Of potential interest to the medical informatics community is the Gartner Group's report "Predicts 2006: Life Science Manufacturers Adapt to Industry Transitions " (unfortunately the full report is only available to Gartner clients).
This report paralleled a
number of my thoughts about improving post marketing drug surveillance via
clinical IT ("Reflections
on the future of drug safety surveillance from the Medical Informatics
perspective"), as well as observing the lack of Medical Informatics
specialists involved in such activities in pharma. I
had been interviewed in the report's preparation after a Gartner principal had
seen my essay on the Web.
Some quotes in the report echoed my essay linked above. In the section "Underutilization of analytical tools to review clinical study data will obscure the risks of approved drugs" the report states:
- The swift and severe judgment in favor of the plaintiff in the first Merck Vioxx trial sent a shock wave through the biopharma industry. It shows that biopharma manufacturers must do more to ensure that healthcare providers and the public have an accurate, ongoing assessment of medication risks. Biopharmas must also ensure that information on these risks is communicated promptly in an open, understandible manner. Posting clinical trial information on a web site is one step towards greater transparency, but does not provide information in a way that enables ... comparions of benefits and risks.
- It is still well recognized that all the possible side effects of a medication cannot be uncovered using a randomized sample of study subjects. The true test of safety and efficacy can only be determined when trial data is combined with other sources of information such as clinical encounters, adverse events (MedWatch) or observational studies (National Registry of Myocardial Infarction).
- In the future, it is hoped that the EMR system will capture point-of-care information in a standardized format that can be used for drug surveillance. Today, biopharmas must be content with these other available, if imperfect, information stores.
- Biopharmas that ignore the opportunity to use analytical tools to proactively review contradictory sources of study information (for example, pre- and post-approval clinical data sets, as well as registries) will miss essential signals regarding product safety. Yet today, only a small percentage of biopharmas routinely utilize personnel with medical informatics backgrounds to search for adverse events in approved drugs.
- Biopharmas ... should look at risk from multiple perspectives ... they must also get actively involved in defining the electronic health and medical record so that it will contain the type of information required to make better safety assessments in the future.
The recognition of a gap in formally-trained medical informatics-trained personnel in the pharmaceutical industry is welcome. For example, from my own experience:
I recall an interview I had last year with the head of an adverse events department at Merck in a rehire situation. I came highly recommended by an Executive Director in the department, to whom I had shown my prior work. This included well-accepted, novel human-computer interaction designs I'd developed for use by busy biomedical researchers for a large clinical study in the Middle East , as well as my work modeling invasive cardiology and leading the development and implementation of a comprehensive information system to detect new device and treatment modality risks in a regional center performing more than 6,000 procedures/year. In addition, I'd worked with the wife of the Executive Director in years prior, when she ran the E.R. of the hospital where I was director of occupational medicine.
Despite all this in my
favor, the Executive Director's boss, himself a former FDA adverse events
official, dismissed me in five minutes as I was showing him the cardiology
project, saying flatly "we don't need a medical informatics person
here." I had driven 80 miles to
Seeing this issue raised by Gartner, a world's leading provider of research and analysis about the global information technology industry, was undoubtedly a positive development.
- 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, p. 102.
It is encouraging to see these words in print from the IOM. Others such as Gartner Group 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 this computer 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.
Regrettably, the computer VP laid me off along with a number of my staff. The company 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, even providing a letter of support from the emeritus scientist Maurice Hilleman, PhD, who had probably saved more children’s lives than anyone in history.
That computer 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.