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A new vaccine provides 100-per-cent protection against two types of a virus that causes cervical cancer, researchers reported Friday in the medical journal The Lancet.

The vaccine could prevent up to 70 per cent of cervical cancers worldwide, says the scientific team, which included researchers from Toronto's Sunnybrook and Women's College Health Sciences Centre and Montreal's McGill University.

The vaccine triggers the immune system to respond against two subtypes of the human papillomavirus, or HPV, which cause about two-thirds of cervical cancers.

The virus is extremely common: the average person faces an 85- to 90-per-cent chance of being infected with HPV at some point during her lifetime.

It's primarily spread through sexual contact, passing through skin or mucous membranes. Even condoms offer no protection, as the viruses are so tiny they easily pass through them.

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In theory, the death rate from cervical cancer in Canada should be zero, since every woman in this country has the right to a free annual Pap smear, which should detect pre-cancerous changes at a point where treatment is minimally invasive.

In fact: eleven years ago, an old friend of ours died of cervical cancer at the age of fifty-three. A talented, meta-educated workaholic, she had not had a Pap smear in ... ten years.

I don't know what the death rate from cervical cancer, a disease that is 100 per cent curable if caught early, is in the U.S., but I believe that it is much higher there than in Canada, simply because the annual Pap smear is guaranteed there only to women who have medical insurance.

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Though HPV is highly contagious, Dr. Lefebvre says most people's immune systems will fight off the virus without these people ever knowing they were infected. However, last year alone, 400,000 Canadian women had abnormal (precancerous) cervical cells, 14,000 were diagnosed with cervical cancer and 400 women died from cervical cancer. "That's one woman a day who dies in Canada from cervical cancer," says Dr. Lefebvre, adding that 99.7 per cent of all cervical cancers are caused by HPV. Cervical cancer is the number one killer of women in developing countries and develops 10 to 15 years after the initial viral infection....

The Merck vaccine is administered in three doses over a six-month period at approximately $135 per dose, totalling $405. Though it will be available through family physicians by autumn 2006, provincial funding for the vaccine has not yet been determined, placing the onus on the individual or parent to cover the costs. - Source

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Here's a question: in order to save 280 lives annually, should this vaccine be funded by medicare, at $405 per woman?

One feminist in the U.S. says no.

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Governor Rick Perry’s decision to sidestep the Texas legislature and issue an executive order mandating that girls entering the 6th grade receive the new HPV vaccine raises troubling questions about the influence pharmaceutical companies wield on the crafting of public health policy. Cervical cancer is only expected to cause 3670 deaths in the US in 2007, a miniscule percentage (less than 2%) of the 270,000 deaths from the disease worldwide and only 1% of the total annual number of deaths from all cancers in the United States.

While cervical cancer used to be one of the deadliest diseases for women in the US, the number of deaths it causes has dropped dramatically (by 74% from 1955-1992) and it continues to drop). Why then are so many states considering mandating a vaccine that costs $300-$500 per patient for a type of cancer that is already largely under control in this country and which can be almost entirely prevented by regular gynecological checkups and Pap smears?
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It is important to note that low income women and women who do not have health insurance are most at risk because they are less likely to get regular Pap smears. More than half of the diagnosed cases of cervical cancer are in women who have not had a Pap smear in three years. While Gov. Perry has mandated that the state of Texas foot the bill for those who can’t afford the expensive HPV vaccine, it is unclear where those funds would come from either in Texas or in other states that are considering making the vaccine mandatory. And obviously the cost of the vaccine makes it prohibitive in the countries where it is most needed and would potentially do the most good.

What is clear is that Merck has a substantial financial interest in the vaccine becoming mandatory even though the added benefit to public health is both minimal and costly. With more than 10 million girls in the US between the ages of 10-14, the drug company stands to make billions of dollars preventing a disease that is already treatable in the targeted population. Since the vaccine does not eliminate the need for regular Pap smears, it would appear that a far more appropriate and cost effective first step would be to make regular gynecological healthcare available for all women regardless of income and medical insurance, particularly since this step by itself would go a long way in reducing the few cases of cervical cancer that still occur in this country.

There is however another significant public health concern in regards to the HPV vaccine, namely that it is a very new drug with no history. We are of course being told that it is perfectly safe and has few side effects, but we were also told that about Thalidomide, DES and Hormone Replacement Therapy.

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[ 11 February 2007: Message edited by: M. Spector ]

Yes, as it is not only saving lives but families, and perhaps even single mothers.

Moreover, the stats presented do not tell the full tale of those who have had to have their cervixes removed, but do not die, and perhaps even having to have ovaries removed because of this virus. Effectively, ending child bearing potential and putting women at risk for subsequent health problems from a lack of ovaries/hormones.

However, I would not personally advocate use, until it has a longer history. Well maybe not after second thought, I used the anti-viral for shingles/chicken pox, and it works so well, that it over road any other health risks that may be associated.

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So far, Gardasil is approved just for girls. They can be vaccinated when they are as young as 9, although it’s recommended for 11- and 12-year-olds, before they are sexually active.

As the commercials show, the pitch to Gardasil Girl’s parents doesn’t need to address sex: it’s about protecting their daughter from a cancer.

By 2009, the vaccine could be approved for boys as well. Although Gardasil also protects against genital warts, which are not life-threatening, the primary reason to extend approval to boys would be to slow the rates of cervical cancer. Public health folks charmlessly call this “herd immunity.”

Will parents of sons consent to a three-shot regimen that has been marketed as benefiting girls? How do you pitch that to Gardasil Boy’s parents?

Think altruism. Responsibility. Chivalry, even? Oh, and yes: some explicit details about genital warts and sexual transmission.

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Originally posted by Michelle:
Now they want to start giving it to boys.

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As they should.

From the same article:

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“You don’t want to say it’s just the girls’ problem,” Mrs. Cattell said hesitantly. “But my sons won’t contract cervical cancer. And genital warts are treatable. I’m very skeptical. What risks will I expose them to?”

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What risks? I wish people would read the research instead of BS put out by sex-hating right wing nutters. It is very thorough and they followed people for many years. That research showed the rate of adverse events was the exact same in the control group as in the vaccination group. Meaning your risk of an adverse event is the exact same if you do get the shot as if you don't. (Conspiracy groups report that a certain number of girls have developed Gillian Barre after receiving the HPV vaccination. Sounds scarey - but they fail to mention that girls who get the HPV vaccination have been developing GBS at the exact same rate (I believe it is 1 - 2 per million per month in that age group) actually slightly lower when I checked the statistics 8 months ago, but within the margin of error, as girls who have not had the shot. So if the vaccination is responsible for GBS among those who get the HPV vaccination, then what the heck is responsible for exact same rate of GBS among those who don't get the shot? Ridiculous)

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Of course, many parents will automatically dismiss Gardasil. They view Big Pharma in general and new vaccines in particular with suspicion. Barbara Goodstein, a Manhattan insurance executive, who has a daughter, 10, and a son, 12, plans to refuse the vaccine for both. “I wouldn’t give children that young a shot without multiple generations of research,” she said.

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We should be suspicious of big pharma and their motives (however if you read the book "The Truth About the Drug Companies" you will find that the author attacks the drug companies non-stop, except for when it comes to vaccinations where the author praises the few companies still willing to develop new vaccines as they are incredibly expensive to do so, with little long term financial benefit - especially compared to drugs - save and improve far more lives than drugs at far less cost to the public, and involve almost no risk - far less than anything else in the industry, plus it is almost a guarentee that the company will have to deal to large scale conspiracy attacks from a group of nutters - as vaccinations are the easiest targets - children afterall are being treated for something before they have the illness - and also have to deal with a skeptical public where the gap in between the truth and what the public believes is at its widest - who on the one hand talk about the expense of medical care and the need for more preventative medicine to reduce costs and illnesses at the same time attack the best example ever of preventative medicine.), but requiring multiple generations of research for vaccination means that the person has zero understanding of how a vaccine works. Adverse events to vaccinations are both extremely rare and early in onset. Refusal to get yourself or your children vaccinated is due to ignorance and selfishness (the one exception might be the flu shot which doesn't cause harm, but might not do a lot of good) - and I say that as someone who spent years fighting against vaccinations (which were required for my job) and was 100% wrong. I had piles of "research" which I had taken from the internet that confirmed by beliefs that they were harmful. But when I actually decided to understand what vaccinations were and check the sources of the my internet research it crumbled like a house of cards. Quite frankly they were completely full of *&it - and not just some of them - all of them.

[ 26 February 2008: Message edited by: Trevormkidd ]

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Since the vaccine does not eliminate the need for regular Pap smears, it would appear that a far more appropriate and cost effective first step would be to make regular gynecological healthcare available for all women regardless of income and medical insurance, particularly since this step by itself would go a long way in reducing the few cases of cervical cancer that still occur in this country.

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Why do we throw billions of dollars at Merck to protect virgins (of both sexes) from some cancers instead of improving preventative and diagnostic services for everyone?
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ETA: Interesting article about vaccination myths.

[ 26 February 2008: Message edited by: M. Spector ]

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Originally posted by M. Spector:
The logic of that seems pretty compelling to me.

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I support all diagnostic and preventative screening being free to all Canadians.

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Why do we throw billions of dollars at Merck to protect virgins (of both sexes) from some cancers

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Why do we teach sex education to virgins? There are about 1450 new cases of cervical cancer each year, and about 400 deaths. I would assume that each of those cases of cervical cancer costs a lot to treat, not to mention the personal and family distress and suffering. Everyone getting pap smears would reduce those numbers (I don't know if there is a cost involved in Canada), but according to Canadian Medical Association Journal the percentage of Canadian women who have never had a pap smear and who don't get regular pap smears has remained constant for the last 25 years (I can't remember the percentages).

Secondly, vaccinations will save far more lives in impoverished areas of the world than other methods might. Vaccinations are always made available there at significantly reduced costs (sometimes free) assuming that the company will be able to recoup its enormous development costs in the first world.

Furthermore, I wouldn't be so certain that Merck is making a mint off this vaccination. Both the book I mentioned above (which was about as anti-drug industry as you can get) as well as the Canadian Medical Association and American Medical Association have for several years been sounding the alarm that unlike drug development which is almost guarenteed to bring astronomical amounts of profits, vaccine development is far more costly and in most cases is lucky to break even. Most drug companies used to develop new vaccines and continue to produce standard ones anyways because it with good PR - polio eradication etc. However now with most people in the first world growing up unaware of the devastating effects of the diseases which vaccines now protect us from that positive PR is gone and most no longer bother to waste their time and resources on products which are not highly profitable - meaning vaccinations. If my memory serves me right the number of drug companies involved in human vaccinations (not counting the flu shot) has fallen from 28 to 5 or 6 in the last 20 years (at the same time the number of companies involved in livestock vaccinations has increased significantly) and there is worry that if any more companies stop producing vaccinations then there will be shortages of standard vaccinations in the first world (there already is in the third world and that shortage is growing).

From the Canadian Medical Association Journal regarding the HPV vaccination, and vaccinations in general.

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While there is guarded optimism about the potential long-term benefit of the 2 new HPV vaccines, there is growing concern that vaccine development efforts may be mothballed in favour of more profitable pharmaceutical products. The high cost of vaccine development and limited markets, coupled with some people's vaccine angst, have conspired to make vaccine development unattractive, especially in comparison to "lifestyle" drugs, such as sildenafil — a surefire money-maker because of its widespread, regular use. Given the magnitude of investment, only a handful of large companies remain committed to vaccine research and development. Yet, as exemplified by the polio saga, vaccines can be remarkably efficacious in preventing diseases and demonstrably diminishing human suffering.

HPV vaccines hold a similar promise. However, they will need a helping hand. Cervical cancer has a predilection for the impoverished and disenfranchised in developed and developing countries. In the Western world, vaccination and cervical cancer screening programs for high-risk individuals, such as Aboriginal youth, street youth and people living in poverty-stricken areas, present significant barriers to eradicating cervical cancer. Worldwide, over 80% of cervical cancer deaths occur in developing countries, where 470 000 cases are confirmed annually (approximating half the number of new cases of breast cancer).2

Developing countries must not be left behind.

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I have read the article in the Skeptical Inquirer when it came out and I think it is very well done. Skeptic magazine also had articles on vaccinations in their issue which came out around the same time (I am not sure if they are available online).

But both are correct, the more evidence that piled up showing the ridiculousness of a link between autism and vaccinations the more loud and hysterical the conspiracy theorists have become. It appears to me that Robert F. Kennedy Jr. has basically ruined his position of being a voice for the environment through being duped by those conspiracy theorists. Any interview that I have seen him in for the past 6+ months the legitimate message that he is trying to present about the state of the environment is drowned out and dismissed due to position on autism and vaccinations. That is very sad, but it only seems fair. Why should people trust him to speak openly on the environment, when he accepted without question and then became a spokesperson for the ridiculous claims (involving no evidence - and indeed dismissing all evidence) of a link between the two.

[ 26 February 2008: Message edited by: Trevormkidd ]

I doubt very much that Merck will fail to cover their development and production costs many times over.

A comment in the CMAJ sounded a cautionary note that I think is being ignored by governments:

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General recommendations for the development of a mass vaccination program against human papillomavirus (HPV) infection:

• Governments should begin immediately to educate the public about the realities of cervical cancer, HPV infection and HPV vaccinations, emphasizing the importance of healthy personal and sexual behaviour practices, good nutrition, smoking cessation, and regular Papanicolaou tests and screening for sexually transmitted infections

• Federal, provincial and territorial policies on reproductive health care should be reviewed to assess the place of any vaccination program within existing services for the prevention and management of cervical cancer

• The goals of any potential mass vaccination program need to be defined to ensure that the most effective and safest vaccine is used in the appropriate populations to meet these goals

• Governments must support unbiased research, free from any conflict of interest, to collect the data now missing but essential for evidence-based policy and health care decision-making. This research needs to include studies that assess the potential impact of vaccination on safer sex practices, on access to reproductive health services and on possible lost-opportunity costs.

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[ 26 February 2008: Message edited by: M. Spector ]

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To Victoria drug policy researcher Alan Cassels, the British Columbia government's announcement of funding for the vaccine sounded more like pharmaceutical marketing than sober public health policy. The announcement made claims that are yet to be proven, said Cassels, the author of two books on drug marketing, including The ABCs of Disease Mongering.

The headline read, "New Vaccine Program to Protect Girls Against Cancer" and Health Minister George Abbott called it "an opportunity to vaccinate against the vast majority of cervical cancers in women." He added, "We want parents and students to know that this vaccine protects girls and women from cancer."

The thing is, said Cassels, while it takes decades to develop cervical cancer, the trials for Gardasil were held over just two or three years. It's too soon to say if the vaccine actually prevents cancer, he said. "There were no cancers prevented in any of the clinical trials. I can say that with a certain amount of confidence."

He compared using the vaccine to taking a cholesterol-lowering drug. For most people taking such a drug, the important thing is whether or not it prevents heart attacks and strokes, not whether it lowers their cholesterol. "I think that's the same question we need to be asking about the vaccine . . . . It's still not a slam dunk in terms of what you're really doing it for."

The outstanding questions do bring B.C.'s motives into question, he said. "If you're going to say point blank, 'this vaccine prevents cancer,' you're misleading the public," said Cassels, who has an 11-year-old daughter who he will discourage from taking the vaccine. "Why would you do that? The headline, it's like a slogan. Why would public health officials be repeating a slogan that isn't true?"

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As for Gardasil, the NEJM study concluded that while the cost benefit of vaccinating twelve-year old girls falls within accepted guidelines for wealthy countries, the cost benefit declines rapidly as age increases. This finding is a major blow to Merck's efforts to promote intensive "catch up" vaccinations of girls and women who are over the age targeted by schools and proposed mandates. The benefit drops dramatically by the time women reach the maximum approved vaccination age of 26. In the even higher age range of 27 to 45 for which Merck is seeking additional approval, the calculated cost benefit is far outside the accepted range.

This information might seem to suggest that it is all the more important to vaccinate girls at the youngest age possible. Merck's Dr. Richard Haupt told the New York Times that the NEJM study "underscores the value of vaccinating pre-adolescent girls." But there is a big hitch. The NEJM study states clearly that its cost-benefit ratios are based on an assumption that the vaccine provides lifetime immunity to HPV. There is no evidence that this is actually the case. In fact, a number of indicators suggest one or more boosters will be needed during the recipients' lifetimes.

Even in the best-case scenario, HPV vaccines would only prevent 70% of cervical cancer cases, which means that regular and consistent screening, such as tried and true Pap smears, will remain critical for women's protection against cervical cancer. This means that the significant costs of the three shot initial Gardasil vaccination series (with a price tag of $450-$1,000, not including a possible booster) will be in addition to the existing costs of screening.

The NEJM article spelled out the bottom line: "If vaccine-induced immunity lasted only ten years, the vaccination of preadolescent girls provide only 2% marginal improvement in the reduction of the risk of cervical cancer as compared with screening alone." Experts closely involved in drug trials for both Cervarix and Gardasil, such as Dr. Diane Harper, feel that immunity is likely to decline after as few as five years.

On August 21, 2008 the New York Times published an article titled "Researchers Question Wide Use of HPV Vaccines," which quoted extensively from the NEJM. The Times article emphasized a key point: Since cervical cancer grows slowly (often a decade from infection to full-blown cancer), there is no hard evidence yet that an HPV vaccine will actually lower the rate of cervical cancer. The vaccines can prevent some HPV infections that may lead eventually to cervical cancer if not diagnosed and treated. However, the tests have not lasted long enough yet to say definitively that the result will actually translate into a real decrease in cervical cancer. Evidence of real benefit therefore won't be available until enough years have passed that girls who receive the vaccine can be compaired against those who don't as they pass into adulthood and beyond.

That is quite a bombshell, and certainly a different message than Merck's marketing blitz has encouraged the public to embrace. Merck and its supporters would have you believe that time is of the essence and that society must move quickly to ensure that every young girl gets vaccinated. The main beneficiary of this hurry-up approach is Merck, not women and girls….

Merck is also eager to get Gardasil approved for vaccinating boys. Why limit your potential market to just half of the population when you can ultimately target everyone? This may be a harder sell than they expect, but I would be surprised if they don't give it their best shot. HPV is implicated in some cases of penile and anal cancer, but neither is widespread in the United States. According to the National Cancer Institute, there are 6,320 cases of these types of cancer per year in the U.S., causing 970 deaths. These numbers do not suggest that the vaccine's benefit to male health is much of a selling point. Merck may try to sell men on the idea of getting vaccinated to avoid passing HPV on to their sexual partners, but altruism can be a tough sell, especially when it involves a painful series of shots and a high price tag. Only time will tell if Merck can successfully finesse the marketing….

There is no doubt that the development of an HPV vaccine could have and should have been cause for celebration -- advances in women's health care are truly few and far between. However, Merck's own overly aggressive PR campaign, its deceit in pushing for mandates through a non-profit front, and its willingness to over-hype its product has made it impossible for many of us to willingly embracing their so-called "vaccine against cancer."…

The debate over Gardasil in Canada provides an interesting comparison to the debate in the United States. I was one of three guests on the Canadian Broadcasting Company's Sunday Edition program on September 7, 2008. Since Canada has a national health system, there are some differences in how this has played out, but there are also many similarities. One that is very reminiscent of the case in Texas in 2007, the federal Canadian government approval CA$300 million for provinces to access in order to implement mass HPV vaccination programs. What came out soon after was that only one short month before Stephen Harper's government put this plan into place, one of his former senior advisors has registered as a lobbyist for Merck. To make it even more questionable, the federal government put a time limit on how long the pool of money was available. In year one, three provinces bought in. In this, the second and last year of the offer, three more joined their ranks, but not without heated debate. – Judith Siers-Poisson

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