The U.S. Food and Drug Administration (FDA) is suffering from a debilitating addiction to doing what's good for the drug industry and bad for the American people. It's going to take more than just a new FDA commissioner to help the agency kick its habit, and we have a 3-step plan (hey, it's easier than the 12-step program!) to help it become an effective regulatory body. If the FDA were a human being, here's what we would say:
Step One: Admit that you are currently powerless over the industry you are supposed to be regulating. You have let Big Pharma take over your life. You have become dependent on drug company money that comes from the Prescription Drug Fee User Act (PDUFA) of 1992, and over the years you have grown too cozy with the industry officials. Admit it. You're so addicted that you don't make a move without consulting first with characters named Merck, GlaxoSmithKline, Lilly and Pfizer. Under PDUFA, you have received approximately $825 million in fees from fiscal years 1993 through 2001. During that period, median drug approval time dropped from 27 months to 14 months for non-priority drugs. At the same time, drug recalls increased from 1.6% for 1993-1996 to 5.4% for 1997-2001. There was Rezulin, Trovan, Baycol, Fen-phen, Bextra, to name just a few, and of course, Vioxx. That drug alone killed 39,000 to 60,000 people before you finally woke up and began listening to your own safety experts and got the manufacturer to withdraw it. It's time to look in the mirror and admit you are powerless.
Step Two: Accept that the public as your higher power -- not Bristol-Myers Squibb or Genentech or any of the other companies you are supposed to be regulating. Stop protecting industry profits over your real task -- safeguarding the public health. This step will require some tough action -- and a tough commissioner. You need a leader who isn't afraid to stand up to industry and to Congress, which is also awash in Big Pharma dollars. It's hardly a surprise that many members of Congress avert their eyes when your own safety experts complain that unsafe drugs are being rushed to market while postmarketing safety studies -- so necessary to ensure the public health - are delayed or simply ignored.
We know you're underfunded, but you should stop taking PDUFA fees directly from industry in exchange for rushing drug and medical device to market. Instead, money should be appropriated by Congress from general revenues to fund both drug approval and postmarketing surveillance. You should also create entirely separate divisions within yourself for drug approval and for safety surveillance, so that the people who approve a drug are not the same people in charge of monitoring its safety once it goes on the market.
Step Three: Find new friends. Even with a new commissioner, it's going to be hard to stay straight if you are still hanging with the same people who were there when you got hooked in the first place. We're talking about the heads of the major FDA drug divisions, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research, and several of their lieutenants. While you're at it, get rid of the lawyers who have focused on protecting Big Pharma from lawsuits, rather than on protecting the public from unsafe or ineffective drugs.
Bring in a new team. Think of them as your sponsors. You also need many new members to serve on your advisory committees, outside experts who don't have financial conflicts of interest with industry. We don't want to hear the excuse that you can't find anybody because all the experts are consulting with Pharma. We happen to have created a long list of industry-independent researchers and physicians who are tops in their fields. Many would be only too happy to serve on your advisory panels or as FDA officials.
To help you get started on the path to doing a better job, we offer a list of candidates for the various jobs that will be available once you make a clean sweep of your top officials. You won't find our picks on the short-lists currently circulating at the Wall Street Journal, the Washington Post, or our friends' blogs.
Those lists typically include names like Dr. Josh Sharfstein, the health commissioner of the city of Baltimore. Sharfstein hasn't yet proven he's tough enough to stand up to Congress and Pharma. Then there's Dr. Peter Rost, former industry marketing executive turned drug company critic. The guy is handsome, charming, a great self-promoter, but is he really FDA commissioner material? The most likely candidates are academic researchers Dr. Robert Califf, of Duke University, and Dr. Steven Nissen, from the Cleveland Clinic, people who look good on paper, but may be too close to the drug industry. The same goes for Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.
Our list, by contrast, includes brilliant, capable, independent leaders in science and policy, real experts and outsiders who could help turn a beleaguered agency around:
Curt Furberg, MD., PhD, a professor Wake Forest University School of Medicine, is a well-known cardiovascular epidemiologist with expertise in clinical trials, drug evaluation, drug safety, and the pricing of drugs. He previously worked at the National Heart, Lung and Blood Institute where he served as Chief of the Clinical Trials Branch. In other words, he knows from clinical trials. He is a former member of the FDA Advisory Committee on Drug Safety and Risk Management and has testified before Congress on drug safety issues.
Michael Wilkes, M.D., Ph.D., Vice Dean of the University of California, Davis Medical School and Director of Global Health, is an international expert in medical education, a clinical epidemiologist, and health services researcher. He has served as an expert consultant for the FDA, US Congress, the Canadian Government, and numerous professional groups around issues related to drug evaluation, pharmaceutical advertising, and physician education. He is an effective leader and consensus builder.
Dr David Schriger, MD, MPH, professor of emergency medicine at UCLA has served as a methodologist on guideline development for the Agency for Health Care Research and Quality and the National Institutes of Health. His research focuses on the quality of the medical literature and methods for decreasing bias in the medical literature. He is a deputy editor of Annals of Emergency Medicine.
Lisa A. Bero, PhD, is pharmacologist and professor at the University of California, San Francisco, who has served as an advisor to the World Health Organization Drug Action Programme and on the Institute of Medicine Committee on Conflict of Interest in Medical Research, Education and Practice. She's an expert in analyzing medical research.
Dr Peter Lurie, MD, MPH, currently the deputy director of Public Citizen's Health Research Group in Washington, DC, has extensive training in epidemiology and AIDS. He has served on advisory panels for the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration.
Dr Jerome R. Hoffman, MD, professor of medicine and emergency medicine at UCLA, is an expert in the critical appraisal of scientific research. His analyses of the medical literature are relied upon by thousands of practicing physicians around the globe. Briefly courted for the head position at the Centers for Medicare and Medicaid Services in 2001, Hoffman is well-known for his critique of conflicts of interest among physicians and scientists, and he advocates fundamental changes in the way research is conducted, published, and disseminated.
Dr Alastair J.J. Wood, MB, a former assistant vice chancellor for clinical research and associate dean at Vanderbilt Medical School, is currently the Managing Director of Symphony Capital LLC, a private equity company that invests in biopharmaceuticals. He has served as a director of pharmaceutical companies; has provided Congressional testimony, and has advised senior White House officials, legislators, and the Secretary of Health. Why recommend him over Nissen or Califf, who we believe are too close to industry? Wood's track record sets him apart. A former member of various editorial boards, including The New England Journal of Medicine, Wood was the chair of the 2005 FDA Advisory Committee that pushed the FDA to remove Vioxx and a related drug from the market.