Could Weight Loss Injections Replace Obesity Surgery?

Glucagon-like peptide 1 (GLP-1) analogs, also called “incretin mimetics” and colloquially referred to as “weight loss injections,” are highly effective for weight reduction in obesity treatment. Will semaglutide, tirzepatide, and similar medications eventually diminish the role of obesity surgery or even replace it altogether?

Dr Matthias Blüher, head of the Adult Obesity Clinic and professor of clinical obesity research at the University of Leipzig in Germany, as well as media spokesperson for the German Obesity Society, explained to Medscape Medical News which patients are more suited for obesity surgery and how incretin mimetics and surgical options currently interact.

GLP-1 analogs are effective for patients with obesity. What does this mean for obesity surgery? Is the number of gastric bypass procedures declining?

There are indications in the United States that this is the case. However, it is not yet entirely clear whether this can be attributed to the effectiveness of the medications, because these drugs have been used in the US for much longer than here. If this trend is confirmed, it would be a positive development, especially considering the risks associated with surgery.

Will this trend also develop in Germany?

That is possible. However, I believe that initially, there will be more patients opting for obesity surgery. The problem is that access to these medications is limited. In Germany, health insurance does not cover the costs. Many people cannot afford these medications, even as a preparatory step for surgical intervention. In contrast, bariatric surgery is usually covered by insurance, so I think surgery will remain the option for many patients.

The second aspect is that there are patients who do not respond well to medication or for whom weight loss from medication is insufficient. These patients will probably find it easier to choose the surgical option, reasoning that they have exhausted all medical avenues and will now proceed with surgery. Therefore, I think the number of surgeries will not decrease in the short term.

Dr Miguel A. Burch, a bariatric surgeon at Cedars-Sinai Medical Center in Los Angeles, speaks of a  “new era” regarding the potential of GLP-1 analogs. Does this mean, speaking broadly, that we will rely on medications instead of surgeries in the future?

It cannot be put so broadly because there will always be patients who will benefit more from surgical than medical therapy owing to their extremely high weight.

It also depends on the risk factors of each patient, as well as consideration of the cumulative costs of lifelong medication, compared with those of surgery. However, the treatment of obesity could include multiple approaches, not just a choice between surgery or weight loss medications.

Could GLP-1 analogs and surgical therapy be combined?

Yes. In Leipzig, for example, we treat patients with semaglutide before bariatric surgery because weight reduction before surgery can be beneficial in reducing surgical risks. We also use these medications postoperatively to minimize the risk for weight regain. Some patients regain weight after surgery, and with GLP-1 analogs, we have the option to counteract that medically.

Is greater weight loss still achieved with obesity surgery compared with GLP-1 analogs?

It is difficult to say for an individual, but on average, surgery remains the more effective method for weight loss. Data show — though there has not yet been a direct comparison between incretin mimetics and bariatric surgery — that tirzepatide, which can lead to an average weight loss of 23%, is still not as effective as surgery.

On average, sleeve gastrectomy or bypass can achieve weight loss of 30%-35%. However, when looking at weight reduction from gastric band surgery, tirzepatide or semaglutide are comparably effective. We can say that weight loss medications are already within the treatment outcome range of gastric band surgeries.

For which patients is surgical therapy more appropriate than medication?

Patients who come to us with a body mass index (BMI) over 50. There are no good data on how effective current medications are in such cases, and for patients with such a BMI, surgical treatment remains more appropriate. 

Additionally, for patients who need to lose a significant amount of weight quickly — such as those with severe heart failure requiring a heart transplant — or patients needing knee or hip replacements who should also lose weight quickly, these cases are good candidates for surgical treatment.

And what do you think is more sustainable?

Medications only work for as long as they are taken. The weight loss achieved through surgery is sustainable. With drug therapy, sustainability is achieved by continuing the medication and combining it with lifestyle interventions.

There are various ways to improve this sustainability — through long-term therapy, increasing the dosage, incorporating exercise, dietary changes, and so on. Ultimately, however, we cannot yet say over a long period of 10 or 20 years whether these medications are as sustainable as surgery, because these medications have not been available for that long.

For my patients with a BMI under 35, I would always recommend starting with diet and exercise therapy. If that is insufficient, then I would move on to medication, and obesity surgery only as a last resort. Especially for patients with 10-20 kg of excess weight, surgical therapy is not a sensible starting point.

https://www.medscape.com/viewarticle/could-weight-loss-injections-replace-obesity-surgery-2024a1000kk1

Coming Soon: A New Disease Definition, ‘Clinical Obesity’

 An upcoming document will entirely reframe obesity as a “condition of excess adiposity” that constitutes a disease called “clinical obesity” when related tissue and organ abnormalities are present.

The authors of the new framework are a Lancet Commission of 56 of the world’s leading obesity experts, including academic clinicians, scientists, public health experts, patient representatives, and officers from the World Health Organization. Following peer review, it will be launched via livestream and published in The Lancet Diabetes & Endocrinology in mid-January 2025, with formal endorsement from more than 75 medical societies and other relevant stakeholder organizations.

On November 4, 2024 at the Obesity Society’s Obesity Week meeting, the publication’s lead author, Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, United Kingdom, gave a preview. He began by noting that despite the declaration of obesity as a chronic disease over a decade ago, the concept is still debated and not widely accepted by the public or even by all in the medical community.

“The idea of obesity as a disease remains highly controversial,” Rubino noted, adding that the current body mass index (BMI)–based definition contributes to this because it doesn’t distinguish between people whose excess adiposity place them at excess risk for disease but they’re currently healthy vs those who already have undergone bodily harm from that adiposity.

“Having a framework that distinguishes at an individual level when you are in a condition of risk and when you have a condition of disease is fundamentally important. You don’t want to blur the picture in either direction, because obviously the consequence would be quite significant… So, the commission focused exactly on that point,” he said.

The new paper will propose a two-part clinical approach: First, assess whether the patient has excess adiposity, with methods that will be outlined. Next, assess on an organ-by-organ basis for the presence of abnormalities related to excess adiposity, or “clinical obesity.” The document will also provide those specific criteria, Rubino said, noting that those details are under embargo until January.

However, he did say that “We are going to propose a pragmatic approach to say that BMI alone is not enough in the clinic. It’s okay as a screening tool, but when somebody potentially has obesity, then you have to add additional measures of adiposity that makes sure you decrease the level of risk… Once you have obesity, then you need to establish if it’s clinical or nonclinical.”

Asked to comment, session moderator John D. Clark, MD, PhD, Chief Population Health Officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “I think it'll help explain and move medicine as a whole in a direction to a greater understanding of obesity actually being a disease, how to define it, and how to identify it. And will, I think, lead to a greater understanding of the underlying disease.”

And, Clark said, it should also help target individuals with preventive vs therapeutic approaches. “I would describe it as matching the right tool to the right patient. If a person has clinical obesity, they likely can and would benefit from either different or additional tools, as opposed to otherwise healthy obesity.”

Rubino told Medscape Medical News he hopes the new framework will prompt improvements in reimbursement and public policy. “Policymakers scratch their heads when they have limited resources and you need to prioritize things. Having an obesity definition that is blurry doesn't allow you to have a fair, human, and meaningful prioritization… Now that we have drugs that cannot be given to 100% of people, how do you decide who gets them first?” I hope this will make it easier for people to access treatment. At the moment, it is not only difficult, but it's also unfair. It's random. Somebody gets access, while somebody else who is very, very sick has no access. I don't think that's what we want.”

Rubino is an advisor to GT Metabolic Solutions and receives research funds and/or speaker fees from Johnson & Johnson (Ethicon), Medtronic, Novo Nordisk, Amgen, and Eli Lilly. Clark has no disclosures. 

https://www.medscape.com/viewarticle/coming-soon-new-disease-definition-clinical-obesity-2024a1000k5r

New Cal. Law Will Restrict AI in Prior Authorization, Coverage Decisions

 California is taking aim at algorithms used by insurers to make prior authorization and other coverage decisions with a new law that will put limitations on how artificial intelligence (AI)–generated formulas are employed.

The state also will start requiring providers to inform consumers when patient communications are generated by AI.

The laws reflect a growing trend among state lawmakers to more strictly regulate the use of AI in healthcare and other arenas in the absence of federal action.

The Physicians Make Decisions Act (SB 1120) takes effect on January 1. It was supported by dozens of physician organizations and medical groups, the California Hospital Association, and several patient advocacy groups. Insurance industry groups opposed the bill.

“As physicians, we recognize that AI can be an important tool for improving healthcare, but it should not replace physicians’ decision-making,” California Medical Association (CMA) President Tanya W. Spirtos, MD, said in a statement.

The new law ensures that the human element will always determine quality medical treatments for patients, said State Senator Josh Becker (D-Menlo Park), who sponsored the legislation.

“An algorithm does not fully know and understand a patient’s medical history and needs and can lead to erroneous or biased decisions on medical treatment,” he said.

The new law requires the use of AI or any algorithms to be based upon a patient’s medical history and the individual’s clinical situation. A decision can’t be based solely on a group dataset, can’t supplant a clinician’s decision, and must be approved by a human physician.

The algorithm is required to be “fairly and equitably applied,” according to the law.

Algorithms have the potential to be biased, Sara Murray, MD, vice president and chief health AI officer for UCSF Health, told Medscape Medical News. She cited a recent paper in Science that found that decisions based on an algorithm that is widely used by health systems (not insurers) meant that Black patients who were sicker than White patients would receive less care.

The law attempts to address the data used to train insurers’ algorithms. “AI tools are only as accurate as the data and algorithm inputs going into them,” wrote Carmel Shachar, JD, MPH, Amy Killelea, and Sara Gerke in Health Affairs.

“It’s really important to have transparency about what data is used as the training set, as well as to make sure that it matches what population the algorithm is actually being used on,” Shachar, assistant clinical professor of law at Harvard Law School, Cambridge, Massachusetts, told Medscape Medical News.

Having a human sign off on AI-generated decisions is important, but “also has risks,” Murray said. “We can become over-reliant on these tools, and we may we're also biased and maybe not prone to seeing bias, or we may not see bias if an algorithm is giving us biased output,” said Murray.

An investigation by ProPublica in 2023 alleged that a Cigna algorithm allowed doctors to quickly reject claims on medical grounds, without reviewing the patients’ files. The publication reported that Cigna-employed physicians denied more than 300,000 claims in a 2-month period, spending an average of 1.2 seconds on each.

California is “reacting to real fears,” she said.

Federal Oversight Lacking

While AI used to detect disease and improve diagnosis and treatment is regulated by the US Food and Drug Administration, the AI tools targeted by lawmakers in SB 1120 “are not subjected to the same scrutiny and have little independent oversight,” said Anna Yap, MD, a Sacramento emergency medicine physician, when she testified earlier in 2024 in favor of SB 1120 on behalf of the CMA.

The California law “is a good first step,” Shachar said. Algorithms have “been sort of a blind spot in our regulatory system,” she said. The new law “empowers state regulators to act, and it provides some sort of accountability and requirements for how insurers are implementing their AI,” she said.

Shachar and colleagues noted that AI had the potential to streamline and speed up prior authorization decision-making.

Neil Busis, MD, a neurologist with the New York University Grossman School of Medicine in New York City, agreed in a paper in JAMA Neurology. “If it can be trained with the proper data, AI can potentially improve prior authorization by reducing administrative burdens, improving efficiency, and enhancing the overall experience for patients, clinicians, and payers,” he wrote.

In a 2022 report, McKinsey & Company touted AI’s potential to make prior authorization more efficient. But the authors noted that the AI would need to be monitored to ensure that it did not learn from biased datasets that “could result in unintended or inappropriate decisions,” especially for patients of lower socioeconomic status. The report concluded that “highly experienced clinicians will remain the ultimate PA decision-makers.”

While the American Medical Association (AMA) did not take a position on SB 1120, in 2023, the organization adopted a similar policy, calling for AI-based algorithms to use clinical criteria and to include reviews by physicians and other health professionals with expertise for the service under review and no incentive to deny care.

AMA Board Member Marilyn Heine, MD, said at the time that even if AI streamlines prior authorization, the volume is growing. “The bottom line remains the same: We must reduce the number of things that are subject to prior authorization,” she said.

Shachar and colleagues wrote that AI could potentially incentivize even more reviews. “We may see ‘review creep,’” they wrote.

In the absence of regulation, several lawsuits have been filed against insurers for their use of AI-based algorithms.

The families of two deceased Medicare Advantage recipients who lived in Minnesota sued UnitedHealth in 2023, stating that the company’s algorithm had a 90% error rate and was illegally employed, according to a CBS News report.

The US Senate Permanent Subcommittee on Investigations reported in October that its in-depth inquiry had found that insurers were using automated prior authorization algorithms to systematically deny post-acute care services for Medicare Advantage enrollees at far higher rates than denials for other types of care for other insureds.

In March, an individual filed a class action suit against Cigna for its use of its algorithm to deny claims, relying on the information reported by ProPublica.

Shachar said that lawsuits are not a satisfactory way to get a handle on the algorithms, in part because “you have to wait for the harm.” The tort system is still formulating how various aspects of the law will apply to AI used by insurers, she added.

More states are likely to follow in California’s footsteps, said Shachar.

An AMA spokesman agreed. “The AMA anticipates future legislative activity in 2025 as we are seeing an increased number of reports about health plans using AI to systematically deny claims,” AMA’s R.J. Mills told Medscape Medical News.

The California governor also signed AB 3030, which requires patient communications that employ AI to indicate that it was generated by AI, unless the communication was first read and reviewed by a human licensed or certified healthcare provider.

Murray said UCSF Health is already doing just that.

The health system has been testing the use of AI in helping to draft physicians’ responses to patient messages, with the goal of helping them answer more quickly. The messages have text that informs patients that AI was used to assist the doctor. It also states that the physician still reviews every communication.

“We just wanted to be very transparent with patients,” said Murray.

AI is “going to be very good for healthcare,” she said. But the new California laws were necessary to provide “guardrails.”

Shachar and Murray reported no relevant financial relationships.

https://www.medscape.com/viewarticle/new-state-law-will-restrict-ai-prior-authorization-coverage-2024a1000krq

Florida alleges FEMA officials conspired to discriminate against Trump supporters after hurricane

 Florida sued the Federal Emergency Management Agency (FEMA) director and an employee who was fired for telling a survivor assistance team after Hurricane Milton not to visit homes displaying signs supporting President-elect Trump’s candidacy. 

Ashley Moody, the state’s Republican attorney general, alleged FEMA Administrator Deanne Criswell “agreed” to deny Trump supporters relief alongside the terminated employee, Marn’i Washington. 

“While the facts will continue to come out over the weeks and months, it is already clear that Defendant Washington conspired with senior FEMA officials, as well as those carrying out her orders, to violate the civil rights of Florida citizens,” reads the complaint.

The lawsuit, filed Wednesday in federal court in Fort Pierce, Fla., asks for unspecified damages and a declaration that the two FEMA officials unlawfully conspired to violate Floridians’ civil rights. 

“It’s unacceptable for the federal government to discriminate against Floridians who voted for Trump, and especially egregious in the aftermath of a hurricane,” Florida Gov. Ron DeSantis (R) said in a statement.

“I’m supportive of this legal action by the Attorney General’s Office, and I have instructed state agencies to likewise take any action necessary to investigate and ensure those who engaged in this behavior are held accountable.” 

A FEMA spokesperson declined to comment. Washington could not be reached for comment. 

Criswell publicly confirmed the employee’s termination Saturday and condemned the incident. 

“This is a clear violation of FEMA’s core values and principles to help people regardless of their political affiliation. This was reprehensible,” Criswell said in a statement. 

In an interview with journalist Roland S. Martin, Washington said FEMA was scapegoating her. It was common practice for teams to skip certain streets after past “hostile” interactions, she said. 

“They all alleged that these actions were made on my own recognizance and that it was from my own political advances. However, if you look at the record, there is what we call a community trend. And unfortunately, it just so happened that the political hostility that was encountered by my team — and I was on two different teams during this deployment — they just so happened to have the Trump campaign signage,” Washington said. 

“FEMA always preaches avoidance first and then de-escalation. So this is not isolated. This is a colossal event of avoidance,” she added. 

The lawsuit was assigned to U.S. District Judge Donald Middlebrooks, an appointee of former President Clinton, the case docket shows.

https://thehill.com/homenews/4990582-florida-sues-fema-director-trump-supporters/

18 states sue SEC, Gensler for ‘regulatory overreach’ on crypto

Eighteen Republican attorneys general sued the Securities and Exchange Commission (SEC) and Chair Gary Gensler on Thursday for allegedly overstepping the agency’s authority in its enforcement actions against the cryptocurrency industry. 

The states, led by Kentucky Attorney General Russell Coleman, argue that the SEC has sought to “unilaterally wrest regulatory authority away from the States” on crypto enforcement.  

“Instead of respecting that constitutional balance of power, and allowing States to develop and enforce their own tailored digital asset regulations based on their own policy priorities … the SEC’s assertion of sweeping jurisdiction without congressional authorization deprives States of their proper sovereign role and chills the development of innovative regulatory frameworks for the digital asset industry,” the complaint reads. 

“Still worse, by attempting to shoehorn digital assets into illfitting federal securities laws and inapt disclosure regimes, the SEC is harming the very citizens it purports to protect, by displacing better-suited state laws that have been carefully designed to ensure consumer protection in the digital asset industry,” it continues. 

The crypto industry has feuded with Gensler and the SEC throughout the Biden administration, arguing that the agency has failed to provide clear rules of the road and has instead regulated crypto via enforcement. 

Gensler defended his record on crypto enforcement earlier Thursday in remarks at a legal conference. 

“Court after court has agreed with our actions to protect investors and rejected all arguments that the SEC cannot enforce the law when securities are being offered — whatever their form,” he said. 

However, with President-elect Trump’s win next week, the SEC appears poised to shift gears on multiple fronts, including digital assets. 

Despite once dismissing crypto as a “scam,” Trump has fully embraced the industry this time around, vowing to make the U.S. the “crypto capital of the planet” and remove Gensler. 

The president-elect also recently launched a crypto platform alongside his sons called World Liberty Financial. 

https://thehill.com/policy/technology/4991491-gary-gensler-crypto-enforcement/

Dan Loeb's Third Point enters Tesla, CVS

 Third Point's Q3 2024 13F filing reveals new stakes in Tesla, CVS Health, and Brookfield Corp

https://seekingalpha.com/news/4292429-dan-loebs-third-pointenters-tesla-cv-sexits-uber-verizonamongtop-q-3-trades

Moderna, Novovax stocks slide after Trump nominates RFK Jr to HHS

 Vaccine stocks slipped in late afternoon trade on Thursday after multiple reports indicated President-elect Donald Trump would name anti-vaccine activist Robert F. Kennedy Jr. to lead the Department of Health and Human Services.

Shares of Moderna (MRNA) fell over 5%, while Novavax (NVAX) stock lost over 7%. Pfizer (PFE) stock also slid more than 2.5%. Shares of both Moderna and Novavax are now down more than 30% over the past month.

Trump confirmed the nomination on Twitter after the market close. The stocks continued to fall slightly in after-hours trading.

Kennedy had been a candidate for president in 2024 before dropping out of the race and pledging his support to Trump.

Trump said during a rally in late October that he would let Kennedy “go wild” on healthcare in the country, and vaccine stocks like Moderna and Novavax have been heading lower since. Thursday's news only furthered that move.

“I’m gonna let him go wild on health. I’m gonna let him go wild on the food. I’m gonna let him go wild on medicines,” Trump said.

Kennedy told NPR in an interview on Nov. 6 that "we're not going to take vaccines away from anybody." But he has been outspoken against vaccines.

Kennedy's nonprofit, Children's Health Defense, has been a vocal critic of childhood vaccinations. And as the AP previously noted, himself has said in interviews, "There's no vaccine that is safe and effective."

https://finance.yahoo.com/news/moderna-novovax-stocks-slide-after-trump-nominates-robert-f-kennedy-jr-to-be-top-health-official-212802309.html