WASHINGTON — The government should reassess its policy of allowing prescription drugs to be advertised directly to consumers, a prominent cardiologist urged Tuesday in the Journal of the American Medical Assn.
The heart attack risks of arthritis painkillers Vioxx, Bextra and Celebrex have exposed a regulatory "house of cards" at the Food and Drug Administration, wrote Dr. Eric J. Topol, chairman of cardiovascular medicine at the Cleveland Clinic.
"Unbridled promotion exacerbated the public health problem," Topol concluded. "The combination of mass promotion of a medicine with an unknown and suspect safety profile cannot be tolerated in the future."
FDA officials have not publicly addressed the issue of whether high-powered advertising campaigns for newly approved drugs are in the best interest of public health.
Other leading academic researchers have suggested that new drugs should be subject to a trial period before they can be touted directly to patients.
Topol's sharply worded opinion article, to be published next month, was posted on the medical journal's website as part of the growing debate.
Critics have accused the FDA of being too cozy with the drug industry and unwilling to pursue evidence of problems with medications that it has already approved.
Manufacturer Merck & Co. withdrew Vioxx from the market in late September after a company-sponsored study confirmed research by Topol and others that it increased chances of heart attacks and strokes. Topol was among the chief critics of the drug.
New warnings have been added to the Bextra label, and concerns have been raised about possible problems with Celebrex, both produced by Pfizer Inc. The company recently agreed to suspend Celebrex advertising while experts sorted out preliminary study findings that indicated a heart risk for patients taking a high dose over many months.
All three drugs are of the same family of chemical compounds.
Celebrex and Vioxx, taken by millions of patients worldwide, were heavily advertised on television and in magazines and were considered blockbuster successes for their manufacturers. But though Vioxx had fewer side effects on the stomach than earlier generations of arthritis medicines, none of the three drugs was proved to be markedly better at reducing pain.
"These drugs were mass-marketed from the moment they were commercially available in the new world of direct-to-consumer advertising, with unrealistic expectations about pain relief, marked gastrointestinal protection and safety," wrote Topol. "One has to question the wisdom of allowing direct-to-consumer advertising for lifestyle medications that have no capability of preserving life or preventing major events such as [heart attack] or stroke."
Proposals for FDA reform include creating an independent office to monitor the safety of drugs already on the market and granting the agency new legal authority to require drug companies to conduct follow-up studies that would identify potentially dangerous side effects.
New drugs are usually tested on several thousand people before being approved, but problems may not emerge until hundreds of thousands of patients have used a medicine.