[General Spine] Reclaiming the Patient Outcome Argument

[Justin]

Reclaiming the Patient Outcome Argument

Orthopedics This Week

Robin Young • Mon, Jan 3rd, 2011
Copyright 2009 - 2011 RRY Publications
Note: emphasis retained from original article

This past week two Bloomberg writers took a tour of one spine surgery center’s poor patient outcomes—patients who’d filed lawsuits, patients who’d filed appeals in worker’s comp court and then paired that sad information with details of the surgeon’s personal lives—including information from divorce proceedings—to paint a damning, even devastating picture of spine surgeons and fusion surgery.

The article, titled “Doctors Getting Rich with Fusion Surgery Debunked by Studies” was published online in Bloomberg News on December 30, 2010. In the article, authors Peter Waldman and David Armstrong used several patient cases from the Twin Cities Spine Center (TCSC), which is affiliated with Abbott Northwestern Hospital, to argue that the Center was performing too many spine fusion surgeries, that the surgeons were getting rich and that patients who underwent spine fusion surgery were often worse off—indeed the article gave six examples of a poor outcome and one example of a favorable outcome.

The Bloomberg article came two weeks after the Wall Street Journal published a story highlighting the size of payments from suppliers like Medtronic to spine surgeons. Both articles put surgeons and manufacturers in unfavorable lights.

This Bloomberg article, however, was particularly damaging because it focused on patient outcomes and then linked poor outcomes to the lifestyles of the surgeons. The Bloomberg article was distributed throughout the world and landed, no doubt, on every regulator and reimburser’s desk.

No Batting Average
The spine surgeons mentioned in the Bloomberg piece work at TCSC. The Center performs roughly 3,000 spine surgeries annually. Using worker’s comp appeals court data, the authors were able to pull out 11 patients to follow. Six made it into the story. All six had poor outcomes. Here, for example, is what the authors wrote about one patient.

“Jean Kingsley, 57, a patient who had had two previous fusion surgeries and was still suffering back pain.” According to a hospital report, her doctor wrote; “that more ‘surgical treatment could provide her with some relief of her pain’ if her symptoms “were extremely severe, unrelenting” and had “failed extensive conservative care,” which “appeared to be the case.” Her third operation, a daylong procedure in September of that year, fused 13 vertebrae along her entire spine and was a disaster. Kingsley, of Milaca, Minnesota, returned home paralyzed from the waist down, according to hospital records in a lawsuit she brought against her surgeon. A jury in Minnesota state court found earlier this year that her surgeon was not negligent in the case. The judge awarded $46,616 in attorney’s fees to Kingsley’s surgeon, which Kingsley said she can’t pay. She has appealed the decision. Her case is a “unique set of events for which even in retrospect there is no obvious explanation that one can prove,” her doctor said in his 2008 deposition, in which he estimated he performed 400 to 500 back surgeries a year. Abbott and Twin Cities Spine billed a combined $239,000 for the surgery, Kingsley’s records show. Insurer Medica says it paid about a third of that amount after a discount. Kingsley arrived home in a wheelchair, wore a diaper for two and a half years and had a home health aide visiting to bathe her in bed, she said in a deposition in the case. As her condition improved, she said she was able to move short distances with the aid of leg braces and a walker.”

Then here is what the authors wrote about one of the surgeons from the Spine Center.

“Porsches, Ferrari, Mercedes. One Twin Cities Spine surgeon earned $1.85 million from the practice in 2007, according to filings in his divorce proceedings that year. He told state superior court in Minneapolis that he and his wife’s assets included two Porsches; a Ferrari 430 coupe; a Mercedes Benz; two other cars; three boats and proceeds from the $1 million sale of a farm where he bred Lusitano horses. The surgeon’s 7,185-square-foot house presides over a wooded promontory on Lake Minnetonka. Valued at $4 million in 2007, the house has a swimming pool and 50 yards of beach.”

(We are not mentioning the names of the surgeons from the Bloomberg article. It serves literally no purpose.)

What struck us about this was the absence of performance metrics for The Twin Cities Spine Center. Where’s the batting average? If, for example, the TCSC has a 0.850 (85%) rate of delighted patient outcomes and the rest of the spine community had a 0.650 (65%) rate, then 6 or 7 poor outcomes would not drive the narrative.

In the absence of a performance measure, the writers resorted to expert opinion quotes (Sohail Mirza, M.D., Chair of the Department of Orthopaedics at Dartmouth: “It’s amazing how much evidence there is that fusions don’t work, yet surgeons do them anyway.”), and cherry-picked negative studies in Spine, Pain and the British Medical Journal between 2003 and 2006.

The average major league baseball player makes $5.1 million a year. The average NFL player makes more than $1 million per year. What separates the highest paid players from the average? Batting averages. On base percentages. Passing yards. Receiving yards. Sacks per game.

Where’s the batting averages for spine surgeons?

What’s the Truth?
Nothing like a tour of a spine center’s failures. The Bloomberg article was ugly. Spine surgery for patients and the surgeons who perform them are routinely getting beat up in the nation’s press. This is serious. If surgeons lose the patient outcome argument then reimbursement, innovation, everything gets tougher.

The truth is that surgical intervention works better than conservative care. Don’t believe it? Neither did Dr. Weinstein at Dartmouth. So he organized the definitive study to, once and for all, put the stake in spine surgery. It has been Dr. Weinstein’s life’s work to show that surgeons have inordinate influence on their patients and that those surgeons tend to perform too many spine surgeries.

Weinstein’s SPORT study (Spine Patient Outcomes Research Trial) was a five-year study that looked at three of the most common back conditions and compared surgical and non-surgical treatments. Approximately 2,500 patients took part in the study, which was conducted at 13 sites across the country.

This NIH (National Institute of Health) sponsored study was the largest, most rigorous effort ever launched to study the effects of spine surgery versus conservative care.

What Are the Results of SPORT?
The results of SPORT were released in three phases, in the order of the three conditions studied:

1. Intervertebral disc herniation, published in JAMA, November, 2006
2. Degenerative spondylolisthesis, published in The New England Journal of Medicine, May, 2007
3. Spinal stenosis, published in The New England Journal of Medicine, February 21, 2008

The first results were from the Intervertebral Disc Herniation trial. The study found that while both groups improved substantially after treatment, the improvement from standard surgery, a procedure called "discectomy", was more rapid. Patients who had surgery also reported better results in physical function and satisfaction one and two years after the operation.

The second results were from the trial for Degenerative Spondylolisthesis. The study found that patients with spinal stenosis accompanied by degenerative spondylolisthesis who were treated surgically showed substantially greater improvement in pain and function through two-year follow-up compared to patients treated nonsurgically. Because patients in the randomized cohort "crossed over" either from the non-operative arm to have surgery or from the surgery arm to remain non-operative, the analyses were non-randomized, as-treated comparisons with careful control for potentially confounding baseline factors.

The third results were from the trial for Spinal Stenosis. The study found that patients with spinal stenosis who were treated surgically showed significantly greater improvement in pain, function and disability through two-year follow-up compared to patients treated nonsurgically. Because patients in the randomized cohort "crossed over" either from the non-operative arm to have surgery or from the surgery arm to remain non-operative, the analyses were non-randomized, as-treated comparisons with careful control for potentially confounding baseline factors.

Surgical intervention - 3 : Conservative Care – 1/2

Wall Street Journal vs. Private Property
What’s wrong with the Wall Street Journal? Do private property rules only apply to non-surgeons?

Five days before Christmas, John Carryrou and Tom McGinty wrote that five surgeons in Louisville, Kentucky, had received about $7 million from Medtronic for an invention they had licensed to the company. These same surgeons are among the most prolific in the U.S. in both amount of spine surgery performed and published research on comparative effectiveness. Both the hospital that grants surgical privileges to the surgeons and Medtronic have in place several conflict of interest rules to ensure that any payments from Medtronic are proper (as defined, incidentally, by the U.S. Attorney) and are not for implants the surgeons use.

But, don’t confuse the Wall Street Journal with facts. Huge dollars are being paid to surgeons who perform lots of spine surgeries. The WSJ is shocked. Shocked!

Well, it seems to us, the WSJ is missing two basic points—one, there is no mention of patient outcomes. By implication, Carryrou and McGinty are saying that patient outcomes were compromised because of the royalty payments. Really? The only point of the WSJ article was that these five surgeons were paid millions of dollars. Some from royalties. Some from hospitals and insurance companies for performing spine surgery. Many other top performers receive millions of dollars too. Professional athletes, business people, lawyers. Surgeons are different?

Second, who owns the inventions of these surgeons? Are they not intellectual property and do they not have a right to license their property?

If Medtronic paid $7 million in royalties to these five surgeons for their invention, the only conclusion that makes sense is that it must have been a great invention since obviously many surgeons are using it. Remember, this invention did not belong to Medtronic. It belonged to the inventing surgeons. It’s called private property.

These are difficult times. The nine-society letter to BCBS of North Carolina was a singular bright spot. The next challenge is the patient outcome debate. Spine surgeons must, must win that argument.

[bigdogchief76]

Justin -

I read the article yesterday.

It was like a body-blow to my gut! How can I possibly get the medical relief that I need, knowing that articles like this are coming into AETNA's hands?

I felt like I took two steps back after reading this. I don't even know where to start with this 2nd level appeal.

You and I both know that the stat's on this article are so whacked out, that, even the person with a low IQ could see it was biased. That doesn't help the patient with chronic back pain. It's simply more fodder for the insurance company.

ARRGGGH!!

[Gilbert P]

Justin

WoW this could affect me when I try to get my surgery covered?

What will happen next?

Thanks

Gil

[Justin]

Justin

WoW this could affect me when I try to get my surgery covered?

What will happen next?

Thanks

Gil

Hi Gil, I'm not sure if I am following you. Could you specify what you mean when you are referring to "this"?

[Espoire]

A great post, with lots to think about. Certainly if people can't make money helping to find better medical and sugical treatments, then we will be worse off. We don't want to live in a world where the only way to make money is as a pop singer or derivatives trader

However, as patients we rely on the honesty and objectivity of the medical research community to report the outcomes of new technologies without the bias introduced by personal financial interests. I am happy if the guy who invents a new and useful device makes a pile of money. He or she deserves it. I would NOT be happy to be a patient in a randomized trial in which my fusion surgery (and postop outcome reporting) is done by a surgeon who stands to make or lose hundreds of thousands based on whether fusion outcomes are worse. Too often in medicine this kind of scenario has occurred. I think this is what these stories are getting at, albeit not in the most objective way.

If the device manufacturers were to conduct well designed trial AND publish the results, this would create the pressure needed to help ensure these procedures were funded. Where are the published trials showing M6 discs are better than fusion? Too soon? What about Mobi-C? LDR completed 24 month follow-up on the 1-level randomized trial vs fusion in 2009 and still the results are not published. Not even the 1-year results, which one assumes were available to the company in 2008. The 2-year followup for mobi-c 2-level trial was completed in spring of 2010. Not published. If the device company won't publish the results of the studies, I think it is reasonable to consider why the insurance company would pay for the devices to be used....

Dave

[KBear]

I agree Dave, very well put. As far as being a patient in a trial where the doctor stands to benefit, I'm that person and I'm okay with it. The doctor who put in my Active L ADR is also the co-inventor of the Active L (along with Dr. Yue.) I'm sure it's safe to assume he will make big bucks if it makes it through FDA approval. This actually made me feel better about the process, because I knew that I had to meet strict clinical trial criteria to have the surgery (so little to no chance of being told you are a good candidate when you are not.) I also felt that the surgeon would do his absolute best surgical job because he wants (and needs) for me to have a good outcome (not saying he otherwise wouldn't have done a good job, just that this gives him more incentive to be on his A game.) Last, the people who take the information for the trial, while located in the doctor's office, are actually a different company. The one at Texas Back Institute (where I do my follow up) is Spine Mark. That person comes in with a completely separate set of forms/ questions at each visit and I have to fill out the forms and initial each one (to make sure they aren't fabricating the information.) The doctor is never in the room at the same time as the person who is taking the information (at least no more than one coming in and the other going out.) Some of the questions are the exact same questions that I have to answer on the doctor's office paperwork at each visit and even though I answered them already, I still have to personally fill out the forms with the answers. I'm sure they do this so there is no question as to whether the surgeon is changing the information and making the results to appear more favorable. From my experience, they are very precise and particular about having the correct information. If I go see my doctor for a non study visit and tell them something that is say different from what the study is last showing for me, sure enough in a couple of weeks the study coordinator will call and ask me about it and record it. Just like when I became pregnant, she called and said congratulations, but then told me she needed more information as this is considered an 'adverse event' per the study. I'm still in the study and will do my normal 2 year follow up, but obviously a pregnancy could potentially ruin a surgery (more likely if I were earlier out) so that needs to be recorded in the data. So far so good, feeling great and I expect to be that way at my 2 year visit too. Anyhow, just wanted to clarify that even though I'm sure it can be and has been done, it wouldn't be easy to falsify study results (from my experience).