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Type 2 Diabetics Taking Avandia, Beware: The FDA Knew About The Drug's Risks 7 Years Ago and Approved it Anyway

Posted Dec 18 2008 7:35pm

Note from Connie: News, revelations and insights about the Avandia-could-lead-to-heart-attacks scare are pouring in at a fast and furious clip. So, given my demanding schedule this week, SUGAR SHOCK! Blog researcher/writer Jennifer Moore brings you this latest update about the drug that's supposed to help type 2 diabetics.

Art_buse_24drug_2190 The FDA is looking worse by the day. Now comes news, as reported by Stephanie Saul and Gardiner Harris at The New York Times, Anna Wilde Matthews and Jeanne Whalen of the Wall Street Journal, and Reuters that John Buse, M.D., Ph.D., president-elect of the American Diabetes Association, wrote the FDA a letter in 2000, warning our watchdog governmental agency about the dangers Avandia may pose to people's hearts.

Dr. Buse, who is also chief of endocrinology at the University of North Carolina in Chapel Hill, wrote that there was “a worrisome trend in cardiovascular deaths and severe adverse events” amongst patients taking Avandia. Dr. Buse also slammed GlaxoSmithKline, the Big Pharma maker and seller of the popular drug, for what he called its "pervasive and systemic efforts" to downplay Avandia's risks and overstate its upside, according to the New York Times.

This comes after news, which Connie posted about earlier on this SUGAR SHOCK! Blog, that Dr. Steven Nissen, the physician who first warned us of the dangers of the now withdrawn painkiller Vioxx, led a team of researchers to sound the alarms about Avandia in the latest issue of The New England Journal of Medicine, which spurred the FDA to issue a safety alert of this very popular medication.

One wonders why the FDA didn't speak up much sooner since they had ample evidence that Avandia could be dangerous to people who are already vulnerable to heart disease because of their diabetes.

Even GlaxoSmithKline told the FDA that Avandia raised the risk of heart attacks in its patients by 30%, according to Brain Wingfield of Glaxo SmithKline's findings, which was revealed to the FDA back in 2005 and again in 2006, are very similar to those of Dr. Nissen and his team, who said that a type 2 diabetic would have a 28.9% chance of having a heart attack within 7 years of taking Avandia, according to the New York Times.

What's more, Stephanie Saul and Gardiner Harris of the Times reports, the FDA reprimanded GlaxoSmithKline for downplaying concerns about the drug's safety in 2001, a year after Dr. Buse wrote his rather troubling letter.

Predictably, Glaxo SmithKline issued a statement vigorously disputing Dr. Buse's analysis, calling it "unbalanced and unsubstantiated." That's a patently absurd position to take, given that Glaxo SmithKline itself admitted that the drug substantially raised heart attack risk. The pharmaceutical company can't have it both ways here.

To be fair, the Wall Street Journal makes the startling observation that Dr. Buse was a consultant for two companies marketing diabetes drugs competing with Avandia at the time he sent his warning to the FDA. And Dr. Buse has said that the FDA should wait for more data before taking any further on Avandia (though, tellingly, he doesn't recommend the drug to his own patients, The Times says).

But since Glaxo SmithKline itself revealed the drug's potential problems, and a second prominent, credible doctor did too, my inclination is to think Dr. Buse's position has a lot of merit. Glaxo SmithKline, on the other hand, is talking out of both sides of its mouth and has a vested interest--to the tune of $3 billion-a-year in sales, says the New York Times --in peddling the notion that Avandia's risks are overstated.

So while I find Glaxo SmithKline's behavior irresponsible, I'll save the bulk of my ire for the FDA, whose job first and foremost is to protect the public. Apparently, though, according to a very informative piece by Marilynn Marchione of the AP, which The Washington Post ran, the FDA doesn't always discover the risks of drugs it allows to hit the market.

In the case of Avandia, Marchione writes, the FDA didn't require Glaxo to show that Avandia had a clear clinical benefit to diabetic patients, like fewer hospitalizations or fewer serious problems with blood sugar, but was instead approved because it showed short-term improvements in certain blood sugar measurements. She writes that Avandia's dangers weren't clear until Dr. Nissen's team gathered all the pertinent data on the 28,000 subjects Glaxo SmithKline itself used in 42 experiments involving the drug.

Excuse me? Isn't it the FDA's job to make sure to get all the critical information about a drug in place before deciding that it can be sold to a trusting public? Shouldn't someone at the FDA have done what Dr. Nissen's team did, if not before approving Avandia for sale, certainly soon thereafter? Isn't that what our tax dollars go to the FDA to do?

Now, because of its apparent lapse, the FDA will have to answer to us and Congress in hearings on June 6. Additionally, Senators Max Baucus of Montana and Charles Grassley of Iowa have written the FDA demanding that the agency tell us what they knew about Avandia and when they knew it, and why they reacted in a "leisurely" fashion to Glaxo SmithKline's revelations about Avandia's cardiovascular risks, says.

The article also notes that the senators wrote a letter to Glaxo SmithKline, claiming that they've heard that the pharmaceutical giant silenced at least one employee who wanted to speak out about Avandia's cardiovascular risks. (Horrendous, if true.)

I can only hope that Avandia didn't cause a heart attack in any of the 6 million Americans who have taken the drug. What an appalling job by the FDA.

From Jennifer Moore for the SUGAR SHOCK! Blog

Note again from Connie: Thanks, Jennifer, for updating us. Folks, while you're learning about this scary drug disaster, make sure to read my follow-up press release, which quotes Dr. Stephen Sinatra (contributing author for SUGAR SHOCK! ) pointing out that if you have type 2 diabetes or are at risk for the disease, you may not even need drugs after all. Kicking sugar, exercising, etc. may be the best treatment.

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