Apple and Johnson & Johnson team up for Heartline Study app - a healthcare wearables breakthrough, or a questionable study?

Here is an announcement that caught my eye. Johnson & Johnson Launches Heartline™, the First-of-its-Kind, Virtual Study Designed to Explore if a “New iPhone App and Apple Watch Can Help Reduce the Risk of Stroke.”

Beyond the purported learnings about heart health, it’s possible the study could actually validate wearables for real applications, health being just one. What are the issues they’ll uncover beyond the study subject?

Catching streaming data from these devices present a set of challenges, or will they be just punctuated as wearers forget to charge them, take them off when boating, do not want to tracked somewhere, or just intermittent lack of connectivity? What are the privacy issues, and what steps will they take to protect the wearers from bad actors?

The stated goal of the program is to study heart health outside of a clinical environment with real-world information.Study participants, all age 65 or greater, must also own an iPhone and agree to hand over their Medicare claims data to a third party company selected by the researchers.

The Heartline "Study" - via iPhones or Apple Watches

One group of participants will only use an app, the Heartline Study, provided by J & J, on their iPhone or Apple Watch. The app offers regular educational notifications, tips, surveys about heart health, and generally improving the organ's functioning (detail on just how specific this is not clear from the announcements).

Another group of participants will need to wear their own Apple Watch (or can buy one through the study) during the study. The Apple Watch will continually transmit the study participants' heart rhythms to the Heartline Study app, which will identify any suspected AFib rhythms and notify users when that happens.

The so-called "gold standard" of clinical trials is the randomized double-blinded trial. This means that participants are assigned to the two or more groups on a random basis. Double-blinded means neither the participants nor the experimenters know if an individual is in one group or the other. Neither of these criteria applies to this "study."

There are precise requirements for conducting studies on live humans. For example:

Cost: Since treatments offered in a clinical trial are experimental, they should be primarily covered by the sponsoring agency or grant running the trial. As of January 2014, the Affordable Care Act requires that insurance companies(including Medicare) cover the cost of approved trials. Some insurance companies may also cover the routine costs that come with these trials, such as transportation to the clinic or extra testing. In this case, participants are required to have, or purchase, and iPhone and iWatch.

Funding: Any bonafide clinical trial is listed on ClinicalTrial.gov site, and the sponsor is listed too. If you see the name of an unfamiliar company or no sponsor listed, a little digging may be in order, to ensure you know who is behind the research. In this case, there is a third-party that accumulates your data.

Informed Consent: All clinical trials require that researchers explain the details of the study to you, in a language you understand, and offer documents that explain these details. This requirement also means you can ask the researchers any and all questions you have about the trial, and they are required to answer them thoroughly before you sign the document certifying your consent to participate. If you’re not sure what questions to ask, there’s a handy list here at the National Institutes of Health (NIH) website. This trial has no center, so presumably, these inquiries would be handled through the app.

And there are ethical issues too. All clinical trials must be approved by an Institutional Review Board (IRB), which ensures that “risks are reduced and are outweighed by potential benefits,” as the NIH handily explains. This has to happen before a clinical trial can proceed. You should ask the sponsor or researchers whether a trial you’re interested in has been approved, and if you’re not satisfied with their answer, check whether the Office for Human Research Protections has registered onefor the trial in question.

What exactly the study aims to understand is unclear, because participants have no restriction on their existing healthcare providers, such as visits, medications, or interventions. Nor is that data from those activities logged by the app, except for subsequent Medicare claims that are monitored, as participants waive their HIPAA rights as part of the participation. In essence, the study, which will include 150,000 people, is so unscientific, it is almost laughable.

What is Apple up to?

It’s not logical that Apple would do this to sell a few watches. Apple is expanding its footprint in healthcare informatics, and will gather some useful information for its expanding program while gaining some credibility for the iWatch as a valid medical device. Here are some other candidates for wearables:

• Insurance: A driver wearing smart glasses can record an accident as it happens, as well as telemetry – speed, stopping distance, awareness, or distraction
• Personal Trainer: Fitness Tracking with a wireless earbud guides and informs the workout
• Arranging a Meeting: Dialog, when, who to invite, etc.
• Memory Aid: More than snapping a picture with your smartphone, your voice describes what you want to recall later
• Policing and Security: Obviously

My take

Somewhere along the line, Apple will certainly provide more apps for these participants and enhance the usability of the iWatch and wearables in general. J & J, however, is a pharmaceutical company not known for testing medical devices. Given the rather dubious value of the information collected (the FDA would never approve a drug based this data), it’s more likely that Janssen Pharmaceutical, owned by J & J, which is conducting the study, sees a marketing opportunity.

One of their newer blockbuster drugs is INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular (CV) events, including heart attack, stroke, or death due to a cardiovascular cause. And there is also XARELTO^®, approved by the FDA to help reduce the risk of blood clots in common conditions like atrial fibrillation (AFib), deep vein thrombosis (DVT), and pulmonary embolism (PE).  More than 40 million people worldwide have been prescribed XARELTO^® Having an app in the hands of 150,000 people with a gentle nudge to mention it to their provider is better than 10,000 drug reps.

In the end, how will they report their findings? A favorite sleight-of-hand of these trials is overstating the benefit. Suppose there were 100 balls, and two of them had the word "loser" on them, and the rest had the word "winner" on them. Most people would say their chance of picking a loser was 2%. If we changed one of the loser balls to say winner, most would say that there was a 1% chance of losing...or their chances of losing dropped by 1.

But in statin studies, they would report that as a 50% reduction in the probability of picking a loser. When you read the results of statin study effectiveness on preventing heart attacks, the decreased odds are often so low that it barely reaches above what most people would consider a random chance. A 50% reduction in heart attacks sounds impressive, until you realize your chance just went from 2% to 1%.

This is so common in drug trials that over 40% of them are reversed over time. This Apple/J&J study is so suspect as to hardly be worth noticing. Consider the almost $1 trillion market for statins over the past 20 years, from The Journal of Controversies in Biomedical Research:

In conclusion, this review strongly suggests that statins are not effective for cardiovascular prevention. The studies published before 2005/2006 were probably flawed, and this concerned, in particular, the safety issue. A complete reassessment is mandatory. Until then, physicians should be aware that the present claims about the efficacy and safety of statins are not evidence-based.

There will be over a billion wearable device in play by 2022, and that’s just the tip of the iceberg. Be ready for some truly remarkable applications, such as

• Pain relief - super-advanced bandages that could help relieve suffering
• Road safety - alerting drivers of notifications without having to check their smartphones
• People with impairments - smart glasses can navigate for the blind people both indoor and outdoor. In addition, with the face recognition function they can know whom they meet. The glasses could also read the signs for the wearer, and warn them if they are faced with a dangerous situation.

As for wearable medical devices, they have a long way to go before they are credible in the detection and management of disease. I’m pretty skeptical that this “study” really aims to find anything with scientific merit, but instead serves a commercial agenda for both companies.