Posts Tagged ‘pharmaceutical’

Unintended Consequences

February 25th, 2011

I read in the New York Times recently about the NIH establishing a National Center for Advancing Translational Sciences, whose purpose is to foster the development of new medicines. The raison d’etre of the new enter is that the pharmaceutical industry is slowing down the entry of new molecules into therapeutics. The cost of bringing a new drug to market now 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 regulatory environment, worldwide concerns about escalating healthcare costs, etc.

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

In the last few years, there have been legitimate and shocking stories about conflicts of interest among some researchers and academics. This has led to intense media focus and scrutiny in the U.S. Senate. As a result, the NIH, FDA, journals, professional societies, and universities rapidly constructed elaborate and often cumbersome mechanisms to avoid the slightest hint of taint. It’s now very difficult for the most knowledgeable experts to advise the the or the pharmaceutical industry, or to work on treatment guidelines and the like. And so we get less of the healthy dynamic — 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 civil liberties and public safety. How can our regulatory systems reasonably leverage the power of academic knowledge and expertise while, at the same time, safeguarding all of us against the rogue scientist who would put personal gain above the welfare of fellow citizens