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Showing results for tags 'Pharma / Life sciences'.
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Content ArticleElizabeth Holmes, the 38 year old founder of failed diagnostic start-up Theranos, was sentenced to more than 11 years in prison this November. The sentence was handed down nearly a year after she was found guilty of defrauding investors about her finger prick blood testing devices, and seven years after the Wall Street Journal published its first investigation exposing the company’s struggles. Theranos’ customers received false laboratory test results indicating life threatening conditions such as cancer and HIV. Patients were left to wait anxiously while traditional laboratories repeated the tests, and at least one customer stopped taking his medication on the basis of erroneous results. Holmes was ultimately not convicted of charges relating to patient harm, instead she will be locked up for misleading wealthy investors.
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Content ArticleThis report by LCP Health Analytics, looks at how inequalities across the medicine life cycle impact patients and populations. It paints a vision of what success could look like, and proposes specific, feasible calls to action across industry, health technology assessment (HTA) bodies and players that could transform the role of the life science sector in reducing inequalities and fostering healthy populations. The report identifies two key challenges in addressing health inequalities that are tractable, and where the life science sector is most likely to make commitments and contributions: Multimorbidity is increasing and embedding inequalities in health Financial incentives across health systems are not aligned with patient and population health
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News Article
Pill to prevent pre-eclampsia gets UK fast track for development
Patient Safety Learning posted a news article in News
A new pill that could prevent pre-eclampsia has become the first pregnancy drug to be fast-tracked for development by the UK’s drug regulator. Scientists at MirZyme Therapeutics, a biopharmaceutical company, believe they have developed a drug that when given to women from 20 weeks of pregnancy could stop them developing the condition. Pre-eclampsia endangers the lives of thousands of expectant mothers and their babies in the UK each year, and has no therapeutic options. Globally, it affects between 2% and 8% of pregnancies and kills up to half a million babies and 100,000 women a year. MirZyme Therapeutics has been awarded an innovative licensing and access pathway (ILAP), or so-called innovation passport, by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The passport was established in January 2021 to expedite access to essential new drugs at the height of the Covid pandemic. It is granted to medicines that address the needs of patients with life-threatening and unmet medical needs, with a view to getting the drug to the market as quickly as possible. Read full story Source: The Guardian, 8 November 2022 -
Content ArticleWe need a public register to show if healthcare professionals are in the pay of industry – or more patients will suffer, writes Margaret McCartney following the publication of the Independent Medicines and Medical Devices Safety Review. Hospitals in England are meant to publish registers of interest of staff – but a 2016 study shows that only a minority give the details they should. A publicly accessible digital register, updated at least annually and compelled by the regulator, would create transparency and get rid of the huge amount of work that campaigners have had to do to untangle where conflicts lie. Declarations alone can’t sort the problems of conflicted medicine. But a public register would allow us to know whose advice isn’t independent. We will still need to be alert to the unintended consequences of a register, and research will be needed. The UK is lagging behind. Kath Sansom, a journalist who founded the Sling the Mesh campaign, told Margaret: “I had no idea that I couldn’t trust my doctor or surgeon to give the best advice. It is essential that medics declare industry funding.”
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Content ArticleDrugwatch is a US consumer advocacy organisation that works with certified medical and legal experts to educate the public on dangerous drugs and medical devices and to empower consumers to assert their legal rights. In this article, Terry Turner, writer for Drugwatch, examines the history of the medical tech company C.R. Bard, which specialises in vascular, urology, surgery and oncology devices. Bard manufactures thousands of medical devices and sells them worldwide. The article looks at how the company was established and then examines several legal issues Bard has faced, including criminal charges stemming from medical fraud and accusations of selling defective devices that have killed patients or caused serious complications. The author looks at criminal charges concerning heart catheters to which Bard pleaded guilty. They also highlight problems with Bard's transvaginal and hernia mesh products and inferior vena cava (IVC) filters—devices designed to catch blood clots before they reach the lungs or the heart.
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News Article
Johnson & Johnson reaches $300m settlement over pelvic mesh implants
Patient Safety Learning posted a news article in News
Pelvic mesh implant manufacturer Johnson & Johnson group has reached a $300m settlement in two class actions, after thousands of women worldwide reported complications from the mesh products including chronic pain, painful sexual intercourse and incontinence. It marks the largest settlement in a product liability class action in Australian history, and is subject to federal court approval. Shine Lawyers led the Australian class actions and alleged Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients. Women have suffered complications including mesh exposure and erosion – when the mesh pokes through the vaginal wall or cuts through internal tissue – vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat. Shine Lawyers’ Rebecca Jancauskas said the settlement would help support women’s ongoing treatment needs. “We welcome this settlement which brings the litigation to an end,” she said. “If the federal court approves the settlement our focus will shift to the important task of distributing the settlement to group members.” Read full story Source: The Guardian, 12 September 2022 -
EventuntilThis FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics in distributed manufacturing and point of care manufacturing. Further information
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EventuntilThe Europe Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. Register
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News ArticleLamborghinis and ski trips to the Swiss Alps were among the incentives a pharmaceutical giant developed to market a surgical device that has ruined the lives of hundreds of Australian women. Documents obtained by the ABC show the extent to which Johnson and Johnson oversold its surgical mesh products, which are used to treat incontinence and prolapse after childbirth. They paint a picture of a company that tried to sell surgeons a jet-setting lifestyle where they could insert four devices "before lunch" and notch up $10,000 in surgeries in a single morning. The mesh devices have left at least 3,000 Australian women with serious side effects including chronic pain, infections and inability to have sex, and are the subject of both a Senate inquiry and a class action. New court documents released in the class action against Johnson and Johnson show that as early as 2009, concerns were raised inside the company that it was making "a huge mistake" by commercialising its latest brand of mesh, was "rushing to market", and opening up the use of the product to "unqualified surgeons". Lawyers from Shine, who are representing the women in the class action, claim the pharmaceutical giant did not investigate proper clinical trials on the possible complications of the mesh. Read full story Source: ABC News, 13 August 2022
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Content ArticleThis report by the consultancy firm Deloitte looks at patient safety across biopharmaceutical (biopharma) value chains, arguing that change is needed to make medications safer for patients and add value to pharmaceutical products. The authors highlight that there is currently great potential for strategies to increase safety, improve equity and enhance patient engagement and experience. Advances in artificial intelligence (AI) technologies and data analytics, combined with increased incidence of adverse event reports (AERs) and increasing expectation of more personalised, preventative, predictive and participatory (4P) medicine, present an opportunity to improve pharmacovigilance.
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News Article
Pfizer fined £63m after overcharging NHS for phenytoin sodium epilepsy drug
Patient Safety Learning posted a news article in News
Pfizer has been fined £63 million after overcharging the NHS for a life-saving epilepsy drug which rose in price by 2,600%. The drug company was fined by the Competition and Markets Authority (CMA) for its involvement in a secret deal to hike the price of phenytoin sodium capsules, which cost the NHS tens of millions of pounds. Pfizer and a small British company, Flynn Pharma, were able to circumvent NHS price controls by de-branding the drug in 2012 and relaunching it under its generic name. The price then rose from £2.83 to £67.50 per pack, pushing up the cost from £2 million a year to £50 million. Internal emails obtained by the CMA showed that Pfizer officials raised concerns about the proposed scheme, with one manager writing: “The top line looks great, however, this would increase the price of phenytoin capsules to the NHS drastically and, to be frank, doesn’t feel right.” Andrea Coscelli, the outgoing chief executive of the CMA, said phenytoin was an “essential drug relied on daily by thousands of people throughout the UK to prevent life-threatening epileptic seizures”. He said the two companies had “illegally exploited their dominant positions to charge the NHS excessive prices and make more money for themselves — meaning patients and taxpayers lost out”. Read full story (paywalled) Source: The Times, 21 July 2022 -
News Article
Becton Dickinson ordered to pay $255k in hernia mesh trial
Patient Safety Learning posted a news article in News
A jury ordered Becton, Dickinson and Co to pay $255,000 to a man who sued the company, alleging he had been injured by its hernia repair surgical mesh, according to a court filing. The verdict in Columbus, Ohio federal court comes in the second bellwether trial in a multidistrict litigation over the company's hernia mesh products, which were sold by C.R. Bard Inc before its 2017 acquisition by Becton Dickinson. The first bellwether trial last year ended with a verdict in favour of the company. More than 16,000 cases have been consolidated before Chief U.S. District Judge Edmund Sargus in Columbus, in the third-largest pending MDL nationwide. Plaintiffs claim that the mesh products caused infections, pain, inflammation and other problems. The verdict came in a case brought by Antonio Milanesi, who had Bard's Ventralex mesh implanted during a hernia repair in 2007, and his wife, Alicia Morz De Milanesi. They claimed that Milanesi developed an infection and bowel abscess because of the mesh, requiring a second surgery in 2017. Like other plaintiffs in the MDL, the Milanesis say the mesh products are defectively designed because their polypropylene material degrades when in implanted in human tissue. Read full story Source: Reuters, 16 April 2022 -
Content ArticleOver the past few years, concerns have been raised about the level of funding and intervention regulators have received from the pharmaceutical industry. In this article for The BMJ, investigative journalist Maryanne Demasi examines whether regulators of medical devices and medications have enough independence from the companies they are meant to regulate. She asked six of the world's biggest regulators about their funding and transparency and found that industry money permeates the world's leading regulators. This casts doubt on their ability to provide effective regulation, especially in the wake of a string of drug and device scandals.
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News Article
Medical regulator faces questions over board members’ links to drug firms
Patient Safety Learning posted a news article in News
The UK medicines watchdog has been urged to strengthen its conflict of interest policy after it emerged that six of its board members are receiving payments from the pharmaceutical industry. Board members involved in overseeing the regulator’s “strategic direction” also have financial interests in companies including US and Saudi drug giants and firms with ambitions to break into the UK’s healthcare market. Some offer consultancy services while others help run or own shares in drug and medical device firms, according to official transparency records. There is no suggestion of wrongdoing, but the findings have led to concerns about perceived conflicts of interest among senior figures at the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care responsible for regulating drugs and medical devices and ensuring they are safe. The MHRA said that “in order to be an effective regulator” it needed to “bring together the right expertise from across industry, academia, the public and beyond”, adding that board meetings are held in public and non-executive board members – to whom the potential conflicts relate – are not involved in “any work or decisions relating to the regulation of any products”. But critics raised concerns about the potential for bias – or the perception of it – and called for stricter rules on conflicts of interest for those working in pharmaceutical regulation. Read full story Source: The Guardian, 17 April 2022 -
News Article
Johnson & Johnson ordered to pay $302M in pelvic mesh case
Patient Safety Learning posted a news article in News
A California appeals court has upheld a lower court ruling that Johnson & Johnson must pay penalties to the state for deceptively marketing pelvic mesh implants for women, but reduced the amount by $42 million to $302 million. Johnson & Johnson had appealed in 2020 after Superior Court Judge Eddie Sturgeon assessed the $344 million in penalties against Johnson & Johnson subsidiary Ethicon. Sturgeon found after a non-jury trial that the company made misleading and potentially harmful statements in hundreds of thousands of advertisements and instructional brochures for nearly two decades. The instructions for use in all of the company’s pelvic mesh implant packages "falsified or omitted the full range, severity, duration, and cause of complications associated with Ethicon’s pelvic mesh products, as well as the potential irreversibility and catastrophic consequences," Presiding Justice Judith McConnell of the appeals court said in a 3-0 ruling upholding the $302 million in penalties. The products, also called transvaginal mesh, are synthetic and surgically implanted through the vagina of women whose pelvic organs have sagged or who suffered from stress urinary incontinence when they cough, sneeze or lift heavy objects. Many women have sued the New Jersey-based company alleging that the mesh caused severe pain, bleeding, infections, discomfort during intercourse and the need for removal surgery. Read full story Source: Fox News, 12 April 2022 -
Content ArticleMedication errors harm patients and cost the NHS money – but with the right approach they can be significantly reduced. An HSJ article with Patrick Wilkinson and Nick Rodger from BD.
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News Article
Harm to AstraZeneca jab’s reputation ‘probably killed thousands’
Patient Safety Learning posted a news article in News
Scientists and politicians “probably killed hundreds of thousands of people” by damaging the reputation of the AstraZeneca vaccine, according to an Oxford scientist who worked on the jab. Prof John Bell said: “They have damaged the reputation of the vaccine in a way that echoes around the rest of the world.” “I think bad behaviour from scientists and from politicians has probably killed hundreds of thousands of people – and that they cannot be proud of that,” he told a BBC Two documentary When the Oxford/AstraZeneca jab was rolled out in the UK government advisers recommended under-40s should be offered an alternative due to a link to very rare blood clots. Fears over the links to blood clots also led other countries, including Germany, France, Spain, Italy, the Netherlands, the Republic of Ireland, Denmark, Norway, Bulgaria, Iceland and Thailand, to pause their use of the vaccine. The AstraZeneca vaccine has also not played a significant role in the booster programme. The BBC reported it accounted for only 48,000 of the more than 37m booster doses given in the UK. Read full story Source: Guardian, 7 February 2022 -
News ArticleSeveral drug companies have been fined £35 million for colluding to raise the cost of an anti-nausea drug used by cancer patients, taking the total fines stemming from a Times investigation to £400 million. The price paid by the NHS for prochlorperazine 3mg dissolvable tablets rose by 700%, from £6.49 a packet to more than £51, between December 2013 and December 2017, costing the NHS an extra £5 million a year. The Competition and Markets Authority (CMA) has ruled that several companies broke the law by fixing the market and agreeing not to produce a rival version of the drug, which is used to treat nausea and dizziness and can be prescribed to patients having chemotherapy. Andrea Coscelli, chief executive of the CMA, said: “The size of the fines reflects the seriousness of this breach. These firms conspired to stifle competition in the supply of this important medication, so that the NHS — the main buyer of the drugs — lost the opportunity for increased choice and lower prices.” He said the CMA would not “hesitate to take action like this against any businesses that collude at the expense of the NHS”. Read full story (paywalled) Source: The Times, 3 February 2022
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Content Article
Pfizer: Medicine safety tips for patients
Patient Safety Learning posted an article in Medication
Medication errors can happen in clinics and hospitals, pharmacies, and at home. Patients and healthcare providers, however, can work together to help prevent these errors. See Pfizer's tips for patients. -
Content Article
ABPI: What is legitimate interests? (9 December 2021)
Patient-Safety-Learning posted an article in Good practice
Disclosure UK is the Database on which all pharmaceutical companies abiding by the Association of the British Pharmaceutical Industry (ABPI) Code of Practice must disclose ‘transfers of value’ to healthcare professionals, other relevant decision makers and healthcare organisations in the UK. Where possible, companies do this by naming the individuals and organisations and according to GDPR law, companies must identify an appropriate lawful basis before they process an individual's information. This guidance document by the ABPI is aimed at pharmaceutical companies using Disclosure UK. It explains and promotes the choice of the basis of 'legitimate interests' for disclosure, with the aim of increasing transparency in the relationships between healthcare professionals, other relevant decision-makers and the industry. -
Content ArticleAdopting the principles and practices of human performance has led to valuable business and safety performance improvements in high-risk high-consequence industry sectors, such as energy and aviation. Eager to realise similar levels of improvement, several companies in the pharmaceutical and biopharmaceutical manufacturing sector have begun the adoption of human performance within their operations. However, the unique industry context and regulatory environment of this sector has proven the adoption of human performance principles and practices to be more challenging and complex than simply copying from the successes of other industries. In this webinar, you'll hear from industry professionals who will share their experiences and perspectives on human performance adoption value, successes and challenges.
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Content ArticleIn this video of a plenary session from the Guidelines International Network (GIN) Conference on 26 October 2021, James McCormack, Professor at the Faculty of Pharmaceutical Science, University of British Columbia, discusses issues with clinical practice guidelines and ways to overcome them.
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Content ArticleTCC-CASEMIX has created a unique infrastructure to provide total traceability of medical device performance. This infrastructure is supported by The Association of British HealthTech Industries [ABHI]. We refer to it as an 'Open Registry Infrastructure' for medical devices. It is 'open', because unlike existing clinically focused registries, which are 'closed', we enable wide searches across the registries connected into it. It is 'open' because registries will 'declare the content' (I don't know what I don't know, so how can I search for what I don't know?) Access to this infrastructure is through a Data Access Portal which is being configured for the specific needs of each stakeholder group. We are seeking interest from patient groups who would like to join an Advisory Board to help specify how data should be presented to patients in a way that is relevant and meaningful. Our vision is to link this portal into an enhanced pre-operative assessment process, and to transform patient informed consent.
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EventuntilHuman performance in pharmaceutical and biopharmaceutical manufacturing: successes and challenges to meaningful industry change Adopting the principles and practices of human performance has led to valuable business and safety performance improvements in high-risk high-consequence industry sectors, such as energy and aviation. Eager to realise similar levels of improvement, several companies in the pharmaceutical and biopharmaceutical manufacturing sector have begun the adoption of human performance within their operations. However, the unique industry context and regulatory environment of this sector has proven the adoption of human performance principles and practices to be more challenging and complex than simply copying from the successes of other industries. In this webinar, you’ll hear from industry professionals who will share their experiences and perspectives on human performance adoption value, successes and challenges. Register now for free Topics and presenters Chairs Dr Brian Edwards trained at Guy’s Hospital, London in hospital medicine and clinical research. He has worked for the Medicines Control Agency, Parexel and Johnson & Johnson, there as a deputy qualified person for pharmacovigilance. For the last 13 years, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK. Brian is Director of ISoP Secretariat Ltd and co-chairs the ISOP Medication Error Special Interest Group, Vice President Pharmacovigilance & Drug Safety in the Alliance Clinical Research Excellence and Safety (ACRES) and Chair of the UK Pharmaceutical Human Factors Group. He has recently been awarded a Fellowship with the International Society of Pharmacovigilance. Currently he consults for his own company, Husoteria Ltd. Julie Avery is former Global Lead for human factors at GSK, with over 20 years in Quality and Operational Excellence. As an independent practitioner, Julie now integrates human performance into existing systems strategically and tactically supporting business goals and KPIs. Julie leads the CIEHF Human Factors Pharmaceutical Manufacturing COP and is a Trustee of the CIEHF representing Associate Members. Topic 1: Why we focus on human performance James Morris, executive director at NSF Health Sciences, has over 30 years’ pharmaceutical operations experience in quality and manufacturing; He’s often leading consulting and training projects in investigation and CAPA management. Topic 2: How human performance reflects a way of thinking – beliefs and principles Amy Wilson has more than 20 years’ experience in biopharma manufacturing, focusing on human and organisational performance, operational excellence, risk management and technical training. John C Wilkes is Human Performance lead for biologics at AstraZeneca. He has more than 25 years’ experience in industry, in manufacturing operations, operational excellence, quality systems and quality control. Topic 3: In terms of internal challenges, how can we get out of our own way? Clifford Berry is head of business excellence for Takeda at its Massachusetts Biologics Operations site. He’s been a human and organisational performance practitioner for over 20 years, with experience in commercial nuclear electrical generation, electric transmission and distribution, and biopharma.
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Content ArticleNine out of 10 medical professional bodies think patients have a right to know if their doctor had financial or other links with pharmaceutical or medical device companies. Abi Rimmer considers the next steps towards implementing a mandatory register of doctors’ interests in the UK.
