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Where does patient adherence technology go in a post smart-pill era? CNNlater in the day, noted that neither Proteus nor Otsuka were willing to comment. Interestingly, both original Big Pharma investors and sponsors of this technology are holding back, with neither Novartis nor Otsuka in a hurry to launch any drugs not even the newly approved Smart Pill version of Abilify - https: The patient target group chosen to put through the FDA approval process Schizophrenia always seemed like an unfortunate choice.
User concern with data security. Electronic ankle bracelet anyone? Yes, my credit card stays in my wallet, too. Proteus states that the chip contains no more Silicon Si than a banana. The banana analogy is alarming, at best. According to WebMd it could contribute to kidney stones, and its safety as a medicinal compound is unknown.
It advises pregnant and breast feeding women to avoid intake of supplemental Si. Proteus attempts to address non adherent forgetful patients. So we are targeting poorly adherent patients with an overwhelming technology burden. The biggest technology hurdle here is the battery running out of juice.
And it warns that the ingestion event might not even be detected by that patch at all. Tolerance of the patch. The patch is just like any other medical patch pain or birthcontrol patches, for instance. A good proportion of the population experiences contact dermatitis.
How many weeks would a patient put up with this?
One of the main issues of adherence drop off is persistence, meaning patients stop being adherent after some time. The patch seems to just aggravate this issue, not solve it. Indeed, the FDA has directed Proteus to specifically say so on their device label.
The fact is, adherence measurement does not equal adherence improvement; unless the measurement data are used in a specific way to coach patients about their adherence pattern.
Nobody has addressed cost, but there is a requirement to re-apply for a drug application each time a Proteus smart chip is combined with an existing drug.
This costs time and money. In clinical trials, where adherence is of paramount significance, the combination of chip and pill might cause unacceptable delays and possibly then force the drug company to go to market with a chip inside every pill whether they want to or not. This would explain why no actual clinical trial seems to have included this chip in its research protocol.
Clinical research involves careful study of side effects. Adding guaranteed side effects by using medical adhesive for the detection patch does not help matters.
There have been effective adherence measurement devices in the market for 30 years. MEMS by Aardex is a smart cap for medicine bottles and has been used in hundreds of studies. Med-ic, also by Information Mediary Corp.
In all cases where the chip is part of the packaging, rather than inserted into the actual medication, FDA does not require complicated, lengthy and expensive approvals. The technology has been used by hundreds of thousands of patients over more than two decades.
It is robust, affordable and easy to deploy. What makes package-based adherence monitoring the sensible choice for researchers and clinicians alike is the fact that it can be innocuous to the patient.JetNet Corporation is a dynamic, innovative company specializing in the design, manufacture and sale of netting and food service products to a variety of industries throughout the world.
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