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Avandia is not to blame for deaths in trial - or so we're told

Blame Game

Say it with me: “Avandia not to blame for deaths in trial.”

There. Now don’t you feel reassured?

When a segment of a major type 2 diabetes trial was recently shut down because of a disproportionate number of deaths in the intervention group, researchers (funded by the National Heart, Lung and Blood Institute) were quick to point out that the diabetes drug Avandia was not to blame for the deaths.

And Reuters news service played right along, putting this headline over its report: “Avandia not to blame for deaths in trial, US says.”

Hey – everyone is saying it – it must be true!

I can’t hear you

Researchers had an interesting idea: Let’s take thousands of longtime type 2 diabetics with a high risk of heart attack or stroke, divide them into two groups, give one group standard care, and give the other group multiple drugs in a highly aggressive regimen to force their blood sugar down to normal, non-diabetic levels.

Turns out, this was a killer idea. Literally.

The trial was halted when the number of deaths (257) in the aggressive intervention group far exceeded deaths (203) in the standard care group. Drugs used in the aggressive care group included Avandia, metformin, Actos, or insulins. Doctors made individual decisions for each subject about what combination of drugs to prescribe.

The Reuters article notes that just last year an FDA analysis linked Avandia to a 43 percent higher risk of heart attack.

And that’s our cue! Say it with me: “Avandia not to blame for deaths in trial.”

Dr. William Friedewald, one of the trial’s directors, told reporters this about the aggressive treatment group: “It appeared that if a heart attack did occur, it was more likely to be fatal.”

And once again – let’s hear it – nice and LOUD now: “Avandia not to blame for deaths in trial.”

See how easy it is to be an “expert” about these things?

Cold comfort

Dr. Friedewald also noted that his team attempted to determine whether there was any link between Avandia and the increased deaths. He said, “At this time we have found no link.”

“At this time”? You mean, at a later time a link might emerge? Whatever! Let me hear it! “Avandia not to blame for deaths in trial.”

In the e-Alert “Heart Floss” – which I sent you about three years ago – I told you about this warning posted on the FDA web site: “When Avandia is taken with other oral diabetes medicines, there’s a risk of “blood sugar becoming dangerously low.” And in 2003, in the e-Alert “Sweet Heart” I told you about a link between Avandia and an increased risk of congestive heart failure.

Come on now – no holding back – “Avandia not to blame for deaths in trial.”

Do you think we’ve said it enough? Apparently so, because Damien Conover, a drug industry analyst, told Reuters that the study “bodes well” for Avandia and “will help the company put positive data in front of doctors.”

Ah. Our work here is done.

To cap off this Avandia lovefest, a spokesperson for GlaxoSmithKline (the maker of Avandia) told Reuters that the findings “appear to raise questions about how aggressively blood sugar should be reduced in managing diabetes.”

Right. That’s all that’s going on here. They were just a little too aggressive in driving blood sugar down. In fact, an NBC report featured one of the subjects from the aggressive therapy group who was about to begin receiving drugs to push his blood sugar UP!

You have to wonder how much faith that poor fellow has in the managers of the study. But at least he can take some cold comfort in being told, in no uncertain terms, that Avandia is not to blame for the deaths in his trial.

“Avandia Not to Blame for Deaths in Trial, US Says” Julie Steenhuysen, Reuters, 2/6/08,