Recent recalls provoke drug-safety debate

The Pharmaceutical Research and Manufacturers of America and numerous patient advocacy organizations spoke out against negative media coverage about recent drug withdrawals from the market.

The new stories, which have appeared on television and in national newspapers such as USA Today, have implied that the drug approval process has been compromised in recent years by initiatives that have sped new drugs to market faster. As a result, unsafe drugs such as Redux, Posicor and Duract, have reached the market and needed to be withdrawn shortly thereafter, the media speculated.

"Evidence does not support this contention," stated Carl Dixon, president and executive director of the National Kidney Cancer Association. Dixon, along with 20 other national patient organizations, such as the Cystic Fibrosis Foundation, the American Cancer Society, the National Mental Health Association and the National Multiple Sclerosis Society, protested the reports in the form of an open letter to USA Today.

"In recent years, the FDA has been able to hire additional employees to review drug applications, and the agency has approved new medicines more quickly as a result. But the FDA has not compromised its world-class standards for the safety and effectiveness of new medicines," the letter read.

PhRMA supported that claim and applied an easily understood metaphor to the changes that have revolutionized the drug approval process: "If your local motor vehicle bureau hired more reviewers and was able to issue more driver's licenses more quickly, it wouldn't mean that safety standards were lowered, just that the lines would be shorter and you wouldn't have to wait as long."

Furthermore, PhRMA noted that the average number of clinical trials conducted per drug has more than doubled to 68 since 1980. The average number of patients who participate in clinical trials has also increased; since 1980, the average number of patients per trial has risen from 1,500 to more than 4,000.

The percentage of new drug applications approved and rejected, however, has stayed the same, PhRMA stated. In the 1970s, 10% to 15% of applications were not approved; that number is roughly the same today.

"Not one safety rule has been modified or changed," said Jeff Trewhitt, a spokesperson for PhRMA. "If anything the FDA has expanded its safety systems."

Although Trewhitt acknowledges that three drug recalls in one year is a lot - possibly the greatest number ever, - he also notes that there have only been 10 to 16 recalls out of the 500 drugs approved since 1980. "The vast majority are still on the market doing precisely what they were approved to do."

Last year, for example, pharmacies filled 2.5 billion prescriptions for medicines to relieve pain, fight infection and enhance quality of life for patients.

If anything, Trewhitt said, the three withdrawals indicate that the FDA is especially concerned with safety issues. "The fact that they withdrew the drugs shows they are paying attention," he said.

He also pointed out that Redux, one of the products in the controversial fen-phen combination, was dangerous as a result of off-label prescribing habits, not FDA negligence. And Duract caused death in some patients because it was taken beyond the indicated treatment time period. Patients did so despite the presence of a prominently displayed black box warning on the product's label.

PhRMA and the patient advocacy organizations expressed concern that media hype over the recalls would cause delays in the approval of useful new drugs. PR