Prisoners ‘to be chipped like dogs’
Though approved by FDA, microchip implants linked to cancer in animal studies
Though approved by FDA, microchip implants linked to cancer in animal studies
September 9, 2007
ORLANDO, Florida: When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients’ medical records almost instantly. The FDA found “reasonable assurance” the device was safe, and a sub-agency even called it one of 2005’s top “innovative technologies.”
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had “induced” malignant tumors in some lab mice and rats.
“The transponders were the cause of the tumors,” said Keith Johnson, a retired toxicologic pathologist, explaining the findings of a 1996 study he led.
Leading cancer specialists reviewed the research for The Associated Press and, while cautioning that animal test results do not necessarily apply to humans, said the findings troubled them. Some said they would not allow family members to receive implants, and all urged further research before the glass-encased transponders are widely implanted in people.
To date, about 2,000 radio frequency identification, or RFID, chips have been implanted in humans worldwide, according to VeriChip Corp. The company, which sees a target market of 45 million Americans for its medical monitoring chips, insists the devices are safe.
“We stand by our implantable products which have been approved by the FDA and/or other U.S. regulatory authorities,” said Scott Silverman, chairman and chief executive officer of the Delray Beach, Florida, company.
Management was “not aware of any studies that have resulted in malignant tumors” in laboratory animals, but he added that millions of pets have been implanted with microchips, without reports of significant problems.
The FDA also stands by its approval of the technology, but declined repeated AP requests to specify what studies it reviewed before approving the implants.
The agency 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 was formally announced on Jan. 10, 2005, Thompson left his Cabinet post, and by July was a board member of VeriChip Corp. and its parent company, 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, and played no role in FDA’s approval.
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, or even been aware of, the literature on cancer in chipped animals?
No, said Dr. Steven Stack, an AMA board member.
___
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, Connecticut, of 177 mice reported cancer incidence to be slightly higher than 10 percent — a result the researchers described as “surprising.”
_ A 2006 study in France detected tumors in 4.1 percent 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.
_ In 1997, a study in Germany found cancers in 1 percent 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, 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 humans are implanted on a large scale, he said, testing should be done on larger animals, such as dogs or monkeys. Sarcomas are life-threatening, he said, “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, said even though the tumor incidences were “reasonably small,” 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. Noting that control mice, which had received no test chemicals, also developed the cancers, he said: “That might be a little hint that something real is happening here.”
Dr. Cheryl London, a veterinarian oncologist at Ohio State University, noted it’s easier to cause cancer in mice than 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 have not reported outbreaks of related sarcomas. (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. 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.
___
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 the anesthetized upper arm. When scanned, it transmits a code that allows medics to access a patient’s medical records. VeriChip Corp. sees an initial market of diabetics and people with heart conditions or Alzheimer’s disease.
Did the FDA review literature on microchip implants and animal cancer before approving the VeriChip?
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, and eventually 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 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.
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.”
Dr. Neil Lipman, director of the Research Animal Resource Center at Memorial Sloan-Kettering, said microchips are not like pacemakers, which are vital to keeping someone alive, “so at this stage, the payoff doesn’t justify the risks.”
___
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.”
Thompson vigorously campaigned for electronic medical records and healthcare technology both as governor of Wisconsin and at HHS. While in President George W. Bush’s Cabinet, he formed a “medical innovation” task force, partnering FDA with companies developing 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: “the implantable chips and scanners of the VeriChip system our agency approved last week.”
After joining the company, 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, according to SEC records. He also received $40,000 (€29,206) 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.
Thompson, who left VeriChip Corp. in March, is a partner at a Washington law firm that was paid $1.2 million (€880,000) for legal services it provided the chip maker in 2005 and 2006, according to SEC filings.
Prisoners ‘to be chipped like dogs’
Hi-tech ‘satellite’ tagging planned in order to create more space in jails. Civil rights groups and probation officers furious at ‘degrading’ scheme
13 January 2008
By Brian Brady
Ministers are planning to implant “machine-readable” microchips under the skin of thousands of offenders as part of an expansion of the electronic tagging scheme that would create more space in British jails.
Amid concerns about the security of existing tagging systems and prison overcrowding, the Ministry of Justice is investigating the use of satellite and radio-wave technology to monitor criminals.
But, instead of being contained in bracelets worn around the ankle, the tiny chips would be surgically inserted under the skin of offenders in the community, to help enforce home curfews. The radio frequency identification (RFID) tags, as long as two grains of rice, are able to carry scanable personal information about individuals, including their identities, address and offending record.
The tags, labelled “spychips” by privacy campaigners, are already used around the world to keep track of dogs, cats, cattle and airport luggage, but there is no record of the technology being used to monitor offenders in the community. The chips are also being considered as a method of helping to keep order within prisons.
A senior Ministry of Justice official last night confirmed that the department hoped to go even further, by extending the geographical range of the internal chips through a link-up with satellite-tracking similar to the system used to trace stolen vehicles. “All the options are on the table, and this is one we would like to pursue,” the source added.
The move is in line with a proposal from Ken Jones, the president of the Association of Chief Police Officers (Acpo), that electronic chips should be surgically implanted into convicted paedophiles and sex offenders in order to track them more easily. Global Positioning System (GPS) technology is seen as the favoured method of monitoring such offenders to prevent them going near “forbidden” zones such as primary schools.
“We have wanted to take advantage of this technology for several years, because it seems a sensible solution to the problems we are facing in this area,” a senior minister said last night. “We have looked at it and gone back to it and worried about the practicalities and the ethics, but when you look at the challenges facing the criminal justice system, it’s time has come.”
The Government has been forced to review sentencing policy amid serious overcrowding in the nation’s jails, after the prison population soared from 60,000 in 1997 to 80,000 today. The crisis meant the number of prisoners held in police cells rose 13-fold last year, with police stations housing offenders more than 60,000 times in 2007, up from 4,617 the previous year. The UK has the highest prison population per capita in western Europe, and the Government is planning for an extra 20,000 places at a cost of £3.8bn – including three gigantic new “superjails” – in the next six years.
More than 17,000 individuals, including criminals and suspects released on bail, are subject to electronic monitoring at any one time, under curfews requiring them to stay at home up to 12 hours a day. But official figures reveal that almost 2,000 offenders a year escape monitoring by tampering with ankle tags or tearing them off. Curfew breaches rose from 11,435 in 2005 to 43,843 in 2006 – up 283 per cent. The monitoring system, which relies on mobile-phone technology, can fail if the network crashes.
A multimillion-pound pilot of satellite monitoring of offenders was shelved last year after a report revealed many criminals simply ditched the ankle tag and separate portable tracking unit issued to them. The “prison without bars” project also failed to track offenders when they were in the shadow of tall buildings.
The Independent on Sunday has now established that ministers have been assessing the merits of cutting-edge technology that would make it virtually impossible for individuals to remove their electronic tags.
The tags, injected into the back of the arm with a hypodermic needle, consist of a toughened glass capsule holding a computer chip, a copper antenna and a “capacitor” that transmits data stored on the chip when prompted by an electromagnetic reader.
But details of the dramatic option for tightening controls over Britain’s criminals provoked an angry response from probation officers and civil-rights groups. Shami Chakrabarti, director of Liberty, said: “If the Home Office doesn’t understand why implanting a chip in someone is worse than an ankle bracelet, they don’t need a human-rights lawyer; they need a common-sense bypass.
“Degrading offenders in this way will do nothing for their rehabilitation and nothing for our safety, as some will inevitably find a way round this new technology.”
Harry Fletcher, assistant general secretary of the National Association of Probation Officers, said the proposal would not make his members’ lives easier and would degrade their clients. He added: “I have heard about this suggestion, but we feel the system works well enough as it is. Knowing where offenders like paedophiles are does not mean you know what they are doing.
“This is the sort of daft idea that comes up from the department every now and then, but tagging people in the same way we tag our pets cannot be the way ahead. Treating people like pieces of meat does not seem to represent an improvement in the system to me.”
The US market leader VeriChip Corp, whose parent company has been selling radio tags for animals for more than a decade, has sold 7,000 RFID microchips worldwide, of which about 2,000 have been implanted in humans. The company claims its VeriChips are used in more than 5,000 installations, crossing healthcare, security, government and industrial markets, but they have also been used to verify VIP membership in nightclubs, automatically gaining the carrier entry – and deducting the price of their drinks from a pre-paid account.
The possible value of the technology to the UK’s justice system was first highlighted 18 months ago, when Acpo’s Mr Jones suggested the chips could be implanted into sex offenders. The implants would be tracked by satellite, enabling authorities to set up “zones”, including schools, playgrounds and former victims’ homes, from which individuals would be barred.
“If we are prepared to track cars, why don’t we track people?” Mr Jones said. “You could put surgical chips into those of the most dangerous sex offenders who are willing to be controlled.”
The case for: ‘We track cars, so why not people?’
The Government is struggling to keep track of thousands of offenders in the community and is troubled by an overcrowded prison system close to bursting. Internal tagging offers a solution that could impose curfews more effectively than at present, and extend the system by keeping sex offenders out of “forbidden areas”. “If we are prepared to track cars, why don’t we track people?” said Ken Jones, president of the Association of Chief Police Officers (Acpo).
Officials argue that the internal tags enable the authorities to enforce thousands of court orders by ensuring offenders remain within their own walls during curfew hours – and allow the immediate verification of ID details when challenged.
The internal tags also have a use in maintaining order within prisons. In the United States, they are used to track the movement of gang members within jails.
Offenders themselves would prefer a tag they can forget about, instead of the bulky kit carried around on the ankle.
The case against: ‘The rest of us could be next’
Professionals in the criminal justice system maintain that the present system is 95 per cent effective. Radio frequency identification (RFID) technology is unproven. The technology is actually more invasive, and carries more information about the host. The devices have been dubbed “spychips” by critics who warn that they would transmit data about the movements of other people without their knowledge.
Consumer privacy expert Liz McIntyre said a colleague had already proved he could “clone” a chip. “He can bump into a chipped person and siphon the chip’s unique signal in a matter of seconds,” she said.
One company plans deeper implants that could vibrate, electroshock the implantee, broadcast a message, or serve as a microphone to transmit conversations. “Some folks might foolishly discount all of these downsides and futuristic nightmares since the tagging is proposed for criminals like rapists and murderers,” Ms McIntyre said. “The rest of us could be next.”