Pandemrix vaccine: why was the public not told of early warning signs?
BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3948 (Published 20 September 2018) Cite this as: BMJ 2018;362:k3948
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Peter Aitken [1] raises some interesting issues. It might also be the case that if governments and health officials are unwilling to share with the public the basis of their decision making then they are making the wrong decisions.
Peter HL Aitken, 'Re: Pandemrix vaccine: why was the public not told of early warning signs?', 9 October 2018, https://www.bmj.com/content/362/bmj.k3948/rr-19
Competing interests: No competing interests
BUT WE DON’T REALLY KNOW IF INFLUENZA VACCINES ARE LIFESAVERS
Peter Aitken writes with passion and sincerity about the importance of influenza vaccines, but I believe he has been misled, along with the majority of the population in the UK and US, by massive and recurrent publicity campaigns. It may seem hard to believe, but repeated pronouncements of “…60% vaccine effectiveness…40% vaccine effectiveness…20% vaccine effectiveness…” are based on biased and quite limited research and do not constitute proof that influenza vaccines have done more good than harm in recent decades.
Macfarlane Burnet, 1960 Nobel Laureate and a primary developer of today’s influenza vaccine, didn’t think it was worth much. (Natural History of Infectious Disease 1972, page 212) Kenneth McIntosh warned that we should not routinely give influenza vaccine to healthy individuals until we did multicenter randomized trials over several seasons to be sure that it was safe and effective. (NEJM 2000;342:225) His advice was ignored and by 2010 the vaccine was being recommended annually to the entire US population. This was largely the result of a “Seven-Step Recipe” sponsored by the CDC to use the media to boost demand for the vaccine. (Doshi, BMJ 2005;331:1419) Peter Collignon and his colleagues said, “We need much larger, independent, and better-reported prospective studies that clearly demonstrate that the benefits of influenza vaccines in children far outweigh harms. If, overall, the increased number of cases of ARI plus vaccine side effects are much larger in vaccine recipients than those on placebo, given the low efficacy of the vaccine, then this is a strong argument against current policies advocating routine vaccination of children.” (Collignon, Clin Inf Dis 2015;60:489) Margaret McCartney questioned the value of mass flu vaccination and called for randomized controlled trials. (BMJ 2014:349:g6182)
Lone Simonsen found that from 1968 to 2001 US flu deaths in the elderly increased in concert with their increasing use of flu vaccine. (Arch Int Med 2005;165:265. Science 2005;307:1026) Recent trends in North America show no decrease in influenza frequency or mortality, and we hear increasingly about increased risk of illness from the vaccines, particularly from H3N2 viruses and among the elderly. A few experts are beginning to wonder if recent bad flu seasons are, in part, the direct result of mass vaccination; herd immunity may now be weaker, and some severe cases may be specifically caused by the vaccine via “antibody-dependent enhancement of infection.”
The CDC exaggerates the risks of influenza infections and downplays the risks of influenza vaccines. For example, when they recommended in August 2016 that the use of FluMist be discontinued for US children they cited “low effectiveness.” (Grohskopf, MMWR Recomm Rep 2016;65(RR-5):1-54) In fact, it actually increased the risk of illness from H1N1 viruses: VE -19% (CI -133% to 33%). (Jackson, NEJM 2017;377:534) This fact was never mentioned, but may be relevant in the February 2016 death of an 8 year-old Utah girl. (Lawrence, “Utah family hopes daughter’s death from influenza after FluMist vaccine leads to reform.” Fox13now.com/2016/09/Utah)
The scattergun US campaign for annual flu shots may be relevant to US cases of acute flaccid myelitis/AFM. There have been 362 cases reported in the US since August 2014, mainly in schoolchildren and occurring mainly in the autumn. (CDC, AFM Investigation 10/5/18) Intramuscular injections are known risk factors for paralytic polio when polioviruses, wild or vaccine-associated, are in circulation. (Mawdsley, Lancet 2014;384:300) The same is likely to be true for non-polio neurotropic enteroviruses such as EV-D68 and EV-A71. US public health authorities have been reluctant to investigate this possibility, but it should not be dismissed, particularly since evidence that flu shots are lifesavers is lacking.
Doctor Aitken’s heart is in the right place, but he gives influenza vaccines credit they don’t deserve.
Allan S. Cunningham
Competing interests: No competing interests
Dr Aitken criticises the BMJ for publishing the article, THIS WEEK OF ALL WEEKS.
But, The BMJ is read the world over, this week and every week. The BMJ cannot observe silence every week.
I had decided to forego flu vaccine this year - as I have done every year. I am aged 86.
And, I am NOT an anti-vaccine person. Have had numerous vaccinations and vaccinated my wife and children too a couple of times. But smallpox is one thing. Influenza is a different matter altogether.
Please Dr Aitken, Look back at the history of influenza vaccination and tell us if it has always been successful. Is it not true that the recipients of a certain age who received a certain vaccine were reportedly “negative beneficiaries?”
Competing interests: No competing interests
Pandemrix vaccine: why was the public not told of early warning signs?
BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3948 (Published 20 September 2018)
Drug company and data stories are news, transparency and confidence in commercial data is important but 2009 is some time ago, in a context when there was a genuine concern in regard to "swine ‘flu pandemic" and a regulatory process that was adjusted by agreement with governments to bring vaccines quickly to the population lest we have a repeat of mortality on the scale of 1918/19.
The BMJ has previously reported on Pandremix in 2013 (1) so why is this news now?
Vaccine scare stories are also news and are known to impact adversely on uptake. You cite Wakefield MMR but as Goldacre (2) argued in 2008, the media may have responsibility to bear in the way they report.
I like many senior medical leaders am asked by the NHS (3) to lead by example, be vaccinated, and ask all our staff to follow suit. We are asked to protect ourselves (4) and the patients we serve by reducing sickness absence and risk of transmission of circulating ‘flu.
Why when NHS trusts are working hard to protect their staff and the public from influenza, launching our annual 'flu jab' campaigns, would the BMJ pick this of all weeks to run this story? How did the Editorial board come to the conclusion that it was in the public interest to run with this story at such a sensitive time for the NHS ‘flu vaccination program?
For the UK's leading medical publication and important contributor to medical continuing professional development to have a lead Editorial and two pages 14/15 on the concern and only 1/2 page on the industry response on p28 I suggest leaves the casual reader in no doubt that there is an issue to be resolved and that can be enough to turn medical people away from supporting vaccination.
What will the lay press make of the BMJ lead here?
Is there a genuine concern about the transparency of data around this year’s vaccines and real concerns about their safety? Should we as senior clinicians be offering a more cautious advice to our NHS trust boards?
If there is a concern about this years’ ‘flu vaccines safety based on a lack of openness and transparency around commercial data please state it clearly.
If not then I think the articles are ill-timed as they are likely to weaken confidence in the current NHS Public Health England ‘flu vaccination program whilst the important issues of data access and transparency are partially obscured and could be addressed separately without risking harm.
( Conflict of interest? I've had this year's quadrivalent vaccine along with 51/52 of my medical colleagues and we are actively advocating vaccination for all our front-line staff)
(1) Miller E, Andrews N, Stellitano L, et al. Risk of narcolepsy in children and young people receiving AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine: retrospective analysis. BMJ 2013;346: f794.
(2) The Media’s MMR Hoax, Bad Science, Ben Goldacre, August 30th 2008 https://www.badscience.net/2008/08/the-medias-mmr-hoax/
(3) Public Health England Flu Fighter, Healthcare Worker Vaccination Clinical Evidence updated 2017
(4) Healthcare worker influenza vaccination and sickness absence - an ecological study Periera at al on behalf of the London Respiratory Network Clinical Medicine 2017Vol 17 No 6 484-9 doi: 10.7861/clinmedicine.17-6-484
Competing interests: No competing interests
Tom Jefferson says "As Healy pointed out, openness and clarity are the enemies of vaccine hesitancy. Non response and obfuscation are gifts to those who are ideologically opposed to vaccines and their use."[1]
Jefferson's bald reference to those "who are ideologically opposed to vaccines and their use", discounts the legitimate concerns of citizens who are alarmed at rapidly increasing vaccination schedules and the arguable over-use of vaccine products.
Vaccination policy is a serious political issue in our liberal democracies, and citizens are entitled to transparency and accountability for taxpayer-funded vaccination schedules.
In my experience of questioning vaccination policy, it’s the protagonists who seem to be ideologically driven, treating ‘vaccination’ as a religion that must not be questioned, and refusing to be accountable for individual vaccine products.
Vaccine products are added without any consultation with the community, and are even being mandated by governments in countries such as Australia, the United States and Italy. It’s astonishing that the move towards mandating the medical intervention of vaccination, and the deleterious impact on the right to 'informed consent', has had such little critical analysis. Associate Professor in International Criminology Paddy Rawlinson is one of the few academics to tackle this subject, in her essay Immunity and Impunity: Corruption in the State-Pharma Nexus.[2]
Transparency and accountability for vaccination policy is seriously lacking. For instance, we need open examination of the committees and groups influencing vaccination policy, including conflicts of interest of participants. The current crisis at Cochrane highlights even further serious problems with conflicts of interest in evaluating medical products, e.g. HPV vaccines.[3]
We need to seriously look at the quality and objectivity of the data underpinning the effectiveness and safety of the ever-increasing number of vaccine products and revaccinations on vaccination schedules. We desperately need truly independent and objective evaluation of vaccine products.
It’s extremely difficult for citizens to gain accountability for vaccination policy, with politicians and vaccination bureaucrats blatantly ignoring citizens' concerns on this matter. It’s also difficult to raise this issue on public forums, where the threat of censorship hovers constantly, and where people hiding behind pseudonyms often try and sabotage debate on mainstream media platforms.
Meanwhile, more and more lucrative vaccine products and revaccinations are being added to international schedules. We have no idea of the long-term cumulative consequences of this increasing vaccine load.
Yes, the desire to prevent disease with a ‘magic bullet’ vaccination is understandable. But problems are emerging, not only with Pandemrix, but also with other vaccines, e.g. the pertussis/whooping cough vaccine[4,] including the pressure for repeated revaccination throughout life with this combination vaccine product.[5]
Citizens are entitled to query whether the over-use of vaccine products could be leading to a disaster even greater than those already unfolding with the over-use of antibiotics, opioids, anti-depressants and other medical products.
Stop the polarised ‘pro’ / ‘anti’ vaccination war that has hindered scrutiny of the booming international vaccine market, and start having some considered discussion on the proliferation of these products.
References:
1. Tom Jefferson provides his interpretation of David Healy’s response. David Healy did not actually use this specific wording in his rapid response on this article.
2. Paddy Rawlinson. Immunity and Impunity: Corruption in the State-Pharma Nexus. International Journal for Crime, Justice and Social Democracy. Vol 6 No 4 (2017): https://www.crimejusticejournal.com/article/view/447
3. See my rapid responses on Fiona Godlee's BMJ article Reinvigorating Cochrane: https://www.bmj.com/content/362/bmj.k3966/rapid-responses and on Nigel Hawkes' BMJ article HPV vaccine safety: Cochrane launches urgent investigation into review after criticisms: https://www.bmj.com/content/362/bmj.k3472/rapid-responses
4. Resurgence of Whooping Cough May Owe to Vaccine's Inability to Prevent Infections, posted on BU School of Public Health, 21 September 2017: http://www.bu.edu/sph/2017/09/21/resurgence-of-whooping-cough-may-owe-to...
5. Six doses of pertussis containing vaccines are ‘recommended’ for children now, plus repeated revaccination of women for every pregnancy, healthcare workers, early childhood educators and carers, travellers etc. See Summary and Recommendations, Pertussis (whooping cough) in The Australian Immunisation Handbook: https://immunisationhandbook.health.gov.au/vaccine-preventable-diseases/...
Competing interests: No competing interests
Elizabeth Hart's report about Markku Partinen's experience with the Lancet and NEJM is very similar to the experience of Danuta Skowronski and her Canadian colleagues when they submitted their report of an increased risk of illness from pH1N1 infections among prior recipients of the seasonal flu shot. After much delay they eventually got it published. (Skowronski et al, PLoS Med 2010;7(4):e1000258) Notably, US public health authorities--the CDC, etc--never publicly acknowledged their report.
Competing interests: No competing interests
May I point to just the last sentence of the text of Jefferson’s response?
I totally agree. Those who have followed the responses on matters relating to vaccination (immunisation) in the bmj, will have noticed that never have the public health specialists in England responded to questions, doubts, queries in the bmj.
Some of us, who served in Public Health when the public health doctors were answerable to the local population and were interrogated by the councillors (in open meetings) and by the press, radio and television, never wore a veil, never played deaf nor dumb.
Competing interests: No competing interests
I do believe Tom Jefferson makes an unwarranted assumption:
"As Healy pointed out, openness and clarity are the enemies of vaccine hesitancy. Non response and obfuscation are gifts to those who are ideologically opposed to vaccines and their use."
Leaving David Healy aside, who may not wish to say any more than he has already said, without "openness and clarity" there is no informed consent, and if people knew more they might possibly be more willing, or they might be less, but I am also not happy with any label which might be hung on me or many others who may just want medical science to be properly grounded. It seems to me more likely that if we have a belief system (aggressively defended) in favour of the extending vaccine schedule without adequate data (and with potentially great commercial advantage) that in itself constitutes an ideology, much more so than people being sceptical of failing or biased systems, who may also have have witnessed harms that are seldom if ever officially acknowledged. Nor, sadly, do I know after 15 years of surveying the field of any vaccine which is adequately tested or monitored, Pandemrix being only one example. Given the pervasive systems failures which Jefferson and Doshi have also recently been highlighting with HPV vaccines, the public have a right to be careful, hesitant and even anti until public health gets its house in order.
Competing interests: No competing interests
Arlett’s statement, “Pandemrix was developed for use specifically in a flu pandemic. It was authorised in the European Union (EU) on 29 September 2009 to immunise citizens against the H1N1 pandemic influenza strain. Information from clinical trials in more than 6,000 subjects was assessed as part of an extensive review of the vaccine’s safety profile before its authorisation, and the outcome of the assessment is available on the EMA website” plays on the average reader’s inability to check facts.
The Pandemrix vaccine referred to by Arlett contained the influenza antigen H5N1 and GSK’s proprietary adjuvant system AS03, as well as stabilisers and preservatives (1, 2, 3). However, the product Pandemrix which went on the market contained AS03 as well as broadly similar quantities and concentrations but the influenza antigens were different: H1N1. This is because in the decade preceding the 2009 epidemic a regulatory process to develop and pre-licence so called mock up vaccines was put in place with the sole purpose of speeding up registration in an emergency. Once the mock-up had received registration (in this case the H5N1 containing vaccine), licensing of the real pandemic vaccine (in this case Pandemrix) was cut down to five days (4).
At the time of provisional licensing (29 September 2009) no data were available for Pandemrix (containing H1N1 and AS03).
The whole pandemic licensing programme at the time of vaccine roll out was based on analogy of the properties of one mock up vaccine compared to the pandemic vaccine which was subsequently used (4).
Analogy, however, in this case has a very weak evidence base. In 2008 the American National Vaccine Advisory Committee (NVAC) report “The role of adjuvants and new technologies” stated “antigen/adjuvant combination is vaccine specific and no data are available currently that would allow an extrapolation to another antigen or even to the same formulation given by a different route”(5). WHO in its 2007 guidance stated that “Because of the inherent variability in the assay systems used to measure immune responses, it is unwise to directly compare results from different studies (6). This view was still held in 2013, when WHO (7) warned that “an adjuvant-mediated enhancement of the immune response to one vaccine antigen, as a rule, cannot be extrapolated to the enhancement of the immune response to another antigen.””. The EMA 2005 Guideline also stresses the uncertainties of novel adjuvant use: “Unpredictability of adjuvant effects in humans results from a complex interplay between such factors as route of administration, antigen dose and the nature of the antigen. For this reason, a final safety evaluation of the newly developed vaccine formulation can only be conducted on the basis of clinical trials”.(8)
The clinical trials of Pandemrix were only just starting at the end of September 2009.
As Healy pointed out, openness and clarity are the enemies of vaccine hesitancy. Non response and obfuscation are gifts to those who are ideologically opposed to vaccines and their use.
1. GlaxoSmithKline. AS03 Adjuvanted H5N1 Vaccine (for pandemic use). Common Technical Document (CTD). Module 5 Volume 1 January 2007. (obtained through Freedom of Information request)
2. GlaxoSmithKline. AS03 Adjuvanted H5N1 Vaccine (for pandemic use). Common Technical Document (CTD). Module 2 Section 2.5. Clinical Overview. (obtained through Freedom of Information request)
3. GlaxoSmithKline. AS03 Adjuvanted H5N1 Vaccine (for pandemic use). Common Technical Document (CTD). Module 2 Section 2.6. Non clinical written and tabulated summary. Available from: http://www.mhlw.go.jp/shingi/2010/01/dl/s0115-7l.pdf Overview.
4. European Medicines Agency. Committee for Proprietary Medical Products (CPMP). Assessment report for the re-assessment of the specific obligations and the benefit/risk profile Invented name/Name: Pandemrix International non-proprietary name/Common name: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A) Authorised Under Exceptional Circumstances EMEA/H/C/832/SW/41 (EMA/CHMP/508065/2010) dated June 2010
5. Dekker C, Gordon L, Klein J. Dose optimisations strategies for new vaccines. The role of adjuvants and new technologies. Report (with recommendations) Approved at the February 2008 American National Vaccine Advisory Committee (NVAC) Meeting. Available from: https://www.scribd.com/document/333541232/Adjuvant-Vaccine-docx
6. World Health Organisation Expert Committee on Biological Standardization. Guidelines on regulatory preparedness for human pandemic influenza vaccines (Adopted 2007). Appendix 2 to the Fifty-eighth report. Available from: http://www.who.int/biologicals/vaccines/Annex_2_WHO_TRS_963-3.pdf
7. World Health Organisation.Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines. October 2013. Available from: http://www.who.int/biologicals/WHO_Guidelines_on_NCE_adjuvanted_vaccines...
8. European Medicines Agency. Committee for Proprietary Medical Products (CPMP). Guideline for Adjuvants for Human Use, 2005 (EMEA/CHMP/VEG/134716/2004). Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/...
Competing interests: TJ was a recipient of a UK National Institute for Health Research grant for a Cochrane review of neuraminidase inhibitors for influenza. In addition, TJ receives royalties from his books published by Il Pensiero Scientifico Editore, Rome and Blackwells. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011-13, TJ acted as an expert witness in litigation related to the antiviral oseltamivir, in two litigation cases on potential vaccine-related damage including Pandemrix (2015-2017) and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997-99), GSK (2001-2), Sanofi-Synthelabo (2003), and IMS Health (2013).In 2014 he was retained as a scientific adviser to a legal team acting on oseltamivir. TJ has a potential financial conflict of interest in the drug oseltamivir. In 2014-16, TJ was a member of three advisory boards for Boerhinger Ingelheim. TJ was holder of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. Between 1994 and 2013, TJ was the coordinator of the Cochrane Vaccines Field. TJ was a co-signatory of the Nordic Cochrane Centre Complaint to the European Medicines Agency (EMA) over maladministration at the EMA in relation to the investigation of alleged harms of HPV vaccines and consequent complaints to the European Ombudsman. TJ is co-holder of a John and Laura Arnold Foundation grant for development of a RIAT support centre (2017-2020) and Jean Monnet Network Grant, 2017-2020 for The Jean Monnet Health Law and Policy Network. TJ is an unpaid collaborator to the project Beyond Transparency in Pharmaceutical Research and Regulation led by Dalhousie University and funded by the Canadian Institutes of Health Research (2018-2022).
Re: Pandemrix vaccine: why was the public not told of early warning signs?
From an article just published we are advised that……….
“The European Medicines Agency (EMA) is the main EU body responsible for pharmacovigilance, which it defines as the ‘science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem’. Whereas EudraVigilance is essentially the system for monitoring the safety of medicines.” (1)
The efficiency of the system, like any other, will depend on the quality and quantity of the material provided. Peter Doshi at the outset questioned why it was that the public weren’t told about the early warning signs in respect of Pandemrix vaccine .(2) In response, Peter Arlett, Head of Pharmacovigilance and Epidemiology at the European Medicines Agency stated that……
“in its effort to provide comprehensive and timely information to the public, EMA published on its website weekly to bi-weekly updates on estimates of exposure, a summary of the pharmacovigilance data collected in the EudraVigilance database and conclusions of safety reviews”(2)
It is clear that the EudraVigilence database was undoubtedly relied upon for signal detection purposes in respect of Pandemrix. Over and over the EMA website has been highlighted as the means by which information in respect of Pandemrix was placed in the public domain.
However, an article by Florence van Hunsel et al in 2012 (with a study timeframe listed as the second half of 2010) notes that the UK and Sweden, at that time, only shared Health Care Practitioner (HCP) reports and not consumer reports with the WHO and the EudraVigilence database. (3)
The authors recognised the consequences in failing to include consumer ADR’s in an overall assessment of product safety.
“The fact that not all countries share their patient reports with the WHO and/or the EudraVigilance database has the consequence that these reports are not taken into account if these databases are used for signal detection purposes.”
The article includes feedback from a number of countries on the role of consumer reporting with Austrailia pointing out that “Consumer reports provide a valuable addition to the data available for the monitoring of medicines safety, and should be encouraged”.
The Netherlands concurred…………
“The past years of experience with patient reporting have taught us that patient reports contribute substantially to the reporting of ADRs, both in quantity and quality”
On 6th July 2009 the MHRA circulated a “Dear Colleague” letter advising of a new “Swine flu ADR Portal” to be used by professionals and public alike to report adverse reactions to either antiviral medications or the swine flu vaccines.
“As with the Yellow Card Scheme, the Swine Flu ADR Portal will be open to members of the public as well as healthcare professionals. Please remind patients of this. The NHS antiviral leaflets, which will be handed to patients with their antivirals, will also encourage use of the Portal to report suspected ADRs to Swine flu medicines.”(4)
With the article by Florence van Hunsel et al in mind, one has to wonder if the reports submitted by the public to the Portal were forwarded for inclusion in either the WHO or EudraVigilence databases. Was it the case that only the HCP adverse reaction reports were submitted, and if so, why?
If patient reporting at that time wasn’t routinely shared by the UK, what reassurance is there that the many reports completed and submitted by affected members of the public in connection with a swine flu product, were included in the overall EMA assessment as to product safety?
The EMA press release dated September 2010 concluded that there was insufficient evidence to determine “whether there is a link between Pandemrix and reports of narcolepsy”(5)
If consumer reporting wasn’t included from the UK and Sweden (two countries which went on to have a significant problem with narcolepsy) how might that have contributed to the fact that in September 2010 there was insufficient evidence of a link between the vaccine and reports of narcolepsy?.
Setting aside the pandemic, one is left wondering why, if patient reporting (in respect of any product) was formally included in the UK Yellow Card Scheme from 18th February 2008 onwards (following a pilot study commenced in 2005), these reports were not being shared by the MHRA with the EudraVigilence database, particularly since a significant proportion may have had EU product licences.
Conversely, if it was the case that the MHRA didn’t share patient reports of adverse reactions, why did the EMA and the WHO tolerate that, and not insist on consumer reports also?
The fact that patient reporting provides a valuable contribution is very well documented. Consumers may contribute different aspects of ADR reporting to that provided by HCP’s alone.
“Patient reporting of suspected ADRs has the potential to add value to pharmacovigilance by reporting types of drugs and reactions different from those reported by HCPs; generating new potential signals; and describing suspected ADRs in enough detail to provide useful information on likely causality and impact on patients’ lives” (6)
Clarification by the MHRA as to whether or not patient Yellow Card reports in respect of swine flu vaccines were forwarded to the WHO and EudraVigilence databases along with HCP reports, would be welcome.
(1) https://www.healtheuropa.eu/pharmacovigilance-eudravigilance/88661/
(2) https://www.bmj.com/content/362/bmj.k3948
(3) Experiences with Adverse Drug Reaction Reporting by Patients An 11-Country Survey
https://www.lareb.nl/media/3059/11-country-survey.pdf
(4) http://webarchive.nationalarchives.gov.uk/20141205203905/http://www.mhra...
(5) 23 September 2010 EMA/CHMP/588294/2010 Press Office
(6) https://njl-admin.nihr.ac.uk/document/download/2002107
Competing interests: No competing interests