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    Monday, December 16, 2002

    USA in the BMJ: The British Medical Journal often has news items from the United States that never get much media attention here. Did you know, for example, that Oregon had a board of State Social Protection, responsible for enforcing eugenics laws as recently as 1983?

    Until reforms in 1967, sterilization was regularly used by state officials as a condition of release from state institutions or to punish people who acted out. Oregon initially used the eugenics laws to punish homosexuals. Later, state officials tended toward castrations instead of vasectomies. It wasn't until 1983 that the board, then called the State Board of Social Protection, was abolished.

    They really are deserving of the moniker People’s Republic of Oregon.

    Or, did you know that outgoing president of the American Heart Association was reprimanded by the FDA for irregularities in his research:

    The complaint cited examples of records being falsified to alter the duration of chest pain; changes in the records that led to the inclusion of patients who were not eligible for inclusion; patients being included despite being enrolled after the time limits; patients being included when they were receiving drugs that should have excluded them.

    Dr Faxon answered the FDA in December 1999,?saying his study's coordinator was responsible for misrepresentation of data and he had no knowledge of the practice. The FDA rejected his response: "We remind you that you are responsible for personally conducting and supervising the clinical investigations since you are the investigator of record. Therefore, we consider your explanation unacceptable."

    In April 2000,- the FDA sent Dr Faxon a "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE)." Few clinical investigators receive such a notice. In 2000, Dr Faxon was one of only six to receive one. In 2001 there were four, and so far this year there have been two.


    The research involved comparing aspirin to another drug to see which was better for protecting the heart from further injury after a heart attack. Neither the BMJ, nor the FDA letter (pdf file) identifies the drug. This may not seem like much, but remember that the American Heart Association makes it their business to write guidelines about treatment care. Not long ago, they came under criticism for recommending the use of a clot-buster of dubious effectiveness. Several members of the panel writing the guidelines and the American Heart Association themselves were financially beholden to the company that makes the drug. Knowing that their former president was also involved in dubious research doesn’t do much to boost confidence in them.
     

    posted by Sydney on 12/16/2002 08:07:00 AM 0 comments

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