Chip Implants Linked to Animal Tumors
By Todd Lewan -
2 days ago (September 9, 2007
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.
Copyright © 2007 The
Associated Press. All rights reserved.
