Bizarrely inappropriate move weakens wall between regulators and drug companies
by Craig Weatherby
If you read our July 11 article, “Diseased by Definition: Drug Profits Distort Medical Decisions,” in Vital Choices issue 31, you know that we share the fears of leading mainstream physicians, many of whom are concerned that drug company money is distorting health care decision-making.
Many observers had expressed dismay when the Bush administration appointed veterinarian Lester Crawford, Ph.D. as FDA commissioner, given his past laissez faire attitudes toward now-pressing concerns such as the overuse of antibiotics in poultry feed.
Those concerns have now been heightened by the appointment of Scott Gottlieb, M.D.—a Wall Street insider with scant medical experience but eager-to-please attitude toward drug and biotech companies—to one of three deputy commissioner posts at the FDA.
As Dr. Jerome Kassirer, former editor of The New England Journal of Medicine, told the Seattle Times in a recent article, Gottlieb's appointment "…further impedes the independence of the FDA. Gottlieb has an orientation which belies the goal of the FDA."
Until July of this year, Gottlieb was editor of the Forbes/Gottlieb Medical Technology Investor newsletter. As one of three deputy commissioners, Gottlieb will oversee the FDA's new fast-track approval process for drug and biotech products.
Dr. Gottlieb was an analyst for a Wall Street investment firm before earning a medical degree from New York’s Mt. Sinai School of Medicine in 1999. His only clinical experience occurred during a two-year hospital internship, and the two or three weekend shifts a month he worked from 2003 until earlier this summer.
Incredibly, in the wake of the country’s recent experiences with Fen-Phen and Vioxx—and several other marginally useful drugs that were soon proved dangerous—Gottlieb supports faster drug approval and wants fewer warnings to the public about the potential side effects of drugs.
Last month, the Seattle Times published their revealing investigation into the practice of doctors leaking details of ongoing drug research to investment firms: a report that led to a Securities and Exchange Commission investigation.
In 2002, Gottlieb wrote an article in the investor publication Barron's, saying "…the tight lid the FDA keeps on clinical-trials data has spawned a thriving niche of boutique investment-research firms that link money managers with medical experts capable of giving investors a wink and a nod."
Gottlieb told the Times he opposes leaks, but he did not call for better enforcement of confidentiality agreements intended to stop leaks. Instead, he believes that the FDA should open up its drug-approval process to investors and the public.
As the NEJM's Dr. Kassirer told the Times, “Releasing data early could result in premature and erroneous conclusions about the drug or device being tested, premature ending of clinical trials and even inappropriate enrollment of patients”.
Dr. Gottlieb’s resume: a revealing read
It strikes us as truly bizarre that this appointment should occur after major drug companies have been caught fudging and hiding negative data on drugs intended to affect the lives of millions of people, to ensure that these products make billions of dollars for corporate officers and investors.
It is instructive to read Dr. Gottliebs’ resume, which appears very thin on medical expertise, but thick with cozy Wall Street/corporate advocacy and consulting.
This version comes from the Seattle Times article by Alicia Mundy titled “Wall Street biotech insider gets No. 2 job at the FDA”, which appeared in the paper’s Nation & World section on Wednesday, August 24, 2005. The sole instance of direct medical experience is underlined:
1994: Bachelor's degree in economics, Wesleyan University
1994-1995: Alex. Brown & Sons, investment bank
1995-1999: Mount Sinai Medical School, New York
1996-2001: Wrote for The Journal of the American Medical Association
1997-2005: Staff writer, British Medical Journal
2000-2002: Author, Gilder Biotech Report
2003-2005: Medical internist, Stamford (Conn.) Hospital
2003: Resident scholar on medical policy, American Enterprise Institute
March 2003-May 2004: Senior adviser, then director of medical-policy development, FDA
June-October 2004: Senior adviser, Centers for Medicare & Medicaid Services
Late 2004-July 2005: Resident scholar on FDA and Medicare policies, American Enterprise Institute
Late 2004-July 2005: Author, Forbes/Gottlieb Medical Technology Report
Late 2004-July 2005: Private consultant/speaker to investment firms and the pharmaceutical industry
Source: American Enterprise Institute and Dr. Scott Gottlieb
When it comes to routine medical services, Dr. Gottlieb may well be a perfectly competent, caring physician. But he wouldn’t be our first choice as a top guardian of Americans’ public interest versus the interests of increasingly powerful, profit-driven drug companies.