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Though approved by FDA, microchip implants linked to cancer in animal studies ... VERY IMPORTANT

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Old May 18th 08, 03:34 PM posted to alt.support.breast-implant,talk.politics.medicine,sci.med.nursing,misc.kids.health
Ilena Rose
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Posts: 1,139
Default Though approved by FDA, microchip implants linked to cancer in animal studies ... VERY IMPORTANT

Health Lover Ilena Rosenthal notes: I spoke with a young mother
recently who told me that the Texas Hospital her daughter had been
born in ... highly recommended she be microchipped.


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, Fla.

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 took effect 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, Conn., 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

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 haven't 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

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 aren't 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 Bush's Cabinet, he formed a "medical innovation" task
force, partnering FDA with companies developing information

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

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 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 for legal services it
provided the chip maker in 2005 and 2006, according to SEC filings.

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