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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.

 

 

 

Questions arising from PHE’s ‘community water fluoridation toolkit for local authorities’

24 Mar

Is it authoritative? Hardly:

“This toolkit has no legal status and does not represent legal advice. A local authority involved with or considering water fluoridation should familiarise itself with the relevant legislation and secure its own legal advice on the interpretation and implementation of that legislation.

Who profits? American manufacturers?

In this report, published by Public Health England, local authorities were said to be the driving force behind the introduction of water fluoridation schemes in England in the 1960s. Were they? Or was it the manufacturers of sodium fluoride, used to fluoridate watersee 25 American companies.

A well accepted process? No only 10% of British people have artificially fluoridated drinking water (see blurred but readable map at the foot of the article)

Fluoridation has been banned by Germany, Finland, Japan, Netherlands, Sweden, Switzerland and Denmark.

“At 1 January 2016, 26 local authorities had Community Water Fluoridation (CWF) schemes covering the whole or parts of their area with some six million people in England receiving a fluoridated water supply, principally in the North-East and in the West and East Midlands”.

But there are 433 principal authorities in the UK: 27 county councils, 55 unitary authorities, 32 London boroughs, 36 Metropolitan boroughs, 201 districts, 32 Scottish unitary authorities, 22 Welsh unitary authorities, and 26 Northern Ireland districts (the City of London and the Isles of Scilly are non-party based).

There is no credible scientific evidence of harm to the health of people supplied with fluoridated water was found: accurate?

Here are a few of the examples recorded in our database:

  • The Irish Examiner ( 09 Jan 2002) reported that research carried out at Boston University of School of Public Health, using data from the Irish National Cancer Registry and its northern equivalent, found 40% more people suffer from the rare bone cancer osteosarcoma in the Republic than the North, where water is not fluoridated. The Washington Post reported in 2005 that federal investigators and Harvard University officials were exploring an allegation that Professor Chester Douglass had tried to suppress research suggesting a link between fluoridated tap water and bone cancer in adolescent American boys.
  • In the Journal of American Physicians and Surgeons, Volume 10 Number 2 Summer 2005, Page 42: “After 20 years, the ten fluoridated cities had 10% more cancer deaths than the non-fluoridated cities. The cancers were found in the tongue, mouth, pharynx, oesophagus, stomach, colon, rectum, pancreas, larynx, bronchi, and lungs”.
  • In 2006 a 500-page review of fluoride’s toxicology was undertaken by a distinguished panel appointed by the National Research Council of the National Academies (NRC, 2006). It concluded that the US Environmental Protection Agency’s (EPA) safe drinking water standard for fluoride (i.e. maximum contaminant level goal or MCLG) of 4 parts per million (ppm) is unsafe and should be lowered. The report listed many basic research questions that have not been addressed over 60 years of fluoridation. The panel reviewed a large body of literature in which fluoride has a statistically significant association with a wide range of adverse effects. These include an increased risk of bone fractures, decreased thyroid function, lowered IQ, arthritic-like conditions, dental fluorosis and, possibly, osteosarcoma.
  • Lead author of a report published in the British Medical Journal, Professor Stephen Peckham, from the Centre for Health Service Studies, said: “I think it is concerning for people living in those areas. The difference between the West Midlands, which fluoridates, and Manchester, which doesn’t was particularly striking. There were nearly double the number of (thyroid) cases in Manchester. Underactive thyroid is a particularly nasty thing to have and it can lead to other long-term health problems. I do think councils need to think again about putting fluoride in the water. There are far safer ways to improve dental health.”

A blank cheque? PHE will keep this arrangement under continuous review. One factor will be changes in unit cost of materials, particularly the fluoridation chemicals

“The secretary of state is required to meet the reasonable capital and operating costs incurred by water undertakers operating water fluoridation schemes in England. The secretary of state has the power to require local authorities whose populations are serves by those schemes to make payments to the secretary of state to meet these costs. At present PHE meets the capital cost of schemes and recovers the operating costs from local authorities. Local authorities also pay for the cost of feasibility studies . . . At present PHE meets the capital costs of schemes and recovers only the operating costs from local authorities . . .

A reversible decision? Only at a cost

A Page 35 link describes how requirements are imposed on how local authorities must exercise their powers to propose, vary or terminate fluoridation schemes: they must (c) consider—

(i) the capital and operating costs which are likely to be incurred in giving effect to such variation of the arrangements as is specified in a variation proposal, or

(ii) the decommissioning and associated costs which are likely to be incurred in giving effect to the termination of the arrangements specified in a termination proposal; and

(d) consider any other available scientific evidence in relation to the variation or termination proposal, including any evidence of benefit to the health and well-being of individuals who would be affected by the proposal.

Can a determined, well–informed public can stop the process? See Hampshire’s example:

  • Despite consultation showing the majority of people who responded did not want it to be implemented, plans to put fluoride into water in parts of Hampshire were approved in 2009 by the South Central Strategic Health Authority.
  • The Parliamentary and Health Service Ombudsman then ‘threw out’ a judicial challenge by New Forest East MP Julian Lewis and Hampshire county councillor David Harrison to stop fluoridation.

But a year later the plans to add fluoride to the public water supply in Southampton and parts of Hampshire were scrapped. Public Health England said it still endorsed water fluoridisation but would not proceed without backing from Southampton City Council.

fluoridation map

The government ‘toolkit’ may be read in full here.

 

Reviews into antibiotics and anti-microbial resistance proliferate

21 Dec

tracy and pigTracy Worcester has drawn our attention to the subject of antibiotic resistance, which is growing – developing not in humans, but in bacteria that can then infect humans. Surgical and cancer chemotherapy patients rely on antibiotics to protect them from potentially life-threatening illnesses and declining efficacy could turn routine procedures into life-threatening ones.

Calls for funding aka ‘adequate market incentives’

antibiotics report coverAmerica’s Center for Disease Dynamics, Economics & Policy (CDDEP) produces independent, multidisciplinary research to advance the health and wellbeing of human populations in the United States and around the world.

Its October publication (right) estimates that between 38·7% and 50·9% of pathogens causing surgical site infections and 26·8% of pathogens causing infections after chemotherapy are resistant to standard prophylactic antibiotics in the USA.

RAND Europe and KPMG have both assessed the future impact of antimicrobial resistance [AMR] and a recent Chatham House report on new business models for antibiotics highlighted the problem of inadequate market incentives.

The use of antibiotics in agriculture

Haroon Siddique writes in the Guardian about another study, commissioned by David Cameron. The Review on Antimicrobial Resistance has been produced by a team of economists and administrators with one scientific adviser, supported by the Wellcome Trust fund.

It finds that the unpredictable nature of the development of resistance to such drugs, and the limits put on the sale of antibiotics to ensure they are used appropriately, are two factors which many pharmaceutical companies mention to explain why they have cut back or stopped altogether their investment in R&D on new antimicrobials.

antibiotics 2approvals to 2010

It warns that the use of antibiotics in agriculture is fuelling drug resistance and must be cut back or even banned where they are important for humans – see CDDEP risk assessment below, deemed over-cautious by some.

antibiotics 2graph by 2050

The review found that global use of antimicrobials in food production at least matched that by humans, extending even to the widespread application in some areas of “last resort” antibiotics for humans – which cannot be replaced when ineffective – to animals.

Acknowledging that the proper use of antibiotics is essential for treating infections in animals, as in humans, and offers considerable benefits for food production, the authors stress that “excessive and inappropriate” deployment, including to stop development of infections within a flock or herd, or simply to increase the pace at which animals gain weight, is a problem.

The team proposes that there should be a limit for each country to reduce antibiotic use in food production to an agreed level per kilogram of livestock and fish.

This should be determined by experts, but they suggest that a good starting point would be reducing levels to that of Denmark – an average of less than 50mg of antibiotics per year per kilogram of livestock in the country. Denmark has combined low use with being one of the world’s largest exporters of pork.

Tracy Worcester has a different proposal: use the power of the purse

Instead of buying meat from animal factories that cram so many pigs into vast sheds which need routine doses of antibiotics to keep the animals alive, we can buy meat from real farms. Pigs on outdoor farms, or indoors with adequate space and bedding, are healthy and hardly ever need antibiotics.

One of her fellow-campaigners, actor Dominic West, opposed a recent factory farming application. He hopes that when we buy British we know we are not supporting this type of cruel and dangerous farming: ‘The costs are much too high, from the superficial horrors of stench and stressed, unhealthy animals to antibiotic resistance that brings us closer to the end of antibiotics as a cure for human diseases. He says, ‘The world must move on, and we can all help by only buying pork from high welfare UK farms.’

Tracy points out that we have the choice to buy meat with the high welfare labels RSPCA Assured, Outdoor Bred, Free Range or Organic – eat less meat as Anna advocates – or go meat-free. See the World Health Organisation on the health issues here.

Frances Kelsey: a true, independent-minded scientist

20 Aug

frances kelseyAs reports about alleged corruption in science surface, following news over the years of the disturbing side effects of potent pharmaceuticals, it is really heartwarming to read the story of Frances Kelsey, US FDA drug regulator, who recently died.

Merrell, an Ohio company, licensed thalidomide from Grünenthal of Germany and it had been available in Europe for years; Merrell expected its application for US approval would be swiftly rubber-stamped, as did Kelsey’s bosses.

After asking ‘questions that regulators elsewhere failed to’ as the FT put it, she became concerned about the lack of evidence to prove the safety of using thalidomide when prescribed to pregnant women for morning sickness.

She was still demanding answers when reports started to emerge from Europe of a link to infants born with missing or deformed limbs. The earliest case involved a girl born with no ears on Christmas Day 1956 — the daughter of a Grünenthal employee. Eventually thalidomide caused birth defects in more than 10,000 people around the world.

Wiki: “Mercédes Benegbi, a thalidomide victim and the head of the Thalidomide Victims Association of Canada, praised Dr. Kelsey for showing strength and courage by refusing to bend to pressure from drug company officials, and said “To us, she was always our heroine, even if what she did was in another country.”

The FT reports that Jerry Avorn, professor at Harvard Medical School, says thalidomide showed the need for regulators to maintain a sceptical approach in the face of industry pressure. “She was vilified as a pointy-headed bureaucrat; someone pushing a pencil and stifling innovation.”

He fears that renewed pharma lobbying to relax regulation is threatening Kelsey’s legacy.

Self-regulated companies: polluting the environment in USA, Canada, India and China

27 Jul

joakim 2 bergmannJoakim Bergman is Chief Executive of Changing Markets, a social enterprise which supports environmentally sustainable companies and products to take market share from less sustainable competitors and helps NGOs to run better campaigns that ‘more efficiently activate market shifts’.

He recently wrote to the Financial Times about the dumping of untreated antibiotic waste affecting the health of local communities and also contributes to the global rise of antibiotic-resistant bacteria. Mr Bergman highlighted a major UK government-backed review into antimicrobial resistance (more here) which estimates that by 2050, drug-resistant infections could kill 10m people per year globally and reported that the UK’s chief medical officer has spoken of this as a “catastrophic threat”.

Some “disturbing” environmental damage in India and China by ‘trusted brands’

He refers to an article in the FT which reports institutional investors’ concerns over the “disturbing” environmental damage resulting from multinational drug companies manufacturing in India. Recent research conducted by Changing Markets confirms many other reports showing that pharmaceutical pollution is a huge problem in China, where between 80 and 90% of the world’s antibiotic raw materials are manufactured. In both countries, multinational pharmaceutical plants are failing to treat and manage toxic and drug-rich waste, while their clients – including trusted brands – are ‘turning a blind eye to the problem’.

water pollution america

To a lesser extent, European countries, Canada and America (above) also have chemically polluted water. Read more here. According to a new Cary Institute study, Emma Rosi-Marshall, the lead author of a new study, has tracked pharmaceutical pollution in waters across the globe leading to disruption of ecosystem of streams, including American rivers in New York, Maryland and Indiana. She said when waste water is moved to sewage treatment facilities it is not treated for the removal of pharmaceuticals. Consequently, streams and rivers are exposed to synthetic compounds including antibiotics, stimulants, antihistamines and analgesics.

Concern about the problem in Eastern Europe is evident in the EU Guidelines on waste disposal and in 1999 the UNO World Health Organisation issued detailed guidelines in a more readable document, including disposal methods. In section 1.8 it stresses many dangers from ‘improper disposal or non-disposal of expired pharmaceuticals, including contamination of water supplies or local sources used by nearby communities or wildlife’.

Many companies, including Pfizer and AstraZeneca, have signed up to the Pharmaceutical Supply Chain Initiative, which has clear guidelines on wastewater management, but in light of the recent revelations it seems that the majority are failing to observe these guidelines.

Bergman concludes: “Without rapid action to remedy this, the global pharmaceutical industry risks becoming complicit in a public health disaster of monumental proportions”.

A pharmaceuticals market of 800,000 – and growing

24 Mar

“Drug companies got out of antibiotics as their attention switched to much more lucrative daily medicines for chronic diseases”

jeremy huntIn March, at the World Health Organisation’s first Ministerial Conference on Global Action Against Dementia in Geneva, Jeremy Hunt, the UK’s health secretary, announced plans to boost early-stage research into Alzheimer’s disease and other forms of dementia in order to find an effective treatment. Just three new drugs for the condition have reached market in the past 15 years and these only alleviate symptoms.

The WHO conference was supported by the Department of Health of the United Kingdom of Great Britain and Northern Ireland, and the Organization for Economic Cooperation and Development (OECD). Both days were webcast.

Ongoing lifelong drug treatment is very profitable – not so pre-emption

The $100m venture capital fund will be backed by the UK government and several of the world’s biggest pharmaceuticals companies, amongst them US investment bank JPMorgan, GlaxoSmithKline, Johnson & Johnson, Pfizer, Eli Lilly and Biogen.

Drug companies had lost billions of dollars in many failed trials and Patrick Vallance, president of research and development at GlaxoSmithKline, said the venture fund was a good way to spread risk and share expertise.

He added that there are rewarding economic incentives for research. “Nobody doubts that if you find an effective medicine for dementia it will be very profitable.”

True – and discovering and addressing the causes would remove this market opportunity.

Today’s broadcast theme:

Infectious bacteria are becoming resistant to the drugs that used to kill them. The last new class of antibiotics was discovered in the 1980s. There is little in the development pipelines of the world’s pharmaceutical industry. Drug companies got out of antibiotics as their attention switched to much more lucrative daily medicines for chronic diseases. Public funding on antibiotic research has also withered.

Juncker’s ‘bad decision’ on pharmaceuticals

17 Sep

juncker eu

President-elect of the European Commission, Jean-Claude Juncker has moved regulation of pharmaceuticals, including drug pricing and medical devices, out of the hands of the new commissioner for health, Dr Vytenis Andriukaitis, and into the portfolio of the commissioner for enterprise, Elzbieta Bienkowska.

emma woodford ephaOn Monday in the Financial Times, Emma Woodford, Interim Secretary-general of the European Public Health Alliance, Brussels, Belgium wrote about Juncker’s decision to return this industry to an environment whuch she alleges favours profit and secrecy over universal access to medicines and transparency.

These dossiers were moved to the health directorate in the first place in response to the H1N1 virus, when member states stockpiled Tamiflu at great expense but the drug proved less effective than expected. Ms Woodford continues:

Should another pandemic break out now, we will be faced with similar problems if the pharmaceutical industry is regulated in the interests of profit rather than public health.

glenis willmott mepEast Midlands Glenis Willmott is the MEP member of the Environment, Public Health and Food Safety Committee who steered the 2014 Medical Products Regulation through the Parliament. She has called on Mr Juncker to reverse his decision:

“When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down. Now they will be overseeing the European Medicines Agency as it implements the transparency regime, which is frankly concerning.

“This was a bad decision from President Juncker, I hope he will quickly come to his senses and rectify it.”