Vaccine sleight of hand

July 18, 2010 by · 7 Comments
Filed under: Opinion, Parents' Pages 

Every Child by Two proclaims that vaccines save money! Lots and lots of money!

Childhood Vaccines Save Lives and Money

But then, on the side of their web-page, is a link to a graphic illustration of the rising costs of childhood vaccination.

Looks like they want it both ways: “vaccines save billions” by reducing health care costs, preventing hospitalizations and doctor visits; BUT  “the newer vaccines are more expensive and we need to put a lot more tax dollars into vaccination programs.”

If the numbers with respect to “dollars saved” were solid and existed across the entire vaccine program, the argument would be a good one. Upon further scrutiny, it looks like they are pulling a bait and switch. They put forward some old numbers based on the less expensive vaccines combined with some inflated statistics for predicted epidemics (see the “33,000 deaths prevented” link above for our detailed analysis of these numbers), then slide right past the huge increase in the number and cost of vaccines in the current U.S. schedule.

On top of this, some of the newer vaccines are aimed at illnesses which are of low incidence or fairly mild in most children.  For example, Hepatitis B is very severe, but it isn’t common among infants born in the U.S. On the other side, chickenpox is usually a minor illness, although common. The chickenpox vaccine cost benefit justification actually depended on a monetary estimate of the cost of parental time lost from work. Some convoluted bookkeeping methods would be needed to demonstrate that universal vaccination with ALL of the vaccines on the current schedule results in overall health care savings. There is certainly no sign of these savings in the escalating cost of health insurance in the U.S. Read more

Indian Physicians slapped with anti-vaccine label!

July 8, 2010 by · 2 Comments
Filed under: News, Opinion, Vaccine Science, WHO Watch 

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

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

Polio and Acute Flaccid Paralysis

In post one of this series on polio, a term was introduced: “Acute Flaccid Paralysis”. [1]

Acute Flaccid Paralysis is a term which applies to the exact clinical symptoms you would expect to see from poliovirus infection, but which are not necessarily caused by polioviruses. Paralytic polio is actually considered a sub-category in the broad umbrella of acute flaccid paralysis. See pages 300-312 [1] for a chart and summary of many other causes of AFP, a few of which are: Guillaine-Barre syndrome, Cytomegalovirus polyradiculomyelopathy, Acute transverse myelitis, Lyme borreliosis, nonpolio enterovirus and Toxic myopathies.

For many years the medical profession assumed that when they saw paralysis with a particular cluster of symptoms, it was poliomyelitis. The 1954 Francis Trials of the Salk vaccine [2] triggered a reconsideration of this assumption, and a major change in the diagnostic criteria.

How were polio cases counted in 1954?

In 1954 most health departments worked with the WHO definition:

“…Signs and symptoms of nonparalytic poliomyelitis with the addition of partial or complete paralysis of one or more muscle groups, detected on two examinations at least 24 hours apart.” [3, p. 88]

How were polio cases counted in 1955?

In 1955 the criteria were changed to conform more closely to the definition used in the 1954 field trials: residual paralysis was determined 10 to 20 days after onset of illness and again 50 to 70 days after onset. [3, p. 88]

Thus, simply by changes in diagnostic criteria, the number of paralytic cases was predetermined to decrease in 1955-1957, whether or not any vaccine was used. At the same time, the number of nonparalytic cases was bound to increase because any case of poliomyelitis-like disease which could not be classified as paralytic poliomyelitis according to the new criteria was classified as nonparalytic poliomyelitis. Many of these cases, although reported as such, were not non-paralytic poliomyelitis. [3, p. 88] (emphasis added)

It was after the SALK vaccine was introduced, when fully vaccinated people continued to get “polio”, that doctors started looking a lot more carefully at the viruses in individuals. Many viruses were found to cause paralysis, for example coxsackie B, enterovirus 71, etc. Read more

Polio 2010

Poliovirus

Over the next few weeks, Inside Vaccines will be taking a closer look at Poliomyelitis infections, exploring aspects of the history of poliomyelitis; describing environmental factors that increase the incidence of paralytic polio; considering the history and efficacy of the vaccines used against polio; and finally, exploring the campaign to eradicate polio.
First, let’s look at some basic information.

When most people think of poliomyelitis, they think of children who had lameness and leg deformities, with their legs in braces, or lying in iron lungs (old-style breathing machines, or ventilators) because they couldn’t breathe. Most people link all paralysis and lameness solely to a group of viruses called POLIOMYELITIS. The World Health Organization describes polio:

Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. [1]

Now for a more accurate picture of exactly what “poliomyelitis” is.

The poliomyelitis viruses fall within a class of viruses called “human enteroviruses” [2]. Polioviruses belong to the viral family Picornaviridae [3]. There are three types: 1 Brunhilde; 2 Lansing; and 3 Leon.   Amongst these types there are hundreds of different strains. Type 1 is considered the most serious virus, followed by type 2.

Technically, a person can “get” poliomyelitis 3 times, since the types do not give cross protection to each other, but in practice, having clinical polio three times is very rare.

How is poliomyelitis virus transmitted?

Poliomyelitis is transmitted by person-to-person spread through fecal-oral and oral-oral routes, or occasionally by a common vehicle (e.g., water, milk). [4]

What happens when people are exposed to polioviruses?

When non-immune persons are exposed to wild poliovirus, inapparent infection is the most frequent outcome (72 percent). [4]

Most people won’t even be aware that they were sick. Read more

Myth: No Rainbow, No Pot of Gold

May 4, 2010 by · 3 Comments
Filed under: General 

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.

New vaccine

July 8, 2008 by · 2 Comments
Filed under: Vaccine Science 
Eleven years ago, Professor Adrian Lee, head of the School of Microbiology and Immunology at the University of New South Wales commented on the failure of the first Helicobacter vaccine to work in a European trial. The Astra Research Center in Boston, USA collaborated with the New South Wales University on the project. Professor Lee believed that two or three recombinant antigens, and a much more potent adjuvant were required. Not only did the first vaccine, which had only one antigen, not work, but the e. coli and cholera toxin adjuvants caused diarrhoea in the vaccine recipients.

Read more

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