Chip Implants
Linked to Animal Tumors
By
TODD LEWAN
The Associated Press
Saturday, September 8, 2007; 2:04 PM
Source:
http://www.washingtonpost.com/wp-dyn/content/article/2007/09/08/AR2007090800997_pf.html
-- 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.