Tamiflu: 14 flu seasons and still questions

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f547 (Published 25 January 2013) Cite this as: BMJ 2013;346:f547

Re: Tamiflu: 14 flu seasons and still questions

It seems to me that RECs have a uniquely powerful opportunity to enforce a much higher publication rate by pharma companies than other entities (such as Medical Journals).

This is because RECs hold the gateway to trials with patients that the pharma companies badly want -- RECs have a very strong bargaining position.

And yet RECs seem very unwilling to step up to their responsibilities, viewing themselves too much as a David facing a Goliath.

Among the excuses I hear for RECs shying away from action are reasonable practical ones: no-one can ensure publication, and arbitrary cut off dates may need extensions for legitimate reasons. When pressed, Pharma companies will produce all sorts of plausible weasel words promising something like "best endeavours" to publish.

I would like there to be a "boiler plate" statement that RECs should require Pharma to sign up to as part of the REC approval process. Sign up (exactly) or no approval for the trial.

My own suggestion for the wording would be as follows:

"We undertake to publish the full results of this trial within one year of the ending of the trial --either in a public journal or, failing that, on our own company website.

In the event that the company has no local website, the results will be forwarded in full to the approving REC, with permission for the REC to disseminate results as it sees fit.

The date of the ending of the trial will be determined by the last interaction with a trial participant in accordance with the protocol described in the trial application."

What could possibly be wrong if all RECs were to make this a standard requirement?

Competing interests: No competing interests

28 January 2013
Alan S Edwards
Retired Company Director
Essex Research Ethics Committee
Downham, Essex