Since this column was published, I’ve had a number of responses from those worried about the safety of HPV vaccination. If you distribute, say, 16 million doses of a vaccine then, by chance alone, some people will die or have serious illnesses after they had the vaccination. It does not mean the vaccine caused these and indeed the same amount of death and serious illness occurs in people who haven’t had the vaccine which is why America’s Centre for Disease Control concluded the two aren’t related and hasn’t withdrawn the vaccines. These scare stories surface with every vaccination programme and the damage they cause is huge (e.g. MMR).

The dangers of drugs sometimes only surface when they’ve been on the market for a while and the pharmaceutical industry has an unfortunate track record of trying to bury bad news. But the CDC is on the case with vaccines and their advice re Gardasil’s benefits and safety is below:

Information from FDA and CDC on Gardasil and its Safety
Gardasil Background

Monitoring the Safety of Gardasil
Summary

Consumers, parents, healthcare professionals, and others have raised questions regarding the safety of the human papillomavirus (HPV) vaccine, Gardasil. FDA and CDC take all concerns about vaccine safety very seriously, and have been closely monitoring the safety of Gardasil. Below is a summary of Gardasil vaccine safety monitoring activities and findings. Based on ongoing assessment of vaccine safety information, FDA and CDC continue to find that Gardasil is a safe and effective vaccine. FDA and CDC continue to monitor the safety of this vaccine with the public’s health and safety our top priority.

Gardasil Background

FDA approved Gardasil vaccine on June 8, 2006 for use in girls and women through 26 years of age. This vaccine prevents infection with the types of HPV that cause most cases of cervical cancer and genital warts. CDC’s Advisory Committee on Immunization Practices (ACIP) recommend routine 3-dose vaccination of girls aged 11 and 12 years. The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or who have not received all 3 doses.
Gardasil was tested in over 11,000 women in the United States and around the world, and found to be safe and effective in preventing serious HPV-related diseases. These studies showed that in women who have never been infected by HPV types 6, 11, 16, or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina, and vulva, and in preventing genital warts often caused by these HPV types.
This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.

Monitoring the Safety of Gardasil
Vaccine Safety Overview

FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS). VAERS receives unconfirmed reports of possible side effects following the use of Gardasil and all vaccines licensed in the U.S. VAERS reports are regularly reviewed for safety concerns or trends of adverse events (possible side effects).
Vaccines are manufactured in batches called lots. All vaccine lots are routinely tested and must pass all tests before they can be used, and vaccine manufacturers must comply with strict manufacturing standards. FDA also analyzes adverse events (possible side effects) associated with individual lots to look for any unusual patterns. No such patterns have been observed in FDA’s review of HPV vaccine lots since the vaccine was licensed.
In addition to VAERS, CDC has two other systems in place to monitor the safety of all licensed vaccines. The Vaccine Safety Datalink (VSD) Project is a collaborative effort between CDC and eight managed care organizations that monitors vaccine safety and immunization. The Clinical Immunization Safety Assessment (CISA) Network is a collaboration with six academic centers in the United States to conduct clinical research on vaccine-associated adverse events.

Adverse Event Reports Following Gardasil

To date, the manufacturer, Merck and Co., has distributed over 16 million doses of Gardasil in the United States. Given the large number of doses distributed, it is expected that by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations. Our monitoring and analysis of reports, including in depth medical review, are designed to detect serious events that occur at rates greater than expected, compared to what would be expected by chance alone.
VAERS receives reports of many events that occur following immunization. Some of these events may occur coincidentally during the time period following vaccination, while others may actually be caused by vaccination. In our analysis of VAERS data, we look for patterns of adverse events that may be plausibly linked to a vaccine. Such patterns of adverse events may require further study.
As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events, and 6% as serious events.

Non-serious Reports (94% of Total Reports)

Since Gardasil was approved, the great majority (94%) of adverse events reported to VAERS after receiving this vaccine have not been serious. These reports include syncope (fainting), pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially among adolescents. Falls after syncope may sometimes cause serious injuries such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. FDA and CDC have taken steps to remind immunization providers about the recommendation that individuals be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine’s prescribing information has changed to include this information.

Serious Reports (6% of Total Reports)

Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of June 30, 2008, 20 deaths had been reported to VAERS. There was not a common pattern to the deaths that would suggest they were caused by the vaccine. In cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.
Guillain-Barré Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS. To date, there is no evidence that Gardasil has has increased the rate of GBS above that expected in the population. While we continue to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS.
Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots, such as use of oral contraceptives which are known to increase the risk of clotting. Thromboembolic disorders as well as other medical events are being studied through the VSD in previously planned controlled studies. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety.

Summary

Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.
CDC has not changed its recommendations for use of Gardasil. FDA has not made any changes to the prescribing information for how the vaccine is used or to the vaccine’s Precautions. In addition, FDA routinely reviews manufacturing information and has not identified any issues affecting the safety, purity, and potency of Gardasil.
Public health and safety are priorities for FDA and CDC. As with all licensed vaccines, we will continue to closely monitor the safety of Gardasil. FDA and CDC continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women by providing protection against the types of HPV that cause the majority of cervical cancer, genital warts, and other HPV-related diseases.

The Health Bill Balls

David Cameron described the Health and Social Care Bill, published on January 19, as a ‘once in a lifetime change’ of the NHS. This is the third ‘once in a lifetime change’ we’ve had in twelve years: Tony Blair and Labour health minister Lord Darzi made the same claim for their reforms. So either we’ve been lied to, or life expectancy is set to fall to four years. The Bill weighs in at 367 pages, even bigger than the 1948 Bill that created the NHS, and it’s an unbelievably tedious read. But there are some surprising changes from the July White Paper.

In the White Paper, it appeared GPs were taking over the NHS with 75 mentions. In the Bill, they get just 2. That’s still 2 more than consultant or nurse, but the consortia they were originally in charge of get 623 citations. Consortia will be controlling most of the NHS budget but now –thanks to the lobbying of large private health companies – the accountable officer doesn’t have to be a doctor. Indeed, consortia aren’t obliged to have a board or any patient representation. But they will be tightly regulated by the NHS Commissioning Board, which can set standards for their creation, direct them, have them taken over, fire their accountable officer and abolish them altogether.1It’s as if GPs are being set up to fail so corporate healthcare can step in.

Pathfinder consortia have set the trend by giving themselves ridiculously corporate names. Fortis Group, The Red House, Bexley Clinical Cabinet, Cumbria Senate. None of these sound remotely NHS. They’re not yet statutory bodies so it’s hard to find out what goes on in their meetings or where the money goes. Some are succeeding in improving care by cooperating with hospital and social care to join up services for patients. But you can integrate care without massive reorganisation, as Scotland has proved. The success of its collaborative approach in improving outcomes and reducing inequalities stems largely from avoiding major structural upheavals over the last 25 years.
The NHS has never succeeded in making the 4% efficiency savings it now needs to hit the £20 billion 5 year target, so it’s hard to see how consortia can succeed in the short term. They will take over explicit rationing of healthcare from NICE and PCTs, and patients are supposed to lobby GPs directly if they don’t like it. And if consortia fail to balance the books, as many surely will, the Commissioning Board can hand them over to UnitedHealth, CareUK or Kaiser.

Foundation hospitals have far more independence than consortia, but are in an equally parlous financial state. Many new buildings look fantastic but typically have a £17-£20 million annual PFI debt to service. Consortia can now go to ‘any willing provider’ prepared to undercut NHS hospitals so many will struggle for business. As compensation, the Bill allows them to do as much private work as they like. Great news for the balance sheet, but not for NHS patients or staff who disagree with a two tier system. And as waiting times rise, as they inevitably do when money is tight, the demand for private treatment rises and compounds the NHS wait.

Labour’s attack on this is weakened by its own clumsy attempts to introduce an NHS market. Private companies were paid above the going rate to cherry pick easier operations, and the money was guaranteed no matter how few patients they treated. Labour too dabbled with the idea of out-sourcing commissioning to large private companies. The Health Bill is far more an extension of the Blair reforms than a retraction. As for patients, Lansley pledge of ‘nothing about me without me’ is looking thin. Like PCTs before them, most patients won’t have the faintest idea what goes on in a consortium. But they will notice money drying up and service cuts. And when they try to complain to Dr Clark, he’ll be down the Red House, up the Fortis Group or in the Senate.

MD 1 Health Service Journal, Essential Guide to the Health Bill, January 21

Secrecy and Suppression in the NHS

Why are most inquiries into NHS failings still held in secret? Without scrutiny of the process, there is no way of establishing their independence and we’re forced to rely on blind trust in the integrity and competence of experts, which is generally why NHS scandals occur in the first place. And given that inquiries are paid for out of public money, it’s absurd that patients should be excluded from hearing the evidence and cross-examination, and giving their own evidence.

The Bristol Pathology Inquiry was run by Verita, cost £700,000 and the report was published 18 months after the Eye first published allegations of serious errors in pathology reporting at University Hospitals Bristol (UHB). These had been circulating around the city for some years, and the hospital management, Bristol PCT, South West Strategic Health Authority and Royal College of Pathologists all knew about them without properly investigating. As the report conceded: ‘This Inquiry was only established because of the articles in Private Eye and, had it not been for them, the issues would have continued to be ineffectively addressed.’

The report found that: ‘The culture in the histopathology department at UHB veers towards the opposite of what is required. We have observed a culture which is at times defensive, responds aggressively to criticism, is sometimes unwilling to acknowledge, let alone learn from, mistakes, and which is based on overconfidence bordering on arrogance.’ However, it concludes that: ‘Overall there is no evidence to lead us to believe that the department provides anything other than a safe service.’

Given that mistakes inevitably occur in all histopathology departments, where complex tissue samples are analysed under pressure, the key factor in making it safe is a culture of openness where the staff accept criticism and scrutiny of their work, and work together to ensure patients get an accurate diagnosis and the best possible treatment. As one senior consultant told the inquiry: ‘I would urge you to ensure that the money invested in this review (money that could have been spent on patient care) is responsibly spent on an in depth investigation into what many believe, but are too frightened to admit in public, is a dangerous histopathology service.’ This failed to make the 264-page final report.

The report’s length belies an adequate analysis of the safety of the reporting. Detailed allegations were made in five areas of tissue reporting – breast, skin, lung, gynaecology and paediatrics. The inquiry should have invited those who made the allegations to present their tissue evidence for independent analysis. They were excluded from this process and have no way of knowing that the 26 samples analysed by the inquiry adequately represented the errors they had observed. There are concerns that nine cases were missed completely. And the paediatric pathology slides weren’t analysed at all.

An audit of the five specific areas is necessary to establish proof of safety but instead, UHB ordered an expensive audit of 3,500 slides in all areas. As the inquiry put it: ‘There is no doubt that the final selection has to some extent diluted the effectiveness of assessing competency in the specific specialist areas of concern.’ So in one area – paediatrics – slides weren’t examined at all, and in four others they were done in a very limited manner in conditions of extreme secrecy. Some serious errors were acknowledged but no patients or relatives who had been harmed were invited to give evidence. On that basis it’s hard to know how safe UHB’s pathology department is. Not great value for £700,000, though it does protect the reputations of senior NHS managers and doctors who knew about the allegations for years but failed to adequately investigate them.

Getting rid of John Watkinson, the whistle-blowing former chief executive of the Royal Cornwall Hospitals’ Trust may cost the NHS over £2 million, after an employment tribunal – held in public with rigorous cross examination – judged that he was substantively and procedurally unfairly dismissed in a ‘travesty of anything approaching basic concepts of fairness’. An inquiry ordered by Andrew Lansley and run by Verita (in secret), has completely absolved South West SHA of any wrong doing, and Verita has threatened legal action against local campaigner Graham Webster who gave evidence and concluded that the inquiry “hasn’t given us the independence and integrity that we were looking for”. Promoting a culture of openness and transparency in the NHS, and re-establishing public trust, is impossible while its inquiries are so non-transparent and defensive.

A detailed critique of the Bristol Pathology Inquiry is at http://drphilhammond.com/blog/category/bristol-path-inquiry/
and the Watkinson Inquiry at http://www.healthpolicyinsight.com/?q=node/903

Letter to the Editor

From: Ken Catchpole Sent: 21 January 2011 12:52
To: Strobes
Subject: Medicine Balls: NHS Secrecy and suppression

Sir,

I write in response to your Medicine Balls article singling out quality issues at the Bristol Pathology Unit. In particular, you make reference to a statement in the Inquiry “…observed a culture which is at times defenisve, responds agressively to critcisim, is sometimes unwilling to acknowledge, let alone learn from mistakes, and which is based on overconfidence bordering on arrogance.” These are in fact properties of all hospitals, so it’s unfair to single UHB out. And by safe of course they mean injuring 1 in 10 and accidentally contributing to the deaths of 1 in 300 actue patients. That is probably an underestimate, judging from my experience of looking at errors in surgery for the last 7 years; virtually all of which are ignored/excused away, never recorded or reported, never learned from, so regularly recurr.

It’s a great game to exchange anecdotes with other patient safety researchers, and only yesterday I was discussing how unwelcome we are made to feel by both managers and clinicans. I’ve worked in half a dozen UK hospitals and am regularly invited to talk all around the world about some of those stories; so I can say with some confidence I’m an expert in the area – yet have been firmly prevented from addressing the well-recognised problems that occur 5 floors beneath my feet in my own hospital. (e.g. http://www.telegraph.co.uk/health/healthnews/7914517/Babies-died-after-junior-surgeon-left-to-cope-on-his-own.html )

Keep up the good work.

Ken.