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What are the lessons from the Gardasil hype?

Tuesday, 22 July 2008

Dr Agnes Vitry, a Senior Research Fellow at the University of South Australia, writes:

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Sally Crossing’s recent article about the media’s overenthusiastic promotion of the breast cancer drug Herceptin (link to Crossing article from 14 July) rang some loud bells for my colleagues and I.

We have analysed the media and political pressures put on the Pharmaceutical Benefits Advisory Committee (PBAC) when it was considering whether Gardasil, the vaccine used to protect against cervical cancer, should be subsidised by the public purse.

Our study, published in Health Policy online, is based upon an analysis of 523 newspaper articles mentioning Gardasil in the two years from December 2004, as well as related interview transcripts, media releases and fact sheets.

As with the Herceptin study, many of the media reports were verging on the promotional, trumpeting the vaccine as a “blockbuster”, “medical miracle” and “lifesaver”.

When the PBAC decided against subsidising the vaccine in early November 2006, the decision was loudly condemned by many politicians, consumers, doctors and advocacy groups. Experts, whose association with the company was not always declared, were also critical. Only one doctor, apart from former PBAC members, was reported as supporting the independence and due process of the PBAC.

CSL was able to provide data supporting its criticism of the decision, but the PBAC members – bound by confidentiality rules - were unable to publicly defend or explain their position.

After requesting further information from CSL, an extraordinary meeting of the PBAC on November 22 recommended funding of the vaccine.

Our study suggests that many in the media, politics, medical profession and advocacy groups did not recognise or understand the importance of the PBAC process.

Many new pharmaceuticals have very high prices with only marginal incremental benefits. The independence of the PBAC listing process is critical to assessing the cost-effectiveness of new medicines and balancing efficiency and equity.

Do media and political campaigns such as those associated with Gardasil risk undermining the independence and sustainability of the PBAC? How will the community be affected if the PBAC’s independence is compromised?

Dr Vitry is based at the Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, School of Pharmacy and Medical Sciences

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Anon Tuesday, 22 July 2008 10:30:49 PM: I believe the Federal Govt did not include any 'safe sex' counselling with its recent Gardasil program, which highlights the incompetence of the 'STI Prevention Branch' of the Dept of Health and Ageing. No national information or media campaign worth talking about has been run since the 'Grim Reaper' campaign, which was not a very good campaign anyhow. STI rates are rising across the board, and very little is being done about it in terms of prevention. Instead, the STI Prevention Branch is just ordered to administer this program to benefit a drug company, and it just becomes an exercise in logistics and money changing hands. Young girls are not advised in the course of receiving the vaccination that this does not make unprotected sex OK, that there are 40 or so HPV strains of which this only protects against a couple, and that there is a huge range of viral and bacterial nasties out there such as HSV-2 (1 in 6 Australian women are currently infected, for life), chlamydia, gonorrhoea, syphilis, and of course HIV. All the usual nasties, plus a few more exotic ones that are less well known. The Federal Govt has been singularly remiss in protecting the health of the citizenry in this regard -- more on this later.
Glenn Salkeld Wednesday, 23 July 2008 10:43:07 AM: I spent 6 years on the Economic SubCommittee of PBAC. The whole process for the selection and reimbursement of pharmaceuticals on the PBS is contestable. Claims are made by sponsors, special interest groups, patients and the media. If these claims form part of the formal submission to PBAC they are scrutinised by independent evaluators, PBAC (and ESC) committee members and evaluated against the evidence-based approach that underpins the whole scheme. If the claims lay outside the formal process - ie through public discourse and media attention, then they cannot legitimately form part of the decision making process. But the PBAC deals with more than just evidence - it must grabble with the inevitable value judgements that guide a final recommendation. None of us are immune to external infuences (including media and political campaigns) but we are accountable for our views. In my experience members of PBAC (and ESC) highly value their independence and their own reputation. So the future of PBAC will continue to rest on the integrity of its members. On that score we have every reason to be optimistic about the future of the PBAC. But we do need greater transparency on the valuation part of the recommendation process. It is here that more can be done to show what factors weighed most heavily in the committees recommendation.
Dr John Dowden Wednesday, 23 July 2008 2:03:27 PM: The Pharmaceutical Benefits Advisory Committee (PBAC) has a crucial role in recommending which medicines should be included in the Pharmaceutical Benefits Scheme. The inclusion of a drug in the Scheme can be worth many millions of dollars to its manufacturer. It is therefore not surprising that the activities of the PBAC are sometimes criticised by parties with an interest in the outcome of its deliberations. There have even been suggestions that such external influences led to the whole Committee being suddenly spilled in 2001. http://www.abc.net.au/4corners/stories/s248583.htm
Liz Johnston Friday, 25 July 2008 2:42:20 PM: When you get over the Gardasil fuss can someone liike Dr Vitry take a look at the use of statins. I am meeting a lot of people who suffer muscular skeletal problems while taking statins. I just stopped them for nine months and my pain certainly went away and strength improved. But with my cholesterol at 9.5 my doctor is seriously concerned and would like me to resume statin treatment. What is the science on taking statins for people over 65 with no obvious signs of heart or blood pressure problems?
Sally Crossing, Chair, Cancer Voices NSW Monday, 28 July 2008 4:03:36 PM: Dr Agnes Vitry is concerned about the influence of the media and advocacy groups on the independence of the PBAC process. Leading a health consumer advocacy group as I do, it seems a good time to come back to the discussion about our role.
Of course there are consumer groups and consumer groups. Professor Lloyd Sansom, Chair of the PBAC was on occasion wont to tar us all with the brush of being in the pockets of big pharma. And some consumer groups are. Some are supported by the drug companies which market the drugs likely to be used by their members, others receive funding for discreet projects, with or without transparency, and then there are the “cleanskins”. The groups which I work with – Cancer Voices NSW, the Breast Cancer Action Group NSW and the peak health consumer group Consumers Health Forum of Australia, do not accept any financial support from the pharmaceutical industry. The latter, CHF, went to some pains to develop a set of guidelines to help its 100 plus member groups to weave their way safely through this minefield.
For the “cleanskin”, the path towards a new drug which may help our members is not straightforward. In our case, we fully support the PBAC process, and welcome recent changes which make it more transparent and even consumer friendly. At the same time, we are aware that its process is hampered by rules which favour the “confidentiality” of the companies marketing drugs. This seem largely unnecessary from their commercial view, when the development of major marketable drugs is not much of a secret –having gone thought the peer review / clinical trial process which by definition is pretty open to view. The confidentiality constraints also means that no-one gets to see the cases being put to the PBAC. As subsidy thought the PBS is essentially the spending of public money, this does not sit well with us.
We understand that the PBAC goes to great lengths and some pain to stick to its processes. We support and respect that process. Political pressure from whatever quarter may have the effect of speeding up the PBAC’s review of specific drugs. This occurred in the case of the drug Gardasil. Some speeding up of a good process, is not harmful in our view – quite the opposite.
What we would like to see from the PBAC process is further transparency. We believe this would enhance the independence and sustainability, not compromise it.

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What are the lessons from the Gardasil hype?

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