Whitehall pharmaceutical blog
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Statistical analysis of over 5,000 published trials has highlighted 90 that contain dubious data.
This is equivalent to around 2% of the trials examined using statistical tools to identify … more
Three US women have been left blind following an experimental treatment that they believed was part of a drug trial.
According to The New England Journal of Medicine, the women suffered … more
The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust have warned that the discovery of new drugs to treat childhood cancers is at risk because of EU legislation intended to … more
According to the World Health Organisation, 25% of deaths of children under 5 are at least partially down to air pollution. Even “safe” levels of air pollution may increase rates of … more
The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s. Since then, many versions have been introduced but the market is still dominated by a single design, sold by … more
Drug discovery is a time-consuming process in any country – trials that follow the proper rules of Good Clinical Practice take a lot of time and money. And that is before you consider the … more
According to two UK cancer charities, thousands of NHS patients could be missing out on cancer treatments they would receive in other “similar” countries.
Breast Cancer Now and … more
Recent US legislation has sought to increase the number of paediatric clinical trials. The aim is partly to increase the number of medicine proven to be effective against primarily childhood ailments. … more
Researchers from John Hopkins University, claim that over a quarter of a million US deaths are down to medical errors every year. This worrying figure is only eclipsed by heart disease and cancer. … more
An article published last week in Science Translational Medicine weighed up the pros and cons of various incentives used to encourage participants to enrol in clinical trials.
The incentives … more
Today, a new weapon in the fight against AIDS was unveiled in South Africa.
Over seven million South Africans are living with AIDS – the largest number anywhere in the world. Poor … more
It goes without saying doesn’t it – the search for new drugs is becoming harder and harder. Why then does the percentage of successful trials seem to be growing?
Bucking the … more
This seems like an odd question, but a recent survey of more than 1,500 consumers and nearly 600 physicians conducted on behalf of Memorial Sloan Kettering Cancer Center (New York), revealed that only … more
Nowadays, the idea of trial data sharing does not seem as far-fetched as it did a few years ago. The all-trials initiative’s call for full disclosure of trial data has been answered by many … more
At the moment in the UK, pregnant women are offered screening at 10-14 weeks to detect whether there is an elevated risk of Down’s syndrome and a couple of other chromosomal conditions. This … more
Antibiotic resistance is a massively high-profile issue. I know I can’t visit the doctor without seeing signs telling me that antibiotics can’t cure all ills and that over prescribing is … more
Is it ethical NHS patients to be bumped down the queue for surgery if they are unwilling/unable to lose weight or stop smoking?
A recent report from the Royal College of Surgeons shows that … more
Chinese healthcare has been rocked by the revelations that for years, many of the vaccines given by state hospitals may have been incorrectly stored or been past their expiry date.
The fraud … more
The Government of Malawi and UNICEF have been testing drones as a way of drastically cutting waiting times for infant HIV tests.
These drones are controlled from a mobile app and crucially; … more
A recent report in JAMA Oncology has espoused the hidden benefits of negative trials results – and this view seems to have been endorsed in new draft guidance from the EMA.
Negative … more
Up to 4% of emergency hospital admissions in the US are caused by adverse reactions to prescription drugs, claims a recent paper from the New England Journal of Medicine.
Are there … more
As the entry price point plummets – I ask, are robot companions an ethical way to meet the emotional needs of vulnerable elderly patients?
My seven year old son would love Paro … more
Cancer Research UK has today announced a breakthrough that could theoretically lead to a new treatment for some cancers within the next five years.
Newly-published research into the genetics … more
Britain is debating how to regulate scientific experiments involving human/animal hybrids or “chimeras” amid concerns about a negative backlash and accusations of Frankenstein science. … more
A recent article in UK journal Nature suggests that published trial results may not always match the original trial designs.
One of the very first things any child learns about science is … more
The earliest lesson of the recent French Trial Tragedy is that it’s dangerous to leap to conclusions.
The trial in question was of a drug intended to treat anxiety and mood disorders … more
One of the things that has pretty much united the pharmaceutical world is the deep dislike of ex-fund manager, Martin Shkreli. He shot to fame in mid-2015 by hiking the price of the 65-year old … more
For those of you who missed the interview with Dr Leann Fieldstad, Vice President, Global Pharmacovigilance Operations, PAREXEL, published earlier this month in Clinical Leader, I thought it was worth … more
The Chinese Food and Drug Administration (CFDA) has issued for comment its proposed revisions to the good clinical practice (GCP) rules for Chinese clinical studies. If the changes pass into law, they … more
A survey carried out for Sanofi has suggested that only 15% of the US public associate counterfeiting with medicines – despite campaigns to raise awareness. Perhaps even more worrying is that … more
Reckitt Benckiser has landed in hot water in Australia because of its pain-specific versions of Nurofen (ibuprofen). The regulator argued that the drug firm is breaking the law, since Nurofen Back … more
The European Medicines Agency (EMA) has stressed the essential role of GCP in a new position paper. It has made it clear that companies cannot replace “pivotal trials” that don’t … more
Over-prescribing of antibiotics is a serious risk to the effectiveness of modern medicine. This fact is well known. But UK General Practitioners (GPs) face a tough choice – if they … more
New legislation came into force today in Wales that presumes by default that anyone above the age of 18 has consented to their organs being used in a transplant. The move was broadly accepted by the … more
A UK trial to investigate the use of specially-trained cancer-detecting dogs has been approved by the NHS following early promising results. In the initial study, the animals successfully detected 93% … more
Whitehall Training’s US GCP course has received a major update – we look at just what has changed since it's last major update, just over two years ago…
To paraphrase ex UK … more
If like me, you thought that the constantly evolving nature of the flu virus meant that annual vaccination was a fact of life for high-risk patients – maybe we should both think again.
… more
Pharmacovigilance is so much easier within the confines of a clinical trial. Everything is under close medical observation, any concomitant medication is well-known, and cause and effect is fairly … more
With Russia taking up so many column inches in the Western press (not all wanted) it seems a strange time to be investing in clinical trials there. However, a perfect storm of factors including easing … more
Inflicting unnecessary pain on newborn babies is hardly the stuff of responsible and ethical trial design – and yet, this is exactly what a large number of studies apparently do.
… more
One in ten high school seniors in the US admits to abusing prescription painkillers. Painkillers are the second-most popular choice for those using illicit drugs for the first time in the US. Of … more
£1.49 billion is the upper estimate of the cost of fraudulent payroll claims made by agency staff working for the NHS, according to a report published this week. The NHS spends approximately … more
A recent Gallup poll has revealed that the US public takes a dim view of the pharmaceutical industry. Every year, Gallup asks people in the US whether they have positive or negative views of 25 … more
Australia currently accounts for less than 3% of global clinical trials (as logged in https://clinicaltrials.gov) and yet is a unique and attractive location for trials for several reasons. Something … more
The Medicines and Healthcare products Regulatory Agency (MHRA) is assessing the feasibility of conducting stand-alone inspections of pharmacovigilance contract service providers.
The move reflects … more
It must be the goal of every pharmacovigilance system to make the capture of accurate and comprehensive ADR data as efficient as possible. Recently, schemes have made it easier for patients to report … more
A judicial review brought by Richmond Pharmacology against the Health Research Authority (HRA), has been upheld by a High Court Judge. The company argued that the HRA had overstepped the law by … more
The UK’s Competition and Markets Authority has released a preliminary report that criticises the massive increase in the price of the epilepsy drug, phenytoin. When the drug was sold by Pfizer … more
The recent Ebola epidemic and the resultant flurry of research activity made me wonder about the ethics of blinded placebo trials when the disease is this lethal. Merck’s trial of rVSV-ZEBOV … more
I have written about the All-Trials Initiative several times. It has many vocal supporters and equally vocal critics – especially in the US. I thought that with the recent EU legislation on full … more
