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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Between 1997 and 2000, ten prescription drugs were withdrawn from the market in the US; eight were judged to be more dangerous for women than for men.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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Encouraging lack of enthusiasm for GM technology at China’s national congress

21 Oct

Those who totally oppose all GM adoption in China because of concerns about the damage caused by the herbicides and pesticides used with the crops and a loose coalition of left-wingers, environmentalists and retired officials will be encouraged by the lack of enthusiasm for GM technology at this week’s national congress of China’s Communist Party.

Lucy Hornby in Beijing, writing in the FT, says that Mr Xi has ‘historically fudged’ his position on GM — urging advocates to be “bold in research, careful in promotion”.

Ms Hornby notes that the coalition had written letters to the top leadership last year opposing ChemChina’s purchase of Swiss seeds and agrochemicals group Syngenta. Reuters put the number of signatories at 400.

Currently – despite US Dow Chemicals’ persistent and energetic lobbying – only GM papaya is planted on a small scale in China, due to domestic fears that foreign GM technology poses a security threat. In addition, at present (June 17th report) GM cotton is grown in China and GM animal feed is imported. Very few genetically modified foods are allowed on the market in China and labelling GM foods is strictly enforced there.

The safety of GMOs is widely debated in China through traditional media and the emerging online social media, where the public expresses deep concerns about the safety of GMO foods.

In 2015, there was a report of a conference on “GMOs and National Security” in Beijing, where scholars warned that the issues relating to GMOs were not just about science or technology, but also about food security, ecological security, and even national security.

A study of a GM grain carried out in China in 2012 caused great concern to the public; a US researcher and her team were accused of feeding Chinese children a GM grain, golden rice, and measuring the effects without telling their parents.

Chinese researchers are vying to promote new plant strains they have developed, while not revealing whether they are genetically modified or developed using traditional breeding practices. Many are grown in demonstration fields but have not been commercialised.

Frank Ning is the head of ChemChina’s rival Sinochem, which markets some Monsanto products. He said that the future direction of Chinese agriculture is the gradual improvement of seed quality and more targeted application of fertiliser and pesticides, which are big sources of soil and water pollution in China:

“Sinochem has transformed. We used to be just a sales operation: selling seeds, selling fertiliser. Now we are a modern agricultural platform: service oriented, promoting better seeds and teaching people to use less fertiliser.”

So far, so good.

 

 

 

 

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A three-part strategy developed to help to identify whether chemicals can have adverse effects at low doses

20 Oct

Rachel Shaffer, a PhD student of Environmental Toxicology at the University of Washington opens her article: Paracelsus, a Swiss physician known as the father of toxicology, proclaimed that “the dose makes the poison. She continues:Increasing evidence suggests that even low levels of endocrine disrupting chemicals can interfere with hormonal signals in the body in potentially harmful ways”.

As standard toxicity tests don’t always detect the effects that chemicals can have at lower levels, the U.S. Environmental Protection Agency (EPA) asked a committee of scientists to study the issue in detail. After several years, the committee’s report was released by the National Academy of Sciences in July. This landmark report provides the EPA with a strategy to identify and analyse data about low-dose health effects, as well as two case study examples. It is an evidence-based call to action for scientists and policymakers.

The committee defined a low dose as “external or internal exposure that falls with the range estimated to occur in humans.” That covers any level of chemical exposure that we would encounter in our daily lives.

It defined adverse health effects as including any biological change that impairs a person’s functional capacity or ability to handle stress, or resist other exposures.

The committee developed a three-part strategy to help the EPA to identify whether chemicals can have adverse effects at low doses which seems to the layperson to be standard scientific procedure:

  • First, actively collect a wide range of data with participation from stakeholders and the public.
  • Then analyse and integrate the available evidence in a systematic way.
  • Finally, act on this evidence to improve risk assessments and toxicity testing.

Using these strategies, the committee conducted a systematic review of two endocrine-disrupting chemicals, assessing the relevant data from human, animal and cell-based lab studies.

The first case study looked at phthalates, chemicals that increase the flexibility of plastic products such as shower curtains and food wrapping. The committee found that diethylhexyl phthalate and other selected phthalates are associated with changes in male reproductive and hormonal health. Overall, the data were strong enough to classify diethylhexyl phthalate as a “presumed reproductive hazard” in humans.

The second case study focused on polybrominated diphenyl ethers, flame retardants used for over 30 years. Though they are now being phased out, these chemicals remain a concern for humans. They are still present in older products and can persist in the environment for many years. Based on data showing the impact of these chemicals on learning and IQ, the panel concluded that developmental exposure is “presumed to pose a hazard to intelligence in humans.”

During its review, the committee encountered a variety of barriers that could impede similar investigations into specific chemicals. Two of several examples were:

  • that the committee noted a discrepancy between the concept of doses used in human and animal studies. This made it difficult to compare data from different sources.
  • that many toxicology studies focus on only a single chemical. However, as all are exposed to many chemicals, these procedures may be of limited use in the real world.

The committee suggested that toxicologists incorporate real-world mixtures into their studies, to provide more relevant information about the risk to human health.

This report demonstrated the challenges facing the field of toxicology and environmental health: How well can existing and emerging laboratory techniques predict adverse outcomes in humans?

As Rachel says, despite the imperfections of our testing methods, there’s ample evidence about low-dose effects from many chemicals. Many general readers will already have been aware of the dangers of phthalates and flame retardants for some time; the real problem appears to be the lack of political will to act on information already in the public domain.

Read her article here:https://theconversation.com/can-low-doses-of-chemicals-affect-your-health-a-new-report-weighs-the-evidence-82132

 

 

 

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Is the balance of nature being adversely affected by pesticides?

12 Oct

In May this year, Horticulture Weekly and other sources reported that most ‘insect-friendly’ plants sold in garden centres and supermarkets are laced with chemicals that could be killing bees.

More than 70% of ‘pollinator-friendly’ specimens from B&Q, Homebase, Aldi & Wyevale, studied by scientists at Sussex University led by Professor Dave Goulson, tested positive for pesticides after screening pollen, nectar and leaves. One type of heather bought from the Wyevale chain contained five insecticides as well as five fungicides. Every retailer sold plants containing the EU 2013 ‘banned’ neonicotinoids (imidacloprid, thiamethoxam or clothianidin.

Quartz updates us: reporting that a study published on Oct. 6 in the journal Science found that a significant amount of the world’s honey contains traces of neonicotinoids,, a class of commonly used pesticides, at levels strong enough to cause brain damage in bees – but not (yet?). human beings.The chemicals are meant to attack the nervous systems of pests and keep them from eating crops.

American environmentalists have expressed concern, since president Donald Trump appointed Scott Pruitt – who has prioritised business interests – to head the US Environmental Protection Agency.

In the past, Pruitt, who has been described by some as being especially friendly with pesticide manufacturers and an ‘ally’ of the fossil fuel industries, has vigorously opposed environmentally beneficial legislation.

What will be the long-term effects of bees, birds,  bats and frogs, butterflies, houseflies, crane flies and other insects dying from chemical pollution?