In its new report “The Future of Drug Safety: Promoting and Protecting the Health of the Public”, the Committee on the Assessment of the US Drug Safety System of the Institute of Medicine has written:
Rec. 4.6: The committee recommends that CDER [FDA's Center for Drug Evaluation and Research] build internal epidemiologic and informatics capacity in order to improve the postmarket assessment of drugs. In recognition of the limitations in human resources in the current employment market to meet this role, a combination of advancing professional skills through continuing education and support for academic training programs is needed.
Informatics experts should track progress on the national health-information infrastructure, look for opportunities to gather information about drug safety and efficacy after approval, coordinate partnerships with external groups to study the use of electronic health records for [drug] adverse event surveillance, participate in FDA’s already strong role in setting national standards and track the development of tools for data analysis in industry and academe, and encourage the incorporation of the tools into FDA practice where appropriate.
The reference for this recommendation is “The Future of Drug Safety: Promoting and Protecting the Health of the Public”, Committee on the Assessment of the US Drug Safety System, Alina Baciu, Kathleen Stratton, Sheila P. Burke, Editors, Board on Population Health and Public Health Practice (BPH), Institute of Medicine (IOM), 2006, page 102.
It is encouraging to see these words in print from the IOM. Others such as Gartner Group, a large IT-related consulting firm, had made similar observations, but don't have the clout of an IOM. Hopefully, the pharma industry will take notice. (There will likely still be resistance in some quarters to this recommendation).
Not to toot my own horn or that of the field of medical informatics, but just prior to the mass layoffs that led to the end of my pharma position managing an internal science research library system and IT group (a position I'd obtained due to a secondary line of research as an informatics postdoc regarding selective information retrieval), I'd emailed the VP over my area about medical informatics.
This company has been struggling with a weak pipeline of new drugs. The VP, a former computer-industry businesswoman with no biomedical experience at all, was directing an entire division of biomedical research computing. As a cost-cutter, she was resistant to ending rationing of critical cheminformatics tools to R&D scientists, despite competitive intelligence data I prepared showing our competitors granted up to ten times the number of R&D scientists at their companies unfettered access to these tools. The cost to end rationing would have been a tiny fraction of the overall corporate R&D budget (assuming that budget could not be increased via a presentation to senior management of the criticality of these tools!)
In my pre-layoff email to the VP, I pointed out that if my area was to be downsized, as information groups often are, my primary expertise in the EMR and its use beyond care delivery for data aggregation, outcomes evaluation, etc. was a strategic skill for this troubled company. I was the only formally-trained medical informaticist (via an NIH-sponsored postdoctoral fellowship) in an international company of ~ 60,000.
Predictably, the VP laid me off along with a number of my staff. The VP also subsequently closed the research library at one of the company's two major R&D sites, something I had explicitly warned against as unwise, up to the highest levels of management.
That VP only lasted a few more years before her contract was not renewed, as I understand it. At last report, the VP was working for a computer gaming-hardware company.
The IOM's observation that there are "limitations in human resources in the current employment market to meet this [informatics] role" does not recognize another layer of human limitation in healthcare management - that of basic insight.
The lesson to be learned is to not hire people lacking biomedical backgrounds and insights into high management positions in biomedical settings. The decisions they make due to lack of expertise, lack of vision, difficulties understanding biomedical risk and the nuances of biomedical R&D (or clinical care in the provider sector), etc., will often be highly damaging.
This basic issue, of course, is often still ignored.