Is the Office of Alternative Medicine an act of political palliation?

Joseph J. Jacobs, M.D., M.B.A. Former Director, Office of Alternative Medicine, NIH; Health-Care Consultant, Guilford, Conn.       YES The OAM was created as a mandate from Congress through the appropriations process for NIH. It owes its life to Sen. Tom Harkin (D-Iowa), then the appropriations subcommittee chairman, who has friends in the alternative-medicine community. The notion of doing honest clinical evaluation of alternative medicine was an NIH sop to Harkin.   Through his staffers, Harkin subjected NIH to political extortion to conduct simplistic and naive research. Instead of randomized, controlled trials, Harkin’s political friends asked me to fund simple observational studies of alternative medicine for diseases such as cancer- studies uncontrolled for patients’ previous chemotherapy and radiation.   Further, these people urged us to establish research protocols that almost ignored basic issues such as the need for protection of human subjects, which is mandated by statute, and informed consent.   I was pressured to support Stanislaw Burzynski’s research on antineoplastins and forced to file an IND on his behalf. That was inappropriate, because we weren’t doing clinical research, but setting an agenda and supporting research.   All the while congressional staffers made subtle threats to our budget when alternative- medicine proponents weren’t satisfied. Ultimately, I felt morally and professionally compelled to resign.   After I left, OAM funded the Bastyr School of Naturopathic Medicine as one of a series of centers for HIV research. It was political pandering to select that type of institution for the sake of placating the alternative-medicine community. Bastyr doesn’t have an established track record in HIV and AIDS research.

Alan Trachtenberg, M.D. Former Acting Director, Office of Alternative Medicine; Adjunct Associate Professor of Health Care Sciences, GWU         NO During the 10 months I ran OAM, Sen. Tom Harkin never attempted to influence the research agenda.   A 1993 article in the New England Journal told us that roughly a third of Americans had used an alternative medical therapy in the past year. This year, Project Hope confirmed some details of the findings. When 80 million people are indulging in a health-related behavior, scientific examination of it becomes a critical public-health matter.   In 1988, when I did epidemio- logic research for the California Office of AIDS, reports suggest- ed that huge numbers of HIV- positive men were pumping ozone up their rectum. Another alternative treatment was DNCB, a chemical that, in vitro, stimulated T cells.   I felt that they might have important public-health impli- cations. Now we know that stimulating T cells increases HIV replication. And now, finally, researchers at Bastyr University in Seattle are looking into the frequency of these behaviors and their outcomes.   This has been disparaged because it is not a clinical trial. But there is probably not an IRB in the country that would give consent to study rectal ozone or DNCB. Critics say one can’t make definitive conclusions about outcomes from observational epidemiology. The point is you have got to find out what people are doing.   Most users of alternative medicine don’t tell their doctors. We need to know how our patients treat themselves.   The New York Times called the OAM a waste. Yet it’s just $5 million to $8 million of NIH’s $10 billion-plus budget, and Americans spend billions on alternative treatments.   Despite the high prevalence of alternative medicine, science and medicine had ignored it. So in this case, politics filled a gap in health research.