There has been a great deal of controversy relating to drug trials over the past several years. In our firm’s involvement in litigation against drug companies we have seen a number of questionable studies and reports from studies. Perhaps a recent revelation that started in an article in the Wall Street Journal was the biggest shock of all. It was reported that a prominent Massachusetts anesthesiologist had fabricated 21 medical studies involving major drugs. Baystate Medical Center, located in Springfield, Mass., has requested several anesthesiology journals to retract the studies which appeared between 1996 and 2008. The hospital says its former chief of acute pain, Dr. Scott S. Reuben, faked data used in the studies. That is big news to say the least and it’s an indictment of the pharmaceutical industry.
Some of the studies reported favorable results from use of Merck’s Vioxx and Pfizer’s Bextra, which as you will recall were subsequently pulled from the market. Other studies offered good news about Pfizer’s pain drugs Lyrica and Celebrex and Wyeth’s antidepressant Effexor XR. It appears that Dr. Reuben enjoyed a stellar reputation and the Journal reports that his work was particularly influential in pain treatment. Many doctors appear to have been shocked by the bad news now learned about the studies. Anesthesiology News first reported on the retractions. Obviously, the retractions will have a huge impact in the discipline of postoperative pain management. It will be interesting to find out what relationships – financial or otherwise – existed between Dr. Reuben and the drug manufacturers. Pfizer had funded some of Reuben’s research and had also paid him to speak on behalf of its medicines.
According to the Wall Street Journal, these studies had a great deal of influence on the practice of medicine. Because of Dr. Reuben’s “research,” it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements. Dr. Reuben even had a good relationship with the Food & Drug Administration and this agency apparently both respected his work and relied on him. This doctor had written the FDA asking it not to restrict the use of many of the painkillers he had studied. Quite often Dr. Reuben cited his fake data to make his case, according to reports in the Journal.
The Wall Street Journal says further that Dr. Reuben’s fraud has caused Anesthesia & Analgesia, a respected journal, to retract ten studies. It also posted a list of 11 other studies that were published in other journals on its Web site. The journal Anesthesiology said it has retracted three of the doctor’s articles. Not surprisingly, Dr. Reuben has strong ties with the pharmaceutical industry. Perhaps the most disturbing aspect of this scandal is that many of the drugs Dr. Reuben researched have been linked to serious side effects.
Like many antidepressants, the labeling of Effexor warns that it has been linked to suicides in young people and children. Both Vioxx and Celebrex have been linked to heart attacks and strokes. Vioxx was recalled in 2006 because of these specific problems. Had Dr. Reuben not been such a fraud, it’s possible that Merck wouldn’t have gotten away with putting Vioxx on the market or at least the company would have had to warn about the known risks associated with the use of the painkiller.
This is actually not the first time the integrity of studies involving Vioxx have come into question. During our firm’s litigation involving the drug, we saw evidence where Merck employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. Merck’s involvement in producing the data wasn’t disclosed. This revelation concerning Dr. Reuben – while a shock to the medical community – didn’t come as such a shock to lawyers in our firm’s Mass Torts Section. We have known for a good while – as a result of our involvement in drug-related litigation – that drug companies can’t always be trusted when it comes to their studies and studies that they finance. The FDA relies on that sort of thing when it approves drugs for the market place.
Source: Wall Street Journal
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