HPV Vaccine Unsafe? Pediatricians Weighed In

Written by Brandon Betancourt

Recently, a parent of one of our patients sent us a link regarding the Gardasil (HPV) vaccine and the claim that it doesn’t protect against cervical cancer.  The headline of the article the parent sent me is titled “Merck Researcher Admits: Gardasil Guards Against Almost Nothing.”

I had never heard of this claim before, so I asked a group of pediatricians what they made of this allegation and if they knew Dr. Diane Harper, the person quoted in the blog post. I also asked if they had any thoughts on the article itself; which was posted by the Population Research Institute, a non-profit organization tasked to debunk the myth of overpopulation.

I got quite bit of feedback that I’d like to share with you because I think it is important for objective individuals to dissect these claims and set the record straight.

By the way, if you would like to read the actual article by the non-profit that makes the claims, you can Google it. I really don’t want to send any traffic to the site. So I’m only going to quote on the pieces that the pediatricians commented on.

The first one to respond, was Dr. Zurhellen. He had an issue with this line from the article:

“…1 out of 912 who received Gardasil in the study died.”

Here is Dr. Zurhellen’s response to that:

If, really, 1 out of 912 girls vaccinated…died…from the vaccine…could this be hidden from us ?  Since over 38 million doses have been given, and that probably represents about fifteen million women/girls…that would translate as sixteen thousand (rough round-offs…) deaths.    Where was the media coverage of 16,000 vaccine deaths?  Nowhere since it did not happen.

Dr. Berman had a very practical analogy that actually makes a lot of sense:

This is kind of like saying seat belts don’t do a thing to prevent drunk driving, so what good are they?

Dr. Horowitz emphasized that in order to deconstruct Dr. Harper’s claims, one needs to understand how medical studies are done, understand the natural history of diseases or medical statistics.

For example, he quoted this from the article

70% of HPV infections resolve themselves without treatment in one year. After two years, this rate climbs to 90%. Of the remaining 10% of HPV infections, only half coincide with the development of cervical cancer.

And had this to say:

So let’s do the math: “only” 5% of cases of HPV infection are associated with cervical cancer. Given infection rates of about 50%, this amounts to 2.5% of the total female population at risk for cervical cancer. This is an enormous number of women.  In the millions…

Dr Horowitz had an issue with this statement as well:

“the death rate from cervical cancer continues to decline by nearly 4% each year.” Let’s do the math. If the 4% annual decline in cervical cancer death continues, in 60 years there will have been a 91.4% decline in cervical cancer death just from current cancer monitoring and treatment.

So let’s attribute this to better overall medical care in general, and earlier detection specifically. However, it is ludicrous to expect this diminution of death rates to continue forever. You may be able to squeeze 2 qts. of water out of a sponge, but it is silly to think that this is a linear relationship, with the amount of water per effort being the same with the 1st squeeze and the 10th.

“The rate of serious adverse events is greater than the incidence rate of cervical cancer.” 

Unfortunately, she shows her ignorance in not understanding what a serious adverse event is. I believe that every kid who fainted had a (serious?) adverse event.

Dr. Lessin added:

A serious adverse event is defined by the FDA as one that causes hospitalization or death.  Extremely few were reported.  The FDA also requires that every event that happens after a research intervention be reported.  This is why you see ear infections as a side effect of many medications.  Clearly there is no causal relationship other than the person got an ear infection around the time of the trial.

Others weighed in as well.

I tried to learn a bit more about Dr. Diane Harper and found numerous articles where she says was misquoted quite badly in other articles, some of which were picked up by the likes of CBS and MSNBC.

… there is some accuracy mixed in with what I would consider a careless disregard for fact. For example, of the 15,000 (now 19,000, depending on the article), adverse effects reported to the CDC, 94% were non-serious, such as swelling around the vaccine point or fainting after receiving the vaccine. Of the 6% that were serious, they have been closely monitored. Of the 23 deaths reported since the vaccine was introduced, none of the deaths were linked to the vaccine.

John Canning shared a Medscape article titled HPV Vaccine Deemed Safe and Effective, Despite Reports of Adverse Events (if you click on the link, Medscape will ask you to signup. But if you Google the title of the article, you can go directly to the article.)

The article is interesting and I encourage you to read it, but in essence, it concludes with this:

“Based on ongoing assessments of vaccine safety information, the FDA and CDC continue to find that Gardasil is a safe and effective vaccine,” the agencies said in a statement released on July 22, 2008. “The benefits continue to outweigh the risks,” they said. “This vaccine is an important cervical cancer prevention tool,” they added.

The takeaway is this

The HPV vaccine is highly effective in preventing four types of HPV in young women who have not been previously exposed to HPV. This vaccine targets HPV types that cause up to 70% of all cervical cancers and about 90% of genital warts.

Moreover, the vaccine has been licensed by the FDA as safe and effective. This vaccine has been tested in thousands of females (9 to 26 years of age) around the world. These studies have shown no serious side effects.

Dr. Harper was very likely misquoted.  If not, then she clearly does not understand statistics or causation and draws conclusions based on her opinion, rather than the facts.

To read more, visit the CDC’s website or click on this link.

Brandon is a practice administrator. He blogs regularly on practice management issues at PediatricInc.com. He and his wife (a pediatrician) are pro-vaccine and have vaccinated their  3 children with all the age appropriate vaccines. 

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