In my group practice, the Yale Medical Group, drug-company sponsored lunches and similar events have been banned. This is part of a trend, at least within academic medicine, to create some distance between physicians and pharmaceutical companies, or at least their marketing divisions. The justifications for this are several, and are all reasonable. One reason is the appearance of being too cozy, which compromises the role of academic physicians as independent experts.
But the primary reason is the belief that “detailing” by pharmaceutical sales representatives has a negative effect on the prescribing habits of physicians. There is reason to believe this may be the case because of cases of bad behavior on the part of pharmaceutical marketing divisions – ghost writing white papers, for example. The concern, backed by evidence, is that pharmaceutical companies introduce spin and bias into the information they provide to physicians, whether though CME, detailing, literature, or sponsored lectures. Even when the information itself is not massaged, it is cherry picked, so in the end physicians are not getting a thorough and unbiased assessment of the facts.
The FDA does heavily regulate the marketing of information about pharmaceuticals, but marketers are very clever about exploiting loopholes and seem to be one step ahead of the regulators.
On the other hand there are those who argue that physicians can handle access to information and they are equipped to take it with a grain of salt and put it into context. Certainly most physicians I speak to believe this about themselves. Further, information provided by pharmaceutical companies may actually improve prescribing habits if it makes physicians aware of new products on the market and new information about the drugs they prescribe. The information itself is FDA approved (or at least should be), even if it is selective and wrapped in spin.
Any promoter of science-based medicine often faces the question – what’s the harm? What is the harm if people try treatment modalities that are not based upon good science, that are anecdotal, or provide only a placebo benefit? There are generally two premises to this question. The first is that most “alternative” placebo interventions are directly harmless. The second is that direct harm is the only type worth considering. Both of these premises are wrong.
The pages of SBM are filled with accounts of direct harm from unscientific treatments: argyria from colloidal silver, death from chelation therapy, infection or other complications from acupuncture, burns from ear candling, stroke from chiropractic neck manipulation – the list goes on. You can read anecdotal accounts of such harm on the website, whatstheharm.net. Of course, as we often point out, harm and risk is only one end of the equation – one must also consider benefit. It is the risk/benefit ratio of an intervention that is important. But generally we are talking about interventions that lack any evidence for benefit, and therefore any risk of harm is arguably unacceptable.
It is always flu season somewhere in the world. As Australia’s flu season comes to a close, we are getting ready for ours in the Northern Hemisphere. This is a good time to start thinking about getting the flu vaccine, and as always there is a lot of flu vaccine news to sort through.
Mark Crislip has already reviewed the evidence for the efficacy of the seasonal flu vaccine. Like most questions in medicine, the evidence is deceptively complex, and Mark does an excellent job of sorting through it, so I won’t repeat it here.
This year the H1N1 pandemic flu virus will be incorporated into the seasonal flu vaccine, so there will not be two separate vaccines as there was last year. H1N1 remains the dominant strain of seasonal flu, and as predicted the pandemic has simply been incorporated into the seasonal flu pattern.
Here are some updates on flu vaccine news – first the good news:
Over the last decade there has been a needed discussion about the relationship between politics and science. This has mostly been spawned by the perceived “Republican War on Science,” at the center of which is the global warming debate. In reality, both ends of the political spectrum (as evidenced, for example, by the Huffington Post) tend to trump science with ideology. That is the nature of politics. But at least the issue has been raised.
Briefly, defenders of science have pointed out that science should inform politics, not the other way around. Ideologues should not be allowed to put their thumb on the scale of science in order to get the result their ideology demands. Further, the optimal policy emerges from an honest assessment of the relevant science. Values still come into play for many issues, so science alone is not enough, but the science has to be right.
Within medicine this issue often involves the regulation of the standard of care and public health policy. An example of the former is the law passed last year is Connecticut that essentially exempts professionals who treat “chronic Lyme disease” from the standard of care – the department of health cannot act against their license for treating this controversial condition with unproven therapies.Rather than allowing experts to determine the standard of care, which is an ever moving target, this law locks into place a very controversial, and in my opinion dubious, practice.
Governments and environmental advocates are promoting compact fluorescent lightbulbs (CFLs) as a way of reducing electricity use, saving money, and reducing our carbon footprint. CFLs are not a perfect technology – when turned on they take a moment to fully brighten and they contain a small amount of mercury which requires special procedures for disposal. CFLs are likely also to be a transitional technology, as more energy efficient light sources (such as LEDs) are already coming onto the market. But CFLs are a safe and energy efficient alternative to incandescent bulbs.
It seems, however, with any new technology comes a wave of internet fearmongering, and CFLs are now a prime target. YouTube videos are circulating claiming that CFLs cause headaches, mercury toxicity, a host of symptoms from electromagnetic sensitivity, and something called “type 3 diabetes.” Let’s take a look at the claims and the science.
Mercury in CFLs
There is a small amount of mercury in each CFL, necessary for the function of the bulb, about 4mg on average, with some newer bulbs having as little as 1.4mg. There is no exposure to mercury from using CFLs, as long as they are not broken. Even if a bulb is broken the exposure to mercury is negligible, far less than eating a tuna fish sandwich. But still, there are recommended procedures for cleaning up and disposing of a broken bulb to further minimize exposure, such as not using a vacuum, and ventilating the area. These procedures represent the cautionary principle in action, but make it easy to fearmonger about the risks of the mercury in the bulb.
If you believe everything you read on the internet, then is seems that a chemical found in thousands of products is causing an epidemic of severe neurological and systemic diseases, like multiple sclerosis and lupus. The FDA, the companies that make the product, and the “medical industrial complex” all know about the dangers of this chemical but are hiding the truth from the public in order to protect corporate profits and avoid the pesky paper work that would accompany the truth being revealed. The only glimmer of hope is a dedicated band of bloggers and anonymous e-mail chain letter authors who aren’t afraid to speak the truth. Armed with the latest anecdotal evidence, unverified speculation, and scientifically implausible claims, they have been tirelessly ranting about the evils of this chemical for years. Undeterred by the countless published studies manufactured by the food cartel that show this chemical is safe, they continue to protect the public by spreading baseless fear and hysteria.
Hopefully, you don’t believe everything you read on the internet, and you don’t get your science news from e-mail SPAM, where the above scenario is a common theme. While there are many manifestations of this type of urban legend, I am speaking specifically about aspartame – an artificial sweetener used since the early 1980s. The notion that aspartame is unsafe has been circulating almost since it first appeared, and like rumors and misinformation have a tendency to do, fears surrounding aspartame have taken on a life of their own.
I am frequently asked my opinion about the safety of aspartame. Nutritionists often council to avoid the sweetener, citing unverified claims that it is unsafe. I was recently sent a chain letter warning that aspartame causes MS (which of course can be cured by simply avoiding aspartame), and Snopes informs me that this particular letter first appeared in 1998.
An article in the latest issue of PLOS Medicine, The Haunting of Medical Journals: How Ghostwriting Sold “HRT”, details the use of ghostwriting as a marketing tool for pharmaceutical companies. It is a chilling discussion of how at least one pharmaceutical company, Wyeth, used the peer-reviewed literature as a method of distributing marketing messages to physicians.
The author, Adriane J. Fugh-Berman, details a practice that cuts at the heart of science-based medicine – the exploitation and distortion of the literature. The medical profession needs to jealously guard the legitimacy and purity of the peer-review process and the medical scientific literature. I am never one to gratuitously bash “Big Pharma” – this is often used as a method of casually dismissing inconvenient scientific evidence. But at the same time, pharmaceutical companies are in the business of making money. While they are a carefully regulated industry, some in the industry seek ways to skirt around regulations that limit their ability to market their products.
While most physicians consider themselves savvy with respect to pharmaceutical marketing, the story told by Fugh-Berman is one of profound naivete. I guess it should not be a surprise that some academics were bamboozled by expert salespersons who spent a lot of time and effort, apparently, figuring out ways to deceive and manipulate them. But now that the story is out, naivete is no longer an excuse. Here is what happened:
There is an AIDS epidemic in Africa, and efforts to fight it are hampered by the endemic social problems of that continent. Chief among them are the lack of sufficient modern health resources, the spread of destructive rumors and myths about HIV/AIDS, and even the persistence of HIV denial in Africa (although this last factor is better than in the past).
The World Health Organization (WHO) and the International HIV/AIDS Alliance are teaming up with the Traditional Health Practitioners Association of Zambia (THPAZ) to address the first problem – the lack of health services. Most Zambians use traditional healers for primary health care. The WHO has therefore decided to utilize traditional healers in the fight against AIDS. There are interesting pros and cons to this policy, but it must first be recognized that there is no ideal solution to the problem. The resources to provide optimal modern health care to treat and prevent HIV/AIDS (which would need to include a massive education program) in Zambia and the rest of Africa simply do not exist. One might argue that the world should provide those resources, but let’s put that issue aside and focus on what to do in the meantime.
The arguments given in favor of this WHO strategy are:
Traditional healers far outnumber biomedical workers in the rural areas.
They are consulted, not only because they are closer and more affordable than their Western-trained counterparts, but also because they are embedded, extensively and firmly, within Ugandan culture.
Traditional healers are highly respected and widely consulted by communities.
Peer-review has been the cornerstone of quality control in academia, including science and medicine, for the past century. The process is slow and laborious, but a necessary filter in order to maintain a certain standard within the literature. Yet more and more scholars are recognizing the speed, immediacy, and openness of the internet as a tool for exchanging ideas and information, and this is causing some to question the methods of peer review. A recent New York Times article discusses this issue.
This issue is very relevant to Science-Based Medicine as this is in part an experiment – an attempt to produce a high quality, editorially filtered, but not peer-reviewed, online journal. Our process here is simple. Outside submissions are reviewed by two or more editors and typically are either accepted with minor revisions or rejected. In addition we have a staff of regular contributors – those who have a proven track record of producing high quality articles. There is no pre-publication review for their submissions, and they are able to post directly to SBM.
Because many of the issues we cover are timely, we emphasize speed of publication. Therefore copy-editing is done post-publication – the notion being that our readers can tolerate a few typos in order to gain access to material more quickly.
Bordetella pertussis is the bacterium that causes whooping cough – the main clinical feature of which is a severe lingering cough that can last for weeks or even months. Right now we are in the midst of an epidemic of pertussis cropping up in pockets throughout the US, most notable California. According to the CDC:
During January 1– June 30, 2010, a total of 1,337 cases were reported, a 418% increase from the 258 cases reported during the same period in 2009. All cases either met the Council of State and Territorial Epidemiologists definitions for confirmed or probable pertussis or had an acute cough illness and Bordetella pertussis–specific nucleic acid detected by polymerase chain reaction from nasopharyngeal specimens.
In addition, if the trends continue through the end of this year, which they are likely to do, this will be the highest incidence of pertussis in almost 50 years. These numbers are not in question, but there is some discussion about what, exactly, is causing it.