by Mitch Kokai
Senior Political Analyst, John Locke Foundation
In 2004, the Infectious Diseases Society asked for attention to “a frightening twist in the antibiotic resistance problem that has not received adequate attention from federal policy makers: The pharmaceutical pipeline for new antibiotics is drying up.” The society published a policy paper called “Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates, A Public Health Crisis Brews.”
Economics reared its ugly head in that report. The society offered numerous causes of the failure to fill the pipeline with new antibiotics, all still valid today:
• When they work, antibiotics work quickly. Even the most serious infections are cured in a month or two. Drug companies and their investors prefer to try to invent drugs that patients will have to take for a lifetime, such as treatments for diabetes, high blood pressure, and arthritis.
• Patent terms expire too quickly. All drugs require a long journey through development and testing. Even though Congress has tinkered with patent law to extend terms beyond the nominal 20 years in some circumstances, not all of the time lost in development and regulatory review is restored. In addition, antibiotics have a special problem: Because doctors keep new antibiotics in reserve, even a great new drug may not be a great seller during its patent term.
• Regulatory hurdles are a problem for all new drugs, but they are especially high for antibiotics. The Food and Drug Administration requires separate clinical trials with large numbers of participants for each type of infection. That basic problem is compounded in testing for effectiveness against drug-resistant bacteria: Researchers have to wait for an epidemic to break out in a hospital, and then enroll patients in clinical trials while they are critically ill.
• The public is not aroused. Doctors and drug companies have not figured out how to “put a human face” on the issue of antibiotic resistance. There are no organized pressure groups demanding change from Congress and the FDA, as AIDS activists and breast-cancer activists and orphan-disease activists demanded attention, funding, and fast-track regulatory processes for their concerns.
• Public hostility to drug companies is common. There are far too many activists actively hostile to Big Pharma, which they see making profit off human misery. They fail to recognize that profit is what drives and funds research and new products.