A new observational study found that people taking Ozempic and Wegovy appeared to experience suicidal thoughts at a higher rate than people on other drugs, though experts raised concerns about the methodology and the findings contradict what some other studies have found about the class of GLP-1 diabetes and obesity drugs, STAT writes. Academic researchers analyzed a World Health Organization database that tracks suspected adverse drug reactions, and found that there was a 45% greater rate of reports of suicidal thoughts associated with semaglutide, the ingredient in Novo Nordisk’s Ozempic and Wegovy, compared with all other drugs in the database.

Eli Lilly is using its runaway success in obesity as a bridge into another lucrative area of medicine: immunology, Bloomberg News tells us. This fall, the company will begin recruiting for trials to test its popular weight loss shot Zepbound with psoriasis drug Taltz to see if the combination boosts effectiveness. The drugmaker is also exploring combination studies with Zepbound in inflammatory bowel disease, another immune disorder. Every top-selling success in the pharma industry is clouded with chronic anxiety over how to follow it up — sooner or later, competition is going to cut into sales. The combination studies are part of Lilly’s efforts to become a top player in immunology while creating a phalanx of drugs to outlive its obesity and diabetes breakthroughs. 

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Driving to a Seattle clinic for surgery to remove fetal tissue, the two felt the heaviness of the moment. They knew they were done trying. Over the previous six years they had become medical sleuths, reading studies, speaking to doctors, and examining all treatments possible. Most doctors pinned Hanson’s losses on fetal abnormalities, but she felt there was more to it. The fact that her miscarriages were unexplained, she says now, was “unacceptable.”

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Questionable rationale

The belief that screening can reduce cancer disparities has emerged in several places. The United States Preventive Services Task Force (USPSTF), in particular, has injected this belief into its recommendations. The task force’s recent decisions to expand lung cancer screening (by lowering the smoking history criterion from 30 packs-years to 20), colorectal cancer screening (by lowering the age of initiation from 50 to 45), and breast cancer screening (by suspending shared decision-making for women in their 40s in favor of a blanket recommendation) have been motivated, at least in part, by the desire to reduce differences in deaths between Black and white Americans.

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U.S. District Judge Ada Brown said Tuesday the FTC did not have the legal authority to create the noncompete ban, which was supposed to go into effect Sept. 4. Brown’s ruling was widely expected after issuing a preliminary injunction against the regulation in July. 

However, a separate federal court in Pennsylvania ruled in July the FTC had the power to eliminate most noncompetes and that employers would not be “irreparably harmed” if the rule went into effect. The differing decisions make it likely that appeals courts, and potentially even the Supreme Court, will have to step in.

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Contrast this with the presidential debate that occurred June 27. The nation was stunned by the frail man who struggled to offer coherent answers. Within weeks, the sitting president had stepped aside as his party’s candidate for re-election. The entire political landscape dramatically changed at that point.

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“For over a decade, it appears that U.S. biopharmaceutical companies conducted clinical trials with China’s military organizations, and specifically with medical centers and hospitals affiliated with the People’s Liberation Army’s,” according to an Aug. 19 letter that the House China committee sent to the Food and Drug Administration. 

The bipartisan inquiry jeopardizes yet another aspect of drug development for which drugmakers increasingly rely on China, where it’s cheaper. However, the letter is focused on trials involving hospitals affiliated with the Chinese military and trials run in the Xinjiang region, where the Chinese Communist Party has been accused of human rights abuses against Uyghurs and other ethnic minorities.

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Academic researchers analyzed a World Health Organization database that tracks suspected adverse drug reactions, and found that there was a 45% greater rate of reports of suicidal thoughts associated with semaglutide, the ingredient in Novo Nordisk’s Ozempic and Wegovy, compared with all other drugs in the database.

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Carbon Health founder steps back from top role

Carbon Health‘s chief executive and co-founder Eren Bali is taking a step back from the primary care tech company, returning instead to the education company Udemy he co-founded as its chief technology officer, he announced in a Tweet late last week. “Udemy is my first baby. It has a special place in my heart and I was always on the board, so never disconnected from the company,” he said. Carbon’s chief operating officer Kerem Ozkay will take over as CEO, and Bali will remain executive chairman at Carbon, he said in the post.

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Rise and shine, everyone, another busy day is on the way. We can tell because the pace of motor vehicles passing by our window is picking up and the official mascots are busy foraging for their breakfast on the campus grounds. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is maple bourbon. Yes, this is real. As always, you are invited to join us. The neurons could use all the help they can get. Meanwhile, here is the latest menu of tidbits for you to digest as you embark on your journey, which we hope is satisfying and rewarding. On that note, time to get cracking. Best of luck, and do keep in touch. …

Eli Lilly’s obesity drug Zepbound significantly cut the risk of developing type 2 diabetes, showing the benefits of long-term use of the blockbuster therapy, STAT says. In a Phase 3 trial that lasted over three years, people with pre-diabetes taking Zepbound had a 93% lower risk of progressing to diabetes compared with people on placebo. The results add to the body of data showing continued use of the class of GLP-1 drugs can help prevent other health problems. Novo Nordisk’s competing drug Wegovy reduced the risk of heart complications in a large cardiovascular outcomes trial and cut the risk of developing diabetes by 73%. The data could boost arguments that the high costs of chronic use of the drugs are justified if these prevent people with obesity from developing other health problems, thereby saving the health system money in the long run. 

Next week, the biopharma world will see eagerly awaited results from a trial that could shape care for patients with an increasingly common heart condition — and determine which companies stand to reap billions, STAT tells us. The trial of vutrisiran, from Alnylam Pharmaceuticals, was already announced as positive, with the drug successfully cutting the risk of death and cardiovascular complications in patients with the disease, called ATTR-CM. Given the strong data, the therapy is expected to win regulatory approval. But Alnylam’s drug is not the only option for patients. Pfizer has a pair of competing therapies, and BridgeBio has one nearing approval. Investors and cardiologists have been anticipating the full results of the Alnylam trial, which are scheduled to be presented next Friday, Aug. 30, in London at the annual meeting of the European Society of Cardiology. 

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Hello and happy Tuesday! Our intrepid First Opinion editor Torie Bosch is back, and she has some big ideas for the section in the coming months. Be sure to get in touch with her, and continue sending news, tips and takes to sarah.owermohle@statnews.com.

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In a Phase 3 trial that lasted over three years, people with pre-diabetes taking Zepbound had a 93% lower risk of progressing to diabetes compared with people on placebo, Lilly said Tuesday. The company did not report absolute risk rates.

The new results add to the body of data showing that continued use of the class of GLP-1 obesity drugs can help prevent other health problems. Novo Nordisk’s competing therapy Wegovy reduced the risk of heart complications in a large cardiovascular outcomes trial. In that study, which enrolled people with obesity and heart disease, Wegovy also cut the risk of developing diabetes by 73%.

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In an analysis in JAMA Network Open, researchers suggest the agency could use large language models or LLMs to enhance Sentinel, the surveillance system for drugs and devices it regulates. Sentinel draws upon clinical records and insurance claims, and the agency uses its analyses to adjust drug labels, convene advisory committees and disseminate drug safety communication, the authors noted. 

AI, the authors suggested, could extract reports of drug safety events from a wider set of sources, including free-text data from electronic health records. But there are still some risks, the biggest of which is the so-called hallucination that LLMs have been known to introduce — by generating false information, LLMs could over- or understate the risks for certain products, for instance. 

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The authors analyzed 40 years of data from a National Science Foundation survey that tracks Ph.D. graduates. They then combined this data with the average team size in a researcher’s field at the time they earned their doctorate, calculated based on the number of authors listed on published research. Doing so showed that, as team size has risen, young researchers have become less likely to earn tenure and secure research funding, and are more likely to leave science altogether. 

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I’ve been masking consistently in public since 2020, when the Covid-19 pandemic began, because I have a kidney transplant and will take immunosuppressant medication for the rest of my life. Unfortunately, my lifesaving medication also makes me more susceptible to infectious diseases like measles, the flu, and Covid-19. Even when people like me are vaccinated against the virus, we are at higher risk of being infected and are more likely to experience adverse health outcomes, including hospitalization and death.

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The trial of vutrisiran, from Alnylam Pharmaceuticals, was already announced as positive, with the drug successfully cutting the risk of death and cardiovascular complications in patients with the disease, called transthyretin amyloid cardiomyopathy, or ATTR-CM. Given the strong data, the RNA-interference therapy is expected to win regulatory approval.

But Alnylam’s drug is not the only option for patients. Pfizer has a pair of competing therapies, and BridgeBio has one nearing approval. Investors and cardiologists have been anticipating the full results of Alnylam’s HELIOS-B trial, which are scheduled to be presented next Friday, Aug. 30, in London at the annual meeting of the European Society of Cardiology. 

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A growing area of focus is on the development of complex generics. These include products with complex active ingredients and complex drug-device combinations, among others. Complex generics are typically difficult to develop, regulatory pathways for them can be convoluted, and the regulatory frameworks differ across health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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It’s the second legal challenge to the rule, following the American Clinical Laboratory Association’s suit in May. The suit, filed in Texas by the Association for Molecular Pathology and University of Texas pathologist Michael Laposata, claims that the FDA overstepped its regulatory bounds when deciding to regulate lab-developed tests. 

“We filed this lawsuit to ask the Court to vacate the FDA rule given the agency’s lack of authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine,” said AMP president Maria Arcila in a statement. 

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Instead, their plan this election cycle evokes President Biden’s slogan to “finish the job” — even though they’re running a new candidate. With the notable exception of calling to erase medical debt by working with states, Democrats are largely eyeing marginal extensions or reinstatements of their prior policy achievements. 

The Democrats’ platform, released Monday, is six times the length of Republicans’ brief 16-page policy plan. The most impactful proposals require cooperation from Congress, which may not be decided in Democrats’ favor, even if they are able to maintain the White House. 

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A self-interested plea from Peter Orszag

Peter Orszag, CEO of Lazard, went on CNBC last week and criticized how the Federal Trade Commission and Department of Justice were gumming up health care mergers. Look closely at what he said (emphasis mine):

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Since news of the epidemic, the media has circulated images of patients infected with mpox. Some of these photographs show mpox on patients’ arms, legs, and hands, but others are headshots that resemble mugshots of African people with mpox covering their faces. The photos include an African patient somberly looking into a camera, a doctor’s hand pointing at vesicles on an African child’s face, and a disturbing image of a child who has his hands raised, as if being held up by the police, revealing pustules on his face, hands, and chest. I am purposely not linking to them, because these images tend to pathologize, even criminalize, the patients.

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