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posted by martyb on Wednesday November 15, @05:45PM   Printer-friendly
from the How-did-I-miss-the-:Analogue"-Pill? dept.

The U.S. Food and Drug Administration (FDA) has approved a "digital pill" that contains a sensor intended to track whether a patient has taken their medicine:

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine. The approval, announced late on Monday, marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, longstanding problem that millions of patients do not take drugs as prescribed.

Experts estimate that so-called non-adherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalization. "When patients don't adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly," said Dr. William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, said the digital pill "has the potential to improve public health," especially for patients who want to take their medication but forget. But, he added, "if used improperly, it could foster more mistrust instead of trust."

FDA news release.


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  • (Score: 1, Funny) by Anonymous Coward on Wednesday November 15, @05:55PM (6 children)

    by Anonymous Coward on Wednesday November 15, @05:55PM (#597387)

    https://www.ncbi.nlm.nih.gov/pubmed/3395000 [nih.gov]

    We present the case of a 31-year-old man who presented to our emergency department in a distressed state complaining of hiccuping for >72 h.
    [...]
    We explained the various pharmacologic interventions, their side effects, and, with certain medications, the need for posttreatment observation. As an alternative, we explained that there were a small number of case reports suggesting the success of digital rectal massage (DRM) for the termination of hiccuping
    [...]
    Before undergoing DRM, we observed our patient hiccuping 40 times in 1 minute. Our patient was placed in a lateral recumbent position with his hips flexed. A gloved lubricated index finger was passed into his rectum. Rectal massage was carried out in a slow, clockwise fashion with moderate steady pressure being applied. On initiation of DRM, hiccuping ceased immediately.

    https://www.ncbi.nlm.nih.gov/pubmed/27717586 [nih.gov]

    • (Score: 1, Troll) by realDonaldTrump on Wednesday November 15, @06:26PM (1 child)

      by realDonaldTrump (6614) Subscriber Badge on Wednesday November 15, @06:26PM (#597396) Homepage Journal

      July 10, 2013 was my last colonoscopy. I did it for the cancer, for a cancer check. I wouldn't do it for the hiccups. It's like some form of punishment. There has to be some form of punishment for folks who get the hiccups or don't take their medicine? No, I don't think so. Not even for getting an abortion, for the gals who get pregnant and they want an abortion. The woman is a victim in this case, as is the life in her womb. If we ban abortion -- @VP Pence keeps reminding me about the ban -- the doctor or any other person performing this illegal act upon a woman would be held legally responsible, not the woman. You punish the doctor. #MAGA 🇺🇸

      • (Score: 2) by meustrus on Wednesday November 15, @07:52PM

        by meustrus (4961) <meustrusNO@SPAMgmail.com> on Wednesday November 15, @07:52PM (#597431)

        In good form as always, leading me to ask: where's the "WTF did I just read?" mod?

        --
        If there isn't at least one reference or primary source, it's not +1 Informative.
    • (Score: 3, Interesting) by edIII on Wednesday November 15, @09:02PM (1 child)

      by edIII (791) Subscriber Badge on Wednesday November 15, @09:02PM (#597456)

      We definitely need a +WTF mod. Truth is stranger than fiction though. I found it quite humorous that DRM means digital rectal message, and that it cures hiccups. What was funnier, is that this is true.

      Not trolling exactly, but weird stories from the ER. I'm afraid if we did create a +5 WTF mod, it would just start a competition.

      • (Score: 0) by Anonymous Coward on Thursday November 16, @01:13AM

        by Anonymous Coward on Thursday November 16, @01:13AM (#597537)

        The difference is this: when the digital rectal massage was administered, the patient didn't have to bend over for it—unlike the other kind of DRM.

    • (Score: 0) by Anonymous Coward on Wednesday November 15, @10:05PM (1 child)

      by Anonymous Coward on Wednesday November 15, @10:05PM (#597486)

      just inhale as much air as possible, block the breath, push your abdominals as you wanted to exhale (but you block the air at the throat level) and wait for the next hiccup, which will be more like a burp. Keep the air a little more, when it becomes uncomfortable exhale and breath normally. I never had hiccups ever after.

      • (Score: 0) by Anonymous Coward on Thursday November 16, @12:45AM

        by Anonymous Coward on Thursday November 16, @12:45AM (#597528)

        This approach suffers from too many ways to "do it wrong". Did I really inhale "as much as possible", I have no idea what it means to "push [my] abdominals as you wanted to exhale", and how are you "block[ing] air at the throat? Etc.

  • (Score: 2) by frojack on Wednesday November 15, @06:27PM (4 children)

    by frojack (1554) Subscriber Badge on Wednesday November 15, @06:27PM (#597397) Journal

    TFA tries to bore you to death before getting to the point.

    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’s 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.

    Also:

    Another controversial use might be requiring digital medicine as a condition for parole or releasing patients committed to psychiatric facilities.

    Abilify is an arguably unusual choice for the first sensor-embedded medicine. It is prescribed to people with schizophrenia, bipolar disorder and, in conjunction with an antidepressant, major depressive disorder.

    --
    No, you are mistaken. I've always had this sig.
    • (Score: 2) by bob_super on Wednesday November 15, @07:20PM

      by bob_super (1357) on Wednesday November 15, @07:20PM (#597415)

      Step 1, Monday morning: tell your employees that, per secret agreement to escape prison, drug dealers in the area have been putting those chips in their products for a little while.
      Step 2: pull out some gizmo with wires, and announce that you will now conduct a drug test.
      Step 3: watch some of the employees' reactions. Remember the ones who anxiously ask whether the chip works if crushed or boiled. Plan to drug test any of those that you want to get rid of.
      Step 4: Tell them that it was a joke to remind them that the drug-free policy isn't a joke.
      Step 5: Watch how many people quit.

    • (Score: 3, Insightful) by Azuma Hazuki on Wednesday November 15, @10:18PM (1 child)

      by Azuma Hazuki (5086) on Wednesday November 15, @10:18PM (#597491)

      Oh, like a potato battery, *and* it's a digital sensor too. Does it snark at you and try to get you killed while messing with the laws of physics?

      • (Score: 0) by Anonymous Coward on Thursday November 16, @05:36PM

        by Anonymous Coward on Thursday November 16, @05:36PM (#597785)

        In layperson's terms, it's like a potato battery but with stomach acid instead of the potato.

    • (Score: 1) by anubi on Thursday November 16, @01:42AM

      by anubi (2828) Subscriber Badge on Thursday November 16, @01:42AM (#597546)

      I wonder if fidgeting with a flashlight cell would spoof it.

      --
      "Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
  • (Score: 0) by Anonymous Coward on Wednesday November 15, @06:37PM

    by Anonymous Coward on Wednesday November 15, @06:37PM (#597401)

    Just wondering about the side effects...

  • (Score: 4, Insightful) by meustrus on Wednesday November 15, @07:59PM (5 children)

    by meustrus (4961) <meustrusNO@SPAMgmail.com> on Wednesday November 15, @07:59PM (#597433)

    The sales pitch is that you share this information with your doctor. That's false. You share the information with a third party who keeps it in a central database. Then your doctor can engage the bureaucracy to get access to your personal data, all without consulting you.

    It's effectively the same thing for patient outcomes, but it has a slew of problems:

    1. The central database is a target for hacks.
    2. Your doctor has to fill out a bunch of paperwork to get the data (or more likely, keep even more paper-pushers in the office to do it for them).
    3. Any doctor can fill out the same paperwork to get the data without the patient knowing who has it.

    And the biggest problem of all:

    4. Because it's all going on behind the scenes, nobody will think too hard about it.

    This will lead further into our EMH hell of more impossible security, less patient engagement, and skyrocketing costs to engage the ever-expanding bureaucracy.

    --
    If there isn't at least one reference or primary source, it's not +1 Informative.
    • (Score: 2, Funny) by Anonymous Coward on Wednesday November 15, @08:56PM

      by Anonymous Coward on Wednesday November 15, @08:56PM (#597451)

      Come on now, do you honestly believe that this proprietary database that you don't have the slightest bit of control over will be insecure? History tells us that companies are astoundingly good at security, so what are you afraid of?

    • (Score: 2) by frojack on Wednesday November 15, @09:15PM (3 children)

      by frojack (1554) Subscriber Badge on Wednesday November 15, @09:15PM (#597460) Journal

      5) If patients are merely forgetful, they could just as well set an alarm on their phone reminding them its time to take their pills.

      6) If patients are avoiding the meds, they just drop the pills into the little quart bottle of orange juice they keep the patch glued to.

      So its totally unnecessary for compliant patients, and easily outwitted by non-compliant ones.

      generates an electrical signal when splashed by stomach fluid ... The patch sends the date and time of pill ingestion and the patient’s activity level via Bluetooth to a cellphone app.

      Clearly the device (they call it medicine, but its clearly a device embedded in medicine) sends a signal to the patch.
      What is the range of that signal? Can it be read by any nearby patch? Can it be spoofed?

      The new patch has to be paired with your phone every 7 days. The old one goes where?

      7) What ever is possible will be mandatory.

      --
      No, you are mistaken. I've always had this sig.
      • (Score: 2) by meustrus on Thursday November 16, @03:02PM

        by meustrus (4961) <meustrusNO@SPAMgmail.com> on Thursday November 16, @03:02PM (#597719)

        To play devil's advocate for a moment, there is a utility to this that has nothing to do with making patients more compliant. Doctors do need to know how compliant the patient is in order to know if the drug is working properly. Forgetful patients won't know exactly how frequently they managed to take their pills.

        Probably the one good part of having it in a central database is so that your doctor can be notified automatically if your forgetfulness is likely to lead to a medical emergency.

        In my humble opinion, though, none of this constitutes a good reason to start pushing centralized medication monitoring on the general population.

        The real solution to this problem is to find a continuous delivery system that doesn't rely on the patient's memory. They make birth control implants now that do exactly this, although they have their own disadvantages that mainly come from not being reloadable once implanted.

        --
        If there isn't at least one reference or primary source, it's not +1 Informative.
      • (Score: 0) by Anonymous Coward on Thursday November 16, @04:33PM

        by Anonymous Coward on Thursday November 16, @04:33PM (#597756)

        5) If patients are merely forgetful, they could just as well set an alarm on their phone reminding them its time to take their pills.

        If patients are forgetful, they'll forget their phone as well. Or forget to charge it. Or forget to set the alarm.

      • (Score: 2) by urza9814 on Thursday November 16, @09:25PM

        by urza9814 (3954) Subscriber Badge on Thursday November 16, @09:25PM (#597913) Journal

        6) If patients are avoiding the meds, they just drop the pills into the little quart bottle of orange juice they keep the patch glued to.

        I'm more curious if the thing can tell the difference between one pill activating vs an entire bottle of them...and what they do if you activate the entire bottle at once...and how many different entities you can sue if the cops break down your door and shoot your dog during the resulting "wellness check"...

  • (Score: 0) by Anonymous Coward on Thursday November 16, @04:28PM

    by Anonymous Coward on Thursday November 16, @04:28PM (#597752)

    OK, I know how to take oral medicine, and how to take rectal medicine. But how would I take a digital pill? Cut my fingers open and insert?

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