Thursday, November 13, 2008

Statins. The New Wonder Drugs.

A recent study finds that statins (cholesterol-lowering drugs) can affect the likelihood of heart attacks and strokes even in individuals whose cholesterol levels were normal. The reason may have something to do with the role inflammation plays in affecting those risks. Statins appear to work on inflammations, too.

The study opens up some very important questions: First, note that it was funded by a company which manufactures the statin used in the study, Crestor:

Although there has been concern about the safety of Crestor, the researchers found no signs of significant risks. The study was funded by AstraZeneca, which makes Crestor, but the company had no influence over the analysis, Ridker said. He and his hospital receive royalties from the high-sensitivity CRP, or HSCRP, test, but other researchers said that was no reason to doubt the findings.

I don't like the principle of drug manufacturers paying for the studies which evaluate how good their drugs are, never mind how carefully such studies are done. What happens to those studies which find the drugs to be ineffective? Are they published with the same alacrity? Perhaps. But note that having drug firms pay for studies means that the study must pose questions about specific drugs rather than about specific diseases. For instance, perhaps there are other ways to lower inflammation in the body (aspirin?) than statins, and perhaps those other ways might have fewer side-effects and/or be cheaper.

Second, note the ethical problems that findings like this pose for insurance providers: Should statins now be covered even for individuals with normal cholesterol levels? Some views on that:

Some skeptics, however, argued that the actual risk reduction for an individual would be very small, given the relatively low risk for most middle-age people, so the benefits easily could be outweighed by the costs of thousands more people taking tests, drugs and being monitored by doctors.

"We're already struggling to provide health services for the 46 million Americans who don't have health insurance in the United States," said John Abramson, a clinical instructor at Harvard Medical School. "This is going to drain away a lot of money from the system for little or no benefit. We know that there are lifestyle interventions that are effective."

Ridker and others, however, said that the benefit was clear.

"We could prevent a lot of heart attacks, stroke, bypass surgeries, angioplasties, and save a lot of lives," Ridker said. "To me, that's a good thing."

There are formal ways of answering the question of what a health care system should pay for and why, and those ways consist of various types of cost-benefit or cost-effectiveness analyses. The former try to compare the benefits from a treatment to its costs, often failing, because it's hard to measure the benefits (reduced morbidity or mortality, reduced pain and suffering) in the same units as the costs (which are mostly in dollar terms).

The latter gets around this problem by looking at the costs per some measure of outcomes (say, lives saved or life-years gained). For example, we might compare the costs of lifestyle modification to the costs of taking statins, both standardized per life-years saved or some other suitable measure of outcome. I'd like to see a study do that, perhaps supplemented with other drug treatments that might work. But a pharmaceutical company is unlikely to fund such a study.

Prevention is a weird medical field, by the way, partly, because many of us have an almost religious affection towards it and partly because many forms of primary or secondary prevention have been eagerly adopted before studies have shown them to be effective or even without any studies at all. But it's a neat field for pharmaceutical companies as the market for their products suddenly becomes much wider than just the sick and because those still-healthy people are able to keep on working and paying for the medications, too. - None of this is intended to bash prevention, just to point out that it should be held to the same standards as other treatment forms.