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Tag: Boston Medical Center

  • The Ozempic Revolution Is Stuck

    The Ozempic Revolution Is Stuck

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    Millions more Americans are now eligible for obesity drugs. But the injections remain maddeningly hard to find.

    Illustration by The Atlantic. Source: Getty.

    The irony undergirding the new wave of obesity drugs is that they initially weren’t created for obesity at all. The weight loss spurred by Ozempic, a diabetes drug in the class of so-called GLP-1 agonists, gave way to Wegovy—the same drug, repackaged for obesity. Zepbound, another medication, soon followed. Now these drugs have a new purpose: heart health.

    On Friday, the FDA approved the use of Wegovy for reducing the risk of heart attack, stroke, and death in adults who are overweight and have cardiovascular disease. The move had been anticipated since the publication of a landmark trial in the fall, which showed the drug’s profound effects on cardiovascular  health. The decision could usher in a new era where GLP-1 drugs become mainstream, opening up access to millions of Americans who previously didn’t qualify for Wegovy.

    Some of the obstacles stopping people from getting the drug may also begin to crumble. Insurance companies commonly deny coverage of Wegovy because obesity is seen as a cosmetic concern rather than a medical one, but that argument may not hold up for cardiovascular disease. “This new FDA indication is HUGE,” Katherine Saunders, an obesity-medicine physician at Weill Cornell Medicine, told me in an email. Wegovy may soon be within reach for many more Americans—that is, if they can find it.

    In practice, Wegovy is maddeningly hard to get hold of. Shortages of injectable semaglutide, the active ingredient in Wegovy and Ozempic, have been ongoing since March 2022; currently, most doses of Wegovy are in limited supply. As the popularity of semaglutide has skyrocketed, demand has completely outstripped the capacity of its manufacturer, Novo Nordisk. The drug comes in injection pens containing a glass vial; “these are not easy products to make,” Lars Fruergaard Jørgensen, the CEO of Novo Nordisk, said in August. In response to the shortages, the company withheld its supply of lower Wegovy doses last year. Because treatment on the medication must begin in low doses, this meant that new patients who wanted to start on Wegovy functionally couldn’t. In January, the company began “more than doubling the amount of the lower-dose strengths” of the drug, a Novo Nordisk spokesperson told me, and it plans to gradually increase overall supply throughout the rest of the year.

    The ongoing shortages have left providers and patients feeling stuck. “It is devastating to prescribe a lifesaving medication for a patient and then find out it’s not covered or we can’t locate supply,” Saunders said. Doctors are scrambling to make do with what’s available. Ivania Rizo, an endocrinologist at Boston Medical Center, told me she has had to turn to older GLP-1 drugs such as Saxenda to “bridge” patients to higher doses of Wegovy, although now that is in shortage too. Patients can spend each day calling pharmacy after pharmacy in search of one with Wegovy in stock, Rizo said. In desperation, some have turned to versions of the drug that are custom-made by compounding pharmacies with little oversight, despite the FDA expressing concerns about them. The shots are supposed to be taken weekly, but others have attempted to stretch their doses beyond that.

    That the new FDA approval could very mainstream obesity drugs may create long-needed pressure to help resolve these shortages. It makes clear that Wegovy is a lifesaving medication not only for people with obesity but also for those with cardiovascular disease—the leading cause of death in the U.S.—putting the impetus on Novo Nordisk to ramp up production. But in the short term, the access issues may persist. “The new approval is very likely to worsen shortages, because the demand for Wegovy will continue to climb—now at an even faster pace,” Saunders said.

    If patients think they’re stuck now, they’re about to feel entrenched. Wegovy is the only obesity drug that has been approved to reduce the risk of heart attacks, but none of its competitors is easily available either. Supplies of certain dosages of Eli Lilly’s Mounjaro, a diabetes drug whose active ingredient is sold for obesity as Zepbound, are limited, and shortages are expected later this year. “We need supply to increase dramatically,” Saunders said. Both Novo Nordisk and Eli Lilly have invested heavily in expanding production capacity, but some of the new plants won’t open until 2029.

    For all of its advantages, the FDA approval has a sobering effect on the unrelenting hype around GLP-1s. So much of the excitement around obesity drugs has focused on the future, as dozens of pharmaceutical companies develop more powerful drugs, and commentators imagine a world without obesity. In the process, the issues of the present have gone overlooked. More drugs won’t make much of a difference if the drugs themselves are out of reach.

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    Yasmin Tayag

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  • Substance use disorders do not increase the likelihood of COVID-19 deaths

    Substance use disorders do not increase the likelihood of COVID-19 deaths

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    Newswise — BOSTON – New research from Boston Medical Center found that substance use disorders do not increase the likelihood of dying from COVID-19. Published in Substance Abuse: Research and Treatment, the study showed that the increased risk for severe COVID-19 in people with SUD that has been seen may be the result of co-occurring medical conditions.

    Multiple large cohort studies from early in the pandemic have shown higher rates of hospitalization, intubation, and death from COVID-19 in those with SUD, while other studies found no association between SUD and COVID-19-related mortality or mixed results depending on substance use pattern. Given these conflicting data, the Centers for Disease Control and Prevention has classified persons with SUD as suggestive of higher risk for severe COVID-19. The goal of this study was to assess the association between SUD and inpatient COVID-19-related mortality.

    “BMC is known for excellent clinical care and innovative research related to substance use disorder. Since the early days of the pandemic, BMC has also been a leader in the treatment of individuals with COVID-19, including persons with complex medical and social needs,” said first author Angela McLaughlin, MD, MPH, an infectious disease fellow at Boston Medical Center. “These findings showing a similar likelihood of COVID-19-related complications in hospitalized patients with and without SUD helps expand knowledge of the infectious complications of SUD.” 

    As BMC sees a high proportion of patients who use substances, it was an apt location for the study: almost 14% of the study population had SUD, exceeding the national average of 10.8% in people ages 18 or older. Researchers reviewed medical records of 353 adults without SUD and 56 adults with SUD admitted to Boston Medical Center early into COVID-19 pandemic and compared the likelihood of COVID-19 related complications between individuals with and without substance use disorders. They compared the relationship between COVID-19 and mortality, clinical complications, and resource utilization.

    “Early in the pandemic, BMC developed protocols to closely monitor and quickly manage COVID-19-related complications in all hospitalized patients,” said senior author Sabrina Assoumou, MD, MPH, an infectious disease doctor at Boston Medical Center and Assistant Professor of Medicine at Boston University Chobanian & Avedisian School of Medicine. “The current findings suggest that such an approach might have benefited many patients, including individuals with substance use disorders.” 

    In this retrospective cohort study of patients admitted to a safety net hospital during the early phase of the COVID-19 pandemic, SUD was not associated with the primary outcome of COVID-19-associated inpatient mortality. The secondary analysis showed that those with and without SUD had similar COVID-19-related clinical complications, including secondary infections, renal failure requiring dialysis, acute liver injury, venous thromboembolism, cardiac complications, and the composite “any complications.” Of note, some clinical outcomes such as stroke were very uncommon overall. Likewise, there was no difference in resource utilization secondary outcomes between the two groups. In contrast to other studies, this found similar likelihoods of mechanical ventilation and ICU admission in patients with and without SUD. Although patients with SUD presented to the hospital earlier in their disease course, their total hospital length of stay was ultimately similar to patients without SUD. Insights such as these into the clinical complications and resource utilization patterns of patients with SUD and COVID-19 can help clinicians anticipate the trajectory of infection and healthcare needs in this vulnerable group.

    There were some notable limitations to the study. The results are from a single site, which might limit generalizability of the findings despite the racial and ethnic diversity of the BMC patient population. Second, the data presented are from the earliest phase of COVID-19 in the United States, so trends may have differed with subsequent waves and as COVID-19 management strategies have evolved over time. Third, there were no specific controls for socioeconomic factors like medical insurance status or income level, as over 75% of the BMC patient population has public payer insurance (Medicare, Medicaid, or Children’s Health Insurance Program) or no insurance. Lastly, differences in COVID-19 outcomes between current versus past SUD could not be detected – this area would benefit from further research.

    In conclusion, in this study of hospitalized individuals at an urban safety net hospital with a diverse patient population in the early days of the COVID-19 pandemic, inpatient mortality and morbidity between patients with and without SUD were similar. The findings provide a detailed evaluation of outcomes in a unique patient population that has been disproportionately impacted by COVID-19 and may provide beneficial insights for similar settings across the country. These results point away from SUD as an independent risk factor for severe COVID-19 and further suggest a focus on medical comorbidities to mitigate the effects of COVID-19. Additional studies are needed to further evaluate for differential outcomes in this high-risk population, particularly in an era of newer COVID-19-directed therapies.

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    About Boston Medical Center

    Boston Medical Center is a leading academic medical center with a deep commitment to health equity and a proud history of serving all who come to us for care. BMC provides high-quality healthcare and wrap around support that treats the whole person, extending beyond our physical campus into our vibrant and diverse communities. BMC is advancing medicine, while training the next generation of healthcare providers and researchers as the primary teaching affiliate of Boston University Chobanian & Avedisian School of Medicine. BMC is a founding member of Boston Medical Center Health System, which supports patients and health plan members through a value based, coordinated continuum of care.

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    Boston Medical Center

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