FDA Head Speaks Up for Science

, sr. Washington rep., Center for Science & Democracy | December 16, 2014, 6:27 pm EST
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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.

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  • As a Stage IV breast cancer caregiver , and pt. rights activist , I support the 21st Century Cures initiative . We activists feel that Dr. Hamburgs ‘ tenure at the FDA has been marked by a failure to keep up with the pace of 21st century drug development . Costing lives . Top cancer research scientists have noted an increase in the development of biologic and immmunotherapy drugs since approx. 2005. This FDA has not kept up . There have been aseries of delayed approvals later reversed , every yr. since 2009 . This FDA since 2009 has been noted for failure to give accelerated approval to life – saving successful drugs such as Kadcyla, Iclusig, Lemtrada, Perjeta , and more . We find Dr. Hamburg to be a defensive, ” circle the wagons ” type defender of the 20th Century status quo. UCS deplores the industry ties at the top of the FDA ; we pt. activists deplore the lack of Stage IV pt. reps at the top of the FDA . We deplore the ” scare tactic” , un- scientific arguments of Dr. Hamburg and her scientist supporters – citing thalidomide, laetrile, and now vioxx , as reasons against reforming the expanded access/ so-called ” compassionate ” use programs. We are disappointed that a scientist active in the early yrs of AIDS tx. would be obstructing expanding early access and compassionate use . My wife is 4 yrs cancer free on Kadcyla- she is being joined by thousands more this yr alone. Dr. Hamburgs’ FDA refused to listen
    to top breast cancer scientists in 2010 and denied early approval for Kadcyla for 3 more yrs. Thousands died needlessly. We cannot afford any more of these major mistakes .

    • Celia Wexler

      Dear Mr. McCartin, I very much appreciate your comments, and I hope that your wife continues to benefit from this new drug. I want to make clear that all of us want the same thing — we definitely want the best available science to improve our lives and our health. Breast Cancer Action is one of the groups in our coalition,and shares our concerns about safety and efficacy. Any patient who wants to try a drug that still carries great risk ought to be able to do so. As you know Kadcyla was approved under expedited review by FDA, and it does have significant side effects. I’m glad that it has helped your wife.
      However, drug companies often increase their profits by selling to millions of patients who will not benefit and may be harmed by a new and untried drug, That’s what we want to prevent. We also think it’s very healthy for Members of Congress to get a balanced view of the potential benefits and harms of this approach.

      • Scientists and science journalists like yourself should be very careful when commenting on drugs that they have little direct experience with . There was nothing ” expedited ” about the FDA’s handling of kadcyla. 7 long years is not expedited . dana farber scientists have since said ” it should have been a slam dunk, instead it took 7 yrs ” . As I noted above , Kadcyla is just the most obvious sign of a dysfunctional drug approval system . The FDA is the main bottleneck but the industry grants pathetically few compassionate use requests and has slow, limited expanded access. Kadcyla is not a cure – all , but it has historic overall survival rates already , and it may very well be a cure for thousands of pts as well. Initially the FDA and Pharma labeled my wife as an ” outlier ” – they cannot label her that any longer . Hundreds of pts now are having similar long term benefits . We Stage IV pts knew in 2010, early 2011 that she was not an outlier. Who knows these drugs better than the Stage IV pts who volunteer for trials in Phase I ? Without our Sacrifice none of these drugs will ever get approved . Now we are claiming our Rights based on those sacrifices. We are tired of being labeled as ” desperate ” – if you were in our place you would be desperate too. We are desperate but not irrational . These 21st century drugs have fewer side effects . They are derivatives of already established science – on monoclonal anti -bodies , for ex. We are the ones who are all too aware of the ‘ ultimate side effect – our death . BC Action does not represent Stage IV breast cancer pts. They actively lobbied against Kadcylas’ early approval . When I said we Stage IV bc activists wanted Stage IV pt. representation at the FDA bc advisory commmittee level , we were well aware that bc action purports to represent all bc pt.’s . They do not ; they have a pro-FDA bias. We are not anti – govt or anti pharma , we are pro – Stage IV pt. We praise the scientific teams that develop these drugs – inside and outside of govt. We take no positions on other issues than those related to accelerated approval, expanded comp use . For ex., the lack of public funding for research . researchers go where the $$ is . We leave that issue to others ; we don’t have the time , literally. There is a groundswell of public support for our cause . This FDA , scientists and the pharma industry take note. Any interested in more on our cause – go to ” Our Her2Cancer Struggle ” on FB , or our website : stageivsurvivor.webs.com .