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Investigation Questions Gardasil Clinical Trial Safety Data

nurse holding up HPV vaccine

“If the purpose of a clinical trial is to establish the safety and efficacy of a new product, whether it’s a vaccine or something else, I would expect that they gathered all relevant data, including whether it had side effects or not.”  — Trudo Lemmens, University of Toronto

While Merck & Co. and many health authorities share the view that the benefits of the human papillomavirus vaccine (HPV), Gardasil, outweigh the risks, an eight-month investigation by medical journalist Frederick Joelving, which was published by the online magazine Slate, confirms that clinical drug trials Merck conducted in 2002 were inadequately designed to reliably assess the safety of the vaccine pre-licensure.1

No Objective Reporting of Potential Side Effects

According to Merck, Gardasil’s safety profile relied heavily on data from two randomized, placebo-controlled trials (Future 1 and Future 2) involving more than 25,000 females and males in several countries, including the United States.

Approximately 2,300 pages of documents obtained through Freedom of Information Act (FOIA) requests, as well as interviews with five study participants, were evaluated during the investigation. Slate concluded that the clinical trial protocol was flawed from the start, although government regulators still used the flawed safety data as the basis for approving Gardasil vaccine for use in young girls and women.

The key piece of evidence arguing against proof of safety pre-licensure is that trial investigators registered complaints of adverse health effects following Gardasil administration by study subjects not as potential vaccine-related adverse events, but as “new medical history.” In fact, the individual clinical trial investigators used personal judgment to choose whether to report health problems as potential Gardasil side effects worthy of further evaluation. Those medical conditions recorded in “new medical history” were allotted one line, lacked details measuring severity, duration, outcome or overall seriousness, and were reserved for issues unreleated to the vaccine. There was no indication in the study’s documents that regulators should use “new medical history” as a safety metric.

Furthermore, Merck designed the clinical trial safety analysis to restrict vaccine adverse event reporting to only those events recorded within 14 days following each dose of the three Gardasil injections administered to participants. Any illnesses or symptoms occurring outside the time period were recorded on a single line as part of the “new medical history” worksheet.

Interviews with Study Subjects Support Questionable Methods

Three female Future 2 clinical trial participants shared their own experience with Slate.

Miam Donslund said that her flu-like symptoms and one hospitalization from infection following immunization were recorded as “new medical history.” Today, she lives with severe joint pain and regularly uses crutches, yet does not have a diagnosis. Stine Sorensen experienced general discomfort, headaches and fatigue following Gardasil vaccination and reported these to the study personnel, but nothing is listed in her trial records.

The health outcome was the worst for Future 2 trial participant Keisa Lyng. Lyng’s grandmother had died of cervical cancer, so when she was offered a spot in the Gardasil trial in 2002 for $500, she opted to participate without hesitation. After her second Gardasil shot on Nov. 14, 2002, Lyng started to experience flu-like symptoms, joint and muscle pains, headaches and debilitating fatigue. Her family doctor started documenting her problems on March 20, 2003, nine days after her third and final Gardasil injection.

Lyng shared her symptoms with study personnel at every visit during the four-year trial, yet there was no mention of these conditions in her Future 2 trial records. The trial investigator who dealt with both Sorensen and Lyng declined an interview with Slate, noting only that she followed the study’s protocol.

Lyng eventually had to quit school and it wasn’t until 2016 that she received a diagnosis of chronic fatigue syndrome, an illness that has roots in a compromised immune system. There have been hundreds of other women reporting the same health issues following Gardasil vaccination, but most accounts have been dismissed as unreliable “anecdotal” evidence.

Officials Uncertain About Merck’s Approach

When reviewing Merck’s marketing application for Gardasil, the European Medicines Agency called the company’s approach “unconventional and suboptimal,” but ultimately considered the trial safety data to be usable enough for approving licensure.

“If I were a research subject, I would feel betrayed,” Trudo Lemmens, a University of Toronto professor of health law and policy told Slate. “If the purpose of a clinical trial is to establish the safety and efficacy of a new product, whether it’s a vaccine or something else, I would expect that they gathered all relevant data, including whether it had side effects or not.”1

Slate’s science editor, Susan Matthews, explained the reason for the magazine’s investigation, “the truth is that science can be imperfect, and evidence can be incomplete. When that is the case, we should be upfront and transparent about it—in fact, I believe that doing so serves to bolster our credibility rather than diminish it.”2


References:

1 Joelving F. What the Gardasil Testing May Have Missed. Slate Dec. 17, 2007.
2 Matthews S. Why is Slate Questioning Gardasil? Slate Dec. 17, 2017.

11 Responses to Investigation Questions Gardasil Clinical Trial Safety Data

  1. Jay Reply

    January 27, 2018 at 1:12 am

    Sorry, UC Berkely

  2. Jay Reply

    January 27, 2018 at 1:11 am

    Duesberg again…….the genius at CU Berkeley

    http://sanevax.org/hpv-not-cause-cervical-cancer/ – What if HPV does NOT cause cervical cancer?

  3. Brenda Reply

    January 26, 2018 at 8:04 am

    Didn’t Ophra Winfrey & other big names tell us in print adverts how SAFE & Wonderful this new vaccine is for our young girls?

    Didn’t the print ads, THEN inform us this vaccine is safe for young boys, AND Women up to age 45?

    Seems to me – this was just a way to enlarge the pool of recipients of this (iffy) vaccine.

    bottom Line – Follow the $$$, WHO got it all?

  4. Jean Matthews Reply

    January 13, 2018 at 3:05 pm

    My daughter was injured in 2003 and still suffers today. We have been ridiculed and lied to by medical professionals. There are 1000s injured by this vaccine. It is truly a crime against humanity. The benefits DO NOT OUTWEIGH THE RISKS!

  5. Eieen DiMeco Reply

    January 13, 2018 at 6:37 am

    This is proof of dishonest people playing with people’s health and endocrine system and lives. It must be stopped.

  6. Sonja Hardy Reply

    January 13, 2018 at 4:41 am

    Another aspect not mentioned in the article is that the ‘placebo’ used in clinical trials for Gardasil was actually the same aluminium adjuvant that is contained in the vaccine. In other words, NOT a true placebo. This smacks of intentional fraud.

    Furthermore, there is much evidence that aluminium is a neurotoxin, and the Gardasil vaccine contains quite a large dose. And of more concern, the new Gardasil 9 contains an even higher dose of this aluminium adjuvant.

    • Tammy Reply

      January 15, 2018 at 4:19 pm

      Have there been any documented cases of patients suffering from extreme anxiety? My daughter started suffering from anxiety around the same time that she started receiving her injections. I have been dumbfounded by this but I can’t help but wonder if this vaccine could have caused this problem.

      • Sonja Hardy Reply

        January 16, 2018 at 6:37 pm

        Tammy, I wouldn’t be at all surprised if this is a reaction to the vaccine, though I can’t recall a specific study mentioning anxiety. There is such a high amount of aluminium in this vaccine, and it makes sense that this neurotoxin could cause anxiety.

        Also, I convinced my daughter and son-in-law to hold off vaccinating their youngest son (wish I could have convinced them not to vaccinate at all). So they held off till he was about to start kindergarten at age 4, when he had a number of ‘catch-up’ shots. Up till then he had been a robust, healthy, confident child. Within a very short time he developed severe anxiety (which thankfully has diminished somewhat over time) as well as quite severe asthma. The more I learn, the more I am convinced no vaccine is safe, nor particularly effective – and that they cause a whole host of other illnesses, more serious than the ones they’re supposed to prevent.

  7. Doctor Jack Reply

    January 13, 2018 at 12:35 am

    The reason these victims became symptomatic is because there’s no such thing as vaccine or medicine but there is a such thing as being injected with deadly chemicals. Because the world is in a medically induced hypnotic trance, people will let “doctors” do anything to them. No symptoms are caused by a drug deficiency so why do people take tjem? Makes no sense unless one is in a medically induced hypnotic trance and will do whatever they’re told. Truth is Health is only produced by healthful living. There is no papiloma virus or cooties for that matter. You’re being lied to as over 80% of medical “science” is deliberately fraudulent.

  8. Kim Reply

    January 12, 2018 at 2:41 am

    I know quite many young girls suffered chronic fatique like symptoms. It is rather irresponsible of the health department to continue rolling out this compulsory vaccine.

  9. Nell veale Reply

    January 11, 2018 at 9:26 pm

    I would hope that my granddaughter will not be a Guinea pig for such research and that other methods of helping young people would be available to offer……maybe give incentives to refrain from behaviours that cause the problems in the first place … PUT SOME MONEY INTO GIVING YOUNG PEOPLE A REASON TO CHOOSE A BETTER WAY OF LIFE….translate: a reward type system …education, travel with a purpose, any alternate ways of motivating young people to set goals that prohibit poor choices….

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