Pfizer (PFE) paid $73,512 for a study of the use of Celebrex in post-operative pain, but the doctor running the study simply made up his results, according to federal prosecutors.Dr. Scott Reuben (pictured), former chief of acute pain at Baystate Medical Center in Springfield, Mass., pleaded guilty to health care fraud and faces up to 10 years in prison, a $250,000 fine and forfeiture of $50,000 in assets.
The conviction raises a question: Were Reuben's efforts related to Pfizer's "Operate for Cash" program, which pushed Celebrex and Bextra for unapproved "off-label" uses in post-surgical pain? (The FDA had not approved either of the Cox-2 painkillers for that purpose.)
Pfizer has not been accused of any wrongdoing in relation to the case. The company said:
"Dr. Reuben's alleged actions are very disappointing. The withdrawal of Dr. Reuben's research due to alleged fabrications and the health care fraud charges filed against Dr. Reuben do not change the risk-benefit profile of Celebrex or Lyrica [another drug studied by Reuben]. Independent clinical research advances disease treatments and improves the lives of patients. As part of such research, we count on independent researchers to be truthful and motivated by a desire to advance care for patients."However, in the $2.3 Bextra settlement, the Department of Justice wrote a sentencing memo that described how Pfizer sales reps were rewarded if they persuaded doctors to write "protocols" for the use of Celebrex and Bextra in postoperative pain -- the area "studied" by Reuben. The memo said:
Many of these rewarded high-performing representatives, managers and districts with trips to places like the Caribbean and Europe. One such contest, the aptly named "OPERATE FOR CASH" contest, specifically rewarded sales representatives for obtaining protocols and standing orders that included Celebrex and Bextra, and thus specifically rewarded the off-label promotion of Bextra.Mary Holloway, a Pfizer sales manager convicted in the Bextra scheme, told a Massachussetts federal court that Pfizer management approved of the scheme to promote Cox-2 painkillers for surgery (download her sentencing memo here):
In April 2002, Pfizer, through Ms. Holloway, presented a $100,000 research grant to a consultant whose Pfizer-sponsored research focused on the use of COX-2 inhibitors, instead of narcotics, for postoperative pain control in joint replacement patients.
Indeed, the company publicized such findings. In February 2002, Pfizer issued a press release boasting that a new study suggested that Bextra was an effective morphine-sparing analgesic in knee replacement surgery.You can read that press release here. Holloway's action won praise at the company at the time, with one of her bosses describing her as "awesome."
When asked, Pfizer declined to say whether Reuben was in any way connected to the Operate for Cash program.
An investigation found that Reuben fabricated some or all of the data in 21 papers he published. Anesthesia & Analgesia retracted 10 of Reuben's studies and the journal Anesthesiology retracted three, the AP reported. The study Reuben did for Pfizer enrolled no patients, and the results were "wholly made up," according to the DOJ.
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