Purdue Pharma promoted a study of OxyContin that purported to show that "withdrawal syndrome was not reported as an adverse event" when the data showed rates of withdrawal symptoms possibly as high as 20 percent, according to an examination of the study and documents filed in a federal court case. Only 15 patients in the treatment arm actually finished the osteoarthritis study, the authors noted.
Purdue's former CEO, Michael Friedman, and its chief legal counsel, Howard Udell, are trying to get a ban on their doing business with the government overturned by arguing that the OxyContin scandal was none of their doing because they "engaged in no misconduct demonstrating untrustworthiness."
A Connecticut federal judge transferred the case to the D.C. circuit on Dec. 28; a ruling is pending; here's the government's response. (BNET previously noted that during Friedman and Udell's tenure Purdue distributed a misleading chart with a logarythmic scale that disguised a steep drop off in OxyContin within users.)
The true meaning of the osteoarthritis study is alluded to in the "Agreed Statement of Facts" that accompanied the criminal conviction of Friedman and Udell for the promotion of misbranded drugs. That document describes -- but, cryptically, does not name -- "an osteoarthritis study that was published in a medical journal on or about March 27, 2000." It quotes the study as saying:
"Withdrawal syndrome was not reported as an adverse event for any patient during scheduled respites..."There was a study published on that date that included that quote. It was titled: "Around-the-Clock, Controlled-Release Oxycodone Therapy for Osteoarthritis-Related Pain," and was published in the Archives of Internal Medicine (Arch Intern Med. 2000;160:853-860). The study shows that 106 patients entered the study but only 15 completed 18 months' of treatment. The study claims that just one patient was recorded as suffering withdrawal syndrome when going off OxyContin. The statement of facts, however, notes that after the study was published Purdue did a review of the data within it. That review found:
... eleven study patients who reported adverse experience due to possible withdrawal symptoms during these periods.That means withdrawal syndrome rates may have been as high as 10 percent among study participants. If you do a little back-of-the-envelope math and assume that only the people in the treatment arm, not those who got a placebo, experienced withdrawal syndrome, then the rate could have been as high as 20 percent.
The statement continues:
On or about March 28, 2001, a PURDUE employee emailed a PURDUE supervisor regarding the review of withdrawal data ... asking: "Do you think the withdrawal data from the [osteoarthritis] study . . . is worth writing up (an abstract)? Or would this add to the current negative press and should be deferred?"
The supervisor responded: "I would not write it up at this point."The company distributed more than 10,000 copies of the study to doctors. The study's conclusion was:
... Use of controlled-release oxycodone, 20 mg, was superior (P<.05) to placebo in reducing pain intensity and the interference of pain with mood, sleep, and enjoyment of life.The statement of facts contains no names identifying the sender or the recipient of the email. Nor does it say who in Purdue ordered the study to be promoted. Perhaps the D.C. judge could ask Friedman and Udell to shed some light on that matter before he or she writes a ruling?