CHALLENGE 9: Creating a bias-free FDA
James A. Simon, MD, CCD, NCMP
Dr. Simon is Clinical Professor of Obstetrics and Gynecology at George Washington University and Medical Director of Women’s Health & Research Consultants in Washington, DC. He serves on the OBG Management Board of Editors.
Most OBG Management readers likely believe your most pressing issues are business-related (i.e., the exorbitant cost of professional liability insurance, which was only given lip service [money to study the problem] in the new health plan). Or maybe you are thinking about poor reimbursement, often less than the Medicare allowable. (As I write this, Medicare is subject to a 21.3% cut.) Or perhaps you think your biggest challenge is the rising cost of office space, equipment, supplies, etc.
Well, I’d like to draw your attention to a more insidious and potentially harmful problem: the FDA. You might expect me to simply repeat the conclusions of a recent GAO report, which advised the FDA to improve performance, recruit better employees, modernize IT, maintain pace with scientific advances, and revise the approval process for medical devices. Or you might think that I am merely going to criticize the agency for its over-emphasis on safety to the near exclusion of new drug approvals. (Only 25 new molecular entities were approved in 2009, of which six were biologics and none were drugs in women’s health.)
Instead, has it ever occurred to you that, by virtue of its very existence, the FDA has a direct conflict of interest, even as it hides behind a façade of “safety at all costs”? Given that the US government, through Medicare and Medicaid, spends more than $800 billion each year, making it the largest purchaser of health care in the United States, doesn’t the FDA have a direct conflict of interest in regulating the approval of new therapies? Won’t there be political pressure to stick with generics already on the market, just to save money?
You don’t believe that the FDA bends to political pressure, you say? Remember that during the Bush administration (“W”), then junior Senator Hillary Clinton called the federal government—including the FDA—an “evidence-free zone”? Clinton’s committee held up Dr. Lester Crawford’s nomination to lead the FDA until he called for a vote (thumbs up or down) on the over-the-counter sale of Plan B. “What we are witnessing is the FDA being run not on the basis of science, but on ideology,” Clinton reportedly said.
So here and now, I call for abolishment of the FDA in its current form and creation of a true public-private partnership with robust firewalls on both the public and private sides. Get the FDA out of the US government! The agency has a direct conflict of interest in regulating drugs and devices that will be paid for by the largest health-care insurance company, the US government! Failure to eliminate this conflict will leave us in the situation we have right now, and under such circumstances, can the FDA function as a truly objective advocate for the public good?
Would you allow the fox to guard the hen house?
Dr. Simon reports grant or research support from BioSante, Boehringer Ingelheim, FemmePharma, GlaxoSmithKline, Nanma/Tripharma/Trinity, Novartis, Proctor and Gamble, QuatRx Pharmaceuticals, and Teva Pharmaceutical Industries Ltd. He has served as a consultant or advisor to Allergan, Alliance for Better Bone Health, Amgen, Ascend Therapeutics, Azur Pharma, Bayer, BioSante, Boehringer Ingelheim, Concert Pharmaceuticals, Corcept Therapeutics, Depomed, Fabre-Kramer, GlaxoSmithKline, Graceway Pharmaceuticals, KV Pharmaceutical, Lipocine, Meditrina Pharmaceuticals, Merck, Merrion Pharmaceuticals, Nanma/Tripharma/Trinity, NDA Partners, Novo Nordisk, Novogyne, Pear Tree Pharmaceuticals, QuatRx Pharmaceuticals, Roche, Schering-Plough, Sciele, Solvay, Teva Pharmaceutical Industries Ltd, Ther-Rx, Warner Chilcott, and Wyeth. He has also served as a speaker for Amgen, Ascend Therapeutics, Bayer, Boehringer Ingelheim, GlaxoSmithKline, KV Pharmaceutical, Merck, Novartis, Novogyne, Sciele, Teva Pharmaceutical Industries, Ther-Rx, Warner Chilcott, and Wyeth.
CHALLENGE 10: The quest for a healthy work-life balance
Serena H. Chen, MD
Dr. Chen is Director of the Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, at St. Barnabas Medical Center in Livingston, NJ. She serves on the OBG Management Virtual Board of Editors.
As a reproductive endocrinologist in a busy IVF practice with too much weekend call, 50 employees, and research and teaching obligations, I see work-life balance as an important goal. In addition to my work, I am the mother of two teenage boys who have too much homework and too many activities; I am also the wife of a man who has an overly long commute.
I have been searching for work-life balance for most of my professional career.