Daily Archives: June 11, 2010

“The Valley of Death” between scientific discovery and the drs office

According to a Newsweek Special Report on Health Innovation.

From 1996 to 1999 the U.S. food and Drug Administration approved 157 new drugs. In the comparable period a decade later—that is, from 2006 to 2009—the agency approved 74. Not among them were any cures, or even meaningfully effective treatments, for Alzheimer’s disease, lung or pancreatic cancer, Parkinson’s disease, Huntington’s disease, or a host of other afflictions that destroy lives.

The report describes how potential cures and treatments:

…are stuck in the chasm between a scientific discovery and the doctor’s office: what’s been called the valley of death.

One of the several factors contributing to the lack of funding for applied research is the complex relationship between publishing (of basic research outputs), patentability and how potential new products get financed.

NIH –the largest funding source for basic medical research in the USA – rewards discoveries that meet peer review standards for publication, and not the arduous and often expensive process of developing a viable, approvable (by the FDA) product.  Investors – who might finance this process – usually want the security of a defensible patent.  And these forces often act in opposition to one another, creating the so-called “valley of death”.

Once a breakthrough invention or discovery is published with enough details, it enters the public domain and loses, therefore, its patentability.  But without publication, no NIH funds.  Without at least a good chance of securing a patent, the venture finance required to fund the applied research is not available and, by the same token, the multinational drug companies are unlikely to be interested.

In his opening remarks at the DoJ-FTC-USPTO workshop US CTO Aneesh Chopra referenced President Obama’s commitment to foster inter-agency collaboration to stimulate innovation, and this is exactly what seems to be called for to unravel the drug development dilemma.

Post written by Peter Bloch, consultant to CAS-IP