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 Pressfrom 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.
Interesting, and addressing some important issues. But what relevance does it have to this website? I can't see that they're making any implausible or paranormal claims, unless the implant chip somehow relies on woo like some of the bomb/gold/whatever detector devices quite properly questioned here. If this site starts addressing issues of ethics and so forth, important though they are, doesn't it tend to lose its focus?
Articles like this I like to find on the excellent Science Based Medicine. Not here.
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... written by Debordian,
March 17, 2010
To me, the story seems to be an examination of the way we are made vulnerable by our scientific illiteracy. If the caregivers from Alzheimer's Community Care had been science-literate, they would have known how to make sure the microchip's manufacturers had done their due diligence before injecting their loved ones. It's an important point: Merely disbelieving in woo isn't enough to save one from the scientifically unscrupulous.
- Thom Debord
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back to basics written by ClareZ,
March 17, 2010
Chilling in its way, but has what to do with JREF? The previous explanation is a huge stretch at best.
I personally, am looking for more paranormal and supernatural claims questioned, debunked or explained.
From the JREF website: The Foundation's goals include:
* Creating a new generation of critical thinkers through lively classroom demonstrations and by reaching out to the next generation in the form of scholarships and awards. * Demonstrating to the public and the media, through educational seminars, the consequences of accepting paranormal and supernatural claims without questioning. * Supporting and conducting research into paranormal claims through well-designed experiments utilizing "the scientific method" and by publishing the findings in the JREF official newsletter, Swift, and other periodicals. Also providing reliable information on paranormal and pseudoscientific claims by maintaining a comprehensive library of books, videos, journals, and archival resources open to the public. * Assisting those who are being attacked as a result of their investigations and criticism of people who make paranormal claims, by maintaining a legal defense fund available to assist these individuals.
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... written by GeekGoddess,
March 18, 2010
@ClareZ
Um, promoting critical thinking by exposing scams? Teaching people to think critically about all sorts of topics will inoculate them against believing in ghosts, alien abductions, pseudoscience and alternative health quacks.
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Sauce for the goose written by pxatkins,
March 18, 2010
Not acquiring an IRB before implanting such devices makes you no better than those aliens that visit US backroads all the time ...
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... written by KRL,
March 18, 2010
If anyone comes up with a "Godwin Award", Glenn Beck would win, hands down. To him, Hitler and/or the Nazis are responsible for damn near everything these days. It's enough to make a grown man cry.
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Just Fox bashing or was there a point? written by Able,
March 18, 2010
Normally I agree with just about every article posted here. However, seems like this was just another Fox bashing (yeah, they deserve it sometimes). However, you didn’t mention the CNN coverage (Miles Obrien for one) which gave it a positive spin esp regarding epileptics, diabetics and other medical conditions. They did not talk about the ethical problems of inserting rfid chips into people who are unable to give consent. However, as had been pointed out, I am not sure what relevance it has to the “James Randi Educational Foundation---resource on the paranormal, pseudoscientific and the supernatural. Please, lets not let our personal bias regarding news sources get in the way of what Randi originally got us together for.
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Maybe useless and unethical marketing but written by Skeptigirl,
March 18, 2010
The rice-grain sized device is stuck into the flesh with a nearly foot-long syringe.
Come on folks. How long the syringe is which is used is absolutely irrelevant. Do you need to exaggerate the harm, pretending this is painful or barbaric, in order to discuss the legitimate issues here of unethical marketing of a product no one needs?
I think not.
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Re informed consent written by Skeptigirl,
March 18, 2010
inserting rfid chips into people who are unable to give consent
Let's get something else straight here. There are more than enough Alzheimer's patients with next of kin to provide consent. If the researchers purposefully looked for patients with no next of kin, that is outrageous. If that were the case, then whomever the legal guardians were which consented should have their bank accounts searched for any payoffs that might have occurred. I doubt this is the case. Even patients with no next of kin are afforded legal guardians by the courts. The guardians are typically volunteers, or they have some other qualifications for which reimbursement is deserved.
There isn't some pool of people out there scattered throughout institutions with no one responsible for their welfare, at least not in the US.
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As for Fox bashing written by Skeptigirl,
March 18, 2010
seems like this was just another Fox bashing
Glenn Beck also promotes investing in gold on his shows while taking money from gold dealers for advertising. Exposing his unethical behavior in a Swift article is more than deserved. Unless I missed it, the only mention of Fox news was a reference to Beck:
On his Fox News show last October, Glenn Beck reinforced the idea that the chip is a big help to Alzheimer’s patients
.
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How is marketing deceit not under the purview of JREF? written by Skeptigirl,
March 18, 2010
But what relevance does it have to this website? I can't see that they're making any implausible or paranormal claims,
Wow! Where did you get the idea critical thinking didn't include addressing the lack of it regarding misleading marketing techniques?
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Lack of Ethical Review Board seems to be the biggest failing here. written by Skeptigirl,
March 18, 2010
That and what looks like creating their own journal to publish in.
Here's the journal suspiciously called RFID making one wonder just who is behind it that isn't involved in selling RFIDs? http://www.rfidjournal.com/article/view/3340 ... and an article about this 'project'/research which states:
Alzheimer's patients who volunteer to participate for this pilot, and their families, must first meet with their physicians. If the physician supports the implantation, the patient or doctor provides VeriChip with that person's medical history, as well as a list hospitals authorized to access the patient's records. All medical records are stored in an Internet-based site, hosted by VeriChip. Hospitals unauthorized to access the records would be unable to open the file.
The chip contains no data other than a 16-digit ID number, says Silverman, preventing inappropriate parties from gaining any information, even if they were able to scan the implant. Moreover, he adds, the VeriMed tag can be scanned only by a VeriMed reader because no other RFID systems can currently read tags with 16-digit ID numbers.
The fact the patient's physician is involved seems to be left out of the cries of 'no ethics oversight'. It's not exactly up to the usual medical research standards, and that is valid criticism. But it would seem some of the 'Mark of the Beast CTers' and other 'government/1984 CT believers' are influencing an exaggeration with a tad of fabrication of the actual issues here.
But I'll defer to other opinions until I read more about it.
None of this means the complaint of marketing a useless product, or, a useful product under bogus claims exaggerating the actual uses is not also a valid criticism here. It's unlikely this will ever be used to find lost patients. But it could be used to provide medical histories for patients without having to find unreachable kinfolk or stored medical records, kind of like a longer version of a medical ID bracelet.
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We need to bash them all. written by Able,
March 18, 2010
Glenn Beck also promotes investing in gold on his shows while taking money from gold dealers for advertising. Exposing his unethical behavior in a Swift article is more than deserved.
Gotten a little off track but had to say good points Skeptigirl. Only problem for me is that CNN, ABC, FOX in fact most of them accept money from Chemical and oil companies and… well as you know they line their pockets with advertising money for many products (even PBS). As for gold, it has treated me very well (nothing to do with Beck). However, kind of wish I hadn’t sold most of it last fall but Sylvia told me it had peaked
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PBS, tell me about it... written by Skeptigirl,
March 18, 2010
had to say good points Skeptigirl. Only problem for me is that CNN, ABC, FOX in fact most of them accept money from Chemical and oil companies and… well as you know they line their pockets with advertising money for many products (even PBS).
Thanks for the compliment.
Re PBS, we could use a Swift comment or two on the fact PBS has adopted a policy of putting on the hourlong infomercials under the guise of some free giveaway to donors. It's like PBS doesn't get it that they've been conned, or they don't care and are happy to raise donations on the coattails of the infomercial scams. Watch the pattern. The seller gets to put on their free infomercial, usually with some self improvement theme, and instead of paying the price of an hourlong infomercial, all they have to do is offer free products to PBS donors. And you can bet those free products come with some arrangement to either pay shipping and handling, or to enroll in an automatic refill program, or maybe to just collect the buyer's address for future direct mail marketing after they've identified as a gullible customer.
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Oh no..... (1) written by kdv,
March 18, 2010
@Skeptigirl
I'm feeling a little sad. I've so often wished I could expressed very good points as well as you do. Yet here, in one topic, I find three consecutive posts from you that I really have to take issue with.
1) Addressed to me: Wow! Where did you get the idea critical thinking didn't include addressing the lack of it regarding misleading marketing techniques?
I have reread my post twice. I cannot find even an implied suggestion that this is my belief. Notwithstanding the fact that it isn't. However, I find it hard to think of any decision in life that doesn't require critical thinking skills. Are you really comfortable with the idea that any issue that could benefit from critical thought should be published on the JREF site? Financial decisions? Where to live? What car to buy? What person you should marry? The site would become like an agony aunt column!
ClareZ quoted from the JREF's goals. There is a lot of stress there on paranormal and pseudoscientific claims. That's why I come here. If I want medical discussions or ethical discussions, I go elsewhere eg Science Based Medicine, which tends to have a contributing team very attuned to and knowledgeable about these issues. The main emphasis of this posting was the ethics of the trial, not the working of the device. I specifically stated that I thought this wasn't an issue for JREF, not that it was unimportant or shouldn't be discussed. My cats have similar ID chips in their shoulders. They work. They have reunited many pets with their owners. Their functioning is not woo. The ethics of their testing or marketing is certainly a valid topic for skeptical assessment, in the appropriate place. I just don't think that this is that place.
Continued next message...
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Oh no..... (2) written by kdv,
March 18, 2010
@Skeptigirl
2) There are more than enough Alzheimer's patients with next of kin to provide consent. If the researchers purposefully looked for patients with no next of kin, that is outrageous. If that were the case, then whomever the legal guardians were which consented should have their bank accounts searched for any payoffs that might have occurred.
I'm sorry, but again, where in the original article does it say that they "purposefully" looked for patients with no next of kin? I realise you used the "If", but asking the question at all raises the suggestion that it may have been their policy. I can see nothing to suggest that here. They say that 'many' of their patients could not give consent themselves, so their guardians did. Given the nature of the device, I'd be surprised if that wasn't the case.
As to your second sentence, I admit that I do not know the legal situation in the US. However, here in Australia, people appointed to manage the finances of an incapable person have to account very carefully indeed for what they do. I know. I am doing it. I have managed ALL my mother-in-law's finances for almost 10 years now, while she sits there with a blank look on her face. Do you have any idea how much work that involves? Do you really, honestly think that it'd be worth somebody's time to do that amount of work just to get whatever trivial [by comparison] bribe by way of allowing their loved one to be subject to an experimental advice? I can think of so many easier ways I could steal from her if I wanted to, despite having to provide the Protective Commissioner a full financial report every year detailing every cent [literally!] I have spent on my mother-in-law's behalf.
I understand that you did not say that *all* carers might do that. You did say they should all have their bank accounts examined. So they all have to prove their innocence, just in case there is a suspicion, unsupported by any evidence, that somebody may have been bribed.
To be continued....
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Oh no..... (3) written by kdv,
March 18, 2010
@Skeptigirl
3) legitimate issues here of unethical marketing of a product no one needs?
The first part, up to 'product', I have no quarrel with. It's the last three words I question. I assume you are basing this on the quoted statements of Dr Fiore. I remind you that she is a professor of ethics. She may well have expertise in geriatric psychiatry, but I see nothing to indicate that. I also see nothing to justify her suggestions ( or accusations ) that the company is claiming, or the patients ( or guardians ) believe, or have been led to believe, that the device will help locate a missing patient. The company head specifically stated that the device helped identify people. It probably does.
What does make me doubt her expertise in the area is the statement "Usually, the difficulty is in finding missing Alzheimer's patients, not identifying them.". Sorry, but I do have a fair amount of experience, both professional and personal, in geriatric care. And my experience is that more often than not, identification is indeed the greater difficulty. Yes, they are eventually identified, but often after a delay of many terribly anxious hours of worry for the patient's family, and for the patient for him/herself if they are aware enough to understand the problem. If something may shorten the pain of everybody involved, at not-too-arduous expense and inconvenience, then that is certainly not useless.
I am not suggesting that this device is necessarily the only, or even the best, way of achieving this. My point is that in this respect, the company involved may be making a valid point. The ethics of their promotion is a separate issue. If I say a nice massage feels good, and it cures cancer, the lie of the second part does not invalidate the truth of first part.
Skeptigirl, I am not trying to flame you. I generally love your posts. But here I have to take exception. Maybe I'm way off beam. Maybe one of us is having a bad day. [ Ok, I definitely am. I'm getting a toothache. All contributions to my upcoming dentist bills will be gratefully received ].
[Ok, begging for money isn't really within the goals of JREF. But you do have to exercise critical thought in deciding whether to send it to me ..... ]
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Pseudoscience is pseudoscience written by Ganymede Ceriaptrix,
March 19, 2010
Pseudoscience of whatever nature is in the JREF's field of endeavour, and it is rightly a concern of the JREF that organisations promoting pseudoscience are called attention to in the JREF's press -- of whatever nature. The Foundation is not The Ghostbuster-Only Club; and, no matter how you cut it, this case is pseudoscience. Implanting ID chips cannot assist Alzheimer's disease patients in any way, even though this is precisely what PositiveID claims.
If the JREF were truly to focus only on claims of the paranormal, where would we be in matters such as (you may recall) the Zicam nasal swabs which contained an active medical ingredient that caused people to lose their sense of taste, the "paranormal" element only existing as a minor claim on the manufacturer's behalf to be "homeopathic"? What sort of responsible skeptics would focus only on those claims they feel jar with irrational beliefs, when those claims that appear to be based on a veneer of rationality and medical sense are just as pernicious?
I sincerely hope that all skeptics will learn this point: that their skills are not only for showing there is no ghost behind the cellar door.
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Reply to kdv: written by Skeptigirl,
March 19, 2010
I'm feeling a little sad. I've so often wished I could expressed very good points as well as you do. Yet here, in one topic, I find three consecutive posts from you that I really have to take issue with.
I appreciate the comments.
I have reread my post twice. I cannot find even an implied suggestion that this is my belief. Notwithstanding the fact that it isn't. However, I find it hard to think of any decision in life that doesn't require critical thinking skills. Are you really comfortable with the idea that any issue that could benefit from critical thought should be published on the JREF site? Financial decisions? Where to live? What car to buy? What person you should marry? The site would become like an agony aunt column!
I think I understand your issue. Point taken about my assumptions regarding your value of critical thinking, so my apologies there. But you are talking about the influence of values in decision making, not empirical critical thinking. I understand how this looks like a matter of values to you here considering the ethics issues discussed. We are looking at two different things within this issue.
Let me give you my perspective here following your further comments:
ClareZ quoted from the JREF's goals. There is a lot of stress there on paranormal and pseudoscientific claims. That's why I come here. If I want medical discussions or ethical discussions, I go elsewhere eg Science Based Medicine, which tends to have a contributing team very attuned to and knowledgeable about these issues. The main emphasis of this posting was the ethics of the trial, not the working of the device. I specifically stated that I thought this wasn't an issue for JREF, not that it was unimportant or shouldn't be discussed. My cats have similar ID chips in their shoulders. They work. They have reunited many pets with their owners. Their functioning is not woo. The ethics of their testing or marketing is certainly a valid topic for skeptical assessment, in the appropriate place. I just don't think that this is that place.
Ethics is integrated into medical research, you cannot segregate it. But that wasn't the key point that concerned me from the article. Because there was some kind of consent here regardless of it being as informed as it should have been, and, the harm to the patients in this case was close to nil. That's why I noted the exaggeration of suffering injecting a computer chip under the skin entailed.
What was unethical, and related to promoting woo, was using the research subjects as pawns in a marketing scheme. The benefit of the implanted tags is already established as akin to a detailed medical ID bracelet. For a patient with no memory, such a product does have some use. The producers apparently want to make the claim this product would help keep wandering Alzheimer's patients safer. That would expand their market. But unlike pets who wander, it's unlikely you need a chip to find the owner of a lost person.
If the chip producers took this "project" through the usual research protocols, the consent is not the issue. What they want to avoid, in my opinion, is having to demonstrate their claim was valid, that this device offers protection for wandering Alzheimer's patients. That is the false claim they are trying to make.
Whenever you see someone circumventing research protocols, informed consent is only one red flag people might want to consider. But chances are pretty good there is something fishy going on.
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Clarification written by Skeptigirl,
March 19, 2010
I'm sorry, but again, where in the original article does it say that they "purposefully" looked for patients with no next of kin?
My point was that was highly unlikely.
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Continued reply to kdv: written by Skeptigirl,
March 19, 2010
The first part, up to 'product', I have no quarrel with. It's the last three words I question. I assume you are basing this on the quoted statements of Dr Fiore. … I also see nothing to justify her suggestions ( or accusations ) that the company is claiming, or the patients ( or guardians ) believe, or have been led to believe, that the device will help locate a missing patient. …
What does make me doubt her expertise in the area is the statement "Usually, the difficulty is in finding missing Alzheimer's patients, not identifying them.". Sorry, but I do have a fair amount of experience, both professional and personal, in geriatric care. And my experience is that more often than not, identification is indeed the greater difficulty. Yes, they are eventually identified, but often after a delay of many terribly anxious hours of worry for the patient's family, and for the patient for him/herself if they are aware enough to understand the problem. ….I am not suggesting that this device is necessarily the only, or even the best, way of achieving this.
My point is that in this respect, the company involved may be making a valid point. The ethics of their promotion is a separate issue. If I say a nice massage feels good, and it cures cancer, the lie of the second part does not invalidate the truth of first part.
How is the expensive chip any better than just putting an ID bracelet on the person? And if there is a demonstrable benefit, why do you think they are skirting using legit research protocols?
Our main difference here seems to merely be one of focus. I brushed off the informed consent aspect from the start and you saw it as the key to the complaint. The red flag for me is, why were these people circumventing research protocols? Surely the informed consent issue would not have been more than a bump in the road.
There are thousands of products which are marketed on the basis of some tiny little pilot study or some other completely inadequate research. Claims are made distorting the scientific evidence. Why go beyond the pilot study and risk finding evidence the product does not do as claimed? This pattern is repeated again and again. In addition to selling these bogus products, these unethical marketers undermine the integrity of science. They water down what it means to be supported by scientific evidence. They confuse people who have not learned what does constitute real scientific research.
Here this company appears to be using a typical technique. Call something a 'project' and not a study. Then imply it was a study without revealing the deficiency, it was never demonstrated that the implanted chip did what was claimed: help an ED manage a 'found' person with no memory.
Here's what the marketers claimed from the link I posted above:
The two-year project, says Mary M. Barnes, president and CEO of ACC, will employ Verichip Corp's VeriMed system to help identify patients who arrive at an emergency room in an unresponsive state. … One safety concern, Barnes says, involves the lack of information available to medical personnel when patients unable to speak for themselves are admitted to a hospital during an emergency, unaccompanied by caregivers. ..
While the benefit would be valid, the circumstances have to occur often enough to support the cost of implanting the chip in thousands and thousands of patients who will never need it.
The question here is, just how many patients of these 200 can be expected to arrive at an ED unaccompanied by a caregiver? If this were a legit claim, there would be no reason not to follow a normal research protocol. So why are they not doing that?
These chip makers are trying to expand their market by claiming a need is met by the chip. They want to say they have research showing the benefit of implanting the chip in Alzheimer's patients. You can bet they are going to (if they haven;t already) proclaim this project was a great success. If they followed a research protocol, peer review would likely say, no harm but no benefit demonstrated. Not a single unaccompanied patient showed up in a single ED during the study period.
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Correction: written by Skeptigirl,
March 19, 2010
Lack of Ethical Review Board seems to be the biggest failing here. written by Skeptigirl, March 18, 2010
I don't agree with my own comments here after more careful look into the issues. Strike "biggest" and insert "one".
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Phew... written by kdv,
March 19, 2010
Thanks for the clarification, Skeptigirl, I think we're probably pretty close, perhaps (as you said) mainly differing on perspective, rather than the fundamentals. For example, you correctly identified some of the examples I raised as being value issues, rather than critical thinking as such. I agree, and that's why I used them. They are indeed value issues, but so is the very nature of 'ethics'. My initial point was that the major focus of this article was on ethics issues ... the lack of a proper approval process, the nature of the consent obtained, and so on. The ethics of the issue is something I don't really feel is relevant to this site [ and I again stress, I am not saying they are unimportant ], hence my usage of other values-based issues. I wasn't suggesting they were equivalent, only that if you stretch the 'critical thinking' rationale too far, it can lead to a diminished focus. I'm sure you understand my point of view, and that I understand yours.
Your point about the identity bracelets was also quite correct. It's why I specifically stated that I wasn't suggesting that these devices were necessarily the only, or the best, solutions to the problem. You identified one area [ medical information ] where they may have some advantage, but I think we'd both like to see more detailed information before deciding that one.
From what I've read in this article, I'd be pretty confident that their 'trial', whatever you call it, would not be either legal or ethical here in Australia, if it was run the way it was described. On the other hand, there are no examples of their advertising quoted, so I'd have to see some to be convinced that their advertising was unethical, much less 'woo'.
I'm glad we're not all that far apart.
I still have a toothache though.
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Forget ethics, think red flag. written by Skeptigirl,
March 19, 2010
no examples of their advertising quoted
If there was an alternative explanation for avoiding normal scientific research protocols and calling something a project instead of a study, you can bet it involves profits and a concern real science might be counter to promoting the product.
Valid scientific protocols don't differ from country to country. False advertising, on the other hand, may be more rampant here in the US. It's one of my pet peeves which is probably why I focused on it in this example.
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Articles like this I like to find on the excellent Science Based Medicine. Not here.