A Florida adult-care facility is going ahead with plans to implant identity chips into patients with Alzheimer's disease who are in its care, despite protests that it is a form of branding.
Alzheimer's Community Care in West Palm Beach will implant a radio frequency identification chip into Alzheimer's patients 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.
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.
The FDA did not reply to requests for comment.
But Albrecht sees VeriChip as a risk without reward.
"There are other technologies that are far less invasive and can achieve the same goal," she said.
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 that existing safeguards protect Alzheimer's patients and others in a similar situation from being exploited for research studies.
In this case, he said, there appears to be minimal risk, and the research is for the direct benefit of the patient.