Electronically tracking Alzheimer's patients is coming into force in the US.
Alzheimer's Community Care in West Palm Beach in Florida said it would implant a radio frequency identification chip into Alzheimer's patients, but only with the consent of their families or the patients themselves if they are deemed competent.
The chip, which is slightly larger than a grain of rice, is implanted under the skin of the right forearm. Each chip will contain a unique 16-digit number that, when scanned in an emergency room, will link to the patient's medical records.
Mary Barnes, the president and CEO of Alzheimer's Community Care, said the RFID chips, manufactured by VeriChip Corp., provided the best means of giving medical personnel access to a patient's medical history, since people with Alzheimer's often cannot relay that information themselves.
"Our patients are the most fragile and vulnerable of any population," Barnes said.
While the RFID implants have been approved by the U.S. Food and Drug Administration, VeriChip is testing the effectiveness of the chips in a real-world situation to see if Alzheimer's patients with the chip receive "quicker and better treatment" than those without, said VeriChip CEO Scott Silverman.
But opponents of the chip program say it raises serious ethical considerations.
"This whole medical trial ... really raises some pretty important issues about informed consent," said Katherine Albrecht, the founder of the advocacy group Consumers Against Supermarket Privacy Invasion and Numbering.
Albrecht is concerned that Alzheimer's patients are being enrolled in what she considers a potentially risky study without their consent.
When the FDA approved VeriChip's product, it mentioned potential problems, including electromagnetic interference, failure of the chip to function properly and adverse bodily reactions.
The FDA approval letter did not specify the severity or likelihood of these risks.
"Any medical device approved by the FDA has potential risk factors listed in the approval letter. VeriChip is no different," said Silverman, who had an RFID chip implanted in his arm in 2002 -- more than two years before the FDA first approved the chips -- and has experienced none of the potential problems.
Albrecht feels there are other technologies that are far less invasive and can achieve the same goal.
Albrecht promotes the MedicAlert bracelet as the ideal way to solve the problem of Alzheimer's patients who cannot relay their medical information reliably. MedicAlert bracelets bear a recognizable medical symbol on the outside and have the patient's medical conditions listed on the back.
While Barnes worries that the MedicAlert bracelet could break off or be removed by the patient, Albrecht believes it is just as likely that an RFID chip would fail or the system that holds patients' electronic records could crash.
Bioethicists don't share all of Albrecht's concerns.
Jason Karlawish of the University of Pennsylvania said, "There is a well-worked-out guide to conduct ethics for what is and isn't permissible," Karlawish said, calling Albrecht's objection to families' consenting on behalf of the Alzheimer's patients "simply not correct."
Jeffrey Spike of Florida State University agreed, pointing out that families are regularly called upon to make life-or-death decisions for loved ones who are mentally incapacitated.
But he worries because the chip program has not yet been evaluated by a review board. Such a board, Spike said, would need to look at potential risks -- both physical and psychological -- and let prospective participants know their right to withdraw by having their chip removed or deactivated.
Barnes said a review board will be assembled in the next few weeks, to be headed by Andrew Passeri, a board member of Alzheimer's Community Care and the former president and CEO of Staten Island University Hospital in New York.
Under the current schedule, Barnes said, the board hopes to begin the program in August.
She suggested that families should start coming for services and resources in the early stages of Alzheimer's, when patients are still competent and can take part in planning their care.
Then patient consent for something like this would be unimpeachable -- it would be their own.