Monday, February 9, 2009

Some grim statistics in The Scientist:

These are distressing but worth discussing

• NIH budget has has declined by more than 10% in real terms over the past 5 years.
• Initial success rates for grants is less than 10%
• Average age of first NIH grant is mid-40s.
• New drugs approved by the FDA has fallen linearly from 53 in 1996 to 17 in 2007 (the same number as 1983). In 2008, 21 druges were approved including 3 that were “reconsidered” and 3 radiocontrast agents
• Pharma has lost 100,000 jobs over the past 5 years

The author lists solutions - my reactions are in (brackets):
• Restore funding to the NIH (Obama has a $10 billion increase so this is fixable)
• Have graded FDA drug approvals (not sure how this would work)
• Reward more personalized medicine (this is a path FDA is taking)
• Increase academia and FDA interactions (drug approvals take 10 years; I don't see how these interactions will improve approvals. Academia is upstream and not connected to drug trials)
• Spend on science in schools (a focus of this administration)

While drug approvals have dropped considerably, its not necessarily a bad thing. Yes, it means a lot of companies and investors have lost money. Scientists have spent lifetimes on products that ultimately weren't approved. But how many of these drugs should have gotten to the market in the first place ? Is there a cure for Alzheimers or Cancer waiting to be approved ? Or a drug that works in 80% of a selective population that was turned down.

I think the FDA needs to rethink approval processes of contrast agents and its diagnostics tests as well. These generally are safer with lesser side effects. The economics simply aren't in favor especially of developing contrast agents through the startup process. Similarly with diagnostics; there needs to be more of a focus on accelerating the approval processes. If we can find it early, we can cure it. Diagnostics tests and contrast agents can help us do that. And while it builds up industries, it will make a real difference for patients as well as the life sciences industry. Death rates are not going down because of better drugs. Its going down because of better screening and imaging.

Click here to read the article

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