[Cagdu] FW: [K9Scoop] USA: concern raised about microchips

[tina thomas]

Subject: [K9Scoop] USA: concern raised about microchips



The motivation for this article is exposure of
potentially negative consequences of using microchips
in humans, but the material contained herein is worthy
of attention for dog-owners. 

Chip Implants Linked to Animal Tumors -
washingtonpost.com

URL: 
http://www.washingt
<http://www.washingtonpost.com/wp-dyn/content/article/2007/09/08/AR200709080
0997_pf.html>
onpost.com/wp-dyn/content/article/2007/09/08/AR2007090800997_pf.html

washingtonpost.com
Chip Implants Linked to Animal Tumors

By TODD LEWAN
The Associated Press
Saturday, September 8, 2007; 2:04 PM

-- 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 in a phone interview the findings of
a 1996 study he led at the
Dow Chemical Co.
in Midland, Mich.

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 of the so-called radio frequency
identification, or RFID, devices 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, as does its parent company,
Applied Digital Solutions,
of Delray Beach, Fla.

"We stand by our implantable products which have been
approved by the FDA and/or other U.S. regulatory
authorities," Scott Silverman, VeriChip Corp. chairman
and chief executive officer, said in a written
response to AP questions.

The company was "not aware of any studies that have
resulted in malignant tumors in laboratory rats, mice
and certainly not dogs or cats," but he added
that millions of domestic pets have been implanted
with microchips, without reports of significant
problems.

"In fact, for more than 15 years we have used our
encapsulated glass transponders with FDA approved
anti-migration caps and received no complaints
regarding
malignant tumors caused by our product."

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.

___

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.
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
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, 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.

___

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."

___

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 chip maker
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.

___

On the Web:

http://www.verichip <http://www.verichipcorp.com> corp.com
http://www.antichip <http://www.antichips.com> s.com
http://www.fda. <http://www.fda.gov/cdrh/> gov/cdrh/
C 2007 The Associated Press

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