The vote is 20-12 against withdrawing GSK’s troubled drug Avandia from the marketplace. Essentially, the FDA says that — in spite of the earlier vote the committee had on positively acknowledging the cardiac risks associated with the drug — those risks were not deemed strong enough to warrant removal. Twelve of the committee’s 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven wanted to add stiffer language to the current label, and 10 wanted both stiffer language and restrictions on its use.

What is known now is that, according to the FDA, unless there is more long-term data on a link between Avandia’s use and cardiovascular death, there is nothing in terms of evidence currently convincing enough to warrant pulling the drug from the market. That’s the official statement by the agency, anyway.

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As the debate over Avandia enters its second day, more controversy is sure to erupt. With both sides clinging to inexplicable minutiae as much as they are to the major points defining this hefty FDA review, the outcome will probably say a lot about the process that leads to it. The latest salvos from Day 1?

An FDA scientist, speaking of GSK’s studies of the drug minimizing risk: You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief.

GSK’s VP of Clinical Development: Our studies provide the most robust and reliable data  to assess Avandia’s safety, and those studies have found no evidence to suggest the drug increases the risk of heart attack or stroke in its users.

Testimony continues today with a decision expected on whether to pull the drug or apply restrictions to its use.

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GSK (then known as SmithKline Beecham) knew in a 1999 trial that Avandia, the drug undergoing scrutiny on its fate in the pharma marketplace today, posed a signficant cardiac risk when compared to its major competitor Actos — and it purposefully covered up that information. This, according to a report obtained by the NYT.

The reports … say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.

GSK has always stuck to its guns in defending its assertions that statements like that are based upon faulty safety information gleaned from major trials casting the drug in a negative light — like the well-known RECORD trial, which found that the overall risk of cardiovascular death of Avandia was not statistically significant. That meta-analysis was commissioned by GSK at the request of the FDA.

This is just the latest revelation in a very public battle over a Pharma company’s credibility in the healthcare marketplace and the validity of new information from a Senate investigation into that company’s handling of the trial results. Implications on who controls subsequent drug safety and treatment data years after a drug’s initial availability and what it means for the welfare of the public taking the drug versus pharma profits from the sale of the drug should be weighing greatly on the FDA panel making the decision on the drug’s ultimate fate. | LINK

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Ordinarily, the nomination by the president of a candidate to the post of CMS chief is a rather staid and mundane affair. The ability to steer the agency responsible for guaranteeing care for the poor, childless, and elderly in this country is a daunting task usually handled without much controversy by the chief executive’s chosen one — an appointee who usually does the job and moves on.

But these aren’t ordinary times, and in this age of close political scrutiny — the politics of healthcare is as ponderous as any other issue dominating the president’s “to-do” list.  That’s why Obama’s choice to head Medicare and Medicaid Services will prove to be an involved and interesting one with respect to Senate confirmation. Those on the right say that Don Berwick’s presumptive appointment smacks of socialized healthcare leanings, as they point to his praise of European systems of healthcare — in particular, the British model.

Liberals praise Berwick’s championing preventive care methods which promote efficient, cost-effective care.^[1] They say he’s the right man for the job. Republicans say he’s all for rationing.

The confirmation process will, as usual, be handled by the Senate Finance Cmte. | LINK

UPDATE: Congress has until 6/21 to reverse yet another looming chance at a Medicare pay cut to physicians. | LINK

1. Berwick has created special teams to promote such initiatives as cutting hospital infection rates and implementing better asthma care and coronary surgery improvements characterized by smaller additional costs in healthcare systems.

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Sometimes the fastest way from an NDA to market is to manufacture the combination of two popular drugs into one. Pharma benefits from a new patent; healthplan formularies benefit from aggressive DTC patient marketing, and the patient ostensibly benefits from a better, cheaper alternative. Usually, the combined agent is two drugs — usually taken together for the treatment of some clinical syndrome. Rarely, three drugs may be combined. But, have you heard of four or even five compounds in a single tablet to treat the number one killer in this country — heart disease? Well, study researchers in Canada and India certainly have. Dubbed the “polypill”, the studied drug is composed of a cholesterol agent, aspirin, and three compounds to control blood pressure. Sure, a 5-in-1 pill enhances patient compliance and would be of low cost (as all drugs would be generic). But medicine is as much an art as it is a science, and one drug — no matter how all inclusive it tries to be — is not all things to all people.  | LINK

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Two-thousand eight has been dubbed the “year of the generic” pharmaceutical formulation, due — in part — to the increased intensity of the FDA approval process and the fundamental shift in health plan negotiations for price controls, such as that seen in the Medicare Part D pricesetting of drugs.  There now comes more evidence that, among cardiovascular agents, generic formulations of the most commonly used preventive medications are just as effective as their branded counterparts. The meta-analysis was published in this week’s JAMA. | LINK

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