SaneVax Open Letter to Margaret Hamburg: When was the FDA informed of viral DNA in Gardasil?

September 10, 2012 By 6 Comments
Sanevax-square

    The Honorable Margaret A. Hamburg, M.D., Commissioner                                                       September 10, 2012 U. S. Food and Drug Administration (FDA) 10903 New Hampshire Ave. Silver Spring MD 20993-0002   Dear Dr. Hamburg: In a public announcement, the FDA stated: “Since the early development of Gardasil, FDA and the manufacturer (Merck and Co., Inc.) have known [...]

[Continue reading...]
Filed Under: FDA, Gardasil / Silgard, United States Concerns

SaneVax Open Letter to Kathleen Sebelius, Secretary of Health and Human Services

January 31, 2012 By 15 Comments

31 January 2012, Open Letter To:  Kathleen Sebelius, Secretary of Health and Human Services – Kathleen.Sebelius@hhs.gov Subject: Rescind approval of Gardasil® due to lack of efficacy during post-licensure monitoring Dear Ms. Sebelius: The quadrivalent human papillomavirus (HPV) vaccine, Gardasil® was approved for marketing as a drug to prevent cervical cancer under the fast track drug [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , , ,

SANE Vax to FDA: Recombinant HPV DNA found in multiple samples of Gardasil

September 2, 2011 By 114 Comments

         The Honorable Margaret A. Hamburg, M.D., Commissioner U. S. Food and Drug Administration (FDA) 10903 New Hampshire Ave. Silver Spring MD 20993-0002August 29, 2011 Dear Dr. Hamburg: At the request of medical consumers concerned about HPV vaccine safety and efficacy, SANE Vax Inc. has retained a private laboratory to test a [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , ,

SANE Vax to CDC: Request for additional data on HPV vaccine post-marketing monitoring

August 31, 2011 By 1 Comment

Lauri Markowitz, M.D. Centers for Disease Control and Prevention MS E05, 1600 Clifton Road Atlanta, GA 30333 lem2@cdc.govAugust 31, 2011 Dear Dr. Markowitz: Thank you for your August 29, 2011 response to my letter requesting additional information about post licensure monitoring for Gardasil™ from the CDC. Before relaying your response to medical consumers, I would [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , , , ,

SANE Vax to CDC: Request for post-HPV vaccination monitoring data

August 31, 2011 By 1 Comment

Lauri Markowitz, M.D.  Centers for Disease Control and Prevention MS E05, 1600 Clifton Road Atlanta, GA 30333 lem2@cdc.gov July 26, 2011 Dear Dr. Markowitz: Thank you for your letter dated July 14, 2011in response to the SaneVax Inc. letter of  28 May 2011, concerning the post-licensure monitoring project on Gardasil™, which was approved for marketing under [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , , ,

SANE Vax to Dr. Mark Schiffman: HPV Vaccine Accountability

August 31, 2011 By 1 Comment

  Mark Schiffman, M.D., M.P.H. Senior Investigator, National Cancer Institute Executive Plaza South, Room 5026 6120 Executive Boulevard Bethesda, Maryland 20892-7335  301-435-3983 301-402-0916 schiffmm@mail.nih.gov  Dear Dr. Schiffman: Since you are the first scientific officer to promote mass HPV vaccination of women as a means to prevent cervical cancer [1], and have been working with the [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , , , ,

SANE Vax to Senator Grassley: Congratulations, keep on investigating

August 30, 2011 By 3 Comments

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 [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , , , , ,

Congressman Charlie A. Wilson to FDA: Gardasil Concerns

August 30, 2011 By Leave a Comment

Dear Ms. Stephens, Thank you for your response to my recent inquiry into the safety and effectiveness of the HPV vaccine, Gardasil. I have studied your letter thoroughly and frankly, am somewhat disturbed by the fact that your response gives rise to more questions than answers. The following quotes from your letter raise these questions: [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , , , ,

SANE Vax to NCI/FDA: Request for reliable HPV genotyping test for medical consumers

August 30, 2011 By Leave a Comment

November 2, 2010 The Honorable Margaret Hamburg, M.D., Commissioner, FDA The Honorable Harold E. Varmus, M.D., Director,NCI  Subject: Request recommending a reliable human papillomavirus (HPV) genotyping test to support the national virology-based cervical cancer prevention program for patient care Dear Dr. Hamburg and Dr. Varmus: A recently published letter to the editor of ‘Obstetrics and [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , , , , , , ,

SANE Vax to Margaret Hamburg: request the FDA rescind Gardasil approval

August 30, 2011 By 2 Comments

            The Honorable Margaret A. Hamburg, M.D., Commissioner                                                       October 19, 2010 U. S. Food and Drug Administration (FDA) 10903 New Hampshire Ave. Silver Spring MD 20993-0002 Subject:    Request that the FDA rescind its approval for Gardasil™ as a vaccine to prevent cervical cancer or to prevent genotype-specific human [...]

[Continue reading...]
Filed Under: United States Concerns Tagged With: , , , ,