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Page 1: Getting under Your Skin

Some features of Applied DigitalSolutions’s VeriChip:

■ 12 millimeters long by 2.1 millimeters wide

■ Encased in glass ■ Special polyethylene sheath

bonds to skin

■ Cost of being “chipped”: $200 ■ Expected lifetime: 20 years

FAST FACTS:CHIPS, ANYONE?

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When identification microchips wereimplanted in members of the Jacobsfamily on the Today show last May,

George Orwell’s surveillance society seemedto be another step closer. But confusion overthe chip’s medical status and even safety,among other stumbling blocks, has left manywondering if the era of the embedded humanID really is at hand.

For several months, Applied Digital So-lutions (ADS) in Palm Beach, Fla., has beenoffering an integrated chip, called the Veri-Chip, that is about the size of a grain of riceand is injected beneath the dermal layers. Op-erating just like those in millions of pets, the

chip returns a radio-frequency signal from awand passed over it. The chip can serve as ba-sic identification or possibly link to a data-base containing the user’s medical records.ADS is also planning a chip with broadcast-ing capabilities—a kind of human “lojack”system that could signal the bearer’s GPS co-ordinates, perhaps serving as a victim beaconin a kidnapping.

As of mid-November 2002, 11 people inthe U.S. and several people overseas had been“chipped,” says ADS president Scott R. Sil-verman. But the company ran into problemsafter the VeriChip’s May rollout. BecauseADS had said the chip data could be trans-

mitted to an “FDA compli-ant” site, the Food and DrugAdministration insisted ontaking a closer look. (Addingto ADS’s woes, stockholdersfiled class action lawsuits al-leging that ADS had falselyclaimed that some Florida-area hospitals were equippedwith scanning devices. Andthe company’s stock price,which rose by almost 400percent last April and May,tanked last summer and wasdelisted from the Nasdaq.)

On October 22, 2002,the FDA somewhat surpris-

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Getting under Your SkinREGULATORY QUESTIONS ABOUT IMPLANTABLE CHIPS PERSIST BY DAVID APPELL

SCANnews

COPYRIGHT 2002 SCIENTIFIC AMERICAN, INC.

Page 2: Getting under Your Skin

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ingly announced that the VeriChip would notbe considered an FDA-regulated device if itwere used for “security, financial, and per-sonal identification/safety applications.” Butit is a regulated medical device “when mar-keted to provide information to assist in thediagnosis or treatment of injury or illness.”The FDA’s Office of Compliance is now study-ing what will be required in the latter case.

Many question the FDA’s decision not toregulate the implant fully, because some re-

search suggests that it is not completely safein animals. A 1990 study in the journal Tox-icologic Pathology by Ghanta N. Rao andJennifer Edmondson of the National Instituteof Environmental Health Sciences in Re-search Triangle Park, N.C., reported that asubcutaneous tissue reaction occurred inmice implanted with a glass-sealed microchipdevice (not unlike the VeriChip). No prob-lems were seen in the 140 mice studied after24 months, except in those mice that had agenetic mutation in their p53 gene. In thatcase, if the device was kept in too long, “thesemice develop subcutaneous tumors called fi-brosarcomas,” Rao says.

In humans, the corresponding p53 muta-tion causes Li-Fraumeni syndrome, a rare dis-order that predisposes patients to a wide va-riety of cancers. Rao sees reason for caution:“More evaluation may be necessary beforethey are used in humans.”

Implanted microchips may not be so sta-

ble under the skin either, according to a 1999paper in the Veterinary Record by JansJansen and his colleagues at the University ofNijmegen in the Netherlands. Jansen foundthat in just 16 weeks chips inserted in shoul-der locations of 15 beagles had moved, a fewby as much as 11 centimeters. (Transpondersimplanted in the dogs’ heads, however, hard-ly moved at all.) An inflammatory response isalso a risk, Jansen observes, similar to whatis sometimes seen with other devices im-

planted in humans. “I’m notclaiming it’s not safe,” he says,“but you have to be completelysure it will not damage patientsin the end.”

ADS insists that the implant-ed chips are safe. The bulk ofthat evidence “obviously lieswith the animal application,” Sil-verman remarks. Other research,such as that reported in 1991 bythe Sandoz Research Institute inEast Hanover, N.J., found no ad-verse reactions in rats, althoughthe rodents were observed foronly a year. Still, more than 25million dogs, cats, racehorses

and other animals have been chipped withoutreports of significant problems. Silvermanalso points out that “no side effects or rami-fications whatsoever” have come to thosepeople who received chips in May, includinghimself and other company executives.

Since the FDA’s partial ruling, ADS hassigned up distributors in Latin America, Eu-rope and China and has four hospitals inFlorida testing the scanners now. Silvermansays that the firm has received inquiries from“several hundred people” interested in get-ting chipped. The procedure can take place ata doctor’s office or in ADS’s “Chipmobile”;it was scheduled to begin this past December.

The VeriChip faces other hurdles as well.Unless a substantial fraction of the popula-tion is chipped, hospitals may not bother in-stalling scanning devices; if that’s the case,what good is being chipped? And, of course,the chip introduces the potential for unso-licited surveillance and various privacy vio-lations, a possibility that makes many peo-ple’s skin crawl, even without a chip under it.

David Appell lives in Ogunquit, Me.

Uses for implantable devices maygo far beyond those envisioned forthe VeriChip. British engineers are

experimenting with a “toothphone,” a chip implanted in a

tooth. Futurist Ian D. Pearson ofBTexact Technologies in AdastralPark, England, foresees circuitry

tattooed into the skin. Such “active skin” would display

television pictures, serve ascosmetics, provide a virtual-reality

interface without data gloves orgoggles, or even—in the ultimate

in cyber-isolation—deliver orgasms by e-mail.

HOLD STILL: Like millions of other pets before it, a Labrador mix has a tracking device implanted underits skin. Humans are getting chipped as well.

SILICONSTITCHING

COPYRIGHT 2002 SCIENTIFIC AMERICAN, INC.