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By Marcia A. Testa, M.P.H., Ph.D.
Ten years ago the Institute of Medicine formed the committee for the Study of the Future of Public Health. Its purpose was to address a growing perception among the Institute's membership that our nation had lost sight of its public health goals and had allowed the system of public health activities to fall into disarray. Public health is what we, as society, do collectively to assure the conditions in which people can be healthy. The Committee concluded their studies in 1988 and reported that "the current state of our abilities for effective public health action is cause for national concern and for the development of a plan of action for needed improvement."
Schools of public health play an extremely important role in helping set public policy and priorities for health programs by providing both leadership through their faculties and research programs and education for individuals who will carry out new and important programs and policies. During the eight years since the committee's report, we might ask ourselves, as faculty and professional in public health and biostatistics, have we addressed our social and policy responsibilities as fervently as we have pursued our basic science goals? We will address this question by reviewing two cases.
The May/June 19965 issue of Nation's Health (the official newspaper of the American Public Health Association) ran a front page article entitled "FDA reform bill seen as public safety threat." This Senate bill, S 1477, sponsored by Sen. Nancy Landon Kassebaum, R-Kan., was initiated to streamline the Food and Drug Administration and speed approvals of new drugs and medical devices. Lawmakers, advocacy groups and individuals opposing the measure stated that the bill if passed would "threaten the health and safety of Americans." Sen. Ted Kennedy, D-Mass. Called the FDA reform "the principal public health challenge in our Congress. We make a mistake on this one, and people are going to die."
The bill cleared the Labor and Human Resources Committee on March 28, 1996 with a strong bipartisan majority on a 12-4 vote. Some of the changes set forth in the bill would: 1) require the FDA to contract out the review process to the private sector if agency staff could not respond to an application within 180 days; 2) reduce the minimum number of clinical trials from two or more to just one; 3) ease restrictions on experimental drugs to allow access for seriously ill patients; 4) allow drug-makers to market "off-label" uses for already approved drugs; and 5) allow a drug to be used pending final approval. The measure "would achieve an unprecedented cutback in drug testing requirement," wrote Thomas Moore, a senior fellow at George Washington University's Center for Health Policy Research, in a Washington Post op-ed piece.
The same week the Senate was considering the bill, the Dept. of Biostatistics held the Schering Plough Workshop (see article in this newsletter), and one of the main points of discussion was to evaluate flexible clinical trials strategies which would hopefully lead to faster and more efficient approval. Many issues were discussed at the workshop, but no presenter mentioned the bill deemed by Kennedy to be "the principal public health challenge in our Congress." While the discussions were state-of-the-art and their relevance to current problems obvious, the disconnection to the pressing concerns in Congress raises questions concerning our public awareness and abilities to affect public policy.
Another case involves the controversy surrounding the evaluation of the health risks of breast implants. Marcia Angell, in her June 6, 1996 article in NEJM, cites the almost cult nature of the litigation and court process in promoting junk science with flagrant distrust and/or disregard for sound epidemiologic and biostatistical studies. She states, "Many people have become alienated from science and scientific habits of thought – at a time when we need science more than ever to help us find our way through an increasing number of serious and complicated questions involving risk to health and safety. To reverse the alienation we need a better public understanding of science. It also means attention to scientific thinking, including an understanding of the nature of evidence, the concepts of chance and error, and the value of skepticism."
As epidemiologists and statisticians we have a responsibility to defend the very science which we helped develop and progress. How can all our progress in the field of quantitative science be whisked aside with a single pound of a court gavel? The Library of Alexandria, which housed all of the scientific discoveries since the dawn of man's history, was burnt to the ground by individuals who feared and did not understand its power. It was 1000 years and dark ages before we even began to recover from that loss.
If we can provide recommendations for designing and analyzing clinical trials in such a way as to speed approval and the delivery of new drugs, it would seem appropriate to let our recommendations and findings be known to those who have the congressional authority to implement those strategies. By advancing so technically ahead, have we left the public behind to form decisions and beliefs ignoring the rules of science in protest to scientific alienation and a willful distrust? The very criteria of intense focus that makes us good basic scientists are also those which might lead to social isolation from our public health responsibility. We need to prioritize our devotion to public health causes and form advocacy and educational groups that can open the doors of our discoveries to the public we have vowed to serve.<\html>