Friday, June 6, 2014

Forbes and the Perfect Storm

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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