In 2018, “The HPV Vaccine On Trial: Seeking Justice For A Generation Betrayed”, was published. It was written by attorneys Kim Mack Rosenberg and Mary Holland, and Eileen Iorio described as a “health coach.”
As the title suggests, the book concluded that the HPV vaccine (from the first vaccine, licensed in the U.S. in 2006) was a betrayal, because it was unjustified, harmful, and with no health benefits. As the authors’ first chapter lays out, their opinion is in tension with statements from health authorities and cancer authorities worldwide – and goes against a large amount of data.
It is no exaggeration to say that the book is ill-founded, misleading, and anti-vaccine to the core. HPV vaccines have been especially signaled out by anti-vaccine activists since their creation. This book draws on anti-vaccine claims made over the years, including most of the older anti-vaccine tropes (claims, by the way, that are not always consistent with each other – for example, is the problem aluminum in vaccines, or a novel and different adjuvant?) and offering new (and ill-founded – see the discussion of chapter 8 below) ones.
To explain the problems with it, three of us divided the subjects in the book, and are reviewing it as a team. A review by Dan Kegel, who has an undergraduate degree in biology from Caltech and maintains a comprehensive site with the data on HPV and HPV vaccines, is found here. A review of the chapters on autoimmunity, aluminum, and a few more by John Kelly, a career biochemist, and molecular biologist and a survivor of HPV+ cancer, will be added later.
The book has four parts. I will not cover all of it, out of concern of making this review overly long. But I will raise some of the highlights. I am putting chapter 2 and 15 aside to address in my discussion below of the general use of anecdotes.
Part I – HPV vaccine fear mongering book
The first part provides a general introduction to HPV and the vaccine – then focuses on clinical trials. In that part, the authors substantially understate the risks of HPV infections, as described by Dan Kegel. Drawing on that, the authors claimed there was no justification for fast-tracking the vaccine because, in essence, they claim that HPV is not a serious problem.
Oddly, to make that point they link to an FDA document that does, in fact, mention that 12,000 women were diagnosed with cervical cancer and 4,000 died in just one year. These statistics certainly do not support the authors’ attempt to downplay the risks of HPV).
The authors treat screening with the pap smear test as an alternative to HPV vaccines, while ignoring some critical issues with the pap test itself. This claim is not supported by the data. Moreover, note that “fast track” does not mean the vaccine is not tested or tested less – it does mean the company can submit parts of its review as it goes along rather than wait till all is done and submit the materials then.
In the next chapter, the authors, echoing a claim often seen on anti-vaccine sites, criticize the use of a solution containing the aluminum adjuvant as a control in the clinical trials, even though there are valid scientific reasons for doing that (as my colleague, John Kelly, will discuss later in detail).
In Chapter 8, the authors suggest that a table in one of the clinical trials – protocol 018 – is evidence that Merck used half the amount of aluminum in the vaccine formula provided, which, they imply, would mask harms from the vaccine. The authors based that on the formulation that says “plus 225 aluminum adjuvant/ml” (which would mean 112.5 mcg for the 0.5 ml of a vaccine dose). See:
The authors conclude from this table that there was malfeasance in the clinical trial and that later studies drawing on that trial are invalid. The entire chapter is based on that claim, and on speculation as to why Merck would cut the dose of adjuvant in half for this trial.
That claim never made sense, for several reasons. There was no logic to the idea that reducing an already tiny amount of adjuvant by half would make a big difference in terms of safety. The amounts in questions are minuscule – we are talking about the difference between 225 millionth of a gram (a gram is about the weight of a paper clip) and 112.5 millionth of a gram, or between half a blip to a blip.
More than that, the much larger amounts of aluminum adjuvants in infant vaccines are not problematic. The claim that halving an already smaller amount than that given to infants in a vaccine given to teens – who are much larger in body than an infant and exposed to a lot more aluminum in daily life – will have a meaningful impact on safety is, well, strange. It only makes sense if you believe anti-vaccine claims about aluminum – experts outside the anti-vaccine movement find no scientific validity in these claims.
It made a lot more sense to me that there was a simple typo in table 210. To check, I emailed the FDA. Within a day I received an answer from Dr. Maureen Hess, from the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research. Dr. Hess said:
Regarding, [sic] the Clinical Study Report for Protocol 018, we can clarify that the information in the table that you provided as a screen shot was erroneous.The table indicates that the formulation used in V501-018 contained 225 mcg/mL of AAHS, implying that each 0.5mL dose contained 112.5 mcg. In fact, each 0.5mL dose of vaccine used in V501-018 contained 225 mcg of AAHS, the identical amount of AAHS contained in each dose of Gardasil licensed by FDA for use in the United States.
Chapter 8, in other words, built a whole set of claims around an error in one table about one protocol. The vaccine used in protocol 018 contained the same amount of aluminum as other formulations.
In Chapter 9, the authors claim that because in some small groups who received the vaccine in the trial, women previously exposed to HPV had higher rates of pre-cancer lesions than women exposed to HPV who received the control, the vaccine increased the risk of cervical cancer in those groups. This is a claim commonly made on anti-vaccine sites. As my colleague Dan Kegel points out on his excellent site, these groups were women already with higher rates of precancer lesions before the trial – and since the vaccine does not cure existing pre-cancers, it did not prevent their precancers from developing to cancers. Larger, later examinations did not raise similar concerns.
Chapter 10 suggests the HPV vaccine may harm fertility. This assertion draws upon claims that miscarriages were high in the trials (even though that’s not fertility effects, and the vaccines are not actually recommended in pregnancy), on small case studies, and on an extremely bad study done by someone whose expertise is not in epidemiology.
In any event, a large study published a month before the book’s publication – maybe, though not clearly, too late to address it – should put the concerns in this chapter to rest. The large study of nearly 200,000 women found no effects on HPV vaccines on fertility. Even if the study came out too late for inclusion, the authors should address the findings in any subsequent editions of their book.
For brevity, I will just mention that the last two chapters in the book were a general criticism of what the authors consider problems with the clinical trials and a review of clinical trials in India. I will just point out none of the regulatory authorities appear to agree with the authors’ criticism of the trials’ procedures. Although there may have been problems with informed consent in the trials in India, these would not directly relate to the data on the vaccine’s safety.(The book indicates that investigations in India are not complete. If there were problems with informed consent, they should be addressed separately.)
Part II – HPV vaccine fear mongering book
In Part II, the authors move to the post-market discussion. Chapter 13 – describes Merck’s marketing efforts, followed by chapter 14 examining early attempts to mandate the vaccine, efforts that backfired. Chapter 16 talks about the National Vaccine Injury Compensation Program (NVICP) – providing a very anti-vaccine view. Its opening sentence: “Although controversial, vaccines have played a prominent role in Western public health for almost three hundred years,” should alert readers to the authors’ anti-vaccine bias: vaccines are not controversial scientifically: nearly all scientists, health authorities, and governments, support vaccines. They’re not controversial among the vast majority of people in the U.S., either (pdf).
The rest of the chapter presents a problematic picture of the no-fault compensation scheme available to people alleging harms from vaccines, a myth that the CDC recommends 69 doses of vaccines, and repeats other anti-vaccine myths, like the claim that there are now “260 vaccines in development.”
It then uses a report of compensating 49 people as evidence, I guess, of the dangers of the vaccine. I looked up the current compensation report, from January 2019, and the authors could update their numbers to 134 people compensated for harms from HPV vaccines.
But that’s out of 111,677,552 doses (pdf), a rate of about 1 compensated alleged harm per million doses. Moreover, 103 of those 134 cases are settlements, where the government routinely denies causation but settles for other reasons. This leaves a grand total of 31 decisions where petitioners met the program’s low burden to show the vaccine caused the harm. I address the other case used – Ms. Christina Tarsell’s tragic death – below in my discussion of the use of anecdotes.
Chapter 17 then claims a conspiracy theory to silence criticism of HPV vaccines, and chapter 18 talks of Australia’s experience (I wish I could go in detail into the country chapters, but this review is already too long, so I am not going to).
Part III – HPV vaccine fear mongering book
In Part III, the authors try to address HPV vaccine science. I will leave that discussion to my colleagues, but I did want to point out that the discussion includes claims that the aluminum in HPV vaccines is dangerous (it’s not), and that the vaccine causes autoimmune diseases (studies in millions show that it does not) and an attempt to create an image that the rest of HPV vaccine ingredients are dangerous with no actual evidence of that (and against evidence that the vaccines are safe http://kegel.com/hpv/safety/), echoing the toxins gambit, which suggests vaccines ingredients are dangerous without regard to the tiny amounts of those ingredients, or to lack of data about any problems from them in vaccines.
Part IV – HPV vaccine fear mongering book
In Part IV the authors try to tell stories of several countries’ experience with the vaccine.
HPV vaccine fear mongering book – anecdotes
Throughout the book, a number of glaring themes emerge. I will touch on two, which are common in anti-vaccine literature: the use of anecdotes and the shill gambit.
The book makes extensive use of anecdotes. Use of stories of vaccine harms are a staple of anti-vaccine sites and activism, and this, too, places the book in line with other anti-vaccine efforts. In this case, the problems are glaring: many or most of the book’s anecdotes are without evidence, or even against large-scale evidence about the vaccine and the alleged harm. The temporal connection is often weak (a pattern in several claims of deaths caused by HPV vaccines). Several of the claims of harm are very implausible. And some are presented in a way that raises red flags. The book seems to accept any claim of injury from the vaccine, however weak the evidence behind it, however problematic the story, as evidence.
Anecdotes are not good evidence of harm, by themselves, in any case. Chapter 2 provides two anecdotes. The first, Kesia, was also featured in a very problematic Slate article. In essence, Kesia has suffered many problems over years, and years after her participation in Gardasil clinical trials has decided, based on online searches, that Gardasil was to blame for her problems.
What the book does not tell you is her diagnosis. Having read the Slate article, I knew what it was from before reading the book: Kesia was diagnosed with chronic fatigue syndrome or CFS. The problem with this story, if presented fully, would face is that the potential link between CFS and HPV vaccines was examined in several large studies, and no such link found. By omitting the diagnosis, the book prevents readers from being able to even consider or search this. It does not, of course, mention the studies that show that HPV vaccines do not cause CFS.
The second anecdote in this chapter was even weaker since the young woman in question got the control – a solution containing tiny amounts of aluminum adjuvants – and not the active vaccine. This lady’s problems consisted of heavy menstrual periods, headaches, allergy to deodorant, and years after, a tumor on her pituitary gland, all things that are difficult to convincingly relate to the vaccine (or the control).
Years after the fact, also after reading online materials, she decided her problems were from the vaccine control. No medical or scientific evidence for this belief is provided in the book. The story is that the tiny amounts – millionths of a gram – of aluminum salt in the control the young lady received were “toxic” to her, even though an adult is exposed to large amounts of aluminum in food, water, and air. The book accepts the claim uncritically and presents it as fact.
Other stories suffer from the same problems. Chapter 15 provides a list of anecdotes, opening with a young girl named Alexis who had type I diabetes, received her first two shots with no problems, went to Germany, and after she came back, behaved differently, including misbehavior in school, panic attacks, lack of sleep. After the last shot, the story claimed she lost weight, could not keep food down, could not sleep. The doctors, after extensive testing, found nothing and concluded the problems were psychosomatic – but later, one doctor hypothesized she had seizures. Testing found nothing, but the young girl continued to have severe medical problems.
There is nothing in the story suggesting there was, at any point, medical evidence connecting the girl’s problems to Gardasil. The timing is problematic: the symptoms began months after the second shot, and before the third. The family does mention problems after the third dose, but the story is of problems starting earlier, after a trip abroad. Besides the family’s own belief it was the vaccine, it’s not clear what the basis is for making the link. And yet, the book accepts it without critical analysis. This is a recurring pattern.
The book, of course, covers several of the cases that star in anti-vaccine claims against HPV vaccines, such as the extremely tragic death of Colton Berrett, which is unlikely to be related to HPV vaccines.
It draws on a number of cases that went through the National Vaccine Injury Compensation Program (NVICP). These include a decision in the case of the tragic death of Ms. Christina Tarsell. In the initial decision in Ms. Tarsell’s case, the Special Master denied compensation. Compensation was then awarded under an extremely weakened and diluted standard of proof set in a problematic decision by a single judge of the Court of Federal Claims. This is not very good evidence.
Similarly, a settlement in the case of Joel Gomez, where the case was supported by problematic Dr. Sin Hang Lee, whose works have been thoroughly criticized in scientific circles, is not evidence of much.
Every death is tragic. Nobody wants children harmed. But accepting unproven claims of harm from the vaccines, with little or no medical and scientific evidence behind them, is extremely problematic. When the authors, as here, use these anecdotes to try and counter large-scale studies showing HPV vaccines safe, it’s worse. Even worse, when you are using these anecdotes in relation to an infection that causes tens of thousands of cancers and thousands of deaths each year in the U.S. alone, and suggesting this small number of unsubstantiated anecdotes are a reason not to use a vaccine that prevents it.
HPV vaccine fear mongering book – Poisoning the well
The book consistently and inaccurately refers to those it disagrees with as representing the pharmaceutical industry. In attempting to paint all those rejecting the anti-vaccine view as tied to industry, the book is attempting to poison the well and delegitimize the abundant data that shows the authors’ views wrong.
For example, the book’s discussion of GAVI, The Vaccine Alliance, starts with “Pharmaceutical executives sit on GAVI’s board…”. While by itself true, the attempt to imply that GAVI’s involvement means pharmaceutical companies have “undue influence” on the project is strange. GAVI is a partnership between the Bill and Melinda Gates Foundation – which is a philanthropic foundation – the World Health Organization, UNICEF, and the World Bank with NGOs and businesses. Implying that it is a component of – or is controlled by – “industry” is grossly inaccurate. <
Likewise, when discussing the Advisory Committee on Immunization Practices (ACIP), the authors describe it as having “institutional and corporate insiders with long and deep connections to industry,” referring to a 2000 Congressional Report prepared by a committee chaired by anti-vaccine Congressman Dan Burton. But whatever the case in 2000, that report does not reflect the current careful procedures for screening conflicts of interests at ACIP.
Here, too, the authors are attempting to delegitimize an organization that disagrees with their views – in this case, a group of experts with deep understanding of the data – by wrongly painting them as shills.
This is done because, as the authors point out, medical organizations, cancer societies, and most governments support HPV vaccines. That is because hundreds of millions of doses of HPV vaccines have been distributed at this point, studies were done in millions, and there is no real safety signal. The authors do not have – and do not try – to provide data to counter that.
So, they attempt to delegitimize the groups standing behind the vaccine by suggesting industry ties. They also attempt to delegitimize scientists doing the work by describing them as industry scientists, and identify the opposition as “hundreds of scientists and doctors around the world, unaffiliated with the pharmaceutical industry.” The implication is that it’s only industry’s malign influence that leads the clear majority of scientists to conclude the vaccine is safe, not data tracking millions of doses.
In some cases, the authors have more basis to suggest conflicts of interest, but even there, their next assumption that alone justifies dismissing data is problematic. For example, in chapter 15 the authors describe one review of HPV vaccine safety studies, which examined “903 articles in medical databases and selected 58 studies for analysis.” The article concluded the vaccines are effective and rejected safety concerns. In criticism, the authors of the book say:
This study had fourteen coauthors, of whom nine were employed full-time by Merck or Sanofi Pasteur, Merck’s former partner in Europe. The article points out that all the other authors have been Merck investigators… Because of those authors’ overt conflicts of interest, one cannot accept their conclusions uncritically.
That sentence is the extent of the authors’ criticism of the review. They point to no flaws in article selection. They suggest no issues in methodology. They simply assert that conflicts of interests invalidate the results of the meta analysis and stop there. That does not negate the 58 studies chosen, though, and does not even show the authors’ conclusions wrong.
The authors’ short dismissal of the review is especially jarring when compared to their treatment of articles that support their preferred conclusion. In the section following their dismissal of the review above, they provide what they consider the “best overview of safety concerns.” It is a book chapter by anti-vaccine scientists, Christopher Shaw and Lucija Tomljenovic. Shaw and Tomljenovic, as the authors must know, have received consistent funding for their work from the anti-vaccine Dwoskin Foundation and the anti-vaccine organization CSMRI. But the authors do not consider that funding source to be relevant. Further, the “best overview” is a book chapter in a book edited by, among others, Tomljenovic. In other words, this not an article we can assume had to go through regular peer review by external, objective reviewers. Worse,it is an analysis of VAERS reports, reports to a passive reporting system that does not show causation. An analysis of the number of reports alone, without investigation – and Shaw and Tomljenovic do not have access to investigate, to my knowledge – is a misuse of the system.
If COIs are enough to dismiss a review when the authors are unable to point to any flaws, it is unclear why they are not enough to dismiss an article where the quality control is suspect and the methodology problematic on its face.
In sum, HPV Vaccine on Trial uses unsupported, often suspect anecdotes, poisoning the well, and ill-founded claims to try to build a case against this vaccine protecting millions from cervical cancer. Their efforts do not effectively counter data from large studies and the views of expert organizations all around the world that HPV vaccines are safe and effective. If the authors have put the HPV vaccine on trial, the clear verdict must be “not guilty.”
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