Fareed Zakaria in his Washington Post opinion piece Can Obama get it right on the economy? wrote:
“The Obama administration, concerned about the dramatic slowdown in drug development, is proposing a new federal research center with a $1 billion budget. A good idea, but U.S. officials should look at the regulatory framework surrounding the process of discovery and development, since the private sector spends more than 50 times that sum every year on drug research. The Food and Drug Administration takes twice as long to approve a drug as its European counterparts. As a result, health-care research has been moving offshore, particularly as China and India innovate in every product and process. “
My wife emailed me the article and asked if it was correct about European vs. US drug approval.
The answer is yes, but it’s the wrong question.
The new federal research center is focused on end-of-the-line research – the final product, which is hugely expensive and highly regulated (testing in humans). Everyone seems to think that is what medical research is about. But real progress comes from looking at upstream events – what causes the disease, how does it get a foothold, what processes allow it to progress, the finger in the dike that prevents the system from collapsing. Finding the right drug for downstream events is reconstructing the wall after the dam has burst.
I assume that
(A) the Director of NIH, Francis Collins is reflecting required statements from the White House about their priorities rather than his, since the policy seems to contradict his earlier persona when he was director of the Human Genome Center or
(B) he just wants to use the machines once applied to seeking the genome that are going to waste, now that better technology has taken over.
The drug development program is such an un-NIH thing to do, and 180° away from what the former NIH director, Harold Varmus initially hired Collins to do.
New Federal Drug Research Center
Fareed Zakaria in his Washington Post opinion piece Can Obama get it right on the economy? wrote:
“The Obama administration, concerned about the dramatic slowdown in drug development, is proposing a new federal research center with a $1 billion budget. A good idea, but U.S. officials should look at the regulatory framework surrounding the process of discovery and development, since the private sector spends more than 50 times that sum every year on drug research. The Food and Drug Administration takes twice as long to approve a drug as its European counterparts. As a result, health-care research has been moving offshore, particularly as China and India innovate in every product and process. “
My wife emailed me the article and asked if it was correct about European vs. US drug approval.
The answer is yes, but it’s the wrong question.
The new federal research center is focused on end-of-the-line research – the final product, which is hugely expensive and highly regulated (testing in humans). Everyone seems to think that is what medical research is about. But real progress comes from looking at upstream events – what causes the disease, how does it get a foothold, what processes allow it to progress, the finger in the dike that prevents the system from collapsing. Finding the right drug for downstream events is reconstructing the wall after the dam has burst.
I assume that
(A) the Director of NIH, Francis Collins is reflecting required statements from the White House about their priorities rather than his, since the policy seems to contradict his earlier persona when he was director of the Human Genome Center or
(B) he just wants to use the machines once applied to seeking the genome that are going to waste, now that better technology has taken over.
The drug development program is such an un-NIH thing to do, and 180° away from what the former NIH director, Harold Varmus initially hired Collins to do.