Scaremongering or Responsible Citizenship? Cervical cancer vaccination – a case in point

Leona’s Blog –
Musings of an Ordinary Woman

June 22, 2009

Singaporeans – including the silver surfers or baby boomers – are increasingly sceptical about the safety and efficacy of drugs.  And they are using the internet to pass – and spread – their own verdicts on drugs.  Is this form of online citizenship harmful or a welcome addition to what’s published in the media?  The verdict is still out.  Should drug firms respond to allegations carried in internet mass mails the way they would to those published in the forum pages of newspapers?  This would entail investment in social media marketing, which is a nascent field in Singapore, especially where pharmaceutical companies are concerned.  What if the allegations were fabricated by the drug firm’s competitors?  Is there a basis for taking legal action against the rumour-mongers?  After all, it is well known that the competition between drug manufacturers can sometimes be vicious.  GSK (Ceverix) and MSD (Gardasil), for example, are engaged in a dog-eats-dog competition to out-vaccinate each other.  Do consumers deserve to receive all kinds of emails – even those that are not fact-based?

My thoughts?  Let the reader judge for himself/herself, after careful consultation with a credible third-party.

I received the following email today from an alumni network:

“Hey xxx

Can you warn your boys if any of their wives/daughters are planning to get a vaccine against cervical cancer via Gardasil.

Please let them know it is not advised at this point in time.

This can be given to the male gender as well to prevent transmission.

Merck is trying to get approval for male gender to receive this vaccine as well.

Let them sort out the situation first.


CDC Takes Closer Look at Gardasil and Paralysis

March 20, 2009 06:08 PM ET

Gardasil vaccine

Phil Tetlock and Barbara Mellers were in a race against time to save their 15-year-old daughter, Jenny. As I reported last summer, Jenny developed a degenerative muscle disease nearly two years ago, soon after being vaccinated against the cervical-cancer-causing HPV. She became nearly completely paralyzed, though her mind was perfectly intact and she could still enjoy her pet parakeet, Hannah Montana, and Twilight.

I’ve been E-mailing Phil regularly over the past year, and up until our last E-mail, one week ago, he had been holding out hope that they would be able to find a cure for his daughter or to at least determine if the human papillomavirus vaccine called Gardasil had caused his daughter’s illness, most likely a juvenile form of amyotrophic lateral sclerosis (aka Lou Gehrig’s disease). Sadly, the clock ran out last Sunday, and Jenny passed away.

Through their efforts to publicize Jenny’s case on their blog, Jenny’s parents have connected with two other sets of parents whose daughters developed what appears to be ALS after being injected with Gardasil. One was 22-year-old Whitney Baird, who died last August, just 13 months after receiving Gardasil. Another is Alicia Olund, a 12-year-old who began having trouble walking after getting her third shot last September. She now uses leg braces and a walker at home as her muscles continue to deteriorate. After ruling out other conditions, her specialists at the University of California-San Francisco Medical Centerwho also treated Jenny suspect that Alicia may have the same condition. “They don’t know what she has,” her mother, Barbara, tells me through tears, “but it’s destroying her nerves and muscles, and none of the treatments they’ve given her are working. Before the vaccine, she was a perfectly healthy child, going for her brown belt in karate.” (They’re awaiting the results of the ALS test.)

I should point out that juvenile ALS is extremely rare, affecting just 1 in 2 million young people. It’s impossible to say at this point whether these girls would have developed the condition regardless of whether they received Gardasil, but government officials who still strongly maintain that the vaccine is perfectly safe and potentially lifesaving are now starting to investigate. Scientists from the Food and Drug Administration met recently with Jenny’s neurologists at UCSF to discuss whether it’s scientifically plausible for a vaccine to trigger ALS. And the Centers for Disease Control and Prevention is planning to scour its adverse-event database, called VAERS, to see whether other vaccinations have led to reports of ALS or other severe neurological complications.

Turns out, warnings concerning ALS and vaccines have been raised before. John Islander, the CDC’s associate director for immunization safety, tells me the agency previously has received reports of ALS following the anthrax vaccine. This, in addition to the deaths of Jenny and Whitney, “kind of tells us that we need to look more broadly at this issue,” he says. He’s quick to add that “we’re doing just an initial review at this point; we don’t have suspicions that these are casually related.”

Merck, the manufacturer of Gardasil, maintains that its vaccine is extremely safe and points out that it could potentially save women from dying of cervical cancer.

“There are unusual and rare diseases that occur in girls and women in this age group whether they’re vaccinated or not,” says Rick Haut, Merck’s head of the clinical program for Gardasil. “These patterns don’t indicate any causality.” He says no cases of ALS occurred in Merck’s clinical trials but also admits that the trials which included thousands, not millions weren’t large enough to detect such rare diseases.

Barbara Shapiro, an ALS expert and associate professor of neurology at Case Western Reserve University School of Medicine who was enlisted by a mutual friend to help the Fetlocks do their research, isn’t ready to dismiss the cases as pure coincidence. She’s pored over the medical records of Jenny, Whitney, and Alicia and sees a striking similarity. “Juvenile ALS tends to progress very slowly over years or even decades, but these girls all seemed to have a more rapid, progressive form.” She also has uncovered another VAERS report in the CDC database that could be similar, but since it was filed by a pharmacist, the CDC told her it doesn’t have details on the girl’s identity. Shapiro worries that there may be more cases out there that the CDC doesn’t know about.



Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.