Avoiding another Vioxx: Guarding against unsafe drugs means major changes

Article Abstract:

Vioxx, an inflammatory drug is found to double the risk of heart attack and stroke on long-term use, which led to its withdrawal. Food and Drug Administration (FDA) orders drug companies to conduct post marketing research as a condition of approval. The FDA program, which gathers reports of adverse effects voluntarily submitted by doctors, has garnered criticism from prominent medical journals and epidemiologists for its underreporting and unreliability.

Complications and side effects, Inflammation, Inflammation mediators, Powers and duties, United States. Food and Drug Administration, Vioxx (Medication)

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Doubt is their product

Article Abstract:

Industry groups sometimes manufacture uncertainty about solid scientific findings in order to fight off government regulation. Many companies that produce hazardous chemicals or drugs like phenylpropanolamine (PPA) and rofecoxib commonly known as Voxx have hired researchers to dispute and reanalyze data showing adverse health effects.

Product development, Science & research, Health aspects, Research, Hazardous substances

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Register or Perish

Article Abstract:

The article examines efforts to bring negative results of clinical trials to public attention. Discussion focuses on the launch of a journal targeting these results, and laws requiring pharmaceutical companies to report their results in a database accessible by the general public.

General services, Clinical trials, Company systems management, Information management, Medical publishing, Adverse drug reactions

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