Should Experts Disclose Ties At Avastin Meeting?
7 CommentsBy Ed Silverman // June 21st, 2011 // 10:13 am
The FDA hearing officer who is presiding over the upcoming Avastin review has rejected a request from her agency colleagues to require all outside scientific experts who speak at the meeting to disclose financial ties to Roche’s Genentech unit or rival manufacturers. The June 17 request had been made by FDA lawyers in the name of greater transparency.
The two-day event, which begins June 28, stems from an unprecedented decision last year by the FDA to yank the breast cancer indication for the best-selling Avastin cancer med. That came after results of four clinical studies showed the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks (see here).
In response, Roche appealed the decision and forced the equally unusual hearing, which will be closely watched for insights into the FDA approach to its accelerated approval program, as well as the types of clinical trials and endpoints associated with accelerated approval, especially for cancer meds.
Meanwhile, the run-up to the gathering is prompting furious behind-the-scenes jockeying between the agency and the drugmaker (see here and here). However, the latest exchange pits FDA officials against one another, and those seeking greater transparency lost out.
The rationale for the request, which was made last week by lawyers at the FDA’s Center for Drug Evaluation and Research, was to correct an “imbalance,” given that members of the FDA’s Oncologic Drugs Advisory Committee will have made such disclosures in forms they are required to fill out (read the letter). This is standard operating procedure, by the way.
But Karen Midthun, who will preside over the two-day hearing that begins on June 28, wrote in response that “it will be apparent to all concerned that these presenters are appearing on behalf of Genentech,” she replied. The FDA can question speakers about their financial ties if the agency “is concerned that there are additional financial interests that affect the credibility of the opinions advanced by the Genentech presenters” (read her letter here).
That may be true, but the FDA lawyers raise a valid point, which is that vested interests should be known in advance, not assumed or left to a guessing game. The counter argument, of course, would be to require every speaker - including members of the public - to disclose this or that financial tie. Where should disclosure begin? Where should it end? What do you think?
Should Outside Experts Disclose Financial Ties Before Speaking At The Meeting?
- Yes (89%, 157 Votes)
- No (12%, 21 Votes)
Total Voters: 177
Loading ...pic thx to jerome kassirer
Mike Wokasch
If disclosures are expected and in many cases required for presentations at scientific meetings, conferences, and in publications, why is this an issue? Oh … maybe there is an issue that probably should be disclosed. Have presenters disclose. No more issue … unless there is an issue. http://www.PharmaReform.com
Bruce Wayne
What Mike said is a great idea.
Anna Gough
Since the experts are testifying on behalf of Genentech, they can be presumed to have a financial interest regarding Genentech. But why should they have to release all of their other clients and funders? That goes beyond what anyone needs to know to assess their testimony concerning a Genentech product. It is a little bit like asking Genentech employees to tell what stocks they own, as if that would matter. This is unlike a presentation at a scientific meeting or conference where there is no demonstration, as is obvious here, what “side” the experts are on. Privacy is also a core value.
harpy
require all outside scientific experts who speak at the meeting to disclose financial ties to Roche’s Genentech unit or rival manufacturers
though I think the argument you pose is quite revealing.
Doc
Any “expert” or other persons standing before the FDA on any drug approval/review should be required to disclose any financial ties to the manufacturer, including the actual dollar amount they receive.
This is so basic to a transparent hearing I am amazed that it is even debated.
Bruce Wayne
Doc,
You speak reason. Why can’t everyone see that this is about the greater good and people could be permanently harmed by hiding the payola? A bad drug could get approved. See Vioxx
Thomas L. Perry, M.D.
It is even more important that disclosures be verifiable, or potentially verifiable. Universities routinely require disclosure, although this is mostly honoured in the breach. E.G. my university dept. of Medicine requires that we all present our disclosures every time we make a presentation to students, post-graduate trainees, or CME - but I seem to be one of the few trying to do so all the time. But how does anyone check to confirm that the disclosure is accurate?
I have seen one peer review in BMC Neurology for which the reviewer failed to disclose a conflict which was well known and obvious from other sources … I’m sure from reading Pharmalot and elsewhere that this is routine practice for many who consider COI a trivial issue.
While some people consider that acceptance of any financial or even non-financial relationship imposes a potential conflict, I still consider that “money talks” … i.e. it would be interesting to know whether the potential COI consists of a $500 honorarium or a regular $50,000-100,000 consulting agreement - or much more.