Medical microchip for people may cause cancer

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?”

Protecting trade secrets
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.”

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