Yet Another Government Scandal

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http://www.bcaction.org/Pages/SearchablePages/2003Newsletters/Newsletter79H.html

 

Newsletter #79–November/December 2003

Yet Another Government Scandal

In a behind-the-scenes effort to undermine the requirements for approving new

cancer drugs, the Bush administration’s National Cancer Institute (NCI) is

calling for relaxed standards for “prevention” drugs. Easing the current

requirements, however, will benefit the pharmaceutical industry and potentially

harm healthy individuals.

Top executives at the NCI are pushing for the accelerated approval of

chemoprevention drugs based on surrogate endpoints, which are substitutes for

more established measures of a drug’s effectiveness. There are many examples of

surrogate endpoints that eventually proved to be wrong: for instance, because

postmenopausal hormones can reduce cholesterol, this endpoint was thought to be

a good surrogate for heart disease prevention—until the Women’s Health

Initiative showed that the pills actually caused more cardiovascular events.

 

The validity of surrogate endpoints, even for cancer treatment drugs, has been

controversial for years. Chemoprevention drugs are potentially harmful pills

given to healthy individuals to reduce their risk of developing a disease. It is

imperative that the FDA not relax its approval standards.

 

TAKE ACTION: Learn how you can let FDA Commissioner Mark McClellan know how you

feel about the proposed change in chemoprevention approval standards—and learn

how you can join BCA and Prevention First, a coalition of independent health

organizations, to advocate on behalf of public health over private profit—at

www.preventionfirstcoalition.org.

 

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