Clinical Trials, Hiding Negative Results

Drug Companies hiding test results that reflected poorly on their own products? Say it ain't so, Joe.

This abstract dated Jan. 17 2008 from the New England Journal of Medicine seems to imply that it Is so.

FDA reviews for studies of 12 antidepressants involving 12,564 patients revealed that:

"Among 74 FDA registered studies, 31%, accounting for 3449 study participants, were NOT PUBLISHED." 37 studies the FDA viewed as positive, were published, with 1 positive study left unpublished.

Negative or questionable studies, with 3 exceptions, tallied 22 left unpublished, or were published (11 studies) so as to convey a positive outcome. What hit the news was a 94% positive outcome, whereas the FDA analysis showed only a 51% positive outcome."

Wouldn't you like to be able to buy $94 worth of groceries on $51 worth of credit?

The British Medical Journal, however, brings us a penetrating Million candle power ray of hope. It seems, that new legislation [The FDA Amendments Act] is going to be whacking such non-reporters for $10,000 per non-report. That's not even a yawn to drug companies, but it Might be one heck of an expensive wake up call to their sales force: Physician/Psychiatrist/Researchers.

We've already seen Pharma picking up the tab for these rascals Continuing Medical Education [CME] bills. I wonder what manner of alphabet soup BS they'll concoct to cover those Researcher fines; supposing those fines are ever actually imposed, in the 6 figure range they Could be imposed in. Ho Hum. Yawn.

Wake me when it happens.

Hold on, here it is, as we knew it would be: the end run.

"Although the act allows for delayed disclosure of results in exceptional circumstances, for instance in the interests of national security,... ."

BMJ gets the final word here.

"At BMJ we support this great leap forward for public disclosure."

Hats off to BMJ and its Deputy Editor Trish Groves, and we hope that this new legislation really works out that way, and Doesn't become the province of National Security, or any other damn Tom Fool Chicanery.