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Friday, November 12, 2010

“Smart pills” have embedded microchip for compliance

Novartis AG, one of the largest drug companies in the world, has announced a plan to begin embedding microchips in pills.

"We hope within the next 18 months to have something that we will be able to submit to the regulators," global head of development Trevor Mundel told Reuters news service. "The regulators all like the concept and have been very encouraging."

The silicon and metal sensor is activated by stomach acid. It then sends data via a wireless radio signal to another chip worn as a skin patch or embedded just under the skin which transmits the information wirelessly to a designated smartphone, e-mail account, etc. The chip's power expires after a few hours. The first use being studied is for a drug for transplant patients that helps avoid organ rejection. Since the drug itself is already approved and established, Novartis might be able to forgo clinical trials and simply conduct bioequivalence tests to show the second-gen pills have the same effect as the originals.

Anticipating that once the sensor-based technology is regulatory approved, the ‘smart-pill’ platform will be transferrable to different drugs, Mundel said future ‘smart-pill’ variants will be able to collect more advanced data, such as a patient’s heart rate, temperature and body movement, to ensure a drug is working effectively.

Rival firm Philips is bringing forward its IntelliCap technology, which was first showcased in 2008. MicroCHIPS, an American start-up, is developing smart, implantable microchips which have reservoirs to hold drugs or tiny monitoring devices. Vitality, an American firm, has come up with a cap for pill bottles that telephones hapless patients if they fail to take their medicine on time.

Dr. Grout’s comment:
 
Is this promising or just creepy? With chip-in-a-pill, we have something you swallow that can both monitor your vital signs and track compliance with prescription drug regimens. They are calling this “personalized medicine.”
 
This new technology will first be used with people who have had organ transplants. They are in a very precarious position; a “smart pill” may seem to make sense for those patients. But what happens when the chip is applied to a wider range of prescription drugs and perhaps vaccines? In the marketing business, this kind of things is called a "continuity program" – a way to make sure repeat sales happen on a regular basis.

Various studies have estimated that a third to half of prescription drugs are not taken as prescribed – or at all – because patients are worried about side effects or just don’t want to take so many drugs. Pharmaceutical companies lose significant revenue from patients skipping out on their prescribed pills; one industry study estimates needless hospitalizations as a result of such failings cost $100 billion a year.

Will patients clamor for more data about their health, much as banks’ customers embraced the internet as a means of keeping better track of their accounts? Or will people come to see the ability for drugmakers to keep such intimate tabs on their customers as too Orwellian?  It represents a new level of intrusion into patients' lives. Will you be forced to take, say, a statin drug which you don’t want to take in order to have the blood pressure medicine you really do want to take?

The microchip itself is said to be about the size of a grain of sand. Although much has been said about the chemical toxicity of discarded computer parts, there is no mention in any of the news reports about the safety of ingesting a circuit board, or the safety of this new form of EMF transmissions within the body.

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