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More than half (60%) of patients in latest trial reached active remission and 41% stopped taking corticosteroid entirely.  

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Kristi Funk, M.D., FACS, discusses the current outlook for breast cancer cases worldwide, underscoring its seriousness. “I think we have to understand everything is getting worse,” she said.

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Thinking of “Carving Out” Specialty Benefits? Your Questions Answered

Putting psychedelic drugs to work in treating mental illness encountered a seeming setback in August when the FDA 

 an application for use of MDMA (3,4-methylenedioxymethamphetamine), also known as ecstasy, as a treatment for PTSD.

This may not have been surprising to some in the medical community. In 

 issued in 2023, the FDA set a high bar for approval of these agents for medicinal purposes.

The use of psychedelics comes with altered mental states that the FDA prefers to classify as adverse events and potential catalysts for substance abuse, two hurdles that make the risk-reward profile of these agents difficult to accept.

Next up at bat will likely be a new drug application (NDA) from Compass Pathways for a psilocybin treatment for treatment resistant depression (TRD). MDMA is a synthetic psychedelic whereas psilocybin is a natural substance found in a certain species of mushroom.

Initial results of a pivotal phase 3 trial are expected in the fourth quarter of 2024.

 reported in November 2022, investigators said a one-time 25 milligram (mg) dose of psilocybin reduced TRD significantly more than a 1 mg dose over a three-week period, although adverse events were associated with treatment.

MDMA is known for its empathogenic and euphoric effects, whereas psilocybin is known for mystical and introspective effects, which has made it a candidate treatment for mood disorders and existential anxiety.

In the PTSD and TRD patient communities, there is a significant unmet need for effective therapies. 

 of patients with major depressive disorder will have TRD. For participants in the Compass phase 2 trial, psilocybin was a third-, fourth-, and even a fifth-line treatment.

Many experts believe that psychedelics will eventually overcome the stigma attached to use of these substances and  find a place in the legitimate  armamentarium.

For Compass Pathways to mount a successful NDA, it will at least have to demonstrate to the FDA they have managed the many moving parts of a psychedelic trial more effectively than did Lykos for its MDMA product.

In highly positive phase 3 results, Lykos reported 

 experienced a clinically meaningful improvement in PTSD symptoms at 18 weeks post baseline, but the devil was in the details. An FDA review panel 

 with numerous aspects of the trial, calling a talk therapy component too loosely structured, finding unanswered questions about the potential for substance abuse and noting an inherent failure to adequately blind the trial because the hallucinogenic effects made it obvious to participants who was receiving the active substance and who had been randomly assigned to take the placebo.

One inescapable reality is that psychedelics are Schedule 1 controlled substances that are going to be handled with extreme prejudice.

The limited guidance that the FDA has put out on psychedelic clinical trials has iis more a minefield than a blueprint for success.

“Because this is an emerging area of drug development, there is limited experience as to the configuration of programs that may support approval of a psychedelic drug,” the FDA wrote in its 2023 draft guidance document.

The FDA rejected an application to approve MDMA, also known as ecstasy, as a treatment for PTSD. Next up among the psychedelics vying for FDA approval: psilocybin for treatment resistant depression.

Clinical

Long Strange Trip Continues for Psychedelics in PTSD, TRD

 from The Ohio State University Wexner Medical Center showed  that nearly 1 in 3 Americans are unaware of the risks associated with eye damage while viewing the upcoming total solar eclipse set to occur on April 8 at 3:20 p.m. ET.

Nearly 32 million Americans will be along the “path of totality” where they will be able to experience an eerie, dawnlike darkness during the height of the eclipse, which will last about 4 minutes.

It is never safe to look directly at the sun, even when the moon is blocking much of it as happens during a solar eclipse, because the brigthness can potentially permanent damage that can occur to the retina and cornea.

“The best way you can enjoy yourself is to be prepared,” Nicholas Kman, M.D., emergency medicine physician at The Ohio State University Wexner Medical Center said in an interview with 

today. “The safest way to view the eclipse is with certified eclipse glasses. There are also different types of welder’s goggles that are designed to protect the eyes from bright flashes of light. Other than that, normal sunglasses would not be adequate for this, even if they seem very dark.”

Eclipse glasses, which are ISO-certified, are available online and may be given out for free at community spaces such as local libraries.

The last eclipse, a partial solar eclipse, happened in 2017. The upcoming total eclipse is much rarer and won’t be seen again in the United States for another 20 years, according to 

. The path of totality will also be much broader than the one in 2017.

“We learned a lot of lessons from the eclipse in 2017 - the traffic jams were incredible," Kman said. "One of the things that we're worried about as a hospital is ‘can we get our staff to work?’ It’s almost like a severe weather event.”

In Ohio, where Kman is based, people within a 124-mile wide band will experience the total eclipse. The zone falls between Toledo and Cleveland and then slices south and west through the state. 

“If the weather's good, there's been estimates of about three times the normal amount of people in each of the counties that are in the eclipse path,” Kman said. “In our smaller counties, three times the number of people would put a large stress on gas stations, cell towers, law enforcement and EMS providers.

Before traveling for the eclipse, Kman recommends that in addition to the right eye protection, people should have a full tank of gas, snacks, cellphone chargers and a plan if the group gets separated.

“We want people to enjoy themselves, but the best way you can enjoy yourself is to be prepared.”

Experts say ordinary sunglasses aren't protective enough for viewers of the solar eclipse on Monday. You need those certified eclipse glasses. Ten-packs were selling on Amazon today for $12.99.

Don't Be Blinded by the Sight of the Eclipse

Comorbid conditions can postpone the diagnosis of lung cancer by occupying the time of general practitioners, thereby diminishing the likelihood of immediate cancer investigations. Additionally, they can provide a credible non-cancer rationale for specific signs and symptoms.

A group of researchers from the Brighton and Sussex Medical School in the U.K. looked to discover the effect of comorbidities on diagnostic interval for lung cancer by using electronic health record data for patients in England.

The results of the cohort study were published on Aug. 23 in the 

 and concluded that clinical guidelines should incorporate the impact of alternative and competing causes upon delayed lung cancer diagnosis.

The study distinguished between “competing demand” and “alternative explanation” conditions.

“We consulted with clinicians — GPs and clinically trained cancer epidemiologists — to classify the conditions into the two groups,” explained Imogen Rogers, research fellow in health data science at the Brighton and Sussex Medical School in the UK, who led the study. “The significance is to elucidate the mechanism by which comorbidities result in diagnostic delay.”

The research team utilized data from 11,879 lung cancer patients and found that the adjusted analyses diagnostic interval was longer for patients with alternative explanation conditions, by 31 and 74 days in patients with one and 2 or less conditions compared to those with zero.

The researchers used a multivariable linear regression models for their analysis.

“As the target audience was clinicians, we wanted to choose a method that would give easily interpretable results, and this method gave the difference in days associated with the presence of comorbidities and the other factors in the model,” Rogers said. “We ran a number of different regression models —including a Cox’s regression model — and they all generated very similar conclusions about the effect of the different factors on time to diagnosis.”

Given that the presence of “alternative explanation” conditions delayed diagnosis significantly, Rogers suggests that clinical guidelines should highlight the potential for conditions such as chronic obstructive pulmonary disease o mask early symptoms of lung cancer.

“Raising awareness of this issue among primary care physicians could help to reduce diagnostic delays,” she said. “This is a retrospective analysis with no control group, so we would stop short of making specific recommendations for clinical guidelines based on this work.”

One possible area of future research, Rogers noted, would be to conduct a retrospective cohort study or a case-control study of patients with COPD/asthma who do and don’t go on to develop lung cancer.

“This could help to define particular symptoms/combinations of symptoms associated with a particularly high risk of developing lung cancer, which could be used to identify patients who might benefit most from regular screening,” she said. “In addition, this could help to avoid over-investigation of patients, which also has its associated harms.”


Researchers that clinical guidelines highlight the possibility of chronic obstructive pulmonary disease and other conditions masking early symptoms of lung cancer. 



New Study Examines How Comorbid Conditions Hinder Timely Lung Cancer Diagnosis

New findings shared by Regeneron Pharmaceuticals, Inc. at the 2024 World Conference of Lung Cancer meeting earlier this month showed that Libtayo (cemiplimab) provides a significant long-term survival advantage at five years for patients with advanced nonsmall cell lung cancer.

Specifically, Libtayo monotherapy nearly doubled the median overall survival and lowered the risks of death and disease progression by 41% and 50%, respectively, compared with chemotherapy, according to the company.

These results come from the final prespecified overall survival analysis of the Phase 3 EMPOWER-Lung 1 trial, which compared Libtayo’s monotherapy with chemotherapy as a first-line treatment for adults with advanced nonsmall cell lung cancer who have 50% or programmed cell death ligand 1  (PD-L1) expression and do not exhibit alterations in the EGFR, ALK, or ROS1 genes. PD-L1 is protein that is often compared to a brake that keeps the body’s immune responses under control. Libtayo is one of many "immune checkpoint inhibitors" that act on immune system cells so they recognize and attack cancer.

Ana Baramidze, M.D., head of clinical research department at the Todua Clinic in Tbilisi, Georgia, noted these enlightening results showcase the durable survival benefit and impressive efficacy of first-line Libtayo monotherapy, including a direct correlation between survival benefits and PD-L1 expression level.

“Furthermore, EMPOWER-Lung 1 continues to offer important new data to help doctors increase their understanding of investigational treatment strategies for patients who progress on PD-1 inhibitor monotherapy,” she said at the conference. “For instance, EMPOWER-Lung 1 was one of the few trials to evaluate survival when adding chemotherapy to a PD-1 inhibitor following progression.”

Previously, a one-year analysis was published in 

in February 2021, but the latest findings demonstrate significantly more promising results.

In the EMPOWER-Lung 1 trial, patients who experienced disease progression were allowed to change their treatment; those initially assigned to Libtayo had the option to add four cycles of chemotherapy. At the five-year follow-up, patients who received the combination therapy showed a median overall survival of 15 months (95% CI: 11 to 18 months), a median progression-free survival of 7 months (95% CI: 6 to 8 months), and an objective response rate of 28% (95% CI: 18% to 40%).

Furthermore, exploratory subgroup analysis of EMPOWER-Lung 1 revealed direct correlations between survival and disease progression benefits and PD-L1 expression level among Libtayo patients, supporting the direct correlation between tumor response and PD-L1 expression level previously observed.

Regeneron Pharmaceuticals noted the potential use of adding chemotherapy to Libtayo following disease progression is still considered investigational, and the safety and efficacy of this regimen have not been fully evaluated by any regulatory authority.

Libtayo monotherapy nearly doubled the median overall survival and lowered the risks of death and disease progression.

Libtayo Significantly Enhances Five-Year Survival for Advanced Nonsmall Cell Lung Cancer Patients, Regeneron Says

Syphilis rates in the U.S. have risen nearly 80% between 2018 and 2022. In 2022 alone, 207,255 cases of syphilis were reported to the CDC. In 2021, there were only 176,663 cases, the CDC reports. 

Currently, rates are the highest they’ve been since 1950 when there were 217,558 cases (146 cases per every 100,000 citizens) according to a CDC 

. The ongoing penicillin shortage, which is the most effective treatment, has only worsened matters.

 chief epidemiologist for the Maven platform at 

, a healthcare data company, says the reasons for the increase in cases are multifaceted. 

“There's a variety of reasons as to why we're seeing a rise not only in syphilis,” Lydiard began. “Funding for STDs [sexually transmitted diseases] tends to be limited, so it's underfunded. We also have a rise in drug use and alcohol use, which tends to lead to riskier sexual behavior.”

On average, symptoms appear 21 days after exposure, a 

 fact sheet reads. There are four stages of syphilis: primary stage, secondary stage, latent stage, and tertiary stage. It can be treated at any stage using antibiotics. The first signs of an infection are sores in the mouth, anus or vagina that disappear within three to six weeks regardless of treatment. Skin rashes or lesions occur in the second stage which also disappear without treatment. There are no symptoms during latent syphilis, which refers to the dormant period, sometimes lasting years. Tertiary syphilis is the rarest and final stage. It begins anywhere from 10-30 years after infection and can cause blindness, paralysis, dementia, heart disease and death.

Syphilis was almost eradicated in the 1990s. In 1990, there were 135,590 cases and by the year 2000, there were only 31,618 cases, a historic low for the disease that may be attributed to safe sex practices adopted after the AIDS epidemic. However, it now seems that advances in HIV prevention have lulled some people into a false sense of safety.

Persisting stigma and COVID loneliness are partly to blame. 

CVS Caremark

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