“A majority of the advisory panel of the Food and Drug Administration voted today to restrict the sales of Avandia, a controversial diabetes drug, because of its potential risk for causing heart attacks. The 33-member advisory committee was deeply divided. Twelve voted to remove Avandia from the market altogether; 10 for continued sale but with new label revisions and possible restrictions; 7 to add more warnings and 3 for no change at all. But the votes can also be viewed as a decision by a majority, 21, to continue allowing sales of Avandia, with more restrictions. A final decision will be made by the F.D.A. at a later date.”
More here from consumer rights campaigner Sidney Wolfe’s group.
This Wall Street Journal health blog also links to a Glaxo statement.
Meanwhile, a little bit of history. In 2007 the Union of Concerned Scientists urged that scientists with ties to the manufacturer be excluded from FDA decisions.
This link shows some of the history on the Therapeutic Goods Administration website, but there’s nothing there – yet – yet about the latest news.
Update: Thanks to Agnes Vitry at the University of South Australia for the pointer to this recent editorial in the Journal of the American Medical Association, which gives a useful overview of the Avandia history, and argues that the safety risks aren’t justified, given the lack of evidence of therapeutic benefit and the availability of a safer alternative. “Rosiglitazone and the Case for Safety Over Certainty” by Dr David Juurlink, from the Sunnybrook Health Sciences Centre in Toronto.
Update: So what do Australian experts think about Avandia and the latest news?
Dr Agnes Vitry, a Senior Research Fellow at the Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, says: “Personally, I don’t understand why such a drug is left on the market. The whole point of controlling blood sugar in people with diabetes is to prevent macrovacular and microvascular adverse events. With no evidence for this benefit with Avandia but having strong concerns about the opposite (increased risk of cardiovascular morbidity and mortality), why would you bother keeping such a medicine on the market? With PBS data showing there have been 69,932 prescriptions this year so far, although the use of this drug is decreasing in Australia, there is still too much used!”
Dr Peter Mansfield, a GP and the Director of Healthy Skepticism, says:
“The FDA committee’s failure to put safety first in the case of Avandia illustrates two key issues: misplacement of the onus of proof and the use of surrogate measures rather than important measures.
Before a drug is approved the onus of proof is on the manufacturer. However all the manufacture is required to do is show that their drug is better than placebo for a surrogate measure. For example Avandia was approved because it reduces blood sugar levels. There was no good evidence available when Avandia was approved regarding what really matters: If diabetics take Avandia do they live longer before having major complications of diabetes such as heart failure and death?
After a drug is approved, the current system incorrectly puts the onus of proof is on anyone who thinks a drug should be banned. To the extent that a company controls the evidence they can keep a bad drug on the market by ensuring it is not studied well enough to prove that it is harmful.
Because drug manufacturers bias, be it intended or unintended, poisons research, pharmaceutical manufacturers should not be allowed to fund research.
Instead, research should be funded by competitive grants from agencies such as the Australian NHMRC and the American NIH. These agencies are not perfect but they are much less biased and much more amenable to improvement.
More than enough money can be found for research from the huge economic benefits that can be gained by abolishing patent monopoly protection.”
This photograph has been provided by Liu, Wei-liang, a pharmacist in Taiwan, via Flickr. Thank you!