Skip to comments.CDC Takes Closer Look at Gardasil and Paralysis
Posted on 03/23/2009 7:21:08 AM PDT by BGHater
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 daughteror 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 Jennysuspect 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 officialswho still strongly maintain that the vaccine is perfectly safe and potentially lifesavingare 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 Iskander, 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 Haupt, 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 trialswhich included thousands, not millionsweren'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 Tetlocks 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.
After all, she tells me, both Whitney and Alicia came to the CDC's attention only after their parents discovered Jenny's blog and Phil Tetlock urged them to file a VAERS report. This system of voluntary reporting of adverse events related to vaccines by doctors and patients is notoriously crude. All too often, adverse events go unreported, whereas many reports that are filed turn out not to be related at all to the vaccines. When I point this out to Iskander, he tells me that while VAERS certainly isn't perfect, it's pretty good at catching rare events.
But what if doctors wouldn ' t think to link the onset of ALS with a vaccination? I press him. "Reports in the media, such as the one you're doing, are a good trigger to get doctors to file reports," he responds. In fact, largely because of media attention, reports of adverse events for Gardasil are about five times as high as the overall average for any vaccine, he adds. So I suppose he's hoping that if there are other girls out there who developed severe physical disabilities after receiving Gardasil, they'll soon be entered into the VAERS database.
Still, I'm troubled by the complexities of all of this. How will the CDC ever be able to know whether there's a true connection between Gardasil and ALS if this disease is so rare? And just how much evidence is needed? Iskander tells me he doesn't make that decision but passes on all the information he has to the government's vaccine working group, which makes recommendations about the national immunization schedule. "They are aware of these cases and that we've started discussions with neurologists and immunologists to determine if there are mechanisms that could explain how a vaccine could cause ALS," Iskander says, adding that "I haven't heard a good answer yet from these experts" when it comes to explaining a mechanism.
Shapiro says her suspicions are raised enough that she's decided not to give her own 11-year-old daughter the Gardasil vaccine. "Let's say it causes just one or two cases of ALS every year out of a million doses that are given. What if your daughter is the one?"
I haven't decided yet whether I want to have my own teenage daughter vaccinated. The arguments for Gardasil are compelling: It protects against viruses responsible for 70 percent of cervical cancers, which still kill many women in this country. Since the vaccine is so new, until more evidence emerges I think it may be prudent for concerned parents to consider holding off until their daughters reach the verge of sexual activity.
Good question. My only comment to that would be there is very little difference, except there are some out there wanting to make gardasil a requirement.
Correct if I am wrong, but why would they want to require girls to get the vaccine and not boys...they are carriers too. Either way, I wouldn’t let my kid get the vaccine.
But then, that would have cut into their sales because our overlords all know that such concepts are so unrealistic and out of date.
“(1996): “Each year, use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) accounts for an estimated 7,600 deaths and 76,000 hospitalizations in the United States.” (NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, ketoprofen, and tiaprofenic acid.)
Source: Robyn Tamblyn, PhD; Laeora Berkson, MD, MHPE, FRCPC; W. Dale Jauphinee, MD, FRCPC; David Gayton, MD, PhD, FRCPC; Roland Grad, MD, MSc; Allen Huang, MD, FRCPC; Lisa Isaac, PhD; Peter McLeod, MD, FRCPC; and Linda Snell, MD, MHPE, FRCPC, “Unnecessary Prescribing of NSAIDs and the Management of NSAID-Related Gastropathy in Medical Practice,” Annals of Internal Medicine (Washington, DC: American College of Physicians, 1997), September 15, 1997, 127:429-438, from the web at http://www.acponline.org/journals/annals/15sep97/nsaid.htm, last accessed Feb. 14, 2001, citing Fries, JF, “Assessing and understanding patient risk,” Scandinavian Journal of Rheumatology Supplement, 1992;92:21-4.
Fair enough, but there are alternatives to aspirin. If a parent thinks his or her daughter is at low risk for VD because she was taught to abstain, I don’t see why they should subject their child to this risk. Poor girl.
Gardasil PING to the Mom’s...........
And they have succeeded in places. Virginia requires it for girls entering 6th grade, which my daughter will be doing in September. However, we will be opting her out of the vaccine, as is permitted under the requirement law.
does the vaccine work on boys?
I have nothing against young women (18+ or even 16+) getting this vaccine to protect against exactly what you are saying here. My entire objection to this is the government mandating it for 11 years olds.
Sure. But, really, the risk seems fairly low if one is good about getting pap smears.
About 3,870 women will die from cervical cancer in the United States during 2008. Cervical cancer was once one of the most common causes of cancer death for American women. The cervical cancer death rate declined by 74% between 1955 and 1992. The main reason for this change is the increased use of the Pap test.
They don’t know, because it wasn’t tested on boys, just girls, primarily because men can’t get cervical cancer.
It will if you “boy” has a cervix I suppose.
and that is another concern in regard to this vaccine --- a false sense of protection. The vaccine does not protect against all strains of HPV that have a causal link to cervical cancer. The concern is more women will fore go having pap smears, possibly resulting in increased numbers of cervical cancers.
silly are we? if it is designed to kill whatever causes cervical cancer why would it not work on both genders, including the carrier?
pinging for actual medical input, not silliness.
“”Let’s say it causes just one or two cases of ALS every year out of a million doses that are given. What if your daughter is the one?””
How many daughters does cervical cancer kill?
And they can't get pregnant, either. Funny about how that affects one's behavioral choices, don't you think? The obvious negative consequences of screwing around are pretty d*mn one-sided ... so why aren't we telling girls this?
Oh come on! I am so sick of hearing the holier than thou parents on FR talking about how this wouldn’t be a problem if other people’s daughters abstain.
Ridiculous and it is ignorant.
YOUR daughter can abstain all day, let’s just hope your daughter’s HUSBAND does as well.
Of course they will mysterio! And we all know that good little Freepers will have good little children who will marry good little men.
(that was total sarcasm by the way)
They recomend getting the vaccine up to 25 years old so after I had my girl the doctor asked if I wanted to have the vaccine. When she was telling me about it she said that at my age it would be useful more if I were going to have more sexual partners. I figured I would go ahead and be happy with the partner I already have and I declined. It makes me feel like they are using it more for protection against some std’s and passing it off as protection against cervical cancer. No matter the protection it provides, our daughters need to know more about the risks.
Very well stated! You’re absolutely right...just because one person abstains, doesn’t mean that the other has.
Ummm, so your answer to not getting vaccinate is that the cancer probably won’t kill you if you catch it early enough?
Which is ridiculous IMO because they have found that oral cancer is also linked to HPV. Boys should at least have the option as well.
As long as they marry men who are also virgins. If they marry a man who had unprotected sex with a woman who was infected with HPV, they will probably be infected. Planning to remain a virgin until marriage is a lofty goal, often not achieved.
The vaccine hasn’t been completely tested in males yet, but it is in trials.
Because it is not in the best interest of the Pharma industry.
See slides 15-18. Guillian Barre is one of the causes people are linking the vaccine to, yet the incidence with the vaccine is the same as without.
As for VAERS, anyone can file a report. I can get a tetanus vaccine, and report that a week later I developed heart failure afterwards. That doesn’t prove a correlation, but the general public seems to think that if it’s in VAERS, it’s true. These are unsubstantiated reports, and must be viewed that way.
I’m not saying that Gardisil is NOT causing paralysis, but rather it has yet to be proven.
Also keep in mind that ANY substance which is introduced into the body carries with it the potential for an adverse reaction, some of which are severe in an extremely small percentage of the population.
Or all the males who want promiscuous young girls available.
So many idjits, so little time.
I agree with you. However, there is no option for boys/men because it has not been tested on them. This is not a cervical cancer vaccine, it is a vaccine against some STDs, some of which cause genital warts and others cause cervical cancer.
My opposition to this vaccine really has nothing to do with the morals of young girls, including my own daughter, but rather the lack of morals displayed by Merck in pushing to have this vaccine added to the list of mandated vaccines.
I see absolutely no need for this to be forced upon 11 year olds, and my daughter will not be getting it this summer.
I’ll stick with my criticism of Big Pharma :) (at least for now)
Given Merck’s antics with Gardasil, that’s more than fair.
Particularly when we have an enemedia culture pushing the notion that people are no different from Tom Cats and anyone who behaves differently is abnormal.
But there was a time in the not so distant past when what my wife and I did was perfectly normal. And, so far, we're batting 1.000 with our three daughters and one son-in-law, the youngest of whom turns 20 next month.
Last week I saw an ad for it. I wanted to throw something at the TV. Not a single mention of the fact that HPV is an STD, just that some HPVs can cause cervical cancer.
so a cervix isn’t a prerequisite, i assume?
I believe this has something to do with the cell types lining the cervical area...which is easier for the tumor cell to take hold. 90% of cervical cancers are squamous cell carcinomas, which are slow growing malignant tumors found in lungs and skin, and also occuring in the anus, cervix, larynx, nose, and bladder. Apparently the disease does not hit the men’s pelvic area the same way it does ours, to cause cancer.
I am also a mother of a 14 year old daughter. I took her to get the vaccine last year. I was worried that even if she did abstain, her eventual marriage partner might not.
CJ is a physician, which is why i pinged him to answer the question as to whether the vaccine would be effective in males. I am the mother of 14 and 20 yo females. my 20 yo turned it down on her own, at the gynecologist, as we had fully discussed it. i declined it on behalf of my 14 yo. we are not ignorant, my husband and i are both lawyers, we are informed.
I'm saying that the danger posed by cervical cancer is perhaps not large enough to justify the risk taken by getting the vaccine. I have no daughters and people need to make their own risk assessment.
Perhaps we'd be better off spending the money on defensive driving courses for our teens, or on looking for safer alternatives to aspirin.
Thanks for your response. I too got informed, and weighed it out. I gave my daughter the option to decline, while informing her of the skyrocketting cervical cancer rates.
I let her make the decision and she had my full support. I pray every day, that it was the right decision, on both our parts.
It takes good parents to stay informed, and too keep their kids informed.
as gabz pointed out, the only real problem with this is the mandatory road they want to go down. it should be up people to make informed decisions on these sorts of things. by the time my daughters are ready to become sexually active, perhaps there will have been progress made in vaccinating male carriers of the organism, as well.
It’s only approved in females ages 11-26. It’s in Phase III trials in boys. The consequences of HPV infection are much more severe in women - cervical or vulvar cancers. Uncircumcised males can develop squamous cell cancer of the penis, but much later in life than women develop cervical cancer. Squamous cell cancer of the anus can occur in both men and women, but more commonly in HIV-infected individuals.
Someone mentioned oral-pharyngeal cancer earlier. That can occur in both males and females regardless of smoking or dipping history, or HIV status.
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