A new pill has been approved by the U.S. Food & Drug Administration (FDA) that, when swallowed, notifies a monitoring device you wear that you actually took the medication. Sounds invasive and a gross violation of your privacy?
Well, it would be. Except for the small problem that every year, millions of people say or agree to take a medication, and then stop taking it when they start to feel better. It’s a long-standing problem for people diagnosed with certain types of mental illness, and leads to serious and significant problems — for the patient, their family, and society as a whole.
The new medication is called Abilify MyCite, and is the result of an innovative collaboration between Abilify’s manufacturer, Otsuka, and Proteus Digital Health, a California company that created the sensor. People who have been diagnosed with schizophrenia or bipolar disorder, and some people with clinical depression, are sometimes prescribed Abilify, an antipsychotic medication. This medication helps treat some of the symptoms associated with these disorders.
The Seattle Times has the scoop:
The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid, like a potato battery, said Andrew Thompson, Proteus’ president and chief executive. After several minutes, the signal is detected by a Band-Aid-like patch that must be worn on the left rib cage and replaced after seven days, said Andrew Wright, Otsuka America’s vice president for digital medicine.
The patch sends the date and time of pill ingestion and the patient’s activity level via Bluetooth to a cellphone app. The app allows patients to add their mood and the hours they have rested, then transmits the information to a database that physicians and others who have patients’ permission can access.
Sounds creepy, right? And it would be too if people with schizophrenia or bipolar disorder — usually chronic, long-term conditions — weren’t grappling with the fact that when they start to feel better, they start to question the need for continuing their medication. And in that questioning, some people decide they would be better off discontinuing the medication. Sadly, this is often done on their own, without ever talking to or further consulting the doctor who prescribed the medication.
Medication Adherence or Forced Treatment?
I hate the term “medication adherence” (and the equally horrible “medication compliance”), because it is so paternalistic sounding — patients doing as they’re told to do by the all-knowing physician. But in truth, most patients with a mental illness work as partners in developing a treatment plan with their treatment team. Treatment plans are usually not forced on a patient, and if a person wants to do something different in their treatment plan, I’ve rarely found a mental health professional who objected (although I’m sure there are still some old-school professionals who come from the, “Do exactly as I say” school of doctor training).
So taking medication that you agreed to take isn’t exactly forced treatment. (If you didn’t agree to take the medication in the first place, that’s a different story.)
People stop taking their medication for a myriad of sometimes very good reasons. The side effects are horrible. The medication doesn’t seem to work as well as it did in the past. The medication is causing me problems with balance or concentration. I can’t drink alcohol while on the medication. And some of us just get lazy and stop following the plan we agreed to for no good reason at all other than it seems like it’s too much work.
Sticking to Your Treatment Partnership
But if treatment is a partnership between you and your therapist or doctor, then you owe it to that relationship to let your professional partner know you want to change things up with your treatment. Unfortunately, most people simply don’t do this. Instead, they decide to stop taking medication on their own.1
Just because you can do something doesn’t mean it’s something you should do, or that it’s a particularly good idea. Many people diagnosed with schizophrenia or bipolar disorder simply cannot function well without medication.2
Some people just repeat the pattern of taking their medications for a time, and then stop taking them without any notice to anyone. Which may become a serious problem when the possible ramifications of being off of your treatment start to rear their head. For instance, when your family (or the police) has to try and talk you down from self-harm or some other type of situation where you become a danger to yourself or others. Or your behavior gets you into criminal or other kinds of trouble (e.g., like a person experiencing a full-blown manic episode in bipolar disorder).
Technology to the Rescue
That’s why the Abilify MyCite pill was invented. While I’m not at all comfortable with its reporting aspects, I understand the problem it’s trying to solve. Long-acting injectables and other long-acting forms of medications are another way of trying to address these same kinds of concerns.
Questions to ask Otsuka about this new medication would be:
- Are the chemicals that dissolve in my stomach to produce the electrical chemical reaction safe for long-term use (e.g., has it been studied in humans for 5 years or longer)?
- Is the patch sensor safe for long-term sue (e.g., has it been studied in humans for 5 years or longer)?
- Does Otsuka receive data transmitted from the smartphone app (even if anonymized)?
- What else does Otsuka do with this data?
- Does Otsuka make this data available to the government or police? Insurance companies? Payers? Other third-parties? And under what conditions?
- If the police request my data, is a subpoena or search warrant needed?
- Where does the data actually reside, on my phone or in the cloud somewhere?
- What kind of security is attached to the data transmission and storage?
- Can I completely delete or purge all of my data whenever I want to?
- Can I get a copy of my complete data records whenever I want to?
- Who specifically in the doctor’s office is doing the actual monitoring of the medication intake?
- What is the response by the doctor’s office when I miss 1 or more doses?
- Do I have any say in the type or frequency of the response of the doctor’s office?
And that’s just where I would start… I wouldn’t even dream of taking this medication without adequate answers to these questions.
One Possible Solution… But Let’s Not Stop There
As you can see, despite the need for solutions, not a whole lot is available to address this problem. It’s a challenge when the disease itself may cause a person to second-guess their treatment plan and discontinue medications without first talking to someone about their concerns and desire to get off of their medication.
This is an interesting idea, combining sensors, an app, and always-connected technology to produce a solution that may or may not work, depending upon a person’s specific situation.
But it also seems like it has multiple potential points of failure, leading to unreliable readings once rolled out to potentially tens of thousands of patients. These potential problems might include:
- The chemical reaction of the pill in a person’s stomach (what if something a person eats negates the reaction, delivering a false positive of medication non-adherence?);
- The potential failure of the sensor to reliably read the data correctly on all skin types, in all conditions of heat, cold, goosebumps, and sweating;
- The potential failure of the app to read the senor’s data correctly or connect to the sensor, especially if the sensor’s battery is low or someone simply forgot to swap it out;
- What if you break or lose your phone that the app resides on?
- Etc. etc.
Perhaps this isn’t quite ready for prime time. I’d surely not be the first person to give it a try. But I appreciate the attempt at innovation. So let’s not stop here, let’s find a way to do this in a less invasive and somewhat less-creepy manner that doesn’t seem so Big Brotherish.
For further information
Read the full article: FDA approves first digital pill to monitor if patient is taking medicine
- Which, while I support 100% that it is your right to do so, doesn’t mean that such a decision is always a good idea, or in the best interests of you or the treatment of your condition. Ultimately, I believe it is the patient who has the final say in what kind of treatment they want or do not want to receive. [↩]
- Don’t know if you’re one of those people? You can work with your treatment team to taper off a medication slowly and under supervision to determine whether or not it would work for you. [↩]