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Antibiotic Resistance: Incentivizing the Disincentive

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By: Aminul Islam, Ph.D

photo credit: danielfoster437 via photopin cc

Thanks to the serendipitous discovery of antimicrobial agents by the Scottish scientist, Sir Alexander Fleming in 1928, society at large has benefited tremendously from improved public health and advanced medical and agricultural practices. However, according to CDC (Centers for Disease Control and Prevention) reports, nearly two million people have become infected with bacteria that are resistant to antibiotics and at least 23,000 people each year die as a direct result of these infections in the U.S. This is in stark contrast to the statement supposedly made by the U.S. Surgeon General Dr. William Stewart in the 1960s that: ‘It was time to close the book on infectious diseases, and declare the war against pestilence won’. So is the golden age of antibiotics really coming to an end?

There are many issues which are thought to have contributed to the rise in antimicrobial resistance to antibiotics. They range from inappropriate prescribing by primary care physicians to reckless overuse within the agricultural industries. One major issue has been the inability of the pharmaceutical industry to continue producing new antibiotics to replace old ineffective ones. Indeed, the pipeline for developing new antibiotics has been pretty bare since 1987 as no new class of antibiotics for treating systemic infections has been developed. As a result, the marketing of a new antibiotic has become rather rare recently with a majority of the major pharmaceutical companies either closing their facilities or withdrawing from the pursuit of new antibiotic development; since it is deemed to be an unprofitable business venture. What is clear is that financial incentives are necessary to encourage research and development for novel antibiotics from within the pharmaceutical industry.

So how can we incentivize “Big Pharma” to once again see the development of new antibiotics as a profitable investment? In my opinion, this would require innovative public-private-partnerships and government policies which incentivize the development of new antibiotics without jeopardizing the preservation of current and future antibiotics. In particular, policies are needed which promote long-term antibiotic stewardship as well as sustainable business models for the private sector. This would be a tough balancing act considering that the success of nearly all pharmaceutical products are intrinsically linked to the number of units sold during the period of market exclusivity by employing aggressive marketing strategies to drive and increase sales – a practice which is all too common within the industry, but counterintuitive with regards to antibiotic preservation. Within the last year, six new antibiotics (dalbavancin, oritavancin, tedizolid, ceftobiprole, ceftazidime-avibactam and ceftolozane-tazobactam) have been approved under the FDA’s Qualified Infectious Disease Product (QIDP) framework based on the Generating Antibiotic Incentives Now (GAIN) Act, passed in July 2012, which gives these drugs an extra five years of market exclusivity. But this legislation does not either account for or guarantee long term antibiotic stewardship for these or any other antibiotics and in my opinion is not a comprehensive answer to the issue of antibiotic resistance.

I personally do not believe the golden age of antibiotics is at an end, primarily due to the attention this important issue is receiving lately (e.g. federal budget proposal for FY16) and by the governments response in setting up the President’s Council of Advisors on Science and Technology (PCAST) and executive order to combat antibiotic resistant bacteria. However, until we truly link both the incentives to developing antibiotics and the remuneration for using antibiotics directly to the conservation of current and future antibiotics, the threat of antibiotic resistance will not be fully eliminated and the market sector will remain disinterested to the needs of society for sustainable antibiotic stewardship.

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Written by sciencepolicyforall

March 30, 2015 at 9:00 am

Posted in Essays

Tagged with ,

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