Back in September, the NIH had released a draft proposal (is that redundant?) that requests the release of NIH-funded research results to a public database within 6 months after being accepted for journal publication. Dr. Elias Zerhouni, DIrector of NIH, had scheduled a teleconference for this past Tuesday, the 11th, and was expected to announce the final rule for publication of such results. It had been widely speculated that the Final Rule would include a compromise with the journals, and allow a 12 month window to publish such results. This really would not be that big a deal - 12 months is a fairly typical timeframe in the industry to allow for the publication of results after either the trial is over or publication in a journal. And remember, this is a request to publish results - not a requirement.
Unfortunately, that teleconference was canceled, and again it is speculated that it was due to concerns from the White House that the rule would become an issue at the confirmation hearings for Michael Levitt as the new head of Health and Human Services. In my opinion, this was a boneheaded move by the White House, NIH or whoever was the person who made the decision.
Let's see ... so your candidate is up for confirmation. Isn't it the job of the confirmation committee to ask some tough questions, make sure the candidate can stand up to the task and understands the issues? The relatively small compromise here (if, indeed, that was going to be the final rule) isn't too hard to explain and shouldn't make your candidate sweat profusely. If it does, he definitely should not be in charge of the CDC, NIH and Medicaid.
This issue isn't exactly a huge, burning issue in the public mind. Not to say it isn't important, but this isn't the kind of thing that will make people take to the streets or write to their Senators and Representatives with scathing words of passion. Prescription drugs? Sure. Drug companies possibly lying about the harm their drugs do? You bet. But something as technical as moving the deadline for a request to publish results from 6 months to 12 months isn't likely to make people scream bloody murder, and the confirmation committee was probably far more likely to light into Mr. Leavitt about the various public scandals that are much sexier than this, which to the average person is just an academic issue.
It absolutely does have bearing on public disclosure of trial results, but it also only has bearing for NIH-funded trials. That's a good percentage, but is not necessarily going to bear on the trials by many of the larger pharma companies that fund their own research.
But canceling the announcement, which would have resolved the issue and would have given companies a true starting point for knowing when they would have to release results and thus start that clock going so the public can know when they'll access to them, was foolhardy. It smacks of another attempt to try to cover up something that could be a bit touchy ... and goodness forbid that any official, actual or potential, actually have to explain the policy to the country and face a few minutes of heat in order to assure us that they really do have our best interests at heart.
Now we'll just have to hope that there is an opportunity for Congress and the media to question Dr. Zerhouni and Mr. Leavitt, to the extent truly warranted, about the policy and the cover-u ... I mean delay.
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