Its a question of trust

Its a question of trust

There are many positive reports about the HPV Vaccine in the wider media this morning.  It is a vaccine that will be rolled out to boys in September 2019.  They report it is safe and it is effective at preventing cancer for up to 10 years – there is an implication that cancer will be cured.  But to be meet benefit over cost targets – reports we have read show that the UK needs at least an 80% uptake in the UK for girls, it may be higher for boys – these targets may be an issue as a recently published report confirms that varying levels of confidence in vaccines expose vulnerabilities in some countries to potential disease outbreak.  The authors of the report also recommend that scientists (and I’d argue the media) need to have access to robust information from those they trust.  And that’s the crux: “Information they trust”. 

 

Information that can be trusted should be subject to scrutiny, but is that happening with the HPV Vaccine and all it can do? Before we go on, I feel I have to declare – I’m not anti-vaccine, all my vaccines are up-to-date.  However, having looked into the information over a number of years and having read in detail information and figures  not seen by the public or, and this is worse, in some cases regulators and MPs making decisions about Vaccines - I am all for safe vaccines, transparency and accountability.  I think there are questions that need to be asked – not just by campaign groups but by us all – and we should be allowed the space to do so.

 

Some scientists ARE raising questions about how modern vaccines are monitored to determine safety issues post launch, and by not doing so trust in vaccine safety and hence regulators is falling.

 

In an article recently published in the BMJ scientists call for “modernising vaccine surveillance systems to improve detection of rare or poorly defined advice events”.  Author of this report, research physician Rebecca Chandler argues that doing so will help restore the public’s trust.  Is it so, therefore, that trust in regulators and vaccines is lacking partly because of the way vaccine injuries are recorded?  Are regulators missing, or ignoring, failures in their systems of record that collect the data on which they rely, as well as dismissing families who raise concerns?

 

Jeremy Hunt, MP, as Health Secretary launched a review into medicines and medical devices in February 2018.  He admitted parent’s views were not accounted for properly and that they may have valid concerns that are ignored.  This on-going review, led by Baroness Cumberlege, covers Vaginal Mesh, the pregnancy test Primodos, and Sodium Valporate, the anti-epilepsy medicine:  “We must acknowledge that the response to these issues from those in positions of authority has not always been good enough,” Hunt said.  “Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse,” he said. 

 

Hunt seems to acknowledge that when your child falls ill after having a vaccine it shouldn’t be a fight to find out what is wrong.  It may not be the vaccine, but this is not the experience of many parents who tell us vaccines are  often dismissed as a cause of their child’s illness and before any tests are done.  From there fight the parents have to, because their children fall ill and no one seems able to find a reason why or a suitable care approach. This is true particularly when raising concerns about a collection of symptoms their daughters experience following the HPV Vaccine, some of which develop over time.  Publically available information on the levels of reported HPV Vaccine harms are vastly better than those held in private by the UK regulator, the MHRA, and received under Freedom of Information. It seems the lessons of history are still to be learnt.

 

The Contaminated Blood inquiry is on-going after decades of campaigning.  The inquiry is investigating claims of a cover-up at the Department of Health, including documents being destroyed.  This year is also the 20th anniversary of the MMR scandal where false claims of harm were made. One, more than the other, influences the ability to question medical products, particularly vaccines. 

 

It seems that since the MMR scandal, those that raise questions, and their head above the parapet, are often labelled as anti-vaccine, scaremongering or, as in Ireland, “emotional terrorists”.  Those who question regulators and authorities are faced with a wall of “available science” that tells us a vaccine is safe.  But, where does much of that “available science” come from?  Often, the manufacturers themselves.  

 

Internal confidential reports, of which we have copies, show that regulators sometimes put more credence on manufacturer information than evidence gathered from those who believe they are vaccine injured.  Known problems with medical products were also kept hidden and out of the public domain, sometimes for years.

 

This was evidenced in a recent court case relating to Pandemrix.  As reported in the BMJ: “new information is emerging from one of the lawsuits that, months before the narcolepsy cases were reported, the manufacturer and public health officials were aware of other serious adverse events logged in relation to Pandemrix”.   Prior to this, authorities used specific language that served to reassure and counter questions raised about Pandemrix “available science” indicating the vaccine is safe, including (a get out of jail free card) “monitoring continues”.   A comment from a retired paediatrician in the USA, asks “Where is the outrage?”.  Where? Indeed.

 

The language used around “available evidence” by health authorities is repeated for the HPV Vaccine.  But, despite private conversations indicating concerns, some medics and scientists have told us that speaking out about the HPV Vaccine can cause a moral dilemma.  This may be because shortly after its 2008 UK launch, the then Minister for Health, Dawn Primarolo MP (now Baroness) described it as “the first vaccine that can directly prevent cancer”.   Such claims have since been toned down to “protect against cervical cancer”; but, medics and scientists we have spoken to whisper “but it’s a cure for cancer” show that this belief remains despite a lack of scientific evidence as to efficacy or direct correlation.

 

Those who support compulsory HPV Vaccination (and for the programme to be rolled out to boys from this September) issued an article stating that those who raise questions are also part of an anti-vaccine lobby.  They obviously have not spoken to the families that we have spoken to over the last few years; whose daughters were healthy pre-vaccine and post vaccine are not. 

 

While they believe their daughters are vaccine injured most still believe in vaccines. They just want to know they vaccines are safe, and find a treatment plan for their daughters.

 

It’s not just the public who question vaccines that are being vilified.  Recent events in the scientific research community also show that those with highly credible scientific backgrounds are at risk.  Professor Peter C. Gøtzsche was recently removed from the board of Cochrane, an organisation whose independence in science helps shape government policy around the world. Cochrane say there have been complaints.  Many in the scientific community believe that he has been ousted because he has been questioning both the methodology of science used to ascertain safety of the HPV Vaccine, and had previously raised question on regulatory transparency around its safety.  Responding to a statement released by Cochrane Gøtzsche says:  “Scientists should challenge the status quo with good science, which is what I have tried to do in my long career, and this will of course lead to “complaints.”” If his treatment is anything to go by then others without such pedigree will be worried about what could happen to them if they too question the status quo.

It seems that as trust in a vaccine falls and questions from the public grow, there is an apparent increase in the rhetoric that much of the media repeats: we should trust the regulators and authorities, without question.  Here, much of the media plays a role.  Today’s reports on the vaccine being rolled out to boys are positive, all reasonable similar – doesn’t that in itself raise questions about whether or not the media are being given the space and time to do so? Granted. both the BBC and ITV have recently reflected on the MRR vaccine and medicine safety more generally.  Questios are being asked – but mainly about whether or not “mandatory vaccinations” should be a “thing”.  It is sad that n these reports those that question vaccines are often labelled conspiracy theorists, or the viewer is told that those who question think they are experts and more clever than doctors because they “Googled it”.  This, without giving parents who believe their children are vaccine injured and are campaigning for safe vaccines a right to reply or a seat on the panel.  There is a cartoon doing the rounds that compares a scientific expert in the lab verses a mum sitting on the loo, “googling”.  The implication being, if you question: you are anti-vaccine or scaremongering or using unreliable evidence. This, despite history showing us that authorities were wrong to ignore those who raised questions about Thalidomide, Vaginal Mesh and Pandemrix to name a few.  In these cases, as in others, the available evidence can tell us that Joe Public is often ahead of the regulators.  

 

Only a few weeks into the review launched by Hunt, surgical mesh for stress urinary incontinence was suspended, immediately.  Baroness Cumberlege said that she was “appalled at the seriousness and scale” of the stories she had heard from women and their families. Women who had been raising concerns, for years.  New advice from NICE is that the pause on use can be lifted but it should only be used as a last resort but concerns continue with Baroness Cumberlege saying her team has set "five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated. Those conditions have not yet been met and it is clear to us that it will be some considerable time before they are.”

 

Medical regulators also seem to believe that any negative media will damage a vaccine programme, when those families and some scientists we have spoken to want transparency, whatever the results.  We all know that there are risks to having a vaccine.  For a public health programme, surely it is not unreasonable to have transparency about what the risks are and if some are more susceptible to those risks than others? Accurate and complete information allows an informed decision and consent.

 

The Daily Mail has lauded the HPV Vaccine as safe, however, the article is a shoddy piece of journalism and littered with out-of-date information.  It not only quotes old figures but also uses the figures related to a vaccine, Cervarix, that has not been part of the UK public health programme for 6 years, another variant, Gardasil replaced it. 

 

The Daily Mail also stated that English health officials received 3,972 'yellow cards' - warnings of side effects - between 2010 and 2013.  Figures received through freedom of Information show that since 2006 the total number of individual adverse effect reports is 9379.  These reports contain 24963 different symptoms recorded and 36% of the individual reports are considered serious.  In fact the percentage of serious reports range from 29% - 54% depending on the manufacturer of the HPV Vaccine that you receive.

 

Many of the symptoms are a combination of gastro, respiratory, muscular and reproductive problems.  Approximately a third are long term or unresolved and reports show multiple symptoms per individual.  Since 2008 there are up to  11  suspected deaths in the UK alone.  Who is looking into these deaths and the growing number of cluster symptoms?

 

Scientists state that only up to 10% of adverse events are reported to a national database. With approximately 3 Million girls vaccinated since 2008, then, if we extrapolate - adverse effects for HPV Vaccine in the UK could be over 3%, and 1% serious. As the numbers of those vaccinated are often based on the number of doses issued, as opposed to administered, these figures could be low.

 

This data may still be, as the UK and European regulators claim, insufficient to determine a causal link, but surely any other product, like a child’s car seat would have been recalled by now for further tests if, at best, over a third of reports received were considered serious.  Who is looking into these harms, or indeed the cluster symptoms?

 

The This Morning report and the Daily Mail headlined article the “HPV vaccine IS safe” elicited a passionate response on facebook from one mum whose daughter was fit and healthy before the HPV Vaccine, and isn’t now.  She runs a (closed) Facebook group (HPV Vaccine - Help and Support for Parents)  for parents wanting more information and to which I was given access more than 6 months ago.  She is not anti-vaccine, both her daughters received the HPV vaccine, and this site does not advocate not having the vaccine, but encourages personal research.  Even so, she has, since her video post, received a message telling her that it is “impossible” that the vaccine could have caused her daughter ill-health.   

 

“Impossible” is overstating the case.  Medics accept that some harm will happen in relation to medicines and vaccines.  That is what the purpose of releasing a medical product with “side effects” - a certain percentage of people are expected to suffer harm - for the greater good.

 

“Expected v observed” is another claim made to bat away challenges over safety.  The Daily Mail article also states that there are no “unexpected” side effects.  This may be true in that “expected” side effects are listed on the patient information leaflet.  But where does it say how long the side effects will last, and how serious they will be?  Most of the 20 or so UK families we have met or spoken to have girls who have been chronically ill for years.  Some up to 8 years after having the vaccine.  The similarities in their stories from around the globe are repeated time and again. How can the long-term nature of the side effects be “expected” when the original trials, where side effects are determined, only lasted 6 months and documentation shows that time to onset of problems post the vaccine can be over a number of years. 

 

It is incomprehensible that those families and the scientific community trying to find out why girls were healthy before the vaccine and why they are not now - are being vilified; particularly when internal information shows scientific questions on safety have been made, but publically - consensus confirming safety is reported, often without question.

 

On the one hand, there is no doubt many vaccines, thoroughly tested do good. But what happens when at best mistakes are made, or signals ignored and a vaccine is rushed to market as sometimes happens.  What happens when corners are cut and you see your child with a collection of symptoms that you believe are adverse effects but current reporting systems don’t recognise varying degrees of a cluster of symptoms. What happens when parents whose children fall ill don’t make a connection to the vaccine because the regulator has said certain side effects are a response to the needle and therefore can not be the vaccine. 

 

Many parents and families want to believe the authorities and regulators, and did so by getting their children vaccinated.  But what do these parents do when they subsequently believe that their child is vaccine injured and no one is listening or helping them, and that efforts to report harms are thwarted by the authorities themselves.  

 

The Sunday Times revealed that Public Health England tried to stop endorsements for a book by Dr Aseem Malhotra , whose advice helped Tom Watson, MP, Deputy Leader of the Labour Party and Shadow Secretary of State for Digital, Culture, Media and Sport - lose 7 stone in weight.   It’s not the only time Public Health England (PHE) have used public money to stop a news report.  Internal documents show that they “geared up to become a proactive engagement strategy if necessary to further inform the media and the public on HPV Vaccine Benefit and known risks.”   According to the BMJ report, a similar strategy happened with Pandemrix.

 

We also have copies of a Freedom of Information request that shows the pressure PHE recently placed on Sky News when they were planning to report on the HPV Vaccine.  PHE stated that it was “irresponsible to call the HPV Programme into question.  Any damage could potentially cost lives” and that “There is categorically no evidence to suggest the HPV vaccine has caused any significant harm in girls” quoting a review from the Cochrane centre.  (This review is the one called into question, by Professor Gøtzsche et al.  Now he has been removed from Cochrane, it remains to be seen if his questions will be answered).

 

PHE made this statement of “no evidence” even after a USA Federal Court, specialising in vaccine injury, determined that that Gardasil as “more likely than not” to have caused the death of  21 year old Christina Tarsell.  The USA are also paying out millions of Dollars for “Injuries and Death” from the HPV Vaccination.  Both the 8-year court case and the details of the US Vaccine National Compensation Programme are publically available.  In an email following a call with the Sky News, PHE reinforced their earlier position: “we would really strongly ask Sky not to run the story”.  They didn’t.

 

The ability to question a vaccine without being dismissed as anti-vaccine, irresponsible, or just plain wrong is, apparently, increasing.  Yet the public health authorities originally dismissed failures in a number of other medical products as, folly.  It was only when impacted families, turned campaigners and scientists kept the pressure on by raising and discussing difficult questions that safety issues were uncovered.  What’s worse in many cases, they regulatory authorities and manufacturers hid what they knew.  As the saying, repeated in the BMJ more that 2 decades ago and referred to by the Judge in the above case:  An absence of evidence does not mean evidence is absent.

 

 Is it any surprise, therefore that trust in vaccines starts to fall when we’re discouraged from questioning a vaccine; vilified if we do; families’ concerns are left unheard; media reports often let statements from the regulators go unquestioned; and the methodologies of research need updating.  

 

If the “available science” was modernised and became fit for purpose and if failures were better acknowledged then surely trust in vaccine safety would not be open to question. If this were true, not only would vaccine programmes meet their targets but even more lives could be saved.

Morag Livingstone

@medialiving 

 

Morag Livingstone is an award winning documentary filmmaker, investigative journalist & internationally published best selling author.  She is co-author of two best selling books ‘Hackney Child’ and ‘Tainted Love’ (Simon and Schuster, 2014). Hackney Child, was on the UK best-seller list for 5 weeks and has also been translated and published in France (Abandonnée de tous: Archipoche, 2016).  Both books are ‘required reading’ at a number of UK universities.  Morag released her debut investigative journalism documentary Belonging the Truth Behind the Headlines in 2017.  Belonging received 9 film festival awards, including 3 Best Documentary Awards. It is available on Amazon Prime, and 10 other Video on Demand platforms around the globe. Morag has an Honours Degree in Business Studies and after 15 years in the corporate sector as a commercial contracts manager, she decided, in 2005, to follow a long held dream of becoming a filmmaker and journalist, attaining a Masters in Photojournalism and Documentary Photography from the London University of the Arts, where she is now an Associate Lecturer. When not writing, she makes films that bring stories of working conditions, poverty, low income and young peoples' mental health to life for the development sector. Like her namesake, the explorer Dr Livingstone, Morag has lived and worked in Zambia. She is related to Dr Livingstone's wife, Mary Moffat, rather than the man himself, but she is still looking for that elusive link.

A hidden earthquake waiting to happen?

A hidden earthquake waiting to happen?