The Cause of the Productivity Crisis in Pharmaceutical R&D; the CBCD Draws Conclusions from a Recent Example

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The Center for the Biology of Chronic Disease (CBCD) analyzes the failure of Achillion Pharmaceutical’s premier drug Sovaprevir as reported in an article published on October 14, 2013 on Classactionnews.com (1).

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The CBCD believes that the current understanding of biology is limited and therefore, the Single Target paradigm is bound to fail. - Greg Bennett, CBCD

The pharmaceutical industry is experiencing a productivity crisis in R&D. What is this crisis? First, every year, the pharmaceutical industry is introducing fewer new drugs. Second, a portion of the FDA approved drugs are withdrawn from the market. Third, an analysis of Drugs.com shows that all other FDA approved drugs have many side effects.

What is the source of the productivity crisis?

A compelling explanation is offered in a paper published on March, 2012 in the medical journal Nature Reviews. The paper said that “Much of the pharmaceutical industry's R&D is now based on the idea that high-affinity binding to a single biological target linked to a disease will lead to medical benefit in humans. Indeed, drug-like small molecules tend to bind promiscuously, and this sometimes turns out to have an important role in their efficacy as well as their so-called off-target effects. Targets are parts of complex networks leading to unpredictable effects, and biological systems show a high degree of redundancy, which could blunt the effects of highly targeted drugs (2).”

In simple terms, the idea that a drug binds with only one target is wishful thinking. As it turns out, every drug binds with many targets in the body, the desired one, and many others. Binding to the ‘other’ targets usually causes all the unwanted, surprising, side effects.

“The CBCD believes that the current understanding of biology is limited and therefore, the Single Target paradigm is bound to fail.” - Greg Bennett, CBCD

A recent example of the failure of the Single Target paradigm is the story of Achillion Pharmaceuticals and their premier hepatitis drug, Sovaprevir, which was approved by the FDA. As it turns out, the FDA re-evaluated the drug and decided to place a clinical hold on Sovaprevir because of its dangerous interactions with other drugs commonly administered to treat hepatitis and/or HIV. “A class action suit was filed in the United States District Court for the District of Connecticut, alleging that Achillion Pharmaceuticals, Inc. ("Achillion") issued false and misleading statements to investors between April 21, 2012 and September 27, 2013, inclusive (the "Class Period") by failing to disclose that sovaprevir in fact did not interact well with other drugs commonly administered to treat hepatitis and/or HIV (1),” according to a press release from the Lifshitz Law firm.

In summary, the Single Target paradigm pursued by the pharmaceutical industry is a failure. There is a growing need for a different approach. In future press releases, the CBCD will suggest such an approach.

The CBCD invites journalists, scientists, and the general public interested in discussing the ideas expressed in this press release to contact the Center at: info (at) CBCD (dot) net.

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References:

(1)    http://classactionsnews.com/investments/achillion-pharmaceuticals-achn-securities-fraud-class-action-lawsuit
(2)    http://www.nature.com/nrd/journal/v11/n3/full/nrd3681.html

The Center for the Biology of Chronic Disease (CBCD, http://www.cbcd.net) is a research center recognized by the IRS as a 501(c)(3) non-for-profit organization. The mission of the CBCD is to advance the research on the biology of chronic diseases, and to accelerate the discovery of treatments.

The CBCD published the “Purple” book by Dr. Hanan Polansky. The book presents Dr. Polansky’s highly acclaimed scientific theory on the relationship between foreign DNA and the onset of chronic diseases. Dr. Polansky’s book is available as a free download from the CBCD website.

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Hanan Polansky
Center for the Biology of Chronic Disease (CBCD)
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