Whitehall pharmaceutical blog
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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
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
