Wednesday, March 09, 2005

Americans lose trust in FDA after Vioxx recall


Consumer response to concerns about COX-2 inhibitors drugs like Celebrex, Vioxx, and Bextra was emblematic of how informed health consumers are changing pharmaceutical manufacturers' susceptibility to shifts in public opinion, consumer confidence, and corporate credibility. Despite the hype, Americans are more confident in safety of prescription drugs than in they are in the Federal Drug Administration's ability to ensure safety with use. (Related article: Dr. David Graham blasts FDA, Merck, Pfizer, and Cox-2 drugs)

The findings of an Associated Press and Ipsos Public Affairs poll suggest that consumers acknowledge the inherent risks in pharmaceutical drugs, but want the risks and benefits to be clearly communicated and effectively scrutinized by the agency approving the drugs that come to market, according to Fariba Zamaniyan, Vice President of Marketing and Business development for the Ipsos Health practice and a specialist in prescription drug purchase trends. Ipsos is a leading global survey-based market research company and conducts polling on behalf of the Associated Press. (Related article: FDA did not do its job in the Vioxx recall case and this will be a point of argument in class action lawsuits against Merck)

The trust in the FDA, supposedly an agency entrusted with the task of ensuring drug safety for Americans (and the world at large since drug regulatory authorities worldwide share information with the FDA), has tanked since it was disclosed that the FDA did nothing to prevent Merck from selling Vioxx that lead to as many as 140,000 injuries (and tens of thousands dead) in the United States alone. Apparently it was arguing with Merck over label changes for over a year without telling the American public that Merck was dragging its feet over label changes so that Americans could be aware of the drug's side effects. (Related article: Merck did not collaborate with Health Canada either)

In the meantime, FDA has continued to side with Merck and Pfizer. In a very bizarre development, a FDA panel set up to review the safety of Cox-2 drugs like Vioxx, Celebrex, Bextra, Arcoxia, and Prexige was filled with drug industry insiders (mainly Pfizer and Merck), and no surprise then, that the panel recommended that Vioxx, a drug deemed so dangerous that Merck voluntarily recalled it, be allowed to resume sales in the US and Celebrex and Bextra both be allowed to stay on the market.

Bextra, that carries a black box warning was banned by Kaiser Permanente since the HMO was not sure about its safety. Louisiana Medicaid has similarly backed off filling prescriptions for Celebrex and Bextra due to safety concerns. Drug agencies worldwide, including European Union, Australia, New Zealand, and Germany have either banned or put strong restrictions on prescriptions of Cox-2 drugs. (Related article: FDA panel recommendations in doubt due to conflicts of interest)

"Americans expect the FDA to do a better job of scrutinizing drugs before they come to market, and of communicating the risks," said Zamaniyan, "but, ultimately, pharmaceutical manufacturers will have to respond quickly and address the public's safety concerns and information demands, or risk losing consumer confidence." In her essay "Dr. Jekyll and Mr. Hyde: Pharmaceutical Companies Contend with Drug Benefit and Risk Communications," that appears in Ipsos Ideas, Zamaniyan examines the new predicament for pharmaceutical manufacturers. "With greater consumer brand awareness comes increased sensitivity to shifts in public opinion, consumer confidence, and corporate credibility."

Recommended articles: Making sense of FDA panel's recommendations on Vioxx, Celebrex, and Bextra

FDA refuses to recall Crestor

FDA must recall Adderall till sufficient risk analysis is completed

Source: Ipsos