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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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Business

Metal is the ideal packaging for vitamins

Carlo Rodrigo Borges, Business Development Manager, Trivium Packaging

The vitamins and supplements market is booming. A 2022 European survey by Ipsos found that in 14 EU member states almost 9 in 10 European consumers had taken food supplements in their lives and 93% had done so in the last 12 months. As a result, the Europe nutrition and supplements market size was valued at USD 61.8 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.8% from 2022 to 2030.

As Europe’s population has become more aware of health and fitness, consumers have been increasingly adopting nutritional supplementation to achieve their dietary and wellness goals. The demand for natural and organic products has grown, alongside the demand for plant-based products and functional foods, owing to the rapidly ageing population.

The push to go green

As a growing sector, there is potential for vitamins and supplements to contribute to consumers’ and brands’ increasing focus on sustainability.

The drive to eliminate wasteful packaging, especially single-use plastic, is well documented.

Brands are under pressure to amplify and fulfil their ESG credentials. In addition to a brand’s own sustainability goals and initiatives, legislation is forcing a shift with a host of sustainability-focused legislation throughout Europe already and likely more to come.

Consumers are also driving pressure on brands to offer more sustainable packaging as they increasingly turn away from single-use plastics and look for more sustainable options. The 2023 Buying Green Report shows that 71% of consumers have chosen a product in the last six months based on its sustainability and credentials and 63% of consumers are “less likely” to buy products in harmful packaging. In addition, 90% of consumers among younger generations (18-24 years old) showed a willingness to pay more for products in sustainable packaging. In

Europe, 60% of respondents considered plastic to be harmful and related plastic to ocean pollution. With 51% of consumers in this region saying they won’t buy products in packaging harmful to the environment, there is a significant opportunity for brands to tap into a wave of consciousness around sustainability.

Metal: a sustainable solution

If you look at vitamins and supplements on shelves in stores today – you’ll see a plethora of plastic containers, and it can be hard to differentiate one brand from the next. Even those containers that are recyclable may not be recycled. Currently, in Europe, only 14% of plastic is recycled. Recyclability depends on multiple considerations including the make-up of the material, whether it has a label, the availability and capabilities of local recycling facilities and, of course, consumer behaviour. The use of metal in packaging minimizes these variables – metal makes it easy to recycle without limits allowing recycling facilities to process it without difficulty. The only variable left is consumer behaviour.

Metal can be easily recycled over and over without degradation. As such, metal is infinitely recyclable, and its true circularity gives it a unique role in helping to protect the planet for generations to come. In fact, 75% of aluminium that’s ever been produced is still in use today. While companies may opt to use glass, the only other infinitely recyclable material, metal has some advantages over glass as it is lighter to transport and more durable for both transit and consumer use. Metal also requires less energy than glass to recycle. In addition, metal packaging allows printing directly onto the bottle, while glass and plastic need adhesive labels which often cannot be recycled by local councils.

As the Protect, Promote, Preserve report explains, choosing the right packaging for a brand’s products is a decision that brands will often dedicate considerable time. Optimal packaging, in terms of format, size, and material can help maintain product integrity and enhance the customer experience. Selecting the right type of packaging is particularly important for products being consumed, which require exceptional protection to reduce the risk of damage and food waste during storage, handling, and consumption. This is why many brands are turning to metal which offers superior levels of robustness and durability relative to alternatives on the market. Metal ensures that oxygen, damaging UV light, and moisture cannot permeate its contents – an important consideration to keep products safe for consumption.

Alongside protecting and preserving their products, metal packaging can be an extremely effective brand tool. Metal packaging provides greater and more sustainable opportunities for brands looking to differentiate their product offerings. By printing directly onto the packaging, brands can use the entire surface area and make use of advanced graphics and prominent colours on their cans and bottles without sacrificing packaging functionality and/or recyclability all without the inclusion of unrecyclable labels. Research suggests that one-third of consumer purchasing choices are based on packaging alone, so the opportunities for brand creativity can be a game-changer for brand growth. Metal printing also does not compromise product safety because of the impermeability of metal, and because the inks used are fully compliant with strict food safety regulations. The metal container itself can also be adapted for numerous different shapes and sizes of containers offering huge versatility. With so many choices, packaging producers can collaborate with their customers and help guide them to the right solution which can be tailored to their audience and brand image.

The vitamins and supplements sector continues to grow, and as the sector grows so does its impact on the environment. Improving sustainability is not just about checking boxes but also about attracting customers and improving the bottom line in an increasingly competitive marketplace. Consumers are taking note of the sustainability of metal packaging and making purchasing decisions based on sustainability, however, consumers continue to remain drawn in by packaging’s presentations and aesthetics. Metal offers a sustainable solution that meets consumers’ needs with a premium look and feel while providing the vital protection needed for the contents inside. Brands that invest – time and money – in the switch to metal packaging now are set up to benefit in the long term.

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Business

The role of social media and celebrity culture in making cosmetic surgery accessible

By Michael Saul, Partner at Cosmetic Surgery Solicitors

The popularity of cosmetic surgery has grown in tandem with social media and celebrity culture. Once thought to be only accessible to celebrities or the rich, cosmetic procedures today are more affordable than ever. The demographic of those facing the knife has changed dramatically over the last few years, and the reason for wanting to may be more linked to celebrity culture than economic access.

Here, Michael Saul at Cosmetic Surgery Solicitors explores how social media and celebrity culture have facilitated widespread access to cosmetic surgery, and the potential implications associated with this trend. For the trend to be understood, we must consider the measures taken by the government and medical professionals to ensure that the priority is to safeguard the health of individuals who pursue procedures.

The popularity of cosmetic surgery  

The increase in popularity can be partially attributed to the influence of social media and celebrity culture, which have made it easier for people to access information about different cosmetic treatments. While the accessibility of these treatments is beneficial in certain circumstances, it has also led to serious concerns. Most notably, it has highlighted the emotional and physical consequences of chasing an ever-changing beauty standard. Wider accessibility also translates to difficulty in regulating procedures on a wide scale.

A report from the International Society of Aesthetic Plastic Surgery (ISAPS) states that there were over 24 million surgical and non-surgical cosmetic procedures conducted worldwide in 2018 – a 4% annual increase. 

Social media giants such as Instagram and Facebook can display information about different cosmetic treatments and procedures to billions of people worldwide. Social media platforms are pedestals for celebrities to constantly flaunt their appearance and endorse particular cosmetic surgery brands or services. The never-ending feed of celebrity content creates pressure on individuals to conform to unrealistic ideals of beauty or attractiveness. In a celebrity-praising society, it is no surprise that many people are led to pursue such treatments to “fit in” with what they are told is the standard.

A growing concern is an ability to control and regulate the emerging offers for cosmetic surgeries. Accessibility without proper regulation can lead to misled, ill-prepared, or unfit individuals undergoing surgery. More businesses in the industry drives price competition between practitioners, potentially resulting in substandard treatment and medical care in an effort to cut costs. In response, governments must put in place more stringent and considered regulations governing who can offer these services, and the expected standard of service from practitioners, to ensure safety for those who opt for such treatments wherever they receive treatment.

The complications with accessible cosmetic surgery

More accessibility to cosmetic procedures without regulation can easily result in a decrease in safety and efficacy standards. Increasing demand has seen some medical professionals cut corners to keep up with unprecedented demand. Cutting medical corners leads to dangerous consequences, such as botched surgeries, infections, and scarring.

It is important to consider that even elective procedures often result in serious psychological implications on the patient if they are not performed properly, or if the patient is not prepared for them. Individuals contemplating cosmetic procedures must consult a board-certified surgeon with longstanding experience in the latest techniques and standards before making any decisions. 

Apart from possible health dangers, there is also worry that the ease of availability of cosmetic surgery may lead to a warped perspective of beauty and body image. While social media has been primarily praised for increasing people’s access to cosmetic treatments, it has also been criticised for encouraging unrealistic beauty expectations. As more people pursue these procedures without understanding the ramifications or investigating all of their alternatives, the danger of needless operations and an unhealthy preoccupation with physical beauty grows.

Is the blame on social media?

Social media has had a huge influence on the cosmetic surgery industry. This is primarily due to the prominence of “influencers” on various social media platforms who advertise themselves and their lifestyles. Several influencers have undergone cosmetic operations, and they frequently show off the results, giving their huge following an idea of what they may look like if they went through with it as well.

This type of promotion can be especially problematic for young people who are easily impressionable. The syndrome known as “Snapchat dysmorphia” has been observed, in which people feel motivated to change their look in order to resemble manipulated photographs that appear on social networking sites.

Additionally, not all cosmetic surgery centres offer safe or high-quality procedures. Untrustworthy therapists may utilise social media to entice vulnerable patients who are yearning for a physical change. Despite warnings from medical professionals, some patients may still be tempted to take this risk just to achieve the same results they see others getting on their timelines and news feeds.

Finally, persons seeking cosmetic surgery operations should be aware that, while it may appear beautiful and easy at first look, social media may be a powerful yet harmful influence when making judgements regarding aesthetic improvement treatments. It is also worth mentioning that certain countries are starting to take action against fraudulent advertising connected to cosmetic surgery, particularly those associated with influencer culture, in order to safeguard consumers from misleading information and potentially dangerous practices.

Is the blame on celebrities? 

Celebrities have been known to impact many elements of life for their fans, including fashion trends and haircuts, as well as lifestyle choices. It has also been proposed that celebrities can have a significant impact on people’s decisions to undertake cosmetic operations.

While celebrities may inspire people to assume that cosmetic surgery is far less dangerous than it is, there are always dangers involved with these treatments. Consumers should also be aware that not all cosmetic surgeons provide the same degree of care or skill; it is critical to conduct adequate research and locate a trustworthy practitioner who follows all safety measures before undergoing any sort of operation.

It’s important to remember that everyone’s body is different, so what works for one person might not work for another. As a result, every choice to proceed with surgery should be made cautiously and with a full understanding of all potential risks and results. Taking ideas from celebrity culture may be entertaining, but when it comes to health care or cosmetic surgery in particular, we must always exercise prudence and make our own educated judgements rather than depending primarily on external influences.

It is undeniable that social media and celebrity culture have made cosmetic surgery more accessible. Governments and medical experts must be mindful of these dangers to protect the safety of people who undergo such procedures before irreversible physical and psychological damage is caused.

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Business

How pharma companies can accelerate customer engagement post-pandemic

By Carolina Wosiack, Managing Director EMEA, CI&T

Throughout the 2020s, pharmaceutical companies have been thrust under the spotlight like never before. Fortunately, they’ve largely responded exceptionally, delivering life-saving vaccine treatments at record speeds. As such, they’ve been handsomely rewarded, too. Pfizer recently announced record earnings of $100 billion for 2022, largely driven by the ongoing rollout of its COVID-19 vaccine and the launch of the antiviral pill Paxlovid. However, the company also expects its revenue to decline by as much as a third this year, as demand for these ‘blockbuster’ treatments reaches a plateau.

Now, pharma companies are moving into new markets and working on new drugs to sustain their growth. In February 2023, AstraZeneca CEO Pascal Soriot stated in the company’s annual results announcement: “…we are on track to deliver industry-leading revenue growth through 2025 and beyond, and have set AstraZeneca on a path to deliver at least fifteen new medicines before the end of the decade.”

These companies already know how to research, create, and test innovative new drugs until the formula is perfected for public use. But when it comes to marketing such products, pharma executives tend to be risk averse and obsessed with outputs. With the pandemic largely behind us, how can pharma companies continue to boost revenues and customer engagement? Let’s take a look.

  • Small, agile product teams can identify opportunities the fastest

If pharma businesses want to continuously unlock new revenue streams, they may need to adapt their working models and mindsets. Large, traditional R&D departments are no longer nimble enough for today’s volatile world. Analysis of over 65 million scientific papers, patents, and software products from Harvard Business Review in 2019 uncovered a near-universal conclusion: “whereas large teams tended to develop and further existing ideas and designs, their smaller counterparts tended to disrupt current ways of thinking with new ideas, inventions, and opportunities.”

For leaders to cultivate true innovation, they must set up compact teams that focus on specific customer needs, identify issues, and then work to address them. Here, it’s often useful to build ‘two-pizza’ teams made up of no more than eight people (the name comes from an Amazon maxim—if it takes more than two pizzas to feed a team, the team is too big). These nimbler groups can discover how to solve these problems at pace, and then recommend their ideas for wider production.

A prime example is the team behind the Oxford–AstraZeneca COVID-19 vaccine. The vaccine’s rapid development was led by just six scientists based at Oxford University.  Manufacturing then expanded to facilities across five global continents—and in less than twelve months after its first approval, two billion doses had been supplied to countries around the world. It’s this ability to embrace change and move quickly that will set companies apart throughout future periods of both calm and crisis.

  • Research and testing will optimise omnichannel customer strategies

Modern customers interact and engage with businesses across numerous digital touchpoints—from PCs to smartphones, websites to social media. But it’s crucial to identify and test which channels are best at delivering customer value, as part of their healthcare interactions and experiences, before companies heavily invest in campaigns within them.

Pharma content marketing, such as articles, podcasts, and webinars, is a good way to educate and entertain your audience. However, content that attracts isn’t always content that sells. Businesses must first grasp and understand their customers’ journeys to create truly relevant content. This process can be complex, and numerous experiments will likely be required to uncover the best way forward. So, pharma companies must ask themselves a) what behavioural changes do they want to elicit amongst their customers? And b) how can they positively influence human behaviour that drives business value?

Managers must also consider customer differences across locations and demographics, and tweak strategies accordingly. For instance, 18 to 24-year-olds are more than twice as likely to use social media for health-rated discussions than those between 45 and 54. Targeting the second demographic via Facebook or Instagram ads may not be cost-effective—so businesses must research more practical avenues.

A cultural change may even be necessary. Fewer organisational silos and a greater focus on digital and omnichannel will help forge collective progress, as new research shows the pharma industry is set to spend $4.5 billion on digital transformation by 2030. More attention paid to delivering strong content and smooth experiences, in the right place and at the right time, will ensure your business remains at the forefront of tech, marketing, and the minds of your customers.

  • Data will uncover increasingly important, multi-layered insights

The role of data in the pharma industry is becoming more critical than ever. It helps companies find patterns that enable better, faster decisions, and unlock growth in new areas via a data-driven and data-backed approach. For instance, data can highlight genetic makeup, disease status, demographics and more to help researchers quickly and cost-effectively find appropriate candidates for an urgent clinical trial. As the price of bringing a new drug to market reaches as high as $1.1 billion, cost optimisation via data is key.

Unleashing data from silos and sharing it between stakeholders will also transform business intelligence and value. Insights from field-based teams are crucial for customer experience and digital design too, as they can inform appropriate upgrades and developments. For example, what information do customers require before making a purchase decision? What are the most popular payment methods?

Pharma companies that combine their data with AI technologies will be able to unearth truly impactful insights that accelerate the market delivery of medicines and products. Ultimately, strong customer engagement along with innovative new products is a combination guaranteed to solidify your presence and supercharge your revenues. 

What’s next for pharma?

The pharmaceutical industry performed perhaps its greatest feat yet in safely guiding the world through the worst of the pandemic. Some companies now find themselves as household names, in unprecedented positions of influence. But to remain successful, the sector’s work is only just beginning.

From Blockbuster to Kodak, all too often we’ve seen heavyweights in other industries squander seemingly unassailable leads. So, companies who pivoted to play an important role in tackling COVID-19 mustn’t rest on their laurels, but instead invest and adapt further to solidify their positions. Meanwhile, challenger pharma brands and wider healthcare organisations must work harder than ever to catch up with competitors and position themselves at the forefront of the industry’s future. The sector is evolving as fast as its treatments. Pharma businesses that build smaller research teams, optimise their omnichannel strategies, and accelerate their data analysis will be well positioned to guide us through whatever the world throws at us next.

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