By Alex Roslin
November 19, 2009
The Georgia Straight
[see the story at the Straight website]
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 [see sidebar, below].
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
dud”.
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.”
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 document”.
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?” 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 maturation”. 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.”
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 vaccine”.
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 reactions”. 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 vaccination”.
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 “flimsy”.
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.”
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 [see here, here, here and here] 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 [see here, here and here].
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.
Chris
Shaw's Key Findings
UBC neuroscientist Chris Shaw’s research raises serious questions about a substance used in many vaccines for decades and long thought to be safe—aluminum salt.
UBC neuroscientist Chris Shaw’s research raises serious questions about a substance used in many vaccines for decades and long thought to be safe—aluminum salt.
Shaw started out looking for an
explanation for high rates of ALS among
soldiers with Gulf War syndrome.
He found that mice injected with aluminum
salt showed symptoms similar to ALS —motor-neuron
loss and neuroinflammation in parts of the spinal chord.
His studies [see here and here] conclude
the soldiers may have gotten ALS from
the aluminum present in the cocktail of vaccines they were given before being
deployed to the Mideast in 1991.
Aluminum salt isn’t present in the H1N1
vaccine, but it is present in nearly half of all vaccines licensed in Canada .
Yet, Shaw said no one has followed up on his study to his knowledge. “It’s one of those topics that’s seen as problematic,” he said. “The lack of official curiosity is kind of disturbing.”
Yet, Shaw said no one has followed up on his study to his knowledge. “It’s one of those topics that’s seen as problematic,” he said. “The lack of official curiosity is kind of disturbing.”