This is what we have been calling for since we reached settlements with GlaxoSmithKline and Forest Laboratories concerning the suppression of negative clinical studies. However, unlike today's proposal by the industry, the registries established as a result of our settlements with Glaxo and Forest are mandatory and must use recognized data disclosure and format standards.
Thus, it is hard to evaluate the industry's proposal at this time. Because contemplated data disclosure is voluntary, some companies may not participate, seriously undercutting its usefulness. And, of course, the disclosure will only be as good as the information it contains. Without knowing what types of data to be disclosed and what mechanisms will be put in place to ensure that all companies are supplying such data for all trials, it is impossible to know whether the proposal will truly provide a transparent window or one that is only somewhat less opaque through which the public may view the effectiveness and safety of drugs.
I urge the drug industry to support federal legislation that would mandate and implement comprehensive disclosure of all clinical research.
