How Crooked is The UK’s Drug Safety Regulator, The MHRA – The Story of Patient Reporting of Adverse Drug Reactions

This is the story of how the UK’s Medicines and Healthcare Products Regulatory Agency [MHRA] blocked the Ministerial mandated introduction of direct reporting of adverse drug reactions by patients.

Does this sound at all crooked to you?

Some History

A few years before the following events occurred a 1996 study in Holland showed that direct patient telephone reporting of adverse drug reactions [ADRs] can give up to 15 months earlier warning of problems than reliance on substantially under reported ADRs from medical professionals and coroners: Toine et al, 1996 Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals BMJ 1996;313:530.

The UK continues to have a system of adverse drug reaction monitoring which is claimed by some to be excellent but which is known to be inadequate. Dr Bill Inman, a retired Professor of Pharmacoepidemiology, University of Southampton, UK, pioneered the system of spontaneous reporting of adverse drug reactions (‘yellow card’) and of prescription event monitoring.  The Yellow Card scheme was a response to the 1960s Thalidomide drug scandal which left many children born with serious deformities including no arms or legs. 

The Yellow Card system could long ago have been improved but was not.  For example Dr Inman considered that there are no national systems in place which might prevent another tragedy like thalidomide: for which a database of pregnant women’s drug histories is critical. The lack of medium-term and long-term (25 years) follow-up for cancer treatments was another concern and he thought the World Health Organistion should be more active in that: “Profile of Bill Inman – Yellow Cards and Green Forms WHO Uppsala Reports 27 October 2004

What Was Meant to Happen in the UK

UK pilot trials for direct patient reporting were announced on 18 November 2002 by what is now the MHRA:

Lord Hunt [a Health Minister] …. announced his intention to introduce a scheme to allow patients to report adverse reactions through NHS Direct and NHS Direct Online in the New Year.”

Professor Alasdair Breckenridge, Chairman of the Committee on Safety of Medicines, said in relation to the extension of the Yellow Card scheme to nursing and other staff:

Doctors up and down the country know the Yellow Card goes hand in hand with improving what we know about drugs and how they are used. And now a new generation of reporters to the scheme – nurses, midwives and health visitors, including nurse prescribers, in the frontline of patient care – will be able to play a full part in making sure that we keep learning and that patients benefit from experience.’

Six months later on 8th May 2003, another MHRA press release stated:

Health Minister David Lammy has announced the first phase of patient reporting of suspected Adverse Drug Reactions (ADRs) via NHS Direct.

The NHS Direct call centre in Beckenham, covering South East London, has become the first centre in the country to introduce patient reporting of ADRs.

Subject to experience at the first call centre, the intention is to roll out the new service to all 22 NHS Direct call centres throughout England.”

Minister David Lammy was quoted:

Today marks an important step in putting patients in England at the heart of systems for promoting and protecting public healthcare by enabling them for the first time to report suspected ADRs.

Rather than having to go to a GP, patients can quickly access advice and report reactions that can help to improve our knowledge of the safe use of medicines.’

Professor Alasdair Breckenridge who was by then the chairman of the MHRA, was also quoted in the press release as saying:

The Yellow Card Scheme has been the cornerstone of monitoring drug safety for nearly 40 years.

We now plan to roll out across England a new service offered by NHS Direct.

This will enable patients to contribute directly to the Yellow Card scheme by reporting their own ADRs. We will be carefully monitoring the results of this pilot.”

[Professor Alasdair Breckenridge was previously the Chairman of the Committee on Safety of Medicines.  The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).]

What Really Happened

The MHRA under Professor Breckenridge’s Chairmanship wrested control of direct patient reporting of adverse drug reactions from the NHS and well and truly buried it.

The pilot trial was for the whole of SE London using what was then the NHS Direct call centre in Beckenham, Kent.  There were only 39 responses for the whole of South-East London in an entire year.

Dr Metters, the Chairman of the ‘independent’ review of the trial was reported in the British Medical Journal saying:

We can only speculate why participation has been so poor”

The truth was it was extensively unpublicised. The MHRA, in the person of Miss Carrie Scott Pharmacovigilance Co-ordinator Room 15-259 in a letter of 11th June 2004 ref: OG 04/43 to Social Audit admitted hardly anything had been spent promoting this scheme. In the letter she wrote:-

The MHRA has not incurred any significant costs due to this initiative. Advertising regarding the Scheme was limited to local press coverage. Due to the small number of reports received no costs were incurred in terms of staff resource.”

This was to cover the whole of South East London, an area with a population of several million people, and yet no significant costs were incurred.  Not even the local Beckenham GP surgeries or pharmacies appear to have had heard of it until some local GPs read an abridged news item in the paper version of the BMJ published Saturday 8th May 2004.  There were no posters in doctor’s surgeries or pharmacies; no patient ‘How To Report’ leaflets; nothing.

The MHRA published FAQ, items 16-19 and particularly item 17 stated:-

the number of reports [39] suggests the Scheme is not universally popular and anecdotal feedback suggests patients would prefer to report direct to the MHRA.”

There were only 39 reports because hardly anyone knew about the scheme.

The UK satirical and political commentary magazine Private Eye reported in an article titled “DRUG SAFETY Yellow fever” 29th May 2004:

But Metters and others should not have been surprised by this. Hardly anybody in the area had heard of the scheme – not even doctors or pharmacists. As one resident said: “My own local GP surgery did not know about it until they read about it in last week’s BMJ.” And as a pharmacist put it: “What scheme? Never heard of it.”

The current next-to-useless drug safety system whereby doctors fill in a yellow card if they suspect a drug or vaccine has caused an adverse reaction, certainly needs improving: it picks up only a tiny fraction of bad reactions.

While NHS Direct would have been an ideal body to collate reports of adverse incidents Metters and colleagues have seized on Beckenham’s “poor response” and suggested that reporting might be improved if patients have direct access to the new Medicines and Healthcare Products Regulatory Agency (MHPA). Unfortunately this would mean that information, and control of that information, would go straight to the body which, with its advisory arm, the Committee on the Safety of Medicine, has been criticised for its secrecy, conflicts of interest and past failings.

Key figures on both bodies have consultancy research, financial or employment links with the big drug companies. For example, the MRHA’s top man is Professor Sir Alasdair Breckenridge, who used to advise GlaxoSmithKline, the manufacturer of the antidepressant Seroxat. It was the failure of the drug regulators to warn doctors earlier about potential problems associated with Seroxat that led to the recent resignation in protest of Richard Brook, the lay member on the CSM.

The scandal prompted Charles Medawar of consumer group Social Audit and author of Medicines Out Of Control to suggest that it was Sir Alasdair who should have resigned. But he didn’t. 

The MHRA also announced:

The MHRA intends to get direct patient reporting up and running as soon as possible.”

But it was already up and running, at NHS Direct. All they needed to do was tell people about it like notifying the GPs and pharmacies and produce the leaflets and publicise it.

As Social Audit noted, there was still after the MHRA intervened with their own system no provision for direct patient reporting via the electronic yellow card scheme. The Scheme invites reports from by doctors, dentists, pharmacists, coroners, radiographers, optometrists and nurses, and expressly confirms no provision has been made for direct patient reporting.

It is not sound to put the MHRA in charge of the information which can show it has been failing in its duties to protect the public.  But that is what happened and the MHRA played its part in making that happen.

There is now a system for patients to report Yellow Card adverse drug reactions online but who knows about it?

European Medicines Agency Condemned Over Dangerous HPV Vaccines – By Respected International Medical Scientific Organisation

The following account is of extraordinary developments in the battle against corruption in drug safety, so settle yourself down and prepare for some surprises and for confirmation that what you already know or suspect is still at least as bad but more likely far worse than ever.

Corruption in governments and their agencies is so widespread in the 21st Century that it is regrettably the case that organisations like the European Medicines Agency [EMA] can sometimes truly, fairly and justifiably support an opinion they can be described as “crooked“.  This example seems to point in that direction. 

Observed to Expected analyses were a significant part of the EMAs clearing of the HPV vaccine.  A previous example showed the EMA for 16 years continued to accept a calculation of the Observed to Expected ratio of deaths of infants reported compared to those expected which was a factor of three times out and when fully corrected for all other factors showed a significant excess of deaths in the vaccinated group: Vaccines Proven To Cause Sudden Death in Children – 67 Deaths Only Explicable As Caused By Vaccines – Drug Safety Regulators Had The Information for Over 2 Years And Let Children Die.  The documents containing this information were leaked and had been kept confidential for over 16 years of annual reporting by the manufacturer.  The EMA keeps key information confidential which prevents public scrutiny and challenge.

At best that demonstrates a very high level of incompetence.  Essentially, they cannot be trusted, crooked or not.

Read on to answer this for yourself and see for yourself the evidence of how dangerous HPV vaccines are for you and your children.

Sadly this is conspiracy fact – not theory. The UK’s recent backlash vote to exit the corrupt undemocratic and institutionally economically and politically flawed European Union will fix none of that.

Some of the “Bad Guys

It is an open secret at the world renowned UK’s Great Ormond Street Children’s Hospital [GOSH] that the HPV vaccines are not safe.  Large numbers of British schoolgirls are routinely referred there for a variety of serious and less than usually-to-expected medical conditions following vaccination with HPV vaccines.  So it is hardly surprising when mothers discover routinely other mothers of girls with the same and similar serious medical conditions following HPV vaccination.

So have we seen public reports from GOSH reporting this phenomenon? No.  Why not?  What is wrong with these people?  Aren’t their patients meant to be able to trust their physicians?  Aren’t the physicians meant to tell them the truth so that they and their siblings and schoolfriends can avoid the harm?

The efforts of the UK’s Medicines and Healthcare Products Regulatory Agency [MHRA] to hide the adverse effects of HPV vaccines, were reported by CHS here:

UK Drug Safety Agency Falsified Vaccine Safety Data For 6 Million

The Danish Health and Medicines Authorities’ [DHMA] 17 April 2015 report on the EMA’s assessment of the HPV vaccine concluded that the benefits of the HPV vaccines outweigh the risks.  This was despite very high levels of under reporting of adverse events.  It was also despite the finding [as at 30 September 2014] of a total of 33 cases of Postural Orthostatic Tachycardia Syndrome (POTS) as a possible adverse reaction to Gardasil having been reported from 2006 to 2014. 

With the full extent of the problem not being reported DHMA claimed “it has not been possible to document a relationship between the vaccine and POTS“.  This is just one serious adverse reaction to HPV vaccines suffered by schoolgirls and women which go un and under reported worldwide.

The European Medicines Agency oddly had held an online video press briefing two weeks before their report was published.  This meant there was no opportunity for independent experts to review their claims in advance so that pertinent questions could be asked.  And that is just what they appear to be – claims.  Also troubling is the absence of hard detail and figures in the EMA’s report.  It is close to a narrative, telling a story of what they claim to have done and expecting everyone to believe them with no hard facts or data to make a judgment.  It is pretty much “we are the experts with all the information and what we say is what it is and we don’t care to prove it“.  One seemingly bizarre aspect was the claim to have carried out numerous analyses taking into account from 1% to 100% under reporting, aside from suggesting they have no idea how high the level of under reporting is.

The briefing can be viewed here.  It is worth watching, especially to see the people behind the report and for the press questions starting at 7 minutes and 45 seconds into the video:

How Modern Government, Its Institutions and Agencies Have Become Ever More Corrupt – but surprisingly – this time – the US Central Intelligence Agency are with the “Good Guys”!

Seemingly corrupt practices at the EMA are all part of a far too familiar story of a wider pattern of corruption in modern governments. 

Before considering the criticisms of the EMA, it is worth considering how far and how blatant this has come.  It puts it in perspective.  State agents too commonly now do whatever they want.

This pattern is set at the highest levels.  The now commonly reviled former UK Prime Minister Tony Blair demonstrated universally in the most public fashion how corrupt governments and their agencies have become in the 21st Century when he helped start a disastrous war in Iraq with false evidence of the Western territories being under threat within 40 minutes of launch of non-existent Iraqi weapons of mass destruction.

In the UK the long delayed Chilcot Inquiry report into the war is due to be published this week – conveniently further delayed until after last year’s UK general election to elect the UK government and Parliament: Iraq War report ‘delayed until after UK election’ BBC News 21 January 2015.

Blair’s false claims were repeated to the UN and world and believed. This enabled some of former US President George W Bush’s supporters to become even richer from US tax dollars on the back of the lives and bodies of US GI’s, British servicemen and women, and an estimated hundred thousand [or more] moslem’s by supplying military ordnance and other support to this illegal war. Obviously, a small minority rather than the majority of Americans who supported Bush benefited.  It is hardly likely the vast majority did.

In parallel to Blair, President George W Bush’s administration was busy fabricating evidence to the same ends.  That is a true life story told in the remarkable film “Fair Game” with excellent performances from actors Naomi Watts and Sean Penn as covert CIA operative Valerie Plame Wilson and her former US Ambassador husband Joe: Fair Game – review – by Philip French Saturday 12 March 2011 UK’s The Observer.

Remarkably, in “Fair Game” the CIA, Plame Wilson and her husband bucked the trend to be portrayed as the “good guys” working to prove the Blair and Bush claims were not true.

On the back of this endemic corruption in governments, social media is overrun by some trolls and bullies who bully, abuse and harass pretty much anyone and everyone who endeavours to expose the modern day corruption in science and medicine.  These are led and/or exhorted by loners like Dr David Gorski on his blog and the activities engaged in worldwide by some of those led and/or exhorted by the activities of non practising psychiatrist Dr Ben Goldacre: Dr Ben Goldacre, Online Abuse, Bullying and the Suicide of a Gentle British Doctor.

People like that distract effort and attention of ordinary people onto the internet and away from demanding answers and accountability of government, government agencies and politicians.  This dilutes public pressure and demands for public scrutiny of the drug industry by elected representatives and government officials.  At the same time it helps make the modern world the nasty place we all now have to live in and for Moms and Dads to raise their kids.

Some of the “Good Guys

Japan, Cochrane’s Nordic Centre and Louise Brinth MD PhD

Japan suspended the recommendation for Gardasil and Cervarix HPV vaccines for women because of large numbers of unexplained serious adverse reactions.

Louise Brinth, MD PhD of the Syncope Unit at Bispebjerg and Frederiksberg Hospital in Copenhagen, having published a number of papers on adverse reactions to HPV vaccines, wrote a December 15th 2015 response to the EMA’s Assessment Report on HPV vaccines of November 26th 2015 supported by the EMA’s plain language news release claiming the:

evidence does not support that HPV vaccines cause CRPS or POTS”

CRPS or “complex regional pain syndrome” is another of the many serious adverse events associated with HPV vaccines which go substantially under reported.

Essentially, Brinth criticises the EMA and sets out good evidence to support the view that HPV vaccines cause serious adverse reactions in children and adults.  Brinth however appears misguided and in error herself in the evidence upon which she relies, not that the HPV vaccines are a cause, but in underplaying the extent of their role in causing serious adverse events.  She with other internationally reputed and respected medical professionals make up for this later as you will see.

Brinth believes, as she wrote, that:

Vaccines are, within medical science, considered a global and groundbreaking health success. Through vaccination programs coordinated and implemented throughout the globe, diseases such as smallpox have been eradicated. Moreover, other infectious diseases have been reduced significantly with impressive impact on both mortality and morbidity worldwide.”

This shows that Brinth is a supporter of the sadly-for-children erroneous mainstream medical view on the safety and efficacy of vaccines, despite being misguided and lacking an appreciation of the falsity of that widespread canard – such as obtained from analysis of well-documented facts from over 200 years of official statistics.

Additionally, it is a certainty that Denmark under reports adverse events to HPV vaccines more so than they might be expected to.  Even Brinth’s report reveals a fundamental misunderstanding of when adverse events should be reported when she writes:

Denmark is a small country. Many patients who suspect that they suffer from side effects to a vaccine tell us that they have felt that their suspicion has been ridiculed or dismissed when presented to medical professionals. We have not reported all the patients who suspected to suffer from side effects as AER. However, if we had a suspicion that their symptoms could be related to the vaccine – and we could not dismiss this suspicion by finding other explanations for their symptoms etc – we reported it. We are obliged to do this by Danish law.”

Failing to report all suspected adverse events regardless of circumstances results in there being insufficient statistical data to judge whether there is a statistically significant signal against the background “noise” of events which are not adverse events. 

So even Brinth and her colleagues are part of the problem she complains about in her response to the EMA but again as you will see she makes up for this with the assistance of the Cochrane Nordic Centre and other respected mainstream vaccine experts.   But it does suggest that under reporting may be higher than might be expected.

This also however illustrates how defective the EMA’s analyses of adverse events to HPV vaccines are.  That is of course entirely usual for the EMA.  It appears an organisation less interested in protecting public health and more interested in making sure that potentially harmful and harmful-in-fact drugs are authorised and remain authorised to the financial profit of the drug industry.  Where do some senior EMA officials look to to get their next job when they retire from the EMA?  Surely not the drug industry perhaps?

So now enter onto the scene as part of the “good guys” the internationally respected Cochrane Nordic Centre and others with an extraordinary refreshing and excoriating 19 page complaint to and critique of the crooked EMA.  This is signed by:

  • Peter C Gøtzsche, DrMedSci, MSc, Director of the Nordic Cochrane Centre, Rigshospitalet, Professor, University of Copenhagen and co-signatories,
  • Karsten Juhl Jørgensen, Deputy Director of the Nordic Cochrane Centre, Rigshospitalet,
  • Tom Jefferson, Honorary Research Fellow, Centre for Evidence Based Medicine, Oxford OX2 6GG, United Kingdom
  • Margrete Auken, MEP (The Greens/European Free Alliance)
  • Louise Brinth, PhD, MD, Danish Syncope Unit, Frederiksberg

We suggest you read the whole document.  The following lengthy extract is from pages 12 to 17:

Are the vaccines safe?

According to the firms they are safe. Initially, the vaccine was compared with a placebo group being vaccinated with physiological serum, whereby the number of adverse reactions was much higher and much more serious than in the control group. After comparing 320 patients in the saline placebo group a quick move was made to an aluminium-containing placebo, in order to be able to only evaluate the effects of the active substance. However, this distorted the comparison, because no one voluntarily wants to be vaccinated with toxic aluminium, as this is not really necessary, when inoculation with a harmless saline solution can be done. The differences between Gardasil and the saline placebo group were, however, already noticeable15. Here we can refer to the Vioxx scandal, where the adverse reactions in fact were known, but concealed by the firm. Here also the difference between the vaccine and the saline placebo is concealed in all publications, as the table below clearly shows. For serious adverse reactions one suddenly takes the saline and aluminium group together, perhaps to cover up the major differences between these two groups.”

These two experts question seriously the prevailing assumption, apparently also at the EMA, that the vaccine is so important for public health that it is justified not to communicate to the public 1) that there are uncertainties related to vaccine safety, 2) that drug companies cannot be trusted; and 3) that it is wrong to lump together results obtained with a genuine placebo with those obtained with a potentially neurotoxic placebo. We agree with the two experts when they suggest that this lumping may represent a cover up and we also find that the EMA should have informed the public about this unacceptable lumping of a true placebo with an active placebo instead of keeping it secret. This is totally unacceptable and contrary to good scientific practice to such a degree that we consider it outright scientific misconduct committed by the EMA.

Conflicts of interest

According to laws of public administration in several European countries, people should never be in a position where they are being asked to evaluate themselves. For example, Danish law states (our translation):

“Anyone who works in the public administration is disqualified in relation to a particular case if he or she has a special personal or financial interest in the outcome … The person who is disqualified in relation to a case does not make decisions, participate in decision making or otherwise assist in the consideration of the case.”

1. The EMA asked the MAHs to provide “a cumulative review of available data from clinical trials, post-marketing and literature in order to evaluate the cases of CRPS and POTS with their product” … an analysis of the observed number of post-marketing cases of CRPS and POTS in association with their HPV vaccine in comparison to those expected in the target population, stratified by region, if available … a critical appraisal of the strength of evidence for a causal association with HPV vaccine for CRPS and POTS” (4, p5).

“The responses submitted by the different companies were assessed by the PRAC’s Rapporteur

(attachment 1) and Co-Rapporteurs (attachments 2 and 3) for this procedure. Before adopting a recommendation, the PRAC decided to convene the Scientific advisory group (SAG) on Vaccines and additional experts on vaccine safety, neurology and cardiology to provide an independent advice and responses to the questions below” (4, p5).

It is clear from its confidential document that the EMA relied heavily on the companies to come up with honest answers to highly complicated questions, and that the work of the EMA’s various assigned experts was not to control what the companies had done, but merely to discuss it (4). We find that this procedure provides poor protection of public health, particularly considering that there are so many egregious examples that companies have cheated by omitting major harms – including deaths – in their reports to the authorities (6, 10). We find it unacceptable that the EMA did not check the veracity of the MAHs’ work.

2. At a hearing about HPV vaccine safety in the Danish Parliament on 17 December 2015, which was video recorded (11), Enerica Alteri from the EMA told the audience that the EMA’s Scientific Advisory Group consisted of members who were independent. However, she also said that they had declared their conflicts of interest (her remarks on this point were not translated by the simultaneous translation). As stated above, we know from the confidential internal EMA report (4) that the members of the Scientific Advisory Group (SAG) are bound by a life-long secrecy clause that prevents them from discussing their disagreements in public. The EMA keeps it secret who they are and what conflicts of interest they have. We have been informed, however, by one of the persons who participated in meetings at the EMA, that some of the SAG members have financial conflicts of interest in relation to companies that sell an HPV vaccine, which means that they are not independent. Enerica Alteri told the audience that the HPV vaccine can prevent most, if not all, deaths from cervical cancer. She walked out immediately after her presentation with no excuse and did not take questions or participate in the panel discussion. This was perceived by some as being blatantly arrogant and counterproductive in terms of building trust in the vaccine and in the EMA.

We find it totally unprofessional and misleading to the extreme to suggest that the HPV vaccine can prevent all deaths from cervical cancer. Such a claim would not have been tolerated by the EMA if it had come from one of the manufacturers. The different vaccines don’t protect against infection from all HPV strains, only from 70%, 80% and 90% of the strains, respectively, and the vaccines are not 100% effective against the targeted strains (2).

We also find it inappropriate to use experts with financial ties to the manufacturers, as it is always possible to find experts without such conflicts.


4. We are aware that some of the top officials at the EMA have failed to declare their conflicts of interest in relation to the work they do at the EMA, although they have a legal obligation to do so. For example, the EMA’s director, Guido Rasi, declared on 20 July 2015 that he had no conflicts of interest (14). On a form called “EMA Public Declaration of Interests,” he replied “none” to all four questions, also to question 4, which is: “Other interests or facts whether or not related to the pharmaceutical industry4 which you consider should be made known to the Agency and the public, including matter relating to members of your household5.”

However a Guido Rasi, which we assume is the same person, holds a number of patents, some of which were filed or approved in 2012 or 2013, and where the applicant was a drug company (Applicant: SciClone Pharmaceuticals, Inc.; Inventors: Guido Rasi, Enrico Garaci, Francesco Bistoni, Luigina Romani, Paolo Di Francesco) (15). As they go back less than five years, we believe he should have declared them, according to the EMA’s regulations concerning the handling of declared interests of its employees (16).

Final remarks

We find that the EMA’s requirement of life-long confidentiality is absurd. All available material about suspected harms of a public health intervention directed towards healthy children should be accessible to anyone. The EMA’s internal report (4) and all other documents related to this case should therefore be made publicly available, without redactions. We did not find any commercially confidential information anywhere in the documents we reviewed.

The American College of Physicians found that 89 cases of premature ovarian failure reported for HPV vaccines (86 for Gardasil and 3 for Cervarix) versus no reports for other vaccines were sufficiently alarming to motivate an alert in January 2016 making physicians and the public aware of a possible link (17). The confidential EMA report mentions in one sentence that the vaccine is under increased surveillance for this possible harm, but the reason is not given: “Adverse events related to potential immune-mediated disease (piMD) following vaccination with Cervarix, as well as primary ovarian failure are currently under close safety surveillance and in depth discussed in PBRER” (4, p175, or 63/77 in the subdocument). In response to an “Expert Submission to EMA relating to absence of ovarian safety research 17-10-2015” (7, p.110), the “Assessor’s comment” is: “This document contains an argumentation that the “ovary safety research” undertaken with the HPV vaccines is insufficient. Ovarian safety is beyond the scope of this referral, and will therefore not be commented in detail. Nevertheless, in October 2013, the PRAC finalised a review of Premature ovarian failure for Gardasii/Silgard. The PRAC concluded that the available evidence did not support a causal association.” There is nothing about this important potential harm in the EMA’s official report (2) although it is widely suspected that the possible severe toxicity of the vaccine is autoimmune-mediated.

The EMA might also have considered that when doctors first alerted the scientific community to the possibility that Pandemrix, one of the pandemic influenza vaccines used in 2009-2010, could be related to the occurrence of narcolepsy in people with a specific tissue type, the reaction was to ridicule these doctors. It has now been firmly established that Pandemrix can cause narcolepsy, a very serious condition, up to several years after vaccination of children and adolescents, and that this disease is immune-mediated. However, there was nothing about this, neither in the EMA’s official report (2), nor in the confidential report (4).

The bottom line for the EMA seems to have been that the vaccine should be protected from criticism at all costs because it is believed to save lives by protecting against development of cervical cancer. One sign of this is that the text in the official report is nearly identical to the assessments of the rapporteur and the companies. However, this paternalistic attitude comes at a great cost. The EMA accepted uncritically substandard research performed by the MAHs and produced a superficial, substandard official report (2) that was clearly flawed and unrepresentative, considering the serious concerns raised in internal discussions, which were sealed by life-long confidentiality agreements. Unprofessional and defamatory criticism, such as the one the EMA raised against the Danish researchers, is not unknown to scientists but it is a serious threat to scientific progress and public health. Those who raise concerns should be complemented for their courage, even if their suspicions are later shown to be wrong. Indeed, it is a requirement by DMHA that Danish doctors raise concerns they might have. Unfounded criticism of whistleblowers from those at the top of the power pyramid are potentially highly damaging as it may prevent important concerns from being raised. Unfounded dismissal of signals from ADR reports as reported by the UMC also seriously undermines this central mechanism to monitor adverse drug reactions. These serious failures on behalf of the EMA could create a problem orders of magnitude greater than declining participation rates in HPV screening programmes. Should the concerns over possible harms of the HPV vaccine be confirmed, the trust in the EMA and in vaccines in general may be damaged beyond repair. In fact, we know that the EMA’s handling of the HPV controversy – pretending that we have sufficient knowledge when we haven’t – has already become a PR disaster. In Funen, the uptake of the vaccine decreased from 74% to 31% in just one year (18).

The EMA’s procedures for evaluating the safety of medical interventions – where the companies are by and large their own judges – need to be fundamentally reworked and all procedures and information should be made transparent to the public. Our societies should no longer accept that assessments of drug safety are left to companies with huge financial interests and to a drug agency that receives 80% of its funding from the drug industry.

The secrecy imposed by the EMA is not in the public interest. Drug regulators tend to have a narrow vision, either because of their remit or because they have become too close to the drug industry by their daily work, which often involves contacts with the industry, and by employment of people with long careers in the industry. As an example, the EMA’s director, Guido Rasi, has brought in a number of people from the drug company Sigma Tau that include Stefano Marino, his head of legal affairs. Rasi has worked with this company for many years and apparently owns several patents together with the company (15).

Public health is about the promotion of health and prevention of disease and disability through the organised efforts of society. This entails protection from harms and involves progression of knowledge in open collaboration. As far as we can see, the actions of the EMA in this case indicates that the agency is more concerned about protecting its own previous decisions and the vaccine than about protecting the citizens and giving them the option of choosing for themselves whether or not they would like to get vaccinated against HPV. Some people will prefer to avoid the vaccine, even if the risk of serious harm is very small, and some will prefer screening instead. It is not within the powers of regulatory authorities to deny citizens’ right to make informed choices about their own health by withholding important information. The citizens need honest information about the vaccine and the uncertainties related to it; not a paternalistic statement that all is fine based on a flawed EMA report (2).