Stopping Medicine's Machines
The Vioxx panic seems to have subsided, but the same kind of alarmism is beginning to wash over health-care fields other than pharmaceuticals. The most recent is medical technology. Now Congress is ready to intervene, so let's try to separate good sense from exaggeration.
On the front-burner for Congressional action is Medtronic, a major medical-device maker, and the controversy surrounding a component of its heart defibrillators. Surgically implanted near the shoulder, these devices treat cardiac arrest by electrically shocking the heart back into regular rhythm. In October, in the face of escalating criticism over safety concerns, Medtronic voluntarily withdrew from the market a type of the complex wires -- called leads -- that connect a defibrillator to the heart muscle and tell it when to deliver therapy.
These Sprint Fidelis leads have a smaller diameter than most others available. Cardiologists have been calling for narrower models because they are easier to thread through the veins during surgery. Once implanted, they are less likely to lead to blood clots or obstructions, or distort heart valves.
While all leads break or "fracture," some evidence began to emerge this year that the Fidelis line, which was made available in the U.S. in 2004 and rapidly adopted, was more prone to early malfunction compared to older alternatives. A fracture can cause painful misfires, or a failure to deliver effective shocks to a dying patient.
Medtronic at first maintained the data weren't conclusive. After further internal studies and advice from its outside panel of heart doctors, it pulled the product. About 268,000 people have the implants world-wide; fractures may have contributed to five deaths. According to the company's composite estimates, 97.7% of the leads will still operate properly after 30 months in the body. The rate for Medtronic's older lead is 99.1%, a difference that isn't statistically meaningful but will be if trends remain constant.
Medtronic CEO Bill Hawkins told us that pulling Fidelis was ultimately "a judgment call." No doubt the medical side of the ledger is vastly complex. Researchers only have a limited understanding of why the leads may be less reliable. Because they were thinner, they may be more vulnerable to stress. Failures may be due to a surgeon's implant technique, or simply due to complications in patients with chronic medical conditions.
But Medtronic's withdrawal may also have been driven by legal and political calculations. Post-Vioxx, companies are under pressure to get out in front of even modest health risks. All therapies carry some risk, so these withdrawals strip choices from patients and their doctors. Mr. Hawkins notes that "society's tolerance for any risks associated with medical technology is nearing zero." The trial bar is a main offender. The first lawsuits against Medtronic were filed literally the morning after the withdrawal announcement, with many to come.
Politically, it's one thing to raise legitimate safety concerns, quite another to turn them into a pretext for longstanding agendas. Republican Senator Chuck Grassley, for instance, is targeting the device makers' consulting agreements with physicians. The implication, as with his campaign against Big Pharma, is that "kickbacks" lead to inferior products and buy "a doctor's allegiance to a particular product line." With Medtronic as Exhibit A, Mr. Grassley is pushing legislation to require regular public disclosure of the terms of all financial relationships.
The device industry says it's fine with transparency -- and who isn't? Well, doctors. Publishing such information without protections, when liability insurance costs are already through the ceiling, would do little more than create a registry of the deepest pockets for trial lawyer browsing.
The collaborations that consulting fees underpin drive innovation. Unlike new drugs, devices aren't "discovered"; they're engineered to fill specific medical needs, which requires the expertise of practicing clinicians. We're going to see a lot fewer advances in technology like defibrillators -- to say nothing of stents, artificial knees and hips, cochlear implants, deep-brain stimulators and so forth -- if doctors can't be fairly compensated for R&D participation.
Other innovation disincentives are provided by Henry Waxman, chairman of the never-sleeping House Committee on Oversight and Government Reform. He's kicked off an investigation into "what is apparently a serious shortcoming" in the FDA's device-approval process, and legislation to make it even more restrictive can't be far behind.
Devices undergo extensive laboratory "bench tests" to simulate how they'll behave under the stresses of the human body. Requiring premarket clinical trials wouldn't even detect the rare or long-term problems like the one that brought down Fidelis, and refinements of existing designs don't need square-one scrutiny. Postmarket surveillance, of the kind Medtronic and other makers conduct with their products, is a better way to monitor safety.
As with so many other medical scandals, the real danger to public health is overreaction to medical risk. Several cardiologists we spoke with (some affiliated with Medtronic) offered anecdotal evidence of high-risk patients refusing care due to the "anxiety-ridden environment," as one electrophysiologist called it. Not having a device is far worse for them than the possibility of malfunction. It might be fatal. That might not be the intent of the politicians and trial lawyers, but it is a consequence of their opportunism.