Imagine a TV ad for a hip replacement device. Over scenes of the puppies and sunsets, a voiceover warns, "Hip replacements may cause tissue death, the destruction of muscles, bones and ligaments, nerve damage, mental changes, thyroid disorder, vision and hearing problems and heart failure." Such ads may soon be part of primetime viewing, not just because the device industry is starting to advertise but because medical device side effects are as scary as, if not worse than, drug side effects.
According to a chilling new book by Jeanne Lenzer, The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It, an estimated 6.7 million Americans a year––almost 70 million in a decade––are implanted with artificial knees, hips and shoulders, spinal hardware, pacemakers, stents, other cardiac devices and more that are woefully under-regulated and under-tested. The widespread public assumption that if a medical device is on the market, the FDA has found it safe and effective is just not so, writes Lenzer, an award-winning investigative health reporter: "The agency requires clinical testing for only a fraction of high-risk devices."
Unlike with drugs, which are labeled, dated and tracked, there is no way to know how many people have devices implanted in their bodies, nor how many people have been injured or died: the technology is lacking. "Walmart tracks every single head of lettuce it buys and sells and can determine how many heads of lettuce are on its shelves at any given moment, yet no one––not the FDA, not Brookings, not anyone––can say how many people are dying because of implanted devices," writes Lenzer. "It is a black hole."
Yet despite the lax regulation and testing, the device industry is more lucrative for many of its components than Big Pharma and engages in similar outrageous profiteering. Hospitals pay up to $7,500 for hip implants that cost $350 to manufacture, writes Lenzer, reminiscent of Martin Shkreli's 2015 price gouging of the Turing drug, Daraprim.
Much of the bribing of doctors seen with Big Pharma is also common with Big Device. Medtronic, one of the biggest device makers, paid as much as $23 million to one writer hyping its products, Lenzer notes. The formerly U.S.-based company that incorporated in Ireland in 2015 to dodge U.S. taxes settled a lawsuit accusing the company of offering surgeons first-class plane tickets to Hawaii, nights at the finest hotels, consulting contracts that involved no work, and outright kickbacks for their spinal hardware business. It paid a University of Wisconsin in Madison spine surgeon $25 million to support its products between 2003 and 2011.
The stories of under-tested and overhyped medical devices that went terribly wrong in the human body are disturbing, including the case of Dennis Fegan, who was given a vagus nerve stimulator to reduce the epileptic seizures that almost killed him.
But Lenzer also clarifies how medicine became the "medical industrial complex" it is today: an entity that "has become so vast, so wealthy, and so powerful that it is increasingly insulated from the effects of its own errors and misdeeds." The three drivers of our obscenely priced medical system were 1) expensive new technologies that no one could afford without insurance; 2) Medicare, which drove up prices and "led to a surge in demand for private and worker-based health insurance, because those without medical care could no longer afford medical treatment"; and 3) the 1980 Bayh-Dole Act, which allowed unprecedented industry profiteering in the form of technology transfer from research often supported by taxpayers.
Can the medical industrial complex and the Big Device it spawned be tamed? Yes, says Lenzer—with repeal of the Bayh-Dole Act, repeal (or modification) of the 21st Century Cures Act, which lowers the evidence required for FDA product approvals, and reform of our other health agencies, starting with the FDA. However, we can't waste any time. Last month there was a class I recall of implantable defibrillators made by Medtronic due to a manufacturing defect.
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