Sratch 'n' sniff

Dr Elaine Murphy, inexplicably, now now Baroness Murphy, has exposed the spurious nature of the alleged male ailment about which her husband wrote to the BMJ in 1974 which was said to affect the scrotum of cellists - exposing also the credulity of generations of medical doctors.

This reminds Lord Patel of the famous incident when Sir Thomas Beecham abruptly brought a rehearsal of the London Philharmonic to an abrupt halt in the middle of an Elgar variation. he looked with scorn at one of the evidently discomfited First lady cellists who instantly became the centre of atention.

"Madame" , he boomed to the silent and serried rows of the orchestra."You have been blessed with an instrument of the most sublime beauty between your legs .....and all you can do is sit there and scratch at it".

NHS decide on vaccine from UK based GSK - Cervarix® for teenage girls for cervical cancer causing HPV virus - genital warts ignored - none for boys

An editorial published in the BMJ on Friday ,claims (the editorial is by Jane J Kim, assistant professor of health decision science Program in Health Decision Science, Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA) that the UK government may save 18.6 million pounds ($37 million) annually as a result of its decision to select GlaxoSmithKline's ( a UK based pharma company) cervical cancer vaccine Cervarix for its human papillomavirus immunisation programme rather than Merck & Co.'s (a US basd pharma company) and Sanofi-Aventis' ( a Paris, France based company) Gardasil. (Search this site on "Gardasil" for post on the subject)

This decision is based on a study Economic evaluation of human papillomavirus vaccination in the United Kingdom by Mark Jit, Yoon Hong Choi, and W John Edmunds, Modelling and Economics Unit, Centre for Infections, Health Protection Agency, London NW9 6BT

The model involves 34 variables (Table 1) about which assumptions are made as rationally as possible on the available evidence (We then generated parameter values for cost and utility weights by Monte Carlo sampling (using the Latin hypercube method) from the joint distribution of plausible ranges of values for each parameter - which sounds impresive but is in reality a sort of re-inforced guess, as so litle actual evidence of use is currently available). To make a detailed evaluation of the methodolgy and the evidence supporting the assumptions is skilled and complicated task. Such modelling can easily be "tweaked" ... "We constructed a total of 2700 possible scenarios " . A stricture used is that users of such Monte Carlo simulations rely entirely on the initial subjective estimates and almost never follow up with empirical observation.i.e they place over reliance on the model.. which they have to because no more empirical evidence is available currently.

Faced with a need to make a decsion within a timeframe these limitations must be accepted - however we have the luxury of time, a delay in decsion making makes the position no worse and affords time to refine procedures, undertake critical analysis and consult other viewpoints.

"Only the 72% of model structures that best fit prevalence data for human papillomavirus were used in the analysis, but care should be taken when interpreting model results not to assume that each of the remaining model structures is equally plausible. etc., etc., caveat, caveat ...."

"Although we have included the estimated impact of screening in the model and tried to account for the accuracy of screening in our results, some of the details of the programme (such as rescreening women more often after a suspect result) are difficult to properly implement in the current model structure."

The conclusion arrived at was that Vaccinating 12 year old schoolgirls with a quadrivalent (protection against 4 known HPV virus' 2 of which cause genital warts) vaccine at 80% coverage is likely to be cost effective at a willingness to pay threshold of £30 000 ( Euros 37 700; $59 163) per QALY gained (quality adjusted life years (QALYs), discounted costs and benefits at 3.5% per year in the base case, and adopted a healthcare provider perspective on costs, as required by the National Institute for Health and Clinical Excellence), if the average duration of protection from the vaccine is more than 10 years.

Implementing a catch-up campaign of girls up to age 18 is likely to be cost effective.

Vaccination of boys is unlikely to be cost effective.

A bivalent vaccine (affording protection against HPV virus' that cause cervical cancer NOT genital warts) with the same efficacy against human papillomavirus types 16 and 18 costing £13-£21 less per dose (this is max. 10% of vaccine costs) (depending on the duration of vaccine protection) may be as cost effective as the quadrivalent vaccine although less effective as it does not prevent anogenital warts

Jane Kim in the editorial said that "the decision to select the bivalent vaccine implies the Department of Health is willing to accept foregone health benefits (and additional cost savings) from averting cases of genital warts for the reduced financial outlay."

Jane Kim added: "Assuming 80-percent coverage of current 12-year-old girls (each year cohort has some 350,000 girls) in the UK with the full three-dose vaccine series, this price differential translates to savings of 11.5 million pounds ($23 million) to 18.6 million pounds ($37 million) from the vaccine price alone in the first year of the programme.”

In response, a spokesperson for the Department of Health noted that "the contract has been awarded for the vaccine that scored best overall against a number of pre-agreed criteria and offers best value overall to the NHS."

This policy of limited protection at a reduced costs is not without its critics. Colm O'Mahony, a consultant in sexual health at Chester Foundation Trust, commented that “all the clinical evidence pointed to Gardasil and instead [the government has] chosen a vaccine suitable for the Third World.”

Natika Halil, director of information at the Family Planning Association, remarked that "genital warts has its own financial cost to the NHS which spends 22 million pounds ($44 million) a year treating it, so it will be interesting to see how this has been factored into the cost analysis.”

As part of the cost analysis it was intersting to note that the NHS accept that the basic pap smear at Pap smear (£21.70, 2002 prices) is less than the recently introduced liquid based cytology (£25.40, 2003 prices). Also Costs for screening at sexual health clinics and outpatient clinics are higher (£37 and £68 respectively, 2003 prices). These costs will not diappear because screening will still be required because the vaccine only affords protection against 70% of potential HPV strains.

GlaxoSmithKline stated that data on Cervarix have demonstrated the prevention of pre-cancerous lesions and a strong immune response for 6.4 years, noting that “this is the longest duration of protection reported for any vaccine against HPV 16 and 18.”

The government's vaccination programme in 12-year-old girls is expected to start in September.

The Department of Health has released Press release today "300,000 more girls to be offered vaccine against Cervical cancer - extension of the HPV vaccination progamme ". This trumpets the decision to choose Cervarix at a lower cost - for a routine vaccination of girls 12-13 years old starting in September which it is claimed will eventually save up to 400 lives for each year of girls receiving the vaccine. As a consequence The national vaccination programme against HPV is being extended to offer protection to an additional 300,000 girls aged 17-18, starting in September.

A 2 year ‘catch-up programme’ will start in the school year 2009/10 to vaccinate girls aged between 15 to 18. Today’s announcement means that girls, who would not otherwise have been included in this catch-up programme, will now be vaccinated this school year. Boys will not be vaccinated at any age.

Dawn Primarolo says the cost of the vaccine is commercially confidential. Cervarix® will be purchased by the Department of Health who will supply it free of charge to the NHS.

The financial consequences will be that The Department of Health will provide additional support to PCTs in guidance and funding to ensure that the roll out of the older cohort is a success.

There will be an additional £10 million for PCTs in the 2008/09 financial year to implement this extra programme.

It is not accidental or incidental that programme on Channel 4 Dispatches (in the UK only), "The Jab that can stop Cancer" presented by Jane Moore (who has paid privately for the vaccine for one of her daughters and will eventually for the younger daughter to have Gardasil) will discuss this subject at 8.pm this evening.

Professor David Salisbury , Director of Immunisation,Dept. of Health made great claims for the precision of the modelling and calculation for costs and benefits - making asinine remarks about the amount of computer time spent in running the models - all weekend, when nobody else was using it - as if that was proof of veracity or accuracy.

A lady epidemiologist pointed out that cervical cancer rates and mortality had fallen dramatically since pap screening was introduced and that 40 wome died per million. She queried whether the costs justified he claimed benefits say against the people who will suffer heat diseases or more common life threatening cancers.

A snapshot was also provided how the UK market was softened u by intensive (and dubious) marketing programs, and thiny veiled surveys paid for by the pharma companies were presented to the press as "evidence".

GP's , now used a better educated and better informed patient were asking for protection for their children- simply assuming the benefits it provided on the wave of "astro-turfing" or the unquestioning and incurious wall to wall press coverage.

No mention was made of the details of the modelling, nor was it made clear that Cervarix provides no protection against other HPV strains ( are over 100 known strains) that cause genital warts - nor was the case examined for protecting boys.

In the world of private medicine, Jane Moore has made her decision , US and French (and those in 100 countries where it is currently approved) citizens will make theirs (although different insurers have different policies)

NHS Choice HPV vaccination information site

How does a parent decide ?

As the NHS / Government have made a decision to supply at no extra cost the parent has to first consider ;
1. Any vaccine carries risks when used, what are those risks ?

To date the only large scale usage has been in the US and we posted about the latest report here Tuesday, July 08, 2008 Gardasil® gets 7,802 adverse reports to CDC by VAERS system

2. Having accepted that risk , what risk is there of my daughter eventually coming in contact with a strain of HPV ?

It is not 100% but near it. The more promiscuous (ie the greater number of sexual partners - of either sex, it can be transmitted between women) she is, the greater the chance. There is no clear evidence that sexually transmitted infections (STI) have any effect on increasing / reducing the impact. Please note that the cervical smear test, whilst it will may discover evidence of STI's , that information in the UK will not be passed on to the patient. It is not a genito urinary test. (As an aside it would be a service to women to re-jig the test to incorportate a genito - urinary test)

The "pap" smear testing will continue (remember that results vary regionally, and are reported differently, the NI method of identification is different to the rest of the UK. The report also identiffies that fact that over time it will be necessary ..." to take account of possible changes to the cervical screening programme, such as the introduction of DNA testing for human papillomavirus, .....It is clear that significant further work on the design of optimal screening and vaccination programmes is required, particularly if the introduction of vaccination accelerates the recent trend for the declining uptake of screening.

i.e it is possible (many would say highly likely) that vaccination will lead to lack of detection in the population as women will think or assure themselves that the unpleasant cervical smear routine can be avoided.

The FDA says the human papillomavirus is the most common sexually transmitted infection in the U.S. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that more than half of all sexually active men and women become infected at some time in their lives.

3. If she contracts an HPV will it be oncogenic (cause cervical cancer) ?

Currently it is felt that the 2 strains afforded protection by both current vaccines accounts for 75-80% of HPV's discovered in pap tests.

Of women conracting oncogenic lesions, the eventual death rate some 40 per 1 Mn a year die, many of course suffer an unpleasant and debilitating illnes for varying periods like all cancers.

4. Will better vaccines become available affording more protection ... ?

No doubt other manufacturers are working , and GSK and Merck will be improving their product - it must be assumed newer products will afford better protection and less risk at lower cost. The timescale is unknown.

To be effective protection must be given prior to any sexual contact - it is not necessary for intercourse to take place for transmission.

This site does not give medical advice, it gives plenty of information and directs the user to sources of further information. Anyone considering having their children vaccinated for HPV must consult their GP.

Joe Moore chose it for her children.

Lord Patel is ;

1. Very sceptical of the need to make a decision - there is no urgency.

2. Not at all impressed by Dr David Sainsbury Salisbury and his fancy modelling - truly it is as good as modern techniques and the data available can provide. The assumptions / guesses used are not based on sufficiently strong evidence .. yet, more will become available as others users / providers take part in a very large experiment on their children. Lord Patel can see no reason why anyone should enter their children in this great experiment. Giving you children a healthy diet, exercise and making sure they never smoke are far greater benefits you can pass on to your kids.

3. Feels that the NHS has higher priorities than providing at zero cost a protection which in essence will stimulate promiscuity rather than restrict it - with the attendant risks of STI's.

4. Is certain that undue pressure (without any proof, but based on wide experience of big pharma) has been put on the decision makers to support a "British" product.

5. It also represents another example of the state usurping personal choices and decisions using a decision making process which is opaque to many people - inlcuding most of the medical profession. (next time you see your GP ask him about the Monte Carlo method usng tjhe latin hypercube method)

Dying in Hospital - Adverse Drug Events in UK Hospitals - Controlling costs to control disease

Colin Norris, 32, a nasty arrogant staff nurse murdered four elderly patients with lethal injections of insulin at Leeds General Infirmary and St James's Hospital in Leeds ("Jimmy's" of TV fame) hospitals and has been given a 20 year sentence.

Dying in hospital is not an unusual event. It is a fate we all fear.

Dying or illness induced by the maladministration of medicines in a UK is not at all unusual. You don't need to meet a Colin Norris or a Beverley Allitt to die from an adverse drug event - events which have to be recorded by statute.

1 in 10 patents entering NHS hospitals will experience an “adverse event”, and 1 in a 100 will die as a consequence wrote the Editor of the British Medical Journal 0n the 8th April 2004.

Nothing has changed since then. Which is the reason that people like Norris - and don't think he is unique - can thrive in the NHS culture.

The unwillingness of the medical establishment, consultants, doctors, nursing staff, pharma companies and the NHS managing bodies, trusts and their elected and un-elected representatives to examine this dark secret within the health services is understandable, if regrettable.

Complacency and inertia well dosed with a wish to leave the washing of the medical profession's laundry in private is a powerful force.

It is even more regrettable that it is only after 60 years of the National and “free at the point of delivery” Health Service (NHS), which was apparently, until recently, “the envy of the world” are the “adverse” effects of hospital treatment being identified and studied.

Especially since Ivan Illych in the early 1970's in his book Medical Nemesis alerted the world to the problems of iatrogenic illness, that is, illness caused by medical treatment. In the UK efforts to quantify and cost these effects in monetary and wasted use of staff, time and resources. Only now are we shuffling towards framing sensible, rational plans to deal with these skeletons in the medical cupboard. Unlike say, the Netherlands where constant monitoring, high levels of isolation of affected patients and rigorous controls have almost completely removed the problem from hospital wards of Hospital Acquired Infections (HAI). A lesson we persist in refusing to learn.

Medical mistakes, misdemeanours, misunderstandings and resulting confusions and cockups are an apparently irredeemable consequence of organisations such as the NHS, the biggest employer in Europe. Plenty of studies on both sides of the Atlantic have shown the varying extent of dishonesty, incompetence and plain stupidity, the costs of which, both in health and money are exacerbated by the introduction of the legal process.

This has led to excessive litigation, overpaid greedy lawyers, fed and funded by obtuse thick skinned and bone headed bureaucrats unwilling to accept the realities of the world, anxious to both conceal and cover-up their organisation's mistakes and errors. Their medical colleagues meanwhile have continued to peddle the popular myths of modern medical practice with it's much publicized store of hi-tech wizardry, golden bullets and glamorous “brilliant” surgeons, fresh from their glitzy tours of the TV studios.

Staphylococcus infections, have been present for decades in UK hospitals, they frequently accelerated death for patients with terminal conditions, and consequently obtained the medically neutral and apparently benevolent description as “the old man's friend”. The problem was trivialised and ignored, a factor affected by changes in hospital management more anxious to control costs than disease. Resistant Staphylococcal aureus strains emerged (MRSA).

Strains appeared in hospitals world wide, often resulting from the use of massive doses of antibiotics, to control wound infections, increasingly because of the use of novel and extensive invasive surgical procedures, especially organ transplants, bio-mechanical implants and more recently the widespread use of very much improved dialysis methods as well as unnecessary catheterization of incontinent patients to relieve nursing care, reduce bed changes and control costs. There is broad agreement that 50,000 patients are affected each year in the UK with 5,000 deaths in hospital (at least) from HAI (not including deaths after discharge which are unknown but must occur).

To MRSA and the more recent epidemic of Clostridium difficile must now be added Multiple Drug Resistant TB (MDRTB) of which there have been (to date) a few isolated outbreaks and deaths which will increase due to in an increase hospitalised HIV / TB patients, especially of infected immigrants from Africa and increasingly Eastern Europe and the new EU states such as Estonia and Slovakia. There is reason to believe that MDRTB is where MRSA was 20/30 years ago – therefore effective prompt action is essential. Care costs for a single patient of MDRTB can be in the hundreds of thousands of pounds and an outbreak in millions.

A DRUGS DOWNER IN LIVERPOOL

Dr Munir Pirmohamed and colleagues in Liverpool reported in 2004 the consequences of admitting patients suffering from adverse drug reactions (ADR) in 2 Liverpool hospitals (BMJ Vol 329 3.7.04. p. 15-19). They studied 18,820 patients admitted over a 6 month period in 2001 over 16 years old, excluding all patients with deliberate or intentional overdosing and women with obstetric or gynaecological problems, a total of 1225 admissions.

This was the largest such study undertaken in the UK and showed that ;

Up to 6.5% of all admissions were related to ADRs, with a median age of 76 yrs compared with 66 yrs for all admissions and with a slight bias to females.

The median bed stay was 8 days or 4% of theoretical bed capacity (equivalent nationally, to seven 800 bed hospitals) involving, at average bed costs of £228 per day an annualised cost to the NHS of £466 Million.

1. 72% of the ADRs were by their definitions “avoidable”.
2. 2.3% of ADR patients died as a direct result of the ADR = 0.15% of all admissions, (broadly equivalent to reports of US experience.)
3. An annualised UK assessment indicates 5700 deaths of the 3.8 million acute hospital admissions per year. If ADRs subsequent to admission are added, this could indicate a total greater than 10,000 deaths per year. The authors indicate that deaths resulting from ADRs not admitted to hospital in primary care are probably equivalent in number. A possible total of 30,000 deaths per year in the UK.

The drugs responsible are in common and widespread use and are mainly basic drugs that have been in use a long time in general practice for many common conditions and include analgesics like aspirin and Non Steroidal Anti Inflammatory Drugs (NSAIDs) like diclofenac, diuretics, steroids such as prednisolene and blood thinning warfarin. Adverse effects may result from single use or in combination.

Besides the unsurprising call for more research, the authors conclude that it is incumbent on primary care prescribers to use the lowest dose necessary to achieve results, they identify evidence from others, that deaths related to aspirin (the cause of most problems and deaths of ADRs in the study, directly and in association with other drugs) could be reduced by 30% with a standard low dose of 75mg.

Funded by the Medicines and Healthcare Products Regulatory Agency (MHRA formerly Medicines Control Agency) the study highlights the needs for urgent action to reduce the burden on the NHS (presumably in money, wasted resource, and opportunity cost, and customer satisfaction), not to mention the anguish to patients and their families of illness, hospitalization and death. It is very good news that several of the authors sit on bodies and authorities who can pursue more research and effectively ensure that the necessary and urgent action is taken. Let us not forget that the initial report quantifying the costs of HAI from the NAO was published over 9 years ago.

What would be nice to report is that the pharmaceutical industry, to which antibiotics represent 2% of worldwide sales has produced a new antibiotic. It is 25 years since any antibiotic has been produced and there is not, nor is there any imminent possibility that a new and unexplored chink has been found in the biochemical pathways and metabolic systems of the major pathogens. These communicable diseases, TB, cholera, typhoid, malaria are now only ravaging the third world, which are set to increase with population growth and with increasing low cost international travel, legal and illegal immigration and the exodus of refugees from wars for resources.

Meanwhile the pharmaceutical giants are desperately seeking a new disease, called female sexual dysfunction, so they can double the market overnight for the lifestyle drug , sildenafyl citrate (Viagra / Cialis etc.,). The results so far, are disappointing. The lady really does have a headache. Lets hope she doesn't OD on the aspirin and end up as one more of the NHS ADRs and ends up boosting Dr Pirmohamed's revealing and alarming statistics.

See an earlier US study Reducing and Preventing Adverse Drug Events To Decrease Hospital Costs. Research in Action, Issue 1. AHRQ Publication Number 01-0020, March 2001. Agency for Healthcare Research and Quality, Rockville, MD.

"Over 770,000 people are injured or die each year in hospitals from adverse drug events (ADEs),1-3 which may cost up to $5.6 million each year per hospital4,5 depending on hospital size. This estimate does not include ADEs causing admissions, malpractice and litigation costs, or the costs of injuries to patients. National hospital expenses to treat patients who suffer ADEs during hospitalization are estimated at between $1.56 and $5.6 billion annually.4-7."

Note also ESF-UB Conference in Biomedicine Pharmacogenetics and Pharmacogenomics:
Adverse Drug Reactions - Hotel Eden Roc, Sant Feliu de Guixols ,Spain - 27 June – 2 July 2008
Chair: Munir Pirmohamed, University of Liverpool, UK
See Program here "Adverse drug reactions are a major problem for healthcare services, the pharmaceutical industry and regulators. This has been highlighted recently with some high-profile drug withdrawals and regulatory decisions." One thinks of Vioxx....

Designer Vaginas - booming business on the NHS

"More and more women are said to be troubled by the shape, size, or proportions of their vulvas, so that elective genitoplasty is apparently a "booming business." Advertisements for cosmetic genitoplasty are common, often including before and after images and life changing narratives. Google produced around 490 000 results when we entered "labial reduction". Forty seven of the first 50 results were advertisements from clinics in the United Kingdom and United States offering cosmetic genital surgery. Television programmes and articles in women's magazines on "designer vaginas" may also fuel desire for ..... "

Requests for cosmetic genitoplasty: how should healthcare providers respond?

Lih Mei Liao, consultant clinical psychologist, Sarah M Creighton, consultant gynaecologist

Middlesex Centre, UCL Institute for Women's Health, Elizabeth Garrett Anderson and Obstetric Hospital, London WC1E 6DH

British Medical Journal 2007;334:1090-1092 (26 May), doi:10.1136/bmj.39206.422269.BE

The U.K.'s National Health Service in 2004 and 2005 paid for elective surgery on 800 women who had the size of their labia reduced. That's more than double the number of procedures funded by the government 6 years earlier.... who says that doubling the expenditure on the NHS isn't producing results ?

UPDATE - Toni Fabuloso calls (she gets weekends off) to tell us that in the business it's called an "Aussie makeover " ... y'know it's "Downunder".

For the diabetics amongst you the issue also contains the following ..

Study indicates diabetes drug linked to cardiovascular death

Janice Hopkins Tanne

A meta-analysis of 42 trials of the type 2 diabetes drug rosiglitazone (Avandia - GSK) has shown a significantly raised risk of myocardial infarction and an increase in cardiovascular deaths that did not quite reach statistical significance (New England Journal of Medicine 2007 May 21 doi: 10.1056/NEJMoa072761).

Sally Clark : A Troubled Life

Sally Clark had a brief and unhappy life. The daughter of a Divisional Commander of South Wiltshire police, a lawyer with a large and prestigious Manchester law firm, her first two children died within months of their birth and she was threatened with having her third child taken from her.

She was initially charged with her husband for murdering her first 2 children. Charges were subsequently dropped against her husband and she faced alone, a trial for their murder. She was found guilty and spent 3 years in prison.

She has now been found dead at the age of 42, the circumstances of which will no doubt become clear in the near future.

BBC (and other news reports) have been endlessly been relaying misinformation about Sally Clark, her trial and subsequent and successful appeal. There are two major points to be made.

1. The BBC have, since the news broke reported that the prosecution displayed her as a weak minded drunk. This is a lie and is based on a complete ignorance of what happened at the trial.

In a curious agreement approved by the judge, the jury were denied hearing anything about Sally Clark's alcoholism, binge drinking .... or evidence concerning her character. Julian Bevan QC, for the Dwefence, that ornament of the Bar, who never met his cleint before the trial, traded with Robin Spencer QC for the prosecution in pre-trial hearings, silence on the alcohol problems Sally had suffered, which it was agreed had no direct bearing on the case, with an agreement not to introduce character witnesses for Sally. The world of high pay, high pressure solicitors who charge hundreds of pounds per day for their time, expertise and legal and technical skills, where taking half bottles of vodka to work and slipping out to Marks & Spencer for gin and tonic mixer drinks is outside most newspaper reader's experience.

At the conclusion of the trial, when the jury had returned their verdict of guilty, the judge allowed Robin Spencer QC who led the prosecution to announce that Sally Clark had received treatment at the Priory Hospital for alcohol problems. This had been revealed when Police found receipts for payment for the treatment when searching their house, long before amy charges had been laid.

This led of course to the publication the following day of an orgy of stores which had long been circulating in those bars in Manchester where the demi-monde of the legal profession, policemen and journalists slake their thirsts and swap gossip.

The Sunday Mirror: “Fall from grace for the woman with everything;” the Daily Mail, “Driven by drink and despair, the solicitor who killed her babies;” Manchester Evening News: “Pregnant days after murdering baby son.” ,”Baby killer was 'lonely drunk” headlined the Daily Telegraph were typical press reaction unleashed by the gratuitous and unecessary post trial revelation of Robin Spencer QC.

Quite how the jury reacted to the failure of the accused to provide a single character witness in forming a judgement about her it is impossible to determine (they voted 10-2 so 2 thought her inoccent) ... it certainly did not help her case. The subsequent Press coverage removed any doubts the public may have had about her guilt.

Paradoxically BBC news and Press reports the many and glowing reports, and support by family and friends - support her lawyers excluded from her trial in a grubby deal between the lawyers and with the collusion of the Judge.

2. BBC news and other reports persist in their hounding of Professor Meadow and his illusory statistics about child deaths. His evidence had negligible effect on the appeal at which the prosecution stated it ..."no longer seeks to uphold these convictions… The Crown does not seek a retrial”

The 2nd appeal at the Royal Courts of Justice on January 28th 2003, before Lord Justice Kay (now dead) (led by Claire Montgomery QC of the famous Matrix Chambers - the defence team having sensibly ditched Julian Bevan QC) was brief and related entirely to a single point.

During the trial there had been a most remarkable intervention in the proceedings by the jury.

On being recalled to give evidence during the trial Dr Alan Williams (pic), a Home Office consultant forensic pathologist was asked to answer questions about blood samples taken from the body of Harry (the second child to die) in a written question submitted by the jury he said “…the chemistry of blood is so unreliable after death as to be of no diagnostic value…”. Of the post mortem blood sample “…it was submitted for toxicological examination and would have been sent for viral studies”.

It was the jury who had penetrated the obfuscating fog of legal terms, medical terminology, and pedantic process. It was these 12 peers, good and true, who identified the simple clear need to answer a simple clear question. A question they framed in writing and presented to the judge. Harry died, blood samples were taken, what did they show?

Faced with this clear simple question, Dr Alan Williams, produced a simple response. He lied.

Cross examined by the defence, Williams claims that the appropriate microbiology reports had been provided to the prosecution (and therefore available under disclosure to the defence). This was untrue. It was a lie. It was a point that Julian Bevan QC failed to pursue. It was this bald faced lie that led to her eventual release from prison and acquittal. Claire Montgomery's appeal notes are available (30 pages Word) the the first 2 paras cover the discovery of the medical reports showing infection in Harry. The 3rd para states;

"This is a clear case of non disclosure by the prosecution. This non disclosure has caused a serious miscarriage of justice. "

Invited to the appeal to explain, Dr Williams failed to show up. Collapse of case. Prisoner acquitted and released.

The truth was, of course revealed after 2 years of terrier like digging and pestering of statisticians, pathologists and paediatricians by her devoted and unswervingly faithful husband Steve Clark and legal defence team.

On Monday 11th February 2002 the 1998 post mortem microbiology report on Harry eventually surfaces from Macclesfield Hospital. It is reviewed by leading pathologists who say that the evidence of 8 sites of Staphylococcus aureus infection in Harry's corpse and the presence of polymorphs within the cerebrospinal fluid show that Harry's death was caused by overwhelming staphylococcal infection and that no other cause of death can be sustained (this presence of infection by SA was known by Dr Wiliiams in February 1998). It later emerges that these samples had been sent at the time to the national reference forensic laboratory at Colindale for further testing. The significance of Dr Williams remarks in answer to the jury's apparently innocent question at the trial about post mortem blood results become crystal clear.

Robin Spencer QC for the Prosecution, probably fingering his collar and raising a degree of sweat on his noble brow addressed the Court...

“My Lords, Dr Williams has decided not to appear as a witness…and the prosecution no longer seeks to uphold these convictions… The Crown does not seek a retrial” (Dr Williams was subsequently banned by the GMC from Home Office pathology work for 3 years but allowed to continue to work as a consultant histopathologist - it also became apparent that Dr Williams had known about Harry's infection since February 1998 but did not tell lawyers in the case and justified this by claiming that he thought the infection was post mortem contamination.)

Later a written report was presented by Justice Kay which dealt with the evidence of Professor Meadows...

."…The statistic 1: 73 million is clearly inadmissible in law, could not have failed to mislead the jury, and should have never been allowed in evidence… Sufficient in itself to make these convictions unsafe. Dr Williams is responsible for failing to disclose a material document, which must have affected the outcome of the trial and is a serious matter. The appeal is allowed with costs. There will be no retrial.”

Whilst the laboratory results might explain the death of Harry they do not of course explain the death of Christopher but made the conviction unsafe.

Professor Meadow's (pic) statistics were never challenged by the gilded mind of Julian Bevan, QC - which it was his duty to challenge - he didn't , through ignorance, torpidity, whoknows? His silence on the matter could reasonably be interpreted by the Jury as acceptance of the truth of Meadow's false statement. We have an adversarial system , for good or ill, and Bevan and his team failed in his job of obtaining opinion (which was not difficult to find) to contradict his amateur statistical claims. It helped to seal Sally Clark's fate.

Curiously the supporters of Sally Clark have conducted a ceaseless and vurulent campaign (almost a witchunt) against Professor Meadow's through the GMC and the Courts - there hasn't been a whisper about Sally Clark's incompetent lawyers. Meadow's has the support of the vast bulk of his professional colleagues, he has advanced the knowledge and understanding of why parents, especially mothers killed their babies.

The matter however has however not been allowed to rest there .... The murders were imaginary, apparently the faulty construct of blinkered and obtuse and elderly experts, their apparent causes illusory, the consequences unimaginable to any parent. The capacity the of medical forensic profession for increasing the population of imaginary murders was not however stilled. Earlier, Professor David Southall had seen a Channel 4 programme concerning the Clark case, he was a colleague of Professor Meadow. He prepared a report which he submitted to the Police on the basis of seeing the programme, stating that Steven Clark, the father, had been involved in the death of his 2 children. This bizarre allegation which he refused to retract, and was repeated to the GMC Professional Conduct Committee was judged on June 5th 2004 by the General Medical Council , they ruled that Prof Southall acted in a manner that was “inappropriate”, “irresponsible” and “misleading” in compiling a report outlining his accusations and concerns.

Subsequently on August 7th he was found found guilty of serious professional misconduct after accusing solicitor Sally Clark's husband of murdering their children.

It is one of the many mysterious aspects of this case, that Mr Clark has never sued Profesor Southall, for what is undoubtedly a gross and serious libel.

For those interested in informing thermselves further about this case should read the partial (as distinct from impartial) account of the trial by a childhood friend of Sally Clark and her family, and solicitor John Batt which Sally Clark helped to write - although it is unclear where Batt ends and Clark begins in the narrative.

As the only published account of the whole trial this book is invaluable to understanding the case of Sally Clark and her troubled life - in which the actions and decisions of powerful "professional" men have played such an important and tragic part.

Stolen Innocence: The Story of Sally Clark by John Batt, Ebury Press 2004 ISBN 0091900700 336 pps.

A useful review is here and a review in the BMJ, with an interesting range of highly informed comment here

Press enquiries should be made to Sue Stapely, Quiller Consultants T: 020 7233 9444 M: 07885 798833 who have handled the publicity machine since before the original
trial.

Legalise Prostitution

The murder of 5 women in Ipswich and mass media coverage has focussed public attention on the confluence of addiction to heroin and crack amongst people called sex workers. Such that John Mann Labour MP for Bassetlaw asked Meg Munn the The Minister for Wimmin & Equality this afternoon ..." What estimate the Government have made of the percentage of women involved in the sex industry who are addicted to class A drugs. "

She replied that a 2004 Home Office study profiled 228 women involved in street-based prostitution and found that 87 % "used "heroin and 64 % "used" crack cocaine. Subsequent anecdotal evidence she said suggests that —in many areas, practically all of those involved in street prostitution used class A drugs.

To which John Mann riposted that the provision by the NHS of effective drug treatment is a key intervention in relation to prostitution, especially street prostitution and Meg Munn agreed claiming ;

1. The Government had introduced a co-ordinated prostitution strategy
2. Recognised that providing appropriate drug treatment was essential and had "invested" £600 Mn in drug treatment provision in the recent past.

Dr Brian Iddon , Labour MP for Bolton, South-East revealed that Wigan and Bolton health authority carried out a survey in recent years, of the "sex industry", which showed that 98 % of the women on-street were addicted to heroin. In contrast few of the women off-street were addicted to any drug at all.

Lorely Burt the deliciously named Liberal Democrat who represents, Solihull , the classier end of Birmingham, spared the sights of streetwalkers, felt that the Gubment's Strategy was merely a watered down change of rules allowing girls to work in pairs from an address, a crackdown on kerb crawlers and help on adiction to class A drugs and called for legalisation. This last brought the preposterous Mr. Denis MacShane scattering aside conventional wisdom (and detailed evidence) about pimps, white slave traffickers, drug dealers, addicts, sex slaves UN treaties, EU conventions and blamed the men. The Liberal Deocratic idea of legalising prostitution was ludicrous. He sat down.

Michael D E Goodyear and Linda Cusick published an Editorial in the British Medical Journal (BMJ 2007; 334: 52-53 12th January - subscription only) Protection of sex workers

A full text of their arguments for legalisation can be found as a Word Document
Remembering Ipswich: a plea for human rights.

A must read analysis, succinct, precise and concise arguments - complete with 124 footnotes and many, many contemporary articles and links - for example the final Note 124 is Matthew Parris. We could have protected the Ipswich women. We failed. The Times December 16 2006.

Another which ecapsulates the dreadful conseqences of life as a "sex worker" is ;

What happens to women who sell sex? Report of a unique occupational cohort.
By H Ward and S Day Department of Infectious Disease Epidemiology, Imperial College London, Norfolk Place, London W2 1PG, UK. h.ward@imperial.ac.uk

BACKGROUND/ OBJECTIVES: Sex work has been seen as both a health and a social problem. However, there is a paucity of evidence on the longer term impact on health. We explored the health and career paths over a period of 15 years among women who have worked in the sex industry. DESIGN: A longitudinal study of sex workers recruited between 1986 and 1993 and followed for 15 years. Outcome data were obtained through interview, clinic records, or third parties. SETTING: Clinic and community settings in London. PARTICIPANTS: We obtained outcome data on 130 (37%) of the original cohort of 354 women, with a combined follow up of 1247 years. MAIN OUTCOME MEASURES: Vital status, most recent occupation, duration of sex work, sexually transmitted infections (STI), major health problems. RESULTS: The majority (73/124, 59%) were still in the sex industry and had sold sex for a mean of 13.6 years (!). There were six deaths, a mortality of 4.8 per 1000 person years. Surviving women had a high cumulative risk (110 of 118, 93%) of STI. Past gonorrhoea was associated with pelvic inflammatory disease (RR 2.28, 95% CI 1.12 to 4.66) and infertility (RR 10.9, 95% CI 1.5 to 77.3). Other outcomes included mental health problems (38 of 97, 40%) and addiction (46 of 72, 64%). There were no significant differences in health outcomes between women who were still in the sex industry and those who had stopped. There was a high level of occupational mobility, and 31 women (of 84, 37%) had completed vocational or higher education, including eight to postgraduate level. CONCLUSIONS: Sex work is associated with excess mortality and morbidity including the sequelae of STI, mental health problems, and substance abuse.

Goodyear and Cusick place the Ipswich murders in context ;

"Several other women have been murdered in the area over a 15 year period, and the number of murdered sex workers around the world continues to grow. Standardised mortality rates for sex workers are six times that of the general population (eighteen for homicide ), the highest for any group of women anywhere, with an estimated murder every two months in Britain. Premature death forms only part of the spectrum of violence and abuse experienced daily, with a high burden of physical and emotional morbidity. , Violence against sex workers is endemic, historical , , , and part of a much broader problem of violence against women. Commentators have angrily pointed out the contrast between the scant attention paid to the regular murder of women compared to a sudden concern that a “serial killer” is involved, when the issue suddenly becomes a matter of public safety. "(This paragraph has 22 references)

They go on to argue strongly for a solution or at least a Remedy ;

"To maintain the status quo is both unacceptable and moral cowardice. The Prime Minister has opposed legislative reform, and attempted to stall the rising clamour for the protection of women, but must now demonstrate leadership to restore dignity, justice and human rights by eliminating prostitution as a crime. In doing so he has a number of lessons from history to guide him. In 1883, Gladstone acceded to public pressure, and suspended the Contagious Diseases Acts following a majority vote in the house. In 2003 Helen Clark, New Zealand’s Labour Prime Minister, emphasised that her actions in supporting decriminalisation was not related to sexual morality, but to a duty to place the welfare of the vulnerable and marginalised first. A similar position was taken by the Green Party"

He finishes by reference to the Ipswich victims ;

Gemma, Tania, Anneli, Paula and Annette were some mother’s daughters, and some childrens’ mothers. Their deaths were inevitable. (*)They deserved better, but we failed them., We will honour them best, not just by memorials, but by doing the right thing.

(*)The deadly effect of zero tolerance --Attempts to stamp out the sex trade will drive it underground and put women's lives at risk

Diane Taylor Wednesday January 18, 2006 The Guradian

Whatever your views on the Legalisation of prostitution, un the UK or anywhere you should read these arguments.

Medical Advances of the last 200 years - Vote Now

The BBC Today programme "Today", reminds us all that the British Medical Journal search for the most important medical advance since the Journal was founded in 1840 will be announced on 18 January 2007 on the BMJ’s "new look website."

Lord Patel brought this to readers attention in September , now you can read the details of the 15 most important advances - and an excellent potted history of recent medical science . Anyone, anywhwere in the world can vote here http://www.bmj.com / from ;

Anaesthesia / Antibiotics
Chlorpromazine / Computers
Discovery of DNA structure / Evidence-based medicine
Germ theory / Immunology
Medical imaging (x-rays, etc.)
Oral contraceptive pill / Oral rehydration therapy
Risks of smoking / Sanitation(clean water and sewage disposal)
Tissue culture / Vaccines

Lord Patel has voted for Vaccines. First described and produced for rabies by Louis Pasteur in 1855 ( Portrait Albert Edelfelt, en el Musée d'Orsay) . Vaccines have seen the end of (often fatal) childhood diseases like diphtheria, whooping cough, measles, rubella, polio, mumps, and rubella rare and distant memories - and now for cervical cancer which is now seen to be the result of a communicable STD. Championed by Michael Worboys, Centre for the History of Science, Technology and Medicine and Wellcome Unit for the History of Medicine, University of Manchester, Manchester

Teachers at all levels - there is valuable resource material here.

BMJ - most important medical advances

The Editor of the British Medical Journal has asked readers to nominate the most important medical breakthroughs since 1840 when the BMJ was first published.... when he points out life expectancy was half what it is today.

Nominations in les than 100 words by Wednesday 20 September. The most popular 15 breakthroughs will then be voted on and the results announced in January 2007.

Entries to date - many and varied, can be read here. Interesting views on medical advances in the last 166 years.

WARNING - a stay in hospital can kill you - inadvertently

The Sunday Telegraph reports brethlessly and in tones of shock, horror, amazement...
http://www.telegraph.co.uk/news/main.jhtml;jsessionid=O21VCMWK4D5NXQFIQMGSFFWAVCBQWIV0?xml=/news/2006/08/27/nhs27.xml

A total of 2,159 people died after serious lapses in care by hospitals, family doctors' surgeries, ambulance trusts, and in community and mental health care last year. A further 4,529 patients suffered severe harm because of avoidable mistakes, the National Patient Safety Agency (NPSA) said.

This is not news, and the levels of adverse events were known of years ago ... in fact "An annualised UK assessment indicates 5700 deaths of the 3.8 million acute hospital admissions per year"

http://www.williambowles.info/env/adverse_events.html
13/07/04 Good News on Adverse Events? By Edward Teague

1 in 10 patents entering NHS hospitals will experience an “adverse event”, and 1 in a 100 will die as a consequence writes the Editor of the British Medical Journal (BMJ) this week.

The piece also reported on ..

Now Dr Munir Pirmohamed and colleagues in Liverpool report the consequences of admitting patients suffering from adverse drug reactions (ADR) in 2 Liverpool hospitals (BMJ Vol 329 3.7.04. p. 15-19). They studied 18,820 patients admitted over a 6 month period in 2001 over 16 years old, excluding all patients with deliberate or intentional overdosing and women with obstetric or gynaecological problems, a total of 1225 admissions.

This was the largest such study undertaken in the UK

Briefly this study showed ..

1. Up to 6.5% of all admissions were related to ADRs, with a median age of 76 yrs compared with 66 yrs for all admissions and with a slight bias to females.
2. The median bed stay was 8 days or 4% of theoretical bed capacity (equivalent nationally, to seven 800 bed hospitals) involving, at average bed costs of £228 per day an annualised cost to the NHS of £466 Million.
3. 72% of the ADRs were by their definitions “avoidable”.
4. 2.3% of ADR patients died as a direct result of the ADR which is equivalent to 0.15% of all admissions, broadly equivalent to reports of US experience. An annualised UK assessment indicates 5700 deaths of the 3.8 million acute hospital admissions per year. If ADRs subsequent to admission are added, this could indicate a total greater than 10,000 deaths per year. The authors indicate that deaths resulting from ADRs not admitted to hospital in primary care are probably equivalent in number.
5. The drugs responsible are in common and widespread use and are mainly basic drugs that have been in use a long time in general practice for many common conditions and include analgesics like aspirin and Non Steroidal Anti Inflammatory Drugs (NSAIDs) like diclofenac, diuretics, steroids such as prednisolene and blood thinning warfarin. Adverse effects may result from single use or in combination.

Remarkably the 1 Mn people employed in the NHS fuck up from time to time, they are humans. As a result some people are ill, some recover, some, mainly the elderly and the very young die.

As far as can be ascertained, the rate of adverse events is roughly equivalenty in the USA and the UK, as is the rate of infection with antibiotic resistant strains of some bacteria.

The TB bacillus is becoming resistant to the armoury of antibiotics, so called Multiple Drug resistant TB MDRTB is on the increase and is prevalent inmany of the new EU states where needle exchange HIV is rampant, especially in prisons.

Not many people are taking much notice of that either. Perhaps the Sunday Telegraph will run a piece in a few years time when it has taken hold in the UK.... although there have been two major (and enormously expensive) outbreaks in London hospitals in HIV units.

4 hrs Jogging a week = 7 years extra life

Chief Cardiologist Peter Schnohr at Bispebjerg University Hospital, Copenhagen reported in the British Medical Journal the aapparent improvement in longevity as a result of jogging - which was discussed in 2000 in the BMJ(1)

The team also reported further studies in 2003(2). This was the first observational population study based on a random sample of 7,000 men and women from Copenhagen, Denmark, we investigated the impact of both regular leisure-time physical activity and altered physical activity on risk of death in healthy younger, middle-aged, and elderly men and women.

Now he and his team have reported in European Journal of Cardiovascular Prevention and Rehabilitation, the results of a further study in the exercise habits of over 5,000 people. They claim they can now directly relate hours of exercise undertaken into extra years of life.

People who exercise 4 hours a week live an average of 7 years longer than people who exercise less than 2 hours per week, concludes the new study based on data collected from the Østerbro Study, which has followed the lives of a group of Danes since 1976.

"Most people know that their health improves and they live longer if they exercise, but what's new is that we can calculate how many years you gain by exercising," Peter Schnohr is reported as saying in the Danish daily Politken.

Dr. Schnohr, who led the study, said the results reconfirm that exercise prevents hardening of the arteries.

"What's more, our study supports the belief that there is a relationship between exercise and mortality from cancer," he adds. "That's good news, because the number of people with colon cancer, lung cancer, breast cancer and prostate cancer is on the rise. Therefore we need to find something we can do to reduce the risk."

The size of the current study was too small to determine which types of cancer could be prevented by exercising he states.

Think you need to run a marathon to benefit ? Nonsense! says Dr. Schnohr The biggest gain comes when you get up from the sofa and start doing something.'

(1) Schnohr P, Parner J, Lange P. Mortality in joggers: population based study of 4658 men.
BMJ 2000;321:602-3. (9 September.)(HERE also )

(2) P. Schnohr, H. Scharling, and J. S. Jensen
Changes in Leisure-time Physical Activity and Risk of Death: An Observational Study of 7,000 Men and Women
Am. J. Epidemiol., October 1, 2003; 158(7): 639 - 644.

Recognise the City of joggers ? Moscow.

Unhealthy surgery.

Blessed with classical good looks, a firm muscular body, a fine head of hair, all my own (albeit snaggly) teeth, and a youthful complexion I have never felt the need to resort to cosmetic surgery (Unlike Snr Berlusconi who has had several "treatments", includinghair transplant / eyelids / face lift - see pic). Last week, the small breasted, big buttocked, bent nosed and sad lined faces thronged Olympia for the Body Beautiful 2005 exhibition.

The British Association of Aesthetic Plastic Surgeons claims to have recorded 16,367 cosmetic procedures in the UK 2004 - which is well up from a total of 10,738 in 2003. Of the people undergoing these procedures, 92% were women, and the most requested surgery was breast augmentation.

It is big and boomingbusiness. The most widely advertised group in the UK is Cheshire based Transform with 22 clinics and 30 years experience in preying on the vain in the UK.

It is an expensive, and one suspects, a very lucrative business, which unavailable on the National Health – except for injuries, post operative work for breast cancer.

Increasingly therefore many are combining a holiday trip with a visit abroad for cosmetic surgery in low cost clinics in a startling range of countries. You can combine a relaxing break, away from the pressures of daily life, with a stay in one of the overseas cosmetic surgery clinics which are now attracting patients from the UK , US Mainland Europe and amazingly Australia (where it was stated this week that 62% of adult makes are obese) the procedures are well established and the success rates are high for - Blepharoplasty (nose jobs), Liposuction, Otoplasty (ear jobs), Face lifts, Hair transplants, Abdominoplasty (tummy tuck), Breast implants or reduction surgery, and Botox facial treatments even labia minora re-shaping and Anal bleaching (don't ask!).

Of course if it all goes wrong - don't expect much help or compensation.

The new you, for the wannabe glamour puss (pic Miss Lola Ferrari who had 3 successive implants and died) is just a plane ride away, and all this is peddled , wrapped up in a luxury holiday.

The destinations are many, various and remarkable -

Cosmetica in Tunis which was featured on GMTV program LK Today on Thursday 6th January 2005, Cosmetic surgery abroad in Barcelona, Evolution cosmetics in Johannesburg, DrKapositas in Athens, RS Cosmetic Clinic in Cairo , Beautiful Beings in Prague , Clinic beauCare in Brussels and Utrecht , Dr Toncic, Zagreb , Croatia. It is noteworthy that they look for customers from the UK, America and Australia.http://www.toncic.net/eng/index.html

Cosmetic dentistry is not available for adults on the NHS, or if available, involves considerable expense – this involves everything from teeth whitening, orthodontics, teeth replacement with titanium implants, and even sparkling “gem” implants. This is also available in such a package but is still in its infancy.

The British Hungarian service, Dr. Volom Aesthetic and also both General Dental Surgery, and Kreativ Dental, all based in Budapest will provide a total package , travel, hotels, airport collection – They all specialise in tooth insertion which they claim provides improved appearance, speech, comfort, eating more self-esteem and better oral health and convenience. It is noteworthy that they look for customers from the UK, America and Australia.

An Estonian clinic offers similar services in Talinn.

Meanwhile the UK , Health Minister Patricia Hewitt announced today that the UK has agreed a contract with the South African Netcare healthcare company for production line / low cost Cataract surgery – selection of the company is very controversial , some of whose Directors are up on charges (BMJ report) with some Israeli doctors on charges of having used donors for renal transplants who were paid to supply their organs. The donors were mostly poor Brazilians willing to sell a kidney for up to $10 000 (£5400; €8000) each. The recipients were Israelis who paid up to 10 times that amount for a kidney. Most of the transplantations, said to number in the hundreds, are alleged to have taken place in two hospitals owned by the Netcare group, with most done at St Augustine’s Hospital in Durban.

It is alleged that when the scheme was running, donors had their passports confiscated on arrival in South Africa, and were provided with a low standard of hotel accommodation. As the investigators arrested participants in the scheme, several of the poorer Brazilian donors found themselves not only without a kidney but without payment when they got back to Brazil.

Health inequalities and New Labour: how the promises compare with real progress BMJ today

Mary Shaw, reader in medical sociology, George Davey Smith, professor of clinical epidemiolog, Danny Dorling, professor of human geography

Inequalities in health between rich and poor areas of Britain widened in the 1980s and 1990s, and the current government has repeatedly expressed its intention to reduce these inequalities. In this article, however, the authors report that inequalities in life expectancy have continued to widen, alongside widening inequalities in income and wealth.



British Medical Journal 2005;330:1016-1021 (30 April), doi:10.1136/bmj.330.7498.1016