NEJM promotes nNew vision of drug safety in the wake of the Vioxx Scandal

In October 2006, the New England Journal of Medicine (NEJM) published two editorials that called for better regulations and more funding to enforce those regulations, citing the removal of Vioxx from the shelves as the prime example of how the system failed. Both editorials were in support of a recent Institute of Medicine (IOM) review of the drug approval system in the United States.

One editorial, “Protecting the Health of the Public — Institute of Medicine Recommendations on Drug Safety,” listed a series of problems in the system including a lack of clear regulatory authority (i.e. problems within the FDA), chronic underfunding, organizational difficulties, and a lack of post-approval research.

Within the FDA itself, the editorial also supported the IOM’s view that the administration suffered from “a suboptimal work environment, a lack of consistency among [Center for Drug Evaluation and Research – CDER] review divisions, polarization between the offices responsible for the pre-marketing review and post-marketing surveillance, CDER management's disregard and disrespect for scientific disagreement, and politicization and a lack of stability in the office of the FDA commissioner.” The editorial stated that there was an “urgent need for cultural change” within the FDA itself.

The editorial also notes that with recent changes to drug safety, including the Prescription Drug User Fee Act of 1992 and 1997, the pharmaceutical industry and the FDA are constantly discussing performance goals. This leads to “the perception that the FDA's client is industry rather than the public.”

The second editorial, “Blueprint for a Stronger Food and Drug Administration,” reinforced the fact that there was an unbalanced approach to drug regulation, with too little emphasis on post-approval regulation. For example, the FDA may approve a certain drug, but also ask for further research into certain aspects of the drug. These studies are usually left “pending” with the FDA powerless to enforce their regulations.

These and all the other problems have led to a mounting public health crisis, according to the editorial. The authors stated that these problems must be addressed, and urged Congress to put the IOM’s recommendations into place.

The ongoing Vioxx story has opened many eyes, from those in the research industry to governmental agencies, physicians, and the general public. The system is broken, and the pharmaceutical companies may be exploiting the cracks to dodge regulations and maximize profits. Vioxx manufacturer Merck insists on fighting every death due to Vioxx in court because it knows that the older population most likely take their painkiller are also the most likely to die from other causes. The company ignored their rights to safe products in the first place, and then continues to ignore their plight when they ask for compensation – all for the sake of saving their profits.

If you or a loved one has been injured while taking Vioxx or any other medication, contact a personal injury attorney with Jim S. Adler & Associates to find out what we can do to help. Pharmaceutical companies rarely pay out victims of their products without a fight, and that means you need someone on your side to help tell your story and secure the compensation you deserve via a Vioxx lawsuit.

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NEJM promotes nNew vision of drug safety in the wake of the Vioxx Scandal

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NEJM promotes nNew vision of drug safety in the wake of the Vioxx Scandal

NEJM promotes nNew vision of drug safety in the wake of the Vioxx Scandal