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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:07 PM
Original message
Family claims cervical-cancer vaccine caused paralysis
Source: Nevada Appeal News Service

Family claims cervical-cancer vaccine caused paralysis

Health Department disputes that determination

by Jo Rafferty
Nevada Appeal News Service
May 17, 2007

Fourteen-year-old Jessica Vega went into the emergency room at Renown Regional Medical Center in Reno on Thursday night when she couldn't move her legs and her arms felt weak. "Her legs are paralyzed, her arms are affected. She is very weak in her arms," said Tondra Vees a family friend. "She has to use a walker. Even with that, she can't get to the bathroom. She can't stand up at all."

Vees said the girl has been determined by her doctor to have Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis.

The girl, whose mother Rhonda Vega is a full-time teacher's aide at Carson Valley Middle School, received her first booster shot of the cervical cancer prevention vaccine Gardasil on May 2. "According to her neurologist, that's what caused this," said Vees,

Nevada State Health Officer Dr. Bradford Lee said the Web sites the Nevada State Health Department checks don't list the girl's symptoms as a side-effect. "We are aware of a report of an alleged side-effect," said Lee. "Based on the CDC's site and the manufacturer's site, this is not a side-effect of the vaccine."

Read more: http://www.nevadaappeal.com/article/20070517/NEWS/105170090



Considering GARDASIL's limited clinical effective (see: http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=909351&mesg_id=909351 ), just a few cases like this per every 10,000 girls vaccinated could make GARDASIL's risks greater than its benefits.

If the CDC won't even report instances like this as a potential side effects, though, we will have to rely on the anecdotal evidence that makes the newspapers.
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rinsd Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:19 PM
Response to Original message
1. Perhaps the mother was influenced by the whackjob anti-vaccine website she went to
"Vees cites a Feb. 21 report on the National Vaccine Information Center Web site, nvic.org, in which NVIC president Barbara Loe Fisher states, "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a TDAP (tetanus-diphtheria-acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre syndrome."

Vees cites that according to nvic.org, the vaccine's manufacturer, Merck & Co., studied Gardasil in fewer than 1,200 girls younger than age 16 in "pre-licensure trials."

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babydollhead Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:29 PM
Response to Reply #1
3. our g.p. was floored when I said "no" for my 11 yr. old
I am NOT doing this to my daughters!
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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:44 PM
Response to Reply #3
9. Since the main research on young girls has only begun (they're accepting
girls into the study until 2008), I think you've made a wise decision.
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antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:51 PM
Response to Reply #9
14. Have people even read the FDA approval letter?
http://www.fda.gov/cber/approvltr/hpvmer060806L.htm

>>
We acknowledge the postmarketing clinical commitments outlined in your submission of June 6, 2006, as follows:

1. You have committed to conduct a short-term safety surveillance study in a U.S. Managed Care Organization (MCO). The study will include approximately 44,000 vaccinated subjects who will be followed for 60 days for assessment of general short-term safety (i.e., emergency room visits, hospitalizations, and deaths). The subjects will also be followed for 6 months subsequent to vaccination for new autoimmune disorders, rheumatologic conditions, or thyroiditis. Also, a sufficient number of children 11-12 years of age will be studied to permit an analysis of safety outcomes. The final study protocol will be submitted by December 31, 2006. Patient accrual will be completed by December 31, 2008. The study will be completed by June 30, 2009. The final study report will be submitted by September 30, 2009.
>>
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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 03:20 PM
Response to Reply #14
18. Merck hasn't been publicizing that much, have they?
:shrug:
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antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 04:01 PM
Response to Reply #18
24. And where is the press coverage? n/t
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Lance_Boyle Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:50 PM
Response to Reply #3
13. Yay for you!
Because the odds of one of your daughters contracting HPV are negligible, right? What? They're not? In fact, your daughters are vastly more likely to contract HPV than to have *any* negative reaction to Gardasil? Well, there's still the "only a small percentage of those infected with HPV develop cervical cancer" thing for you to fall back on...

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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 03:24 PM
Response to Reply #13
19. The real question is not what are the lifetime odds of an 11 year old
contracting HPV, but what are the odds that the girl will contract it BEFORE the research on the vaccine's safety for children is completed.

That parent knows the girl better than we do, and I think the decision was a wise one. Let the safety research be completed, then get the vaccination.

Unless you CHOOSE to be one of the research subjects.
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StarryNite Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 04:21 PM
Response to Reply #13
25. How long will that vaccine
protect a girl/woman for? You don't know, because big pharma doesn't even know. Will it protect against all forms of cervical cancer? No, only some types. How do you know what the chances of getting a negative reaction to the vaccine are when "they" don't even know and that's why it is still being tested?
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 04:58 PM
Response to Reply #13
29. Even if vaccinate your kids before any HPV exposure, assume lifetime protection,
and consider cost beside the point, you have to weigh the vaccine's risks against GARDASIL's limite efficacy against ALL HPV dangerous cancer associated HPV strains, not just the two it protects against.

http://content.nejm.org/cgi/content/full/356/19/1915

Among women who tested negative for both HPV-16 and HPV-18 at enrollment (4693 in the vaccine group and 4703 in the placebo group), high-grade cervical disease developed in 95 subjects in the vaccine group and in 130 in the placebo group, a reduction of nearly 27% in the vaccine group.

That's a reduction of just 35 subjects with eminently treatable lesions over a three year period out of 4700 women vaccinated. That's over 134 subjects vaccinated (at a cost of over $60,000) per woman with high grade lesion(s) prevented. And this is in the previously unexposed group. You must consider these limited benefits against the 1 in X chance that your child reacts severely to the vaccination itself. Of course, if Merck had run its clinical trials using a real inert placebo instead of highly pharmacologically active alum "placebo", then we might be able to accurately assess these risks. Unfortunately, our current belief that Merck's benefits far outweigh its risks is based on faith rather than hard clinical evidence.
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StarryNite Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 03:44 PM
Response to Reply #3
22. You were wise
to not let your daughter become a guinea pig for big pharma. Down the road it may turn out that this vaccine is the best things since sliced bread. But it's way too early for them to know what side effects it holds.
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kimmerspixelated Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 04:48 PM
Response to Reply #3
27. SAme here!
With you on that!!
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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:41 PM
Response to Reply #1
8. Are you suggesting Guillain-Barre syndrome is not real?
Edited on Thu May-17-07 02:42 PM by pnwmom
That this patient is an hysteric?

I think the neurologist is in a better position to judge that than you are.
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rinsd Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:50 PM
Response to Reply #8
12. No, I am suggesting the mother is misinformed by anti-vaccine zealots (nt)
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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 03:27 PM
Response to Reply #12
20. The girl's neurologist says she has G-B, and it happened after the vaccine.
No anti-vaccine zealots were involved. Just a pro-vaccine mother who took her daughter voluntarily in for her SECOND shot of the vaccine, and then watched her collapse.
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 04:41 PM
Response to Reply #1
26. If only this information had been censored like they do in China!
All of this bad corporate publicity then might have been averted!
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Gormy Cuss Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:26 PM
Response to Original message
2. On Guillian-Barre syndrome
Edited on Thu May-17-07 02:27 PM by Gormy Cuss
from NIH, bold emphasis added:
http://www.ninds.nih.gov/disorders/gbs/gbs.htm
What is Guillain-Barre Syndrome?

Guillain-Barré (ghee-yan bah-ray) syndrome is a disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until the muscles cannot be used at all and the patient is almost totally paralyzed. In these cases, the disorder is life-threatening and is considered a medical emergency. The patient is often put on a respirator to assist with breathing. Most patients, however, recover from even the most severe cases of Guillain-Barré syndrome, although some continue to have some degree of weakness. Guillain-Barré syndrome is rare. Usually Guillain-Barré occurs a few days or weeks after the patient has had symptoms of a respiratory or gastrointestinal viral infection. Occasionally, surgery or vaccinations will trigger the syndrome. The disorder can develop over the course of hours or days, or it may take up to 3 to 4 weeks. No one yet knows why Guillain-Barré strikes some people and not others or what sets the disease in motion. What scientists do know is that the body's immune system begins to attack the body itself, causing what is known as an autoimmune disease. Guillain-Barré is called a syndrome rather than a disease because it is not clear that a specific disease-causing agent is involved. Reflexes such as knee jerks are usually lost. Because the signals traveling along the nerve are slower, a nerve conduction velocity (NCV) test can give a doctor clues to aid the diagnosis. The cerebrospinal fluid that bathes the spinal cord and brain contains more protein than usual, so a physician may decide to perform a spinal tap.


It may be the case that the girl's Guillian-Barre was triggered by her Gardasil vaccination but that is not the same as saying this specific vaccination caused the syndrome. Any number of vaccinations have been associated with the onset of Guillian-Barre but as it states in the excerpt no specific disease-causing agent has been identified.

Thus, the state health officer and the manufacturer can say that it is not a known side-effect of this specific vaccine.
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jilln Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:33 PM
Response to Reply #2
5. Let's hope that's what it is...
Because the article says most people recover from even the most severe cases.
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Gormy Cuss Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:41 PM
Response to Reply #5
7. Most do, but it's often a long time before they recover.
Edited on Thu May-17-07 03:28 PM by Gormy Cuss
Think 6 months or more.

on edit: again with NIH's word on the topic:

Guillain-Barré syndrome can be a devastating disorder because of its sudden and unexpected onset. Most people reach the stage of greatest weakness within the first 2 weeks after symptoms appear, and by the third week of the illness 90 percent of all patients are at their weakest. The recovery period may be as little as a few weeks or as long as a few years. About 30 percent of those with Guillain-Barré still have a residual weakness after 3 years. About 3 percent may suffer a relapse of muscle weakness and tingling sensations many years after the initial attack.
[/div}
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jilln Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 03:00 PM
Response to Reply #7
16. Sad, but better than permanent paralysis.
Although I guess there must be other things that would have that effect that last less time too. In any case, I hope it's temporary.
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EvolveOrConvolve Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:31 PM
Response to Original message
4. Relying on anecdotal evidence is the incorrect way to assess any situation
I have a good idea: perhaps we should just ban all vaccines and go back to a "faith based" medical system. Fuck all the people that might die from cervical cancer that might have been saved by getting the vaccine.
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xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:40 PM
Response to Reply #4
6. i like the way you think.
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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:47 PM
Response to Reply #4
10. Or how about waiting to give the youngest girls the vaccination
until the primary research on them has been carried out? It's still in the very earliest stages at this point -- they're still inducting girls into the study.
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antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:53 PM
Response to Reply #10
15. From post #14 above -- the FDA approval letter
http://www.fda.gov/cber/approvltr/hpvmer060806L.htm

>>
We acknowledge the postmarketing clinical commitments outlined in your submission of June 6, 2006, as follows:

1. You have committed to conduct a short-term safety surveillance study in a U.S. Managed Care Organization (MCO). The study will include approximately 44,000 vaccinated subjects who will be followed for 60 days for assessment of general short-term safety (i.e., emergency room visits, hospitalizations, and deaths). The subjects will also be followed for 6 months subsequent to vaccination for new autoimmune disorders, rheumatologic conditions, or thyroiditis. Also, a sufficient number of children 11-12 years of age will be studied to permit an analysis of safety outcomes. The final study protocol will be submitted by December 31, 2006. Patient accrual will be completed by December 31, 2008. The study will be completed by June 30, 2009. The final study report will be submitted by September 30, 2009.
>>
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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 03:19 PM
Response to Reply #15
17. Thanks, antigop, for providing the details. n/t
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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 02:49 PM
Response to Reply #4
11. I guess you would also say
F-- all the people who died from the old DPT vaccine, like my baby sister. They're just part of the anecdotal evidence, right?

Fortunately, others felt differently and that's why we have a much safer DPT vaccine now.
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mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 05:02 PM
Response to Reply #4
31. I have a better idea. Let's just put our faith in every product Merck
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pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 03:41 PM
Response to Original message
21. They have very circular reasoning, don't they?
Edited on Thu May-17-07 04:14 PM by pnwmom
They KNOW that the only side effects are minimal, so when reports of more serious side effects come in, they can't be the result of the vaccine. Why? Because they KNOW that the ONLY side effects are MINIMAL. So the anomalous side effects, when they occur, don't get reported!

This happened to one of my children with the old DPT vaccine. My child had a fever and screaming for a full week after the vaccine (but not a high enough fever to qualify for withholding the vaccine in the future.) My pediatrician claimed that it could not be a side effect of the vaccine. Why? Because it wasn't listed as a potential side effect (only a fever for 48 hours). So he wouldn't report it as an adverse effect. He said it must be a coincidence and that my son must have had some other virus that made him sick for that long.

It was only after that that I learned my own sister had developed encephalitis and died after her third DPT vaccine. My mother had never told me because no one had ever told her that encephalitis was a rare complication of the vaccine. She had always thought that it was just a coincidence that my healthy six month old sister died the day after her well-baby check-up and third DPT shot.

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Truthseeker013 Donating Member (93 posts) Send PM | Profile | Ignore Thu May-17-07 04:01 PM
Response to Original message
23. Damned money-grubbing drug companies...
"It's just part of the statistical curve" I'm sure they'll say. Doesn't help that little girl.
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kimmerspixelated Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 04:52 PM
Response to Reply #23
28. And isn't it odd that
The drug companies and the FDA(or maybe FUCKed DUMB AMERICANS) have grown less and less reliable as a source of HONEST health information in the last 6 or 7 years...gee let me see, why that was when Ther CHIMP arrived!!!Connect the dots! I really despise what the big pharmas and the politicians that support them are doing to the world!
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militaryspouse Donating Member (198 posts) Send PM | Profile | Ignore Thu May-17-07 05:01 PM
Response to Reply #28
30. ..
I don't have the time to find the link but there have been studies shown.. that girls have had serious reactins to the shots..which included seizures. I believe it was around 200. Not sure on the exact number tho...all I know is that it was MORE than a handful of girls that had bad reactions to it.
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notadmblnd Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 05:21 PM
Response to Original message
32. Thanks for posting this..
you've just given me my thesis for my research paper. That the HPV vaccine "Guardisil" is dangerous and should not be mandatory.
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central scrutinizer Donating Member (1000+ posts) Send PM | Profile | Ignore Thu May-17-07 06:01 PM
Response to Original message
33. My 16 year old daughter completed the series two months ago
She has had no side effects at all. While this story is tragic, please be aware that it is an anecdote, not a study. Negative stories are much more likely to be broadcast since they are so tragic.
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jazzinger Donating Member (1 posts) Send PM | Profile | Ignore Sun May-20-07 04:17 PM
Response to Reply #33
34. vaccine
Hi All, This is my first post so I hope I do it right. Anyway, below is a letter I sent to our state rep. here in Nevada, Dina Titus. As far as I am concerned there never is much info out to the public about the drugs the FDA approves. I have been studying this for some time and as a teacher I can't help sharing info. This is a long read with good info. Titus sponsored a bill to mainstream this drug here.................................................


Hi Dina, I must tell you I am very disappointed to see you support this bill. I am enclosing this information from a doctor who has 31 years of clinical practice with woman's issues. You may enjoy her site for your own health issues, www.drerika.com Thanks for you time and I hope maybe this information will change your mind. Peace, Diana Smith 702-876-1926

These are two seperate pieces from Dr. Erika
January,07
I’ve been inundated with questions about the new HPV vaccine. Most e-mails and calls come from mothers of young girls who are confused about what to do with their daughters. It seems that the pediatricians have picked up the drug companies’ baton and are out to immunize every young girl in sight.

Should you vaccinate or shouldn’t you?

I know the CDC in conjunction with the American Cancer Society have been quite diligent about providing FAQs and other informational pamphlets on the topic of the HPV vaccine, its use and recommendations.

However complete and detailed these materials are, keep in mind the final decision is a personal decision and in the case of the HPV vaccine, it falls all in the lap of the parents.

As a parent and a physician I’d like to give you some insight into my own understanding and position on this issue. As a parent, my daughters are 22 and 29 and thus I need not make this difficult decision but as a caring and honest physician I can promise you that my advice is given to you as I would for my own girls.

Relevant Background

* HPV is considered as common as the common cold virus by most practicing physicians in the US. It is that common and that innocuous.
* There are more than 100 strains of HPV
* 60 cause regular non-genital skin warts
* 40 cause genital warts.
* 6 million people get infected yearly with this virus that we know of
* 70% of those infected are clear of any sign of the infection within a 1 year
* 90%  have no sign of infection by 2 years.
* HPV viruses that are associated with a high incidence of cancer (by the way, no one really knows the true statistics of infected healthy people without immune system problems) include HPV 16, 18, 31, 35, 45, 51, 52, 58 and others.
* You cannot distinguish the type of HPV causing a particular infection with normal blood testing
* The HPV vaccine was approved by the FDA a couple of months ago so it has no track record of safety or long term side-effect evaluation
* The vaccine protects from 2 high risk HPV viruses-#16 and 18 which cause 70 % of cervical cancers and HPV #6 and 11, the strains that cause 90% of genital warts


We do not know anything about the vaccine’s long term effectiveness or dangers in general and in specific on American girls. Before its approval by the FDA the vaccine was tested in other countries around the world for only 5 years.

Now that you are a little less scared about being non-compliant by keeping your daughter away from the vaccination, let’s look at a couple of more issues.

So who is at highest risk of getting cervical cancer caused by HPV virus?

Young women- teen to early twenties with multiple sex partners who lack access to preventive and regular Pap smears and routine check-ups.

Let me make it a bit clearer: if my daughters were in the HPV immunizable age group I would not have them immunized with the HPV vaccine.
The reason: Once they became sexually active my daughters started going for regular Pap smears. Pap smears diagnose HPV related problem early and the gynecologist then treats the problem and prevents it from becoming cancer.
Cervical cancer is a disease created by lack of preventive care.
If our girls have routine Pap smears once they are sexually active, they are okay.

If your daughter may not have access to consistent preventive care, if you cannot afford it or you are not sure you can help your daughter get into a supportive and protective health environment, then protect her by immunizing her.

If your daughters are going to get routine PAP smears once they are sexually active,
if they are going to be supported and given encouragement and example to help them develop self-esteem and self-confidence, they will become self- protective and care enough about their bodies and their health not to lead risky lifestyles that expose them to STDs or other abusive situations. In this case they will not need the HPV vaccine.

Besides my concerns with the long term effect of the HPV vaccine I have one last nagging concern I want to share with you.

What message are we giving our daughters if we immunize them at the age of 9 against a sexually transmitted disease? Are we giving them a false sense of security and implicit encouragement for reckless sexual behavior?

You make that decision and don’t let the doctor, the school nurse, the drug rep or your neighbor tell you what to do!
================
       

February 07
Dear Community,

Gov. Rick Perry (R.) of Texas this month signed an order mandating that schoolgirls in his state be given the HPV vaccine. Legislators in other states are pushing similar measures. This is an act of aggression against our daughters who are becoming victims of pharmaceutical greed.

Before you allow your girls to be vaccinated, consider the following information “they” DON"T tell you about this vaccine to be given three different times into the bodies of your daughters...

The HPV vaccine has only been tested for five years on possibly as low as 100,000 ten year old girls in Africa. No one knows what will happen to those girls or our girls in the five, 10 or 20 years after the vaccine has been administered. The only science here is the real live testing about to be done on our daughters, who are technically, like the African ten year olds, the guinea pigs. Remember Lyme vaccine? What happened to that cure-all?  It killed a few people and was quickly taken off the market.

Merck pharmaceutical is the manufacturer of Gardasil, the HPV vaccine. Merck is investing millions in increased lobbying efforts to get state agencies to make Gardasil mandatory. It stands to make billions from the vaccine.
In Texas, Merck’s lobbying effort was doubled and the results paid off big time. Gov. Perry issued an executive order to the Texas Health and Human Services Commission to vaccinate all 170,000 girls entering sixth grade as of September 2008 at a cost of $60 million. The Texas legislature has no authority to repeal the order.

A spokesman for the governor, Robert Black, discounted news accounts that Merck’s high-powered lobbyist in Austin, Mike Toomey — chief of staff for Mr. Perry from 2002 to 2004 as well as for a Republican predecessor, William P. Clements — might have swayed his former boss. “I don’t put a whole lot of stock in that talk,” Mr. Black said. The governor’s order, he said, “protects human health; it was the right thing to do.”

According to a recent Associated Press story, Merck could generate billions in sales if Gardasil - at $360 for the three-shot regimen - were made mandatory across the country.

Merck is bankrolling efforts to pass state laws elsewhere. It has funneled money through Women in Government, an advocacy group made up of female state legislators around the nation.

Gov. Perry also has ties to Women in Government. His current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government.

The governor also received $6,000 from Merck's political action committee during his re-election campaign.

A top official from Merck's vaccine division sits on Women in Government's business council, and many of the bills around the country have been introduced by members of Women in Government.
The practice of medicine and pharmacy is legislated at the state level and, as you can see from what is happening in Texas, you need to be careful about the politicians you vote for and their affiliations.

The Center for Disease Control approved Gardasil last June. But remember: the CDC is a Federal Government agency with the mandate to help public health. Public health applies to the population at large and it has an enormously beneficial role in the case of underprivileged populations without access to preventive and routine health care. Anything the CDC recommends is offered to us through the prism of large populations and epidemiologic data.

Before you agree to allow Merck and their lobby to dictate your child’s future, please stop and ask a few questions. If your child needs the vaccine, do it because you believe it is safe and right for your daughter. If not, don’t do it

DrErika


================
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