The FDA restricts the functions on the Apple Watch, even though it saves lives by helping people diagnose and manage ailments. For example, the FDA bans the Apple Watch from warning users that they are experiencing atrial fibrillation, if users admit they have a history of atrial fibrillation.
The Wall Street Journal reports that the “Apple Watch is becoming doctors’ favorite medical device”:
“Doctors are using the Apple Watch as part of how they diagnose and help their patients manage disease—whether or not it’s been specifically approved for such applications by the Food and Drug Administration or other regulatory bodies. My own mother, who has a history of atrial fibrillation, a heart-rhythm disorder, is one such patient. The Apple Watch SE she bought on her doctor’s advice has been, by her account, a lifesaving intervention. It allows her to send data gathered by her watch directly to her doctor, as part of the continuing management of her lifestyle and medication. There’s a large and growing body of research on how the Apple Watch is being used informally in medical care, despite other approved devices being available to track the same metrics.
Not a week goes by in my clinic in which someone doesn’t come by and say, ‘My Apple Watch says I have an abnormal heart rhythm,’ ” says Dr. Rod Passman, a cardiologist and professor of medicine at Northwestern Medicine in Chicago….data from the Apple Watch can be used in an app to significantly reduce the amount of time people with atrial fibrillation have to spend on blood-thinning medications. Currently, such patients must be on them all the time, even though they come with risks….with an Apple Watch detecting if atrial fibrillation is actually occurring, patients will only have to take these drugs for 30 days after an episode has occurred….
Doctors are telling their patients to go out and buy an Apple Watch to alert them to episodes of atrial fibrillation, despite the fact that the watch is not [FDA] approved for performing this function in patients who already have a history of the disorder. (Apple Watch is FDA approved for alerting people with no history of atrial fibrillation that they are having an episode of it, but before you can turn on that function, you must answer “no” when the watch asks if you have a history of the issue)…the device continuously gathers activity and heart-rate data. It can perform an electrocardiogram when a user initiates that process. All this data can then be exported and analyzed without Apple or anyone else intervening. Compared with previous methods of studying patients, the continuous monitoring made possible by the Apple Watch generates an avalanche of potentially useful data…
In addition to restricting useful functions on the Apple Watch, the FDA is cracking down on useful and reliable home medical tests that have revealed cancers and other serious illnesses, and helped cure serious ailments, banning them unless they go through a lengthy, obstacle-filled FDA approval process first. Requiring FDA approval for useful home medical tests will prevent them from being sold for years or decades. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people got infected with AIDS as a result of the delay in approving it. As Roger Parloff of Fortune noted, the FDA’s delay in approving the home HIV test was a “scandal.” It caused the deaths of thousands of people, given the mortality rate from AIDS. It may also have caused billions of dollars in additional costs for taxpayers, given that AIDS is a costly and debilitating disease to treat, resulting in treatment costs of perhaps $600,000 per AIDS sufferer.
The FDA is a huge impediment to accessing life-saving medical devices and drugs. FDA employees commonly take years to approve life-saving drugs. That results in the deaths of hundreds of thousands of people who could have been saved by earlier approval of those drugs. For example, at least a hundred thousand people died waiting for the FDA to approve beta blockers. One of the FDA officials involved in delaying their approval was John Nestor. Nestor was notorious for following rules in ways designed to frustrate and inconvenience other people. As the Journal of American Physicians and Surgeons notes:
Nestor had the unique habit of getting into the leftmost lane [on the highway] with his cruise control set at 55 mph, the posted speed limit. He would drive at this speed regardless of what came up behind him. Cars would zoom up close to his rear bumper; drivers would flash their lights and blast their horns,some swerving around him on the right while giving him the finger—none of this fazed Nestor in the least. As he explained it, 55 mph was the law, and he had a right to drive in whichever lane he chose: “Why should I inconvenience myself for someone who wants to speed?”
Nestor followed this rigid mindset in his work at the FDA. He was very good at using agency red tape, and minor risks or side effects of drugs, as an excuse to avoid approving life-saving drugs.
