Breaking: FDA approves the first drug with a digital ingestion tracking system

Not many drug approvals warrant an FDA press release, but this one did and deservedly so. The US Food and Drug Administration (FDA) approved a version of the psychiatric drug Abilify (aripiprazole) equipped with the Proteus Digital Health ingestible tracking system. Abilify MyCite has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It is the first approved commercial version of a drug equipped with the Proteus Discover system, which tracks the ingestion of the pill from a sensor in the tablet activated by gastric juices to a patch worn by the patient and then to a smartphone app. The patient, caregivers, and physicians can track medication usage (timing and compliance) through the app, adjusting dosage and timing as needed.

The Proteus press release states that the rollout is gradual through select health plans and providers, targeting a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder. It is contra-indicated for pediatric patients and adults with dementia-related psychosis.

Abilify, developed by Japan’s Otsuka and originally marketed in the US with Bristol-Myers Squibb (BMS), has been generic since 2015. This Editor finds it interesting that Proteus would be combined with a now off-patent drug, creating a new one in limited release. Proteus’ original and ongoing tests were centered on combining their system with high-value (=expensive) drugs with high sensitivity as to dosage times and compliance–for instance, cardiovascular and infectious disease (hepatitis C, TB). Here we have a focus on managing serious mental illness and treatment. 

Editors (Steve and Donna) first noticed Proteus as far back as September 2009. Looking back at our early articles, Proteus has come a long way from ‘creepy’ and ‘tattletale’. With nearly half a billion dollars invested and a dozen funding rounds since 2001 (Crunchbase), approvals were long in coming–nine years from submission of patch and tablet sensor to the FDA (2008), seven years from the patch approval (2010), five years from the tablet sensor approval (2012), to release of a drug using the Proteus system. The only thing this Editor still wonders about is what happens to the sensors in the digestive tract. They contain copper, magnesium, and silicon–copper especially can be toxic. If the sensors do not dissolve completely, can this be hazardous for those with Crohn’s, colitis, or diverticulitis/diverticulosis?  Hat tip to Bertalan Meskó, MD, PhD, via Rob Dhoble, on LinkedIn.

Also, if you can stand it, a lengthy article from the New York Times with lots of back and forth about the existential threats of monitoring drugs, potential coercion (preferable to injected Abilify), how some with schizophrenia already manage, and Proteus as a ‘biomedical Big Brother’. (Some commenters appear to have the very vapors about any digital trackers, including AiCure and etectRx.)

Hospitals snooping on your shopping and eating

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/10/Doctor-Big-Brother.jpg” thumb_width=”150″ /]Another charming use for Big Bad Data. Hospitals are investigating whether available data on patients–prospective and current–on shopping patterns and other purchase behavior such as gym memberships can be used to predict patient risk of disease. Leading the way is Carolinas HealthCare System, which operates the largest group of medical centers in North and South Carolina. With more than 900 care centers including nursing homes, they have 2 million patients to analyze for risk, using data points such as purchases a patient has made using a credit card or store loyalty card, to create predictive models on patient risk and eventually to reach out to patients. Of course this data crunching  has a purpose, and that is to meet quality metrics imposed by HHS and CMS. The goal would be to change the risk curve (more…)

Tons of app health data, bound for…third parties?

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2013/04/obey_1984.jpg” thumb_width=”150″ /] The law of unintended consequences also applies to Quantified Selfers. Health apps seem to be reaching beyond the QS early adopters and becoming a commonplace, whether on your wrist or built into your smartphone. Apple, Google, IBM and Samsung are all in.The DH3 set (Digital Health Hypester Horde) could not be more pleased. But where is that data going? According to the US Federal Trade Commission (FTC), it’s ending up where your online data goes–profitably sold by developers large and small to your friendly data broker and onward to marketers. You may think it’s private, but it isn’t. There is the famous case of an Target (store) app used to determine whether female customers were pregnant (purchases such as pregnancy tests) and then market related and baby products to them. Commissioner Julie Brill doesn’t like the possibility that health data could be part of the Spooky Monster Mash that is Big Data. “We don’t know where that information ultimately goes,” Brill told a recent Association for Competitive Technology panel. “It makes consumers uncomfortable.” (Ahem!) From the consumer protection standpoint, the FTC would like to do something about it, and they happen to be very good at that type of regulation. Compliance will not only be an added cost of doing business, it will cut into that ol’ business plan. And you thought that the only problem around apps and the Feds was gauging risk to users. Do you have that creepy ‘Big Brother is Watching You’ feeling?  Health IT Outcomes, FierceMobileHealthcare, VentureBeat.