As part of the Insider’s relentless effort to understand what goes on inside a doctor’s brain, today we examine the choice of hardware for spinal implants. When a doctor does an implant, which product does he or she use? Is the decision based upon the merits of the product, or are there extraneous factors such as financial incentives (i.e., bribes)? How can you be sure that the doctor about to operate on your spine has made an objective choice?
In the past we have blogged the decision-making process that leads a doctor to prescribe designer drugs (Oxycontin or Vioxx), as opposed to cheaper generics. Drug companies appeal to the doc’s stomach (free meals) and to the lower regions (cheerleaders as drug salespeople). Today our colleague Joe Paduda points us toward a lawsuit involving Medtronic, a manufacturer of medical devices. A company whistle blower alleges payments to doctors in the hundreds of thousands of dollars, as incentives (“bribes”) to use Medtronic devices.
Reed Abelson writes in the New York Times (registration required) that a variety of techniques have been used to get doctors to choose one brand of devices over another. Hire the doctor as a consultant. (One doc, Thomas Zdeblick, a Wisconsin surgeon, was paid $400,000 a year for eight days of consulting.) Invite the doctors to a resort. (Medtronics commonly paid for doctors to attend professional meetings and picked up the tab for snorkeling or golf.)
My favorite example of entertaining doctors involves a Memphis strip club called PlatinumPlus. When Medtronics brought doctors to the club, they disguised the expenses as an evening at the ballet. La Fille mal Gardee, for sure! Perhaps they should have been more upfront (so to speak) about the strip club. After all, the entertainment provided unobstructed views of flexible and presumably healthy spinal cords in action. You could count the ribs, if you were so inclined. That’s work-related for a surgeon, isn’t it?
Ethical Dilemmas
While paying doctors for legitimate consulting is above board, the payments become illegal when they are linked to a doctor’s use of a particular device and violate the federal law against kickbacks. But even if the payments are within the law – and Medtronic has not been found guilty of any illegal activity – the increasing amounts being given to doctors distort their judgment, said Arthur Caplan, a medical ethicist at the University of Pennsylvania, who said such industry payments were “too damn lucrative to believe anyone can resist.” Too damn lucrative, indeed. The path to the brain might not always be through the wallet, but you’d be hard pressed to prove otherwise with these amounts of money changing hands.
Invasion of the Tissue Snatchers!
Medtronics took another hit on its credibility when a subsidiary apparently harvested tissue from corpses, undocumented and authorized, and recycled it into the bodies of living people. The process involves allografts (defined here).The FDA has advised doctors of the potential problems – they want recipients tested for a number of communicable diseases including HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis.
Medtronics put out a Q & A for tissue recipients here, but confined their comments to the living. As one tissue recipient put it, “It’s very unsettling and nerve racking because I don’t know who it came from. I don’t know about their medical history…” There is one thing you do know about the donors: they’re all dead.
Ethical Cleansing
Medtronics has taken steps to clarify their ethical standards. You can read their impressive Code of Conduct here (PDF). They are denying any wrong-doing and taking aggressive action to clean up their image. But this is not just an image problem. There is no doubt that surgeons have a role to play in the improvement of medical devices. But how and when to pay them, how to encourage them to use your products without resorting to bribes or dubious entertainment, that can be a tough line to draw. I may not be able to tell one implant device from another, but I think I know the difference between a ballet and a strip club. Let’s hope that the Medtronic sales force can figure it out as well.