Healthy Skepticism Library item: 16564

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Edwards J
PhRMA's New Clinical Trial Guidelines Leave Plenty of Room for Maneuver
BNet 2009 Oct 1
http://industry.bnet.com/pharma/10004556/phrmas-new-clinical-trial-guidelines-leave-plenty-of-room-for-maneuver/

Full text:

Two cheers for PhRMA, which has produced a set of guidelines urging its members to conduct clinical trials in a more fair manner – and to stop bribing doctors with fancy trips to the Caribbean.

Read PhRMA’s new clinical trial rules here.
In terms of whether these guidelines have any teeth, this quote in the WSJ tells you all you need to know:

Jeffrey K. Francer, PhRMA’s assistant general counsel, told the Health Blog that the trade group could get into antitrust trouble for making the rules mandatory.

So we can probably expect the same sort of response to the new rules that companies displayed when PhRMA unveiled a new set of rules governing DTC advertising. Those rules urged drug ads to be educational and balanced. But there is no sanction for breaking them, even among signatories to the rules themselves (which includes all the major pharma companies).

PhRMA has made only desultory efforts to track whether its members followed the rules. In their last compliance report, PhRMA noted that companies had been the subject of 1,065 complaints, almost all from members of the public.

But that last compliance report covers 2007. Even though it is now October 2009, there is no report for 2008. A case of compliance delayed, compliance denied?

Three other highlights:

Companies are urged not to treat the Third World like a sluice room: Companies are urged to “collaborate with other relevant parties, such as local health authorities and host governments, to address issues associated with the conduct of the proposed study and its follow-up.” Not too onerous. But then, even when a foreign drug trial gets spectacularly screwed up, the financial consequences aren’t too huge.
No more conferences in Puerto Rico: “When clinical investigators and their staff are required to travel to meetings in conjunction with a clinical trial, they may be compensated for their time and offered reimbursement for reasonable travel, lodging, and meal expenses. The venue and circumstances should be appropriate for the purpose of the meeting; specifically, resorts are not appropriate venues. While modest meals or receptions may be appropriate during company-sponsored meetings with investigators, companies should not provide recreational or entertainment events in conjunction with these meetings. It is not appropriate to pay honoraria or travel or lodging expenses for those who are not involved in the clinical trial.”
No more ghostwriting: “Authors should identify individuals who provide writing or other assistance and disclose the funding source for this assistance.”