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End in sight for Avandia?

Health Canada waits to see which way FDA will jump

The diabetes drug rosiglitazone (Avandia) may shortly become the latest high-profile pill to meet an early demise after serious side effects emerged in real-world use.

The U.S. Food and Drug Administration will be meeting next week to consider the fate of the insulin sensitizer, whose cardiac safety has been called into question. Elevated risk of heart attack and other cardiac events has been documented by several studies.

An FDA advisory committee has already reviewed the evidence once in 2007. They concluded that rosiglitazone caused more ischemic events than placebo, but not more than metformin or a sulfonylurea.

The , however, seems likely to drive a stake into rosiglitazone's heart [JAMA, June 2010;304(4)]. For one thing, this retrospective review of 227,000 elderly American patients compared rosiglitazone directly against the other drug in the thiazolidinedione class, pioglitazone (Actos), and found increased risk of stroke, heart failure, and all-cause mortality.

Worse for maker GlaxoSmithKline, the study was led by David Graham, the FDA's associate director of drug safety. Reporting a "number needed to harm" of 60 patients, Dr Graham recommends that rosiglitazone be taken off the market.

Dr David Juurlink of Toronto's Sunnybrook Health Sciences Centre, lead author of the largest on the drug's safety (BMJ 2009;339:b2942), echoes Dr Graham's call in a in the same issue of JAMA.

In the past, beleaguered drugs have sometimes survived these FDA reviews after panel members with extensive ties to manufacturers voted to keep them on the market. But today's FDA is a chastened agency, stung by conflict of interest scandals. They need to show their regulatory teeth, especially in the current U.S. political environment where lax regulators are the villain of the moment.

Nobody at the FDA will feel like going to bat for rosiglitazone anyway, since the agency was criticized earlier this year in a by the Senate Finance Committee for letting trials continue even as the extra heart attacks piled up among rosiglitazone patients – the FDA itself has estimated that the drug played a role in 83,000 heart attacks from 1999 to 2007. The Senate also accused the drug's maker of knowing the dangers early but sitting on the information, an accusation that GlaxoSmithKline vehemently denies.

Canadian regulators, meanwhile, say "the benefits are still considered to outweigh the risks" when the drug is used according to Canadian monographs, and within additional limits set by warnings issued in 2007. They will “monitor” the FDA meeting and will continue to review evidence submitted to them by the manufacturer.

that Canada should remove rosiglitazone from the market now, since doing it right after the FDA would be bad “optics”. Health Canada issued a statement on rosiglitazone today, proudly pointing out that their post-market recommendations on the drug's use are actually somewhat tighter than those of the American agency.

But Health Canada's warnings about rosiglitazone were issued in November 2007, right after the FDA reviewed the issue and decided to give it their notorious “black box”.

It's inevitable that, being a government ministry and therefore insufferably pompous, Health Canada will deny to their last breath that they follow the FDA. But if the FDA pulls rosiglitazone, can anyone envisage Health Canada keeping the drug on the market? Now that would be bad optics.


1 comments:

sharon (aka Purley Quirt) said...

'It's inevitable that, being a government ministry and therefore insufferably pompous, '

"bias" casts a shadow on any type of reporting.........