Health

Gardasil controversy: Freedom of Information disclosure reveals more deaths in Australia after HPV vaccination

It has been confirmed that 11 deaths after HPV vaccination have been reported to Australia’s Therapeutic Goods Administration (TGA). They include one neonatal death in 2008, the death in June this year of an 11-year-old boy who had brain cancer, two deaths that are directly stated to be from cervical cancer, and two in which the adverse reaction is simply described as “vaccination failure”.

The new FOI release also includes four cases of spontaneous abortion after HPV vaccination.

The latest information has come to light via a second Freedom of Information (FOI) request submitted to the TGA by Michelle Stubbs, whose daughter Asha became seriously ill after HPV vaccination.

The response to Stubbs’ first FOI request revealed that more than one hundred cases of reported adverse reactions after HPV vaccination have been excluded from the TGA’s public Database of Adverse Event Notifications (DAEN). and are only recorded in its Adverse Event Management System (AEMS) internal database.

Stubbs, who lives in northern Queensland, is organising a class action lawsuit against Merck, who manufacture Gardasil and Gardasil 9. A total of 150 potential claimants have come forward in less than two months.

For the past couple of years Stubbs has been doggedly chasing up information, putting questions to the TGA and the Department of Health about her daughter’s case and HPV vaccination in general.

Gardasil is promoted as an “anti-cancer” vaccine and pro-Gardasil lobbyists claim, without foundation, that it will lead to the elimination of cervical cancer in Australia.

Official statistics show the opposite and indicate that, in Australia, Britain, Sweden, Norway, Denmark, and the Netherlands, the incidence of cervical cancer has increased among young women since HPV vaccination began. It has never been proved that HPV vaccination has, or ever will, prevent a single case of cancer.

The information just released to Stubbs indicates that two of the reported deaths after HPV vaccination occurred within a period of four days in 2018 (in both cases the adverse effect is listed as vaccination failure). Three of the deaths that year occurred over a period of three weeks. In all three cases, vaccination failure is specified. Cervical cancer is specifically cited as an adverse reaction in only one of those cases. The patient’s age in that case is not given.

In the case of one of the deaths listed in the new FOI disclosure the 23-year-old woman had hypertrophic cardiomyopathy, a condition in which a portion of the heart becomes thickened. This results in the heart being less able to pump blood effectively. In another, a 13-year-old girl died after suffering from a progression of motor neurone disease.

The TGA says that the case of the woman suffering from hypertrophic cardiomyopathy “was not considered to be related to the vaccine based on clinical review and consideration of the information provided by the reporter”. It is therefore not included in the DAEN.

The TGA has told Stubbs in an email that vaccination failure “refers to a situation where the vaccine has not been effective in preventing the disease it is intended to protect against”.

The administration stated that, in the context of a HPV vaccine, “the TGA may receive a report of a vaccinated individual developing a cervical abnormality (e.g. dysplasia or carcinoma)”.

It added: “However, to confirm a vaccine failure information is required to show that vaccination was performed prior to exposure to HPV, and that the HPV variant associated with the cervical abnormality was covered by the vaccine”.

There is no specific prescreening for HPV prior to HPV vaccination so, if a vaccinated person does develop dysplasia or carcinoma, it is highly unlikely that she would know whether she had been exposed to HPV prior to receiving the vaccine.

Only one death recorded in the DAEN

The TGA includes only one death after HPV vaccination in the DAEN.

The report of this death can only be seen by searching in the category “Human Papillomavirus Recombinant Vaccine Quadrivalent”, not under Gardasil. The death is recorded in the “Medicine summary” section as “vaccination failure” and “cervix carcinoma”, but there is no detailed report in the DAEN that refers specifically to the death.

This case is included in the latest FOI release.

Spontaneous abortions

In her latest FOI request Stubbs asked for “all adverse reaction reports received by the TGA against all HPV vaccines, that reported death as an outcome, or reports where the outcome was death, including miscarriages, foetal demise, instantaneous abortions, and neonatal deaths”. She asked for information made public in the DAEN and that contained in the private AEMS database.

The four cases of spontaneous abortion after HPV vaccination that are reported in the new FOI disclosure are recorded in the DAEN. One of the cases is described as a “complete” spontaneous abortion and, in another, the patient suffered from systemic lupus erythematosus¹. In one case, the patient, whose age is not given, suffered an anaphylactic reaction².

In the case that is not included in the DAEN, but only in the TGA’s internal database, the 22-year-old had an induced abortion after what is described as “exposure during pregnancy”.

Merck itself says that the safety and effectiveness of Gardasil has not been established for pregnant women.

In three of the cases of spontaneous abortion, the age of the patient is not given.

‘A clear and real conflict of interest’

Stubbs points to the lack of important information in the TGA reports: “We have 11 deaths reported in this latest FOI release and, in three of those reports, there is not even an age given.”

One report refers to a death in May 2017 and the only information provided is that the person who died was female, and was injected with quadrivalent Gardasil.

“How is this possible?” Stubbs said. “That there can be a death, possibly of a child, and this is all the information that is reported, and it is only reported in the TGA’s internal database, not in the DAEN.

“Where is the follow up? Where is the concern? Where is the standardised process for reporting adverse effects that would ensure the adequate capture of information?”

Stubbs added: “At a time when the confidence of parents in vaccine safety is clearly on the decline, it is simply not good enough that post-marketing surveillance of adverse reactions to vaccines is being conducted by the regulatory body that deemed the vaccine safe for market.”

This, Stubbs says, is a clear and real conflict of interest.

“What my latest FOI says to me is that the TGA has been intent on keeping the number of deaths reported after Gardasil vaccination down to as few as possible. Only one of the 11 reported deaths is recorded in the public DAEN database and it is very hard to find.”

In reality, Stubbs says, the TGA has been receiving reports of death since 2008, with as many as three deaths reported last year alone.

“They have chosen, from their conflicted position, to keep all but one of these deaths hidden from the public.

“This is a disgrace, and I have to wonder if the Department of Health and the health minister are aware of this deceit, masquerading as regulation. Certainly parents aren’t aware and that appears to be exactly what the TGA wants.”

On its website, in an update dated May 13, 2015, the TGA states: “There have been no reports of death associated with Gardasil vaccination in Australia.” This was clearly untrue, as evidenced by the latest FOI disclosure.

The TGA reiterated its statement in an email to Changing Times, saying: “When the webpage was published in 2015, the statement that ‘there have been no reports of death associated with Gardasil vaccination in Australia’ was correct at that time.”

The TGA also stated publicly in June 2010 that no deaths directly linked to Gardasil had been reported in Australia, the United States, or Europe, and said on its website in May 2013 that no deaths directly linked to the vaccine had been reported in Australia.

The administration states that “cases that do not appear in the Database of Adverse Event Notifications (DAEN) may have insufficient information and/or no reasonable temporal association and/or the relationship between the medicine/vaccine and the adverse event appears to not be related as judged by a health professional and/or the report may be a duplicate of a case included in the DAEN and/or the report may have been received by the TGA within the last 90 days”.

Stubbs was shocked to discover that a nurse or pharmacist can request exclusion from the DAEN of a reported adverse reaction, even in circumstances where a doctor reported the reaction.

“The TGA have confirmed to me in writing that the health professional who makes the call not to publish a reported adverse effect on the DAEN could be a nurse, a pharmacist, or a doctor,” Stubbs told Changing Times.

The TGA has stated in an email to Stubbs: “When the TGA receives an adverse event report it is entered into the Adverse Event Management System by staff in the Pharmacovigilance and Special Access Branch.

“If there appears to be insufficient information and/or no reasonable temporal association and/or the relationship between the medicine/vaccine and the adverse event appears to not be related, the cases are reviewed by a health professional (doctor, nurse or pharmacist), who may seek further information from the reporter.”

The TGA says adverse event reports are reviewed by TGA staff “with relevant clinical background”. The administration told Stubbs that some cases may be referred to an external advisory committee, or the TGA may seek other expert advice as required.

“Even if these cases do not appear on the DAEN, all cases received by the TGA remain in AEMS and, if further information is received from the reporter, then the case will be reviewed,” the TGA told Stubbs in an email.

The administration told Stubbs that about 90 percent of the reports it receives are included in the DAEN and added that “the vast majority of the reports not included in DAEN are either duplicate reports for a single case or reports for unregistered medicines”.

Gabby Larkin

Stubbs questioned the TGA after she saw that the report of a death after HPV vaccination that she thought had to be that of 16-year-old Gabby Larkin had been removed from the DAEN.

Larkin, from Mont Albert North in the Australian state of Victoria, died on June 4, 2009, at the age of 16. She had an extremely rare form of ovarian cancer.

Patrice Larkin with a photo of her daughter Gabby.

The DAEN and internal database reports never include names so it is not clear whether the following reported death, which is included in the latest FOI release, is that of Gabby Larkin. The report appears only in the AEMS internal database and concerns a 16-year-old girl developing ovarian cancer. It would be very surprising if it does not refer to Gabby Larkin.

The second case of a death from ovarian cancer after HPV vaccination that is listed in the latest FOI disclosure does not include an age.

Katy Cobb

One of the cases that appears not to be reported anywhere in the TGA databases is that of Katy Cobb, who died from cervical cancer on July 29 last year, aged 33. She was vaccinated with Gardasil when she was 23. She was diagnosed with cervical cancer at the age of 30.

Cobb said in a video interview with the Australian Vaccination-skeptics Network that she was already sexually active when she was vaccinated with Gardasil so may already have been exposed to HPV.

It is possible that the report of vaccine failure dated November 20, 2018, could refer to Cobb’s death, but that date is nearly four months after her death.

According to Merck’s own trial data, Gardasil vaccination of women who are already seropositive and polymerase chain reaction (PCR) positive for vaccine-relevant HPV genotypes has been found to increase the risk of developing high-grade precancerous lesions by 44.6 percent.

Stubbs says she knows of another case of a death after HPV vaccination that is not recorded as a death in either of the TGA databases. Numerous adverse reactions are recorded in the report of the case in the DAEN, but not the death. Stubbs will be following up to see why that death is not included in the latest FOI disclosure.

The response to Stubbs’ first FOI request listed 101 cases that are included in the TGA’s AEMS internal database and do not appear in the DAEN. They include deaths, four cases of cervical cancer, two cases of ovarian cancer, and reports of pancreatitis, premature menopause, paralysis, and multiple sclerosis.

A lack of crosschecking

Stubbs points out that there was legislation in place for a decade in Australia that provided for monitoring the effectiveness of HPV vaccination in preventing certain cervical cancers “by allowing for future cross referencing of data against Pap smear and other cervical cytology or cervical cancer registers maintained by States and Territories”.

She has been unable to find any evidence of such crosschecking being carried out. “I was asking the Department of Health about this for nearly a year, but they refused to be drawn on the issue in any way,” Stubbs said.

“That 2007 legislation has now been superseded by the 2017 Australian Immunisation Register and Other Legislation Amendment Act, and the specific HPV Register is now closed.

“If crosschecking was an intended purpose of the HPV Register legislation, it should have been done, particularly when we know that the incidence of cervical cancer in the vaccinated cohort is increasing.”

The HPV Register was established in 2008 and was closed on December 31 last year.

In late 2018, all HPV vaccination records held in the HPV Register were transferred into the Australian Immunisation Register (AIR), which is a record of all vaccinations given to people of all ages by a registered vaccination provider.

Stubbs also points to the fact that not only pharmaceutical companies but also health professionals have access to the internal AEMS database. “The TGA leads the public to believe that there have been no deaths reported after HPV vaccination, but doctors can see from the AEMS database that there have been at least 11, and they are still giving this vaccine to children,” she said.

“We have a conflicted regulator, hiding reported deaths from the public, with no information provided about who decided that the reported death wasn’t related to the vaccine and what evidence they used to come to that conclusion.”

The public is expected to just have faith in the TGA that there was an unbiased investigation to determine that the reported deaths were unconnected to Gardasil, Stubbs says.

“Looking at the TGA’s recent failures – surgical mesh and breast implants – that’s a big ask. Exactly the same problems arose with these approved medical devices: adverse reactions were underreported and then all but ignored by the TGA over many years,” she added.

“It’s high time that post-marketing safety surveillance was put into the hands of a body that is less conflicted and more impartial.”

VigiBase statistics

The World Health Organisation’s pharmacovigilance database, VigiBase, currently records 93,254 reports of adverse reaction following HPV vaccination. Reports often include several adverse drug reactions (ADRs) and the number of ADRs now totals more than 335,000.

 

  1. Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue in many parts of the body.
  2. Anaphylaxisis a serious allergic reaction that is rapid in onset and may cause death. It typically causes more than one of the following: an itchy rash, throat or tongue swelling, shortness of breath, vomiting, lightheadedness, and low blood pressure. These symptoms typically come on over minutes to hours.

There is more information about the cases of Asha Stubbs and Gabby Larkin in this earlier article.

The TGA is obliged to publish FOI disclosures within ten working days from the time they are made available to the applicant. When the latest release to Michelle Stubbs is published, it will be available here.

The email contact address for anyone who thinks that they or their child may have been injured by Gardasil and wishes to contact Michelle Stubbs is gardasilclassactionaustralia@protonmail.com.

Michelle Stubbs with her daughter Asha.

Update: the latest document released to Michelle Stubbs is now available here.

Update 4/9/2019

The global number of deaths after HPV vaccination is now listed on VigiBase as 493. The reports of death are not listed in the main alphabetic list, but are included under the section “General disordes and administration site conditions”.

There are also 33 other listed reports:

  • Sudden death (22)
  • Neonatal death (6)
  • Sudden cardiac death (3)
  • Sudden infant death syndrome (1)
  • Sudden unexplained death in epilepsy (1)