Looking to the Future

In the wake of recent cases of adverse drug reactions, FDA announced plans in February 2005 for a new Drug Safety Oversight Board that will monitor Phase IV (postmarket) pharmaceutical use. Questions about the status of drug research, especially widely circulated claims that pipelines are empty, may be more difficult to resolve than concerns about side effects. Yet some of these claims are exaggerated; in 2004, FDA approved 34 new molecular entities and biologics, including innovative treatments for diabetes, Parkinson's disease, pain, macular degeneration, and several therapies for cancer. This is a drop in numbers of new approvals compared with the mid-1990s; however, contrary to some pundits' arguments, new drugs continue to offer improvements to medical care.

Recent criticisms of both regulators and regulated create a dilemma for public policy. Are government interventions necessary, and if so, what unintended consequences will they inflict? Pharmaceutical manufacturers have long operated on the boundary between, on the one hand, acting as free-market inventors and sellers of drugs, and on the other, serving the public interest by providing an essential health service. Thanks to this unique market position, the industry has played a leading role in globalization, developed innovative scientific advances in a wide range of medical fields, and pioneered academic-industrial research collaborations.

Balancing of private and public interests is unquestionably difficult; yet pharmaceutical invention and delivery to patients have relied on medicine being run as a business. Interestingly, new initiatives, including those for HIV and tuberculosis put forth by the Bill & Melinda Gates Foundation and the Drugs for Neglected Diseases Initiative launched by Doctors Without Borders, seek to challenge this model by sponsoring not-for-profit drug invention. Given the time frame of two to 10 years from promising chemical compound to an approved drug, their success will take some time to judge. Nevertheless, proponents suggest that nonprofit drug developers, either government or foundations, will serve the public interest better than the pharmaceutical industry.

Physicians, the pharmaceutical industry, and government regulators are in an awkward dance around the molecules synthesized by medicinal chemists. Cases like the analgesic Vioxx are but the most recent incarnation of what M. N. G. Dukes, author and editor of several books on the drug industry, characterized in 1979 as "the love-hate relationship which exists between the public and its drugs--substances which are hailed one moment as the solution to every problem and castigated the next as the cause of every ill." Pharmaceutical policy today is in a trap: Stronger regulation may lead to fewer medicines, while weaker regulation may lead to more drug disasters, and strong enforcement of patent rights may lead to less affordable medicines, while weaker enforcement of intellectual property may eliminate incentives for innovation. Better policies for government regulation and incentives for the industry will only come from a less polarized debate, lowered expectations for miracle cures, and a renewal of chemists' passion for the molecules they discover.