David Graham (epidemiologist)

Last updated

David J. Graham is an American epidemiologist who is 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." [1] [2]

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.

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" [3] [4]

In 2010, 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. [5]

Related Research Articles

Food and Drug Administration Agency of the US Department of Health and Human Services

The United States Food and Drug Administration 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 safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

GlaxoSmithKline British multinational pharmaceutical company

GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical company headquartered in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, GSK was the world's sixth largest pharmaceutical company according to Forbes as of 2019, after Pfizer, Novartis, Roche, Sanofi, and Merck & Co. GSK is the tenth largest pharmaceutical company and #296 on the 2019 Fortune 500, ranked behind other pharmaceutical companies including China Resources, Johnson & Johnson, Roche, Sinopharm, Pfizer, Novartis, Bayer, Merck, and Sanofi.

Troglitazone

Troglitazone is an antidiabetic and anti-inflammatory drug, and a member of the drug class of the thiazolidinediones. It was prescribed for people with diabetes mellitus type 2.

Rosiglitazone Chemical compound

Rosiglitazone 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 pharmaceutical company GlaxoSmithKline (GSK) as a stand-alone drug or for use in combination with metformin or with glimepiride. First released in 1999, annual sales peaked at approximately $2.5-billion in 2006; however, following a meta-analysis in 2007 that linked the drug's use to an increased risk of heart attack, sales plummeted to just $9.5-million in 2012. The drug's patent expired in 2012.

Rofecoxib nonsteroidal anti-inflammatory drug

Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). It was marketed by Merck & Co. to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea. Rofecoxib was approved in the US by the US Food and Drug Administration (FDA) in May 1999, and was marketed under the brand names Vioxx, Ceoxx, and Ceeoxx. Rofecoxib was available by prescription in both tablet-form and as an oral suspension.

Valdecoxib Nonsteroidal anti-inflammatory drug

Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor. It was patented in 1995.

Telithromycin

Telithromycin is the first ketolide antibiotic to enter clinical use and is sold under the brand name of Ketek. It is used to treat community acquired pneumonia of mild to moderate severity. After significant safety concerns, the US Food and Drug Administration sharply curtailed the approved uses of the drug in early 2007.

In the United States, a boxed warning is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text. The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.

Shivdarshan. L. Chopra or commonly Shiv Chopra, was a Canadian microbiologist and human rights activist. Chopra stood for food safety and testified before the Senate of Canada in defending the public from hormones, antibiotics, genetically modified organisms, rendered animal proteins, and pesticides.

Kohn, Kohn & Colapinto American law firm in Washington, D.C.

Kohn, Kohn & Colapinto is a Washington, D.C.-based international whistleblower rights law firm specializing in anti-corruption and whistleblower law, representing whistleblowers who seek rewards, or who are facing employer retaliation, for reporting violations of the False Claims Act, Foreign Corrupt Practices Act, Dodd-Frank Wall Street Reform, Sarbanes-Oxley Acts, Commodity and Security Exchange Acts and the IRS Whistleblower law.

Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation. The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from animals sold as pets to donations of human blood and tissue.

The National Whistleblower Center (NWC) is a nonprofit, nonpartisan, tax exempt, educational and advocacy organization based in Washington, D.C. It was founded in 1988 by the lawyers Kohn, Kohn & Colapinto, LLP. As of March 2019, John Kostyack is the executive director. Since its founding, the Center has worked on whistleblower cases relating to environmental protection, nuclear safety, government and corporate accountability, and wildlife crime.

Liraglutide Anti-diabetic medication

Liraglutide, sold under the brand name Victoza among others, is an anti-diabetic medication used to treat type 2 diabetes, obesity, and chronic weight management. In diabetes it is a less preferred agent compared to metformin. Its effects on long-term health outcomes like heart disease and life expectancy are unclear. It is given by injection under the skin.

Muraglitazar

Muraglitazar is a dual peroxisome proliferator-activated receptor agonist with affinity to PPARα and PPARγ.

Harry Markopolos American accountant who exposed the Madoff investment scandal

Harry M. Markopolos is an American former securities industry executive and a forensic accounting and financial fraud investigator.

Sidney M. Wolfe

Sidney M. Wolfe is an American physician and the co-founder and director of Public Citizen's Health Research Group, a consumer and health advocacy lobbying organization. He has publicly crusaded against many pharmaceutical drugs, which he and his organization believe to be a danger to public health.

Merck & Co. American multinational pharmaceutical company

Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Kenilworth, New Jersey. It is named after the Merck family, which set up Merck Group in Germany in 1668. The company does business as Merck Sharp & Dohme (MSD) outside the United States and Canada,

Steven E. Nissen is a cardiologist, researcher and patient advocate. He was chairman of cardiovascular medicine at the Cleveland Clinic, in Cleveland, Ohio.

Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement, and Merck $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).

Seafood species can be mislabelled in misleading ways. This article examines the history and types of mislabelling, and looks at the current state of the law in different locations.

References

  1. ↑ David Brancaccio (January 7, 2005) Interview with Dr. David Graham . Now on PBS Transcript. Retrieved August 26, 2013.
  2. ↑ Matthew Herper (December 13, 2004) Face Of The Year: David Graham . Forbes . Retrieved August 26, 2013.
  3. ↑ DICK CAROZZA (September/October 2005) FDA Incapable of Protecting U.S., Scientist Alleges . Fraud Magazine Cover Story. Retrieved August 26, 2013.
  4. ↑ DICK CAROZZA (September/October 2005) FDA Incapable of Protecting U.S., Scientist Alleges Archived 2012-07-31 at the Wayback Machine . National Health Federation (Full original interview available with the permission of Fraud Magazine). Retrieved August 26, 2013.
  5. ↑ Diabetes Drug Avandia Targeted By Reviewers on Safety. ABC News, 2010-02-23.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.