Chips and Cancer: Who Knew?

The AP published a story by Todd Lewan which is full of descriptions all sorts of problems with public safety, science and ethics in the US. Underlying it all is the active resistance to both governmental and private organizations and individuals to do the right thing. Over and over and over, known problems are hidden from view, and appointed government officials jump from their positions where they have oversight and regulatory authority to the very organizations for which they were charged to oversee on behalf of the public interest and safety.

When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients’ medical records almost instantly. The FDA found “reasonable assurance” the device was safe, and a sub-agency even called it one of 2005’s top “innovative technologies.”

This story chronicles the problems with the implanted RFID chips commonly found used in pet identification, but which have also passed FDA approval for use as medical identifiers in humans.

But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had “induced” malignant tumors in some lab mice and rats.

“The transponders were the cause of the tumors,” said Keith Johnson, a retired toxicologic pathologist, explaining in a phone interview the findings of a 1996 study he led at the Dow Chemical Co. in Midland, Mich.

Leading cancer specialists reviewed the research for The Associated Press and, while cautioning that animal test results do not necessarily apply to humans, said the findings troubled them. Some said they would not allow family members to receive implants, and all urged further research before the glass-encased transponders are widely implanted in people.

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.

Once again, a Republican appointee acted in a way that is a clear conflict of interest with his role as the head of the FDA and his jump to an agency that he should have had no dealings with in any capacity. HHS continues to exhibit this unethical pattern with Dr. John Agwunobi’s leap from his Assistant Secretary of the HHS position to that of Wal-Mart’s Director of Health and Wellness position.

In the latter case, the AMA and the state medical board where Agwunobi is licensed should take a hard look at this disturbing breach of the public trust.  Public health officials deal with patients as communities, and this is surely a breach of the physician patient relationship.  Who can trust Agwunobi when his alliance is clearly to an organization paying his salary instead of as a professional advocate – as his profession stipulates – to his patients?

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.

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.

So much for protecting the public.  The HHS, the FDA, the AMA – all of the agencies charged with assuring the public’s safety and holding the public’s trust – have not only failed to do that, but they actively undermine efforts to do what they are charged to do.

Where does that leave Americans?

Former US Surgeons General have testified that science is being distorted and suppressed.  They have testified that the public’s safety has been subjugated by political partisanship.

The first thing Americans must do is to mandate full Congressional oversight into the HHS, FDA, CDC, and all governmental agencies that are charged with protecting the public’s safety.

The public must demand that the AMA, American Nurses Association, and the American Public Health Association put into place tough ethical conditions of membership, and that they publicly disclose members who are expelled or applications that are rejected for breaches of patient trust.

Henry Waxman has introduced legislation to protect and to demand the independence of the US Surgeon General position, and this is a good start.

Congress must enact tough legislation that clearly prohibits any elected or appointed official from having any relationship with entities for which they have oversight or regulatory authority and responsibility.  No more revolving door from comfy governmental position to private sector conflict of interest lobbying and advocacy.  None.  The policy must clearly and transparently be, if it appears to be a conflict of interest, it is, and therefore, it is not tolerated, nor is it acceptable.

The private sector is concerned with maximizing profits for its investors.  Period.

Government is charged with protecting the public’s welfare and safety.

Let the two remain separate and distinct entities.

And let the chips fall where they may. In Veri-Chip’s case, may that be in a red bottom line for its egregiousness.