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Cancer vaccine for girls suffers new delay

Cancer vaccine for girls suffers new delay

Published: 22 Sep 2011 11:13 GMT+02:00
Updated: 22 Sep 2011 11:13 GMT+02:00

A vaccination programme to combat cervical cancer has suffered further delays after GlaxoSmithKline appealed a deal agreed between Swedish health authorities and a rival firm.

The Swedish Association of Local Authorities and Regions (SALAR) recently announced that a purchase agreement had been signed with Sabofi Pasteur MSD for the procurement of its product Gardasil.

The agreement meant that the vaccine, already substantially delayed, could be offered from October.

But following an appeal by pharmaceutical giant GlaxoSmithKline the delays are set to continue and thousands of young Swedish females will remain at risk from cervical cancer, according to the National Board of Health and Welfare (Socialstyrelsen).

GlaxoSmithKline has argued that their vaccine Cervarix provides better protection that Gardasil. SALAR is furthermore accused of having breached procurement legislation by ignoring its own criteria.

"We have got ourselves in a very unfortunate situation," said Anders Tegnell at the health and welfare board.

"We are starting to get close to the line where there are girls who don't have time to get protection before their get the infection and thus run a slightly heightened risk of getting cancer."

When the decision was taken to incorporate the vaccine into the general vaccination programme offered by the public health service, the health and welfare board estimated that 100 lives would be saved per annum.

This is the second time that the procurement process has been appealed. Last time the purchase agreement was won by Cervarix, and it was then MSD's turn to appeal.

Anders Tegnell fears that there is a risk that the pharmaceutical companies will continue to appeal incessantly.

"It seems that in theory they could continue as long as they like."

"The losers are the public," said Göran Stiernstedt at SALAR.

Stiernstedt is critical to procurement legislation and concluded that it is completely without risk for all parties to appeal.

"I think the risk is relatively small that we lose this time. There are few procurement processes which are as scrutinised legally as this one. And we naturally won't make the same mistake again."

The deal which the vaccine manufacturers are fighting over concerns healthcare worth between 250 and 300 million kronor ($44 million).

This is the amount that the counties, according to the agreement, will pay for the vaccination over the coming four years, which is the duration of the agreement.

The sum is not particularly considerable in the context of the pharmaceutical industry.

But according to Bo Claesson at SALAR, a reason for the legal battle in Sweden could be that it is part of a larger game - played out in front of an international audience.

"Sweden has quite a good reputation and several countries look at what we choose and what we pay. Primarily countries are interested in how we value the condyloma protection afforded by the vaccine which won the contract."

The National Association for Sexuality Education (RFSU) have reacted to GlaxoSmithKline's decision to appeal the contract.

"It's time to start vaccinations now. It is a serious disease which in the worst cases can be fatal. It is cynical to let the girls wait for a vaccine that can actually save lives," said secretary-general Åsa Regnér.

She says that the delay has already led to a situation whereby girls with parents prepared to pay have already been vaccinated, while others have not.

The decision to vaccinate all girls born 1999 and later was taken by the board of heath and welfare in 2008. The responsibility for the vaccination was delegated to the counties.

According to the plan the vaccine is to be given to girls in grades five and six, when they are eleven or twelve.

Furthermore SALAR would like for further age groups to be included, those born between 1993 and 1999 and who would have got the vaccine had the programme not been delayed several years.

Cervical cancer afflicts relatively young women. The average age of sufferers in Sweden is around 55-years-old, but a quarter are younger than 40.

Around 450 women are diagnosed with cervical cancer each year in Sweden. This is around half compared to the 1960s, with the decline attributed to the regular check-ups offered all women aged between 23 and 60.

Despite the gynaecological examinations around 200 women die each year from the illness.

The county health authorities hope that a general vaccination programme to combat the human papillomavirus (HPV) with halve this number.

TT/The Local/pvs (news@thelocal.se)

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12:24 September 22, 2011 by JannySt
16 September 2011, in response to an inquiry about SANE Vax's recent discovery of genetically engineered HPV DNA in Gardasil™[i], the following announcement was broadcast on Tipp.fm radio out of Clonmel, County Tipperary, Ireland:

"The IMB (Irish Medicines Board) and European Medicines Agency (EMA) are aware of the recent communication from Sane Vax and following on from this, the EMA requested the marketing authorisation holder conduct an immediate assessment of the risk of contamination.

The IMB, through its participation in EU Scientific Committees is contributing to the ongoing EU assessment of this issue and will continue to do so at further EU meetings scheduled over the coming week. Any updates on the outcome of these discussions and any recommendations will be highlighted, as appropriate. At present, the balance of risks and benefits for the vaccine remains positive.

The Gardasil vaccine has been licensed for use in the EU since 2006. The IMB together with the EMA continue to monitor the benefit-risk profile of Gardasil."

This is particularly good news for medical consumers in the 27 countries belonging to the European Union (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom). An 'immediate risk assessment' should mean the marketing authorisation holder must now:

* Determine the extent of the contamination

* Determine any potential health risk that could result from HPV rDNA attached to aluminium adjuvant being injected into the human body

The critical issue here is not that the vaccine has residual DNA in it, but that the contaminating HPV DNA is genetically modified and firmly attached to the aluminium adjuvant - making it an unknown quantity as far as potential health risks.

Is recombinant (genetically engineered) HPV DNA, or adventitious DNA, capable of altering human DNA potentially initiating cancer, or a host of autoimmune disorders?

The manufacturer of Gardasil™, Merck, went to great lengths to assure government health authorities around the world there was no viral DNA in the vaccine.[ii] [iii] Merck repeatedly told health authorities that this vaccine only contained virus-like particles manufactured from the L1 protein - NO HPV DNA. Recognizing the potential health risks of residual DNA, government health officials relied on this assurance when they approved the vaccine for use in their countries.

http://sanevax.org/gardasil-contamination-ema-steps-up-to-the-plate-fda-drops-the-ball/
13:06 September 22, 2011 by Imperor
The way I understand it, the major risk would be if this modified DNA should prompt a mutation in the Virus-DNA, causing a new and more severe disease than the one we're trying to combat!
13:22 September 22, 2011 by Opinionfool
The original report and JannySt's followup make for an interesting juxapositon of issues. GlaxoSmithKline is seemingly only concerned that it has been excluded from a potentially lucrative western European health contract. Where as JannySt is concerned with the potential harmful effects of the vaccine upon the girls who are to injected with it. So which is the morally better opposition to Gardasil?

Of course there is an alternative (I can heard the shrieks of other commenters already) to this vaccine. Abstenance followed by a lifelong monogamous sexual relationship with a partner who has similarly abstained until the start of this same lifelong monogamous sexual relationship. But that is never raised as an alternative to commerically driven multiple sexual partners. And certainly not when GSK's or SANE's profits are concerned.
14:04 September 22, 2011 by Shibumi
If I may be among those to shriek... while it is true that complete abstinence followed by total monogamy would indeed reduce the risk of contracting HPV to nearly zero, you and I and everybody else knows that it is not a realistic solution for the vast majority of today's population. Just because such an option exists does not mean that a medically sound alternative need not be sought and offered to the 95%+ (yes, I made that statistic up) of women who will have more than one (also virgin) sexual partner in their lives, and who would rather not get cervical cancer.
15:19 September 22, 2011 by Opinionfool
I'm well aware that most people won't want to follow the abstinence route but it always gets overlooked and ought to be presented as an option. But at least there is a choice: GSK's vaccine (that may or may not be contaminated), the SAGE vaccine that appears to be contaminated, don't use the vaccine thereby accepting the risk of contracting HPV and possibly developing cervical cancer, or abstinence. Oddly the latter social-derided choice could well be the one with lowest risk of contracting HPV and then suffering the consequences or of getting aluminum poisoning. But, of course, our hedonistic society promotes only the first three choices.

What is perhaps more of a concern for the SAGE vaccine is that not only does it show contamination with HPV rDNA but also to be formulated with aluminum, which is highly toxic when ingested. Samples of rDNA contaminated vaccine have been located across the globe; it isn't just an Irish problem as might be inferred from the press report in JannySt's comment. And all GSK are being portrayed as worrying about is that they have been excluded from getting a share of the cake.

When the vaccine was first distributed in Britain two or three years ago I was working in a 16+ college. All female students were called in turn to receive the vaccine. Some parents objected to their daughter being injected on religious grounds. But eaves-dropping on conversations amongst the students prior to the event it was clear that most were already sexually active and had been for some time. Indeed it wasn't unknown for girls not-yet 16 years of age to enroll pregnant. (At least one of them for the second time.)
15:48 September 22, 2011 by Svensksmith
I, or I should say, my wife had both of our daughters vaccinated...but not without trepidation as expressed by JannySt. Hopefully it was the right decision.
16:24 September 22, 2011 by Opinionfool
Svensksmith that is all we can do when making decisions for our children that may affect their futures, right from the beginning when we decide to have them, which school they should attend, what leisure activities we encourage, what TV programs we watch and let them watch, even the clothes that we buy for them. We trust that at every instant in time we are making the right decision.
16:38 September 22, 2011 by Nemesis
The sooner the vacination for HPV for the entire population is rolled out, the better.

It is not just girls that should be vacinnated. Boys are the carriers. Both girls and boys should be vaccinated in early childhood, with a further booster vaccination in the teens, so as to give maximum coverage of the vaccination.

All people, regardless of sex or age, when attending a doctor or nurse, should be given the vaccination. Only then will HPV be safely removed from the population and the horrific deaths from the cancers that it causes, be reduced.
16:55 September 22, 2011 by Opinionfool
Nemesis, yes indeed why aren't boys being vaccinated too? There are consequences to them catching HPV too.

But how realistic is vaccination of the global population? And without it being global the possibility remains that the virus will be re-introduced into an area formerly thought clear. Such global eradication has been done once (for small pox, I think) however it took several decades to achieve. And will countries and societies that supposedly follow "no sex before marriage" and strict monogamy as a political ideal be persuaded that in fact their youngsters are at it like rabbits despite what the state religion says. The southern African experience of trying to deal with HIV/AIDS does not instill confidence that such a wide-spread vaccine for sexual health will be adopted.

Laudable aim but realistically about as much chance of it being effective as my suggestion of abstinence.
17:21 September 22, 2011 by ctinej
Beware of Drug Company pressure. This is about money, not lives!!!

$44 million to save 100 lives a year?? This is NOT the best use of that much money. That $44m would save many more lives if spent on just about anything else.

There are risks and side affects as well.
18:47 September 22, 2011 by redfish
HPV vaccination isn't that big of a deal , someone could contract it even if they remained abstinent and did everything right in their lives... girls can be raped, after all... partners can lie about their sexual history. It isn't the same thing as handing out condoms, at all.

But, it is a bit creepy that politicians, the media, and even some physicians are referring to this as a "cancer vaccine" rather than an STD vaccine. Its true the HPV virus can lead to cancer (the article here says only "a slightly higher risk" , if they don't do it before the infection, I don't know if that's accurate), but other STDs can cause just as serious health effects in completely different ways... Its just not very honest and direct to market it as an anti-cancer measure.
19:01 September 22, 2011 by Opinionfool
Less that $500 000 per life. If it was your daughter wouldn't you consider than cheap?

But much of that $44million is the phrams company simply being opportunistic and charging a price they believe someone will be stupid enough to pay. South Africa set a precendent a few years ago. Told the pharms company they weren't going to pay their exorbitant prices for HIV/AIDS drugs but were instead going to manufacture generics for themselves. Pharms caved in and set a realistic price. More governments/national health services should do the same with all medications. And don't tell me they need to recoup development costs before the patent(s) run out; I'm a paid up member of the PiratPartiet. Patents, like HPV and other life-threatening diseases, should be eradicated.
19:05 September 22, 2011 by rybo1
All or most of vaccines suck or cause greater damage. Narcolepsy ?
19:20 September 22, 2011 by Opinionfool
@Redfish

Infecting someone with HPV either through rape or lying should be considered in law no differently from infecting someone with HIV/AIDS through rape or lying. Actually the deliberate infection of anyone with *any* STD should attract the same punishment. Last night's episode of the BBC TV series Who Do You Think You Are? featured an incident in which a child went blind shortly after birth because the mother passed them gonorrhea as the foetus passed down the vagina. Indeed in earlier episodes other celebrity ancestors were found to have contract gonnorrhea or syphilis from their partner. We may be able to cure these diseases today with a course of anti-biotics but back then such remedies were not available.

But the "big" deal here is that one of the available HPV vaccines being used is a) contaminated with HPV rDNA on a grand scale and b) deliberately formulated with a highly toxic metal. One would be bad enough but both together!!!! Large numbers of young girls who are still developing are being injected with this stuff ... that is a big deal. And you think that similar issues don't exist with other medications.
23:11 September 22, 2011 by Scepticion
The solution is to stop the government "monopoly". Why does all of Sweden have to have the same vaccine? Offer both vaccines as choice, it will give market pressure to lower prices. And you wouldn't have all the legal wrangling.

As side benefit, a follow-up study could show which is more effective and safe.
23:40 September 22, 2011 by johan rebel
What exactly is the problem here?

Anybody who want get a vaccination can go right ahead. All they have to do is pay.

But aaah . . . this is Sweden . . . the Swedes worry themselves sick about cancer (and everything else), but if something is to be done about it, then somebody else has to pay, i.e. the taxpayers.
23:53 September 22, 2011 by Opinionfool
@Scepticion

So the test for effective and safe is how many women who had GSK's vaccine develop a serious cancer compared to how many who had SAGE's vaccine develop that cancer instead. Heartless, cruel ... those are the more polite words I'd describe that suggestion as.

Of course, if one of the vaccine's is contaminated we won't know it an uncontaminated version would be safer.
10:11 September 23, 2011 by Scepticion
@Opinionfool

This is not a drug test, both are already approved and if you read the article, you would know that either one (depending on who wins the contract), will be the sole supplier for Sweden. I don't know if you still would have the option of privately getting the other one, once a supplier has been selected.

At present we have only the two companies claiming theirs is better, based on studies they probably paid themselves. And whether you like it or not, only long term studies will show, which one is really better. Nobody can deny the benefit of polio vaccines, smallpox vaccines (eradicated now), even though for example at the beginning of the polio vaccine there was also a fight over which vaccine is better.

It's your choice to not take any medicine, but then stay in a cave and don't come running to a doctor when you are sick. There are no miracle cures, you have to balance pros and cons. Ultimately, after many lab and animal tests, drugs need to be tested on humans. So, even approved drugs, it would be wise to test decades later the effectiveness.

As to providing both versions on the free market, that would help force the companies to actually make sure their products are not contaminated. The one who has a problem on its hand will quickly try to clean up its act, since it couldn't sell anything anymore.

In the monopoly situation, it wouldn't be forced to do that, they just could keep arguing it doesn't matter.

A competitive market certainly works in other areas, where people buy good products and avoid bad ones.
11:47 September 23, 2011 by Opinionfool
Indeed the vaccines have been approved ... and with the evidence of wide-spread contamination of Gardasil that makes the various national drugs regulators cupable. In the light of that evidence it would also make the Swedish health system culpable too. We only have to look at those children whose mothers took thalidomide to know what havoc a tested and approved drug can do.

As to a free market making for better quality, experience in other areas tells us the exact opposite will happen. A free market results in corners being cut (that would result in greater not less contaminated product), and a torrent of other quality control issues all in the name of giving the shareholders a better return. People don't buy based on good or bad products per se they buy on price differentiation and claimed USP.

Living in a cave, me?, no. But when my doctor prescribes medication I want to know what the side-effects are --- and on one occasion refused a chemical treatment plan because its side-effects would have been worse than the illness being treated. I don't want to live in a cave because that will deny me Internet access and prevent me from checking (as I did for Gardasil) whether there are any safety notices posted by national health agencies and information from pressure groups and independent monitors. Only then, when I have something passing for "informed consent", will I take the drug. Whereas the girls being vaccinated with Gardasil or Cervarix (its GSK equivalent) are a) not being the choice of informed consent with refusal usually being on parental religious-moral grounds, b) probably incapable of understanding the risks, and c) merely doing what their parents and government advise anyway.
16:36 September 23, 2011 by Nikki Lindqvist
I agree with ctinej. "Beware of Drug Company pressure. This is about money, not lives!!!"
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