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MMR: why not allow the single vaccine option, in use elsewhere and widely accepted in ‘60s & ‘70s Britain?

30 Apr

 

As Dr Michael Jarmulowicz (FRCPath, MBBS) wrote in the BMJ:

“What I find puzzling is the adamant refusal of the authorities to facilitate the availability of the single measles vaccine, to the point that the Department of Health has banned its use within the NHS. How does this fit with the growing acceptance of patient autonomy and patient
choice? . . .

“Other countries with equivalent medical and ethical standards make them freely available.”

Other countries with equivalent medical and ethical standards do indeed make single vaccines freely available – indeed, Japan, a country with an excellent child health record, completely stopped using the MMR vaccine in 1993 after 1.8 million children had been given two types of MMR and a record number developed non-viral meningitis and other adverse reactions

The Merck measles, mumps and rubella (MMR) vaccine is a mixture of live weakened viruses of the three diseases. The first dose is generally given to children around 9 to 15 months of age and a second dose at 15 months to 6 years of age, with at least 4 weeks between the doses, according to PubMed (US government document – though the country’s National Center for Biotechnology Information (Centers for Disease Control and Prevention) states that the vaccine is only licensed for use in children who are 12 months old.

The scientific argument for immunising infants against measles is to establish a good herd immunity, protecting unvaccinated babies, children and adults who could not be given the vaccination.

Doctors and parents are urged to acquire and carefully read the information leaflets relating to whatever vaccine they are considering and an online search of medical journals finds material which would make a thoughtful parent pause before agreeing to have their baby injected with the MMR vaccine.

The World Health Organisation (a UN affiliated body) reports that Live Attenuated Vaccines (LAVs) raise some general safety and stability concerns and lists six. A snapshot of the measles section follows:

Mass measles immunization campaigns – reporting and investigating adverse events following Immunization – notes that seizure risk is age-dependent, and lower for children over six years, who are unlikely to have febrile seizures. Allergies (especially to gelatine) and general illhealth is a contraindication to vaccination with MMR vaccine.

The most common programme error is an infection as a result of non-sterile injection. The infection can manifest as a local reaction (e.g., suppuration, abscess), systemic effect (e.g., sepsis or toxic shock syndrome), or blood-borne virus infection (e.g., HIV, hepatitis B).

Establishing a profitable monopoly

In the U.S. more than a million dollars has been paid in compensation over the last ten years to parents alleging their children were harmed by the MMR jab, Merck and Co USA. Despite this, the manufacturers of Mumpsvax (Jeryl Lynn strain) announced in January 2010 that it would no longer provide mumps vaccines as single doses. The single dose rubella vaccine has also been halted. Single measles vaccines and a combined measles/rubella vaccine are still available.

Prolonged legal action in its tenth year against Merck, the manufacturers of the MMR vaccine.

The Wall St Journal and many other news outlets have reported that Stephen A. Krahling and Joan A. Wlochowski, former Merck virologists, filed a lawsuit in 2010, accusing the drug maker of falsifying data about its mumps vaccine. The case has not yet been settled nine years later and the virologists complain that the company is not making some documents available to the court.

Single vaccines are used privately in Britain

Although separate vaccines for measles, mumps and rubella are now unlicensed in Britain, it is not illegal for doctors and clinics to import the vaccines as long as they inform the Medicines Control Agency (MCA) that they are bringing the vaccine into the country.

Dr Richard Halvorsen, a GP with over 20 years’ experience and the author of OK Vaccines: Making the Right Choice for Your Child (2017), has written widely on the subject. He runs an immunisation service in Britain that offers parents a choice of buying single and small combination vaccines which includes the single measles and measles/rubella vaccines.

Should not all parents have the right to request the single vaccines for measles, mumps and rubella under the NHS system?

 

 

 

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Report research results separately to ensure new medicines are safe and effective for both sexes

19 Mar

“Women are not small men,” said Jeanine Roeters van Lennep. of the Erasmus Medical Centre in Rotterdam (right):

“There are biological differences in hormones and body composition. Women have smaller kidneys so it’s more difficult to clear medication. They have a different fat and water composition.”

A study published in February showed that trials were more likely to report results for women separately if they had a female lead author, with only one in three papers reporting results separately. The Lancet, which published that research, is one of the few major journals that tell researchers to analyse separately.

Research on drugs withdrawn from the market published by the United States General Accounting Office found that eight out of ten drugs withdrawn from the market between 1997 and 2001, after approval in the US, turned out to have higher health risks for women.

One example was Posicor, which was approved for the treatment of hypertension and angina and slowed or stopped the heart rate in otherwise healthy people, especially elderly women, and interacted with 26 different drugs.

Cholesterol-lowering statins are Britain’s most commonly prescribed medicine but in 45 trials Dr van Lennep analysed, 82% of those studied were men and only five trials made data available on men and women separately. This meant that there was not enough data to show statins prevented heart attacks, strokes and deaths in women with an acceptable number of side-effects, unlike for men.

She said it was probable that statins did work for women, with previous studies suggesting a similar benefit for both sexes, and is not advising women prescribed them to stop. However, she argues, doctors cannot be certain because of sexism which is largely unconscious:

“It’s shocking. Men forget to do sex-specific analysis, to be really polite about it. If 50% of the population is female you can’t just say it’s an optional extra. It’s a blind spot because right now the triallists are generally men. I don’t think it’s malice that they don’t want to perform this analysis; they just really don’t think about it . . . We think journals should make it compulsory to report results for men and women separately.”

A Times article summarises the problem: doctors argue that an absence of women in clinical trials and failure to report results by sex have resulted in an evidence gap that is likely to be hampering treatment. They insist that medical journals should force researchers to report results for men and women separately to be sure that new medicines are safe and effective for both sexes.

 

 

 

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Medic’s warning: prescribed medication caused a 50% increase in emergency admissions & nearly 100,000 hospitalisations a year in England

10 Feb

 

An article by Dr Mark Porter (December 2018) opens, “The first thing I do when faced with a poorly patient is to look at their medication to see if it could be responsible. You would be surprised how often it is”. Polypharmacy is rife: 1 in 18 of the population is taking ten medicines or more and potent pharmaceuticals carry risks as well as benefits. Millions of people are taking medication such as blood pressure pills and statins to prevent problems they may never have.

The really important message that reducing your risk of heart disease is best done by an improved diet and lifestyle is getting ‘crowded out’

Repeated campaigns have advocated mass medication – for example the February 2014 drive by the National Institute for Health and Care Excellence (the ‘health watchdog’) saying that the vast majority of men aged over 50 and most women over the age of 60 should take the drugs to guard against strokes and heart disease – though studies have suggested that up to one in five patients taking statins suffers some kind of ill-effect, including muscle aches, memory disturbance, cataracts and diabetes.

The Times reported on February 1st that a study published in the Lancet says all men over 60 and women over 75 are at high enough risk of cardiovascular problems to be eligible for the drugs. Professor Colin Baigent from Oxford University, a ‘co-investigator’, says “The risk of heart attacks and strokes increases markedly with age, and yet statins are not utilised as widely in older people as they should be”.

Dr Porter writes: “it is not illegal drug use in older people that concerns me most. I am embarrassed to report that prescribed medication exacts a far bigger toll on the nation’s health. Since 2008 there has been a 50% increase in the number of emergency admissions to hospitals for adverse drug events caused by medicines. In England alone such reactions are responsible for nearly 100,000 hospitalisations a year”.

He explains that anti-inflammatories such as ibuprofen and naproxen can work wonders for aches and pains from arthritic joints, but they have worrying side-effects and don’t mix well with many drugs commonly prescribed to treat high blood pressure (BP). They can damage the lining of the stomach, causing life-threatening bleeds (responsible for thousands of admissions every year) and can lead to kidney failure (on their own and when taken with BP drugs).

More subtle reactions impairing the quality of life are far more common and much easier to miss. Dr Porter gives a few examples from an ‘endless list’:

  • Blood pressure and heart pills that cause coughs (e.g. ramipril) and erectile dysfunction.
  • The prostate drug tamsulosin that can make you light-headed and increase the risk of falling.
  • Statins that cause aches and pains and reduce mobility.
  • Sleeping tablets that lead to addiction.
  • Cramp pills (quinine) that can cause heart problems.

He gave a striking case history:

“An elderly man with “early dementia” and diabetes was admitted to a residential home on our patch, where the staff reported that their new resident just sat in the corner all day looking vacant. His drug chart revealed he was taking an old-fashioned treatment for diabetes (gliclazide) that was pushing his blood sugars too low. It was stopped and two weeks later he was a new man and back in his own home. It is a lesson I have never forgotten”.

In October, an analysis in the British Medical Journal cautioned against any expansion in prescribing. One of its authors, Dr John D Abramson, clinical lecturer in primary care, from Harvard Medical School, last night said: “I think we have become victims of the drug companies. All the research is funded by them, and the really important message – that reducing your risk of heart disease is best done by an improved diet and lifestyle – is getting crowded out.”

 

 

 

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Following today’s news about emergency admissions & hospitalisations a year in England due to medical error, we turn to iatrogenic disease and death

10 Feb

Up-to-date figures for iatrogenic disease and deaths (inadvertently caused by a surgeon or physician or by a medical or surgical treatment or a diagnostic procedure) are not readily available in UK or USA. the US Department of Health and Human Services Office of the Inspector General examining the health records of hospital inpatients in 2008, reported 180 000 deaths due to medical error a year among Medicare beneficiaries alone.

Paul Wearn from the Office for National Statistics – 9 June 2011 – finally answered a FOI request for information about the number of iatrogenic deaths each year: “ONS do not have a National Statistics definition for iatrogenic The causes most closely fitting this concept are ‘complications of medical and surgical care’, ICD 10 codes Y40-Y84. Table 5.19, from the annual ‘Mortality Statistics’ publication shows that there were 236 male deaths and 226 female deaths where the underlying cause was a complication of medical and surgical care, in England and Wales, for 2009”.

In the British Medical Journal (2016, sometinmes requires reader to login) Professor Martin A Makary, department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA explains that a major limitation of the death certificate is that it relies on assigning an International Classification of Disease (ICD) code to the cause of death so causes of death not associated with an ICD code, such as human and system factors, are not captured. can directly result in patient harm and death.

  • communication breakdowns,
  • diagnostic errors,
  • poor judgment,
  • and inadequate skill

Currently, deaths caused by errors are unmeasured and discussions about prevention occur in limited and confidential forums

Hospital committees undertake internal root cause analysis and departments hold morbidity and mortality conferences but these review only a fraction of detected adverse events and the lessons learnt are not disseminated beyond the institution or department.

Strategies to reduce death from medical error should include:

  • making errors more visible when they occur so their effects can be intercepted;
  • having remedies at hand to rescue patients
  • and making errors less frequent by following principles that take human limitations into account
  • death certificates could contain an extra field asking whether a preventable complication stemming from the patient’s medical care contributed to the death.
  • hospitals could carry out a rapid and efficient independent investigation into deaths to determine the potential contribution of error.
  • Standardized data collection and reporting processes are needed to build up an accurate national picture of the problem. 

World Health Organisation statistics show that strategies to reduce the rate of adverse events in the European Union alone would lead to the prevention – on average – of more than 750 000 harm-inflicting medical errors per year, leading in turn to over 3.2 million fewer days of hospitalization, 260 000 fewer incidents of permanent disability, and 95 000 fewer deaths per year.

 

 

 

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Mass-medication 3: is compulsory fortification of all flour with folic acid imminent?

17 Oct

The Guardian reports that senior government sources say compulsory fortification of all flour with folic acid will be introduced within weeks.  

Theresa May, who was opposed to the measure, has been persuaded to back a plan to add folate supplement to food after a campaign to reduce the number of babies born in the UK with the neural tube defect (NTD). The Independent adds that the Department of Health and Social Care said the proposal is still being considered.

Two years ago, when the second reading of the above bill was debated, Lord Prior quoted from a report by the UK government’s Scientific Advisory Committee on Nutrition (SACN):

“The fortification of white bread flour with folic acid should be introduced only if it is accompanied by a number of preconditions: for example, action to reduce folic acid intakes from voluntary fortified foods, to ensure that individuals do not substantially exceed their safe maximum daily intake of folic acid . . . It also told us that there is inconclusive evidence on several possible adverse health effects of the mandatory fortification of flour with folic acid. For example, for people aged 65 and over, folate fortification of flour may result in cases of vitamin B12 deficiency not being diagnosed and treated”.

Clinical Education reports that Dr Edward Reynolds from King’s College, London has researched this matter, reviewing the literature from the 1940’s. He maintains that the recommended current upper limit of folate -1 mg – is too high.

In the 2016 debate, however, Lord Prior said the dangers of over-medication are small: “The issue is one of balancing the scientific and medical arguments with issues around choice and whether or not it is right to medicate the entire population for the benefit of a fairly small part of it”.

All women are recommended by the NHS to take a daily supplement of 400 micrograms of folic acid while they’re trying to get pregnant and during the first 12 weeks of pregnancy, when the baby’s spine is developing. The BDA asserts that very few women take this advice and according to research published in a 2015 paper in the British Medical Journal, the prevalence of NTD pregnancies was 1.28 per 1000 total births.

A reader comments on the Independent article: “70 million people to be mass-medicated for the sake of 1000 women… well that makes sense doesn’t it?”

 

 

 

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Mass-medication 2: the prevention element – a potential revenue stream?

23 Sep

As Andrew Miles, senior UK vice-president of GlaxoSmithKline observed cryptically in the Financial Times recently, “As much as people might think that the prevention element may not be a revenue stream for the company, it provides phenomenal insights.”

In July, the journal Science Translational Medicine published a report of the trial at Novartis Institutes for Biomedical Research in Massachusetts into a treatment, administered as two daily pills. A Times article noted that it was found to cut the number of infections in older people. Stephen Evans, the professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said that the study was only an incremental improvement on the treatments already available and there are unanswered questions about the possible side-effects of the drugs.

Mass medication is an iatrogenic catastrophe

In June, this view was expressed in a BMJ article by James Le Fanu, retired GP and journalist. He wrote that ‘profligate’ prescribing has brought a hidden epidemic of side effects and no benefit to most individuals. There is no drug or procedure with its “chance of good” that may not harm some. The more doctors do, the greater that risk. Over the past 20 years there has been:

  • a dizzying fourfold rise in prescriptions for diabetes treatments,
  • sevenfold for antihypertensives,
  • and 20-fold for the cholesterol lowering statins.
  • Meanwhile the number of people taking five or more different drugs has quadrupled to include almost half of those aged 65 or over.

He continues: “The consequences of this massive upswing in prescribing? A hidden epidemic of immiserating symptoms such as fatigue, muscular aches and pains, insomnia, and general decrepitude, a 75% rise in emergency admissions to hospital for adverse drug reactions (an additional 30 000 a year) …

Proposals have been made in the past for mass or even universal medication by aspirin and statins

The NHS now concludes that the risk of side effects (particularly the risk of bleeding) outweighs the benefit of preventing blood clots. It has long been known that the pills carry a risk of gastro-intestinal bleeding. But a new University of Oxford study, published in The Lancet, suggests that the danger increases far more sharply with age than was thought, according to Professor Peter Rothwell, lead author. A Telegraph artlcle reports on his 2017 findings, adding that taking a daily aspirin is more dangerous than was thought, causing more than 3,000 deaths a year.

Britain is already the “statins capital” of Europe

The UK has the second highest prescribing levels in the Western world, with aggressive prescribing of the medication by GPs, whose pay is linked to take-up of the pills.

In 2014 it was reported that twelve million people (one in four adults) would be told to take statins under controversial new NHS guidelines. Draft proposals from health watchdogs were that the vast majority of men aged over 50 and most women over the age of 60 are likely to be advised to take the drugs to guard against strokes and heart disease. The National Institute for Health and Care Excellence (Nice) had cut the “risk threshold” for such drugs in half and experts said that the number of patients advised to take the drugs is likely to rise from seven million to 12 million.

And current medical guidance says that anyone with a 20% risk of developing cardiovascular disease within 10 years should be offered statins.

Almost all men over 60 and all women over 75 in England qualify for statin prescriptions under guidelines adopted by the National Institute for Health and Care Excellence in 2014, a 2017analysis shows – see BMJ.

However, some health experts have questioned the industry forces behind these studies. The first recommendation was put out in 2013 by the American College of Cardiology (ACC) and the American Heart Association (AHA).  CNN reports that a number of experts who worked on the ACC/AHA guidelines had financial links to drug companies, which they disclosed publicly. No conflicts of interests were reported by the authors of the United States Preventive Services Task Force guidelines, but nearly all of the trials they included in their analysis were sponsored by industry, according to Dr Rita Redberg, who stressed this point in a January 2017 editorial in the journal she oversees. “The ACC did not follow its own conflict of interest guidelines“..

Fluoridation – or any practice that uses the public water supply as a vehicle to deliver medicine – violates medical ethics in several important ways:

  • It deprives the individual of his or her right to informed consent to medication.
  • It is approved and delivered by people without medical qualifications.
  • It is delivered to everyone regardless of age, health or nutritional status, without individual oversight by a doctor and without control of dose.
  • The safety of fluoridated water has never been demonstrated by randomized controlled trials–the gold standard study now generally required before a drug can enter the market.

Fluoridating water is a form of mass medication and most western European nations have rejected the practice — because, in their view, the public water supply is not an appropriate place to be adding drugs.

Who profits from all these instances of largescale medication?

 

 

 

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Biomedical research: the gender dimension

1 Aug

Dr Elizabeth Pollitzer, Director of Portia, recently wrote to the Financial Times.

Portia was established by a group of female scientists working at Imperial College, to respond to government concerns about under-representation of women in Science, Engineering and Technology.

Portia’s mission is to help women and men have the same opportunities for engagement and advancement in science, across all science disciplines, and to further the understanding and appreciation of the gender dimension in science knowledge making.

Dr Pollitzer responded to Anjana Ahuja’s article: “Britain must stop inflating the biomedical bubble” (July 17, probable paywall) which highlighted the issue of the failure of biomedical industry to translate the huge investment in research into improvements in the quality of medicine.

She pointed out that in 2014, following problems in replicating early pre-clinical studies and differences in efficacy and adverse effects of drugs in women and men, the US National Institutes of Health called for gender to be taken into account in study design and data analysis.

Between 1997 and 2000, ten prescription drugs were withdrawn from the market in the US; eight were judged to be more dangerous for women than for men.

Dr Pollitzer continued:

“Gene expression, immune response and how drugs are metabolised have been shown to differ between women and men. Taking into account these basic biological differences would improve the rigour, transparency and generalisability of pre-clinical research findings.

“Biomedical research has historically relied on experiments that used significantly more males than females as subjects (cells, tissues, animals, people) creating bias in fundamental knowledge of disease processes”.

She ends by saying that this research bias has an impact on how disease outcomes and responses to treatment are determined, resulting potentially in poorer quality of results for women.

Elizabeth Pollitzer has 20 years’ experience teaching and researching in the Department of Computing at Imperial College, University of London. Her original training was in Biophysics. She now applies this scientific background to promoting effective strategies for gender equality in Science, Engineering and Technology.

 

 

 

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