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

caused.



... 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