Pfizer defends Bextra and calls it safe
Pfizer is still adamant that Bextra is a safe drug and the FDA might have committed a grave mistake by banning it. This comes after the FDA found that Vioxx was not a safe drug either, and also put its strongest black box warning on Pfizer's other drug Celebrex.
Julie Appleby of the American newspaper USA Today spoke to Pfizer's CEO Hank McKinnell about Bextra, drug prices, pharmaceutical advertising and his book, "A Call to Action: Taking Back Healthcare for Future Generations."
It may be recalled that after Merck recalled Vioxx in September 2004 after it was found that Vioxx's cardiovascular risks were just too high for it to be left on the market. It was later found by an FDA expert that as many as 140,000 Americans may have sustained personal injuries and of these 40,000-50,000 may be dead. However, while these pieces of data were being released, Pfizer was pumping its Cox-2 drugs until more data released showed that both Celebrex and Bextra were equally, if not more, dangerous. (Related article: Canada also decides to review Celebrex, Bextra, Vioxx, and Mobic)
After several months of debate among medical experts and publication of research that showed that both Merck and Pfizer may have oversold their Cox-2 drugs and put misleading messages in their advertisements, FDA forced Pfizer to recall Bextra in April this year.
McKinnell was reminded by Appleby that according to the FDA, Bextra's risks outweighed its benefits. She asked him if Bextra would return to the market. Like previous statements that he has been making, McKinnell said, "I don't know. I do know for many people it is the best option. It has the risk of a serious skin reaction. We think with the appropriate safety program in place, there is a possibility it could be returned to market." Merck has been making similar statements though many experts believe that this is only something that is being done as part of their legal strategy. It is highly unlikely that these drugs would ever return.
Another issue that came up in the interview was the lack of trust the Americans have in the drug industry. It is no secret that America is the most medicated nation in the world and Americans consume more drugs than anyone else. Americans also see the most direct-to-consumer ads and despite the proclamations of the pharma companies, they pay the highest prices in the world for drugs. Americans are also being attacked indirectly by the drug firms in collaboration with the FDA by not allowing them to import prescription drugs from Canada and Mexico.
When asked if Americans should trust the drug industry, McKinnell offered a scripted answer, arguing that due to the strict control of drug supply, only 1% of drugs are counterfeit here. He added, "But the public needs to understand that there is no such thing as an absolutely safe medicine. Any drug powerful enough to do good can also do some harm. ... I would not say people should trust the drugs, they should trust their doctors."
That is another debatable point that received some attention during recent hearings on Capitol Hill. It was pointed out during those hearings that American doctors do not take the trouble of keeping up to date with research, rely on pharma firms to teach them about new drugs, often cave in to pressure from patients when the ask for specific drugs (whether it will be good for them or not), and rarely disclose their conflicts of interest to their patients. (Related article: Impact of pharmaceutical promotions on a doctor's prescription patterns)
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