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Tuesday, October 1, 2024

Doctors Seek Additional Obesity Training in Wake of Obesity Patient Boom

 Gitanjali Srivastava, MD, professor of medicine, pediatrics & surgery, and the medical director of obesity medicine at Vanderbilt University School of Medicine in Nashville, Tennessee, was nearly 10 years into practicing pediatric medicine when she graduated from the obesity medicine fellowship at Massachusetts General Hospital in Boston in 2013. "We were the very first sort of fellows to speak of then; there were no standards or curriculum," she said.

Obesity was already epidemic, but stigma and bias were still pervasive in the medical community and within the public. After graduating, Srivastava spent months vying for a position with hospital CEOs. She traveled across the country explaining the specialty and its value, going into detail about the budget, business model, space requirement, and revenue potential of obesity medicine. 

Today marks a very different era.

Obesity medicine is exploding. Patients are spilling into doctors' offices looking for obesity treatment. Healthcare systems are seeking out obesity specialists and building metabolic health centers. Since 2020, the number of doctors board-certified by the American Board of Obesity Medicine has nearly doubled, and the number of obesity medicine fellowships across the country has more than doubled. Next month, another 2115 doctors from primary care, surgery, orthopedics, pediatrics, fertility, endocrinology, and beyond will sit for the 2024 exam. The once niche specialty is quickly becoming intertwined with most of modern medicine.

The Need to Treat

It's no mystery that the rapid expansion of obesity medicine coincides with the US Food and Drug Administration's approval of GLP-1 injections. The drugs' radical weight loss properties have captured headlines and driven up patient demand. Meanwhile, doctors are finally able to offer effective treatment for a disease that affects 40% of US adults.

"We are finally treating it as a chronic disease, not as a lifestyle," said Marcio Griebeler, MD, director of the obesity medicine fellowship at the Cleveland Clinic. And "I think it's fulfilling for physicians," he said. 

For so long, the advice for obesity was about lifestyle. Move more, eat less, and harness willpower, "which really is a fallacy," said Kimberly Gudzune, MD, MPH, an obesity medicine specialist and chief medical officer for the American Board of Obesity Medicine (ABOM) Foundation. For people with obesity, "your brain is operating differently," she said. "Your body really is set up to work against you." 

Brianna Johnson-Rabbett, MD, medical director of the ABOM, told Medscape Medical News that with the advent of GLP-1s, "there's a clearer recognition that obesity is a disease that needs to be treated like other diseases." Some of that is, thanks to clinical trial data showing that just as with other diseases like high blood pressure or diabetes, obesity can be treated with medication and it resurges when the medication is stopped, she said.

Doctors don't have to go looking for patients with obesity, Griebeler adds. Now that treatment options exist, they're showing up in droves at the doctor's office — all the doctors' offices. In primary care, endocrinology, surgery, pediatrics — a wide variety of doctors are being asked about obesity drugs, Griebeler noted.

And while doctors are often just as excited as patients about the potential for treatment, many find themselves under-equipped when it comes to obesity. "More physicians are…recognizing the value in treating this, and some are realizing, "Oh gosh, I never learned how to do this," said Gudzune.

Information Patients Waiting For

Medical training has traditionally devoted minimal, if any, curriculum to obesity and metabolism. "To be honest, we didn't really cover this at all in my training," said Nina Paddu, MD, obesity medicine specialist at Maimonides Medical Center in New York City who finished her training only 2 years ago. "The guidance even in residency was 'let's send them to nutrition' and 'recommend exercising.'"

In addition to the medical education gap, until recently there was a "paucity of robust evidence," Srivastava said. Leaders in the field wanted to establish standards and guidelines, but there wasn't enough strong evidence on obesity and its treatments to build them, she said. 

Only in the last 5 years or so has the evidence-based understanding of obesity's pathophysiology truly accelerated: The brain's driving roles, its interplay with hormones, and its interactions with other diseases. "We are just at the cusp of understanding all the different factors," Gudzune said.

But already endocrinologists, surgeons, fertility specialists, gynecologists, and oncologists, to name a few, see the critical overlap with their own field. "Conditions were once suspected of being intertwined [with obesity], and now we have data to connect them," Srivastava said. For example, there's now data connecting semaglutide to a 20% reduction in cardiovascular events for people with obesity. That's a game changer for multiple specialties, she told Medscape Medical News. 

Getting Trained in Obesity Management

The recent uptick in obesity insights and increased patient need has doctors from every career stage seeking additional training.

The ABOM offers two board certification pathways: 60 hours of CME credits or a 12-month fellowship. Both paths require doctors to pass the board's exam. 

Many doctors incorporate the training into their existing practice. The CME credit pathway, especially, is designed to help get doctors up to speed without requiring them to upend their lives for a fellowship.

Srivastava said that the fellowship is more consuming and immersive. While it's often younger doctors just out of training who apply to fellowship, every year, "I'm astonished at the number of talented physicians with clinical and research experience who want to immerse themselves in a fellowship experience."

Some doctors return to their previous specialties after fellowship. But many will go on to take obesity medicine–specific roles or set aside clinic hours for obesity medicine. Their credentials are "really attractive to institutions, especially those looking to open up obesity medicine or weight management programs," said Srivastava.

Paddu, who finished her obesity medicine fellowship this year, said there are a variety of obesity medicine jobs to choose from — far different from Srivastava's job search 15 years ago. Paddu's new role combines 2 days of primary care with 2 days devoted to obesity medicine and 1 day each week set aside for administrative work so she can build up the hospital's new metabolic health clinic. 

Still Not Enough Obesity Specialists

As with all things, rapid growth requires careful oversight. "Part of the responsibility of the board is to think critically of how the field is growing" and conduct ongoing monitoring, Gudzune said.

This is also why the board's credentials are time-limited and must be recertified, Johnson-Rabbett added. 

But even with the rise in certified doctors and obesity medicine positions, the 8263 doctors certified by ABOM are only a tiny fraction of US physicians. As a result, there's genuine likelihood that many patients seeking GLP-1s or other obesity treatment don't yet have access to the holistic care they need. Plus, doctors may still not have obesity expertise within their networks.

"The field has grown rapidly, but it's still such a small field relative to the patient need," said Gudzune.

https://www.medscape.com/viewarticle/doctors-seek-additional-obesity-training-wake-obesity-2024a1000hu5

Does Metformin Therapy Impact CVD in T2D? 'It's Complicated'

 Metformin is taken every day by more than 200 million people worldwide. Its value as a glucose-lowering agent has been established for decades. But does metformin hold similar promise for reducing rates of cardiovascular disease (CVD)? 

This question was the focus of a thought-provoking presentation by Simon Griffin, MD, leader of the Prevention of Diabetes and Related Metabolic Disorders in High Risk Groups program at Cambridge University, Cambridge, England, at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

Griffin began by noting that trials such as the Steno-2 trial have shown that lifestyle interventions alone in patients with type 2 diabetes (T2D) reduce the risk for cardiovascular (CV) events and death. Similarly, the 30-year follow-up of the Da Qing study found there was a significant reduction in the risk for CV events associated with a lifestyle intervention for people with impaired glucose tolerance.

However, using rosiglitazone to prevent diabetes does not have a beneficial role in reducing the risk for CV events, as the DREAM study showed.

"The moment you stop the tablet that lowers glucose, the incidence of diabetes is the same as if you hadn't given participants the tablet in the first place," Griffin said. "The more difficult conclusion to swallow is that rosiglitazone actually increases the risk of CV events."

Metformin's Role in Diabetes

Metformin is a resounding success reducing the risk for diabetes, said Griffin.

"In the Indian Diabetes Prevention Program me [native Asian Indians], 250 mg twice a day of metformin reduced diabetes incidence by 26% in the 531 people with impaired glucose tolerance, despite of a relatively small change in weight."

And, in the US Diabetes Prevention Program Research Group trial, where people were randomized to receive placebo, 850 mg of metformin twice a day, or a lifestyle-modification program, there were "dramatic reductions" in the incidence of T2D: 31% with metformin and 58% with the lifestyle modification program. Furthermore, metformin was cost-saving, Griffin said.

"Metformin is good if you've got diabetes and it's cost saving if you've got so-called prediabetes. And unlike rosiglitazone, metformin appears to have a legacy effect; the moment you stop the tablet, the benefits don't appear to disappear."

Does Metformin Cut CVD in Diabetes? 

To answer the question posed by his presentation, Griffin turned to the results of several meta-analyses, with varying inclusion criteria.

"The trials are very different to current trials, and frequently CV events weren't the primary outcome; they were merely adverse events documented somewhere in the text of the paper," he noted. In addition, "most of the CV endpoint trials of metformin didn't feature a placebo group, and unsurprisingly, the meta-analyses are dominated by the UK Prospective Diabetes Study (UKPDS)."
 

They are informative, nonetheless. He highlighted the following studies in particular: 

  • Selvin reported a significant reduction in CV mortality of 26% with metformin, but a nonsignificant 15% reduction in CV morbidity
  • Lamanna reported a nonsignificant 6.3% reduction in CV events and a 10% reduction in the risk for myocardial infarction. 
  • Griffin's group reported an 11% reduction in the risk for myocardial infarction. 
  • In an update of Lamanna's review, Minami reported a 48% reduction in CV events and a nonsignificant 20% reduction in all-cause mortality. 
  • The UKPDS reported a consistent 31% reduction in the risk for CV events over time associated with metformin. 

'Should Metformin Be in Water Supply?'

Griffin then asked, does metformin reduce CV events among people with impaired glucose tolerance or those with normoglycemia? 

"Unfortunately, after 3 years of 850 mg twice a day of metformin vs placebo in the US Diabetes Prevention Program, there was no effect on CV events."

However, an important consideration in assessing metformin trials is that they're mostly old and different from more recent CV endpoint trials, he noted. Because the drug is off patent and a first-line treatment for diabetes and prediabetes in many countries, it's difficult to do a CV endpoint trial with it.

"What you might do instead is a metformin trial in people who haven't got diabetes, but with intermediate endpoints," Griffin said.

This is exactly what researchers did in the CAMERA trial, observing that despite the effect on weight and A1c, there was no impact on carotid intima-media thickness or carotid plaque score.

By contrast, a recent study found that disrupting metformin-targeted genes was associated with a 37.8% lowering of the risk for CVD in the general population.

To reduce the burden of CVD related to hyperglycemia, a complimentary approach is needed to shift the population distribution of underlying determinants, per Rose's prevention paradox, Griffin said. The paradox shows a population-based preventive health measure brings large public health benefits, although it offers little benefit to each individual participant. This means a study to lower the CVD burden of hyperglycemia would need an individualized component as well as a public health component.

Asked during the Q&A whether he could provide examples of countries where such an approach has worked, Griffin pointed first to the Västerbotten intervention.

"This was an individual-based approach to glucose tolerance tests on 40-, 50- and 60-year-olds, encouraging them to change their lifestyle," he said.

"But it also had a public health component of trying to change the food offerings in local supermarkets from the original, very fatty northern Scandinavian food to a slightly less fatty northern Scandinavian food and that appears to have had a positive impact on risk of CVD in that population."

Another example is The North Karelia Project, which led to significant reductions in CVD mortality and prompted an aggressive salt-reduction program and other public health measures in Finland.

"Should we give up on metformin as a preventive therapy for cardiovascular disease in people without diabetes," another meeting attendee asked.

"No, I would say not," Griffin responded. "If someone's got so-called prediabetes, then you should encourage them to change their lifestyle. You should treat their blood pressure aggressively, treat their cholesterol aggressively, and offer people metformin. I might want to follow them up and remeasure some of their blood tests and possibly even suggest they take added B12 or measure their B12," because metformin can reduce B12 levels.

"The question is, should you give metformin to people with normoglycemia? You give statins to people whose cholesterol is not very high. You give blood pressure treatment to people whose blood pressure is not very high just because they're at high CV risk," he pointed out. In short, "should metformin be put in the water supply or doled out like statins?"

The VA-Impact trial is looking at just that. The trial is recruiting people without diabetes but with existing CVD. 

"I think we should wait for those results in 2029," Griffin concluded.

Griffin declared honoraria from AstraZeneca and Eli Lilly and Company for postgraduate education meetings. Over 5 years ago, he undertook an independent feasibility study for a CV endpoint trial of metformin among people with prediabetes, for which Merck Serono provided the active drug and placebo.

https://www.medscape.com/viewarticle/does-metformin-therapy-impact-cvd-t2d-its-complicated-2024a1000huv

Novo Nordisk has mitigation plans to minimize disruption from port strikes

 Danish drugmaker Novo Nordisk said on Tuesday it has mitigation plans in place to minimize or prevent any disruption to its production due to sea port strikes in the United States.

The maker of popular drugs, Wegovy and Ozempic, plans to ship its products to and from the U.S. via air freight, a company spokesperson said.

The company imports some of its active pharmaceutical ingredient, or semaglutide, into the U.S. for its blockbuster diabetes drug Ozempic and weight-loss treatment Wegovy, according to CNBC, which first reported on the mitigation plans.

The U.S. Department of Health and Human Services (HHS) said earlier on Tuesday its preliminary analysis showed a strike by U.S. East Coast and Gulf Coast dockworkers should have limited impact on the availability of essential goods such as medicines and medical devices.

The dockworkers began their first large-scale stoppage in nearly 50 years, halting about half the country's ocean shipping after negotiations for a new labor contract broke down over wages.

https://finance.yahoo.com/news/novo-nordisk-mitigation-plans-minimize-174556379.html

DOJ Backs SEIU Antitrust Case Against Pittsburgh Hospital

 

The US Department of Justice threw its support behind a lawsuit alleging a major Pennsylvania medical center wields illegal power over hospital workers thanks to a series of acquisitions and restrictive employment contracts.

The department’s antitrust division in a late Monday filing pushed the US District Court for the Western District of Pennsylvania to reject the University of Pittsburgh Medical Center’s position on the workers’ claims.

Adopting the healthcare firm’s stance risks handing “monopsonist employers a blank check to wield unlawfully acquired market power,” the DOJ said, “which could result in reduced wages and worse working conditions in concentrated markets.”

https://news.bloomberglaw.com/antitrust/doj-backs-worker-antitrust-claims-targeting-state-health-giant

Health insurers unveil Medicare Advantage plans for 2025

 Health insurers Cigna, CVS Health, Humana Centene and UnitedHealth on Tuesday released details on their government-backed health insurance plans for next year for people aged 65 and above.

The announcements come ahead of the beginning of enrollment for Medicare Advantage plans on Oct. 15, which will continue through Dec. 7.

Medicare Advantage plans are offered by private insurers who are paid a set rate by the U.S. government to manage healthcare for older people looking for extra benefits not covered in regular Medicare coverage.

Cigna said it would offer some prescription drug plans with low premiums that will help save costs.

CVS' health insurance unit, Aetna, estimates 83% of Medicare-eligible beneficiaries in the United States will have access to a $0 monthly premium plan.

Humana, which has a total of 793 individual Medicare Advantage plans across the country for next year, said all plans that provide coverage for prescription drugs will see some benefit enhancements in 2025 under the Inflation Reduction Act.

The health insurers will also offer special needs plans, where individuals are enrolled under Medicare and receive assistance from Medicaid that covers medical expenses for people with low income.

The companies will provide dental, hearing and vision coverage as well.

Centene said it will offer $0 copay for primary care physician visits on all plans and for certain drugs at preferred pharmacies for most plans.

UnitedHealth's unit said it will be introducing 140 new plans for 2025.

The unit, UnitedHealthcare, will be expanding certain plans to help lower the cost of care for people managing chronic conditions.

Medicare Advantage plan enrollment is projected to grow to 35.7 million people in 2025, the Centers for Medicare and Medicaid Services said on Friday.

https://finance.yahoo.com/news/cvs-cigna-unveil-medicare-advantage-120456383.html

NC Gov: $2 Billion Wilson County Investment by Johnson & Johnson for New Manufacturing

 Governor Roy Cooper announced Johnson & Johnson (J&J), a world-leading healthcare company, will create 420 jobs in Wilson County. The company says it will invest more than $2 billion in a new pharmaceutical manufacturing campus for innovative biologics in the City of Wilson.

“We welcome this tremendous investment by Johnson & Johnson as they expand their global manufacturing footprint,” said Governor Cooper. “Life sciences leaders continue to select North Carolina because our world-class workforce will help the company successfully produce innovative medicines that will make a profound impact on our state and patients around the world.”

With expertise in Innovative Medicine and MedTech, Johnson & Johnson is uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. 

“A strong, global supply chain is crucial, and we purposefully invest to ensure our transformational medicines reliably and efficiently reach patients around the world,” said Dapo Ajayi, Vice President, Innovative Medicine Supply Chain, Johnson & Johnson. “We are investing in capacity and new technologies to enhance our industry leading capabilities and ensure a resilient supply chain for the future. North Carolina is an important hub for biopharmaceutical manufacturing and talent, and we are pleased to join this thriving life sciences ecosystem and become part of the Wilson community.”

“North Carolina has one of the largest biologics manufacturing workforce in the nation,” said N.C. Commerce Secretary Machelle Baker Sanders. “Economic and workforce development collaboration is critical to ensuring we have the foundation and business climate for innovators like Johnson & Johnson to succeed, and we are grateful for the partners that are helping us strengthen our life sciences reputation.”

New positions for the project will include analysts, engineers, microbiologists, scientists, specialists, managers and senior leaders. Although salaries will vary by position, the average annual wage is $108,823, which exceeds the Wilson County average of $52,619. These new jobs could create a potential payroll impact of more than $45.7 million for the region each year.

J&J’s project in North Carolina will be facilitated, in part, by a Job Development Investment Grant (JDIG) awarded to Janssen Biotech, Inc. (a subsidiary of J&J), which was approved by the state’s Economic Investment Committee earlier today. Over the course of the 12-year term of this grant, the project is estimated to grow the state’s economy by $2.3 billion. Using a formula that takes into account $1 billion of the company’s investment as well as the new tax revenues generated by the new jobs, the JDIG agreement authorizes the potential reimbursement to the company of up to $13,666,000, spread over 12 years. State payments only occur following performance verification by the departments of Commerce and Revenue that the company has met its incremental job creation and investment targets.

The project’s projected return on investment of public dollars is 262 percent, meaning for every dollar of potential cost to the state, the state receives $3.62 in state revenue. JDIG projects result in positive net tax revenue to the state treasury, even after taking into consideration the grant’s reimbursement payments to a given company.

A performance-based grant of $1,500,000 from the One North Carolina Fund will also help facilitate J&J’s new operation in North Carolina. The One NC Fund provides financial assistance to local governments to help attract economic investment and create jobs. Companies receive no money upfront and must meet job creation and capital investment targets to qualify for payment. All One NC grants require matching participation from local governments and any award is contingent upon that condition being met.

https://governor.nc.gov/news/press-releases/2024/10/01/governor-cooper-announces-2-billion-wilson-county-investment-johnson-johnson-new-manufacturing

OpenAI introduces new tools to fast-track building of AI voice assistants

 OpenAI unveiled a host of new tools on Tuesday that would make it easier for developers to build applications based on its artificial intelligence technology, as the ChatGPT maker wrestles with tech giants to keep up in the generative AI race.

The Microsoft-backed MSFT.O startup said a new real-time tool, rolling out immediately for testing, would allow developers to create AI voice applications using a single set of instructions.

The process earlier required developers to go through at least three steps: first transcribing audio, then running the generated-text model to come up with an answer to the query and finally using a separate text-to-speech model.

A large chunk of OpenAI's revenue comes from businesses that use its services to build their own AI applications, making the rollout of advanced capabilities a key selling point.

Competition has also been heating up as technology giants, including Google-parent Alphabet GOOGL.O, integrate AI models capable of crunching different forms of information such as video, audio and text across their businesses.

OpenAI expects its revenue to jump to $11.6 billion next year from an estimated $3.7 billion in 2024, Reuters reported last month. The company is also in the middle of a $6.5 billion fundraise that could value it at $150 billion.

As part of Tuesday's rollout, OpenAI introduced a fine-tuning tool for models after training that would allow developers to improve the responses generated by models using images and text.

This fine-tuning process can include feedback from humans who feed the model examples of good and bad answers based on its responses.

Using images to fine-tune models would give them stronger image understanding capabilities, enabling applications such as enhanced visual search and improved object detection for autonomous vehicles, OpenAI said.

The startup also unveiled a tool that would allow smaller models to learn from larger ones, along with "Prompt Caching" that cuts some development costs by half by reusing pieces of the text AI has previously processed.

https://www.xmtradecenter.net/cn/research/markets/allNews/reuters/openai-introduces-new-tools-to-fasttrack-building-of-ai-voice-assistants-53937072