blow ye winds…

Posted on Thursday 23 October 2014

Well, the Clinical Trial Cops look to be getting Smart®-er [and you’ve just got to admire yankee ingenuity]. Smart® is a device that takes the "non" out of non-compliance. Your study medicine has a little additive. So you take your pill and push a button, and after 20-30 minutes, it alerts you to blow into the machine. The additive has by then been absorbed and can be detected in your expired breath. If it’s there when you blow, this little machine takes a digital photo and sends it to an online database for facial recognition software to authenticate that the real subject took the pill. Check it out [how it works]! And the company [Xhale] has big plans for use beyond just Clinical Trials as you might imagine. How did I find this peculiar little piece of equipment? Creative use of the Physician Payments Sunshine Act Database. I just looked up a KOL [Alan Schatzberg] and found what he’s investing in. Voila` – Xhale!

Oh yeah, Waiting to Xhale:
    SMART® products have not been cleared for sale or use within the United States. The company is neither soliciting nor accepting any orders for the products. All benefits and claims made are concerning future generations of the product line, which are still under development.
  1.  
    Bernard Carroll
    October 23, 2014 | 3:37 PM
     

    Ever heard the expression pharmaceutical bottom fishing? It’s a specialty of KOLs. LOL.

  2.  
    wiley
    October 23, 2014 | 4:47 PM
     

    That has a dystopian feel to it.

  3.  
    October 23, 2014 | 5:02 PM
     

    The funny part is that using Smart® means the subjects will take all the pills and report the full compendium of adverse effects…

  4.  
    Bernard Carroll
    October 23, 2014 | 6:23 PM
     

    Oh, great! Turns out that the Xhale corporation’s SMART products will be laced with one or more of several organic alcohols that will then be converted to ketones, which are to be detected by the ‘breathalyzer.’ Here is the patent description.

    Just as we are working to get rid of unnecessary organic chemicals as food additives, these guys want to put them in our pills. Pharmaceutical bottom fishing, indeed.

  5.  
    October 23, 2014 | 7:22 PM
     

    Just say no to drugs.

  6.  
    Bernard Carroll
    October 23, 2014 | 8:23 PM
     

    Alto, that last comment from you doesn’t move the ball down the field.

  7.  
    Arby
    October 23, 2014 | 8:29 PM
     

    Being a clinical trial subject is still mostly voluntary.

    I just can’t wait for these machines to come to the doctor’s office tied to insurance coverage /sarc

  8.  
    October 23, 2014 | 9:39 PM
     

    and then there’s this – a whining pill carton [from eyeforpharma 2014]

  9.  
    Arby
    October 23, 2014 | 11:20 PM
     

    Thanks, Dr. Nardo!

    I could use that whining pill carton to increase my FICO® Medication Adherence Score

  10.  
    Arby
    October 24, 2014 | 8:14 AM
     

    Even though my comments have been snarky about “medication adherence” products, as a techno-junkie, I think some of them are kind of cool and I would use them.

    It isn’t what patients can do with these products that troubles me. It is what’s going to be done to us through them by managed care, administrators and government.

    Pharmaceutical/med device/EHR opportunists being only part of the problem here.

  11.  
    October 24, 2014 | 10:01 AM
     

    I think the idea is pretty good. Medication compliance is a frequent problem in getting patients to stability, and patient reports are often inaccurate. It would be wonderful to have an unobtrusive means of documenting medication compliance and linking it with treatment efficacy. It seems that the main problem is one humanity always faces — our technical capacity outrunning our moral capacity. My biggest worry (along with Arby) is what managed care will do with this.

  12.  
    AA
    October 25, 2014 | 5:08 AM
     

    On a related note, I am on pap therapy and submit data cards to physicians for downloads of the data. Unfortunately, even if I feel like crap, if the data looks good, that is all the doctors seem to care about. Concerned the same thing will happen in this situation and the patient will stop being listened to. Of course, not to disparage all doctors but that is already a big problem in medicine even when technology isn’t an issue.

    Even more concerning to me is what happens when the patient has a disagreement with his/her psychiatrist about the usefulness of the med and starts taking himself/herself off of it. Doctor sees this from the compliance data and threatens the patient with involuntary commitment if this person doesn’t get back on the med.

    Finally, just so the psychiatrists on this blog can see I am not picking on them, what if a patient goes to a “conventional” doctor who recommends a med that is a disaster and the he/she refuses to do anything about. Insurance company decides that because patient isn’t complying with treatment, doctor visit will not be paid for.

  13.  
    October 25, 2014 | 3:24 PM
     

    I apologize for my failed attempt at ironic humor, referencing Nancy Reagan in the mid-1980s.

    Personally, I would not want to be monitored in this way should it become widespread in prescribing. I would refuse the drug instead.

    As wiley said, this idea is dystopian.

  14.  
    James O'Brien, M.D.
    October 25, 2014 | 7:42 PM
     

    I’m all for reducing “noise” in clinical trials. I think it’s a good idea, given that we’ve complained here about older studies being better because they were done on inpatient units with better control. I wouldn’t worry about managed care, they won’t want to pay for it.

  15.  
    Arby
    October 26, 2014 | 11:09 AM
     

    Dr. O’Brien, I think you are looking at this from the wrong angle.

    If they can show non-compliance with treatment, they can refuse to pay for any of it. Now that the pre-existing condition exclusion is gone, they’re probably salivating over this idea.

    Check out the CPAP industry for an example of what is on the horizon.

  16.  
    James O'Brien, M.D.
    October 26, 2014 | 11:47 AM
     

    Do you know what the compliance rates is for CPAP? Considering the cost of a PSG, and how few people actually use CPAP for OSA frankly I don’t blame them. PSG is now a racket. Besides there are better and cheaper alternatives now.

  17.  
    AA
    October 26, 2014 | 2:07 PM
     

    My previous comment was deleted in which I did mention the use of the cpap as an example so I am reluctant to comment but will take a risk. Dr. O’Brien, as an FYI, I could do go into a million reasons why cpap compliance is low as someone using the machine. But to keep this discussion in a positive mode and to not get too far off track, any physician who visits this list who has a patient who is struggling with pap therapy, might want to refer their patient to http://www.cpaptalk.com which has excellent members who help people troubleshoot various issues that keep them from being compliant with the therapy. For example, many patients are given wide open prescription ranges that cause them to feel suffocation due to the minimum pressure being too low which will cause the machine to take too long to reach optimal pressure.

    So of course, the person is going to feel like ditching the machine without knowing what is going on. Of course, they should ideally consult the doctor but many times, sadly, they don’t get any help. That is why cpaptalk.com is so valuable as a site in encouraging patients to stick to therapy with their assistance. And it is free.

    Back to regularly scheduled programming.

  18.  
    October 26, 2014 | 2:20 PM
     

    AA
    It wasn’t deleted. My filter marked it for approval first all by itself while I was watching Atlanta lose in the last 4 seconds [gloom]…

  19.  
    James O'Brien, M.D.
    October 26, 2014 | 2:22 PM
     

    Sorry for the horrible grammar in my last post. Anyway…putting aside the issue of CPAP..

    I don’t have a problem with insurance companies making sure the treatment they (and by extension all the subscribers) are paying for is actually being used. That seems more than reasonable if other people are paying for it, especially taxpayers. There have been Medi-fraud cases involving ambulatory devices that were never used by the patient and were total billing scams. If a patient on Medicare runs up five figure bills for a treatment he is not complying with, that is an abuse and the tragedy of the commons at work.

    However, I don’t think insurance is going to like the additional costs involved with this kind of enforcement. They will make the calculation that compliance costs probably do not exceed the financial benefits of this.

  20.  
    Arby
    October 26, 2014 | 3:06 PM
     

    I mentioned the CPAP industry because the DME companies already use RF units. And, like AA stated, everything around OSA treatment has to be validated with you showing them your machine data. It’s a template of things to come.

    Have you seen the numbers they are throwing around about the costs of non-compliance with medications?

    The logic of “they’re not using X, so I don’t blame Y for not paying for it or for the consequences” is exactly how this will be promoted.

    I can follow this line of reasoning to a certain point, but, I know that it only makes sense in a perfect world with perfectly identified illnesses and perfect treatments that work the same for everyone.

    However, as far as the managed care point I was making, I was speaking to the Faustian bargain we’ve made by paying (taxes/premiums) for someone else to pay our medical bills. Monitoring compliance non-voluntarily will be pursued, and mostly likely by the gov’t first, to save on costs; damn the patient.

  21.  
    Arby
    October 26, 2014 | 3:08 PM
     

    Dr. O’Brien, we cross-posted. I didn’t see your response above before making my own.

    The cost of the compliance was not born by managed care directly. the DME’s absorbed it. Looked for pharmacies to do the same for medications. Of course, the companies don’t ultimately pay for it, we do.

  22.  
    AA
    October 26, 2014 | 6:36 PM
     

    Thanks Mickey. My apologies for making invalid assumptions.

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