Merck Mess Shows FDA's Flaws

When activists were battling to accelerate the approval of AIDS drugs in the late 1980s, they surely never dreamed that a souped-up pain pill like Vioxx would ride on their coattails.

The crusaders made history. They stormed the headquarters of the Food and Drug Administration in the fall of 1988, making a powerful statement for dying AIDS patients. Just eight days later, the agency adopted regulations aimed at trimming a thicket of red tape. It quickly began blessing new AIDS treatments in the years that followed.

"Without this [process], we would not have the cocktail" famous for treating AIDS and saving countless lives, says Michael Weinstein, president of the AIDS Healthcare Foundation.

But despite the early success, fast-track approval has started looking like a double-edged sword -- for the pharmaceutical industry as well as for consumers. While some treatments clearly merit special handling, critics say, the push to bring new products to market has compromised the integrity of the agency's drug-approval apparatus.

"The drug industry drove a Mack truck through the exception created for life-threatening illnesses," Weinstein continues. "Basically, everything became 'fast-track.' "

Questions about the FDA's approval process, and the agency's oversight of drug safety in general, loom especially large in the wake of Merck's (MRK Quote) mishandling of Vioxx.

The New Jersey pharmaceuticals titan stunned the world in late September by suddenly yanking Vioxx, one of its bestselling drugs, after a study showed that it increased the chances of heart attacks. Rival Pfizer (PFE Quote) has since warned that its own so-called Cox-2 inhibitor, Celebrex, could pose cardiac risks as well, though the New York-based company continues to sell its drug. Both companies had touted their painkillers as safe in the past.

In this second of five articles, TheStreet.com examines how the government's lax regulatory stance laid the groundwork for a drug disaster that ultimately proved hazardous to consumers and to Merck itself.

Test Market

Weinstein calls Vioxx a "me-too drug for arthritis pain" that should never have merited a priority FDA review. He claims that Merck "hijacked" the fast-track approval process, which allows drugs to hit the market after just six months of study by the government, and unnecessarily placed the public at risk as a result.

Vioxx Pain Lingers

Mess Shows FDA Flaws

Wednesday: Ads Added to Vioxx Sizzle

Thursday: Sizing Up Coutroom Foes

Friday: CEO's Ultimate Challenge

For its part, Merck insists that it carried out multiple studies that exposed no cardiac risks before it submitted Vioxx to the FDA for review. It also says that it sought quick approval for the drug because it offered pain relief without the serious, and sometimes fatal, stomach problems caused by other treatments.

The FDA offered Vioxx its blessing, comparable to the Good Housekeeping Seal of Approval in the eyes of the public, in mid-1999. But the agency did so despite its own concerns -- and lack of information -- about cardiac risks that, some experts already feared, could far outweigh any stomach protection offered by the drug.

One lawmaker marveled at the situation during a special November hearing of the U.S. Senate called by Iowa Republican Charles Grassley.

"If I knew that FDA had approved this drug for my use, but there was a couple of paragraphs back at FDA that said, 'It may cause heart attacks possibly, but we don't have enough data, and no more data is needed.' ... I don't think I would have taken it," said Sen. John Breaux, a Democrat from Louisiana. "It would scare the hell out of me."