Urgent diabetic medication warning (which the FDA is too inept to share)

Going Forward

After a fox raided the henhouse a second time, the farmer said to his watchdog, “What’s wrong with you? How did you miss that fox TWICE?”

Watchdog: “After the first raid I formed an advisory committee to look into the matter. Clearly a fox was in the henhouse, but among the expert committee members, opinions were mixed about whether or not the fox actually killed the chickens.”

Farmer: “Opinions? I don’t care about their OPINIONS! I don’t want any foxes in the henhouse!”

Watchdog: “I anticipated your concern. That’s why I organized another advisory committee to investigate. I expect to receive their report sometime next summer.”

And that’s how the watchdog ended up in a kennel at the ASPCA.

If only – IF ONLY! – we could do the same with our “watchdog” – the hapless, inept, and thoroughly dysfunctional FDA.

Meanwhile, prepare to hit the “forward” button, because if you know someone who might be taking the diabetes drug Avandia, this little fable about the watchdog, the farmer, and the slowest advisory committee ever is a story they MUST hear.

The alarming setup

Let’s start off with a strong contender for Most Clueless Quote of the Year.

This is from a recent New York Times report: “GlaxoSmithKline said that it had studied Avandia extensively and that ‘scientific evidence simply does not establish that Avandia increases’ the risk of heart attacks.”

And why is that quote so stark raving clueless?

I’ll answer that question with another quote – this one from the Avandia website (avandia.com): “AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction).”

This sort of “up is down” Avandia reality has been the norm for several years.

In 2007, an FDA advisory committee concluded that Avandia might increase the risk of heart attack. The committee’s recommendation: Keep Avandia on the market. And of course, FDA officials thought that was a wonderful idea. After all, they’re the prime enablers of drug company cluelessness.

But not all of them.

Dr. David Graham is a sort of FDA Robin Hood. As I’ve mentioned before, Dr. Graham is an FDA drug safety scientist who has consistently pestered FDA officials about dangerous drugs. For instance, he was way out ahead of everyone in warning about Vioxx. The same with Avandia. Dr. Graham and a colleague authored an internal FDA report that calls for Avandia to be removed from the market.

According to the Times, another internal report concludes that if everyone who is now taking Avandia switched to Actos (another diabetes drug), as many as 500 heart attacks and 300 heart failures might be averted EVERY MONTH.

And the FDA response? They’ve formed another advisory committee. The report is expected next summer.

Today is March 4. So if the report arrives on, say, July 4…well the math is too tragic and too easy: a potential 2,000 heart attacks and 1,200 heart failures.

I’m not what you’d call a real big fan of politicians, but today I’m going to give the last words to a couple of U.S. senators: Charles E. Grassley and Max Baucus. For several years, Grassley and Baucus have been conducting an investigation of the way the FDA conducts its business.

Here’s Senator Baucus, getting straight to the heart of the Avandia situation: “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”

No gray areas there.

And here’s Senator Grassley commenting on the need to allow Dr. Graham and others like him to have a louder voice at the agency: “It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision. The Avandia case may be the most alarming example of the problem with this setup.”

Many thanks, senators! And way to hang tough, Dr. Graham!

Now, if you will, please hit that forward button and maybe some lives will be saved…

To Your Good Health,

Jenny Thompson

Source:
“Controversial Diabetes Drug Harms Heart, U.S. Concludes” Gardiner Harris, New York Times, 2/20/10, nytimes.com