Office of drug safety

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The Big Fat Health and Fitness Lie Craig Pepin-Donat See book keywords and concepts

He is a Yale graduate who has worked for the FDA for more than 20 years and, at the time of this writing, was the associate director for science and medicine in the FDA office of drug safety. On November 18, 2004, Graham testified before the Senate Finance Committee regarding the Vioxx recall issue and the FDA approval process. I have read almost every media publication on the Vioxx issue, but not until I read his complete testimony did I realize the extent to which there is a major problem with the drug approval process within the FDA.

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To find out more information on the medications that have black-box warnings, visit the US Food and Drug Administration's office of drug safety at www.fda.gov/cder/ offices/ods. The Many Dangers of Over-the-Counter Drugs Larry Sasich, PharmD, MPH, a licensed pharmacist, public policy expert and pharmaceutical research analyst for Public Citizen, a nonprofit consumer advocacy organization, Washington, DC.

Big Pharma: Exposing the Global Healthcare Agenda Jacky Law See book keywords and concepts

Graham, an associate director in the FDA's Center for Drug Evaluation and Research's office of drug safety, had written a report, made public in August 2004, based on a study of Vioxx using patients' insurance records. It estimated 28,000 Americans had had heart attacks and strokes as a result of taking the drug while he was arguing with his FDA superiors about the risks. He maintained the equivalent in deaths of two to four jumbo jets dropping out of the sky every week, a figure that has been hotly disputed.

FDA accused of suppressing drug safety information (commentary) Mike Adams, the Health Ranger See article keywords and concepts

Andrew Mosholder, an expert at the FDA's office of drug safety, who presented an analysis of 22 different studies on more than 4,000 children, covering nine antidepressants. He found that the risk of suicide-related events was twice that of children given a placebo. For those who can't do the math, that's a 200 percent increase, or twice the chance. That's a tremendous increase in the risk of suicide-related events for taking these drugs. The FDA is committing crimes against humanity Keep on dosing these children. That's right, call it a brain chemistry imbalance and put those kids on drugs.

Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies Greg Critser See book keywords and concepts

David Graham, a veteran epidemiologist for the FDA's office of drug safety and a noted expert on drug-induced liver injury. Graham is now best known as the FDA renegade who blew the whistle on Vioxx. But his legacy is longer and deeper than that, if only grudgingly acknowledged. It is Graham who is credited with the adverse-event reporting and tough-minded analysis that led to the withdrawal of Rezulin. His methods are now studied by a new generation of drug safety students in universities around the country.

Reputation of the FDA in shambles after Vioxx scandal; calls for wholesale FDA reform gain momentum Mike Adams, the Health Ranger See article keywords and concepts

David Graham, associate director for science in the office of drug safety at the FDA. He had directly warned the agency about the cardiovascular risk presented by Vioxx, and yet his supervisors essentially told him to sit down and shut up. Dr. Anne Trontell, one such supervisor, called the studies showing heart damage from Vioxx, "nothing more than a scientific rumor." That's how the FDA and people in the medical community shut down critics: they just declare anything they don't like to be "unscientific." The FDA censors its own scientists Another FDA researcher, Dr.

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