In July 2015, it was reported that the European Medicines Agency (EMA) had launched an investigation into the safety of human papillomavirus (HPV) vaccines. The investigation followed a request by the Danish Health and Medicines Authorities (DHMA) to assess the research linking HPV vaccines to serious harms. This research included published peer reviewed articles by whistle-blower physician, Dr. Louise Brinth from the Danish Syncope Unit at Frederiksberg Hospital in Copenhagen, describing possible serious neurological harms from the vaccine. Specifically, there was concern that two severe, disabling conditions, namely, Complex Regional Pain Syndrome (CRPS) and Postural Orthostatic Tachycardia Syndrome (POTS), may be causally linked with receipt of the HPV vaccine.
Japan’s Ministry of Health had previously suspended the HPV vaccine from its recommended schedule back in 2013 due to similar concerns. The suspension remains in force to date.
The National Institute of Neurological Disorders and Stroke describes CRPS as a condition believed to be caused by damage to, or malfunction of, the peripheral and central nervous systems, and which can be triggered by medical procedures such as needlestick. POTS is described as one of a mysterious group of disorders whose chief symptom is orthostatic intolerance which is said to arise from an excessively reduced volume of blood returning to the heart after an individual stands up from a lying down position, leading to fainting and a rapid increase in heartbeat.
A documentary, ‘The Vaccinated Girls’, was broadcast on Danish television during 2015. It follows the stories of three young Danish women who developed disabling symptoms shortly after HPV vaccination, and documents their efforts to have these symptoms recognised by the medical profession as being causally linked to the HPV vaccine. The documentary, provided below, is in Danish, but comes with English subtitles.
A similar documentary entitled ‘Cause or Coincidence’, which covered more HPV vaccine horror stories, but this time about New Zealand girls, was broadcast on New Zealand television late last year.
On 26 November 2015, the EMA released its 40 page investigation report which has been condemned by Nordic Cochrane. Cochrane – formerly the Cochrane Collaboration – is an independent, not-for-profit, research organisation comprising thousands of volunteers from many countries of the world, including Australia. Cochrane is highly regarded for its fearless approach to evaluating the rigour of published medical research.
In a damning complaint to the EMA – which everyone interested in the vaccine issue should read in full – Cochrane notes many deficiencies in the investigation and reporting process.
We are concerned about the EMA’s handling of this issue as reflected in its official report and ask the EMA to assess:
- Whether the EMA has been open and accountable to the citizens and has respected their rights to know about the uncertainties related to the safety of the HPV vaccines.
- Whether the EMA has lived up to the professional and scientific standards that must be expected of the agency to guarantee that the administration enjoys legitimacy when evaluating the science and the data related to the safety of the HPV vaccines.
- Whether the EMA has treated fairly – in a manner that guarantees that the administration enjoys legitimacy – a Danish whistleblower, PhD Louise Brinth, when she raised concerns about possible serious harms of the HPV vaccines.
- Whether the EMA has treated fairly – in a manner that guarantees that the administration enjoys legitimacy – the observations and concerns the Danish Health and Medicines Authorities and the Uppsala Monitoring Centre had raised about possible serious harms of the HPV vaccines.
- Whether the EMA’s procedures for evaluating the safety of medical interventions guarantee that the administration enjoys legitimacy. The EMA asked the manufacturers of the vaccines to assess potential harms of their own products in which they have huge financial interests.
- Whether the extreme secrecy, with life-long confidentiality agreements, which the EMA imposed on its working group members and scientific experts, is needed; is legitimate; is in the public interest; and guarantees that the administration enjoys legitimacy.
- Whether the redactions the EMA imposed on documents it delivered to the citizens according to Freedom of Information requests were needed; were legitimate; are in the public interest; and guarantees that the administration enjoys legitimacy.
- Whether the EMA has behaved in a manner that guarantees that the administration enjoys legitimacy in relation to declaring conflicts of interest. We noticed a Guido Rasi’s name associated with patents for inventions and wonder whether this is the same person who is the EMA’s director. If so, we believe Rasi has failed to declare his conflicts of interest. We also believe that the rapporteur for the EMA’s report, Julie Williams, has failed to declare her conflicts of interest.
- Whether the EMA behaves in a manner that guarantees that the administration enjoys legitimacy when the agency use experts with financial ties to the manufacturers, in particular considering that it is always possible to find experts without such conflicts.
- In the interest of transparency, we urge the EMA to ensure that the names of all the experts consulted are disclosed together with their conflict of interest declarations. We also urge the EMA to ensure that the conflicts of interest statements from the rapporteur, the co-rapporteurs (JeanMichel Dogne (BE) and Qun-Ying Vue (SE)), their contact persons at the EMA and everyone else who has given statements to the EMA are brought out in the open. Finally, we urge the EMA to ensure that Declarations of Interests for officials at the EMA are honest.
Concerns about use of aluminium adjuvant as a placebo
Of particular interest is Cochrane’s stated concern with the use of aluminium adjuvants as a placebo in control groups, a common clinical trial practice which vaccine safety advocates have been condemning for many years.
In all the vaccine trials, apart from a small one, the “placebo” contained aluminium adjuvant, which is suspected of being neurotoxic. It is therefore difficult to find a difference between harms of the vaccine and the “placebo,” but the EMA failed to address this fundamental problem in its official report. It is clear from the EMA’s internal report that the marketing authorisation holder (pharma company) simply lumped together the results from trials with a genuine placebo with those that had a potentially neurotoxic “placebo”.
The marketing authorisation holder (pharma company) was requested to provide an in depth review of the CRPS and POTS cases observed within all clinical studies. To respond to this request, the marketing authorisation holder has pooled the safety data from 18 completed and unblinded studies designed with an active comparator group (either placebo or another vaccine other than an HPV vaccine, i.e. Hepatitis B, Hepatitis A) which includes a total of 42,047 vaccinees (21,268 in HPV group and 20,779 in comparator groups)” (4, p119 in the pdf, or 7/67 in the subdocument). We believe this constitutes scientific misconduct, but the EMA accepted it nonetheless, without reservations. (page 7)
Although the complaint is to the EMA, it’s every bit as applicable to the Australian situation, because we use the same vaccines as in Europe, and the Australian regulator – the Therapeutic Goods Administration (TGA) – relies on the same questionable studies as the European regulator when deciding whether or not to approve a vaccine for use in Australia. For this reason, the TGA should conduct an immediate investigation into the quality of information relied on by the pharmaceutical companies to secure product licenses for the HPV vaccines, but I’m not holding my breath. Without political will behind such an investigation, it will be business as usual at the TGA, ATAGI, NHMRC and all of the other acronyms charged with overseeing the vaccination programme. It’s also the case that the TGA is entirely funded by the pharmaceutical industry.