Benefit of Popular Spinal Surgery Is Questioned

[question everything]

AUGUST 6, 2009

Benefit of Popular Spinal Surgery Is Questioned

By JOSEPH PEREIRA AND KEITH J. WINSTEIN
WSJ

In the past decade, a low-risk technique for repairing fractured bones in the spine has surged in popularity, to an estimated 100,000 operations last year in the U.S. But in the first two studies to rigorously examine the effect of the procedure, known as vertebroplasty, researchers found no detectable benefit when compared with a placebo group of patients who received a sham procedure that only mimicked the real thing... Vertebroplasty is usually performed by radiologists, who inject bone cement directly into a fractured vertebra to shore it up. The procedure, which is covered by Medicare, ranges in cost from $2,000 to $5,000.

(snip)

The results, published in this week’s New England Journal of Medicine, will also focus more attention on “comparative-effectiveness” research—studies, endorsed by the Obama administration and draft health-care bills in Congress, that aim to assess the benefits of different treatments already on the market. A number of Republicans in Congress and others have opposed more federal funding for such research on the ground that it will lead the government to decline payment for new treatments of individuals until they are proven to work on large groups.

Some members of the Society of Interventional Radiology, which recommends the procedure, disagreed. “We take a patient who’s been lying in bed in a hospital, bedridden, you do the procedure and they’re home the next day. That is not a placebo,” said Allan Brook, the director of interventional neuroradiology at Montefiore Medical Center in New York City. Dr. Brook contended that patients in the studies may not have been the ones who could benefit most from the surgery—those with the most pain. He noted that most patients who were offered the chance to participate declined to enroll, which he says suggests that they didn’t want to take the chance of being assigned to the “control” group that received the fake surgery.

(snip)

The federally funded study signed up 131 patients in the U.S., Britain and Australia. Half of them received a vertebroplasty, in which the back is numbed, an injection is made into the vertebra, and bone cement is injected by a radiologist or spine surgeon to shore up a fracture. The other group of patients received a sham procedure, including the numbing, but no injection. The doctor opened the container of bone cement so its scent would fill the operating room to disguise whether these patients were receiving a real surgery or not. After a month, both groups saw a substantial reduction in various measures of disability and pain, assessed by a questionnaire. But the reductions were a statistical tie—the actual procedure yielded no gain beyond the placebo effect of the sham surgery. A separate study, including 78 patients and conducted similarly, was funded by the Australian government and Cook Medical Inc., a U.S. manufacturer of bone cement. It reached a similar conclusion: Vertebroplasty didn’t relieve pain any more than the sham surgery, measured three months later.

(snip)

The results follow a 1999 loosening of regulations concerning the marketing of bone cement. In that year, orthopedic makers persuaded the Food and Drug Administration to downgrade the classification of bone cement to a low-risk regulatory category that doesn’t necessarily require clinical trials to show a product is effective at what it claims to do. At that time, the cement was sold to attach prosthetic joints to the bone, such as in the knee or hip. Five years later, the FDA allowed makers of bone cement, including Stryker Corp., Johnson & Johnson and Cook, to market their products for use in a vertebroplasty—without a prosthetic, and without needing a controlled clinical trial that vertebroplasties are effective. An FDA official said the agency’s decision was based on previous use of bone cements to fill in fractured bones. “We determine it’s not so extremely different that it’s outside the box,” said Heather Rosecrans, who directs the agency’s review of such devices.

(snip)

http://online.wsj.com/article/SB20001424052970203674704574332771250497610.html (subscription)

Printed in The Wall Street Journal, page D1

[MineralMan]

1. My 85 year old mother fell last year and had a compression

fracture in two vertebrae. They did this procedure on her and she was out in the garden weeding the next day. It works. It may not work in every case, but it sure did on my mother.

[mopinko]

2. i think this is probably true-

Dr. Brook contended that patients in the studies may not have been the ones who could benefit most from the surgery—those with the most pain.

i know i sure the hell wouldn't sign up for a study if i was in real pain.