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Wednesday, October 27, 2010

Most New Drugs Offer More Harm Than Benefit

In a recent study, independent reviewers found that approximately 85% of new drugs brought to market have few if any new benefits over existing drugs and that many are associated with harmful adverse effects.

Donald Light, author of “Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm,” explained in a press statement that only “one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the U.S. Food and Drug Administration (FDA), including black box warnings, adverse reaction warnings, or even withdrawal of the drug.”

According to Light, an analysis of 111 pharmaceutical applications for FDA approval revealed that evidence of efficacy was lacking in 39%, flawed testing of dosages was found in 40%, adequately randomized trials were lacking in 42%, and 49% raised concerns about serious side effects.

Pharmaceutical companies design their own studies and the research is often biased, too short to uncover long term problems, and conducted on people who are healthier than the target population. And because the FDA is funded in part by the drug companies it oversees, applications are often sped through the review process without adequate consideration. When important details of dangerous drugs finally come to light, many times it is too late.

According to the FDA, studies published in the Journal of the American Medical Association indicate that more than 2 million serious adverse drug reactions (ADRs) occur each year and that ADRs are the fourth leading cause of death in the United States.

References

American Sociological Association. Toxic drugs, toxic system: sociologist predicts drug disasters. Washington DC, 3 August 2008. http://www.asanet.org/press/20080803_2.cfm (accessed September 2010).

Lazarou J et al. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. Journal of the American Medical Association. 1998 Apr 15;279(15):1200-5.

Light D. Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm. 105th Annual Meeting of the American Sociological Association, Atlanta, 17 August 2010.

US Food and Drug Administration. Preventable Adverse Drug Reactions: A Focus on Drug Interactions. http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm110632.htm#ADRs:%20Prevalence%20and%20Incidence (accessed September 2010).

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