Dr. Olivier Ameisen is a prominent French cardiologist who believes that the muscle-relaxant drug baclofen relieves the cravings of alcoholism. This is indeed an interesting, and as yet unsettled, scientific medical question. Dr. Ameisen has decided to take his personal scientific opinion directly to the public in his book – Le Dernier Verre (The Last Glass). The result has been a surge of interest among alcoholics for this new “miracle cure” for their affliction.
Increasingly the medical community is caught between two opposing imperatives. There is the desire to make medical information freely available and the process of medical research transparent. On the other hand, the public is best served when new ideas in medicine are put through the mill of science before they become part of medical practice. As we enter headlong into the information age these two imperatives are increasingly at odds.
Problems arise when a new treatment, syndrome, intervention, or concept in medicine is promoted to the public prior to undergoing a reasonable degree of scientific vetting. What is the point, after all, of spending tremendous resources on medical research if proponents are going to bypass the process altogether to market their modalities and promote their ideas directly to the public?
Dr. Jay Gordon is a pediatrician and one of the stars of the anti-vaccinationist movement. (Dr. Gorski wrote an exellent criticism of many of his claims recently on SBM.) He is, in fact, the pediatrician to Jenny McCarthy’s son, Evan (who she claims was injured by vaccines). Several months ago he published an “open letter on vaccinations” which is now making the rounds on anti-vaccine websites. The letter is a work of pure arrogant pseudoscience – a crafted piece of anti-vaccine propaganda. He begins:
I don’t give a lot of vaccines.
I still give DPT vaccinations to some children, chicken pox shots to kids who haven’t been able to acquire natural immunity by age ten years or so, and I give polio vaccines very infrequently. The polio vaccines are given for what I call “emotional” reasons because my exposition of the “numbers” (2000 cases of polio out of six or seven billion people) doesn’t counteract the very strong memory of a beloved aunt or uncle who had polio in fifties or sixties. And many parents feel much more comfortable traveling to India or parts of Africa with updated polio immunity for their children and themselves. By the way, 2007-2008 statistics don’t support that discomfort, but I don’t argue much.
In 2007, there were 1314 cases of polio on the planet and 127 of them were in “endemic” countries: 873 in India, 285 in Nigeria, 41 in the Congo, 32 in Pakistan and 17 in Afghanistan.
As of July 1, 2008, halfway through the year, we’re running a similar pace with 714 cases of polio reported worldwide. Nigeria has had 353 cases, India 287.
His argument is that because the risk of catching polio is so low, the benefits to the individual child are not balanced by the risks of the vaccine. His argument, however, is bogus on many levels. First, the benefits of the vaccine to the individual child do outweigh the risks. That is largely due to the fact that the polio vaccine is very safe. Serious complications are extremely rare.
Pat Wagner (or “The Bee Lady,” as she likes to be called) treats herself for multiple sclerosis (MS) by allowing bees to sting her. She calls this bee-venom therapy (BVT) and believes it has saved her from MS.
There are now thousands of people who administer BVT to themselves or others, mostly in private homes by unlicensed practitioners. BVT is not prescribed by a doctor, yet it is used like any other drug, given in regular doses at regular intervals. There is no scientific evidence to support its use, and yet thousands of multiple sclerosis sufferers and others tout its effectiveness.
BVT, which is one modality within Apitherapy, or the use of various bee products as a medical treatment, is still a relatively small phenomenon. It is largely an unrecognized grassroots or folk medicine treatment – but like all such phenomena has been given a huge boost recently by the easy spread of information via the internet. It has also been adopted by many so-called alternative medicine (CAM) practitioners, and has been increasingly wrapped in the typical marketing jargon of CAM. So, in a way, this grassroots treatment has been corporatized by the CAM industry.
Freedom is a cherished commodity in our culture, as it should be. Our laws are largely based upon the premise that individuals should have the liberty to do what they want, unless there is a compelling public or governmental concern that overrides such liberties.
It is therefore no surprise that freedom is a common marketing theme – selling the idea of individuality or personal freedom of choice.
The marketers of dubious, unscientific, or fraudulent health care products and services are savvy to the marketing theme of freedom and have used it to great effect. It is all ultimately, however, a deception. There is an ulterior motive that has nothing to do with the freedoms of the public but rather is an end run around regulations meant to protect the public.
So-called off-label uses of prescription drugs is an enduring controversy – probably because it involves a trade-off of competing value judgments.The FDA is considering loosening its monitoring of off-label prescriptions, but critics are charging that, if anything, regulations should be tightened. Many issues of science-based medicine are at the core of this controversy.
In the US the FDA (Food and Drug Administration) regulates the sale of drugs. In order for a pharmaceutical company to get a drug on the market they must complete FDA monitored clinical trials and demonstrate adequate safety and effectiveness for a specific indication. The specific indication for which a drug is approved is the on-label indication, and all other uses are off-label.
A new study published in the Archives of Pediatrics and Adolescent Medicine shows a positive correlation between counties in California, Oregon, and Washington with greater precipitation and a higher incidence of autism. While the results of this study are interesting, it needs to be put into proper context. Also of note, the authors had presented early results from this data previously.
Correlation is not Causation
This type of study is a correlational study, which means it asks whether or not there is a statistical correlation between two variables – in this case the rate of autism and the amount of precipitation. This type of data is extremely useful to medical science, but it has known limitations, which can be summarized by the statement that correlation is not causation.
I wrote previously on NeuroLogica blog about Morgellons disease. Both Peter Lipson and Wallace Sampson have also covered this interesting syndrome here on SBM. Briefly, sufferers of this dubious syndrome believe they have foreign material exuding from their skin, causing chronic itching and sores. The evidence suggests that in truth they suffer from something akin to delusional parasitosis – the false belief of foreign parasites in their skin, leading to chronic itching which causes the sores and also works clothing fibers into the skin, which are later exuded.
Morgellons, in short, is a fake disease, a false and somewhat far-fetched explanation for symptoms that have a much more prosaic, if undesired, explanation.
Those who believe they have Morgellons, however, are legitimately ill and are an extremely vulnerable population. They feel they have a serious and mysterious illness, and worse the medical profession does not understand their illness and so denies that it exists. This is a perfect setup for snake oil-peddling con-artists.
The science in science-based medicine includes all of science, but relies most heavily on the biomedical literature – published studies that collectively represent our scientific medical knowledge. The scientific basis of medicine is only as good as this body of knowledge and the manner in which it is interpreted and put into practice.
We often discuss on this blog how to evaluate individual studies- the need for blinding, randomization, the importance of study size to meaningful statistical analysis, and other features that distinguish a reliable study from a worthless one. This is important, but only half of the equation. We also at times discuss the medical literature as it relates to a specific medical question or set of related questions – does homeopathy work or are statins beneficial for cholesterol reduction, for example. This requires not only the ability to judge individual studies, but a higher order analysis of the overall pattern of evidence among all relevant studies. Failure to do this, by focusing only on individual studies, results in the failure to see the forest for the trees.
It is this higher order analysis that I wish to discuss in this entry.
When arguing against a specific scientific claim it is always desirable to be able to say that the claim violates an established law of science. Creationists attempt this with their argument that evolution violates the second law of thermodynamics (it doesn’t). The temptation is that such arguments are short and pithy, they seem conclusive, and they avoid the need to wade through a dense and complex set of scientific evidence and theories.
In the “diet wars” the first law of thermodynamics has been thrown around a lot. Up to now I have been aware of two camps defending their position with thermodynamic arguments. The first (and the one that I find most compelling) is the calorie in vs calorie out camp, that argues that the laws of thermodynamics apply to people too. This means that weight management must be a function of calories in (the total calories consumed by a person) – calories out (the total caloric expenditure, including metabolic processes, waste heat, exercise, and others). Thermodynamics must be obeyed and so if one wishes to lose weight they must burn more calories than they consume.
The Nobel Prize in Medicine was awarded this week to two French virologists, Françoise Barré-Sinoussi and Luc A. Montagnier, for discovering the AIDS causing virus, the Human Immunodeficiency Virus (HIV). They will share half the prize of 1.4 million dollars, the other half going to three Dr. Harald zur Hausen for discovering the human papilloma virus and its relation to cervical cancer.
The prize comes 25 years after Barré-Sinoussi and Montagnier, working at the Pasteur Institute in Paris, published their paper identifying what was later called HIV. The last quarter of a century has proven their discovery to be a triumph of science-based medicine. The Nobel committee is correct, in my opinion, in waiting such long periods of time before granting such recognition. It reflects that fact that, even in a fast-paced arena of science such as medicine, it takes time for the meticulous process of science to work itself out. It takes decades to garner the perspective necessary to tell the difference between a crucial breakthrough and a false lead.