Pharmacy chains defend actions as landmark U.S. opioid trial nears its end
CLEVELAND, Nov 15 (Reuters) – Lawyers for pharmacy chains including CVS and Walgreens on Monday argued they were not to blame for the U.S. opioid epidemic, as jurors prepared to consider whether to hold them responsible for the devastation the drug crisis caused in two Ohio counties.
Mark Lanier, a lawyer for Lake and Trumbull counties, told a federal jury in Cleveland that a verdict in the case against CVS Health Corp (CVS.N), Walgreens Boots Alliance Inc (WBA.O) and Walmart Inc (WMT.N) would have ramifications across the country.
The trial is the first the pharmacy chains have faced in thousands of lawsuits by states and local governments seeking to hold them liable for an epidemic that U.S. health officials say has led to nearly 500,000 opioid overdose deaths over two decades.
“You get to decide what will be the most seminal case in pharmacy history,” Lanier said in his closing argument.
He argued that companies created a public nuisance in the form of the epidemic by failing to prevent excessive amounts of addictive pain pills from flooding the counties or by stopping bogus prescriptions from being filled.
“A pharmacy is not a gum ball machine,” Lanier said. “They have more responsibility than simply taking your money and getting you your pills.”
Defense lawyers countered that the companies took steps to guard against the diversion of pills and blamed others for the deadly epidemic.
“There are many, many actors who played a role in the opioid crisis: The manufacturers, government agencies, doctors, drug cartels,” CVS attorney Eric Delinsky said.
Brian Swanson, a lawyer for Walgreens, said it had policies in place since 1997 to identify “red flags” of misuse and kept improving them.
“A company that’s constantly updating and improving its policies is not a company acting intentionally to cause an opioid crisis,” he told jurors.
LAWSUITS FILED NATIONWIDE
Should the jurors find the pharmacies created a public nuisance, U.S. District Judge Dan Polster would decide how much they owe to abate, or address, it. The counties’ lawyers have said the costs are potentially $1 billion for each county.
The Ohio trial follows recent setbacks for plaintiffs pursuing some of the 3,300 opioid cases filed against drug manufacturers, distributors and pharmacies.
Oklahoma’s top court last Tuesday overturned a $465 million judgment against drugmaker Johnson & Johnson, and a California judge this month ruled in favor of four drugmakers in a case brought by several large counties.
Those lawsuits also accused the companies of creating a public nuisance. A similar lawsuit by Washington state against three drug distributors went to trial on Monday. read more
Reporting by Grant Segall in Cleveland and Nate Raymond in Boston; Editing by Will Dunham, Noeleen Walder, Aurora Ellis and Dan Grebler
Our Standards: The Thomson Reuters Trust Principles.
The tech-enabled R&D opportunities Pharma is still missing.
Neil Thomas, Partner and Head of Health Care and Life Sciences for EMEA at Infosys Consulting
The life sciences industry is arguably experiencing the greatest period of disruption and transformation ever witnessed. The convergence of COVID, global geopolitical and supply chain obstacles, and the reality of climate change has left the industry grappling with higher costs, difficult operating conditions, and market flux. However, these threats also run alongside an explosion of technological advancement.
Capitalising on today’s nascent technologies, pharma now has the opportunity to realise radical transformation – especially within the most challenging area of R&D. While considerable breakthroughs have been achieved through digitalisation, opportunities to streamline innovation are being missed. Here we explore three areas in which pharma can focus on technologies to drive cost-effective transformation in R&D and beyond.
Embracing blockchain for cost-effective R&D
As with all sectors, data is the true lifeblood of life sciences, but despite leaps in its use in R&D, there is still a lack of effective strategies that ensure the safe and effective use of big data to drive cost-effective innovation. Consider blockchain, a technology already used to significant effect in the financial services sector, similar in its high security and data regulation levels.
Clinical trial data is an essential component of drug development, and the integrity and security of this data are critical to ensuring patient safety and bringing new drugs to market. However, to realise the power of data within R&D, companies must be able to securely access and analyse sensitive data at scale.
As recent research published in the International Journal of Molecular Sciences highlights, “one of the major problems in the use of big data in medicine is that medical data has been collected across different states, hospitals, and administrative departments using different protocols. Therefore, new infrastructure resources are required to better cross-examine the medical data through proper collaboration between different data providers.”
Blockchain distributed ledger technology can help to address some of the challenges associated with managing vast sets of clinical trial data, including data privacy, security, and transparency – especially when considering the collaborative nature of today’s R&D. By storing clinical trial data on a blockchain, pharmaceutical companies can ensure that patient data is protected and anonymised while providing greater transparency and accountability to the numerous stakeholders involved in the process.
Furthermore, blockchain technology can help streamline data management. Automating processes such as data verification and validation reduces the time and cost of managing clinical trial data, freeing up resources to focus on other aspects of drug development. Trust, transparency, and immutability – the three fundamentals of blockchain – align perfectly with the requirements of the pharma industry. By improving data security, transparency, privacy, and efficiency, blockchain can help to improve patient safety, increase trust in the drug development process, and accelerate the pace of innovation in the industry.
Realising the potential of personalised precision medicine
One of the pervasive issues in the industry is the escalating costs of R&D. Not only that but patients and governments increasingly want more for less, especially in this new era of personalisation. As Elias A. Zerhouni, MD, former director of America’s National Health Institutes and Centres, accurately predicted, we are now in the era of P4 medicine – predictive, personalised, pre-emptive, and participatory. Now individuals expect services to be tailor-made and targeted to their specific needs.
Personalised precision medicine aims to provide individualised treatments based on a patient’s genetic makeup, lifestyle, and other factors and relies heavily on the effective use of big data and AI. This is where blockchain technology could come into its own, enabling big data and AI to come together to develop hyper-personalised medicine at scale.
While personalisation is often associated with higher costs, AI can reduce the cost of drug development for hyper-personalised medicine by enabling researchers to predict drug efficacy and safety more accurately. By analysing vast amounts of data, including genetic data, medical histories, and drug response data, AI can identify biomarkers and other indicators that can predict how an individual patient will respond to a given drug. This can reduce the need for expensive clinical trials and help researchers identify promising drug candidates more quickly.
AI-enabled hyper-personalisation approaches can also help researchers design clinical trials that are more targeted and efficient, reducing the cost and time required to bring a drug to market.
As the above research summarises, “Advanced machine learning approaches such as artificial intelligence and deep learning represent the future toolbox for the data-driven analytics of genomic big data. The emerging progress in these areas will be indispensable for future innovation in health care and personalised medicine.”
Bring potential to life with 3D printing
Developing personalised medicine through AI opens many doors, but production is another challenge. This is where 3D printing technology can support the development of small-batch medication, whether for prototyping or personalisation. For example, 3D printing can allow pharmaceutical companies to easily adjust the production process to accommodate small batch sizes, allowing the fast development of prototypes and custom medications for individual patients, supporting the aim of ‘batch of one’, through personalised precision medicine.
By enabling more targeted drug development, more efficient clinical trial design, and more accurate prediction of drug efficacy and safety, AI is critical to R&D and will be fundamental to the realisation of personalised medicine. Add to this the secure foundation of blockchain and the potential of 3D printing to support effective production, and the roadmap for future medicine is paved with today’s most innovative technologies. Through focused digitalisation within R&D, the industry can realise innovative channels for growth that could redefine life sciences for the better of all.
How running can help improve mental health- the 4 key benefits
An analysis of Google trends data shows that searches for “what are the symptoms of depression” are up by 350%, and “how to deal with depression” up by 70% over the past 30 days, suggesting that many are starting off 2023 suffering from low mood and depression. A huge contributing factor to this will be seasonal affective disorder, which is a depression experience by many during the darker winter months.
To help, the experts at New Balance share four key ways in which exercise, and running in particular, can help improve your mental health.
- Release of happy hormones
Research by Mayo Clinic which found that exercising for about 30 minutes three to five times a week can help relieve depression symptoms. Exercise in general also helps release the feel-good hormones like dopamine, serotonin, oxytocin and endorphins, which can negate the symptoms of depression and low mood.
New Balance marathon runner Jonny Mellor explains: “You always feel good after a run. There’s never a feeling of, ‘I shouldn’t have done that’. Getting out of the door is the hardest step. Then once you’re out, you’re set up to be in a better mood. After running, or any other exercise, endorphins are released in the body, and you feel much better.”
- Increases oxygen and Vitamin D exposure
During the cold and dark winter days it can be difficult to find the motivation to get outside, but in fact running, as a form of exercise, is actual extra beneficial during winter months. Opting for a run outside during the day instead of in the gym exposes you to fresh air, which increases the amount of oxygen in your body, helping white blood cells to function more efficiently and keep the winter bugs at bay. Not only this, but it also increases exposure to sunlight during a time of the year where vitamin D levels are typically not high enough. In fact, studies have shown that we get 90% of our vitamin D from the sun, if not taking any additional supplements, which means we should make a conscious effort to expose ourselves to the sun during the winter months.
Although there is limited evidence that a Vitamin D deficiency directly contributes to depression, the symptoms of a deficiency are aching bones, sore muscles and joints as well as constipation, all of which can affect a person’s quality of life and therefore mood.
- Aids better sleep
It is typical of those that have depression to be experiencing poor sleep, in fact, studies have shown that insomnia occurs in about 75% of adult patients with depression but according to the Sleep Foundation, depression and sleep have a bidirectional relationship, meaning it is difficult to prove whether it is depression causing poor sleep or poor sleep contributing to depression. Either way, improving the amount and quality of sleep will improve mood and overall health- and one way to do this is to increase exercise levels.
Moderate exercise, such as running, has been proven to aid a restful night’s sleep by reducing the time it takes for sleep onset, which is the time it takes to fall asleep, this decreases the amount of time people lie awake in bed during the night. There is also the benefit that you are using more energy in the day to exercise, meaning there is less pent-up energy in the evening, essentially you wear yourself out.
Also, if you exercise outside it can help regulate your circadian rhythm. Exposure to sunlight lets our body know when it should be awake, meaning that when the sun sets, our bodies then produce melatonin to induce sleepiness and promote sleep. Increasing the time spent outside is a simple and effective way to trigger the natural chemicals in our brain that promote high-quality sleep.
It is, however, important to bear in mind that the timing of your run will impact the effect it has on sleep. Exercising too close to bedtime can have the opposite desired effect, as exercise releases endorphins, adrenaline and raises body temperature it can make sleeping more difficult. Avoid exercise at least 2 hours before bedtime.
- Improved self-esteem
There are many physical health benefits of running such as improved cardiovascular fitness, decreased blood pressure, and, of course the more obvious one, weight management. Whether your goal is to feel healthier and fitter or your goals is to lose weight, taking up running can help improve how you feel about yourself- your self-esteem, and you don’t need to be running marathons to feel the benefit.
The NHS physical activity guidelines state that to help reduce the risk of heart disease or a stroke: “Adults should aim to do at least 150 minutes of moderate intensity activity a week or 75 minutes of vigorous intensity activity a week.” Running is classed as a vigorous activity by the NHS, meaning that just 15-minute run 5 days a week will see adults achieving their recommended activity goals and therefore positively affect other goals which helps boost self-esteem.
Taking next-generation motion from concept to reality
~ How free motion can address challenges in the pharmaceutical industry ~
If companies were to take home one lesson from the COVID-19 pandemic, it should be that flexibility is key. This statement is no less true for the pharmaceutical industry, which has been pushing for flexibility for years. With a pandemic almost behind us and the challenges of a rapidly ageing population, flexible manufacturing is needed now more than ever. In this article , Adnan Khan, manager of pharma industries at Beckhoff UK, discusses the challenges of pharmaceutical production lines and how next-generation motion can help.
While there are many tips for creating a more flexible manufacturing process, from plug-and-play robotics to single-use manufacturing, few tips focus on motion control in production lines. Motion control has the power to make production lines more flexible and efficient, but few motion control systems provide the freedom and range to maximise their benefits.
From concept to reality
In interviews conducted by Donna Ritson, president of DDR communications and Paula Feldman, senior director of Business Intelligence, 75 per cent of pharmaceutical manufacturers said they were increasing their level of automation going forward. So for those wanting to invest in optimising their production lines, where should they spend their money?
Over the years, technology has advanced, allowing the pharmaceutical industry to advance with it. However, despite the introduction of sophisticated technology, challenges still occur in the production of pharmaceutical products, such as flexibility and efficiency. The XPlanar, a first-of-its-kind planar motor system, can help address these challenges.
The XPlanar system comprises the mover, tile and control software. The magnetically driven mover is wireless, with six degrees of jerk-free movement, allowing for the technology to effortlessly levitate over the tiles, which can be moved and placed as a facility needs. With each singular mover having a bare load of up to 4.2 kg, a maximum speed of 2 m/s and an easily wipeable surface, the XPlanar is bringing the reality of next-generation motion to the pharmaceutical industry.
Flexible and efficient
Flexibility has always been an issue in the pharmaceutical industry, as traditional plant layouts make it hard to switch over or adjust equipment to produce different products. Due to a large number of sensitive chemical processes in pharmaceutical manufacturing, moving equipment around requires equipment recalibrations and strategic positioning. However, with new methods such as modular manufacturing, allowing for multiple different drug productions in one facility, these challenges are slowly being addressed.
Modular manufacturing refers to a type of manufacturing where there is no fixed equipment, meaning facilities can be broken down and rearranged as needed. As modular manufacturing is embraced, new techniques will be needed to achieve a modular facility. The XPlanar system elevates this manufacturing method to a more efficient, flexible and long-lasting one. Like with many of the equipment used for modular manufacturing, the XPlanar system can be laid out freely in a multitude of arrangements to suit the pharmaceutical facilities’ requirements.
The XPlanar system provides the pharmaceutical industry with the production flexibility needed to not only create a modular manufacturing facility but a more efficient manufacturing facility. The XPlanar system allows manufacturers to create a flexible production line with movements of 360 degrees, allowing for easy and efficient product inspection, alignment or processing.
The easy adaptability of the movers and tiles ensures the technology can last in an ever-evolving technological landscape. Using this free-moving system the pharmaceutical industry can see the benefits of next-generation motion becoming reality.