Wikipedia: Homeopathy and Evidence for Unpatentable Medications

Wikipedia: Homeopathy and Evidence for Unpatentable Medications

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flying cadeuciiRecently, I have had some interesting conversations with doctors and medical students of Naturopathic Medicine. I am slowly getting involved in editing Wikipedia medicine articles, and I was approached by several proponents of Naturopathic Medicine, who were upset about the following phrases from the Wikipedia article on Naturopathy:

Naturopathic philosophy is based on a belief in vitalism and self-healing, and practitioners often prefer methods of treatment that are not compatible with evidence-based medicine. Naturopathic medicine is replete with pseudoscientific, ineffective, unethical, and possibly dangerous practices.

Of course, they felt this was unfair. In their mind, the Wikipedia article was “wrong” and needed to be fixed and they were frustrated by the tendency for Wikipedia editors to thwart their efforts to “fix” the article.

This put me in an uncomfortable position. I had the option of remaining entirely silent, or informing these followers of Naturopathy of several issues:

  1. Wikipedia has become a “court for facts”. The Wikipedian community focuses on what has become verifiable scientific consensus.

  2. There is very little scientific consensus supporting Naturopathic methods while there is is a substantial amount of scientific consensus opposing some Naturopathic methods.

  3. Naturopathic methods tend to layer “placebo effects” (Ben Goldacre is the inevitable reference for how that works).

  4. These layered placebo effects tend to make the patients of naturopaths and the naturopaths themselves, believe that their methods are way more effective than they actually are.

  5. I have to admit that I fully expected to have a serving of Tim Minchin’s Storm. But what the hell. Why not?? So I jumped and put the basic issues forward.

The results of the interaction, which I discuss below, gave me pause. In some senses, the Naturopathic movement was way worse than I had been made to understand. But in others, their positions are reasonable and defensible.

I write about this now, because the FDA has recently asked for comments on Homeopathic Product Regulation. As per my habit, I will be submitting this blog post as a comment. I should mention at the outset that I plan to use the terms “Naturopathic” and “Homeopathic” interchangeably, and will try and clarify why much later.

There is a small possibility that Ben Goldacre himself will not have time to comment on this, and also that no one else will bother to simply submit Ben’s wonderful corpus of online videos to the FDA as comment. To avoid this minor catastrophe, I am going to link to all of my favorite Ben Goldacre lectures here:

It brings me happiness to imagine that someone at the FDA will have the opportunity to listen to 6 hours of Ben lecturing on a subject that he knows well and obviously loves… and to think about how best to apply his insights to the issue of regulating homeopathic medications and treatments.

Generally, Ben and others in the evidence-based medicine community, are justifiable disturbed by the damage that is regularly done under the rubric of Alternative/Naturopathic/Homeopathic medicine. It is the primary role of the FDA to protect patients from these kinds of harm. Some have suggested that Homeopathic approaches can be tolerated as “harmless placebos” chemically. Perhaps in some cases they are. But there are trends in some parts of the Homeopathic community that make this kind of tolerance dangerous.

The first trend is the “herbal tincture” trend. It might be well established that taking extra vitamins of a particular type are usually harmless, and leads to nothing more than expensive urine. But the habit that naturopaths have of taking several substances, distilling them, and offering them as a “herbal tincture” makes it difficult to evaluate whether or not these substances are dangerous. Despite the fact that these treatments are distilled (which may or may not impact any potency they have) and combinatorially intractable (which also may or may not impact any potency they have), these medicines are almost always regulated as foods, or supplements by the FDA, using substantially lower oversight and regulation.

The second trend is the “all and nothing” trend. Once a person has been convinced that a Naturopathic treatment is best, they will frequently cut out nearly everything but the treatment in question. Many patients become convinced (for example) that the “cure” for what bothers them is eating lots of shrimp, and they then decide to eat “only” shrimp. While the FDA might have access to research on the impact shrimp eating, there is not much evidence on what eating only shrimp does to a person.

These two problems create an insidious problem with “alternative” treatments. The “treatments” that are suggested tend to hover around what the FDA does not regulate. Changing what is regulated as a medication will only change which substances are used as the “natural” cure. Put another way: If you decide regulate snake oil, then the snake oil sellers will just start selling olive oil as a cure-all.

As long as the general population in the United States remains scientifically illiterate and suspicious of the scientific community, there will be a marketplace for quackery. The FDA should consider how it can address these underlying issues, and it should participate in efforts to fix how the population regards science. But it is obvious that the FDA, like other scientific bodies, must also learn how to operate in a marketplace which does not understand or accept the core principles of the scientific process. This is not any kind of failure on the part of the FDA, but merely an acknowledgement that the FDA is not in a position to correct a culture.

Which brings me to the more reasonable points made by my Naturopathic friends. They hold the “Naturopathic community” had recently shed its anti-science history. They believed the modern Naturopathic education process was as scientific as it could be, given the lack of accessible evidence around Naturopathic treatments.

The Naturopaths argued that evidence supporting Naturopathic methods are generally lacking in Western literature, because there is no incentive for drug companies to pursue research for substances which could not readily be patented. It is difficult for me, as someone who has limited direct experience with either Naturopathic/Homeopathic methods or clinical concepts, to evaluate whether this is correct. However, I believe that the lack of attention that is generally paid to out-of-patent medications from a surveillance perspective is a strong indication that the Naturopaths might be correct about this assertion. We can assume that the attention given to side-effects and surveillance on medications that “no longer affect the bottom line” of pharmaceutical companies, is largely the same as those that “never have and never will affect the bottom line”.

At a minimum the FDA should invest resources in improving the creation of new evidence regarding both off  patent and alternative therapies, since pharmaceutical companies have little financial interest in either. If the FDA makes a concerted effort to develop improved surveillance processes for off patent medications, these efforts might be dual-purposed and made effective for naturopathic treatments as well.

In fact, the FDA should seek to find other ways to get double returns on investigation into homeopathic approaches. Many Naturopaths claim that the evidence for “alternative” treatments could be found in other languages, like Chinese. The FDA should invest in translating articles that impact both out-of-patent medications and Traditional/Natural/Homeopathic/Other treatments at the same time.

The FDA should sponsor research into alternative and homeopathic treatments as well as for alternative uses of out-of-patent medications. This is critical, because the marketplace needs new incentives to treat research into off patent medications and traditional treatment options as opportunities. This should not be done out of any illusion that we will find more treatments, but so that both currently popular and future quackery can be avoided.

Naturopathic practitioners remain concerned that medication development is entirely “for profit” and that this profit motive means that “Evidenced Based Medicine” as a perspective remains biased by “evidence that is profitable to pursue”. Homeopathic proponents will be able to continue painting all of western medicine as “science for profit”, until the FDA can demonstrate that investments in “naturopathic” techniques and “off patent” techniques are adequately pursued. While I struggle to imagine what “adequate” might mean, it should certainly mean that the rate of development of evidence for unstudied aspects of off-patent medications should be roughly the same as for on-patent medications, and we are no where near that threshold.

To the degree that the FDA will tolerate “Alternative” medications and treatment practices, it should encourage ongoing digital monitoring of the patients in question. If some poor soul is stubbornly convinced that eating nothing but shrimp for a year is going to treat his cancer, society should at least get data on shrimp-only diets out of it. The FDA should extend its surveillance techniques with intention and for the most part without judgement into the quantified self community. Patients in pain are often so desperate that they are doing things to themselves that the Nazi doctors would have considered a harsh. Ethically, medicine should do its best to prevent needless harm from self experimentation. But in the context of informed consent, the FDA should be doing more to gather the results of these self-experiments at scale. This is fundamentally compatible with the President’s Precision Medicine Initiative, and should be a central part of new policies regarding Homeopathic substances. I do not mean to trivialize the difficulty in designing systems to incorporate patient self-experimentation into a regulatory process. But it can be done, and the FDA should lead the effort.

 

At the heart of this design should be true informed consent, something to the tune of “There is zero evidence that a shrimp-only diet is an effective cancer treatment, and there are proven alternatives and you still want to eat just shrimp?? O.K. sign here.” This kind of “deep consent” will allow the FDA to ethically collect data from a multitude of n-of-one experiments. Many of these will be ill-advised but fascinating and while others will be rational, mundane but still useful.  Please consider reviewing the notions of portable consent (now called participant-centric consent). By improving using technology to improve the depth, portability and quality of consent, the FDA can pursue the use of API’s for surveillance. Eventually, the FDA should be able to consume all kinds of properly consented, digital feeds that individually cannot provide evidence medication efficacy and safety, but can eventually establish the mass needed to inform further scientific pursuits. In short… go digital with this evidence stuff, it will pay off in the end.

 

The central valid point that is coming out of the Naturopathic/Homepathic community in response to the charge “you have little formal evidence to support your treatments” is essentially “Yes but we really do not have the budget to acquire formal evidence”. It is not going to be possible for the FDA to conjure the kinds of investments that currently go into patentable medications, to research unpatentable treatments. But there should be more resources devoted to the study of unpatentable treatments, both those whose patents have already expired and those that are not patentable because of their use in traditional medicines. Like orphan diseases, we still need medical research into topics that lack “backers”. This makes it more important for the FDA to find ways to embrace the inexpensive natural experiments that are occurring in the quantified self community.

 

Lastly, we should be careful with our words. I have used the terms “Naturopathy” and “Alternative”, while the FDA is specifically asking about “Homeopathy”. For the most part, these are used interchangeably by the public. The Medical community has attempted to create new terms, for the combination of traditional Western medical techniques and those Eastern medicine techniques for which there is evidence. Terms like Integrative Medicine, or Functional Medicine are sometimes used in this way. But as soon as a term has some medical legitimacy, it attracts medical practitioners who are classic science deniers and quacks. This has the effect of damaging the brand of any effort to reconcile disparate medical traditions, and makes it very difficult to discuss this topic intelligently. As the FDA reads and responds to comments with policy, I ask them to keep in mind that use of terms may establish or destroy the credibility of terms in the public’s mind. Using that power wisely, the FDA might be able to encourage a kind of self-policing around the various terms that will be very helpful to later regulatory efforts. The Office of the National Coordinator for Health IT has used the branding around EMRs vs EHRs very successfully in this manner.

 

As always I like to end my comments with a joke (usually stolen from Reddit, just like this one). In order to reward the poor souls who have to read thousands and thousands of boring and repetitive comments.

 

Q: What do British nuclear engineers eat ????

A: Fission chips.

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11 Comments on "Wikipedia: Homeopathy and Evidence for Unpatentable Medications"


Member
Today 2:39 pm
Guest
JR Bak, MD JD FAAP
May 1, 2015

Thanks for a very thoughtful article and resources that I will enjoy when I have the time.

I second the apt comment that we allopaths live in a bit of a glass house-of-medicine: our colleagues hand out ineffective treatments for self-limited conditions, or more expensive choices with no marginal benefits, and we lose the critical high-ground.

But so does the community that promotes these “alternatives,” as this industry grows. There is excess revenue for research. Heck, there is sufficient revenue for manufacturing quality, which seems to be sorely needed, independent of proven benefit. Afterall, the cold-and-cough remedy business has to meet that standard, even though there is no proven/ proven no benefit (and ample public demand).

I fear we are returning to the Gilded Age on many fronts, not the least the which is a culture where purveyors of remedies, delivered through our phones and watches, tout results of all kinds, extracting what they can from folks, because they can.

The FDA was established as a result when it happened the first time. This article points out that they may have some tools that help them mitigate it some this time.

Looking forward to more comments…

Guest
JR Bak, MD JD FAAP
May 1, 2015

Thanks for a very thoughtful article and resources that I will enjoy when I have the time.

I second the apt comment that we allopaths live in a bit of a glass house-of-medicine: our colleagues hand out ineffective treatments for self-limited conditions, or more expensive choices with no marginal benefits, and we lose the critical high-ground.

But so does the community that promotes these “alternatives,” as this industry grows. There is excess revenue for research. Heck, there is sufficient revenue for manufacturing quality, which seems to be sorely needed, independent of proven benefit. Afterall, the cold-and-cough remedy business has to meet that standard, even though there is no proven/ proven no benefit (and ample public demand).

I fear we are returning to the Gilded Age on many fronts, not the least the which is a culture where purveyors of remedies, delivered through our phones and watches, tout results of all kinds, extracting what they can from folks, because they can.

The FDA was established as a result when it happened the first time. This article points out that they may have some tools that help them mitigate it some this time.

Looking forward to more comments…

Guest
transposition
Apr 30, 2015

I don’t even know where to begin…

Pity the poor naturopaths and homeopaths that they cannot scrape together the funds for a clinical trial! There is more to proof than clinical trials, of course. And I, for one, have no interest in US taxpayer dollars spent in trying to pursue this “effort”, such as it is described (be it FDA, NIH or anywhere else).

Borion, the French homeopathic manufacturer, has a market capitalization of nearly $2 billion. I would hope that they could spare a bit of that to properly resource tests of the safety and efficacy of their products. And this is only one of many homeopathic manufacturers.

If these “practitioners” could collaborate, design and conduct studies of their various nostrums and procedures, including measurements of treatment effects and adverse events, perhaps they would be less in need of whining and complaining about how Big Pharma and the government are conspiring against them.

Guest
transposition
Apr 30, 2015

I don’t even know where to begin…

Pity the poor naturopaths and homeopaths that they cannot scrape together the funds for a clinical trial! There is more to proof than clinical trials, of course. And I, for one, have no interest in US taxpayer dollars spent in trying to pursue this “effort”, such as it is described (be it FDA, NIH or anywhere else).

Borion, the French homeopathic manufacturer, has a market capitalization of nearly $2 billion. I would hope that they could spare a bit of that to properly resource tests of the safety and efficacy of their products. And this is only one of many homeopathic manufacturers.

If these “practitioners” could collaborate, design and conduct studies of their various nostrums and procedures, including measurements of treatment effects and adverse events, perhaps they would be less in need of whining and complaining about how Big Pharma and the government are conspiring against them.

Guest
Apr 30, 2015

Homeopathy IS quackery.

https://www.sciencebasedmedicine.org

Guest
Apr 30, 2015

Homeopathy IS quackery.

https://www.sciencebasedmedicine.org

Guest
Apr 30, 2015

Nice talk. Loved the “first published clinical trial, Daniel 1:12.” Stealin’ that.

In investigatory methodology, there are only “science” and “not-science.” Not that real science is always dispositive — hence the word “trials” in clinical trials. Conclusions can be nul, weak, tentative, transitory, unhelpfully narrow in scope, etc.

Guest
Apr 30, 2015

Nice talk. Loved the “first published clinical trial, Daniel 1:12.” Stealin’ that.

In investigatory methodology, there are only “science” and “not-science.” Not that real science is always dispositive — hence the word “trials” in clinical trials. Conclusions can be nul, weak, tentative, transitory, unhelpfully narrow in scope, etc.

Guest
Peter1
Apr 30, 2015

Bobby, you need to watch, “Battling Bad Science TED talk” linked above.

Quackery runs in both directions.

Guest
Peter1
Apr 30, 2015

Bobby, you need to watch, “Battling Bad Science TED talk” linked above.

Quackery runs in both directions.