A major step has been taken by medical technology towards the dream of a so-called ‘smart pill.’
Trevor Mundel, global head of development for the Swiss firm Novartis AG, plans to move aggressively ahead with a plan to introduce a breakthrough pill that contains a robotic-like microchip that will report back to doctors via wireless transmissions.
Mundel explained that initially an existing tablet the Swiss company already manufactures will be used. The medication is currently taken by transplant patients as part of a therapeutic regimen to ward off organ rejection.
“We are taking forward this transplant drug with a chip and we hope within the next 18 months to have something that we will be able to submit to the regulators, at least in Europe,” Mundel told a reporter for a major news service.
Mundel envisions applications of the technology with a variety of other pills. “I see the promise as going much beyond that,” he stressed.
Proteus Biomedical of Redwood City, California developed the prototype dubbed within the industry as a ‘chip-in-a-pill.’ The privately owned biotech firm, funded by venture capitalists, signed an agreement with Novartis in early 2010 to provide the European pharmaceutical giant with exclusive access to the pioneering advancement.
Company spokespersons explained that a patient’s stomach acids activates the ingestible chip. Acting then as an RFID chip (radio frequency identification), it will share the realtime medical data with a small patch attached to the patient’s skin, The patch will act as a miniature radio repeater and transmit the data via Bluetooth technology to a doctor’s smartphone. The Internet can also be used to receive and analyze the data.
For the time being the data collected and transmitted form the organ transplant patients will be limited to biometric data on an organ, and to make sure the patients are taking the prescribed drugs on a timely basis.
But the future of these robotic data collectors is limited only by the imagination. Eventually they will be able to monitor and report on virtually every aspect of the human body including its biochemistry.
Novartis does not foresee large scale clinical trials on the device. Because they will be used in tandem with approved pharmaceuticals, Mundel expects the company will provide ‘bio equivalence tests’ demonstrating that the chips will not impede nor change the function of the approved drug.
Privacy issues raised
Some organizations that have been monitoring this emerging medical technology have already raised red flags about patient privacy. Can the wireless data be intercepted by unauthorized individuals? What information may—or may not—be collected? Will the data stream be encoded? Can it be protected from hackers?
Regulators in Switzerland, the US, Canada, the UK, Germany and other countries are debating these concerns.
“The regulators all like the concept and have been very encouraging. But…they want to understand how we are going to solve the data privacy issues,” Mundel admitted.
Someday—in the not too distant future—you may hear your stomach grumbling and it won’t be gas, It will be a smart little chipbot swimming around inside you spilling its guts about your guts.