A recent article in Forbes argues that misplaced public distrust of the pharmaceutical industry could harm the research and development of important antibiotics. Entitled, "Pharma's Poor Reputation Doesn't Help in the Fight of Superbugs," the article examines the industry's reputation in light of the antibacterial resistance epidemic.
As a background, an April report published by the World Health Organization stated that antibiotic resistance is an increasingly serious threat in every part of the world and a "problem so serious that it threatens the achievements of modern medicine." The report gets pretty gloomy: "A post-antibiotic era, in which common infections and minor injuries can kill, far from being an apocalyptic fantasy, is instead a very real possibility for the 21st century."
Incentivizing Antibiotic R&D
The New York Times expounded on the study. Their article, "The Rise of Antibiotic Resistance," outlined the problem and potential solutions. Two aspect of their analysis stuck out:
- (1) "The most urgent need is to minimize the overuse of antibiotics in medicine and agriculture, which accelerates the development of resistant strains."
- (2) "The pharmaceutical industry needs to be encouraged to develop new antibiotics to supplement those that are losing their effectiveness."
In essence, people are looking to pharmaceutical companies to develop antibiotics, but the need to limit overuse will result in very low sales. Thus, the industry needs incentives to invest time and money into the research.
The Forbes article, written by John LaMattina, argues that offering the industry incentives is unfortunately easier said than done.
"The issue lies, to a certain extent, in the traditional business model for drug R&D," states LaMattina. "Normally, companies will take 10 – 15 years and invest about a billion dollars to discover and develop a new medicine. If these efforts are successful, they'll begin to sell the drug with the hope that it will quickly generate sufficient sales to not only recoup their initial investment but also grow the company and allow for the reinvestment of profits back into R&D."
While this is true for many disease areas, antibiotics are different. "If a novel antibiotic were to be approved for a resistant life-threatening infection such as MRSA (methicillin-resistant Staphylococcus aureus), federal agencies would try to prevent its overuse," LaMattina notes." Thus, such a new antibiotic would be prescribed as a last line of defense and used only in patients where all else has failed."
"Quite frankly," says LaMattina, "[t]he financial returns for such R&D don't measure up to the returns that companies can realize in other disease areas such as heart disease, diabetes, and cancer. Research and development is both extremely expensive and unpredictable. As a result, many have put forward suggestions to address the problem of trying to reward companies for developing new antibiotics that will be rarely used."
LaMattina references an article by Ben Hirschler and Kate Kelland entitled "How to fix a broken market in antibiotics" which expressed a number of potential incentives:
- Extend patents for antibiotics. Since antibiotics typically reach peak sales after 13 years on the market, compared to just six for other drugs, antibiotic peak sales often occur after the drug's patent has expired. Extending the patent life will better enable a pharmaceutical company to profit on its breakthrough.
- Allow a company a "transferable patent extension" for other medicines. While the breakthrough antibiotic will not be commercially successful, allow the innovator company to extend the patent of an already profitable drug for a period as a reward for its commitment to antibiotic R&D.
- Have the government support a portion of antibiotic R&D funding by creating a public-private partnership. This will lessen the money that a company would need to invest to carry out antibiotic research.
Unfortunately, LaMattina argues that these options are good in theory, but ignore the "elephant in the room."
Pharma's Poor Reputation Doesn't Help in the Fight of Superbugs
"Most people believe (incorrectly) that pharmaceutical companies are already enormously profitable," states LaMattina. "Furthermore, most believe that drug research is largely carried out in academic labs or research institutes like the NIH. They unfortunately believe that Pfizer , Merck , Novartis , etc., license drugs from the outside and then simply manufacture them and charge high prices. Furthermore, many doubt the safety of new medicines. Thus, the thought of the government taking steps perceived to help pharma grow its coffers even more is abhorrent to many."
This is bad news for antibiotic research. "Against this backdrop, it is hard to imagine that the public would support any initiative designed to help prod pharma companies into returning to antibiotic R&D," says LaMattina, who anticipates the public outcry:
- Why should governments allow companies to extend their monopolies on medicines?
- Why do you have to prod companies into doing what's best for people?
- Why should the government use tax payer dollars to support pharma's work?
Pharma's public image needs to be rectified, argues LaMattina, before any of these incentives will come to fruition.
It is also important to keep in mind that sometimes the public is not entirely to blame. This is not to say the pharmaceutical industry has been perfect, but the government often plays a role in, if not condemning pharma, not articulating the value of industry. One need only read the criticism of Gilead's Hepatitis C drug to understand that manufacturers face criticism even when they find cures for disease.
The public for the most part remains unaware about pharmaceutical companies' extensive role in funding important research. Industry must consciously articulate their work in getting treatments and cures to patients. This is especially true with the upcoming Sunshine Act data release. Companies and doctors shouldn't have to hide their collaboration, but the public needs context around these relationships.