Saturday, March 30, 2019

Rockland County measles overreach: trial balloon? My online letter in the BMJ today

Why Americans Don't Trust Vaccine Makers: My Op-Ed in the Bangor Daily News, 3/28/19

Why Americans don’t trust vaccine makers

George Danby | BDN
Trust in the pharmaceutical business hit a low in 2018. Only 38 percent of those Americans polled by the Edelman Trust Barometer said they trusted the industry. Some of the reasons for this are likely high prices, false advertising, and concealing of side effects that harm and kill consumers, as happened with Vioxx, an anti-inflammatory medication. A Lancet study estimates that Vioxx caused 38,000 deaths from heart attacks.
Five and a half years after it was licensed, Merck was forced to withdraw Vioxx. A total of 80 million patients had taken it, and annual sales had topped $2.5 billion.
Merck agreed to pay $4.85 billion to settle 27,000 injury claims. A University of Michigan professor commented that this was the cost of doing business.
Merck moved on. It had already found a less risky business model to expand into: no-fault vaccines. Since 1988, there has been no industry liability for injuries related to vaccines approved by the Centers for Disease Control and Prevention for the childhood schedule.
Instead, a 75 cent tax for each individual vaccine sold is placed in a fund, administered by the Department of Health and Human Services, to compensate Americans for vaccine injuries. In 30 years, this fund has paid out about $4 billion to claimants who proved their injury was caused by a vaccine.
Merck makes all measles, mumps, rubella, chickenpox and human papilloma virus (HPV) vaccines marketed in the United States. Sales of these vaccines brought in $4 billion in 2017. Merck makes 11 of 17 vaccines recommended by the CDC, with additional vaccines in development.
Paradoxically, most Americans trust vaccines, yet most do not trust the pharmaceutical industry. Merck is the world’s second largest vaccine company. Merck spent five years trying to cover up the lethal side effects of Vioxx. Then it paid its fines. None of its executives went to prison.
While we expect vaccines to be thoroughly tested and as safe as possible, it should be understood that vaccines are just another product in a cutthroat industry. Their manufacturers are rushing to get their products to market before the competition.
The latest example of how this behavior hurts consumers occurred in the Philippines. Sanofi’s Dengvaxia was the first dengue virus vaccine out of the gate, and the Philippines was the first country to use it. Dengvaxia was purchased by the Philippines government before it was even licensed, and rushed into use in 2016 before testing had been completed. Although the World Health Organization had warned of the potential for vaccinated children to develop a deadly form of dengue, the vaccine was given to 800,000 children.
The program rapidly unraveled. Vaccinated children had higher than expected rates of death from dengue. The deaths of 10 children have been blamed on the vaccine, and 119 others are being investigated. This month, the Philippines Department of Justice recommended criminal charges against six Sanofi officials and 14 health department officials for improprieties in the vaccine program.
The European Medicines Agency approved Dengvaxia for use in December. And last October, the U.S. Food and Drug Administration granted Dengvaxia a priority review. Dengue is endemic in Puerto Rico and the Virgin Islands, and cases have occurred in Florida, Texas and Hawaii.
Before the FDA issues a license, it usually presents its findings to an advisory committee. And the FDA almost always concurs with the committee’s advice. Two weeks ago, FDA’s advisory committee voted in favor of licensing Dengvaxia for patients between ages 9 and 17, but not for use of the vaccine in a broader age group.
While we expect that there will be sufficient testing of our vaccines and a scrupulous review process, human error (and human weakness) can never be discounted.
If the Maine Legislature votes to remove vaccine exemptions, we will lose the opportunity to pick and choose among our children’s vaccines. Absent a medical waiver, if children are to attend school, they will have to be inoculated with every mandated vaccine, no matter how, where, and by whom they are made. Or tested. Or licensed. Do we trust the pharmaceutical industry enough to give up our right to make this choice?
Meryl Nass of Ellsworth is an internal medicine physician and has testified before six congressional committees, primarily on the anthrax vaccine.

Friday, March 29, 2019

My 2015 article on the IOM and Hepatitis B

Sunday, July 5, 2015

Public Health Gone Awry: Birth Dose of Hepatitis B Vaccine (IOM chimes in on lack of good vaccine data)

Hepatitis B is a serious disease.  It is highly prevalent in many countries in Asia (nearly 10% of Chinese carried the illness in 1992), but fortunately is of low prevalence in the US.  Per CDC, the overall reported US incidence rate for 2013 was 1.0 case per 100,000 population. After adjusting for under-ascertainment and under-reporting, an estimated 19,764 acute hepatitis B cases occurred in the US in 2013. 

Hepatitis B is due to a virus transmitted by sex, vertical transmission from mother to newborn, from blood products and iv drug abuse primarily. There is no casual transmission. The graphs below show that disease rates in all age groups were dropping even before hepatitis B vaccine was recommended for children with no risk factors, in late 1991.

Acute hepatitis B cases in children are now extraordinarily low: according to CDC, they have fallen "from 1.2 cases per 100,000 population in 1990 to 0.02 cases per 100,000 population in 2007," or one new, acute case per 5 million children per year.  (The same CDC report notes there were 87 perinatal cases reported from 22 states in 2007, a higher incidence. I am guessing that the perinatal cases were detected via maternal screening, while the prior estimate was derived from new clinical cases in older children.)

The reduction in disease incidence is fantastic. CDC's recommendation that all pregnant women be screened for hepatitis B in 1988, and that they and their newborns be treated, is likely the major reason for the decline in pediatric and young adult cases.

But CDC didn't stop there.  CDC made stepwise recommendations for hepatitis B vaccinations for all children (who were by age at lowest risk of hepatitis B) during the 1990s, and specified a dose at birth for all newborns in 2002, even though the risk to newborns with hepatitis B negative mothers was close to zero even then. (A well-publicized controversy in France over hepatitis B vaccine-induced multiple sclerosis in the mid 1990s had affected vaccination acceptance here.  The multiple sclerosis issue was never fully resolved, while the birth dose of hepatitis B vaccine may have contributed to greater vaccine uptake in the US, according to CDC.)

What do other countries with low prevalence of the disease do with respect to vaccinating newborns, a strategy that only helps those from Hepatitis B-infected families? Data on vaccine policy for all countries in Europe can be found on the ECDC website. 

Only 6 of europe's 31 countries recommend a dose of hepatitis B vaccine for newborns whose mothers are Hepatitis-B negative: Bulgaria, Lithuania, Poland, Portugal, Romania and Spain.

Incidence* of acute hepatitis B, by age group and year --- United States, 1990--2007
Incidence* of acute hepatitis B, by age group and year --- United States, 1990--2007
* Per 100,000 population.

Incidence* of acute hepatitis B, by sex and year --- United States, 1990--2007
Incidence* of acute hepatitis B, by sex and year --- United States, 1990--2007
* Per 100,000 population.
 The bars indicate the rate per 100,000 (left y-axis) by sex; the line is the ratio (right y-axis) of the incidence rate among males compared with that among females.

But here's the thing:  

Public health decisions must balance risk and benefit to the entire population when determining policy.  In the case of vaccinations, it can be devilishly difficult to ascertain vaccine causality: the true rates, types and severity of adverse reactions remain questionable, since they may be delayed by weeks, months or even years following a vaccination. (Local reactions, rarely severe, such as redness, swelling, or tenderness at the injection site are easy to assign to a vaccine, while systemic reactions are not.)

When a disease is common in the population, in order to reduce its incidence via vaccinations, one can accept a certain degree of (estimated) adverse events due to vaccinations.  

When a disease is rare, but you are still vaccinating the same number of people, the number of  vaccine-induced adverse events does not drop--but your population benefit is reduced, since you are preventing fewer cases.  Given the reduced benefit, the adverse reactions may no longer be counterbalanced by the population benefit.  But have CDC's public health professionals reevaluated their hepatitis B vaccine policy in light of current disease rates? 

There is a big, big problem at the heart of vaccination policies: there simply are no reliable adverse reaction data.  In the specific case of hepatitis B vaccine, a newborn gets vaccinated on the first day of its life, and since the parents have no prior experience with that baby, it is especially difficult to identify a systemic adverse reaction to the initial dose of vaccine.

One "non-systematic" review reported:  "After reviewing the literature, we observed that complications seen after Hepatitis B vaccination are sudden infant death syndrome, multiple sclerosis, chronic fatigue syndrome, idiopathic thrombocytopenic purpura, vasculititis, optic neuritis, anaphylaxis, systemic lupus erythematosus, lichen planus and   neuro-muscular disorder."  Observed.  Not measured.  Who knows what it means?

The label for Glaxo's Engerix-B vaccine is vague regarding causality and severity of adverse events. A WHO information sheet on Hepatitis B adverse reactions is equally troubling, as the literature it cites is full of contradictions. Hand-waving by WHO to dismiss unwanted findings is unconvincing, when a vaccination policy appropriate for reducing hepatitis B transmission to newborns in low resource areas of the world (areas without assured screening during pregnancy) has been imposed in the US on our high resource, highly screened population of mothers and infants.

I know that what I am writing seems difficult to believe.  How could vaccines be licensed by FDA without good adverse event data?  But the fact is that when they are licensed, all the data FDA evaluates have been generated by the manufacturer.  Later, it is usually not beneficial to the manufacturer to actively seek evidence of harm.

The US government requests advice from the Institute of Medicine (founded in 1970 and part of the National Academy of Sciences, chartered by Congress in 1863) regarding issues of public health.

In 2012, an Institute of Medicine which had been asked to investigate the adverse event literature for Hepatitis B and other vaccines, issued this report

Adverse Effects of Vaccines: Evidence and Causality


Committee to Review Adverse Effects of Vaccines; Institute of Medicine; Stratton KFord ARusch EClayton EW, editors. Washington (DC): National Academies Press (US); 2012.
The report's conclusions state:
The committee acknowledges that some readers may have concerns about two aspects of the report. First, the committee does not make conclusions about how frequently vaccine adverse events occur. Secondly, the committee concluded, for most analyses, that the evidence is inadequate to accept or reject a causal relationship and some readers might interpret the committee's language in different and inaccurate ways. The committee offers concluding comments to address these two issues.
This report is not intended to answer the question “Are vaccines safe?”. The committee was not charged with answering that question. Other bodies make that determination and contribute to ongoing safety monitoring, including governmental agencies, care providers, and industry, as they determine the benefits and risks of marketing a product. At all levels, policy determining vaccine use requires a balancing of risks and benefits. As described in Chapter 1 and the Preface, that is outside the bounds of this committee's assignment. It should also be noted that where the committee has found evidence of a causal relationship, it does not make conclusions about the rate or incidence of these adverse effects.
Determining the rate of specific adverse events following immunization, in the general population or a subset thereof, is challenging. It would be possible, for example, to estimate a rate of the occurrence of a specific adverse effect in a vaccinated population or susceptible subgroup of interest. This could be done using a summary relative risk or absolute risk difference (e.g., estimated from a set of consistent reports reviewed by the committee) if there were large population-based studies of the occurrence of the adverse event in unvaccinated individuals (e.g., in the general population or susceptible subgroups of interest) who do not substantially differ from those vaccinated on any known, important confounders (e.g., age and exposure to other vaccinations or other agents or factors known to cause the adverse event). None of these preconditions is fully met for the adverse events reviewed in this report.
The committee also notes here that large epidemiologic studies that report no cases of the adverse event of interest in vaccinated study participants, if included in our analyses, raise particular concerns. If at least some cases of the adverse event occurred in a study's unvaccinated comparison population, an upper limit of the 95% confidence interval (CI) for the study's relative risk or absolute risk difference could be estimated, but one would be unable to rule out a possibly increased risk unless the vaccine was significantly protective against that particular adverse effect. Also, including such studies may have exacerbated problems with detection biases unless precautions were taken to ensure equal surveillance for the adverse event in the unvaccinated and vaccinated populations being compared...

So there it is.  In the absence of good data, it is hard to make good public health decisions--but they get made nonetheless, and the decision-making is population-based, independent of any individual's unique risk-benefit profile.

But for an individual, you can make an assessment that includes your risk factors for the disease, the vaccine efficacy (very good for Hepatitis B vaccine, although duration of protection is uncertain)
 and see how that balances with the (unknown) degree of risk from the vaccination.  If you are at more than infinitesimal risk for the disease, include a factor for the considerable health risks inherent in the disease, were you to develop it in the absence of vaccination. Caveat emptor.

Thursday, March 21, 2019

Indisputable: CDC is not making prudent vaccine recommendations

Hepatitis B vaccine (HBV), administered according to the CDC's schedule on the day a baby is born, is the thread that unravels the claim that "science" underpins the CDC's childhood vaccine schedule.  Hepatitis B vaccine is unnecessary for 99% of newborns:  those whose parents and siblings do not have contagious Hepatitis B.  Hepatitis B is spread by contaminated needles and sex with an infected partner.  It is not spread like polio (oral-fecal) or measles (by particles in the air).  It is not spread through casual contact.  Babies in uninfected families just don't get it. 

Jeremy Hammond, a wonderful writer, has posted a superb piece about this subject here. Four years ago, I wrote an interesting article about hepatitis B vaccine, telling my own story of how I came to be vaccinated, while eschewing vaccination for my grandchildren.  A bit later, I wrote about how it was that CDC kept moving the Hepatitis B vaccine goalposts, until newborns became the primary target, for whom uptake was almost 100%

Hepatitis B is a killed vaccine and protection wears off over time, so babies may actually lack protection if and when they do become "at risk" of contracting Hepatitis B, as a teen or adult.

If the goal was to provide adolescents with protection when they become sexually active, they should be vaccinated later, as is recommended for the Tdap and Men A vaccines.  After all, immunity from vaccination in the first six months may have worn off by then.

The fact is, no public health agency has ever provided a scientific or logical reason why babies need to be given this vaccine at birth.  Here is CDC's 2017 explanation, which makes absolutely no sense if the family is uninfected:

For children and adolescents, the new guidelines strengthen the recommendation that the birth dose of the HBV vaccine be administered to infants within 24 hours of birth. This is a change from previous recommendations that were more flexible, allowing for vaccination at birth or at first pediatric visit, often 2 or more weeks after birth. However, delaying vaccination leaves infants at risk for a longer period of time. Additionally, providing the vaccine as soon as possible after birth can provide some protection for infants whose mothers had undiagnosed HBV at the time of delivery. 
These updated recommendations strengthen our national response to viral hepatitis and contribute to implementing strategies identified in the National Viral Hepatitis Action Plan, 2017 – 2020.
But what are babies "at risk" for if they and their mothers tested negative?  And why is your newborn needed to "strengthen our national response" anyway?

The state of Oregon does its best to provide a "better" reason.  The reason is--get this--that, although mothers and newborns are all tested for Hepatitis B and should therefore be treated when found to be positive, well, sometimes people make mistakes.  Results might get lost.  So we better vaccinate every baby (4 million babies a year at 3 doses each, costing an estimated $500 million/year)-- just in case a positive result gets lost.  (I guarantee that if hospitals were told they would be fined $50,000 for losing a single Hepatitis B test, not a single one would ever be lost.)  From Oregon:
We all know that medical errors happen—some serious—and with some regularity. Because HBV positive test results don’t always find their way to the birth hospital, or to the right person, many U.S. children are now chronically infected with HBV and at least one infant has died...The birth dose of hepatitis B vaccine serves as a “safety net” to prevent perinatal infection in these infants.
You've gotta be kidding me.  Not only do mothers and newborns have to pay to be tested for Hepatitis B, they have to pay (and risk an adverse reaction) for 3 doses of vaccine in case the hospital loses their test results.  What is wrong with this picture???

Here is the information CDC provides about the number of perinatal cases of Hepatitis B in 2016 (below).  It would be interesting to know how many of these cases were vaccinated, and how many were detected through lab testing.  Why did these cases occur? Were they cared for appropriately? 

Would it not make more sense to put the effort and expense of 12 million Hepatitis B shots yearly into correctly identifying the small number of truly at-risk newborns and making certain they are optimally treated by their medical providers?

Update:  Only about 73% of US newborns actually receive the Hepatitis B vaccine within 3 days after birth.  The rest have savvy parents or health professionals.

Table 3.6. Number of newly reported case* reports† of perinatal hepatitis B§ submitted by states and jurisdictions, 2016

Table 3.6.
State/JurisdictionNo. Perinatal hepatitis B
case reports† submitted
New York2
North Carolina1
West Virginia1
Source: CDC, National Notifiable Diseases Surveillance System.
*For case-definition, see
†Reports may not reflect unique cases.
§ Perinatal hepatitis B is not reportable disease in ALL jurisdictions
Here are the ingredients in the 2 hepatitis B vaccines sold in the US, in addition to the Hep B antigens:

Hep B (Engerix-B): 250 mcg aluminum as aluminum hydroxide, up to 5% yeast protein, sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate 

Hep B (Recombivax): soy peptone, dextrose, amino acids, mineral salts, phosphate buffer, formaldehyde, 250 mcg aluminum, yeast protein 

Wednesday, March 20, 2019

"inactive" ingredients in medications can and do make people sick

A premier science journal, Science Translational Medicine, pointed out that extraneous substances in medications can and do make people sick--in an article written by scientists at MIT and published March 13, 2019. 

Why would anyone assume the same is not true of vaccines?

“Inactive” ingredients in oral medications

1.     Daniel Reker1,2,3,*
2.     Steven M. Blum1,4,5,*
3.     Christoph Steiger1,2,3
4.     Kevin E. Anger4
5.     Jamie M. Sommer6
6.     John Fanikos6 and 
7.     Giovanni Traverso1,2,3,4,7,

Science Translational Medicine  13 Mar 2019:
Vol. 11, Issue 483, eaau6753
DOI: 10.1126/scitranslmed.aau6753

Oral forms of medications contain “inactive” ingredients to enhance their physical properties. Using data analytics, we characterized the abundance and complexity of inactive ingredients in approved medications. A majority of medications contain ingredients that could cause adverse reactions, underscoring the need to maximize the tolerability and safety of medications and their inactive ingredients.