Kevin Trudeau has made millions of dollars selling dubious medical products. He started his snake-oil salesman career selling coral calcium through infomercials. Trudeau claimed that this magical form of calcium could cure cancer and whatever ails you. The Federal Trade Commission (FTC) investigated Trudeau, who was making millions off his claims, and found that he was being, let us say, less than honest. As a result the FTC banned Trudeau from selling health products through infomercials.
But Trudeau is tenacious and creative – an innovator. Prior to getting into infomercials he was small time – he was convicted for writing bad checks and credit card fraud and spent some time in prison. I always find it interesting that convicted con-artists seem to hit upon such well-guarded secrets. Dennis Lee claims to have found the secret of limitless energy, if only he were not attacked by Big Oil and a corrupt government. Kevin Trudeau claims to have found the cures for just about everything, but The Man is trying to shut him down.
Undeterred by the FTC ban, Trudeau decided that even though he could not sell health products he could sell information – that was protected under free speech – so he started selling books through infomercial, including Natural Cures They Don’t Want You To Know About. Trudeau claimed he went from writing bad checks to discovering not only hundreds of natural cures but uncovering a government and Big Medicine conspiracy to keep this vital information from the public.
The marketing of so-called CAM or integrative medicine continues. These terms are just that – marketing. They are otherwise vacuous, even deceptive, and meant only to conceal the naked fact that most medical interventions that hide under the CAM/integrative umbrella lack plausibility or credible evidence that they actually work.
Medicine that works is simply “medicine” – everything else needs marketing.
Last week in the British Medicine Journal (BMJ) Hugh MacPherson, David Peters, and Catherine Zollman wrote a very telling editorial entitled Closing the evidence gap in integrative medicine, which Edzard Ernst has rightly characterized “a masterpiece in obfuscation.”
The essence of the editorial can be boiled down to this – proponents of integrative medicine are disappointed that scientific research has not validated their failed modalities. Therefore they want to weaken the rules of evidence so that they can get the results they desire.
Perhaps the biggest hurdle to broader acceptance of the need for a consistent scientific basis for medical interventions is the attitude that worthless treatments are harmless. I often have the experience, after reviewing the evidence showing lack of efficacy for a specific intervention, of getting the head-tilt and shrug along with some variation of the dismissive attitude, “Well, if people feel better, then what’s the harm?” In my opinion, ethics and intellectual honesty indicate that we have to do better than that.
The “what’s the harm” refrain is so tired and overused that it prompted a website by that name, documenting direct harm caused by unscientific treatment modalities. This is a helpful reminder that any intervention that actually does something (has biological activity) must also contain some risks. But this site also has significant limitations. First, it is anecdotal. But also it emphasizes direct harm, while the indirect harm of unscientific methods (for example by delaying definitive treatment) likely vastly outweighs the direct harm. However, indirect harm is extremely difficult to quantify.
Studies looking at the net clinical effects of using or relying upon unscientific methods is therefore desirable. Recently Danish researchers have published one such study: Use of complementary and alternative medicines associated with a 30% lower ongoing pregnancy/live birth rate during 12 months of fertility treatment.
A recent survey of 599 primary care physicians and 600 psychiatrists found that:
The adjusted response rate was 47%, respondents were similar to non-respondents, and physicians commonly prescribed the drugs examined. The average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians’ belief that an indication was FDA-approved and greater evidence supporting efficacy for that use (Spearman’s 0.74, p < 0.001). However, 41% of physicians believed at least one drug-indication pair with uncertain or no supporting evidence (e.g., quetiapine [Seroquel®] for dementia with agitation) was FDA approved.
These results are interesting, but deserve to be dissected a bit further. Taken at face value they indicate that physicians need better education regarding the FDA indications and (more importantly) the evidence-base for commonly prescribed drugs. This is an uncontroversial recommendation, and I personally strongly advocate more thorough physician continuing medical education.
Of course, at SBM we have to also dissect the weaknesses of any study we examine. This was a voluntary survey with a 47% response rate, which opens the door for significant responder bias. The survey does not broadly represent different specialties and therefore its relevance beyond primary care and psychiatry is uncertain. The details of the study may also have greatly influenced the outcome.
For example, one of the drug-indication pairs was gabapentin for diabetic peripheral neuropathy. Gabapentin is not specifically indicated for diabetic neuropathy, but it is indicated for post-herpetic neuralgia. Both conditions are forms of neuropathic pain, and it is highly scientifically plausible for a treatment of one condition to also be effective for the other. In fact, there is strong evidence that gabapentin is effective for diabetic neuropathy, and it is commonly prescribed for this condition (in fact insurance companies often require that it is first line treatment as it is now available generically and is therefore less expensive than newer drugs that are indicated specifically for diabetic neuropathy). In other words, this was one of the easiest mistakes to make.
We frequently receive requests from readers, our colleagues in medicine or fellow science bloggers for the best reference site that has all the information they need on a specific topic. There are many excellent resources on the net, but nothing I know of that quite puts it all together in that way – one-stop shopping for up-to-date information on the topics we are most concerned with.
So we decided to create just such a resource.
You will now see at the top of this page a new link for SBM Topic-Based Reference which leads to our new section by that name. There you will see the list of topics we are currently working on, and once they are complete more will be added. As of today only one topic is reasonably complete, Vaccines and Autism.
The format (which is subject to change as we build and use the resource) is as follows: We start with a brief topic overview. This is not meant to be a thorough discussion of the topic, but a quick summary to get people started. This is followed by an index of all SBM posts on that topic and then links to outside resources that we recommend.
It is my contention that terms such as “complementary and alternative medicine” and “integrative medicine” exist for two primary purposes. The first is marketing – they are an attempt at rebranding methods that do not meet the usual standards of unqualified “medicine”. The second is a very deliberate and often calculating attempt at creating a double standard.
We already have a standard of care within medicine, and although its application is imperfect its principles are clear – the best available scientific evidence should be used to determine that medical interventions meet a minimum standard of safety and effectiveness. Regulations have largely (although also imperfectly) reflected that principle, as have academia, publishing standards, professional organizations, licensing boards, and product regulation.
With the creation of the new brand of medicine (CAM and integrative) came the opportunity to change the rules of science and medicine to create an alternative standard, one tailor made for those modalities that do not meet existing scientific and even ethical standards for medicine. This manifests in many ways – the NCCAM was created so that these modalities would have an alternate standard for garnering federal dollars for research. Many states now have “health care freedom laws” which create a separate standard of care (actually an elimination of the standard of care) for self-proclaimed “alternative” practices.
Reuters recently reported on the raid of a stem-cell clinic in Hungary. This is welcome news, if the allegations are correct, but really is only scratching the surface of this problem – clinics offering dubious stem cell therapies to desperate patients. And in fact this is only one manifestation of a far greater problem – the quack clinic. They represent a serious problem for patients, doctors, and health care regulation.
Stem Cell Clinics
There is a very disturbing trend in the last few years – the proliferation of clinics offering stem cell therapy for a variety of serious, often incurable, diseases such as spinal cord injury, ALS, Parkinson’s disease, and other neurological disorders. These clinics claim to improve and even cure these diseases by injecting stem cells into the spinal cord or other parts of the body. Treatments typically cost 20-25,000 dollars, plus travel expenses, for a single treatment.
The problem is that these clinics do not have any published evidence that their treatments are valid. There is good reason to think that they are not – stem cell technology is simply not at the point yet where we can use them to cure such diseases. There are many technical hurdles to be overcome first – knowing how to control the stem cells, to get them to survive and become the types of cells necessary to have the desired therapeutic effect, and also figuring out how to keep them from growing into tumors. Basic issues of safety have not yet been sorted out.
Last year Simon Singh wrote a piece for the Guardian that was critical of the modern practice of chiropractic. The core of his complaint was that chiropractors provide services and make claims that are not adequately backed by evidence – they are not evidence-based practitioners. In response to his criticism the British Chiropractic Association (BCA) sued Simon personally for libel. They refused offers to publish a rebuttal to his criticism, or to provide the evidence Simon said was lacking. After they were further criticized for this, the BCA eventually produced an anemic list of studies purported to support the questionable treatments, but really just demonstrating the truth of Simon’s criticism (as I discuss at length here).
In England suing for libel is an effective strategy for silencing critics. The burden of proof is on the one accused (guilty until proven innnocent) and the costs are ruinous. Simon has persisted, however, at great personal expense.
This is an issue of vital importance to science-based medicine. A very necessary feature of science is public debate and criticism – absolute transparency.This is also not an isolated incident. Some in the alternative medicine community are attempting to assert that criticism is unprofessional, and they have used accusations of both unprofessionalism and libel as a method of silencing criticism of their claims and practices. This has happened to David Colquhoun and Ben Goldacre, and others less prominent but who have communicated to me directly attempts at silencing their criticism.
This behavior is intolerable and is itself unprofessional, an assault on academic freedom and free speech, and anathema to science as science is dependent upon open and vigorous critical debate.
What those who will attempt to silence their critics through this type of bullying must understand is that such attempts will only result in the magnification of the criticism by several orders of magnitude. That is why we are reproducing Simon Singh’s original article (with a couple of minor alterations) on this site and many others. Enjoy.
A new study suggests that it may not be uncommon for patients who are in a minimally conscious state to be misdiagnosed as being in a persistent vegetative state. The study underscores the necessity of using standardized and objective diagnostic criteria in diagnosing coma. However, it also leaves some important questions unanswered.
As background it is essential to understand a bit about consciousness and coma, for not all comas are created equally. In order to be conscious a person requires at least one hemisphere of the brain be mostly functioning and they require a functioning brainstem. The cortical hemispheres contain the gray matter – that part of the brain that thinks. So it makes sense that a certain minimal amount of gray matter is necessary to generate consciousness. As gray matter is damaged or inhibited from functioning one’s level of consciousness decreases until it descends beyond that fuzzy boundary into unconsciousness. When such unconsciousness is persistent we call that coma.
But interestingly the cortex by itself cannot generate consciousness. It requires constant prodding by a diffuse region in the brainstem (that primitive part at the base of the brain that connects the brain and the spinal cord) called the brainstem activating system. This region sends a constant barrage of electrical signals through the thalamus (the relay center of the brain) and then onto the cortex. Without this constant stimulation the cortex will lapse into sleep and coma.
On July 9th we held our first Science Based Medicine conference in Las Vegas. The event was definitely a success – we filled our room to capacity (150 attendees) and almost everyone stayed until the end. It also appeared that most attendees were actually awake, a rarity for a full-day medical conference. The Q&A session at the end was lively and interesting.
Kimball Atwood and I covered the history of science-based medicine and explored the differences between EBM and SBM. David Gorski discussed cancer quackery, including specific cases to illustrate the potential harm of pursuing worthless therapies for serious diseases. Harriet Hall gave us an overview of the the pseudoscience endemic in chiropractic. Mark Crislip discussed the chronic Lyme disease controversy. And Val Jones discussed health information online.
Based upon the feedback from those attending the conference, as well as the general enthusiasm, it seems that there is a hunger for this type of information. The audience was split about even between health care professionals and interested lay public. Many people asked if we plan on giving the conference again, and the answer is definitely yes. We have no plans set as of yet, and will certainly announce any future conferences here.