Article by Lalita Panicker, Consulting Editor, Views and Editor, Insight, Hindustan Times, New Delhi
Eli Lilly, maker of the anti-obesity drug Zepbound, announced last week the launch of LillyDirect, a direct-to-patient portal, allowing some patients to obtain its drug for as little as $25 a month.
The move is seen as a major shift in the way these popular medications can reach patients. https://www.medscape.com/s/viewarticle/eli-lilly-offers-obesity-drug-directly-consumers-2024a10000fl?
For many of the 42 million Americans with obesity, weight loss medications such as Wegovy, Saxenda, and the brand-new Zepbound can be a godsend, helping them lose the excess pounds they’ve struggled with for decades or a lifetime.
But getting these medications has been a struggle for many who are eligible. Shortages of the drugs have been one barrier, and costs of up to $1,300 monthly – the price tag without insurance coverage – are another hurdle.
But 2024 may be a much brighter year, thanks to Lilly’s new portal as well as other developments:
- Insurance coverage on private health plans, while still spotty, may be improving. Federal legislators are fighting a 2003 law that forbids Medicare from paying for the medications when prescribed for obesity.
- New research found that semaglutide (Wegovy) can reduce the risk of recurrent strokes and heart attacks as well as deaths from cardiovascular events in those with obesity and pre-existing cardiovascular disease (or diseases of the heart and blood vessels), a finding experts said should get the attention of health insurers.
The medications, also referred to as GLP-1 agonists, work by activating the receptors of hormones (called glucagon-like peptide 1 and others) that are naturally released after eating. That, in turn, makes you feel more full, leading to weight loss of up to 22% for some. The medications are approved for those with a body mass index (BMI) of 30 or a BMI of 27 with at least one other weight-related health condition such as high blood pressure or high cholesterol. The medicines, injected weekly or more often, are prescribed along with advice about a reduced-calorie diet and increased physical activity.
Eli Lilly launched its direct-to-patient portal on 04 January, providing its obesity medicine (as well as diabetes and migraine drugs) direct to the consumer. Patients can access the obesity medicines through the telehealth platform FORM. Patients reach independent telehealth providers, according to Lilly, who can complement a patient’s current doctor or be an alternative to in-patient care in some cases.
Eli Lilly officials did not respond to requests for comment.
“It’s a great move for Lilly to do,” said Caroline Apovian, professor of medicine at Harvard Medical School and co-director of the Centre for Weight Management and Wellness at Brigham & Women’s Hospital in Boston, who is also a veteran obesity specialist. “It is trying to help the accessibility issue and do it responsibly.”
There are still concerns and questions, Zeev Neuwirth, a former executive at Atrium Health who writes about health care trends said, ” this is to my knowledge the first of its kind in terms of a pharmaceutical manufacturer directly dispensing medication in this non-traditional way.”
He called for transparency between telehealth providers and the pharmaceutical company to rule out any conflicts of interest.
The American College of Physicians, an organization of internal medicine doctors and others, issued a statement expressing concern. Omar T. Atiq, group’s president, said his organization is “concerned by the development of websites that enable patients to order prescription medications directly from the drugmakers. While information on in-person care is available, this direct-to-consumer approach is primarily oriented around the use of telehealth services to prescribe a drug maker’s products.”
The group urged that an established patient-doctor relationship be present, or that care should happen in consultation with a doctor who does have an established relationship (the latter an option offered by Lilly). “These direct-to-consumer services have the potential to leave patients confused and misinformed about medications.”
Previous research has found that the GLP-1 medicines such as Ozempic (semaglutide), which the FDA approved to treat diabetes, also reduce the risk of cardiovascular issues such as strokes and heart attacks. Now, new research finds that semaglutide at the Wegovy dose (usually slightly higher than the Ozempic dose for diabetes) also has those benefits in those who don’t have a diabetes diagnosis but do have obesity and cardiovascular disease.
In a clinical trial sponsored by Novo Nordisk, the maker of Wegovy, half of more than 17,000 people with obesity were given semaglutide (Wegovy); the other half got a placebo. Compared to those on the placebo, those who took the Wegovy had a 20% reduction in strokes, heart attacks, and deaths from cardiovascular causes over a 33-month period.
The study results are a “big deal,” Louis Aronne, director of the Comprehensive Weight Control Center at Weill Cornell Medicine in New York City said. The results make it clear that those with obesity but not diabetes will get the cardiovascular benefits from the treatment as well. While more analysis is necessary, he said the important point is that the study showed that reducing body weight is linked to improvement in critical health outcomes.
In an email, David Allen, a spokesperson for America’s Health Insurance Plans, a health care industry association, said: “Every American deserves affordable coverage and high-quality care, and that includes coverage and care for evidence-based obesity treatments and therapies.”
“And some patients are experiencing bad effects related to these drugs such as vomiting and nausea, for example, and the likelihood of gaining the weight back when discontinuing the drugs,” Allen said.
Research suggests the obesity medications must be taken continuously, at least for most people, to maintain the weight loss. In a study of patients on Zepbound, Aronne and colleagues found that withdrawing the medication led people to regain weight, while continuing it led to maintaining and even increasing the initial weight loss. While some may be able to use the medications only from time to time, “the majority will have to take these on a chronic basis,” Aronne said.
The hepatitis B vaccine is one of the most potent immunizations, usually providing decades of protection against the deadly liver virus. But in about 10% of people it doesn’t work, and in 2020, Amy Huei-Yi Lee, a systems biologist at Simon Fraser University, and her colleagues set out to determine whether they could predict who would benefit. https://www.science.org/content/article/giant-project-will-chart-human-immune-diversity-improve-drugs-and-vaccines?
The scientists found that data on recipients’ immune systems such as the abundance of certain proteins and the activity patterns of a few genes foretold whether they would generate defences against the virus. “We got a sense of what factors drive the vaccine response and what [doesn’t],” Lee says.
She and her colleagues were only able to take measurements from a handful of patients, but an ambitious effort slated to begin early this year will collect such data from hundreds of thousands of volunteers throughout the world. Called the Human Immunome Project (HIP) and backed by an international consortium of companies, government agencies, and universities, the effort will probe thousands of immune variables in blood and tissue samples. The result will likely be the world’s largest and most comprehensive immunological database, a resource for scientists investigating immune system differences and how they influence our responses to vaccines and drugs and our vulnerability to illness. “There’s a huge opportunity here in terms of understanding human disease,” says immunologist Mark Davis of Stanford University, who is not involved in the project.
And that’s just the start for the effort, which currently operates on about $5 million a year in funding but could ultimately cost billions. An offshoot of a previous effort known as the Human Vaccines Project, HIP will also use the data as fodder for new artificial intelligence (AI) models that could predict immune system responses across entire populations, providing valuable insights not just for pharmaceutical companies and governments, but even for doctors and patients. “The impacts will be felt globally,” says neuroscientist Hans Keirstead, the Irvine, California–based project’s CEO.
Scientists unconnected to the project say its goal of compiling a basic immune database for the world is feasible. “We have the experience and technology,” says immunologist Allison Greenplate of the University of Pennsylvania. But she and others question how much insight AI will add.
In the field of cardiology, a lipid panel reveals a lot about a patient’s cardiovascular health and risk of disease. Immunology, however, doesn’t have a comparable set of simple measurements that indicate the status of a person’s immune system, Davis says. Some data can provide a rough gauge: Patients with reduced numbers of neutrophils, for instance, are prone to infections. But such data are limited. HIP aims to come up with a uniform group of measurements that can, like a lipid panel, provide a readout of the immune system’s functioning.
A few public and private efforts have scooped up some basic immune data from large numbers of people, including All of Us, the U.S. National Institutes of Health’s program to gather genomic and medical data from 1 million people, and Project Baseline from the Google offshoot Verily, which tallied information on how individuals responded to COVID-19 infection. But such projects have collected limited categories of information and, in Project Baseline’s case, haven’t made the data available publicly.
Another area where research has fallen short is “the understanding of human immune variation and diversity,” says John Tsang, a systems immunologist at Yale University who helped develop HIP’s scientific plan. A litany of factors—including age, sex, diet, living conditions, previous disease exposure, and genetics—shapes how the immune system functions. But most immunological studies are conducted on small, homogenous populations, usually in the United States or Europe, Tsang says. Relying on such a narrow slice of humanity “has biased our understanding,” Thomas says.
HIP aims to address that lack of diversity. “We want baseline data from every human population,” Keirstead says. To capture human variety, HIP’s plans call for up to 300 collection sites on all of the inhabited continents. Each site will measure the same set of variables in as many as 10,000 people, from different socioeconomic levels and a range of ages, from new-borns to centenarians. In addition, they will include healthy people as well as individuals who have medical problems such as autoimmune diseases, cancer, and allergies. All volunteers will have to undergo medical exams and provide a detailed health history.
Although HIP intends to begin this global data collection phase in 2027, the effort’s first phase, launching this year, will be smaller and likely involve seven to 10 clinical research centres, including facilities outside the wealthy countries, that are already adept at gathering and analysing immune data, Keirstead says. At each site, the project will study about 500 people, measuring immune variables including the abundance of different types of immune cells, gene activity, concentrations of metabolic molecules, and DNA sequences. “The idea is that we will go deep and measure as much as possible,” Tsang says. From this mass of data, the project will then select a few variables that provide the clearest picture of how the immune system is working. They will also provide the basis for an immune monitoring kit, a standard set of assays that all the sites in the second part of the project will use.
In the end, HIP will generate nearly 2 trillion immune measurements, which will be publicly available through a central database. With this data haul and other information, HIP will build a predictive AI model that can forecast—based on immune profile, ancestry, economic status, age, and other information—how individuals will respond to stresses or challenges, such as a particular drug or pathogen. The model could help pharmaceutical companies identify opportunities for new treatments and drug reactions to avoid. And by providing a much more detailed view of a population’s health and vulnerability to side effects, the model could enable countries to better decide which drugs are needed by and suitable for their populations, thus allowing them to reduce health care costs, Keirstead says.
What HIP is aiming for with its AI ambitions has “never been done before,” Kierstead says, which is probably why this part of the project draws more scepticism from outside researchers. The project intends to generate not just predictive models, but also ones that replicate how the immune system operates. Mathematical biologist Reinhard Laubenbacher of the University of Florida says the AI will detect patterns of responses but doubts it will open a deeper understanding of the immune system. “Data collection efforts like this are tremendously helpful, but we will probably need more than that,” he says. A priority is “building [a] theoretical framework” to understand the information the project will accrue, he says.
Another challenge is money. To realize its ambitions, HIP will require a supersize budget, about $1 billion to $3 billion over the next 10 years, Keirstead says. To raise the needed funds, HIP now hopes to go beyond its current partners to philanthropies, governments, and other pharmaceutical companies. “I am targeting everyone. There is not going to be a stone left unturned,” he says.