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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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Weigh the value of new ‘tools’; apply the precautionary principle

3 Jun

There is mounting evidence of unintended harmful consequences in many sectors – including medicine, pharmacology, agriculture, energy generation, finance, engineering and transport. The most widely read post on this site in May reported the Lancet’s publication of the World Health Organisation’s finding that glyphosate, a widely used ingredient in weedkiller, is probably carcinogenic.

Michael J. Coren‘s article in Quartz magazine summarised the findings of Jameson Wetmore, an engineer turned social researcher at the Arizona State University’s School for the Future of Innovation in Society. Wetmore opened:

“The motto of the 1933 World Fair in Chicago was “Science Finds, Industry Applies, Man Conforms. Governments and companies were saying that technology can lead us out of this. It may not always be comfortable, but we have to ride it out. Household technologies were all the rage. When you hit the 1960s and 1970s, there is this shift.

“I think the hallmarks of that shift are the dropping of the atomic bomb, and then of course you have Ralph Nader’s Unsafe at Any Speed, and you also have Rachel Carson’s Silent Spring”.

“Whereas much of the contemporary world sees technological progress as inevitable, even a moral imperative, Wetmore finds that the Amish watch their neighbours and carefully consider how each one will change their culture before embracing it: They . . . watch what happens when we adopt new technology, and then they decide whether that’s something they want to adopt themselves.”

We don’t think about the impact technology might have on our lives beyond the initial big idea.

“The automobile was sold to us with this idea of a freedom we never had before. With that freedom came a heavy toll of injury and death. So can we anticipate unintended consequences way the Amish do, or are these systems just too complex to go much beyond first-order effects?

A more rigorous application of the EU’s Article 191 (left) would help to do this.

“Less than a mile from where I’m standing [in Phoenix, Arizona], Elaine Herzberg was killed by an autonomous Uber vehicle. I fully recognize the only way we’re going to automated vehicles is running in this world is to test them on city streets. Now, if we were to sit back and think about the values of the society here, we might say that testing those vehicles at 10 PM at night outside of a concert hall where a huge amount of alcohol had been served was not the best place to be testing. Perhaps testing in a school zone when children are present is not the best place to test an autonomous vehicle. But those are decisions that local people did not have the chance to make.”

The idea that technology is an unmitigated good is beginning to be questioned

Wetmore thinks that today Americans have a much more nuanced view of things. The number of people who think technology is an unmitigated good is continuing to shrink, but most haven’t abandoned the idea that there are a lot of problems and technology will play a role in solving them.

The precautionary principle detailed in Article 191 of the Treaty on the Functioning of the European Union aims at ensuring a higher level of environmental protection through preventative decision-taking in the case of risk. It also covers consumer policy, European Union (EU) legislation concerning food, human, animal and plant health. It has been recognised by various international agreements, notably in the Sanitary and Phytosanitary Agreement (SPS) concluded in the framework of the World Trade Organisation (WTO).  

Jeremy Corbyn led the proposal (right) to retain Article 191’s environmental principles after exit day, narrowly defeated by 16 votes.

 

Time for change?

 

 

 

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Probe launched into dengue fever vaccine

29 Dec

Dengue Fever Swept Southeast Asia in 2013 and in February 2016 Sanofi Pasteur, the vaccines division of France’s Sanofi SA, made Dengvaxia, its vaccine for dengue fever, widely available in the Philippines. Sanofi said the vaccine had later been launched in ten other countries: Brazil, Mexico, Costa Rica, Indonesia, Guatemala, Salvador, Peru, Singapore, Paraguay and Thailand.

Dengvaxia was said to have been recommended for use by the World Health Organization in April 2016 – but WHO denies this.

In a July report, the World Health Organization noted that the vaccination “may be ineffective or may theoretically increase the future risk of hospitalized or severe dengue illness” in those who have not had dengue at the time of vaccination.

After a fast-track approval process more than 730,000 people, mostly children older than nine, were given the vaccine, manufactured by the vaccinations division of French pharma giant Sanofi SA.

However, Jake Maxwell Watts, writing in the Wall Street Journal on December 4th, reports that the Philippines has suspended the Dengvaxia dengue fever vaccine. An investigation has been launched, after evidence showed it could worsen symptoms in some cases.

Representative of Paris based pharmaceutical company Sanofi-Pasteur, Thomas Triumphe Head for Asia Pacific, answers questions during the senate inquiry on the Dengvaxia vaccine

Sanofi said new data found the vaccine was effective for people who had already had dengue, but not for those who hadn’t. Regulators have now been asked to change the vaccine label to recommend that people don’t take the vaccine if they haven’t been infected previously to avoid developing a more severe form of the disease.

The government has suspended its vaccination program. Though no deaths or cases of severe dengue have been definitely linked to the vaccine, some politicians have pointed to cases of children who have died since receiving it.

Philippine Health Secretary Francisco Duque III told local media that the government would assess responsibility for the vaccine, which was approved under the previous administration, and consider charges against its manufacturer.

 

 

 

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Valproate: rely on self-regulation?

29 Sep

The advisory European Medicines Agency – which has no legal power – is examining the effectiveness of Valproate warnings

Valproate is an anti-epilepsy drug first licensed in the UK in 1975. Taking the drug during pregnancy had – for some years – been suspected by epilepsy experts to have a strong link with the development of ‘dysmorphic features’ – such as eyes set wider apart and a thinned upper lip – in children born subsequently. They also suspected that valproate use in pregnant mothers might lead to longer term developmental problems – but the evidence for this was anecdotal at the time. More evidence emerged throughout the 1990s. In 2005, UK patient information leaflets included concerns about delayed development in children.

In 2004 the New Scientist reported that a study (BMJ reference: Journal of Neurology, Neurosurgery and Psychiatry (vol 75, p 1575), led by Dr Naghme Adab from the Walton Centre for Neurology and Neurosurgery, Liverpool, UK, showed that children born to mothers who were on valproate when pregnant were eleven times more likely to have a verbal IQ score of 69 or below, compared with children born in the general population. To read the statistics and percentages click on the link above.

The researchers added that their results could have been partly skewed because only 40% of the mothers contacted for the study actually responded – mothers who cooperated might be more likely to believe their children were harmed by anti-epilepsy drugs. They added, however, that even if it is assumed the other 60% of children all had normal IQs, the children of valproate users would still be twice as likely to have a low IQ (below 79) than the general population.

“Epilepsy is the second most common cause of maternal deaths,” Tim Betts, a neuropsychiatrist at the University of Birmingham UK, told New Scientist. He warns that women should not stop taking prescribed anti-epilepsy drugs during pregnancy without consultation, and adds that safe alternatives are available. “When we see women before pregnancy we invariably try to get them off valproate,” he says.

Instructions for doctors – and, more recently, patient leaflets – say valproate should not be used during pregnancy unless there is no safer alternative and only after a careful discussion of the risks. The medicines regulator said warnings had been updated as more information had become available. Many women whose babies were affected say nobody warned them of the extent of the dangers. Warnings were only added to the outside of valproate pill packets in Britain last year.

Humane French politicians put Britain’s business friendly government to shame

In France, 1,200 families are preparing to sue the drug manufacturer, accusing it of failing to sufficiently inform women of the risks. The French government is supporting the legal action and has put aside about £9m (€10m) to compensate the families.

By contrast in 2010, families in England and Wales had to abandon a court case when their legal aid was withdrawn three weeks before the case was due to begin. They signed letters promising never to sue again, and in return were not billed for Sanofi’s multi-million pound legal costs. They are now calling for a judge-led public enquiry. An article on a BBC website this month adds that about 20,000 babies in the UK alone have been left with disabilities since valproate was introduced in the 1970s.

It also reports that women whose children have been harmed by the epilepsy drug sodium valproate are giving evidence to a European-wide safety review in London. The European Medicines Agency will examine whether warnings about risks to unborn babies are strong enough. Reuters reports that a  final recommendation is expected in December.

 

 

 

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Science, precaution, innovation: learn tragically ‘late lessons from early warnings’

30 Jul

 

Glyphosate herbicides, harmful pharmaceuticals, infected blood transfusions, mercury preservative in infant vaccines, organophosphate insecticides, GM technology and fluoridation of the water supply . . . the damage to human and environmental health has been incalculable.

pprof mcgladeAs Professor Jacqueline McGlade, Chief Scientist and Director of the Division of Early Warning and Assessment of the United Nations Environment Programme, said in her preface to Late lessons from early warnings: science, precaution, innovation:

“There is something profoundly wrong with the way we are living today. There are corrosive pathologies of inequality all around us — be they access to a safe environment, healthcare, education or clean water. These are reinforced by short-term political actions and a socially divisive language based on the adulation of wealth . . .

“One thing that has become clearer over the past decade is that certain chemical substances are highly stable in nature and can have long-lasting and wide ranging effects before being broken down into a harmless form. The risk of a stable compound is that it can be bio-accumulated in fatty tissues at concentrations many times higher than in the surrounding environment . . . So exposure to toxic chemicals and certain foodstuffs are at risk of causing harm, especially to vulnerable groups such as foetuses in the womb or during childhood when the endocrine system is being actively built. Even with small dose exposures, the consequences can in some instances be devastating with problems ranging from cancer, serious impacts on human development, chronic diseases and learning disabilities”.

chemical exposures coverProfessor McGlade points out that well-informed individuals and communities would ‘more properly’ set ‘the power to act’, than current political systems which have become ‘silted up by vested interests and a determination to protect assets’ – and, we would add, to accumulate profits. She calls for “a more ethical form of public decision-making based on a language in which our moral instincts and concerns can be better expressed . . .”

Above, a book by Claudia Miller, M.D., M.S., a tenured Professor in Environmental and Occupational Medicine and Vice Chair of the Department of Family and Community Medicine of the University of Texas Health Science Center at San Antonio (UTHSCSA), who has written extensively on the health effects of low-level chemical exposures.

One simple measure could be adopted. Every scientific report or review should be prefaced by a declaration of the researcher’s competing financial interests

From the Nature/ British Dental Journal’s declaration of the authors’ competing financial interests Critique of the review of ‘Water fluoridation for the prevention of dental caries’ published by the Cochrane Collaboration in 2015, we learn that – out of 17 – these authors had such an interest – see footnote, with names added to the initials in the list.

The Cochrane review noted- amongst many other findings – that only two studies since 1975 have looked at the effectiveness of reducing cavities in baby teeth, and found fluoridation to have no statistically significant impact – and within the ‘before and after’ studies none showed the benefits of fluoridated water for adults.

In view of the authors’ competing interests it is not surprising that they cast doubt on the validity of the unfavourable findings of the Cochrane Review, which is ’unconstrained by commercial and financial interests’.

Footnote:

  1. A. J. Rugg-Gunn: AJRG was a member of the MRC (UK) working group on water fluoridation and health and is a trustee of The Borrow Foundation (long associated with milk fluoridation).
  2. A.J. Spencer: AJS is a member of the Australian Government Department of Health, Nutritional Reference Values Fluoride Expert Working Group and the National Health and Medical Research Council Fluoride Reference Group.
  3. H.P. Whelton: HPW is Principal Investigator of the FACCT study funded by the Irish Health Research Board and is an evaluation of the impact of changes in the policy on children’s oral health in Ireland. She is an independent advisor to the British Fluoridation Society.
  4. C.Jones: CJ is a member of the British Fluoridation Society, the Cochrane Oral Health Group and commented on the Cochrane review protocol.
  5. J. F. Beal: JFB is vice-chairman, British Fluoridation Society.
  6. P.Castle: PC is a communications adviser to the National Alliance for Equity in Dental Health and the British Fluoridation Society. 
  7. P.V. Cooney: PVC was Chief Dental Officer for Canada.
  8. J. Johnson: JJ is President, American Fluoridation Society. 
  9. M.P. Kelly: MPK is co-investigator on the CATFISH study of a water fluoridation scheme in Cumbria.
  10. M.A. Lennon: MAL was a member of the Advisory Panel for the York Review, a member of the MRC Expert Group and formerly Chair of the British Fluoridation Society.
  11. J. McGinley: JMcG is manager, Fluoridation Activities, American Dental Association.
  12. D. O’Mullane: DO’M is a member of the Irish Expert Body on Fluorides and Health.
  13. P.P. Sharma: PPS is the President, Ontario Association of Public Health Dentistry. 
  14. W.M. Thomson: WMT was a member of the panel which produced the Royal Society of New Zealand report on community water fluoridation.
  15. S. M. Woodward: SMW works for The Borrow Foundation.
  16. S.P. Zusman: SPZ is Chief Dental Officer with Israeli Ministry of Health.