Pharmaceuticals
A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked.
Source: The New York Times
A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.
Brian Shelton’s life was ruled by Type 1 diabetes.
When his blood sugar plummeted, he would lose consciousness without warning. He crashed his motorcycle into a wall. He passed out in a customer’s yard while delivering mail. Following that episode, his supervisor told him to retire, after a quarter century in the Postal Service. He was 57.
His ex-wife, Cindy Shelton, took him into her home in Elyria, Ohio. “I was afraid to leave him alone all day,” she said.
Early this year, she spotted a call for people with Type 1 diabetes to participate in a clinical trial by Vertex Pharmaceuticals. The company was testing a treatment developed over decades by a scientist who vowed to find a cure after his baby son and then his teenage daughter got the devastating disease.
Mr. Shelton was the first patient. On June 29, he got an infusion of cells, grown from stem cells but just like the insulin-producing pancreas cells his body lacked.
Now his body automatically controls its insulin and blood sugar levels.
Mr. Shelton, now 64, may be the first person cured of the disease with a new treatment that has experts daring to hope that help may be coming for many of the 1.5 million Americans suffering from Type 1 diabetes.
“It’s a whole new life,” Mr. Shelton said. “It’s like a miracle.”
Diabetes experts were astonished but urged caution. The study is continuing and will take five years, involving 17 people with severe cases of Type 1 diabetes. It is not intended as a treatment for the more common Type 2 diabetes.
“We’ve been looking for something like this to happen literally for decades,” said Dr. Irl Hirsch, a diabetes expert at the University of Washington who was not involved in the research. He wants to see the result, not yet published in a peer-reviewed journal, replicated in many more people. He also wants to know if there will be unanticipated adverse effects and if the cells will last for a lifetime or if the treatment would have to be repeated.
But, he said, “bottom line, it is an amazing result.”
Dr. Peter Butler, a diabetes expert at U.C.L.A. who also was not involved with the research, agreed while offering the same caveats.
“It is a remarkable result,” Dr. Butler said. “To be able to reverse diabetes by giving them back the cells they are missing is comparable to the miracle when insulin was first available 100 years ago.”
And it all started with the 30-year quest of a Harvard University biologist, Doug Melton.
‘A Terrible, Terrible Disease’
Dr. Melton had never thought much about diabetes until 1991 when his 6-month-old baby boy, Sam, began shaking, vomiting and panting.
“He was so sick, and the pediatrician didn’t know what it was,” Dr. Melton said. He and his wife Gail O’Keefe rushed their baby to Boston Children’s Hospital. Sam’s urine was brimming with sugar — a sign of diabetes.
The disease, which occurs when the body’s immune system destroys the insulin-secreting islet cells of the pancreas, often starts around age 13 or 14. Unlike the more common and milder Type 2 diabetes, Type 1 is quickly lethal unless patients get injections of insulin. No one spontaneously gets better.
“It’s a terrible, terrible disease,” said Dr. Butler at U.C.L.A.
Patients are at risk of going blind — diabetes is the leading cause of blindness in this country. It is also the leading cause of kidney failure. People with Type 1 diabetes are at risk of having their legs amputated and of death in the night because their blood sugar plummets during sleep. Diabetes greatly increases their likelihood of having a heart attack or stroke. It weakens the immune system — one of Dr. Butler’s fully vaccinated diabetes patients recently died from Covid-19.
Added to the burden of the disease is the high cost of insulin, whose price has risen each year.
The only cure that has ever worked is a pancreas transplant or a transplant of the insulin-producing cell clusters of the pancreas, known as islet cells, from an organ donor’s pancreas. But a shortage of organs makes such an approach an impossibility for the vast majority with the disease.
“Even if we were in utopia, we would never have enough pancreases,” said Dr. Ali Naji, a transplant surgeon at the University of Pennsylvania who pioneered islet cell transplants and is now a principal investigator for the trial that treated Mr. Shelton.
Blue Clues
For Dr. Melton and Ms. O’Keefe, caring for an infant with the disease was terrifying. Ms. O’Keefe had to prick Sam’s fingers and feet to check his blood sugar four times a day. Then she had to inject him with insulin. For a baby that young, insulin was not even sold in the proper dose. His parents had to dilute it.
“Gail said to me, ‘If I’m doing this you have to figure out this damn disease,’” Dr. Melton recalled. In time, their daughter Emma, four years older than Sam, would develop the disease too, when she was 14.
Dr. Melton had been studying frog development but abandoned that work, determined to find a cure for diabetes. He turned to embryonic stem cells, which have the potential to become any cell in the body. His goal was to turn them into islet cells to treat patients.
One problem was the source of the cells — they came from unused fertilized eggs from a fertility clinic. But in August 2001, President George W. Bush barred using federal money for research with human embryos. Dr. Melton had to sever his stem cell lab from everything else at Harvard. He got private funding from the Howard Hughes Medical Institute, Harvard and philanthropists to set up a completely separate lab with an accountant who kept all its expenses separate, down to the light bulbs.
Over the 20 years it took the lab of 15 or so people to successfully convert stem cells into islet cells, Dr. Melton estimates the project cost about $50 million.
The challenge was to figure out what sequence of chemical messages would turn stem cells into insulin-secreting islet cells. The work involved unraveling normal pancreatic development, figuring out how islets are made in the pancreas and conducting endless experiments to steer embryonic stem cells to becoming islets. It was slow going.
After years when nothing worked, a small team of researchers, including Felicia Pagliuca, a postdoctoral researcher, was in the lab one night in 2014, doing one more experiment.
“We weren’t very optimistic,” she said. They had put a dye into the liquid where the stem cells were growing. The liquid would turn blue if the cells made insulin.
Her husband had already called asking when was she coming home. Then she saw a faint blue tinge that got darker and darker. She and the others were ecstatic. For the first time, they had made functioning pancreatic islet cells from embryonic stem cells.
The lab celebrated with a little party and a cake. Then they had bright blue wool caps made for themselves with five circles colored red, yellow, green, blue and purple to represent the stages the stem cells had to pass through to become functioning islet cells. They’d always hoped for purple but had until then kept getting stuck at green.
The next step for Dr. Melton, knowing he’d need more resources to make a drug that could get to market, was starting a company.
Moments of Truth
His company Semma was founded in 2014, a mix of Sam and Emma’s names.
One challenge was to figure out how to grow islet cells in large quantities with a method others could repeat. That took five years.
The company, led by Bastiano Sanna, a cell and gene therapy expert, tested its cells in mice and rats, showing they functioned well and cured diabetes in rodents.
At that point, the next step — a clinical trial in patients — needed a large, well financed and experienced company with hundreds of employees. Everything had to be done to the exacting standards of the Food and Drug Administration — thousands of pages of documents prepared, and clinical trials planned.
Chance intervened. In April 2019, at a meeting at Massachusetts General Hospital, Dr. Melton ran into a former colleague, Dr. David Altshuler, who had been a professor of genetics and medicine at Harvard and the deputy director of the Broad Institute. Over lunch, Dr. Altshuler, who had become the chief scientific officer at Vertex Pharmaceuticals, asked Dr. Melton what was new.
Dr. Melton took out a small glass vial with a bright purple pellet at the bottom.
“These are islet cells that we made at Semma,” he told Dr. Altshuler.
Vertex focuses on human diseases whose biology is understood. “I think there might be an opportunity,” Dr. Altshuler told him.
Meetings followed and eight weeks later, Vertex acquired Semma for $950 million. With the acquisition, Dr. Sanna became an executive vice president at Vertex.
The company will not announce a price for its diabetes treatment until it is approved. But it is likely to be expensive. Like other companies, Vertex has enraged patients with high prices for drugs that are difficult and expensive to make.
Vertex’s challenge was to make sure the production process worked every time and that the cells would be safe if injected into patients. Employees working under scrupulously sterile conditions monitored vessels of solutions containing nutrients and biochemical signals where stem cells were turning into islet cells.
Less than two years after Semma was acquired, the F.D.A. allowed Vertex to begin a clinical trial with Mr. Shelton as its initial patient.
Like patients who get pancreas transplants, Mr. Shelton has to take drugs that suppress his immune system. He says they cause him no side effects, and he finds them far less onerous or risky than constantly monitoring his blood sugar and taking insulin. He will have to continue taking them to prevent his body from rejecting the infused cells.
But Dr. John Buse, a diabetes expert at the University of North Carolina who has no connection to Vertex, said the immunosuppression gives him pause. “We need to carefully evaluate the trade-off between the burdens of diabetes and the potential complications from immunosuppressive medications.”
Mr. Shelton’s treatment, known as an early phase safety trial, called for careful follow-up and required starting with half the dose that would be used later in the trial, noted Dr. James Markmann, Mr. Shelton’s surgeon at Mass General who is working with Vertex on the trial. No one expected the cells to function so well, he said.
“The result is so striking,” Dr. Markmann said, “It’s a real leap forward for the field.”
Last month, Vertex was ready to reveal the results to Dr. Melton. He did not expect much.
“I was prepared to give them a pep talk,” he said.
Dr. Melton, normally a calm man, was jittery during what felt like a moment of truth. He had spent decades and all of his passion on this project. By the end of the Vertex team’s presentation, a huge smile broke out on his face; the data were for real.
He left Vertex and went home for dinner with Sam, Emma and Ms. O’Keefe. When they sat down to eat, Dr. Melton told them the results.
“Let’s just say there were a lot of tears and hugs.”
For Mr. Shelton the moment of truth came a few days after the procedure, when he left the hospital. He measured his blood sugar. It was perfect. He and Ms. Shelton had a meal. His blood sugar remained in the normal range.
Mr. Shelton wept when he saw the measurement.
“The only thing I can say is ‘thank you.’”
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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.
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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.
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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.
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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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