karlak's Cancer Blog

September 16, 2007

White House Ooposes Clinical Trials Database

Views: 242

This was in the New York Times

White House Opposes Clinical Trials Database
September 15th, 2007 6:51 pm By Ed Silverman

The position against the House version of the FDA reform bill, which is labeled ‘unofficial,’ centers on three concerns – the FDA and NIH wouldn’t be able to validate the accuracy of the trial results posted; results data is too technical, and lay summaries may have too much bias, according to Consumers Union. White House opposition was first reported by Inside Health Policy (subscription required).

Both House and Senate FDA reform bills require that drug trials are publicly registered, but the House bill would require a public technical trial results database, as well a lay summary of a drug trials, on the Internet. The Senate bill only calls for a study on how to create such a results registry, and gives the FDA 2-1/2 years to make it happen. A final version of the Food and Drug Administration Revitalization Act is being negotiated.

The White House position – official or unofficial – is in line, as it so happens, with PhRMA’s position. And there is one problem with this view – failing to make trial results public would allow drugmakers to hide safety problems. Drugmakers may be worried that results can be misinterpreted, but after several years filled with controversies over safety data – antidepressants, Vioxx, Avandia, Ketek, Trasylol, to name a few – industry brought the congressional push for a public database on itself.

“If this is truly the administration’s position, it’s shocking,” said Bill Vaughan, senior health policy analyst with Consumers Union. “At a time when parents can’t even trust their kids’ toys to be safe, it doesn’t make sense the White House would oppose legislation to help make prescription drugs safer.”

“White House opposition to this aspect of the FDA reform bill is in line with its general approach to open government, which is to say, it opposes it,” writes Merrill Goozner in GoozNews, adding that the NIH’s Library of Medicine database links to scores of articles not yet validated by peer review. “But disclosure of clinical trial results data is crucial if independent researchers are going to be able to conduct meta-analyses of problematic drug

Posted on September 16, 2007 at 12:15:25 AM by Sherri ( White House Ooposes Clinical Trials Database, 1 comment)

What is going on in this country? Everything important is being put on the back burner! We need to start all over with our Government. Throw everyone out (Congress especially!) and start all over with some new young faces with good-worthwhile ideas for OUR people! I mean look at our health care! Does Congress care that sooooo many USA citizens are suffering everyday and dying because they can not get care in the richest country in the world?? I wish all of them (and their familes) had to live in poverty for a year and then see what thier ideas and priorities would be all about! Sorry I got carried away! :-)

Posted on September 20, 2007 at 7:06:10 AM by sue123