Chip Implants Linked to Animal Tumors
- From: HL. Ward <hward@xxxxxxxx>
- Date: Sat, 08 Sep 2007 15:48:32 -0500
Chip Implants Linked to Animal Tumors
AP IMPACT: Though Approved by FDA, Microchip Implants Linked to Cancer
in Animal Studies
By TODD LEWAN
The Associated Press
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.verichipcorp.com
http://www.antichips.com
http://www.fda.gov/cdrh/
http://abcnews.go.com/US/wireStory?id=3575737
.
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