PBS Dr. David Graham shows how FDA managers tried to silence him for indicating Vioxx unsafe.

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FDA and Drug Approval Overview
Vioxx was one of the most widely used prescription drugs in the world and, for many, it may have been a killer. The Food and Drug Administration (FDA) is supposed to guarantee the safety of the medicines we take, but some say it may have disregarded warnings from its own scientists about this looming public health disaster. NOW's BAD MEDICINE explores the drug approval process and talks with FDA whistleblower, Dr. David Graham, who reveals how his FDA managers tried to silence him and quash evidence that indicated Vioxx was unsafe.
Approval Process

The drug approval process overseen by the FDA has been subject to complaints from many sides. In the 1990s it was criticized for being too slow ? keeping potentially life-saving drugs off the market and adding to development costs. The most recent controversies come from another perspective, questioning whether the process is too quick and relies too much on information from the pharmaceutical industry.

Approving prescriptions drugs is the job of FDA's Center for Drug Evaluation and Research (CDER). The process begins when a manufacturer has tested a new drug on animals and concluded three phases of testing on humans. The results from this process forms the basis of a "new drug application" (NDA), which the company submits to the CDER.

The NDA is then reviewed by CDER scientists who evaluate both the efficacy and safety of the drug and its risk/benefit ratio. The CDER reviewers may request more information from the developer and seek additional opinions from outside experts. CDER also checks the label information and investigates the manufacturing plant. The CDER director completes a final review and decides if the drug is ready for market. View an interactive graph of the process from CDER.

Some of the criticism Dr. Graham has leveled at the FDA process relates to what happens after a drug is approved. The FDA is also charged with monitoring drug safety of drugs on the market. The FDA tracks "adverse events" or negative "side effects" of drugs through the Office of Drug Safety, also a part of CDER. An adverse effect is a reaction which "results in death, disability, hospitalization, is life-threatening, causes a congenital anomaly, or requires treatment to prevent permanent damage."

Doctors and other healthcare personnel usually report these occurrences to the drug companies which are in turn required to notify the FDA of any serious incidents within 15 days of the original report. If a drug is new, the company must forward all reports quarterly for three years. After that time, all reports are filed annually. In addition, the FDA maintains a system of voluntary reports called MedWatch. Here, consumers and health care workers can submit reports which are then sent on to staff for evaluation.

In his November 2004 testimony before Congress, Dr. Graham suggested that the FDA is reluctant to admit that there are problems with drugs it has already approved. The FDA responded to Dr. Graham's testimony with a public rebuttal. In December 2004, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (JAMA) echoed some of Graham's criticism, publishing a series of papers which question the relationship of drug companies to the approval process. According to THE ECONOMIST, the makers of some of the drugs mentioned by Dr. Graham are feeling a financial effect. AstraZeneca's share price fell by 10%. Shares in GlaxoSmithKline fell by 6%. And as for Merck, the maker of Vioxx, traders have made a $40 billion reduction in the company's value. (Read Dr. Graham's testimony and the JAMA articles.)