Discussing human papilloma virus vaccination
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2730 (Published 22 June 2017) Cite this as: BMJ 2017;357:j2730All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Whatever may be regarded as ideal sexual practices to reduce the incidence of sexually transmitted infections including HPV, and subsequent development of cervical cancer, unfortunately we still live in a world where many women have no choice in these matters. Many countries report the incidence of rape at about 28 per 100 000 of population (Gazette Review, 2017) though true rates are likely to be much higher due to under-reporting. This is so much more than being about morals and values. Of course many of these women do not have adequate access to care after such sexual assault and may be unaware of potential longer term adverse consequences to their health.
Competing interests: No competing interests
In his response, acknowledging comments about the above article which he co -authored, Yang Ling Quah states “ there is no proven linkage between HPV vaccination and mortality following the vaccination. “ Nor, for that matter, is there any linkage nor proof that the vaccine reduces the incidence of cancer, as the article confirmed.
The billions of dollars in income for Merck and GSK, and for doctors outside the UK NHS, who administer the HPV vaccine, are dependant on the media hype which often suggests that the HPV vaccine prevents cancer. (1)
Peter English, a Public Health Physician suggested in an earlier response that young people might best be greeted with the words “ You’ve come for your HPV vaccine to prevent cancer ? ”.
Is this Public Health England policy ?
The article by Quah and Aggrawal has a confident, optimistic tone which does not reflect the extent of post vaccination morbidity, and deaths, that have been reported, and referenced in part, in my earlier response, and also summarised, country by country, by Handley. (2)
An editorial in the current BMJ “ Judging the benefits and harms of medicines” suggests that “optimism bias” is one of the most relevant factors in formulating such judgements.
” Poor science, research misconduct, and publication bias all contribute to the systematic exaggeration of benefit and understatement of harm.” (3)
I noted in my earlier response that Jefferson has pointed out the difficulty in putting the doubts about HPV vaccine safety into professional and public debate. (4)
One experienced US paediatrician who began to use the HPV vaccine in 2009 has written “ In my practice we saw a child lose consciousness within minutes of vaccination, which left me and my staff deeply concerned. I started doing extensive research to better understand the risks and benefits of this vaccine. “
As a result of his research, he concluded, “ Is this vaccine safe ? Clearly it is not.
Do the benefits outweigh the risks ? Weighing the the risk of death or of a severe vaccine reaction, including the possibility of a lifetime of pain, thyroid malfunction or autoimmune disease against theoretical prevention of a slow growing highly treatable cancer, I would have to say no. Japan has got it right . “ (5)
Japan stopped using the HPV vaccine five years ago, because of safety concerns.
Medical journals enjoy a significant income from reprints ordered by pharmaceutical companies.
Is it likely that Merck and GSK, makers of Gardasil and Cervarix, will purchase and distribute reprints of Quah and Aggarwal’s article, to further increase the marketing success of their HPV vaccines, with the added recommendation that the BMJ imprint ensures ?
GSK Biologicals, Singapore, manufacturer of Cervarix HPV vaccine, is listed as the first Research Collaborator of Singhealth Polyclinics, Singapore, on the Singhealth website.
Singhealth is given as Quah’s address, and as Aggarwal’s email address, in the BMJ.
The authors declared that they had no competing interests.
.
Quah explains that the European Medicines Agency continues to survey the safety of HPV vaccines. When the EMA recently protested about a BMJ report on the finding of particles in vaccines, the EMA responder declared that she had no competing interests. (6) The EMA website states that 89% of EMA funding comes from fees and charges for regulatory services, presumably from Pharma.
These observations may be dismissed as inconsequential, not necessarily raising any conflict of interest issues.
Nevertheless they perhaps illustrate why your editorial wrote of “ the systematic exaggeration of benefit and understatement of harm “, which interfere with our attempts to judge between benefits and harm.
These are phenomena that often remain in the shadows when important decisions are made about patient safety, and profits.
1 http://www.globalresearch.ca/big-pharma-and-big-profits-the-multibillion...
2 HPV (Gardasil ) injury scandals worldwide, Why is US media silent. Parents beware.
https://medium.com/@jbhandley/hpv-gardasil-injury-scandals-worldwide-why...
3 BMJ 2017;357:j3129
4 http://www.dailymail.co.uk/health/article-3106372/Just-safe-cervical-can...
5 Paul Thomas and Jennifer Margulis, The Vaccine Friendly Plan, Ballantine 2016,
pp274-279
6 http://www.bmj.com/content/356/bmj.j596/rr-0
Competing interests: No competing interests
Many thanks for the numerous feedbacks and responses to our article since its publication.
In response to Dr Peter M English, we do agree that providing too many details may create ‘unnecessary anxiety’ in patients, and this applies to many aspects of healthcare provision. However, physicians ought to be well versed with the indications, contraindications, adverse effects, alternatives of any treatment proposed in order for patients to make an informed consent. It is therefore imperative to explore your patients’ knowledge regarding HPV vaccination prior to clarification of any doubts or misconceptions that they may have. This article is designed to guide the flow of the conversation, but each discussion should be individualized to your patient’s concerns.
Dr Noel Thomas raises an important point regarding the risk of deaths that have been reported following the administration of HPV vaccines. We do agree that it should be emphasized to patients or parents should they question, that there is no proven linkage between HPV vaccination and mortality following the vaccination. The World Health Organization Global Advisory Committee for Vaccine Safety (GACVS), the UK Medicines and Healthcare Products Regulatory agency (MHRA) and the European Medicines agency have previously reviewed and still continue the surveillance on safety of HPV vaccines.
As discussed in the paper, the published studies regarding the vaccine efficacy are based on the immunogenicity studies and hence it is even more important to highlight to patients the significance of regular cervical cancer screening.
We also recognize the importance of safe sex practices which is out of the scope of this article. As wisely pointed out by Dr JK Anand, careful weightage of the risk profile of your patient is required in order to tailor an individualized discussion with your patients (and their parents) regarding this sensitive topic. Should there be a need for a more thorough discussion, the discussion could, and should stretch more than a 10-minute-consultation. It should be emphasized that while the vaccine is proven to be effective while administered at a younger age, this does not equate encouraging onset of sexual intercourse at an earlier age. Delaying sexual intercourse indeed, does decrease the risk of contracting the infection.
Competing interests: No competing interests
I started writing a long response to Dr Anand's very relevant questions. Then I stopped. All that has to be said is That's right.
Competing interests: No competing interests
1. Nowhere do the authors mention that the longer YOU, the GIRL CHILD delay sexual intercourse - regardless of the route - the lower the chances of your contracting the infection.
2. Nor do the authors mention that the sexual experiences of your male partner will have a bearing on your contracting the virus.
3. Nowhere is to be seen a recognition that in SOME societies the risks of Cervial cancers are lower.
Please see CytoJournal, 2015, 12:13 ! Cervical intraepithelial lesions in females attending Women's Health Clinics in Alexandria, Egypt. The authors, Abdel-Hadi et al cite The Middle East Cancer Consortium as reporting a 0.027% prevalence rste for cervical cancer in EGYPTIAN women. The highestage-standardised rate for cervical cancer was observed in Israeli Jews (5.3) followed by Cypriots, Egyptians, Jordanians and the lowest in Israeli Arabs (2.5).
Let us note the Cypriot situation. Perhaps sexual mores?
4. The 10 minute consultation is from Singapur. Surely even in that cosmopolitan country sex at the age of nine years is frowned upon?
5. Coming back to our own country ENGLAND, does PUBLIC HEALTH ENGLAND require those charged by it for carrying out HPV vaccination, to discuss with the parent and child, the desirability of postponing sexual adventures a few years beyond the age of nine? Or, is too embarrassing.? Or, too time consuming? More than the ten minutes?
6. In England we do have populations originating from cultures in which unmarried girls are discouraged from premarital sex. Eg, Cyprus, Afghanistan, Iran, Iraq, Syria, Turkey. Does our government (Public Health England) take this in to account when formulating guidance or directives in this matter? If not, why not?
Competing interests: No competing interests
Discussing human papilloma virus (HPV) vaccination in a comprehensive and open minded way, with young people and their parents, is an ideal to which we should all aspire.
Such is the amount of misinformation in the medical and public press, and so large are the profits to be made - “ Gardasil brought in $1.7billion for Merck “ (1) that Tom Jefferson, reviewer for the Cochrane Collaboration, and vaccine expert, remarked that “ the HPV vaccines’ benefits have been hyped, and the harms hardly investigated. It is extremely difficult to publish anything against HPV vaccination. Vaccines have become like a religion. They are not something you question. If you do, you are seen as an anti -vaccine extremist. “ (2)
Quah and Aggarwal point out that “ evidence on long term immunogenicity and prevention of cervical cancer is not available “, which may sound odd, if explained, as it should be, to young people and adults who assume from media hype that their life time cancer risk will be reduced by the HPV vaccine.
The authors do not enlarge on the evidence regarding the frequency and seriousness of alleged side effects, and the many deaths that have been reported, (3,4,5) following injection of a vaccine whose long term effects are unknown.
The suggestion in an earlier response from Peter MB English that “ a tentative “are you sure ? “ approach by healthcare workers is associated with a poorer uptake than a more direct “announcement” style of communication”, is interesting. He seems to assume that the higher the uptake of HPV vaccine, the better, something that many people who are aware of the uncertain safety profile of the vaccine would not agree with. (6)
The suggestion by English that one suitable approach is to say “ You’ve come for your HPV vaccine to prevent cervical cancer ? Are you happy for me to go ahead ? “ raises further problems.
Where is the evidence that the vaccine prevents cervical cancer ?
See the quote from Quah and Aggarwal above.
How well does the “announcement” style of communication suggested by English, fit with our current UK situation, following the Montgomery case ?
The onus is now on doctors to provide all relevant information about the risks of any proposed treatment, to enable fully informed consent.
Godlee, in a BMJ editorial, pointed out that such essential information does not simply reflect “.. a responsible body of medical opinion, the judgement now rests with ‘ a reasonable person in the patient’s position’ “. (7)
There can be few more important topics for doctors to consider and discuss, as part of their CPD/CME, than the ambivalent roles of HPV vaccines, as a means to affect, for better or worse, peoples’ health and well being.
Does this article help to clarify the issues, in a debate already beset by concerns about transparency, and possible conflicts of interest ? (2,6)
Some readers may be impressed by the confident advice in this article, and conclude that much anxiety about the vaccine is, as English writes, “ misplaced and undue “.
Others may wish to seek out more information, on side effects, safety and effectiveness, and patient experiences, before reaching conclusions about HPV vaccines.
1 http://www.globalresearch.ca/big-pharma-and-big-profits-the-multibillion...
2 http://www.dailymail.co.uk/health/article-3106372/Just-safe-cervical-can...
3 https://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.html#A7
4 http://www.trueactivist.com/its-official-139-girls-have-died-from-hpv-va...
5 Jonathan Irwin describes the alleged effects of HPV vaccine on his daughter, and the difficulties in accessing advice and support from various sources. https://www.youtube.com/watch?v=yeP-eIyibQM
6 https://over-vaccination.net/cochrane-collaboration/
7 New rules of consent : the patient decides. http://www.bmj.com/content/350/bmj.h1534
Competing interests: No competing interests
My thanks to the authors for this excellent article.
It is important that vaccinators are able to discuss HPV vaccination in detail, as the authors propose. However, it's also important to note that in most cases patients (and, where relevant, their parents) are content to have the vaccine, and don't necessarily want to discuss it in any great detail. In such circumstances discussion beyond - "You've come for your HPV vaccine to prevent cervical cancer? Are you happy for me to go ahead?" - can cause unnecessary anxiety. Certainly, in some places, where there is considerable (albeit misplaced and undue) anxiety the vaccine, it seems that a tentative "are you sure?" approach by healthcare workers is associated with a poorer uptake than a more direct "announcement" style of communication.[1]
I'm not for a moment suggesting that patients not be given sufficient information to provide properly informed consent; but I think (and suspect that the authors would agree) that in many cases going into the level of detail in this article would be inappropriate.
REFERENCES
1. Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Pediatrics 2016 PMID: 27940512 [10.1542/peds.2016-1764]: 10.1542/peds.2016-1764. (http://pediatrics.aappublications.org/content/early/2016/12/01/peds.2016...).
Competing interests: No competing interests
It would be interesting to follow all these vaccinated women to examine breast cancer incidence.
Since HPV infections are associated with breast cancers[references below], effective vaccinations might prove protective!
References
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4791894/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4705232/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4679879/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4676430/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4494820/
http://www.ncbi.nlm.nih.gov/pubmed/19851859
http://www.ncbi.nlm.nih.gov/pubmed/19773762
http://www.ncbi.nlm.nih.gov/pubmed/19724278
http://www.ncbi.nlm.nih.gov/pubmed/18936692
http://www.ncbi.nlm.nih.gov/pubmed/18427947
http://www.ncbi.nlm.nih.gov/pubmed/16865407
http://www.ncbi.nlm.nih.gov/pubmed/23183846
http://www.ncbi.nlm.nih.gov/pubmed/23011481
http://www.ncbi.nlm.nih.gov/pubmed/22566779
http://www.ncbi.nlm.nih.gov/pubmed/22214962
http://www.ncbi.nlm.nih.gov/pubmed/22012724
http://www.ncbi.nlm.nih.gov/pubmed/18648363
http://www.ncbi.nlm.nih.gov/pubmed/18413729
http://www.ncbi.nlm.nih.gov/pubmed/17310842
http://www.ncbi.nlm.nih.gov/pubmed/16780823
http://www.ncbi.nlm.nih.gov/pubmed/16222323
http://www.ncbi.nlm.nih.gov/pubmed/15642157
http://www.ncbi.nlm.nih.gov/pubmed/15494272
Competing interests: No competing interests
Re: Discussing human papilloma virus vaccination
Sub Title: Should Japan’s ‘active promotion’ of HPV vaccination be resumed?
In fact, since promotion ended there have been continuing reports of serious side effects.
In its June to August 2017 editions, BMJ published a debate entitled ‘Discussing human papilloma virus vaccination’ concerning the safety of HPV vaccination. In that discussion, Dr Noel Thomas wrote, ‘Japan stopped using the HPV vaccine five years ago, because of safety concerns.’ In fact, stated correctly, ‘On 14 June 2013 the Japanese Government took measures to end “the active promotion of regular inoculation”.’ Since then, those who wish to be inoculated have continued to be so.
We checked the number of reports of negative side effects since around the time these measures were taken by investigating reports by doctors to the Ministry of Health, Labour and Welfare (case outlines are published on the Ministry’s web site). We found that in the over four years since vaccination promotion was stopped, there were a total of 84 reported cases of suspected side-effects to the two agents Cervarix and Gardasil. Of these, in 45 cases (54%) the symptoms were ‘serious’. Of the 84, 39 (46%) were assessed by the administering doctor as ‘having a causal relationship to the vaccination’ and 18 (46%) of those were ‘serious’. (One case was in an 11 year-old girl who had 33 symptoms including ‘generalized aching’ and ‘involuntary movements’. Another case was in a 14 year-old girl for whom 11 symptoms were listed, including CRPS and orthostatic intolerance.)
The above results do not contradict the theory that there is a causal relationship between HPV vaccine injection and various symptoms that occurred after injection.
Kiyohiko Katahira, PhD
Researcher
Institute of Clinical and Social Pharmacy, Kenwa-kai, Takano 4-510-1, Misato, Saitama, Japan
katahirakiyohiko@gmail.com
Hiroaki Enoki, PhD
Researcher
Institute of Clinical and Social Pharmacy, Kenwa-kai, Takano 4-510-1, Misato, Saitama, Japan
Kiyoshi Uchide, MD
Professor (Special appointment) of Komatsu Junior College
Competing interests: No competing interests