In 2007, the PositiveID Corporation in Florida injected microchips into Alzheimer’s patients as part of what it termed a “two-year study.” Up to 200 test subjects, many incapacitated, were supplied by a nursing home in West Palm Beach called Alzheimer’s Community Care, which PositiveID has sponsored at fundraisers.
Today, based on new information, doctors allege the study violated medical ethics and regulatory law. PositiveID appears to have abused science for profit, banking on public and even professional ignorance of medical ethics.
PositiveID, known as VeriChip at the time of the study, markets the world’s first human-implantable microchip, approved by the FDA for medical use in 2004. (In 2005, former Secretary of Health and Human Services Tommy Thompson resigned from government and joined the company’s board.) The rice-grain sized device is stuck into the flesh with a nearly foot-long syringe. It contains a serial number that can be read by a scanner and then matched with a person’s online medical profile in an emergency.
PositiveID and Alzheimer’s Community Care claimed Alzheimer’s patients were in special need of implantation. The CEO of the ACC, Mary Barnes, told USA Today that the chip “could be invaluable in identifying lost patients – for instance, if a hurricane strikes Florida.” But Dr. Robin Fiore, a professor of ethics at Florida Atlantic University and a national lecturer on medicine, said Barnes’ claim amounts to pseudo-science. Usually, the difficulty is in finding missing Alzheimer's patients, not identifying them. “This is not going to find lost people,” she said, noting that PositiveID’s chips are not GPS-equipped. “And if [the patients’ caregivers] think this will help them find their lost loves ones, they’re just confused. They’ve just been misinformed.” Mrs. Barnes also told USA Today that “both the patients and their legal guardians must consent to the implants before receiving them.” To the contrary, PositiveID admits that many patients were unable to give informed consent, so their legal guardians enrolled them.
On his Fox News show last October, Glenn Beck reinforced the idea that the chip is a big help to Alzheimer’s patients, while dispelling conspiracy theories about the company. “They have fantastic technology if you’re an Alzheimer’s patient,” he assured. But “it’s very, very bad if, say, Hitler has this technology.” He urged his viewers to be skeptical. “You must stay vigilant, be aware, watch for it… I know the times we’re living in.Vigilance is the key word.” If Glenn Beck had not merely repeated the word “vigilance” and instead approached the company as a skeptic, he would have discovered that the experiment on Alzheimer’s patients lacked standard scientific oversight.
As PositiveID spokeswoman Allison Tomek now admits, no Institutional Review Board (IRB) ever approved the study, which ended in 2009. IRBs are integral to sound medical science. As panels of experts and laymen, they’re supposed to authorize and oversee all studies on humans in order to guard against abuse and protect subjects' rights. According to four experts, PositiveID’s study would’ve required an IRB under federal regulations.
In a phone interview, Mrs. Tomek offered an excuse for not getting one. She insisted the Alzheimer’s initiative was a “project, not a study.” In an email, she explained: “…Our relationship with Alzheimer’s Community Care to provide their patients and caregivers with the microchip… was not a research study or experiment, so IRB review is not required.”
Her claim is belied by a company press release in which PositiveID CEO Scott Silverman explicitly called the initiative a study. “We are extremely pleased to partner with Alzheimer's Community Care on this relevant study,” he said. And, in filings to the SEC, PositiveID again called it a “two-year, 200 patient study.” The filing states: “We believe that if the results of these and other clinical studies… are sufficiently compelling, the Center for Medicare and Medicaid Services may determine that the Health Link microchip… is reimbursable under Medicare and Medicaid.” The transformation of the “study” into a “project” seems to be a recent semantic development.
Reached by phone, the CEO of Alzheimer’s Community Care, Mary Barnes, repeated the mantra that it was a so-called project. “We did participate in a project with [PositiveID],” she said, pausing dramatically. “A project. We had legal documents reviewed by counsel. The project was for the benefit of patients and caregivers…” When asked if the ACC had gotten an IRB, she abruptly hung up the phone.
“Whether you call it a project or a study is irrelevant,” said Dr. Robin Fiore, the FAU professor. “You could call it Fred. It’s obviously human subjects research.”
Dr. Kenneth Goodman, head of the University of Miami’s Bioethics Program, said of the study: “Any research that does not include an IRB does not meet the ethical standard.”
PositiveID’s study may have violated more than just a universal ethical standard for research. Dr. Deborah Peel, a practicing physician and founder of two national organizations on patient privacy, said in a phone interview that she thought the study “probably violates federal law.”
FAU professor Dr. Fiore agreed: “The problem here is failure to conform to regulations governing research,” Dr. Fiore said. “So it’s a regulatory violation subject to fines.” She confirmed PositiveID could even lose its FDA approval for the microchip. “It’s possible. That’s pretty nuclear, so the violation would have to be egregious."
And a CDC official in charge of regulating human research, who asked to remain anonymous, concurred, calling the study a “slam-dunk regulatory violation.” He elaborated in an email: “To conduct [a study] without independent review is not right — it may place people who have volunteered their time at risk… In terms of regulation, the device is not approved for this use, it falls under FDA regulation, and it requires independent review by an IRB.”
FDA press spokeswoman Karen Riley said by phone that she had asked the FDA’s own ethicists whether the study required an IRB. The answer she got was yes. “The bottom line is you would need an IRB because it’s a trial of a medical device,” she said. Another FDA spokesman, Dick Thompson, confirmed the study wouldn’t have been ethical without an IRB, but left the legal question open. In an email, he said: “We can't make a determination about this particular study based on the information we have in hand.” But, he said: “In general, we believe an IRB or its equivalent is ethically appropriate — if not required — for any study involving a human population, especially a population of vulnerable people such as those with Alzheimer's disease.”
Dr. Fiore articulated the risks of doing the study on Alzheimer’s patients. “There’s the question about implanting something in a person that may have health risks for frail people: their skin doesn’t heal as well and they’re much more subject to infections.” Alluding to reports in the Associated Press from 2005 that the chips caused tumors in mice, she also said: “It’s important to note that their [2004] FDA approval came before the information about the potential cancer risks occurred…The question of whether those are reasonable risks to express to people is part of what the IRB would have to decide. Without an IRB, I’m guessing they would never be mentioned."
It’s also doubtful whether PositiveID let test subjects know that the chip, according to its own manual, could malfunction in ambulances and around MRIs and X-ray machines due to radio interference. That would call into question the chip’s very purpose as a means of pulling up a person’s medical information in ambulances and hospitals.
What makes PositiveID’s alleged regulatory violation especially worrying is that the company announced last December it will be conducting a study on people with diabetes in Florida. Asked if there would be an IRB for that study, the company’s spokeswoman, Mrs. Tomek, said there “might or might not, depending on the elements in the study.” Meanwhile, Alzheimer’s Community Care, whose CEO hung up the phone rather than disclose whether her organization consulted an IRB, has been nominated for the 2010 “Best Practices Award” for non-profits by Palm Beach County’s Clerk and Comptroller.
Capping off the irony, this June the ACC and PositiveID will launch the 2010 Alzheimer’s Educational Conference, attracting speakers from across the United States to “educate family caregivers and healthcare professionals about the latest research and standards of care for those with Alzheimer's.” Given the accusation that the ACC and PositiveID flouted FDA regulations, those companies may be the ones most in need of an education.