Whitehall pharmaceutical blog
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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.
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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.
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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
A recent study shows that around 10% of serious and unexpected drug adverse reactions (SUSARs) miss the FDA’s mandatory 15-day reporting window. What seems even more alarming is that the … more
The European Union (EU) has banned the marketing of around 700 generic medicines because of alleged manipulation of clinical trials conducted by Hyderabad-based GVK Biosciences. The EU-wide suspension … more
The Institute of Economic Affairs (IEA) has published a report arguing that UK government research funding is encouraging “pointless” research and skewing research priorities as … more
I always thought headache pills were white because that makes them cheaper to make – how naïve of me! According to a recent study, people are more likely to believe that … more
The Japanese health ministry wants generics to account for 80% of prescriptions in the country by 2017 – but the country has one of the lowest uses of generics. There is some general suspicion … more
At the end of June, the US Supreme court ruled that the EPA needs to consider the cost of implementing regulations to curb emissions from power plants.
The problem is that one side of the … more
The US Food and Drug Administration (FDA) is facing a lawsuit for failing to respond to a freedom of information request covering a trial of two Hepatitis C drugs.
The request covers Gilead … more
China’s recent biotech research has shocked many observers for apparently crossing ethical boundaries.
China is investing massively in biomedical research. Earlier this year, … more
Ten of the world's largest drugs manufacturers, including Johnson & Johnson, Pfizer and AstraZeneca, are taking part in a TransCelerate-run project, which aims to create a secure supply chain for … more
The CIA has come in for a lot of public criticism over the last few years, centring on its treatment of prisoners. A fresh argument has reared its head, suggesting that the CIA may have broken the … more
Today, the UK MHRA (Medicines and Healthcare products Regulatory Agency) announced biggest haul of counterfeit and unlicensed medicines in the agency’s history – almost double its total … more
The MHRA is surveying UK healthcare professionals to discover the best ways to keep patients informed when a drug’s risk profile changes.
The survey forms part of initiative, SCOPE - … more
The MERS (Middle East Respiratory Syndrome) virus has not received the same hysterical media coverage as Ebola but it has already killed at least 444 and infected over 1,200. South Korea has the … more
What does the word “imminent” mean to you?
In the case of the start of a trial for a drug to help children with the most severe epilepsy, it means well over a year away with no … more
It’s a well-worn principle. When the poorest in society need healthcare, it falls on the state to meet their needs – to some extent at least. But what when we are talking about the … more
Apparently, NHS patients admitted to hospital on a Sunday are 16% more likely to die in hospital than those admitted on any other day. This fact nicely demonstrates the danger of … more
India has been vocal about investment in its pharmacovigilance programme over the last year. However, despite being a US$ 3.1 billion market for medical devices, it has no equivalent process for … more
This week, the University of Bradford has been holding a series of “Death Cafés” with sessions on subjects ranging from how to donate organs and tissue to biobanks to how to plan … more
Cuba is famous for several things – Fidel Castro, communism, Guantanamo Bay, rum and cigars... The latter have been enjoyed by moneyed smokers the world over – albeit covertly in the US. … more
The number of links between drugs and adverse events identified by the European Medicines Agency fell by 17% in 2014. However, the EMA does not believe that the drop is a sign of an inherent increase … more
A recent case in Milwaukee has highlighted the vital importance of accurate and effective real-time tissue tracking.
The tissue in this case was destined for the treatment of a 25-year … more
According to Tamarra James-Todd, an epidemiologist at Harvard Medical School, female subjects have historically been excluded from toxicology or biomedical research.
Even when women are … more
Many paediatric studies depend upon the collection and storage of biological material from children with the condition being investigated. A paper recently published in Nature examines the legal … more
The UK is soon to become the first nation routinely to immunize babies against Meningitis B. However, the decision took over a year from the Department of Health being recommended that Bexsero MenB … more
The British Medical Journal has alleged that Novartis has been using some shady practices to hinder trials comparing Lucentis and Avastin for wet age-related macular degeneration.
For many … more
