FDA Head Speaks Up for Science

December 16, 2014
Celia Wexler
Former contributor

When President Obama asked Dr. Margaret Hamburg to head the Food and Drug Administration in 2009, he chose a seasoned scientist with a demonstrated passion for public health.  She’s a physician and longtime advocate for public health, whose varied background includes stints as an AIDS researcher, and senior scientist at the Nuclear Threat Initiative, a nonprofit working to reduce the threat of nuclear and bioterror weapons. She also directed public health efforts in New York City, promoting needle-exchange programs to curb the spread of AIDS and reducing the climbing rate of tuberculosis cases in the city.

But even a seasoned professional like Dr. Hamburg has been challenged by what she’s faced at FDA. Dependent on fees from drug and device companies to support a significant portion of its approval budget, the FDA finds itself under siege as these industries press for an expedited process, their requests often amplified by many members of Congress. Patient groups, some representing rare and/or incurable diseases, often lobby the agency as well.  The FDA also is the target of our Center and other groups who feel that the agency’s oversight of drugs and devices is not stringent enough.  We also have raised concerns about FDA advisory panels that often contain experts with industry ties.

“Faster cures”

These days, the push for “faster cures” is gaining momentum, particularly on Capitol Hill.

We can only hope to see Dr. Hamburg’s vision of the importance of safe drugs and medical devices will be heard by members of Congress pushing through the 21st Century cures initiative. (Photo: FDA)

Everyone wants faster cures. Who wouldn’t? But the FDA’s mission is to ensure that the drugs and devices it approves are both safe and effective. Earlier this month, Dr. Hamburg found the ideal venue to emphatically make this case.

Hamburg was selected to give the Edward N. Brandt Jr. Memorial Lecture in Women’s Health at the George Washington University Milken Institute School of Public Health in Washington.

The annual lecture is co-sponsored by the Oklahoma University Health Sciences Center College of Public Health and honors Brandt, who died in 2007. As a senior official in the Department of Health and Human Services during the Reagan administration, Brandt sounded the alarm on the new disease – AIDS – that was becoming a major public health threat. He found ways to push back against attempts from the White House to cut spending on AIDs and other crucial public health work. He also was a pioneer when it came to promoting more research for women’s health.

Hamburg had met Brandt, although she had never worked closely with him. Nevertheless, you could perceive her respect and empathy for a professional trying to serve the priorities of public health while dealing with many external pressures.  Brandt, she observed, knew that government had a crucial leadership role in protecting public health. The foundation for that work, she stressed, must be the “best available science.”  Brandt’s efforts to get more federal support for AIDS, women’s health and other issues “were often made in the face of significant opposition and questioning, both in and out of government.  And yet he persevered.  And he made an enduring difference.”

Hamburg’s remarks were all the more important as the House of Representatives is preparing to advance a legislative proposal that might place even more pressure on the agency to emphasize “faster” over safer.

Safety first

The initiative, 21st Century Cures, has been the subject a scores of bipartisan meetings and hearings in 2014, in Washington and throughout the country.  Rep. Fred Upton (MI), a Republican, joined with Rep. Diana DeGette (CO), a Democrat, to explore the possibility that new technology might greatly expand the opportunities for effective new drugs.  The problem with this effort is that its message is heavily skewed. Its supporters believe that the FDA’s current approval process is “in many ways the relic of another era.” And its events and white papers have been dominated by groups, scientists and industry officials that are strong advocates for innovation and streamlining of established practices at the agency.  Those voices certainly deserve to be heard, but it’s been far more difficult for voices of caution – including that of our Center for Science and Democracy – to receive equal attention.  We want to make sure that this discussion is balanced, and reflects the views of those who want innovation, but not at the expense of safety and efficacy and science-informed regulation.

I asked Commissioner Hamburg about this initiative.  She, too, has reservations.  The effort, she said, “may bring positives” but she is concerned that too rapid a push towards innovation could also “decrease standards and authorities” that the FDA needs to achieve its mission to ensure that the medical products it approves are safe and effective.

We know what happens when drugs are approved and then prove to have serious side effects.  Vioxx’ impact on heart health caused tens of thousands of deaths and eventually led its maker, Merck, to stop selling the drug.  Safety concerns about the painkiller emerged early, but it took years, and many deaths, before the public learned of the safety problems.

Science, Hamburg stressed throughout her speech, must inform regulatory policy. And innovation must be harnessed to science-informed regulation if it is to “bridge the gap between scientific discovery, good ideas, and meaningful products and actions to address the public health issues of today and tomorrow.”

We can only hope that Hamburg’s vision prevails.  And that the drive towards “faster cures” does not jeopardize public health and safety in a race to get untried and untested therapies to the marketplace.