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THE CANCER CONTROVERSY:
DOUBLESPEAK FROM VERICHIP AND THE MAKERS OF THE HOMEAGAIN® PET IMPLANT

Q. How has the VeriChip Corporation responded to the cancer issue?

Since research linking the implantable microchip to cancer first received widespread public attention in September 2007 (see the previous section of this document for details on chip-induced cancer), representatives of the VeriChip Corporation and its affiliate companies have made a number of inaccurate statements to the media about the findings. This section addresses those statements in detail.  

Q. What are some of the inaccurate statements made by microchip company executives?

The VeriChip Corporation and its affiliate companies Digital Angel and Destron Fearing have made numerous misstatements about the cancer studies to Business Week (17), Time Magazine (18), the RFID Journal(19), and other media outlets. Perhaps the lengthiest and most incriminating of these statements was made by VeriChip CEO Scott Silverman in an article he authored for Business Week magazine in January 2008. The article, titled "Myths About Implantable Chips,"(20) contained numerous false assertions that are reprinted below. A brief correction is provided beneath each statement, with greater detail provided in subsequent Q&A passages.

Mr. Silverman wrote:

"Last year a story was published by the Associated Press alleging implantable microchips cause cancer—an accusation we firmly dispute. This story referred to three studies that linked implantable microchips to malignant tumor formation."

That number is inaccurate. The AP actually reviewed eight studies that linked implantable microchips with cancer.

"It is important to point out that none of these studies was designed to investigate the microchip as a cause of tumor growth and the findings were incidental to the research."

Although this is technically accurate since investigators discovered the cancer in the course of other research, it is hardly "important" since it has no bearing on the published findings.

"It is also important to note that these studies used mice and rats specially bred and altered to increase their susceptibility to cancers."

That statement is inaccurate. Only one of the six rodent studies that found cancer involved genetically modified mice. What's more, since the modified mice had been bred to develop cancer only in the presence of specific toxins, the high rate of cancer in those mice is particularly damning evidence against the implants.

"It is also critical to note that as part of the primary design of the studies, the mice and rats were exposed to various cancer-causing agents such as X-ray radiation and chemical carcinogens.

This is misleading and irrelevant. Both experimental and control animals (animals with no exposure to chemical or x-ray agents) developed cancer from the microchips.

"It is therefore impossible from these three studies to relate any tumor growth directly to the implanted microchips."

That is not true. The researchers themselves clearly state that the microchips induced the tumors.

"The medical profession and those familiar with laboratory research understand these very important differentiators and the public must as well."


On the contrary, members of the medical community, including Dr. Robert Benezra, head of the Cancer Biology Genetics Program at the Memorial Sloan-Kettering Cancer Center in New York, and Dr. George Demetri, director of the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute, were among the medical professionals alarmed by the cancer findings. (21)

"Most importantly, the FDA continues to support its approval of the product."

The evidence suggests that the FDA (the U.S. Food and Drug Administration) was not aware of the cancer studies when it approved the VeriChip implant for human use in 2004.

The following questions address the issues raised by VeriChip and its affiliate companies in Business Week, Time Magazine, and elsewhere.

Q. Did the Associated Press review only three articles as Mr. Silverman claimed?

No. Although Scott Silverman erroneously claimed in his Business Week article that the Associated Press reviewed just three studies, (22) the AP actually reviewed eight studies linking microchip implants to cancer. (23) Six of the reviewed articles reported that laboratory mice and rats had developed malignant tumors around microchip implants, and two additional articles reported that dogs had developed cancer surrounding or attached to implants.

These eight articles are discussed in the previous section of this FAQ, and they are examined in great detail in our comprehensive overview of the research titled "Microchip-Induced Tumors in Laboratory Rodents and Dogs: A Review of the  Literature 1990–2006."(24)

Q. Were the cancer studies conducted in tumor-prone animals?

No. In five of the six studies in which lab animals developed cancer, ordinary laboratory rodents were used. These rodents are bred for uniformity and hardiness, and are used in cancer studies for their ability to respond to carcinogenic substances while remaining relatively free from spontaneous tumors that are unrelated to carcinogenic test substances. When they develop cancer, it is a strong indication of exposure to cancer-causing agents- which is precisely the reason they are used for cancer studies.

Details on the exact strain of animal used in each of the studies are provided in a table in our comprehensive overview of the research titled "Microchip-Induced Tumors in Laboratory Rodents and Dogs: A Review of the Literature 1990–2006." (25)

The two cases in which dogs developed cancer from the microchip involved a French bulldog and a mixed breed dog. These dogs were household pets with no special propensity for developing tumors.

Q. Weren't the genetically modified mice used in one study specially bred to produce tumors?

No. The  p53+/- mice used in the 1999 Blanchard study are not "specifically bred to produce tumors" as VeriChip has claimed. Rather, they are genetically modified to have an increased susceptibility to cancer only when exposed to genotoxins, or substances that damage genetic material. These mice are not known to develop spontaneous tumors in the absence of genotoxins within the first six months of life, which is when the mice in the study developed the microchip-induced tumors.

The high rate of cancer development in these mice (10.2%) in just six months strongly suggests that implanted microchips may either be genotoxic or may generate genotoxic byproducts in the host that can give rise to cancer.(26) The researchers stated as much, writing, "the presence of the foreign body [microchip implant] may elicit tissue reactions capable of generating genotoxic byproducts."(27)

The extraordinarily high rate of cancer in these mice is a disturbing finding that raises a serious red flag about the safety of the microchip.

Q. Could the cancers have been caused by other chemicals instead of the microchip?

No. It is clear that the malignant sarcomas that formed around the microchips were caused by the microchips themselves, not by other chemical compounds that were administered to some of the animals. We know this because both control and experimental animals developed cancers around the implants. In other words, animals that were not exposed to any chemicals at all developed cancer around the microchips.

In several of the studies, researchers had not initially set out to investigate the effects of microchip implants. Instead, they were looking at the safety of various chemical compounds. As a routine procedure, they microchipped all of the animals for identification purposes, then set a number of them aside to serve as a control group while they administered experimental compounds to the rest. After a period of time, the researchers were startled to find that animals in both the control and experimental groups had developed malignant tumors around the microchips. They found these chip-induced cancers so significant that they published their findings, even though that outcome was not what they had initially set out to investigate.

Q. Is it true, as VeriChip claims, that no link can be made between the tumors and the implanted microchips?

No. As discussed earlier in this document, the researchers themselves clearly stated that the tumors were caused by the microchips. They are quite firm on this point.

"The transponders were the cause of the tumors." (28)

Retired toxicologic pathologist Dr. Keith Johnson, in a phone interview with the Associated Press on the findings of a 1996 study he led at the Dow Chemical Co. in Midland, Michigan.

"There was an unequivocal [unmistakable] association between the [microchip

 implant] and sarcoma." (29)

Dr. Kerry Blanchard and colleagues from their 1999 study finding that 10.2% of mice studied developed cancer around the microchips. (p. 526)


The tumors "are clearly due to the implanted microchips." (30)

Dr. Thomas Tillmann and colleagues, from their 1997 study that found cancers around microchips in 0.8% percent of 4,279 chipped mice. (p. 200)

Q. Is it true the tumors were benign and not harmful?

No, it is not true. Benign means non-cancerous. The tumors found in lab animals were not benign. They were malignant sarcomas, fibrosarcomas, and other deadly forms of cancer. The microchip-induced tumors were fast-growing, malignant cancers that often led to a rapid death in the animals they afflicted. In fact, most of the animals that developed microchip-associated tumors died prematurely as a result of the tumors , as these researchers' statements attest:

"Most of the animals with microchip-associated tumors died prematurely" (31)

- Researcher Sophie Le Calvez and colleagues (p. 258)

"Electronic microchip technology ...may affect animal moribundity and mortality [i.e., illness and death rates], due to the large size and rapid growth of microchip-induced tumors as well as the occurrence of metastases." (32)

Researcher Laura Elcock and colleagues (p. 491)

"Most tumors arising from foreign bodies are malignant . . . and have a rapid growth rate, killing the animal in a matter of weeks." (33)

- Elcock and colleagues (p. 491)

Q. Have there been studies in which chipped animals did not develop cancer?

Yes, several studies in which chipped animals did not develop cancer have been cited as evidence that implantable microchip devices are safe (see Table 1 below). However, those studies either involved a very small number of animals or the animals were only observed for a very short period of time. In most of the studies where cancer was found, it occurred during the second year of exposure to the device, or in the latter half of the animal's lifespan. Animals would not be expected to develop cancer after only a few days or weeks of exposure.

TABLE 1: Studies in which microchip-induced cancer was not found

Author(s)

Species

# animals

Length of Exposure

Cancer rate

Murasugi et al., 2003

dogs

2

2

2

2

1

3 days

3 months

1 year

3 years

6 years

none

observed

Ball et al., 1991

rats

10

10

10

10

2 weeks

3 months

6 months

1 year

none

observed

Rao & Edmondson, 1990

mice

10

10

39

74

3 months

15 months

less than 2 years

2 years

none

observed


In contrast, when researchers looked at thousands of animals over longer periods of time they consistently found cancer in connection to the microchips, as Table 2  illustrates.(34)

TABLE 2: Studies that found microchip-induced cancer

Author(s)

Species

# animals

Length of Exposure

Cancer rate

Le Calvez et al., 2006

mice

1,260

2 years

4.1%

Vascellari et al., 2006

dog

 N/A

  7 months (at age 9)

1 dog

Vascellari et al., 2004

dog

 N/A

18 months (at age 11)

1 dog

Elcock et al., 2001

rats

1,040

2 years

0.8%

Blanchard et al., 1999

mice

  177

6 months

10.2%

Palmer et al., 1998

mice

  800

2 years

2.0%

Tillmann et al., 1997

mice

4,279

lifespan

0.8%

Johnson, 1996

mice

2,000

2 years

~1.0%

Q. Was the FDA aware of the cancer link when it approved the VeriChip for human use?

Based on the available evidence, it appears the FDA was not aware of the cancer studies. When the FDA approved the VeriChip for human use in October 2004, it relied on the company to disclose any risks associated with the device.(35) It was VeriChip's responsibility to alert the FDA to the cancer findings and provide copies of the studies to the FDA for review. However, since VeriChip senior executives have publicly stated that neither they nor the company knew about the studies at that time, they could not possibly have provided them to the FDA.

VeriChip's CEO Scott Silverman and its chief medical officer Dr. Jonathan Musher have both stated that they had no knowledge of the cancer studies before the Associated Press broke the story in September 2007. In a written statement to the Associated Press, Mr. Silverman stated that his company was "not aware of any studies that have resulted in malignant tumors in laboratory rats, mice and certainly not dogs or cats." (36) He later reaffirmed the denial during a national television interview on ABC's "Good Morning America" in September 2007.(37) VeriChip's Chief Medical Officer Dr. Jonathan Musher also denied any knowledge of the studies in a 2007 interview with the Atlanta CBS television affiliate, WGCL. (38)

Q. Did the VeriChip Corporation (then operating as "Applied Digital Solutions") intentionally fail to provide the cancer studies to the FDA?

Yes, it appears that VeriChip officials intentionally withheld at least two of the cancer studies from their FDA application. Despite repeated claims that the company had no knowledge of any studies linking microchips to cancer, Mr. Silverman later acknowledged to Time Magazine that the company had been aware of one of the most damning cancer studies, the 1999 Blanchard study—and intentionally chose to withhold it from the FDA. According to Time Magazine

"As for the third study [the 1999 Blanchard study in which 10.2% of chipped mice developed cancer around the microchips], Silverman says it was conducted in mice specifically bred to produce tumors,(39) and was therefore omitted from the sheaf of studies included in the FDA application."(40)

The company could not have made a decision to omit a study from its FDA application unless it knew that the study existed. And since the company knew of the Blanchard study, it must also have known that researcher Keith Johnson in the course of his own investigations had independently found that "subcutaneous sarcomas at the site of transponder implants were reported in approximately 1% of mice," since that information was clearly printed in the Blanchard article.

Though VeriChip must have have been aware of Johnson's research, there is evidence (discussed later in this FAQ) that strongly suggests that VeriChip withheld that study from the FDA as well.

Q. Should the Blanchard study have been included in the FDA application?

Absolutely. According to the authors of the study, the high rate of cancer development (10.2%) in the genetically modified p53+/- mice after just six months of exposure suggests that implanted microchips may have genotoxic attributes or give rise to the production of genotoxins in the host. (41) This raises serious concerns about the safety of the microchip, and could help explain the cancer findings in the other studies. What's more, the Blanchard study contained a reference to the Johnson study in which microchipped mice also developed cancer.

Had VeriChip provided these two studies to the FDA, it is almost certain the agency would have conducted a comprehensive literature review to find all published research related to microchip implants and cancer. That search would have uncovered the Elcock, Palmer, and Tillmann studies, all of which had been published at the time of the VeriChip application in 2004.

In sum, data from the Blanchard study should have been provided to the FDA for careful consideration when the agency was evaluating the safety of microchip implants for use in humans. It was inappropriate, negligent, and deceptive of VeriChip to omit this important information from the FDA application.

Q. Is there additional evidence the company did not tell the FDA about the cancer studies?

Yes. Mr. Silverman made statements in his Business Week article that further indicate that the company did not provide any of the cancer studies  to the FDA.

He wrote:

During the FDA approval process we provided 34 studies to the FDA demonstrating the safety of implantable microchips.

[Note: It would appear from this statement that the company provided 34 carefully-chosen studies that confirmed the safety of the implant, while failing to provide any of the studies showing a cancer link.]

There have been numerous studies in mice, rats, woodchucks, rabbits, guinea pigs, pigs, and dogs that investigated the microchip and potential adverse effects of inserting it into subcutaneous tissue. None of these studies showed any tumors or other significant problems.

[Note: This statement further confirms that the company did not provide the FDA with any of the studies linking implantable microchips with cancer.]

Scott Silverman, "Myths About Implantable Chips", Business Week,
January 30, 2008.(42)

Q. Has the FDA been asked whether it reviewed the cancer studies before it approved the VeriChip?

Yes, this question has been asked on multiple occasions, but as of this writing the agency has refused to provide a direct answer. According to the Associated Press (AP), the FDA declined repeated AP requests to specify what studies it reviewed before approving the VeriChip.(43) And in October 2004, this researcher (Katherine Albrecht) filed a Freedom of Information Act (FOIA) request with the FDA asking what documents the agency had reviewed during the approval process. More than a year later, the agency responded with a form letter stating that there were no documents on file matching the request.

The AP filed a similar FOIA request in early 2007 and is still awaiting a response.(44)

Q. Have other false or misleading statements been made about the research?

Yes. The following are among the other inaccurate statements Scott Silverman and Destron Fearing have made about the cancer studies.

  • The tumors in the Le Calvez study were not malignant

  • The tumorous mice in the Tillmann study were "healthy"

  • Most of the tumors in the Tillmann study were "benign"


Each of these statements is addressed in the following pages.

► MISSTATEMENT – The tumors in the Le Calvez study were not malignant

Shortly after AP reporter Todd Lewan broke the cancer story, Digital Angel's chief technology officer Zeke Mejia was interviewed by the RFID Journal. In that interview, Mr. Mejia accused the AP of "misconstruing" the research studies and claimed that the tumors found in one study were not malignant.

"...Meija says even the studies themselves may have been misconstrued by [AP Reporter Todd] Lewan. One example was a French study, cited in the [AP article], which found that about 4.1 percent of the 1,260 implanted mice developed tumors. Although the study did not state any of the tumors were cancerous, the news story implied they were malignant. Mejia states that such an implication 'was distorting and really sad to hear.'

'I just want to have the truth being published,' Mejia says. And from his standpoint, the truth is that the studies fail to prove any connection between tumors in animals and RFID microchip implants." (45)

- RFID Journal, quoting Zeke Mejia, Digital Angel Chief Technology Officer

A month later, VeriChip CEO Scott Silverman made a similar statement to Time Magazine during an exclusive interview with the magazine:

 "The second study, conducted in France in 2006, two years after VeriChip's FDA application was approved, found that while 4% of the 1,260 mice in the study developed tumors, none of them were malignant." (46)

- Time Magazine, citing information provided by VeriChip CEO Scott Silverman

► FACT – The tumors were malignant sarcomas that killed many of the animals

The statements are false. Not only were the tumors in the French study malignant, they were deadly. Researcher Sophie Le Calvez and her colleagues were shocked to find that more than 4% of mice they had implanted with microchips developed malignant sarcomas surrounding or adjacent to the implants within two years of exposure. Most of the animals that developed the tumors died prematurely as a result. (47)

The tumors were initially identified by morphology as fibrosarcoma (17 cases), rhabdomyosarcoma (12 cases), leiomyosarcoma (2 cases), malignant fibrous histiocytoma (3 cases), mammary gland adenocarcinoma (2 cases), and other sarcomas (16 cases). Researchers later reclassified the tumors as "sarcomas not otherwise specified (NOS) with a large myofibroblastic component" (p. 255) after additional testing. A sarcoma is a malignant tumor of soft tissue that connects, supports or surrounds other structures and organs of the body.

Once initiated, the malignant tumors grew rapidly. Not only were the tumors malignant, but they often infiltrated nearby muscle tissue, and several metastasized (spread) to cause further cancer in the lungs, liver, pancreas, and stomach of the animals.

Additionally, many of the implants migrated from the original implantation site on the backs of the mice to cause cancer in other parts of the body. Nineteen percent of the cancers found involved microchips that had migrated from the back to the limbs, abdomen, or head of the mice. The animals were literally riddled with cancerous tumors.

► MISSTATEMENT – The tumorous mice in the Tillmann study were "healthy"

"In an exclusive interview with TIME, [VeriChip CEO Scott] Silverman provided [one of the studies] mentioned in the AP article, which showed that less than 1% of 4,279 chipped mice developed tumors 'clearly due to the implanted microchips' but were otherwise healthy, and that 'no clinical symptoms except the nodule on their backs were shown.'" (48)

- Time Magazine, October 18, 2007

► FACT – The mice had invasive cancers

The mice in question had invasive cancer, regardless of any other health problems they may or may not have had. The 1997 Tillmann study, to which this passage refers, reported   that of 4,279 mice implanted with microchips, 0.8%, or 36, of them developed malignant cancers that were clearly caused by the microchips. These tumors were identified as being of two main types: fibrosarcomas involving "extensive local invasion of the surrounding tissues," and malignant fibrous histiocytomas with "zones of necrosis and high mitotic activity."(49) (p. 198)

Not only were the tumors malignant, they often grew to a diameter of an inch or more, as can be seen from  a photograph that appeared in the original article.(50) It would not be accurate to classify mice with large, malignant tumors as "healthy."

► MISSTATEMENT – Most of the tumors in the Tillmann study were "benign"

In late 2007, Destron Fearing, manufacturers of the HomeAgain® pet implant, issued a report on the cancer studies that contained the following erroneous statement:

"The majority of tumors [in the 1997 Tillmann study] were benign fibrosarcomas..."(51)

- Destron Fearing, makers of the HomeAgain® pet implant

FACT – The tumors were malignant (cancerous) sarcomas

There is no such thing as a "benign fibrosarcoma." A fibrosarcoma is a type of sarcoma, a malignant tumor of soft tissue that connects, supports or surrounds other structures and organs of the body. It is, by definition, malignant. As discussed earlier, the tumors found in the 1997 Tillmann study were primarily fibrosarcomas and malignant fibrous hystiocytomas—both malignant cancers. The word "benign" does not appear anywhere in the Tillman article.

Dr. Timothy Jennings, an expert on implant-induced cancers in humans has confirmed that there is no disease entity known as 'benign fibrosarcoma'" and that "any tumor classified as sarcoma should be viewed as malignant."(52)

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