- A surprise decision by the Food and Drug Administration
permits the use of implantable ID chips in humans, despite an FDA investigator's
recent public reservations about the devices.
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- The FDA sent chip manufacturer Applied Digital Solutions
a letter stating that the agency would not regulate the VeriChip if it
was used for "security, financial and personal identification or safety
applications," ADS said Tuesday.
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- But the FDA has not determined whether the controversial
chip can be used for medical purposes, including linking to medical databases,
the company added. In the United States, ADS has principally marketed VeriChip
as a life-saving tool, saying, for example, that unconscious patients brought
to emergency rooms could be scanned to determine their medical histories.
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- Repeated phone calls to the FDA's press office were not
returned Tuesday, and ADS refused to provide the media with a copy of the
agency's letter.
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- The decision comes five months after ADS made international
headlines by implanting three members of a Florida family with the VeriChip,
which is slightly larger than a grain of rice and emits a 125-kilohertz
radio frequency signal that can be picked up by a scanner up to four feet
away.
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- In an interview earlier this month, FDA investigator
Wally Pellerite said he was unaware of any implantable device that was
not regulated by the FDA. Cosmetic implants -ñ including breast
and penile enhancers -ñ undergo a rigorous FDA examination to determine
their effect on the human body despite having no medical function.
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- Although ID chips have been used in animals for years,
they may have "inherent risks" when used in humans, Pellerite
said in the interview.
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- On Tuesday, Pellerite referred questions to the FDA press
office.
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- "At this point, I can't say anything other than
to represent what the official agency opinion is in this matter,"
he wrote in an e-mail. "Previously I was free to give you both sides
of the argument and to point out the pros and cons to each. I am no longer
free to do that."
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- Applied Digital Solutions has gotten into hot water in
the past for issuing conflicting statements to the media and to the FDA
about the VeriChip's intended use. In May, the FDA launched an investigation
into the VeriChip when the company repeatedly referred to the chip as a
medical lifesaver in the media, yet assured officials it was merely an
identification device.
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- Tuesday's press release was also confusing, with ADS
repeatedly referring to VeriChip as a medical device despite the fact that
the FDA has not ruled whether the chip may be used for health purposes.
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- ADS president Scott Silverman did not comment on the
release, but said he was pleased with the FDA's decision.
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- "We'll now go into high gear with our sales, marketing
and distribution plans in the U.S.," he said, adding that the company
would be focusing on the security and ID aspects of the microchip.
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- Silverman said security applications could include using
the chip to control access to sensitive structures such as nuclear power
plants, government buildings or private businesses. An example of an ID
application could include "chipping" an Alzheimer's patient who
suffers memory loss and wanders away from home, he added.
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- Richard Smith, a privacy expert who <http://www.computerbytesman.com/>follows
the VeriChip, suggested the device should have been subjected to a full
FDA review to determine its safety.
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- "Does ADS have any data for complications of VeriChips
being installed in animals?" Smith asked. "Are there ever infection
problems or autoimmune rejections? Since the FDA has chosen to not test
the device, the next best thing is to try to understand if there have been
health-related problems in animals."
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- Meanwhile, Leslie Jacobs, the matriarch of the Florida
family chipped in May, said she hoped the FDA would approve the VeriChip
for medical use. Both her husband and son experience ongoing health problems.
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- "People who need this should be able to elect to
have it," she said. "The VeriChip could help saves lives."
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- http://www.wired.com/news/politics/0,1283,55952,00.html
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