Risky Drugs: Why The FDA Cannot Be Trusted | Edmond J. Safra Center for

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** Risky Drugs: Why The FDA Cannot Be Trusted **

July 17, 2013

/by Donald W. Light/

A forthcoming article for the special issue of the /Journal of Law,
Medicine and Ethics/ (JLME), edited by Marc Rodwin and supported by the
Edmond J. Safra Center for Ethics, presents evidence that about 90 percent
of all new drugs approved by the FDA over the past 30 years are little or
no more effective /for patients/ than existing drugs.

All of them may be better than indirect measures or placebos, but most are
no better for patients than previous drugs approved as better against these
measures. The few superior drugs make important contributions to the
growing medicine chest of effective drugs.

The bar for “safe” is equally low, and over the past 30 years,
approved drugs have caused an epidemic of harmful side effects, even when
properly prescribed. Every week, about 53,000 excess hospitalizations and
about 2400 excess deaths occur in the United States among people taking
properly prescribed drugs to be healthier. One in every five drugs approved
ends up causing serious harm,^1 while

Source: ethics.harvard.edu/blog/risky-drugs-why-fda-cannot-be-trusted

can fda be trusted

Criticism of the Food and Drug Administration - Wikipedia, the free


** Criticism of the Food and Drug Administration **

From Wikipedia, the free encyclopedia
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Numerous governmental and non-governmental organizations have *criticized
the U. S. Food and Drug Administration* of either over- or
under-regulation. The U.S. Food and Drug Administration (FDA) is an agency
of the United States Department of Health and Human Services and is
responsible for the safety regulation of most types of foods, dietary
supplements, drugs, vaccines, biological medical products, blood products,
medical devices, radiation-emitting devices, veterinary products, and
cosmetics. The FDA also enforces section 361 of the Public Health Service
Act and the associated regulations, including sanitation requirements on
interstate travel as well as specific rules for control of disease on
products ranging from animals sold as pets to donations of human blood and

A $1.8 million 2006 Institute of Medicine report on pharmaceutical
regulation in the U.S. found major deficiencies in the FDA system for
ensuring the safety of drugs on the American market. Overall, the authors
called for an increase in the regulatory powers, funding, and independence
of the FDA.^[2]^[3]


· 1 Charges of over-regulation

· 1.1 Alleged problems in the drug approval process
· 1.2 Allegations that FDA regulation causes higher drug prices
· 1.3 Allegations of censorship in food and drug labeling

· 2 Charges of under-regulation

· 2.1 Allegations that the FDA covered up exportation of unsafe products
· 2.2 Allegations that unsafe drugs are approved
· 2.3 Allegations that unsafe food additives and processing technologies
are approved

· 3 Charges of FDA bias

· 3.1 Allegations of undue pharmaceutical industry influence
· 3.2 Allegations of bias against gay men

Source: en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration

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