Though FDA approved, microchip implants linked to animal cancer

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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.

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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.

"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.

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.

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.

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."

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."

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.

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.

Advanced ID Corporation announced a distribution agreement with Carlyle Group that calls for mandatory microchip identification of over 1 million dogs in Guangdong province.

The Carlyle Group is a registered company in China which is owned 40% by the Chinese government.

"There are well over 50 million dogs in China and this distribution partnership is the beginning of providing products, software and know-how through Advanced ID Corporation to meet this large market, we are proud to have been selected as a partner to this most important and evolving market. Our contract terms include supplying over 550,000 Advanced ID Pet Microchips in just the first few years of our distributorship agreement. This program is a good example of our efforts in this most important region", according to Dan Finch, President and CEO of Advanced ID Corporation.

Guangdong Carlyle RFID Technologies , a venture company developed specifically by Carlyle and the government for companion and livestock animal identification efforts, says this is the first step in a goal to develop both a companion animal and livestock tracking system for China.

Tracking systems like these can also be used to get faster information about the source of human maladies such as bird flu or mad cow disease.