SANE Vax to Senator Grassley: Congratulations, keep on investigating

Dear Senator Grassley:

The SaneVax Team read your October 22, 2010 letter to Dr. Harold E. Varmus, director of the National Cancer Institute (NCI), with great interest. We would like to congratulate you on your efforts to examine the ethical questions raised by NCI employees accepting extensive travel sponsored by private companies. NCI is the nation’s top institute in cancer science. Publications and opinions from its intramural scientists have great impact on national health care policies affecting American consumers. Because their influence carries so much weight in the medical community, their reputation should be beyond reproach. We appreciate your office initiating this investigation into the ethics of those NCI employees who are apparently accepting excessive travel funds from private companies.

Along the same line, the SaneVax Team would like to bring to your attention another even more disturbing issue involving two senior NCI scientists who knowingly promote an unreliable human papillomavirus (HPV) test for patient care, and the development and monitoring of genotype-specific HPV vaccines in promoting a virology-based business agenda.

In a recently published financial disclosure^[1] Dr. Mark Schiffman, a NCI senior investigator, stated that he “works with the U.S. Food and Drug Administration (FDA) as well as the National Cancer Institute (NCI). He is the medical monitor of the independent human papillomavirus (HPV) vaccine trial of Cervarix being conducted by the NCI, for which he does not receive compensation. GlaxoSmithKline pays costs related to regulatory use of the data. He also works on the development of HPV tests for low-resource public health settings and is collaborating with Qiagen on this effort. Qiagen is providing free test supplies for this research effort but has no role in the evaluation of performance.”

In this disclosure, Dr. Schiffman did not mention that a similar Qiagen test has also been used in the U.S. as the only FDA-approved HPV test for American women for the past 20 years. Digene Corporation with its HC2 HPV test kit was sold to Qiagen, a Dutch company for $1.6 billion in 2007^[2], with a 5-times value appreciation over less than 5 years.

During the past 20 years, Dr. Mark Schiffman and Dr. Philip Castle, the two senior NCI officials promoting the virology-based agenda, have co-authored numerous articles with Dr. A. Lorincz, the chief scientist employed by Digene Corporation^[3] as scientific literature endorsing the Digene HC2 test. A PubMed search revealed that Dr. Schiffman and Dr. Lorincz coauthored 34 such articles from 1988 to 2005^[4], and that Dr. Castle and Dr. Lorincz coauthored 15 similar articles from 2001 to 2007^[5]. The NCI endorsement has undoubtedly boosted the sales value of Digene Corporation.

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 that a reliable genotyping of HPV is a method based on “PCR system with short target sequences,” a methodology the NCI and the 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, an exorbitant amount of our tax money for a small number of tests.

The obvious conclusion is that these two NCI scientists have been promoting a test kit which the NCI knows is not as reliable as “a PCR system with short target sequences” for patient care. The NCI scientists responsible for the HPV project have apparently maintained a double standard, a reliable HPV test for good science and another unreliable HPV test for patient care. 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.^[6]

We believe 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^[7] is highly speculative for the following reasons:

• The currently marketed HPV vaccines lack proven efficacy in cervical cancer prevention and are associated with potentially serious side effects.
• They can only protect against a fraction of high-risk HPV genotypes, provided there is no prior vaccine-related HPV infection.
• Cervical cancer is not a contagious disease.
• There is no epidemic of cervical cancer in the United States.
• The perceived cervical cancer crisis in the United States is obviously man-made news.
• Cervical cancer can be prevented with good gynecological care. This is a proven fact.
• Progression from persistent HPV infection to cervical cancer is a complicated pathological process which is not well understood, even among scientists.
• Clinical trials for efficacy of HPV vaccines used the wrong endpoint to prove their value to medical consumers.
• Reliable HPV genotyping methods were not used in the development of HPV vaccines.
• Reliable HPV genotyping methods are not currently available to American medical practitioners, or consumers for post-marketing monitoring.
• At least two National Cancer Institute employees have co-authored promotional articles with a senior employee of a private company to promote an unproven virology-based cervical cancer prevention program to the American public while knowing the device being promoted is unreliable.
• The NCI virology-based program is apparently being advanced by individuals with a personal agenda, rather than any interest in national health.

Therefore, the SaneVax Team believes medically and scientifically the currently marketed HPV vaccines’ benefits do not justify the costs and the potential side effects for medical consumers in the United States.

The SaneVax Team has expressed our concerns to the FDA Commissioner, Dr. Margaret Hamburg and the NCI director, Dr. Harold Varmus, respectively [see attached letters in references #8 and #9]. We have not received a response from either of these two government agencies.

We respectfully request that the ethics investigation of your Senate Committee extend to examine the appropriateness of the two senior NCI officials named above and their efforts to promote an HPV test kit the NCI knows to be not a reliable genotyping method and the circumstances surrounding the FDA approval of two currently approved HPV vaccines, Gardasil and Cervarix.

I am looking forward to receiving your response to this request on behalf of American medical consumers.

Yours respectfully,

References:

1. Schiffman M, Wentzensen N.  From human papillomavirus to cervical cancer. In Reply to a Letter to the Editor. Obstet Gynecol 2010;116:1221-2.
2. Qiagen bought Digene-SAN FRANCISCO (MarketWatch) News attached.
3. Lorincz and Digene-News report attached.
4. Lorincz Schiffman coauthored, attached PubMed search.
5. Lorincz Castle coauthored, attached PubMed Search.
6. Stout NK, Goldhaber-Fiebert JD, Ortendahl JD, Goldie SJ. Trade-offs in cervical cancer prevention: balancing benefits and risks. Arch Intern Med 2008;168:1881-9.
7. Schiffman M, Wentzensen N. From human papillomavirus to cervical cancer. Obstet Gynecol 2010;116:177-85.
8. Sane Vax Inc. Letter requests FDA Commissioner to rescind Gardasil.
9. Sane Vax Inc. Letter urges NCI and FDA to establish reliable HPV genotyping for better patient care.