Fears of 'overcaution' by FDA after Vioxx woes go unfounded

BETHESDA, Md. -- Drug company officials, Wall Street analysts, and investors have nervously predicted that drug regulators would slow approval of new therapies after safety problems forced Vioxx from the market last year.

But recent votes by federal advisers -- whose actions are often heeded by the Food and Drug Administration -- suggest to some that those worries are misplaced.

For instance, after two days of testimony last week by drug company executives and sometimes tearful cancer patients, advisers recommended that the FDA approve three of the four cancer drugs up for consideration.

Merck & Co.'s decision to pull the painkiller Vioxx triggered congressional hearings and a flurry of proposed bills designed to improve drug safety. Many who track the pharmaceutical industry worried a newly cautious FDA would delay drug approvals.

Even the FDA's former chief counsel, Daniel Troy, predicted drug-safety controversies would induce ''deadly overcaution." Last week's hearings in a Maryland hotel ballroom proved him wrong, he admitted.

''Coming from my bearish perspective, I was very heartened and, in some cases, pleasantly surprised," by the federal advisory panel approval votes, Troy said.

The drug industry pays especially close attention to advisory panels that assess cancer drugs because such products have the most revenue potential. Cancer drugs sold by prescription amounted to the $11.2 billion in 2004. It is a segment of the pharmaceutical market that is crowded with 400 products in the pipeline, and it is also littered with failures. The FDA weighs the most complicated applications in public, using outside experts like the members of the oncology drug panel that gathered here.

AIDS treatments and cancer drugs originally prompted the FDA to devise ways to speed its drug review process. Regulators said they were willing to delay receipt of key facts, like a true picture of whether a drug works, in exchange for getting life-saving products to patients faster. For example, in 2002 the FDA approved the colorectal cancer drug Eloxatin just days after Sanofi-Synthelabo submitted the last part of its application.

Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said the agency's panels shift subtly in response to science, not dramatically due to the fall of a blockbuster drug like Vioxx, he said.

''I think the speculation that FDA is going too fast, or too slow, and is reacting to the political environment isn't really true," Gottlieb said.

Peter Barton Hutt, another former FDA chief counsel, said allegations in the 1990s that accelerated agency reviews led to the withdrawal of scores of unsafe drugs caused the FDA to toughen its approval process.

''Since 1999, clinical trials are longer, more complex, have more dosage levels in them, more patients, longer follow-up and, indeed, more clinical trials are required," Hutt said. ''So, when Vioxx came along, FDA couldn't be more conservative."

But the chairwoman of the panel in Maryland said the FDA should be even more cautious in its approach to new drugs for the 1.4 million Americans diagnosed with cancer each year.

''My goal is to find new drugs for them, but it has to be to find new drugs that really work," Dr. Silvana Martino said in an interview. ''Not just drugs that we sort of pretend could work, might work, or have a whiff of activity."

Martino, a breast cancer expert at Keck School of Medicine in Santa Monica, Calif., strikes fear in the hearts of hopeful drug makers. But she shrugged off her reputation for being hostile to the industry.

''I am not here for any drug company. I am not here for FDA. I'm not here for you, as the media. I am here for patients. It's that simple," she said.

Derek Taller of the New York brokerage firm Cathay Financial Inc. said the true impact of Vioxx on the approval process may not be known until the end of the year, when the agency grades itself on deadline performance. In exchange for user fees paid by drug makers, the FDA is mandated by Congress to process drug applications in a timely manner.

That may not be happening, Taller said. For example, a small pharmaceutical company that should have had an FDA approval decision in March was kept on hold until August. Taller, a senior biotechnology analyst for Cathay, expects more companies will face similar delays.

''That's where I believe there is going to be a discernible trend," Taller said. ''They're just not rushed. They're trying to make sure everything has been done to completion, so people can't come back at them for sloppily done work."

Diedtra Henderson can be reached at dhenderson@globe.com.