A Pox on the Taxpayer
Filed under: CDC Watch, Opinion, Vaccine Science, Vaccine/Disease Analysis
A handful of countries recommend the chickenpox (varicella) vaccine for all children and an even smaller group have a chickenpox booster on the schedule. The US leads the pack of countries with a 2 shot schedule, and following along are Ecuador, Saudi Arabia, Germany, Greece, and part of Australia.
Some countries give the shot to adolescents, others offer it to members of “risk groups”… and a few have a one-shot schedule for toddlers: Canada, Costa Rica, Uruguay, Cyprus, Latvia, and Korea. A grand total of 26 countries offer the shot in one way or another. [1]
The US was the first country to recommend the shot for all toddlers, in 1996 :
…. empiric data on medical utilization and costs of work-loss resulting from varicella were used. The results of this study, which were determined using an estimated cost of $35 per dose of vaccine and $5 for vaccine administration, indicated a savings of $5.40 for each dollar spent on routine vaccination of preschool-age children when direct and indirect costs were considered. When only direct medical costs were considered, the benefit-cost ratio was 0.90:1. [2] (emphases added)
But it turned out that a single shot of varicella vaccine didn’t work to suppress chickenpox.
…varicella outbreaks have regularly been observed in populations with high vaccination coverage and are the cause of sizable disease and economic impact for public health departments and the US health system overall. To further reduce varicella disease burden, a routine 2-dose varicella vaccination recommendation was approved by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) in June 2006 (first dose for children 12–15 months of age, second dose for children 4–6 years of age) . [3]
The single-shot regimen showed a narrow margin of benefit only when placed alongside income lost by parents staying home to care for sick children.
But when the one-shot program failed, the ACIP came up with another cost/benefit justification for the second shot where the evidence….
….included ongoing disease burden and varicella-zoster virus transmission, including transmission from breakthrough cases to high-risk persons that may lead to severe disease and even death (CDC, unpublished data); partial or complete susceptibility in 1-dose vaccine recipients as they become adults; the burden on public health agencies due to varicella outbreaks in highly vaccinated school settings, which have proven disruptive to society and costly to control; and the increased immunity and disease protection from a second dose. Overall, the 2-dose strategy still provides very high cost savings (>$0.9 billion from societal perspective). [3] (emphases added)
So the ACIP justifications for adding a second dose, used the consequences of their decision to recommend the first dose of varicella vaccine. These ingenious calculations created a bigger cost savings than their first round! Read more
Indian Physicians slapped with anti-vaccine label!
Why? Because they questioned a WHO (World Health Organization) diktat in favor of universal Hib vaccination in India.
Sorry, but this is getting ridiculous. Anyone, at any time who raises any concern about the safety, efficacy, or appropriateness of any vaccine is now called anti-vaccine.
Here is a potted history of the recent outbreak of name-calling.
In the July 2010 issue of the Indian Journal of Medical Research this editorial appeared: Introducing pentavalent vaccine in the EPI in India: A counsel for caution.
The latest WHO position paper on Hib says ‘Hib vaccine should be included in all routine immunization programmes. This suggests that Hib vaccine should be included in the immunization programme universally, irrespective of an individual country’s disease burden, not withstanding of natural immunity attained within the country against the disease, and not taking into account the rights of sovereign States to decide how they use their limited resources. The mandate and wisdom of issuing such a directive, for a disease that has little potential of becoming a pandemic, needs to be questioned.
The editorial reviews the available data and on the basis of the science, questions the need for the Hib vaccine in India.
In response to this thoughtful challenge to the WHO policy on Hib, a news commentary was published in the BMJ (British Medical Journal) which called the concerned doctors an “anti-vaccine lobby.” This article, which is unreferenced, claims:
The Hib organism, which can cause severe bacterial meningitis and pneumonia, is estimated to kill more than 370 000 children worldwide each year, GAVI said. Nearly 20% of these deaths occur in India.
In response to the BMJ article, a rapid response was published in the online version of the BMJ by eight members of the supposed “lobby”
The doctors wrote:
The thrust for including Hib vaccine in India is based on 2 arguments. The first is that there is anecdotal evidence of the existence of Hib disease and Hib meningitis in India and that Hib meningitis may lead to long term morbidity. The second argument is that the well-to-do parents sometimes buy Hib vaccine in the open market to vaccinate their children. The Government of India must therefore provide it free for the poor, on the grounds of equity and fair play (2).
The problem with the anecdotal reports is that they do not specify the size of the universe from which the samples are drawn and public health policies cannot be based on these figures without a denominator. The many systematic surveys done to look at the magnitude of the problem of Hib disease in India have nearly always shown that the incidence of Hib disease is much lower than what was projected for India. Most of these studies have been funded by the WHO and these have been reviewed recently in an open access journal (3).
So, we have the BMJ calling names and publishing an unreferenced attack claiming high numbers of deaths from Hib, while the supposed anti-vaccine lobby provides carefully referenced information debunking the claims.
The pro-vaccine lobby has plumbed to new depths.
Polio and Sanitation
Filed under: CDC Watch, Parents' Pages, Vaccine Science, Vaccine/Disease Analysis, WHO Watch
KHAGARIA: On the sandy banks of Kosi river in north Bihar, a quiet crowd of several hundred people is waiting in the sizzling morning sun. A speck appears in the pale blue summer sky, rapidly growing in size — its a gleaming white helicopter. Within seconds it is hovering above the opposite bank, amidst the cornfields.
The crowd is awestruck at the monstrous machine as it settles down in billowing clouds of sand. Out comes the man everybody has been waiting to see — Bill Gates.
Bill Gates has come to find out why polio eradication is failing in Bihar. He asks questions about immunization strategies and tries to figure out what sort of technical problems are blocking universal vaccine delivery.
People complain of lack of basic health facilities…There are only 49 auxilliary nurse and midwives under the PHC, against a sanctioned strength of 76…So, the delivery of basic health services is itself a distant dream…The villagers hope against hope. Isn’t the spread of polio linked to lack of sanitation and basic health facilities? Gates acknowledges this fact but says that it is for the government to do the needful. “We are concentrating on the eradication of polio, which is achievable through vaccines,” he says. [1]
Polio epidemics first appeared in the mid-nineteenth century. Many doctors and scientists struggled with the mystery: why, as living conditions improved, did incidents of paralysis increase? Out of all the changes that came with modernity, improved sanitation was chosen as the change which caused polio to turn from a mild illness to one that left death and permanent damage in its wake. Here is an excellent example from a 2007 medical article which summarizes the concept:
Prior to the 20th century, virtually all children were infected with PV while still protected by maternal antibodies. In the 1900s, following the industrial revolution of the late 18th and early 19th centuries, improved sanitation practices led to an increase in the age at which children first encountered the virus, such that at exposure children were no longer protected by maternal antibodies. Consequently, epidemics of poliomyelitis surfaced . [2] Read more
Myth: No Rainbow, No Pot of Gold
Note: separate re-issue of part two of one of our myths blogs. We got a complaint that this one was too hard to find and link to. The easiest fix was to split it into a separate article. Thanks for your understanding.
Myth: Vaccines aren’t money makers for drug companies.
Reality: As spoken by Tom Broker about Gardasil and Merck (see page 19 of pdf)
“From a purely business point of view, they’ve been facing some real interesting challenges over the Vioxx issue and they are looking at this as the foundation and the savior of the company. Believe me, they have a huge stake in this, just as we all do.”
How profitable are vaccines? Prevnar did very well for Wyeth:
… Prevnar, which had $2.7 billion in sales last year. Prevnar is Wyeth’s No. 2 product by revenue, behind antidepressant Effexor.
Some business press projections on the potential in the vaccine market:
Gardasil sales totaled $365 million in the first quarter of 2007, helping Merck reach nearly $1 billion in total vaccine sales for the quarter, more than triple vaccine sales from a year earlier. Analyst projections have ranged up to $4 billion in annual sales for Gardasil, assuming the government mandates widespread vaccinations for girls.
Merck launched two other vaccines in 2006 – Zostavax, for the prevention of shingles, and Rotateq, for the prevention of a rotavirus that causes diarrhea in infants. Les Funtleyder, analyst for Miller Tabak, estimates that these vaccines could reach hundreds of millions of dollars in annual sales.
“Merck showed that you can make quite a bit of money with vaccines, and I think that got a lot of people’s attention,” said Funtleyder.
If vaccines have the potential to offer huge profits to pharmaceutical companies–just like other blockbuster drugs–Lipitor or Vioxx are good examples, I think we can reasonably assume that the temptation to publish ghostwritten studies, suppress unwelcome results and use Key Opinion Leaders to subtly sell product is there with vaccines, too. And vaccines offer two additional benefits, available for no other drugs: mandates and immunity from lawsuits (in the US). Who wouldn’t be tempted by a package involving a guaranteed market, and tort immunity?
There was a period, quite a long time ago now, when vaccines were not profitable. But time past is not time present. This myth is long past its sell-by date.
Vaccine Myths 3.1: The Scourge of Childhood
Filed under: CDC Watch, Parents' Pages, Vaccine Myths, Vaccine/Disease Analysis
“…young parents of today do not remember…”
In 1974 the St. Petersburg Times wrote:
So many people are neglecting to get immunity shots that doctors fear the seven one-time scourges of childhood–polio, mumps, measles, rubella, diphtheria, lockjaw and whooping cough–may strike American communities again.
However, just six years earlier, in 1968, newspaper stories said things like this:
Although mumps is a relatively mild childhood disease, it can cause sterility when it strikes adult males.
At that time the recommendation was to give the recently developed shots to boys if they hadn’t had the mumps by the time they hit adolescence. Read more
For the Good of the Herd
Filed under: CDC Watch, Parents' Pages, Vaccine/Disease Analysis
In an era where CDC experts are saying, “Just line up for Gardasil, and you’ll have a 70% reduced chance of getting cancer”, are parents asking any critical questions about the crystal ball gazing abilities of these experts now and in the past? Why is there talk of adding a third MMR vaccine into the childhood schedule, and also putting it into adult vaccination programs as regular boosters?
Will most people just roll up their sleeve, assuming the new ideas will have the good outcome the CDC will predict?
Most of those people won’t know, that in 1967, the CDC said: *
For centuries the measles virus has maintained a remarkably stable ecological relationship with man. The clinical disease is a characteristic syndrome of notable constancy and only moderate severity. Complications are infrequent, and, with adequate medical care, fatality is rare.
Effective use of these vaccines during the coming winter and spring should insure the eradication of measles from the United States in 1967. Read more
Where to start?
Parenthood is tough! Decisions, decisions, decisions. And here in “The Information Age”, many parents feel that there is no room for poorly informed choices for The Big Decisions. For many parents, the issue of vaccines was at one time a “no brainer”. Children were “completely” vaccinated. Everyone believed that vaccines were necessary to save your baby’s life. For the majority, vaccines were completely beyond debate. Today, many parents are questioning the safety and necessity of the large numbers of vaccines on the schedule, particularly for obscure or milder diseases. Vaccine necessity, which used to be taken for granted, has suddenly become an uncertain, debatable matter that has to be researched in depth.
What are the issues which require consideration as one steps outside the “Just do whatever your doctor tells you to do!” mindset?
- 1) the ethics of vaccine decisions in light of herd immunity
- 2) the immediate risk to the baby or child from both the diseases and the vaccines
- 3) the social stigma of possibly going against the flow and not following the recommended schedule
- 4) and the confusing, often conflicting ocean of scientific literature on the topic.
So where should a parent start? Read more
MRSA and Child Flu Deaths
Recent news stories about a link between MRSA and flu deaths in children raise some interesting questions in light of our Sisyphus series (Part I, Part II and Part III).
“Being a carrier of MRSA has increased a lot, especially among school-aged kids,” said Lyn Finelli, chief of influenza surveillance at the CDC. “And being colonized may put them at risk for a severe staph aureus infection when they get the flu.”
This particular news story blames the problem on antibiotic overuse, and, of course, recommends the flu vaccine to save children from this dangerous situation. Read more
Vaccine Information Statements For Dummies
Before any doctor gives your baby vaccines, you should be given Vaccination Information Sheets (VISs) to read.
Developed by the CDC, they inform vaccine recipients, their parents or legal representative, about the benefits and risks of vaccines. (1) Federal Law requires their use. This is a result of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-26. (1) Before 1986, parents didn’t have any right to printed information about vaccines.
VISs sound like a good system. Parents get concise and easy to understand information on a vaccine’s risks and benefits so they can make an informed decision.
Is that really how it works? Let’s examine the nuts and bolts of VISs.
Read more
Sisyphus and the Conjugate Vaccines III
Part III of a three part series. Parts one and two can be found here and here.
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The big question with these conjugate vaccines is “What is the overall effect?”
How many fewer cases of invasive bacterial disease are happening after replacement is accounted for?
The more narrowly you look, the better these conjugate vaccines look. The more broadly you look, the more the apparent effects melt away to nothing. With Hib and “replacement disease”, if you just compare h influenza serotype B to serotype A, it would appear that killing off Hib via mass vaccination was extremely successful in the grand scheme of things. When you look at nontypeable (also known as “non capsulated”) h influenzae plus Hia and Hif, that’s when you start seeing that we’re not really any better off now than we were before the Hib conjugate vaccine. Read more