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View Full Version : When a shot in the arm's no silver bullet



Momtezuma Tuatara
12-03-09, 12:21 PM
http://www.nzherald.co.nz/opinion/news/article.cfm?c_id=466&objectid=10559401 (http://www.nzherald.co.nz/opinion/news/article.cfm?c_id=466&objectid=10559401)

Tapu Misa: When a shot in the arm's no silver bullet

4:00AM Monday Mar 02, 2009
By Tapu Misa (http://www.nzherald.co.nz/opinion/news/%20/tapu-misa/news/headlines.cfm?a_id=11)

The TV advertising campaign for the "anti-cancer vaccine" Gardasil makes it look like a no-brainer. "It's your choice," the ads say about the vaccine that's now being offered free in our schools to girls aged from 12 to 18. But it sounds more like no choice. What caring parent wouldn't choose to vaccinate her daughter from a potentially deadly cancer when three shots are "all it takes to protect her from cervical cancer".

You'd have to be a pretty bad mother not to encourage your daughter to get vaccinated.

There's no doubting the persuasive power of the marketing campaign that was launched here in early 2007, not long after Medsafe had approved Gardasil's use in New Zealand.

In the US, a slick advertising campaign funded by Merck, Gardasil's maker, was unleashed on American mothers and teenage girls even before the FDA had fast-tracked its approval of the vaccine. The ads stressed the link between the common virus, HPV, and cervical cancer - exaggerating the threat of girls getting what the National Institute of Health refers to as "a rare disease". Award-winning TV ads since then have made vaccination seem like the latest must-have accessory no American girl can live without.

And maybe it is. Information put out by the Ministry of Health says Gardasil is safe, that it protects against 70 per cent of cervical cancers, and that it's been licensed for use in over 100 countries around the world including Australia, the US, Canada and the UK.

It's also very expensive. The immunisation programme announced by the previous Government - two months before the last election - was costed at $177 million over the next five years, with an ongoing price tag of $16 million a year.

To say that this money might be better spent elsewhere - say, in treating actual cancers and other diseases - would seem heartless when estimates put the number of lives saved at around 30 a year.

But as women's health advocate Lynda Williams has pointed out, it will take 20 years before we know for sure if Gardasil is the life-saving "anti-cancer vaccine" it's been hyped up to be, because it takes around 15 years for cervical cancer to develop - and the trials weren't long enough to tell us that. There's no guarantee, either, that the vaccine will provide immunity for longer than five years, which means expensive booster shots may be needed.

Certainly, the vaccine has already been a lifesaver for Merck, which needed an infusion after it was forced to withdraw its anti-arthritis drug Vioxx from the market. Merck now faces 11,500 lawsuits after Vioxx - which had also been fast-tracked by the FDA - was found to increase the risk of heart attacks and strokes.
A cynic might see a link between this and the drug company's aggressive lobbying to make Gardasil mandatory for girls in the US. The New York Times reported last year that 24 states had put forward proposals requiring the vaccine for girls in middle school. Vaccination is now a requirement of school entry in Virginia, but a similar move was overturned by the Texas legislature after it was found that Merck had hired the Texas governor's chief of staff as a lobbyist, and made financial contributions to the governor.

As a 2007 article in the Wall Street Journal observed: "Mandatory vaccination across the US would make an automatic blockbuster for Merck at a time when the patents on some of its bestselling drugs are expiring and it's desperate to replace their revenue streams."

The HPV virus that causes 99 per cent of cervical cancers is transmitted through sexual contact. The vast majority of sexually active women can expect to be infected by HPV at some time in their lives, but most of these infections clear up on their own. Only a small proportion will lead to cancer. Trials show that Gardasil is effective against the two types of HPV that cause up to 70 per cent of all cervical cancers.

But as an August 2008 editorial in the New England Journal of Medicine points out, there are reasons for caution. "The bad news is that the overall effect of the vaccines on cervical cancer remains unknown ... the real impact of HPV vaccination ... will not be observable for decades." In other words, just because Gardasil has been shown to be highly successful in preventing pre-cancerous lesions caused by HPV doesn't mean that the vaccine will ultimately prevent cervical cancer and death.

Indeed, a number of "critical questions remained unanswered". For instance, since most HPV infections are easily cleared by the immune system, how would vaccination affect natural immunity against HPV, and with what implications? How long would protection last? How would the vaccine affect pre-adolescent girls, given that the clinical studies didn't include girls under 16?

And might the suppression of HPV16 and HPV18, the two types of HPV targeted by Gardasil, make room for other cancer-causing strains to emerge in their place? Published reports of trials suggest just such a trend.

There've been safety concerns, too - claims that Gardasil has caused serious illness and even death - although no causal link has been proven.

Of concern, too, is the effect mass vaccination will have on what is still the most effective weapon against cervical cancer: prevention, not through a vaccine, which may head off only 70 per cent of cancers, but through regular cervical smears with a proven 90 per cent success rate.

Gardasil doesn't do away with the need for the smears, and it doesn't protect for life. But the false sense of security it gives girls may well cost them their lives.
* Tapu.Misa@gmail.com (tapu.misa@gmail.com)

Momtezuma Tuatara
12-03-09, 12:22 PM
http://www.nzherald.co.nz/opinion/news/article.cfm?c_id=466&objectid=10560820 (http://www.nzherald.co.nz/opinion/news/article.cfm?c_id=466&objectid=10560820)

Mike Taylor: Preventing deaths is a clear measure of a vaccine's success

4:00AM Tuesday Mar 10, 2009

I am writing in response to the column by Tapu Misa (Herald, March 2). In it she raised a number of questions regarding HPV vaccination (Gardasil) that have been discussed for many years and were well considered in the registration and reimbursement of Gardasil here in New Zealand. Tapu Misa: When a shot in the arm's no silver bullet (http://www.nzherald.co.nz/opinion/news/article.cfm?c_id=466&objectid=10559401)

Gardasil works by helping the body develop protection against the human papillomavirus (HPV) types 6, 11, 16 and 18. These four HPV types account for the majority of cervical cancer cases and a large number of cervical abnormalities.

An in-depth health economic evaluation has been completed on Gardasil here in New Zealand and overseas. Gardasil has been shown to be extremely cost-effective due to the large reduction in HPV-related cervical abnormalities that no longer require extensive follow-up and treatment as well as deaths that are prevented.

It is well understood that Gardasil does not protect against every type of HPV and that regular cervical smears will still be required.

Gardasil has undergone extensive clinical trials including appropriate evaluation in girls aged 9-15 years. More than five years of follow-up data has now been gathered from over 20,000 women in 33 countries including New Zealand.

Ongoing follow-up of 5400 of these women will continue for at least a further 10 years.
Clinical data shows the vaccine remains 100 per cent effective against preventing pre-cancerous lesions from all four HPV types in the vaccine with no evidence of breakthrough of disease. In addition Gardasil has demonstrated immune memory which is a true hallmark of long-term protection.

This means that the body has stored the memory of the vaccine's HPV types so if a woman is exposed to infection the body will automatically produce antibodies to prevent it.

It is not ethical to use cancer as a clinical trial endpoint and it is well recognised that pre-cancers are exactly that, pre-cancers that lead to cancer. By reducing pre-cancers you reduce cancer.

Independent scientists and international medicines safety authorities in over 100 countries have shown that Gardasil is safe and effective.

The most common reactions to Gardasil, as with all vaccines, include soreness, redness and swelling at the injection site, (approximately 90 per cent of all adverse events). Nausea, light-headedness and slightly raised temperature are also relatively common. Any adverse events are followed up in accordance with regulatory guidelines and carefully evaluated, which is the case with all of our medicines and vaccines.

Gardasil is considered a breakthrough in the prevention of cervical cancer and as a result has recently been awarded the 2008 International Galien Prize (pharmaceutical equivalent of a Nobel Prize) by an independent jury of clinicians, toxicologists and pharmacologists.

* Mike Taylor is country manager of CSL Biotherapies NZ, which supplies the vaccine to New Zealand health authorities.

Momtezuma Tuatara
12-03-09, 12:23 PM
My response, not published:

Dear Sir,

It is astonishing that the New Zealand manager of CSL, in replying to Tapu Misa, should cough up so many inaccuracies. Amongst the many, are these two:

1) “clinical data shows the vaccine remains 100% effective against preventing pre-cancerous lesions from all four HPV types in the vaccine, with no evidence of breakthrough disease.”

Notwithstanding this astonishing phrase (effective against preventing pre-cancerous lesions) how could he state that all four HPV types cause cancer, when only two of those types have been found in cervical cancer lesions? Has he not read his own vaccine insert? And is five years long enough to provide evidence of breakthrough disease, when cervical cancer takes sometimes 30+ years to develop?

2) “it is well recognised that pre-cancers are exactly that, pre-cancers that lead to cancer.”

On the contrary, many medical articles comment on surprisingly high “spontaneous reversion” statistics in supposed pre-cancers seen in swabs CIN I to CIN III. Is Mike Taylor attempting to credit the vaccine with eliminating many cancers which medical literature shows might never have become cancer anyway?

You would think that the manager of CSL would be prepared to convey basic information accurately. Given that he has not, we all have the right to ask what else in his infomercial is similarly misleading.