British Medical Journal  Published 30 November 2011

Phil Hammond, general practitioner, broadcaster, and journalist hamm82@msn.com

The UK at last follows other countries in providing the Gardasil vaccine

Health campaigning, like much of public health, can be a slow, repetitive business. The media will break a big story once and then tend to lose interest unless a fresh scandal surfaces. But to change culture, opinion, or behaviour the same message may have to be drip fed over many years. And if the story doesn’t lend itself to a cute front page photo the chance of success is remote. Genital warts will never make the headlines in the Daily Mail or indeed any other newspaper—which makes the government’s decision to switch to a multipurpose vaccine against human papillomavirus all the more remarkable.1

 The Lancet kicked off the campaign in October 2006, with an editorial titled “Should HPV vaccines be mandatory for all adolescents?”2 It argued that Gardasil, which protects against HPV types 6, 11, 16, and 18, could dramatically reduce not just the incidence of cervical cancer but unpleasant conditions such as genital warts, anal cancer, and other malignancies affecting both sexes. It concluded, “EU member states should lead by making the vaccinations mandatory for all girls aged 11-12 years.” Australia, the United States, and many European countries promptly introduced vaccination programmes, but the NHS dithered—doubtless taken aback at the cost of £241.50 (€280; $357) for a pack of three doses—and in 2008 went with the bivalent vaccine Cervarix, which protects against cervical cancer only.

My daughter was due to join the vaccination programme at the time, but every sexual health consultant I knew recommended the wider coverage offered by Gardasil. Despite the Labour government’s commitment to patient choice, my primary care trust would not provide it or allow me to top up the difference in price. So I paid for it privately and recouped the money by writing a personal view in the BMJ.3 It attracted a surprising number of responses, indicating that the mainstream media’s lack of interest in genital warts had left a large gap in the market.

Warts are far more common than cervical cancer, can be devilishly difficult and expensive to treat, and, although they won’t kill you, can destroy your sex life, which seems a compelling reason to prevent them if you can. In Private Eye magazine I kept drip feeding the same message, often triggered by the excellent campaigning of the British Association for Sexual Health and HIV (BASHH), which—in the run up to the latest tender—conducted a survey that found that “93% of UK sexual health clinicians would advise friends and colleagues to obtain the multi-purpose vaccination for their daughters, and that 63% with teenage daughters had paid privately for the multi-purpose vaccine rather than accept the free single-purpose vaccine provided at schools.”4 This allowed me to be especially pompous: “If Andrew Lansley is to be a credible Secretary of State for Public Health, he must offer all patients the same protection against disease as the daughters of doctors.”4

And what of the evidence? In Australia 70% of women under 28 have been vaccinated with Gardasil. New cases of genital warts among young women started falling after six months, and now, three years into the programme, they have fallen by nearly 75%.5 Even cases among (unvaccinated) heterosexual men fell by one third, because of herd immunity. In contrast, since England’s school based HPV vaccination programme began in 2008 there has been no significant change in numbers of cases of genital warts, with some 91,000 new cases diagnosed each year and a further 70,000 cases undergoing repeat treatments. It costs the NHS £31m a year to treat genital warts, and preventing most of these would free up time for staff to prevent and treat other infections. In addition, Gardasil prevents 30% of minor smear abnormalities and a rarer but often fatal condition called recurrent respiratory papillomatosis, in which babies develop florid warts on the vocal chords and in the throat. Babies who survive face multiple and extremely unpleasant treatments, costing the NHS £4m a year.

As for the economics, BASHH predicts that “if we continue to vaccinate just 70% of 12 to 13 year old girls, genital warts should be eradicated in heterosexual women and men within 20 years, through the herd immunity effect.”6 A health economics analysis in the BMJ was slightly less gushing, concluding that Gardasil may have an advantage over Cervarix in reducing healthcare costs and the number of quality adjusted life years lost but that Cervarix may have an advantage in preventing deaths from cancer.7 It also concluded that significant uncertainty remains about the differential benefits of the two vaccines.

Policy decisions often have to be made against a backdrop of imperfect science and should be changed as the evidence accrues. In a statement GlaxoSmithKline, the manufacturer of Cervarix, said that it chose not to participate in the latest NHS HPV vaccine tender process because the criteria show that “the government’s priorities have shifted from cervical cancer to also incorporate HPV-related non-cervical cancers and an increased focus on protecting young girls against genital warts.”8 However, it’s worth remembering that the UK’s HPV vaccination programme has been a huge success, achieving higher rates of coverage than in any other country. If the same coverage continues, the incidence of cervical cancer and genital warts will be markedly reduced.

This is a time not just for celebration but also to launch the next campaign. We should make the vaccine freely available to young homosexual men, so they can benefit from protection against anal and oral cancer, as well as anogenital warts. Any takers?

Notes Cite this as: BMJ 2011;343:d7779

References

1.Kmietowicz Z. UK will use Gardasil in its HPV vaccination programme from next September. BMJ2011;343:d7694.FREE Full Text

2.Should HPV vaccines be mandatory for all adolescents? Lancet2006;368:1212.Medline

3.Hammond P. (Not) warts and all. BMJ2008;337:a2186.FREE Full Text

4.Hammond P. Warts and all (again, again). Private Eye 1282 (18 Feb 2011):12.

5.Fairley CK, Hocking JS, Gurrin LC. Rapid decline in presentations for genital warts after the implementation of a national quadrivalent human papillomavirus vaccination program for young women. Presented at 2010 Australasian Sexual Health Congress, Sydney, 18-20 October 2010.

6.British Association for Sexual Health and HIV. BASHH welcomes HPV vaccine decision, and calls for vaccination of young homosexual men at sexual health clinics (media statement). BASHH, 24 Nov 2011.

7.Jit M, Chapman C, Hughes O, Choi YH. Comparing bivalent and quadrivalent human papillomavirus vaccines. BMJ2011;343:d5775.FREE Full Text

8.GlaxoSmithKline. GlaxoSmithKline statement on UK HPV immunisation programme. http://hcp.gsk.co.uk/therapy-areas/vaccines/cervarix/product-news/glaxosmithkline-statement-on-uk-hpv-immunisation-programme.

Link to BMJ

http://bmj.com/cgi/content/full/bmj.d7779?ijkey=oyGUNqWaPQ0EoL0&keytype=ref

 

Click below to download Shoot the Messenger – How NHS whistleblowers are silenced and sacked – by Phil Hammond and Andrew Bousfield, which appeared in Private Eye Issue 1292 (8 July -22 July 2011).  Back orders are available by calling Private Eye Subs on 01795 414870. Updates to stories are available at www.medicalharm.org

Shoot the Mesenger

 

 

 

(Not) Warts and All

 

British Medical Journal  2008  

Phil Hammond

General practitioner, writer, and broadcaster

 

‘You’d be mad not to protect your daughter against genital warts if you can afford to.’ So advised Peter Greenhouse, a sexual health consultant inBristol, when I asked him which human papilloma virus (HPV) vaccine I should choose for my daughter. The NHS vaccination programme may have opted for the bivalent vaccine (Cervarix) to concentrate resources on preventing cervical cancer, but every doctor I’ve spoken to has chosen the quadrivalent vaccine (Gardasil) for their own daughters (and the odd off-licence son).

 

Genital warts genital warts are common (100,000 new cases inEnglandeach year) and they’re on the increase, particularly amongst the young (60% of warts in women occur in the 16-24 year old age group). They don’t kill you, but they can kill your sex life and in some people they can be recurrent and extensive. Health minister Dawn Primarolo claims warts are ‘preventable’ but meticulous condom usage only cuts HPV transmission by 50%. A far safer option is to vaccinate.

 

The NHS Choices (sic) website promotes Cervarix but doesn’t return a single hit for Gardasil. Having chosen one vaccine for us, the government has decided we don’t need information about another that could prevent 90% of warts (as well as 70% of cervical cancer). Those administering Cervarix at my daughter’s school offer no information about Gardasil. Whatever happened to informed choice?

 

The NHS vaccination site (www.immunisation.nhs.uk) is also a Gardasil-free zone. An editorial in Sexually Transmitted Infections describes the government’s decision as ‘a sad day for sexual health.’¹ It also doesn’t seem to make long-term economic sense. Within 3 or 4 years, the use of Gardasil ‘would begin to have a big financial payback, as the current estimate of treating genital warts inEngland every year is £23 million.’

 

So why did the government opt for Cervarix? The Joint Committee on Vaccination and Immunisation is most illuminating.² ‘If the vaccines were offered at similar prices, then the committee recommended choosing the quadrivalent vaccine, which protects against cervical cancer and genital warts.’ According to the British National Formulary, the two vaccines are exactly the same price (£80.50 for each of three injections), so GSK (the makers of Cervarix) must have offered a huge discount to undercut Sanofi Pasteur (makers of Gardasil).

 

I have no issue with this. New drugs are ludicrously expensive and the NHS deserves credit for beating GSK down. Or perhaps GSK was desperate to break into a market dominated in most other developed countries by Sanofi Pasteur. The size of the discount is ‘commercially confidential’, according to my MP, Dan Norris. I asked him because I wanted to ‘top up’ the difference so that my daughter can have Gardasil with her classmates, within the NHS programme. But this choice, apparently, is not allowed.

 

Parents who choose Gardasil will almost certainly have to pay privately for it. £350-£400 seems to be the going rate in local GP practices. We can (reluctantly) afford this, but many parents can’t. My Primary Care Trust (BANES) allows those in the vaccine programme to have Gardasil if there is ‘a specific clinical need’, without defining what this means. For girls particularly at risk of genital warts (e.g. those with type 1 diabetes or extensive verrucae or hand warts) or skin conditions that make genital warts particularly unpleasant (e.g. extensive psoriasis or eczema), it seems unethical not to offer them Gardasil.³ And how long will it take for a woman with warts to sue the NHS for not offering her the choice? Women who later develop warts or cervical cancer may also sue if they were denied an NHS vaccine because they were ‘outside’ the screening programme. Doctors are supposed to use clinical judgement in individual cases, but the pressure to reduce prescribing costs is relentless.

 

The cheap GSK deal only applies to vaccines used in the programme – the vaccines are the same price when offered outside it. Many doctors will recommend Gardasil in these circumstances, so we may end up with all women in the programme getting Cervarix and most outside it getting Gardasil. This clearly has the potential to undermine the programme (or at least it would if anyone was brave enough to shout about genital warts).

 

For any licensed treatment, the public (and NHS staff) need quick and easy access to unbiased efficacy and safety data, updated as it emerges. The NHS website would seem a logical gateway for this, but currently restricts information about treatments it doesn’t wish to fund. Vaccination programmes have a coercive flavour but some parents, quite legitimately, may want to delay vaccination until more comprehensive safety and efficacy data emerge.⁴ Others simply don’t trust data presented and controlled by drug companies. They should not be made to feel guilty if they decide against vaccination

 

I’ve worked in sexual health and seen plenty of people whose warts have been successfully treated. I’ve seen others with extensive, recurrent warts requiring prolonged and fiddly treatment, and florid ano-genital warts that resisted just about every treatment. We’ve opted to pay for Gardasil. Unlike the Blairs, I’m happy to go public about vaccination (but not point of conception). I tell patients if they ask me, would prescribe it on the NHS and I’ve written about it in Private Eye. If it was breast cancer, there would doubtless be an industry-supported march on Downing Street, but the genital warts lobby is largely undercover. There are no letters to the Times, and warts have never made it to the cover of the Mail. But follow this link⁵ to see what we could be preventing.

 

 

1. O’Mahony C. Government decision on national human papilloma virus vaccine programme is a sad day for sexual health. Sex Transm Infect 2008; 84: 251

 

2 http://www.advisorybodies.doh.gov.uk/jcvi/HPV_JCVI_report_18_07_2008.pdf

 

3 http://sti.bmj.com/cgi/eletters/84/4/251

 

4 http://content.nejm.org/cgi/content/full/359/8/861

 

5 http://www.chestersexualhealth.co.uk/genitalwarts.htm

 

 

November 24, 2011

BASHH welcomes HPV vaccine decision, and calls for vaccination of young homosexual men at sexual health clinics

 

 

 

The British Association for Sexual Health and HIV (BASHH) today welcomed news that the Government are switching to a multi-purpose HPV vaccine.

 

Peter Greenhouse, spokesperson for the British Association of Sexual Health and HIV commented:

 

“All of us atBASHHare delighted by the news that the next generation of teenage girls will receive a multi-purpose HPV vaccine which will protect them against cervical cancer AND genital warts.

 

“The UK-wide school cervical cancer vaccination campaign has produced higher rates of coverage than achieved in any other country – if we can keep this up we should expect to see genital wart infections start to reduce in teenage girls within five years, and slightly later in boys: If we continue to vaccinate just 70% of 12-to-13 year-old girls, we can predict** that genital warts should be eradicated in heterosexual women and men within 20 years, through the herd immunity effect.

 

“We would also want to make sure that the vaccine is made freely available to young homosexual men on their first visit to Sexual Health clinics – along the same lines as the successful Hepatitis B vaccination programme – to make sure that they can also benefit from protection against anal & oral cancer and genital warts.”

 

BASHHhave been making the case for the multi-purpose vaccination since the previous purchasing decision in 2008: A survey conducted earlier this year found that 93% of UK sexual health clinicians would advise friends and colleagues to obtain the multi-purpose vaccination for their daughters, and that 63% with teenage daughters had paid privately for the multi-purpose vaccine rather than accept the free single-purpose vaccine provided at schools.

 

** Prediction of genital wart eradication – please see reference over page

 

Visit: www.bashh.org

 

 

• The single-purpose vaccine (Cervavix) protects patients against strains 16 and 18 of HPV which are responsible for around 70% of cervical cancer cases.  The multi-purpose vaccine (Gardasil) additionally protects against over 90% of genital warts, minor (non-serious) cervical smear abnormalities, and Juvenile Onset Recurrent Respiratory Papillomatosis (warts on the vocal cords) which is passed from mother to baby.

 

• The British Association for Sexual Health and HIV – BASHH– is the professional organisation for clinical staff and researchers working in the UK’s sexual health clinics. It sets standards for clinical care, training and education, and supports Public Health by treatment and prevention of infections and care of other conditions related to sexual health. For more information please visit www.bashh.org

 

• BASHHmedia spokespersonPeter GreenhouseFRCOG FFSRH, Consultant in Sexual Health at Bristol & Weston, is available for comment via the number above.

 

• Reference for vaccine coverage rates: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_123826.pdf

 

• Reference for prediction of eradication of genital warts in heterosexuals within 20 years:

http://www.ncbi.nlm.nih.gov/pubmed/20924049

 

Burying Bad News No 789

The repeated refusal of the Government to publish its ‘risk register’ for the Health and Social Care Bill is unsurprising given the culture of secrecy and cover-up in the NHS. Information commissioner Christopher Graham has now judged that the document should be published, but health secretary Andrew Lansley is likely to sit on it for 28 days before deciding whether to launch an appeal. The Bill is littered with risks, most notably that billions of pounds will be spent on another massive, rapid, ill thought-out restructure that ends up roughly where we started but with staff demoralised and patients neglected.

As one GP commissioner put it: ‘We were initially told we could choose the size of our consortium, so we went small so we could be flexible. Then we were told we had to be much bigger to have any clout so we merged with other local consortia, which was a huge hassle.  Now we’ve been told we’re the wrong shape and have to mirror the local authority boundary. That’s three reorganisations in under a year. Are they making it up as they go along?’ The GP consortia (now renamed clinical commissioning groups) will be advised by ‘commissioning support organisations’ which – miraculously – are shaping up to be the same size as the Primary Care Trusts they will replace. But many PCT staff have now left the NHS so management consultants such as McKinsey and KPMG are being called in, which was probably Lansley’s plan all along. Amidst the confusion, 20,000 forgotten patients have waited over a year for treatment – slightly longer than the 18 week pledge.

Meanwhile, staff who try to raise concerns about poor patient care are being scared off by lawyers. The super-gagging of former United Lincolnshire Hospitals NHS Trust (ULHNT) chief executive and all of his employment tribunal witnesses (Eye last) prompted Peter Bottomley MP ‘To ask the Secretary of State for Health if he will instruct each part of the NHS to lift any gagging restrictions on (a) present and (b) former NHS staff that (i) have and (ii) have had the effect of withholding from the public and the media information, evidence or justified concerns about levels of care in the NHS.’

Health Minister Anne Milton replied that ‘the Public Interest Disclosure Act provides that any clause or term in a contract, or other agreement between a worker and their employer is void in so far as it purports to preclude the worker from making a protected disclosure. Health Service Circular 1999/198 made it clear that local NHS trusts should have in place policies and procedures which prohibit confidentiality “gagging” clauses in contracts of employment which seek to prevent the disclosure of information in the public interest, which includes information, evidence or justified concerns about levels of care in the NHS.’

 Alas, NHS trusts often ignore both PIDA and DH circulars, knowing that a scarily worded legal letter will silence many NHS whistleblowers, especially those who have been sacked and find themselves unemployable and facing bankruptcy, without the resources to mount a legal challenge should they wish to test Milton’s theory that their gagging order is ‘void.’ The Times has unearthed 3 gagging clauses that prevent whistleblowers taking concerns about colleagues to the GMC. And Walker’s witnesses have received solicitors’ letters that state ‘Please ensure that you and your partner and immediate family do not disclose to anyone the terms of any agreement reached and we would ask that you undertake not to disclose in the future to anyone the terms of any agreement. We are instructed that our client requests that you take this request seriously and ensure you abide by this request. Further all the information and documentation our client or we passed to you was done so confidentially and is not to be distributed any further.’ As one witness put it: ‘I have seen much of the evidence which would have been heard in public in the Tribunal; in my opinion it would have been extremely damaging to a number of very senior officials within the NHS.’

 The DH didn’t listen when Gary Walker blew the whistle that patients were in danger and he was sacked. Care at ULHNT then became so bad that even the Care Quality Commission spotted it (Eye last). For Milton to claim NHS staff are free to speak up about poor patient care when her own department buries it is clearly nonsense. Something for Lansley’s secret risk register, perhaps?

The Mother of All Gags?

 

The most keenly awaited NHS employment tribunal in years has ended in secrecy, making a mockery of the government’s commitments to transparency, accountability, patient safety and the protection of whistleblowers. Gary Walker, the former chief executive of the United Lincoln Hospitals Trust (ULHT), lost his job in February 2010 after blowing the whistle on how government targets were harming patient care.  The trust claims he was sacked for saying ‘fuck’ nine times over 2 years¹.

 

The tribunal was important because Walker had blown the whistle both to his SHA chief executive, Barbara Hakin – now the DoH’s Director of Commissioning – and the NHS chief executive David Nicholson. The allegation that the two most senior managers in the NHS may have played a role in the destruction of Walker’s career whilst failing to address patient harm should have been dissected under oath but the NHS legal machine ensured the claim was ‘settled’ on the eve of the tribunal.

 

Walker is now not able to speak about the case. Ever.  Neither can any of his many witnesses who were prepared to testify about serious cases of patient harm, fiddling of figures, the bullying behaviour of the strategic health authority and a whitewash external review that only looked for bullying ‘in writing.’ Neither will any witnesses confirm or deny the existence of any gagging clause. All those who were due to testify against the trust, the SHA, the DoH, Nicholson and Hakin – and substantiate allegations of ‘third world care’ and avoidable patient harm  –  have been so effectively silenced at public cost that they are too scared to say how or why.

 

So MD put five specific questions to the trust. 1.What was the precise claim that Mr Walker made against the trust? 2.What was the amount of the settlement and the precise terms? 3.Did anyone have to sign a compromise agreement (‘gagging clause’) as a result of the settlement? 4.How much in total has the trust spent in legal and other fees in preparing for and settling this claim? 5.What direction did the trust receive from the DoH settling this claim and enforcing any compromise agreements?

 

The trust’s response? “The parties reached an amicable resolution of the differences between them and agreed not to comment further.” MD asked the same questions of the DoH and for clarification of Nicholson’s written assertion that ‘there is no evidence whatsoever of bullying or harassment of the trust by the SHA’. The DoH said: “This is a matter between the trust and the individual”.  As for patients, specific allegations made by trust staff will not now be properly scrutinised. Walker missed targets to save patients, but after he was sacked, a woman allegedly suffered severe complications when a consultant was pulled out of the theatre to operate on another patient who was going to breach the 18 week target, and an otherwise healthy patient who died following a radical prostatectomy after extra cases were added to an operating list to hit targets.

 

In February 2011, the Care Quality Commission failed ULHT on 12 of 16 essential quality and safety standards. Two  statutory warning notices were issued and student nurses were removed from training posts. The CQC has just declared that ULHT poses “a current risk to patients of being exposed to poor care”¹. It has taken the trust “considerable time to investigate, respond to and resolve” serious incidents and “learning from these has been minimal”. In an NHS culture where even a chief executive can’t safely blow the whistle without having his career destroyed, it’s hardly surprising that no-one at Mid Staffs spoke up. The NHS needs to learn to value and support whistleblowers, and the NHS must stop using public money to suppress information in the public interest. The Public Accounts Committee (PAC) made precisely this point this year, and yet the NHS appears to have responded by issuing the mother of all gags, so powerful that no-one may acknowledge its existence. PAC must now investigate how much public money has been spent silencing Walker and his colleagues, protecting Nicholson and Hakin and covering up another scandal. And who signed the cheque? It’s inconceivable the health secretary, Andrew Lansley, wouldn’t be aware of a cover up on this scale, even if he doesn’t wish to be held accountable for it.

 

MD

¹ Shoot the Messenger, Eye 1292                      

 2 www.cqc.org.uk