October 14, 2016 at 5:00 am ET
It’s always tempting for politicians to put off addressing something that is a known problem but isn’t an immediate crisis – whether it be long-term solvency for Social Security and Medicare, adequate funding for state and local government pension plans, or growing fiscal deficits. We all know that the longer the politicians put off fixing these problems, the more fiscally painful the ultimate solution will be. But there’s one current problem where the consequences of putting off action are not just monetary but a matter of life or death. Failing to develop new antibiotics to address the growing problem of antibiotic resistance will, in the space of a single generation, result in the premature deaths of tens of millions of people each year worldwide.
In a nutshell, the problem is that disease-causing bacteria are evolving to develop resistance to existing antibiotics faster than we are developing new antibiotics. When I began my medical career in the late 1990’s as an infectious diseases specialist at the University of Texas, a relative golden age of anti-infectives with numerous effective agents was coming to an end with the emergence of vancomycin resistant enterococcus. While some bacteria had developed resistance to some of these drugs, the existing antibiotic armamentarium was adequate to address virtually anything we encountered. Moreover, there was a big pipeline of antibiotics under development, with between 10 and 16 new antibiotics being approved every five years. This constant flow of effective antibiotics led to the treating community getting used to cheap and effective therapy.
The situation is completely different now. Hospitals are seeing more infections with gram negative bacteria that have developed resistance to most or all existing antibiotics and the emergence of community acquired multi-drug resistant organisms e.g. MRSA. The medical community is doing its best to identify these infections and prevent their transmission. But the nightmare scenario that we could be facing imminently if this is not addressed is that not only will these “superbugs” be transmitted to other patients, but their drug resistance traits will be passed on to other types of bacteria. And there are precious few new antibiotics currently under development or being approved to counter this threat. Moreover, inexpensive generic options are no longer effective treatment for many of these infections.
There are a number of steps being taken to slow the spread of antibiotic-resistant diseases, including: preventing infections through immunization, safe food preparation, handwashing, and using antibiotics only when necessary; tracing antibiotic-resistant organisms and their origin; encouraging appropriate antibiotic prescribing, including eliminating the estimated half of unnecessary antibiotic use in humans and choosing the right antibiotic for the disease, and a concerted effort to remove antibiotics from the food animal industry.
But, it’s unclear how effective these steps will prove. A solution to addressing antibiotic resistance clearly requires a plentiful supply of effective new antibiotics available and under development at all times.
For drug manufacturers trying to decide where to invest their limited drug research and development dollars, the choices are stark. On the one hand they can invest billions of dollars to develop, for example, a new Alzheimer’s or cancer drug that has a high risk factor (because the experiments may fail, the drug may not be approved, or a competitor may develop and have approved first a similar drug) but that also has a high reward factor – a group of patients that will potentially benefit from long term therapy and therefore provide the company with the opportunity to reap a return on investment during the patent period.
New antibiotic development has the same risks and costs but is handicapped in ways that these other therapies may not be. Generally, antibiotics cure infections in relatively short time periods (days to weeks), payers limit reimbursement and because of resistance development, new antibiotics are kept as a last resort. In addition, if resistance to the product does develop, the utility of the drug may be significantly shorter than the patent period.
I’m proud to work for a company that has committed, in its social contract with patients, to risking billions of dollars to develop life-enhancing innovations. We have brought to market several antibiotics and have additional compounds now under trial. But, because of the skewed risk/reward calculation for developing antibiotics, we are in an increasingly small group of companies working on coming up with new antibiotics. We need to find a way to reverse this trend and get a group of pharmaceutical companies focused on a robust effort to develop new antibiotics. There are a number of good ideas for righting the antibiotic risk-reward calculation, including in a recent report by the Review on Antimicrobial Resistance.
One approach would be to reform the current Medicare reimbursement rules applicable to antibiotics. Under the current regime, reimbursements to a hospital are bundled for various types of patient encounters, with the reimbursement being fixed regardless of the types of drugs that may be administered. This has the effect of discouraging hospitals from using a new, more expensive antibiotic even when it may be the most appropriate (or only effective) drug. Providing an enhanced reimbursement for high-value antimicrobials, as proposed in H.R. 512, The DISARM Act, would be a significant improvement.
Another approach would be to give pharmaceutical manufacturers an incentive to develop treatments for “priority infections.” Companies developing these antibiotics could be given a limited extension of exclusivity for some other drug that would provide sufficient reward for undertaking the risks of developing the antibiotic. The House Energy and Commerce Committee included this idea in its discussion draft of the 21st Century Cures Act, and I believe the idea should be given serious consideration.
Without increased incentives for drug companies and other researchers to be involved in developing new antibiotics, I fear that the human race may lose the antibiotic resistance race.
Gavin Corcoran, MD, is the chief medical officer of Allergan, plc.
An earlier version of this op-ed misstated the author’s position at Allergan.
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