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
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.
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.
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
"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
"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.
the agency know of the tumor findings before approving the chip
implants? The FDA declined repeated AP requests to specify what studies
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.
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
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
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.
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."
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.
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.
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.
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
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
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
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.
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.
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.
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.
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
The company is spending millions to assemble a national network of hospitals equipped to scan chipped patients.
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?
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."
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."
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
And what of former HHS secretary Thompson?
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
FDA's Watson said: "I have no recollection of him being involved in it at all." VeriChip Corp. declined comment.
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
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
"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
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
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.
a TV interview while still on the board, Thompson was explaining the
benefits - and the ease - of being chipped when an interviewer
"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?"
But to date, Thompson has yet to be chipped himself.