Friday, September 7, 2007

There is a movement in medicine called comparative effectiveness. Quite simply, the cost or comparative effectiveness crowd claims that, opposed to drug companies, it is guided purely by scientific and economic facts about which medicines are more effective for the money. And they only have our better health in mind — no matter what it costs. There’s even a part of the current SCHIP bill that would tax health premiums to set up a nice new Comparative Effectiveness Board to make sure Medicare could generate comparative effectiveness studies to come up with “best buys,” just like Consumers Union or Public Citizen.

Except that what guides these decisions smells more like bias or fear, not science. And both can kill.

A couple of years ago my daughter was being treated for an eating disorder that required the use of Abilify, an atypical anti-psychotic. Public Citizen calls it a “worst pill” that should not be on the market at all. Consumers Union calls a 30-year-old drug that causes cognitive impairment a “Best Buy.” Ditto many health plans that cheerily link to the Consumer Union “best buy” site that ignores the side effects.

When my cholesterol nearly reached Barry Bonds levels, I went initially on a generic drug that was a Consumers Union best buy. My legs and arms cramped up in a week and my cholesterol levels were unchanged. I was gene tested and found that lovastatin, simvastin and Lipitor would cause muscle pain but that Crestor would not. The comparative effectiveness crowd hates gene testing because it identifies individual differences that screw up their ability to make sweeping judgments about what’s best for everyone. Crestor is not a best buy and Public Citizen tells people not to use it. Today my cholesterol, which has been linked to three heart attacks in my family, is super.

Black Americans have an 80 percent higher death rate associated with strokes due to hypertension than the general population. For years cardiologists have sought to find — in the absence of fully understanding the complex interaction of genetic, lifestyle and clinical factors — a treatment that could cut into the death rate. So the Association of Black Cardiologists cosponsored the research on a drug called Bidil. The FDA initially rejected the drug as a blood pressure treatment when it first tested on everyone. But sub-population and the sort of genetic analysis the comparative effectiveness people deride as “surrogate endpoints,” suggested that it worked to reduce death in blacks. It retested the drug against placebo on blacks and demonstrated a 43 percent reduction in death.

Jerry Avorn, a Harvard Medical School professor, who is a high priest of comparative effectiveness research, when he isn’t testifying on behalf of trial lawyers who sue drug companies for a living, derided the results. He called FDA regulation a “minimal standard that would be unacceptable anywhere else in research.” He claimed since Bidil wasn’t tested against other drugs the results were meaningless. Meaning, Avorn wants some of that taxpayer-funded comparative-effectiveness dough.

Ironically, the evidence-based crowd wants us to trust them that their approach to research is purer and better because they say so. There’s a reason they don’t like being held up to scrutiny. Indeed, while they kvetch about “minimal standards” Avorn and others look the other way when comparative effectiveness trials are rigged to demonstrate cheaper drugs are more effective, even at the expense of patient well being.

For instance, the comparative effectiveness crowd point to the government funded Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (or ALLHAT) as the gold standard of what they are talking about. That five-year, 42,000-patient trial studied the comparative effectiveness of older blood-pressure drugs (diuretics) against newer medicines in reducing heart attacks. Patients were allowed to switch to a combination of drugs only if they ‘failed’ on the older medicine first. ‘Failed’ is another word for having a stroke or heart attack.

ALLHAT concluded that diuretics were more cost-effective in reducing death from all forms of heart failure, (not heart attacks) and were therefore cost-effective overall. Yet, as Dr. Michael Weber, one of the members of the ALLHAT steering committee, noted, the entire “cost-benefit” of the older drugs was driven entirely by a 40 percent excess stroke rate in black patients that was predictable before the study began. So, Avorn opposed approval of Bidil, which reduced deaths from stroke among blacks by 43 percent but is making money peddling the ALLHAT regimen to doctors even though it increases stroke related death among blacks by 40 percent. Can you say Tuskegee study?

Comparative effectiveness has nothing to do with patient wellbeing or better evidence. It’s about hating drug companies and know-it-alls claiming they know better. Such studies are rigged against new drugs and designed to eliminate the individual differences that are at the heart of the next generation of personalized medicines. Drugs that Avorn, ALLHAT and Public Citizen claim are cost-effective could be hazardous to your health. Want to feel better or stay alive? Take a medicine advertised on TV instead.

Robert Goldberg is vice president of the Center for Medicine in the Public Interest.

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