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 The chair of the European Medicines Agency scientific advisory group on diabetes argues the pill should be withdrawn.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Human Medicines - an independent panel advising the goverment - had actually recommended in July that Avandia should be withdrawn.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In her editorial, BMJ editor Fiona Godlee writes that Avandia "should not have been licensed and should now be withdrawn," and she called for systemic changes.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."