Bacterial resistance is a devastating problem for healthcare even now, especially in hospitalized patients. If current trends continue, we are all facing a real crisis. In an op-ed by former ACSH trustee, the Hoover Institution s Dr. Henry Miller, and co-author David Longtin,a DC-based medical writer, in Forbes.com, they warn that we may be on the verge of returning to a pre-antibiotic era. They say, We are quickly running out of therapies to treat some of these infections that previously had been eminently treatable. There are bacteria that we encounter, particularly in healthcare settings, that are resistant to nearly all or, in some cases, all the antibiotics that we have available to us, and we are thus entering an era that people have talked about for a long time.
He highlights the reasons that we are finding ourselves in this dire situation. The number of pharma/biotech companies devoting resources to developing new antibiotics is rapidly decreasing due to lack of industry productivity, the low return on investment of antibacterials compared with other therapeutics, difficulty in identifying new compounds with traditional discovery methods, regulatory requirements that require large and complex clinical trials for approval, and initiatives that encourage antibiotics to be used as sparingly as possible (to minimize the spread of resistance).And until recently, the government was not supporting this necessary research.
Miller also quotes ACSH advisor, Dr. David Shlaes, the former head of infectious disease research at Wyeth, and a fierce proponent of research of new antibiotics: Programs with modest potential markets and large costs are automatically deprioritized unless there is some other, overriding strategic issue to be considered. Thus, one unintended result of promulgating these guidelines [requiring about double the number of enrollees per trial] will be a decrease in the number of companies performing antibacterial research.
Dr. Miller goes on to discuss several options that may help to encourage more companies to take on the development of new antibiotics: requiring smaller, less expensive clinical trials in studying the effectiveness and safety of new drugs; developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2014, which would require the Federal government to provide higher reimbursements for certain specific, pre-identified high-potential drugs; and a priority review voucher which a drug developer could use to move a new drug to the head of the FDA queue.
But these are only proposed fixes to this problem and there is no guarantee they will work. Dr. Miller concludes, With more enlightened regulation and improved return on investment, which are necessary to make antibiotic development attractive, perhaps we can avoid the extinction of the antibiotic era and the reversal of our species increasing longevity. Perhaps.
Read the full op-ed here.