Correspondence: NYS HPV Vaccine Legislation On Hold

To: ‘schneide@senate.state.ny.us’; ‘liz@lizkrueger.com’; ‘etd1@cornell.edu’; ‘ncowmail@gmail.com’; ‘kmikesr@yahoo.com’; ‘klrehman@yahoo.com’; ‘nickhaas@medicalvoices.org’; ‘lisarudley@yahoo.com’; ‘kopach@senate.state.ny.us’
Subject: RE: Thank you for your letter Re: S.4779

Dear Mr. Schneiderman and Ms. Kureger:

Below, Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, who is the acknowledged HPV expert offers the New York State Senate Codes Committee her expert opinion.

Dr. Harper conducted the pre-marketing clinical trials for both Merck’s Gardasil and GlaxoSmithKline’s Cevarix vaccines–she has had access to, and analyzed the scientific HPV vaccine trial data. 

Dr. Harper’ publications include:

Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic Quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial.  Lancet Oncology. 6(5):271-8, 2005 May.

Villa LL, Ault KA, Giuliano AR, Costa RL, Petta CA, Andrade RP, Brown DR, Ferenczy A, Harper DM, Koutsky LA, Kurman RJ, Lehtinen M, Malm C, Olsson SE, Ronnett BM, Skjeldestad FE, Steinwall M, Stoler MH, Wheeler CM, Taddeo FJ, Yu J, Lupinacci L, Railkar R, Marchese R, Esser MT, Bryan J, Jansen KU, Sings HL, Tamms GM, Saah AJ, Barr E.  Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18.  Vaccine. 2006 Jul 7;24(27-28):5571-83. Epub 2006 May 15.

Garland S, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GWK, Ferris DG, Steben M, Bryan J, Taddeo F, Railkar R, Esser MT, Sings HL, Nelson M, Boslego J, Sattler C, Barr E, and Koutsky LA, for the FUTURE I Investigators.  Efficacy of a quadrivalent HPV (Types 6/11/16/18) L1 VLP Vaccine against external anogenital, vaginal, and cervical disease. A randomized controlled trial.  NewEngl J Medicine.  2007: 356(19):1928-43. 

Garland SM, Steben M, Hernandez-Avila M, Koutsky LA, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GWK, Ferris DG, Esser MT, Vuocolo SC, Nelson M, Railkar R, Sattler C, and Barr E on behalf of the 012 Study Investigators.  An evaluation of non-inferiority in antibody response to human papillomavirus (HPV) 16 in subjects vaccinated with monovalent (HPV 16) and quadrivalent (HPV 6, 11, 16, 18) L1 virus like particle vaccines.  Clinical and Vaccine Immunology. 2007. 

Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM,  Perez G, Koutsky LA, Garland SM, Harper DM, Tang GWK, Ferris DG,  Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego J, Sattler C, Barr E, Paavonen J.  Efficacy of a quadrivalent prophylactic human papillomavirus (types 6/11/16/18) L1 virus like particle vaccine against high-grade vulval and vaginal lesions: A combined analysis of three clinical trials.  Lancet 2007. 

Cutts FT, Franceschi S, Goldie S, Castellsague X, de Sanjose S, Garnett G, Edmunds WJ, Claeys P, Goldenthal K, Harper DM, Markowitz L. Human Papillomavirus and HPV vaccines: a review. Bulletin of the World Health Organization. 85(9):719-26, 2007 Sep.

The Alliance for Human Research Protection urges the Senate committee to consider the scientific evidence and to respect (rather than circumvent) parental decision-making pertaining to their adolescents’ healthcare. Ill-advised (or ill-considered) healthcare legislation has the potential of causing much unintended harm. Who will bear moral and financial responsibility for harm resulting to NYS youngsters administered a vaccine without parental consent?

Sincerely,

Vera Hassner Sharav
President
ALLIANCE FOR HUMAN RESEARCH PROTECTION

veracare@ahrp.org
212-595-8974

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February 18, 2010 12:58 PM
Subject: Proposed legislation in NY
From: Diane Harper [mailto:diane.m.harper@gmail.com]
To: VERACARE

Dear Mr. Eric T. Schneiderman,

It has come to my attention that there is a bill pending in the NY State Legislature that would allow school nurses to provide HPV vaccines to school girls without their parents’ permission.

As an expert in HPV diseases and the sentinel researcher in both of the HPV vaccines, this legislation is a silly idea.

It is clearly understood in the pediatric world that adolescents do not have the developmental maturity (brain development) to make life balancing decisions.  So asking the adolescents’ permission is not recognized by ethical boards nor is asking for an adolescent’s permission recognized for any medical treatment unless the minor is emancipated.

Family history about vaccine adverse reactions is not something that an adolescent will necessarily know.  The decision to vaccinate must come from an informed decision that balances the benefits and risks of vaccination and Pap screening. Most adolescents will involve an adult (usually a parent) in this discussion.

For many reasons, medical and ethical, it is not appropriate to have a school nurse give vaccinations without the parents’ explicit approval.

I am happy to talk to you further about this.

Sincerely,
Diane M Harper, MD, MPH, MS
Professor
Vice-Chair, Research
University of Missouri-Kansas City, School of Medicine Departments of Community and Family Medicine Obstetrics and Gynecology Informatics and Personalized Medicine

Feb 17. 2010
Subject: Thank you for your letter

To: etd1@cornell.edu; ncowmail@gmail.com; kmikesr@yahoo.com; veracare@ahrp.org; klrehman@yahoo.com; nickhaas@medicalvoices.org; lisarudley@yahoo.com; kopach@senate.state.ny.us
From: kopach@senate.state.ny.us [mailto:kopach@senate.state.ny.us] On Behalf Of schneide@senate.state.ny.us

Dear Sir or Madame,

Thank you for your letter regarding Senate bill S.4779, sponsored by Senator Liz Krueger, regarding the treatment of sexually transmitted diseases.

This bill was held in the Senate Codes Committee on February 9, 2010 at the request of the sponsor. During this time, with the input of constituents and advocacy groups, the sponsor will have the opportunity to improve and clarify the bill’s language.

Currently, there is no other legislative action on this bill. If you have any additional questions or concerns, please feel free to contact my office, or the sponsor of the bill, Senator Krueger, at (518) 455-2297.

Sincerely,

(Embedded image moved to file: pic10381.jpg)

Eric T. Schneiderman

~~~~~~~~~~~~~~
Feb 8, 2010
Subject: URGENT: NYS Legislation to Vaccinate Children WITHOUT Parental Consent

FY I/ ACTION

To: schneide@senate.state.ny.us; bonacic@senate.state.ny.us; breslin@senate.state.ny.us; jdefranc@senate.state.ny.us; duane@senate.state.ny.us; flanagan@senate.state.ny.us; golden@senate.state.ny.us; golden@senate.state.ny.us; shuntley@senate.state.ny.us; jdklein@senate.state.ny.us; lanza@senate.state.ny.us; parker@senate.state.ny.us; perkins@senate.state.ny.us; saland@senate.state.ny.us; sampson@senate.state.ny.us; squadron@senate.state.ny.us; volker@senate.state.ny.us

The New York State Senate is about to vote on legislation that will give a school nurse or doctor the power to vaccinate children under- age 18 years of age with controversial vaccines such as GARDASIL and Hep B– WITHOUT parental "consent or knowledge." Sexually transmitted diseases are NOT communicable through casual contact. The Gardasil vaccine is engulfed in much controversy because it is not at all proven that its risk / benefit ratio favors children’s welfare.
Indeed, the vaccine’s period of effectiveness is unknown while mounting evidence shows that it poses serious risks for some children and young women exposed to it.

See: The Risks and Benefits of HPV Vaccination by Charlotte Haug, MD, PhD, MSc JAMA. EDITORIAL. 2009;302(7):795-796. 
http://jama.ama-assn.org/cgi/content/full/302/7/795?home

Not be ignored is Merck’s record of aggressive, illegal marketing of drugs including the Gardasil vaccine: Merck is on record of having bribed state legislators to mandate Gardasil.

Let the NYS legislators below know that S4779B violates parental rights and responsibility to make healthcare decisions on behalf of their children.
S4779B is  BEYOND THE BOUNDS OF SCHOOL AUTHORITY.

Who will bear moral, medical, and financial responsibility should a child be harmed by a vaccine that was administered to a child WITHOUT parental knowledge or consent?

Vera Hassner Sharav