Wednesday, February 16, 2005

Blind leading deaf: U.S. to create oversight board to alert public on new drugs

Is the article below, "U.S. to create oversight board to alert public on new drugs", an example of the blind leading the deaf? An apparently toothless board that is to be part of the FDA seems more likely to be ineffectual than useful.

Philadelphia Inquirer, Wed, Feb. 16, 2005, excerpts:

WASHINGTON - Amid concern that the government has not done enough to ensure the safety of prescription medications, the Bush administration announced yesterday that it was setting up an oversight board to more quickly inform the public of side effects after a drug goes on the market.

Health and Human Services Secretary Mike Leavitt said the Drug Safety Oversight Board, to be part of the Food and Drug Administration, would consist of scientific experts from throughout the government. The board would be responsible for monitoring reports of potentially hazardous drug reactions and posting that information on a Web page. Its role would be largely advisory. It would not have power to take a drug off the market or change the circumstances under which it was sold, though it could make recommendations on these issues to senior FDA officials
Representatives of the pharmaceutical industry reacted cautiously yesterday, arguing that drugs' potential side effects should be weighed against benefits in any review process. "It is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk," the main industry trade group, Pharmaceutical Research and Manufacturers of America, said in a statement.

Being part of FDA is bad enough. However, there is an even more important issue than organizational reporting and governance for such a board. The issue is summarized by the "law" in the book The House of God : The Classic Novel of Life and Death in an American Hospital by Samuel Shem which I paraphrase as "you can't find a fever if you don't take a temperature." Pharma has been doing a rather deficient job of taking that temperature, to the point of congessional investigations and massive personal-injury and wrongful-death class action lawsuits.

For example, regarding the Pharmaceutical Research and Manufacturers of America's statement regarding the importance of "making regulatory decisions based on sound science and carefully considered judgments", there is a major problem. Reliance on small clinical trials and voluntary reporting of adverse effects of "blockbuster" drugs taken by millions via the FDA Medwatch system -- where no report gets filed if an event is not recognized as possibly drug-related (e.g., a myocardical infarction in a patient taking a COX-2 inhibitor up to a few months ago) -- is neither sound nor "considered judgment" in my opinion.

As to pharma's seriously taking into account other types of data such as from payors in producing a "risk portfolio" for a drug that includes multiple study types, or making serious efforts to support the implementation of full EMR's that can start providing better, regular data flows that might be helpful in identifying adverse events before they become public health debacles, there seems insufficient effort.

Pharma also seems to ignore the field of Medical Informatics that was designed and funded by NIH for the purpose of expanding use of technologies such as EMR, among others. That I and others in Medical Informatics cannot seem to secure employment at present in pharma (not for lack of trying), and that I was laid off from a pharma instead of, say, a non-medical person with a bachelor's degree in computers making nearly as much as an M.D. with postdoctoral certification in Medical Informatics and clinical computing, speaks to the third component of the "blind, deaf and..." triad.

In fact, in one pharma I know where the information scientists reported to the IT personnel (a major structural misalignment not uncommon in industry), the term "medical informatics" did not appear at all in their controlled vocabularies. Further, terms describing the core competencies of information professionals such as library scientists, informaticists, and the like, were simply absent from the Human Resources taxonomy of skills used for performance review and for hiring. Terms describing computer programming and project management skills were abundant, of course.

In other words, this pharma was blind to information management professionals and their skillsets in hiring, promotion, and performance review.

Pharma prides itself on being an "information intensive" industry. And my name is Mata Hari.

-- SS

No comments: