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Healthy Skepticism Library item: 15331

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Edwards J.
Pfizer District Sales Manager Guilty of Altering Off-Label Celebrex Documents
BNet 2009 Mar 19
http://industry.bnet.com/pharma/10001405/pfizer-district-sales-rep-found-guilty-of-altering-off-label-celebrex-documents/


Full text:

Thomas Farina, a former district sales manager at Pfizer, was found guilty of obstruction of justice after he was found altering documents on his computer during a federal investigation of off-label sales of Bextra and Celebrex. He faces a possible 20 years in prison and a $250,000 fine.

He also allegedly instructed three of the reps he supervised to delete and alter incriminating documents on their computers. The verdict came in a criminal trial in federal court in Massachusetts.

The two Cox-2 painkillers were approved for osteoporosis pain, rheumatoid arthritis and menstrual cramps, but Pfizer ended up promoting them for postsurgical pain at higher doses than the 20mg approval, the feds alleged.

The FDA had not approved those brands for that use because of “safety concerns, including in particular, concerns about potential cardiovascular risks,” according to the indictment.

The Farina indictment gives a tick-tock of how he altered his documents when he knew they had already been subpoenaed by federal investigators, and how he persuaded three of the reps he supervised to join him in the conspiracy.

March 12, 2004: Pfizer’s legal department sent a note to all employees asking that documents be preserved and retained for the investigation.

May 25, 2004: Farina did a compliance training session for his staff. “Farina showed his team a compliance video. This video specifically reviewed the fact that ABC Corp. was under government investigation with respect to X-Drug.” (ABC and X-Drug were the pseudonyms used in the original indictment to keep the investigation under wraps. Pfizer’s Celebrex, acquired from Pharmacia, has been of inerest to the feds since at least 2004.)

August/September 2004: Farina opened up his Celebrex documents, reset the time and date on his computer, altered the documents to remove off-label references, and then resaved the document so that it appeared to be older. He deleted the originals. He successfully instructed one of his sales reps to do the same thing.

Sept. 16, 2004: Pfizer Legal sent a memo instructing Pfizer reps to turn in their Celebrex documents. Farina then instructed two other reps to search for and delete those documents from their computers. But one rep secretly kept a copy of the deleted files. The reps are identified with initials NB, IG and AA. It was AA who kept copies.

Note that Pfizer cooperated with authorities in the investigation of Farina.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909