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Wednesday, February 16, 2011

Is surgery overdone?

A silent scandal simmers untended in American medicine. Every year surgeons perform thousands upon thousands of questionable or unnecessary procedures on unwitting patients. The complications can be deadly, and the costs potentially add up to billions of dollars. In some cases the surgery itself is of doubtful value. In others the operation works just fine, but drugs or other nonsurgical remedies may be safer or cheaper.

This epidemic of uncertain care is an unintended outgrowth of a decades-long boom in elective surgery. Despite managed care's unceasing attempts to restrain the costs of health care, aging baby boomers are rushing to repair their creaky joints, valves and tendons in record numbers. Nationally, 72 million operations are performed a year, with most of the growth in the mushrooming ambulatory care market. The most popular orthopedic procedures, including back, knee and rotator-cuff surgery, are growing at 10% a year or more.

Researchers have barely begun trying to assess what portion of all this care is wasted. At issue are some of the most commonly performed operations in the nation, including arthroscopic surgery to clean up arthritic cartilage in the knee; a much-debated procedure to ease lower-back pain by fusing vertebrae in the spine; carotid endarterectomy to prevent stroke; and hysterectomy, the removal of the uterus. Little if any definitive data exist on how often unnecessary surgery occurs, but some evidence suggests the problem is bigger than surgeons like to admit. Studies conducted in the early 1990s by Rand Corp. found that 10% to 30% of many common operations were inappropriate or questionable. If these rates hold true across the board, it would mean 7 million to 20 million questionable operations each year, possibly wasting tens of billions that might be put to better use.

Adding to the doubts; your chances of undergoing a particular operation can vary vastly from one zip code to another, fluctuating by as much as tenfold. This owes to more than just income levels and age distributions--it also can be shaped by how many specialists operate in your hometown. It may well be that "we are making a lot of scars that aren't necessary," says Dartmouth University orthopedic surgeon James Weinstein.

The cumulative risks are enormous. Spinal fusion surgery has a 17% complication rate, including infections and, in rare cases, nerve damage. Hysterectomy takes women out of commission for weeks, and up to 9% of the women who get one, or 60,000 patients, encounter complications. Carotid endarterectomy has a 2% mortality rate. "My belief is that if you are talking about patient safety, this is the number one problem in medicine," says Dr. Robert Brook, a UCLA professor and director of health sciences for Rand. "It wastes money and kills people." More disturbing, some observers attribute part of the problem to greed. Unneeded surgery "is an enormous scandal, white-coat crime as far as I am concerned, and it is just being ignored," says Charles Inlander of the consumer group People's Medical Society.

Patients assume doctors base their decision to operate on hard data, but some surgeons still operate based on conviction rather than solid evidence. "They believe they can look at an MRI and, like Carnac from Johnny Carson, say, ‘This is the disc that is causing pain and I will fuse it,'" says University of Pennsylvania physiatrist Curtis Slipman, who treats pain without surgery. New drugs are subjected to rigorous trials comparing them with existing treatments or placebos before they are allowed on the market. But surgery sometimes goes mainstream without ever being evaluated in a randomized, controlled trial. One problem is that surgery can have an enormous placebo effect, masking a reality of meager benefits in exchange for the risk and cost it entails. "There is the potential that the majority of surgery we do for symptom relief is only effective because of the placebo effect--with significant potential of harming the patient," says Dr. Nelda Wray, research chief at the U.S. Department of Veterans Affairs.

But surgeons have largely escaped scrutiny. They believe in what they do and reign as the main arbiters of whether an operation should be performed--and insurers pay per procedure. Their complicit partners: hospitals, insurers and patients themselves. Hospitals reap ancillary charges related to a procedure. Insurers are reluctant to second-guess. Patients are eager for a quick fix; some refuse to take no for an answer.

Now some researchers, abetted by federal officials tired of paying the bill for questionable procedures, are pushing for more rigorous tests of new operations. The Veterans Administration, one of the biggest health care providers in the nation, is targeting up to six common surgeries for clinical trials, likely including back surgery and non-urgent gall bladder surgery. Dartmouth's James Weinstein is leading a 2,500-person, $14 million study comparing surgery with non-surgical treatment for back pain.

The push already is yielding results. A study last year found that one of the most common operations for arthritis of the knee, performed for decades, was actually no better than a placebo. A 1,218-person study this spring found that lung-volume-reduction surgery for emphysema, touted as a breakthrough in the early 1990s, failed to significantly boost exercise capacity for 84% of the patients who received the procedure, while some high-risk patients died sooner. While all of the following procedures are beneficial for some patients, controversy surrounds how often they should be done and on whom they should be performed.

A Trick Knee
Each year hundreds of thousands of arthritic Americans undergo arthroscopies in which surgeons shave away rough cartilage from the knee joints, at a cost of $5,000 per procedure. It turns out the procedure is no better than fake surgery in alleviating arthritis pain. That is the conclusion of an innovative study published last summer in the New England Journal of Medicine. Dr. Wray and others at the VA Medical Center in Houston randomly assigned 180 arthritis patients to get one of two arthroscopic procedures or a fake surgery. In the sham operation patients were wheeled into the operating room, sedated and cut just enough to give them a convincing scar. (All patients consented in advance.)

The fake surgery was so controversial that it took ten years to plan and complete the trial. The results are unambiguous. At no point in two years of follow-up was the real surgery better than the fake one. Six patients who got the fake operation liked it so much that they came back to have it on their other knee.

Medicare now proposes to stop reimbursement for arthroscopies for arthritis pain. Surgeons who favor the procedure are fighting back, arguing it helps ease popping and other "mechanical" symptoms. But that view is nonsense, says Bruce Moseley, the surgeon who did all 180 procedures in the study. "It's desperate people trying to discredit the study. They are looking for a loophole," says Moseley, from the Baylor College of Medicine. The VA study does not call into question arthroscopy for major cartilage tears and acute injuries. But even here, unscrupulous doctors sometimes perform unneeded arthroscopies for minor injuries that will heal on their own, says Ronald Grelsamer, a knee surgeon at Maimonides Medical Center in Brooklyn. Go to some hospitals and you'll find "a doctor who does ten a week[of which] nine are unnecessary," he says.

Spine Spin Some 125,000 times a year neurosurgeons perform spinal fusion surgery, using a bone graft or metal implant rods or plates to fuse together two vertebrae in an attempt to relieve lower-back pain from degenerated discs, the spongy shock absorbers between vertebrae. Patient traffic has quadrupled in a decade, and fusion now costs about $30,000. Surgeons who perform these operations rake in a median salary of $545,000 a year, almost double what most specialists earn, says the Medical Group Management Association.

Fusion caught on decades ago as a well-accepted treatment for deformities, fractures and dislocations, but surgeons later expanded it to treat back pain as well. The evidence that fusion works well for regional back pain is "essentially nonexistent," says University of North Carolina rheumatologist Nortin Halder. "If this were a pill and I used it, I would probably lose my license and go to jail."

University of Washington internist and fusion skeptic Richard Deyo MD, working under a government grant for the U.S. Agency for Health Care Policy & Research to help devise guidelines for back-pain surgery, surveyed the literature in 1992 and found a dearth of random, controlled trials, wildly varying success rates and unreliable data. When the resulting guidelines concluded there was little evidence that fusion for lower-back pain works, some outraged surgeons tried (unsuccessfully) to get Congress to kill the agency that sponsored the study. They did however, successfully remove the funding to the agency, and required the agency to stop putting out policy guidelines.
The U.S. Agency for Health Care Policy & Research concluded that the best outcome for back pain treatment was from manipulation and exercise, along with stress management. (Isn’t it great Wade & Associated Chiropractic provides you with this type treatment.)

One of the few controlled studies since then, a Swedish trial of 294 back patients, found 63% of patients who got the operation reported some improvement, versus 29% who didn't get operated on. Surgeons say it is unfair for critics to demand spectacular results, given that the operation is performed as a last-resort for severe cases. But Deyo says the Swedish study is flawed because it didn't offer much new treatment to the non-surgery group. He points to a new 64-patient Norwegian study that compared spinal fusion surgery for back pain with a vigorous program of psychological and exercise therapy. The non-surgical regimen was about as effective as surgery, caused no complications and cost a fraction what surgery costs, says study leader Jens Ivar Brox at Oslo's National Hospital.

Some doctors, such as University of Michigan physical medicine specialist Andrew Haig, spend a lot of time seeing failed fusion patients. One of Haig's patients is 65-year-old minister Melvin Harrell, who has suffered unrelenting back pain since falling down the stairs in the 1960s. Harrell has undergone three spinal fusion operations involving five vertebrae; none slashed his pain. "When the orthopedist says you need surgery and you are in terrible pain, you assume he is right," Harrell explains. He plans to stick with Haig's non-surgical program and advises others considering fusions: "Think long and hard."

Unsure Shoulders
Another hot operation is arthroscopic surgery to relieve shoulder tendonitis caused by rubbing of the rotator cuff tendons against the shoulder blade. Surgeons disagree on when this operation is needed. The theory behind the surgery, developed in the 1970s, is that too much rubbing, or impingement, causes the rotator cuff to fray and eventually tear. In a procedure called acromioplasty, surgeons shave away some of the bone to make more room for the rotator cuff, in hopes of alleviating pain and preventing tears. The surgery can be done on an outpatient basis. "You can do a lot of these in a short period of time," says Dr. Brox of Oslo. "It's an easy way to make money, even in Norway."

In the early 1990s Brox conducted one of the few controlled studies of this procedure, comparing surgery with physical therapy in 125 patients with chronic shoulder pain. He found that the surgery was not significantly better than physical therapy in relieving pain, and only 22% of those in the physical therapy group needed surgery two and a half years later. But he says his result has been ignored by "snobbish" surgeons in the U.S.

Doctors disagree on what constitutes impingement and whether it is always the culprit in shoulder pain. One doubter, University of Washington surgeon Frederick Matsen, frequently sees patients who have been told they need impingement surgery but in reality simply have stiff shoulders. He sends them home to try a six-week regimen of shoulder stretches. Few come back.

Most surgeons are still believers in the operation and cite good results in 90% of patients. "Impingement is probably overdiagnosed and operations are done that shouldn't be, but to say impingement doesn't exist is insanity," says Columbia University shoulder surgeon Louis Bigliani. One way to resolve the debate is a trial comparing real surgery with fake surgery in people with shoulder pain. .Says Matsen: "It could be the best thing ever, or it could be no better than placebo, and until we do the study we will never know."

Dousing Heartburn
Despite the spread of powerful heartburn drugs like Prilosec, surgery to stop acid reflux has surged in recent years. An estimated 65,000 surgeries are performed annually at a cost of $10,000 each, up almost sixfold in 15 years. By fixing the faulty valve that lets stomach acid seep back into the esophagus, surgeons seek to cure reflux and eliminate the need for popping pills. The operation also may help prevent esophageal cancer, a possible reflux complication.

Both claims are controversial. Stuart Jon Spechler, a gastroenterologist at the VA Medical Center in Dallas, has conducted one of the few trials comparing surgery and drug therapy, looking at 247 patients with severe reflux. When the study began in the 1980s drugs like Prilosec weren't available and surgery was more effective. But in 2001 Spechler decided to go back and examine how the original patients were doing.

He found that 62% of 37 surgery patients remaining alive after ten years still needed drugs to control their heartburn, according to results published in the Journal of the American Medical Association. The surgery patients had no better quality of life than 92 drug-only patients, nor did they have fewer reflux complications such as cancer. Mysteriously, surgery patients were slightly more likely to die of heart disease. Dr. Spechler theorizes that the surgical repair breaks down after several years. "When you look at the data it is hard not to be biased against surgery," he says.

NOTE: The nerves which control the esophagus and upper stomach also control the heart! If the roots of the tree are cut, the tree dies. Similar results will occur if the spine is pinching the nerves to the esophagus or heart. Surgery may remove the dead fruit, but eventually the tree dies.

Surgeons disagree. "The comment I most often get from patients is, ‘Why did I wait so long?'" says University of Southern California heartburn surgeon Steven DeMeester. DeMeester says that gastroenterologists like Dr. Spechler are biased because they see only the handful of surgery patients with complications, not the vast majority who are cured. Various studies show that 90% or more of surgery patients are satisfied with the result.

Similarly, the debate over whether surgery slashes cancer risk is so heated that "You get guys in fistfights up on the dais at national meetings," says West Virginia University surgeon David McFadden. Surgeons cite early studies hinting at reduced risk, but none are definitive. Meanwhile, the odds of dying from heartburn surgery, according to a University of Washington study, are about 1 in 125, although risks are lower with veteran surgeons.

The Expendable Uterus
The quintessential example of an overused operation is hysterectomy, or removal of the uterus. While hysterectomy can be lifesaving for women with cancer, most patients get it for quality-of-life problems, such as pain or bleeding caused by benign fibroids. Studies have long found the operation is often performed on women who don't need it. Yet hysterectomy rates remain stubbornly high, with 650,000 done every year. "The quality of care women get around hysterectomy has been really poor in this country for 50 years," says gynecologist Michael Broder, who has studied hysterectomy overuse.

He and a Rand research team surveyed almost 500 women who had undergone hysterectomies at several California managed care organizations. They found that 70% of the surgeries had been done without first conducting adequate diagnostic tests to ensure the surgery was appropriate. Some 14% of the women shouldn't have gotten a hysterectomy under any circumstances; 21% of 340 patients with fibroids had surgery without first trying drugs or other treatments that might have curbed their symptoms. "The medical establishment puts no value on having a uterus if a woman is no longer having babies," Broder says.


Bypassing Obesity
So-called gastric bypass operations are on the rise, thanks to a new, less invasive technique that gets patients out of the hospital quickly. This operation unquestionably works: Patients can lose 100 pounds or more. The International Bariatric Surgery Registry pegs the 30-day mortality rate at a reassuring 1 in 300. But the real mortality rate may be far higher than that--almost one death in 50 cases, close to the death rate from coronary surgery.

That finding emerges from David Flum, a University of Washington gastrointestinal surgeon who surveyed a representative sample of several thousand patients who underwent gastric bypasses, by which a surgeon reduces the stomach to a fraction of its normal size to render overeating impossible. Flum attributes the high complication rate, in part, to inexperienced surgeons rushing to offer a lucrative but technically demanding plumbing job. "You have lots of obese patients, insurers willing to pay and doctors just learning the operation. It is the perfect storm for bad outcomes," he says. The operation can work wonders, Flum says, "but patients need to go in with their eyes open."

Physician Payday

Median salaries for several types of doctors.

Spine surgeons: $545,000

General orthopedic surgeons: $364,000

All specialists: $275,000

General surgeons: $255,000

All primary care docs: $153,000

Source: Medical Group Management Association.





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