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CDC Takes Closer Look at Gardasil and Paralysis
US News & World Report ^ | 20 Mar 2009 | Deborah Kotz

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 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 Center—who 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 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 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 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.


TOPICS: Health/Medicine; Science; Society
KEYWORDS: cdc; cervicalcancer; corporatism; gardasil; hpv; hpvvaccine; vaccine
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To: Dianna

Yes! You’re absolutely right! Sorry I didn’t catch it the first time.

Thank you.


61 posted on 03/23/2009 1:05:17 PM PDT by Atom Smasher
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To: mysterio; MamaTexan; Paleo Conservative; ConservaTexan; Politicalmom; CindyDawg; BykrBayb; ...

Pap tests will still be needed and those girls should be getting them anyway.

Someone recently posted some statistics that most of the cases of cervical cancer occurred in women who either have not had a PAP test in the last 5 years and/or are extremely sexually active, as in prostitutes.

There is the added risk factor that excessive exposure to sperm increases the chance of cervical cancer.

Offer the vaccine? Sure. Mandate it? NEVER!


62 posted on 03/23/2009 2:38:20 PM PDT by metmom (Welfare was never meant to be a career choice.)
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To: mysterio

20,000 deaths per year from asprin? Where’d you get those figures?

A quick google search gives these, which includes all NSAIDS, not just aspirin.

(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.

http://drugwarfacts.org/cms/?q=node/30

You just lost major amounts of credibility unless you can provide statistics which support your statement.


63 posted on 03/23/2009 2:44:03 PM PDT by metmom (Welfare was never meant to be a career choice.)
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To: AD from SpringBay

Bad statistics.....

See post 63


64 posted on 03/23/2009 2:44:52 PM PDT by metmom (Welfare was never meant to be a career choice.)
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To: mysterio; AD from SpringBay

It’s not anti-vaccine hysteria.

It’s reasonable concern over a vaccine that has yet to prove it’s worth that has been reported to be causing a fairly high rate of serious side-effects.

How about teaching boys to keep their pants zipped, or get the vaccine themselves?


65 posted on 03/23/2009 2:47:48 PM PDT by metmom (Welfare was never meant to be a career choice.)
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To: BGHater; minor49er

I’ve never liked this vaccine. It was rushed to market; the pressure to be vaccinated is intense. Regular pap tests are all that’s needed.


66 posted on 03/23/2009 2:58:18 PM PDT by ContraryMary (New Jersey -- Superfund cleanup capital of the U.S.A.)
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To: Tax-chick; Gabz
Given Merck’s antics with Gardasil, that’s more than fair.

Heck, given that it's Merck......

67 posted on 03/23/2009 3:09:58 PM PDT by metmom (Welfare was never meant to be a career choice.)
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To: metmom
I was wrong. The 7,600 number is the correct figure. The 20,000 number came from a search I didn't spend much time on because I was busy.

However, the vaccine is safe. The anti-vaccine crowd swarms all over the internet spreading misinformation, and that gets people sick or dead when they could have been safely vaccinated.

I'm not advocating forcing some kid to get Gardasil. But I will refute anti-vaccine hyperbole every time I see it.
68 posted on 03/23/2009 3:58:49 PM PDT by mysterio
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To: metmom

Sure, teach your kids not to have sex. That’s fine by me.


69 posted on 03/23/2009 4:03:53 PM PDT by mysterio
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To: mysterio

The vaccine is safe??????? and you know this for a certainty, how?????? That is as definitive a statement as your 20,000 die each year from aspirin statement.


70 posted on 03/23/2009 5:05:08 PM PDT by Arizona Carolyn
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To: mysterio

It’s safety has yet to be established, and people opposed to a relatively untested vaccine administered to a group of people who it hasn’t been tested on, are not *anti-vaccine*.

If you read the posts, for the most part, the objections are to mandating it for a condition for which it may not be really effective and which is not nearly as fatal as it could be if other less risky health practices were followed.

The whole anti-vaccine label attached to people who have reasonable concerns about something is hyperbole at it’s worst. You’d find a lot more people willing to listen if you’d quit with the blanket labels when they express legitimate concerns.

If you want your kids to get the vaccine, knock yourself out. Just don’t demand that everyone else do it because you think they should and don’t go hysterically mislabeling everyone as *anti-vaccine* as if they oppose them all, when they are merely being cautious about one.


71 posted on 03/23/2009 6:15:19 PM PDT by metmom (Welfare was never meant to be a career choice.)
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To: metmom
There have been 7,803 adverse side effects for 13.5 million doses according to this source. That's .06 percent.
72 posted on 03/23/2009 6:29:32 PM PDT by mysterio
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To: mysterio

See 72.


73 posted on 03/23/2009 6:31:13 PM PDT by mysterio
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To: Arizona Carolyn

See 72.


74 posted on 03/23/2009 6:31:33 PM PDT by mysterio
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To: Atom Smasher

Well, if all of the girls abstained, who are the boys doing it with?

And why not have the same expectation of boys, to abstain.

Finally, along with a criminal background, credit history, we will have to have thorough medical checkups before hopping into bed with someone.


75 posted on 03/23/2009 6:38:20 PM PDT by ican'tbelieveit ((Join FreeRepublic's Folding@Home team (Team# 36120), KW:Folding))
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To: ican'tbelieveit

The only reason I brought up girls was because I have a 14 year old daughter. I would sure hope that young men (teens) are getting the same advice.

And you’re right, it is going to get to that point...its going to get to where you can’t kiss anyone anymore unless a piece of plastic or some other material goes up between each others mouths.

How sickening that its gotten this out of hand.


76 posted on 03/23/2009 7:41:00 PM PDT by Atom Smasher
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To: Atom Smasher

I have a 17yo daughter and a 19yo son. I hope that neither get hurt.


77 posted on 03/24/2009 9:45:28 AM PDT by ican'tbelieveit ((Join FreeRepublic's Folding@Home team (Team# 36120), KW:Folding))
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To: ican'tbelieveit

Your children are in my prayers. I used to say “well, if the parents would this or that...” and you know what, the parents are 3/4 of a child’s influence, and peers are the other 1/4...or sadly to say, sometimes 1/2 or more. I just continually remind my daughter of the dangers and pray to God that he watches over her.

It’s good to know there are still a lot of good parents out there in today’s society.


78 posted on 03/24/2009 4:38:13 PM PDT by Atom Smasher
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To: Atom Smasher

I home schooled. We are so far ahead of the game. I cannot begin to impress on parents the difference their relationship would be with their children if they didn’t put them in a public school.

I remember not being able to talk to my mom about anything. One, she flat out told me I was exaggerating; she didn’t quite have a grasp of the peer pressure. But our relationship was so confrontational.

A majority of the time, I can have fantastic conversations with my daughter. There are still the teenage hormonal moments, but they are brief and easily forgiven.


79 posted on 03/24/2009 4:43:51 PM PDT by ican'tbelieveit ((Join FreeRepublic's Folding@Home team (Team# 36120), KW:Folding))
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To: ican'tbelieveit

I envy your foresight. I feel like I’ve done everything pretty much right, but now I’m starting to look like the bad guy when I am forbidding my daughter to associate with bad apples.....but I don’t care.

We have only 1 chance to do right by our kids, and we owe that to them.

Ping!


80 posted on 03/24/2009 4:50:11 PM PDT by Atom Smasher
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