Avandia: Big Trouble, Time for Action

Today's big news suggesting that the blockbuster diabetes drug Avandia can increase risk for heart attacks and death is itself a blockbuster. It's got all of the trackmarks of a health story with serious staying power, maybe the biggest since Vioxx:

• A blockbuster drug for a condition shared by millions of people shown to be dangerous
• A study in a first-rate journal (New England Journal of Medicine) by first-rate researchers
• A big drug company (GlaxoSmithKline) claiming the findings are wrong
• A suggestion of coverup and profiteering likely to set mainstream health journalists a-slobberin'
• A huge opportunity for personal injury lawyers

Bottom line first
Diabetics taking the drug Avandia seem to have a higher risk of heart disease and death due to heart-related causes than those using other treatments.

This study in 75 words or fewer
The meta-analysis combines data from 42 existing studies with almost 28,000 participants. It compared heart attacks and heart deaths in people taking Avandia with those taking placebos or other drugs. The Avandia group had a 43 percent higher risk of heart attack and 64 percent higher risk of cardiovascular death.

Yes, but. . .
When you look at lives affected, the numbers are small: For every 1,000 Avandia patients, about 9 would have died. For every 1,000 in the control group, 4 would have died. Co-author Steven Nissen gets a lot of support from big pharma, but reports that all the money is given to charities.

Having said that. . .
Nissen of the Cleveland Clinic is one of the biggest names in cardiology research. Heart disease is the leading cause of death for diabetics, so any apparent increase in risk is worth taking a hard look at. "Only" 5 extra deaths out of 1,000 matters a lot if you're related to one of them.

So what are you going to do about it?

• If you're on Avandia--or any diabetes medication--talk to your doctor immediately. Expect him or her to provide a don't-panic response. But it's a good time to push for a talk about alternatives, your heart disease status, etc.
• Critics charge that Avandia isn't much better than older, cheaper drugs at controlling blood sugar. This study may shift the risk/benefit ratio in favor of other treatments.
• People with uncontrolled blood sugar can't afford to ignore it: untreated diabetes leads to heart disease, amputation, blindness and, not to put too fine a point on it, death.
• Many cases of type 2 diabetes are essentially the product of lifestyle--and reversible, or controllable--with a remarkably intuitive diet and exercise regimen: Eat less crap, lose some weight, and take a brisk, 30-minute walk nearly every day. This simple stuff often gets overlooked when people start yammering about the glycemic index, starch exchanges and so on. The American Diabetes Association has details on the diet and exercise regimen.

Oh, one more thing
Depending on your viewpoint, a meta-analysis is either the best or worst way to summarize research. (Using more data adds statistical power; mixing different studies dirties the data.) Expect GSK, the FDA, Public Citizen and doctors to be fighting this one out for a long time. And did we mention the personal injury lawyers?