UK Regulator Says Avandia Should Go
7 CommentsBy Ed Silverman // September 6th, 2010 // 8:22 am
There is a flurry of activity surrounding the controversial Avandia diabetes pill. The UK’s Medicines and Healthcare products Regulatory Agency says the GlaxoSmithKline drug “no longer has a place on the UK market.” The chair of the European Medicines Agency scientific advisory group on diabetes argues the pill should be withdrawn. And the same sentiment is expressed by the BMJ, a leading medical journal, in an editorial that accompanies an investigation into regulatory footdragging.
Moreover, the EMA on Wednesday will hold an extraordinary meeting to review Avandia (see this) in advance of a regularly scheduled meeting later this month that will finalize its decision. “Doctors were advised not to use the tablet in anyone who was at risk of heart failure,” says Edwin Gale, who chairs the EMA scientific advisory group on diabetes. “How long do you wait? How important is it to be absolutely certain and at what point do you start saying – this game isn’t worth it, people’s lives may be at risk, something should be done about it?”
The move comes as the FDA undertakes its own deliberation after an advisory committee two months ago recommended the diabetes pill remain available, but with restrictions (see here), underscoring a delicate policy question for an agency that has been beset with infighting for three years over questions surrounding Avandia.
Meanwhile, BMJ reports that the UK’s Commission on Human Medicines – an independent panel advising the goverment – had actually recommended in July that Avandia should be withdrawn. But the MHRA, instead, sent a July 26 letter to docs that merely advised them to “consider alternative treatments where appropriate.” Now, however, an MHRA spokesman says the agency has communicated its flip-flop “robustly” to the EMA and would highlight its concerns at this week’s special meeting.
In her editorial, BMJ editor Fiona Godlee writes that Avandia “should not have been licensed and should now be withdrawn,” and she called for systemic changes. “Europe’s regulators should be much more transparent. They should require a higher quality of evidence, including proof that new drugs are better than existing drugs before being licensed. And if they do ask the manufacturer to undertake post-marketing trials, they must do a better job of overseeing the way these trials are designed and done…
“We all need the pharmaceutical sector to flourish and innovate. We should also seek to modify the increasingly destructive relationship between industry and the public. This would require concessions on both sides: far greater transparency from industry and the regulators, including access to raw data and funding for independent trials; and greater understanding from the public that there is no such thing as a completely safe drug.”
Here is the Glaxo statement in response to the BMJ articles and on a BBC report
The UK media is replete with stories today: The BBC, The Guardian, The Independent and Reuters.
Justice in MI
Gale wrote one of the better commentaries in the BMJ post-Vioxx, on the topic of the “evidence-free zone” post-launch and the power of marketing during that period.
Avandia is obviously a different history, but not entirely unrelated.
Happy Labor Day!
Condor
Because the truth is always far stranger. . .
Here, we learn (courtesy of a friend of us both, Ed!) that GSK has now POSTED the entire Avandia audio-recording (a 58 Mb mp3 file — load it as a podcast! Heh!) of Dr. Nissen’s meeting in 2007 with four GSK representatives. GSK had subpoenaed the file; what is extraordinary is that GSK’s own website now hosts — and provides it, free(!) — with the following text:
. . .On 10 May 2007, four GSK medical and clinical experts met with Dr Nissen to discuss the scientific data on Avandia. An audio recording of this meeting was made covertly by Dr Nissen. At no stage before or during the meeting was GSK informed that the meeting was being recorded.
The company understands that the BBC Panorama programme to be broadcast 6 September will feature the recording of this meeting. Selected extracts from this audio recording have already been provided by Dr. Nissen to The New York Times newspaper.
In pre-publicity materials for the programme, BBC Panorama suggests that this recording is the “secret tape the drug company would rather you didn’t hear.”
On Friday 3 September 2010, following the issuing of a subpoena (legal request) to Dr. Nissen, GSK obtained a copy of the audio recording. The company today has posted the recording.
The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context. . . .
W I L D !
Namaste, and happy Labor Day (in the USA)!
pharmavet
I commend Dr. Nissen on his subterfuge. In the beginning of the tape he pulls the ruse of “renovating his office” as a means to maneuver equipment and people around the table in order to optimize his secret recording operation. At least that was what was evident to me. As for the meeting, it’s pretty much what’s been reported. I couldn’t look at my Windows Player, however during the meeting. The psychedelic background reminded me of the Joshua Light Show at the old Fillmore East Theater in Greenwich Village.
pharmavet
This entire episode did not go without consequences. The GSK biostatistician on the project, accordintg to her Linkedin page is on a “Personal Sabbatical”. Nice going, Steve.
Bob Fiddaman
The Guardian reported that the MHRA had said it had not passed on the recommendation to withdraw Avandia because it would create confusion, and was awaiting a decision by the EMA.
I’m confuzzled!
truthman30
I have just listened to this entire 2 hour recording and I have to say Dr Steve Nissen handled himself very well considering the seriousness of the Avandia scandal about to erupt and the pressure he must have befod under, I thought the GSK Employees sounded completely in denial.. Amazing recording, well done Nissen.. We need more people like you with the courarage of their convictions and the integrity to go with it.. I Wouldn’t be surprised if more people being to tape the shananigans that go on between the industry and doctors.. Fascinating stuff nonetheless..
truthman30
ooops .. typo’s all over that …