Skepticism about science and medicine

In search of disinterested science

HPV vaccines: risks exceed benefits

Posted by Henry Bauer on 2017/07/09

“Vaccination” is publicly argued in black/white, yes/no fashion, as though one had to be either for or against ALL vaccinations. But the fact is that the benefits of some vaccinations far outweigh the dangers of occasional harmful “side” effects whereas that is not clear with other vaccines. Polio vaccine, for example, seems to have been wonderfully effective and is still so in many countries; on the other hand, in regions where polio is no longer endemic, the risk of contracting polio from oral vaccine exceeds the danger of contracting it when not vaccinated (see links near the end of What to believe? Science is a red herring and a wild-goose chase).

Immune systems are complex and not fully understood, and there are individual variations galore — as when one of my friends came down with shingles shortly after being vaccinated against shingles. (The doctor of course assured him that the outbreak would have been more painful had he not been vaccinated; an ex cathedra assertion without possibility of verification.)

I was reminded of the issue of HPV vaccination by a brouhaha in Europe between the European Medicines Agency (EMA) and medical practitioners and researchers who had come across a substantial number of cases of harm seemingly following HPV vaccination, harm specifically in the form of chronic autoimmune ailments. Since vaccination affects the immune system, such an undesired effect in some individuals seems perfectly plausible.

The Nordic Cochrane Center exists for the purpose of evaluating the evidence underlying medical practices. The Cochrane Center and others have been campaigning for many years to have the data from clinical trials made available to all researchers (1). Last year it lodged a complaint (2) against EMA for conflicts of interest with drug companies exacerbated by the secrecy of discussions that led to criticism of physicians’ reports about autoimmune symptoms appearing after vaccination against HPV. That secrecy is truly extraordinary, virtually an admission of conspiracy: “experts who are involved in the process are not named and are bound by lifelong secrecy about what was discussed” (3).

An EMA publication had severely criticized publications by Louise Brinth and others who had published reports of autoimmune symptoms following vaccination (4); Brinth has delivered a blistering response to the EMA insinuations (5).

The supposed benefit of vaccinating against HPV is to decrease the risk of certain cancers, primarily of the cervix. There are perhaps a hundred types of HPV, of which about 40 are sexually transmitted, and two to four of these seem to be statistically correlated with cancer:
“High-risk HPV strains include HPV 16 and 18 . . . . Other high-risk HPV viruses include 31, 33, 45, 52, 58, and a few others. Low-risk HPV strains, such as HPV 6 and 11, cause about 90% of genital warts, which rarely develop into cancer” (What is HPV?).

HPV infections are the most common sexually transmitted infection: “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives” (Human Papillomavirus (HPV) Statistics). Thus most infections do not lead to cancer, which might induce thought about what “cause” could mean in this context. About 4% of Americans are infected each year with a “high-risk” strain, about 6 million women (USA population is about 320 million, so roughly 160 million women). There are only about 12,000 cases annually of cervical cancer: thus only about 1 in 500 of even “high-risk” infections is associated with this cancer. Thus vaccinating about 500 “high-risk” women might prevent 1 cervical cancer; NNT (number needed to be treated for 1 person to benefit) = 500.

On the other hand, there appears to be about 1 chance in 200 of an adverse effect from vaccination by Gardasil (Gardasil and the sad state of present-day medical practices); about 8% (~ 1 in 12) of adverse events are “serious”, so there’s about 1 chance in 2500 of a serious adverse event. NNH (number needed to be treated for one person to be seriously harmed) = 2500.

For any medical treatment to be desirable, it should be necessary to treat many more people to harm a single one than the number needed to be treated to benefit a single person; NNH should exceed NNT by a substantial amount.
The numbers just mentioned yield a ratio of only 5 — in other words, there’s something like a 1 in 5 chance, 20%, that HPV vaccination would harm rather than benefit. But those numbers apply if only those women infected with high-risk strains are vaccinated. However, the advocates of HPV vaccination, which includes official agencies in the USA and some other countries, recommend HPV vaccination for all girls. That increases NNT by a factor of 25 and reverses drastically the benefit/cost ratio: It is 5 times more likely that an HPV vaccination will result in a serious adverse event than that the vaccination prevents a case of cervical cancer — even if HPV is the actual cause of cervical cancer, which remains to be proved beyond a mere weak statistical correlation.

It is simply not known whether HPV causes cancer at all. Certainly it does not always cause cancer. An extended article on the invaluable Snopes.com website that debunks urban legends is judicious on this matter by pointing out that the claimed association of HPV vaccination with autoimmune symptoms is only speculative. On the other hand, it also concludes in an update of 12 June 2017:
“An earlier version of this story incorrectly stated that countries with high HPV vaccination rates show declines in cervical cancer diagnoses. Both Gardasil and Cervarix have demonstrated efficacy in preventing HPV infections that cause cervical cancer, and evidence suggests declines in precancerous lesions and other abnormal growths as a result of HPV vaccination. There is debate over evidence for declines in cervical cancer diagnoses — as well as over how much time it would take after the introduction of the vaccine to see any effect on cancer diagnoses” [italics added].

The vaccines against HPV are successful against HPV — but it has never been proved that HPV (or the four strains of it supposed to be associated with cervical cancer) actually causes cancer. Since the rate of HPV infections exceeds the rate of cervical cancer by a huge amount, any “causative” action of HPV must be very indirect, especially since only a small percentage of HPV strains shows even a statistical association with cancer.
Recall that the usual test of “statistical significance” in medicine is p ≤ 0.05, meaning that there is less than a 5% chance that the association is owing only to chance. If there are 100 possible associations, about 5 of them will seem significant even though they are not, being picked out purely by chance because of the (weak!) criterion for statistical significance (6). If there are 100 strains of HPV, then at p ≤ 0.05, purely by chance about 5 strains will seem to be correlated with cervical cancer — or with just about anything else.
Before accepting any role fort HPV in cervical cancer, one should want a demonstration of the mechanism of the claimed causative effect.

***************************************
(1) “Opening up data at the European Medicine”, Peter Gøtzsche & Anders Jørgensen, British Medical Journal, 342 (28 MAY 2011) 1184-6; “EMA must improve the quality of its clinical trial reports”, Corrado Barbui , Cinzia Baschirotto & Andrea Cipriani, ibid., 1187-9
(2) Complaint to the European Medicines Agency (EMA) over maladministration at the EMA, 26 May 2016
(3) “Complaint filed over EMA’s handling of HPV Vaccine safety issues”, Zosia Chustecka, 5 July 2016
(4) “Suspected side effects to the quadrivalent human papilloma vaccine”, Louise Brinth, Ann Cathrine Theibel1, Kirsten Pors & Jesper Mehlsen, Danish Medical Journal, 62 (#4, 2015) A5064
(5) “Responsum to Assessment Report on HPV-vaccines released by EMA November 26th 2015” by Louise Brinth, MD PhD, Syncope Unit, Bispebjerg and Frederiksberg Hospital, Copenhagen, December 15th 2015
(6) For a thorough discussion of the pitfalls of interpreting p values, see Gerd Gigerenzer, “Mindless Statistics”, Journal of Socio-Economics, 33 (2004) 587-606.

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2 Responses to “HPV vaccines: risks exceed benefits”

  1. Vortex said

    Welcome to the Mad in America (MiA), Dr. Bauer! It was a very pleasant surprise to find your article there:

    https://www.madinamerica.com/2017/07/has-psychiatry-gone-uniquely-astray/

    I suspect you consciously restrained your expression there by not directly mentioning anthoropogenic global warming (AGW) and HIV-AIDS: you were probably reading MiA for a long time, and noticed the Left-leaning nature of the site… with all characteristic Left positions regarding AGW and HIV-AIDS.

    If you haven’t noticed it (which is unlikely, but possible), I want to give you a friendly warning to be very cautious concerning these issues on MiA. Remember, I’m one of the very few people who can separate the ethical and pragmatic preferences on political, economic and social issues from the intellectual positions on the scientific, technological and medical ones. Most people, including most members of MiA community, are evidently unable to do it. So, their Left-leaning preferences will ensure that the disclosure of your positions on AGW and HIV-AIDS will be met with extreme hostility by them and may devaluate your other positions in their eyes (and may even led to demands to banish you from the community and attacks on the MiA administration for letting you speak).

    I, myself, has to be silent there about my pervasive doubts in connection with certain scientific controversies like AGW.

    Anyway, I hope this is not the last time I encounter you on MiA. With some caution not to evoke rage against yourself (which I describe above), you may find many intersting discussions there.

    • Henry Bauer said

      Vortex:

      Yes.

      Quite in general, it is a good idea not to profess more than one unorthodox view at a time. That’s the main message of my new book. For most people it is simply inconceivable that “science” could be wrong about anything, let alone anything major like HIV/AIDS or global warming. That science or medicine could be wrong on more than one thing is totally incredible and marks the person who claims it as a crank, a crackpot.
      People who by chance, usually bitter personal experience, discover that science is wrong about something don’t then conclude that it could be wrong about other things too.
      Most of the correspondents who agree with me about global warming think I’m a nutcase for claiming that HIV doesn’t cause AIDS, and vice versa.
      One reason for that is that there is no precedent I know of where science was so wrong about something so major, that affects so many people, as the mistaken belief that HIV causes AIDS or the belief that carbon dioxide causes climate change. History of science has innumerable examples of the scientific consensus later turning out to be wrong, but those issues were until now of importance to few people, they were mainly of intellectual or academic interest only.

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