PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: Pfizer's Chantixgate: "Safety not supported by the data," according to ABC News contributor.

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Pfizer's Chantixgate: "Safety not supported by the data," according to ABC News contributor.

Following only a few months after Schering-Plough's Vytoringate, here comes Pfizer's Chantixgate, unfolding at a rapid pace, day-by-day:

According to ABC News, Dr. John Spangler, director of Tobacco Intervention Programs at the Wake Forest University School of Medicine in Winston-Salem, N.C., questions the safety of Chantix. Spangler is a contributor to

Spangler as early as May 2007 raised questions over the adequacy of the long-term safety of Chantix. He raised concerns about heart and vision effects in people who took the drug for at least one year. He brought them to the attention of the medical community, the U.S. Food and Drug Administration and Pfizer, the company that manufactures the drug.

At the center of these concerns was a study that purported to record side-effects of the drug, also known as varenicline, when used for an entire year.

Spangler says the safety study by researchers employed by Pfizer and published in a relatively obscure medical journal looked at far too few subjects — a total of only 251 taking the drug — to determine whether or not the drug is safe when used over that duration.

Yet, the conclusion of the study reads, "Varenicline 1 mg BID can be safely administered for up to 1 year" — a conclusion, Spangler says, that is not supported by the data.

Story on ABC News.


Anonymous Anonymous said...

Kind of interesting that contributing writer Dr. John Spangler is employed by Wake Forest University, which was FOUNDED by, and is heavily funded by RJ Reynolds Tobacco Co.(in Winston-Salem, NC)...hmm lets see, he's against a successful tobacco cessation product available for smokers fighting to quit this lethal habit.
Seems like a conflict of interest to work for a University heavily funded by a tobacco company, and be one of the only people out-spoken against this product, except for of course the other WAKE FOREST EMPLOYEE, and AUTHOR of the recent criticism, Dr. Curt Furberg, of again Wake Forest University, or should we say RJ Reynolds Tobacco University. It's pretty clear what's going on here..what a shame that Tobacco lies continue on, and that 400,000 lives are lost to tobacco illnesses every year.. How can you believe a word about any tobacco related health issues from ANYONE employed by a University founded on Tobacco money. What a joke. Check out this link to Wake Forests "Adjunct Professors" list. Recognize all the RJ Reynolds- "Targacept" chronies, and employees. "Targacept" is a competing product to Chantix, and was founded by RJ Reynolds!!. What a circle.


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