Is the 'Digital Pill' an Invasion of Privacy?

Arthur L. Caplan, PhD


December 03, 2015

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Hi. I am Art Caplan from the Division of Medical Ethics at New York University (NYU) Langone Medical Center in New York City.

A new pill is awaiting US Food and Drug Administration (FDA) approval, not because it is a new chemical composition but because it is the first digital pill. This pill actually sends a signal to the doctor when the person who is supposed to take the pill has taken it.

The drug is aripiprazole, which is commonly used by people with mental illnesses such as schizophrenia or bipolar depression. The pharmaceutical company that manufactures aripiprazole decided that it would be important to know whether people are taking their medications. So, they worked with another company, Proteus, which designed a little chip that is added to the pill and a patch that is placed on the patient's arm. When the patient takes the pill, a signal is sent to the patch and then relayed to the doctor's office. Everyone is happy, and we know you are taking your medications.

The need for this pill is very real. Remember that just because someone writes a prescription does not mean that the patient is going to fill it or take it. The best estimates are that 20% of patients who get prescriptions do not fill them, and of the 80% who do fill the prescription, about half take them as they are prescribed.[1,2] Many people stop taking their medications when their symptoms go away. They do not finish the run of antibiotic, or they go off their blood pressure pill because they feel okay. Others just get forgetful; other reasons are anyone's guess. Regardless, adherence to what is prescribed is a huge problem.

This "digital" pill absolutely has a place. This technology will help to assure that if someone did not take their medications, the doctor's office will find out relatively quickly and can intervene, call and talk to the patient, and make sure the patient takes the medication or find out why the patient is not taking it.

Many Questions, Few Rules

This technology is all well and good except that there are enough questions to keep 100 ethicists busy for the next decade. It is great that the FDA has this request to approve the digital pill, but we need some rules in place. For example, some people with mental illness may not be competent. Who is going to give permission for these patients to have the digital pill? Maybe these patients do not want their families to know they have a mental illness. Maybe they are worried that other people would find out if they see a pillbox that is clearly for the digital pill or a patch that indicates that they are sending signals to the doctor's office. What about children? Are we going to monitor them? Are we going to tell their teachers? Will people at their schools know that they have a particular mental illness?

Suppose the use of the digital pill expands? Would we all be comfortable having information about our gonorrhea, urinary incontinence, or mental illness sent to the doctor's office? I am not sure we would, with third parties in the office being able to access information about potentially stigmatizing illnesses.

Are these devices easy to hack? Thus far, even the best cyber-protections have not turned out to be very good. What privacy assurance do we have that some third party will not be able to listen to these messages?

What if a judge or a parole officer says this digital pill is great, and I am going to order you to take your medication as a condition of getting out of jail, getting out of prison, staying on parole, or being admitted to certain jobs? Suppose you have to let your boss know that you are taking this pill or you have to let legal authorities know that you are taking the pill.

I am not saying that all of these circumstances are off limits, nor am I saying that every one of these cannot be resolved. But before the digital pill gets too far down the digital highway, we need to start thinking about the rules of the road. We need ethical principles and boundaries if we are all going to start taking pills that talk to the doctor.

I am Art Caplan, Division of Medical Ethics at NYU Langone Medical Center. Thanks for watching.


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