Opportunity was missed in choice of cervical cancer vaccine, health campaigners sayBMJ 2008; 336 doi: https://doi.org/10.1136/bmj.a451 (Published 26 June 2008) Cite this as: BMJ 2008;336:1456
All rapid responses
To vaccinate or not? That is the question for thousands of parents as
the HPV immunisation programme rolls out in the UK this autumn.
The transparent optimism of those wide eyed ‘key opinion leaders’
like Peter English is clear testimony to the absolute clarity on the long
term ‘cancer busting’ benefits of such an expensive vaccine.
Parents will be encouraged.
But what of safety?
Parents will want to be sure that their young daughters will be safe.
Of course, the NHS contract has been awarded to the Cervarix vaccine for
reasons that have not been fully clarified. Perhaps the reason is the
superior vaccine safety of Cervarix.
Judicial Watch, a US public interest group that investigates and
prosecutes government corruption, has been chasing the U.S. Food and Drug
Administration (FDA) about the safety data on Gardasil, the rival vaccine.
The report is disturbing.
Judicial Watch President, Tom Fitton said,
“Given all the questions about Gardasil, the best public health
policy would be to re-evaluate its safety and to prohibit its distribution
to minors. In the least, governments should rethink any efforts to mandate
or promote this vaccine for children.”
Of course, British parents will be relieved to hear that Cervarix has
been chosen over Gardasil on the grounds of safety.
Competing interests: No competing interests
Ministers - and the officials who persuaded them to do so - are to be applauded for agreeing to implement such an expensive vaccination campaign, especially given the long-term nature of the benefits. It must be very difficult for politicians, who are unlikely to be in power by the time the benefits start to accrue, to commit such funds, even when there will clearly be long-term benefits that justify the cost.
Nevertheless, their decisions should be open to public and professional scrutiny.
In the case of this decision, we are told:
"The contract has been awarded for the vaccine that scored best overall against a number of pre-agreed criteria and offers best overall value to the NHS... The vaccination programme has always been about cervical cancer protection, irrespective of which vaccine was chosen."
"The criteria used for the adjudication had been shared in advance with the companies which tendered. Based on this assessment, the Department of Health has chosen to purchase Cervarix... The cost of the vaccine is commercially confidential."
Since both the pre-agreed criteria and the prices offered by the two companies involved during during the tendering process seem to be secret, we have no way of scrutinising the decision.
Was, as seems to have been hinted ("The ... programme has always been about cervical cancer protection"), cervical cancer the only benefit considered in a cost-utility analysis? It is quite possible, for example, that ministers were unsettled by concerns that this is a vaccine to prevent a sexually transmitted infection; and that consideration of the benefits of preventing genital warts, with their high "yeuch" factor and perceived triviality, was ruled out for fear of a backlash from the "moral majority".
One can understand that the tenders offered should be a secret during the negotiating and tendering process. But why should they remain a secret afterwards? Does the public not have the right to ask what was on offer?
It is quite possible that the best and most appropriate decision was made; but by keeping these secrets, how will we ever know?
Without answers to these questions, how can we be sure if a full cost-benefit analysis was undertaken, looking both at all the costs, and all the likely benefits? How can we know that the decision was not based on a more narrow cost-minimisation or cost-utility analysis that did not consider all the likely benefits, and which may have resulted in the choice of a product which, while cheaper, will not provide overall best-value?
The medical profession should be at the forefront of asking these questions.
As a secondary issue, as a doctor employed by the state I am very anxious to ask these questions, and dare not state exactly which state body employs me while doing so for fear of disciplinary action for daring to question the decisions of the Department of Health.
1. BBC News. Row over cervical vaccine choice. 2008; Accessed: 2008(23 June 2008)(http://news.bbc.co.uk/1/hi/health/7462028.stm).
2. Department of Health. Press release: Department of Health awards contract for HPV vaccine. London: Department of Health, 2008(http://nds.coi.gov.uk/environment/fullDetail.asp?ReleaseID=371095&NewsAr...).
I have given occasional lectures for, received expenses for professional conferences from, and participated in advisory boards for various pharmaceutical companies, including Glaxo SmithKline, Sanofi Pasteur MSD, and others.
Competing interests: No competing interests