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.
- 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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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.
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.
Reducing birth defects in women with epilepsy : prescribing responsively leading to results – Aug 2019
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).
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).
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.
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.
Inside Out London, 22.01.2018 Full Version
We expose the government documents that we obtained concerning Sodium Valproate and the defect risk when taken during pregnancy and the worrying transgenerational link it will affect our grand children.
In a special edition of Inside Out London, Tarah Welsh investigates the shocking truth behind an anti-epilepsy drug which has harmed thousands of children. She uncovers new medical evidence suggesting that birth defects caused by the drug could be passed down through generations of the same family. Archives.
Pubertal development after unintended intrauterine exposure to oral contraceptives: a nationwide cohort study
2019 Study Abstract
To study the associations between exposure to oral contraceptives before conception and early in pregnancy and pubertal timing in boys and girls.
Population-based cohort study.
Overall, 15,800 children (70%) born during 2000–2003 into the Danish National Birth Cohort were categorized according to maternal use of combined oral contraceptive pills or progestin-only pills reported around gestational week 17: no exposure (reference), exposure 4 months before conception, and exposure in early pregnancy. Children self-assessed pubertal status using Web-based questionnaires from 11 years and biannually throughout puberty.
Main Outcome Measure(s)
Adjusted mean age differences (months) for attaining individual pubertal milestones and overall pubertal timing. Proportion mediated by prepubertal body mass index.
- In boys, intrauterine exposure to oral contraceptives showed a tendency toward slightly earlier mean age for voice break (months, −3.8; 95% confidence interval [CI] −6.5, −1.0) and first ejaculation (months, −2.9; 95% CI −5.9, 0.1) and a mean difference of −1.4 months (95% CI −3.3, 0.4) for overall pubertal timing.
- Girls with intrauterine exposure tended to have slightly earlier age at menarche (months, −1.9; 95% CI −4.0, 0.3) and Tanner breast stages and had a mean difference of −0.9 months (95% CI −2.7, 1.0) for overall pubertal timing.
- Exposure before conception was not associated with pubertal timing. Prepubertal body mass index did not play a mediating role.
This study shows some evidence that intrauterine exposure to oral contraceptives might slightly affect pubertal timing.
Monitoring, sources, receptors, and control measures for three European Union watch list substances of emerging concern in receiving waters, 2017
2017 Study Abstract
Pollution of European receiving waters with contaminants of emerging concern (CECs),
- such as with 17-beta-estradiol (a natural estrogenic hormone, E2),
- along with pharmaceutically-active compounds diclofenac (an anti-inflammatory drug, DCL)
- and 17-alpha-ethynylestradiol (a synthetic estrogenic hormone, EE2))
is a ubiquitous phenomenon. These three CECs were added to the EU watch list of emerging substances to be monitoring in 2013, which was updated in 2015 to comprise 10 substances/groups of substances in the field of water policy.
A systematic literature review was conducted of 3952 potentially relevant articles over period 1995 to 2015 that produced a new EU-wide database consisting of 1268 publications on DCL, E2 and EE2. European surface water concentrations of DCL are typically reported below the proposed annual average environmental quality standard (AA EQS) of 100ng/l, but that exceedances frequently occur. E2 and EE2 surface water concentrations are typically below 50ng/l and 10ng/l respectively, but these values greatly exceed the proposed AA EQS values for these compounds (0.04 and 0.035ng/l respectively). However, levels of these CECs are frequently reported to be disproportionately high in EU receiving waters, particularly in effluents at control points that require urgent attention.
Overall it was found that DCL and EE2 enter European aquatic environment mainly following human consumption and excretion of therapeutic drugs, and by incomplete removal from influent at urban wastewater treatment plants (WWTPs). E2 is a natural hormone excreted by humans which also experiences incomplete removal during WWTPs treatment. Current conventional analytical chemistry methods are sufficiently sensitive for the detection and quantification of DCL but not for E2 and EE2, thus alternative, ultra-trace, time-integrated monitoring techniques such as passive sampling are needed to inform water quality for these estrogens. DCL appears resistant to conventional wastewater treatment while E2 and EE2 have high removal efficiencies that occur through biodegradation or sorption to organic matter.
There is a pressing need to determine fate and behaviour of these CECs in European receiving waters such as using GIS-modelling of river basins as this will identify pressure points for informing priority decision making and alleviation strategies for upgrade of WWTPs and for hospital effluents with advanced treatment technologies. More monitoring data for these CECs in receiving waters is urgently needed for EU legislation and effective risk management
Water Pollution Caused by Birth Control Poses Dilemma – Environment International, 2017
2017 Study Abstract
Since the inception of global industrialization, steroidal estrogens have become an emerging and serious concern. Worldwide, steroid estrogens including estrone, estradiol and estriol, pose serious threats to soil, plants, water resources and humans. Indeed, estrogens have gained notable attention in recent years, due to their rapidly increasing concentrations in soil and water all over the world. Concern has been expressed regarding the entry of estrogens into the human food chain which in turn relates to how plants take up and metabolism estrogens.
In this review we explore the environmental fate of estrogens highlighting their release through effluent sources, their uptake, partitioning and physiological effects in the ecological system. We draw attention to the potential risk of intensive modern agriculture and waste disposal systems on estrogen release and their effects on human health. We also highlight their uptake and metabolism in plants.
We use MEDLINE and other search data bases for estrogens in the environment from 2005 to the present, with the majority of our sources spanning the past five years. Published acceptable daily intake of estrogens (μg/L) and predicted no effect concentrations (μg/L) are listed from published sources and used as thresholds to discuss reported levels of estrogens in the aquatic and terrestrial environments. Global levels of estrogens from river sources and from Waste Water Treatment Facilities have been mapped, together with transport pathways of estrogens in plants.
Estrogens at polluting levels have been detected at sites close to waste water treatment facilities and in groundwater at various sites globally. Estrogens at pollutant levels have been linked with breast cancer in women and prostate cancer in men. Estrogens also perturb fish physiology and can affect reproductive development in both domestic and wild animals. Treatment of plants with steroid estrogen hormones or their precursors can affect root and shoot development, flowering and germination. However, estrogens can ameliorate the effects of other environmental stresses on the plant.
There is published evidence to establish a causal relationship between estrogens in the environment and breast cancer. However, there are serious gaps in our knowledge about estrogen levels in the environment and a call is required for a world wide effort to provide more data on many more samples sites. Of the data available, the synthetic estrogen, ethinyl estradiol, is more persistent in the environment than natural estrogens and may be a greater cause for environmental concern. Finally, we believe that there is an urgent requirement for inter-disciplinary studies of estrogens in order to better understand their ecological and environmental impact.
Novartis contre la Colombie ; la guerre du prix du Glivec – 2015-2019
En Colombie, le prix d’un médicament anti-leucémique est devenu trop élevé pour le budget de la santé publique. En 2015, le gouvernement décide donc d’émettre une déclaration d’intérêt public pour le Glivec, privant ainsi le géant pharmaceutique Novartis de son monopole de production, dans un espoir de faire baisser le prix du médicament en faisant jouer la concurrence. Mais Novartis, craignant de voir sa poule aux œufs d’or lui échapper, menace d’attaquer la Colombie devant un tribunal d’arbitrage international. Si le prix du Glivec finit par baisser, les tactiques d’intimidation de Novartis ont aussi raison des velléités du gouvernement de mettre fin au monopole de Novartis. Le géant suisse parvient à éviter un fâcheux précédent, qui en faisant des émules, aurait pu entamer ses énormes bénéfices dans le monde.
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New drugs : where did we go wrong and what can we do better ?
More than half of new drugs in Germany lack proof of added benefit over existing treatments. International drug development processes and policies are responsible and must be reformed, the BMJ reports.
“Medicines regulators around the world are pursuing a strategy aimed at accelerating the development and approval of drugs. These approaches are based on the assumption that faster access to new drugs benefits patients. The rhetoric of novelty and innovation creates an assumption that new products are better than existing ones.
But although gaps in the therapeutic armamentarium undoubtedly exist, research covering drug approvals since the 1970s suggests only a limited number of new drugs provide real advances over existing drugs. Most studies put the proportion of true innovation at under 15%, with no clear improvement over time.”
… continue reading on The BMJ, 10 July 2019.