an awful lot of people are getting the protection from cancer offered by gardasil

[xchrom]

Merck report: $358m in Gardasil sales for Q2; $1 billion total for vaccines

While we don't typically highlight corporate earnings reports or similar news, the quarterly report released Monday by Merck for April-June 2007 provides some new information about the growing market for vaccines, and, in particular, Gardasil. Here's coverage from yesterday's New York Times, "Another Quarter of Strong Results by Merck," and a similar story from Reuters.
Since this news comes directly from the company, the Merck press release is particularly useful. Here's part of what it says about vaccines:

"Total vaccine sales, as recorded by Merck, were $1.0 billion for the quarter, compared to $349 million in the second quarter of 2006. The growth in vaccine sales was led by the performance of GARDASIL along with strong contributions from ROTATEQ and other pediatric vaccines. Vaccines in most major European markets are sold through the Company’s joint venture, Sanofi Pasteur MSD, and the results from its interest in the joint venture are recorded in equity income from affiliates.
Total sales as recorded by Merck for GARDASIL, the Company's cervical cancer vaccine, were $358 million for the second quarter. As of the second quarter, GARDASIL has been approved in 80 countries, many under fast-track or expedited review; and launched in 59 of those countries. The vaccine remains under review in approximately 40 other countries.

http://www.vaccineethics.org/labels/Gardasil.html

[Maraya1969]

1. I think these people should be shot. Cervical cancer does not develop

until usually you are after 40 and they are giving a vaccine to young girls now?

I don't think it has been proven that those certain kinds of STD's cause cancer anyway. I think it was a correlation that because a causation without the proper medical peer reviews.

I would never give my child another unnecessary vaccine, especially one that is supposed to stop an illness in 35 years.

[JeanGrey]

2. Gee that would be news to my neice who had HPV and now

has cervical cancer at 24.

[xchrom]

3. your post is the most perfect example of the ignorance that is running rampant

in society today.

[Maraya1969]

16. So give your little girl another vaccine with mercury in it to protect against

a disease whose connection has not been proven. Tell me then why the number of rates of autism have risen from 1 in over 1,000 to 1 in 164.

Do you think it has to do with the overdose of mercury we give these babies and children for diseases that they probably would never get.

When I was a kid we all got the childhood diseases And we are not the worse for them Now each kid is inoculated against them.

And you want one more vaccine?

It is easy to treat CV if you get a screening every year. I've had pre-cancerouss cells removed. 6 moths later I was tested again and 6 months after that. Now I go every year.

And as far as I know I do not have HPV


EDIT: It also has not been proven that there is a causation between HPV and cervical cancel. There is a correlation but that is not a causation. And according to the advertising itself that vaccine does not prevent all types of HPV

[cosmik debris]

17. You must have forgotten the :sarcasm: smiley n/t

[LeftishBrit]

28. Most childhood vaccines *do not* contain mercury

And as far as the childhood diseases leaving us 'none the worse' - this is not true of many people. Childhood diseases killed many children, and still do in the developing world. I know someone who has severe motor disabilities due to having whooping cough as a baby, and another who is deaf from maternal rubella.

There is now overwhelming evidence that vaccines do *not* cause autism (unlike maternal rubella, which does in about 5% of cases). But even if they did, Gardasil is not given until well after the age when it is is possible for autism to develop.

[Maraya1969]

29. It is not the mercury but a component that causes the problem and your

evidence regarding autism and vaccines is right now being rebutted on many levels.

[NickB79]

32. What is the name of this component?

And if mercury isn't an issue (which isn't used in Gardisil btw), why did you specifically mention mercury in your previous post?

[Maraya1969]

74. Thimerosal

[NickB79]

76. Thimerosal IS mercury

And it was removed from vaccines in 2001 per the CDC, with the exception of some flu vaccines.

You specifically stated components OTHER THAN mercury:

"It is not the mercury but a component that causes the problem".

What is the component?

[Maraya1969]

75. Thimerosal

[LeftishBrit]

34. Rebutted by whom? In any case, you cannot develop autism for the first time at the age of 10 or 11..

so that *even if* there were a vaccines/autism link, it would not be relevant to vaccines given to school-age children.

[WillYourVoteBCounted]

42. riiiight. Just because it makes toddlers sick doesn't mean its bad for other human beings

great logic.

Yep, must be good for ya if it makes toddlers sick.

That is faith based medicine, trust Merck/FDA and other big corporations.

But hey, its in the US, what do you care.

[LeftishBrit]

67. HOLD on, it's not only in the US that people need vaccinations!

I care about my own and other people's RIGHT to have vaccinations!

Since you mention my not being in the US: in Britain, and most Europaean countries, vaccinations are universal, free but *not* mandatory. Perhaps that is a better system.

And you are twisting what I said. I said that vaccinations D0 NOT cause autism in toddlers. I STRONGLY support vaccinating toddlers for childhood diseases!!! I did also say that one cannot become autistic at the age of 10 or 11, so that it is CERTAINLY no reason for avoiding vaccinating older children.

I do not necessarily 'trust Merck/ FDA' or my own government - but I trust the diseases, against which vaccines are intended, even less.

And once again - if you don't like other people questioning or impugning *your* motives, please don't do it to us!

[WillYourVoteBCounted]

72. HOLD ON, the US handles vaccinations differently than YOUR country

IN YOUR COUNTRY, WHICH IS NOT THIS ONE, YOU HAVE ACCESS TO MEDICAL CARE IF YOU TAKE
SOME FUCKED UP VACCINE THAT ISN'T SAFE.

SO, WHEN GARDASIL PARALYSES SOME GIRLS, CAUSES MASSIVE DEEP WARTS IN OTHERS, CAUSES MIGRAINES, IRREGULAR PERIODS, DEPRESSION, STROKES, MUSCLE WEAKNESS, GUILLAME BARRE DISEASE, HEART PROBLEMS -
IN THE US WE AREN'T GUARANTEED HEALTH CARE.

I care about my own and other people's RIGHT to NOT have vaccinations that are making healthy girls sick, and some dead.!

In some countries, people have universal health care and can get pap smears on a regular basis.

In some countries, if a vaccine like Gardasil damages your health, YOu CAN GO TO A DOCTOR.

And you are twisting what I said.

I said that just because you think that the only worry is mercury in vaccines, DOESNT MEAN THAT YOU CAN ATTRIBUTE THOSE THOUGHTS TO CRITICS OF BIG PHARMA OR GARDASIL.

Unlike your presumptions, NOT EVERYONE thinks that VACCINES ARE OK AS LONG AS THEY DON'T HAVE MERCURY IN THEM.

That is very simplistic thinking, and works well for vaccine crusaders, BUT ISN'T HONEST.

WE don't know why, BUT GARDASIL MAKES SOME HEALTHY GIRLS SICK, AND SOME HEALTHY GIRLS DEAD.

You HAVE NO RIGHT to speak for me or others who oppose questionable medicines.

I don't give a rats ass what you recommend for children or adults in our country.

YOU CAN TRUST YOUR FEARS OF A DISEASE AND LET IT LEAD YOU TO PUSH A VACCINE THAT MAY BE MORE HARMFUL THAN ANY PRESUMED THREAT.

BUT you will not stifle me nor speak for me.

I don't care what or whom you trust, I and others do not trust the Gardasil vaccine, will not have it administered to our daughters, and I will continue to teach my daughter NEVER to be the BETA test for Big Pharma.

[LeftishBrit]

80. I cannot stifle or speak for you; but neither can you for me!

You are right that America has faults in its medical system that we don't. Not that it's perfect here, but a national health care system is much better than no national health care system.

However, having an NHS does not make people more inclined to risk illness just because we could see a doctor if we do get ill. Most of us don't want to get ill regardless.


'I and others do not trust the Gardasil vaccine, will not have it administered to our daughters'

That's fine. I don't think it should be mandatory. But those who DO want it should have the right to have it.

[LeftishBrit]

82. P.S. I was responding in my 'mercury' remark to a statement about the dangers of mercury!

I was NOT saying that the opponents of vaccines all think that the only problem is the mercury. I was responding to someone who WAS bringing up the mercury. Good grief.

And please don't speak for me either. My support for people's RIGHT to have vaccines is NOTHING to do with any support for Big Pharma!!!

I certainly have no power to make you, or people in your country, or even in mine, have any vaccination that they don't want to. But I will continue to advocate the RIGHT of everyone, worldwide (and most of all in the developing countries where vaccines are often unavailable) to have any vaccine that they want to. People should also have a right not to have them. But they should not be deprived of access to them.

[NickB79]

4. Guess my ex-girlfriend in college, who had cervical cancer, was lying about her age then

Damn, she looked like a hot 21-yr old college student to me, but you must be right; she was really a 40-yr old woman.

Same goes for a friend of mine who just had a complete hysterectomy last year for cervical and ovarian cancer. She says she's only 26, but what do I know?

[Maraya1969]

25. Everyone gets cancer earlier now. And poisons of all types are part of the equation

in my opinion. Including Mercury poison. I am sorry about your girlfriend but one person or a few does not verify shooting a person up with a known carcinogen

[NickB79]

33. Mercury is no longer used in vaccinations

Per the CDC: "Since 2001, with the exception of some influenza (flu) vaccines, thimerosal is not used as a preservative in routinely recommended childhood vaccines."

[LeftishBrit]

36. Gardasil doesn't include mercury

and neither do most vaccines nowadays.

[WillYourVoteBCounted]

43. Gee, but without investigation, we won't know what is making these girls sick after Gardasil

And the lobbiests will drown out any studies or opposition voices, so we
won't know why Garadil makes some girls sick and kills others.

Because some refuse to admit that there could be something about this vaccine that
causes harm to some humans.

Because it would be "unscientific" to study it or ask those questions, according to the
pro Gardasil clan.

:sarcasm:

[LeftishBrit]

70. What precisely has that got to do with the statement that it doesn't contain mercury?

[Hannah Bell]

57. The fact remains, most cc develops in women over 40, as the poster said.

[LeftishBrit]

14. Many people get it at younger ages

E.g. Jade Goody, a British TV celebrity, has just been diagnosed with the disease. She is 27.

[Hannah Bell]

101. nevertheless, most people get it over 40. i believe something like 75%.

[Fire_Medic_Dave]

24. Advocating killing public health researchers is way over the top.

Given your ignorance of the issue, it's not surprising though.

David

[Maraya1969]

30. Would you give it to your own 11 year old child then?

[Fire_Medic_Dave]

64. Big leap from not giving a vaccine to killing vaccine researchers.

If I had an 11 year old girl I would have no problem giving her all of her vaccinations.

David

[Maraya1969]

83. Do you know what a figure of speech is?

You must be the only person in this thread that believed I truly meant I wanted to "Kill people when I used the words, "They should be shot"

Most realize that it was just a figure of speech. But in order to make things clear let me say I advocate the deaths of NO PERSON.

[Fire_Medic_Dave]

85. How big of you.

[LeftishBrit]

68. Yes - if I had a child that age, I would

I've looked into it for myself; but I am older than the age where it's likely to be effective.

[Maraya1969]

77. You should trust less and research more

http://www.newmediaexplorer.org/emma_holister/2006/10/11/profit_as_usual_and_to.htm



The following items might help to clarify issues:

‘It's Not Just Religious Conservatives Who Oppose Mandatory HPV Vaccination - The Missing Debate on the HPV Vaccine’ by Suzanne Nelson


“Yes, 3,700 women in the United States die of cervical cancer every year. But just having HPV doesn't mean you're going to get cancer. The FDA said as much in its press release: ‘For most women, the body's own defense system will clear the virus and infected women do not develop related health problems.’ Estimates of the number of people with HPV in the United States vary wildly, but perhaps up to 80 percent of women are infected with HPV at one time or another before they are 50 . . .

. . . In terms of long-term safety, one sentence in the FDA's insert is particularly revealing. ‘Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity,’ according to the insert. Yes, carcinogenicity means the ability to cause cancer. It's also not known whether the vaccine can cause chromosomal damage. We don't know because researchers didn't look. The trials were not set up to examine that question . . .

[LeftishBrit]

81. I don't 'trust' and I do 'research'.

And vaccines do *not* cause genotoxicity or chromosomal damage. They work by stimulating the immune system and that cannot affect the genes. There is a good reason why researchers didn't look for this!

I note that, even when people have alleged that other vaccines have caused illness or disability or death, the possiblity of affecting the genes has not been raised. I wonder if the difference regarding concerns about this vaccine is that it immunizes against an infection that affects the reproductive system? But the vaccine itself does not target the reproductive system - just the virus.

[psychmommy]

5. i am concerned with fast tracking.

what is fast tracking and expedited review? this article discusses the financial side of guardrail and how usa leads the way in purchase of this this vaccine. the article underneath discusses a mandate and that makes me nervous. my insurance company has it on the list of vaccinations each child should have at my daughters age. i am not convinced and i am not comfortable. i think fast tracking and expedited review means, the vaccine needs to be studied more before it is given to prepubescent girls.

[xchrom]

6. this vaccine was not fast tracked and was studied in both europe

and the u.s before it came on line.

it is not only 100% effective targeting those hpv it was designed for it -- protects against othe lesions as well.

[Hannah Bell]

8. yes, it was given expedited review. you should check the facts before venturing your "opinion"

"For much of 2006, it appeared that the introduction of the HPV vaccine was on a fast track to being one of the great public health success stories of our time (related article, Fall 2006, page 12). Gardasil, developed by Merck, had been shown to be virtually 100% effective in preventing the strains of HPV responsible for 70% of cervical cancer cases.

Review of the vaccine (but not the research itself) was expedited by the federal Food and Drug Administration (FDA) under a priority process designed for products with potential to provide significant health benefits, and approval was granted in early June. (A second vaccine, Cervarix, was submitted to FDA in March of this year by GlaxoSmithKline. Although Cervarix is not being given expedited review, it could be approved as soon as early 2008.) In addition, Gardasil has been approved in 75 other countries around the world (related article, page 15)."

[Liberal Veteran]

15. Fast tracking is merely a way of expediting review of studies.

So for instance, a novel HIV medication would get priority review over yet another hydrocodone/apap tablet.

It has nothing to do with whether or not a product was adequately tested.

[Hannah Bell]

40. priority review = reviewing data in less time.

http://www.fda.gov/oashi/fast.html#fast

gardasil was fast-tracked; it was approved even before the end of phase 3 trials, with a shortened review process. In addition, the studies in some cases used surrogate end points (e.g. dysplasia, not cancer, was endpoint).

testing & review was different from pre-fast-track standards.

[Liberal Veteran]

41. No, it means the review goes to front of the line.

[Hannah Bell]

44. "Priority review" per fda:

"Priority Review is a designation for an application after it has been submitted to the FDA for review for approval of a marketing claim. Under the Food and Drug Administration Modernization Act (FDAMA), reviews for New Drug Applications are designated as either Standard or Priority.

A Standard designation sets the target date for completing all aspects of a review and the FDA taking an action on the application (approve or not approve) at 10 months after the date it was filed. A Priority designation sets the target date for the FDA action at 6 months."

http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm

[Liberal Veteran]

45. Well, then...since the clinical trials of Gardasil were over 10 years...then it wasn't fast tracked.

Review happens AFTER each clinical trial.

[Hannah Bell]

55. as for the clinical trials, your statement that "clinical trials were over 10

years" before approval is also incorrect.

People keep saying this, i've asked several times for documentation, no one's given it.

I finally found the history.

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf.

Merck started Phase 1 Trials in 1997. That's where the "ten years" or "over 10 years" comes from, because it's mid-2008 now.

But there was not 10 years of clinical trial data in 2006, when Gardasil was approved.


Here are the facts:

Small phase 1 & 2 trials went on 1997-2004, mostly to test dosing & safety at different doses. Only one of these studies (of ~2400 people) was double-blind, randomized, etc.

1997-2001 fewer than 4300 subjects participated.


In 2001 the first of 2 large randomized/placebo Phase 3 clinical trials began.

In 2005, the data up to that point was "locked" for FDA review, though the trials were still ongoing.

So approval was based on 8 years of data.


Four of those data years consisted of short-term studies to assess preliminary safety & dosing questions, & enrolled <4300 people.


Four of those data years were to assess efficacy & longer-term safety issues, & enrolled about 18,000 people.


Future 1 was still ongoing at the time of data review, & had mean follow-up of about 1.7 years.

Future 2 mean follow-up was 1.4 years, & was also still ongoing at the time of review.


So in terms of what people commonly think of as "clinical trials" - large randomized, placebo-ed studies where people are followed for a long time to see what happens: the data for approval was 2 studies in which the "average" subject was followed less than two years, & no subject could have been followed more than 4 years. Both of which hadn't concluded at the time of approval in 2006.

Also, people keep saying gardasil was "tested in europe," as though these were tests different from the clinical trials.

No, they were the same trials.

[Liberal Veteran]

58. Given that Phase IV is ongoing and that testing on males is also ongoing...

It has been in trials LONGER than 10 years. Honestly, you were the one who pointed out Dr. Harper spent 20 years working on this vaccine, were you not, now you want to pass it off as something just whipped up in a couple of years?

You added the "before it was approved". Nice attempt to put words in my mouth.

So here we are, at least a decade into testing and a couple of years on the market and STILL you cannot provide any evidence that the vaccine unsafe.

Try as you might, you can't twist the facts.

[Hannah Bell]

61. it was fda APPROVED june 2006, before completion of phase 3

trials, which had, at that point, followed 18000 people for a mean 1.4-1.7 years.

Data collected after 12/05 wasn't reviewed for approval.

you can blow all the smoke you want, but that's the fact.

[Liberal Veteran]

63. And you think it hasn't been reviewed since? Apparently you don't know shit about post-approval.

...follow-up of biologicals.

And the fact that despite all the alarmism coming from the anti-vax contingent has failed to bear even a casual link to the many "possible serious adverse effects" that were proffered as a reason to not trust this vaccine, here we are years into testing and a couple of years into use in the general populace and still there is no evidence that we should rethink the safety profile of Gardasil.

[Hannah Bell]

65. The drug was put on the market in 2006, even before completion

of phase 3 trials, on the basis of less than 2 years' large-scale trials data.

It was then recommended to physicians, sold & given to thousands of people.

This is the fact.

[Liberal Veteran]

66. And still, I haven't been shown evidence that the vaccine is unsafe.

So why the obsession over it? My instincts and reason tells me there are two possible explanations why people would fixate on this. 1. It's Merck. 2. Some people have bought the anti-vaccine thing.

[WillYourVoteBCounted]

69. Haven' t been shown, or just unable to see

I guess it depends on perspective.

[Liberal Veteran]

71. I think we've about exhausted the possibilities of this discussion.

[Liberal Veteran]

46. You left this bit out also....

A request for Priority Review must be made by the drug company. It does not affect the length of the clinical trial period. FDA determines within 45 days of the drug company’s request whether a Priority or Standard Review designation will be assigned. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary.

[Hannah Bell]

49. ...

"It does not affect the length of the clinical trial period"

No, & I didn't say it did. I said it shortened the review period. You disagreed, & you were wrong.

However, Gardasil was fast-tracked. Fast-track has several possible components, & at least one of them is, indeed, alteration in standard clinical trials procedure, i.e. permission to use surrogate endpoints. It appears Merck was allowed to do this.

I don't think that is particularly surprising for a supposed cancer vaccine, since most cancers take a long time to develop. Nevertheless, the clinical trials didn't use full-blown cancer as an endpoint, & the drug was approved before phase 3 trials were complete, on the condition that the researchers would continue with all phases of trials, e.g. phase 4, which does follow recipients long enough to see whether there are fewer cancers in the treatment group.

[Liberal Veteran]

51. And without surrogate endpoints....the time to bring the drug to market would have been 30 years.

And no, I was not wrong. You were attempting to spin fast-tracking as bypassing the clinical trial process which is patently wrong.

I've seen this argument made more than once about the evils of fast-tracking as though it undermines the process and it is simply not the case.

Are you really saying that an extended formulation of generic ibuprofen should get precedence in the review process over a novel cancer therapy or HIV treatment and that the FDA should be "first come, first served"?

That's the point of fast tracking, giving precedence to drugs where an unmet medical need exists over more common drugs where there is already a treatment.

[Hannah Bell]

53. Surrogate endpoints aren't "standard". I'm quite willing to admit

that for a cancer vaccine, it may be reasonable to approve on the basis of surrogate endpoints when cancers take a long time to develop. But it's not standard practice for drug approvals generally.

You keep turning the conversation to my motives, etc.

I don't turn it to yours.

We're not discussing ibuprofen, & the question is not, should gardasil get priority over ibuprofen, but WAS GARDASIL FAST-TRACKED, & if so, under which sections of fact-track?

Whether that's good or bad is not my interest. My interest is, what happened, what's the true history here?

My interest is in the FACTS, not discussants' motives, & not straw men.

[Liberal Veteran]

54. Given there was an unmet medical need to prevent hpv infection....fast tracking was called for.

Now you can argue the merits of that approval of fast track status to your heart's content, but honestly, no one has produced anything other than some
post hoc ergo propter hoc anecdotes which are in the EXTREME minority 0.000038095%, and thus, the safety of this vaccine is generally better than aspirin or tylenol and warrants little more than eye rolling at the alarmists.

Now if you want to have a discussion on the cost to benefit of this vaccine or the need for mandates or aggressive marketing, that's a separate discussion entirely.

And you have to admit, the bulk of the arguments about this vaccine are based on inherent mistrust of big pharma by the opponents rather than actual science.

[Hannah Bell]

56. That's an opinion, & irrelevant to the question under discussion.

But since you now concede gardasil WAS fast-tracked, & that priority review = review in less time, my work is done.

[Liberal Veteran]

59. ROFLMAO! Is your contention that waiting in line makes a product safer?

You have fucking got to be kidding me!

Let me spell it out for you simply since you seem to be unable to comprehend the review process.

There is a HUGE backlog of data regarding clinical trials that is submitted for review to the FDA.

The review boards are given a list of trials to review.

Priority review means that they are going to look at the data on one particular trial/drug/device/procedure, prior to another.

If you are going to convince me that somehow the time a piece of paper sits on a desk waiting to be looked at changes the data on that piece of paper, you are going to have to do better than that.

Essentially, they are prioritizing tasks and saying "Hey! This drug that is being tested to shrink brain tumors and extend life in patients who were dying is MUCH MORE important than a new formulation of viagra that is faster acting. Let's review the brain tumor drug data FIRST because it is more important."

Prior to fast tracking, it was basically, "first come, first served" with regards to review priority, so if Johnson & Johnson developed an enteric coating that helped prevent stomach upset was given priority over potentially life-saving drugs because they submitted their data for review first.

It is becoming obvious to me that you don't seem to have a clue about the review process works.

[Hannah Bell]

60. no, my contention is gardasil was fast-tracked & its review process was

sped up.

something you first denied, despite the smoke you're blowing now.

[Liberal Veteran]

62. Okay. Let's try this analogy. Let's say you have a copy Moby Dick and a copy of Tom Sawyer.

And you can only read one at a time. If you read Tom Sawyer, is the information contained in the printed version of Moby Dick going to change while sitting on your desk?

Or let's try this. You have blood work to process on a bunch of patients at the hospital. The doctor tells you to check the white blood cell count on a critical patient's blood and run a tox-screen on it quickly. So you review that blood first even though you got a three vials to do of a routine CBC that came to the lab first. Does that mean that you shortchanged the the WBC/tox-screen patient by prioritizing it and running it prior to the non-urgent CBC vials?

See that is what priority review is. It isn't about skimming the data haphazardly. It's about putting the important work first.

Data submitted for review from a clinical trial isn't like a fine wine that gets better with aging. The data remains the same in that report if you study it today or study it a week from today.

Is that so difficult to understand?

[Hannah Bell]

50. Per FDA:

A drug that receives Fast Track designation is eligible for SOME OR ALL of the following:

-More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval

- More frequent written correspondence from FDA about such things as the design of the proposed clinical trials

- Eligibility for Accelerated Approval, i.e., approval on an EFFECT ON A SURROGATE OR SUBSTITUTE ENDPOINT reasonably likely to predict clinical benefit

- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDaA, and

- Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a PRIORITY REVIEW.

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within
sixty days based on whether the drug fills an unmet medical need in a serious disease.

http://www.fda.gov/oashi/fast.html#fast


Gardasil got fast track status. Since it was approved before completion of Phase 3 trials, & since Phase 3 endpoints were dysplasias rather than cancers, & since one of the conditions of approval was that trials continue into Phase 4 (following treatment/placebo groups to compare incidence of cancer in both), Merck apparently was approved on the baasis of SURROGATE ENDPOINTS.

As for the studies & approvals overseas, Merck's own press release says:

"As of the second quarter, GARDASIL has been approved in 80 countries, MANY UNDER FAST-TRACK or expedited review"

[Liberal Veteran]

52. And so the system worked.

What's the problem?

Are you insinuating that the more than a decade of clinical trials was insufficient to determine the safety of the vaccine?

Where is the epidemic of exploding vaginas and flipper babies?

[Hannah Bell]

103. the REQUEST doesn't alter the length of review. The designation of priority DOES,

it shortens it to 6 months or less.

per the fda.

[psychmommy]

10. your article discusses it. i read your link

and asked my questions from what i read.

[xchrom]

27. then you don't know how to comprhend what you read. nt

[psychmommy]

73. insults instead of info.

i am so not surprised.

[Hannah Bell]

47. Merck filed Gardasil with the FDA on Dec. 1 (2005) and requested fast-track review

http://money.cnn.com/2005/12/16/news/fortune500/merck/index.htm


Per Merck itself:

"As of the second quarter, GARDASIL has been approved in 80 countries, many under fast-track or expedited review; and launched in 59 of those countries. The vaccine remains under review in approximately 40 other countries."

http://www.vaccineethics.org/2007/07/merck-report-358m-in-gardasil-sales-for.html


"The Food and Drug Administration approved the sale of Gardasil, produced by US pharmaceutical firm Merck, after a six-month fast-track clinical test." (Note: I believe this should read "review," not test.)

http://www.newscientist.com/channel/health/dn9305-first-cervical-cancer-vaccine-is-approved.html

2/6/06

"The FDA has put Merck's experimental cervical cancer vaccine Gardasil on its fast track. The decision moves the agency's deadline to June 8."

http://www.fiercebiotech.com/story/spotlight-fda-grants-fast-track-status-for-gardasil/2006-02-07

[Liberal Veteran]

48. Meaning that review of the data from the clinical trials got priority review.

That is was fast-tracking really is.

I can't believe you don't understand the need for such a process. It began with AIDS activists who realized the bureaucracy of the FDA was set up in such a way that drugs for which there was already a need met were taking precedence over anti-virals (meaning that ddi or d4t or crixivan had to sit in the queue behind a new formulation of prozac or proton pump inhibitor) and people were DYING while waiting for life-saving drugs to come to market.

[Hannah Bell]

104. no, fast-tracking is not identical to priority review.

Fast-tracking & several components, & f-t designation makes one eligible for priority review.

If you'd read the fda material, you'd know that.

The review for approval, as i said, was based in 4 years of phase 1/2 (preliminary) studies on about 4000 people &4 years of phase 3 studies of about 180000 people who were followed an average of less than 2 years.

Phase 3 trials had not been completed when approval was granted.

[xchrom]

7. kick

[WillYourVoteBCounted]

9. How many lulled into complacency by this unproven claim?

This vaccine has not been proven to prevent cancer.

If you have proof or documentation that it has, please provide it with citations.

In fact, Gardasil has not been tested to see if it may be carcinogenic.

How many are being lulled into a sense of complacency because of the misinformation surrounding this vaccine?

[cosmik debris]

11. Same old talking points over and over and over and over and over and over

You are beginning to sound like a trained parrot.

[Liberal Veteran]

12. The Parrot Anti-Defamation League would like to protest your comparison...

...of a parody of legitimate scientific concern with your highly intelligent parrots.

[cosmik debris]

13. I apologize to parrots every where. mea culpa. n/t

[Name removed]

18. Deleted message

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

[cosmik debris]

19. I can't believe you said that. I just don't believe it. Nobody would be that crass.

That's one of the most sick and disgusting things I have ever read on DU. I hope you have already picked out your tombstone.

[Liberal Veteran]

20. It was a "what fresh hell is this?" moment, when I read that.

[cosmik debris]

21. I hope everyone alerts on that post. I did. n/t

[agent99]

22. whew!

that was my tame joke. it's a good thing i didn't write my REALLY nasty gardasil joke!

hope your boxers get unknotted soon, hombre!

[cosmik debris]

23. Come back some time when you can't stay so long. n/t

[varkam]

31. I think you messed something up, though:

jokes are supposed to be funny.

[xchrom]

26. kick

[Name removed]

35. Deleted message

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

[semillama]

37. What's your favorite frozen pizza?

Inquiring minds want to know.

[cosmik debris]

38. I heard Skinner has a vending machine full of frozen pizzas!

[Name removed]

39. Deleted message

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

[xchrom]

78. kick

[mhatrw]

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

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

[cosmik debris]

84. How many is enough?

[Hannah Bell]

86. is what she says true, or false?

if it's true, i'd think it's important for people to know.

if it's false, better to demonstrate that than attack the poster.

[cosmik debris]

87. How many time does it need to be said?

Remember the boy who cried wolf?

Even if it was true, It has been presented in a manner that is unlikely to convince anyone because the contempt and belligerence is so transparent.

If the goal is to inform, wouldn't it have been better to do so with out all the spite and animosity?

The Anti-merck posters have poisoned their own argument by making it an emotional matter rather than an intellectual matter.

Screaming WOLF! WOLF! WOLF! over and over is not the way to communicate a rational position.

And apparently they believe that they need to cry "wolf" even more. If it failed 15 times, try 20 times. Go figure?

[Hannah Bell]

88. so if thAt's the cAse, why do you jump into every threAd with spite &

Animosity? this is the source of the seriAl posting.

[cosmik debris]

89. How many times does it need to be said.

I know you believe Merck is evil.

How many more times do you need to say that? What do you hope to accomplish?

What is your goal?

How do belligerent tactics contribute to that goal?

How is that working out for you?

[mhatrw]

91. I don't think Merck is any more evil than the average huge corporation driven by the profit motive.

It's just that Merck pretends it puts the health of girls first in ads that run on TV 24/7.

I am morally compelled to try to get the other side of story out so that parents can make informed decisions knowing all the facts, both pro and con.
\
Why do you do fervently wish to censor me? Why can't you simply ignore me?

[cosmik debris]

92. Now I see! You are a Moral Crusader!

"I am morally compelled to try to get the other side of story out..."

A moral crusade to bring everybody in to line with your way of thinking.

Boy, does that sound familiar. Where have I heard that before? I think you know.

Well, at least now I know that your goal is to force your morals on everybody else in the world.

So let's move on to the second question. How do belligerent tactics and rude, mean, hateful, comments further the cause of forcing your morals on the rest of the world? What do you expect to gain by that? Is pissing off a lot as people supposed to help?

[mhatrw]

95. If you love Big Pharma, anyone trying to help people make informed

medical decisions is evil.

[cosmik debris]

98. And if you hate big pharma with your passion

Any company trying to return dividends to the shareholders is evil incorporated.

So how do you see your moral crusade ending? Do you expect to save the world or just the DU health forum?

Have you made any converts, or have you just pissed off a lot of people?

[LeftishBrit]

100. The VERY NEXT TIME that anyone calls supporters of access to Gardasil (or any other medication)...

'lovers of Big Pharma', I shall be very tempted to call them 'lovers of cost-cutting insurance companies'!

Yes, it would be unfair no doubt. But so is the other.

More people have suffered and died - in the USA, in the UK, and most of all in developing countries - from being DENIED access to expensive medications, than from having medications pushed on them. Yes, quite a big part of this is Pharma's fault for making and keeping the medications so expensive in the first place, and I certainly don't love Big Pharma!

But too many people on this board ONLY attack Pharma for 'pushing' treatments of which they *don't* approve, and spend far less time on the problem of people's *lack of access* to medication - and this often leads to minimizing the diseases for which the treatments and vaccines are intended (But cervical cancer ONLY kills a few hundred more Americans each year than were killed on 9-11 - and lots more of course in developing countries. But cervical cancer shouldn't be taken too seriously - after all more women die in car accidents, so that means that we can afford to economize on these patients. After all, two-thirds of cervical cancer patients do survive - even if they have permanent side-effects and are usually left infertile - so that makes it a trivial disease!) And this is in a sense giving aid and comfort to governments and insurance companies who cut costs by denying patients access optimal treatment - a very important part of the 'profits before patients' equation.

And if you think what I've just said is an unfair characterization of the anti-Gardasil posters - well, I'm only giving them a tiny, almost *homeopathic* dose of their own medicine!

[LeftishBrit]

93. Why is arguing with you 'fervently wishing to censor you'?

Are you then, by the same token, 'fervently wishing to censor' the pro-Gardasil people?

[cosmik debris]

94. She is "morally compelled" to shout down all opposition.

She has un-masked what we all knew was true. This is a moral compulsion to force everyone to listen and agree.

That means that it will not end until Merck is bankrupt and the whole world shares her obsession with little girl's private parts.

[mhatrw]

97. I am speaking out in an effort to get both sides

of the story out so that people can make fully informed medical decisions.

This can be spun as a negative only by one who is an enemy to free and open discussion.

[cosmik debris]

99. So how long do you have to keep repeating the same message?

Do you honestly believe that there are people on this board who are not aware of your position?

You have gone way beyond saturating the market.

Now you are just like the Head-On commercials, obnoxious, pointless, and peddling a bogus product.

[mhatrw]

102. I believe there are people on this board who refuse to logically consider my data.

You serve as a prime example.

[cosmik debris]

105. Do you think you can change my mind just by being obnoxious?

The point I've been trying to make is that your tactics are self-defeating. If you want to change my mind about Gardasil or Merck, the first thing you have to do is be polite to me. That hasn't happened yet.

I don't know who your target audience is, but I doubt that they are convinced by rudeness either.

So if you want your me to logically consider your data, stop being an ass.

[mhatrw]

96. You have not been trying to censor me.

You have been discussing the issues at head in good faith as far as I can tell. Thank you.

[beam me up scottie]

90. You're responsible for proving your claim "a vaccine that does 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

[xchrom]

106. kick