Friday, February 25, 2005

NIH Regs Based on Bad Data

"Sentencing first, then the trial later." If you thought only Lewis Carroll's Queen of Hearts worked this way, you haven't been following the story out of the National Institute of Health. They instituted new and draconian conflict of interest regulations and smeared about a hundred researchers, before they discovered that the data they based all of this on was erroneous. The Washington Post reports. Link.
Most of the 100 or so National Institutes of Health researchers who the agency has said are under investigation for allegedly engaging in secret deals with pharmaceutical and biotechnology companies have been cleared by NIH investigators, according to agency officials.

The unexpected finding that as much as 80 percent of the seeming improprieties were actually the result of errors by government investigators has undermined the rationale behind NIH Director Elias A. Zerhouni's recent decision to impose severe restrictions on the personal activities and finances of all of the agency's more than 5,000 employees, said scientists and NIH officials upset about the new rules. (...)

Zerhouni has repeatedly said that a congressional committee's discovery several months ago that about 100 NIH scientists had failed to notify the agency about their outside deals, as required, compelled him to impose the new limits. The rules, which took effect Feb. 3, are forcing thousands of employees and their family members to sell stock holdings. They also ban scientists from accepting even uncompensated professorships and board positions with professional societies on their own time. (...)

The confusion over the alleged failure to report consulting arrangements dates back to last year, when congressional investigators asked 20 pharmaceutical and biotechnology companies for the names of all NIH scientists with whom they had consulting arrangements. When Congress compared those lists to a similar list provided by NIH officials, about 130 arrangements on the company lists involving about 100 scientists did not appear on the NIH list, suggesting that those scientists had not reported the arrangements to their NIH superiors as required.

Zerhouni, who until then had been a staunch defender of such collaborations as an important means of speeding the translation of research into marketable treatments, recently said he felt "shot in the back" when he learned that so many scientists were ignoring the rules. Convinced that "the system was broken," he and Kington instituted the Feb. 3 restrictions. (...)

But a detailed NIH review of the 100 or so scientists identified by the congressional inquiry has found that "more than half," and perhaps up to 80 percent, were mistakenly implicated, said Suzanne Servis, director of the NIH Office of Management Assessment, who has been overseeing the internal review.

In some cases, discrepancies arose because NIH provided data on collaborations only through Dec. 31, 2003, while the drug companies included the names of people going into 2004 who, it turned out, had gained NIH permission.

In other cases, people whom the drug companies named as having collaborations with them had the same names as scientists at NIH but were not NIH employees.

If you make it to the end of the article, you will learn that the NIH is now having trouble recruiting new researchers because of the severity of the new regulations. I wouldn't hold my breath waiting for these regulations to be revoked just because they were based on fantasies and they are seriously harming one of the few federal agencies that actually accomplishes some good. It all seems so depressingly typical.


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