Posts Tagged ‘NIH’

Unintended Consequences

March 1st, 2011
I read in the New York Times recently about the NIH establishing a National Center forAdvancing Translational Sciences, whose purpose is to foster the development of newmedicines. The raison d’etre of the new center is that the pharmaceutical industry is slowingdown the entry of new molecules into therapeutics. The cost of bringing a new drug to marketnow stands north of $1 billion. One of the areas of greatest concern is psychiatric therapeutics.

There are many valid explanations for this worrisome slowdown in drug development:changing business models, shifting subject populations in clinical trials, an evolving regulatoryenvironment, worldwide concerns about escalating healthcare costs, etc.


But a recent development that troubles me is the growing rift between talented experts inbiomedical research and the development process.


In the last few years, there have been legitimate and shocking stories about conflicts of interestamong some researchers and academics. As a result of This has led to intense media focus andscrutiny in the U.S. Senate., As a result, the NIH, the FDA, journals, professional societies, anduniversities rapidly constructed elaborate and often cumbersome mechanisms to avoid theslightest hint of taint. It’s now very difficult for the most knowledgeable experts to advise theNIH, the FDA, or the pharmaceutical industry, or to work on treatment guidelines and the like.Because of restrictions on research, paperwork, and fear of embarrassment if they consult withindustry, many experts stay home and focus on their science. And so we get less of the healthydynamic—the flow of knowledge and perspective—that enhances new-product development.


Pendulums swing. I worry about the unintended consequences of how far this one has swung.This challenge for our society is vaguely analogous to the need to strike a balance between civilliberties and public safety. How can our regulatory systems reasonably leverage the power ofacademic knowledge and expertise while, at the same time, safeguarding all of us against therogue scientist who would put personal gain above the welfare of fellow citizens?

- Alan J. Gelenberg, M.D.
Editor,
Biological Therapies in Psychiatry
Professor and Chair, Psychiatry, Penn State University
Editor-in-Chief,
Journal of Clinical Psychiatry

ACNP Musings

December 8th, 2010

Attending the annual meeting of the American College of Neuropsychopharmacology is always a heady experience. The membership and guests are among the most brilliant humans anywhere, and I am invigorated that so many devote their lives to explicating the brain’s mysteries.

Here in a chilly South Florida, there is much about which to be optimistic. Presenters are young scientists, insuring a continuing pipeline of talent to the labors of cracking the code of brain diseases. And the science and its promise are rich and exhilarating.

But there is fodder for the pessimists and worriers too. Whither healthcare reform, with its promise of extending and rationalizing health care, of stopping discrimination against the mentally ill? And what will happen to the NIH budget, which nourishes the science and scientists on whom we vest our hopes for a better future? Big pharmaceutical companies are pulling back from psychiatric research and products. Where will that leave us over the decades to come?

There is cause for hope. And worry.

- Alan J. Gelenberg, M.D.
Editor,
Biological Therapies in Psychiatry
Professor and Chair, Psychiatry, Penn State University
Editor-in-Chief,
Journal of Clinical Psychiatry