Researcher Faked Data for 21 Studies Involving Vioxx, Celebrex and Other DrugsMar 11, 2009 | Parker Waichman LLP
Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs. According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr. Scott S. Reuben, had faked data used in the studies.
In addition to Vioxx and Celebrex, some of the 21 studies involved the fibromyalgia drug Lyrica and the antidepressant Effexor XR. Reuben's study claimed to show that these drug worked well as painkillers, the Journal said. All of the studies were published between 1996 and 2008.
According to The Wall Street Journal, these studies had a great deal of influence on the practice of medicine. Because of 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, the Journal said.
Reuben even had the ear of the Food & Drug Administration (FDA), and had written the agency asking it not to restrict the use of many of the painkillers he studied. He often cited his fake data to make his case, the Journal said.
According to The Wall Street Journal, Reuben's fraud has caused the journal Anesthesia & Analgesia to retract 10 studies. It also posted a list of 11 others that were published in other journals on its Web site. The journal Anesthesiology said it has retracted three of Reuben's articles.
Not surprisingly, Reuben has strong ties with the pharmaceutical industry. According to the Journal, he had been a paid speaker on behalf of Pfizer - the maker of Lyrica and Celebrex - and it paid for some of his research.
Baystate Medical Center has placed Reuben on indefinite leave. He has also vacated an appointment as a professor at Tufts University's medical school, the Journal said.
Perhaps the most disturbing aspect of this scandal is that many of the drugs 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 Celebrex and Vioxx have been linked to heart attacks and strokes, and Vioxx was actually recalled in 2006 because of these problems.
This is actually not the first time the integrity of studies involving Vioxx have come into question. Last April, we reported that an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck & Co. 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. According to the analysis, which was published in the Journal of the American Medical Association, Merck’s involvement in producing the data wasn’t disclosed in many cases.