Healthy Skepticism Library item: 11633

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Goozner M.
The failure of FDA reform
The Guardian 2007 Oct 1
http://commentisfree.guardian.co.uk/merrill_goozner/2007/10/fda_reform.html

Full text:

Despite an effort to change its culture, commercial interests still trump safety concerns at America’s drug oversight body.

Drug safety scandals have often served as the handmaiden of reform at the Food and Drug Administration. In 1938, after a hundred kids died from an antibiotic suspended in antifreeze, Congress told an adolescent drug industry that from now on its drugs had better be safe before they put them on the market. A quarter century later, fears that pregnant women might be exposed to thalidomide ushered in the modern era of drug testing – where drugs had to be proven effective as well as safe.

And in this decade, the Vioxx disaster, where a minor pain reliever wound up killing at least 40,000 people from premature heart attacks and strokes, led most observers, including the powerful Pharmaceutical Research and Manufacturers Association, to assume the FDA was on the eve of another major overhaul – this time making post-approval drug safety, not rapid approval of new drugs, the central focus of the agency.

Yet the legislation signed by President Bush last week falls far short of the major changes sought by consumer groups and the agency’s sternest critics. Asked by reporters Thursday if the changes in the bill would shift the agency’s emphasis from rushing new drugs to market to better surveillance of existing drugs, FDA commissioner Andrew von Eschenbach said only: “The new authorities are going to be helpful.”

Not by much, claimed David Graham, the man who nearly lost his job in the agency’s safety department after going public with his analysis of the damage done by Merck’s Vioxx. “So much more needs to be done,” he told a gathering of supporters this week at a fundraiser for his pro bono law firm, the Government Accountability Project, which defends government whistleblowers. “The legislation was supposed to put safety on the front burner. But what it really does is speak to the power of the pharmaceutical industry.”

One measure of the industry’s power is that there wouldn’t have been any reform at all if it hadn’t been for the Prescription Drug User Fee Act, which has to be reauthorized every five years. Under PDUFA, initially passed in 1992, the FDA charges drug and medical device companies fees to process their new drug applications. The fees generate nearly $400 million a year or about a quarter of the agency’s funds.

An Institute of Medicine report released last year castigated the user fee program for contributing to a culture at the FDA where the agency charged with ensuring the safety of the nation’s food and drug supply was more concerned with pleasing its funders by speeding new drugs to market than in protecting public health. The report called for a complete change in the way the agency does business.

The agency’s safety department needed to be beefed up and given an independent voice within the agency, it said. It is currently housed within the part of the agency that reviews and approves industry drug applications.

There also needed to be a ban on direct-to-consumer advertising, especially in the first few years after a new drug is on the market and its long-term risks are not yet known. And, critics said, the agency needed to sharply curtail conflicts of interest on its advisory committees, ending the practice where physicians who consult for drug companies or speak at drug company sales meetings also sit on the new drug review panels whose advise the agency usually follows.

Instead, the changes were much more modest. Companies will now have to step up monitoring of riskier new drugs after they’ve been approved, and adopt strategies for keeping them out of the hands of patients most likely to suffer from their side effects. The legislation should also improve the electronic system for physicians to report adverse drug events among their patients. There will be a small reduction in the number of conflicted physicians allowed to serve on advisory panels.

Congress did enlarge the safety section, but kept it within the office that approves new drugs, whose leaders, generally more closely aligned with industry, usually get the final say. The legislation also gave the FDA the right to penalize companies that fail to complete post-marketing safety trials demanded by the agency. About two-thirds of the clinical trials requested by the FDA at the time of a drug’s approval never get completed.

There is one provision that did cheer independent safety scientists. From now on, companies will have to register clinical trials in a public database, and post the results within a year. Steven Nissen of the Cleveland Clinic, who was among the first physicians to raise alarm bells about the cardiovascular risks associated with Vioxx, lobbied hard for the new disclosure requirements. “The problem we’ve had with companies refusing to reveal studies that show safety problems should come to an end,” he said.

But that’s hardly an earthshaking change. Billy Tauzin, who left Congress in 2005 to run PhRMA after helping the industry win a friendly version of the senior citizen prescription drug benefit, praised the legislation. It is “a vital step to both strengthen our nation’s drug safety system – already the world’s best,” he said.

Not so, the FDA’s Graham told the whistleblowers meeting. “What really needed to happen in this legislation just didn’t happen.” But at least he still has his job – and a few more tools with which to do it.