What’s in your H1N1 flu vaccine?

[Guest guest]

What’s in your H1N1 flu vaccine?

 

By _Alex Roslin_ (http://www.straight.com/archives/contributor/15)

_http://www.straight.com/article-270843/vancouver/whats-your-vaccine?awesm=f

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(http://www.straight.com/article-270843/vancouver/whats-your-vaccine?awesm=fbsha\

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Chris Shaw wasn’t always skeptical about vaccines. The neuroscientist at

the University of British Columbia had his teenage son vaccinated with most

of the recommended shots. But then he started studying some of the

ingredients commonly found in vaccines.

What he discovered caused him to go cold turkey on all shots for his

six-year-old daughter. And that includes the vaccine for the H1N1 flu.

“I am not convinced H1N1 is sufficiently hazardous to most people to risk

the potential downside of the vaccine,†Shaw said over the phone from his

office in the research pavilion at the Vancouver Coastal Health Authority.

Shaw isn’t an easily dismissed vaccine conspiracy theorist. He is a

leading expert on amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s

disease)

and Parkinson’s disease. While investigating unusually high rates of ALS and

other neurological disorders among veterans who have Gulf War syndrome, he

found evidence that the cause may have been aluminum salt, an ingredient in

the cocktail of vaccines given to soldiers before deployment.

Although aluminum salt isn’t present in the H1N1 vaccine, Shaw’s

discovery made him concerned about other vaccines, including the swine-flu shot.

He

isn’t alone in his thoughts.

Despite a full frontal assault of news about the dangers of the flu and

the importance of vaccination, a survey in late October revealed that only 36

percent of Canadians said they would get the shot. Lack of trust in the

vaccine was cited as the main reason for vaccine opposition. Another poll in

November found that 65 percent of Canadians believe the media has

overreacted to the threat of swine flu.

Even many health workers aren’t convinced. In two separate surveys, in the

U.K. (Pulse) and Hong Kong (British Medical Journal), published in August,

half of health-care professionals said they didn’t intend to get the

vaccine.

Canadian health officials and some newspaper columnists have reacted by

accusing vaccine opponents of being conspiracy mongers or just plain

irresponsible.

Who is right? Is the cure really worse than the disease? Let’s look at

some numbers.

First, the disease. Swine flu had killed 161 Canadians as of November 12.

That works out to one death per 200,000 Canadians in the past

six-and-a-half months. Over the same period of time, major cardiovascular

diseases

typically claim 240 times more Canadian lives (about 39,000), cancer claims 230

times more (37,000 deaths), pneumonia kills 18 times more (2,800), and

accidental falls claim eight times more (1,260), according to calculations

based on 2005 Statistics Canada figures.

H1N1 has about the same death rate as hernias. But we don’t see scary

front-page headlines for months on end about hernias, pneumonia, or falling

down.

“It’s really not causing—and is not going to cause and nowhere has

caused—

significant levels of illness or death,†Dr. Richard Schabas, Ontario’s

former chief medical officer of health, told the CBC on November 12.

Schabas said H1N1 “has ultimately turned out to be, from a pandemic

perspective, a dudâ€.

What about the vaccine? Is it safe? Despite the onslaught of confident

pronouncements from health officials and doctors, Shaw says he hasn’t seen

enough information on the safety of the vaccine. “If the science were there,

we could make a rational decision. But it’s a coin toss.â€

Looking for answers, Shaw turned to the 24-page product-information

leaflet on the vaccine released by drug giant GlaxoSmithKline. Health Canada

used

this document in approving the shot.

The leaflet leaves Shaw cold. “You couldn’t turn this in as a master’s

thesis anywhere I know of and get a passing grade,†he said, calling the

leaflet a “shocking documentâ€.

Shaw said the material lacks basic information. For example, there is no

safety data at all for several groups of people—pregnant women, people aged

over 60, kids aged 10 to 17, and children under three. For kids three to

nine years old, there is only “very limited†data

 

 

“Where is the safety data that the government used to license the vaccine?â€

Shaw asked.

Health Canada would not talk to the Straight, and the Public Health Agency

of Canada did not respond to a request for an interview.

The H1N1 vaccine includes a component called an adjuvant—which is used to

boost the drug’s effectiveness—that has raised a lot of questions.

GlaxoSmithKline says the adjuvant has been tested on 45,000 people

worldwide and that clinical trials are now being done on children. In an

e-mail,

spokesperson Melanie Spoore said the company is planning 25 trials of its

various H1N1 vaccines before November 2010.

She also said a different but closely related vaccine made by the company,

for the H5N1 flu, includes the same adjuvant and “is generally

well-tolerated and has an acceptable safety profile†in both kids and adults.

But Shaw has concerns about the company’s trial results for the H5N1

vaccine. The product leaflet mentions a study in which the company injected the

vaccine into pregnant rats. It found “an increased incidence of fetal

malformations†and “delayed neurobehavioural maturationâ€. Another study

did not

produce the same outcome.

But Shaw says the rat results deserve more study. “Anytime you observe

such outcomes, it is a concern,†he said.

The leaflet also mentions a study on ferrets. The animals were given

adjuvanted and nonadjuvanted H5N1 vaccines and then exposed to the flu. The

ferrets that got the adjuvanted vaccine were protected by the vaccine. But

those that got the nonadjuvanted vaccine all died.

This result could be a concern, Shaw said, because Canadian authorities

are telling pregnant women to get the nonadjuvanted H1N1 vaccine since the

adjuvanted version hasn’t ever been tested on pregnant women. Shaw also said

the animal-study information in the leaflet lacks many important details

and would be “unpublishable†as presented. “Any [medical-journal] referee

would kick this out the window.â€

The company’s leaflet also paints a picture of the vaccine’s side effects

in humans somewhat different than the usual line from health authorities.

The Public Health Agency of Canada says on its Web site that the adjuvanted

vaccine is as safe as the nonadjuvanted shot. It also says the rate of “

serious adverse events†from vaccination is extremely low—typically “about

one for every 100,000 doses of vaccineâ€.

What we don’t often hear is that the adjuvanted vaccine caused

dramatically more side effects than the nonadjuvanted version. Ninety percent of

62

subjects reported pain (versus 37 percent of 62 people for the nonadjuvanted

vaccine), 34 percent had muscle soreness (compared to 8 percent with the

nonadjuvanted shot), and 14 percent experienced a headache (as opposed to 8

percent for the nonadjuvanted shot), according to the product-information

sheet.

Although these reactions are minor, the leaflet also says four of 253

people studied experienced “severe adverse reactionsâ€. Three of the four

were

deemed to be unrelated to the vaccine, but one case of hypersensitivity

(which can mean anything from an allergic reaction to autoimmune disease) was

determined “to be related to vaccinationâ€.

That one serious reaction might not sound like a lot, but it actually

translates into a rate of 395 cases per 100,000 people. That’s more than 50

times the rate of hospitalization due to H1N1 itself: 7.3 per 100,000

Canadians.

Sucharit Bhakdi is concerned some serious vaccine reactions could go

unnoticed. He is a professor of medical microbiology at the Johannes Gutenberg

University of Mainz in Germany. In October—in a coauthored paper in the

journal Medical Microbiology—he warned of a possible increase in the risk in

heart problems due to mass H1N1 vaccination.

Speaking by phone from his office, Bhakdi cited the higher rate of heart

problems when 1.4 million U.S. soldiers were vaccinated for smallpox before

the 2003 Iraq war.

Soldiers who received the vaccine had almost 7.5 times the rate of heart

inflammation of nonvaccinated personnel, according to a study by U.S.

military medical researchers in 2004 in the American Journal of Epidemiology.

“Unexpected serious adverse effects thus may follow in the wake of a

general vaccination program,†Bhakdi’s paper said.

Yet health authorities and doctors are urging people with heart problems

to get the H1N1 vaccine on a priority basis and do not appear to be

monitoring them for possibly elevated risks, he said.

Shaw is also concerned about Canada’s monitoring of the side effects of

vaccinations, calling the system “flimsyâ€.

What especially worries Shaw is the possibility of longer-term side

effects from the vaccine. Most vaccine safety studies monitor patients for a

few

days or, at most, several months.

That isn’t enough, Shaw says. With some vaccines, the most serious

reactions have taken years to surface. “Neurological problems don’t happen

overnight,†he said. “It took five to 10 years to see the bulk of the Gulf

War–

syndrome outcomes.â€

One of the best examples involves a controversial ingredient present in

the H1N1 vaccine: thimerosal. Thimerosal is a form of mercury used in some

vaccines as a preservative. Drug makers agreed to phase it out of most

vaccines after the U.S. Food and Drug Administration found in 1999 that mercury

levels in children who had gotten multiple shots often exceeded safety

levels set by the Environmental Protection Agency (EPA). Nonetheless,

thimerosal

still remains in many flu vaccines.

Controversy has raged for years about whether or not thimerosal is behind

soaring childhood autism rates. While that debate continues, a 2008 study

in the U.K. journal Toxicological and Environmental Chemistry found that

boys who were given a vaccine containing thimerosal were nine times more

likely to have developmental problems than unvaccinated boys.

The Public Health Agency of Canada says on its Web site that thimerosal is

safe and that the amount in the H1N1 vaccine is below Health Canada’s

daily safety limit set for mercury. “There’s significantly less mercury in

the

vaccine than you would find in a can of tuna fish,†the site states.

In fact, the amount of mercury in the nonadjuvanted H1N1 vaccine does

actually exceed the daily safety level for pregnant women. Health Canada has

established the safe dietary level of mercury for pregnant women at 0.2

micrograms (millionths of a gram) per kilo of body weight. The nonadjuvanted

H1N1 vaccine contains 25 micrograms of mercury.

Simple math tells us an average Canadian pregnant woman—weighing 80

kilograms at term—gets about 56 percent more than the daily safe level of

mercury

when given a dose of the nonadjuvanted vaccine. By the EPA’s stricter

standards, that same dose is actually triple its daily safe level.

What’s more, Shaw notes, those daily safety levels were set for

consumption of mercury in food, not for injection directly into the body.

Injecting a

neurotoxin like mercury has much more impact than eating it, he said.

Squalene is another controversial component of the swine-flu vaccine. It’s

an oil found in animal livers and is used as an adjuvant in vaccines and

also as a moisturizer in cosmetic products. It is primarily gotten from

shark livers—a fact that has upset conservation groups worried about

endangered

shark populations. Some companies, like Unilever and L’Oréal, have agreed

to stop using squalene in cosmetic products.

Debate has raged for years about whether or not squalene is responsible

for Gulf War syndrome. Most research suggests that’s not the case, but in

recent years much more solid evidence has found squalene can cause autoimmune

diseases like lupus and rheumatoid arthritis in animals.

Still other questions have been raised about polysorbate 80, another

component of the H1N1 vaccine adjuvant. Studies have found it can cause severe

allergic reactions and hypersensitivity.

In the end, we might only get a good picture of the vaccine’s side effects

long after swine flu has run its course. Then again, with Canada’s lax

monitoring system for side effects, we may never know which was worse.