MedWatch Online Voluntary Reporting Form (3500)

Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:

• FDA-regulated drugs,
• biologics (including human cells, tissues, and cellular and tissue-based products)
• medical devices (including in vitro diagnostics)
• special nutritional products and cosmetics

A Message about Privacy

You can continue to make adverse event reports under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The HIPAA Privacy Rule is not intended to disrupt or discourage adverse event reporting in any way. In fact, the Privacy Rule specifically permits covered entities (such as pharmacists, physicians or hospitals) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.

For more information, please go to the Medwatch HIPAA Compliance page.

What NOT to Report to MedWatch Using Online Form 3500

• Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://secure.vaers.org/VaersDataEntryintro.htm.
• Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
• Mandatory reporting:
  Drugs and Biologics
  Devices

Frequently Asked Questions: submitting your voluntary report online (both versions):

• Will my report be secure when submitted over the internet?
• Can I submit attachments using this online reporting form?
• Are instructions for completing this form available?
• How will I know that this report has been received?
• I don’t want to submit a report now but have a question about a medical product. How can I get my questions answered?
• What browser and technical requirements are needed?
• Will I be able to print or save my report on my computer?

©2012 An Inconvenient Woman. All Rights Reserved.

FDA for Fast Tracking Licensure

NVIC Press Release

June 27, 2006

MERCK’S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS
National Vaccine Information Center Criticizes
FDA for Fast Tracking Licensure

Washington, D.C. – The National Vaccine Information Center (NVIC) is calling on the CDC’s Advisory Committee on Immunization Practices (ACIP) to just say “no” on June 29 to recommending “universal use” of Merck’s Gardasil vaccine in all pre-adolescent girls. NVIC maintains that Merck’s clinical trials did not prove the human papillomavirus (HPV) vaccine designed to prevent cervical cancer and genital warts is safe to give to young girls.

“Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials,” said NVIC president Barbara Loe Fisher. “Merck’s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”

The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo.[1] A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.[2]

Animal and human studies have shown that aluminum can cause nerve cell death [3] and that vaccine aluminum adjuvants can allow aluminum to enter the brain, [4 5] as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue.  [6 7] Nearly 90 percent of Gardasil recipients and 85 percent of aluminum placebo recipients followed-up for safety reported one or more adverse events within 15 days of vaccination, particularly at the injection site.[8] Pain and swelling at injection site occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. [9 10] Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

“Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were less than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.”

According to the Merck product manufacturer insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.

“There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it,” said Fisher. “Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls – especially simultaneously with hepatitis B vaccine – will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing about one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group.”

The National Vaccine Information Center (NVIC), founded in 1982 by parents of vaccine injured children, has been a leading critic of one-size-fits-all mass vaccination policies and the lack of basic science research into biological mechanisms and high risk factors for vaccine-induced brain and immune system dysfunction.  As a member of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC), Barbara Loe Fisher urged trials include adequate safety data on pre-adolescent children and warned against fast tracking Gardasil at the November 28-29, 2001 VRBPAC meeting .

Full 2001 FDA Transcript: http://www.fda.gov/ohrms/dockets/ac/cber01.htm#Vaccines & Related Biological

For more information go to www.NVIC.org.

-end-

1. Merck & Co., Inc. 2006. Gardasil [Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert. Table 6.
2. Food and Drug Administration. May 18, 2006. FDA Background Document for Vaccines and Related Biological Products Advisory Committee: Gardasil HPV Quadrivalent Vaccine.
3. Kawahara M et al. 2001. Effects of aluminum on the neurotoxicty of primary cultured neurons and on the aggregation of betamyloid protein. Brain Res. Bull. 55, 211-217.
4. Redhead K. et al. 1992. Aluminum-adjuvanted vaccines transiently increase aluminum levels in murine brain tissue. Pharmacol. Toxico. 70, 278-280.
5. Sahin G. et al. 1994. Determination of aluminum levels in the kidney, liver and brain of mice treated with aluminum hydroxide. Biol. Trace. Elem. Res. 1194 Apr-May;41 (1-2):129-35.
6. Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle. Brain, Vol 124, No. 9, 1821-1831.
7. Shingde M eta la. 2005. Macrophagic myofastitis associated with vaccine derived aluminum. MJA, 183 (03):145-146.
8. Merck & Co. May 18, 2006. Merck briefing document for Vaccines and Related Biological Products Advisory Committee: Gardasil. Table 24.
9. Merck & Co., Inc. 2006. Gardasil product insert: Serious Adverse Experiences.
10. Food and Drug Administration. May 18, 2006. FDA Background Document for Vaccines and Related Biological Products Advisory Committee.: Gardasil. Table 32.
11. Food and Drug Administration. November 29, 2001. Vaccines and Related Biological Products Advisory Committee. Excerpt from transcript.

Where Do Inconvenient Women Go to Learn More

I do my best to site every one of my sources. I read hundreds of newsletters, RRS feeds, periodicals, articles and emails from other “Inconvenient Women each week. One of my favorite Inconvenient Women is Barbara Loe Fisher, Co-Founder of National Vaccine Information Center (NVIC)

“If the State can tag, track down and force citizens against their will to be injected with biologicals of unknown toxicity today, there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow.”

— Barbara Loe Fisher, Co-Founder and President of the National Vaccine Information Center Complete Bio

The National Vaccine Information Center (NVIC) is a national, non-profit educational organization founded in 1982. The oldest and largest consumer organization advocating the institution of vaccine safety and informed consent protections in the mass vaccination system, NVIC is responsible for launching the vaccine safety and informed consent movement in America in the early 1980′s.

The Mission of The National Vaccine Information Center (NVIC) is dedicated to the prevention of vaccine injuries and deaths through public education and to defending the informed consent ethic. As an independent clearinghouse for information on diseases and vaccines, NVIC does not promote the use of vaccines and does not advise against the use of vaccines. We support the availability of all preventive health care options, including vaccination, and the right of consumers to make educated, voluntary health care choices.

NVIC provides assistance to those who have suffered vaccine reactions; promotes research to evaluate vaccine safety and effectiveness, as well as to identify factors which place individuals at high risk for suffering vaccine reactions; and monitors vaccine research, development, regulation, policy-making and legislation. NVIC works to protect the right of citizens to exercise the human right to informed consent to medical interventions which carry a risk of injury or death for themselves or their children, including vaccination.

©2012 An Inconvenient Woman. All Rights Reserved.