The recent Vioxx withdrawal and testimony from an FDA insider accusing the agency of failing to protect public health are fueling such heightened concern over drug safety that valuable medicines could be kept from patients, doctors said on Friday.
In a congressional hearing to investigate the recall of Merck & Co. Inc.’s arthritis drug Vioxx, a senior Food and Drug Administration safety official on Thursday accused the agency of being “incapable of protecting America.” That has led to calls for an independent office of drug safety and predictions by industry observers that the FDA will become more cautious in how it approves drugs. But some doctors fear that could ultimately do a disservice to patients. “I think this is really blown out of proportion,” said Dr. Carl Lavie, medical director of preventive cardiology at Ochsner Clinic Foundation, in New Orleans. “I don’t think it’s easy at all to get a new drug approved, and if you start being extremely conservative you stand the risk of taking good medicines from people.” Congressional testimony by FDA official David Graham that singled out five other drugs on the market he said need closer scrutiny, has heightened concern to an extent that is becoming irrational, doctors said. “The scare factor has been overwhelming,” said Seymour Katz, clinical professor at New York University School of Medicine. Graham did not immediately return calls for comment. Some doctors say drug companies brought the problem on themselves through overly-aggressive marketing that does little to alert consumers or physicians to their drugs’ risks. As a result, medicines that can be valuable if used carefully become time-bombs when used indiscriminately by millions. “This is a wake-up call to the pharmaceutical industry that if they’re going to go big-time with advertising they’d better be prepared if anything goes wrong,” said Dr. William Berger, clinical professor in pediatric allergy and immunology at the University of California at Irvine. “They’re a victim of their own desire to create blockbuster drugs.” Yet drug companies are under pressure to market more aggressively than ever as they seek to boost profit growth amid increasing competition from cheaper generics and a scarcity of new drugs in late stages of development. Doctors said many of the problems with drug safety have less to do with the drugs — all of which have a risk-reward ratio — than on how they are prescribed. Drug companies, they argue, have by-passed physicians with their advertising campaigns, leading consumers to demand medications that could be harmful to them.”My personal bias is that there should be no mass marketing of prescription medicines to patients,” said Dr. David Peura, professor of medicine at the University of Virginia and president-elect of the American Gastroenterological Association. He said Vioxx had been an important drug for patients with stomach problems. William Douveia, associate professor of medicine at Tufts University School of Medicine, said problems with clinical use of drugs have traditionally been addressed by physicians. “But with the marketing of Vioxx, a clinical event has become a political event,” he said. In his Vioxx testimony, Graham raised concern over Abbott Laboratories Inc.’s weight-loss drug Meridia, AstraZeneca’s cholesterol fighter Crestor, Pfizer Inc.’s arthritis treatment Bextra, Roche’s acne drug Accutane and GlaxoSmithKline’s asthma drug Serevent. The five companies have all defended the safety of their products and doctors interviewed said there was a place for each of those drugs despite safety concerns. Both Serevent and Advair, which has Serevent as a component and is the leading asthma treatment, carry “black box” warnings — the most serious a drug can carry. However, Berger said despite known risks and a tendency for overprescription, it would be “disastrous” for patients if they were withdrawn. Despite Graham’s warnings, Berger said these are in fact the best of times for patients. “We’ve got the best drugs ever available to physicians in the history of patient care,” he said. “People are living longer and better lives than ever in the history of man.” (Source: Reuters, Nov 2004)