Since 09-10-07
Complete text of AP's cancer
chip implant story
Since 09-10-07
From: caspian-newsletter-l-bounces@nocards.org [mailto:caspian-newsletter-l-bounces@nocards.org]
On Behalf Of Katherine Albrecht
Sent: Monday, September 10, 2007 8:00 AM
To: newsletter
Subject: [Caspian-newsletter-l] Complete text of AP's implant story // Radio
today
Here is the full text of the AP's cancer chip article. Be sure to click the link
right under the headline, to see all the photos that accompanied the story.
I'll be covering this issue on my radio broadcast all week on We The People
Radio Network from 10:00 AM - Noon EST. (
http://www.wtprn.com ) This morning I'll be interviewing Danielle
Brian from The Project on Government Oversight to discuss Tommy Thompson's role
in this debacle.
We'll also be opening the phone lines for your comments. Join us!
- Katherine Albrecht
________________________________________________________________________
Chip Implants Linked to Animal Tumors
TODD LEWAN, Associated Press
http://www.bradenton.com/439/story/141238.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.
,,,
On the Web:
http://www.verichipcorp.com
http://www.antichips.com
http://www.fda.gov/cdrh/
Article's URL:
http://www.bradenton.com/439/story/141238.html