Thursday, December 16, 2004

New Worries About Drug Safety

The EMR will likely be of great value in improving the large-scale postmarketing surveillance of new drugs. However, there seems to be a near-complete lack of EMR expertise (especially in Medical Informatics specialists) in the pharmaceutical industry. One must wonder why an important specialty whose training is funded in many Ivy-League universities by NIH for well over a decade, and privately by many other reputable universities, is poorly-represented in industry.

    New Worries About Drug Safety: Forbes

    NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.

    The survey, which was obtained by two non-profit advocacy groups, the Union of Concerned Scientists and Public Employees for Environmental Responsibility, under the Freedom of Information Act, has some severe limitations--most notably, that only 47% of the 846 FDA staff who were queried responded to the late-2002 survey. Still, it would seem to boost the case of FDA whistleblower David Graham, who has warned about the current system for insuring drug safety. (See: Face of the Year: David Graham)

    FDA officials were not immediately available for comment.

    Graham, a proponent of drug safety, said in testimony before a Senate committee, that the current drug safety monitoring system could not prevent another case like the withdrawal of Vioxx, the Merck (nyse: MRK - news - people ) arthritis drug, that was pulled from the market because it raised the risk of heart attack and stroke with long-term use. The drug had been on the market for five years.

    ...In previous interviews, Graham has outlined the problems with the system. Doctors report side effect voluntarily, and the FDA only finds out about a small fraction--at most one-tenth--of these side-effect cases. This makes it incredibly difficult to figure out how often a problem is occurring. With Vioxx, there was an added problem, because heart attacks and strokes are common in the same arthritis patients who took the drug for pain. Therefore, it's possible they could slip under the radar entirely.

At present, the FDA depends on the voluntary participation of clinicians to both recognize and then report the side effects of drugs, such as in the Medwatch program. Symptoms observed might not be recognized as drug-related. For example, MI's and CVA's in patients taking COX-2 inhibitors would likely not have been recognized as dangerous side effects until recent announcements regarding VIOXX.

The scope of the drug surveillance "radar screen" will be expanded exponentially when EMR technology becomes commonplace, providing significantly more data for analysis for possible drug side effects. Pharma needs to pay attention to this technology.

In a large pharma company I recently worked for, the field of Medical Informatics was nearly unknown to scientific, information technology, and HR/talent management executives and staff. I was hired only to run a scientific library before being laid off in a large reduction in force. I then was turned down for roles in the adverse events data collection and analysis section, characteristically enough, by a former FDA senior adverse events official retained by the company.

-- SS

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