Merch suspends lobbying for mandatory vaccine

[Jetsetlemming]

Merck suspends lobbying for vaccine
http://www.businessweek.com/ap/financialnews/D8NDNR0O0.htm

Merck & Co. is immediately suspending its lobbying campaign to persuade state legislatures to mandate that adolescent girls get the company's new vaccine against cervical cancer as a requirement for school attendance, the company said Tuesday.

The drug maker had been criticized by parents and doctors' groups for quietly funding the campaign via a third party to require 11- and 12-year-old girls get the three-dose vaccine in order to attend school.

Some had objected because the vaccine protects against a sexually transmitted disease, human papilloma virus, which causes cervical cancer. Vaccines mandated for school attendance usually are for diseases easily spread through casual contact.

"Our goal is about cervical cancer prevention and we want to reach as many females as possible with Gardasil," Dr. Richard M. Haupt, Merck's medical director for vaccines, told The Associated Press.

"We're concerned that our role in supporting school requirements is a distraction from that goal, and as such have suspended our lobbying efforts," Haupt said, adding the company will continue providing information about the vaccine if requested by government officials.

Merck launched Gardasil, the first vaccine to prevent cervical cancer, in June.

Sales totaled $255 million through the end of 2006, according to Merck.

Last month, the AP reported that Merck was channeling money for its state-mandate campaign through Women in Government, an advocacy group made up of female state legislators across the country.

Conservative groups opposed the campaign, saying it would encourage premarital sex, and parents' rights groups said it interfered with their control over their children.

Even two of the prominent medical groups that supported broad use of the vaccine, the American Academy of Pediatricians and the American Academy of Family Practitioners, questioned Merck's timing, Haupt said Tuesday.

"They, along with some other folks in the public health community, believe there needs to be more time," he said, to ensure government funding for the vaccine for uninsured girls is in place and that families and government officials have enough information about it.

Legislatures in roughly 20 states have introduced measures that would mandate girls have the vaccine to attend school, but none has passed so far. However, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring that schoolgirls get the vaccinations, triggering protests from lawmakers in that state.

The vaccine also is controversial because of its price -- $360 for the three doses required over a six-month stretch. Because of that cost and what pediatricians and gynecologists say is inadequate reimbursement by insurers, many are choosing not to stock the vaccine or requiring surcharges to administer it, adding to parents' difficulties.

Merck shares were down in after-hours trading on the New York Stock Exchange, falling 35 cents to $44.15 after rising 22 cents in regular trading to close at $44.50.



~I'm not the only one who's feeling really uncomfortable with the concept of a drug company lobbying to make it's product- it's expensive, rare, and under-tested product- mandatory for the public at large, am I?

[悲しいパンダ]

$360 is a lot. Us, poor people don't have a extra $360.

[Angelyne]

[B]
~I'm not the only one who's feeling really uncomfortable with the concept of a drug company lobbying to make it's product- it's expensive, rare, and under-tested product- mandatory for the public at large, am I?


No, you're not the only one. This is very good news.

[SlickWilly440]

To hell with the mandatory Vaccinactions for the students, that's just a waste of money. I really doubt the most hideous girl in school needs HPV prevention, when she is probably not going to get touch for the very first time for most of year life. Unless she tricks some drunk guy from getting it on. Teaching kids about Abstinence and self play is a whole lot cheap.

[Pierrot le Fou]

To hell with the mandatory Vaccinactions for the students, that's just a waste of money. I've lived many years without a single cervical cancer scare!
Fixed it for you.

[Kass]

$360 is a lot. Us, poor people don't have a extra $360.

Almost every single state health department will provide mandatory vaccines for free or reduced prices if you walk in and say "I can't afford it and don't have insurance for vaccines." Texas and Virginia both do and they are bassackwards about nearly everything. They don't even ask for any proof. I've got ALL my daughter's vaccines before she was five that way. It's the law in most states.


To hell with the mandatory Vaccinactions for the students, that's just a waste of money. I really doubt the most hideous girl in school needs HPV prevention, when she is probably not going to get touch for the very first time for most of year life. Unless she tricks some drunk guy from getting it on. Teaching kids about Abstinence and self play is a whole lot cheap.

By the time girls turn 18, nearly 60% of them have HPV. I've seen estimates from the American Gynecological Association that say that 80% of college-aged women have HPV. Condoms do NOT stop the spread of HPV and even one sexual contact can give you HPV because for every infected woman, there is at least one man who is a carrier. Intercourse is NOT required to spread the disease. HPV is spread through both hetero- and homosexual contact. Close vaginal contact is sufficient to infect someone. Once you are infected, the vaccine is useless. The only way to protect women against the four strains of HPV Gardasil protects against is the vaccine BEFORE they become remotely sexually active.

Cost is irrelevant. The public health is what matters. All vaccines, adjusting for inflation, cost this much when initially offered. It costs a LOT to develop the vaccine and companies have to recoup their investment. Once that is done, the cost goes down. It happens with ALL medications.

Thousands of women die every year from cervical cancer in the US alone. Worldwide, the number is obscenely high. Men see far less urgency in this since they aren't the ones having their reproductive organs removed or dying from it.

The criticism from religious groups is insanely stupid. When it was discovered that penicillin cured a variety of STDs, no one said don't give it out because it encourages people to have sex. This is the same thing. This is one case where uppity, rich white men with nothing better to do than pass judgment have absolutely no business whatsoever chiming in on a subject. When this necessitates the chopping off of their penises, I'll care whether or not they think this sends the right message. Of course, I'm sure they will think the vaccine is wonderful then.

[Jetsetlemming]

The vaccine itself is good, and I think that, barring any finds of more serious side effects (it looks to me like it is indeed not tested in a wide enough group), then it should be wide-spread and commonly used. However, I STILL don't like the idea of a drug corporation like Merch, or ANY business, lobbying the government to make it's product mandatory for the public! That's just chock full of corruption. I'm 100% positive they weren't doing this lobbying out of the goodness of their hearts. $360 per head, on every single schoolgirl in the country? That's one hell of a big pile of money.

[Kass]

The beauty of free speech is you don't get to decide who uses it. If Merck (not MercH) wants to spend its money lobbying, its not your right to say no they can't do it. You've every right to lobby against it, but no right to silence anyone.

Drug companies aren't nearly as profitable as everyone thinks. The bulk of their earnings is poured back into R&D that often goes nowhere. For every successful trial like Gardasil or Viagra or Prozac, there are three failed trials that were nothing but money losers. Yes, they make money, but that isn't a crime. It's the whole point of being in business.

Merck doesn't have to make its vaccines mandatory to turn a profit. They can just come out with another Viagra-like product that men will pay out the ass for and fund research into another Gardasil-like product. (When was the last time you heard of illegal chicken pox vaccine rings selling stolen vaccines? Viagra is one of the most commonly stolen and resold non-narcotic drugs.) Their profits don't come from the Gardasils. They come from Viagras, Wellbutrins and the other "quality of life" pills this country pops like candy everyday. If Merck, Abbott Labs and other pharmeceutical companies just wanted to make money, they'd ignore completely research into things like cervical cancer and other gender/race specific illnesses and only make pills like anti-depressants.

There's no real profit in doing narrow research. The market isn't large enough, the demand too low, public acceptance less likely and they cost themselves money by making unnecessary more expensive medications like chemotherapy drugs (one does of chemotherapy can be several thousand dollars). Do the math. How would pharmeceuticals make more money? Preventing an illness for $360 or treating the same illness for $100,000, a large part of which is medications.

Are their motives purely altruistic? Of course not. They have employees to pay, shareholders to account to and everyone would love to make more money at the end of the day, but it isn't in their best financial interests to prevent cancer. They make money off of cancer.

The cost of giving every school girl in the country the vaccine is FAR less than the costs of treating cervical cancer every year and after an initial period, the price of the vaccine would go down as Merck recouped its R&D investment. It ALWAYS happens with medications. It happened recently with Wellbutrin. The price dropped by at least half after generics were allowed to be sold and the genrics are cheaper still.

The cost savings in the US from administering the Hepatitis B vaccine was $72.9 million. That's savings which means over and above what is paid for the vaccine. Actual costs of the vaccine are already subtracted out. That kind of gives us an idea of what a vaccine can save in monetary terms. If Gardasil has the same impact, saving $72.9 million dollars would pay for 202,500 vaccines at $360 for the series.

Since the cost of treating cancer is typically higher than treating Hepatitis B and the number of vaccines administered cut by half since it is girls-only right now, the savings would be higher.

According to the American Cancer Society, the total cost of cancer-related care in the US is $209.9 billion. I doubt vaccinating every girl in the US even comes close to making a dent in that, though I don't know the number of girls the right age in the US to do the math.

Vaccines are virtually worthless in the big picture if everyone doesn't get them. If people can freely opt out of a vaccine, there is no way to eradicate the disease. It will continue to spread and cause cancer as long as there are people carrying it and people will continue to carry it as long as they are not vaccinated.

In an ideal world, everyone but you would get vaccinated. That way no one else has it to give to you so you won't get it, but this isn't ideal. It's the real world and everyone can't be the one person who doesn't get vaccinated. And just because Merck says that all girls should get the vaccine doesn't make the statement wrong. They did the research. They're in the best position to know.

Oh yes, Merck also underwrites programs to provide vaccines and medications free of charge to people who can't afford them. All the pharmaceutial companies do. It's too bad no one pays attention to that.

[Roxie]

To hell with the mandatory Vaccinactions for the students, that's just a waste of money. I really doubt the most hideous girl in school needs HPV prevention, when she is probably not going to get touch for the very first time for most of year life. Unless she tricks some drunk guy from getting it on. Teaching kids about Abstinence and self play is a whole lot cheap. Woooow.

Luckily for you and any woman might have...unique chance of having intercourse with...you

I have a pamplet from www.maketheconnection.org about HPV.

cerivcal cancer is one of the most preventable cancers, yet remains the world's second-leading cancer killer of women. Of the 490,000 women diagnosed every year, more than 280,000 die from it.
In the U.S. an estimated 9,700 women will develop cerivcal cancer this year, resulting in about 3,700 deaths.
HPV is a common virus which infects about half of all people at some point in their lives. Approximately 80% of women will become infected with HPV by age 50.
The CDC estimate that 20 million Americans are infected with HPV each year with approximately 6 million becoming newly infected. Of the esitmated 20 million Americans infected, almost half are between the ages 15 and 24
While in most cases HPV does not have any sumptoms and clears on its own, that's not always the case. Certain high-risk types of HPV can cause cerivcal cancer. Other types of HPV can cause diseases such as benign cervical changes and gential wartsYes, let's do what's cheap.

[Jetsetlemming]

I agree that the vaccine should be widely used and HPV prevented. I STILL think that a company lobbying the government to make it's product mandatory is unethical and wildly corrupt.
This isn't a "free speech" issue, Kass. They have every right to say whatever they want. They doesn't make underhandedly talking the government into making their product mandatory (Behind closed doors and in as much a hidden way as possible- the article mentions they did the lobbying through a third party and did their best to avoid public attention) sets off all kinds of warning signs to me.
Whether the cancer vaccine should be mandatory to everybody or not is another matter entirely, one that I haven't touched. It's just the "who", and the "how" behind this particular story that I in particular find fucked up.

[Angelyne]

Since Merck holds the patent to this vaccine, they stand to make a ton of money until the patent runs out. This is why they were so quick to push legislation to make the vaccine mandatory--they want to milk as much money as possible from it before they lose their monopoly in 10+ years. We will only see the cheaper, generic substitutes after Gardasil's exclusivity patent runs out, and until then, Merck will see every bit of profit from each $360 vaccine sold to the public over the next decade. Don't pretend that isn't a lot of profit.

And while it is great that the vaccine was approved and I support any woman's choice to use it, what ultimately irks me about the debate is the fact that many "right to choose" advocates are pushing so hard for mandatory vaccinations. What happened to choice? Why should I have to be forced to buy a STD vaccination because someone Congressman received a handsome bribe from a drug company? Why should I be forced to spend my own money when I am currently not at risk of catching HPV (because not all insurance programs cover this vaccine, and not all state programs have health policies that cover Gardasil's cost completely--even Texas' state healthcare system is requiring a small payment for it). And since we have no idea what the longterm effects of this vaccine are, why should I needlessly put myself at risk?

Let's face it--HPV is not exactly the same as polio, measles, or any other disease that they currently vaccinate against. There is simply no other way to prevent those diseases, whereas HPV can be prevented through lifestyle choices. Over the course of what is legally required in a normal school day, there is no possible way for a student to acquire and spread this disease. And no, "after school activities" don't count because student sex lives are outside the jurisdiction of the school. Therefore, there is no reason to force students to get this vaccine--leave up to the individual to decide what is best for them.

P.S. Stop calling it the "cancer vaccine". It doesn't prevent all strains of HPV, and it doesn't guarantee that you will never develop cervical cancer.

[Campion]

The beauty of free speech is you don't get to decide who uses it. If Merck (not MercH) wants to spend its money lobbying, its not your right to say no they can't do it. You've every right to lobby against it, but no right to silence anyone..

If free speech held the same power as lobbying, Merck wouldn't have bothered spending a reputed $40,710,294 between 1998 and 2004 (www.public-i.org) to ensure its voice was heard. Money talks a lot louder than words. To equate the two is a denial of the power that money plays in politics, I have no doubt that if JSL had that kind of money politicians would be falling over themselves to hear what he has to say.

As it stands Gov. Rick Perry of Texas didn't let anyone else exercise their freedom of speech when he issued his executive order for mandatory treatment.. So to suggest that lobbying is in some way equitable to the freedom of speech genuinely offends me.

Kass, you claim drug companies are nowhere near as profitable as everyone thinks, yet since the 80's the pharmaceutical industry has been one of the most profitable sectors in America (and yes it still is), in the year 2000 for instance (according to a fortune500 report of 2001) Mercks profitibility of 17% (of revenues) beat Disney (4%), Walmart (3%) and Nike (6%).

The bulk of Big Pharmas' money does not go in to R&D as you assert, it goes into marketing and administration. Marketing chews up twice as much money as R&D does in a lot of the pharmaceutical companies. in 1999 for instance, 6.3% of Mercks revenue went on R&D while 15.9% went on Marketing and Administration. (http://www.actupny.org/reports/durban-licensing.html) in 2000 it was 6% on R&D and 15% on Marketing, Advertising and Administration (http://www.actupny.org/reports/drugcosts.html#chart_one) and I haven't seen anything since that could suggest a reversal in this trend.


Merck doesn't have to make its vaccines mandatory to turn a profit.

No but it sure helps.. Especially when your customers have no alternative medicine (no competition from other Pharma) and each person will need a booster shot every four and a half years, so that's what? Fifty percent (roughly) of the United States population, once every four to five years possibly in perpetuity.. $360 a shot. That's one hell of a license to print money.

Your suggestion that they would make more money treating Cancer rather than trying to prevent it doesn't make sense to me. Currently they share the cancer treatment pie with a lot of other drug companies, they want a slice that would cut GlaxoSmithKline out of the cervical cancer market by mandatory use of only their own pre-emptive treatment before any competition can come to market to undercut their pricing.

Cancer related care costs $209.9 billion in the US? I'll accept that figure, but in my opinion if Merck get their way on this, that figure will actually go up in the future and not down.



Campion.

[Roxie]

why should I needlessly put myself at risk? Unless you plan to be a life long virgin, then you are already putting yourself at risk.

Let's face it--HPV is not exactly the same as polio, measles, or any other disease that they currently vaccinate against. There is simply no other way to prevent those diseases, whereas HPV can be prevented through lifestyle choices. A "lifestyle choice" that the very healthy majority of people will not choose, nor adhear to.

P.S. Stop calling it the "cancer vaccine". It doesn't prevent all strains of HPV, and it doesn't guarantee that you will never develop cervical cancer. And? That's no good reason to not take it.

I mean, can you really afford to not take it?

[Campion]

I just remembered where I last heard the name Merck. it was 2004 and the product was Vioxx.

http://news.bbc.co.uk/1/hi/business/4189354.stm

http://www.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm



Campion.

[Angelyne]

Unless you plan to be a life long virgin, then you are already putting yourself at risk.

I've been in a monogamous relationship for over five years and neither my partner nor I have any STDs. How exactly does this make me at risk for catching HPV?

A "lifestyle choice" that the very healthy majority of people will not choose, nor adhear to.

That is hardly a justification to force millions of people to bow to the whims of the drug lobby. Again, why are so many "Right to Choose" advocates ready to so willingly throw away more control to the government? Especially to the Bush administration and other Republican-majority state governments who have a history of being against reproductive rights?

And? That's no good reason to not take it.

I mean, can you really afford to not take it?


Why does it matter? It's my choice to expose myself to that risk--not yours and certainly not the governments.



Edit: I suck at formatting.

[Pierrot le Fou]

And how pray tell would you know if you had HPV? Many strains have no symptoms. Ditto with herpes, which is also quite difficult to test for.

Have you been specifically tested for these things? I doubt it.

[Kaji]

It's a public health matter. As noted above, you can't effectively eradicate a disease without having everyone vaccinated. Do you think we killed smallpox in the wild by just letting the 10% of the population who did it for fun take the vaccine?

[Disney's doug89]

This vaccine saves lives, and those saying you can go without it: Take the seatbelts out of your car.

lifestyle choices

"I drive slow so I don't need seatbelts."

[Roxie]

I've been in a monogamous relationship for over five years and neither my partner nor I have any STDs. How exactly does this make me at risk for catching HPV?
So, you were both virgins when you met each other? HPV test has to be asked for specifically.

let me restate:

The CDC estimate that 20 million Americans are infected with HPV each year with approximately 6 million becoming newly infected. Of the esitmated 20 million Americans infected, almost half are between the ages 15 and 24If you have any friends/relatives in this age group, will be in this age group, or has been in this age group, you should be concerned.


That is hardly a justification to force millions of people to bow to the whims of the drug lobby. Again, why are so many "Right to Choose" advocates ready to so willingly throw away more control to the government?
To save lives.
Especially to the Bush administration and other Republican-majority state governments who have a history of being against reproductive rights?
With such a history they are unlikely to approve such a thing, so really, I don't think we'll ever need to get that far. And if they did approve such a thing, it would make it even more serious due to their well known stance aganist reproductive rights.


Why does it matter? It's my choice to expose myself to that risk--not yours and certainly not the governments.
Nah, son. This is bigger than you.

HPV is a common virus which infects about half of all people at some point in their lives. Approximately 80% of women will become infected with HPV by age 50.

[Kass]

Angelyne, HPV can go undetected for up to 20 years in a woman's body. You cannot screen for it UNTIL symptoms are present such as cervical tissue changes. If you have had a single sexual partner with more than one partner, you likely have contracted a strain of HPV. In fact, it is 80% likely that you have contracted a strain of HPV. If you've had more than one partner ever, odds are even better that you've contracted a strain of HPV and have just not been symptomatic. Many women never develop symptoms. Many women wouldn't know if they did because they don't get regular GYN exams.

If you have had sex with more than one person EVER, odds are you are HPV positive. If you've had sex with one person who has had sex with more than one person ever, odds are you have HPV. If you share towels with another woman who is sexually active, you can contract HPV. If you have had oral sex, odds are you have HPV.

There is only a 20% chance you DON'T have HPV.

~~~~

No, this virus isn't a "cancer vaccine" but to be pissed off about calling that is stupid. It's a vaccine that prevents a virus that causes cancer AND genital warts. There are four strains of HPV that cause cancer I believe two that cause genital warts. This vaccine protects against the strains that cause genital warts and two of the four cancer-causing strains. It DOES prevent cancer.

Vioxx is irrelevant in condeming only Merck because ALL the major pharmeceutical companies had similar drugs that were taken off the market at the same time, Celebrex (Pzizer) and Bextra (Monsanto) for example. That happened because the approval process was rushed--at the request of the AMA and others. The drugs worked but with pretty bad side effects. I do know my uncle would rather risk the side effects and still have access to the ONLY medication that alleviated his pain from osteoarthritis than live everyday in agony.

Merck is also not the only maker an HPV vaccine. GlaxoSmithKline is seeking approval for its vaccine, Cevarix. Cevarix is also shown to be 100% effective in preventing the two strains of cancer-causing HPV that Gardasil does, but does not prevent the two strains that cause genital warts. It's approval is expected anytime now.

Even dividing up the profits from chemotherapy treatments and other cancer-related medications, a single drug company will make more in a year on those products than they will on a vaccine, regardless of the $360 price tag. $209 billion per annum (and rising every year) divided up is still more than the estimated profits for Gardasil and Cevarix, especially in a market that will be big initially and decline over time until it holds steady with the birth rate of girls.

By the way, lobbying is protected free speech, which is why it is so hard to regulate. Just because it costs money doesn't make it not speech. They are exactly the same thing just like any campaign contribution you make is free political speech.

HPV and the vaccine have NOTHING TO DO WITH REPRODUCTIVE RIGHTS. This is NOT A CHOICE/ABORTION ISSUE. Quit dragging in irrelevant, emotional arguments because you're pissed off at a drug company for making money. Preventing cancer and genital warts has nothing whatsoever to do with reproductive rights.

This is a purely health issue that puts you, your daughters, me and my daughter and EVERY SINGLE WOMAN IN THIS COUNTRY (and a small number of men) at risk. If this vaccine prevented the Epstein-Barr virus that causes mononucleosis, nasopharylyngeal carcinoma, post-transplant lymphoproliferative disease (cancer common in transplant patients), and Hodgkin's disease (lymphoma), no one would be saying boo about making it mandatory, especially since the type of Hodgkin's EBV causes primarily afffects young men between the ages of 18 and 25. (Just FYI, post-transplant lymphoproliferative disease killed one of my dearest friends and another friend at the ripe old age of 20 had Hodgkin's and thankfully has been cancer free for 2.5 years now. I'd love to see a vaccine for EBV.)

But God fucking forbid we find a preventive treatment to a disease that primarily affects only women and their cervix. That's a bad thing and don't you dare make anyone take one simple step to stop the proliferation of the most common virus in women after the common cold and one that can kill you, unlike the common cold.Oh, and don't you dare lift a finger or cough up $20 to the state of Texas to help stop the spread of this disease.

Getting this vaccine does not in any way affect anyone's ability to have or not have children. What affects that? Whether or not you develop cancer and have to have a hysterectomy--the only truly effective treatment for cervical cancer. Chemotherapy and radiation have not been shown to be effective in preventing the return or spreading of the cancer. A complete hysterectomy is the recommended treatment PLUS chemotherapy and radiation.

If the objection is because this is primarily a sexually transmitted disease, then you'd better stop prescribing antibiotics too because they treat syphillis and other STDs. People might think it's okay to have sex since we have antibiotics.

Oh, and by the way, it does not bypass any legal avenues for the governor to mandate the vaccine. That is common in Texas because of its state govenrment structure. The governor has the authority to do this and that authroity is frequently used for this kind of issue because the state legislature only meets every two years and cannot deal with these things in a timely manner. That's how the initial vaccination program started in the first place. (The governor has very little other authority, but this he has.)


The simple fact is the public good outweighs personal objections in cases like this. In 2000, there were 83,114,968 women aged 16 and up. Of those women, 66,491,974 are probably HPV positive. What other virus with potentially fatal outcome of HPV affects that many people? EBV sure doesn't. Any objection to Merck, money or vaccines does not outweigh the health benefits to 83,114,968 people--unless of course, those are all women, right?

[Campion]

Kass,

I am genuinely sorry to hear that your uncle is in so much pain he would choose the increased risk of stroke or heart-attack linked to the Vioxx product over the pain that he suffers on a daily basis. That must be a truly horrible thing for someone to go through. The fact that he now knows the risks but would still choose it is an awful thing for me to consider. He has my most sincere and deepest sympathy.

I now fully appreciate that you have a vested interest in this topic and by continuing it I have no desire to upset you further, however one of your assertions in your previous post is near tantamount to an open accusation that any detractor of your argument is a misogynist, I strenuously deny this unfair suggestion. Just because I appear to disagree with you on certain points does not in some way make me or any other detractor of your argument a sexist bully. For someone so fond of free speech I am disappointed that you appear awfully keen to use a style of rhetoric famous for shutting down any point of an oppositional debater without raising a valid point in itself.

Let me make this absolutely clear, if this drug is a magic-bullet and Merck are not obfuscating its value, or worse any potentially serious side-effects I would be ecstatic to see it as a mandatory drug, for all girls worldwide, period. Unfortunately the information I have currently at hand just tells a different story.



Also the current screening of HPV/cervical cancer for women is believed to reduce the risk of cervical cancer death by 80 percent, according to Angela E Raffle who published her correspondence in The Lancet 2007; 369:367-368 to oppose the compulsory inoculation of HPV vaccine. As she said, this HPV vaccine offers little gain if any.

While this Merck's HPV vaccine MAY help prevent about 70 percent of cervical cancer cases, like many other clinical trials, the trials of this vaccine were performed for a relative short term, 2 and 3 or no more than 5 years. This means that the long term efficacy and toxicity of the vaccine remain to be guessed by everyone. This is one reason for some people to reject the vaccine.

According to news media, one of Perry's arguments is that using this HPV vaccine not only saves some women's lives, but saves money as well because treatment of cervical cancer is costly. While this HPV vaccine may save around 700 women's lives in Texas, the medical cost would increase from 7.7 million a year for treatment of cervical cancer to 126 million a year for the HVP vaccine.


So the Lancet no less, is suggesting that current screening practices are believed to reduce the risk of death from cervical cancer by 80% yet inoculation will only reduce the risk by 70%. It is also noted that the increase to the cost of cervical cancer in Texas will go up by 119 million dollars if Merck get their way. I’ve said it before and I’ll say it again, that’s one hell of a license to print money.

My problem is not that it shouldn’t be ratified by the FDA because it is gender specific (heaven forbid), or even because it will cost more. My problem is a problem of trust in a company that has a rather unfavorable track record in recent history including Fosamax and Vioxx, which is why I brought the latter up in a recent post.

For more information on Fosamax see: http://www.newscientist.com/channel/health/mg19025483.000-merck-in-court-over-osteoporosis-drug.html

If you really want this company to inoculate all of America’s female children without prior long-term testing given their previous track-record then that’s your position and I can’t change it, but if I had children I would want to know I can trust the drug before it was forced into them by government diktat ala Governor Perry whom may I note I did not accuse in any way of acting contrary to Texas law.


Campion.

[Pierrot le Fou]

Campion, please edit the link out of your quote. It scrolls the forum and makes your post a massive pain in my royal ass to read.

Thank you.

[SlickWilly440]

So can Guys get cancer from HPV since Kass has stated that men can carry it over?

[Pierrot le Fou]

So can Guys get cancer from HPV since Kass has stated that men can carry it over?
Yes.

Men can get cervical cancer.

Just ask Plekto, it follows the same principles as women getting prostate cancer.

[Campion]

Campion, please edit the link out of your quote. It scrolls the forum and makes your post a massive pain in my royal ass to read.

Thank you.

Edited for your delectation your highness.



Campion.

[Roxie]

Yes.

Men can get cervical cancer.

Just ask Plekto, it follows the same principles as women getting prostate cancer.
awww, but he tried so hard!

[Pierrot le Fou]

Campion, short-term costs would (obviously) increase. That's the way it works. You pay more now to save more later. Especially when projecting into the future, cost projections tend to favor the argument one is trying to make. With greater consumption, the cost of the vaccine would almost certainly drop, and it would become cheaper.

Would you also be opposed to groups of gynecologists lobbying for regular cervical cancer checks being covered by insurance?

[Kass]

So can Guys get cancer from HPV since Kass has stated that men can carry it over?

Yes. They can get anal cancer, which is also caused by the HPV virus. However, roughly 2% or less of men exposed to HPV ever develop symptoms, either genital warts or cancer. Men are almost exclusively carriers.

Thanks, PLF for pointing out what I've tried to say several times and was ignored. The INITIAL cost will be high, however, over the mid- and long-term, drugs drop dramatically in price if they are commonplace.

Within 2-3 years, the vaccine price will drop and all those projections will be wrong. They are basing their numbers on this vaccine a) being the only one (it isn't) and b) remaining at this price forever. By the end of this year, GlaxoSmithKlein will have its HPV vaccine out and Gardasil will have competition. Granted, it is competition it trounces health-wise simply because Glaxo's vaccine only protects against two of the four strains that Gardasil does. It doesn't protect against the two strains that cause genital warts. Nonetheless, it is competition that will affect cost.

The first vaccination cost billions of dollars in R&D. Everyone after that is cheap. Drug companies have to recoup that investment and fund continuing research. They won't see a profit on this immediately when you do a cost average. As well, work is ongoing to test the vaccine on men (difficult to say the least since there is currently NO way to test for the virus in men). They are also working on an addition to the vaccine that will make it effective on the remaining two cancer-causing strains of the virus. Someone has to pay for that.

NO vaccine has ever come on the market and had a "medical history." It's impossible. The MMR vaccines, varicella vaccines, flu vaccines (which are new EVERY year), DPT (diptheria, pertussis, tetanus), etcetera--all of them had the exact same testing that Gardasil did. It has fewer side effects than the flu vaccine. Drug companies lobbied for those to be mandatory too and NO ONE said boo about it.

What didn't they have? A sexual connotation and a gender-specific audience. While one person here might not have mysoginistic intentions, the EFFECT is mysoginistic. The political decision-makers on this issue are 95% rich, white men with exactly ZERO vested interest in seeing HPV go away. Sex and women ARE the only differences. This is neither urgent nor important to most of them for anything other than a soundbite. I'd bet every penny I have ever laid hands on that if this were a vaccine that prevented testicular cancer, any protests would be completely ignored.

The vaccine demostrated no serious side effects in the trials and testing. Even Cox2 inhibitors like Celebrex, Bextra and Vioxx showed some risk of heart problems in testing. The worst side effects were nothing more than any other vaccine--soreness at the injection site, slight fever, fatigue.

The vaccine HAS to be administered BEFORE exposure to the virus. The only way to do that is innoculate girls BEFORE the average age they become sexually active, which tragically is now about 13-14 years old. Remember, actual intercourse is not required to transmit this virus and condoms offer NO protection against transmission.

By the way, without insurance, some vaccines run $70+ per shot. More than one of the required vaccines is a series of innoculations (polio, MMR, DPT). If you stop and add that up, it isn't that much less than Gardasil. Most of these vaccines started out costing about the same as Gardasil and are cheaper now. The number of shots required is from the list of required immunizations for school attendance. I couldn't find the price for the OPV/IPV polio vaccine (three shots/doses), the Hib (haemophilus influenza type B) vaccine (one shot) and the PCV (Pneumococcal 7-valent conjugate) vaccine (two to four shots).

Various costs per Pharmacychecker.com (all prices are from Canadian Costcos, the cheapest I could find):
Tetramune: $70 per shot (Three shots)
Varivax: $75 per shot (one shot)
MMR vaccine: $70 per shot (two pediatric doses and boosters in high school and adulthood)
Recombivax (hepatitis B vaccine): $76 (three shots)
DPT: $15 per shot, (minimum three shots, but can require up to six)
Tdap (booster for DPT for 6th grade students): $45 (one shot)

Oh, and Canadian drugs are cheaper because the Canadian government allows their pharmeceutical companies to violate patent laws and trade agreements to steal (reverse engineer) formulas from other international pharmaceutical companies.

The simple fact is more than half the population of this country NEEDS this vaccine to protect themselves. It's just the wrong half.

[Campion]

IRT PLF:

I am not against lobbying, I am against lobbying being equated to free speech. I find the money and political influence often associated with lobbying stretches the ideal of free speech a bit too wide for me to take any comparison seriously.


IRT Kass:


GARDASIL may not fully protect everyone and does not prevent all types of cervical cancer, so it is important to continue regular cervical cancer screenings.

Anyone who is allergic to the ingredients of GARDASIL should not receive the vaccine. GARDASIL is not for women who are pregnant.

GARDASIL will not treat these diseases and will not protect against diseases caused by other types of HPV.

So basically, the only manufacturer currently ratified by the FDA (Merck) is saying that not only do they expect you to pay for Gardasil, you will also have to keep the current screening process (and therefore its associated costs). How does this make any part of the process cheaper in the long-term? You will have two pharmaceutical costs associated with treatment instead of one, I haven't been ignoring you Kass, I have consistently said this is a license to print money and it clearly is. This is a win-win situation for Big Pharma.

EDIT: Yes the price of the drug will go down in the long term, but the overall cost of treatment will actually rise with the mandatory use of these vaccinations.

Why do you think Merck wants to make this mandatory prior to competition being approved by the FDA? I would wager it is because they want the biggest slice of the money estimated to be worth over one hundred million dollars in the first year (in Texas alone) to themselves.

As I said in a previous post, I am not against it on cost grounds if it is a magic bullet, but the sums and the facts don't add up in your arguments favour.



Campion.

[Jetsetlemming]

What didn't they have? A sexual connotation and a gender-specific audience. While one person here might not have mysoginistic intentions, the EFFECT is mysoginistic. The political decision-makers on this issue are 95% rich, white men with exactly ZERO vested interest in seeing HPV go away. Sex and women ARE the only differences. This is neither urgent nor important to most of them for anything other than a soundbite. I'd bet every penny I have ever laid hands on that if this were a vaccine that prevented testicular cancer, any protests would be completely ignored.

Absolute bullshit. No matter what the sex and color of anyone, they would still want cervical cancer to go away. They have wives, daughters, mothers, sisters, friends who are female and can get it. Nobody wants anybody to get cancer. And I and the people who are against this current issue- Merck lobbying to make it's product mandatory- would protest it no matter what company and no matter what drug. I don't care if it grants immortality, permanently prevents cancer, aids, baldness, and infertility, I still don't at all trust a corporation using the US government to force the public at large to buy it's product. That's anything but freedom. The point here is not "Oh, Gardisil isn't anything important", or "Who the fuck cares about women? Let them get cancer!". It's "I refuse to accept a company bossing around my government into forcing me to do their bidding." Who you think it OK if Microsoft lobbied congress and made Windows Vista mandatory in every home and business? Would you be fine with Verizon lobbying congress so everyone has to use their phone service? Would you be fine with PITA lobbying congress to force everyone to be a member? Stop changing the subject and sticking words down our mouths to fit your twisted view of our reasons for disliking this. It's Merck's ACTIONS, not their product, that's the bad thing.

[Campion]

The first vaccination cost billions of dollars in R&D. Everyone after that is cheap. Drug companies have to recoup that investment and fund continuing research. They won't see a profit on this immediately when you do a cost average.

Citation needed there Kass, I can't find any development costs associated with Gardasil that have been made available to the public, if you have this costing can you please show me where I can find this information?

Regardless of me not being able to find a quote for the actual development cost, let us say it did indeed cost Merck $2 billion to develop, according to the New York Times, a federal vaccine advisory panel recommendation "all but commits the federal government to spend $2 Billion alone on a program to buy the vaccine for the nation's poorest girls from 11 to 18." (Gardener Harris. nytimes.com =2006.06.30)

Well, there's your costs refunded at any rate and let's look at the development cycle of this drug, did Merck actually start off with this idea or did someone else discover the key process behind it? According to the Rochester review, the key developments were made by Rochester and Georgetown Universities, so Merck didn't swallow all of any estimated development costs on their own. (http://www.rochester.edu/pr/Review/V68N3/feature1.html)

Let's also do a brief look at Mercks earnings. According to google finance, in worldwide sales Merck turned over $22Billion each year for the last two years, there's only one way to make that kind of money and that's to spend some of it, 'you have to spend money to make money' as the maxim goes, so it's not entirely inconcievable that if you want to make billions, you have to spend billions is it?


NO vaccine has ever come on the market and had a "medical history." It's impossible.

According to medicalaccountability.net the package insert itself includes the warning that 'the vaccine has not been tested for altering genes in the patient or her future children (genotoxicity).' (http://www.medicalaccountability.net/essay_gardasil.html)

Some might say that's a pretty important test for this type of product, particularly when 'rich white men' are trying to make it mandatory for girls.


The MMR vaccines, varicella vaccines, flu vaccines (which are new EVERY year), DPT (diptheria, pertussis, tetanus), etcetera--all of them had the exact same testing that Gardasil did. It has fewer side effects than the flu vaccine. Drug companies lobbied for those to be mandatory too and NO ONE said boo about it.

A lot of people 'said boo' about the combined mumps measles and rubella (MMR) vaccines Kass, maybe not in America but it was a pretty hot topic in Europe.
http://news.bbc.co.uk/1/hi/health/1808956.stm


Oh, and Canadian drugs are cheaper because the Canadian government allows their pharmeceutical companies to violate patent laws and trade agreements to steal (reverse engineer) formulas from other international pharmaceutical companies.

TRIPS? Do you really want to go down that road Kass?


Campion.

[Kass]

Absolute bullshit. No matter what the sex and color of anyone, they would still want cervical cancer to go away. They have wives, daughters, mothers, sisters, friends who are female and can get it. Nobody wants anybody to get cancer. And I and the people who are against this current issue- Merck lobbying to make it's product mandatory- would protest it no matter what company and no matter what drug.

No, they wouldn't. Cervical cancer is a sexually transmitted disease and as far as the moral majority, it is a person's own fault if they get one and refuse any public support for the prevention and treatment of them As far as a vast number of politicians are concerned, STDs are absolutely not to be associated with. The religious right just come out and object and the rest dodge the issue to avoid offending their constituents. The number one argument against the vaccine is that it prevents an STD, therefore it encourages sex and God knows, we can't do that. Like penicillin encourages sex becuase it treats the clap. Right.

I've never heard a more blind and ignorant group as the mothers who are quoted on TV saying they won't vaccinate their daughters because they don't want them to have sex. Stupid cows. Like the fear of STDs stops kids from screwing around as it is.

If this were anything but a sexually transmitted disease that affects a gender decidedly NOT in political power, there would be no real debate about requiring it. If HPV was transmitted in the same manner as EBV, the vast majority of people who object to this would not object.

I don't care if it grants immortality, permanently prevents cancer, aids, baldness, and infertility, I still don't at all trust a corporation using the US government to force the public at large to buy it's product. That's anything but freedom. The point here is not "Oh, Gardisil isn't anything important", or "Who the fuck cares about women? Let them get cancer!". It's "I refuse to accept a company bossing around my government into forcing me to do their bidding." Who you think it OK if Microsoft lobbied congress and made Windows Vista mandatory in every home and business? Would you be fine with Verizon lobbying congress so everyone has to use their phone service? Would you be fine with PITA lobbying congress to force everyone to be a member? Stop changing the subject and sticking words down our mouths to fit your twisted view of our reasons for disliking this. It's Merck's ACTIONS, not their product, that's the bad thing.

The comparison is completely idiotic. Neither Windows Vista nor Verizon prevent a disease and directly affect the health of all women in this country (and a small percentage of men). This is NOT the same.

Theyhave every right to lobby for this and you have NO right to deny them the free exercise of political activity just because you don't like money being involved. I never hear anyone complaining about the money the ACLU spends lobbying congress. It's selective. You pick the causes you don't like and object to them spending money. Like it or not, it IS POLITICAL SPEECH and you've NO RIGHT to block it anymore than you have the right to say to whom and how much money I give to a candidate or cause. The only difference between my financial donations and theirs is the size. The goal is the same--to affect political change. Political speech/activity is actually the only kind of speech the founding fathers intended to protect, but it is the first people seek to limit anymore.

It doesn't matter what Merck's motivations are anyway. It's the RIGHT THING TO DO. Diseases will never go away unless we take active steps to do so and this one affects more people than many others we mandate vaccinations to prevent. Where was th outcry when the varicella vaccine was made mandatory in the US? MMR (the associated links to autism were AFTER approval and are not confirmed)?

FYI, autism is increasingly common even incountries that BAN MMR (http://www.newscientist.com/article.ns?id=dn7076) and the link, particularly as defined by DR. Wakefield are unprovable and disputed (http://www.bupa.co.uk/health_information/html/health_news/280703mmr.html, http://www.healthwatch-uk.org/mmr.pdf, http://www.immunize.org/mmrautism/ [this one is on a site I consider one-sided, but the links to the studies aren't. They link to the Lancet, etc.], http://www.spiked-online.com/Articles/0000000CA59F.htm). The latest information on autism causes is an inability to process essential fatty acids (http://www.nj.com/news/ledger/index.ssf?/base/news-11/117177694297300.xml&coll=1, http://science.slashdot.org/science/07/02/19/2252244.shtml, http://www.sundaymirror.co.uk/news/tm_headline=blood-test-for-autism--&method=full&objectid=18673060&siteid=62484-name_page.html).

[Campion]

I've never heard a more blind and ignorant group as the mothers who are quoted on TV saying they won't vaccinate their daughters because they don't want them to have sex.

They take one moral stand..


It doesn't matter what Merck's motivations are anyway. It's the RIGHT THING TO DO.


..and you take another, far be it from me to agree or disagree with either of you, this is only obfuscating the issue with sentiment. It isn’t that it is definitively the right thing to do, it is the right thing to do in your opinion and others disagree.

I have stated throughout this thread my objections to mandatory vaccination with Gardasil and explained why, I have no objections to it on religious grounds, I have no objections to it based on cost and I have no objection to it on the basis that it is gender specific.

Primarily I currently disagree with the mandatory vaccination on two fronts.

One is on an issue of trust with a company that has yet to perform adequate testing (genotoxicity) on a product that deals with the future fertility of potentially an entire country’s worth of kids. Considering this company’s immediate past history with the Vioxx and Fosamaxx products I think that is a valid concern to have. I hope and pray it is a concern invalidated by future testing and the saving of many women’s lives by this product and not validated by the jeopardizing of the girls of the entire state of Texas.

Two is on the issue of best practice, the current screening tests catch 80% of cases of Cervical Cancer and Gardasil catches maybe 70%. I have what I think is a valid concern that people might misinterpret the advertising for Gardasil and see it as a magic bullet and then wind up not following the required steps for the current and still most effective method for prevention and treatment of cervical cancer.

On the issue of Lobbying and Free Speech, may I say that no-one has attempted to deny Merck their right to lobby members of the American government; I see a difference in equality between the two forms and you don’t, each position is the prerogative of its holder. My reasoning is that as Merck is a company and not an individual their lobbying is therefore commercial speech. As far as I can ascertain commercial speech is not afforded the full protection of the first amendment, why not if there is no difference between the two?



Campion.

[Pierrot le Fou]

Well, there's your costs refunded at any rate and let's look at the development cycle of this drug, did Merck actually start off with this idea or did someone else discover the key process behind it? According to the Rochester review, the key developments were made by Rochester and Georgetown Universities, so Merck didn't swallow all of any estimated development costs on their own. (http://www.rochester.edu/pr/Review/V68N3/feature1.html)
From your article:But the vaccine’s journey from bench to bedside included some legal pitfalls. The technology was licensed in 1993 to Praxis, then a small pharmaceutical company in Rochester. But the company was bought out by American Home Products, which declined to pursue the vaccine work. In 1994, the patent was returned to the University.

“Then we were really high and dry,” says Reichman. “We had no one to help us.”

Getting a patent returned “is always a hard situation for universities,” with its implication that the technology is not worthy, says Robert Goodwin, president of LygoCyte Pharmaceuticals in Montana. During the 1990s, while a technology transfer specialist at Rochester, he helped secure critical funding for developing the vaccine. “A vaccine against cervical cancer,” he says, “was an untested market.”

Especially needed is an outside partner. Even in the best of situations, says Goodwin, universities are not prepared to go beyond research to manufacture and test something like a vaccine.

Reichman credits Goodwin (“He was a dream”) with rescuing the idea of an HPV vaccine. He came across MedImmune, a small company in Maryland that would take on the project and assume the patent rights. The company made a test vaccine in sufficient amounts for Rochester to conduct the first human trial, a near-perfect Phase 1 that looked at 64 people. It proved that the harmless virus-like particles were safe and could induce antibodies that block an HPV infection.
Research and Development are two different aspects -- even if Rochester did the research, they aren't willing to develop and manufacture it, let alone run trials. It costs money. Furthermore, they were selling the rights to the patent -- not giving them out of the generosity of their hearts. It isn't as if the researchers made this breakthrough, published it for the world to see, and said, "Take it! It's pure research! For free!"

So please, Merck paid for the discovery, they paid for the development, and they're paying royalties on any profits.

Think about that.

[Kass]

Gardasil PREVENTS 70% of cervical cancer. Catching cervical cancer in screenings is an entirely different thing. By then, YOU ALREADY HAVE CANCER. It's too late. By then, you're options are a hysterectomy, chemotherapy and radiation or a hysterectomy, chemotherapy and radiation. Chemo and radiation alone have proven woefully inadequate to prevent a re-occurence of cervical cancer or prevent the spread of the cancer.

Pap smears are a common test yes, but most women in America don't get them routinely (the number of women who don't get them is particularly high in the lower economic groups, even though the tests are widely available for free or at a reduced cost through clinics and planned parenthood), which is why roughly 14,000 women are diagnosed with and 3,800 US women a year die from cervical cancer. The National Cervical Cancer Association says that 11% of US women report they don't get routine pap smears, but that is based on a voluntary, limited survey, not statistics on the number of pap smears done and the adult female population. A quick survey amongst my friends showed that exactly two of us out of 20 had had a pap smear in the last year and only two of us routinely get them, even though they are recommended annually. (The other 18 also have never had a mammogram either.) At the office, the numbers were similar. One out of 11 had a pap smear in the last year and two had a mammogram.

Pap smears also happen to be the most commonly misread medical test performed because the cellular structure and make up of a woman's cervix naturally changes during a complete menstrual cycle. It doesn't change drastically, but it does change enough that some potentially pre-cancerous readings are written off as normal changes and normal changes are often read as pre-cancerous cells. Doctors and labs only test for HPV if abnormal cells are seen, so any test dismissed as normal or having normal cellular change does NOT get tested for the presence of HPV. HPV can go undetected for years, even a decade or more, because of a lack of routine testing or poorly read pap smears.

[Pierrot le Fou]

Gardasil PREVENTS 70% of cervical cancer. Catching cervical cancer in screenings is an entirely different thing. By then, YOU ALREADY HAVE CANCER. It's too late. By then, you're options are a hysterectomy, chemotherapy and radiation or a hysterectomy, chemotherapy and radiation. Chemo and radiation alone have proven woefully inadequate to prevent a re-occurence of cervical cancer or prevent the spread of the cancer.

Pap smears are a common test yes, but most women in America don't get them routinely (the number of women who don't get them is particularly high in the lower economic groups, even though the tests are widely available for free or at a reduced cost through clinics and planned parenthood), which is why roughly 14,000 women are diagnosed with and 3,800 US women a year die from cervical cancer. The National Cervical Cancer Association says that 11% of US women report they don't get routine pap smears, but that is based on a voluntary, limited survey, not statistics on the number of pap smears done and the adult female population. A quick survey amongst my friends showed that exactly two of us out of 20 had had a pap smear in the last year and only two of us routinely get them, even though they are recommended annually. (The other 18 also have never had a mammogram either.) At the office, the numbers were similar. One out of 11 had a pap smear in the last year and two had a mammogram.

Pap smears also happen to be the most commonly misread medical test performed because the cellular structure and make up of a woman's cervix naturally changes during a complete menstrual cycle. It doesn't change drastically, but it does change enough that some potentially pre-cancerous readings are written off as normal changes and normal changes are often read as pre-cancerous cells. Doctors and labs only test for HPV if abnormal cells are seen, so any test dismissed as normal or having normal cellular change does NOT get tested for the presence of HPV. HPV can go undetected for years, even a decade or more, because of a lack of routine testing or poorly read pap smears.
Sweet Jesus women love to whine, yeah? Suck up that cervical cancer you whore -- were you not fucking every Joe Marine that stepped off the pier and were a good Christian woman, this would never happen...

...what's that you say? Common sense? Why would I need something that impractical?