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Posts Tagged ‘overtreatment’

Back surgery compared to non-surgical treatment

Posted by medconsumers on January 1, 2007

Back Surgery Compared to Non-Surgical Treatment

People with severe back pain due to a ruptured disk usually recover whether they have surgery or decide to wait it out, though an operation brings immediate pain relief. And contrary to what many people are told by their surgeons, avoiding surgery does not result in nerve damage. These findings are from a large clinical trial published in November in the Journal of the American Medical Association.

Many back surgeons criticized this trial before it began because they were convinced of disk surgery’s benefit. Some refused to refer their patients to a trial they saw as unethical because surgery would be withheld from some study participants, a necessary component to a study intended to randomly assign half to non-surgical treatment.

But the research team led by James N. Weinstein, DO, Dartmouth Medical School, had these justifications for going ahead: 1) ruptured disks are often seen on the CT or MRI scans of people without any back symptoms and these scans also show that untreated ruptured disks can regress in time; 2) the rate of disk surgery in some regions of the U.S. is 15 times higher than that of other regions and other Western countries, thus raising suspicion that many disk operations are unnecessary.

The clinical trial went forward despite surgeons’ objections, and 2,000 people were treated at one of 13 U.S. spine clinics. All had scan-confirmed disk herniation and the persistent back and leg pain of sciatica for at least six weeks. Some of the participants agreed to be assigned randomly to receive either back surgery or non-surgical therapy (physical therapy and counseling and anti-inflammatory painkillers). Other participants, however, wanted to choose their own treatment, and they formed the basis of a separate trial called an observational study.

The results did not identify one treatment as superior to the other because so many study participants “crossed-over.” Only 50% of the people assigned to undergo surgery actually had the operation, and 30% of those assigned to non-surgical therapies decided to have the operation.

A co-author of the observational study Richard A. Deyo, MD, Professor of Medicine and of Health Services, University of Washington, Seattle, was asked for the take-home message of both trials. “Most people got better, regardless of whether they had surgery. Surgery typically offered faster relief, but by two to four years, people are the same whether or not they had surgery,” he responded in a telephone interview. Surgery can be avoided, if the pain is tolerable and the patient is “risk averse,” he explained, referring to the small but definite risks of surgery, such as nerve injury, scarring, and anesthesia mishaps.

The risks of surgery, though small, are greater than any risk of the wait-and-see approach, he continued. “Many people have the impression they will become paralyzed or [suffer] permanent muscle weakness if they delay, but patients needn’t worry.”

Will the new findings reverse back surgeons’ opinions? “This study replicates a trial done in Norway 30 years ago with much the same results,” said Dr. Deyo, noting that many American back surgeons could be unaware of this trial. “It might bring some surgeons up to date,” he said, answering the question of whether the findings will reduce the country’s high number of herniated disk operations, estimated to be 300,000 yearly.

“But it’s spinal fusion surgery that is now the most controversial,” said Dr. Deyo, referring to another back surgery now done in excess. “It has exploded [in growth] over the last decade, and there is no evidence for it.” There are huge financial interests involved in terms of equipment, hospitals, and physicians, explained Dr. Deyo, and the circumstances for which the operation may be warranted, such as spondylolisthesis (vertebrae out of alignment), spinal fracture, and cancer metastasis to the spine—are all uncommon.

Maryann Napoli, Center for Medical Consumers ©
January 2007

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Angioplasty: No Effect on Future Heart Attack

Posted by medconsumers on April 1, 2006

Dramatic Rise in Cardiac Procedures, But Heart Attack Rate Stays Constant

Over the last 10 to 15 years there has been a dramatic increase in cardiac procedures in the U.S. and Canada. Coronary artery bypass surgery and artery-opening procedures are intended to restore blood flow to the heart in order to prevent heart attacks. One might reasonably expect each country’s rate of heart attack to show an equally dramatic decline. But the heart attack rate stayed relatively constant in both countries. The findings came from two studies, one in the U.S. and one in Canada, published in the January 24 issue of the journal Circulation. They appear to validate the longstanding, but widely ignored, research indicating that today’s cardiac surgeons are still operating on an outmoded understanding of heart disease.

Each country’s study drew on claims data from its publicly funded Medicare program to determine the cardiac procedure rate. Medicare in the U.S. primarily covers people age 65 and over, while Medicare in Canada covers everyone, though the study looked solely at adults in Ontario. At the start of the study period, Canada’s rate of cardiac procedures was lower than that of the U.S., but both countries showed similar massive increases. The researchers determined the heart attack rate by looking at the claims submitted by people hospitalized for a heart attack during a 15-year period in the U.S. study and a 10-year period in the Canadian study.

“There are a couple of different messages for consumers in our study,” said F. Lee Lucas, PhD, Center for Outcomes Research and Evaluation, Maine Medical Center, the lead author of the American study. “The increased rates [of bypass surgery and artery-opening procedures] over time likely mean that doctors are quicker to intervene for milder and milder symptoms, particularly in white men,” she noted in a telephone interview. Dr. Lucas explained that the data collected in her study did not allow conclusions to be drawn regarding the percentage that might have been unnecessary.

David Waters, MD, who was not involved in either study, was less reticent about their implications. “We can assume that that these procedures are not influencing the heart attack rate, and some may be unnecessary,” he said in a telephone interview. Dr. Waters is chief of cardiology at San Francisco General Hospital and professor of medicine at University of California, San Francisco.

The two studies also indicate that an outmoded understanding of heart disease still dominates the way it is treated. According to the so-called new view of heart disease, a major constriction in the coronary artery is not where a future heart attack will occur. “There’s lots of data to show that opening a narrowed artery will not reduce your chances of having a heart attack,” said Dr. Waters, citing the one exception. “If, however, a person is having a heart attack, and that person has an artery-opening procedure while having the heart attack, there is good evidence that this will reduce the risk of dying of that heart attack.” In other words, the procedure will have no effect on future heart attacks.

The old model for the development of a heart attack is based on heart disease as a plumbing problem. The metaphor, which is still served up to the public to explain heart attacks, goes like this: A coronary artery slowly becomes narrowed with plaque in much the same way a pipe becomes corroded with rust and other gunk. In time, the artery becomes so constricted that blood flow to the heart is eventually shut off with a blood clot.

New Mechanism for a Heart Attack

The new understanding of heart disease is far more complex and is based on the observation that the vast majority of heart attacks do not occur in the portion of the artery that is most obstructed. Instead, most heart attacks occur where plaque breaks off and a clot forms over the area that can abruptly stop blood flow to the heart. In this scenario, the plaque is soft, symptomless, and would not be seen as an obstruction to blood flow. Heart disease is an inflammatory process by which the coronary arteries are subjected to a constant cycle of irritation, injury, healing and reinjury that makes the plaque likely to rupture. The solutions are the standard prevention advice: stop smoking, and take drugs to reduce clotting, inflammation, blood pressure and cholesterol.

If the new view of heart disease has been around for more than a dozen years, why hasn’t this changed the way it is treated? Do heart surgeons know about it? “The interventional cardiologists know about it, but they ignore it,” answered cardiologist Thomas Graboys, MD, in a telephone interview. “A new breed of over-trained cardiologists has now flooded into the community,” said Dr. Graboys, professor of medicine at Harvard Medical School and president of the Lown Foundation. It is no longer the large urban-based academic medical centers that come overstocked with interventional cardiologists. They have now come to the community hospital near you. And there is a strong financial incentive for them to look for constricted arteries and open them. “Economics drive the train,” said Dr. Graboys. “The starting salary of an interventional cardiologist is $300,000-400,000 a year, and for one that has been in practice three years, it is $500,000 to $600,000.”

Dr. Waters also sees money as the driving force. “If you have chest pain and the cardiologist you see does coronary angiography (see sidebar below) and that pays for his kids to go to college; well, are you are more likely to wind up with that procedure?” He advises, “Get a second opinion from a cardiologist who is not in the same building, the same group, or the same hospital as the first opinion cardiologist.” Dr. Waters also suggests that people give careful thought to the type of cardiologist chosen for a second opinion. There are, he explained, regular cardiologists who prescribe drugs; interventional cardiologists who do cardiac catheterizations, artery-opening procedures and stenting; and cardiovascular surgeons who perform coronary bypass surgery. The received opinion will likely mirror the doctor’s area of expertise.

The number of people undergoing artery-opening procedures continues to rise not only because they are huge money-makers but they are also very effective at relieving the severe chest pain of angina, which is a common symptom of heart disease. They are virtually useless, however, in stopping the progress of the disease itself. “The public is looking for a magic bullet,” observed Dr. Graboys, who offered this advice to people who are not in an acute situation. “Go to a non-hospital-based doctor in the community. A well-trained internist can take care of the lion’s share of people with coronary heart disease. The vast majority of people do well on medication—cholesterol-lowering drugs, antihypertensives, low-dose aspirin.”

Still, clogged arteries cannot be good. Won’t they eventually close off? “The body performs its own bypass,” explained Dr. Graboys, describing what is often seen during cardiac catheterizations. “The body forms new blood vessels around the constricted area, thus restoring blood flow.”

Dr. Graboys knows whereof he speaks; he is a cardiologist at the Lown Cardiovascular Center in Brookline, Massachusetts, a second opinion consultation center affiliated with Brigham and Women’s Hospital. For over two decades, the Center has helped many people avoid unnecessary surgery. Long before others made this connection, Dr. Graboys began to see the stress test and cardiac catheterization—two diagnostic procedures—as somewhat akin to a conveyer belt that funnels people to an artery-opening procedure or bypass surgery. A constricted artery is discovered, often several (not at all unusual in anyone over age 55), and the person goes on to what doctors call “a cascade of interventions”. In fact, the odds are so high that a cardiac catheterization will set people on to this course of events that Dr. Graboys advises a second opinion before agreeing to it.

A second opinion is all the more important given that Dr. Lucas, the lead author of the American study, said her data suggest that the threshold for deciding who is a candidate for an artery-opening procedure has been lowered over time. “Rates of bypass surgery have leveled off. This is due to the fact that bypass surgery is clearly the more invasive procedure requiring prolonged anesthesia and use of a heart/lung machine, etc., but with artery-opening procedures you’ve got the person in the cath lab, and you’ve got that catheter in there already; it’s tempting to go ahead and do the procedure, so the threshold for performing the procedure might be lower than it would be for bypass surgery,” Dr. Lucas explained. “Many people who have had it done firmly believe that it saved their lives, but the benefit of most procedures is [solely] control of symptoms.”

What does all this mean to the average older person who suspects that one day he or she might wind up in an emergency room with chest pains? To Dr. Waters, the people who show up in the emergency room with severe chest pain are the ones most likely to require an artery-opening procedure. “The person I worry about is the person who goes to the doctor with a vague symptom and finds himself with a doctor who is not skilled at distinguishing the important symptoms of a heart disease from other symptoms.”

Asked for an example of a vague symptom that an unskilled physician might mistakenly identify as heart-related: “I was recently playing catch with my dog and now have shoulder pain,” he responded, suggesting that this could be enough to start the cascade of interventions. It is, in fact, common for symptom-free people to be told to have a stress test and this alone can start the cascade.

The cascade may be worth it, if all these cardiac procedures were lifesaving, but so far proof is lacking. “There is no evidence to show that artery-opening procedures will prolong life,” said Dr. Graboys, citing the exception of a person in the midst of a heart attack. “Although these procedures are good at alleviating the heart-related chest pain called angina, so too are drugs and lifestyle changes.” Dr. Graboys continued, “Data show that people with angina can be treated successfully with medicines and lifestyle changes like stress reduction, regular exercise, smoking cessation, and treatment of risk factors like high cholesterol and high blood pressure.”

For more information on different types of angioplasty, see below.

The U.S. study led by F.L. Lucas, PhD, was supported in part by a grant from the National Institute of Aging. The Canadian study led by David A. Alter, MD, PhD, was supported in part by a grant by the Heart and Stroke Foundation of Canada.

Maryann Napoli, Center for Medical Consumers ©
April, 2006


Cardiac Procedures Explained

Cardiac catheterization is a general term for a group of procedures involving a thin tube (catheter) inserted into a blood vessel in the groin or arm. The catheter is threaded up to the coronary arteries andpositioned either in the chambers of the heart or at the arteries supplying the heart. Once the catheter is in place, the doctor can inject a special dye or fluid that is visible by x-ray. This produces motion x-ray pictures called an angiogram, which are used to diagnosed the health of the coronary arteries. Other names for cardiac catheterization are coronary angiography and coronary arteriography.

This diagnostic technique becomes therapeutic once the doctor decides to widen a constricted artery in another procedure called angioplasty. This can be done in several ways. The plaque can be pressed against the walls of a constricted artery with an inflated balloon at the tip of the catheter. In the currently most popular version of angioplasty, tiny wire cages called stents are used to destroy the obstruction and keep the constricted artery open. In the new study by Dr. Lucas and colleagues, artery-opening procedures were grouped under the name of percutaneous coronary interventions.

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Early Promoters Of PSA Screening For Prostate Cancer Do A Turnabout

Posted by medconsumers on February 1, 2005

At first, it appeared to be heresy. A paper published last October in the Journal of Urology indicates that the PSA screening test for prostate cancer has lead to widespread cancer diagnoses in men who did not need to be treated. The paper entitled, “The prostate specific antigen [PSA] era in the U.S. is over for prostate cancer: what happened in the last 20 years?” received surprisingly little publicity. What made it so remarkable was the fact that the lead author, Thomas A Stamey, MD., and colleagues at Stanford University are credited with early promotion of PSA screening in a paper published in 1987. Now, their recent data present a powerful argument against this use in symptomless men.

The paper describes a study that shows the presence of cancer in the prostate increases with age. Autopsies conducted on 525 men, equally divided between white and black men, killed accidentally on the streets of Detroit , showed that 8% of those in their 20s had prostate cancer. There was a linear increase in prostate cancer with each increasing decade of life. About 80% of the men (of both races) who were in their 70s had invasive prostate cancer.

The fact that most prostate cancers will remain dormant is demonstrated aptly by another statistic in this paper: “[Prostate cancer] has an extraordinarily small death rate of 226 per 100,000 men older than 65 years,” wrote Stamey and colleagues. Deaths from prostate cancer are rarer yet in men under age 65, according to the National Cancer Institute. Yet despite these statistics that make a case for not screening symptomless men for prostate cancer, the PSA blood test began to go into widespread use in the late 1980s. There is still no test that can accurately distinguish slow-growing or latent prostate cancer from the type that is moderately rapid and fatal.

Over the course of two decades, Dr. Stamey and colleagues assessed 1,317 consecutive prostates that had been removed surgically between 1983 and 2003—what they called the “PSA era.” The idea was to see how well the PSA test given before surgery accurately reflected the size of the largest cancers. Here’s what they found: “In the first ten years after PSA screening was introduced, there was a reasonably good, although not great, correlation between serum PSA and prostate cancer volume.”

But, as the years went by, things changed completely. When the researchers assessed the prostates removed most recently, that is, between 1998 and 2003, they found that the PSA tests were detecting benign enlargement of the prostate, rather than cancer. Benign prostatic hyperplasia, or enlarged prostate, is a common condition in men over age 60.

Dr. Stamey and colleagues explained their findings in this way: American men between 50 and 80 years have been screened so intensely over the last 20 years that the most significant of the prostate cancers had already been detected. However, they glossed over the substantial harm done to men in the PSA era in terms of unnecessary prostatectomies and unnecessary radiation therapy. The issue was alluded to in only one sentence, using one word— overtreatment.

In a telephone interview, Dr. Stamey said he had no hope that the huge industry that has now built around PSA screening will disappear with his findings. So he stressed the importance of informed consent where it concerns the use of the PSA test in symptomless men. “It is immoral for surgeons not to tell patients that we [men] all get prostate cancer as we age,” said Dr. Stamey, after describing himself as a 76-year-old surgeon who hasn’t had a screening PSA test in several years.

“Patients should be told that there’s a high chance of having prostate cancer that rises with age, but a very low chance of dying of it. Do we really want to screen 100,000 men to save 226 from dying of prostate cancer? In fact, it’s about the same chance of my not driving home safely tonight.” What’s more, he continued, 20 years ago, the prostate was biopsied in only six places, now it’s 36.

What about the PSA test’s possible role in the slight dip in the U.S. prostate cancer death rate? Dr. Stamey gave no credit to PSA screening.

“The death rates from several other common cancers have fallen, too, but we have no idea why.”

Maryann Napoli, Center for Medical Consumers ©
February 2005

Posted in Cancer, Men's Health, Screening | Tagged: , , , | Comments Off

 
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