Questioning Offit. Part 10. HPV

Previous parts:
Part 1: Introduction
Part 2: DTP
Part 3: Encephalopathy
Part 4: Dravet syndrome
Part 5. SIDS
Part 6. West syndrome
Part 7. Hib
Part 8. Hepatitis B
Part 9. Pneumococcus and rotavirus

Ignorance more frequently begets confidence than does knowledge.
Charles Darwin

Chapter 5 (ending)

Human Papillomavirus (HPV)

Having dealt with rotavirus, Offit moves on to the HPV vaccine:

Another vaccine licensed on Fisher’s watch, and one that incurred her greatest wrath, prevented human papillomavirus (HPV), a known cause of cancer of the cervix. Cervical cancer isn’t rare, causing ten thousand American women to suffer and four thousand to die every year. The bad news is that about thirty different strains of HPV cause cancer. The good news is that two of the strains contained in the vaccine prevent 70 percent of cases. And HPV isn’t one of many viruses that cause cervical cancer; it’s the only virus that causes it. So, the HPV vaccine was a lifesaving breakthrough.

Regarding the claim that HPV is the sole cause of cervical cancer, Offit is being disingenuous, to say the least. While HPV types 16 and 18 are believed to play a major role in the development of cervical cancer, HPV infection is neither a necessary nor a sufficient cause of the disease.


Offit is correct that around 4,000 American women die from cervical cancer each year—that's about 1 in 500. But on average, they die at age 59. Cervical cancer takes decades to develop. Therefore, to truly prove that the HPV vaccine prevents cervical cancer, a clinical trial would need to run for several decades. Naturally, pharmaceutical companies aren’t willing to wait that long, so instead of actual cancer outcomes, vaccine trials use surrogate markers—namely, CIN 1-3 dysplasias, which appear more quickly. But because the vast majority of these dysplasias resolve on their own, they are poor proxies for cervical cancer.

A 2020 analysis of HPV vaccine clinical trials concluded that these studies were based solely on dysplasia outcomes—primarily CIN 1 lesions, which spontaneously regress in 99% of cases—and therefore cannot provide meaningful evidence about the vaccine’s effectiveness against cervical cancer.

Cervical cancer incidence in the U.S., which had been steadily declining until the mid-2000s, has since plateaued—coinciding with the time HPV vaccines were added to the immunization schedule. The same trend has been observed in the the UK, Australia and Sweden.

USA:

UK:

Australia:

Offit:

Although HPV vaccine was new, the strategy used to make it wasn’t. It was made with the same technology used to make the hepatitis B vaccine twenty years earlier. By 2006—when the CDC recommended it for teenage and adult women—HPV vaccine had been tested for seven years in more than thirty thousand women. Other than pain and tenderness at the site of injection, and occasional episodes of fainting, the vaccine didn’t appear to have any serious side effects.

Offit conveniently fails to cite any clinical trial to back up this claim. Instead, he merely refers to his own book. In the HPV vaccine clinical trials, aluminum was used as used as the placebo. As we’ve already seen when analyzing the pneumococcal vaccine trial, if the control group receives a substance that is just as harmful—or in some cases even more harmful—than the vaccine itself, then using that study to conclude the vaccine is safe amounts to scientific fraud, to put it mildly.

Incidentally, the trial participants were not informed that the placebo contained aluminum. They were told the control group was receiving a saline solution. Moreover, it wasn’t even the standard aluminum hydroxide typically used in vaccines. Gardasil contains a different adjuvant called Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS). This adjuvant was never tested for safety. The FDA and EMA (European Medicines Agency) simply assume that all forms of aluminum are safe and do not require safety testing for any aluminum-based adjuvants.

So when Offit writes that “the vaccine didn’t appear to have any serious side effects,” this is, of course, untrue. The truth is that the vaccine caused just as many serious side effects as the aluminum compound used as the placebo. (More on the risks of aluminum in vaccines can be found here.)

Peter Gøtzsche, founder of the Nordic Cochrane Centre, analyzed 112,000 pages of documents provided by Merck and wrote a 350-page report concluding that Merck manipulated the data to such an extent that it’s nearly impossible to accurately assess the vaccine’s harms.

The Gardasil trials recruited healthy girls and young women between the ages of 9 and 26. Over the course of the three-year trial, 75% of participants developed some new medical condition, and 2.3% developed an autoimmune disorder (see page 137).
Given all this, can we really claim that the vaccine is safe?

Offit:

[CDC] examined reports of paralysis and found “there has been no indication that [HPV vaccine] increases the rate of Guillain-Barré Syndrome [GBS, a rare cause of paralysis] in girls and women above the rate expected in the general population.” They also examined the medical records of twenty-seven people who had died soon after getting the vaccine, finding nothing to suggest that the vaccine had been the cause.

How exactly did the study Offit cites prove there is no link between the vaccine and Guillain–Barré syndrome? It simply refers to a CDC report, which, after analyzing 42 reported cases of Guillain–Barré syndrome in the VAERS system, concluded that there was "a temporal association only, without evidence to support a causal relationship to vaccination". Since VAERS is a passive reporting system, it is, by definition, incapable of proving causality. Its purpose is only to identify temporal patterns that should then be investigated further to determine whether a causal link exists.

According to a Canadian study, 10% of the 195,000 girls who received the HPV vaccine visited an emergency department within 42 days of vaccination. Is that a lot or a little? Let’s calculate.

According to the study, 25% of adolescents visit the emergency room in a given year. That translates to about 2.9% over a 42-day period (25 × 42 / 365). A threefold increase in ER visits did not raise any red flags, and the vaccine was deemed safe.

A study conducted by the CDC and FDA in 2009 found that the reported rate of adverse events from the Gardasil vaccine was three times higher than the rate for all other vaccines combined. Among girls aged 6 to 29, 65% of all serious vaccine-related adverse events were attributed to the HPV vaccine.

Many previously healthy girls began experiencing orthostatic hypotension almost immediately after vaccination. They suffer from cognitive impairments, fainting, pain, insomnia, and general dysfunction, forcing them to quit school or work. [1] [2]

According to clinical trial data, the vaccine shows negative efficacy in individuals already infected with HPV—it actually increases the risk of cervical dysplasia. [1]

For a vaccine administered at age nine, whose potential benefits may not manifest for several decades, to be justified, it must be exceptionally safe. If a vaccine saves a life at age 59 but causes disability at age 9, no one will want it. A rational person would rather live 50 healthy years than 70 as a disabled individual.
Can we really conclude, based on these data, that the vaccine is safe?

Offit:

By 2009, more than thirty million doses of HPV vaccine had been given without serious consequences. Women who choose to believe Barbara Loe Fisher’s warnings and refuse the HPV vaccine are at increased risk of cervical cancer: an event that occurs twenty to twenty-five years after this very common infection.

And here’s what happens to women who choose to trust Paul Offit. They experience strain replacement. After mass vaccination began, it turned out that some HPV strains previously classified as low-risk for cancer were in fact high-risk oncogenic strains [1] [2] [3].

A large study conducted by the CDC found that while vaccination reduces the prevalence of the specific strains targeted by the vaccine, there is no overall change in HPV prevalence when all strains are taken into account. These findings have been confirmed in other studies as well [1] [2] [3].
Therefore, based on the existing body of research, it cannot be claimed that HPV vaccination is effective—at least not if we consider all HPV strains—despite its efficacy against certain individual types.

A more detailed post about the HPV vaccine.


Medical Paternalism

Offit:

Perhaps Barbara Loe Fisher’s most enduring legacy can be found in the comments of Samuel Berkovic, the Melbourne neurologist who had found the real cause of seizures and mental retardation in children claimed to have been damaged by pertussis vaccine. Berkovic remembered the reaction of parents after his discovery: “Most of them were incredibly grateful because they had carried the guilt. They had taken the child to the doctor or maternal/child-health nurse and handed the kid over, and the infant got the vaccine. It was their fault. [They thought] ‘if only I’d listened to the lady down the street who said “Don’t give your kid a vaccine,” I’d have a healthy child.’ And when we tell them that that’s not right, that sadly your child had this change in the sodium channel that happened at conception and there was nothing you could do about it—that your child was destined to get this—there was an enormous sense of relief. For most, it’s relieved decades of guilt.” By telling parents that diabetes, multiple sclerosis, asthma, allergies, seizures, mental retardation, paralysis, and autism are all caused by vaccines, Barbara Loe Fisher—whether intentionally or not—puts the burden of their children’s illnesses squarely on the shoulders of those parents. If only they hadn’t gotten their children vaccinated, none of these horrors would have happened. But now it’s too late; the only thing left is to be angry—angry at a government lost in bureaucracy, pharmaceutical companies in it for the money, and doctors who don’t care. By claiming that vaccines cause chronic diseases, Fisher contributes to this cycle of guilt, anger, and blame.

On one hand, Samuel Berkovic is absolutely right in pointing out that when parents realize their decision to vaccinate may have led to their child becoming disabled, it often results in overwhelming guilt. For many parents, it’s easier to live with the belief that the child was born that way—that it was fate, bad luck, or simply out of their hands. Shifting responsibility onto God, chance, genetics, or physicians can offer psychological relief by lifting the burden of guilt.

But on the other hand, offloading responsibility also drastically narrows the space for seeking solutions. Parents may feel emotionally relieved after shifting the blame—but accepting responsibility often drives action. If a parent understands that a vaccine may have triggered their child’s epilepsy, and feels accountable for that decision, they’re far more likely to actively look for ways to help the child. There are many cases where parents, realizing the medical system would not help them, took responsibility into their own hands—and succeeded in helping their child recover from autism or epilepsy.

So the question of whether to accept or offload responsibility is really a question of priorities: what matters more to the parent—psychological comfort, or a healthy child? Psychological comfort is always short-lived, because caring for a chronically ill child is inherently distressing. True comfort only comes from achieving real improvements in the child’s condition.

Paradoxically, the pursuit of psychological comfort never actually brings it. True comfort comes only through taking responsibility. And often, taking responsibility also leads to partial or even full recovery of the child.

Modern medicine still largely follows a paternalistic approach to parenting. Physicians and health authorities claim to know what’s best for children better than their parents do. Some parents welcome this approach, while others strongly reject it. Barbara Loe Fisher and others tell parents that they can take responsibility themselves—and give them the tools to do so. Naturally, this approach is deeply unpopular among physicians and health agencies.

Absolute medical paternalism has dominated the profession since the time of Hippocrates. In 1847, the Code of Ethics of the American Medical Association declared:

The obedience of a patient to the prescriptions of his physician should be prompt and implicit. He should never permit his own crude opinions as to their fitness, to influence his attention to them. A failure in one particular may render an otherwise judicious treatment dangerous, and even fatal.

An 1888 physician's manual "encouraged physicians to withhold information to prevent patients from becoming medically self-sufficient." Physicians were encouraged to obfuscate test methods, medication names, and treatments, as well as withhold the abusive and addictive potential of medicines used at the time.

In the 1950s, a Journal of the American Medical Association article debated whether cancer patients and their families should even be informed of a cancer diagnosis, in an effort to minimize potential stress. Instead, patients or their families might be told the issue was an infection or a bowel obstruction requiring surgery. If, after being informed, the patient experienced high levels of stress, it was recommended that they be treated “like a child,” which could potentially warrant a prefrontal lobotomy: "In addition to relieving intractable pain, prefrontal lobotomy usually results in the loss of this preoccupation with self and future, which leads some chronically ill patients to suffer out of all proportion to their illness." As recently as 1961, 90% of American physicians did not disclose cancer diagnoses to their patients. This approach began to shift only in the latter half of the 20th century. In 1972, the American Hospital Association published the Patient Bill of Rights, which established a patient’s fundamental right to be informed. Paternalism was gradually replaced by the principle of collaborative care, in which the patient is informed at every stage of treatment and gives consent before any procedure is performed. By the late 20th and early 21st century, paternalism was increasingly rare, and informed consent had become the norm.

In recent years, however, the paternalistic approach has started to return. For example, in 2016, the U.S. passed a "21st Century Cures Act" allowing researchers to waive the requirement for informed consent if a clinical trial poses “no more than minimal risk.” In 2020, with the onset of the pandemic, paternalism once again became nearly absolute—patients hospitalized with COVID-19 often had no say in their treatment, and family members were barred from visiting and unable to influence doctors’ decisions.

Today, more and more countries are passing mandatory vaccination laws. Yet, unlike in other areas of medicine, preventive medicine has never truly abandoned the paternalistic model. Public health agencies always repeated the same mantra: all vaccines are safe and effective.

Back in 1938, Charles Cyril Okell, a leading expert in infectious diseases, wrote: "Those who have had to take detailed notice of the immunisation accidents of the past few years know that to get the truth of what really went wrong generally calls for the resources of something like a secret service".

Half a century later, in 1984—when paternalism in other areas of medicine was already fading—the FDA wrote in its official bulletin: "any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation’s public health objectives." This statement referred to the oral polio vaccine. Sixteen years later, the vaccine was discontinued in the United States—because it was found to occasionally cause paralysis.

***

Offit then goes on to recount in detail the story of John Salamone. In 1990, following an oral polio vaccine, his four-month-old son became completely paralyzed from the waist down, and his right leg atrophied. He was initially diagnosed with “neuropathy of unknown etiology.” At age three, he was finally diagnosed with a congenital immune deficiency. Only then did doctors realize he had vaccine-derived poliomyelitis. John Salamone became a vaccine safety advocate and founded the organization “Informed Parents Against Vaccine-Associated Paralytic Polio.”

“At first you feel guilt,” recalled Salamone. “Because you say to yourself, ‘we brought our child to the doctor and gave him polio.’ Then we got mad, upset, when we found out that there were other options of polio vaccine out there. So we said to ourselves, ‘Why wouldn’t they be giving that to everyone? Why would you even take a chance?’ Then we found out that there were a number of kids every year who were getting polio from the vaccine and I started to identify them little by little and communicate with those families.

Offit compares Barbara Loe Fisher and John Salamone:

In many ways, John Salamone and Barbara Loe Fisher are similar. Both are passionate advocates, both are superb writers and powerful speakers, both have had ready access to the media, and both have had the opportunity to make their case in front of congressional committees. But whereas Salamone’s concerns have been supported by science, Fisher’s haven’t.

The fact that Salamone’s concerns had a solid scientific basis was only acknowledged ten years after he first began voicing them. Offit criticizes Fisher primarily because her agenda is broader than Salamone’s. That’s why Salamone is a hero to him, and Fisher is not. Offit faults Fisher for not “trusting doctors,” unlike Salamone. Yet it was precisely Salamone’s blind trust in doctors, and the doctors’ blind trust in scientists with conflicts of interest, that led to his son’s suffering. Because of that trust, John Salamone’s son lived his entire life disabled and died at the age of 28.

The only real difference between Barbara Loe Fisher and John Salamone is that in Salamone’s case, one vaccine was simply replaced with another—not necessarily a safer one. The oral polio vaccine causes side effects immediately, and those effects are nearly impossible to attribute to anything else. The inactivated vaccine, on the other hand, contains aluminum, and its adverse effects may appear months or even years later—by which time no one connects them to the shot.

The clinical trial for the safety of the inactivated polio vaccine IPOL—the vaccine that replaced the oral one—lasted only 48 hours. Moreover, it was administered together with the DTP vaccine, and there was no control group.

Barbara Loe Fisher calls for more rigorous safety research for vaccines. She and many others argue that a clinical trial lasting 48 hours and lacking a control group cannot possibly be used to prove a vaccine is safe.

David Salamone’s story is also telling in how irrelevant scientific studies can be when it comes to actual decisions about introducing or removing vaccines from the schedule. Walter Orenstein, who directed the U.S. immunization program at the CDC from 1988 to 2004, recalled in a 2018 interview: "When eight to 10 children a year contracted polio, and millions of others were protected, “my feeling was it was a small price to pay". Then he heard David’s story: "Suddenly, the eight to 10 people were not just tiny numbers but were real people,” Orenstein said. “Just seeing how these people’s lives were ruined made a big difference. I went overnight from being an OPV hawk to being an IPV hawk.”

By the way, although the live oral polio vaccine is no longer used in the U.S. and Europe, it continues to be used in most other countries.

At the end of the chapter, Offit writes:

In contrast, Barbara Loe Fisher, rather than appreciating the researchers who spent millions of dollars on studies to answer her questions, had disdain for them. She believed that studies that failed to support her beliefs were useless—or, worse, fabricated. “Those determined to deny an association between vaccine-induced inflammatory conditions in the body usually like to use retrospective, case-controlled ‘studies’ that look at old medical records,” she blogged. “Using pencils and calculators to dismiss causal associations between vaccines and chronic diseases is easier than having to look at real live patients....

At this point, it can no longer be said that Barbara Loe Fisher is wrong. In defense of vaccine safety, Offit relies almost exclusively on case-control studies—a study design that, by definition, cannot prove the safety of anything.
Ironically, through his own book, Offit ends up validating her point.

*****

Chapter Four contains 72 footnotes, which include 10 footnotes with studies:

The studies cited tell us that:

Vaccines are unsafe (5 footnotes).
Studies unrelated to vaccination (2 footnotes)
Studies already discussed in the previous chapter (1 footnote)
10 studies are presented as evidence of vaccine effectiveness or safety and were discussed in this and previous entries.