Democratic Underground Latest Greatest Lobby Journals Search Options Help Login
Google

Gardasil: "Save the girls . . . and Merck!" (And what about boys?)

Printer-friendly format Printer-friendly format
Printer-friendly format Email this thread to a friend
Printer-friendly format Bookmark this thread
This topic is archived.
Home » Discuss » Archives » General Discussion (1/22-2007 thru 12/14/2010) Donate to DU
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 01:37 AM
Original message
Gardasil: "Save the girls . . . and Merck!" (And what about boys?)
http://accidentalblogger.typepad.com/accidental_blogger/politics_world_affairs/index.html

SNIP

. . . My own considered opinion is that the vaccine should be made freely available. Insurance should be required to pay. Those without insurance should be subsidized. But the decision to vaccinate (or not) should be left to parents, as of now. Many parents of young girls have naturally reacted with some alarm at Governor Perry's high handedness - some because of moral concerns(?) and others due to health related issues.

More than the debate over whether the vaccine should or should not be mandatory, the question that intrigued me was why our otherwise conservative and generally vacuous governor took this bold and drastic step which flies in the face of what his conservative base thinks of the vaccine. Halfway through the report, I got the answer that cleared up my fog of confusion - Perry's erstwhile chief of staff is now a lobbyist for Merck, the pharmaceutical company that manufactures Gardasil. Whoops! One sure fire way to boost sales and ensure an undying cash cow for a drug manufacturer is to make a pharmaceutical product mandatory. And here I was, puzzled and pleasantly surprised that Governor Goodhair had suddenly become a champion of women's health and had acted solely on an uncharacteristic progressive impulse of ensuring their well being. Silly me!

SNIP

Mike Toomey, former chief of staff to Perry, is a lobbyist for Merck. The pharmaceutical company has donated $6,000 to Perry since 2005 and $38,000 to legislative leaders and lawmakers. Merck spokesman Ray Kerins downplayed the company's role in Perry's order, saying "we're working in all 50 states to achieve the widest vaccination possible...."

By the way, why is the vaccine being aimed only at girls? Gardasil is a vaccine against the human papilloma virus (HPV), not cervical cancer. Although only girls are at risk of developing cervical cancer when infected with HPV, boys too get infected by the virus and can spread it to their sexual partners. Should yet another onerous burden of responsible sexual behavior be borne just by young women? The report on Gardasil says:

....A recent study found that 90 percent of cervical cancer cases could be eliminated if boys and girls got the vaccine. If only girls get it, just more than three quarters of cases would be eliminated. (italics mine)
Printer Friendly | Permalink |  | Top
Eurobabe Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 01:56 AM
Response to Original message
1. K & R
Thank you for this pnwmom. :hi:
Printer Friendly | Permalink |  | Top
 
Warren DeMontague Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:40 AM
Response to Original message
2. So. Can someone please explain in direct terms what a, quote, "Moral concern(?)" is?
...
Printer Friendly | Permalink |  | Top
 
AngryOldDem Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 10:54 AM
Response to Reply #2
8. I can
Many people think that once their kids get the shot, it will be license for wanton sexual promiscuity. Others say that introducing the topic of sexuality and sexual behavior to children as young as 9 is problematic as well.

Printer Friendly | Permalink |  | Top
 
Warren DeMontague Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 01:59 PM
Response to Reply #8
23. Exactly what I thought.
Total bullshit masquerading as "morality".
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:46 PM
Response to Reply #23
44. It IS ridiculous
for the fundies to think that this particular vaccine will make girls run wild, when they still will be subject to a myriad of other sexually transmitted diseases, including AIDS.
Printer Friendly | Permalink |  | Top
 
Warren DeMontague Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:09 PM
Response to Reply #44
47. I'm astounded that anyone thinks keeping their kids virginal is more important
than keeping them alive.
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:16 PM
Response to Reply #47
50. I'm sure they don't think of it that way.
But I don't know WHAT they think! I can't get into those thought patterns.
Printer Friendly | Permalink |  | Top
 
Warren DeMontague Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:59 PM
Response to Reply #50
56. I'm sure the thinking is, they can protect their kids from worldly temptation.
Nevermind the fact that 90% of everyone in this country has sex before marriage, and even if -by some slim chance- their daughters ARE virgins when they marry, their husband would have to be, too.

Doubtful.
Printer Friendly | Permalink |  | Top
 
Obamarama Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:54 AM
Response to Original message
3. Actually, they are working on rolling it out for males, too.
From what I understand Merck is doing studies right now, with the intent to have FDA approve it for males as well as females.
Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 06:08 AM
Response to Original message
4. sigh -- boys WILL get the vaccine...
HPV: favorable data for male vaccination; VFC action; CDC shift in research focus

A paper published in the November issue of the journal Pediatrics includes new data from Merck on some of their ongoing trials of Gardasil in different populations. It's a highly technical paper with an equally complex title: "Comparison of the Immunogenicity and Reactogenicity of a Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine in Male and Female Adolescents and Young Adult Women." (free abstract; subscription required for full-text).
To summarize, the paper reports the results of trials examining whether the vaccine's response in 10-15 year olds mirrors what's been shown in older females (16-23 year-olds). The short answer is that it does generate a comparable ('noninferior,' in scientific jargon) immune response in younger populations. Good news. The most interesting finding from the perspective of potential ethical issues is the comparison of data between 10-15 year old boys versus girls. Boys had a nearly identical response to the vaccine as their female counterparts did as well as a virtually identical safety profile between genders. As the paper's authors (all of whom are employees or consultants of Merck, critics might note, despite that being an obvious result of a Merck trial) note:

"Our findings in boys lend support for implementation of gender-neutral immunization using this vaccine for the purpose of preventing the widespread morbidity and mortality from anogenital cancer, as well as dysplastic cervical and external genital lesions, in the general population."
Speaking of Gardasil, news earlier this week that the vaccine has officially been added to the federal government's Vaccines for Children program, ensuring its availability to uninsured children age 18 or under. Here's a brief story from UPI.
One final related item: a story from Wednesday's Washington Post, "CDC Shifts Vaccine-Data Focus," reports on the decision to refocus intensive data-collection activities on immunization in 22 major cities on teenagers rather than young children. The move is a result of multiple new vaccines recommended for adolescents, including vaccines against HPV, meningococcus, and tetanus/diphtheria/pertussis (Tdap).

Labels: CDC, Gardasil, HPV, Pediatrics (journal)
http://www.vaccineethics.org/labels/Gardasil.html

the .eu., australia and other countries will be vaccinating -- and it will happen here too.
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 10:35 AM
Response to Reply #4
6. Thanks for the link.
I was interested in this statement: "Speaking of Gardasil, news earlier this week that the vaccine has officially been added to the federal government's Vaccines for Children program, ensuring its availability to uninsured children age 18 or under." -- This takes away from one of the arguments I've read for why it should be mandated.

Your link also led to a link to a USA today article that spoke to some of my concerns:

http://blogs.usatoday.com/oped/2007/02/post_19.html

The history of new drugs and vaccines is that unexpected adverse events might not be detected until after millions of people have used them, and the FDA does a poor job of tracking post-approval effects.

Merck's Vioxx, a blockbuster painkiller drug, was withdrawn in 2004, five years after it was introduced, after studies revealed significant heart risks. A vaccine made by Wyeth, to prevent a highly contagious rotavirus that can cause severe diarrhea and vomiting in children, was withdrawn in 1999, just over a year after it was approved, because of safety concerns.

So far, every indication is that Gardasil, the world's first anti-cancer vaccine, has only rare and minor side effects. Clinical trials of more than 11,000 females ages 9 to 26 showed it was 100% effective in preventing cervical cancers linked to two types of human papillomavirus (HPV), a sexually transmitted disease. But no one will know the complete picture until more people are vaccinated for more time. At the moment, Gardasil is so new that scientists aren't sure how long it's effective for.
Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 10:50 AM
Response to Reply #6
7. this is under review globally and was created side by side with
Pasteur of france.

HPV vaccines
Vaccines are being developed to prevent HPV infection.  There are many different HPV strains.  Some are known to be high risk for cervical cancer.  If we had effective vaccines against all these strains, we might be able to prevent cervical cancer altogether.  Several research trials have been testing vaccines as a way of preventing infection with HPV.
A trial testing Gardasil called FUTURE II reported its results in October 2005.  This phase 3 trial involved over 12,000 women aged between 16 and 26.  These women did not have HPV before the start of the trial.  The women were divided into two groups.  Half the women were given Gardasil and the other half had a dummy vaccine (placebo).  Both groups of women had 3 injections of either the vaccine or placebo over six months.  Over the following two years the women had regular checks to see if they had developed HPV, or had any precancerous changes to the cells of the cervix, which could develop into a cancer.  The group who had the vaccine showed no precancerous changes.  Of the 5,258 women who had the placebo, 21 had precancerous changes, which is 0.4%.  The researchers found that Gardasil protected against HPV types 6 and 11, as well as 16 and 18.  Gardasil was licensed for use within the European Union in September 2006.  
Two other phase 3 trials have tested the vaccine Cervarix.  The first was for women under 26 and closed in July 2005.  It involved over 18,000 women from all over the world, including the UK.  This study was called ‘PATRICIA’ (PApilloma TRIal to prevent Cervical cancer In young Adults).   The second was for women of 26 and over, and closed in August 2006.  The aim of the trial is to find out the effect of the Cervarix vaccine on long term HPV infection. So it will be some time before we know the results.
It is possible that these vaccines will be used in a national vaccination programme in the UK in the future.  The research suggests that they would dramatically lower the number of cases of cervical cancer.  They would also reduce the need for colposcopy.  At the moment, they are only available on private prescription.  There is more information about HPV vaccines and cervical cancer in the cervical cancer questions and answers section of CancerHelp UK.
http://www.cancerhelp.org.uk/help/default_printer_friend.asp?page=9596

merck is not the only company who developed this vaccine -- a french drug company was also the developer

Comparable strategies needed to evaluate human papillomavirus vaccine efficiency across Europe

K Soldan1 (kate.soldan@hpa.org.uk), J Dillner2

1Health Protection Agency Centre for Infections, London, United Kingdom
2Dept of Medical Microbiology, MAS University Hospital, Lund University, Malmö, Sweden
A quadrivalent vaccine against human papillomavirus (HPV) types 16, 18, 6 and 11, known as GardasilTM (or Silgard, see note) was granted a marketing license by the European Commission in September 2006 following the positive opinion of the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use in July 2006 <1>.

HPV infection is the most frequent sexually transmitted infection in Europe. Certain HPV types have been established as causative agents of cervical cancer (and its precursor stages that are the target of cervical screening), as well as of some other rare cancers of the ano-genital tract and oral cavity. A meta-analysis of published studies found just over 70% of invasive cervical cancer cases in Europe to be positive for HPV types 16 or 18 <2>. Pre-cancerous stages of cervical disease are common and often resolve with time. However, their follow-up, including treatment, repeated screening and examination of the cervix (colposcopy), is associated with considerable costs and anxiety. HPV 6 and 11 are not causally linked to cervical cancer, but are associated with some low-grade cervical lesions, the vast majority of genital warts and the rare condition of recurrent respiratory papillomatosis <3>.

The Gardasil vaccine is composed of virus-like particles (VLP) generated by the synthesis and self-assembly of the major HPV capsid protein (L1) in yeast cells (Saccharomyces cerevisiae). Gardasil has been licensed for the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3), cervical cancer, high-grade vulvar intraepithelial neoplasia (VIN grades 2 and 3), and external genital warts (condyloma acuminata) causally associated with HPV types 6, 11, 16, and 18 <1>. Trials have been undertaken to demonstrate the efficacy of the vaccine in women aged 16 to 26 years and immunogenicity in girls and boys aged 9 to 15 years. Protective efficacy in males has not been reported in the literature yet, but the results of more trials involving males are expected over the next few years.

Another vaccine composed of virus-like particles (VLP), a bivalent vaccine for HPV 16 and 18, manufactured by GlaxoSmithKline, is currently under evaluation by the EMEA. Both these prophylactic vaccines have been shown to have very high efficacy in uninfected women against infection, cervical intraepithelial neoplasia and, by implication, against cervical cancer caused by the HPV types targeted by the vaccine <4>.

The availability of efficacious vaccines now means that vaccination strategies should be designed and evaluated to inform decisions on efficient control of HPV-related diseases. Several questions about HPV vaccination efficacy and effectiveness are still under consideration <5> For example, data on its efficacy against disease in males and in women aged over 26 years (of whom many could have been previously infected) are still awaited. A longer follow-up of vaccine programmes is needed to determine the duration of protection. The impact of vaccination on the epidemiology and disease burden of HPV types not covered by the vaccine is also uncertain. There are some data from trials which suggest cross-protection against HPV-types closely related to the vaccine types. The possibility of type-replacement with non-vaccine types emerging as the cause of more disease is also a concern to be evaluated further. It is likely that most European countries will first consider vaccination of girls who have not yet become sexually active
http://www.eurosurveillance.org/ew/2006/061123.asp

regarding the stigma around hpv --
Social Stigma
 
"There is unfortunately a social stigma associated with cervical cancer because HPV is a direct cause in approximately 70% of cases," Dr. Makhija told Medscape. "People are under the impression that this means the patient slept around or was in some way more sexually active, but this is often not the case, and she may well have been with 1 person who had the infection."
 
HPV is the most common sexually transmitted infection in the US. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with HPV every year and that over half of all sexually active men and women become infected at some time in their lives.
 
"Our expectation is that the far-right machine will gear up its disinformation and fearmongering tactics, all aimed at reducing availability of the vaccine by threatening funding and clouding the facts regarding the safety and the need for this vaccine," Ms. Julie Kay, an attorney for Legal Momentum, a New York City–based women's-rights organization, said in a statement to the press.
 
But Dr. Makhija said she has been pleasantly surprised by reaction so far. "I think people are realizing that this is not a political issue so much as a health issue." Based in Alabama, the investigator had worried about how difficult it might be to recruit women in the Deep South for the trial. "But we enjoyed an enormous response and had no trouble at all," she said. "People realized that this is something that could potentially protect their daughters, and the response has been excellent."
 
"Exciting Win Against Cancer"
 
Mr. Alan Kaye, from the National Cervical Cancer Coalition in Van Nuys, California, called the news "an exciting win against cancer." He is looking forward to what this could mean for public health.
 
But he is also glad from a personal perspective. Mr. Kaye founded the cancer coalition with his wife before she died of cancer. Today is the 5-year anniversary of her death. "It's wonderful to think that this amazing step forward has taken place on such an important day," he said. "My wife would be pleased."
 
http://www.brodstonehospital.org/your%20health.htm

other countries approve gardasil --
During an interview with Medscape, Jaime de la Garza, MD, from the Instituto Nacional de Cancerología in Tlapan, Mexico, agreed that the vaccines represent an important advance. He says they will be especially important for women in developing countries. "The incidence of cervical cancer is continuing to rise, and mortality rates are especially high in poor countries. If we can get vaccines such as these to patients, it will make a big difference."
 
Gardasil was approved last week for use in Mexico and is currently under review with regulatory agencies in the European Union, Argentina, Australia, Brazil, New Zealand, Singapore, and Taiwan.
http://www.brodstonehospital.org/your%20health.htm

this from an interview with dr tristram in the uk

Dr Tristram said, "This vaccine has to be given as a preventative, before there is any contact with the virus.


"If we are looking at the population and asking who should be vaccinated, we have to consider that one in four young people are sexually active before the age of 16, so we have to look at a younger age group.


"Another issue to consider is that, at around the time of puberty, if the cervix comes into contact with HPV, it is more likely to cause problems."

more --

Q Will the vaccine replace the need for regular smear tests?


A Dr Tristram said, "Cervical screening has been very successful in reducing the incidence of cervical cancer and this should not stop just because a vaccine has been introduced.


"There are lots of different types of HPV which can cause cervical cancer, not just 16 and 18, for which the current vaccine offers protection.


"The vaccine will reduce the incidence of cervical cancer further, but it will not get rid of it."

it also looks like some hpv related cancers are becoming MORE virulent and difficult to treat.

meps' in the uk supporting the use of gardasil

glynis wilmot is the labour mep for the west midlands

Cutting cancer deaths

I reported in the October edition that European Commission had licensed Gardasil, the first vaccine against HPV which can lead to cervical cancer. 

I am pressing the Commission on its plans to ensure that vaccination programmes are introduced in all member states, as well as a comprehensive programme of education to inform parents about the vaccine. Immunising every 12 year old girl could cut deaths from cervical cancer by more than 75%.

Latest information

http://www.gleniswillmott.labour.co.uk/ViewPage.cfm?Page=20338

planned parenthood's statement on gardasil

 Planned Parenthood Applauds FDA Approval of Gardasil
HPV Vaccine Is Crucial Step Forward for Women's Health  

New York, NY — Planned Parenthood Federation of America (PPFA) commended today's action by the U.S. Food and Drug Administration (FDA), which approved the first vaccine against two types of human papilloma virus (HPV) that cause about 70 percent of cervical cancer cases. 

"This is a huge step forward for women’s health.  Prevention is the key to good health, and this vaccine will give future generations the promise of health, safety and peace of mind," said PPFA President Cecile Richards.  “Now we must move forward to educate the public about the vaccine and ensure it is available to all Americans, regardless of their income level.” 

Planned Parenthood provides more than 1,000,000 women with cancer screenings each year.  This new vaccine will hopefully save lives. 

"The HPV vaccine is a public health breakthrough," said Richards.  "On behalf of the millions of women, men and teens Planned Parenthood serves every year, I thank the FDA for today's action." 

Worldwide, cervical cancer is the second leading cause of cancer deaths among women.  Each year approximately 10,000 cases of cervical cancer are diagnosed in the United States, and 4,000 American women die from the disease.    

###
http://ww1.ppgi.org/includes/media/prjune_06_c.asp

canada approves gardasil{ but of course merck has subverted the entire world to it's sinister plans}
HPV VACCINE APPROVED

In July 2006, a new vaccine to prevent against four strains of the Human Papilloma Virus was approved for use in Canada by Health Canada. Gardasil will be available by the end of August 2006 through Canadian physicians and pharmacists, and is designed to prevent cervical, vulvar, and vaginal cancer as well as genital warts.

For more information, please visit: http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm.
http://www.optionsforsexualhealth.org/

Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 11:53 AM
Response to Reply #7
9. Thalidomide was also studied widely in Europe, but it turned out
to have a few more problems than they realized.

:sarcasm:

I don't have any problem with Gardasil being made available, or for states paying for it so that it can be given for free. I just have a problem with it being mandated so early. There's no public health emergency; this isn't the bird flu. Let the vaccine be on the market for long enough to know whether there are any unsuspected adverse effects.
Printer Friendly | Permalink |  | Top
 
The Cleaner Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:17 PM
Response to Reply #9
12. Thank you, pnwmom.
Edited on Thu Feb-15-07 12:18 PM by The Cleaner
I share your views and totally understand your concerns. I agree that making this thing mandatory is the wrong way to go - and you're right, "fast-tracking" it as we saw here in TX is a MAJOR red-flag.

That's why so many are questioning our Governor Rick Perry's motives. With GSK's HPV vaccine coming out in 6 months, many are wondering whether Perry agreed to mandate it in TX just so Merck could corner the market.

Makes one wonder...
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:26 PM
Response to Reply #12
14. See post below -- is the 'fast track' because of Merck's IRS settlement? n/t
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:28 PM
Response to Reply #12
15. Absolutely, The Cleaner -- Perry's motives & methods need to be questioned here n/t
Edited on Thu Feb-15-07 12:31 PM by antigop
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:21 PM
Response to Reply #12
35. And thank you. I didn't realize that a competitor was on the horizon.
That explains a great deal.
Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:48 PM
Response to Reply #9
19. look at the numbers for third world countries -- and look at the stubborn
persistance of a set number of cervical cancers in first world countries in spite of increases in pap smears.

you're talking about many, many thousands of lives lost every year to what is now preventable.

but -- whatever.
Printer Friendly | Permalink |  | Top
 
mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:24 PM
Response to Reply #19
31. How are third world countries supposed to afford it at $360 for three shots?
Why would they even want to consider GARDASIL before they know how long the resistance GARDASIL confers lasts and whether or not it has any long term side effects?
Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:33 PM
Response to Reply #31
32. brasil and mexico are two countries that will be
giving the vaccine to women.

the un is also involved with getting this vaccine to women.
Printer Friendly | Permalink |  | Top
 
mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:11 PM
Response to Reply #32
34. Really? At what negotiated cost?
You seem very knowledgeable about Merck's international dealings.
Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:18 PM
Response to Reply #34
51. merk co produced this vaccine with
Printer Friendly | Permalink |  | Top
 
iverglas Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:23 PM
Response to Reply #34
52. this needs to stop. NOW.
You seem very knowledgeable about Merck's international dealings.

So this would be relevant to:

- the cost of Gardasil
- the long-term effectiveness of Gardasil
- the possible adverse effects of other components of the vaccine
- the apparently improper relationship between Merck and holders of political power
- the adequacy of the testing of Gardasil

... and any other objection or purported objection you are fond of voicing to the vaccine / the provision of the vaccine to anyone ... HOW?

Anybody who has expended the slightest effort to following debate of this issue, here or in the media, knows that health authorities in a lot of countries have expressed great interest in this vaccine, and in making it available to populations at risk for the diseases it prevents.

Really? At what negotiated cost?

Myself, I wasn't aware of specific countries that plan to make Gardasil available to their populations free of charge at present, but I had read several reports of actions planned by the Bill and Melinda Gates Foundation to assist in delivery to populations in less developed countries. But information is pretty fucking easy to find for someone with an internet connection an interest.

Google for gardasil developing countries, and the third result in the list is this:

http://www.medicalnewstoday.com/medicalnews.php?newsid=58937
Gardasil, which has been approved in 50 countries, will be sold by Merck at "dramatically lower prices" in developing countries, Gregg Sylvester, Merck senior medical director for adolescent health, said. Deborah Myers, GSK director of external and government affairs and public partnerships, said the company will implement a "tiered pricing" system for Cervarix that bases the price on a country's gross domestic product and the size of its orders (Bloomberg, 12/12).
Anyone who cared to know could have known this for two months now.

And now you know it. You'd better be careful, though. If you say it out loud (like this is something you're likely to acknowledge knowing ...), somebody is bound to be insinuating that you have a financial interest in Merck.

This tactic is despicable, vicious, stupid and intolerable in a place like this. It needs to stop.


Printer Friendly | Permalink |  | Top
 
mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Feb-16-07 02:47 AM
Response to Reply #52
73. Whoa! I guess I really touched a nerve there!
Great that the US is against footing the lion's share of the R&D budget of a Big Pharma company for a vaccine that actually helps third world countries far more than it helps the US in terms of potential life years gained!

Lord knows that we Americans have to do our part to make sure every Big Pharma product (even the largely untested ones) are extremely profitable because almost every other country has the benefit of socialized health care!
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:32 PM
Response to Reply #19
38. That's not an argument for mandating it prematurely,
as opposed to making the vaccine freely available to those who wish it -- as is being done here in Washington state, where the vaccine itself will be available at no cost to anyone who asks for it.
Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 06:46 PM
Response to Reply #38
61. that's a matter of personal opinion.
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 08:28 PM
Response to Reply #38
62. Thank you, pnwmom! There is no argument for Perry's dictatorial mandate! n/t
Printer Friendly | Permalink |  | Top
 
AX10 Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 08:51 PM
Response to Reply #38
64. And that is my belief on vaccines. They should be made...
available at no cost to you directly. That is fair. Washington has a good thing going there.
Printer Friendly | Permalink |  | Top
 
HiFructosePronSyrup Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 01:15 PM
Response to Reply #9
22. Thalidomide wasn't widely studied in Europe.
Nor the U.S.

That's why the U.S. never approved of it's use in the United States, the precursor of the FDA hadn't finished testing and they had serious concerns about the antiquated European safety agencies.

"There's no public health emergency"

Tell it to the thousands of women who die every year.
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:26 PM
Response to Reply #22
36. It was approved for release in several European countries after
numerous studies -- and all the government agencies there were convinced that it was extremely safe.

There isn't a public health emergency that justifies mandating this vaccine for 9 and 10 year olds. The overwhelming majority will be just as safe if they delay having the vaccine until more is known about possible adverse effects.
Printer Friendly | Permalink |  | Top
 
HiFructosePronSyrup Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:38 PM
Response to Reply #36
42. Yes.
But it wasn't approved here because the U.S. knew the testing in Europe was shoddy and incomplete.

European testing of pharmaceuticals has significantly improved over the last forty years.

"There isn't a public health emergency that justifies mandating this vaccine for 9 and 10 year olds."

Millions of people contract HPV every year and thousands die from it. Sounds like an emergency to me.

Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:51 PM
Response to Reply #42
45. And how many 9 year olds are having sex? It's not an emergency
that justifies mandating it to children.

Only 1% of cancer deaths are due to cervical cancer. One REAL public health emergency is lung cancer -- and we could cut that completely, couldn't we? But instead we allow companies to sell it to people.

Follow the money . . .
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:05 PM
Response to Reply #45
46. Yep. Follow the money....... n/t
Printer Friendly | Permalink |  | Top
 
HiFructosePronSyrup Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 06:30 PM
Response to Reply #45
60. About 27% of girls, 16% of boys.
Found in a retrospective study of those who report child sexual abuse. Median age being nine and a half.

Of course, the whole point is to vaccinate before one becomes sexual active.

Far more women die every year of cervical cancer than died on 9-11. Yet you're not worried about it.

If there were a vaccine for lung cancer, I'm sure there'd be nutcases against that too.
Printer Friendly | Permalink |  | Top
 
tavalon Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Feb-16-07 08:42 AM
Response to Reply #60
74. If there were a vaccine for lung cancer, I'm sure there'd be nutcases against that too.
I'm sure there would be a few wackos wanting it to be freely available and subsidized but not made mandatory. Actually, if we want to decrease lung cancer, we should mandate that everyone stop smoking. But that wasn't your point, was it?
Printer Friendly | Permalink |  | Top
 
Digit Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 11:31 PM
Response to Reply #9
72. Exactly!
I want to see if it has any adverse effects before giving the rubber stamp of approval.
We just don't KNOW what ill effects it might have on our youth. Can you imagine if it made them all impotent, or gave them some horrible health issues to deal with for the rest of their lives?
How could we justify the rush to immunize from something they may or may NOT get without knowing more?
Printer Friendly | Permalink |  | Top
 
mhatrw Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:20 PM
Response to Reply #4
30. So we are going to ignore the cost part of the equation entirely?
Even assuming that GARDASIL has zero risks (unproven) and lifetime efficacy (there is only evidence for five years of efficacy and even that is slight), how many US life years gained in the best case scenario are we talking about for injecting three shots of GARDASIL into little boys at a cost of nearly $500 per boy?
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:33 PM
Response to Reply #30
39. good question.
Printer Friendly | Permalink |  | Top
 
zbdent Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 08:27 AM
Response to Original message
5. How about abolishing "genital mutiliation" because mothers are "too lazy"?
Circumcision done without anesthesia, not for "religious reasons", but because it would be "too hard" to keep it clean (and how many boys realize how good it is to soap that area up in the bath/shower as they get older ... hmm ...)

Implying that women are too lazy to make sure their baby boys are free of infection ...
Printer Friendly | Permalink |  | Top
 
hulklogan Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:00 PM
Response to Reply #5
10. On the other hand -- circumcision has been found to reduce the risk of HIV infection
So we may see mandatory snipping of foreskins as well!
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:08 PM
Response to Reply #10
11. Good point.
Welcome to DU, hulklogan!
Printer Friendly | Permalink |  | Top
 
zbdent Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:09 PM
Response to Reply #10
25. ah, but isn't HIV (precursor to AIDS) also God's curse on the
hummasexuals for sinning?
Printer Friendly | Permalink |  | Top
 
Canuckistanian Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 11:05 PM
Response to Reply #25
69. Good point! HIV is Gawd's punishment for sinners
How dare we thwart Gawd's will? :sarcasm:
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:23 PM
Response to Original message
13. You also have to ask about Merck's $2.3 BILLION (billion with 'B') IRS settlement
Certainly the cast of characters and their connections should be questioned, but one should also look at Merck's financials:

Business Week reports it.

http://www.businessweek.com/ap/financialnews/D8N9H3M00.htm

>>
Pharmaceuticals maker Merck & Co. said Wednesday it settled a dispute with the Internal Revenue Service regarding its taxes for the years 1993 to 2001.

Merck said the final net cash cost to the company is expected to be about $2.3 billion,...
>>
Printer Friendly | Permalink |  | Top
 
The Cleaner Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:36 PM
Response to Reply #13
16. Hmph. Perry executive order + gardasil + Merck + Fast-tracking the mandate + Huge Merck loss
Edited on Thu Feb-15-07 12:39 PM by The Cleaner
+ Rick Perry's former chief of staff now lobbyist for Merck + his other Merck ties and Women in Government + Merck being one of Perry's largest campaign donors =


BINGO

Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:29 PM
Response to Reply #16
37. Don't forget all Gardasil promoters who simply own Merck stock.
Edited on Thu Feb-15-07 04:29 PM by pnwmom
But they're not influenced by that at all and none of them are DUers, of course.

;)
Printer Friendly | Permalink |  | Top
 
Morgana LaFey Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:26 PM
Response to Reply #16
53. And yet there are DUers who either know ALL that or most of it
who STILL don't get it that this scheme isn't a good idea. I don't get it.

Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:59 PM
Response to Reply #53
55. You are correct -- this scheme isn't a good idea n/t
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 06:00 PM
Response to Reply #16
57. Hey, Cleaner -- there may be more to add to your formula-- have you checked Merck's 10-k? n/t
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:40 PM
Response to Reply #13
18. Oh, geez -- is Merck under tax investigation in Canada, too?
http://new.quote.com/stocks/story.action?id=KRO046e5691

>>
Merck still faces a tax investigation in Canada, which could result in the company's paying back taxes of $1.4 billion and interest of $360 million.
>>
Printer Friendly | Permalink |  | Top
 
The Cleaner Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:55 PM
Response to Reply #18
20. Wow! Good catch.
Edited on Thu Feb-15-07 12:58 PM by The Cleaner
Maybe you could start a thread on this topic? Of Merck being in debt and needing to quickly make it up? Perhaps, gee whiz, even colluding with a *certain* state governor to fast-track a *certain* vaccine via anti-democratic executive order? Where that state governor has clear direct ties to Merck and where Merck is a major campaign donor?

Gee, I dunno...duh...it just can't be for greed, can it...or encroaching fascism...or conflicts of interest...duh...

:shrug:
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:16 PM
Response to Reply #20
26. I think encroaching fascism fits the bill ---notice how "they" don't reply to any of this n/t
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:35 PM
Response to Reply #26
40. I was wondering about that. Where are they?
They came out in droves the first time I posted about Gardasil, accusing me of being a "loony."
Printer Friendly | Permalink |  | Top
 
Bridget Burke Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 03:04 PM
Response to Reply #20
33. He doesn't start threads....
He has about 5 comments that he cycles through. On a loop.

Printer Friendly | Permalink |  | Top
 
TZ Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 06:03 PM
Response to Reply #33
58. the same exact thing over and over
and a lot of times not really relevant to whats going on elsewhere. Thats why we ignore it.
Printer Friendly | Permalink |  | Top
 
AX10 Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 08:53 PM
Response to Reply #33
65. And you refuse to reply to this very real situation...
Edited on Thu Feb-15-07 09:10 PM by AX10
regarding Merck's financial order.

Slick way of skirting the question at hand.

Merck is need of the cash, NOW! That is a fact.
Printer Friendly | Permalink |  | Top
 
Rainscents Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 12:39 PM
Response to Original message
17. I agree!
Edited on Thu Feb-15-07 01:06 PM by Rainscents
After reading everything about Perry, he has motive for doing what he did and this was main reason, why, I was against vaccinating... RUSHING into it and making it mandatory raised my concern about vaccine and his action.
Printer Friendly | Permalink |  | Top
 
The Cleaner Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 01:06 PM
Response to Reply #17
21. Exactly, which is why the OP is 100% accurate and relevant.
I K&R'd this thread on account of it. Rick Perry's suspect motives here, colluding with Merck, are becoming VERY CLEAR and ALARMING. I think the OP is correct - It's all about saving Merck.

I think it's unconscionable.
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:16 PM
Response to Reply #21
27. It's absolutely unbelievable what Perry is doing! n/t
Edited on Thu Feb-15-07 02:17 PM by antigop
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:38 PM
Response to Reply #17
41. It makes perfect sense to me now, hearing that there will be a competitor
soon. They want to sell as many expensive doses as possible on a exclusive basis now, while they have a chance. A competior will force them to lower their prices.
Printer Friendly | Permalink |  | Top
 
iverglas Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 06:19 PM
Response to Reply #41
59. too bad, soooo sad

http://www.governor.state.tx.us/divisions/press/exorders/rp65
The Health and Human Services Executive Commissioner shall adopt rules that mandate the age appropriate vaccination of all female children for HPV prior to admission to the sixth grade.
Since pretty much no one is admitted to any grade in February, obviously this means:

http://www.governor.state.tx.us/divisions/press/pressreleases/PressRelease.2007-02-02.0949
... rules requiring all girls age 11 and 12 to receive the Human Papillomavirus (HPV) vaccine prior to entering sixth grade, effective September 2008.


http://business.scotsman.com/latest.cfm?id=91832007
Cervarix should win regulatory clearance in Europe in the first half of 2007, according to Glaxo, but it has not yet been submitted for approval in the all-important U.S. market. The company now has a goal of a U.S. filing by April.

One can certainly expect that Cervarix will be on line by September 2008. That leaves Merck a year of free rein.

There were ~324,000 children enrolled in grade six in 2006 (a decline of nearly 5,000 from the previous year):
http://www.tea.state.tx.us/research/pdfs/enrollment_2005-06.pdf

Allowing for opt-outs and boys, let's guess 150,000 children will receive the vaccine before the competitor comes on the market.

That's $60,000,000. After that, there's competition.

Now, I wonder whether any of the legion of Merck stockholders here can clue us in as to how much of that is actual profit ...





Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:07 PM
Response to Original message
24. patial list of vaccines produced or co-produced by merck
and being used in canada.

Hepatitis B vaccines marketed in Canada are produced by Merck Frosst & GlaxoSmithKline

Recombivax HB

Produced by Merck Frosst

Description:

RECOMBIVAX HB ® is a non-infectious subunit viral vaccine consisting of surface antigen (HBsAg or Australia antigen) of hepatitis B virus produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.

Two formulations are available:

* 10 µg/1.0 mL formulation: each 1.0 mL dose contains 10 µg of hepatitis B surface antigen adsorbed onto approximately 0.5 mg of amorphous aluminum hydroxyphosphate;
* 40 µg/1.0 mL formulation: each 1.0 mL dose contains 40 µg of hepatitis B surface antigen adsorbed onto approximately 0.5 mg of amorphous aluminum hydroxyphosphate;


Thimerosal (mercury derivative) 1:20,000 (50 µg/mL) has been added only to the preservative-containing formulations. All preparations have been treated with formaldehyde prior to adsorption onto amorphous aluminum hydroxyphosphate. The vaccine is of the adw subtype.

For information on precautions and adverse events, go to:   http://www.merckfrosst.ca/e/products/monographs/RECOMBIVAX_773-b_10_03-E.pdf

********************
http://www.vran.org/vaccines/vacing/vac-ing-can.htm

GENERAL ISSUES: VACCINE INGREDIENTS


CHILDHOOD VACCINES IN CANADA
PRODUCTS & INGREDIENTS LIST

Prepared by VRAN – Vaccination Risk Awareness Network Inc.
www.vran.org

While health officials recommend an ever increasing quantity of vaccines for babies and young children, they are less than forthcoming with the ingredients list of vaccine additives and the potential for reactions. Today’s parents are concerned about the health impact of multiple vaccines & additives on their children’s health. Vaccine product monographs listing ingredients can be located in the CPS index (Compendium of Pharmaceuticals and Specialties) obtainable through any pharmacy in Canada. Some vaccine product monographs can be accessed on line at the manufacturers’ websites.

Starting at two months of age, most babies are injected with the following vaccines: Diphtheria, Tetanus, acellular Pertussis, Polio, Act-HIB (haemophilus influenza B), Hepatitis B, 7 valent Pneumococcal vaccine, Meningococcal C vaccine. Babies may be injected with as many as 8 vaccines concurrently. See the Canadian Immunization Guide for details of the vaccine schedule and number of doses given of each vaccine:
http://www.phac-aspc.gc.ca/publicat/cig-gci/index.html English
http://www.phac-aspc.gc.ca/publicat/cig-gci/index_f.html French

In the northern territories, babies are also routinely injected within hours of birth with BCG (tuberculosis vaccine) & hepatitis B vaccine. The province of New Brunswick vaccinates newborns with hepatitis B vaccine within hours of birth.

A two dose schedule of MMR (measles, mumps, rubella) vaccine is generally started at 12 months and given again at 18 months or 4-6 years. Varicella (chickenpox) vaccine is also injected at 12 months of age. Additionally, Influenza vaccine is now recommended for all children starting at 6 months of age. Babies and young children are injected with two doses of flu vaccine 30 days apart.

Health officials keep vaccine reaction reports under wraps. Unlike the U.S. where the VAERS (Vaccine Adverse Events Reporting System) is accessible on line and can be searched by anyone for vaccine reactions, Canadians do not have access to the vaccine reaction data base held by Health Canada. Only by filing an Access to Information request with the specific lot number of a vaccine, is it possible to obtain limited vaccine reaction information.

People should also know that the manufacturers do not disclose all the ingredients nor full details of the manufacturing process. Health Canada protects the "proprietary rights" of these companies and upholds their right to secrecy - something the greater Canadian public should be up in arms about. That parents are expected to submit their children for injection with multiple vaccines without first having full disclosure of all known ingredients is a disturbing statement on the control exerted by monopoly medicine and corporate and government allies.

Thimerosal (a preservative comprising 50% ethyl mercury) was phased out of early infant shots in Canada when polio vaccine was combined with DPT. Mercury is a potent neurotoxin. Apparently inactivated, injectable polio vaccine is degraded by thimerosal, hence vaccine combinations that contain polio vaccine do not contain thimerosal. Thimerosal may, however still be used in the manufacturing process, then filtered out. The question remains however, whether trace amounts of thimerosal still persist in the final product. Thimerosal was replaced by 2-phenoxyethanol, another toxic substance used in antifreeze and is contained in Pentacel, the DTPaP+Hib vaccine injected into most Canadian babies starting at 2 months of age.

Currently the two vaccines given to Canadian babies that may still contain thimerosal are influenza vaccine and hepatitis B. Both vaccines are available in single dose vials without thimerosal. Parents who choose to inject their babies with these vaccines should know they do have a choice to choose thimerosal free vaccines.
(top)


Your Baby’s First Shot - Five Vaccines in One:

Pentacel – combines Act-HIB and Quadracel vaccines(4 vaccines)
Produced by Sanofi Pasteur

Description:

Act-HIB ® Reconstituted with QUADRACEL ®Haemophilus b Conjugate Vaccine (Tetanus Protein - Conjugate) Reconstituted with Component Pertussis Vaccine and Diphtheria and Tetanus Toxoids Adsorbed Combined with Inactivated Poliomyelitis Vaccine.

Each single dose (approximately 0.5 mL) after reconstitution contains:

* purified polyribose ribitol phosphate capsular
* polysaccharide (PRP) of Haemophilus influenzae type b
* covalently bound to 20 µg of tetanus protein 10 µg
* pertussis toxoid (PT) 20 µg
* filamentous haemaglutinin (FHA) 20 µg
* fimbrial agglutinogens 2 + 3 (FIM) 5 µg
* pertactin (PRN) 3 µg
* diphtheria toxoid 15 Lf
* tetanus toxoid 5 Lf
* poliovirus type 1 (Mahoney) 40 D-antigen units
* poliovirus type 2 (MEF1) 8 D-antigen units
* poliovirus type 3 (Saukett) 32 D-antigen units
* aluminum phosphate 1.5 mg
* 2-phenoxyethanol (not as a preservative) 0.6% v/v
* polysorbate 80 10 ppm (by calculation)
* bovine serum ?50 ng
* trace amounts of formaldehyde
* trace amounts of polymyxin B and neomycin may be present from the cell growth medium


For information on precautions and adverse events, go to:  http://198.73.159.214/statics/vaccines/english/Pentacel_E.pdf

********************


Hepatitis B vaccines marketed in Canada are produced by Merck Frosst & GlaxoSmithKline

Recombivax HB

Produced by Merck Frosst

Description:

RECOMBIVAX HB ® is a non-infectious subunit viral vaccine consisting of surface antigen (HBsAg or Australia antigen) of hepatitis B virus produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.

Two formulations are available:

* 10 µg/1.0 mL formulation: each 1.0 mL dose contains 10 µg of hepatitis B surface antigen adsorbed onto approximately 0.5 mg of amorphous aluminum hydroxyphosphate;
* 40 µg/1.0 mL formulation: each 1.0 mL dose contains 40 µg of hepatitis B surface antigen adsorbed onto approximately 0.5 mg of amorphous aluminum hydroxyphosphate;


Thimerosal (mercury derivative) 1:20,000 (50 µg/mL) has been added only to the preservative-containing formulations. All preparations have been treated with formaldehyde prior to adsorption onto amorphous aluminum hydroxyphosphate. The vaccine is of the adw subtype.

For information on precautions and adverse events, go to:   http://www.merckfrosst.ca/e/products/monographs/RECOMBIVAX_773-b_10_03-E.pdf

********************


ENGERIX ® -B

Produced by GlaxoSmithKline

Hepatitis B Vaccine (Recombinant)

Composition:

The vaccine is a slightly opaque, white, sterile suspension. A slow settling of the white aluminum hydroxide may occur during storage leaving a clear colourless supernatant liquid. Each 1 mL adolescent/adult dose of vaccine contains 20 µg of hepatitis B surface antigen adsorbed onto 0.5 mg of Al +++ as aluminum hydroxide. Each 0.5 mL pediatric dose contains 10 µg of hepatitis B surface antigen adsorbed onto 0.25 mg of Al +++ as aluminum hydroxide. Multi-dose presentations contain 5.0 mg of 2-phenoxyethanol per mL as preservative.

The ENGERIX ® -B formulation contains a trace amount of thimerosal (‹0.5 µg mercury in the 0.5 mL pediatric dose and ‹1.0 µg mercury in the 1.0 mL adolescent/adult dose) from the manufacturing.

For information on precautions and adverse events go to:  http://www.gsk.ca/en/products/vaccines/engerix-b_pm.pdf

********************


Prevnar – 7-valent conjugate pneumococcal vaccine

Produced by Wyeth Lederle

Website does not allow consumers to view a product monograph.   http://www.prevnar.com/ Ingredients list is taken from CPS 2004 edition, product monograph page 1587:

Prevnar is a sterile solution of saccharides of the capsular antigen of S.pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F and diphtheria CRM197 protein. Individual polysaccharides are prepared from purification of the culture broth of each serotype. The saccharides are directly conjugated to the protein carrier CRM197 protein by reductive animation. CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of C. diphtheriae strain C7(B197) and/or C.diphtheriae strain C7 (B197) pPx350 grown in a casamino acids and yeast extract-based medium. CRM197 is purified through ultrafiltration, ammonium sulfate precipitation, and iron-exchange chromatography to high purity. Each serotype is conjugated as a monovalent preparation prior to compounding as a multivalent vaccine. Individual glycoconjugates are analyzed for saccharide to protein ratios, for molecular size, free saccharide and free protein.

Each dose (0.5ml) contains:

* 2ug of each saccharide for serotypes 4, 9V, 14, 18C, 19F and 23F,
* and 4 ug of serotype 6B (16 ug total saccharides);

and approximately

* 20ug of CRM197 carrier protein.


Nonmedicinal ingredients:

* aluminum phosphate adjuvant
* sodium chloride
* and water for injection
.

For information on precautions and adverse reactions, see the CPS Index available at any pharmacy or medical library in Canada.

********************
(top)


MENJUGATE® - Meningococcal Group C–CRM197 Conjugate Vaccine

Produced by Merck Frosst

Description:

Menjugate ® (Meningococcal Group C–CRM197 Conjugate Vaccine) is intended for the prevention of meningitis and/or septicemia caused by Neisseria meningitidis group C in infants and older age groups. Menjugate ® is composed of meningococcal group C oligosaccharides conjugated to a protein carrier, a non-toxic mutant of diphtheria toxin, CRM197. In the final vaccine, aluminum hydroxide is used as an adjuvant.

Composition:

Menjugate ® (Meningococcal Group C–CRM197 Conjugate Vaccine) is formulated as a powder for suspension with each 0.5 mL dose containing 10 micrograms of meningococcal C oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein (12.5 to 25.0 micrograms).13 Mannitol, sodium phosphate monobasic monohydrate, and sodium phosphate dibasic heptahydrate are present as excipients in the final lyophilized formulation. The lyophilized product is to be reconstituted with an adjuvant diluent containing aluminum hydroxide (1.0 mg per 0.5 mL dose) and sodium chloride in sterile water for injection. Menjugate ® contains no preservative.

For information about precautions and adverse effects go to: http://www.merckfrosst.ca/e/products/menjugate/home.html

M-M-R ® II Measles, Mumps and Rubella Virus Vaccine, Live, Attenuated, MSD Std.

Produced by Merck Frosst

Composition:

M-M-R ® II (Measles, Mumps and Rubella virus vaccine, live, attenuated, MSD Std.) is a sterile lyophilized preparation of (1) ATTENUVAX ® (Measles virus vaccine, live, attenuated, MSD Std.), a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) MUMPSVAX ® (Mumps virus vaccine, live, attenuated, MSD Std.), the Jeryl Lynn ® (B level) strain of mumps virus propagated in chick embryo cell cultures; and (3) MERUVAX ® II (Rubella virus vaccine, live, attenuated, MSD Std.), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in human diploid lung fibroblasts.

The reconstituted vaccine is for subcutaneous administration. When reconstituted as directed, the dose for injection is 0.5 mL and contains not less than the equivalent of 1,000 CCID50 (50% cell culture infective dose) of measles virus 5,000 CCID50 of mumps virus; and 1,000 CCID50 of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum (‹1 ppm), other buffer and media ingredients and approximately 25 µg of neomycin. The product contains no preservative.

The growth medium for measles and mumps is Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and human albumin) as stabilizer and neomycin.

The growth medium for rubella is Minimum Essential Medium (MEM) (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing human serum albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.

The cells, virus pools, fetal bovine serum, and human albumin are all screened for the absence of adventitious agents. Human albumin is processed using the Cohn cold ethanol fractionation procedure.

For information about precautions and adverse events, got to: http://www.merckfrosst.ca/e/products/m-m-r_ii/home.html

********************
VARIVAX® III varicella virus vaccine, live, attenuated (Oka/Merck) is a live, attenuated virus vaccine (a lyophilized preparation of the Oka/Merck strain of varicella).

COMPOSITION- Active Ingredients:

VARIVAX ® III , when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.5 mL dose contains a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 30 minutes.

Non-Medicinal Ingredients:

Each 0.5 mL dose contains approximately 18 mg of sucrose, 8.9 mg hydrolyzed gelatin, 3.6 mg of urea, 2.3 mg sodium chloride, 0.36 mg monosodium L glutamate, 0.33 mg of sodium phosphate dibasic, 57 µg of potassium phosphate monobasic, 57 µg of potassium chloride. The product also contains residual components of MRC-5 cells including DNA and protein; and trace quantities of neomycin, and fetal bovine serum from MRC-5 culture media. The product contains no preservative.

For information about precautions and adverse events, go to:  http://www.merckfrosst.ca/e/products/varivax/home.html
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 04:43 PM
Response to Reply #24
43. Thanks for all the info, xchrom. Unfortunately, the Merck links
have been taken down.
Printer Friendly | Permalink |  | Top
 
xchrom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:15 PM
Response to Reply #43
49. this is the link where i got the originals from
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:18 PM
Response to Original message
28. Thanks, pnwmom -- Good info! Keep questioning Perry's dictatorial mandate n/t
Printer Friendly | Permalink |  | Top
 
pnwmom Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:14 PM
Response to Reply #28
48. Have you heard whether they're mandating it anywhere else?
I believe I read that someone had introduced a bill to that effect in Michigan, but I don't know the outcome.
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 05:57 PM
Response to Reply #48
54. No-- but we need to keep digging on Perry and why he cut out the state legislature n/t
Printer Friendly | Permalink |  | Top
 
iverglas Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 02:19 PM
Response to Original message
29. Yawn. Now how 'bout those birth control pills for men?

Should yet another onerous burden of responsible sexual behavior be borne just by young women?

Like the onerous burden of unwanted pregnancy -- the real onerous burden here is CERVICAL CANCER. And it is borne by WOMEN.

Y'all may want to rely on your partners having taken their birth control pills that morning, or having got their HPV shots (before being infected with HPV), to protect yourselves (and to rely on your daughters' partners to have done same, to protect your daughters). I wouldn't choose to be quite such a fool, myself, given that I and not my partner would be bearing the burden if he happened to err or lie.



Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 08:36 PM
Response to Original message
63. Does something else need to be added to Cleaner's formula in post #16?--Vioxx lawsuits?
Edited on Thu Feb-15-07 08:41 PM by antigop
From Merck's 10-K
http://sec.gov/Archives/edgar/data/64978/000095012306003031/y18212e10vk.htm#005

>>
The Company faces significant litigation related to Vioxx.
On September 30, 2004, the Company voluntarily withdrew Vioxx, its arthritis and acute pain medication, from the market worldwide. As of December 31, 2005, approximately 9,650 product liability lawsuits, involving approximately 19,100 plaintiff groups, alleging personal injuries resulting from the use of Vioxx, have been filed against the Company in state and federal courts in the United States. The Company is also a defendant in purported class actions related to the use of Vioxx. (All of these suits are referred to as the “Vioxx Product Liability Lawsuits”). In addition to the Vioxx Product Liability Lawsuits, a number of purported class actions have been brought against the Company and several current and former officers and directors of the Company alleging that the Company made false and misleading statements regarding Vioxx in violation of the federal securities laws (all of these suits are referred to as the “Vioxx Securities Lawsuits”) and the Employee Retirement Income Security Act (“ERISA”) (all of these suits are referred to as the “Vioxx ERISA Lawsuits”). In addition, a number of shareholders have filed derivative suits and one shareholder
has filed a demand asserting claims against the Board members and Company officers. (All of these suits are referred to as the “Vioxx Derivative Lawsuits” and, together with the Vioxx Securities Lawsuits and the Vioxx ERISA Lawsuits, the “Vioxx Shareholder Lawsuits”). The Company has also been named as a defendant in actions in various countries outside the United States. (All of these suits are referred to as the “Vioxx Foreign Lawsuits”). The Company has also been sued by four states with respect to the marketing of Vioxx. The Company anticipates that additional lawsuits relating to Vioxx will be filed against it and/or certain of its current and former officers and directors in the future.
The SEC is conducting a formal investigation of the Company concerning Vioxx. The U.S. Department of Justice has issued a subpoena requesting information relating to the Company’s research, marketing and selling activities with respect to Vioxx in a federal health care investigation under criminal statutes. There are also ongoing investigations by certain Congressional committees and local authorities in Europe. A group of Attorneys General from thirty-one states and the District of Columbia are conducting an investigation of the Company’s sales and marketing of Vioxx. The Company is cooperating with authorities in all of these investigations. (All of these investigations are referred to as the “Vioxx Investigations”). The Company can not predict the outcome of any of these investigations; however, they could result in potential civil and/or criminal liability.
>>

Do your due diligence and read the rest starting on page 24.
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 10:50 PM
Response to Original message
66. Oh,, my! Did the Texas Attorney General file suit against Merck?????
Edited on Thu Feb-15-07 10:51 PM by antigop
Page 25

http://sec.gov/Archives/edgar/data/64978/000095012306003031/y18212e10vk.htm#005

>>
As previously reported, the Company has also been named as a defendant in separate lawsuits brought by the Attorneys General of Louisiana, Mississippi, and Texas. The Attorney General of Alaska has also recently filed a lawsuit. These actions allege that the Company misrepresented the safety of Vioxx and seek (i) recovery of the cost of Vioxx purchased or reimbursed by the state and its agencies; (ii) reimbursement of all sums paid by the state and its agencies for medical services for the treatment of persons injured by Vioxx; (iii) damages under various common law theories; and/or (iv) remedies under various state statutory theories, including state consumer fraud and/or fair business practices or Medicaid fraud statutes, including civil penalties.

>>
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 10:56 PM
Response to Original message
67. Shareholder suits in addition to Vioxx product liability suits???
Page 26
http://sec.gov/Archives/edgar/data/64978/000095012306003031/y18212e10vk.htm#005

>>
As previously disclosed, in addition to the Vioxx Product Liability Lawsuits, the Company, along with various current and former officers and directors of the Company, are defendants in a number of putative class actions and individual lawsuits filed in (or removed to) federal court by shareholders under the federal securities laws (the “Vioxx Securities Lawsuits”), all of which have been transferred by the JPML, along with related lawsuits discussed below, to the United States District Court for the District of New Jersey before District Judge Stanley R. Chesler for inclusion in a nationwide MDL for coordinated pretrial proceedings (the “Shareholder MDL”). Judge Chesler has consolidated the Vioxx Securities Lawsuits for all purposes. On June 9, 2005, plaintiffs in the Vioxx Securities Lawsuits filed a Fourth Consolidated and Amended Class Action Complaint superseding prior complaints in the various cases (the “Complaint”). Plaintiffs request certification of a class of purchasers of Company stock between May 21, 1999 and October 29, 2004. The Complaint alleges that the defendants made false and misleading statements regarding Vioxx in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and seeks unspecified compensatory damages and the costs of suit, including attorneys’ fees. The Complaint also asserts a claim under Section 20A of the Securities and Exchange Act against certain defendants relating to their sales of Merck stock. In addition, the Complaint includes allegations under Sections 11, 12 and 15 of the Securities Act of 1933 that certain defendants made incomplete and misleading statements in a registration statement and certain prospectuses filed in connection with the Merck Stock Investment Plan, a dividend reinvestment plan. Defendants have filed a motion to dismiss the Complaint, which is pending.
>>

Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 10:57 PM
Response to Original message
68. And international lawsuits????
Page 27
http://sec.gov/Archives/edgar/data/64978/000095012306003031/y18212e10vk.htm#005
>>
International Lawsuits
As previously disclosed, in addition to the lawsuits discussed above, the Company has been named as a defendant in litigation relating to Vioxx in various countries (collectively, the “Vioxx Foreign Lawsuits”) in Europe, Canada, Brazil, Australia, Turkey, and Israel.

>>
Printer Friendly | Permalink |  | Top
 
sweetheart Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 11:10 PM
Response to Original message
70. "save us all." make all the products mandatory
Lord save us poor stupid masses of walmart shoppers and regular people, save us
by making macdonald's fries mandatory for avoiding anorexia. Then, as we are force fed
a million macdonald's french fries per day, every day, forever, we will be saved
from free will and the responsibility of being sentient,
proles after all, unthinking reproducers duracell'ing away to power the militaristic imperial scam.
Printer Friendly | Permalink |  | Top
 
antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Feb-15-07 11:11 PM
Response to Original message
71. Item 3. Legal Proceedings. Goes from page 24 to page 34
Printer Friendly | Permalink |  | Top
 
DU AdBot (1000+ posts) Click to send private message to this author Click to view 
this author's profile Click to add 
this author to your buddy list Click to add 
this author to your Ignore list Wed May 08th 2024, 06:48 PM
Response to Original message
Advertisements [?]
 Top

Home » Discuss » Archives » General Discussion (1/22-2007 thru 12/14/2010) Donate to DU

Powered by DCForum+ Version 1.1 Copyright 1997-2002 DCScripts.com
Software has been extensively modified by the DU administrators


Important Notices: By participating on this discussion board, visitors agree to abide by the rules outlined on our Rules page. Messages posted on the Democratic Underground Discussion Forums are the opinions of the individuals who post them, and do not necessarily represent the opinions of Democratic Underground, LLC.

Home  |  Discussion Forums  |  Journals |  Store  |  Donate

About DU  |  Contact Us  |  Privacy Policy

Got a message for Democratic Underground? Click here to send us a message.

© 2001 - 2011 Democratic Underground, LLC