David J. Graham is an American

epidemiologist Epidemiology is the study and analysis of the distribution (who, when, and where), patterns and determinants of health and disease conditions in a defined population. It is a cornerstone of public health, and shapes policy decisions and evidenc ...

who is the Associate Director of the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

's Office of Drug Safety. Graham has spent his career at the FDA studying the safety of drugs, many of them after approval using data from medical insurance companies. He claims successes in removing from the U.S. market the unsafe drugs Omniflox an antibiotic, Rezulin, a diabetes treatment,

Fen-Phen The drug combination fenfluramine/phentermine, usually called fen-phen, was an anti-obesity treatment in the early 1990s that utilized two anorectics. Fenfluramine was marketed by American Home Products (later known as Wyeth) as ''Pondimin'', but ...

and Redux, weight-loss drugs, and

phenylpropanolamine Phenylpropanolamine (PPA) is a sympathomimetic agent which is used as a decongestant and appetite suppressant. It was commonly used in prescription and over-the-counter cough and cold preparations. In veterinary medicine, it is used to cont ...

, an

over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...

decongestant, and in restricting the use of Trovan, an antibiotic, to use in hospitals. He also had a part in the removal of Lotronex,

Baycol Cerivastatin (INN, brand names: Baycol, Lipobay) is a synthetic member of the class of statins used to lower cholesterol and prevent cardiovascular disease. It was marketed by the pharmaceutical company Bayer A.G. in the late 1990s, competing wi ...

, Seldane, and Propulsid. On November 18, 2004, Dr. Graham testified before the

U.S. Senate Committee on Finance The United States Senate Committee on Finance (or, less formally, Senate Finance Committee) is a standing committee of the United States Senate. The Committee concerns itself with matters relating to taxation and other revenue measures generall ...

about Merck's withdrawal of the popular anti-inflammatory drug Vioxx the previous month because of serious safety concerns. In his testimony, he asserted his personal belief that the policies within the U.S. Food and Drug Administration were insufficient to protect the public from drugs which carry unacceptable risks, saying "I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless." After his testimony, Graham was publicly criticized by the FDA. He contacted the nonprofit

Government Accountability Project The Government Accountability Project (GAP) is a nonprofit whistleblower protection and advocacy organization in the United States. It was founded in 1977. Activities In 1992, GAP represented Aldric Saucier, who had lost his job and security cl ...

, a whistleblower protection organization, for advice on getting his findings on Vioxx published over the objections of his superiors. In a 2005 interview, Dr. Graham was asked "What Specifically do you believe is broken in the FDA and what needs to be done to fix it? What must be done to improve the drug vetting system ?" his response: " FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed" In 2010, Graham and one of his FDA colleagues, Kate Gelperin, have called for the popular diabetes drug

Avandia Rosiglitazone (trade name Avandia) is an antidiabetic drug in the thiazolidinedione class. It works as an insulin sensitizer, by binding to the PPAR in fat cells and making the cells more responsive to insulin. It is marketed by the pharmaceutica ...

to be pulled from the market. Their study of the drug found possible evidence of an increased incidence of mortality; however, they found no indication of an increased risk of heart attack, contrary to other published studies.Diabetes Drug Avandia Targeted By Reviewers on Safety

ABC News ABC News is the journalism, news division of the American broadcast network American Broadcasting Company, ABC. Its flagship program is the daily evening newscast ''ABC World News Tonight, ABC World News Tonight with David Muir''; other progra ...

, 2010-02-23.

References

External links

*
Judge orders FDA whistleblower to testify
, ''Associated Press'', March 15, 2006.

- Interview with David Graham broadcast on

PBS The Public Broadcasting Service (PBS) is an American public broadcaster and non-commercial, free-to-air television network based in Arlington, Virginia. PBS is a publicly funded nonprofit organization and the most prominent provider of ed ...

's '' NOW'' January 7, 2005.
Face Of The Year: David Graham
- ''

Forbes ''Forbes'' () is an American business magazine owned by Integrated Whale Media Investments and the Forbes family. Published eight times a year, it features articles on finance, industry, investing, and marketing topics. ''Forbes'' also r ...

'', December 13, 2004
Congress Told FDA Failed Public on Vioxx
- ''

Reuters Reuters ( ) is a news agency owned by Thomson Reuters Corporation. It employs around 2,500 journalists and 600 photojournalists in about 200 locations worldwide. Reuters is one of the largest news agencies in the world. The agency was est ...

'', November 18, 2004.
Whistler-Blower Guardians Say FDA Officials Tried to Undermine Critic
- ''

San Francisco Chronicle The ''San Francisco Chronicle'' is a newspaper serving primarily the San Francisco Bay Area of Northern California. It was founded in 1865 as ''The Daily Dramatic Chronicle'' by teenage brothers Charles de Young and Michael H. de Young. The pap ...

'', November 24, 2004.
Attempt to discredit whistleblower alleged
''Washington Post''. 23 November 2004.
Graham's Senate testimony in 2004
{{DEFAULTSORT:Graham, David American public health doctors Drug safety American whistleblowers Living people Food and Drug Administration people Year of birth missing (living people)