Healthy Skepticism Library item: 8657

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Publication type: news

McColl G.
Healthcare's sticking point
The Age (Melbourne) 2007 Feb 25
http://www.theage.com.au/news/national/healthcares-sticking-point/2007/02/24/1171734074136.html

Full text:

The battle to list anti-cancer vaccines highlights how commercial pressure and a new kind of political opportunism are threatening the independence of our healthcare system, writes Gina McColl.

IN APRIL, 12-year-old girls around the country will wince as they receive the first of three Gardasil shots. Added to the immunisation register in controversial circumstances late last year, the vaccine prevents infection by two strains of the human papilloma virus that cause 70 per cent of cervical cancers, the second biggest killer of Australian women.

Gardasil has been widely hailed. The vaccine was developed by Parkville-based pharmaceutical giant CSL from breakthrough research by Professor Ian Frazer, who was anointed Australian of the Year for his genius. It is a story that has it all: sex and death, nationalism and money, miracle cures and kids.

But it is only half the story. Gardasil is an anti-cancer vaccine, but it also protects against genital warts, a common sexually transmitted disease (STD). In a remarkable admission, CSL has told The Sunday Age that the genital warts protection was included to make the vaccine more marketable to teenagers, raising important issues of drug safety and patient choice.

Why does Gardasil need to be made to appeal to kids? Because a competitor is waiting in the wings. Cervarix, GlaxoSmithKline’s anti-cervical cancer vaccine, could be approved for use in Australia within months. When it is, Gardasil’s additional STD protection will give it a point of difference – making it Coke to Glaxo’s Pepsi.

Drug companies are under constant scrutiny for the ways they influence doctors’ prescribing choices and medical research. The case of Gardasil reveals how systemic that influence is becoming. Not only is marketing embedded in the drug-development process, but the rigorous process by which drugs are listed in this country is also in danger of being compromised. Some public health experts see the story of Gardasil – its development, appraisal and listing – as a case that shines a spotlight on how commercial pressure and a new kind of political opportunism are threatening the independence of our healthcare system.

Australia’s Pharmaceutical Benefits Scheme (PBS) is envied worldwide for its independence in assessing new drugs and ensuring their affordability. Its gatekeeper is the Pharmaceutical Benefits Advisory Committee (PBAC). This panel undertakes a thorough cost-benefit analysis before listing new drugs at a certain price, ensuring the public gets good value for money.

Big pharmaceutical companies are trenchant in their opposition to PBAC, because its central price-fixing ability can seriously crimp their profits.

New drugs cost big bucks. Biomedicines cost an average of $1.2 billion to develop, when you include those that fail, according to CSL’s chief economist, Sam Lovick. These huge costs need to be recovered. But PBAC is not interested in a company’s profits. It recommends a price based on the drug’s cost-effectiveness to the community: which health costs might be saved, and how length and quality of life will be improved.

Drug companies are fighting back by merging their R&D and marketing. CSL combined the anti-cancer protection in Gardasil with an anti-STD component with the express purpose of increasing its appeal to teenagers.

Playing to teen anxieties works. CSL’s trials have shown “(what sex) gains, particularly in the teenage to 26-year-old group because of genital warts”, says CSL’s director of corporate affairs, Dr Rachel David.

“Marketing and science are really enmeshed at the level at which we operate,” David says. “What’s going to motivate someone aged between 16-26 to go out and get (this vaccine)? Is it the thought that in future they might get cancer? Well, no: they smoke, they lie in the sun, they eat terrible food, they do all the naughty things. Or is it the thought they might get a hideously embarrassing and nasty STD after a night on the town?”

INFECTION with sexually transmitted HPVs is common – about 75 per cent of women become infected at some point. Almost all abnormal Pap smear results are caused by HPVs, but in 98 per cent of cases the virus clears by itself.

Yes, STDs and abnormal Pap results are unpleasant, time-consuming and costly. But bundling a potentially life-saving therapy with one that is simply life-enhancing raises issues of patient choice.

Some oppose it on moral grounds. Christian conservative groups in the United States fret that immunising young children will encourage early sexual activity. Australia’s Senator Barnaby Joyce is circumspect about his own four daughters being vaccinated; he fears “an overwhelming (public) backlash from people saying, ‘Don’t you dare put something out there that gives my 12-year-old daughter a licence to be promiscuous’.”

Is vaccinating girls against HPV really like providing condoms in schools, risking sexualising them at too young an age? There is no evidence for that one way or the other, says Dr Nicholas Tonti-Filippini. But he is opposed to Gardasil’s listing on the immunisation program, and warns that mass-vaccination may give rise to lawsuits.

Because it is spread through sex, HPV is different from mumps or measles, Tonti-Filippini argues. This difference raises important ethical questions. Is each child really at risk at such a tender age? Is she ready to understand why she might need this procedure? Shouldn’t parents choose whether it’s in their daughter’s best interests? Parents need an education program that helps them advise their kids, and gives them scope to decide whether or not the vaccine is necessary, he says. “(Otherwise it) leaves whoever gives the vaccine open to legal problems for not (obtaining) informed consent.”

Tonti-Filippini is also critical of the bundling of two different kinds of therapy in a single vaccine. Some doctors say bundling therapies can be desirable. Young children get combination measles/mumps/rubella vaccines, for example, reducing the trauma and cost. PBAC chairman Professor Lloyd Sansom sees Gardasil’s dual protection as “value-adding”. He says the addition of genital warts protection made little difference when evaluating the vaccine’s cost-effectiveness.

But bundling is risky. “When you bundle vaccines together, you’re exposing the child to an assault on its immune system that is more complex than you would normally encounter in the ordinary environment,” Tonti-Filippini says.

Another possible disadvantage is that each drug has different side effects or drug interactions. People who only need one are being exposed to unnecessary risks, says Dr Thomas Faunce, the director of a globalisation and health project at the Australian National University.

So why take the risk? At first glance, CSL’s desire to make its vaccine attractive to teenagers is perplexing. A yearly batch of consumers is assured thanks to its listing on the National Immunisation Program. Marketing may be lucrative in the US, where direct-to-consumer advertising is permitted. But in Australia, direct-to-consumer advertising of prescription medicines is banned.

So why does CSL feel that the vaccine needs to appeal to teenagers any more than the polio vaccine needs to appeal to four-year-olds? Some doctors suggest that the reason is likely to be the imminent release of GlaxoSmithKline’s Cervarix.

There are more than 100 different types of HPV, commonly thought of as the warts virus. A subset of about 30 are transmitted through sexual contact. A further subset of about 12 can lead to the development of cervical changes that may in turn lead to cancer.

Gardasil offers protection against HPV types 16 and 18 (associated with cancer) and 6 and 11 (associated with genital warts). Cervarix offers protection against types 16 and 18, and “substantial” protection against types 45 and 31 (all associated with cervical cancer).

Cervarix could be listed on the PBS by mid-2007. GSK is so confident about Cervarix’s superior cancer protection that in January it announced head-to-head trials with Gardasil. This kind of trial is rare in the history of medicine, let alone vaccines. It is a symbol of how tough the marketing campaigns – and lucrative the multibillion dollar products – are expected to be. In this context, Gardasil’s addition of an anti-STD component to make it more compelling for teenagers looks like a smart defensive strategy.

And taxpayers will pay the price. Research indicates that marketing makes up at least 40 per cent of an overall drug development budget. Beyond the expensive dinners, overseas conferences and freebie pens, there are other ways the tentacles of drug marketing reach into the healthcare system. One is getting other people to agitate for a drug’s approval.

Healthy Skepticism is an international group that lobbies against misleading drug promotion. Spokesman Dr Jon Jureidini says it’s called “astroturfing – getting patient representative bodies to make a noise about the need for a drug, lobbying doctors, creating key opinion leaders among doctors who are prepared to talk up the drug, (and) spending lots of money lobbying politicians.”

Dr Tim Woodruff, president of the Doctors Reform Society of Australia, is shocked by CSL’s candour, but not by the revelation that drug marketing and R&D are intertwined. “The company is going to use whatever it can to pursue its interests,” he says.

Woodruff says PBAC, which bases its assessment on clinical evidence, is a great check on the excesses of marketing. That is, until its processes are compromised, as they were in the case of Gardasil.

PBAC knocked back CSL’s first application to list the vaccine on the national immunisation register last November because of “uncertainty about the duration of effect and unfavourable cost-effectiveness”.

Knockbacks happen all the time; eight other first-applications were knocked back at the same meeting. But a hue and cry ensued in Gardasil’s case. Politicians quickly took advantage of the popular clamour. Twenty-one female senators from across the spectrum signed a petition calling for PBAC to review its decision.

HEALTH Minister Tony Abbott defended the decision. But the public outcry continued and within days Prime Minister John Howard stepped in. Howard promised the vaccine would be approved, quickly bringing Abbott into line.

Departmental staff met with CSL and by the end of the month PBAC had called an extraordinary meeting and approved the vaccine as soon as the company lowered its price.

Public health advocates were appalled. They say the politicisation of the independent, scientific process sets a worrying precedent.

“For the Prime Minster to come in and say this will be approved was irresponsible,” Woodruff says. He suspects the political pressure allowed the company to drive a harder bargain, knowing the vaccine’s approval was guaranteed.

“We’ve got a robust system of negotiating that gets our products on to the market, subsidised at a cheaper price than most countries pay. We should support it rather than roll over at the first (potential for) political opportunism,” Woodruff says.

And it could be the thin end of the wedge. Faunce fears that politicians are using the PBS as a new form of pork-barrelling.

Within a month of the Gardasil furore, Howard again circumvented the PBAC process and promised that two osteoarthritis drugs would be made more widely available. It was good politics – the change is estimated to help 40,000 people in the first year.

“He’s using (the health budget) for electioneering purposes (by promising) the PBS is going to list (certain drugs). It doesn’t augur well for the future of PBAC,” Faunce says

There is a sense that a green light has been given to challenge PBAC decisions, and this green light is coming – subtly – from the Government.

The new drug on the block
What is Gardasil?
A vaccine that protects against four strains of the human papilloma virus: types 16 and 18, which cause 70 per cent of cervical cancers, and 11 and 16, which cause 90 per cent of genital wart cases. It is administered by three shots over three months. The vaccine is most effective if administered before the recipient becomes sexually active.

Who can get it?It was added to the National Immunisation Program last November for all 12-year-old girls. Funding for a two-year catch-up scheme for women and girls aged 13 to 26 was also announced. It has been approved by the Therapeutic Goods Administration for males aged nine to 15, but this use is not subsidised.

What does it cost?A three-injection course is about $460. It is free for women and girls aged 12 to 26 as part of the immunisation program.

Does it remove the need for Pap smears?No, as it does not provide 100 per cent protection against the HPVs that cause cervical cancer.