Prescription for Failure

Prescription drug benefits are shaping up as one of the defining issues in this fall's campaign. Drugs are now the fastest-growing component of medical care. Elderly people spend more on drugs than on doctor bills. HMOs are squeezing other kinds of care because of their own rising drug costs.

There are really two big questions here: Should more Americans get more drug coverage, and should government play a direct role in limiting drug prices?

The reasonable answer to both questions is a resounding yes.

Medicare does not cover prescription drugs. Private supplemental Medigap policies are available, but the ones with good coverage cost hundreds of dollars a month. Some HMOs offer Medicare recipients drug coverage via managed care plans, but they are finding it ever harder to make money on Medicare patients, and millions of patients have been dropped.

Ever since Medicare was enacted in 1965, drug companies have resisted adding full drug coverage to Medicare for fear of controls on drug prices and profits. With managed care constraining every other part of the health system, drug companies are the only purveyors of health services that get to charge whatever they like.

Last month, on a party-line vote, the Republican House passed a bill to subsidize private insurers to offer partial drug coverage. This bill would only compound the current problem because it fails to deal with escalating drug prices.

The Clinton administration wants partial drug coverage for the elderly, directly through Medicare. Last week a key Republican senator, William Roth of Delaware, broke ranks and supported this approach. But both Roth and the Clinton administration have stopped short of the kind of controls on drug prices common in countries with universal health coverage.

The drug industry has put on a public relations blitz to convince you that drug costs are so high because it costs so much money to develop a new drug. Yet much of the cost has already been born by taxpayers in publicly funded basic and applied research.

Moreover, the drug companies benefit from generous patent protection, which protects their high prices.

In the past decade, drug companies have abandoned longstanding ethical constraints against marketing prescription medicines directly to consumers. Very powerful drugs, many with serious adverse effects, have become familiar advertising icons.

Now the industry wants the FDA to take several popular drugs available only by prescription and make them marketable over the counter. At a hearing before an FDA panel Thursday, industry representatives tried to persuade FDA experts to allow over-the-counter sale of one of the most widely prescribed kind of anticholesterol drugs, known as statins. After deliberating all day, the panel rejected the proposal.

Of 11 witnesses testifying at the public session, two were from companies that make cholesterol detection devices and eight were from groups that get drug industry funds. They all thought selling statin drugs over the counter was a swell idea. The only opposing witness was the industry's longtime critic, Dr. Sidney Wolfe of the Public Citizen Health Research Group.

Wolfe noted that the very material submitted by Merck, maker of the statin drug Mevacor, showed that 64 percent of people who volunteered for a key study ended up not taking the drug because their cholesterol wasn't in the range appropriate for the over-the-counter dose.

But if such drugs were approved for over-the-counter sale, many such people would buy them anyway.

Wolfe added that other research conducted by Merck and analyzed by the FDA revealed that some 78 percent of the people that Merck identified as potential over-the-counter buyers would get no proven clinical benefit from taking the drug. These are people without demonstrated heart disease, with HDL (good cholesterol) levels of 40 or higher.

There are two big problems with selling drugs like Mevacor over the counter. First, a lot of people who don't need the drug will buy it, further increasing drug costs and profits. Second, the drug can have potentially dangerous and even fatal effects.

Used as a prescription drug, Mevacor guidelines instruct the prescribing doctor to perform periodic liver function tests and to be alert to potentially fatal interactions with commonly prescribed antibiotics. Over the counter, these medical safeguards vanish.

As long as profit dominates public policy, Americans will get too many of the wrong drugs at too high a price and not enough of the prescription drugs we really need at costs we can afford. While the Democrats' plan is more comprehensive than the Republicans', neither party has had the nerve to take on this politically potent industry.

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