Cardiologists say Apple is overselling its health rollout while FDA applauds

By DARIUS TAHIR

03/04/2019 10:59 AM EST

Apple is touting its new health software with an aggressive public relations strategy that worries many cardiologists, who feel the company is exaggerating the significance of the Apple Watch readings of a heart condition called atrial fibrillation.

Critics are also concerned that the FDA’s unusual celebration of Apple’s new tech — which is central to the company’s move into health care — represents boosterism that distorts the agency’s role of assuring the safety and efficacy of medical devices.

The concerns center on an algorithm accessible through the Apple Watch that detects atrial fibrillation, an irregular heart rhythm that can elevate some individuals’ risk of stroke. In many cases, the watch has given users warnings that led them to get necessary and even life-saving medical help.

Stacey Recktenwald, a nurse, said her daughter’s kidney failure “really would’ve been missed” without an Apple Watch warning that her heart rate was elevated. The family later learned that several members shared a genetic condition with her daughter that puts them all at risk of kidney failure. After Recktenwald wrote to Apple with thanks, CEO Tim Cook responded, and the company relayed her story to "Good Morning America."

“[Users are] telling me they found a problem with their heart they didn’t know existed, and if they wouldn’t have reached out to a doctor, they might’ve died. These are life changing things,” Cook told CNBC’s Jim Cramer in January.

But doctors are worried that when used by millions, the atrial fibrillation warnings could lead to unnecessary or even harmful medical care. That's why Apple's marketing of the success stories bothers them.

Recktenwald’s case was one of at least five instances in which Apple encouraged users of the watch to share their stories with news media, including the South China Morning Post, The Independent in the United Kingdom and U.S. media. (POLITICO has a content-sharing partnership with the South China Morning Post.)

Apple executives, who declined to comment on the record for this story, have also exaggerated the novelty of the watch’s atrial fibrillation feature, critics say. At the launch event for Apple Watch, company Chief Operating Officer Jeff Williams claimed it was the first FDA-approved over-the-counter gadget of its type. Days later, Cook repeated the claim in a "Good Morning America" appearance.

In fact, another company, AliveCor, had the first mobile atrial fibrillation device. Apple’s claim to novelty was its “own version of alternative facts,” AliveCor’s then-CEO Vic Gundotra told Business Insider in September. His company won FDA approval for an EKG smartphone accessory in 2012 and got approval for a wrist strap that attached to the Apple Watch in 2017.

Cardiologists, meanwhile, are concerned many people using the Apple Watch might respond to detection of atrial fibrillation by unnecessarily seeking treatment. To date, the benefits of treating the condition have been proven only in certain at-risk populations, such as the elderly, the hypertensive and diabetics.

Many Apple Watch users are younger, wealthier and healthier than the general population. In these groups, the EKG may pick up atrial fibrillations in users who aren’t seriously sick and aren’t necessarily in danger of future cardiac events.

For a young patient, with no specific symptoms or risk factors, there’s “very little chance that finding out you have afib is going to mean anything,” said Ethan Weiss, a cardiologist at University of California, San Francisco. No one knows what percentage of healthy people might have an atrial fibrillation that has no medical significance.

“It might turn out to be the case that if you put a monitor on a hundred people who’ll never turn out to have a stroke, some of them might have tiny amounts of afib throughout their life,” said University of Michigan nuclear cardiologist Venk Murthy.

Treating atrial fibrillation often involves a lifetime of blood thinners, which is far from risk-free. “You carry a risk of bleeding. You have to take that drug every day, which isn’t fun,” said Murthy.

FDA officials have taken an enthusiastic approach to Apple Watch and comparable devices. They have downplayed any risks from the Apple device.

Even if patients face little risk of stroke, they might want to know they have atrial fibrillation because the condition can cause other problems, said Bram Zuckerman, director of the agency’s division of cardiovascular devices.

Yet it’s not even clear how reliable the watch is at detecting the condition. While FDA approved the product’s algorithm, Apple hasn’t yet published peer-reviewed studies describing its performance.

If the performance is less than nearly perfect, the device could cause big problems, said another cardiologist, Jonathan Hsu of the University of California, San Diego. Many of the arrhythmias found by the watch are likely to be false positives that lead to unnecessary or even harmful medical tests, he said.

Of the three suspected cases of atrial fibrillation brought before him by earlier versions of the watch, Weiss said, all were false positives. Even when such readings don’t lead to overtreatment, they can provoke anxiety in affected patients.

Zuckerman said the data from the company showed good performance on detection, and he argued that providing more data to patients was, in general, positive.

“We’re in a digital age, where patients want to know more about their medical problems,” he said. Devices like the watch can provide helpful information, even if they are “not a substitute for good, present diagnostic practice for interactions with a physician and just common sense.”

Apple has acknowledged some criticism of the device. But “the feedback [from doctors] has been pretty decent so far,” the company's vice president of health, Sumbul Desai, told industry publication MobiHealthNews in February. Some providers are finding it difficult to process the new information, she said, but "the customer stories have actually been really amazing."

Weiss and Hsu said they were interested in the watch’s potential to detect potentially dangerous atrial fibrillation, but think news coverage has exaggerated its proven capabilities.

“The types of stories I have seen are younger individuals who state they would not have otherwise been able to detect atrial fibrillation,” said Hsu. “They need to be taken with a grain of salt.”

In December, the company published some data on the watch’s atrial fibrillation capabilities, revealing sensitivity and specificity rates in excess of 98 percent, which Murthy described as a “moderately good” result. Even that high level of accuracy could mean thousands of cases of misunderstanding or misdiagnosis, he said.

“Take a moderately good test and apply it to a population with a very low risk of atrial fibrillation, and you will have a lot of false positives,” Murthy said.

The watch also has a sensor intended to ascertain when its user has a fall. If the user can’t get up, it can call emergency services on the user’s behalf. But the company hasn’t released data on how often the sensor detects real versus false falls.

Apple’s health product releases have piqued consumer interest, and that gets them to keep buying new iPhones and watches, market analysts say. When the company rolls out a new edition of the watch this year, it will probably add new health features. Apple has patented a wristwatch band that measures blood pressure, to take one potential example, and Bloomberg reported the company is considering adding sleep tracking functions.

As it increasingly emphasizes health care, Apple has moved to influence government policies. In the process it has shifted the regulatory landscape to favor developers. The firm is participating in FDA’s pre-certification pilot, which would approve trustworthy digital health companies. These companies would then face an eased oversight process for new products, or none at all.

When FDA gave a so-called de novo clearance to the watch’s atrial fibrillation program last fall, Commissioner Scott Gottlieb enthused about what he called a “significant step forward in FDA policy because we decoupled review of the app from review of the watch itself.”

Gottlieb described Apple as an example of a new type of health care company — a welcome influx into an industry insufficiently welcoming to disruptive technologies. Joe Grogan, then with the Office of Management and Budget and now director of the Domestic Policy Council, said medical device regulation was an “old system that’s barbaric,” and endangered America’s predominance in innovation.

But the administration’s rosy assessment worried some regulatory observers. Grogan’s comments, said Jason Brooke, a medical device regulatory expert with Navigant Consulting, suggest that “FDA at the highest level took extra efforts to accommodate one company.”

“The FDA is responsible for regulating the industry, not fostering its growth,” Brooke wrote in an email. “Their mission is to promote and protect the public health.” The agency eroded its standards in its rationale for approving the device, creating a worrying precedent, he said.

The atrial fibrillation function on the watch relies on two distinct technologies: a physical sensor, which picks up data off the human body; and software, which interprets the sensor data. The agency approved the software, but not the physical device. That’s a flawed approach, Brooke argued, because it means the agency is overseeing only half the product. If the product’s machinery changes, it could change how well the software works, he said.

The FDA has considered that possibility and expects companies to “build in those risk mitigation processes,” said Bakul Patel, associate director for digital health.

The agency also says it’s not easing standards. “Software is different, and raises different challenges,” said Jeff Shuren, the FDA’s head of medical devices. With Apple, the agency emphasized “interactive review,” in which it has discussions with companies before and during the formal submission of the product.

The pre-certification program and the interactive reviews are part of adaptive changes at the agency, he said. “Within a year you’re going to highlight other products for which we’re trying new approaches,” he said.

That’s not reassuring for Brooke. "What are the different approaches that the agency is trying out?" he asked. "Who gets which approach?”

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