Pfizer and the Bextra Scandal
In April, 2005 the FDA removes Pfizer's' Bextra from store shelves. The company has bowed out to the FDA's requests as the Pfizer painkiller Bextra has had mounting concerns centered on its increasing of heart attack risks.
This move may have been considered surprising as the drug was recently, yet narrowly approved to remain on the shelf due panel speculation that its benefits outweigh its potential threats.
Perhaps this is a new chapter in the relationship between the FDA and the big pharmaceutical companies, but perhaps this is just a cheap ploy to take some of the heat off of the horrendous consequences of recent drug scandals by drug companies Pfizer and Merck.
The FDA explained in a statement that the overall risks from Bextra tilted the balance toward withdrawal of the drug. The agency cited an absence of long-term safety data for Bextra combined with known risks from the drug after heart surgery. In addition, Bextra has been linked to rare and sometimes fatal skin reactions, a phenomenon already noted in the drug's label. A final strike against Bextra, the FDA said, is that it lacks demonstrated advantages compared with other pain relievers.
In November 2004, Curt D. Furberg, a professor at Wake Forest University in Winston-Salem , North Carolina , was removed from an FDA panel reviewing the safety of COX-2 inhibitors in including Bextra. These are drugs of the same class as the recently withdrawn painkiller Vioxx, which was found to be causing tens of thousands of heart attacks.
Furberg looked at the data and found similarities between Merck's Vioxx and Pfizer's Bextra. Incredibly, when he expressed his preoccupation about the obvious similarities, he was removed from the panel as "biased".
"They'd said because I had taken a public position, I was disinvested". He added that he felt he wasn't biased, and he was "trying to be evidence-based" in making findings about Bextra from an analysis of data. "I collected the information to get evidence to contribute to the debate, I drew a conclusion, Dr. Furberg said.
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