exercise duration in patients with congestive heart failure receiving standard medical therapy,” for which investigators concluded “we detected no objective benefit from coenzyme Q10 administration in patients with heart failure” and that their “study shows no benefit to adding coenzyme Q10 to the standard treatment of heart failure.” Dr. Katz was very unhappy about this and characterized this study as being used to “drive the final nail in the CoQ10 hypothesis,” while mentioning that within a year a large RCT of a prescription drug carvedilol (trade name: Coreg) was published showing that it was safe and effective for the treatment of heart failure. To Dr. Katz, this is the evidence of big pharma primacy and the premature rejection of a promising treatment.
He then goes on:
It took more than a decade after that to undo the damage, but eventually it happened: trial data came in to show that co-Q10 could reduce heart failure mortality by about 50 percent. In other words, ten years after being declared defunct, the co-Q10 “hypothesis” was not only vindicated, but seemed to represent the greatest advance in the treatment of heart failure in years.
First of all, I can’t help but note that if the CoQ10 hypothesis was truly dead, then why was a relatively large randomized, double-blind study begun a mere three years later? Something doesn’t jibe here. If the 2000 study had truly “closed the door,” then no IRB would have approved a bigger study. Clearly, the forces of big pharma were not as powerful as Dr. Katz insinuates. I also find it odd that he didn’t actually link to the primary study by Mortensen et al, which was published in JACC Heart Failure in December. In any case, one thing that I noticed about this study right away is that there were no differences in short term endpoints; so in that, at least, this study by Mortensen agrees with the 2000 study. It was only in long-term outcomes that it showed a significant difference, with a major decrease in mortality.
The other thing that I noticed is that, judging from the introduction and discussion by Mortensen et al, Dr. Katz appears to be giving a highly biased account of what happened. There were clearly a lot more uncertainty and conflicting data than his accounts would leave you to believe, and, of course, it was completely appropriate for the original study authors to conclude that, based on their results, it was not appropriate to recommend CoQ10. That’s a provisional conclusion justified by the study at the time. That’s the way clinical science progresses after preclinical validation. Pilot studies are done. If they are promising, then small RCTs are done. If those are promising (and sometimes if they are mixed, as judging from the introduction and discussion of this paper), then larger RCTs are done. There’s nothing outrageous here, and Mortensen et al also acknowledge that their study might have enrolled a larger proportion of patients with milder symptoms than other trials.
In an accompanying editorial, Justin Ezekowitz notes that there were accrual problems, which is why the study took ten years, noting that it’s “unclear whether this situation resulted from patients’ acceptance of the experimental therapy, the ability of the sites and investigators to conduct a trial, the intensity of follow-up, or other features that are not further elucidated.” He also notes that it is premature to recommend CoQ10 as part of standard guidelines for treating heart failure, noting that these “striking results should be interpreted with caution given the small population and event numbers and the large treatment effect; many of these results were not replicated when a subsequent adequately powered trial was done (11).”
Note that the reference refers to a study by John Ioannidis that found that smaller studies generally produce large treatment effects that decline when larger trials are done.
To complete my deconstruction of Dr. Katz’s complaint about no money for studying supplements like CoQ10, I like to echo Dr. Ezekowitz’s remonstration with Mortensen et al:
Enthusiastically, the investigators have said that CoQ10 “should be added as standard therapy” based on these results, and additionally, it is a “natural and safe substance” (12). Perhaps this second statement is driven by the fewer side effects in the CoQ10 group than in the placebo group (13% vs. 19%). Further study in adequately powered clinical trials is required because it is premature to suggest that this finding reaches the necessary efficacy or safety bar required to consider prescribing this drug. Additionally, Although CoQ10 is widely available and taken as a supplement, safety cannot be assumed for any drug in this context, and so much broader and more detailed experience is required to declare this substance acceptably safe. Finally, CoQ10 is natural, naturally made in a factory by pharmaceutical-grade processes of medicinal chemistry and yeast or bacterial fermentation.
Indeed. What was that about Dr. Katz denying that he believes that “natural is better,” again? After all, if CoQ10 does “work,” improving outcomes in heart failure—and it very possibly does, given the results of Mortensen’s trial—it’s working as a drug, and the actual supplement used is manufactured in a manner very much like the methods used to manufacture pharmaceuticals. In particular, I like how Dr. Eskowitz fires a shot across the bow of advocates like Dr. Katz and the supplement manufacturers:
Nutraceutical manufacturers must step up and, like pharmaceutical and device companies, fund a trial for which an indication is sought or advertised, not solely through governmental funding agencies. If 1% of the estimated $1 billion annual market for CoQ10 was reinvested into an adequately powered, appropriately designed, academically led trial to demonstrate the efficacy and safety of CoQ10, then perhaps we would have a scientific advance worth being excited about.
Yes, the lack of patentability is a problem, but it’s not an insurmountable one. The problem is that supplement manufacturers want it both ways, and, thanks to the DSHEA of 1994, a law that basically lets supplement manufacturers get away with all sorts of vague health claims without evidence, they can have it both ways. Why would they want to spend even 1% of their profits and subject themselves to FDA pharmaceutical regulation if they don’t have to? There’s more greed over nutraceuticals than just big pharma and the lack of patentability. Funny how Dr. Katz never seems to acknowledge that.Integrative medicine “individualization”
Now let’s go back to Dr. Katz’s “more fluid concept of evidence,” which, given his arguments, sure sounds like an excuse to change the rules of evidence in the middle of the game, as Steve has charged. In the case above of CoQ10, he argues that if only there had been a more “fluid” concept of evidence applied to the original 2000 trial, then maybe 13 years might not have been “wasted” and we might have been able to incorporate this miraculous supplement into treatment regimens of people with heart disease. I view it more as a cherry picked example, of Katz being lucky in probably having guessed right. How much more often do clinical investigators guess wrong after an initially promising clinical trial? That’s what the whole concept of the “decline effect” is about, where initially impressive effect sizes tend to decline with time as further studies are done. As I like to say, the “decline effect is science correcting itself over time.
Be that as it may, Dr. Katz, not satisfied with complaining about funding and nefarious pharmaceutical companies, launches into what I like to call the “personalization” gambit:
First, the evidence from any given clinical trial, however methodologically robust, may or may not pertain to any given patient. The application of evidence from trials to the care of individuals not in those trials is itself a product of the art of medicine, not the science. To my knowledge, there has never been a randomized trial examining different ways clinicians might decide if trial results pertain to a specific patient. That may result from the developing field of pharmacogenomics, but we have a ways to go. In other words, for now, the application of the evidence in evidence-based medicine to the actual care of patients is not, itself, evidence-based. That’s a fact.
No, actually, it is not a “fact.” It is Dr. Katz’s opinion. Also notice how Dr. Katz subtly attacks a straw man version of EBM by emphasizing only RCTs, implying that nothing is known because there hasn’t been an RCT of applying evidence-based practice (EBP) guidelines. For one thing, it’s just not true that nothing is known about the application of EBM. True, not enough is known, but a lot is known. Moreover, there have been studies of EBP guidelines, both prospective and also both simulated and in the real world. Has Dr. Katz ever heard of a surgical checklist? These are checklists that must be done before surgery to ensure that various EBP items on the list are “checked off,” thus ensuring adherence to EBP guidelines. No doubt Dr. Katz would claim that these are not applicable because they are used in a much more controlled, regimented world and don’t show how physicians apply guidelines to individual patients, but surgical patients are individual patients and checklists allow for not performing an intervention if it is deemed inappropriate for a given patient.
I also can’t help but note that in the case of CoQ10, Dr. Katz seems rather eager, based on one RCT, to adopt a “one size fits all” guideline recommending the addition of CoQ10 supplementation to the treatment of heart failure patients.
Be that as it may, Dr. Katz is also attacking a straw man. No one—and I mean no one—arguing for SBM and against the sort of integrative relativism espoused by practitioners like Dr. Katz claims that randomized clinical trial (RCT) results must always apply to a given patient with a disease presenting for evaluation. That’s why it’s called science-based medicine. Heck, that’s why EBM was originally referred to as evidence-based medicine. That’s because, ideally, medicine is based in science and evidence, but science and evidence are not the be-all and end-all.
What the patient values, for example, matters. For example, I routinely tell women diagnosed with breast cancer that mastectomy and lumpectomy followed by radiation therapy both produce equivalent survival rates. In women for whom it is appropriate, I generally recommend breast-conserving surgery (lumpectomy) first. However, even though the survival rates are the same for the two procedures, there is a somewhat higher chance of a local recurrence (recurrence in the breast). The reason that that local recurrence doesn’t portend a higher risk of death is because such local recurrences can be “salvaged” with mastectomy. Some women have a very hard time dealing with even the relatively low risk of local recurrence inherent in breast conserving surgery even if the survival is the same. There’s also the issue that radiation therapy, as given, can be rather inconvenient. Most regimens involve daily treatments for four to six weeks (it used to be always six weeks), which can be a pain if the woman doesn’t live close to a center with a radiation oncology facility.
So is it “wrong” do do a mastectomy to treat a small breast cancer that could be treated with breast-conserving surgery? Of course not. I admit that I will at least try to persuade a woman whom I deem a good candidate for breast conserving surgery out of a mastectomy because it’s a much bigger operation, but if she insists on mastectomy I will do it. The point here is that informed consent is a critical component of EBM and SBM, but that informed consent must be truly informed. In other words, the information given to the patient must be accurate and based on the best science available. That’s where integrative medicine fails, both as EBM/SBM and ethically. I’ve frequently referred to the concept of “misinformed consent.” What integrative medicine does is to introduce treatments not based in science as though they were.
Dr. Katz then invokes a common scenario in medicine:
Second, the needs of patients all too often go on when evidence runs thin, or out entirely. This is why I went into “integrative” medicine in the first place — and why I am now involved in the online delivery of holistic care to a larger population.
By working with colleagues trained differently than I, naturopathic physicians in particular, we had more treatment options together than we did alone. When patients had been everywhere, tried everything subtended by RCTs and still weren’t better, they came to us. And we, generally, could come up with something reasonable to try. Admittedly, it wasn’t yet in the textbooks — but that was the point. These were the folks that had already run off the pages of textbooks, and still needed help.
This, of course, is another straw man view of EBM and SBM. Indeed, one of our criticisms of EBM is similar, but different, than Dr. Katz’s. I like to refer to it as methodolatry, defined as the profane worship of the randomized clinical trial as the only valid method of investigation. So there we agree! The RCT should not be the be-all and end-all of investigation! After all, there will never be large, double-blind RCTs to answer every medical question that needs answering. Sometimes it’s unethical to do an RCT. Sometimes it’s too impractical, either because of expense, time, or both. Sometimes the condition is just so uncommon that there will never be enough patients to do an RCT. For instance, at the recent Society of Surgical Oncology meeting in Houston, it was discussed how doing an RCT of standard pancreatectomy with minimally invasive pancreatectomy (laparoscopic or robot-assisted) for pancreatic cancer looking at overall survival as the main outcome would require over 6,000 patients and several years. In such cases, we are forced to use the best evidence available.
Here’s the problem, and here’s where Dr. Katz and I diverge. We at SBM advocate that patients are best served when they are not subjected to unscientific and pseudoscientific medicine and when the treatments recommended to them are firmly rooted in science. Just because there is a lack of evidence regarding the best management for a given patient does not mean you can scientifically or ethically justify recommending pseudoscientific treatments like homeopathy as though they have evidence to support them! Irish comedian Dara O’Briain has a brilliant retort to this kind of argument, which is basically of the same general form of (medical) “science doesn’t know everything”:
Jesus, homeopaths get on my nerves with “science doesn’t know everything.” Well science knows it doesn’t know everything. Otherwise, it’d stop…But just because science doesn’t know everything doesn’t mean you can fill in the gaps with whatever fairy tale most appeals to you.
That’s exactly what integrative medicine does by advocating the use of modalities such as reiki, homeopathy, naturopathy, and much of traditional Chinese medicine. And that’s exactly what Dr. Katz is doing when he advocates a “more fluid concept of evidence.” Don’t believe me? Behold these words from Dr. Katz:
Nowhere in the argument for a more fluid application of evidence to the care of people is there an argument to reject evidence when it is clear. The evidence in support of immunization is clear. A connection between the two argument is specious; a non sequitur.
Note that apparently Dr. Katz was criticized that his a more “fluid” concept of evidence has been used by the antivaccine movement. Now contrast the above passage with these words from Dr. Katz:
And the anecdotal evidence that homeopathy might be effective was brought up by the naturopaths. We tried it. It worked.
If there’s a form of quackery other than homeopathy for which the evidence is more clear that it does not work better than a placebo, that, physically according to what we know from chemistry and physics, it cannot work, I am unaware of it, with the possible exception of reiki. In 2008, Dr. Katz was clearly willing to reject clear evidence that homeopathy is pseudoscience. What other clear science has he been willing to reject when he sees fit? How “fluid” is his concept of evidence? In the final section, we shall see.Dr. Katz’s lovefest with naturopaths
Dr. Katz works a lot with naturopaths. We’ve known this for nearly eight years. Apparently, his definition of evidence is “fluid” enough to embrace a specialty with as tenuous a relationship with science as naturopathy whole-heartedly, to the point where he’s recently given testimony to the Public Health Committee in the Connecticut State House of Representatives in support of a naturopathic licensing bill. In his written testimony, he brags about how he has “worked extensively with naturopathic physicians in every context relevant to the advancement of medicine” and gushes shamelessly about how he has been “richly rewarded by all of these collaborative activities.” He even refers to naturopaths as “ideally suited to meet the primary care needs of Connecticut residents.”
What is it about naturopaths Katz so admires that he’s willing to go to bat for them in front of the legislature in his own state and speak of them in such glowing terms? Is it their use of quack treatments, such as unsupported thyroid tests and treatments for “systemic candidiasis”? Given Katz’s admirable defense of vaccines in wake of the Disneyland measles outbreak, it their almost universal antivaccine views, even among naturopaths who think of themselves as “not antivaccine”? Is it their advocacy of chelation therapy and other quackery for autism, a potentially deadly pseudoscientific treatment? Is it their advocacy of intravenous peroxide to treat a wide variety of conditions? Is it how naturopaths embrace the four humors? Is this what he means by embracing a “more fluid concept of evidence”? Apparently so. After all, the humors were believed to be fluids.
Or perhaps Dr. Katz really doesn’t know what naturopathy is actually about. If that’s the case, I’ll take the opportunity to educate him and suggest that he read Kimball Atwood’s classic critical appraisal of the vitalistic pseudoscientific mystical practice that is naturopathy, after which he might be interested in what naturopaths say amongst themselves when they think no one is listening. Then he should read Britt Hermes’ confessions of a former naturopath and her description of naturopathic education. Let’s just say, it contrasts with Katz’s naive view in his testimony. A lot.
Seven years after he introduced his more “fluid” concept of evidence, Dr. Katz has failed to give a satisfactory or convincing answer to the question of just what he meant. The best he can come up with, after whining about how nasty we “self-appointed guardians of the definition of EBM” with an Internet connection and too much time on our hands are, seems to be either to substitute anecdotal evidence for RCT evidence whenever he thinks it appropriate or to seek a “middle way” between SBM and quackery. If that means embracing homeopathy, traditional Chinese medicine, and naturopathy, apparently that’s fine with him.Additional reading: