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 ABCNews.com.
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.