Vioxx, Celebrex and Bextra may have passed the acid test when a 32-advisors panel voted for the drugs to remain on the shelves, but the controversy they created have opened the eyes of the average American to the side effects presented by drugs.
Also, the dilemma faced by Food and Drug Administration (FDA) has now become public.
No drug is devoid of risks and side effects, says Dr Alastair J J Woods, associate dean, Vanderbilt University Medical Center. He feels that the side effects are the price that consumers pay for the benefits.
Even if the benefits outweigh the risks, the chances of pill-poppers facing grievous harm cannot be ruled out. Also, knowing the risks of a certain drug isn’t easy since the ads push only the health benefits while conveniently sidestepping the risks involved. Dr David J Graham, an FDA safety official, said, “For most drugs, we know little about how well they work and less about how safe they are.” More often than not, the risks of any drug are known only after it is well established in the market and becomes a habit for many users.
Where does that solution lie? Most of the advisors who decided the fate of Vioxx felt that direct to consumer advertising should be banned and ‘black box’ warnings should be printed on the covers of the drugs. While close monitoring and regulations of drug ads may offer a solution to a certain extent, greater participation from doctors prescribing drugs is required, since these ads target consumers who are easy to convince.
Critics argue that aggressive branding without the mention of risks targets the population that is suffering from chronic illnesses and is ready to believe the miracles promised by the manufacturer. James Fries, a Stanford University professor, said that direct-to-consumer advertising should be completely done away with because the harm outweighs the good.
But another lobby votes for direct advertising with the argument that such ads encourage savvier conversations between doctors and patients. One such proponent is FDA’s own acting commissioner Lester Crawford, who feels that many patients ask questions after seeing ads.
He, however, has announced that his agency would closely monitor ads that make unrealistic promises without mentioning the accompanying risks. “We have to send out letters instructing firms in no uncertain terms to stop this line of advertising and get back to informing the public about the virtues and the limitations of a drug,” Lester said.
Going by the fact that FDA took regulatory action against an Amgen television ad that overstated the benefits of Enbrel, a plaque psoriasis drug, and against Pfizer for skipping risk information about Bextra and Celebrex in its ads, one can assume that Crawford means business.
Meanwhile, the only advice that Woods has for consumers is treating every drug with caution.
