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.
Thompson, until recently a candidate for the 2008 Republican presidential nomination, says he had no personal relationship with the company as the VeriChip was being evaluated, nor did he play any role in FDA's approval process of the RFID tag.
"I didn't even know VeriChip before I stepped down from the Department of Health and Human Services," he said in a telephone interview.
Also making no mention of the findings on animal tumors was a June report by the ethics committee of the American Medical Association, which touted the benefits of implantable RFID devices.
Had committee members reviewed the literature on cancer in chipped animals?
No, said Dr. Steven Stack, an AMA board member with knowledge of the committee's review.
Was the AMA aware of the studies?
No, he said.__
_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.
_ A 1998 study in Ridgefield, Conn., of 177 mice reported cancer incidence to be slightly higher than 10 percent _ a result the researchers described as "surprising."
_ A 2006 study in France detected tumors in 4.1 percent of 1,260 microchipped mice. This was one of six studies in which the scientists did not set out to find microchip-induced cancer but noticed the growths incidentally. They were testing compounds on behalf of chemical and pharmaceutical companies; but they ruled out the compounds as the tumors' cause.
Because researchers only noted the most obvious tumors, the French study said, "These incidences may therefore slightly underestimate the true occurrence" of cancer.
_ In 1997, a study in Germany found cancers in 1 percent of 4,279 chipped mice. The tumors "are clearly due to the implanted microchips," the authors wrote.
..... 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."
FDA's Watson said: "I have no recollection of him being involved in it at all." VeriChip Corp. declined comment.
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.
The Project on Government Oversight called Thompson's actions "unacceptable" even though they did not violate what the independent watchdog group calls weak conflict-of-interest laws.
"A decade ago, people would be embarrassed to cash in on their government connections. But now it's like the Wild West," said the group's executive director, Danielle Brian.
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.
http://www.washingtonpost.com/wp-dyn/content/article/2007/09/08/AR2007090800997_pf.html
pfft.
"Thou wast heedless of this; now have We removed thy veil, and sharp is thy sight this Day!"
