Category Archives: Obesity Treatment

Talk Is Cheap: Now Trump Must Deliver On His Healthcare Promises

Posted on by • Posted in 2026 Mid Term Election Issues, 2028 Election Issues, Artificial Intelligence, Artificial Intelligence Generative, Artificial Intelligence Investment Funding, Food Health, Health Policy, Healthcare Reform, High Drug Prices, Medicare Drug Price Negotiation, Obesity, Obesity Treatment, Opioid Epidemic, Outcomes, Pharmaceutical Industry, Quality, Quality Measures, Quality of Care, Quality of Life • Tagged , , , , • Leave a comment

https://www.forbes.com/sites/robertpearl/2025/06/09/talk-is-cheap-now-trump-must-deliver-on-his-healthcare-promises/

President Donald Trump has made big promises about fixing American healthcare. Now comes the moment that separates talk from action.

With the 2026 midterms fast approaching and congressional attention soon shifting to electoral strategy, the window for legislative results is closing quickly. This summer will determine whether the administration turns promises into policy or lets the opportunity slip away.

Trump and his handpicked healthcare leaders — HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary — have identified three major priorities: lowering drug prices, reversing chronic disease and unleashing generative AI. Each one, if achieved, would save tens of thousands of lives and reduce costs.

But promises are easy. Real change requires political will and congressional action. Here are three tests that Americans can use to gauge whether the Trump administration succeeds or fails in delivering on its healthcare agenda.

Test No. 1: Have Drug Prices Come Down?

Americans pay two to four times more for prescription drugs than citizens in other wealthy nations. This price gap has persisted for more than 20 years and continues to widen as pharmaceutical companies launch new medications with average list prices exceeding $370,000 per year.

One key reason for the disparity is a 2003 law that prohibits Medicare from negotiating prices directly with drug manufacturers. Although the Inflation Reduction Act of 2022 granted limited negotiation rights, the initial round of price reductions did little to close the gap with other high-income nations.

President Trump has repeatedly promised to change that. In his first term, and again in May 2025, he condemned foreign “free riders,” promising, “The United States will no longer subsidize the healthcare of foreign countries and will no longer tolerate profiteering and price gouging.”

To support these commitments, the president signed an executive order titled “Delivering Most-Favored-Nation (MFN) Prescription Drug Pricing to American Patients.” The order directs HHS to develop and communicate MFN price targets to pharmaceutical manufacturers, with the hope that they will voluntarily align U.S. drug prices with those in other developed nations. Should manufacturers fail to make significant progress toward these targets, the administration said it plans to pursue additional measures, such as facilitating drug importation and imposing tariffs. However, implementing these measures will most likely require congressional legislation and will encounter substantial legal and political challenges.

The pharmaceutical industry knows that without congressional action, there is no way for the president to force them to lower prices. And they are likely to continue to appeal to Americans by arguing that lower prices will restrict innovation and lifesaving drug development.

But the truth about drug “innovation” is in the numbers: According to a study by America’s Health Insurance Plans, seven out of 10 of the largest pharmaceutical companies spend more on sales and marketing than on research and development. And if drugmakers want to invest more in R&D, they can start by requiring peer nations to pay their fair share — rather than depending so heavily on U.S. patients to foot the bill.

If Congress fails to act, the president has other tools at his disposal. One effective step would be for the FDA to redefine “drug shortages” to include medications priced beyond the reach of most Americans. That change would enable compounding pharmacies to produce lower-cost alternatives just as they did recently with GLP-1 weight-loss injections.

If no action is taken, however, and Americans continue paying more than twice as much as citizens in other wealthy nations, the administration will fail this crucial test.

Test No. 2: Did Food Health, Quality Improve?

Obesity has become a leading health threat in the United States, surpassing smoking and opioid addiction as a cause of death.

Since 1980, adult obesity rates have surged from 15% to over 40%, contributing significantly to chronic diseases, including type 2 diabetes, heart disease and multiple types of cancers.

A major driver of this epidemic is the widespread consumption of ultra-processed foods: products high in added sugar, unhealthy fats and artificial additives. These foods are engineered to be hyper-palatable and calorie-dense, promoting overconsumption and, in some cases, addictive eating behaviors.

RFK Jr. has publicly condemned artificial additives as “poison” and spotlighted their impact on children’s health. In May 2025, he led the release of the White House’s Make America Healthy Again (MAHA) report, which identifies ultra-processed foods, chemical exposures, lack of exercise and excessive prescription drug use as primary contributors to America’s chronic disease epidemic.

But while the report raises valid concerns, it has yet to produce concrete reforms.

To move from rhetoric to results, the administration will need to implement tangible policies.

Here are three approaches (from least difficult to most) that, if enacted, would signify meaningful progress:

  • Front-of-package labeling. Implement clear and aggressive labeling to inform consumers about the nutritional content of food products, using symbols to indicate healthy versus unhealthy options.
  • Taxation and subsidization. Impose taxes on unhealthy food items and use the revenue to subsidize healthier food options, especially for socio-economically disadvantaged populations.
  • Regulation of food composition. Restrict the use of harmful additives and limit the total amount of fat and sugar included, particularly for foods aimed at kids.

These measures will doubtlessly face fierce opposition from the food and agriculture industries. But if the Trump administration and Congress manage to enact even one of these options — or an equivalent reform — they can claim success.

If, instead, they preserve the status quo, leaving Americans to decipher nutritional fine print on the back of the box, obesity will continue to rise, and the administration will have failed.

Test No. 3: Are Patients Using Generative AI To Improve Health?

The Trump administration has signaled a strong commitment to using generative AI across various industries, including healthcare. At the AI Action Summit in Paris, Vice President JD Vance made the administration’s agenda clear: “I’m not here this morning to talk about AI safety … I’m here to talk about AI opportunity.”

FDA Commissioner Dr. Marty Makary has echoed that message with internal action. After an AI-assisted scientific review pilot program, he announced plans to integrate generative AI across all FDA centers by June 30.

But internal efficiency alone won’t improve the nation’s health. The real test is whether the administration will help develop and approve GenAI tools that expand clinical access, improve outcomes and reduce costs.

To these ends, generative AI holds enormous promise:

  • Managing chronic disease: By analyzing real-time data from wearables, GenAI can empower patients to better control their blood pressure, blood sugar and heart failure. Instead of waiting months between doctor visits for a checkup, patients could receive personalized analyzes of their data, recommendations for medication adjustments and warnings about potential risk in real time.
  • Improving diagnoses: AI can identify clinical patterns missed by humans, reducing the 400,000 deaths each year caused by misdiagnoses.
  • Personalizing treatment: Using patient history and genetics, GenAI can help physicians tailor care to individual needs, improving outcomes and reducing side effects.

These breakthroughs aren’t theoretical. They’re achievable. But they won’t happen unless federal leaders facilitate broad adoption.

That will require investing in innovation. The NIH must provide funding for next-generation GenAI tools designed for patient empowerment, and the FDA will need to facilitate approval for broad implementation. That will require modernizing current regulations. The FDA’s approval process wasn’t built for probabilistic AI models that rely on continuous application training and include patient-provided prompts. Americans need a new, fit-for-purpose framework that protects patients without paralyzing progress.

Most important, federal leaders must abandon the illusion of zero risk. If American healthcare were delivering superior clinical outcomes, managing chronic disease effectively and keeping patients safe, that would be one thing. But medical care in the United States is far from that reality. Hundreds of thousands of Americans die annually from poorly controlled chronic diseases, medical errors and misdiagnoses.

If generative AI technology remains confined to billing support and back-office automation, the opportunity to transform American healthcare will be lost. And the administration will have failed to deliver on this promise.

When I teach strategy at Stanford’s Graduate School of Business, I tell students that the best leaders focus on a few high-priority goals with clear definitions of success — and a refusal to accept failure. Based on the administration’s own words, grading the administration on these three healthcare tests will fulfill those criteria.

However, with Labor Day just months away, the window for action will soon close. The time for presidential action is now.

Drug shortages reach all-time high

Posted on by • Posted in Drug Shortages, Generic Drug Supply, Generic Drugs, Medicare, Medicare Payment, Obesity Treatment, Pharmaceutical Industry • Leave a comment

https://www.axios.com/2024/04/11/drug-shortage-record-high

With 323 medicines in short supply, U.S. drug shortages have risen to their highest level since the American Society of Health-System Pharmacists began tracking in 2001.

Why it matters: 

This high-water mark should energize efforts in Congress and federal agencies to address the broken market around what are often critical generic drugs, the organization says.

  • The Biden administration last week issued a drug-shortage plan that called on Congress to pass legislation that would reward hospitals for maintaining an adequate supply of key drugs, among other measures.
  • As a “first step,” Medicare yesterday proposed incentives for roughly 500 small hospitals to establish and maintain a six-month buffer stock of essential medicines.

The big picture: 

Many of the issues behind shortages are tied to low prices for generics that leave manufacturers competing on price.

  • “It’s been a race to the bottom. We need more transparency around quality so that buyers have a reason to not chase the lowest price,” said Michael Ganio, senior director at the ASHP.
  • Drugmakers that can demonstrate safer, higher-quality manufacturing practices should earn a higher price, he said.
  • Manufacturing quality concerns in particular have fueled shortages of chemotherapy drugs and some antibiotics.

Between the lines: Other factors are also driving drug shortages.

  • Controlled substances, such as pain and sedation medications, account for 12% of active shortages, which are tied to recent legal settlements and Drug Enforcement Administration changes to production limits, per ASHP.
  • Not surprisingly, the blockbuster category of anti-obesity drugs known as GLP-1s are in shortage largely because of outsized demand.
  • That’s also the case for ADHD drugs and hormone therapies used in gender-affirming care.

Medicare Can Cover Anti-Obesity Drugs for Heart Disease — But at What Cost?

Posted on by • Posted in Cardiovascular Disease, Chronic Diseases, Congressional Budget Office (CBO), Food and Drug Administration (FDA), Health Equity, Health Policy, Medicare Part D, Obesity, Obesity Treatment, Public Health, Wegovy, Weight Loss Drugs • Leave a comment
https://www.medpagetoday.com/opinion/the-health-docket/109555?xid=nl_secondopinion_2024-04-09&eun=g885344d0r

On March 8, 2024, FDA approved Wegovy (semaglutide)opens in a new tab or window to treat cardiovascular disease risks — heart attack, stroke, and death — for obese or overweight adults with a history of cardiovascular disease, making it the first anti-obesity medication (AOM) to obtain such approval. Studies showopens in a new tab or window that semaglutide reduces heart disease risks when accompanied by blood pressure and cholesterol management and healthy lifestyle counseling. FDA noted that this approval is “a major advance in public health.”

Less than 2 weeks after FDA approved the new indication (semaglutide is also approved for chronic weight management and type 2 diabetes), CMS issued a memorandumopens in a new tab or window stating that Medicare Part D plans may cover AOMs if they are FDA approved for an additional medically accepted indication beyond only weight management. CMS’ guidance is prospective and is not limited to semaglutide. The guidance applies to all AOMs that may be approved in the future to treat other conditions. To ensure that AOMs are used for medically accepted indications, CMS clarified that Part D sponsors may employ common utilization management tools like step therapy and prior authorization.

Notably, FDA’s approval of semaglutide for cardiovascular disease is likely a harbinger of similar approvals in the near future — along with their coverage by Medicare. While the benefits are substantial, so too may be the costs as more and more drugs and patients receive coverage.

Obesity and Public Health

Obesity is a pressing public health crisis that requires robust, multidimensional solutions, including medical interventionsopens in a new tab or window. The CDC considers obesity an epidemicopens in a new tab or window, and in 2013, the American Medical Association recognized obesity as a diseaseopens in a new tab or window. Although there isn’t consensus in the scientific community as to whether obesity is a disease, one thing is clear: medical interventions (including AOMs) are key to addressing obesity, along with other public health measures.

Obesity prevalence in the U.S. is 41.9%opens in a new tab or window, with rates higher for Black and Hispanic adults — the very populations that face the greatest socioeconomic barriersopens in a new tab or window to accessing healthcare and medications. While AOMs offer a significant public health benefit, ensuring equitable and affordable access is vital.

Economic Implications

Analyses have foundopens in a new tab or window extraordinarily high prices for Wegovy , with a list price up to $1,349 and a net price (received by the manufacturer) of $701 for a 4-week supply. It is estimated that 6.6 million Americans opens in a new tab or window would benefit from medications like semaglutide for cardiovascular event reduction. Because AOMs are so costly, increasing their coverage and use could result in substantial Medicare spending, as well as higher premiums and cost-sharing for enrollees.

In 2022, Medicare gross total spending on semaglutide and tirzepatide for diabetes reached $5.7 billionopens in a new tab or window, up from $57 million in 2018. With FDA’s approval of these drugs as AOMs, Medicare spending for new indications can be expected to increase dramatically in the next few years.

In March 2024, the Congressional Budget Office (CBO) found that Medicare coverage of AOMs would result in considerable demand for and use of AOMsopens in a new tab or window by enrollees. CBO expects that generic competition, which could moderate prices and lead to higher rebates, would start in earnest only in the second decade of a policy allowing Medicare Part D to cover AOMs. However, even that assumption is not certain as pharmaceutical companies seek to “evergreen”opens in a new tab or window patent protection and market exclusives. CBO also acknowledges the possibility of new drugs that are more effective, have fewer side effects, or can be taken less often, which could translate to higher prices. Furthermore, if AOMs are stopped, weight then increases, meaning that these medications may have to be taken lifelong.

Arguably, reducing obesity rates could reduce the incidence of many chronic diseases such as diabetes and heart disease, potentially creating a net benefit in the long term. And even in the near-term, the Inflation Reduction Act (IRA) may help curb costs.

CBO and other reportsopens in a new tab or window suggest that semaglutide is likely to be selected by CMS for drug price negotiation opens in a new tab or window under the IRA within the next few years. If chosen in 2025, a negotiated Medicare price would be available by 2027. Successful CMS price negotiation is likely to address some of the cost concerns.

The IRA also has other mechanisms that may help address the high costs. The IRA’s rebate program, for example, ensures cost containment by requiring manufacturers of drugs that don’t have competitors to pay rebates to HHS if the prices of those drugs increase faster than the inflation rate. The IRA also caps out-of-pocket spending for prescription drugs at $2,000 starting in 2025opens in a new tab or window. (Although a $2,000 cap helps limit costs, spending that amount of money is still burdensome, especially for people of low socioeconomic status who are disproportionately impacted by obesity.)

In short, the IRA may alleviate, but not eliminate, Medicare spending concerns. The IRA’s ability to address the cost concerns of AOM coverage depends on various factors, and it is likely that those cost containment measures will take many years to materialize. As AOMs continue to be approved for new uses, the intense demand for these drugs coupled with their high costs are likely to place pressures on Medicare spending for years to come.

Takeaways

CMS has made clear that Medicare should cover semaglutide or other AOMs only when needed to avert cardiovascular or other serious diseases. This rule will have to be rigorously enforced and monitored.

Savvy Medicare enrollees could try to game the system, using medications primarily for weight loss purposes — which would be inconsistent with CMS’s approval. Some physicians might also engage in dishonest prescribing. Also, given the racial and ethnic disparities in access to obesity treatment, marginalized groups are unlikely to reap equal benefit from AOMs. For those reasons, robust and thoughtful strategies are needed to ensure that coverage for such drugs is not exploited. Without clear limits on the use of AOMs, Medicare could be overwhelmed with costs.

Beyond Medicare spending, there are wider equity concerns about access to drugs that treat medical conditions associated with obesity. Even if marginalized individuals can gain access to the medication, obtaining optimal health benefits of AOMs is likely to remain a challenge. FDA notes that semaglutide is most effective when it is taken together with other lifestyle or behavioral changesopens in a new tab or window, such as diet and exercise. Because healthy lifestyles and behaviors are mostly influenced by broader social and commercial determinants, the full health benefits of AOMs may elude those most at risk. To harness the public health benefits, AOMs must be seen as part of a broader approach to address health risks associated with obesity; they should not detract from the interventions targeted at socio-structural determinants of health that shape individual and population health outcomes.

To some, semaglutide and other AOMs are a miracle of modern science. Yet, we should entertain some skepticism about miracle solutions to deeply complex health threats. Medicare should extend coverage for AOMs under criteria that meaningfully considers the competing concerns and tradeoffs. Meanwhile, public health professionals and clinicians should continue to use all the tools at our disposal to reduce the burdens of disease caused by overweight and obesity, while also fighting against the stigma, shaming, and discrimination that are widely prevalent in our society.

How GLP-1 agonist drugs could change healthcare demand

Posted on by • Posted in Chronic Diseases, Health Insurance Coverage Adequacy, High Deductible Health Plans, High Drug Prices, Life Expectancy, Mounjaro, Obesity, Obesity Treatment, Out of Pocket Expenses, Ozempic, Wegovy, Weight-Related Surgery • Leave a comment

https://mailchi.mp/edda78bd2a5a/the-weekly-gist-june-23-2023?e=d1e747d2d8

With more than two in five American adults considered obese, the potential for GLP-1 agonist drugs like Wegovy, Ozempic, and Mounjaro to revolutionize obesity treatment seems limitless.

In the graphic above, we looked to quantify how much these drugs could potentially change healthcare expenditures and demand. Using Wegovy’s list price of $1.3K per month, a GLP-1 drug prescription for every obese American adult would cost as much as $1.3T annually—30 percent of total US healthcare expenditures. 

Analyst projections of GLP-1 drugs forecast revenue to grow by over 5x by 2028, from $3 billion to $16 billion annually. While it’s unlikely that every overweight American will access the drugs, growing use of GLP-1 agonists will likely drive down obesity rates, and downstream care demand could shift in expected and unpredictable ways. Demand for weight-related surgeries, including joint replacements and bariatric surgery, will likely drop. Incidence of chronic diseases like diabetes and cardiovascular disease could also drop, potentially raising life expectancy. 

But even if we’re living longer thanks to the new drugs, we’ll still die of something eventually: expect a secondary rise in cancers and Alzheimer’s, as well as surging demand for eldercare. While these effects will take years to materialize, leaders planning for long-term care needs would be wise to consider scenarios where these and other potential “blockbuster” drugs may disrupt demand patterns and spending for a wide range of services.