Thursday, August 28, 2014

Pharmaceutical Failures and Near Misses: More Examples of Why Finding New Drugs is Too Important to be Driven Solely by the Profit Motive.


Recent stories arising from medical areas as diverse as breast cancer and Ebola illustrate the failures and near-failures of drug discovery by for-profit pharmaceutical companies.

An article in SCIENCE (1) recounts the twists and turns of the highly promising anti-cancer drug palbociclib. This agent selectively inhibits CDK4, a kinase that is involved in cell cycle control and that is crucial to the growth of certain cancers. The history of this drug goes back to the 1990s when it was developed by researchers at Parke-Davis Co. When the giant pharmaceutical company Pfizer acquired Parke-Davis in 2000 palbociclib was almost dropped and its development was delayed for years during the various twists and turns of Pfizer’s recent corporate history. Its re-emergence as a promising drug for breast cancer is primarily due to several independent clinical researchers who championed its use. This type of on-again off-again drug research is all too common in ‘Big Pharma’ where science is often subverted by marketing and corporate strategy issues.

The recent explosion of concern regarding anti-Ebola drugs reflects another aspect of the failure of for-profit major drug companies to deal with problems of great public health concern. As stated nicely in a recent blog post (2) from the CSPO at Arizona State “when we rely on a market-based system to drive medical research that may not be profitable in the short term or even medium term, that system is unlikely to respond to potential future threats — no matter how high the potential cost — if there is not a reasonable promise of economic return in the end“. This of course exactly describes the situation with Ebola as well as with many other diseases that primarily affect less-developed countries and that thus do not provide the prospect of lucrative profits.

The BBC website has summarized recent efforts on Ebola drug development (3). Although several companies are involved in this process, it is important to note that much of the early-phase research on drugs for exotic diseases has been sponsored by governments. For example, promising drugs for Marburg and Ebola viruses being developed by Sarepta Therapeutics and Tekmira Pharmaceuticals, two small biotech companies, have been sponsored by the US Dept. of Defense.

The role of governments in developing innovative technology is often under-appreciated (4); in contrast private companies (particularly pharmaceutical companies) use highly developed public relations tools to claim a leading role in innovation. The emergence of pandemics such as the current Ebola outbreak should be readily anticipated based on the phenomenal increases in both population and mobility occurring in Africa in recent years (5). However, it has been governments and non-profits rather than Big Pharma that have led the way in preparing for such public health emergencies. All of this inevitably leads to the conclusion that drug discovery and development is too important to be driven solely by the quest for corporate profits.








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