Mind-Brain-Law Reading Group – 2 Oct 2015
Ingestible Sensors to Monitor Drug Compliance

Article for Discussion "Why Pharma wants to put sensors in this blockbuster drug" by Sarah Zhang, Wired.com Sept 21, 2015.

Abstract:  

The FDA recently received an application for a medication which would combine the popular Abilify (an antipsychotic used to treat schizophrenia, bipolar disorder and depression) with an ingestible sensor which would keep track of when the pill was taken. Both the medication and the drug-sensor-app-system have been approved separately. The company advancing the application claims the new digital medicine is about patient empowerment. However, it raises many issues around consent, coercion, and medical compliance.

Summary of the Group Discussion:

 

Benefits of this technology

·       There are pros and cons of ingestible sensors of this type. 

·       On the positive side, the approach is practical and could help distracted and forgetful patients, and allow doctors to ensure patients safety.  If there are costs in terms of privacy and autonomy of patients, there are upsides in terms of patient safety and treatment efficacy.

·       The failure to complete courses of antibiotics raises risks of developing antibiotic resistant pathogens.  This monitoring technology could have public health benefits.

Reliance on this technology as a kind of “harm”

·       To the extent that patients embrace this technology as a way of keeping track of their medications (rather than collecting the information for the use of others), are there any risks in “outsourcing” responsibility for doing so to a technology?  Do we become dependent upon a technology in a way that makes us less able to manage on our own, and vulnerable if the technology breaks down in some way.

Is this the right direction for pharmaceutical innovation?

·       Should R&D and product development really be going into the monitoring mechanisms as opposed to better medications or other treatments?

·       Part of the problem perhaps is that we have not succeeded in creating a good antipsychotic drug that people want to take, and the remedy is to try to make people compliant with drugs that have undesirable side effects. This constitutes an attempt to remedy an inadequate technology with more bad technology.

What are the privacy implications?

·       This technology gathers private information about health conditions and prescriptions.  This raises privacy and data security concerns, particularly if the information is being transmitted to third parties.

·       Concepts of privacy, and the sphere of privacy that we expect are changing and eroding.  The infrastructure is already in place to collect and share unprecedented quantities of personal information.

·       One can imagine other contexts in which this type of monitoring would be of interest.  Perhaps health or life insurance companies would be interested in ensuring that a person is taking medication as prescribed.  Perhaps premiums would be affected by a person’s record of medication compliance?  Would disability insurance programs seek to know if a person is taking his or her medication as prescribed?

·       Diversion of controlled prescription medications (e.g. methadone, oxycodone) is an important public health risk, and may also extend to diversion of ADHD drugs like Ritalin for cognitive enhancement purposes.  This seems like another application to allow for monitoring and control of drugs.

Coercion, control, and surveillance

·       There are many reasons to regard this technology as aiming more at control and surveillance of patients rather than at their empowerment.  The fact that this is being aimed at a psychiatric population often viewed as “non-compliant,” “treatment resistant” or “lacking insight,” rather than at elderly patients with dementia, for example, shows that it is about control rather than helping with forgetfulness.

·       Compulsory outpatient treatment is sometimes used in psychiatry, and this is a means to monitor and enforce medication compliance.  It is troubling, as enforcement is not in the community, it is in some ways inside the patient’s body.

·       What if all (or many) prescription medications were eventually made this way? It would be understood that treatment comes with monitoring.  Would consent to treatment include consent to the monitoring?

How is this actually different from long-acting injections of antipsychotic medication? 

·       Long-acting injected antipsychotics are sometimes used to address problems with medication compliance.

·       In some ways, injectables are not difference from ingestible sensors.  Compliance is being ensured in both cases, albeit in different ways.

·       Perhaps a difference is the timeline. Long-lasting injections don’t allow for ongoing consent, whereas the choice to take the ingestible is made with each pill. This allows for more ongoing autonomy, and the ability to revoke consent to treatment.

·       The human interaction associated with a long-term injection may seem more coercive than the ingestible monitoring. With the ingestible sensor, the patient chooses to ingest the drug, rather than having it administered, and the third party as monitor or “coercer” can be kept at a distance.  On the other hand, perhaps the invisibility of the surveillance is more troubling?