Saturday, January 30, 2016

Michele Bachmann, please pick up the white courtesy phone

Do you remember this?
Michele Bachmann is still defending her opposition to the vaccine that prevents HPV, the leading cause of cervical cancer. At a campaign event in Sheldon, Iowa on Monday night, she sympathized with a mother who believes her daughter Jessica, now 16, has been debilitated by headaches, pains and seizures brought on by the vaccine three years ago and can no longer attend school.

"Michele, on behalf of myself and a lot of other mothers that have a child that’s sick from the Gardasil vaccine, I would like to thank you for the attention that you brought to it," Julie Wepple said, according to the Des Moines Register.

Bachmann thanked Wepple for bringing up the vaccine issue. "Parents have to make that decision for their kids because it isn't the schools that are going to follow up with Jessica," she said. "It isn’t the schools that live with Jessica every day. It’s Jessica who’s having to have her body live with the ravages of this vaccine."
Bachmann got hooted off the stage for her antics. I don't have a problem with her being out of public life, for a variety of reasons, but it's worth noting this development, four years on:

The American College of Pediatricians (The College) is committed to the health and well-being of children, including prevention of disease by vaccines. It has recently come to the attention of the College that one of the recommended vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause. There have been two case report series (3 cases each) published since 2013 in which post-menarcheal adolescent girls developed laboratory documented POF within weeks to several years of receiving Gardasil, a four-strain human papillomavirus vaccine (HPV4).1,2 Adverse events that occur after vaccines are frequently not caused by the vaccine and there has not been a noticeable rise in POF cases in the last 9 years since HPV4 vaccine has been widely used.

Nevertheless there are legitimate concerns that should be addressed: (1) long-term ovarian function was not assessed in either the original rat safety studies3,4 or in the human vaccine trials, (2) most primary care physicians are probably unaware of a possible association between HPV4 and POF and may not consider reporting POF cases or prolonged amenorrhea (missing menstrual periods) to the Vaccine Adverse Event Reporting System (VAERS), (3) potential mechanisms of action have been postulated based on autoimmune associations with the aluminum adjuvant used1 and previously documented ovarian toxicity in rats from another component, polysorbate 80,2 and (4) since licensure of Gardasil® in 2006, there have been about 213 VAERS reports (per the publicly available CDC WONDER VAERS database) involving amenorrhea, POF or premature menopause, 88% of which have been associated with Gardasil®.5 The two-strain HPV2, CervarixTM, was licensed late in 2009 and accounts for 4.7 % of VAERS amenorrhea reports since 2006, and 8.5% of those reports from February 2010 through May 2015. This compares to the pre-HPV vaccine period from 1990 to 2006 during which no cases of POF or premature menopause and 32 cases of amenorrhea were reported to VAERS.
Long and the short of it -- there will need to be more testing, especially more longitudinal testing, but this isn't looking good for those who have called for this vaccine to be mandatory.

Bachmann was trying to gain a political advantage over Rick Perry, who had ordered girls from Texas to get the vaccine. I thought she was playing a dangerous game then, but there's a reason why categorical judgments sometimes bite us in the butt years later.

3 comments:

Brian said...

1) rats are a lousy model for long term ovarian function.
2) "possible association" = somebody thinks it is possible and no one has proven it
3) "potential mechanism of action" = see point 2
4) 213 VAERS reports in a decade for a vaccine administered to to roughly 40% of teenage girls is actually...quite good, and that's without parsing the word "associated"

Finally and most importantly, the American College of Pediatricians is a social conservative organization of a couple hundred doctors (contrast with the 60,000-member American Academy of Pediatrics, no small number of whom are very likely themselves card carrying Christians, conservatives, and/or Republicans) that are widely known to misrepresent research to advance a socially conservative agenda.

Mr. D said...

Hope you are right, Brian.

Bike Bubba said...

My view is that the biggest issue with Gardasil is the political games they've played with it--yes, eventually on both sides, but starting really with the proponents. You had a vaccine that could have, if properly administered, eliminate about 70% of HPV infections among teens, and you simply jam it into the mandatory vaccines instead of letting people explain themselves?

Really, it's a PR move that reminds me of little so much as the "click it or ticket" campaigns they make for seatbelts.