RFID & FDA
Wireless RFID TAGS AND READERS FOR HUMANS
https://www.psqh.com/sepoct05/barcodingrfid1.html
Let's first look at the product - a tracking device on a pill - produced by Proteus Digital Health - partners of the Bill & Melinda Gates Foundation:http://web.archive.org/web/20130523013419/http://proteusdigitalhealth.com/company/partners
Press Release 14 November, 2017
Otsuka and Proteus® Announce the First U.S. FDA Approval of a Digital Medicine System: Abilify MyCite® (aripiprazole tablets with sensor)
Tokyo, Japan and Redwood City, Calif. – November 13, 2017 – Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announce that the United States Food and Drug Administration (FDA) has granted the first approval of a digital medicine system, ABILIFY MYCITE® (aripiprazole tablets with sensor), a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE® Patch (a wearable sensor, developed by Proteus); the MYCITE® APP, a smartphone application (app), used with a compatible smartphone to display information for the patient; and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. Only functions of the app related to tracking drug ingestion have been approved by the FDA.
Reading the WARNINGS AND PRECAUTIONS for this device (it can hardly be called a drug), you will notice that possibility of Sudden Death is mentioned:
It is an electronic device, which can involve risks.
This does not mean that if a patient is paralyzed, needs a pacemaker or any other device that can help them function, this kind of intervention is always wrong.
But these devices have obvious risks, shown in many studies, so there must be a good reason to use them.
Btw., according to a number of studies, psychological disorders are associated with increased levels of oxidative stress.
N-acetylcysteine NAC: The Amino Acid That Turns Psychiatry on Its Head - Research on N-acetylcysteine (NAC) illuminates an old question.
https://www.sciencedirect.com/science/article/abs/pii/S1471489216300558 Oxidative stress: a potential link between emotional wellbeing and immune response
CONCLUSION
In summary, accumulating evidence implicates free radical-mediated pathology, altered antioxidant capacity, neurotoxicity and inflammation in neuropsychiatric disorders. To what extent oxidative stress contributes to specific clinical symptomatology of these complex and debilitating psychiatric ailments remains to be seen. A major question remains regarding the causal role of oxidative stress in these illnesses, which is highly critical for early and preventive intervention.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9312055/ Oxidative Stress and Psychiatric Disorders: Evidence from the Bidirectional Mendelian Randomization Study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3964745/ Oxidative Stress and Psychological Disorders
and so on
At cardiovascular levels, oxidative stress is highly implicated in myocardial infarction, ischemia/reperfusion, or heart failure. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7554855/ Oxidative Stress in Cardiovascular Diseases - PMC (nih.gov)
Injectable Electronics
RFID & FDA
In 2004, the US Food and Drug Administration (FDA) approved Applied Digital Systems microchip implants for storing medical information.
In addition, the FDA also approved the Eversense Continuous Glucose Monitoring sensor in 2018.
RFID tags can be combined with a GPS and follow pets and people in real-time.
Description
Radio Frequency Identification (RFID) refers to a wireless system comprised of two components: tags and readers. The reader is a device that has one or more antennas that emit radio waves and receive signals back from the RFID tag. Tags, which use radio waves to communicate their identity and other information to nearby readers, can be passive or active. Passive RFID tags are powered by the reader and do not have a battery. Active RFID tags are powered by batteries.
RFID tags can store a range of information from one serial number to several pages of data. Readers can be mobile so that they can be carried by hand, or they can be mounted on a post or overhead. Reader systems can also be built into the architecture of a cabinet, room, or building.
Uses
RFID systems use radio waves at several different frequencies to transfer data. In health care and hospital settings, RFID technologies include the following applications:
Inventory control
Equipment tracking
Out-of-bed detection and fall detection
Personnel tracking
Ensuring that patients receive the correct medications and medical devices
Preventing the distribution of counterfeit drugs and medical devices
Monitoring patients
Providing data for electronic medical records systems
The FDA is not aware of any adverse events associated with RFID.
(!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!)
However, there is concern about the potential hazard of electromagnetic interference (EMI) to electronic medical devices from radio frequency transmitters like RFID. EMI is a degradation of the performance of equipment or systems (such as medical devices) caused by an electromagnetic disturbance.
The FDA is not aware of any adverse events associated with RFID…
https://www.medicalnewstoday.com/articles/82032#1
The articles cited by AP that were reviewed by the cancer experts were studies on lab mice and rats that sometimes developed sarcomas, or malignant tumors, after being implanted with microchips. The sarcomas sometimes encased the implants, said the AP report.
The articles were published in toxicology and veterinary journals between 1996 and 2006 and included:
A study conducted in 1996 by (now retired) toxicologic pathologist Keith Johnson at the Dow Chemical Co. in Midland, Michigan. Johnson said in a phone interview with AP “the transponders were the cause of the tumors”.
A study conducted in Germany in 1997 that found 1 per cent of over 4,000 RFID chipped mice had cancer which the authors concluded were “clearly due to the implanted microchips”.
A study conducted in Ridgefield, Connecticut, in 1998, on 177 mice that suggested the incidence of cancer was raised by just over 10 per cent.
A study conducted in France in 2006 where tumors were detected in 4.1 per cent of mice with microchip implants. The scientists were not looking for cancer induced by microchips when they started the study. They were testing chemicals but they ruled them out as the cause of the tumors.
For example, Dr Robert Benezra, who is head of the Cancer Biology Genetics Program at the Memorial Sloan-Kettering Cancer Center in New York said that:
“There’s no way in the world, having read this information, that I would have one of those chips implanted in my skin, or in one of my family members.”
https://abcnews.go.com/Technology/story?id=3577029&page=1
The FDA also stands by its approval of the technology.
Did the agency know of the tumor findings before approving the chip implants? The FDA declined repeated AP requests to specify what studies it reviewed.
The FDA is overseen by the Department of Health and Human Services, which, at the time of VeriChip's approval, was headed by Tommy Thompson. Two weeks after the device's approval took effect on Jan. 10, 2005, Thompson left his Cabinet post, and within five months was a board member of VeriChip Corp. and Applied Digital Solutions. He was compensated in cash and stock options.
Thompson, until recently a candidate for the 2008 Republican presidential nomination, says he had no personal relationship with the company as the VeriChip was being evaluated, nor did he play any role in FDA's approval process of the RFID tag.
"I didn't even know VeriChip before I stepped down from the Department of Health and Human Services," he said in a telephone interview.
Also making no mention of the findings on animal tumors was a June report by the ethics committee of the American Medical Association, which touted the benefits of implantable RFID devices.
Had committee members reviewed the literature on cancer in chipped animals?
No, said Dr. Steven Stack, an AMA board member with knowledge of the committee's review.
Was the AMA aware of the studies?
No, he said.
Malignant tumors found
Published in veterinary and toxicology journals between 1996 and 2006, the studies found that lab mice and rats injected with microchips sometimes developed subcutaneous "sarcomas" — malignant tumors, most of them encasing the implants.
• A 1998 study in Ridgefield, Conn., of 177 mice reported cancer incidence to be slightly higher than 10% — a result the researchers described as "surprising."
• A 2006 study in France detected tumors in 4.1% of 1,260 microchipped mice. This was one of six studies in which the scientists did not set out to find microchip-induced cancer but noticed the growths incidentally. They were testing compounds on behalf of chemical and pharmaceutical companies; but they ruled out the compounds as the tumors' cause. Because researchers only noted the most obvious tumors, the French study said, "These incidences may therefore slightly underestimate the true occurrence" of cancer.
• In 1997, a study in Germany found cancers in 1% of 4,279 chipped mice. The tumors "are clearly due to the implanted microchips," the authors wrote.
Caveats accompanied the findings. "Blind leaps from the detection of tumors to the prediction of human health risk should be avoided," one study cautioned. Also, because none of the studies had a control group of animals that did not get chips, the normal rate of tumors cannot be determined and compared to the rate with chips implanted.
Still, after reviewing the research, specialists at some pre-eminent cancer institutions said the findings raised red flags.
"There's no way in the world, having read this information, that I would have one of those chips implanted in my skin, or in one of my family members," said Dr. Robert Benezra, head of the Cancer Biology Genetics Program at the Memorial Sloan-Kettering Cancer Center in New York.
Before microchips are implanted on a large scale in humans, he said, testing should be done on larger animals, such as dogs or monkeys. "I mean, these are bad diseases. They are life-threatening. And given the preliminary animal data, it looks to me that there's definitely cause for concern."
Dr. George Demetri, director of the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute in Boston, agreed. Even though the tumor incidences were "reasonably small," in his view, the research underscored "certainly real risks" in RFID implants.
In humans, sarcomas, which strike connective tissues, can range from the highly curable to "tumors that are incredibly aggressive and can kill people in three to six months," he said.
At the Jackson Laboratory in Maine, a leader in mouse genetics research and the initiation of cancer, Dr. Oded Foreman, a forensic pathologist, also reviewed the studies at the AP's request.
At first he was skeptical, suggesting that chemicals administered in some of the studies could have caused the cancers and skewed the results. But he took a different view after seeing that control mice, which received no chemicals, also developed the cancers. "That might be a little hint that something real is happening here," he said. He, too, recommended further study, using mice, dogs or non-human primates.
Dr. Cheryl London, a veterinarian oncologist at Ohio State University, noted: "It's much easier to cause cancer in mice than it is in people. So it may be that what you're seeing in mice represents an exaggerated phenomenon of what may occur in people."
Tens of thousands of dogs have been chipped, she said, and veterinary pathologists haven't reported outbreaks of related sarcomas in the area of the neck, where canine implants are often done. (Published reports detailing malignant tumors in two chipped dogs turned up in AP's four-month examination of research on chips and health. In one dog, the researchers said cancer appeared linked to the presence of the embedded chip; in the other, the cancer's cause was uncertain.)
Nonetheless, London saw a need for a 20-year study of chipped canines "to see if you have a biological effect." Dr. Chand Khanna, a veterinary oncologist at the National Cancer Institute, also backed such a study, saying current evidence "does suggest some reason to be concerned about tumor formations."
Meanwhile, the animal study findings should be disclosed to anyone considering a chip implant, the cancer specialists agreed.
To date, however, that hasn't happened.
'Who's covering our backs?'
The product that VeriChip Corp. won approval for use in humans is an electronic capsule the size of two grains of rice. Generally, it is implanted with a syringe into an anesthetized portion of the upper arm.
When prompted by an electromagnetic scanner, the chip transmits a unique code. With the code, hospital staff can go on the Internet and access a patient's medical profile that is maintained in a database by VeriChip Corp. for an annual fee.
VeriChip Corp., whose parent company has been marketing radio tags for animals for more than a decade, sees an initial market of diabetics and people with heart conditions or Alzheimer's disease, according to a Securities and Exchange Commission filing.
The company is spending millions to assemble a national network of hospitals equipped to scan chipped patients.
But in its SEC filings, product labels and press releases, VeriChip Corp. has not mentioned the existence of research linking embedded transponders to tumors in test animals.
When the FDA approved the device, it noted some Verichip risks: The capsules could migrate around the body, making them difficult to extract; they might interfere with defibrillators, or be incompatible with MRI scans, causing burns. While also warning that the chips could cause "adverse tissue reaction," FDA made no reference to malignant growths in animal studies.
Did the agency review literature on microchip implants and animal cancer?
Dr. Katherine Albrecht, a privacy advocate and RFID expert, asked shortly after VeriChip's approval what evidence the agency had reviewed.
When FDA declined to provide information, she filed a Freedom of Information Act request. More than a year later, she received a letter stating there were no documents matching her request.
"The public relies on the FDA to evaluate all the data and make sure the devices it approves are safe," she says, "but if they're not doing that, who's covering our backs?"
Late last year, Albrecht unearthed at the Harvard medical library three studies noting cancerous tumors in some chipped mice and rats, plus a reference in another study to a chipped dog with a tumor. She forwarded them to the AP, which subsequently found three additional mice studies with similar findings, plus another report of a chipped dog with a tumor.
Asked if it had taken these studies into account, the FDA said VeriChip documents were being kept confidential to protect trade secrets.
After AP filed a FOIA request, the FDA made available for a phone interview Anthony Watson, who was in charge of the VeriChip approval process.
"At the time we reviewed this, I don't remember seeing anything like that," he said of animal studies linking microchips to cancer. A literature search "didn't turn up anything that would be of concern."
In general, Watson said, companies are expected to provide safety-and-effectiveness data during the approval process, "even if it's adverse information."
Watson added: "The few articles from the literature that did discuss adverse tissue reactions similar to those in the articles you provided, describe the responses as foreign body reactions that are typical of other implantable devices. The balance of the data provided in the submission supported approval of the device."
Another implantable device could be a pacemaker, and indeed, tumors have in some cases attached to foreign bodies inside humans.
But Dr. Neil Lipman, director of the Research Animal Resource Center at Memorial Sloan-Kettering, said it's not the same. The microchip isn't like a pacemaker that's vital to keeping someone alive, he added, "so at this stage, the payoff doesn't justify the risks."
Silverman, VeriChip Corp.'s chief executive, disagreed. "Each month pet microchips reunite over 8,000 dogs and cats with their owners," he said. "We believe the VeriMed Patient Identification System will provide similar positive benefits for at-risk patients who are unable to communicate for themselves in an emergency."
Tommy Thompson
And what of former HHS secretary Thompson?
When asked what role, if any, he played in VeriChip's approval, Thompson replied: "I had nothing to do with it. And if you look back at my record, you will find that there has never been any improprieties whatsoever."
FDA's Watson said: "I have no recollection of him being involved in it at all." VeriChip Corp. declined comment.
Thompson vigorously campaigned for electronic medical records and healthcare technology both as governor of Wisconsin and at HHS. While in President Bush's Cabinet, he formed a "medical innovation" task force that worked to partner FDA with companies developing medical information technologies.
At a "Medical Innovation Summit" on Oct. 20, 2004, Lester Crawford, the FDA's acting commissioner, thanked the secretary for getting the agency "deeply involved in the use of new information technology to help prevent medication error." One notable example he cited: "the implantable chips and scanners of the VeriChip system our agency approved last week."
After leaving the Cabinet and joining the company board, Thompson received options on 166,667 shares of VeriChip Corp. stock, and options on an additional 100,000 shares of stock from its parent company, Applied Digital Solutions, according to SEC records. He also received $40,000 in cash in 2005 and again in 2006, the filings show.
The Project on Government Oversight called Thompson's actions "unacceptable" even though they did not violate what the independent watchdog group calls weak conflict-of-interest laws.
"A decade ago, people would be embarrassed to cash in on their government connections. But now it's like the Wild West," said the group's executive director, Danielle Brian.
Thompson is a partner at Akin Gump Strauss Hauer & Feld LLP, a Washington law firm that was paid $1.2 million for legal services it provided the chipmaker in 2005 and 2006, according to SEC filings.
He stepped down as a VeriChip Corp. director in March to seek the GOP presidential nomination, and records show that the company gave his campaign $7,400 before he bowed out of the race in August.
In a TV interview while still on the board, Thompson was explaining the benefits — and the ease — of being chipped when an interviewer interrupted:
"I'm sorry, sir. Did you just say you would get one implanted in your arm?"
"Absolutely," Thompson replied. "Without a doubt."
"No concerns at all?"
"No."
But to date, Thompson has yet to be chipped himself.
From this study: https://onlinelibrary.wiley.com/doi/10.1002/adma.201907478 Injectable Biomedical Devices for Sensing and Stimulating Internal Body Organs
‘Lastly, electronic chips like radiofrequency identification (RFID) tags in high aspect ratio form could be injected into the subcutaneous region without surgery.
7.1. Injectable Radio Frequency Identification Tags
‘Microchip implants that can offer safe and permanent identification are essential for millions of animals around the world, as well as for humans. In 2004, the Food and Drug Administration (FDA) has approved an injectable form of RFID microchip for humans.’
https://www.sciencefocus.com/news/the-injectable-nanosensor-that-will-one-day-read-your-thoughts/
Researchers behind NeuroSWARM3 say its gold-plated nanosensors, which are the size of a single viral particle, could travel through the bloodstream and cross the blood-brain barrier. Once inside the brain they would act like a kind of antenna, turning neural activity into optical signals that could be wirelessly sent to an external device.
Longer term, potential applications sound like the stuff of science fiction: composing messages with your thoughts, controlling exoskeletons with your mind, the ability to monitor neurological disease with no invasive procedures.
"NeuroSWARM3 can convert the signals that accompany thoughts to remotely measurable signals for high precision brain-machine interfacing," said A Ali Yanik, co-author of the study.
"The technology is similar to RFID," Yanick told Science Focus, referencing the wireless radio frequency technology that underpins things like paying for goods with a smartphone.
"With RFID, you have a back-scattering signal and then you read a static signal which delivers you the barcode or whatever it may be. In our case, we have this barcode, which is the electrophysiological signal of the cells, but it's not static and we are reading it wirelessly."
The fact that the technology operates at the nanoscale is what makes it incredible. Despite their tiny size, each nanosensor particle includes wireless power transfer, electronic translation of neural signals and broadcasting of those signals. And because the neurosensors can pass the blood-brain barrier, it means that it can be injected directly into the bloodstream.
https://www.photonics.com/Articles/Injectable_Biosensors_Convert_Brain_Activities/a67210
To enable contactless measurement of brain activity, the nanoparticles that make up NeuroSWARM3 are injected into the bloodstream or directly into the cerebrospinal fluid. Once in the brain, the nanoparticles are highly sensitive to local changes in the electric field and can function indefinitely without a power source or wires.
The nanoparticles consist of a silicon oxide (SiO2) core measuring 63 nm across and a thin layer of electrochromically loaded poly (3, 4-ethylenedioxythiophene). A 5-nm-thick gold coating covers the nanoparticles and enables them to cross the blood-brain barrier.
The optical signals generated by the nanoparticles are detected using near-infrared light at wavelengths between 1000 and 1700 nm.
The researchers compare NeuroSWARM3 to a nanosize, electrochromically loaded plasmonic (electro-plasmonic) antenna operated in reverse. Its optical properties are modulated by the spiking electrogenic cells within its vicinity, rather than by a predefined voltage.
“We pioneered [the] use of electrochromic polymers — for example, PEDOT:PSS — for optical, wireless detection of electrophysiological signals,” Yanik said. “Electrochromic materials known to have optical properties that can be reversibly modulated by an external field are conventionally used for smart glass/mirror applications.”
A similar approach to NeuroSWARM3 uses quantum dots to respond to electrical fields. When the UCSC researchers compared the two technologies, they found that NeuroSWARM3 generated an optical signal that was four orders of magnitude larger than the quantum dot technology, and that the quantum dots required 10× higher light intensity and 100× more probes to generate an equivalent signal.
“We are just at the beginning stages of this novel technology, but I think we have a good foundation to build on,” Yanik said. “Our next goal is to start experiments in animals.”
https://ieeexplore.ieee.org/document/9217912
Impact Statement:
Implantable sensors are pivotal to telehealth systems enabling continuous monitoring of a patient's vital health signs wirelessly.
• Antennas are an integral element of these systems whose design is a complex task due to harsh and highly volatile in-body environment and requirements of robust and reliable performance while offering miniature structure, patient safety and biocompatibility. • A comprehensive critical review on the antenna design for implantable medical devices highlighting requirements, challenges, antenna types and human body effects on their performance shows that slotted patch antennas operating at higher frequencies can serve the purpose optimally. • The slotted patch antenna designed in the light of recommendations made offers a small size of 7.5×5×0.25 mm3 with a -10 dB bandwidth of 25 MHz, a near-omnidirectional pattern and a gain of 1.7 dBi.
Abstract:
Biomedical telemetry has gained a lot of attention with the development in the healthcare industry. This technology has made it feasible to monitor the physiological signs of patient remotely without traditional hospital appointments and follow up routine check-ups.
Implantable Medical Devices (IMDs) play an important role to monitor the patients through wireless telemetry.
IMDs consist of nodes and implantable sensors in which antenna is a major component.
The implantable sensors suffer a lot of limitations. Various factors need to be considered for the implantable sensors such as miniaturization,
patient safety, bio-compatibility,
low power consumption, lower frequency band of operation and dual-band operation to have a robust and continuous operation. The selection of the antenna is a challenging task in implantable sensor design as it dictates performance of the whole implant. In this paper a critical review on implantable antennas for biomedical applications is presented.
Great info on Neuroswarm, thank you. At least the good news is that God and Nature already gave us nanotech in our skin called melanin, which acts as a potential detox mechanism for heavy metals:
https://romanshapoval.substack.com/p/can-we-detox-nanotech-with-sunlight?
Are we nuts! Merging man and machine until the carbon based human is replaced by the silicone based cyborg! We are going down the path of exterminating humans! The only question I have is if nuclear eradication will come first!