"HUMANITIES are the hormones"

Therapeutic innovation

Do we need New Year's resolutions?

by Dr. John Crellin

Although New Year's resolutions usually focus on redressing sins and failings, innovations demand equal consideration.

Innovative development, something of a current buzz phrase, is an issue for all institutions, including medical schools. Historians of medicine, in looking at prerequisites to medical innovation, have shown that diverse and complex backgrounds exist behind new drug development. However, the confluence of key individuals, of new technologies, and of a critical mass of interdisciplinary ideas generated by pure science and market needs are frequently significant.

Particular attention has been given to barriers to innovation. Still quoted is a remark from a 1976 Presidential Panel report stating that that the FDA's stringent controls imposed on drug marketing constituted a "hazard to public health." Although the statement focused mostly on the increasing length of time taken for drug approval, concerns also exist that regulatory burdens have hampered drug innovation. One thoughtful commentator, David Healy, has argued that 1962 U.S. regulations on prescription drugs have limited patterns of research into psychoactive drugs during the past 40 years.

These comments are by way of asking, What New Year's resolutions can research-oriented institutions make to maximize therapeutic innovations? Such a challenge is made, indirectly, by ethicist George Agish in recent comments on the regulatory ethics paradigm, namely that "we need to seriously consider that [it] may not represent the best statement of the ethical standards appropriate for innovative care." The paradigm, of course, holds that, since any deviation from standard care involves some element of experimentation, investigatory procedures used must assure the rights and welfare of the subjects of research.

Agish perhaps had in mind "big" issues such as xenotransplantation, but concerns also exist over complementary/ alternative medicine and its claims to offer innovative care, indeed to offer an innovative paradigm.

How should medical institutions respond to such claims? Do they have a responsibility to review critically current discussions on, for example, integrative care at various levels, including health care systems and practitioner delivery? Should they evaluate initiatives such as the Prince of Wales' Foundation on Integrated Medicine and the research roles recently given to it by the British government? And, in Canada, should the question be asked: How successful is the Vancouver-based Tzu Chi Institute? Does it offer a model for elsewhere? And, do institutions have a responsibility to promote evaluations of health care practices that are widely used by patients?

Evaluating specific complementary/alternative claims can be difficult - for instance, whether standard clinical trials are appropriate for holistic therapies such as acupuncture when controls are problematic. Although differences of opinion over clinical trials have long vexed developments in complementary/ alternative medicine, they will become more of an issue with the following growing demands for evidence-based data in the field, newly available funds to pursue research in the area, the continuing growth of interest in "integrative" medicine among the health professions and the general public, and the current climate for health care reform.

A consideration of such questions invariably prompts debate over the use of pragmatic clinical trials (close to real life situations) rather than fastidious trials with minimal variables. It is well known that many physicians feel that pragmatic clinical trials are inappropriate because of "unscientific" complementary/alternative concepts. They feel it unethical on the basis of the Regulatory Ethics Paradigm, even though conventional treatments may not be especially effective for a particular condition and a complementary/alternative practice has a positive reputation with many people. However, Agish's challenge has to be explored: that "the Regulatory Ethics Paradigm may not represent the best statement of the ethical standards appropriate for innovative care."

New Year's resolutions are usually remembered when forgotten! Therapeutic innovation, however, is an important public issue that should be a permanent topic of interdisciplinary debate in all medical schools.