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1. the FDA and NIH wouldn’t be able to validate the accuracy of the trial results posted.

Why not? They can verify who submits AE reports. NIH has a login process for companies submitting grants. You can track IP addresses. FDA investigators can obtain documentation. If you know who is posting the data, and there is ever a questions about the accuracy, you can go back to the source.

2. results data is too technical.

So what? Don’t insult my intelligence by keeping information away from me. There are plenty of smart people who can understand data, and people who can explain data to those who can’t interpret the primary source. If those interpreters oversimplify, manipulate or lie about the data, other smart people will point it out. It happens all the time–notably when Nissen applied a meta-analysis that may have been inappropriate.

3. and lay summaries may have too much bias.

Again I say, so what? If you release the primary data, there are enough people who will catch such biases and expose them.

The last thing I need is the government protecting me from myself, whether it benefits the drug companies (such as in this case), or harms them (such as the Provenge debate).

And for the drug companies to take this stand certainly undermines the image they want to cultivate of having patients’ best interests at heart.

Granted, this is different than the FDA hosting one, but I think it’s quite misleading of consumersunion.org to say that the pharmaceutical industry isn’t/doesn’t want to disclose results.

Moreover, from the article, it seems that the administration isn’t opposed to an FDA database, but rather, are opposed to the 2 areas mentioned in the bill: the FDA can’t confirm the accuracy, and that the lay summaries may be biased.

Experts in various specialties spar over results, typically with multiple interpretations of the same study. We can’t and shouldn’t expect the average high school or college graduate to understand these results.

So, if the experts can take diametrically opposed views after “studying” the data–applying their own metrics and interpretation–how can the “average” high school graduate miss the mark? He will obviously be no more right or wrong than some leading expert.

1. The proposals I’ve heard about require publication of results within one year. However, it can take longer than one year to publish, especially if the investigators submit the results to a couple journals that reject the article after a long review. If the law then requires industry to disclose these results on a website, then many journals will no longer consider the data for publication since it was already published.

2. It will complicate collaborations between industry and academia, since academics will not face this requirement, but are instead encouraged to pursue the most high profile publications possible.

3. Although many in the media do there job with a mind towards fairness and balance, dramatic negative results sell best. So, IMO, the media does fixate on negative safety data and can ignore positive efficacy data.

Atlex,
“Folks including the news media,do not have the capability to understand trial results”

Please speak for yourself!!
And as far as the Media is concerned,many of the Reporters are highly INTELLIGENT.The Industry understands this.