This week an article by David Longtin and Henry Miller appeared in Forbes. They decry the possibility that a post-antibiotic world will arrive soon if nothing is done and they make a number of suggestions to avoid this tragedy. They discuss the importance of business considerations in the prioritization process within the pharmaceutical industry. These considerations include the cost of clinical trials and the ultimate market for the product. I was widely quoted, especially for the prediction that Bob Moellering and I made back in 2002 that FDA’s insistence on increasing clinical trial stringency and with it costs for antibiotics would drive companies out of the antibiotic business. That prediction was unfortunately, accurate. But the trend had started back in 1999 with Roche’s announcement that it was renouncing antibiotic research and development (Roche has recently jumped back into the game).
Miller and Longtin sidestep the issue of inadequate funding
for antibiotic research by NIH (see my previous blog
on this). They also failed to discuss the importance of training our academic
researchers within the pharmaceutical industry.
This is an effort that should be funded by NIH. The problem is that most academicians have no
clear understanding of everything that is involved in translating a scientific
observation in the laboratory into an actual product. The people with this expertise are to be
found (almost exclusively) within the pharmaceutical industry. I have discussed this on several occasions
with NIH and was initially told that such funding exists or would be made
available. But a recent discussion and
research on the NIH website (to which I was referred) shows that there is no
specific funding for such training. To
me, this is a complete failure of NIH to address the need to replace
pharmaceutical industry in our search for new antibiotics. Not only are their funding levels for grants
inadequate, but they do not offer the kind of training that academicians need
to succeed in these efforts. Of course,
Congress could help fix this by providing additional funding (ha, ha, ha).
Miller and Longtin also discuss the importance of an LPAD
pathway for the development of new antibiotics.
In this paradigm, clinical trials are smaller, more streamlined and
tightly focused on the resistant organisms targeted by new antibiotics. The risks of bringing such a product to
market increase because there is less information on product safety – but the
benefit of being able to treat otherwise resistant infections makes this risk
acceptable. In fact, as I pointed out to
Longtin, it is still not clear to me that there is a statutory need for
legislation designating this pathway and it seems to me that the FDA is already
doing this anyway even though FDA thinks they need such legislation. I think they just want cover from further
congressional volcanoes when one of these higher risk antibiotics runs into
safety problems. I also think that the
legislation will not provide that cover.
Europe has been ahead of FDA by several years in this regard in any
case.
One of the solutions Miller and Longtin suggest is a priority review
voucher such that if you develop a needed antibiotic, another one of your
products that might nor ordinarily qualify gets priority review. While I think
that this might be useful, I don’t think it will turn the tide to convince more
companies to get back into the antibiotics business. The one thing that will clearly work is
MONEY. Either, as Miller and Longtin
suggest, by providing some sort of guaranteed market post-approval, thus
de-linking the product from the necessity of some marketing expense; or by
increasing the price of antibiotics enough to guarantee a return on the
investment in the research and development that is required to bring them all
the way to the market.
Finally, I am not quite as pessimistic here as some. I do not believe that we are yet at the
advent of a post-antibiotic era. There
are antibiotics in the pipeline that will be helpful for resistant Gram-negative
pathogens. My only hope is that the
companies developing them (like AstraZeneca) don’t screw things up!
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