SaneVax Team Asks Senator Grassley to Expand NCI Ethics Investigation

Business Wire

November 28, 2010

TROY, Mont.–(BUSINESS WIRE)–In a letter addressed to U.S. Senator Charles Grassley, the SaneVax Team congratulated the senator on his recent efforts to examine ethical questions raised by National Cancer Institute (NCI) employees accepting extensive travel sponsored by private companies and identified two senior NCI scientists who knowingly promote unreliable human papillomavirus (HPV) tests for patient care, and the development/monitoring of genotype-specific HPV vaccines to promote an unproven virology-based cervical cancer prevention business agenda.

One of the two NCI senior scientists recently admitted that he works with the U.S. Food and Drug Administration (FDA) and the NCI in the human papillomavirus (HPV) vaccine trial project, as well as working on the development of HPV tests, which were previously marketed by Digene Corporation and are now by Qiagen Corporation, a Dutch company.

These two senior NCI scientists have co-authored, with the chief scientific officer of Digene Corporation, a total of 36 articles endorsing the only FDA-approved Digene HC2 HPV test in the U.S. The NCI endorsements undoubtedly boosted the final sales price of Digene Corporation to Qiagen at $1.6 billion, said Ms. Erickson.

However, the Digene HC2 HPV test is not a reliable HPV genotyping test, as well known in the NCI. A public document titled “HPV genotyping,” identified as Solicitation Number: NCI-100143-MM, reveals the NCI acknowledges a reliable genotyping of HPV is a method based on “PCR system with short target sequences,” a methodology the NCI and FDA do not encourage companies to develop in this country. They prefer to pay $13.5 million to contract a foreign laboratory to test 230 biopsy samples using this reliable HPV genotyping, an exorbitant amount of our tax money for a small number of tests, Ms. Erickson pointed out in her letter to the Senator.

“The NCI scientists responsible for the HPV project have apparently maintained a double standard, a reliable HPV test for good science; and unreliable HPV tests for patient care and vaccine development/monitoring. The unreliable Digene HC2 HPV test has sent numerous American women to harmful cervical biopsies, 95% of which are unnecessary, at a great cost to individuals and society,” said Ms. Erickson.

The letter outlines 12 evidence-based reasons that the NCI-promoted virology-based program, which depends on massive HPV vaccination of young American girls, HPV screening and colposcopic biopsies, to replace the traditional Papanicolaou test for cervical cancer prevention is highly speculative, and should not be adopted prematurely.

Because the SaneVax Team received no response to letters expressing their concerns to Dr. Margaret Hamburg, FDA Commissioner, or Dr. Harold Varmus, NCI director, on this very important women’s health care issue, they feel it is necessary to seek assistance from the office of a concerned U.S. Senator.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.