Some Prescription Drug Experts Question FDA Approval Process

The AP/Las Vegas Sun on Wednesday examined recent criticism of FDA's drug approval and safety monitoring system, as "many medical authorities" within and outside the government have begun to question "the fundamental safety guarantees for American drugs."

According to the AP/Sun, recent "troubling news" about several high-profile drugs -- including the voluntary withdrawal of Merck's painkiller Vioxx and scrutiny about the safety of antidepressants in children -- has "sapped confidence" in FDA, which over the past 40 years has "rarely" been so intensely criticized.

The AP/Sun reports that medical experts say no approved drug is ever really more safe than "a drive down the highway"; FDA is not designed to catch rare side effects until after it approves a drug; and FDA is "often powerless to spot mistakes quickly and reluctant to jump on them" in post-approval monitoring.

Some say "far too many" of the estimated 100,000 annual drug deaths can be linked to FDA's efforts in the past decade to streamline the approval process, while others say the flaws reflect the recent nationwide increase in drug use, the AP/Sun reports.

Merck spokesperson Tony Plohoros said that requiring more safety data would slow the drug approval process, delaying the availability of new drugs and inhibiting innovation. However, FDA last year viewed only a quarter of the 72 new drugs as "significant improvements" over drugs already on the market.

Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said new drugs must face "a high hurdle" for approval, but he added, "Everybody knows that the system we have now is not adequate to pick up all adverse events that will occur once a drug gets out into the population. The question is, are we willing to pay for more trials?"

Some experts say the drug industry is too closely affiliated with the trial, approval and monitoring process. Marcia Angell, a former editor in chief of the New England Journal of Medicine, said, "The industry has now captured the agency that is supposed to be regulating it."

Alastair Wood, a Vanderbilt University pharmacologist and FDA drug safety adviser, said, "If a plane crashes off the coast of New York, we don't leave the investigation to the controllers that were controlling the plane and the airline that was flying it."

According to the AP/Sun, "[n]early everyone believes repair is possible, but few predict quick sweeping action," and FDA and industry officials say the drugs they approve are still safe. FDA Acting Commissioner Lester Crawford recently said, "Medicines that receive FDA approval are among the safest in the world."

Jeff Trewitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that the recent safety problems occurred in only a few of the more than 10,000 currently approved drugs, adding, "In the vast majority of cases, these medications are doing what they are supposed to be doing" (Donn, AP/Las Vegas Sun, 12/1).

Eric Topol, chair of cardiovascular medicine at the Cleveland Clinic and "one of the most outspoken critics" of Merck's handling of Vioxx, served as a paid adviser to a hedge fund that "bet the company's stock would fall," the Wall Street Journal reports.

Connecticut-based Great Point Partners "shorted" -- or bet against -- Merck's stock, and two of the company's health-care oriented hedge funds through September were up about 25%, "in part due to the Merck bet," the Journal reports. Merck's share price has decreased by about 40% since the Sept. 30 withdrawal of Vioxx.

As reported in the most recent issue of Fortune, Topol has been advising the hedge fund since 2003, and the firm mentioned its relationship with him in a recent letter to investors. The letter stated: "Vioxx, while good for your arthritis, can be very bad for your heart. Eric Topol M.D., of our Medical Advisory Board, has been singing this tune since 2002, and we were on the right side (short) of that situation."

Topol, who has publicly criticized Vioxx since 2001, said he was paid $12,000 annually by Great Point and was unaware the company had shorted Merck's stock or used his name in promotional materials. Topol, who also noted that he did not invest in the hedge fund, said he resigned from the company after hearing it had advertised its relationship with him. Topol added, "Nearly all experts in academic medicine have served as consultants to industry and have relationships with companies in carrying out research, providing advice as a consultant" (Anand/Zuckerman, Wall Street Journal, 12/2).