Questioning Offit. Part 8. Hepatitis B

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

If the American people knew some of the things that went on at the FDA, they’d never take anything but aspirin.
— Len Lutwalk, FDA scientist

Chapter 5 (continued)

Hepatitis B

After the Hib vaccine, Offit writes, Barbara Loe Fisher shifted her focus to opposing the hepatitis B vaccine. "Although most parents had probably never heard of Hib, they had all heard of and feared meningitis. So the Hib vaccine was an easy sell. But while most parents know what hepatitis is, they had never considered it a disease of children."

The hepatitis B vaccine was licensed in 1981. Initially, health authorities decided that the best way to eradicate the disease was to recommend the vaccine only to high-risk groups, such as healthcare workers, intravenous drug users, prisoners, and men who have sex with men. Unfortunately, these groups were reluctant to get vaccinated. "So, government officials embarked on the second stage of their plan, recommending three doses of the hepatitis B vaccine for all babies, the first to be given soon after birth. The new hepatitis B vaccine policy was a public relations nightmare", - writes Offit.

Barbara Loe Fisher added fuel to the fire and found another physician ally, Bonnie Dunbar, who claimed that the hepatitis B vaccine could lead to multiple sclerosis. In 1999, a popular TV show claimed that the vaccine could cause death and that infants didn't need it since they couldn't contract hepatitis B

Offit details a 1999 TV segment on ABC's "20/20" that caused a public outcry and deeply scared the American public. The report featured a woman who went blind three weeks after vaccination and several healthcare workers who were diagnosed with multiple sclerosis shortly after getting the shot.

One alarming case after another was presented:

"Three-day-old Ben Converse’s seizures began less than twenty-four hours after his first shot. Now Ben is developmentally disabled. Thirty-three hours after his vaccination, thirteenday-old Nicky Sexton’s heart stopped. The coroner said it was Sudden Infant Death Syndrome, or SIDS. Lyla Belkin’s death was also attributed to SIDS. She had received her first shot at six days old: the second one, a month later...On September 16, 1998, Mrs. Belkin nursed Lyla at 5:30 a.m., not long after, she found her pale and cold... She died early in the morning about sixteen hours after vaccination."

But Offit argues that the main flaw of the program wasn't the number of tragic stories but the claim that infants were not at risk of contracting hepatitis B.
Offit:

Although it is true that most disease and death caused by hepatitis B virus occur in adults, every year before the hepatitis B vaccine about sixteen thousand children less than ten years of age were infected by nonsexual, person-to-person contact. (Hepatitis B virus can spread fairly casually, such as by sharing toothbrushes.)

First, is it true that 16,000 children under ten were infected with hepatitis B annually in the U.S.? No one really knows. The article Offit references isn't a study but a statistical model based on assumptions that have little to do with reality. According to official CDC data, before the widespread vaccination of infants, only one in a million children under 15 contracted acute hepatitis B.

Even if these model estimates were accurate, Offit fails to mention the key point. Almost all these children were infected at birth by their mothers. If hepatitis B vaccination makes sense, it's primarily for infants born to hepatitis B-infected mothers. However, these mothers are identified in advance since all pregnant women in the U.S. are screened for hepatitis B. If the infection is detected, newborns receive not only the vaccine but also immunoglobulin, as the vaccine alone isn't very effective.

Hepatitis B is transmitted through blood or sexual contact. The chance of children contracting it through everyday contact is extremely low and mostly theoretical. The studies that claim a household risk of infection were conducted in impoverished countries where families share a single toothbrush and razor.

Offit:

Worst of all, infants infected with hepatitis B virus are at the highest risk of long-term problems; many develop cirrhosis or liver cancer later in life. Although childhood infections accounted for fewer than 10 percent of all infections in the United States, they accounted for 20 percent of all cases of chronic liver disease. This is the reason public health officials had recommended the vaccine for newborns.

Offit doesn't provide any references to support his final statement because he's simply not being truthful. Health authorities recommended infant hepatitis B vaccination solely because adults refused to get vaccinated. In 1991, they wrote:

"A vaccine for hepatitis B was licensed a decade ago, but it has found little use, even among health workers, drug users, the sexually promiscuous and others at high risk of developing the disease. Since most Americans who get hepatitis B are infected as teen-agers or adults, the benefits of a hepatitis vaccine program will not be apparent for about 20 years. "This approach to immunize children to prevent a serious chronic adult disease has never been tried before," said Dr. Harold Margolis, the chief of the hepatitis branch at the Federal Centers for Disease Control... He said officials hoped that the three shots would give lifetime immunity against hepatitis B, but that there was no way to be sure because the vaccine had only been around for 10 years."

No one at the CDC planned to protect children from hepatitis B. It was well known that if children contracted the virus, it was almost exclusively during birth from infected mothers. Even breast milk doesn't transmit hepatitis B. [1] Most family doctors and pediatricians opposed the recommendation to vaccinate infants against hepatitis B. [1]

Offit then discusses Michael Belkin, the father of Lila Belkin, who died 16 hours after receiving the hepatitis B vaccine. At a meeting of a federal vaccine advisory group at the CDC, Belkin stated, “I hold each one of you who participated in the promulgation or perpetuation of that mandated newborn vaccination policy personally responsible for the death of my daughter". Later, speaking before a Congressional committee, Belkin said, "Almost every newborn U.S. baby is now greeted on its entry into the world by a vaccine injection against a sexually transmitted disease for which the baby is not at risk—because they [health officials] couldn’t get the junkies, prostitutes, homosexuals, and promiscuous heterosexuals to take the vaccine. Parents need to understand that the system providing the vaccines injected into their children’s veins is corrupt and scientifically flawed".

Offit, of course, disagrees with this perspective. He writes that numerous studies have found no link between the hepatitis B vaccine and sudden infant death syndrome. Therefore, he argues, the vaccine is unrelated to Lila Belkin's death, which occurred 16 hours after vaccination. To support his position, Offit cites three scientific studies.

The first article is a 1995 New Zealand case-control study. It was published in response to media reports of newborns suddenly dying after vaccination and pressure from anti-vaccine groups claiming that New Zealand's infant mortality rate was too high compared to other countries. They linked this to the fact that New Zealand vaccinated infants with the DTP vaccine at an earlier age than other countries and, unlike other countries, vaccinated against hepatitis B.

The study found that vaccination not only didn't increase but actually halved the risk of sudden death. The authors explained this by suggesting that vaccinated infants become more irritable, restless, and sleep poorly, which might reduce the risk of sudden death. We've already discussed that such studies don't account for the "healthy vaccinee effect," meaning that premature infants or those with congenital or genetic conditions are less likely to be vaccinated. We will examine this in more detail below.

The second study is an analysis of infant death reports registered in the VAERS system. The authors found 18 deaths following hepatitis B vaccination over eight years and concluded that while no causal conclusions could be drawn, 18 deaths seemed relatively few, suggesting the vaccine wasn't to blame. The fact that less than 1% of all adverse effects are reported to VAERS wasn't considered by the authors.

The third study, published in 2004, is a large population-based study using a closed database, with a significantly better design than other studies on this topic. Therefore, we'll examine it in detail.

The authors analyzed 1,363 cases of neonatal death. Of these, 72 infants had been vaccinated against hepatitis B, and among these 72 cases, 22 deaths were classified as "unexpected." Thus, 31% of vaccinated deceased infants died unexpectedly.

The authors then attempted to compare this percentage with the percentage of unvaccinated infants who died unexpectedly. However, the vast majority of unvaccinated infants were born prematurely. The authors understood that mortality among premature infants couldn't be compared to that of full-term infants. So they excluded all those born before 24 weeks or weighing less than 600 grams. After this, 196 unvaccinated infants remained, of whom 68 (or 35%) died unexpectedly.

Based on this, the authors concluded that the rate of sudden death was nearly the same between groups, meaning the hepatitis B vaccine wasn't linked to neonatal mortality.

Now let's compare the two groups.

In the vaccinated group, the median birth weight was 3,100 g, while in the unvaccinated group, it was 1,358 g.

In the vaccinated group, the median gestational age (i.e., the week of birth) was 39 weeks, while in the unvaccinated group, it was 28 weeks.

In the vaccinated group, the median Apgar score was 8, while in the unvaccinated group, it was 5.

There were also statistically more pregnancy and childbirth complications among mothers in the unvaccinated group.

The authors honestly report all this information, but it doesn't stop them from comparing mortality in these two very different groups and concluding that since unexpected death rates don't differ much, hepatitis B vaccination doesn't affect neonatal mortality.

So, in essence, this study assumed that premature infants weighing 1.3 kg, born at 28 weeks, have the same likelihood of dying as full-term infants weighing 3 kg, born at 39 weeks.

On one hand, I'm not sure if this can be called scientific fraud. After all, the CDC authors honestly report all the information. But they only write it in the text. In the abstract, they don't mention that the groups being compared are completely different. And hardly anyone reads the full texts of studies. This article has been cited 50 times in other studies and is regularly used as evidence of the safety of hepatitis B vaccination in newborns.

This study should be retracted. It's not science. It's at least an attempt to mislead. But it won't be retracted, because that would mean retracting about 80% of vaccine-related studies. The entire safety of vaccination is proven by studies like these.

The fact that Offit cites such a study as the main evidence of no link between the vaccine and infant mortality speaks volumes about the lack of proper studies proving the safety of hepatitis B vaccination. This is the best study modern science can offer to prove the safety of vaccinating newborns against hepatitis B.

One of the authors of this study is Frank DeStefano, director of the Vaccine Safety Office at the CDC. DeStefano is listed as an author or co-author of over 200 studies.

When a study emerges that hints at possible harm from vaccination — and it suddenly makes its way into the press (for example, whether the Hib vaccine causes diabetes, or whether there’s a link between mercury in vaccines and autism) — the CDC calls in its agent, Frank DeStefano, and tells him: do whatever you have to, DeStefano, but prove that vaccines are safe. And DeStefano doesn’t disappoint. He conducts a new study (usually a case-control study), and time after time proves that vaccines are safe. That the panic was unfounded. That everyone can sleep soundly. You can count on Frank DeStefano to always prove what needs to be proven. And if proving a vaccine’s safety requires assuming that a baby born at 28 weeks weighing 1.3 kg has exactly the same risk of death as a full-term newborn weighing 3 kg — well, Frank DeStefano won’t blink. If it must be done, it will be done. But vaccines will be safe."

Frank DeStefano’s name on a study’s author list is always a signal that you should start looking for where the problem is buried. Sometimes it lies right on the surface, like in this study. Sometimes you have to dig deeper. But it’s always there. We will meet Frank DeStefano again in the next parts.

Back to the book:

Sylvia Chase’s 20/20 segment also trumpeted the notion that hepatitis B vaccine caused multiple sclerosis—an accusation that didn’t hold up. Two years after the program, investigators published two large studies that assessed whether the vaccine caused multiple sclerosis (it didn’t) or worsened symptoms in people who already had the disease (again, it didn’t).

The first article Offit cites is his own, in which he discusses the proposed biological mechanisms that could link vaccination to autoimmune diseases. In the context of multiple sclerosis, he writes:

Both hepatitis B and influenza vaccines have been proposed to cause or exacerbate multiple sclerosis by the process of molecular mimicry. The concept that molecular mimicry might cause autoimmune disease in the central nervous system was first tested in 1985.
Rabbits were inoculated with a peptide contained within the hepatitis B virus polymerase protein that was identical to a region of rabbit MBP (myelin basic protein). Peptide was administered in a potent adjuvant consisting of a mixture of mineral oil and killed mycobacterial bacilli. Four of 11 rabbits inoculated with this shared peptide developed experimental autoimmune encephalomyelitis.
This finding launched the notion that immunization with hepatitis B vaccine might cause multiple sclerosis. The hypothesis was further fueled by anecdotal reports of multiple sclerosis after hepatitis B immunization and 2 case-control studies showing a small increase in the incidence of multiple sclerosis in vaccinated individuals that was not statistically significant.
As a consequence of these reports, the French government temporarily suspended their school-based program of hepatitis B vaccination.
However, the hypothesis that hepatitis B vaccine causes multiple sclerosis is flawed for several reasons. First, the only protein contained in the hepatitis B vaccine, hepatitis B surface antigen (HBsAg), is not similar to human MBP... Second, natural infection with hepatitis B virus is associated with production of large quantities of HBsAg, but is not associated with an increased risk of developing multiple sclerosis.

While mentioning the use of a "potent adjuvant" in the rabbit study, Offit does not say a word about aluminum hydroxide—a potent adjuvant that is actually present in hepatitis B vaccines. Aluminum is considered by many scientists to be the most likely factor contributing to the development of autoimmune diseases. Moreover, aluminum is commonly used to create models of autoimmune disorders in laboratory animal studies.

For example, in a 2005 study, the simplest way to induce asthma in mice was through two injections of aluminum hydroxide administered along with ovalbumin—a protein found in egg whites. In another study, published in 2014, injections of aluminum and ovalbumin were used to induce allergic rhinitis in mice. And in a 2015 study, aluminum hydroxide and ovalbumin were used to provoke food allergies in mice. Aluminum hydroxide has also been used to induce allergies in dogs and sheep.

The other two studies Offit cites are case-control studies that found no association between hepatitis B vaccination and multiple sclerosis.

The first of these studies was heavily criticized in the medical literature. Some researchers took issue with the fact that the authors excluded 68% of multiple sclerosis cases, which caused the observed twofold increase in risk to lose statistical significance. Others criticized the study for excluding all women whose MS symptoms began before 1986. They argued that had these women been included, the study would have shown a doubled risk of developing the disease after vaccination. They also claimed that if the study had not restricted the time window between vaccination and disease onset, it would have revealed a twelvefold increased risk of MS following hepatitis B vaccination.

The second study falls into that peculiar category of self-controlled designs we discussed earlier. In this design, patients serve as both their own cases and their own "controls." The authors assumed that if there were a link between multiple sclerosis and vaccination, the disease could only begin within three months of receiving the vaccine. Therefore, if someone was vaccinated and developed MS four months later, they were essentially counted as evidence against a connection between vaccination and MS.

When Offit writes about “case-control studies showing a small increase in the incidence of multiple sclerosis in vaccinated individuals that was not statistically significant" and "French government temporarily suspended their school-based program of hepatitis B vaccination", he omits the existence of studies that did find a statistically significant increased risk of multiple sclerosis following vaccination.

For example, a 2004 Harvard study found a threefold increased risk of multiple sclerosis associated with the hepatitis B vaccine. A 2009 French study showed that the Engerix-B vaccine was associated with a 2.8 times higher risk of multiple sclerosis compared to other hepatitis B vaccines. Another French study from 2014 found that the number of MS cases increased by 65% following the start of mass hepatitis B vaccination. It also revealed a very strong correlation between the number of vaccine doses administered and the number of MS cases one and two years after vaccination (with correlation coefficients of 0.93 and 0.73, respectively).

An analysis of the VAERS database showed that cases of multiple sclerosis were reported five times more frequently in adults vaccinated against hepatitis B compared to those who received the tetanus vaccine.

A 2005 British study found that 60% of people developed a cross-reactive immune response to myelin proteins after receiving the hepatitis B vaccine. This response weakened over time, which could explain a potential mechanism for the development of MS after vaccination.

A 2011 report by the Institute of Medicine concluded that there was insufficient evidence to either confirm or rule out a causal relationship between the hepatitis B vaccine and multiple sclerosis.

When Offit chooses to present only the studies that support his point of view while ignoring those that contradict it, he commits a logical fallacy known as selective reporting—or “cherry-picking.”

Effectiveness

Having concluded his "proof" of the vaccine's safety using such one-sided studies, Offit moves on to discussing the effectiveness of hepatitis B vaccination:

At the time of the 20/20 broadcast, the hepatitis B vaccine had been given to fifty million infants and children and seventy million teenagers and adults in the United States. Since 1991, when it was first recommended for all infants, the vaccine has virtually eliminated the disease in children. Barbara Loe Fisher used her considerable platform in the 1990s to warn American parents that the hepatitis B vaccine was unnecessary, that it caused SIDS, and that it caused multiple sclerosis—positions that could have misled parents into avoiding a vaccine that has prevented a great deal of suffering and death.

The incidence of hepatitis B began to decline in 1988—three years before the start of mass infant vaccination—and continued to decline in the years that followed. To assess whether vaccination played a role in this trend, we can compare the incidence patterns of hepatitis B and hepatitis C. Hepatitis C is transmitted in much the same way as hepatitis B.

As the graph shows, the rise and subsequent fall in the incidence of both diseases occurred almost in parallel. However, while the decline in hepatitis B cases is commonly attributed to vaccination, in the case of hepatitis C, the CDC notes that “The reasons for this decrease were unknown but probably reflected changes in behavior and practices among injection-drug users.”

Clinical Trials

Interestingly, Offit never mentions the clinical trials of hepatitis B vaccines for infants—despite the fact that such trials could serve as the ultimate proof of safety. Surely, one would assume, clinical trials were conducted to establish that the vaccine is safe for newborns?

The safety trial for the Recombivax HB vaccine included 147 infants and children, and monitored them for only 5 days after each dose. There was no control group.

The clinical trial for the Engerix-B vaccine lasted just 4 days after each dose. It also had no control group.

Nevertheless, this limited data was deemed sufficient to recommend hepatitis B vaccination for newborns worldwide—including on the very first day of life. Perhaps that’s precisely why Offit chose not to draw attention to these trials. Even he must have found it uncomfortable to cite studies that were so clearly inadequate.

*****

A more detailed post about the studies on the hepatitis B vaccine: https://www.scibook.org/content/vaccines/hepatitisB

In the next part, we'll talk about the pneumococcal and rotavirus vaccines.