Category: Blog

Exposing drug industry funding of UK patient organisations

Drug firms ‘could shape the profiles of patient organisations through heavy investment’ even if they don’t have a say in their content of campaigns or research

Big pharma poured £57m into UK patient charities which could influence NHS drug decision makers, Bath University researchers’ analysis finds, the independent reports Read University of Bath blog.

Key messages

  • From 2012 to 2016 the drug industry donated over £57m (€65m; $73m) to UK patient organisations, with the annual sum more than doubling over the period
  • The funding benefited a small number of organisations and activities related to research and public involvement
  • The industry gave priority to commercially high profile conditions
  • Industry payment disclosures had limited transparency

We’ve been banging the drum about transparency of payment to doctors for years – we’ve even put a moratorium on financial conflicts of interest in the authors of any of our education articles. Not because we think that all doctors who receive money from industry are being influenced to push their agenda – but because we have no way of telling when that’s happening…

At the same time, and rightly, patient groups are becoming more involved in setting things like research priorities, and in guideline development – and we’re campaigning to increase that involvement. but as that involvement increases, it’s also important to make sure that potential industry influence is made transparent.

Piotr Ozieranski, is an assistant professor at the Department of Social and Policy Sciences at the University of Bath and one of the authors of a new analysis which attempts to build a picture of industry funding of UK patient groups.

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Noresthisterone period delay pill now sold over the counter : is it safe ?

What will be the real cost of “giving women more choices” and messing with their bodies” ?

“The Period Delay Pill has been available on our Online Doctor service previously and now introducing it in our pharmacies and nurse clinics with a consultation and questionnaire allows women to make the choice easily and quickly should they choose to delay their period.”

Michael Henry, healthcare director for Superdrug.

Reported Side Effects

Asthma; cardiac dysfunction; conditions that may worsen with fluid retention; diabetes (progestogens can decrease glucose tolerance—monitor patient closely); epilepsy; history of depression; hypertension; migraine; susceptibility to thromboembolism (particular caution with high dose).

When used for contraception

Active trophoblastic disease (until return to normal of urine- and plasma-gonadotrophin concentration)—seek specialist advice; arterial disease; functional ovarian cysts; history of jaundice in pregnancy; malabsorption syndromes; past ectopic pregnancy; sex-steroid dependent cancer; systemic lupus erythematosus with positive (or unknown) anti-phospholipid antibodies with intramuscular use for contraception disturbances of lipid metabolism; history during pregnancy of deterioration of otosclerosis; history during pregnancy of pruritus; possible risk of breast cancer.

Cautions, further information

A possible small increase in the risk of breast cancer should be weighed against the benefits.

The product literature advises caution in patients with history of thromboembolism, hypertension, diabetes mellitus and migraine; evidence for caution in these conditions is unsatisfactory.

Read NICE guidelines about norethisterone.

“Like the contraceptive pill, period delay pills are not side-effect free. Norethisterone is a synthetic version of the naturally occurring hormone progesterone and, like the other synthetic hormones in contraception, it can cause breast tenderness, nausea, headaches, low libido and, crucially, ‘disturbances in mood’. What the NHS likely means by this is mental health side effects which can range from ‘feeling a bit low’ to full-blown depression and anxiety. No two women are the same and so no two women will respond to a pill in the same way.”

Read Why no one’s talking about the worrying side effects of period delay tablets on Metro, 10 Aug 2019.

Des LeauKaTerres, jeunes engagés, apportent leur soutien au maire anti-pesticides de Langoüet

Des ados parcourent 211 km à vélo pour aller soutenir l’arrêté de Daniel Cueff contre les pesticides près des habitations

“Leur association s’appelle “les leaukaterre“, autrement dit locataires de la terre, un jeu de mot qui dit tout. Cinq de ces jeunes de Riec-sur-Belon sont partis vendredi 16 août d’Hennebont dans le Morbihan pour rencontrer Daniel Cueff, maire de Langouët, qui s’oppose à l’utilisation des pesticides.”

Référence.

Vidéo publiée le 16 août 2019 par France 3 Bretagne.

  • Soutenez le maire de Langouët sur agirpourlenvironnement, sur change. ou sur mes opinions.
  • Pesticides. En Ille-et-Vilaine, le maire de Langouët tient tête à la préfète de Bretagne, ouest-france, 25/06/2019. Lire la réponse du maire.
  • Daniel Cueff, le maire breton qui invente le village de l’après-pétrole, Le Monde, 19 juin 2019.
  • Arrêté contre les pesticides en Bretagne. C’est le tribunal administratif qui devra trancher, ouest-france, 11/06/2019.
  • Bretagne. La préfecture demande au maire de Langouët de retirer son arrêté contre les pesticides, ouest-france, 11/06/2019.
  • Pesticides à Langouët : un arrêté discutable mais une opportunité, selon la Conf’paysanne, ouest-france, 04/06/2019.
  • Langouët, village breton 100 % écolo, veut interdire les pesticides, ouest-france, 23/05/2019.
  • Ille-et-Vilaine. Le maire de Langouët interdit les pesticides près des habitations, ouest-france, 18/05/2019.

Occurrence of microplastics in raw and treated drinking water

Microplastics: new methods are needed to filter tiny particles from drinking water, 2019

The presence of plastics in aquatic environments is a growing concern across the EU. This study explored the amount of microplastic particles present in raw and treated water at three water-treatment plants in the Czech Republic. While treated water contained fewer particles than raw1 fresh water, the amount found in treated water was not negligible, and largely comprised tiny particles of <10 micrometres (μm) in diameter. Ways to filter microplastics from potable water must be identified and their risk to humans, sources and routes into drinking water determined, say the researchers, Science for Environment Policy reports.

Highlights

  • Microplastics were present in all water samples from different treatment plants.
  • The concentration of microplastics was higher in raw water than in treated water.
  • Particles of 1–10 μm were the most abundant, accounting for up to 95%.
  • Polyethylene terephthalate, polypropylene and polyethylene microplastics prevailed.

Abstract

The study investigates the content of microplastic particles in freshwater and drinking water. Specifically, three water treatment plants (WTPs) supplied by different kinds of water bodies were selected and their raw and treated water was analysed for microplastics (MPs). Microplastics were found in all water samples and their average abundance ranged from 1473 ± 34 to 3605 ± 497 particles L−1 in raw water and from 338 ± 76 to 628 ± 28 particles L−1 in treated water, depending on the WTP. This study is one of very few that determine microplastics down to the size of 1 μm, while MPs smaller than 10 μm were the most plentiful in both raw and treated water samples, accounting for up to 95%. Further, MPs were divided into three categories according to their shape. Fragments clearly prevailed at two of the WTPs and fibres together with fragments predominated at one case. Despite 12 different materials forming the microplastics being identified, the majority of the MPs (>70%) comprised of PET (polyethylene terephthalate), PP (polypropylene) and PE (polyethylene). This study contributes to fill the knowledge gap in the field of emerging microplastic pollution of drinking water and water sources, which is of concern due to the potential exposure of microplastics to humans.

Foetal oestrogens and autism

High Levels of Sex Hormones in The Womb Linked to Autism Once More

A small new study has once again found a link between elevated hormone levels in the womb and the likelihood of developing autism. But this time, instead of major androgens such as testosterone, researchers are pointing the finger at estrogen, medicalxpress and sciencealert report. Image.

Abstract

Elevated latent prenatal steroidogenic activity has been found in the amniotic fluid of autistic boys, based on measuring prenatal androgens and other steroid hormones. To date, it is unclear if other prenatal steroids also contribute to autism likelihood. Prenatal oestrogens need to be investigated, as they play a key role in synaptogenesis and corticogenesis during prenatal development, in both males and females. Here we test whether levels of prenatal oestriol, oestradiol, oestrone and oestrone sulphate in amniotic fluid are associated with autism, in the same Danish Historic Birth Cohort, in which prenatal androgens were measured, using univariate logistic regression (n = 98 cases, n = 177 controls). We also make a like-to-like comparison between the prenatal oestrogens and androgens. Oestradiol, oestrone, oestriol and progesterone each related to autism in univariate analyses after correction with false discovery rate. A comparison of standardised odds ratios showed that oestradiol, oestrone and progesterone had the largest effects on autism likelihood. These results for the first time show that prenatal oestrogens contribute to autism likelihood, extending the finding of elevated prenatal steroidogenic activity in autism. This likely affects sexual differentiation, brain development and function.

“In conclusion, we have demonstrated that prenatal oestradiol, oestriol and oestrone are elevated in in boys who went on to develop autism. This extends our previous finding of elevated prenatal steroidogenesis in the same cohort and provides further evidence for the prenatal steroid theory of autism. High levels of prenatal oestradiol contribute to a greater degree to autism likelihood than other prenatal sex steroids, including testosterone. We conclude that prenatal oestrogenic excess is a characteristic of autism and may interact with genetic predisposition to affect neurodevelopment.”

See studies in ref to DES and autism, ADHD, Down’s syndrome.

Corruption in the pharmaceutical sector

Diagnosing the challenges, Transparency International UK, 2016

Summary

Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes. Whether it is a pharmaceutical company bribing a doctor for prescribing its medicines irrespective of a health need or a government employee facilitating the infiltration of substandard medicines into the distribution system, public resources can be wasted and patient health put at risk.

For policy makers to implement successful anti-corruption measures there is a need to identify and understand corruption vulnerabilities in the pharmaceutical sector. To support this task this paper identifies key policy and structural issues in selected activities of the pharmaceutical value chain, along with relevant anti-corruption policies. This analysis showed that anti-corruption policies are needed throughout the pharmaceutical value chain to increase transparency around key decision points and strengthen the accountability of actors.

Four overarching challenges derived from structural issues and anti-corruption policies across the selected activities of the value chain have been identified. These are:

  • A lack of objective data and understanding of corruption inhibited by environmental context, the complexity of issues in the sector and policy makers not viewing corruption as an issue.
  • A weak legislative and regulatory framework because of poor investment, a lack of oversight and national regulatory frameworks that are often decentralised and reliant on self-regulation for key decision-point.
  • The potential for undue influence from companies due to a high degree of autonomy over key decision points and unparalleled resources, on policy and regulation so profit maximisation goes beyond ethical norms and negatively impacts health outcomes and public health objectives.
  • A lack of leadership committed to anti-corruption efforts from all actors. National leaders often only implement reforms after a crisis, with their inaction regularly hindering other actors.

Similarly, three key action areas to mitigate corruption vulnerabilities in the pharmaceutical sector are examined. These include establishing leadership committed to addressing corruption, adopting technology throughout the value chain and ensuring accountability through increased monitoring, enforcement and sanctions.

These overarching challenges and action areas are neither novel nor resource-intensive, stressing the lack of effective action in the past; as well as the difficulty of dealing with corruption in a sector that is extremely complex, has a high level of government intervention and often has regulatory systems in place that are inadequate to properly govern the value chain. Only by overcoming these challenges and focusing on these action areas will the global health community be better able to meet the health Sustainable Development Goals.

The Myth of Scientific Objectivity

Dr. Terence Kealey during a CrossFit Health event on March 9, 2019

“I think there is a vast myth that scientists are somehow objective and honest.”

~Dr. Terence Kealey~

Kealey is a former vice-chancellor of the University of Buckingham, a professor of clinical biochemistry, a scholar affiliated with the Cato Institute, and author of the book Breakfast Is a Dangerous Meal. During his presentation, he discussed the myth of scientific objectivity, drawing examples widely from history as well as his personal experiences within many of the most reputable scientific institutions.

Video published on 12 Aug 2019. Reference. Full transcript.

Primodos survivors take on drugs firm

Primodos: Firms and govt face legal action over claims pregnancy drug ‘damaged babies’, Sky News, Aug 2019

“Parents who say their babies were damaged by a pregnancy test drug have warned manufacturers and the government that they are preparing to take legal action.”

Primodos, a pregnancy test drug, has led to a decades-long campaign by parents and children who claim it has caused a range of devastating birth defects.

In 2017, Sky News revealed how documents were destroyed and information withheld about the drug that may have deformed and killed babies in the womb.

Now, parents who say their babies were damaged by the drug have warned manufacturers and the government they are preparing to take legal action.

Lawyers representing more than 200 claimants accuse two drug companies and UK regulators of putting patients at risk.

More information

Declining malformation rates with changed antiepileptic drug prescribing – An observational study

Reducing birth defects in women with epilepsy : prescribing responsively leading to results – Aug 2019

Abstract

Objective
Changes in prescribing patterns of antiepileptic drugs (AEDs) in pregnant women with epilepsy would be expected to affect the risk of major congenital malformations (MCMs). To test this hypothesis, we analyzed data from an international pregnancy registry (EURAP).

Methods
EURAP is an observational prospective cohort study designed to determine the risk of MCMs after prenatal exposure to AEDs. The Cochrane-Armitage linear trend analysis was used to assess changes in AED treatment, prevalence of MCMs, and occurrence of generalized tonic-clonic seizures (GTCs) over 3 time periods: 2000–2005 (n = 4,760), 2006–2009 (n = 3,599), and 2010–2013 (n = 2,949).

Results
There were pronounced changes in the use of specific AEDs over time, with a decrease in the use of valproic acid and carbamazepine and an increase in the use of lamotrigine and levetiracetam. The prevalence of MCMs with monotherapy exposure decreased from 6.0% in 2000–2005 to 4.4% in 2010–2013. The change over time in MCM frequency after monotherapy exposure showed a significant linear trend in the crude analysis (p = 0.0087), which was no longer present after adjustment for changes in AED treatment (p = 0.9923). There was no indication of an increase over time in occurrence of GTCs during pregnancy.

Conclusions
There have been major changes in AED prescription patterns over the years covered by the study. In parallel, we observed a significant 27% decrease in the prevalence of MCMs. The results of adjusting the trend analysis for MCMs for changes in AED treatment suggest that changes in prescription patterns played a major role in the reduction of teratogenic events.

Spin in Published Biomedical Literature : A Systematic Review

Medical research publications : how to modify (abstracts) perception of results

Quinn Grundy presents original research that explores the nature and prevalence of spin in the biomedical literature. Video published on 11 Oct 2017. Reference.

Objective
To explore the nature and prevalence of spin in the biomedical literature.

Design
In a systematic review and meta-analysis, we searched MEDLINE, PreMEDLINE, Embase, Scopus, and handsearched reference lists for all articles published between 1946 and 24 November 2016 that included the quantitative measurement of spin in the biomedical literature for at least 1 outcome. Two independent coders extracted data on the characteristics of articles and included studies, methods for assessing spin, and all spin-related results. The data were heterogeneous; results were grouped inductively into outcome-related categories. We had sufficient data to use meta-analysis to analyze the association of industry sponsorship of research with the presence of spin.

Results
We identified 4219 articles after removing duplicates and included 35 articles that investigated spin: clinical trials (23/35, 66%); observational studies (7/35, 20%); diagnostic accuracy studies (2/35, 6%); and systematic reviews and meta-analyses (4/35, 11%), with some articles including multiple study designs. The nature and manifestations of spin varied according to study design. We grouped results into the following categories: prevalence of spin, level of spin, factors associated with spin, and effects of spin on readers’ interpretations. The highest, but also greatest variability in the prevalence of spin was present in trials (median, 57% of main texts containing spin; range, 19%-100% across 16 articles). Source of funding was hypothesized to be a factor associated with spin; however, the meta-analysis found no significant association, possibly owing to the heterogeneity of the 7 included articles.

Conclusions
Spin appears to be common in the biomedical literature, though this varies by study design, with the highest rates found in clinical trials. Spin manifests in diverse ways, which challenged investigators attempting to systematically identify and document instances of spin. Widening the investigation of factors contributing to spin from characteristics of individual authors or studies to the cultures and structures of research that may incentivize or deincentivize spin, would be instructive in developing strategies to mitigate its occurrence. Further research is also needed to assess the impact of spin on readers’ decision making. Editors and peer reviewers should be familiar with the prevalence and manifestations of spin in their area of research to ensure accurate interpretation and dissemination of research.

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