My college boyfriend and I used to have this conversation:
Me: “I’m so broke.”
Him: “Yeah, me too.”
Which was almost always followed, a few days later, by this conversation:
Him: “Let’s go get a beer.”
Me: “I thought you said you were broke?”
Him (after a puzzled pause): “Well, yeah, I was. But then I went to the bank.”
How is this relevant, you ask? Like this. When it comes to antibiotic resistance — that is, to the increasing number of infections against which many drugs are no longer effective — people seem to think like my ex: When we’re out, we go back to the bank for more. The problem is, when it comes to antibiotics, we’re not temporarily out. We’re broke for real.
For the most serious resistant infections — MRSA, CRKP, MDR-TB, Gram-negative bacteria carrying the gene for NDM-1 — there are, in each case, only one or two drugs that still work, some of them old, many of them imperfect. There are no excellent, broad-spectrum compounds sitting on the shelf waiting to be used. There are few of them in the development pipeline, either, largely because so many companies have found antibiotic manufacturing unproductive and backed away from it.
The bad-bug behavior of the organisms gets a lot of attention; it’s one of the reasons this blog gets the traffic it does. The lack of new drugs to counter that somehow gets much less.
It did get some attention last week, though — in Congress. Late Wednesday, Rep. Phil Gingrey introduced a bill called GAIN, for Generating Antibiotic Incentives Now. Gingrey is a physician from a district northwest of Atlanta, and also a Republican, but before the bill’s introduction, he recruited Democratic co-sponsors: Reps. Gene Green (D-Texas), Diana DeGette (D-Colo.) and Anna Eshoo (D-Calif.) (as well as fellow Republicans Mike Rogers of Michigan, Ed Whitfield of Kentucky and John Shimkus of Illinois).
The bill doesn’t appear to be on Thomas.gov yet, so I put a copy on Scribd. Here’s what it would do, briefly:
- recognize that new compounds to address highly resistant bacteria deserve priority review and fast-track approval, to get out to the marketplace faster
- grant companies who produce those new compounds an additional five years of market exclusivity for them, so that they make more money off them before beginning to compete against comparable or generic products
- confers an extra six months of exclusivity if a company also brings out a diagnostic test for the organism, because using a diagnostic increase the chances that the new compound will not be wasted
- take another look at creating more incentives for manufacturing antibiotics, and also for redesigning the requirements for clinical trials of new drugs.
The bill’s introduction was applauded by the Infectious Diseases Society of America, which has been campaigning for action to stimulate antibiotic manufacturing; the Pew Charitable Trusts, which has been campiagning to raise awareness of antibiotic resistance and reduce misuse; and by Cubist Pharmaceuticals Inc., makers of the last-resort drug daptomycin, whose senior vice-president Dr. Barry Eisenstein said: “We are approaching a crisis point with antibiotic resistance and the lack of new drugs to treat resistant infections… We encourage Congress and the Administration to act and implement the policies in the GAIN Bill to provide companies with the right incentives to restore a robust antibiotic pipeline and avoid this looming health crisis.”
So, everyone’s in favor of incentives. Are these the right ones?
I’m a public health geek, not an economist, so I’m not going to attempt to argue for or against the details. Fortunately, others have already done that for me. There’s a stack of proposals already out there, including:
- a comprehensive overview of proposals from the London School of Economics and the European Observatory on Health Systems and Practices;
- the IDSA’s recommendations, which include passage of GAIN;
- an argument in favor of trading exclusivity for public health goals, so that manufacturers are rewarded not for pursuing sales at all costs but rather for encouraging appropriate use;
- patent extensions and wild-card patents, which extend the patent on a different drug (here’s an argument for and an argument against);
- public-private development partnerships, that is, throwing in federal money by direct appropriation or grant;
- and big cash prizes.
I know there are drug-development people lurking out there among my readers. Any comments, any of you? What incentives — these or others — would work?