When we represent clients at the Alaska Personal Injury Law Group, we do our homework. When serious injuries occur, we have to become experts ourselves in the particular medicine being used to treat our clients. We thus comb through and rely extensively on medical literature in virtually every case we handle. We use it in our work with the medical experts we engage to help our clients, and we also share it with our clients.
And whether you realize it or not, you rely on medical literature every time you see a doctor or take any medication. This is because the engine of medicine runs on the data from medical literature. That data is what the FDA uses to decide whether to allow a medication or medical device to be sold, and what your doctor relies on to decide if a treatment, medical device, or medication will help you. Extraordinary rules and guidelines are put in place to make sure that the scientific findings in a particular study are objective and scientifically verified.
So it is always shocking when we learn that a manufacturer has taken liberties with the research data to make it appear that their product works when it really doesn’t. (We saw this repeatedly in the litigation against diet supplement manufacturers: Talbert v. E’ola Products, Inc.) We know why this happens: millions and sometimes billions of dollars are made by manufacturers in these endeavors, and greed can be a powerful motivator. Every time we learn about one of these situations, it reaffirms the need to vigilantly enforce the principles that guide regulators and researchers who develop research data. Western medicine is so profoundly effective because it is “evidence-based medicine”. If we allow clinical researchers to get into bed with the manufacturers, how can we trust that the research data they create for the manufacturers is valid, objective and truly “evidence-based”?
Today’s when-the-cat’s-away lesson involves Synthes, the manufacturer of an artificial spinal disc called the Prodisc. It turns out that doctors at about half of the medical facilities conducting clinical trials, i.e., performing surgeries, using the Prodisc stand to profit handsomely if the Prodisc is approved by the FDA. For example, 12 of the surgeons involved in the study had also invested in Synthes. The concern is that the study results submitted by the manufacturer to the FDA did not contain data about a large number of patients, some of whom said they had poor outcomes. Those critical of this conflict of interest suggest that the data casts the Prodisc, scientifically speaking, in “an overly flattering light.” Was it because surgeons in the study were also investors in the device? We can’t know for sure, but we do know that the research data is now tainted because of this impropriety.
This situation gives us yet another example of how conflicts of interest can distort scientific data and why the FDA and other gatekeepers should vigilantly eradicate them. The FDA should not accept data from clinical trials conducted by those who would profit from market approval of the device or medication being studied. The hospitals and universities conducting such trials should not permit their researchers and physicians to financially benefit from the studies being conducted. As professionals, the physicians themselves should recognize such conflicts of interest and refuse to participate as researchers or investors-attorneys, for example, are ethically barred from representing clients when such conflicts exist and are professionally bound to recognize when a conflict exists and refuse to represent a client when a conflict is present.
This situation with Synthes is also remarkable because these issues have actually come to light-most such conflicts of interest do not. Until the clinical data on the Prodisc is substantiated by objective researchers, surgeons and potential patients should steer clear of this device. If you can’t trust your doctor, who can you trust?
Source: N.Y. Times:
http://www.nytimes.com/2008/01/30/business/30spine.html;
Association for Ethics in Spine Surgery:
http://ethicalspinesurgeon.org/