A Food and Drug Administration advisory panel’s recommendation to ban drugmakers from marketing certain pain medicines directly to consumers could be the first step toward limiting a lucrative privilege the government granted the drug industry eight years ago.The FDA’s 1997 decision to make it easier for drug companies to tailor commercials for the public opened up the advertising floodgates--especially on nightly television--and is now blamed, in part, for the skyrocketing of health-care costs the past several years.In a stinging rebuke, advisers to the FDA last week asked the agency to ban direct-to-consumer ads for Cox-2 drugs, which had been among the most-promoted drugs in the U.S. before Merck & Co. pulled Vioxx from the market Sept. 30 and Pfizer Inc. suspended ads for Celebrex in December.The drugmakers’ decisions came in the wake of revelations about increased risks for heart attack and stroke from use of the drugs.The panel, the recommendations of which the FDA usually follows, blamed industry ads for putting Cox-2 painkillers in consumers’ hands despite the absence of data to prove that they were actually more effective and safer than existing medications and despite their being more expensive."There’s no such thing as informed decision-making,” says FDA safety researcher Dr. David Graham, who has publicly challenged his employer’s performance in ensuring drug safety. Graham said he believes consumers have become “victims of Madison Avenue."Consumer drug advertising has tripled to more than $3 billion annually since late 1997 when the FDA said drug companies could eliminate a number of disclaimers in their advertisements that effectively kept drugmakers from advertising on television. Instead, advertising now mainly urges consumers to talk to their doctors.But with congressional and public pressure building on the FDA in the wake of a number of unsafe drugs having reached the market, the agency panel was emboldened last week to take action."Congress can tell the FDA to start enforcing the law,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.Last year, for example, Wolfe said the FDA asked drugmakers to pull ads just 24 times, compared with 157 in 1998, the first full year after the agency eased restrictions on consumer advertising."There has to be better oversight,” Wolfe said.Although free speech laws would preempt an outright ban on direct-to-consumer ads, observers say the FDA could do more to regulate ads that overstate a drug’s benefits or understate its risks."I think the direct-to-consumer advertising has created some false impressions in consumers’ minds about the overall effectiveness and utilities for these drugs,” said Dr. Edward Langston, a member of the American Medical Association’s board of trustees and a family physician from Lafayette, Ind. “I think one of the weaknesses of [direct-to-consumer] ads is it creates some false expectations for our patients because they just hear what is emphasized."Merck has yet to decide if it will bring Vioxx back on the market, let alone advertise it. Pfizer says it will continue its three-month-old voluntary ban on consumer advertising, pending discussions with the FDA.The 1997 change allowed drugmakers to limit lengthy, specific safety warnings in ads by instead urging patients to “ask their doctors” or call a toll-free number for more detailed information about the medicines they were pitching.But even when so-called side effects are listed, doctors question whether the public really understands the information.FDA advisory panel chairman Dr. Alastair Wood alluded to ads for the impotency drug Cialis, in which viewers are warned about the possibility of a four-hour erection. Wood said the warning could be construed as a selling point, causing some “to assume more potency."Cialis is sold by Icos Corp. and Eli Lilly & Co., which defended the ads, saying the possibility of a four-hour erection is clearly identified as a side effect that should be discussed with a doctor.Drugmakers defend direct-to-consumer ads as a tool to drive patients to see their doctors for conditions for which they might not otherwise seek treatment."[Erectile dysfunction] can point to other serious to life-threatening conditions like diabetes or heart disease,” Lilly spokeswoman Kindra Strupp said."Anything that would get a man into the physician’s office for screening for other illnesses is a good thing,” Strupp said.
