Monday, June 13, 2011
Dr. Margaret Hamburg on Biocentury TV
Yesterday I watched an interview with Dr. Margaret Hamburg, Commissioner of FDA on Biocentury TV. In general, the questions were softball. I think the word antibiotic was used only once. That was for a comment the interviewer heard from a venture capitalist. The VC said that he had three no-go areas for investing in pharmaceutical start-ups – diabetes, obesity and antibiotics. At least antibiotics is in good company these days. Dr.Hamburg responded by stating that she and the FDA are aware of this issue and that her interest remains in putting in place the regulatory science that will allow for trials that can show safety and efficacy such that Americans can have access to new therapies in these areas. But I have to admit that I don’t know what the “new” regulatory science is. We have used Bayesian approaches to trial design in oncology for years. We have used validated biomarkers in HIV and for oncology for years.
During the entire interview, I think I heard the word feasibility once. It seems clear that, at least in some areas, FDA understands that trials must be feasible, but is struggling to find a “correct” scientifically based way forward. The idea of conditional approvals was discussed – but only superficially and nothing new seemed in the offing.
Its as if the fact that somehow “new” approaches exist means that our old ones are no longer valid. You hear that often at meetings – at least as a subtext. During the last 60 years, it seems to be assumed that FDA approved ineffective antibiotics and that because so called biocreep towards inefficacy is a theoretic possibility, it must have occurred. But, to my knowledge, this has never been shown scientifically. So where and what is the “new” science after all?
If Dr. Hamburg and the FDA want to lay the foundations for new trial designs for antibiotics – more power to them. But what is the problem with continuing with our “old” trial designs while the new templates with feasible designs are put in place? Why can’t we grandfather such designs until such time as new and feasible designs are ready for prime time? If we could do something like that, maybe cethromycin from Advanced Life Sciences would already be approved, maybe doripenem and telavancin would be approved for hospital acquired pneumonia is the US as well as in the rest of the world. In fact, it is clear that if we don’t do something like grandfathering the more traditional designs, Americans will be deprived of new and needed antibiotics for years to come. The current FDA approach is certain to have a negative effect on the global supply of new antibiotics as well as on public health of Americans.
It is long past time to rethink.