John Carreyrou and Tom McGinty on the WSJ.com Health Industry page:
--illustrate for us just how hard it is to get the goods on the medical device industry and the bribes and kickbacks that are paid to their top guns to promote the use of lucrative implants and other devices.
Carryrou and McGinty delve into Medtronic and its royalty and consulting payments to spine surgeons. Medtronic is the prime manufacturer of the equipment used for spinal fusion surgery (binding two adjacent vertebrae together using hardware). A single surgery can use up to $20,000 worth of devices, with a single screw to hold the hardware to a vertebra costing $1000-2000. Medicare now pays the surgeon a much higher fee to do the more-hardware-intensive form of surgery, giving both the surgeon and the device maker (but not the hospital, incidentally) a strong financial incentive to do more of these procedures than is strictly necessary.
There are several back problems where all experts agree that implants are the best answer. The problem lies with the very common problem of degenerative disc disease. It's been shown many times now that if you lined up a lot of patients complaining of chronic lower back pain, and gave them all MRI scans, a bunch of them would have degenerative disc disease. If you also lined up a lot of people of the same age complaining of no back pain at all, and did the same scans, a bunch of them would have degenerative disc disease. There is no reliable correlation between any anatomic abnormality of the spine and most cases of chronic low back pain; and patients who have surgery very commonly end up having about as much pain afterwards as they did before. The only difference is that those who have surgery, besides often having just as much pain in the long haul, also suffer from the many possible complications of the surgical procedure itself. Still, both doctors and patients get desperate after struggling for months or years with chronic pain, so if you add extra financial incentives, the field is ripe for unnecessary surgery.
The national average is that 17% of spinal fusion surgery is done for patients who have degenerative disc disease (and as I say, that's probably far too many anyway). The reporters went out looking for hospitals and docs whose average was considerably above the national numbers. They struck pay dirt at (among other places) Norton Hospital in Louisville, where the docs on staff report doing 24% of their fusions for degenerative disc disease.
The reporters then hit a brick wall with confidentiality requirements (based on a 30-year-old court ruling). They were able to identify a number of surgeons whose personal statistics suggested a major overuse of this procedure, but they were prohibited from publishing their names. They could only publish the statistics for a hospital.
But they were able to name five surgeons who all worked at Norton and who, in the first 9 months of 2010, received a combined $7 million in royalty and consulting payments from Medtronic.
The surgeons and the hospital all countered that nothing was amiss. The surgeons said that some of the billing codes are nonspecific so the WSJ.com data on their surgeries was probably not fully accurate. They also include in the consent forms signed by their patients a notice that they have a financial relation with Medtronic. Finally, the hospital and the company both protest that there's a firewall because the surgeons receive royalty and consulting fees only for products that they personally do not use in their surgeries, eliminating any possibility that the payments are pure payola based on volume.
Over against this account is, first, a statement from two unidentified former Medtronic employees whom initiated whistleblower lawsuits, that "the royalty agreements are intended to disguise the fact that the payments the company makes to surgeons are really kickbacks for using Medtronic devices."
Second, there is the interesting statement in defense of the current payment arrangements, that the firewall works because the surgeons are not paid for consulting on the devices that they actually use every day in their own procedures, but some other devices instead. Really? These docs, though they may be excellent docs, are after all practicing surgeons. They are not academic investigators. What is the great and wonderful knowledge that these guys bring to the company, that's worth a cool $1.4M (per doc average) in only 9 months, about some device that they do not use? "Oh, that device. I've heard of it"? It would seem that if these folks have anything useful to teach the company about how to improve their product, it would be with regard to a device for which they have daily practical familiarity.
Let's for a minute, on the other hand, give vent to cynicism, and imagine that these payments are nothing but payola in exchange for high volume of use of Medtronic products. If that were the case, then it would be just as easy for Medtronic to agree to pay these dudes consulting fees for some product they never use, as for the fees to be paid for the spinal implant devices they do use.
Perhaps giving support to the cynical take on the issue, Carryrou and McGinty appeared unable to find anyone at Medtronic to explain exactly what were the great intellectual insights that were provided by these surgeons in exchange for their lavish fees.
Bottom line: some of my surgeon colleagues who actually care about professionalism and ethics believe that these "royalty and consulting" payments are a huge cesspool. It's that much harder to get to the bottom of it because the device companies have been smart about how to cover their tracks. (If anything, they're doing better than the pharmaceutical companies so far.)