Gardasil: USPPI Patient Information about GARDASIL® - size 349.39 kB - Package Insert (PDF - 350 KB) - Approved: September 12, 2008
Merck PAC/Lobbying Payouts: Merck PAC Money To States (From Lobby Watch) - size 199.01 kB - List of Merck Lobbying Money spent in Texas, and summary amounts from Pennsylvania, North Carolina, Oklahoma and Iowa.
Deceptive Publications: Australasian Journal of Bone & Joint Medicine Vol. 2 Issue 1 2003- size 2.53 MB - A fake medical journal that Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products.
Deceptive Publications: Australasian Journal of Bone & Joint Medicine Vol. 2 Issue 2 2003- size 4.77 MB - A fake medical journal that Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products.
FDA: Clinical Review of Biologics License Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae) (STN 125126 GARDASIL), manufactured by Merck, Inc. - size 4.86 MB -
FDA: Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal - size 2.52 MB -
CERVARIX: Suspected Adverse Reaction Analysis CERVARIX Human papillomavirus (HPV) vaccine 5_march_2009- size 280.3 kB - This report summarises the adverse reactions suspected to have been caused by Cervarix human papillomavirus (HPV) vaccine in the UK. This includes reports received between 14 April 2008 and 4 March 2009. These reports have been voluntarily submitted to the MHRA by healthcare professionals and members of the public via the Yellow Card Scheme (visit www.yellowcard.gov.uk) and by the manufacturers of the vaccine as part of their legal requirements.
Gardasil: RKI One Mother's Plea - size 31.5 kB - Karen Maynor of New Mexico lost her daughter, Megan Hild to the Gardasil vaccine on November 15, 2008. Megan was a healthy, vital 20-year-old young woman with great aspirations –and no history of previous medical problems. Megan had just finished the second in the series of the Gardasil vaccination in September of 2008. On November 15, Megan called her family’s home to let them know that she would be over later in the morning. That was the last that anyone heard from her. Days before Megan had complained of severe headaches (migraines) and stomach pains.
CERVARIX: The Dutch Cervarix Concerns - size 34 kB - Annelies Witlam and Janny Stokvis The Netherlands We probably speak a different language than you do. Not only because we're Dutch, but also because we're not scientists, medical specialists or journalists. We consider ourselves professors in everyday life and even more, we're mothers. It was September 2008 when we first read an article about Gardasil. Meanwhile it has become a daily routine to read all the news (good and bad) about HPV, Gardasil and Cervarix. Although we had read enough about what was going on in the US we never expected to come in the middle of the same scenario in Holland.
CERVARIX: United Kingdom Concerns Regarding HPV-GM Vaccines - size 55.5 kB - Authors: Freda M Birrell and Christina England, Student Journalist writing for the American Chronicle, New Media Journal and Blitz Weekly on adverse reactions to vaccines. The following points are the serious concerns of the above authors from the United Kingdom (representing Scotland and England) who have researched the Cervarix vaccine in depth. They have noted media concern over many young girls adversely affected by serious illnesses, such as several forms of paralysis including Bells palsy, hemiparesis, hypoaesthesis and Guillaine-Barre Syndrome. Convulsions, seizures and epileptic fits, along with diminished vision have also been cited. The UK Health Minister, Dawn Primaralo and Scottish Health Minister Shona Robison, deny that these illnesses are connected to the vaccine and that they are coincidental in nature. Please note that many of the adolescent girls in the UK, as well as their counterparts in America who are being vaccinated with the sister HPV vaccine Gardasil, report similar complaints and adverse events after inoculation. How can a causal relationship to the vaccine be denied?
Gardasil: United States Concern for Europe with regards to Cervarix HPV vaccine. - size 42.5 kB - Authors: Cynthia Janak, Research Journalist, President of an International Coalition, Leslie Botha Researcher and Broadcast Journalist, Vice-President of an International Organization This paper will focus on four areas: (1) European Public Assessment Report, (26/11/2008 Cervarix-H-C-721-II-04), (2) Cervarix© Product Information (PI_Cervarix.pdf.), (3) MHRA (Medicines and Healthcare products Regulatory Agency) March, 2009 and May, 2009. (4) Media reports. (brackets my emphasis) Reports from around the world in regards to the HPV vaccines concern us greatly in the United States. Many of us have friends and family in Europe. We do not want to see any harm come to any citizen because of this kinship. That is why we felt it to be of paramount importance to add this information about the Cervarix © vaccine.
Gardasil: Treatise on Gardasil from the United States - size 61.5 kB - Authors: Cynthia Janak, Research Journalist, President of an International Coalition, Leslie Botha Researcher and Broadcast Journalist, Vice-President of an International Organization, H. Sandra Chevalier-Batik, Research Analyst This paper will focus on five areas: (1) Compromised immune systems in adolescents and potential vaccine reaction; (2) Exposure of HPV to infants and children prior to inoculation; raising concern that the vaccine will be rendered ineffective (Botha); (3) Examination of FDA documents regarding adverse events and efficacy. Neurological affects of Aluminum (Janak); (4) The fast tracking of Gardasil through the FDA without due scientific process and adequate research (Janak); (5) The pharmaceutical industry in the United States has systematically influenced the regulatory agencies and research facilities to fast track drug trials and manipulated their outcome. (Chevalier-Batik)
FDA: GAO INFORMATION TECHNOLOGY REPORT 06.08.2009- size 652.77 kB - GAO INFORMATION TECHNOLOGY REPORT FDA Needs to Establish Key Plans and Processes for Guiding Systems Modernization Efforts
New IT Medical Applications: Rubicon iPhone User Survey 03.31.2008 - size 377.07 kB - The Apple iPhone: Successes and Challenges for the Mobile Industry — A study of iPhone users How is it being used? What effect is it having on customers and on the technology industry? To help answer those questions, Rubicon Consulting conducted a detailed survey of 460 randomly-selected iPhone users in the US. This report summarizes the findings from the survey, and what they mean for users and other companies.
Human papillomavirus (HPV) vaccine: Human Papillomavirus Vaccination — Reasons for Caution 6.10.09- size 50 kB - Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer. Several strains of human papillomavirus (HPV) can cause cervical cancer, and two vaccines directed against the currently most important oncogenic strains (i.e., the HPV-16 and HPV-18 serotypes) have been developed. That is the good news. The bad news is that the overall effect of the vaccines on cervical cancer remains unknown. As Kim and Goldie1 point out in this issue of the Journal, the real impact of HPV vaccination on cervical cancer will not be observable for decades.
Gardasil: HPV vaccine (GARDASIL) Advice from the Australian Therapeutic Goods Administration 05.05.09- size 139.24 kB - Human papillomavirus vaccine (GARDASIL) Advice from the Therapeutic Goods Administration Updated 5 May 2009 Australia was one of the first countries to roll out a national cervical cancer immunisation campaign using Gardasil. Gardasil is a vaccine that protects young women from the strains of human papillomavirus (HPV) that cause 70% of cervical cancers.
Gardasil: Information Pertaining to Labeling Revision for Gardasil 06.09.2008- size 69.26 kB - Vaccines, Blood & Biologics Information Pertaining to Labeling Revision for Gardasil Reminder to HealthCare Providers: 15-minute Observation Period Needed After Vaccination On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination.
Gardasil: Hightlights Of Gardasil Prescribing Information 06.09.2009.1- size 474.89 kB - These highlights do not include all the information needed to use GARDASIL safely and effectively. Limitations of GARDASIL Use and Effectiveness • Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18. (1.2) • Women who receive GARDASIL should continue to undergo cervical cancer screening. (1.2) (17.1) • GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. (1.2) (14.2) • GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN. (1.2) • GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (1.2) (14.3) • GARDASIL does not protect against genital diseases not caused by HPV. (1.2) HB. (7.1) — USE IN SPECIFIC POPULATIONS— Safety and effectiveness of GARDASIL have not been established in the following populations: • Pregnant women. Physicians are encouraged to registerpregnant women exposed to GARDASIL by calling 1-800-986-8999 so that Merck can monitor maternal and fetal outcomes (8.1) • Children below the age of 9 years and pediatric males of any age. (8.4) • Immunocompromised individuals. Response to GARDASIL may be diminished. (8.6) • Women 27 years of age and older. (14.4). See PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 06/2009
Gardasil: USPPI Patient Information about GARDASIL® 06.09.2009- size 32.78 kB - 9883611 USPPI Patient Information about GARDASIL® (pronounced “gard-Ah-sill”) Generic name: [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] Read this information with care before getting GARDASIL. You (the person getting GARDASIL) will need 3 doses of the vaccine. It is important to read this leaflet when you get each dose. This leaflet does not take the place of talking with your health care provider about GARDASIL.
H1N1 Influenza Vaccines: Safety of Adjuvanted Influenza Vaccines 07.04.2009- size 118.69 kB - Summary of: WHO Virtual Consultation on the Safety of Adjuvanted Influenza Vaccines Held by teleconference on June 3 2009 15:30-17:30 CET A consultation was held by teleconference to review the safety of adjuvanted influenza vaccines. The purpose of this consultation was two-fold: (1) To review known and theoretical safety concerns associated with using adjuvants in influenza vaccines; (2) To discuss ways to prospectively evaluate vaccine safety. Participants in the teleconference included vaccine manufacturers, experts in adjuvant development, influenza vaccines and safety evaluation, as well as representatives from regulatory agencies, WHO and other stake-holders.
Human papillomavirus (HPV) vaccine: Suspected Adverse Reaction Analysis Human Papillomavirus (HPV) Vaccine 07.02.2009- size 227.63 kB - Medical Health Products Regulatory Agency an Executive Agency of the Department of Health, UK This report summarises the reports of adverse reactions suspected to have been caused by human papillomavirus (HPV) vaccine for which information on the specific brand administered (whether Cervarix or Gardasil) is currently unavailable. This includes reports received up to 1 July 2009. Separate Adverse Reaction Analysis summaries exist for reports in which the brand was stated. These reports have been voluntarily submitted to the MHRA by healthcare professionals and members of the public via the Yellow Card Scheme (visit www.yellowcard.gov.uk) and by the manufacturers of the vaccine as part of their legal requirements. www.mhra.gov.uk
H1N1 Influenza Vaccines: Flu Shot Fact Sheet 06.30.2009- size 229.64 kB - "By 1853, Parliament began passing laws to make the untested vaccine compulsory throughout the British Empire. Other countries of Europe followed suit. Once the economic implications of compulsory vaccinations were realized, few dared to disagree. Then, as now, the media were controlled by the vaccine manufacturers and the government, who stood to make huge money from the sale of these spurious vaccines."... Tim O'Shea, D.C.
Safety Studies on DNA Vaccines: Preclinical and Clinical Safety Studies on DNA Vaccines 07.06.2009- size 263.03 kB - ABSTRACT: DNA vaccines are based on the transfer of genetic material, encoding an antigen, to the cells of the vaccine recipient. Despite high expectations of DNA vaccines as a result of promising preclinical data their clinical utility remains unproven. However, much data is gathered in preclinical and clinical studies about the safety of DNA vaccines. Here we review current knowledge about the safety of DNA vaccines. Safety concerns of DNA vaccines relate to genetic, immunologic, toxic, and environmental effects. In this review we provide an overview of findings related to the safety of DNA vaccines, obtained so far. We conclude that the potential risks of DNA vaccines are minimal. However, their safety issues may differ case-by-case, and they should be treated accordingly. Johanna A.C. Schalk1, Frits R. Mooi2, Guy A.M. Berbers2, Leon A.G.J.M. van Aerts1, Hans Ovelgönne1, Tjeerd G. Kimman2, 1Centre for Biological Medicines and Medical Technology; and 2Laboratory for Vaccine-Preventable Diseases; National Institute for Public Health and the Environment; Bilthoven, The Netherlands. Correspondence to: J.A.C. Schalk; Centre for Biological Medicines and Medical Technology; National Institute for Public Health and the Environment; PO Box 1; 3720 BA Bilthoven, The Netherlands; Tel.: +31.0.302744554; Fax:+31.0.302744421; Email:email@example.com Received 12/02/05; Accepted 01/16/06 / Previously published online as a Human Vaccines E-publication: http://www.landesbioscience.com/journals/vaccines/abstract.php?id=2620 ACKNOWLEDGEMENTS: This study was financed by Netherlands Commission on Genetic Modification.
Human papillomavirus (HPV) vaccine: Society of Gynecologic Oncologists Issues White Paper on HPV Vaccine's Impact on Cervical Cancer Prevention 08.04.09- size 39 kB - The Society of Gynecologic Oncologists (SGO) has published the first in a series of four papers on a variety of cervical cancer issues and topics that were the focus of its Forum "The Future Strategies for Cervical Cancer Prevention: What Do We Need to Do Now to Prepare," held last September in Chicago, Illinois. The paper, entitled "The Impact of Human Papillomavirus Vaccination on Cervical Cancer Prevention Efforts," is featured in the August, 2009 issue of Gynecologic Oncology. It includes data relevant to HPV natural history as well as excerpts from Forum discussions regarding the limits of current screening, the impact that eliminating HPV 16/18 through vaccination may have on rates of cervical precancer and cervical cancer screening, strategies to measure vaccine uptake and obstacles surrounding separate screening for vaccinated women.
Gardasil: A Judicial Watch Special Report: Examining the FDA’s HPV Vaccine Records 06.30.2008 - size 372.01 kB - Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment. This Judicial Watch Special Report is an analysis of records obtained from the Food and Drug Administration (FDA) concerning a recent vaccine called Gardasil. Gardasil helps protect against four types of human papillomavirus (HPV). The vaccine was approved in May 2006 and was created and marketed by Merck & Company Incorporated. The records include Merck’s patent and drug information submitted to the FDA, transcripts and briefing material from approval meetings, and reports documenting health, safety, and efficacy test results, as well as Vaccine Adverse Event Reporting System (VAERS) documents detailing 8,864 cases of adverse effects experienced by people after receiving the Gardasil vaccine. VAERS reports show that at least eighteen people have died after receiving Gardasil. Many health officials believe that adverse reactions to medications are widely underreported, therefore the actual number of adverse events occurring after vaccination with Gardasil is likely to be higher.
Health Care Reform: FEMINISM AND PROFIT IN AMERICAN HOSPITALS The Corporate Construction of Women’s Health Centers 08.20.09- size 144.83 kB - Paper by JAN E. THOMAS, Kenyon College and MARY K. ZIMMERMAN, University of Kansas Provides a critical analysis of the evolution and impact of hospital-sponsored women’s health centers. Using original data gathered from interviews, participant observation,and content analysis of documents and brochures, the authors describe the development of four models of hospital-sponsored women’s health centers and illustrate three specific mechanisms of the co-optation process. They show how many elements of feminist health care were used for the purpose of marketing and revenue production rather than for empowering women and transforming the delivery of care. Following Stratigaki’s notion of negative counter effect, the authors show how the key feminist concepts of women-centered care and empowerment ended up contradicting their original meaning and purpose. Rather than being the subject of care, women became the object of treatment and revenue production.
- GAO INFORMATION TECHNOLOGY REPORT (254)
- VRBPAC Background Document - GardasilTM HPV Quadrivalent Vaccine (203)
- Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal (193)
- Clinical Review of Biologics License Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae) (STN 125126 GARDASIL), manufactured by Merck, Inc. (191)
- Merck PAC Money To States (From Lobby Watch) (478)
- USPPI Patient Information about GARDASIL® (390)
- HPV vaccine (GARDASIL) Advice from the Australian Therapeutic Goods Administration (288)
- Information Pertaining to Labeling Revision for Gardasil (277)
- Treatise on Gardasil from the United States (255)
- GAO INFORMATION TECHNOLOGY REPORT (254)
- The Dutch Cervarix Concerns (252)
- Rubicon iPhone User Survey (249)
- United States Concern for Europe with regards to Cervarix HPV vaccine. (247)
- Suspected Adverse Reaction Analysis CERVARIX Human papillomavirus (HPV) vaccine (245)