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From documents filed by federal prosecutors against Mary Holloway, believed to be a Pfizer employee, it appears that a rogue sales unit existed within Pfizer whose goal was to sell the painkiller Bextra, now withdrawn from the market for causing strokes and heart attacks, for off-label uses and at doses unapproved by the FDA.

Branchburg, New Jersey resident Holloway has pled guilty to violating the Food, Drug and Cosmetic Act by marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration. She now faces up to six months in prison and a fine of up to $100,000.

According to federal prosecutors, Holloway made particularly blatant efforts to promote Bextra using deceptive techniques, even towards her own sales team. She requested that her sales reps not be told about the FDA’s refusal to approve Bextra for certain types of post-surgery pain, and encouraged them to promote the drug for these uses. She fabricated safety claims as well as clinical showing that Bextra was safer than Vioxx. Her team went so far as to concoct a completely fake protocol for the use of Bextra to treat OB/GYN surgery pain (at unapproved doses nonetheless), despite its failure to gain approval for this use.

Holloway instructed her sales team to claim that Bextra could be used before, during and after surgery to reduce the risk of Deep Vein Thrombosis or “DTVs,” a form of life-threatening blood clots that can form during or after surgery, even though she knew there were no studies of Bextra showing that it was safe or effective for this use.

She also instructed her sales force to send out unsolicited medical letters to Vioxx loyalists as if they had asked Pfizer a medical question. -Jim Edwards, BNet.

The charges against Holloway appear to be related to those filed against ex-Pfizer executive Thomas Farina, who also pled guilty to off-label Bextra marketing last March.

Strangely, the federal documents don’t make a single mention of drug company Pfizer by name. Federal documents refer to her company only as “Pharmco.” Former Pfizer Marketing VP Peter Rost speculates that Pfizer negotiated a deal in its recent $2.3 billion settlement with the federal government to keep their name out of the Holloway scandal. Holloway shows up as a Pfizer employee on LinkedIn as well as Cafe Pharma.

BNET noted that Pfizer only revealed the settlement on the same day it acquired Wyeth; thus eclipsing the scandal. Further, Pfizer kept the settlement contingency out of its investor relations press releases even though they were included in its disclosures to the SEC. –BNet

The news from the drug companies just keeps getting worse…and weirder. My money is on the economy bottoming out first.

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