Friday, January 14, 2005

Extry! Extry! EMR invented!

Yesterday I wrote that my letter published in BusinessWeek (suggesting that the EMR held a potential solution to postmarketing drug surveillance) might have been the first time such an opinion appeared in the general business periodical literature. After I wrote that, I was then concerned that may have I made an overstatement.

In today's Forbes article "FDA Fix No. 3: Track Side Effects", however, I was reminded that perhaps my statement was indeed close to the truth. Note the absence of mention of the EMR:

NEW YORK - One of the clearest lessons from the Vioxx debacle is that the
Food and Drug Administration's side effect tracking system is woefully
inadequate. Its current system relies on doctors to voluntarily report when a
drug causes a problem. This works great for finding rare side effects that would
be unlikely to happen without the drug, such as liver or kidney problems or
allergic reactions. But it doesn't work well for picking up common problems such
as heart attacks and strokes--exactly the ills Vioxx and its kin may have

... One solution, proposed by Raymond Woosley, the Vice President for Health
Sciences at the University of Arizona, is to carefully track the first 100,000
patients who take a drug in order to look for higher rates of common health
problems. That might be prohibitively expensive.

A similar idea is to start what are known as patient registries. People who
either take a drug or have a particular disease are put into a database and
monitored for side effects and potential benefits. Richard Gliklich, a Harvard
professor, runs a profitable, closely-held business called Outcome that develops
such prospective databases for big drug companies and organizations like the
American Heart Association. "There are going to be drugs that are going to be
toxic to some segments of the population, and very beneficial to other segments
of the population," he predicts Another fix: make the Office of Drug Safety,
currently part of the FDA, a separate agency.

Experts like comparing such a step to the creation of the National
Transportation Safety Board. The NTSB makes recommendations to the Federal
Aviation Administration, for instance, and thought they are not binding, they
are often followed. In the same way, a separate drug safety office could create
a public watchdog that makes sure studies into side effects of commonly
prescribed drugs are getting done.

Even some drug executives have backed doing more studies of the type done
by FDA safety expert David Graham, who was one of those to warn about Vioxx.
"While I don't think that a separate office for post-marketing surveillance is
likely, a strengthened Office of Drug Safety is almost a certainty," says David
Kessler, a former FDA commissioner who is now a dean at the University of
California, San Francisco. "In the past, we have seen examples of the
accelerated approval of drugs without the appropriate follow-up, and I think
that will be a thing of the past."

In a setting where the NIH has been funding postdoctoral-level training in Medical Informatics to produce EMR experts for well over a decade, and where a long-range national EMR initiative (coined the Decade of Health Information Technology) has been launched in the U.S. by the Department of Health and Human Services to:

"bring information tools to the point of care; build an interoperable health information infrastructure; use HIT to give better access to patients and more involvement in decision making; and improve public health monitoring and quality care assessments with faster application of research advances in actual medical practice",
the lack of mention of the EMR as a possible solution for enhancing postmarketing drug surveillance (possible right now, this minute via pilot projects with existing EMR installations) is a strong sign of a pernicious compartmentalization of the pharmaceutical industry from the healthcare delivery sector, and a severe strategic blindness to EMR developments in pharma.

The scarcity in Big Pharma of formally-trained Medical Informatics experts with insights in implementation and leveraging of EMR technology is another symptom of this apparent blindness.

-- SS

1 comment:

Roy M. Poses MD said...

At least looking at the Forbes article, I agree that this process seems to be proceeding in too much isolation. Where is the input, not only from medical informatics, but from the people who have been doing academic post-marketing surveillance for years, on one hand, and from the EBM and medical decision making communities, who would have something to say about how to weigh benefits and harms, on the other?