As the issue of Medicare drug coverage is resurrected yet again, watch as facts are twisted to focus on the price of drugs rather than on the cost and benefits of treating patients. It is easier to pick on drug companies than to do what is right for people. Exhibit One: the manhandling of a study conducted by the National Heart Lung and Blood Institute (NHLBI), a branch of the National Institutes of Health (NIH), to determine the comparative benefits of older and newer medications in reducing the rate of heart disease. The NHLIB concluded that patients on older drugs (diuretics) have less stroke and heart failure than patients on newer medications (calcium channel blockers and ACE inhibitors).
Led by the New York Times (its editorial page ran a screed entitled “Cheaper is Better”), major newspapers have seized on that finding as an example of pharmaceutical greed over public health. The Times concluded that this “demonstration that a cheap, older drug can treat high blood pressure more effectively than its newer, costlier competitors is not just a valuable signpost for doctors and patients. It also underscores the distorting impact that aggressive marketing campaigns can have on medical prescribing.”
But neither the Times nor the NHLBI told the whole story: Most of the cheaper-is-better rhetoric rests largely on the fact that there was a 40-percent increase in strokes in African Americans receiving ACE inhibitors instead of diuretics. And it turns out that the increase was a function of the study design: Heart specialists know that blacks are less likely to die of stroke on diuretics. Yet many blacks in the study received the ACE inhibitors first and were not allowed diuretics anyway, since the inhibitors were being tested against the other drugs. It is not a far stretch to say this study demonstrated the stroke benefit of diuretics by unfairly denying blacks optimal care. What would have happened if blacks had been treated appropriately in the first place?
Indeed, since combination therapy is crucial to superior outcomes, it’s curious the study should have obsessed about the drug-to-drug face-off. The hypertension study found that in the first year, about 17 percent of all patients each were randomly assigned to a medicine had switched to another drug for reasons including such side effects as increased cholesterol or risk of diabetes. In the first year, at least 25 percent of all patients were taking one or more other blood-pressure drugs in addition to the one assigned to them in the experiment. By the end of the study — the fifth year — 40 percent of all patients were taking a combination of drugs that included beta blockers (which were not even evaluated in the head-to-head part of the study).
So why would the NIH recommend switching people who are already stable on one drug to diuretics, when combination treatment is standard, and diuretics are known not to help heart patients live longer? NIH told the media and the public that “physicians and patients should consider changing antihypertensive therapy to a thiazide-type diuretic if a different type of medication is currently taken — even if the patient’s blood pressure is well controlled… with the alternate medication. The patient is likely to benefit from the enhanced effectiveness of the diuretic as well as the reduced cost of the drug.” Such medical advice — which flies in the face of the study’s findings — borders on malpractice.
It does, however, give aid and comfort to those looking to use the study as a platform for claiming that most new drugs add nothing to public health, during the coming Medicare drug debate. Now they have the misconstrued NIH study to support them in their effort.
That would be a huge mistake. Large-scale trials should focus on comparing approaches to treatment — not just drugs. As the study shows: Unless they compare all patients in all circumstances, trials tell us little more than what we want to hear. The NHLIB study must receive further scrutiny before the politicians and pundits begin attempting to dictate Medicare prescription-drug policy. To do any less would be to allow medical research to become a political tool, and to place life-and-death decisions in the hands of the New York Times and elected officials, not doctors and patients.