Antibiotic research is drying up because of a politically inspired demand for larger clinical trials and a push for placebo controlled trials where they need not be required. Congress tosses money at the problem when reform is needed. So I agree with Sid Wolfe when he says: “I’m tired of all these lures to an industry making so much money today that they can’t even see straight,â€
The lures are to biotech start ups mostly. But mostly they need regulatory help and money for Critical Path. Two weeks ago the FDA, academics and industry held a workshop on clinical trial design in cooperation with the Infectious Disease Society of America. The key issue was when to use adaptive trials and other approaches. This is like returning to "GO" in Monopoly. We should be much farther ahead in our approach to drug development in infectious diseases. Kudos to Helen Boucher, David Shlaes and FDAer Ed Cox who have been nurturing this working relationship. It needs -- via support for Reagan Udall -- support from unusual suspects such as hospital groups, private foundations, food companies, as well as FDA senior leadership, from HHS and Congress. Oh wait, this might lead to conflicts. So forget it, let a thousand bugs multiply. What's a thousands deaths and disease when the real disease we are trying to contain is the corruption of our medical research establishment at the hands of BIg Pharma?
http://blogs.wsj.com/health/2008/01/28/new-antibiotics-grow-scarce-as-bad-bugs-multiply/
The lures are to biotech start ups mostly. But mostly they need regulatory help and money for Critical Path. Two weeks ago the FDA, academics and industry held a workshop on clinical trial design in cooperation with the Infectious Disease Society of America. The key issue was when to use adaptive trials and other approaches. This is like returning to "GO" in Monopoly. We should be much farther ahead in our approach to drug development in infectious diseases. Kudos to Helen Boucher, David Shlaes and FDAer Ed Cox who have been nurturing this working relationship. It needs -- via support for Reagan Udall -- support from unusual suspects such as hospital groups, private foundations, food companies, as well as FDA senior leadership, from HHS and Congress. Oh wait, this might lead to conflicts. So forget it, let a thousand bugs multiply. What's a thousands deaths and disease when the real disease we are trying to contain is the corruption of our medical research establishment at the hands of BIg Pharma?
http://blogs.wsj.com/health/2008/01/28/new-antibiotics-grow-scarce-as-bad-bugs-multiply/
