The Statin Mafia Strikes Again

Can somebody help me out here? Am I off base in this analysis?

The Journal of the American Medical Association today published an editorial urging older patients who’ve already had heart attacks to step up their intake of statin drugs to super shrink their “bad cholesterol” levels. The editorial was written in response to the latest clinical trial – funded by Pfizer – showing that high doses of its drug Lipitor, which is already the best selling drug in the world, is allegedly superior to routine doses of Zocor, which is made by Merck and will come off patent next year.

I write “allegedly” in the last sentence because that’s what the Scandinavian doctors, at least three of whom were on Pfizer’s payroll, concluded from the data in the so-called IDEAL trial (Incremental Decrease in End Points through Aggressive Lipid Lowering).

Here’s my problem: more people died from cardiovascular disease including heart attacks in the high dose Lipitor arm of the trial.

You read that right. Here’s the details. Over 4,400 people up to 80 years of age who had already had one heart attack were in each arm of the trial. After four years, 223 of the men and women on high dose Lipitor (80 milligrams daily, average “bad cholesterol” of 81) had died of some form of cardiovascular disease, including heart attacks. Only 218 of the folks on low-dose Zocor (20 milligrams daily, average “bad cholesterol” of 104) had suffered a similar fate.

It took me a while to figure that out because the authors never revealed the number. They instead reported that slightly more people died from other causes in the Zocor arm (156 versus 143 on Lipitor) and slightly more on Zocor died overall (374 versus 366 on Lipitor). Subtract the numbers and you’ll see what I mean.

My first instinct as a journalist was to ask, Don’t they have editors at JAMA? In a trial testing drugs on people with a previous history of heart attacks, this higher mortality stat sure seems relevant to me.

The Pfizer-funded docs chose to dwell on the positive. They led their report with the fact that their primary endpoint showed there were 52 fewer major coronary events in the Lipitor arm of the trial, 411 versus 463. However, this was not statistically significant, so the bottom line is that the trial failed. They then went on to highlight the fact that the high-dose Lipitor folks had 54 fewer non-fatal heart attacks, 267 verus 321, which did creep into the statistically significant territory.

A word of warning, though, before all you heart attack survivors out there sign up for high dose statin treatment to marginally lower your risk of suffering a second heart attack (even though it won’t reduce your risk of dying). About 5 percent or 220 people on high-dose statins developed seriously elevated liver enzymes and 43 had to withdraw from the trial compared to just 5 withdrawals from the Zocor group.

Even more amazing than the sleight of hand in the study was the over-the-top enthusiasm for high-dose statin therapy in the accompanying editorial by Dr. Christopher Cannon of the Harvard Medical School (whose financial disclosures showed he’s consulted for most major drug companies including Merck). “Lower is better,” he wrote. The study should “motivate any patients who have been hesitating about treating their cholesterol to talk to their physicians to get the benefits of intensive cholesterol lowering.”

Does that wording, “talk to your physician,” sound familiar? It the same language used in most statin drug ads.

Company-funded studies that bury significant data and editorial touts filled with Madison Avenue clichés. The editors at JAMA should be ashamed.

Posted by gooznews at November 15, 2005 11:39 PM