DR. HOOK- Diabetes lawsuits: don't blame the drug for the disease

The Bachelor: Officer & a Gentleman– yuck, please give me a break! How can a soldier and a doctor go onto a game show of marriage, pledge his love to one woman but then marry the hotter woman?

Not everyone in this country can even get married, but you don't see anyone creating legislation against TV marriage game shows or against the 60 percent of Americans getting divorced or against all the congressmen and senators who cheat on their wives. No, no, no! Instead TV has women fighting over one man to marry them. (Egads, I hope all the contestants got their HPV vaccine.) 

 Zsa Zsa Gabor's husband is like 1,000 years old, and he just had to jump into the pot and claim he could be the father of Anna Nicole Smith's surviving daughter. Where was Zsa Zsa in all of this? If she could slap a police officer in the face, you would think she threw the dining room table on her idiot husband?

 The medical world is not much different. Medical researchers are trapped behind beakers and Petri dishes like Yentl was before she dressed like a boy to go to Yeshiva school. So when there can be any chance of stirring controversy over one's research, some take it. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. NEJM 5/21/07; 356 might be an example of this. But is the news making Avandia into Anthrax?

Avandia, technically Rosiglitazone, is a medication used to treat insulin resistance in Type II Diabetes. It has been clinically proven to improve blood sugar control in type II diabetics and available in the market, like the Prince song, since 1999.

 Since 65 percent of type II diabetics die of cardiovascular reasons, some researchers did a meta-analysis on Avandia. A meta-analysis is not as solid as a randomized clinical trial, but they are interesting because they pool data from a ton of studies to see if there are any associations. 116 studies have been conducted on Avandia. This meta-analysis took 42 of these studies which met their criteria, leaving 15,560 people in the Avandia treated group and 12,283 in the "control" treated group. (Control patients took insulin, sulfonylurea, metformin, and placebo.) Both groups had poor diabetic control upon entry of each study and were followed for at least 24 weeks.

 So in the meta-analysis, they took all this data from the 42 studies and compared the outcomes of MI (myocardial infarction, AKA heart attack) or CV deaths (cardiovascular deaths). Here are the results, Vern.

In the Avandia group, there were 86 MIs (0.55%) and in the Control group 72 MIs (0.58%). For cardiovascular deaths, the Avandia group had 39 deaths (0.25%) and the Control group had 22 deaths (0.18%).

Avandia had a 1.43 times increased risk of death due to MI, and that may appear statistically significant. But in epidemiology, 43% increase risk is a weak to mild association. You need something like a 200 to 300 percent increased risk to be considered a strong association. Also if you just look at the numbers, 86 heart attacks out of 15,560 isn't a whole lot in particular vs. 72 heart attacks out of 12,283 controls. And the media are claiming a 64% increase in CV deaths with Avandia– but it is not statistically significant, which means "not proven."

 Already lawyers are advertising, sue, sue, sue! (I wonder if lawyers name their daughters "Sue"?) But isn't the real killer the diabetes itself– and in particular the obesity that causes the type II diabetes? Smoking, lack of exercise, and eating too much aren't sensationalized because Americans don't want to hear it, in particular Tyra Banks. We like the drama of blaming something else during its 15 minutes of infamy.