Something serious is happening when scientists who question the safety of the papilloma vaccine have to publish their data and hypotheses with a pseudonym. The commotion produced after the publication in the Indian Journal of Medical Ethics of a Commentary that hypothesizes that the important increase in incidence of cervical cancer occurred in Sweden could be due to the incidental vaccination of non-virgin women (probably infected before vaccination) has uncovered that the author had sent the text under a pseudonym because «Under the current circumstances where publication of any information critical of vaccines can have serious personal repercussions, the author has chosen to publish under this pseudonym.»
Juan Gérvas comments on the case, the well-known and unknown evidence in this regard and, in his opinion, justify a global moratorium waiting for reliable data on effectiveness and safety.
About the Sweden problem with increased incidence of cervical cancer, and the paper published last 30th April in the Indian Journal of Medical Ethics
«The increase in the incidence of cervical cancer» in the Indian Journal of Medical Ethics, with a correction of authorship:
Author: Lars Andersson (email@example.com), Medical scientist. Under the current circumstances where publication of any information critical of vaccines can have serious personal repercussions, the author has chosen to publish under this pseudonym.
In fact, I have contacted the author when spreading the paper in the Net (2nd and 3rd May) finding no one work in the Karolinska Institute at that time on the problem; his answer the same day:
I am a retired professor of pharmacology at the Karolinska institutet.
The Karolinska Institut asked for a correction as the author was not an employee there, and does not support the conclusions of the study
The Journal corrected the authorship. The Journal has not retracted the paper
As editors, we are wary of the extreme ideological divide that views discussions on vaccines as either “pro” or “anti”. In low and middle-income countries like India, where early HPV infection and incidence of carcinoma cervix are relatively high, scientific discussion and resolution of issues concerning the HPV vaccine is critical, for women receiving it, and for policy making on its introduction in the universal immunisation programme. We hope that the hypothesis of possible harm of vaccinating women previously exposed to HPV is carefully explored in future studies.
– Editors, Indian Journal of Medical Ethics
«We hope that the hypothesis of possible harm of vaccinating women previously exposed to HPV is carefully explored in future studies».
What nobody reject is the fact than in Sweden is an increase of cervical cancer (in females not included in the official program of HPV vaccination)
There is a lack of information about how and who are vaccinated «out» of the program (in Spain thousands, as probably in Sweden because gynecologists are strongly recommending the vaccine as «curative» after having contact/infection with the HPV)
This recommendation has no scientific base:
«In women positive for HPV DNA, HPV-16/18 vaccination does not accelerate clearance of the virus and should not be used to treat prevalent infections.»
The question is important and plausible; see the report of the FDA:
«In subjects non-naïve at baselne – with either evidence of previous infection (seropositive) or baseline infection (PCR positive), the efficacy estimates are wide and the lower bound of the 95% CI less than zero. In the subgroup of subjects seropositive and PCR positive at baseline, efficacy is -25.8% (95% CI: -76.4, 10.1%). (pg 359-360)
See table 275 (pg 360) Gardasil efficacy 9,1% year versus 7,3% placebo; HR 1,26 (0,9-1,76); RRR -26 (-76% a 10%); RAR -1,8% (-5,22% a 0,71%); NNT -56 (140 a -19) per year. The RCT was not enough powered (Gardasil 473 females, control 479) they need at least 3,666 each arm
In India there is great concern about the HPV vaccine; see for example:
«India HPV vaccine. We do not know its impact on mortality, with failed RCT, no enough information about adverse effects and no cost-effective.»
We can understand the «anonymous» behaviour, as pointed in the journal Science:
«Many influenza researchers are hesitant to discuss problems with the vaccine «because they’re afraid of being tainted with the antivaccine brush.»
We are losing academica and scientific freedom in the field of vaccines, which harms populations because the needed improvement in vaccines
All of this is not probably innocent:
«Vaccines. Education or lobbying? Vaccine advocacy groups lacks sufficient transparency. #vaccineswork Vacunas. De cómo su promoción oculta información sobre negocio y corrupción (cabildeo, lobby).»
Meantime new evidence published in the Cochrane Library shows that human papilloma virus (HPV) vaccines protect against cervical lesions in young women, particularly in those who are vaccinated between the ages of 15 and 26. In older women vaccinated between 25 to 45 years the HPV vaccine does not work as well. This might be because older women are more likely to have been exposed already.
The evidence also shows that the vaccine does not appear to increase the risk of serious side effects which was about 7% in both HPV vaccinated or control groups. The researchers did not find increased risk of miscarriage in women who became pregnant after vaccination. However, they emphasize that more data are required to provide greater certainty about very rare side effects and the effect vaccines have on rates of stillbirth, and babies born with abnormalities in those who became pregnant around the time of vaccination.
According to this Cochrane Review:
1/ NNV (number needed to vaccine to avoid ones cancer in situ): 1000
2/ Per 1000 vaccinated 17 less CIN2
3/ Death as adverse effect, 14 per 10.000 in the vaccinated group and 11 per 10,000 in the control group
4/ 3 of the four authors have had links with Glaxo
The Cochrane review 26 studies, but there are 206:
“We indexed 206 clinical studies: 145 industry and 61 non-industry funded studies. One of the four HPV vaccine manufacturers (GlaxoSmithKline) provided information on its study programme. Most studies were cross-verified from two or more sources (160/206, 78%) and listed on regulatory or industry trial registers or journal publication databases (195/206, 95%)—in particular, on ClinicalTrials.gov (176/195, 90%).»
However, study results were only posted for about half of the completed studies on ClinicalTrials.gov (71/147, 48%). Two thirds of the industry studies had a study programme ID, manufacturer specific ID, and national clinical trial (NCT) ID (91/145, 63%). Journal publications were available in journal publication databases (the Cochrane Collaboration’s Central Register of Controlled Trials, Google Scholar and PubMed) for two thirds of the completed studies (92/149, 62%).
Synthesis: HPV vaccines should be not marketed anymore, awaiting full review of all clinical studies.
Juan Gérvas, médico general rural jubilado, Equipo CESCA, Madrid