Whitehall pharmaceutical blog
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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
Making the best use of scarce resources makes sense in all areas of life – none more so than in the vastly expensive world of pharmaceutical development. A trial at University College … more
Informed consent is much more than just getting a signature on a form. Whilst the ICF (Informed Consent Form) still plays a vital role, it is only part of an increasingly diverse picture. Recently … more
The latest Canadian implementation of Whitehall Training’s sister product, Ethics Review Manager, was officially launched by Clinical Trials Ontario (CTO) earlier this month under the name of … more
A study at Imperial College, London is examining the use of stem cells to help predict cytokine storms in first human trial participants.
Back in 2006, the papers were full of stories and horrific … more
A study at the University of Arizona is investigating whether pet dogs may help cultivate probiotics in their owners. My first thoughts were around how you’d study this whilst following … more
Some reports claim that as many as 90% of adverse drug reactions go unreported. Will moves to widen the net of pharmacovigilance fill in the gaps or will it point to previously unsuspected ADRs? … more
“Now everybody can do their part to advance medical research.” This is the up-beat message emblazoned across the webpage Apple uses to promote its new ResearchKit app. An application … more
A recent viral video shows Saudi cleric, Sheik Bandar al-Khaibari, explaining in some detail why the Sun clearly revolves around a stationary Earth. Indeed, he claims that air travel would not … more
"As a global pharmaceutical company, our systems are subject to frequent attacks."
The quote above caught my eye and comes from the risk factor section of Pfizer’s US Securities and … more
The MHRA’s report, Delivering high standards in medicines advertising, was published yesterday and reveals a fall in complaints received last year. In 2014, it received 193 complaints, down from … more
The press agencies like nothing more than bad news – disaster sells. But the opposite seems true in clinical research, according to a recent paper in JAMA (Journal of the American Medical … more
Recent research showed that strenuous jogging is actually as likely to shorten your lifespan as taking no exercise – except of course that it doesn’t show this at all!
A study … more
Earlier this week, the UK House of Commons voted in favour of allowing the use of DNA from a third person in IVF to help eliminate mitochondrial disease. This was hailed as a major development … more
Retraction Watch (the body that monitors academic retractions and criticism) has posed an interesting ethical question – if researchers are found to have falsified data in publicly-funded … more
According to China Youth Daily, more than one-third of deaf-mute children (under the age of seven) in the country became deaf as a direct result of antibiotic use.
Back in September 2013, I … more
Yesterday I heard the news that two climbers had become the first to successfully free-climb a sheer 3,000 ft rockface in Yosemite National Park – for some reason this leapt to the forefront of … more
The European Medicines Agency (EMA) has selected the first six drugs for its fast-track “adaptive pathways” pilot programme.
The adaptive pathways programme was announced in March … more
This has been an interesting week for manufacturers of oncology drugs. On Wednesday, the US FDA’s ODAC (Oncologic Drugs Advisory Committee) unanimously recommended approval for the … more
Whitehall Training's sister ethics approvals product, EthicsRM, has just shared two ethics approvals forms, which are from an actual implementation of the software at King's College, London. … more
The US FDA plans to tighten control of human antibiotic use in livestock but will its measures prove effective at kerbing over-use?
I find myself coming back to antibiotic resistance with … more
Over the Christmas break, I found myself thinking about experimental design – specifically how to design a trial to determine categorically whether or not the widely-accepted … more
One of the fundamental tenets of Good Clinical Practice is that foreseeable risks and inconveniences of a trial should be weighed against the anticipated benefit to the individual trial … more
How big is 100 trillion? It’s hard to get your head around massive numbers like these, but let me try to help…
A pile 100 trillion sheets of paper would stretch to the moon … more
The West African Ebola epidemic is still raging, but the race is now on to fast track the trials of possible treatments. The WHO has set out the ground rules to try and ensure that these highly … more
Earlier this month, the shocking news came from India that 15 women had died and many more had been hospitalized following their participation in a government-run sterilization programme. Recent … more
According to researchers from Brazil’s São Paulo State University, a lack of pharmacovigilance training is a key factor behind underreporting of adverse drug reactions in the country. … more
A UK author has come up with a novel solution for funding trials that otherwise wouldn’t happen – sell places on the trial for $2 million.
Alexander Masters’ best friend … more
Until now, clients have always needed to buy our courses in small batches when they need them – for instance to coincide with the start of a new study. However, buying this way can mean missing … more
The EMA has expanded the coverage of its pharmacovigilance website, to allow patients, the public and healthcare professionals to report suspected side effects encountered with any … more
Medical stories can fiercely divide the press – the recent announcement of an apparently extremely effective treatment for Clostridium difficile infections has done just that.
The early … more
Mobile phone tracking software is viewed with suspicion by many but it could be helping save lives by tracking movements in Ebola-torn West Africa.
Over 4,400 lives have been already lost in … more
The drug pricing debate isn’t going away, but it took a new turn after a study suggested that high-priced speciality drugs could well represent good value for money after all.
In 2013, … more
Antibiotic resistance hit the headlines again last week as US President Obama announced the formation of a task force to develop a national anti-resistance strategy.
Antibiotic resistance is linked … more
I’ve written many pieces about the counterfeit drug trade – we all know that it’s a big problem. It now seems that Roche’s cancer and rheumatoid arthritis treatment, rituximab, … more
Australian company, Hyperion, was recently forced to halt development of its type 1 diabetes drug following serious breach of Good Clinical Practice rules.
Development of DiaPep277 has been … more
An argument is brewing over the potential effect on the pharmaceutical sector and the UK NHS of international trade talks aimed at stimulating European Growth.
The Transatlantic Trade and … more
A new project has been launched to investigate novel ways to capture information about adverse drug reactions.
A consortium of organisations, led by the MHRA and including European medicines … more
A row is brewing in the US over biosimilars. This time, it’s not about efficacy – it’s about what they should be called…
According to a survey of European prescribers … more
Carrying excess weight has long been linked with problems such as diabetes and cardiovascular disease – but now it seems also to affect the likelihood of developing certain cancers.
A … more
A couple of weeks ago, two US aid workers joined the growing list of those infected in the West African ebola epidemic. However, like the unfolding plot of a movie, these were different. They both … more
