Laminectomy versus fusion

[Guest guest]

The New York Times has a long story today on an alleged scandal involving

spinal-fusion surgery. According to the article, surgeons often opt to

perform a fusion instead of a laminectomy because fusions are much more

lucrative.

I'm curious, because this goes against what I thought I knew about back

surgery. My understanding is that the laminectomy is the surgery that

actually relieves pressure on the spinal cord. Then, spinal fusion is done

because the laminectomy has made the spinal column less stable.

In other words, instead of this being a matter of laminectomy versus fusion,

they are actually *both* performed as part of the same procedure.

I actually had an opportunity to watch Dr. Ain perform a spinal

fusion on a man who was having a laminectomy done by another surgeon. Both

surgeons were in the operating room, each doing his own thing. Afterwards,

Ain actually showed me a model of the spinal column, and explained how the

two procedures work together.

As you will see, the Times quotes a lot of experts who clearly know what

they're talking about. Which leaves me confused.

Since this is a matter of such vital interest, I am posting the entire

article. I believe this falls under the " fair use " provision of copyright

law - my purpose is not so much to inform everyone as it is to encourage

discussion and debate.

Thanks!

Dan Kennedy

---

THE NEW YORK TIMES

December 31, 2003

An Operation to Ease Back Pain Bolsters the Bottom Line, Too

By REED ABELSON and MELODY PETERSEN

A complex operation called spinal fusion has emerged as the treatment of

choice for many kinds of unrelenting back pain. A quarter million of the

procedures, in which metal rods are screwed into the spine to stabilize it,

were performed this year in the United States, three times as many as a

decade ago.

But a number of researchers say there is little scientific evidence to show

that for most patients, spinal fusion works any better than a simpler

operation, the laminectomy. And laminectomies get patients out of the

hospital and back to their daily routine much faster. Some people, experts

add, would be better off with no surgery at all. Even doctors who favor

fusions say that more research is needed on their benefits.

In the absence of better data, critics in the field point to a different

reason for the fusion operation's fast rise: money.

Medicare can pay a surgeon as much as four times more for a spinal fusion,

some doctors say, as for a laminectomy, an operation in which some bone is

removed from the spine to relieve pressure on the spinal cord and nerves.

Hospitals also collect two to four times as much, a gulf that has grown

steadily as fusion operations have grown more complex. Medicare spent an

estimated $750 million last year on spinal fusions, said Sam Mendenhall,

the editor and publisher of Orthopedic Network News, a newsletter.

So like hysterectomies or certain forms of prostate surgery, some doctors

say, back surgery is an example of how money can influence decisions about

which treatments to use ‹ especially when there is limited evidence about

which treatments work best. Indeed, as the nation's biggest health plan,

Medicare plays a huge role in shaping American health care, from the kinds

of hospitals that get built to the amount of chemotherapy drugs that cancer

doctors prescribe.

" The reality of it is, we all cave in to market and economic forces, " said

Dr. C. Benzel, a spine surgeon who is chairman of the Cleveland

Clinic Spine Institute. Though doctors, as a rule, should favor the least

complicated treatment ‹ with surgery being the last resort ‹ Dr. Benzel

estimated that fewer than half of the spinal fusions done today were

probably appropriate. He described the current system of paying doctors as

" totally perverted. "

Doctors and hospitals are not the only players with a financial stake in

fusion operations. Critics blame the companies that make the hardware for

promoting more complex fusions without evidence that they are significantly

more effective. Some sort of hardware is used in almost 90 percent of

lower-back fusions, Mr. Mendenhall said, compared with fewer than half in

1996. Between Medicare and private insurers, the national bill for the

hardware alone has soared to $2.5 billion a year, he said.

" A lot of technological innovation serves shareholders more than patients, "

he said.

The hardware makers acknowledge giving surgeons millions of dollars in

consulting fees, royalty payments and research grants, but say the money

promotes technical and medical advances that improve back care.

" We can't innovate to help patients without these physician relationships, "

said Bob Hanvik, a spokesman for Medtronic , the Minneapolis company that is

the biggest maker of spinal hardware. " Most physicians don't want to give

away their time. "

Some former Medtronic employees, however, have accused the company of

paying surgeons kickbacks. A lawsuit brought by A. Wiese, a former

sales representative, accused Medtronic of trying to persuade surgeons to

use its products with offers of first-class plane tickets to Hawaii and

nights at the finest hotels. Some of those lucrative consulting contracts,

the suit claimed, involved little or no work.

Medtronic said it did nothing wrong, and it denied the accusations in the

lawsuit, which was filed in 2001 and settled in 2002. But the company

disclosed earlier this year that the federal government was investigating

charges that it paid illegal kickbacks to surgeons. Federal officials

declined to comment on the investigation, and Medtronic said it would

vigorously defend itself.

Still, between the allure of money and the quest for breakthroughs in

treatment, some prominent spinal surgeons say that back care has gone

astray.

" I see too many patients who are recommended a fusion that absolutely do not

need it, " said Dr. Zoher Ghogawala, a Yale University clinical assistant

professor of neurosurgery who is conducting a study comparing spinal fusion

with laminectomy. Health experts note that if Medicare is overpaying doctors

for back operations, other kinds of care are shortchanged, because the

program is budgeted a fixed amount each year for doctor's fees.

Fees vary widely around the country, but several surgeons said that Medicare

reimbursed doctors roughly $4,000 for a spinal fusion, versus $1,000 for a

laminectomy. Mr. Mendenhall said that hospitals typically collected $16,000

for a fusion ‹ and $10,000 more for an increasingly common " 360 degree "

operation in which hardware is attached to both the front and back of the

spine ‹ versus $7,000 for a laminectomy.

" The money is driving a lot of this, " Mr. Mendenhall said. The cost to

patients will differ based on their insurance coverage, and patients with

traditional Medicare coverage will have to shoulder some of the higher

surgeon fees. But some patients may push for what they believe is the

most-advanced treatment.

Many spine surgeons defend fusion operations, saying that some patients

clearly benefit from them, even if some of the procedures are not warranted.

" There is some indication that if you do it right, it can benefit people, "

said Dr. J. Woodard, a spine surgeon at Brigham & Women's Hospital in

Boston, who noted that a well-designed Swedish study recently showed

positive results for some patients. More research needs to be done, he

added, to identify the category of patients who have the best odds of being

helped. In the meantime, Dr. Woodard said, many doctors are being more

selective about who gets a fusion operation.

In part, the rise of spinal fusions represents the natural process of

medicine. Surgeons perform operations, and when ‹ as in the case of back

pain ‹ the outcomes are mixed, surgeons strive to improve their techniques.

The Medicare payment system, in turn, rewards complexity, because it lets

doctors bill for the individual procedures they perform within a single

operation. It also tries to encourage the development of new medical

technologies. And the makers of medical devices like fusion hardware exert

themselves with frequent success in persuading Medicare to pay for their new

products.

Earlier this year, for example, Medtronic persuaded the government to cover

a new kind of bone graft material, called Infuse, for use in spinal fusions.

Surgeons describe the new material as having the potential to represent a

real advance. Still, Medtronic scored a significant coup, experts said, in

Medicare's decision to make an additional payment, as much as $4,450, to

hospitals to help cover the cost of Infuse, on top of the flat fee paid for

the operation.

" The power of the device industry is growing tremendously, " including its

ability to influence Medicare officials, said Bartlett Foote, a

professor of health policy at the University of Minnesota.

Medicare officials are unaware of any problems concerning reimbursements for

spinal fusions, an agency spokeswoman said. Industry executives said that

Medicare patients deserved quick access to breakthrough treatments that

might improve the quality of their lives.

Because of the scant data on the benefits of back operations, patients with

similar complaints receive widely differing treatments for their pain,

according to a 1999 study by researchers at the Center for the Evaluative

Clinical Sciences at Dartmouth College. The National Institutes of Health is

doing a large study to determine which patients will benefit from various

treatments.

" There is a real paucity of convincing science about spinal fusion in

particular, " said Dr. A. Deyo, a professor of medicine and of health

sciences at the University of Washington. He was involved in the attempt by

the federal government in the mid-1990's to issue guidelines for back

surgery.

The guidelines, which recommended a conservative approach and discouraged

surgery, were roundly attacked by spine surgeons. Indeed, the surgeons

nearly succeeded in persuading Congress to eliminate financing for the

federal Agency for Health Care Policy and Research, which developed the

guidelines. Sofamor Danek, the Medtronic unit that makes fusion hardware and

was then an independent company, unsuccessfully sued to prevent the agency

from making its recommendations public.

Some surgeons are disturbed by the level of influence that industry has on

their profession, particularly in research. " This is a topic which

orthopedic surgeons, neurosurgeons and the societies associated with both

their groups are definitely concerned about, " said Dr. Brett A. , an

orthopedic surgeon at Washington University in St. Louis.

The absence of solid research means that patients sometimes have little to

go on in deciding whether to have surgery.

Three years ago, Dr. Sam Ho, the chief medical officer of PacifiCare, a

California insurer, suddenly developed severe back pain, the result of an

extruded disc. His neurosurgeon, he said, insisted that he needed a

laminectomy, but the surgeon could not offer any studies indicating that the

operation would help. Nor, Dr. Ho said, could the surgeon tell him how many

operations he had performed or how his own patients had fared.

Dr. Ho said he refused the surgery and made a complete recovery within two

months.

Spinal fusion has a history of controversy. Device makers were the subject

of numerous lawsuits in the early 1990's charging that they were paying

surgeons illegal kickbacks to use their screws. Most suits were

unsuccessful, often because courts were not convinced that the screws had

caused injury or pain.

But similar accusations have surfaced in recent years. In his lawsuit, filed

in a state court in Los Angeles, Mr. Wiese, the former Medtronic sales

representative, said that he was told by his bosses to do " whatever it

takes " to sell fusion hardware. Two doctors demanded consulting contracts in

return for using Medtronic's products, the suit contended, but the contracts

were a " sham, " because little work was done for the pay. The suit was

settled for undisclosed terms, and Mr. Wiese's lawyer declined to comment

on the matter.

In interviews, two other former Medtronic employees said that the company

engaged in similar practices as recently as last year. They said that

Medtronic's sales representatives routinely offered enticements to surgeons

to use the company's hardware, including lavish trips and visits to a strip

club near the Memphis headquarters of the Sofamor Danek division. The former

employees said they had spent as much as $1,000 a night per doctor for a

night on the town.

" It's a business deal, " said one of the employees, who declined to be named

because he still works in the medical device industry. " It takes money to

make money. "

A document provided by one of the former employees listed about 80 surgeons

who have consulting agreements with Medtronic that pay as much as $400,000 a

year.

Mr. Hanvik, the Medtronic spokesman, said that the company had policies in

place to prevent its sales agents from providing improper inducements to

surgeons. The company works closely with some surgeons, he said, and pays

them fairly for their time creating new devices and improving the design of

existing products. The annual amounts on the list are the maximum each

doctor can receive. " They only get paid for the work they do, " he said.

Trying to rise above the flood of money, researchers like Dr. Ghogawala at

Yale say they are now conducting studies free of industry support in search

of basic answers about the efficacy of back operations. Having raised

private money to finance his pilot study comparing fusions and

laminectomies, Dr. Ghogawala plans to apply for government financing for a

larger, five-year study.

" I think we are identifying who needs it and who does not, " he said. " It's

critical to know if it's a lot of unnecessary surgery for a lot of people. "

END

[Guest guest]

> Dan said:-

>

> I'm curious, because this goes against what I thought I knew about back

> surgery. My understanding is that the laminectomy is the surgery that

> actually relieves pressure on the spinal cord. Then, spinal fusion is done

> because the laminectomy has made the spinal column less stable.

>

> In other words, instead of this being a matter of laminectomy versus

fusion,

> they are actually *both* performed as part of the same procedure.

>

> ------------

>

> Obviously you are going to get a lot of answers/replies to this one.

>

> Suffice to say, Lin's had three laminectomies, I've had two, and a friend

of

> ours has had two. None of us has had spinal fusions. Also, one time, my

> doctor told me (after the first one) that no, it didn't make the spine any

> weaker.

>

> As I understand it, a laminectomy 'only' snaps off the laminar. i.e. the

> 'wings' which stick out at the sides of the spine, from whence the nerves

> emanate. The idea being, snapping them off stops them nipping the nerves

as

> they emerge.

>

> HOWEVER, one of the s Hopkins eminent surgeons who was visiting here

in

> England told me that in the States BOTH neurological AND orthopaedic

> surgeons operate on the person. One does HIS job, then the other does

his!

>

> Having said that, ANOTHER eminent medical man who studied in the States

etc,

> suggested that this 'twin' routine COULD be for the sake of the insurance

> pay outs, as opposed to the best possible medical procedure.

>

> How the waters get muddied when one begins to peer into them:-)

>

> Just the thoughts of a laminectomised person:-)

>

> Fred

>

[Guest guest]

I am a diastrophic and have had 2 laminectomies without a fusion. My wife is

an achon and has had 2 laminectomies without a fusion. The same neurosurgeon

did all 4 surgeries. Valuckas, Tacoma,WA