Combine girls, vaccines, and sex, and you apparently get a recipe for sensationalism and poor reporting. CNN yesterday featured a piece, “” 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 My 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 read/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.
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 , 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.
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 the large, bolded headline, “Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 ‘Serious’ Adverse Events Related to Gardasil.” However, 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 read 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 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 My blog post.