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Exclusive: Eli Lilly’s recalled emergency diabetes drug came from plant cited by FDA

Source: Reuters

Oct 4 (Reuters) – A recently recalled batch of Glucagon Emergency Kits, Eli Lilly and Co’s (LLY.N) therapy for diabetic patients in crisis, was manufactured at an Indiana factory cited by U.S. health regulators this year for quality-control violations, including several involving that product, according to the company and a Reuters review of federal inspection records.

The Indianapolis-based company on Sept. 24 issued a voluntary U.S. recall of one lot of the kits whose key ingredient is Glucagon, a drug used to treat dangerously low blood sugar in diabetes patients. The company issued a voluntary recall in Canada the following day.

Lilly’s recall notices said that the company had received a report of a patient who experienced seizures even after being injected with the drug, a sign that the treatment was not potent enough to work. The company said the product failure might be related to its manufacturing process, without elaborating.

In response to Reuters’ inquiries, Lilly told the news organization that the affected kits were produced at a company facility in Indianapolis, and that the kit that prompted the recall had been distributed in Canada. As Reuters reported in May, the Indianapolis plant had been cited by U.S. health regulators for substandard sanitation and quality control procedures.

Separately, Lilly is facing a federal criminal investigation into alleged manufacturing irregularities involving another of its U.S. factories in New Jersey, details of which were first reported by Reuters earlier this year. The recall of Glucagon kits made in Indianapolis is the first indication of potential patient harm due to recent manufacturing issues at the company’s plants.

“Lilly is deeply committed to manufacturing high-quality medicines for patients who need them—nothing is more important to us,” the company said in a statement. “We take our obligations seriously and have rigorous quality systems in place to ensure compliance with stringent regulatory requirements.”

In all, roughly 66,000 Glucagon Emergency Kits were affected by the recalls, Lilly spokeswoman Kathryn Beiser told Reuters. She said about 19,000 of those were distributed to U.S. customers and nearly all the rest in Canada. She said the kits were produced at the Indianapolis plant around May 2020. Beiser declined to say whether Lilly has received other reports of adverse events related to the Glucagon kits.

EMERGENCY KITS

The recalled Glucagon Emergency Kit was designed for diabetes patients whose blood sugar is plummeting, and who need to raise it quickly to avoid complications that can include seizures or death. The kit consists of a vial, which is supposed to contain freeze-dried Glucagon powder, and a separate syringe filled with liquid.

Normally, a caregiver inserts the liquid-filled syringe needle into the Glucagon vial in order to dilute the powder before administering it. Lilly’s recall announcement said the vial used by the stricken patient contained liquid, instead of powder.

The company’s Indianapolis plant performs what is known in the industry as “fill and finish” – receiving raw drugs made at other facilities, putting them into vials and syringes, and shipping them to customers.

U.S. Food and Drug Administration inspection records from March 2021 viewed by Reuters cited numerous quality-control violations at that plant, such as staff failing to properly monitor environmental conditions where the finished drugs are made and failing to establish appropriate procedures to prevent contamination.

The FDA inspectors said they observed lapses in the manufacturing of the Glucagon kits as well as in Lilly’s COVID-19 antibody therapy bamlanivimab and several other drugs, according to the inspection records, dated March 16. They concluded that Lilly must take steps to remedy the lapses but did not recommend regulatory action on the part of the FDA.

Lilly spokeswoman Beiser said U.S. distribution of Glucagon Emergency Kits from the lot that was later recalled had ceased by March 25, a little more than a week after the FDA inspection report. Beiser said the distribution of the lot followed its regular process via wholesaler channels and was not related to the FDA report, adding that “any suggestion” it ended for other reasons is false.

Meanwhile, emergency kits from that same batch continued to be distributed in Canada, Beiser said. Distribution of 44,000 kits in Canada began in February 2021 and continued through the middle of September, she said. The patient complaint that triggered the late September recall involved a kit that had been shipped to Canada, Beiser told Reuters.

Beiser declined to comment specifically on why distribution of Glucagon Emergency Kits from the batch continued for another six months in Canada after distribution had ceased in the United States. She did not answer questions about whether the affected patient recovered.

Health Canada, a regulatory agency similar to the U.S. FDA, declined to comment about Lilly’s voluntary recall of the Glucagon Emergency Kits, or why kits from the batch continued to be distributed in Canada for months after they had ceased to be distributed in the United States.

The FDA declined to comment on distribution of the kits, whether it had received other reports of adverse events, had re-inspected Lilly’s Indianapolis facility or if it planned additional actions related to the recall.

“It is important to note that this recall was a voluntary action taken by the company,” FDA spokesman Jeremy Kahn said, without elaborating. “We have been closely evaluating this event and will continue to monitor the marketplace and manufacturing efforts to help ensure the availability of safe products for U.S. consumers.”

FEDERAL PROBE

The recall comes as Lilly faces a criminal investigation by the U.S. Department of Justice into alleged manufacturing irregularities and records-tampering at a separate factory in Branchburg, New Jersey, that produces bamlanivimab and other drugs.

The Justice Department has not accused Lilly of any wrongdoing, and the company said earlier this year that it is cooperating in the probe. Lilly did not respond to a question from Reuters about the status of that investigation. The Justice Department did not respond to a request for comment.

Bamlanivimab, the COVID-19 antibody, manufactured at the Branchburg facility has been sent to the Indianapolis fill-and-finish plant to be put into vials and shipped.

A group of FDA inspectors arrived at the Indianapolis plant in mid-February and stayed for more than two weeks, according to a redacted version of their report, which Reuters obtained via a Freedom of Information Act request.

In their report, the inspectors listed Glucagon as among the drugs where Lilly “failed to establish an adequate system for monitoring environmental conditions,” and noted that Lilly failed to establish and follow appropriate written procedures “to prevent microbiological contamination of drug products purporting to be sterile.”

In addition, the inspectors said Lilly did not properly conduct quality-control sampling of glass components like vials and pharmaceutical ingredients for drugs including Glucagon, bamlanivimab and the cancer drug Cyramza.

In Lilly’s April 6 response to the FDA obtained by Reuters through an open records request, the company said it takes the inspectors’ findings “very seriously” and is implementing actions to resolve concerns “on aggressive timelines.”

Lilly said it has established a comprehensive environmental monitoring program designed to assess microbiological control of manufacturing spaces, the redacted response said. The company did not respond to questions about the status of its efforts to rectify violations noted by the FDA at the Indianapolis plant.

Reporting by Dan Levine in San Francisco and Marisa Taylor in Washington, DC; Additional reporting by Allison Martell in Toronto; Editing by Michele Gershberg and Marla Dickerson

Our Standards: The Thomson Reuters Trust Principles.

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Lifestyle

Ushering in a more personalised healthcare system

Subhro Malik, Senior Vice President & Head Life Science, Infosys

Millions of users across England are using the NHS App to quickly access various digital services such as scheduling doctor appointments, checking their records, referring to repeat prescriptions etc. The UK government wants to extend the app’s usage with ambitious plans to enrich its features over the next couple of years, and eventually accelerate the digital revolution in healthcare. By March 2024, the government hopes to have at least 75% of the adult population relying on the app for a wide array of healthcare services.

These ambitions clearly indicate the growing acceptance of technology as an enabler of healthcare on a massive scale. In the modern context, public healthcare needs to be patient-centric, holistic, anytime and anywhere, and stakeholders are increasingly depending on technology to deliver at scale. Digital interventions can truly transform the way healthcare services are delivered and bring these in line with end-user expectations.

Technologies such as the Internet of things, artificial intelligence, big data analytics, blockchain, and wearables can enable remote monitoring, exchange, and capture of relevant patient information. Studies show that healthcare providers harnessing such technologies and digital solutions are better placed to improve patient outcomes. The use of data enables more accurate diagnoses, better decision-making, self-management, and personalization of care. Medical device companies are also adding value by embedding digital assistants and apps into their products to enable a more personalised user experience.

For example, patients ailing from cardiovascular diseases, diabetes mellitus, chronic pain, or spinal disorders are required to strictly following prescribed medication, exercise, and nutrition regimens to manage their condition. It calls for a high degree of health and nutrition literacy and support in tracking and monitoring regimens, while remaining mindful of ambiguities and consequences. Patients already grappling with chronic conditions often feel overwhelmed by the complexities involved. They tend to lean heavily on professional supervision and interventions, expecting support on-demand.

In such situations, digital health platforms can become their lifelines. By seamlessly integrating real-time data from medical devices, wearables, mobile apps as well as other digital devices, these platforms enable clinicians to remotely monitor each patient’s progress. Digital health platforms also aggregate and analyse data to produce insights tailored to help each patient. They focus on enabling self-management of chronic conditions, and forming positive habits, thus helping them work towards a better quality of life.

A host of digital tools such as virtual coaches and digital diaries are available today that make patient-centred care, a reality. Patients with chronic pain can record, monitor, and access their pain data, closely trace patterns. These insights that can inform and push them towards choosing a better diet, exercise routine, and lifestyle.

Patients want more accessibility to their healthcare provider and may require support anytime. However, this support can be hard to come by, especially at odd hours. On the other hand, one of the biggest advantages of virtual tools is that support is available anytime, anywhere. This makes them an ideal solution for patients with chronic pain to avail on-demand support. In the absence of a consistent in-person supervisor, they can use a virtual coach who remotely monitors and guides them through their medication and exercise regimens that are integral to pain management. They are also able to log their pain patterns, moods, sleep data, and activities and understand whether their coping strategies are effective or need improvement.

Undoubtedly, digital platforms are valuable in the management of patient care with their strong alignment to each patient’s expectation and needs of personalised care. They can play a key role in enabling easy access to reliable information, on-demand support, user-friendly navigation etc. There are challenges, however, that could derail the radical changes, which technology can bring to healthcare systems. For instance, research suggests that patients feel a natural reticence in sharing highly personal/confidential health data on an app or online tool. Patient sensitivities over data privacy and security breaches can override the advantages of any feature or functionality these apps promise.

After all, the success of personalised digital health systems depends on the extent to which patients can trust the healthcare provider with regards to: “Is my confidential data in safe hands? And is my care provider using the most relevant insights to deliver the care I need when it matters the most to me? Health care providers and medical device manufacturers investing in digital solutions need to address these concerns and plug systemic vulnerabilities, on priority. Some of the measures that have proved to be effective include implementing physical and digital access controls, electronic audit trails, and risk analyses. Of course, giving the patient the choice to share their personal information voluntarily and the choice to opt out is important too.

Ensuring the data safety and empowering patients with knowledge and choice will be key in shaping the future of digital healthcare.

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Lifestyle

HALF OF ADULTS SUFFER ANXIETY, REVEALS NEW RESEARCH

Leading Experts Identify ‘Epidemic Of Anxiety’ and Call for Empowerment Tools

New research reveals that half (48%) of all adults in the UK experience anxiety, equating to nearly 26 million people.[i] Given the widespread prevalence of this mental health condition, leading health experts have identified an ‘epidemic of anxiety’.

Commenting in a new ‘Empowerment in the Epidemic of Anxiety Report’,[ii] the panel of community and industry health experts highlighted the growing burden of mental health issues on an already overstretched NHS. They conclude that the way forward must include empowering and supporting those with mild anxiety to develop coping strategies.

Surge of Anxiety

The UK has seen a marked rise in generalised anxiety over the past decade, especially among younger people and women.[iii] Over 8 million people (around 1 in 10) are living with a diagnosable anxiety disorder at any one time,[iv] but this may not paint the whole picture. New research commissioned by Kalms Herbal Remedies shows that half (48%) the adult population often suffers from anxiety at a level that impacts their day-to-day living.i

Dr Sarah Jarvis, general practitioner, clinical consultant and expert panellist, comments: “We have a perfect storm of issues in relation to anxiety. The figures for people suffering with anxiety have increased considerably during the pandemic. To add to the problem, waiting lists for mental health services have increased further. This lack of availability of service inevitably has a huge impact on general practice as well – people with anxiety consult their GP more often, and I have found it increasingly difficult to be able to offer services for people at the milder end of the anxiety and depression spectrum.”

Self-Help Toolbox

To help prevent mild anxiety from progressing, and to improve the quality of people’s lives sooner, the expert panel recommend that people utilise a ‘mild anxiety toolbox’ – a series of powerful, evidence-based tools that can be employed into everyday life.

Talking therapies are a mainstay for many mental health concerns, including anxiety. Several of the methods used in formal talking therapies can be adapted and learned as a form of self-help therapy without the assistance of a professional.[v] For example, CBT-inspired self-help strategies and techniques such as reframing helpful thoughts, tackling worries and facing fears can be practiced at home.

Complementary therapies or practices can be integrated into everyday life to either help ease mild anxiety symptoms or to help prevent anxiety altogether. For example, mindfulness can work well alongside yoga and hypnotherapy. Developing an awareness of one’s thoughts, feelings and behaviours can help to break negative habits and improve self-esteem. vi,[vi]i

Lifestyle changes such as getting more sleep, eating a balanced diet, limiting caffeine and alcohol, and exercising can go a long way toward easing anxiety. For example, just 30 minutes or more of exercise a day for three to five days a week can significantly improve anxiety symptoms.[vii]i

Numerous de-stressing and mood-boosting apps are available to help reduce anxiety. A good place to start is the ‘Hub of Hope’ app – the UK’s leading mental health support database, which brings local, national, peer, community, charity, private and NHS mental health services together in one place. Some mild anxiety sufferers may also benefit from group discussions; organisations offering a range of resources include Anxiety UK, SANE and Mind.

Many people rely on herbs to help with mild to moderate mental health conditions, including anxiety, whilst avoiding the unwanted and negative side effects of medications. For example, studies have shown reductions in cortisol levels and anxiety following the use of ashwagandha.ix Lavender oil contains terpenes, such as linalool and linalyl acetate, which may have a calming effect on chemical receptors in the brain.ix,x Studies have shown that a daily capsule of pharmaceutical-quality lavender oil, found only in Kalms Lavender, is as effective as commonly prescribed anti-anxiety medications such as lorazepam and paroxetine.xi, xii

If mild anxiety worsens or becomes disabling, the next step is seeking professional help in order to receive an accurate diagnosis and effective treatment.

-Ends-


[i] Survey by Census Wide, commissioned by Lanes Health. Conducted on 3,726 Respondents – including 2,000 nationally representative respondents. October 2023.

[ii] Lanes Health. Empowerment in the Epidemic of Anxiety: Equipping patients and healthcare providers with the necessary tools and skills to manage mild anxiety. 2023.

[iii] The Guardian. UK has experienced ‘explosion’ in anxiety since 2008, study finds. September 2020. Available at: https://www.theguardian.com/society/2020/sep/14/uk-has-experienced-explosion-in-anxiety-since-2008-study-finds (Accessed: April 2023).

[iv] Mental Health UK. What is anxiety? Available at: https://mentalhealth-uk.org/help-and-information/conditions/anxiety-disorders/what-is-anxiety/ (Accessed: April 2023).

[v] Mental Health UK. Treatments for anxiety disorders. Available at: https://mentalhealth-uk.org/help-and-information/conditions/anxiety-disorders/treatment/ (Accessed: May 2023).

[vi] Royal College of Psychiatrists. Hidden waits force more than three quarters of mental health patients to seek help from emergency services. October 2022. Available at: https://www.rcpsych.ac.uk/news-and-features/latest-news/detail/2022/10/10/hidden-waits-force-more-than-three-quarters-of-mental-health-patients-to-seek-help-from-emergency-services (Accessed: April 2023).

[vi]i Mind. Types of complementary and alternative therapies. Available at: https://www.mind.org.uk/information-support/drugs-and-treatments/complementary-and-alternative-therapies/types-of-complementary-and-alternative-therapies/#Hypnotherapy/ (Accessed: May 2023).

[vii]i Mayo Clinic. Depression and anxiety: Exercise eases symptoms. September 2017. Available at: https://www.mayoclinic.org/diseases-conditions/depression/in-depth/depression-and-exercise/art-20046495 (Accessed: May 2023).

ix Salve J, et al. Cureus. 2019;11(12):e6466.

x Malcolm BJ and Tallian K. Ment Health Clin. 2018;7(4):147–155.

xi Woelk H and Schläfke S. Phytomedicine. 2010;17(2):94–99.

xii Kasper S, et al. Int J Neuropsychopharmacol. 2014;17(6):859–869.

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Business

How Gen AI Opens a Whole New World for Dyslexic Individuals

Boris Krumrey, Global VP of Automations at UiPath

Growing up in 1970s West Berlin, I experienced a lack of attention from primary school teachers who were not equipped to address special needs for dyslexic children. While teachers were somewhat aware of conditions like dyslexia, they lacked the necessary training to support students like me. I vividly remember the disheartening moments of reading aloud, as other children would complain about my struggles, with the teachers choosing not to intervene. Writing assignments was even more demoralising, as the teacher looked at me with disappointment, regardless of the pressure I faced, as my spelling and handwriting showed no improvement.

Living with dyslexia can pose significant challenges in reading and writing, making self-expression daunting. However, new tools and technological developments are presenting exciting opportunities for workers who are neurodiverse or are living with learning difficulties.

Any traumatic experiences faced by dyslexic individuals often lead to deep disbelief in one’s abilities. Often simple tests such as identifying a series of numbers or words can frustrate people and even lead to misdiagnosis or failure to receive new opportunities. However, a new horizon of possibilities has emerged with the advent of generative artificial intelligence (Gen AI). Thanks to the content writing capabilities, data analysis and automation, Gen AI is poised to be an ideal tool for dyslexic individuals, empowering them to overcome writing obstacles and unlock their full creative potential.

Understanding the use cases

Gen AI can act as an important catalyst for a business on its automation journey, unlocking the door to a wealth of new opportunities. Technology, such as AI, can seem intimidating at first, but taking the first step to an intelligently automated business truly can improve efficiency and workplace experience dramatically for individuals.

Of course, before implementing AI solutions, it is important to understand the exact use cases and where they can be applied for many tasks. Looking first at enhancing writing efficiency, generative AI provides invaluable assistance in improving writing efficiency for dyslexic individuals. The technology offers real-time suggestions, corrections, and alternative phrasing as a reliable companion during the writing process. Dyslexic writers can focus on their ideas and thoughts while the AI refines the expression, eliminating the frustration caused by dyslexia-related writing challenges.

Predictive capabilities are perhaps one of the remarkable features of Gen AI. The ability to anticipate words and phrases, often aligning perfectly with the writers’ intentions has proven to be a real game changer. It significantly reduces the time and effort required to produce coherent and correctly written content, enhancing both speed and accuracy in the writing process.

Gen AI understands the unique challenges faced by dyslexic individuals, particularly in terms of visual perception. Dyslexia commonly involves difficulties accurately reading letters or words, resulting in visual confusion. The customisable features of AI can address this, for example, tailoring the text presentation to suit individual needs. It can also make the writing experience more accessible and enjoyable.

This all draws back to the essential principles of boosting confidence and self-expression among workers. The stigma surrounding learning difficulties, such as dyslexia, can negatively impact self-confidence, but Gen AI is the equivalent of a supportive partner, encouraging dyslexic writers to express themselves freely without the fear of judgement or misunderstanding. Providing real-time feedback and assistance instils an important sense of assurance, empowering individuals to embrace their unique voices and share their ideas with the world.

Spotlighting the human impact and AI limitations

The ways in which Gen AI can overhaul work should not be conflated with a testament to the decline of human intelligence and value in the workplace. In fact, it is quite the opposite. Workers with learning disabilities often let self-doubt block potential due to mistakes that they do not see among the wider pool of workers. This idea of being ‘other’ can distance workers for the wrong reasons. If AI can free workers of tasks that fuel self-doubt, they can apply their specialist skills and stop feeling as though they are being dragged down by perceived weaknesses. Gen AI is bringing out the human value to work more than some individuals might have ever believed.

However, as with every technology and human relationship, it is essential to analyse and limit possible negative impacts. Starting with language formulation, Gen  AI’s predictive capabilities and real-time suggestions can influence the language formulation process. While this can be beneficial for dyslexic individuals who struggle with word recall or spelling, there is a possibility AI’s suggestions may steer the writing towards a more standardised or conventional form. This may inadvertently dilute the writer’s authentic expression, altering their unique style or creative choices.

To mitigate this, AI usage should be selective and applied only to areas of struggle, such as sentence structure and spelling, letting creative flair do the rest. It’s also recommended that teams and dyslexic individuals retain manual reviewing and editing. This ensures they maintain control over the final product, making deliberate choices that align with their authentic voice and personal style.

Authenticity lies in embracing imperfections and unique qualities. Dyslexic learners can celebrate their distinct perspectives, creative approaches, and personal growth throughout their writing journey. Acknowledging and highlighting their individuality can create a genuine connection with their readers which is the core goal of any copy. Once the concerns about authenticity have been addressed, it is key to strike a balance that allows the AI to support and amplify their writing while maintaining the authenticity and genuine expression that make their work truly remarkable.

A powerful AI and human partnership

I once met a friend who struggled with dyslexia but had a talent for working with computers. He helped run his father’s real estate business, but when I asked him why he didn’t study computer science, he explained that his dyslexia made him worry about the amount of time he would have to spend debugging his code due to syntax errors.

As someone who studied computer science, I never fully appreciated the challenge dyslexic individuals face when it comes to coding. Computers are patient and tireless, always correcting mistakes as long as the user persists. However, with Gen AI, coding challenges for people with dyslexia can be immediately filtered out before compilation.

In the future, automation platforms like UiPath will integrate Gen AI into all tools that support intelligent automation for daily knowledge work. Dyslexia will no longer be a barrier to unleashing creativity.

Gen AI emerges as a transformative tool for dyslexic individuals, revolutionising the writing and coding experience. It empowers writers and developers to overcome the barriers imposed by dyslexia and unlock their full creative potential. By providing tailored support, boosting confidence, and facilitating effective communication, Gen AI ensures the written word becomes a playground for self-expression rather than a source of frustration. We should celebrate the union of technology and humanity as dyslexic individuals triumph over their writing challenges and share their remarkable stories with the world.

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