A recent editorial in PLOS Medicine discusses the need for transparency in the medical literature, specifically with regard to comparative effectiveness research (CER). The editorial makes many excellent points, but also puts into clear relief the double standard that is consciously being fabricated by proponents of non-science-based medicine.
I wrote previously about another editorial that took a very different approach. Speaking for The Kings Fund, Professor Dame Carol Black said.
“The challenge is to develop methods of research that allow us to assess the value of an approach that seeks to integrate the physical intervention, the personal context in which it is given, and non-specific effects that together comprise a particular therapy.”
The editorial essentially defended the use of CER and other forms of evidence to bolster the evidence base for so-called CAM (complementary and alternative medicine) in order to promote its use.
As you can see, Science-Based Medicine is now back online and fully functional. We have moved to a new host and a faster dedicated server. It seems that our problem was just that we outgrew our previous host.
Sorry for the inconvenience and thank you for your patience. We will now resume our usual schedule of postings.
As many of you have probably noticed, the science-based medicine site has been having connection problems for the last week, and was in fact down for most of Friday. We are actively working on the problem and hopefully will have it fixed soon. The site is functioning now, but remains very slow.
Thanks for your patience, and sorry for any inconvenience.
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.
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.
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.