Fear-Mongering on Gardasil

Fear-Mongering on Gardasil

Rachel Walden

There may be serious issues with Gardasil that warrant a new assessment of the risks and benefits. But incomplete and inaccurate reporting does nothing to assist women and families in making decisions about vaccination and safety.

Combine
girls, vaccines, and sex, and you apparently get a recipe for
sensationalism and poor reporting. CNN last week featured a piece, "Should parents worry about HPV vaccine?"
which notes that "Gardasil has been the subject of 7,802 ‘adverse
event’ reports from the time the Food and Drug Administration approved
its use two years ago."

What the article doesn’t explain is how the Vaccine Adverse Event Reporting System (VAERS)
system works. Reports to VAERS can be submitted by anyone, and are not
verified or definitively linked to the vaccine without further
investigation. This understanding was not demonstrated by the piece,
which simply conceded,

"The company said in a
statement that an adverse event report ‘does not mean that a causal
relationship between an event and vaccination has been established —
just that the event occurred after vaccination.’"

This
phrasing makes it seem as though it’s just the company (that stands to
make money) that believes that reports don’t indicate a causal
relationship – it seems designed to make the average reader believe
that this characterization is just the vaccine maker protecting its
financial interests. While Our Bodies, Ourselves often points out ways in which
pharmaceutical companies and medical device companies prioritize their
own financial interests above people’s health, in this instance the
company is simply explaining how the reporting system works.
 
The piece also doesn’t address how this figure compares to
anticipated adverse events estimated from the original studies, how it
compares to the rates of adverse events for other vaccines, or that,
due to the current system, there are always

more/different side
effects reported after a drug is approved (in the "post-marketing"
period) due to the numbers of individuals involved. For example, if a
drug causes death in 1 in 500,000 people, and was tested in 2,000, the
possibility of the drug causing death is not likely to be realized
until it is on the market and prescribed to a large population.

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On the other hand (and unmentioned in the CNN article), many adverse
events may occur that are not reported. "Post-marketing surveillance" –
including analysis of reports from those who have received the drug or
vaccine after it has been approved – is a crucial aspect of
safeguarding the public from dangerous drugs. Because individuals and
physicians may not associate an outcome with the vaccine, and many
individuals may not realize that they are allowed to submit reports directly,
underreporting of effects is both possible and likely. The FDA uses
this surveillance system to make changes to labels, educate physicians
about risks, and re-evaluate their approval of a drug or vaccine, so it
remains important that adverse outcomes are reported, despite the
cautions about making judgments based on raw numbers of reports and
difficulties in later determining which of those outcomes were directly
linked to a specific drug, vaccine, or other product.

Habladora at Feministe has an excellent summary
of how CNN’s piece omitted crucial information in favor of drumming up
parental anxiety, touching on many of these same issues. She notes:

"Finally, CNN presents us with the terrifying story of
a teenager who developed pancreatitis not long after taking the
vaccine. While I am not insensible to how horrifying such a serious
illness would be for a young girl and her family, it should be CNN’s
responsibility to verify whether or not her fear that it was related to
the vaccine could be founded – by researching how many of those
incident reports dealt with pancreatitis, for example, or other
autoimmune diseases. This type of reporting is important, after all,
since it could impact women’s decisions and, consequently, their
health."

This approach is not limited to CNN – Judicial Watch is currently featuring
the large, bolded headline, "Judicial Watch Uncovers New FDA Records
Detailing Ten New Deaths & 140 ‘Serious’ Adverse Events Related to
Gardasil." However, the CDC has reported
that of the 10 deaths they have analyzed, they could not establish a
causal relationship between the vaccine and the deaths, and notes that
"While Gardasil was being tested in the U.S. before it was licensed, 10
people in the group that received the HPV vaccine and 7 people in the
placebo group died during the trials. None of the deaths was considered
vaccine-related."

In their report, Judicial Watch also suggests that Gardasil wasn’t
adequately tested for adverse effects because the comparison placebo
vaccine contained an aluminum "reactive, potentially harmful
substance." Without reading the original studies, this probably makes
the comparison more valid instead of less, because the real vaccine
also contains an aluminum compound (as do many other vaccines), and
omitting it from the placebo vaccine would have skewed the comparison
by confusing adverse effects of the aluminum with adverse effects of
the actual vaccine substance.

I have to wonder if we’d be seeing the same level of fear-mongering
if this were another vaccine, if opponents hadn’t suggested that it
would cause young girls to become sexually active and that girls from "good homes"
don’t get HPV. Yes, of course we should keep watch when a new drug,
vaccine or product is approved and is targeted to women. Of course we
should attempt to tease out real and serious side effects that didn’t
appear in the smaller trials, and be wary of the financial motives
companies have to put the best light on their product. Of course we
should be aware of mandates for vaccination and ensure that adequate
information and opt-out provisions are available. It may still turn out
that there are serious issues with Gardasil that warrant a different
assessment of the risks and benefits. However, incomplete and
inaccurate reporting and misrepresentation of the science does nothing
to assist women and families in making decisions about vaccination and
safety.

For further discussion, see Gardasil: What you need to know about the HPV vaccine and this previous OBOS blog post.

This post originally appeared on Our Bodies, Our Blog

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