Monday, December 05, 2005

Report: Life Science Manufacturers Adapt to Industry Transitions

Of potential interest to the medical community, the Gartner Group's recent report " Predicts 2006: Life Science Manufacturers Adapt to Industry Transitions " (unfortunately only available to Gartner clients) agreed with a number of my assessments about improving postmarketing 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 furure, 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 Rahway for this interview to save the executive a trip to Pennsylvania, where I was originally scheduled to come for the interview, since the executive's father was ill in the hospital. In an instance of profound social ineptness, my effort was not even acknowledged. Perhaps he was in a bad frame of mind, but the dismissal under the circumstances was all the more disappointing.

Seeng 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.

-- SS

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