The transparency mantra lands at doorstep of FDA

June 3, 2009
Ronald Piana

Newly appointed FDA commissioner, Margaret A. Hamburg, MD, has created a task force to study how to make the agency's processes more transparent. When it comes to cancer drugs, she's got a tough road ahead.

One buzz-phrase cemented into the lexicon of government bureaucracy is " a need for transparency." FDA, which contains nine centers that regulate US food and drugs, overseeing what amounts to a mind-bending 25% of the nation's GDP, has long been criticized as one the least transparent parts of federal government-particularly the offices that oversee the drug approval process.

According to newly appointed FDA commissioner Margaret A. Hamburg, MD, the agency has created a task force to study how to become more transparent. "Over the years there have been complaints about FDA's lack of transparency. FDA has been referred to as a "black box" that makes important decisions without explaining them...this task force is an agency-wide effort to try to make the agency more transparent to the public," Dr. Hamburg said during a recent news conference.

To kick off the transparency initiative, FDA will conduct two public meetings, the first on June 24th where anyone can comment on what needs to be done to make the agency more open. The FDA is also taking comments online-the deadline is August 7th.

The move is part of a larger effort by the Obama administration to make all federal agencies more open to the public. However, this effort might need more than a task force and public service campaign when it comes to explaining why certain cancer drugs are approved, and others are not.

The Office of Oncology Drug Products (OODP) headed by Richard Pazdur, MD, reviews all drugs intended for the treatment of cancer in the United States. It is a rigorous and much misunderstood scientific challenge to ensure that cancer drugs meet the agency's public standard for approval.

Here's where the transparency issue runs into a public relations problem.

OODP has regularly been cast by mainstream press as a Byzantine roadblock to drug approval, especially in experimental agents that are seen as the only hope for life in terminally ill patients. The rationale is simple; if a cancer patient is given a terminal diagnosis, allow that person every pharmacologic opportunity available. It is unethical to do otherwise.

If FDA wants to be more open, it needs to answer the question: Why deny a dying patient the right to use an experimental drug. The short answer is, the vast majority of "experimental" cancer drugs are denied approval because they simply don't work. And approving an agent that confers no benefit would be tantamount to giving cancer patients toxic placebos.

Most importantly, the FDA needs to explain that cancer drugs need to be safe and show benefit in the patients they're intended for. However, in cancer, the risk-to-reward ratio in toxicity and safety is relative to efficacy. In short, if the drug works, it is generally worth the risk imposed by the side-effect profile.

OODP wants very much to approve new cancer drugs. The more the better. As long as they work.

***Look for an upcoming series in the July issue of Oncology News International, "Inside the Black Box." ONI gives its readership an insider's look into the OODP.

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