What's the Harm?

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What's the Harm?

Postby malernee » Sat Nov 22, 2003 12:45 pm

November 22, 2003
What's the Harm?

Alternative medicine is not everything to gain and nothing to lose
By Michael Shermer

After being poked, scanned, drugged and radiated, your doc tells you nothing more can be done to cure what ails you. Why not try an alternative healing modality? What's the harm?
I started thinking about this question in 1991, when my normally intelligent mother presented to a psychiatrist symptoms of cognitive confusion, emotional instability and memory loss. Within an hour it was determined that she was depressed. I didn't buy it. My mom was acting strangely, not depressed. I requested a second opinion from a neurologist.

A CT scan revealed an orange-size meningioma tumor. After its removal, my mom was back to her bright and cheery self-- such a remarkably recuperative and pliable organ is the brain. Unfortunately, within a year my mom had two new tumors in her brain. Three more rounds of this cycle of surgical removal and tumor return, plus two doses of gamma knife radiation (pinpoint-accurate beams that destroy cancer cells), finally led to the dreaded prognosis: there was nothing more to be done.

What is a skeptic to do? An ideological commitment to science is one thing, but this was my mom! I turned to the literature, and with the help of our brilliant and humane oncologist, Avrum Bluming, determined that my mom should try an experimental treatment, mifepristone, a synthetic antiprogestin better known as RU-486, the "morning after" contraception drug. A small-sample study suggested that it might retard the growth of tumors. It didn't work for my mom. She was dying. There was nothing to lose in trying alternative cancer treatments, right? Wrong.

There is only scientific medicine that has been tested and alternative medicine that has not been tested.

The choice is not between scientific medicine that doesn't work and alternative medicine that might work. Instead there is only scientific medicine that has been tested and everything else ("alternative" or "complementary" medicine) that has not been tested. A few reliable authorities test and review the evidence for some of the claims-- notably Stephen Barrett's Quackwatch (www.quackwatch.org), William Jarvis's National Council against Health Fraud (www.ncahf.org), and Wallace Sampson's journal The Scientific Review of Alternative Medicine.

Most alternatives, however, slip under the scientific peer-review radar. This is why it is alarming that, according to the American Medical Association, the number of visits to alternative practitioners exceeds visits to traditional medical doctors; the amount of money spent on herbal medicines and nutrition therapy accounts for more than half of all out-of-pocket expenses to physicians; and, most disturbingly, 60 percent of patients who undergo alternative treatments do not report that information to their physician-- a serious, and even potentially fatal, problem if herbs and medicines are inappropriately mixed.

For example, the September 17 issue of the Journal of the American Medical Association reported the results of a study on St. John's wort. The herb, derived from a blooming Hypericum perforatum plant and hugely popular as an alternative elixir (to the tune of millions of dollars annually), can significantly impair the effectiveness of dozens of medications, including those used to treat high blood pressure, cardiac arrhythmias, high cholesterol, cancer, pain and depression. The study's authors show that St. John's wort affects the liver enzyme cytochrome P450 3A4, essential to metabolizing at least half of all prescription drugs, thereby speeding up the breakdown process and shortchanging patients of their lifesaving medications.

But there is a deeper problem with the use of alternatives whose benefits have not been proved. All of us are limited to a few score years in which to enjoy meaningful life and love. Time is precious and fleeting. Given the choice of spending the next couple months schlepping my mother around the country on a wild goose chase versus spending the time together, my dad and I decided on the latter. She died a few months later, on September 2, 2000, three years ago to the day I penned this column.

Medicine is miraculous, but in the end, life ultimately turns on the love of the people who matter most. It is for those relationships, especially, that we should apply the ancient medical principle Primum non nocere-- first, do no harm.

Michael Shermer is publisher of Skeptic (www.skeptic.com) and author of How We Believe and In Darwin's Shadow.



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Think harm always

Postby guest » Fri Jul 09, 2004 7:07 am

BMJ 2004;329 (3 July), doi:10.1136/bmj.329.7456.0-g

Think harm always

How do you deal with something unpleasant? The commonest way is not to think about it. That, I suspect, is why medicine has paid so little attention to the harm it may cause—despite the ancient instruction "first, do no harm." Many people try to deal with death by not thinking about it, but Montaigne advises us to do the opposite and think about it all the time. The same advice might apply to thinking about harm: every intervention by a doctor, even a throwaway comment or a test "just to be sure," carries the potential for harm, whereas many of those interventions have no possibility of bringing benefit. This long overdue theme issue explores some of the many ways in which health care might result in harm.

Very few people attend a doctor thinking that they may come out worse than when they went in. But many do. When referring a patient to hospital should a doctor say: "I must warn you that the simple fact of being admitted to hospital means that you have something above a one in 10 chance of suffering an adverse event and a one in a 100 chance of dying"? I put this point to the Helsinki meeting of the World Medical Association, a body that has made its name (and possibly created harm) by promoting informed consent. The audience looked quizzical, and I've never heard of a doctor issuing such a warning. But doctors will regularly warn patients of much less common risks attached to particular interventions.

Imagine an applicant to medical school answering the universal question of "Why do you want to study medicine?" with "My main ambition is to try to do less harm than good" or "I'd like to devote myself to exploring the harms caused by doctors." The applicant would be thought very odd even though he or she would be enlarging on "first, do no harm." Yet the balance between doing good and creating harm in a lifelong medical career undertaken with commitment and compassion may be fine. The harm is omnipresent, the benefit sometimes fleeting.

As a junior doctor I dutifully prescribed lignocaine to many patients who had had heart attacks. The logic was, I believe, that the drug would prevent the arrhythmias that might kill patients. It never occurred to me that this might kill patients rather than save them, but I learnt years later that the result of my hard work was more not fewer deaths. As my parents took me to hospital as a 7 year old and left me alone (on the hospital's instructions) to have my tonsils removed they never for an instant thought that the harm of the procedure might outweigh the benefit—but it probably did. The hospital admission certainly made me miserable and caused me to miss my big break playing the Archangel Gabriel.

Hard and uncomfortable as it may be, we need to think about harm all the time.

Richard Smith, editor


moving more slowly on trying to prevent overuse Kolata nyt

Postby malernee » Sun Dec 26, 2004 10:51 am

Program Coaxes Hospitals to See Treatments Under Their Noses

Published: December 25, 2004

he federal government is now telling patients whether their local hospitals are doing what they should.

For now, the effort involves three common and deadly afflictions of the elderly - heart attacks, heart failure and pneumonia - and asks about lifesaving treatments that everyone agrees should be given but that hospitals and doctors often forget to give.

The expectation, though, is that this is just the beginning; other diseases, other treatments and surgery are next. Within a few years, individual doctors will be rated as well.

Using incentives like bonus pay and deterrents like public humiliation, it is a bold new effort by the federal government, along with organizations of hospitals, doctors, nurses, and health researchers, to push providers to use proven remedies for common ailments.

And it is a response to a sobering reality: lifesaving treatments often are forgotten while doctors and hospitals lavish patients with an abundance of care, which can involve expensive procedures of questionable value. The results are high costs, unnecessary medicine and wasted opportunities to save lives and improve health.

Simple things can fall through the cracks.

"In some ways, it's kind of scary," said Dr. Peter Gross, the chief of the department of internal medicine at Hackensack University Medical Center in New Jersey. "The doctor today is much too busy and has too much to remember."

The hospital ratings are being done by Medicare and posted on the Internet (www.cms.hhs.gov/quality/hospital/).

And already, hospitals are responding, often with shock, when they discover they have been forgetting some of the very treatments that can make a difference between life and death, or sickness and health.

At Duke University's hospital, for example, when patients arrived short of breath, feverish and suffering from pneumonia, their doctors monitored their blood oxygen levels and put them on ventilators, if necessary, to help them breathe.

But they forgot something: patients who were elderly or had a chronic illness like emphysema or heart disease should have been given a pneumonia vaccine to protect them against future bouts with bacterial pneumonia, a major killer. None were.

All bacterial pneumonia patients should also get antibiotics within four hours of admission. But at Duke, fewer than half did.

The doctors learned about their lapses when the hospital sent its data to Medicare. And they were aghast. They had neglected - in most cases simply forgotten - the very simple treatments that can make the biggest difference in how patients feel or how long they live.

"It's like the Elisabeth Kübler-Ross stages of grief," said Dr. Robert Califf, a professor of medicine at Duke. "First you're in shock, then denial, and then you gradually come to terms with what needs to be done."

Now, Dr. Califf said, the hospital is scrambling to make sure such treatments are not neglected again.

Department of Veterans Affairs doctors had also been forgetting treatments like the pneumonia vaccine, said Dr. Jonathan Perlin, the agency's acting under secretary for health. "Everyone knows who should get the vaccine," Dr. Perlin said. "They can recite chapter and verse."

But not long ago, only 30 percent of V.A. patients who should get the vaccine received it (the national average is 50 percent). The rude awakening came when the department showed individual teams of doctors and individual clinics and hospitals how often they were vaccinating and how their rates compared with those of other medical teams. "It's pretty revealing to have the data," Dr. Perlin said. "Absent the data, you think you are doing a pretty good job."

Now 90 percent of V.A. patients who should get the vaccine do.

"By increasing the rate of pneumonia vaccination just for patients with emphysema, the V.A. saved 6,000 lives," Dr. Perlin said.

The same strategy worked with beta blockers - drugs, costing pennies a day, that should be given to nearly all heart attack patients within 24 hours of arriving at the hospital and should be prescribed when they leave. Nationwide, less than half who need these drugs get them. Yet beta blockers, which slow the heart rate, can prevent hospitalizations, prolong lives and save more than $6,000 per patient in hospitalization over five years.

The Department of Veterans Affairs has gone from giving beta blockers to about 60 percent of its heart attack patients to giving them to 98 percent.

Sometimes, disclosure of lapses in one area can elicit changes in a hospital's entire system, saving patients' lives across the board.

That happened when Duke researchers asked 315 hospitals for data on nine drugs that everyone agrees should be provided to heart attack patients.

For example, the hospitals were asked how often their heart attack patients got aspirin when they arrived (that alone can cut the death rate by 23 percent). When they were discharged, did they also get a statin to lower cholesterol levels? Nearly all should, with the exception of patients who have had a bad reaction to a statin and those rare patients with very low cholesterol levels. Did they get a beta blocker?

Once hospitals learned their score, it was up to them what to do. Over the next year, ones that improved in these measures saw their patient mortality from all causes fall by 40 percent. Those whose compliance scores did not change had no change in their mortality rate, and those whose performance fell had increases in their mortality rates.

"Those are the most remarkable data I have ever seen," said Dr. Eric Peterson, the Duke researcher who directed the study and has reported on it at medical meetings.

The new efforts to improve care came about because the time was right, health care researchers say. "It's really an accumulation of scientific knowledge about what quality means," Dr. Califf said. And there was a growing realization that quality care was not always being provided.

But when it comes to improving care, there is always the contentious issue of deciding what is good medicine.

"Most of what we do has a modest effect, and that means, by the very nature of the effects, that you can't tell whether what you are doing is effective unless you do a study," Dr. Califf said.

But that takes time, money, and often thousands or tens of thousands of patients. In most cases, such studies have not been done.

Dr. Califf and others cited bed sores as an example. The nation spends billions of dollars a year on special bandages and beds and treatments. "None of these is proven," Dr. Califf said. "But if you are making a ton of money being reimbursed by Medicare, the last thing you want to do is put your treatment to a test."

So, at Medicare, administrators decided to focus on just a few treatments at first, for a few common diseases - pneumonia, heart attacks and heart failure - where there was little controversy about whether those treatments worked and an abundance of data showing that doctors and hospitals often did not provide them.

"We made an initial decision, which was very political," said Dr. Stephen Jencks, Medicare's director of quality coordination. "We were going after things where there was complete agreement that a service was not being provided."

They are only a start. "Almost everyone would agree they are a very narrow slice of the health care pie."

So the agency asked the nation's hospitals to report how well they did in providing these treatments if they wanted this year's cost-of-living increase in Medicare payments. Ninety-eight percent complied.

Medicare expects that now that the hospitals' performances are public, many will try to improve. "People will begin to feel a little awkward if everyone else is doing better and they're not," Dr. Jencks said.

The next step, Dr. Jencks said, is "aligning payment with what you want people to do."

To that end, Medicare has a pilot program to pay hospitals for improving on a number of quality measures, including mortality rates and readmission rates for hip or knee surgery. Hospitals in the top 10 percent for a given condition, for example, will be paid an extra 2 percent. The agency will pay less if performance deteriorates. The project involves 278 hospitals affiliated with Premier, a nationwide organization of nonprofit hospitals.

The new initiatives have one thing in common - they abandoned the traditional assumption that if doctors know what works, they will provide it.

Doctors do know what works, said Dr. Steven M. Asch, a health care researcher at the V.A. Greater Los Angeles Health Care System and the RAND Corporation in Santa Monica. But, he found, Americans got just half the tests and treatments they should be getting.

"Basically, it was a flip of coin, whether you got good medical care or you didn't," Dr. Asch said. "It didn't matter where you lived. The shortfalls were constant."

"That challenged us to ask why these medical care problems were so pervasive," he said.

At least part of the answer, he and others say, is that doctors are unaware of their shortfalls and are rewarded no matter how well they do.

"Medical care is one of those very strange parts of the economy where you get paid no matter what the quality of the service you provide," Dr. Asch said. "It is like you went to a car dealership and your Mercedes is going to cost you the same as your Yugo."

Administrators at Medicare are well aware of the problem, Dr. Jencks said.

"We've reached a conclusion," he said. "We have to change the system."

Dr. Jencks said he expected that in the future hospitals and doctors would be paid according to whether they gave patients treatments that worked. "It is very clear that we are moving toward pay-for-performance," he said.

Change, though, will require fundamental alterations in how hospitals and doctors' offices operate, health care researchers say. And it is not so easy to change a medical system, as Hackensack University Medical Center discovered.

"We tried to come up with a standardized order set," with all the measures that Medicare was asking about, Dr. Gross said. "But the doctors didn't want to use the sheet," insisting they would just remember those items. Then they forgot.

The solution, Dr. Gross said, was to assign specially trained nurses to see what care was provided and remind doctors when important steps were omitted. The result was immediate improvement, Dr. Gross said, even in items not on Medicare's list.

For example, doctors at Hackensack were keeping pneumonia patients in the hospital, receiving intravenous antibiotics, for one to two weeks when many could go home within days with antibiotic pills, avoiding the discomfort from the intravenous lines and the ensuing risk of infection. By putting a nurse on the case, patients were sent home sooner. The hospital saved $500,000 a year by refilling its beds with other patients. Medicare, which pays most of the bill for pneumonia patients, reimburses for a diagnosis - pneumonia - and not for the number of days a patient spends in the hospital, so keeping patients in the hospital longer costs money.

Of course, the economics of medical care are rarely simple and the new programs have so far steered clear of the most difficult category: medical care that is useless or unnecessary, a category that costs the nation hundreds of billions of dollars a year.

"That will be a bitter pill to swallow, and I'm not sure people will swallow it," Dr. Califf said. "There's a lot of money being made on things that don't work well."

Dr. Jencks agreed.

"I would say we are moving much more slowly on trying to prevent overuse than in trying to fix underuse," he said. "If I tell a physician he shouldn't do a surgery he wants to do, I personally would anticipate a lot more resistance than if I told him he should give a medicine he wasn't thinking of giving."
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