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Posts with tag AP

Government panel recommends Avandia stay

Earlier today I blogged about the Avandia advisory panel which met today. As of earlier today, the word was an FDA official, David Graham, had issued a written preview of the comments he intended to make. In it, Graham stated his view that GlaxoSmithKline's diabetes drug Avandia is dangerous and should therefore be removed from sale.

Now comes breaking news from the Associated Press that the panel will recommend, against the wishes of many - Dr. Graham included, that Avandia stick around. According to the AP, government health advisers have argued that, hey, sure Avandia may cause increased risk of heart attack, but let's just keep it out there. What?! As of writing, the AP was still waiting for a tally of how the panel voted on the issue, but word is a majority voted against recommending a ban.

The FDA's patient representative for the panel was quoted as saying studies indicating Avandia causes heart trouble "have very significant weaknesses and are inadequate for us to make that kind of decision." In short, the FDA seems to be saying Avandia causes heart damage, but the study-based proof is not strong enough for a ban. Talk about your contradictory messages! Baffled? Disgusted? Join the club.

Avandia side effect reports soar

According to a new Associated Press (AP) feature, federal regulators have experienced a dramatic surge in reports of Avandia-related side effects. In fact, they say they are receiving triple the number of reports just in the last month. This trend began when news broke that the drug, which has been a big money maker for GlaxoSmithKline, may increase the risk of heart trouble.

The data supporting the claim was gathered by the AP from the US Food and Drug Administration. Whoever wrote this article makes a point of noting that the figures were obtained with the backing of the Freedom of Information Act, although the report does not say the FDA resisted handing the information out. The key finding: in the thirty-five days before the Avandia story broke in the media, only five heart attacks were reported as side effects involving rosiglitazone. Rosiglitazone is the active ingredient in Avandia and its little cousin Avandamet, which combines that drug with metformin. Yet in the thirty-five days following the revelation, that number soared to ninety. The AP also says reports of heart-related hospitalizations increased dramatically.

The AP says that several experts consulted for the article agree that doctors are probably attributing patients' heart problems to the drug, whereas before they likely would not have made the connection. The report also touches on the problem that's at the heart of the Avandia story: the dire need for reform of the FDA. Right now, there is no organized governmental oversight of drug safety once a drug is on the market and all reporting of side effects is voluntary. No one is driving the bus, basically. Click here to read more.

Don't know about the Avandia scandal? Want to read more on the background to this story? Click here for just one of a gazillion news stories published recently on Avandia and the FDA.

Snack food makers on the offensive

Say you're in the snack food business. Your products are popular amongst kids and adults alike. You rely on an arsenal of creative marketing to keep the money rolling in. Also, although your snack products are - when you get down to basics - really just reconstituted corn and its byproducts, they involve some pretty high-tech manufacturing techniques. So when the profitability of those products is threatened, you'd fight like the Dickens to protect yourself, wouldn't you?

That's exactly what's going on now, as manufacturers like Coca-Cola, Hershey, Kraft, Kellogg and Frito-Lay tweak their product lineup a little. Juuust enough, mind you, to meet criticism that they are contributing to the so-called obesity epidemic - and it's terrible health complications including heart disease and Type 2 diabetes - through peddling their fat and sugar-saturated products. As this AP article details, the snack food industry changes represent an attempt to, firstly, capitalize on the growing consumer demand for "healthy" food choices and, second, to undermine their critics (including those in government) who accuse them of direct responsibility for the health crisis.

From Kellogg to McDonald's, big business execs are scrambling to protect their companies: their brand image, their profitability, their investments and, yes, their employees. No, this is not really about the health of the nation or anything lofty like that. It's about cynically protecting the bottom line. Yet, strangely, I feel no sense of outrage about this. Can you blame them for giving just a little instead of a lot? What's more, while fatty snacks may be contributing to an overall decline in public health, I'd argue it's a step too far to compare the manufacturers to, say, the tobacco industry. After all, Fritos may be a nutritionist's nightmare but there's no addiction factor here to muddy the ethical waters. Nevertheless, given what happened to Big Tobacco, the snack food industry is taking no chances.

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