Thursday, Oct. 18, 2007
You may not know what
RFID stands for, but
you're probably using
the technology on a
daily basis. RFID (that
is, radio frequency
identification) is in
passports, in electronic
toll-collection tags, in
credit cards, metrocards,
library books and car
keys. Like conventional
bar codes, RFID chips
store and relay
information, and allow
for the identification
of commercial products —
and, now, of house pets
and people too. Human
"tagging" was approved
by the Food and Drug
Administration in 2004
to facilitate retrieval
of private medical
records, but the
procedure has had few
takers. It's still
purely voluntary and
last week, California
Gov. Schwarzenegger
sought to keep it that
way, signing a bill that
makes it illegal for
employers to force
workers to have RFID
devices implanted as a
means for receiving
paychecks or government
benefits.
But this summer, a large
pilot program involving
hundreds of human
patients got underway at
the Alzheimer's
Community Care agency in
West Palm Beach,
Florida. The maker of
the RFID chips used in
the program, VeriChip
Corporation, a
subsidiary of the Delray
Beach–based Applied
Digital Solutions, is
funding the initiative
and wants to market its
tags to the roughly 45
million high-risk
patients in the U.S.
with diseases such as
Alzheimer's, diabetes,
cancer and heart
disease. The company
says these patients can
benefit from having
instant and accurate
access to medical
records, which the chip
would provide. "The
medical community
understands the need for
a comprehensive
electronic medical
record that has
portability," says
VeriChip Chairman and
CEO Scott Silverman.
"What goes on in
emergency rooms and even
in practices today is
archaic. Pen-and-paper
record keeping is 97% of
medical records today;
98,000 deaths occurred
last year in emergency
rooms because of no
information or
inaccurate information."
To date 2,000 people
worldwide have
voluntarily had the
VeriChip tag implanted
into their upper right
arms, among them
patients with chronic or
debilitating disease —
as well as VIP patrons
of a Barcelona nightclub
and investigators
requiring special access
to confidential
drug-trafficking case
files at the Ministry of
Justice in Mexico. Over
the next two years,
VeriChip and Alzheimer's
Community Care plans to
inject 110 patients with
dementia or Alzheimer's
with the chip as well.
But VeriChip came under
fire in September —
shortly after the first
90 or so Alzheimer's
patients received its
chips in Florida — after
an AP report unearthed
studies suggesting the
chips may cause cancer
in laboratory animals.
Within two weeks of the
AP report, VeriChip's
stock plummeted from
just under $6 a share to
a low of $3.50, a
company spokesman says.
The AP cited three
studies published
between 1996 and 2006
that "found that lab
mice and rats injected
with microchips
sometimes developed
subcutaneous sarcomas —
malignant tumors, most
of them encasing the
implants."
In an exclusive
interview with TIME,
Silverman provided a
list of 34 studies the
company included in its
FDA application,
including one of the
three mentioned in the
AP article, which showed
that less than 1% of
4,279 chipped mice
developed tumors
"clearly due to the
implanted microchips"
but were otherwise
healthy, and that "no
clinical symptoms except
the nodule on their
backs were shown." The
second study, conducted
in France in 2006, two
years after VeriChip's
FDA application was
approved, found that
while 4% of the 1,260
mice in the study
developed tumors, none
of them were malignant.
As for the third study,
Silverman says it was
conducted in mice
specifically bred to
produce tumors, and was
therefore omitted from
the sheaf of studies
included in the FDA
application. Other
studies that were sent
to the regulatory agency
also showed tumor
growth, but associated
only with vaccination
sites.
Dr. Lawrence D. McGill,
a veterinarian and
leading expert in animal
pathology says the tumor
development in rodents
is unsurprising. "Even
if you put in a bland
piece of plastic, it
will produce tumors in
rats and mice," says
McGill, who assessed the
studies on behalf of
VeriChip. He says it
would be a leap to apply
the findings of studies
in mice to cats or dogs
— or to humans, for that
matter — which are much
more complex animals.
Few official scientific
studies have been
conducted on the effects
of microchip implants on
house pets, but none
have found a link
between the chips and
cancer, says McGill. If
there were a problem, he
says, we would have
already seen lots of
cancer among the
approximately 10 million
pets that have been
chipped over the past 15
years. Says Silverman,
"There are no reported
incidents to the FDA of
any cancer formation
around that."
In fact, there has been
one case of cancer — in
a French bulldog named
Leon — according to a
2006 study in Veterinary
Pathology. But it
remains unclear whether
the cancer was caused by
a microchip or as the
result of an injection,
or who the maker of the
chip was. The dog's
tumor was removed in
2004, and a later
examination found no
recurrence. It seems
that no one notified the
FDA about Leon, but his
case doesn't appear to
worry the agency, as
evident from a statement
it issued when the AP
brought Leon's story to
light in September. "At
this time, we continue
to believe that the
VeriChip is safe for
humans," the FDA said.
"In all the safety data
the FDA has reviewed for
this device, including
extensive animal data,
we have seen no evidence
suggesting toxic or
carcinogenic effects."
News of the tumor
studies haven't yet
dissuaded other groups,
including Alzheimer's
Community Care and the
American Veterinary
Medical Association (AVMA),
from encouraging the use
of RFID microchips.
Given the large number
of Alzheimer's patients
in South Florida and the
potential for natural
disasters such as
hurricanes and floods,
the VeriChip comes in
handy, says Mary Barnes,
president and CEO of
Alzheimer's Community
Care, because, unlike a
medical medallion, it
cannot be taken off or
lost. "In Palm Beach
County and South
Florida, we have
projected over 200,000
Alzheimer's patients,"
Barnes says. "When
you've got that kind of
risk out there for our
family members ... this
type of technology is a
godsend."
Over the next two years,
Barnes will monitor how
often medical records
change for each of the
patients in her agency's
RFID program, and will
track how the caregivers
work with the new
technology. "You don't
have to be a brain
surgeon to figure out
this has great
possibilities," she
says.
Meanwhile, a handful of
concerned pet owners
have expressed interest
in removing RFID chips
from their furry
companions, but VeriChip
hasn't heard of anyone
doing so yet. The AVMA
officially counsels
against removing the
chip, while assuring pet
owners it will continue
to monitor the
situation. "At this
point we do not
recommend that people
should stop
microchipping," says Dr.
Rosemary LoGiudice, a
veterinarian and
assistant director with
the AVMA. "We are
actively watching. For
the number of animals
that are said to
actually have
microchips, when you
consider the number of
animals that have been
microchipped and
returned to their
owners, the benefits are
huge compared to the few
and suspect cases that
have been reported to
have tumor formation."
At VeriChip, the outlook
remains hopeful.
Silverman says his
company is bracing for
the negative press by
gathering up studies
that prove the safety of
its product. Even though
the public hasn't yet
warmed to RFID tagging,
Silverman says that
sales are brisk and
expects this year to
double the 1.7 million
chips sold in 2006.
