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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Research on drugs withdrawn from the market published by the United States General Accounting Office found that eight out of ten drugs withdrawn from the market between 1997 and 2001, after approval in the US, turned out to have higher health risks for women.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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Over 159 American cities oppose section 9101 of the Federal Farm Bill blocking local pesticide controls

15 Dec

More than 150 U.S. cities and counties have created “organic-first” policies and in some cases banned the use of specific chemicals that may harm people or the environment.

PR Newswire refers to a letter sent by local officials to Congresswoman Nancy Pelosi    noting that research has increasingly connected some pesticides with Parkinson’s disease and honey bee die-offs, A rapidly growing body of evidence links pesticides to a wide range of diseases and conditions including Parkinson’s disease, diabetes, leukemia, lymphoma, lupus, rheumatoid arthritis, dementia, reproductive dysfunction, Alzheimer’s disease, and variety of cancers including breast, colon, prostate and lung cancer.

Recognizing these risks, many communities have passed progressive policies to restrict the use of pesticides and protect our residents before any harm comes to them.

Some local officials in Irvine have opted to go further than federal or state laws and have restricted pesticide use on public land such as parks, sports fields and landscaped central road reservations. The city now uses organic products with ingredients such as corn gluten meal and oil from soybeans, lemongrass or rosemary.

Detailed information and photograph (above) may be seen in https://ocweekly.com/how-irvine-became-socals-first-non-toxic-city-7317638/

However, though the bill has attracted attention by legalizing hemp, bolstering farmers markets and rejecting stricter limits on food stamps pushed by House Republicans, California’s Orange County Register reports that a four-page provision (Section 9101) tucked away in the 748 page 2018 federal farm bill could block local governments in the United States from making their own rules about pesticides, ‘effectively neutering’ local control over pesticides, blocking cities, counties and school districts from restricting the use of on playgrounds and parks.

Felicity Arbuthnot draws attention to a report by the Environmental Working Group, commenting: “It truly says it all when government attempts to force people to eat cancer causing poison and feed it to their families and friends”. The EWG report records that:

  • the National League of Cities and
  • the League of California Cities, sent letters of opposition to congressional leaders.
  • The National Association of Counties – representing all 3,069 U.S. counties – and
  • a diverse coalition of over 170 organizations dedicated to public health urged Congress to reject the rider.
  • The National Audubon Society and
  • the American Academy of Pediatrics also sent letters.
  • A lettersigned by over 60 local officials in 39 communities from 15 different states, urged the conference committee to reach an agreement on a final 2018 farm bill that does not include this rider.

Despite all these representations, on 12th December, the U.S. House of Representatives passed the 2018 Farm Bill by a vote of 369 to 47. The next step to permanent legalization is the President’s signature.

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Will any British city follow Irvine’s lead? 

In 2017 Horticulture Week reported Edinburgh City Council’s decision to pursue an herbicide-reduction policy at the end of 2016 followed a year-long trial of alternatives to chemicals run by the council’s parks department. An online search revealed that similar moves have been proposed and discussed by councils in Dundee, Bristol and Belfast.

Today, the Times reported that Dublin city council is to use alternatives as part of a move towards a “herbicide and pesticide-free city” in the spring.  In 2015 Kaethe Burt-O’Dea (above) started a campaign to stop Dublin City Council from using a weedkiller. She is seen above near the community garden started up more than 10 years ago as a place for the street’s residents to compost their organic waste.

 

 

 

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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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Roundup glyphosate: risk of cancer to ‘exposed’ agricultural workers and gardeners

7 Dec

A huge mistake? The European Commission will formalise on 12 December Monday’s decision by member states to renew for five years the licence for the herbicide glyphosate.

Weasel words in the FT last week:

“Although the World Health Organization last year said the herbicide was “probably carcinogenic”, the latest joint assessment by UN agencies concludes there is no risk to humans from exposure through the diet” – implying that evidence shows that the use of the herbicide is risk free.

In May last year, the UN agencies said:

“The overall weight of evidence indicates that administration of glyphosate and its formulation products at doses as high as 2000 mg/kg body weight by the oral route, the route most relevant to human dietary exposure, was not associated with genotoxic effects in an overwhelming majority of studies conducted in mammals, a model considered to be appropriate for assessing genotoxic risks to humans. The meeting concluded that glyphosate is unlikely to be genotoxic at anticipated dietary exposures” (emphasis added).

Dr Christopher Connolly, a reader in neurobiology at the University of Dundee, said in an article in the Science Media Centre journal: “The evidence on the risk to human health from glyphosate is highly controversial, making it difficult for politicians to make a sound science-based decision. It is alarming that it is so ubiquitous that it is found commonly in human urine. We must make the next five years count, so that an evidence-based decision may be made at the end of this period.

Prof. David Coggon, Professor of Occupational and Environmental Medicine at the University of Southampton, said:

“IARC classified glyphosate as probably having the potential to cause cancer in humans. This was based on evidence of carcinogenicity in animals and suggestions of an association with lymphoma in exposed people (mainly agricultural workers, landscapers, nursery workers and home gardeners).

Cancer incidence among glyphosate-exposed pesticide applicators in the Agricultural Health Study (2005)

Summary:

We evaluated associations between glyphosate exposure and cancer incidence in the Agricultural Health Study (AHS), a prospective cohort study of 57,311 licensed pesticide applicators in Iowa and North Carolina. There was a suggested association with multiple myeloma incidence (a type of bone marrow cancer) that should be followed up as more cases occur in the AHS. Given the widespread use of glyphosate, future analyses of the AHS will allow further examination of long-term health effects, including less common cancers.

The World Health Organization’s International Agency for Research on Cancer in March 2015 said that glyphosate is “probably carcinogenic to humans” (PDF), adding “The evidence in humans is from studies of exposures, mostly agricultural, in the USA, Canada, and Sweden published since 2001”.

The latest news was reported by CNN in May this year, opening with story of Christine Sheppard

For 12 years, she had no idea what might have caused her non-Hodgkin’s lymphoma — until the IARC reported that glyphosate, the key ingredient in the weed killer Roundup, is probably carcinogenic. Roundup is the herbicide she sprayed on her coffee farm in Hawaii for five years.

That report spurred hundreds of non-Hodgkin’s lymphoma patients to sue Monsanto. Timothy Litzenburg’s law firm represents more than 500 of them. He said most of the patients didn’t know about a possible link between Roundup and non-Hodgkin’s lymphoma until the report came out.

Other companies also sell products containing glyphosate, why target Monsanto?

Litzenburg points out that Monsanto invented Roundup, they held the patent for many years, they are the EPA registrant for glyphosate, and they continue to dominate the market, adding:

“We are not alleging that our clients got cancer from glyphosate alone. We are suing because our clients got cancer from Roundup. … Roundup contains animal fats and other ingredients that increase the carcinogenicity of the glyphosate.”

Though UN agencies concluded that as yet no risk to humans from exposure through diet has been found, studies find that workers and gardeners using Roundup risk contracting non-Hodgkin’s lymphoma and multiple myeloma (a type of bone marrow cancer) – surely sufficient reason to withdraw the herbicide from use.

Media reports, including by EUobserver and Dutch magazine OneWorld, have shown that Efsa conclusions on the safety of glyphosate were partially based on scientific evidence provided by Monsanto, Roundup’s manufacturer. On 19 October, also the European Parliament expressed doubts over the scientific evaluations of glyphosate carried out by the European agencies.

Despite these findings, the European Commission will formalise on 12 December a decision by member states to renew the licence for the herbicide glyphosate for five years: https://euobserver.com/environment/140065.

Will Brexit give people in this country the opportunity to denounce the use of this and other dangerous substances and technologies and bring about beneficial change?

 

 

 

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The HPV vaccine – another case for adopting the precautionary principle

24 Nov

The use of HPV (human papillomavirus) vaccines for sexually transmitted diseases has been questioned since its earliest days.

According to a paper in the Annals of Medicine, Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?: “At present there are no significant data showing that either Gardasil or Cervarix (GlaxoSmithKline) can prevent any type of cervical cancer since the testing period employed was too short to evaluate long-term benefits of HPV vaccination.”

In the US, France, Spain and Denmark, more than 250 court cases are being mounted over HPV vaccinations. Damages have been won in the US and France.

However, the UK medicines watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA) and Public Health England say that the HPV jab is the most effective way to protect against cervical cancer, which kills 900 UK women each year and the American government’s CDC (Centers for Disease Control and Prevention) recommends the Gardasil vaccine, made by Merck Pharmaceuticals, for all females between 9 and 26 years to protect against HPV.

This conflicts with safety statements made by the American government’s Food and Drugs Administration (FDA) recalled by the Washington News which reported adverse reactions:

”26 new deaths between September 1, 2010 and September 15, 2011 as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short term memory loss and Guillain-Barré Syndrome”. In 2014 6m dollars in compensation was paid and only half the cases had been heard.

The Japanese government withdrew its recommendation of the HPV vaccine in 2013, after highly publicised cases of alleged adverse events in girls who had been vaccinated. 63 women are separately suing the government over claims that the jab causes serious neurological conditions and vaccination rates in the country have collapsed from 70% to less than 1%. In December last year, the Financial Times reported that Shuichi Ikeda, dean of the school of medicine at Shinshu University, one of a group of doctors suggesting a link between the human papilloma virus (HPV) vaccine and neurological illness, is suing Dr Riko Muranaka, a lecturer at Kyoto University’s school of medicine, for libel as she claimed that he had fabricated research results.

In July this year, a British health professional, whose daughter had been ‘severely disabled by obvious adverse reaction to the HPV vaccine’ for six years, wrote in the BMJ:

“There is ZERO evidence that Cervarix and Gardasil will ever prevent a single case of cancer. The manufacturers, GSK and Merck, only ever state they are ‘intended to’ or ‘expected to’.

Though The Times reported in August that Simon Harris, the Irish health minister, has renewed his drive for girls to receive the vaccination, an online search on the words ‘death’ or ‘disability due to the HPV vaccine’ will bring up many cases reported in the mainstream press – and the precautionary principle may be invoked, according to the European Commission, when a phenomenon, product or process may have a dangerous effect, identified by a scientific and objective evaluation.

There remains such great uncertainty about the safety of this vaccine, surely further investigation is warranted before continuing to administer it.

 

 

 

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