The need for transparency in medical studies

To help reduce the incidence of the publication of misleading medical studies, the Physician Payment Sunshine Act will require medical journals to disclose how much money researchers receive to conduct a medical trial.

I am often asked about new medical procedures and devices. As a director of the American College of Occupational and Environmental Medicine, I was glad to have the opportunity to attend a presentation related to this topic at the society’s April conference. Neurosurgeon Charles D. Rosen gave the presentation. He explained that he often sees patients for “salvage” procedures after they’ve undergone a prior procedure. Sometimes the initial surgery or surgeries did not resolve a problem or, worse, they introduced new problems. This prompted Dr. Rosen to delve deeper into the research behind the drugs and other products that physicians used in the surgeries.

Medical companies sometimes pay researchers large sums of money. They do this for various reasons, including defraying research costs. This is not a problem in itself, but large payments raise flags. Dr. Rosen’s research into some of these studies led him to some startling discoveries.

Medical studies can be deceptive when one assesses only the outcome. The way the study is conducted is just as important as the conclusions researchers draw, and these details are sometimes misleading.

Dr. Rosen gave an example of a study in which the researchers deemed a spinal fusion system successful based merely on X-ray evidence of bone fusion. They failed to mention that the system left two-thirds of treated patients dependent on narcotics for pain control.

In another instance, a drug company set out to prove that its new drug was no worse than an established drug in terms of side effects and reported only on the favorable comparison. The company neglected to mention any novel problems the new drug may have had.

There was even a case of a medical-journal editor who was “bought” to keep him from publishing dissenting opinions on an article on a particular medical procedure.

Perhaps the most despicable account was the case in which a researcher fabricated the participants in a drug study.

Dr. Rosen has testified to Congress on behalf of the Physician Payment Sunshine Act. This act, to be implemented in 2013, will require medical journals to disclose the amount of funding researchers receive to conduct a human trial on a drug, device or procedure. Traditionally, physician researchers simply acknowledge that they receive funding from another party without having to specify the extent of the monetary support.

Some medical device and pharmaceutical companies have been court-ordered to open their books. This information is available on the Ethical Doctor website, which also provides analyses of some medical studies. If you and your doctor are considering treatment changes, the site may offer some useful perspective.

Brian Svazas, M.D., M.P.H.