This working paper is available here as an Adobe Acrobat PDF.
Project Bioshield was intended to stimulate the production of medical countermeasures to would-be agents of bioterrorism. The legislation was visionary and monumental. But by many accounts, it has been off to a slow start.
There are many reasons. But above all else, developing medical countermeasures is a complicated affair challenged not only by unique science and regulatory requirements, but also politics.
On the science, creating new drugs and vaccines targeted against pathogens that can be used as bioweapons includes all the challenges of creating traditional drugs against traditional diseases, with the added caveat that the weaponized pathogens that you are targeting do not exist in nature.
There can be long lead times needed to develop these new medical products, special medical requirements, and uncertainty over a regulatory process that is not as clearly defined as for conventional drug developers.
On the political side, the marketing of these products is also fraught with uncertainty. It relies on government purchases, and government contracting for these products through a process that is unfamiliar to life science companies and for the government, not as simple as contracting for other defense items like weapons systems and airplanes.
Policies aimed at stimulating development of these products have not fully taken note of these challenges, nor have all of the policy makers, who are rightfully eager to improve America’s biodefense, but whose political activity may be undermining the very efforts and outcomes that they aim to promote.
The result is that some of the solutions to these challenges have only served to harden them by injecting political considerations into a drug development process that should be guided by purely by science and the public health imperative.
Indeed, as this paper will note, some recent reports of political intrusion into the scientific process for procuring a new smallpox and anthrax vaccine, as well as countermeasures to radiation poisoning, has added to the cost of capital for these endeavors--in some cases, putting products further out of reach, and in all cases, making would-be investors increasingly reluctant to enter the market for developing bioterrorism countermeasures.
This experience, and the unhelpful impact of politics on drug development, is not unique to medical products aimed at biodefense. It is also occurring in other therapeutic areas where new drug development is marked by a high degree of political interest and public need, including HIV/AIDS and antipsychotic drugs.
Yet in each of these cases, there is one abiding lesson: Political intrusion into drug development only serves to increase the costs, and the uncertainty of coming up with drugs uniquely targeted to these ailments.
In the end, politics becomes one more factor they need to accommodate, amidst challenges of anticipating science and judging the marketplace. Yet politics is the one factor that they are least skilled at managing, and therefore the most eager to avoid. The end result is very clear, as this paper will demonstrate: less development work gets done in therapeutic areas that are in political play. Biodefense is high among them. And in the end, fewer new drugs are developed.
Scott Gottlieb, M.D., is a resident fellow at AEI. He has done consulting work in the past for Vaxgen on issues related to those discussed in this analysis.
