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【medical-news】美国专家认为需要更多的脊柱融合
US experts call for more data on spinal fusions
By Susan Heavey
BALTIMORE, Nov 30 (Reuters) - Spinal disc fusion surgery to treat low-back pain is not very likely to be better than other, more conservative options such as physical therapy over the long term, most members of a panel of U.S. medical experts told Medicare officials on Thursday.
The outside experts were more divided over whether data from various clinical trials conducted on mostly younger patients without complicating factors could apply to elderly and disabled patients in the Medicare insurance program.
Medicare called for the advisory panel to discuss fusion to treat low back pain in patients with degenerative discs that usually stem from aging. The procedure binds discs together with bone grafts, screws, plates or other hardware.
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The Centers for Medicare & Medicaid Services said it is not formally seeking to alter its current policy of covering the surgery, but some analysts and doctors have voiced concern that officials may use the panel recommendations to reverse course.
Such a turnaround would affect a number of companies that make related products, including Medtronic Inc (MDT.N: Quote, Profile, Research), Stryker Corp (SYK.N: Quote, Profile, Research) and Johnson & Johnson's (JNJ.N: Quote, Profile, Research) DePuy unit, as well as some hospitals and surgeons. Many private insurance companies also base their own coverage on Medicare policy.
At the meeting, most panelists said overall fusion was reasonably likely to be beneficial in the short term but less likely in the long term, based on available data.
Results from several major studies are less likely to be useful in determining possible risks for Medicare patients, they also said. The panel was more mixed over whether the findings could help gauge pain relief for those patients.
The panelists told Medicare officials that current studies are flawed and more solid trials are needed. Continued...
"I don't think there's enough information," to compare the various data, panelist Dr. Steven Ondra, a surgeon at Northwestern University, said. "What we're really looking for is how do we design a study to answer these questions."
Six groups representing surgeons told panelists that while more evidence is needed, data now show fusion helps some patients regain basic functions like walking. Most of the doctors who spoke said they received some funding from devicemakers.
Another expert, University of Washington surgeon Dr. Sohail Mirza, told the panel the number of fusion procedures for degenerative discs is growing, especially among the elderly.
In 1992, Medicare paid $75 million to cover fusion compared to $482 million in 2003, he added.
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Devicemakers are developing more artificial spinal discs as an alternative that aim to relieve pain while allowing the spine to move.
"Artificial disc replacement may get around some of the problems with fusion...but that, I think, remains to be shown," Mirza said.
Medicare earlier this year agreed to pay for Johnson & Johnson's Charite disc for those younger than 60 but questioned its benefits as well as those of fusion. This week, the agency said it would reconsider its spinal disc coverage.
That could pave the way for older Medicare patients to receive Synthes's (SYST.VX: Quote, Profile, Research) ProDisc, which won U.S. approval in August. Medtronic and Stryker are also developing their own discs, which have not yet been approved.
Steve Phurrough, director of coverage for the Centers for Medicare & Medicaid Services, said the agency was unlikely to curb coverage. "I think we would have a difficult time saying we would not pay for fusion except in trials. That would be a challenge," he said.
Medicare is expected to post the final panel votes on its Web site by Monday.
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作者:admin@医学,生命科学 2010-09-22 17:11
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