The latest in a long line of disgraceful behaviour comes from bizjournals.com where Eric Convey writes that a former GlaxoSmithKline associate general counsel was charged Tuesday in federal court in Boston with obstruction and false statements in connection with an investigation into the promotion of a prescription drug.
The Department of Justice says Lauren Stevens of Durham of North Carolina signed several letters to federal health regulators denying that her company had promoted its drug for unapproved uses. However, an indictment filed in Maryland alleges Stevens knew the company had paid physicians to promote the unapproved uses.
A GlaxoSmithKline spokeswoman confirmed Stevens worked in the company's legal department but has retired.
Her profile on LinkedIn still shows her as Vice President & Associate General Counsel at GlaxoSmithKline.
Ed Silverman at Pharmalot has posted the indictment for your perusal.
You will note that Glaxo's name has been changed in the indictment to 'K-Corp', I imagine this is because of press coverage. There is no mention of the actual brand name of the drug either but, according to the indictment it is believed to be a weight loss/obesity drug.
On or about February 28, 2003, STEVENS sent a letter to the FDA that included the following false and misleading representations:
a. "[K-Corp.] has not developed, devised, established, or maintained any program or activity to promote or encourage, either directly or indirectly, the use of [W-Drug] as a means to achieve weight loss or treat obesity. . . . [K-Corp.]'s promotional material and activities for [W- Drug] are consistent with the approved Prescribing Information and the supporting clinical data."
b. "[K-Corp.] has not developed or maintained promotional plans or activities to directly or indirectly promote [W-Drug] for weight loss or the treatment of obesity."
c. "[K-Corp.] has two types of advisory boards – National Advisory Boards and Local Advisory Boards. . . . [K-Corp.], through its field-based Market Development Managers, has established Local Advisory Boards in certain sales regions for the purpose of obtaining specific advice from health care professionals in that locale for [W-Drug] and/or issues relating to the therapeutic area of depression. Pursuant to [K-Corp.] policy, no sales region may have more than two Local Advisory Boards, and no such board may meet more than twice per year."
By February 28, 2003, STEVENS knew that K-Corp. had maintained programs and activities that directly and indirectly promoted and encouraged the use of W-Drug to achieve weight loss and treat obesity, and that K-Corp.'s promotional activities for W-Drug had not been consistent with the approved prescribing information.
On behalf of Seroxat Sufferers, I'd like to wish Lauren Stevens all the best and hope that she can find herself a decent lawyer - maybe she should go for the team that got Stevie Wonder his driving licence!
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
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