… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Saturday, September 18, 2010
White Coat, Black Hat:
Adventures on the Dark Side of Medicine
From the Globe:
(Dennis Rosen, MD, a pediatric lung and sleep specialist at Children’s Hospital Boston.)
Science is the central pillar of modern medicine. This is why physicians prescribe antibiotics instead of snake oil when deciding how to care for ailing patients. It is also what gives patients confidence in the prescribed treatments despite the associated costs and risks.
Carl Elliott’s excellent account of the interaction between the pharmaceutical industry and physicians over the last several decades paints a troubling picture. The book is a cross between investigative journalism and a reflection on how greed and a lack of concern for the health and well-being of the public have undermined the scientific foundation of medicine to the point where a severe crisis of confidence has emerged. To appreciate this, one need only consider the persistence — in some sectors — of the belief that vaccines cause autism, despite overwhelming scientific evidence to the contrary.
Elliott, a professor at the Center for Bioethics and the departments of pediatrics and philosophy at the University of Minnesota, starts by investigating how clinical trials are conducted. Clinical trials determine the safety and efficacy of new therapies. Randomized double-blind studies are considered the gold standard.
Contrary to what one might expect, the majority of these studies are not conducted by physicians at academic centers, but by private companies with a financial stake in completing them as quickly as possible. This often involves recruiting “professional guinea pigs,’’ people who participate in multiple studies over a short period of time for financial reward.
In order to prevent research subjects from quitting a study early once they discover that they don’t enjoy undergoing the procedures or conditions involved, companies often withhold the bulk of their compensation until the study is completed or the subjects are forced to withdraw because of an adverse event. Elliott discovers that this often leads to subjects faking side effects in order to quit and still get paid, which can profoundly affect the findings of a study meant to determine whether a drug is safe. So much for the gold standard.
Once a drug is approved, there is tremendous pressure on the drug company to market it and get a return on investment.
This has led to the planting of ghostwritten articles in medical journals under the names of people considered to be leaders in their fields (a practice that has fallen into disrepute), the cultivation of “key opinion leaders’’ to act as paid spokespeople for pharmaceutical companies, and the distribution of gifts to physicians so they will agree to meet with salespeople. These range from lunches to junkets, golf clubs, and in one case, the hiring of a financial consultant to advise a physicians’ practice, at a cost of $50,000 to one drug company.
Elliott points out that while most physicians deny any correlation between the gifts they receive and their prescription practices, research has found that the opposite is true.
There is increasing backlash against these excesses, among the public and within the medical community. For example, Harvard Medical School recently announced new guidelines, to be implemented in 2011, prohibiting faculty from accepting meals and gifts and participating in industry speaking bureaus, among other restrictions.
It is important to remember that many of the medications and devices we rely on today are available only because of the innovation of biomedical and pharmaceutical industries, driven in part by the motivation for profit. It is also important to consider what can occur when this motivation is allowed to supersede all others. Elliott’s book, accessible to the lay reader, is a powerful description of exactly that, and will hopefully serve to strengthen those who would try to prevent it from destroying the very foundations of the profession itself.