David Graham (whistleblower)
Encyclopedia
David J. Graham, M.D., M.P.H., is an American epidemiologist who is currently the Associate Director of the Food and Drug Administration
'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
and Redux
, weight-loss drugs, and phenylpropanolamine
, an over-the-counter
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, Seldane, and Propulsid.
On November 18, 2004, Dr. Graham testified before the U.S. Senate Committee on Finance 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
, a whistleblower protection organization, for advice on getting his findings on Vioxx published over the objections of his superiors.
Recently, Graham and one of his FDA colleagues, Kate Gelperin, have called for the popular diabetes drug Avandia 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.
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
'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
Fen-phen
The drug combination fenfluramine/phentermine, usually called fen-phen, is an anti-obesity treatment that utilizes two anorectics. Fenfluramine, its S-enantiomer dexfenfluramine, and a few other serotonin agonists were shown to cause potentially fatal pulmonary hypertension and heart valve...
and Redux
Dexfenfluramine
Dexfenfluramine, marketed as dexfenfluramine hydrochloride under the name Redux, is a serotoninergic anorectic drug: it reduces appetite by increasing the amount of extracellular serotonin in the brain...
, weight-loss drugs, and phenylpropanolamine
Phenylpropanolamine
Phenylpropanolamine , also known as the stereoisomers norephedrine and norpseudoephedrine, is a psychoactive drug of the phenethylamine and amphetamine chemical classes which is used as a stimulant, decongestant, and anorectic agent. It is commonly used in prescription and over-the-counter cough...
, an over-the-counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
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, Seldane, and Propulsid.
On November 18, 2004, Dr. Graham testified before the U.S. Senate Committee on Finance about Merck
Merck & Co.
Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. The Merck headquarters is located in Whitehouse Station, New Jersey, an unincorporated area in Readington Township...
's withdrawal of the popular anti-inflammatory drug Vioxx
Rofecoxib
Rofecoxib is a nonsteroidal anti-inflammatory drug that has now been withdrawn over safety concerns. It was marketed by Merck & Co. to treat osteoarthritis, acute pain conditions, and dysmenorrhoea...
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
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
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
Government Accountability Project
The Government Accountability Project is a leading United States whistleblower protection organization. Through litigating of whistleblower cases, publicizing concerns and developing legal reforms, GAP’s mission is to protect the public interest by promoting government and corporate accountability...
, a whistleblower protection organization, for advice on getting his findings on Vioxx published over the objections of his superiors.
Recently, Graham and one of his FDA colleagues, Kate Gelperin, have called for the popular diabetes drug Avandia 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.
External links
- "Judge orders FDA whistleblower to testify", Associated Press, March 15, 2006.
- "Bad Medicine" - Interview with David Graham broadcast on PBSPublic Broadcasting ServiceThe Public Broadcasting Service is an American non-profit public broadcasting television network with 354 member TV stations in the United States which hold collective ownership. Its headquarters is in Arlington, Virginia....
's NOW January 7, 2005. - Face Of The Year: David Graham - ForbesForbesForbes is an American publishing and media company. Its flagship publication, the Forbes magazine, is published biweekly. Its primary competitors in the national business magazine category are Fortune, which is also published biweekly, and Business Week...
, December 13, 2004 - Congress Told FDA Failed Public on Vioxx - ReutersReutersReuters is a news agency headquartered in New York City. Until 2008 the Reuters news agency formed part of a British independent company, Reuters Group plc, which was also a provider of financial market data...
, November 18, 2004. - Whistler-Blower Guardians Say FDA Officials Tried to Undermine Critic - San Francisco ChronicleSan Francisco Chroniclethumb|right|upright|The Chronicle Building following the [[1906 San Francisco earthquake|1906 earthquake]] and fireThe San Francisco Chronicle is a newspaper serving primarily the San Francisco Bay Area of the U.S. state of California, but distributed throughout Northern and Central California,...
, November 24, 2004. - Attempt to discredit whistleblower alleged Washington Post. 23 November 2004.
- Graham's Senate testimony in 2004