Newest NEJM study on the cost effectivenes of Gardasil

[mhatrw]

http://content.nejm.org/cgi/content/full/359/8/821#F2

Assumptions:

• 100% efficacy against HPV-6, 11, 16 and 18 resulting in a full 70% decrease in cervical cancer among the vaccinated group for the period of efficacy assumed
  
  
• Gardasil poses absolutely no short or long term health risks of any kind whatsoever.
  
  
• Zero increase in the baseline risk of infection with high-risk types of HPV other than HPV-16 and HPV-18
  
  
• None of the 4 HPV strains Gardasil protects against are ecologically antagonistic to the 13 (and counting) other high risk HPV strains that Gardasil does not protect against.
  
  
• Without Gardasil, cervical cancer contraction and mortality rates would have suddenly stopped decreasing by the average 3% per year they have been consistently decreasing by for the last 40 years.
  
  
• $360 total cost of Gardasil (complete bullshit, as anyone who has gotten the three shots knows)

Results:

If vaccine-induced immunity lasted only 10 years, the vaccination of preadolescent girls provided only 2% marginal improvement in the reduction in the risk of cervical cancer as compared with screening alone, and it cost $144,100 per QALY, whereas catch-up programs were more costly and less effective than screening alone. With a completely efficacious vaccine booster at 10 years, the cost of vaccination of preadolescent girls was $83,300 per QALY, although catch-up strategies exceeded $125,000 per QALY. ...

If 5% of women in the United States were neither screened nor vaccinated, all strategies that involved a catch-up program exceeded $100,000 per QALY; catch-up to 26 years of age exceeded $200,000 per QALY (Table 4). The ratios became even less attractive when we assumed that girls who were vaccinated were preferentially screened more frequently in adulthood. ...

Even if all women were equally likely to be screened, the cost-effectiveness of vaccination was influenced by the frequency of screening and test protocols. With annual and biennial screening, the cost of vaccination of preadolescent girls increased to $118,200 and $45,800 per QALY, respectively; the negative effect on the cost-effectiveness of catch-up programs was greater, with catch-up vaccination of girls and women up to 26 years of age increasing to more than $300,000 and approximately $190,000 per QALY, respectively. ...

With partial natural immunity to type-specific infection, if a vaccinated girl loses vaccine-induced protection and becomes susceptible at a later age when the risk of cancer may be higher, an increased risk of cervical cancer is plausible. There are no empirical data to show whether reinfection or reactivation of a previous infection predominates in older women; as previously described,17 which one of these predominates will influence the implications of waning vaccine protection. There are other important uncertainties. Although HPV infections may be independent from one another,56 our exploratory analysis showed that replacement of the vaccine-targeted types of HPV with other high-risk types could be influential. Vaccination against HPV may also alter sexual behavior in the population or lead to a misperception that screening is no longer necessary. These uncertainties highlight the priorities for surveillance of epidemiologic characteristics and behaviors after vaccination against HPV. ...

Our findings, which were consistent with those of others,20,22 were that high vaccination coverage warranted modification of screening protocols and that the cost-effectiveness of vaccination was enhanced with less frequent screening with more sensitive tests and beginning at later ages.

***

Faith-based medicine. If Gardasil lasts forever with 100% efficacy against the four HPV strains, if Gardasil is perfectly safe in both the short and long term, if there is zero increase in the baseline risk of infection with high-risk types of HPV other than HPV-16 and HPV-18, if you can get the same vaccination coverage among poor and uninsured as among the rich and insured, and if you can somehow purchase the three shots of Gardasil for $360, the QALY for vaccinating 12 year olds come out to the "bargain basement" price of $43,600. If any of these faith-based assumptions goes wrong, Gardasil's QALY -- even for 12 year old girls -- soars well past $50,000 and often well past $100,000. For example, merely substituting the actual Gardasil cost of $450 for the faith-based price of $360 raises Gardasil's best case QALY to $54,500.

[Name removed]

1. Deleted sub-thread

Sub-thread removed by moderator. Click here to review the message board rules.

[WillYourVoteBCounted]

2. here' s another one: You don't love our girls as much as TX Gov Rick Perry

[mhatrw]

5. .

[Name removed]

3. Deleted message

Message removed by moderator. Click here to review the message board rules.

[Name removed]

4. Deleted message

Message removed by moderator. Click here to review the message board rules.

[mhatrw]

6. Kick n/t

[WillYourVoteBCounted]

7. Motley Fool: A Gardasil Gotcha

Well, here's another prudish post as part of the conspiracy against Gardasil:

A Gardasil Gotcha
By Brian Orelli
August 21, 2008 Comment (1) Recommend (1)
Getting a drug through the FDA often isn't enough for drug companies. To make money, they've also got to persuade someone -- usually health insurers like UnitedHealth Group (NYSE: UNH) or Aetna (NYSE: AET) -- to pay for the product.

That's what makes this week's article and editorial in The New England Journal of Medicine about Merck's (NYSE: MRK) Gardasil so worrisome for Merck and GlaxoSmithKline (NYSE: GSK). Glaxo is hoping to bring its own human papillomavirus (HPV) vaccine, Cervarix, to the U.S. market. The article basically concludes that the vaccination is worth the money -- about $360 to $400 for a three-dose series -- for young girls, but not for women in their 20s. One of the authors said that "the vaccine becomes less cost-effective" for older women.

The problem is that Gardasil is approved for females aged 9 through 26. That's fine as far as it goes, but Merck has been trying to get it approved for women through age 45. Even if it succeeds in getting the label expanded, it might be difficult to get insurers and government agencies to pay for the vaccine.

http://www.fool.com/investing/value/2008/08/21/a-gardasil-gotcha.aspx

Surely the government will buy Gardasil for ALL women, ALL men, ALL boys and girls?

So what if it would mean eliminating other health care programs?

[csibona]

108. Arbitrary

26 years old seems rather arbitrary...

[WillYourVoteBCounted]

8. This vaccine is desperately needed to help Merck recover from paying Vioxx victims

[mhatrw]

9. What Gardasil lacks in cost-effectiveness, it more than makes up in marketing.

http://www.burtonmail.co.uk/burtonmail-news/DisplayArticle.asp?ID=342331

It comes just days after Big Brother star Jane Goody was told by her doctor that she has cervical cancer live on India's version of the cult TV hit, Bigg Boss.

[mhatrw]

10. Let's consider just three of this study's baseline assumptions further.

1) Gardasil can possibly confer lifetime resistance to HPV 6, 11, 16 & 18 with 100% efficacy.

How many other vaccines confer lifetime resistance with 100% efficacy? Note that Gardasil requires a regime of three vaccinations for a reason. Merck deemed two vaccinations insufficient to maintain antibodies at a high enough level for the vaccine to retain full efficacy over the trial period required for vaccine approval. So what are the odds that Gardasil will set a new world record among all vaccines for long-term efficacy?

2) Future cervical cancer rates contraction and mortality would have remained at their current levels for the next 50+ years without Gardasil.

Prior to the introduction of Gardasil, US cervical cancer contraction and mortality rates had been trending down at a steadily decreasing rate of 3.7% per year for the last decade. Note the cervical cancer mortality rate rated also declined by 74% between 1955 and 1992 (a downward trend of about 3.6% per year), so this downward trend has been very consistent for the past 52 years. In 2007, reported cervical cancer mortality incidences were 3670 women. Projecting the consistent 3.7% rate of decline into the future results in the following predicted mortality rates:

2012 (5 years) - 3040 annual deaths (17% decline from the 3670 baseline over 5 years)
2017 (10 years) - 2517 annual deaths (32% decline from the 3670 baseline over 10 years)
2022 (15 years) - 2085 annual deaths (43% decline from the 3670 baseline over 15 years)
2027 (20 years) - 1727 annual deaths (53% decline from the 3670 baseline over 20 years)
2032 (25 years) - 1430 annual deaths (61% decline from the 3670 baseline over 25 years)
2037 (30 years) - 1184 annual deaths (68% decline from the 3670 baseline over 30 years)
2042 (35 years) - 981 annual deaths (73% decline from the 3670 baseline over 35 years)

This means that even without Gardasil, we would have expected declines of 53% in cervical cancer incidences over the next 20 years and 68% over the next 30 years, if only the consistent downward trend of the last half century had been maintained. Considering that the only cost effective strategy determined by this study was for vaccinating 12 year old girls (assuming 100% lifetime efficacy, of course), it is conservative to assume that the any potential benefit for even the first of this vaccinated group would be delayed on average more than 30 years in the future. Therefore, the QALY figures for this group should have all been multiplied by an adjustment factor of approximately 3 in order to take this into account, raising the best case QALY for the vaccination of 12 year olds to well over $120,000.

3) Gardasil poses absolutely no short or long term health risks of any kind whatsoever.

Of all the assumptions made by the NEJM's cost analysis, this is the one most egregiously biased in Gardasil's favor. No scenario was even considered in which Gardasil vaccinations were projected to result in any negative health effects for any percentage of any vaccinated population. It is both well-known and accepted that vaccinations result in serious negative health effects for a small percentage of vaccinated subjects in all cases. And, unlike almost all other vaccinations, Gardasil consists of three injections. Since Gardasil's controlled testing on girls 12 or under consisted of far less than 1000 total subjects, there are no clear data available on the percentage of serious side effects that will result from Gardasil vaccinations among this population. Furthermore, there is no possible way that Gardasil's clinical tests of just 20,000 combined total adult subjects (10,000 injected with a "placebo" and 10,000 injected Gardasil) could have uncovered any serious long term side effects to due Gardasil nor any serious short term side effects with any incidence level smaller than 1 in 5,000 vaccinated.

So let's do a back of the envelope comparison of potential benefit vs. potential harm among the recommended vaccinated population of 12 year old girls. Even assuming a lifetime efficacy of 100%, universal coverage and no upward changes in any incidence or virility rates of the 13 (and counting) high risk HPV strains Gardasil does not protect against, the greatest number of women Gardasil could save from cervical cancer mortality is 830 annually. That's 70% of the 1134 mortality incidences that we would have expected due to cervical cancer 30 years from now, given the clear and consistent incidence and mortality trends of the last half century.

Assuming that 100 million US girls have been vaccinated by that time (a very conservative assumption given current trends), if Gardasil vaccinations cause severe, long term health effects in just 1 in 10,000 vaccinated girls, then 10,000 vaccinated 12 years old will have suffered generally immediate negative long term health problems in order to extend the lives of at best 830 (and decreasing) older women annually. Considering the cost of vaccinating 100 million girls is more than $40 billion, is that a reasonable cost plus risk vs. benefit trade off for anyone but Merck's stockholders?

[cosmik debris]

73. Link to the study please.

(And not the journal summary of the study, but the text of the original study.)

And cite the paragraph where those assumptions were made.

Considering your track record of making up facts, I suspect that you are making up the bit about assumptions too.

I'm sure you will be able to provide the proof of your statements. But be sure to provide the links to the study just so it can be verified.

[mhatrw]

78. The link was provided in the OP.

You haven't even read the NEJM's study yet? What a surprise!

No medical costs of any adverse effects associated Gardasil were considered. I can't cite the paragraph because no adverse health effect costs associated Gardasil were ever mentioned in the entire article.

The appendix of the study states that the study derived its excess mortality rate for women with cervical cancer from the CDC's 1975-2001 Cancer Statistics Review, which would means that the baseline risk which means that the value was about 20% higher at minimum than if the study had used the 2006 mortality rates instead of the 2001 mortality rates. So the results were even more skewed in Gardasil's favor than I thought.

As for the 100% lifetime efficacy assumptions, you can't miss them if you read the article.

[cosmik debris]

97. Ooops, another false statement

"No medical costs of any adverse effects associated Gardasil were considered. I can't cite the paragraph because no adverse health effect costs associated Gardasil were ever mentioned in the entire article."

That's the kind of mistake you make when you read a summary of the study and skip over the details.

That's the kind of sloppy research that cost you credibility.

But you certainly did not disappoint anyone, because you have lowered expectations so far with your other made up facts.

[mhatrw]

99. Great. Where did the study consider the costs of the adverse

effects of Gardasil?

[mhatrw]

103. Your accusation of falsehood was false.

No costs of any potential adverse Gardasil side effects were considered in any part of this study.

[beam me up scottie]

74. How do your assumptions prove that women "have more risk of dying from an injection of Gardasil"?

mhatrw (1000+ posts) Wed Aug-13-08 02:32 PM
Response to Reply #130

172. The VAERS is NOT worldwide, just US.
And the population getting the vaccine is FAR younger and healthier than the population dying from cervical cancer.

Girls are getting this vaccine with the unproven promise that it may help protect an extremely small percentage of them from cervical cancer 30+ years down the line. If even a tiny percentage of them experience serious adverse health effects because of Gardasil, the harm outweighs the potential benefit.

mhatrw (1000+ posts) Wed Aug-20-08 08:31 AM
Response to Reply #3

6. Gardasil is terrible because its risks outweigh its tiny potential, unproven rewards

among its targeted market group.

Fire_Medic_Dave (1000+ posts) Wed Aug-20-08 12:10 AM
Response to Reply #136

137. Let's try this, do rich white women have any risk at all of contracting cervical cancer?


mhatrw (1000+ posts) Wed Aug-20-08 12:12 AM
Response to Reply #137

139. Let's try this. They have more risk of dying from an injection of Gardasil. n/t

mhatrw (1000+ posts) Mon Aug-25-08 02:28 AM
Response to Original message

79. Merck raking in $1.4 billion a year on a vaccine that does more harm than good.

mhatrw (1000+ posts) Mon Aug-25-08 02:53 AM
Response to Reply #15

16. The reason to opt out is that Gardasil will almost certainly do more harm than good.

[mhatrw]

75. Prove that Gardasil can reduce the incidence of cervical cancer.

The "burden of proof" is on you.

[beam me up scottie]

77. Nice try but I made no claims, you did. Now prove Gardasil is deadlier than cervical cancer.

The Burden of Proof:

Outside a legal context, "burden of proof" means that someone suggesting a new theory or stating a claim must provide evidence to support it: it is not sufficient to say "you can't disprove this." Specifically, when anyone is making a bold claim, either positive or negative, it is not someone else's responsibility to disprove the claim, but is rather the responsibility of the person who is making the bold claim to prove it. In short, X is not proven simply because "not X" cannot be proven (see negative proof).

Taken more generally, the standard of proof demanded to establish any particular conclusion varies with the subject under discussion. Just as there is a difference between the standard required for a criminal conviction and in a civil case, so there are different standards of proof applied in many other areas of life.

The less reasonable a statement seems, the more proof it requires. The scientific consensus on cold fusion is a good example. The majority believes this can not really work, because believing that it would do so would force the alteration of a great many other tested and generally accepted theories about nuclear physics.

http://en.wikipedia.org/wiki/Burden_of_proof

[mhatrw]

79. So you don't think that Gardasil reduces the incidence of cervical cancer?

Glad to hear it!

We have nothing further to discuss in that case.

[beam me up scottie]

80. Stop obfuscating and prove your claim that Gardasil is deadlier than cervical cancer

mhatrw (1000+ posts) Wed Aug-13-08 02:32 PM
Response to Reply #130

172. The VAERS is NOT worldwide, just US.
And the population getting the vaccine is FAR younger and healthier than the population dying from cervical cancer.

Girls are getting this vaccine with the unproven promise that it may help protect an extremely small percentage of them from cervical cancer 30+ years down the line. If even a tiny percentage of them experience serious adverse health effects because of Gardasil, the harm outweighs the potential benefit.

mhatrw (1000+ posts) Wed Aug-20-08 08:31 AM
Response to Reply #3

6. Gardasil is terrible because its risks outweigh its tiny potential, unproven rewards

among its targeted market group.

Fire_Medic_Dave (1000+ posts) Wed Aug-20-08 12:10 AM
Response to Reply #136

137. Let's try this, do rich white women have any risk at all of contracting cervical cancer?


mhatrw (1000+ posts) Wed Aug-20-08 12:12 AM
Response to Reply #137

139. Let's try this. They have more risk of dying from an injection of Gardasil. n/t

mhatrw (1000+ posts) Mon Aug-25-08 02:28 AM
Response to Original message

79. Merck raking in $1.4 billion a year on a vaccine that does more harm than good.

mhatrw (1000+ posts) Mon Aug-25-08 02:53 AM
Response to Reply #15

16. The reason to opt out is that Gardasil will almost certainly do more harm than good.

The Burden of Proof:

Outside a legal context, "burden of proof" means that someone suggesting a new theory or stating a claim must provide evidence to support it: it is not sufficient to say "you can't disprove this." Specifically, when anyone is making a bold claim, either positive or negative, it is not someone else's responsibility to disprove the claim, but is rather the responsibility of the person who is making the bold claim to prove it. In short, X is not proven simply because "not X" cannot be proven (see negative proof).

Taken more generally, the standard of proof demanded to establish any particular conclusion varies with the subject under discussion. Just as there is a difference between the standard required for a criminal conviction and in a civil case, so there are different standards of proof applied in many other areas of life.

The less reasonable a statement seems, the more proof it requires. The scientific consensus on cold fusion is a good example. The majority believes this can not really work, because believing that it would do so would force the alteration of a great many other tested and generally accepted theories about nuclear physics.

http://en.wikipedia.org/wiki/Burden_of_proof

[mhatrw]

81. Prove that Gardasil can reduce the incidence of cervical cancer.

Thus ends your idiotic sophistical game.

[cosmik debris]

82. You are changing the subject because you got caught in a lie. n/t

[mhatrw]

84. I am not changing the subject. I am making a point.

The "claims" I am making are informed estimates, exactly like the informed estimate that Gardasil can potentially significantly reduce the cervical cancer incidence and mortality rates of vaccinated 12-year-olds some 30+ years in the future. None of these "claims" can be strictly proven. As such, the demand for "proof" is nothing but a sophistical game meant to shut down any and all reasonable discussion of Gardasil's potential risks vs. its potential future benefits.

[beam me up scottie]

85. So you made it up.

Again.

Shocking.

[mhatrw]

88. Just as Merck "made up" its claims that Gardasil prevents cervical cancer. n/t

[cosmik debris]

92. Their made up facts justify your made up facts?

That's a novel morality. Where did you learn that?

[mhatrw]

94. Cute. n/t

[cosmik debris]

96. Just more evidence of you shifting morality.

Apparently it is OK for you to make up facts, but it is not OK for others.

[beam me up scottie]

95. Sure, except their claims are backed by science and your claims are backed by ignorance.

Willful ignorance at that.

[cosmik debris]

87. Finally an admission that you can't prove your claims

"None of these "claims" can be strictly proven."

It took long enough for you to admit it!

[mhatrw]

91. I've admitted that from the start. Nobody can "prove" what may happen in the future.

Or is that concept beyond you, Miss Cleo?

If you want to play sophistical games, PM your buddy. I wish to discuss the cost and risk vs. benefit profile of Gardasil.

[beam me up scottie]

83. I made no claim, you made several you can't prove. Typical for someone who makes up their own facts.

mhatrw (1000+ posts) Wed Aug-13-08 02:32 PM
Response to Reply #130

172. The VAERS is NOT worldwide, just US.
And the population getting the vaccine is FAR younger and healthier than the population dying from cervical cancer.

Girls are getting this vaccine with the unproven promise that it may help protect an extremely small percentage of them from cervical cancer 30+ years down the line. If even a tiny percentage of them experience serious adverse health effects because of Gardasil, the harm outweighs the potential benefit.

mhatrw (1000+ posts) Wed Aug-20-08 08:31 AM
Response to Reply #3

6. Gardasil is terrible because its risks outweigh its tiny potential, unproven rewards

among its targeted market group.

Fire_Medic_Dave (1000+ posts) Wed Aug-20-08 12:10 AM
Response to Reply #136

137. Let's try this, do rich white women have any risk at all of contracting cervical cancer?


mhatrw (1000+ posts) Wed Aug-20-08 12:12 AM
Response to Reply #137

139. Let's try this. They have more risk of dying from an injection of Gardasil. n/t

mhatrw (1000+ posts) Mon Aug-25-08 02:28 AM
Response to Original message

79. Merck raking in $1.4 billion a year on a vaccine that does more harm than good.

mhatrw (1000+ posts) Mon Aug-25-08 02:53 AM
Response to Reply #15

16. The reason to opt out is that Gardasil will almost certainly do more harm than good.

The Burden of Proof:

Outside a legal context, "burden of proof" means that someone suggesting a new theory or stating a claim must provide evidence to support it: it is not sufficient to say "you can't disprove this." Specifically, when anyone is making a bold claim, either positive or negative, it is not someone else's responsibility to disprove the claim, but is rather the responsibility of the person who is making the bold claim to prove it. In short, X is not proven simply because "not X" cannot be proven (see negative proof).

Taken more generally, the standard of proof demanded to establish any particular conclusion varies with the subject under discussion. Just as there is a difference between the standard required for a criminal conviction and in a civil case, so there are different standards of proof applied in many other areas of life.

The less reasonable a statement seems, the more proof it requires. The scientific consensus on cold fusion is a good example. The majority believes this can not really work, because believing that it would do so would force the alteration of a great many other tested and generally accepted theories about nuclear physics.

http://en.wikipedia.org/wiki/Burden_of_proof

[mhatrw]

86. The name for a person who "debates" without making any claims

is a sophist. I don't "debate" sophists because nothing can be learned and nothing can gained from such disruptive puerile nonsense.

[cosmik debris]

89. The name for a person who "debates" making false claims

is mhatrw

[beam me up scottie]

90. You just admitted you made it up: "The "claims" I am making are informed estimates"

mhatrw (1000+ posts) Wed Aug-13-08 02:32 PM
Response to Reply #130

172. The VAERS is NOT worldwide, just US.
And the population getting the vaccine is FAR younger and healthier than the population dying from cervical cancer.

Girls are getting this vaccine with the unproven promise that it may help protect an extremely small percentage of them from cervical cancer 30+ years down the line. If even a tiny percentage of them experience serious adverse health effects because of Gardasil, the harm outweighs the potential benefit.

mhatrw (1000+ posts) Wed Aug-20-08 08:31 AM
Response to Reply #3

6. Gardasil is terrible because its risks outweigh its tiny potential, unproven rewards

among its targeted market group.

Fire_Medic_Dave (1000+ posts) Wed Aug-20-08 12:10 AM
Response to Reply #136

137. Let's try this, do rich white women have any risk at all of contracting cervical cancer?


mhatrw (1000+ posts) Wed Aug-20-08 12:12 AM
Response to Reply #137

139. Let's try this. They have more risk of dying from an injection of Gardasil. n/t

mhatrw (1000+ posts) Mon Aug-25-08 02:28 AM
Response to Original message

79. Merck raking in $1.4 billion a year on a vaccine that does more harm than good.

mhatrw (1000+ posts) Mon Aug-25-08 02:53 AM
Response to Reply #15

16. The reason to opt out is that Gardasil will almost certainly do more harm than good.

mhatrw (1000+ posts) Thu Aug-28-08 05:45 PM
Response to Reply #82
84. I am not changing the subject. I am making a point.

The "claims" I am making are informed estimates, exactly like the informed estimate that Gardasil can potentially significantly reduce the cervical cancer incidence and mortality rates of vaccinated 12-year-olds some 30+ years in the future. None of these "claims" can be strictly proven. As such, the demand for "proof" is nothing but a sophistical game meant to shut down any and all reasonable discussion of Gardasil's potential risks vs. its potential future benefits.

"informed estimates" = uninformed assumptions posted as facts

[mhatrw]

93. I wish to discuss the cost plus risk vs. benefit profile of Gardasil.

How about you?

[cosmik debris]

76. And you prove these assumptions were made.

The burden of proof is on you.

[mhatrw]

102. Still hoping for some reasoned, scientific discussion on this. n/t

[WillYourVoteBCounted]

11. New England Journal of Medicine? isn't that some right wing rag?

just wondering, since they apparently are toting the right wing line,
anti sex prudes.

[mhatrw]

12. Additional Vaccination (Gardasil) to be REQURED (VA)

http://www.whsv.com/news/headlines/27294279.html

[beam me up scottie]

13. Parents will also have the opportunity to opt out for any reason.

According to the Department of Health, parents of fifth grade girls will start receiving information from schools at the end of this school year. Parents will also have the opportunity to opt out for any reason.

[mhatrw]

14. How about the reasons listed above?

Could we somehow rush them to the parents in question?

Any ideas on how we could do that?

[beam me up scottie]

15. You're citing the article and you didn't even read it? Did you read my post?

According to the Department of Health, parents of fifth grade girls will start receiving information from schools at the end of this school year. Parents will also have the opportunity to opt out for any reason.

[mhatrw]

16. The reason to opt out is that Gardasil will almost certainly do more harm than good.

See post #10 on this thread.

[beam me up scottie]

19. You're responsible for proving your claim: "Gardasil will almost certainly do more harm than good"

Outside a legal context, "burden of proof" means that someone suggesting a new theory or stating a claim must provide evidence to support it: it is not sufficient to say "you can't disprove this." Specifically, when anyone is making a bold claim, either positive or negative, it is not someone else's responsibility to disprove the claim, but is rather the responsibility of the person who is making the bold claim to prove it. In short, X is not proven simply because "not X" cannot be proven (see negative proof).

Taken more generally, the standard of proof demanded to establish any particular conclusion varies with the subject under discussion. Just as there is a difference between the standard required for a criminal conviction and in a civil case, so there are different standards of proof applied in many other areas of life.

The less reasonable a statement seems, the more proof it requires. The scientific consensus on cold fusion is a good example. The majority believes this can not really work, because believing that it would do so would force the alteration of a great many other tested and generally accepted theories about nuclear physics.

http://en.wikipedia.org/wiki/Burden_of_proof

Get busy.

[WillYourVoteBCounted]

100. a case of Big Brother if ever there was

I am very disappointed in Virginia - this is just plain bad to trot this crap out en masse on
such young girls.

We are just learning about the adverse events.

Oh, and I know one of the wing nuts will jump on me for saying that self reports or even doctor reports of illnesses to VAERS just don't count at all.

Thats bullshit, VAERS was implemented for a reason, just like the Vaccine Injury Program was implemented for a reason.

I've never seen big corporations so vigorously defended or questionable medicines advocated in spite of the indication that some healthy people are being harmed.

And I am not used to being attacked for wanting to know why something is harming some people.

We should find out what it is that causes the Gardasil vaccine to make some girls sick, and some die.

It should be investigated.

Why not avoid needless injuries and death if possible?

I know it might cost Big Pharma some of its profits, but our health is more important.

[mhatrw]

17. Here is a thread filled with brand new content worthy of civil discussion.

Why are all the threads talking about people talking about people talking about Gardasil so popular while a thread like this that has some actual substantive discussion on the benefits vs. cost and risks of Gardasil is avoided like the plague?

Why has ridicule, abuse, dismissal and calls for censorship superseded free, open discussion and civil debate in this forum?

[cosmik debris]

18. Post #2 and #6 pretty much ended any chance of civil discussion.

They are hateful, vicious, nasty, and sick.

And it is my opinion that people who post that crap deserve to be banned from DU. That is an embarrassment to liberal values of all DUers.

[mhatrw]

20. It's hateful, vicious, nasty and sick to suggest that huge corporations like Merck sometimes

put profit before concern for people's health?

Whose "liberal values" are you talking about? Adam Smith's?

[cosmik debris]

21. Thus ends civil discussion. n/t

[mhatrw]

23. Because I questioned one of your many insulting overstatements?

Is your skin really that skinny?

[cosmik debris]

24. No, civil discussion ended when you posted the hateful comments

And the case was closed when you tried to excuse your hateful comments by claiming that Merck is evil.

Just because Merck does not live up to your standards is no reason for YOU not to live up to YOUR standards.

Do I really need to tell you that two wrongs don't make a right?

You can't use Merck's evil to excuse your own bad behavior.

[beam me up scottie]

22. I think the "Colon Head" comment did it for me. Well, that and being called "murderous assholes".

I don't know what's worse, the spam or the inherent misogyny behind it.

[antigop]

25. WSJ: Study questions cost-effectiveness of Gardasil Cervical-Cancer Vaccine

http://online.wsj.com/article/SB121928503311259059.html?mod=googlenews_wsj

A new study suggests that giving Merck & Co.'s cervical-cancer vaccine Gardasil to women through their mid-20s may not be worth the price, despite U.S. recommendations that this age group receive the costly shot.

The study, published online Wednesday by The New England Journal of Medicine, comes as Merck already is having difficulty persuading college-age and older women to get the vaccine, which was introduced in 2006 and costs about $360 for a three-dose regimen. This has contributed to a slowdown in Gardasil sales, casting a cloud on Merck's financial outlook.

[salvorhardin]

26. You missed the key paragraph

The study published by researchers from the Harvard School of Public Health suggests Gardasil's cost is justified in pre-adolescent girls, partly because they are less likely to have already been exposed to HPV. But among older females, the cost-effectiveness of Gardasil becomes less and less favorable, researchers concluded. "Under most scenarios, extending the catchup to 26 wasn't cost-effective," Jane Kim, an assistant Harvard professor, said in an interview.

[cosmik debris]

28. It is really sad that we can't protect women who were born too early

for this vaccine.

But that certainly doesn't justify denying protection to the generations that can be vaccinated against those strains of HPV.

[salvorhardin]

29. Well, the earlier the better to be sure

But that doesn't mean women into their mid-twenties should forgo the vaccine either.

Ms. Kim and Harvard colleague Sue Goldie concluded that it cost about $43,600 per "quality-adjusted life year" gained, when HPV vaccine is administered to 12-year-old girls. This falls below the $50,000 per quality-adjusted life year threshold that some researchers use as a maximum for cost-effectiveness. Other researchers use a higher maximum benchmark of $100,000 per QALY to gauge cost-effectiveness. ...

It would cost $97,300 per QALY, however, to vaccinate girls and women through age 18, $120,400 per QALY for girls and women up to age 21, and $152,700 for girls and women up to age 26. The cost-effectiveness becomes more attractive when protection against genital warts is factored in.

The researchers arrived at these numbers by projecting HPV infection rates in various age groups, gauging the effectiveness of the vaccine and estimating cervical-cancer screening rates. Screening via Pap smear is recommended for women who are sexually active, even with the availability of Gardasil. The screenings can detect pre-cancerous lesions that can be removed; the availability of these tests has helped reduce the cervical-cancer death rate in the U.S. dramatically since the 1950s.

Studies such as these are useful in developing public policy, especially in deciding where public dollars should be spent in providing government subsidized vaccination programs. The Harvard study suggests that it would be money well spent to vaccinate pre-adolescent girls but the money that might be spent subsidizing HPV vaccination programs for college age students might be better applied elsewhere. Perhaps remedial sex education to undo the damage done by the abstinence only sex ed they received in high school.

ETA: The last sentence is :sarcasm: in case there's a doubt.
ETA 2: And grammar.

[cosmik debris]

30. That was very informative, thank you. n/t

[mhatrw]

35. That's assuming lifetime efficacy.

Without lifetime efficacy, testing alone did a better job of preventing cervical cancer among any population group over 18.

[mhatrw]

34. We can protect these women. We can give them HPV tests.

And we can make better HPV tests.

If HPV dysplasias are caught early enough, cervical cancer can already be well-controlled if not prevented.

[beam me up scottie]

36. "we can make better HPV tests." Now there's some faith based medicine.

Right, anything and everything but a vaccine.

[mhatrw]

41. There are already a slew of advanced HPV tests in production.

QIAGEN, SensiGen, Third Wave & APTIMA (Gen-Probe) are just a few.

Autogenomics has another that not yet been approved for production. Roche has AMPLICOR.

Molecular Diagnostics has its InPath In-Cell HPV test ready.

GenoID has a great new HPV test.

So what is "faith-based" about better HPV testing again?

[beam me up scottie]

42. How about you leave MY BODY OUT OF YOUR FUCKING CRUSADE?

You are not a doctor, you don't even work in medicine, and I am so sick of religious morons and paranoid conspiracists thinking they have the right to dictate what's good for me.

You don't believe in vaccinations, fine, don't get the fucking vaccine, but stop trying to prevent others from making their own decisions by spamming this board with right wing scare tactics.

[mhatrw]

44. LOL!

Is that what you always do whenever you lose an argument?

[beam me up scottie]

46. Where is your proof that this "vaccine that does more harm than good"?

Every time you're caught making shit up, you try to distract and then disappear.

[mhatrw]

54. See post #10 on this thread. n/t

[beam me up scottie]

55. I did, it doesn't prove your claim. Prove that the vaccination is more dangerous than cancer.

You may need to use your secret decoder ring and psychic powers.

[mhatrw]

57. See post #10 in this thread.

Respond to post #10.

[cosmik debris]

59. You are stumped!

All you can do is stutter ppppost 10, ppppost 10.

:rofl:

[mhatrw]

60. Respond to post #10. And can pick the discussion up there. n/t

[cosmik debris]

61. Prove that the vaccination is more dangerous than cancer.

You made the claim, now back it up.

And no made up facts this time OK?

[mhatrw]

62. Why are you so frightened of responding to post #10?

If you have any problems with my analysis, why not enumerate them so we can discuss the issues rationally?

[cosmik debris]

63. I'm just waiting for you to prove your claim. n/t

[beam me up scottie]

64. Her "back of the envelope comparison of potential benefit vs. potential harm" claim?

How can you possibly dismiss BOTE claims? Those are the bestest kind!

[cosmik debris]

65. Hey! you got here just in time for the tantrum!

I've got two stalkers at the same time.

I'm so proud of myself.

[mhatrw]

66. Respond to post #10. If you wish to discuss the substance of these issues, that is where to start.

[beam me up scottie]

67. Can you prove your claim that Gardasil is "a vaccine that does more harm than good" or not?

Apparently your definition of 'substance' means parroting the same claim over and over and over again, denying that you ever made such statements, and then running away when we ask you to prove them.

Here are your claims again:

mhatrw (1000+ posts) Wed Aug-13-08 02:32 PM
Response to Reply #130

172. The VAERS is NOT worldwide, just US.
And the population getting the vaccine is FAR younger and healthier than the population dying from cervical cancer.

Girls are getting this vaccine with the unproven promise that it may help protect an extremely small percentage of them from cervical cancer 30+ years down the line. If even a tiny percentage of them experience serious adverse health effects because of Gardasil, the harm outweighs the potential benefit.

mhatrw (1000+ posts) Wed Aug-20-08 08:31 AM
Response to Reply #3

6. Gardasil is terrible because its risks outweigh its tiny potential, unproven rewards

among its targeted market group.

Fire_Medic_Dave (1000+ posts) Wed Aug-20-08 12:10 AM
Response to Reply #136

137. Let's try this, do rich white women have any risk at all of contracting cervical cancer?


mhatrw (1000+ posts) Wed Aug-20-08 12:12 AM
Response to Reply #137

139. Let's try this. They have more risk of dying from an injection of Gardasil. n/t

mhatrw (1000+ posts) Mon Aug-25-08 02:28 AM
Response to Original message

79. Merck raking in $1.4 billion a year on a vaccine that does more harm than good.

mhatrw (1000+ posts) Mon Aug-25-08 02:53 AM
Response to Reply #15

16. The reason to opt out is that Gardasil will almost certainly do more harm than good.

Allow me to display another of your quotes, this time to exhibit your blatant hypocrisy:

Please stop playing dumb to make disingenuous arguments.

[cosmik debris]

68. Four times you have been caught using made up facts

How can you be trusted to discuss the substance when you use made up facts to support you points?

[Hannah Bell]

56. The question is, what's the appropriate comparison group:

E.g.: For the 11-12 yo target group, what's the risk of serious harm from vaccination v. cervical cancer within, say, 1-5 years of vaccination?

For childhood vaccines, within this short-term framework, there was a benefit which could be shown.

For gardasil - not so much. It's likely no child in 1 million will die of CC in that time frame, & maybe <1 might be dx with cc.

It's likely vaccine-related rxns will be much higher.

[Fire_Medic_Dave]

98. No mention of the fact that the efficacy goes down significantly in women already exposed.

I haven't heard anyone say that Gardasil is designed to stop teenage cervical cancer.

David

[Hannah Bell]

105. no one said it was; that was my point. the cost is all in the young years

the benefit all in older years.

i understand that efficacy goes down once you're sexually active. do you understand that fact is irrelevant to the point i'm making?

[Hannah Bell]

104. yours is the faction pushing to mandate it for everyone. who's trying to control whose body?

get the damn vaccine, give it to your family & pets, but leave my body out of your crusade, & merck's hands out of the public purse.

[cosmik debris]

43. It's a good thing Big Pharma isn't producing any of those.

I'd hate to think that big pharma would make a profit off of the suffering of women.

Oh wait! Big Pharma is producing ALL of those.

RUN AWAY! RUN AWAY!

[mhatrw]

45. Every medical decision must be examined on a case by case basis.

Blanket generalizations are not helpful when it comes to making informed medical decisions.

[beam me up scottie]

47. Blanket generalizations like this is a "vaccine that does more harm than good"?

We're still waiting for you to prove your claims.

[cosmik debris]

49. It takes a while to make up that much data. n/t

[beam me up scottie]

50. "it's not a fact. It's an unknown" !

:rofl:

[mhatrw]

51. It's not a blanket generalization. It's about one specific vaccine. n/t

[cosmik debris]

48. So when you say Big Pharma, you really mean

the one company you have an intense grudge against.

I'm glad we cleared that up.

Edit: That is, the one company that sells a "sex vaccine" that provoked your moral crusade.

[mhatrw]

52. I have no grudge against Merck. They just happen to make a lot

of crappy products.

[cosmik debris]

53. Could have fooled me.

You certainly appear to have an intense animosity and a hard core grudge going.

Perhaps you should examine the image you project if it is not what you want it to be.

[WillYourVoteBCounted]

101. Maybe Merck is like Diebold Voting Systems

Diebold isn't the only crappy voting vendor, they all have their faults.

But Diebold exceeds in doing stupid stuff and maybe is more insecure than any other voting system,
or at least is the dumbest at covering up their mistakes.

Maybe Merck is the "Diebold" of Big Pharma.

[Stop_GMO]

106. Finally you said something that I can debate with you!

"But that certainly doesn't justify denying protection to the generations that can be vaccinated against those strains of HPV."

Disappointing though, as you are still carefully avoiding saying the words "prevents cancer". Actually you have avoided saying anything at all.

Care to reference a study demonstrating any HPV vaccine protects better than the immune system?

The CDC, FDA and ACS say that 90-95% of people clear HPV naturally. Funny that they don't mention that it's the immune system doing the "clearing".

By the way, the quote in all of your posts "Many doctors now argue that reporters should treat the anti-vaccine lobby..." What's the story surrounding that quote from the Times? Please, enlighten us.

[varkam]

107. Welcome back!

I missed you! :hi:

[cosmik debris]

27. All the more reason to vaccinate early

When the vaccine has 100% effectiveness against the HPV strains it was designed for.

Waiting until women are in their mid-twenties is like waiting until you already have polio to get the polio vaccine.

[mhatrw]

31. Consider that 95%+ of Gardasil's test subjects were adults, not little girls.

Now consider that the Gardasil's length of efficacy is unknown.

Unknown safety among the recommended population and unknown efficacy among the recommended population.

[cosmik debris]

32. 100% efficacy among those who had not been exposed.

So it is 100% effective for an unknown length of time and you say that's a bad thing?

The incidence of serious adverse reaction was minuscule in tests and you say that is unknown?

You continue to make false statements and you seem to want the other posters to give you a free pass on your misinformation.

I guess that's the way moral crusaders work.

[mhatrw]

33. Gardasil was clinically tested on fewer than 1,200 total subjects under 16.

That's fewer than 600 test subjects and fewer than 600 control subjects. How can clinical testing this limited possibly uncover any low incidence side effects to a statistically significant level? It cannot.

Gardasil's efficacy past 5 years is unproven in ANY population.

Yet here you are advising parents to get their little girls injected early.

What happens when their little girl is the 1 in 1,000 who has a severe adverse reaction to Gardasil, even though her chances of getting cervical cancer from HPV 16 or 18 some 30 to 50 years down the line was less than 1 in 5,000?

What happens when Gardasil's efficacy wears off just when their little becomes sexually active?

[cosmik debris]

37. Is that a real fact or a made up fact?

"1 in 1,000 who has a severe adverse reaction to Gardasil"

I suspect it is a made up fact.

[mhatrw]

38. No, it's not a fact. It's an unknown.

Given the limitations of clinical testing, it is a hypothetical rate of incidence that could not have been disproven by Gardasil's trials, just as Gardasil's long term safety and efficacy could not have been proven.

[cosmik debris]

39. So you are making up numbers just to scare people.

I'm glad we got that cleared up.

[beam me up scottie]

40. !

[Evoman]

58. The Gardasil vaccine is awesome.

[antigop]

69. So has anyone actually replied to mhatrw's post #10? If not, why not?

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=222x42443#42792

[cosmik debris]

70. That poster uses made up facts to support her points

And she creates straw men and calls them assumptions.

Between the bad logic and the bad science, there is nothing there worthy of a response.

If that poster would cite and link to the scientific study in which those "assumptions" were documented, she might have enough to make discussion worthwhile. In stead, she only links to a journal where the study was summarized.

To claim that these assumptions were made requires proof. She has offered no proof. And her history of making up facts has reduced her credibility to the point where it would be foolish to accept anything she says without a link to the original study.

[beam me up scottie]

71. *SQUAWK* Post #10! Post #10! *SQUAWK*

Since you're so fond of her posts, why don't you prove her claim that Gardasil does more harm than good?

[mhatrw]

72. Because they don't want to go there.

It's far easier and far more strategic to hurl insults than it is to debate an issue reasonably when the facts and numbers are not on your side.

[xchrom]

109. yours is the 'faith based' myth

this study and yours say much the same --

that a vaccine is MORE cost effective than not.


http://www.ajmc.com/supplement/managed-care/2006/2006-02-vol12-n1Suppl/Feb06-2255pS03-S16

The researchers found that although a prophylactic vaccine against high-risk HPV types was more expensive than current practice, it resulted in greater quality-adjusted life expectancy. They predicted that such vaccination would avoid more than 224 255 cases of HPV; 112 710 cases of squamous intraepithelial lesion, a precancerous condition; 3317 cases of cervical cancer; and 1340 deaths related to those cancers. Their sensitivity analyses found the vaccine would be cost effective, even assuming booster shots every 3 years and an efficacy as low as 40%.35

[xchrom]

110. comapring treatments would be reasonable for a truly 'concerned' person.

now i don't you're think 'concerned' -- i don't think you care about those with cancer -- cervical or anal cancer-- at all.

i think you are out of your mind crazy over the first -- first anti-cancer vaccine ever.

you'ld compare the costs of a vaccine aganst chemo and radiation if you were.
the costs of one persons advanced cancer care would pay for a lot of vaccines.

you have not -- not proved that the vaccine doesn't do what it says -- nor have you proved that not getting the vaccine is better for those who actually come down with cervical or anal cancer.

http://www.healthsquare.com/fgwh/wh1ch38.htm

Treating Cervical Cancer

Preinvasive cancer (carcinoma in situ) can be treated with the same procedures described for cervical dysplasia. However, conization or hysterectomy are more frequently recommended to prevent the disease from spreading. Without treatment, carcinoma in situ usually develops into invasive cancer. Untreated, invasive cervical cancer will travel to other pelvic structures, then invade the lymph nodes located in the groin, then finally spread into the lungs, liver, and bones. Your doctor may refer to cancer that has spread beyond the pelvis and groin as metastasis.

Surgery and radiation therapy are equally successful treatment options for invasive cervical cancer. Chemotherapy does not work as well against cervical cancer as it does against other forms of the disease, but doctors do prescribe it to treat recurrent cervical cancer.
Surgery

Surgery is used to treat cancer when the disease is confined to the cervix. Options include total hysterectomy (removal of the cervix and uterus); radical hysterectomy (removal of the cervix, uterus, upper vagina, and the lymph nodes in the area); surgical removal of the tumor; or, if a woman wants to preserve her ability to carry a child, merely conization. The choice of procedure depends on a woman's age and overall health as well as the size of the tumor.

The consequences of hysterectomy have already been touched on. But, as serious as this surgery is, both medically and emotionally, it may be the best option for treating cervical cancer. It's important to discuss the risks and benefits of the procedure, as well as the longúterm consequences, with your doctor.
Radiation Therapy

Radiation therapy, which destroys the ability of cells to grow and divide, can be used alone or in combination with surgery to treat large tumors and cancers that have grown beyond the cervix. Two forms of radiation therapy are employed: internal radiation, in which radioactive implants are placed directly into the cancerous site, and external radiation, in which a machine directs high doses of radiation into the diseased tissue.

Internal radiation, called brachytherapy, destroys less of the healthy tissue around the cancer and causes fewer side effects than external radiation. Radioactive implants are inserted through the vagina, into the cervix and the uterus. Internal radiation is not always possible if the disease or earlier surgery has dramatically altered the region.

External radiation can be administered on an outpatient basis and is normally given 5 days a week for several weeks. Internal radiation usually requires a short hospital stay; the implant is left in place for 2 to 3 days.


http://www.ajmc.com/supplement/managed-care/2006/2006-02-vol12-n1Suppl/Feb06-2255pS03-S16

Another example comes from Sanders et al, who used decision analysis to assess the cost effectiveness of a potential vaccine for human papillomavirus (HPV) as a way to prevent cervical neoplasms. Cervical cancer is one of the most common malignancies in women, diagnosed in about 13 000 women per year and responsible for the death of about 4000 women per year.35

Researchers built a decision tree to evaluate length of life and cost for vaccinating adolescent girls against high-risk types of HPV. The target population was all adolescent girls in the United States, with a base case of 12-year-old girls (sexual activity before age 12 is considered rare). This assumption was tested in a sensitivity analysis.

The analysis assumed universal vaccination, although during the sensitivity analyses the researchers did evaluate the cost effectiveness of targeting only high-risk girls. The model included data on incidence of HPV infection; low-versus high-risk HPV types; rates of HPV progression; cancer surveillance, treatment, and progression; benign hysterectomy (assuming such women were protected from cervical cancer); HPV vaccine characteristics; and the effects of HPV infection and cervical cancer on quality of life and costs.

The researchers found that although a prophylactic vaccine against high-risk HPV types was more expensive than current practice, it resulted in greater quality-adjusted life expectancy. They predicted that such vaccination would avoid more than 224 255 cases of HPV; 112 710 cases of squamous intraepithelial lesion, a precancerous condition; 3317 cases of cervical cancer; and 1340 deaths related to those cancers. Their sensitivity analyses found the vaccine would be cost effective, even assuming booster shots every 3 years and an efficacy as low as 40%.35

please note -- those with aggressive cervical cancer have to go back for repeated treatments -- at least one of those treatments for people with cervical cancer -- mid or late stage -- is an hysterectomy -- how cost effective is that?

you also need to figure in anal cancer to with cervical cancer -- which raises the numbers.
we separate them out but many anal cancers are caused by the smae hpv viruses that cause cervical cancers.

hpv is an easily spread virus -- as reported on DU before -- it can be spread by fingers.
i