Number needed to treat: gardasil

[Hannah Bell]

http://www.cmaj.ca/cgi/content/abstract/177/5/464

These researchers calculated the number of people that would have to be treated (in Canada) to prevent one case of genital warts or one case of cevical cancer (subjects without prior sexual history):

"Results:

Among 12-year-old girls, we estimated that the number needed to vaccinate to prevent an episode of genital warts would be 8, and a case of cervical cancer 324.

These estimates were based on the assumption that the vaccine procures lifelong protection and that its efficacy is 95%.

If vaccine protection is assumed to wane at 3% per year, the predicted number needed to vaccinate would increase to 14 and 9080, respectively. The latter number would be greatly reduced with the addition of a booster dose, to 480 (80% CrI 254–1572)."

Cost (vaccine only) to prevent one case of cervical cancer at $360 per initial series & $120/booster series:

Case 1: $116,640 (324 vaccinated at $360)

Case 2: $3,269,800 (9080 vaccinated at $360)

Case 3: $230,400 (480 vaccinated + booster at $480)


So to prevent 1000 deaths/yr, mainly in women over 40, under the most likely case (3), you'd have to vaccinate 480,000 12 yr olds every year at a minimum cost of $230,000,000 (lowest cost I've seen for the vaccine only, not including costs of personnel to administer).

[MannyGoldstein]

1. Probably Cost Efffective By Typical Standards

The rule of thumb is that anything that costs less than $50,000 per year of life saved is cost effective. Given these figures, if Gardasil saved 5 or more years in each person whose cancer was prevented (which is likely), it is cost effective.

[Hannah Bell]

2. do you have a cite for that statement?

[MannyGoldstein]

3. Sure. It's Quite A Standard Figure.

Doing a quick Google I find:

http://en.wikibooks.org/wiki/Radiation_Oncology/Cost-Effectiveness
http://www.lww-medicalcare.com/pt/re/medcare/abstract.00005650-200804000-00003.htm;jsessionid=LpBcJJk6nHxwQpL21Hpcy27dJC07lWhRjGG08FbnGcT1NBSG6RK8!2129441969!181195629!8091!-1
http://www.google.com/url?sa=t&ct=res&cd=11&url=http%3A%2F%2Fjco.ascopubs.org%2Fcgi%2Freprint%2F18%2F2%2F284.pdf&ei=xECpSP_uLpDEigG9soDgCQ&usg=AFQjCNGV4YB-5aPLKkBkYrvQvK0P5Xe4lg&sig2=b6QPFfxFhHR9Kwd71sDihA

Seems odd at first that there's a value on a year of life, but it makes sense. Actually, many or most common medical interventions cost more than $50,000 per year of life saved.

[Hannah Bell]

10. well, apparently most vaccines cost

[Hannah Bell]

71. less than $5/dose. don;t know why this part disappeared,

[mhatrw]

4. Bullshit. Virtually all US deaths from cervical cancer are preventable

without Gardasil.

[trotsky]

11. Back that claim up. n/t

[mhatrw]

16. Google "cervical cancer preventable"

Why do so many Gardasil lovers constantly demand backing for common knowledge?

[trotsky]

17. "virtually all" means more than 90% to me.

Does it to you? See, the standard procedure here is that if you make a claim, you should be the one to back it up. So sorry to impose! :eyes:

[mhatrw]

20. See post 18. n/t

[Name removed]

21. Deleted sub-thread

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

[cosmik debris]

14. Virtually all US deaths from cervical cancer are preventable?????

What about the other 3 Billion women on this planet? Don't they deserve a vaccine that will prevent that cancer?

I'm not conceding your point about being preventable because I haven't seen the stats, but it sure seems strange that you are willing to write off all the women who don't live in the US.

[mhatrw]

15. Yes, Merck should give Gardasil to poor nations for free.

You know, one less and all that.

[Liberal Veteran]

24. A funny thing happened on September 26, 2007 - Merck agreed to donate at least 3 million doses...

NEW YORK, Sept. 26, 2007 - Merck & Co., Inc. today committed to donate at least three million doses of GARDASIL® , the cervical cancer vaccine, for use in demonstration projects in lowest income nations throughout the world. The program, part of Merck's comprehensive approach to bringing newer vaccines to the developing world, was announced today as Merck's commitment at the Clinton Global Initiative.

Merck is pursuing a systematic approach to the global introduction of two of its vaccines, ROTATEQ® (rotavirus vaccine, live, oral pentavalent) and GARDASIL, and is committed to making both vaccines available to developing world nations at dramatically lower prices at which Merck will not profit.

[mhatrw]

26. Wow! Does that make up for the billions they've made targeting

rich white girls at almost zero risk for cervical cancer with their "One Less" marketing blitz?

[beam me up scottie]

27. You just don't know when to quit, do you?

Here's a hint; when your ass is handed to you on a plate with a garnish, it's too late.

[Name removed]

28. Deleted message

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

[beam me up scottie]

29. You should really be talking to trotsky.

You never proved your claim, remember?

One would almost think you weren't capable of backing up your statements with facts.

[mhatrw]

30. How about if YOU back up HIS counter-claim?

You have nothing as usual.

[beam me up scottie]

31. We already dug up your info source, now it's up to you to prove your claims.

Surely Cynthia gave you data to back up the claims she you made.

Maybe you should be more careful the next time you quote Googlologists verbatim in this forum.

[mhatrw]

32. How about if YOU show us something other than your infinite ability to

question and ridicule?

Otherwise we will all have to conclude that you are simply ignorant on this subject. It's actually quite painfully obvious to us all that you are bluffing. The only thing that any of you ever do is personally attack anyone who doesn't toe the Big Pharma line.

[beam me up scottie]

33. yawn...still waiting for those facts...

Doggone lazy trotsky gave up and went to bed...

[mhatrw]

35. I'm still waiting for the evidence that 10% of cervical cancers are NOT preventable.

Put up or shut up.

[beam me up scottie]

38. ...yawn...I made no claims. If you have the data just post it. If not, admit it and move on.

You made a claim that you can't verify and now you're going all PeeWee Herman on us.

[mhatrw]

43. What claim did I make? n/t

[beam me up scottie]

49. You forgot it again?

Virtually all US deaths from cervical cancer are preventable without Gardasil.

[mhatrw]

62. It's 100% true. Just google "cervical cancer preventable" n/t

[beam me up scottie]

65. No, you posted the claim and now you're trying to weasel out of proving it.

It's called 'burden of proof' in case you need to look it up.

[mhatrw]

66. I posted the claim as well as the proof.

Just admit that you cannot muster a single contrary shred of evidence.

[beam me up scottie]

68. Really? Which post? Point it out so we can see your "proof".

I'll wait.

[mhatrw]

69. Google "cervical cancer preventable"

Take your choice.

[beam me up scottie]

74. Why? You said you posted the proof already, where is it?

Your words:

I posted the claim as well as the proof.

[varkam]

40. Are you delusional?

Where did anyone make that claim? Please provide a link.

[mhatrw]

44. Cute. n/t

[varkam]

51. Provide a link. What was it that you said - "Put up or shut up"?

[varkam]

34. Well...she's not the one taking talking points from Renew America.

:shrug:

[mhatrw]

36. Show us that over 10% of cervical cancer cases are not preventable.

You have nothing but attack the messenger bullshit, as usual.

[varkam]

37. Oh, I'm sorry, I meant to say that Renew America is a reliable source. Why...

I do believe there's a "I stand with Jerome Corsi" article on the front page right now.

:rofl:

And I have no idea where you're getting this "10%" claim that you keep babbling about.

[mhatrw]

39. What did I quote from Renew America other than Merck's own charts?

Nothing. So you have nothing except kill the messenger bullshit. As always.

[varkam]

41. Yeah, except now we know where you're going for your dose of woo.

It would, by the way, be helpful if you would cite sources in the future. We here in academics call that sort of thing plagiarism. Though, if you're trolling through Renew America for your sources, I can understand your reluctance to cite it here on DU.

[mhatrw]

45. BULLSHIT. The charts are Merck's own. n/t

[varkam]

52. You're missing the point (surprise!)

Yes, they are Merck's charts - but the images that you posted in your message to me were sourced from Renew America, as well as the conclusions that you were trying to draw.

[mhatrw]

56. Um, no. The charts were Merck's and the conclusions were mine.

The nit picking, kill the messenger data server attacks are all yours, though.

[varkam]

83. If you say so, Mr. Keyes. eom

[beam me up scottie]

54. But the paranoid commentary isn't.

Plagiarism I think it's called.

[mhatrw]

59. Yes, I plagiarized Merck. Sue me. n/t

[beam me up scottie]

42. If you like their home page, check out Dobbs:

The Dobbs Health Report

It is solemn duty of each American to consume as many pharmaceuticals as humanly possible in order to allow drug manufacturers to invent new ones.

-John Dobbs (2008)

No bias there, no siree.

[Name removed]

46. Deleted message

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

[Fire_Medic_Dave]

47. Now thats funny.

Which one of us is getting rich arguing with you on an anonymous message board?

David

[mhatrw]

48. Good question. n/t

[varkam]

53. I think she might actually believe that we're being paid or something.

:scared:

[Name removed]

57. Deleted message

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

[beam me up scottie]

55. Paranoia is a nasty drug.

You might want to call Merck and see if they're working on a vaccine for it.

[mhatrw]

58. Yes, a vaccine for paranoia would make billions!

Just because it's mandatory doesn't mean they aren't out to get you.

[beam me up scottie]

61. You should take your show to the Dungeon.

They love conspiracies that can't be backed up with evidence too.

[mhatrw]

63. This is a dungeon and you are a torturer.

You add no substance to any discussion here that I have ever seen.

[beam me up scottie]

67. When it comes to your posts and these threads there was never any substance to add to.

Just parroted stats and cut and paste comments.

[mhatrw]

70. Show me any substance you have ever added to anything around here.

I'll believe it when I see it.

[cosmik debris]

77. What kind of genocidal ethnic cleansing crap is this?

You spent so much time saying that Gardasil is dangerous and now you want Merck to give it away FREE to poor people?

THAT'S INSANE!

If you really believe it is dangerous, you should oppose it in ALL cases.

Apparently you just want to kill a bunch of poor people and protect the rich Americans.

That's about as close to pure evil as I have ever seen on this board.

You need to take a break and re-think your position.

[WillYourVoteBCounted]

7. the cost effectiveness is debatable

Human papillomavirus, vaccines and women’s health: questions and cautions
Abby Lippman PhD, Ryan Melnychuk PhD, Carolyn Shimmin BJ, Madeline Boscoe RN DU
Research Early release, published at www.cmaj.ca on Aug. 1, 2007. Subject to revision.

A recent opinion article by Abby Lippman PhD, Ryan Melnychuk PhD, Carolyn Shimmin BJ, and Madeline Boscoe RN DU published in the Canadian Medical Association Journal on August 1, 2007 argues that there remain a number of unanswered questions about the HPV vaccine, and that a universal vaccination program in Canada "is premature and could have unintended negative consequences."

They also said "we must be certain that spending an estimated $2 billion to vaccinate a population of girls and women in Canada who are already mostly well protected by their own immune systems, safer sex practices and existing screening programs will not perpetuate the existing gaps in care and leave the actual rate of deaths from cervical cancer unchanged."

http://www.cmaj.ca/cgi/rapidpdf/cmaj.070944v1

But I first want to see what is causing some girls to get sick or harmed after having the vaccine.
We don't know enough.

[Hannah Bell]

72. well this is interesting. she says it would cost an estimated $2 billion

the number i got for the us, based on one paper, was about 1/4 billion $. it would be useful to know why the difference...

[mhatrw]

5. This study makes many assumptions.

• Lifelong efficacy of a vaccine that requires 3 doses as well as an alum adjuvant.
  
  
• Cervical cancer contraction and mortality rates that have been decreasing every year for the last 40 years would not continue to decrease without Gardasil.
  
  
• The poor, health disadvantaged groups that cervical cancer disproportionally affects will be vaccinated at the same rate as the richer, health advantaged groups for whom cervical cancer mortality is already an infinitesimal risk.
  
  
• HPV strains 16 and 18 actually cause cervical cancer in the 70% of cervical cancer victims today for which HPV 16 & 18 are present.
  
  
• The current percentages of high risk HPV strains associated with cervical cancer would have remained constant over the next 100 years without Gardasil.
  
  
• Protection against the far more common HPV 6 and HPV 11 strains does not increase one's susceptibility of contracting the thirteen high risk HPV other than HPV 16 & 18.
  
  
• Protection against HPV 16 and HPV 18 strains does not increase one's susceptibility of contracting the thirteen other high risk HPV strains.
  
  
• No other high risk HPV strains will become more prominent or deadly among vaccinated women over any of their lifetimes.
  
  

[mhatrw]

6. More assumptions

• Gardasil is perfectly safe and doesn't cause any negative health issues in vaccinated women.
  
  
• No advanced detection tests, therapies, treatments or cures for cervical cancer will be discovered in the next 50 years.

[WillYourVoteBCounted]

8. "There is no epidemic of cervical cancer in Canada"

This article "Human papillomavirus, vaccines and women’s health:
questions and cautions" says that there is no epidemic, that Canadian officials are jumping the gun.

Also the authors say it is wrong to conflate HPV infection with cervical cancer.

And finally, the sensible part - it says that the goal of the vaccination program
isnt' stated and should be made clear.

If the goal is to eliminate certain strains of HPV, then boys and men should be vaccinated.

If the goal is to eliminate cervical cancer then a vaccine should be directed at more than the
2 high-risk HPV types in Gardasil.

See below:


There is no epidemic of cervical cancer in Canada to warrant
the sense of urgency for a vaccination program initiated
by the federal finance minister’s announcement.

...Thus, HPV infection and cervical cancer must not
be conflated: cervical cancer will not develop in most
women who are infected with even a high-risk strain of
HPV.8 Unfortunately, there are no data on clearance rates
among girls, nor even about the actual HPV prevalence
rates among youth and children, yet this is critical information
for developing, and subsequently evaluating, policy
proposals.

• The nature of a vaccination program is necessarily dependent
on the definition of clear and tangible goals. To
date, such goals have not been made explicit with regard
to a Canadian initiative. Is the aim of the vaccination program
the eradication of high-risk HPV types from the
population?

Or is it to reduce the number of deaths from cervical cancer? These different goals require different strategies. For example, pathogen eradication would imply
a herd-immunity goal, thus possibly necessitating the vaccination
of boys and young men. In contrast, the reduction
of deaths from cervical cancer would suggest the need for
a vaccine directed against more than the 2 high-risk HPV
types in Gardasil, which may account for only somewhat
more than two-thirds of cervical cancer cases.

http://www.cmaj.ca/cgi/rapidpdf/cmaj.070944v1

[Hannah Bell]

9. there's none in the us, either.

[trotsky]

12. So is your opinion that unless there exists an epidemic of something,

we shouldn't vaccinate against it?

There are no longer measles epidemics in the US, should we stop vaccinating against that?

[mhatrw]

18. Measles are contagious through casual contact.

Measles vaccines confer immediate protection against measles, not possible protection against a possible health threat that takes decades to develop.

http://www.msnbc.msn.com/id/8702775

Virtually all deaths from cervical cancer are preventable, yet the disease will kill almost 4,000 women in the country this year. Frustrated scientists know who most of them will be: black women in the South, Hispanics along the Texas-Mexico border, white women in Appalachia, and Vietnamese immigrants.

Kudos to Merck for reaching out directly to these health disadvantaged groups with free vaccinations rather than rich white girls who are not at risk! :sarcasm:

[Fire_Medic_Dave]

50. So rich white girls aren't at risk to get cervical cancer? Care to back that up.

[mhatrw]

60. They have a very limited risk. n/t

[trotsky]

13. Response to that article

http://www.cmaj.ca/cgi/eletters/177/5/484#15927

We were disturbed by unfounded criticisms by Lippman et al. about HPV vaccination recently published in CMAJ. We have followed the development and testing of HPV vaccines and new cervical cancer screening technologies, such as HPV testing, with much appreciation for the science propelling the evidence that will ultimately revolutionize cervical cancer control. The points of disagreement between our views, as McGill University epidemiologists working on cervical cancer etiology and prevention, and those in the commentary are simply too many to fit in a letter. We trust that arguments against the commentary’s ill-conceived conclusions will be given by eminent groups such as the Society of Obstetricians and Gynaecologists of Canada and Society of Gynaecologic Oncologists of Canada, as well as by Canada’s National Advisory Committee on Immunization, all of which issued favourable positions concerning HPV vaccination. To summarize, we echo the concluding remarks from the meta-analysis of Rambout and Colleagues: ”Vaccination appears to be well tolerated and safe. Data to help reconcile the gap between the impressive vaccine efficacy demonstrated in these trials and the potential effectiveness of vaccination at reducing the global burden of cervical cancer and death from the disease should be forthcoming from phase IV trials currently underway”.

As with most new vaccines, cost is a concern. With time, competition and economies of scale make vaccination policies more affordable. A paradigm change in cervical cancer screening based on the use of HPV testing technology is likely to take place in synergy with HPV vaccination and will help the case for cost-effectiveness. Surely there are lessons to be learned but adjustments in policies can be made as the emerging science produces its dividends. What cannot be dismissed, however, is the fact that the quality and quantity of evidence already accrued in favour of HPV vaccination is just as good, if not better, than that for preventive strategies in any other area of cancer control. Seemingly cautious arguments to the effect that we do not know enough about vaccination of girls and adolescents are irrelevant and untenable. The vaccines have been (i) thoroughly tested in women at risk of HPV exposure (ages 15-25 years) and proven safe and efficacious; (ii) immunobridging studies have shown that the immune response in adolescents is stronger than that in young and old adults; and (iii) to be of maximal benefit in reducing cervical cancer burden in the future vaccination should focus on pre-exposure prophylaxis. The argument about herd immunity is not yet one that we can use in cervical cancer prevention. Eventually, phase IV trials may point to policy revisions and male vaccination could become a complementary prevention strategy in the future. As for the argument that cervical cancer will not develop in most women infected with oncogenic HPVs, it ignores basic cancer epidemiology. Most smokers will not develop lung cancer, yet we hold smoking cessation in high esteem as cancer prevention target. More importantly, one can develop lung cancer despite never having smoked but an infection with an oncogenic HPV type is a necessary precursor for cervical cancer. Incidentally, safe sex is practically an oxymoron when it comes to preventing HPV infection; condom use is not protective <4>.

Finally, we take issue with the argument that there is no cervical cancer epidemic in Canada to justify a sense of urgency in adopting new policies. Low fertility, universal access to care, and intensive screening with the relatively inefficient Pap test have collectively contributed to keep cervical cancer rates low in Canada, but the enormous cost and morbidity resulting from frequent screening and management of cervical cancer precursors are seldom appreciated. By analogy, childhood cancer mortality has declined but not fast enough. We believe one would not be arguing against a new federal policy that could reduce cancer risk in children by 50%-70%. Cervical cancer strikes relatively young women compared with other cancers. The 400 Canadian women who die of cervical cancer every year suffer unbearable pain, loss of function and form, and see their dignity slip away as the disease progresses and treatment fails. Pelvic exenteration, a heroic act by gynecology oncologists trying to rescue cervical cancer patients with locally advanced disease, is one of the most gruesome and complex among all surgical procedures and is psychologically devastating. No health economic analysis can assign a proper value to these procedures or, to the patient, the avoidance of what brought them so much suffering.

Eduardo L. Franco, Alexandra de Pokomandy, Andrea R. Spence, Ann N. Burchell, Helen Trottier, Marie-Hélène Mayrand, Susie Lau

Department of Epidemiology, Biostatistics, and Occupational Health McGill University, Montreal, Quebec

[mhatrw]

19. Even Gardasil's strongest advocates admit that the only way it is cost effective

is if is it used to reduce the HPV testing that is still the only way to prevent the 13 high risk HPV strains that Gardasil does not confer any protection against.

[trotsky]

22. You've got your facts so mixed up it's hilarious.

I'm glad you're on the anti-Gardasil side - I'd much rather have you out there making your side look like uninformed zealots.

[mhatrw]

23. Yeah, that's the ticket!

Why post a substantive response when a substanceless personal attack is so much easier and more satisfying?

[trotsky]

25. Trust me, if I personally attack you, you'll know it.

However, I was merely stating that you can't keep your facts straight. Your self-contradictory posts give it away.

[mhatrw]

64. Please demonstrate your baseless accusations. n/t

[trotsky]

75. Sure thing!

1) Click this link:
http://www.democraticunderground.com/discuss/duboard.php?az=search_simple&select_forum=222

2) Enter "mhatrw" in the Key Words box.

3) Under "Search which fields?" select Author.

4) Click Search Now!

There's my documentation.

[mhatrw]

84. So you have nothing. What a surprise! n/t

[Hannah Bell]

73. hmm ... they don't seem to disagree with her "2 billion to vaccinate".

so if that's a good estimate for canada, my 230 million is way low-ball for the us.

[trotsky]

76. Hmm... they don't seem to agree, either.

Probably not reasonable to say one way or the other. But since they disagree with all the other inflammatory and false information, I suppose it makes sense for you to ignore that and just focus on the one detail that's not covered.

[Hannah Bell]

78. They speak to cost. If they'd not mentioned it, i'd have thought "no position". But they

mentioned cost & implied it was high, but would become "more affordable" over time.

I take this as no serious disagreement with the figure (which i'd guess comes from some official estimate, which is why they didn't counter it.)


"As with most new vaccines, cost is a concern. With time, competition and economies of scale make vaccination policies more affordable. A paradigm change in cervical cancer screening based on the use of HPV testing technology is likely to take place in synergy with HPV vaccination and will help the case for cost-effectiveness. Surely there are lessons to be learned but adjustments in policies can be made as the emerging science produces its dividends."


Scientists disagree with each other. The earlier letter isn't "inflammatory," the writers are reputable. Your attempt to broad-brush paint all disagreement as nuttiness is what's inflammatory.

[trotsky]

79. You are apparently thinking it was a focus for them.

I don't see that from their position. I believe you are reading more into the piece than is warranted.

AND, as I pointed out, you're focusing on that one detail at the exclusion of everything else that dismisses your article.

[Hannah Bell]

80. no, i don't think it was a focus, but i see they addressed it & agreed

cost was high. That leads me to suspect some study exists which estimated cost at around 2 billion.

[trotsky]

81. And so all the other points are irrelevant, huh? n/t

[Hannah Bell]

82. the other points are what they are: debatable. I was simply interested

they seemed to agree with the cost estimate. Which is probably also debatable, but they didn't debate it - which suggests there's so "authoritative" estimate floating around.

[WillYourVoteBCounted]

85. "they will be worth the cost only if the vaccines are proven to protect girls for a lifetime"

From an article by a Harvard researcher:

The second paper published this week, a study by Jane Kim and Dr. Sue Goldie of Harvard, looks at the issues of costs and concludes that the vaccines will be cost-effective only if used in certain ways. In particular, the researchers say, they will be worth the cost only if the vaccines are proven to protect girls for a lifetime and if current methods for screening for cervical cancer using pap smears can be safely adjusted to reduce costs there. Further research is required in both areas.
http://www.iht.com/articles/2008/08/20/africa/vaccine.php

[WillYourVoteBCounted]

86. "the protection of the vaccine wanes after 10 years, vaccination is much less cost-effective

The New England Journal of Medicine has a report out today about the Cost Effectiveness of
the HPV vaccines.

The model presented by Kim and Goldie is well done and ambitious, and it includes most of these factors. They conclude that under certain assumptions, vaccinating 12-year-old girls is associated with an incremental cost-effectiveness ratio of $43,600 per QALY gained, whereas adding a catch-up program for older girls and women is not cost-effective. However, their base-case assumptions are quite optimistic. They presume lifelong protection of the vaccine (i.e., no need for a booster dose), that the vaccine has the same effect on preadolescent girls as on older women, that no replacement with other oncogenic strains of HPV takes place, that vaccinated women continue to attend screening programs, and that natural immunity against HPV is unaffected. Whether these assumptions are reasonable is exactly what needs to be tested in trials and follow-up studies. If the authors' baseline assumptions are not correct, vaccination becomes less favorable and even less effective than screening alone. For example, as shown in the article, if the protection of the vaccine wanes after 10 years, vaccination is much less cost-effective and screening is more effective than catch-up programs.

http://content.nejm.org/cgi/content/full/359/8/861