Last Updated Apr 6, 2009 11:44 AM EDT
Holloway is charged with marketing Bextra for uses and dosages that were not approved by the Food and Drug Administration. She has pled not guilty. She faces six months in prison if convicted.
The Holloway charges appear to be linked to those against ex-Pfizer exec Thomas Farina, who pled guilty to off-label Bextra selling in March.
Federal prosecutors allege an unusually brazen effort by Holloway to promote the drug, based extensively on lies. Among those alleged lies: Holloway asked that her sales reps not be told that the FDA had not approved Bextra for certain types of post-surgery pain; Holloway and her team promoted Bextra for unapproved uses, invented false safety claims, and invented false clinical claims such as that Bextra was safer than Vioxx. Holloway's team even invented a fictional protocol for Bextra use in OB/GYN surgery pain, even though Bextra was not approved for such. Of course, the bogus protocol used Bextra at unapproved dosages.
Here's a digest of the charges against her (you can download the entire document here).
The document starts by describing how the FDA informed Pfizer by letter that it was not approving Bextra for acute pain because of CV events in coronary bypass graft surgery:
Holloway received a copy of the FDA's letter raising these concerns and forwarded it to other Pharmco managers. Holloway asked these managers not to share the FDA's letter with the sales representatives.("Pharmco" is the euphemism the feds use for Pfizer. See an explanation of this below.)
Holloway promoted and caused the promotion of the sale and use of Bextra for a variety of uses and at dosages other than the Approved Uses and Dosages, ...Holloway later praised this rep in an email for the "Fantastic protocol."
Holloway and those acting at her direction routinely did not disclose that the FDA had specifically declined to approve Bextra as safe and effective for these uses.
Holloway also caused her sales force to promote Bextra with false claims of safety, including that Bextra had no dose proportional increase in hypertension and edema, that Bextra had no cardiovascular risks and that Bextra had placebo-like side effects.
Holloway also caused sales representatives to promote Bextra by telling physicians that Bextra was safer and more effective than Vioxx, despite the fact that there was no head-to-head studies of Bextra and Vioxx for the approved uses of Bextra that showed that Bextra was safer or more effective.
... a sales representative working under Holloway in Massachusetts drafted and recommended a protocol for the unapproved use of Bextra to control pain in OB/GYB surgeries, including at unapproved dosages, to a physician in Massachusetts.
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.
Rost notes that Pfizer is not mentioned in the document, even though her name pops up as a Pfizer employee on both LinkedIn and Cafe Pharma. He claims that part of Pfizer's $2.3 billion deal with the feds includes a promise that the feds will not name Pfizer in connection with off-label Bextra sales ever again. "Maybe this is what you get when you pay $2.3 billion to the government--the Pfizer name kept out of the press?" he says.
That's probably exactly it. A $2.3 billion settlement is huge. 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.
Such massive settlements usually include language that bring the matter to a close. In order not to disrupt the settlement, the feds seem to have chosen to avoid mentioning Pfizer's name in their ongoing mop-up of the individual clowns involved.
- Previous BNET coverage of Bextra:
- Pfizer District Sales Manager Guilty of Altering Off-Label Celebrex Documents
- Federal Prosecutor Warns Drug Companies on Off-Label Promotion: "This Must Stop''
- How Pfizer Hid a $2.3 Bill. Bextra Settlement in Plain Sight
- Pfizer's Wyeth Buy Eclipses $2.3 Bill. Bextra Troubles; 19,000 Layoffs to Come