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Some drugs are ineffective, research finds

Sunday, August 17, 2008
(Updated 3:00 am)

Cholesterol-lowering statins don’t reduce your risk of a heart attack — unless you’ve already had one.

Prostate exams for cancer in men older than 75 don’t help much and can lead to harm.

Methodical monthly breast self-exams won’t reduce your chances of dying of breast cancer.

Reducing blood-sugar levels in people with diabetes apparently doesn’t protect them from heart attacks, strokes or other serious side effects.

Lots of things you think you know about medicine are wrong. And a lot of doctors, too busy to keep up with every new development, are in the same boat. Most aren’t fatal, but some drugs, devices and procedures, for which there is no provable benefit or for which benefits don’t outweigh risks, are literally killing us.

It’s not clear exactly how many deaths they cause, but an estimated 30,000 Medicare patients alone die each year from unnecessary or unproven care, says Shannon Brownlee, the author of “Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer.”

“So not only are we paying for stuff that we don’t know whether it works or not, we know we’re paying for stuff that causes harm,” says Brownlee, a senior fellow at the New America Foundation, a nonpartisan think tank.

A recent example is the painkiller Vioxx, which was taken off the market after fears arose that it might have caused tens of thousands of heart-attack deaths within just a few years.

Ineffective care also may provide a false sense of security. NBC newscaster Tim Russert died in June of a heart attack just six weeks after taking a cardiac stress test.

Russert had exhibited no previous signs of heart disease, and for people in similar circumstances, the test is far less accurate than for those known to have some heart disease.

Unproven and ineffective care is killing us financially, too. In his call to weed out ineffective treatments, Congressional Budget Director Peter Orszag has said they cost $700 billion annually, about a third of U.S. health-care spending.

Debating the PSA test

On Aug. 4, the government-appointed Preventive Services Task Force reported that doctors should stop the routine blood test for prostate cancer, known as the PSA test, in men older than 75 because it offers little or no benefit.

One reason is that prostate cancer, though a common cancer in American men, often moves very slowly. Many more men die with it than of it.

Moreover, even in men younger than 75, the evidence on whether the PSA test leads to a reduction in prostate-cancer deaths is inconclusive.

Yet those tests have led to high levels of prostate surgery and radiation in the U.S. compared with other countries. Those treatments can cause impotence and incontinence, and in about half of those cases the effect is permanent, Brownlee says.

“You might or might not reduce your risk of dying prematurely from cancer, but it’s at the expense of not being able to have sex and having to wear diapers,” Brownlee says.

Root of the problem

Why is this unnecessary or unproven medical care so common?

One reason has to do with the association between certain symptoms and what are thought — often erroneously — to be their underlying causes, says Dr. Curt Furberg, professor of public health sciences at Wake Forest University Baptist Medical Center.

For example, “when we say this drug lowers blood pressure or lowers cholesterol, (we think) therefore it must reduce heart attacks,” Furberg says. “That’s where we go wrong.”

That’s because drugs that lower cholesterol do not significantly affect risk of heart attack, except in patients who already have had one. They also carry a risk of such side effects as muscle pain, liver problems and memory loss.

Another reason is that Americans exaggerate the importance of small differences, says Dr. Nortin Hadler, a professor of medicine at UNC-Chapel Hill and author of “Worried Sick: A Prescription for Health in an Overtreated America.”

Suppose the death rate in patients who don’t take a certain drug is 0.2 percent and the rate among patients who do is 0.1 percent. It is accurate to say that the drug reduces the death rate by 50 percent. But the difference is tiny in comparison to the number of patients.

Brownlee cites two other reasons for the trend. First, because medical procedures aren’t regulated, knowledge of them advances by “fits and starts,” with a bias toward what’s new, she says.

“Say, a breast cancer specialist comes up with a method of treating it and runs around the country telling other breast cancer specialists,” she says. “Pretty soon everybody is doing it, and nobody has (tested it).”

Second, Brownlee says, about 80 percent of the money for research on people in the U.S. comes from the pharmaceutical industry — which therefore gets to decide what kinds of research get funded.

“Right now they’re focused on blockbuster drugs, drugs that sell $1 billion a year,” she says.

That means they’re leaving all kinds of discoveries on the bench, undeveloped, because there isn’t going to be a market.”

One successful drug that nearly fell into that category is Herceptin, a breast-cancer treatment picked up by the drug company Genentech.

Genentech had halted work on the drug until a senior vice president’s mother developed breast cancer, according to “HER-2: The Making of Herceptin,” by Robert Bazell. That vice president pushed the company to finish research and bring the drug to market.

'Do you really need this?’

Not all problematic approaches to health care require significant change. For example, skipping a prostate PSA test that might or might not provide any benefit costs the patient nothing.

Another example is the monthly breast self-exam. It has been recommended for years, but women who were taught a specific technique had about the same breast-cancer death rates as women who were not, says Dr. Therese Bevers, medical director at the M.D. Anderson Cancer Center at the University of Texas.

Still, millions have been spent producing instructional materials on the technique.
But women “don’t have to have a specific technique taught to them to figure out if there’s a change,” Bevers says.

“What we see in reality is that women who come in with something weren’t doing (a specific breast exam),” Bevers says. “They were showering and felt something, dressing and felt something. … It’s just a part of the activities of daily living.”

The government also ought to require drug makers to make drugs that deal with underlying causes and their complications, not symptoms, to win approval, Furberg says.

One important recent example, he says, is reducing blood sugar levels in people with diabetes. A Food and Drug Administration panel recently said diabetes drugs should reduce heart attacks and strokes associated with diabetes, not just blood-sugar levels, he says.

In fact, the National Institutes of Health halted a diabetes study in February because more people were dying in the group targeted for aggressive lowering of blood sugar than in the group receiving standard care.

“The industry is screaming, 'This means we have to do more studies!’ and I say, 'So what?’” Furberg says. “One of the (goals) of treating diabetes is that you have to deal with the complications.”

Furberg also thinks drugs ought to be tested on more people and for longer than one year, currently the standard.

Hadler says the payment system that strongly influences how doctors interact with patients also must be changed, adding that the system doesn’t “reward talking to patients and thoughtfulness and the 'Do you really need this?’ kind of questioning.”

Is change coming?

Relying on more evidence would be a big change in the health care system, but the beginnings of such a project may be in sight.

On Aug. 1, Sen. Max Baucus, D-Mont., and Sen. Kent Conrad, D-N.D., introduced a bill that would create a Comparative Effectiveness Institute.

It would be private and funded by the government, private insurers and self-insured companies. It would set priorities, pay for research, ensure research integrity and make findings widely available.

“It’s basically the idea of finding out what works, what doesn’t and for which patients,” Brownlee says. Drug and device companies, and maybe even some doctors, will oppose the project, she predicts.

“But if we do this right, we can get buy-in from all the key people: patients, physicians, payers,” Brownlee says. “And we could really change the course of American medicine.”

Contact Lex Alexander at 373-7088 or lex.alexander@news-record.com

Accompanying Photos

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