Analysis: New call for FDA openness

WASHINGTON, March 6 (UPI) -- Two researchers Tuesday urged a change in U.S. Food and Drug Administration policies to allow the scientific community access to pharmaceutical manufacturers' clinical trial data in order to help reveal safety issues with new drugs.

The call comes at a time when the agency is facing a barrage of criticism about how it handled several drugs, including Vioxx and anti-depressants. The momentum to change the policy of business as usual at the FDA has been intensified by recent negative reports from the Institute of Medicine and the Government Accountability Office and the Democrats in Congress, who have tightened oversight of the agency.

The researchers, who include Aaron Kesselheim of Brigham and Women's Hospital and Michelle Mello of Harvard's School of Public Health, argue in the March/April issue of Health Affairs that it would be in the best interest of public health for the FDA to release safety data about new drugs from clinical trials.

"The FDA is taking an unnecessarily expanded view of confidential obligations and it could and should be releasing this data," Mello told United Press International.

The FDA's view that information is protected because it is proprietary is reasonable when it comes to data about the molecular structure of a drug or even efficacy data, but it's a stretch to make that argument when it comes to safety information, Mello said.

The researchers argue in their article that disclosing the research data may help "reveal dangerous drug side effects that call into question manufacturers' claims or the FDA's decisions."

In addition to Merck's Vioxx and Pfizer's Bextra, Kesselheim and Mello cite several examples of approved drugs that were later discovered to be more dangerous than initially thought.

This includes Scios' Natrecor, for which the company issued a warning to physicians to limit their use of the drug after the data related to the medication was reviewed by an expert panel.

After an FDA advisory committee recommended Bristol-Myers Squibb's Pargluva for approval, other researchers analyzed the data released by the FDA and found an increased risk of death and cardiovascular complications. The company subsequently withdrew the drug from FDA consideration.

There is some indication that companies may be becoming more open about releasing safety data and conducting postmarketing surveillance in the wake of some of these revelations, but that may not be enough to appease the critics.

"That's not a substitute for having data available for other people to conduct their own independent analyses," Mello said.

The FDA could act on its own to change its policies because the statutes and regulations give a broad definition of what constitutes a trade secret, she said. They could also require companies to meet a heavier burden of proof that releasing this data would result in competitive harm.

But if the FDA does not act, congressional action might be necessary, Mello and her co-author argue in their article. This is a situation that is more likely now that the Democrats control Congress.

The Pharmaceutical Research and Manufacturers of America did not respond to UPI's request for comment by press time.

Peter Lurie, of the watchdog group Public Citizen, told UPI the crux of the issue is the struggle between scientific openness and the corporate necessity for trade secrets.

"Science is all about openness, sharing and building upon successes and failures of others, whereas the corporate world is all about secrecy and confidentiality," Lurie said.

"They're at war with one another and at least up until now, corporate concerns have tended to trump public health ones," he added.

Lurie disagreed with the rationale for separating safety data from efficacy data, saying that both need to be considered to determine a drug's balance of risks to benefits.

"Both need to be made public, and I think they should be made public from the very beginning of the drug approval process," he said.

Lurie thinks Congress will have to pass legislation addressing this issue because it is unlikely the FDA will address it on its own.

He noted the agency has proven unwilling to change its policies on disclosure of information under the auspices of the Freedom of Information Act and has not requested Congress to enact legislation that would free it from the constraints of protecting confidentiality even when public health may be jeopardized.