Just Say Yes…

To registering all pharmaceutical company clinical trials. Whether or not anti-depressants actually do more harm than good for adolescents is still being debated, but the drug manufacturers might have avoided this controversy if they'd released all the data from all their research trials in the first place.

Now the editors of some of the world's leading scientific journals are requiring that pharmaceutical companies register their drug trials before they will publish research findings based on the trials. The idea is that such registration will lead drug manufacturers to report all data, both good and bad, from clinical trials.

The industry trade group, the Pharmaceutical Research and Manufacturers of America (PHRMA), just issued new guidelines for the conduct of clinical trials that require that there be "timely communication of meaningful study results, regardless of the outcome of the study." While certainly a step in the right direction, to retain public confidence and to avoid ugly lawsuits, the new PHRMA guidelines are not enough. The industry should embrace the editors' private initiative wholeheartedly before a slow costly bureaucratic system is imposed on them.

Comments

[Evan Williams]

What’s all this “we should make this happen before legislative action is considered” nonsense?

Good old dirtbag that he is, CA’s Henry Waxman is already trying to codify this bullshit into law. He claims that the only way to really fix the problem is to get the federal government involved. Hell, that provided me with a good hearty laugh on the way home yesterday, especially given that the NPR “journalist” repeated that statement, verbatim, without even a hint of irony. Say, when’s the last time the federal government got involved and ended up solving the problem? I’m drawing a blank.

[Douglas Fletcher]

Yeah, it can’t even fix Henry Waxman’s nose, for god’s sake.

[thoreau]

From the title I assumed this must be a Jacob Sullum thread.

My bad.

[Ruthless]

Is it Reason’s job to help bureaucrats and pharmaceutical companies unravel the unintended consequences of insane drug laws?

The second Bill of Rights should have protected our right to put what we wish into our bods.

[Shannon Love]

This is an incredibly good idea but I think it might terrify the pharm companies lawyers. Every study will show some negative side effects and the raw data will be very ambiguous to a lay jury. Given the problems the tort system now has processing scientific information it really got to worry them about the potential to manufacture a problem.

[cdunlea]

Shannon, I’d have to take the opposite POV here. My wife is a senior CRA (clinical research associate)whose job it is to oversee the clinical trials on new pharma by doctors (the “investigators”). Specifically, she makes sure the doctors and their staff follow the study protocols to the letter. The stories she comes home with are frightening: doctors not reading the study protocols before enrolling patients, filling out forms incorrectly, pushing people into the study to make more $$$, and not returning phone calls for weeks. My favorite? The time when she, with a scientific but not a medical background, cited the Physicians’ Desk Refernce and tore a doctor a new hole for prescribing medication contra-indicated by the study! You think if the patient died there might be a lawsuit…?

Bottom line: if these investigators, some of whom build their practices around these studies like some lawyers build theirs around hospital emergency rooms, don’t quit their God complex and start following procedures more seriously, that cumbersome bureacracy is only a matter of time. That, or a fresh wave of lawsuits.