Open Letter to FDA Commissioner: Investigate Gardasil Clinical Trials

by SaneVax, Inc.

The following open letter to FDA Commissioner, Dr. Scott Gottlieb, calling for immediate investigations into many facets of the clinical trials for Gardasil sponsored by Merck was emailed today.

If you support this request, please leave a note in the comment section here that includes your name, title, and organization. Help the FDA understand how deeply concerned you are about the sanity of HPV vaccination programs.

Dr. Scott Gottlieb
Food and Drug Administration Commissioner
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

November 9, 2018

Dear Dr. Gottlieb:

Gardasil Vaccine Clinical Trial Investigation

This open letter, written on behalf of medical consumers around the world, is an urgent request for you to investigate potential malfeasance perpetrated by Merck during their clinical trials of Gardasil, the human papillomavirus vaccine that the FDA approved in June 2006. A new book, The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed, by Holland, Rosenberg, and Iorio, outlines at least four areas requiring the FDA’s urgent attention. (A copy has been sent to you under separate cover.)

Protocol V501-018

Protocol V501-018 was the only controlled trial in the target age group of 9-15-year-olds. This Protocol is the basis for the only long-term safety and effectiveness research in this population. Pediatric Infectious Disease Journal and Pediatrics have published results suggesting that the vaccine is safe and effective after ten years of use. However, the FDA’s June 2006 Clinical Review Table 210 (Appendix I) shows that the vaccine formulation in Protocol 018 contained only half the amount of Merck’s adjuvant amorphous aluminum hydroxyphosphate sulfate (AAHS) compared to marketed Gardasil. This failure to compare the marketed vaccine, containing 225 mcgs of AAHS, against the carrier solution control, suggests the intent to mislead. It also suggests reckless overexposure of children worldwide who received the marketed vaccine to double the AAHS amount in Protocol 018, helping to explain the high level of reported injuries and deaths worldwide. An emerging scientific consensus finds that aluminum-containing vaccine adjuvants, including AAHS, likely cause a myriad of serious health problems. (Appendix II).

New Medical Conditions

About half of all clinical trial participants for Gardasil and Gardasil 9 reported “new medical conditions” during or immediately after receiving the vaccine series. (Appendix III). “New medical condition” is not a defined term in Merck’s study protocol. How is the FDA certain that “new medical conditions” that emerged after vaccination are not simply adverse reactions in disguise? What documentation did trial investigators provide to the FDA for “new medical conditions” as compared to “adverse reactions” or “adverse events”? How did the FDA evaluate these conditions in half of all previously healthy trial participants?

Protocol 015 Deprivation of Informed Consent

Documentation in HPV Vaccine on Trial shows that clinical trial subjects in Denmark received false information about Gardasil safety and the placebo used. The authors provide evidence from two clinical trial subjects, who reported that they did not give informed consent because of the false information they received about the placebo and vaccine safety profile. The deprivation of informed consent to these and potentially other subjects calls into question the ethics and legality of the clinical trials.

Use of an Undisclosed and Unapproved Adjuvant

The FDA has previously acknowledged that Gardasil contains HPV DNA fragments, despite earlier denials. Dr. Sin Hang Lee, who first detected the DNA fragments in both tissue samples and Gardasil vials, has theorized that these fragments are TLR9 agonists acting as an adjuvant, further boosting the vaccine’s immunogenicity. This additional undisclosed and unapproved adjuvant, in combination with the AAHS adjuvant, makes the vaccine potentially more toxic and dangerous. Merck filed a TLR9 agonist vaccine adjuvant patent and joined with other companies to expand this adjuvant’s commercial use. Dr. Lee has testified to the National Vaccine Injury Compensation Program on injuries arising from this undisclosed adjuvant. What is the FDA’s knowledge of this technology and its use in the Gardasil vaccine?

Each of the issues noted above – Protocol 018, “New Medical Conditions,” Protocol 015 Deprivation of Informed Consent, and Use of an Undisclosed and Unapproved Adjuvant – call into question the safety, ethics, effectiveness, and legality of Gardasil and Gardasil 9. We are gravely concerned that the FDA failed to review the Gardasil clinical trials with sufficient rigor.

We hope to hear from you in the near future regarding a reopened, thorough investigation of the Gardasil clinical trials. Medical consumers worldwide will anxiously await your response.

Sincerely yours,

Norma Erickson,

President, SaneVax, Inc.

View attachments to this letter here.

Read this letter in Spanish here.

Read the full article at SaneVax.org.

More information about Gardasil

Illinois Teen Dies Three Weeks After Being Injected with HPV Gardasil Vaccine

California Nurse Gives Gardasil Vaccine to Own Daughter who Develops Leukemia and Dies

Infant Accidentally Vaccinated with Gardasil – Mother Blamed for Vaccine Injuries and Baby Medically Kidnapped

The Happy-go-Lucky Girl I had Pre-HPV Vaccine is Gone Forever

Iowa Girl Faces Death: Life Destroyed by Gardasil Vaccine

Gardasil Vaccine Given without Consent and Ruins Life of 14 Year Old Girl

After 3 Years of Suffering 19 Year Old Girl Dies from Gardasil Vaccine Injuries

Gardasil: The Decision We Will Always Regret

15 Year Old French Girl’s “Descent into Hell” After Gardasil Vaccine – Wheelchair Bound and Paralyzed

The Gardasil Vaccine After-Life: My Daughter is a Shadow of Her Former Self

Gardasil: An Experience no Child Should Have to Go Through

I Want my Daughter’s Life Back the Way it was Before Gardasil

Gardasil Vaccine: Destroyed and Abandoned

15-Year-Old Vaccinated by Force with Gardasil now Suffers from Paralysis and Pain

Recovering from my Gardasil Vaccine Nightmare

Gardasil: We Thought It Was The Right Choice

“HPV Vaccine Has Done This to My Child”

13 Year Old World Championship Karate Student Forced to Quit After Gardasil Vaccine

If I Could Turn Back Time, Korey Would not Have Received any Gardasil Shots

What Doctors Don’t Tell You: Our Gardasil Horror Story

Family Fights U.S. Government over Compensation for Gardasil Vaccine Injuries

Gardasil: When Will our Nightmare End?

HPV Vaccine Injuries: “I Cannot Begin to Describe What it is Like to Watch your Daughter Live in Such Agony”

Gardasil: Don’t Let Your Child Become “One Less”

The Gardasil Vaccine Changed Our Definition of “Normal”

Gardasil: I Should Have Researched First

“They’ve Been Robbed of Their Womanhood” – Local Milwaukee Media Covers Gardasil Vaccine Injuries

Gardasil: The Day Our Daughter’s Life Changed

Gardasil: The Decision I will Always Regret

Gardasil Vaccine: One More Girl Dead

Gardasil: A Parent’s Worst Nightmare

After Gardasil: I Simply Want my Healthy Daughter Back

Gardasil: My Family Suffers with Me

Gardasil Changed my Health, my Life, and Family’s Lives Forever

Gardasil: Ashlie’s Near-Death Experience

Gardasil: My Daughter’s Worst Nightmare

My Personal Battle After the Gardasil Vaccine

Gardasil: The Worst Thing That Ever Happened to Me

A Ruined Life from Gardasil

HPV Vaccines: My Journey Through Gardasil Injuries

The Dark Side of Gardasil – A Nightmare that Became Real

Toddler Wrongly Injected with Gardasil Vaccine Develops Rare Form of Leukaemia

Order Here!

Leaving a lucrative career as a nephrologist (kidney doctor), Dr. Suzanne Humphries is now free to actually help cure people.

In this autobiography she explains why good doctors are constrained within the current corrupt medical system from practicing real, ethical medicine.

One of the sane voices when it comes to examining the science behind modern-day vaccines, no pro-vaccine extremist doctors have ever dared to debate her in public.

Book – The Vaccine Court, by Wayne Rohde – 240 pages

“The Dark Truth of America’s Vaccine Injury Compensation Program”

FREE Shipping Available!

ORDER HERE!

Published on November 11, 2018

2 Comments

Sandy Lunoe November 15, 2018 at 11:47 am - Reply

To FDA Commissioner, Dr. Scott Gottlieb,

I strongly support this request for thorough investigations into many issues of the clinical trials for Gardasil sponsored by Merck.

The system upon which clinical trials for vaccines is based is grossly inadequate regarding safety for vaccine recipients and should be considerably revised.

Protocols for clinical trials which are compiled by the industry should be subjected to close scrutiny by unbiased experts (including statisticians) with no conflicts of interest whatsoever and who may approve or reject the protocols.

Phase four for clinical trials which involves large groups in populations is totally inappropriate regarding registration of adverse events. New, reliable and effective systems for reporting of these must be implemented.

The ethical aspects of all clinical trials which Merck and other vaccine manufacturers undertake, including those which take place in both developed and developing countries should be seriously addressed.

Only trials for safety using completely inert placebos should be approved. Vaccines produced by Merck and other manufacturers where approval has been based on safety trials involving false placebos should be withdrawn.

Merck’s use of false, active placebos in clinical safety trials for Gardasil is research fraud and should be regarded as a criminal act.

Likewise, Merck’s failure to respect rights of consumers regarding informed consent should also be considered illegal.

Merck’s exclusion criteria for the Gardasil clinical trials amounted to the vaccine being tested on handpicked groups which were not representative of the groups which were potential vaccine recipients.This issue should also be seriously investigated.

Extrapolatlon of results of clinical trials from one age group to another should not have been undertaken. One reason is that it does not address the issues of the delicate hormonal balance and changes (for example regarding puberty) in the different age groups.

Instead of imposing gigantic fines on Merck or other vaccine manufacturing companies the leader at the utmost top level should be made personally and legally responsible for research fraud and for other crimes committed within the company.

bookwarm November 15, 2018 at 11:45 am - Reply

HI, REMEMBER THE PROMOTION OF THE THALIDOMIDE TABLET;THERE ARE OTHER SIMILIAR CASES OF THE INDIVIDUALS CONCERNED MAKING VAST PROFITS WITHOUT ANY MORALS ABOUT THE SUFFERING THEY CAUSE. IF THEY CAN DO IT THEN THEY CAN DO IT NOW WITHOUT ANY MISGIVINGS.

Public Petitions FDA to Investigate Gardasil Vaccine Fraud