Yale and NIH trained psychiatrist S. Paul Berger, MD, soon to be the director of the non-profit Skybridge Foundation, writes in the October 11, 2008 issue of The Lancet commentary titled “Psychiatrist calls for American Policymakers to Consider Implementing Recommendations from a British Report” that he supports the recommendations in the report “Brain Science, Addiction, and Drugs” on how to turbocharge clinical translation of basic research in the neurosciences.
“It is real paradox” said Dr. Berger that, despite “rocket science” by bench scientists there has not been comparable progress on the clinical side. He believes that the British have “hit the nail on the head” by recommending a vast increase in the number of physicians trained to do translational research.
Dr. Berger said “This is far preferable to the ‘big science’ National Institutes of Health (NIH) approach of funding unproductive translational centers, nodes and consortiums. When I entered academia 20 years ago, I thought I would be one of hundreds of psychiatric researchers doing bench and Phase II clinical trial medication development. Instead, I am one of only a handful of lab-based clinically practicing psychiatrists. I see so much ‘low hanging fruit’ in the preclinical bench journal literature. For example, it is fairly obvious from the bench and clinical research that it should be possible to prevent Post Traumatic Stress Disorder (PTSD) if people are treated with medications for the weeks right after they are traumatized. But there are not enough researchers on the clinical side able to see the possibilities in the bench literature, let alone undertake the needed clinical trials. The Department of Defense and the NIH can throw as much money as it wants at this area.”
But until the British approach of training more researchers is implemented, Dr. Berger predicts progress will continue to languish.
And what if an academic physician or pharmaceutical company wants to target prevention of PTSD? The current system of intellectual property creates a strong incentive to go back to the drawing board and develop an entirely new drug from scratch in order to get maximum intellectual property protection.
“Traumatized soldiers and veterans need help now, not in a few decades” laments Dr. Berger. Therefore, he advocates in The Lancet for intellectual property reform. A company or academic institution deserves financial reward if it can convince the FDA that a medication prevents PTSD when administered right after trauma. “Preventing PTSD would be so much better than the current approach of trying to suppress it with years of prescriptions that cost the system billions. Intellectual property reform of orphan drug development by Congress has been spectacularly successful, a clinical godsend” said Dr. Berger.
Dr. Berger argues that common disorders like PTSD deserve intellectual property reform, too. “Let us bring sanity to our intellectual property law by recognizing the value of new uses for old medications, thereby unleashing the bench scientists and pharmaceutical industry to solve PTSD, drug abuse and other pressing medical problems.”
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Source
S. Paul Berger, M.D.
Director, Skybridge Foundation
bergerp(at)ohsu.edu