December 18, 1998: D. Craig Brater, Indiana University School of Medicine

I should like to offer brief comment on the potential Request for Applications (RFA) that will be released concerning Centers for Education and Research on Therapeutics (CERTs). Firstly, the explosion of events concerning therapeutic misadventures offers compelling testimony to the need for such centers. Examples include the proliferation of publications about the prevalence of adverse drug reactions and their cost in terms of morbidity and mortality, publications concerning the frequent co-prescribing of drugs that interact and the consequences therein, and recent withdrawal of drugs from the market. The totality of this evidence is that health care providers have a poor understanding of therapeutic agents and as such they misuse them; moreover, established systems such as those that screen for drug interactions are obviously not working. My own bias is that the explosion in therapeutic advances has not been matched by a similar explosion in education and information dissemination. The result is that the practicing physician is ill-prepared to prescribe drugs intelligently and effectively.

Because the need is so great and the problem is so large, I strongly advocate attempts to secure additional funding to make this program as robust as it needs to be. I suggest that as many as 20 CERTs may be needed and funding should be in the range of that of any major center grant; namely $1 million/year. Without such a commitment, this initiative will only scratch the surface.

What should CERTs do? To be effective they should traverse the entire spectrum from a research perspective. So doing will allow one to better predict adverse drug effects and interactions and thereby better educate health care providers and the public. This spectrum entails bench research into mechanisms of drug effect coupled with patient-oriented studies assessing translation of bench results into man, and with further coupling to research into the relevance of these findings to populations of patients (namely, health services research). Lack of any of these research components seriously compromises the whole, so all should be sought even if so doing requires collaboration outside of an individual institution.

There also needs to be an educational component, preferably educational research aimed at discerning how best to disseminate information and induce health care providers to change their habits.

I hope these thoughts are helpful as you ponder the substance of the RFA.

D. Craig Brater, M.D.
Chairman, Dept. of Medicine
Director of Clinical Pharmacology
Indiana University School of Medicine
Indianapolis, IN
dbrater@iupui.edu

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