Telehealth startup allegedly treated minors without parents' consent

 Telehealth startup Cerebral has been accused of prescribing minors prescriptions without the consent of their parents, The Wall Street Journal reported Sept. 29. 

Cerebral has a software that verified customers' IDs, but the software didn't identify patients' ages, according to former employees and documents reviewed by the Journal. Clinicians were allegedly supposed to verify patient ages during 30-minute video chats. 

"We have provided much-needed care to hundreds of thousands of patients, many of whom would not have had access to critical mental-health support without Cerebral's telemental health services," Cerebral told the Journal. 

Cerebral also said it tested different ways to verify IDs in its registration process and has always met legal requirements.

A 17-year-old from Missouri, Anthony Kroll, signed up for Cerebral and went through the ID software, which showed he was a minor. 

He proceeded to meet with a clinician, stating that he had suicidal thoughts, and she prescribed him an antidepressant that had a warning label for adolescents, according to medical records reviewed by the Journal. Mr. Kroll later died by suicide.

Mr. Kroll's parents said they did not know he was seeking mental health treatment nor were they made aware that he was taking an antidepressant. 

Missouri law prohibits clinicians from providing mental health treatment to people under 18 without parental consent. 

Cerebral said Mr. Krol misrepresented his age. 

The company later identified 17 minors who enrolled in their services between May 2021 and April 2022, including Mr. Krol. 

According to the documents and employees, the company enrolled people with bipolar disorder, suicidal thoughts and other serious conditions, giving some patients appointments without properly vetting their IDs. Cerebral has said it no longer prescribes most controlled substances to new patients, according to the Journal.

https://www.beckershospitalreview.com/telehealth/telehealth-startup-allegedly-treated-minors-without-parents-consent.html

Higher Dose, Longer Treatment With Eylea Shows Promise in Eye Disease

 Bumping up the dose of aflibercept (Eylea) led to prolonged treatment intervals for neovascular eye disease without a loss in efficacy or major increase in adverse events, two randomized trials showed.

Dosing the VEGF inhibitor at 8 mg every 12 or 16 weeks achieved non-inferiority to treatment with 2 mg every 8 weeks with respect to best-corrected visual acuity (BCVA) in patients with diabetic macular edema (DME). More than 90% of patients randomized to 8 mg maintained the 12-16 week dosing interval through 48 weeks, according to a presentation at the American Academy of Ophthalmology (AAO) meeting.

Also at AAO, investigators presented results from a separate randomized trial involving patients with neovascular age-related macular degeneration (AMD). It showed that 8 mg every 12 or 16 weeks achieved BCVA similar to 2 mg every 8 weeks at 48 weeks.

PHOTON

"The 48-week results show the non-inferiority of 8 mg Q12 or Q16, despite greatly increased dosing intervals," said David Brown, MD, of Retina Consultants of Texas in Houston. "Remarkably, 91% of patients can be maintained on Q12 and 89% of Q16 and overall, 93% on Q12 or greater. We hope to get this benefit out to our patients in the coming future."

Brown reported initial results from the phase II/III PHOTON randomized trial evaluating a novel 8-mg formulation of aflibercept. The four-times higher molar dose compared with standard aflibercept dosing is hypothesized to achieve a longer effective vitreal concentration and more sustained inhibition of VEGF signaling.

Investigators in the PHOTON trial randomized 658 patients with untreated DME 1:2:1 to intravitreal aflibercept 2 mg every 8 weeks (2q8), 8 mg every 12 weeks (8q12), or 8 mg every 16 weeks (8q16). Patient age was around 62, about 39% were female, and about 72% were white.

Patients in the 2q8 arm initially receive five monthly doses of aflibercept whereas patients in the two 8-mg arms received three monthly injections. Baseline characteristics did not differ significantly among treatment groups, including a mean hemoglobin A1c of 8% across the three groups.

The primary endpoint was change in BCVA from baseline at 48 weeks, and the trial was statistically powered for non-inferiority. The primary analysis showed improvement in BCVA of 8.7 letters with the 2q8 group, 8.1 letters in the 8q12 group (P<0.0001) and 7.2 letters in the 8q16 group (P=0.0031), meeting prespecified statistical criteria for non-inferiority.

Maintenance of dosing intervals in the experimental arms was a secondary endpoint. The results showed that 91% of patients randomized to 8q12 remained at that interval, as did 89% of patients randomized to 8q16. Overall, 93% of patients randomized to 8 mg maintained dosing intervals ≥12 weeks, said Brown.

Change in central retinal thickness also did not differ significantly among the three groups, ranging from -148 µm in the 8q16 arm to -172 µm in the 8q12 arm.

Rates of adverse events (AEs, all grades) averaged 31.0% across the three treatment arms and did not differ significantly. Rates of individual types of AEs also did not differ across the treatment groups. The incidence of intraocular inflammation averaged 0.8% and did not differ significantly among the treatment groups.

AAO panelist Shlomit Schaal, MD, PhD, of the University of Massachusetts in Worcester, pointed out that the higher dose of aflibercept produces the same number of anti-VEGF molecules as bevacizumab (Avastin) after 4 weeks.

"Wouldn't you think that rather than increasing the dose, you should focus on other mechanisms of the disease in DME, not just increasing the same molecule?" she asked Brown.

Acknowledging the presence of "millions of cytokines produced by diabetic eyes" as potential treatment targets, Brown said anti-VEGF remains the "big gorilla." Any strategies that can increase dosing intervals, even modestly, will make a "big difference in this working-class population that has to take off school or get a substitute teacher. Anything we can do to decrease treatment burden [is helpful]."

PULSAR

The same three dosing intervals were evaluated in the phase III PULSAR trial, which included 1,009 patients with untreated neovascular AMD, randomized 1:1:1 to the three dosing schedules. The primary endpoint was change from baseline to 48 weeks in BCVA, said Paolo Lanzetta, MD, of the University of Udine in Milan. Overall, 93.3% of patients (age around 74, more than half female, more than three-fourths white) completed the 48 weeks of treatment and follow-up.

At 48 weeks, all three groups achieved improvement in BCVA from baseline: 7.0 letters with 2q8, 6.1 letters with 8q12, and 5.9 letters with 8q16. The 8q12 (P=0.0009) and 8q16 (P=0.0011) treatment groups demonstrated non-inferiority to the 2q8 group. Overall, 83% of patients randomized to 8 mg injections of aflibercept maintained ≥12-week dosing intervals through 48 weeks.

Significantly more patients in both 8-mg groups had no retinal fluid in the center subfield at 16 weeks, a secondary endpoint. The percentage of patients without fluid in the center subfield was 63% in the two 8-mg groups combined versus 52% in the 2q8 group (P=0.0002).

Mean reduction in central retinal thickness from baseline was 147 µm in the 8q16 group, 142 µm in the 8q12 group, and 126 µm in the 2q8 group.

The incidence of AEs was similar across the treatment groups.

Disclosures

The trials were supported by Regeneron/Bayer.

Brown disclosed relationships with Regeneron/Bayer and Genenteh/Roche.

Lanzetta disclosed relationships with Aerie, Allergan, Apellis, Bausch & Lomb, Bayer, Biogen, Boehringer Ingelheim, I-Care, Genentech, Novartis, Outlook Therapeutics, and Roche.

Primary Source

American Academy of Ophthalmology

Source Reference: Brown DM, et al "Intravitreal aflibercept injetion 8 mg for DME: 48-week results form the phase II/III PHOTON trial" AAO 2022.

Secondary Source

American Academy of Ophthalmology

Source Reference: Lanzetta P, et al "Intravitreal flibercept injetion 8 mg for nAMD: 48-week results from the phase III PULSAR trial" AAO 2022.

https://www.medpagetoday.com/meetingcoverage/aao/101010

Horizon: Thyroid Eye Disease May Remain Activated In Patients with Low Clinical Activity Score

 -- Oral presentation at AAO 2022 suggests IGF-1 and its related pathways are extensively upregulated throughout all stages of TED --

Horizon Therapeutics plc (Nasdaq: HZNP) today announced the presentation of new data defining molecular patterns in TED and further implicating the role of insulin-like growth factor-1 (IGF-1) in patients with low CAS. These data were presented during the American Academy of Ophthalmology Annual Meeting (AAO 2022), Sept. 30 – Oct. 3 in Chicago.

TED is a progressive and potentially vision-threatening rare autoimmune disease, which has been historically characterized as biphasic: acute, which is traditionally believed to be patients with high CAS and earlier in their TED journey; and chronic, traditionally believed to be patients with low CAS and later in the course of their disease.¹ This analysis reveals that in patients with both high and low CAS, there is clear activation of IGF-1 and related pathways, as well as the extracellular matrix (ECM) organization, a structural network that supports cellular processes.²

“By demonstrating that disease activity remains in patients with low CAS, this analysis may help explain why many patients who have lived with Thyroid Eye Disease for several years are still struggling with challenging symptoms that can be debilitating,” said Shoaib Ugradar, M.D., The Jules Stein Eye Institute at University of California, Los Angeles (UCLA). “It is important for physicians to be aware of the continued activation of IGF-1 throughout the course of the disease and its potential impact on treatment decisions.”

The study analyzed genome ribonucleic acid (RNA) sequencing and pathway analysis in orbital tissue from patients with a CAS of ≥ 3 and patients with a CAS ≤ 2, as well as five control subjects. Though high CAS patients are often distinguished by activation of immune system pathways, which remain largely unaffected in low CAS patients, IGF-1 and its related pathways were found to be upregulated in both stages of disease. Additional analysis suggests that IGF-1 activity plays a central role in linking immune and ECM pathways in people with TED.²

The upregulation of IGF-1 found in low CAS patients with extended disease duration is further supported by a growing body of evidence that outlines the impact of TED on people who have lived with it for several years.³ One assessment published in the journal Ophthalmology and Therapy in 2021 found that disease burden continues well into the chronic phase, affecting daily lives with appearance and persistent visual changes, increasing risk for anxiety and depression

https://www.marketscreener.com/quote/stock/HORIZON-THERAPEUTICS-PUBL-18100076/news/New-Data-Reveal-Molecular-Drivers-of-Thyroid-Eye-Disease-TED-May-Remain-Activated-In-Patients-with-41910064/

The Next Pandemic: Anxiety Over Life Itself

 A medical advisory group to the federal government has just recommended that all adult Americans age 19 to 64 be screened for anxiety. Earlier this year, the U.S. Preventive Services Task Force—which advises both the Department of Health and Human Services and Congress—recommended anxiety screening for children 8 to 18.

One could see this coming: The ultimate pandemic is now life itself. It’s hard to know whether the recommendation of mass anxiety screening should be met with satire or chagrin.

What took them so long? The idea that we live in an Age of Anxiety has been common at least since W.H. Auden’s book-length poem with that title appeared in 1947. In 1993 the psychiatrist Peter Kramer produced a best-selling book, “Listening to Prozac,” a meditation on the implications of the quickly adopted antidepressant drug approved in 1987.

The task force’s recommendation that virtually all adults be screened for anxiety will be significant if support builds for its adoption as standard care. That would move what most people consider a recurring condition of life—such as happiness or sadness—closer to something that would be submissible for control by formal institutions, including the state. The question is: Will this make us better or worse?

Much of the public isn’t in the mood for public-health interventions. The Covid-19 pandemic is winding down amid a broad reckoning about the restrictive policy recommendations scientific authorities made and imposed on the public. This striking headline appeared recently in the publication Education Week: “The Pandemic Was a ‘Wrecking Ball’ for K-12, and We’re Still Tallying the Damage.” Including anxiety.

So skepticism is inevitable when an arm of the science-policy community emerges at the pandemic’s end to say all children and adults (but not adults over 65) should somehow be screened for anxiety disorders. It’s already clear that a post-Covid care industry is emerging. Anxiety mitigation would provide lifetime work in schools, medicine and the media.

By the way, before the task force publishes the final version of its anxiety recommendations, the document will be available for public comment on the organization’s website until Oct. 17.

To be clear, these recommendations are only indirectly about the disease of depression. They focus explicitly on generalized anxiety disorder, social anxiety disorder, panic disorder, separation anxiety disorder and phobias.

Unmistakably, anxiety can become a pathway to disabling and destructive ailments. Moreover, the task force’s draft statement itself is refreshingly modest in its assertions of what science knows about anxiety or could achieve with mass screening. The panel “concludes with moderate certainty that screening for anxiety in adults, including pregnant and postpartum persons, has a moderate net benefit.”

As to therapies and treatments, psychological intervention produces “a small but statistically significant reduction” in anxiety symptoms. Psychopharmacologic drugs—mainly antidepressants and benzodiazepines—benefit some people. But that raises an age-old question similar to administering drugs for ostensibly hyperactive boys in grade school: Would anxiety screening put many more millions on a lifetime regimen of pharmaceuticals?

Unaddressed is how many primary-care docs will want to add formalized anxiety tests to what hospital systems or insurers already ask them to do. One task-force member, Dr. Lori Pbert, did address that for the New York Times, suggesting providers should “do what they already do on a daily basis: juggle and prioritize.” Perhaps the panel should next propose anxiety screening for doctors and nurses.

The first adopters are likely to be K-12 public schools, whose teachers unions would cheerfully add anxiety screeners to their expanding categories of membership. By the way, the task force notes that a positive screen for anxiety would then require a fuller, confirming diagnosis. The screenings themselves, especially in schools, could become a source of dread.

Yes of course the recommendation includes comments about race, wealth inequities, etc. And the panel exempts the 65+ population, not because their lives are more settled by then but because some symptoms of anxiety, such as sleeplessness or pain, overlap with the “natural signs of aging.”

This looks like a tide impossible to resist. We saw a great shift occurring away from calmer, more outward-looking lives toward predominantly self-directed obsessions when campuses created “safe spaces” for students who couldn’t cope. The Preventive Services Task Force provides 30 footnotes of research behind its recommendations but makes no attempt to explain how we arrived at a state of mass anxiety or what did this to us. The words “social media” and “web” appear nowhere, suggesting that for these doctors the only clinically relevant issue now is how to treat this universal malady.

Still, it’s sad to think that if we are helpless before the relentless salami slicer of daily life, mass psychological disorder is to be the unavoidable norm. One sure thing: Sellers of solutions will surf the anxiety wave.

Mark Zuckerberg renamed Facebook as Meta because he believes the future will consist of people by the millions strapping on headsets to inhabit whatever me-only metaverse they wish to live in. Don’t laugh. He’s done OK already with one dystopia.

https://financetin.com/the-next-pandemic-anxiety-over-life-itself/

For lower life expectancy, health care has less influence than individual choices

 Progressives like to point out that Americans pay more for health care yet have poorer outcomes than people in countries of similar wealth.

New life expectancy data from the Centers for Disease Control and Prevention seems to indicate that things are getting only worse. Between 2020 and 2021, American life expectancy decreased 0.9 years. That follows a drop of 1.8 years in 2020.

But there are many factors that influence our longevity more than the health care system does. In fact, much of the decline in life expectancy has little to do with our health care system.

Life expectancy has gone down in most countries, thanks to the COVID-19 pandemic. In an Oxford University study of 29 well-off countries, 27 saw a fall in life expectancy in 2020.

But the coronavirus alone doesn’t fully explain the U.S. decline. New CDC research attributes it mostly to two factors, the pandemic as well as “unintentional injuries.”

Sixteen percent of the decline in life expectancy between 2020 and 2021 was a function of an increase in accidents and unintentional injuries.

The age-adjusted death rate for unintentional injuries increased nearly 17% between 2019 and 2020.

Fatal car crashes increased by 6.8% from 2019 to 2020, resulting in nearly 40,000 lives lost — the highest number since 2007, according to the National Highway Traffic Safety Administration.

Drugs are claiming more lives too. Drug overdose deaths from April 2020 to April 2021 reached 100,306 — a 28.5% increase from the prior period. In the 12 months ending March 2022, overdose deaths surpassed 109,000.

The increase in traffic and drug deaths is tragic. But even before 2020, Americans got into more traffic accidents and overdosed more often than people in other countries.

A 2016 CDC report concluded that the United States had the worst car-crash death rate among 20 affluent nations. And a 2018 study of 13 peer countries published in the Annals of Internal Medicine found that the U.S. had the highest rate of drug overdose deaths.

Americans are also disproportionately likely to die from gun violence. The U.S. firearm homicide rate is more than eight times that of Canada — and 23 times Australia’s.

Individuals’ choices and behavior contribute to these higher death rates. The U.S. health care system does not have the power to stop people from abusing drugs, driving recklessly or shooting one another.

Similarly, Americans suffer from obesity and diabetes at higher rates than residents of other countries. Both conditions increase the risk of dying from our country’s biggest killer, heart disease. But they stem largely from poor diet and lack of exercise, behaviors that our health care system has relatively little influence over.

To see the role of cultural influences in life expectancy, we need only look at regional variations throughout the U.S. There’s a nearly nine-year difference between the state with the highest life expectancy — Hawaii, at 80.7 years — and the state with the lowest — Mississippi, at 71.9 years, according to the CDC.

And the recent drop in life expectancy wasn’t as severe in the Pacific Northwest or New England as in the South and Southwest.

Americans across the board routinely receive better care than people elsewhere for certain diseases — notably cancer, our second-leading cause of death. In fact, the U.S. has a lower than average mortality rate from cancer relative to other wealthy countries, according to data from the Organization for Economic Co-operation and Development.

Progressives tend to blame systems, rather than individual choices, for disparities in everything from income to health. But sometimes, those choices matter more than any system.

Sally Pipes is president, CEO, and Thomas W. Smith fellow in Health Care Policy at the Pacific Research Institute. Her latest book is “False Premise, False Promise: The Disastrous Reality of Medicare for All.”

https://www.chicagotribune.com/opinion/commentary/ct-opinion-life-expectancy-us-health-care-system-20220915-s2he5vvwyng27flhldwu4eztcm-story.html

If You Don’t Exercise, You’re Screwing Over Your Grandchildren

 According to a study published in Molecular Metabolism, the exercise you accomplish today could pay dividends for future generations, effectively strengthening the cells of your children and grandchildren.

It’s the latest entry in a field of research known as “developmental programming,” which was defined in 2016 in the journal Obesity as “the ability of exposures during prenatal or early postnatal development to cause permanent changes to the physiology, metabolism and epigenome of an individual which subsequently will affect health and increase risk of disease.”

In simpler terms, the lifestyle habits of a mother and a father have genetic consequences (the study of such consequences is called epigenetics), which are then passed on down the family tree. If you never exercise, subsist on the Standard American Diet — lots of simple carbs, saturated fats and processed sugar — and eventually develop obesity or diabetes, your children and your children’s children are starting their lives at a disadvantage. There’s nothing they can do about it. Even if they make healthy choices, they’re at a heightened risk of developing metabolic disorders.

On one hand, this sort of research offers a sobering explanation for our skyrocketing rates of heart disease and stroke. But it should also function as a call to action to make elemental changes in your exercise and nutritional patterns; certain lifestyle choices become a bit more difficult to justify if you’re determined to bring children into the world.

Still, while poor prenatal habits will endanger your children, proactive prenatal habits can actually buttress them against potentials diseases or syndromes. Research from Harvard Medical School’s Dr. Laurie Goodyear has illustrated on two previous occasions that when mothers and fathers run before mating, offspring are born with stronger metabolisms, healthier brains and noticeable protections against obesity and diabetes.

These studies invariably involve mice, mind you, but the epigenetic reasoning is sound. And besides, as with the new study, which focused on grandchildren, it would take decades to document the impact in human beings.

In Dr. Goodyear’s latest, researchers bred three generations of mice, controlling here and there for which ones ate healthy, which ones ate high-fat chow, which ones ran, and which ones never got a turn on the hamster wheel. The results were profound. As the lead author on the study, Dr. Ana Alves-Wagner, told The Washington Post, “It was remarkable. Exercise had improved the metabolic health of multiple generations.”

The mice with active grandparents had healthier bones. They were trimmer. They didn’t battle blood-sugar irregularities or insulin sensitivities as they aged. Those findings were all starkly opposite for those whose grandparents hadn’t exercised. Another relevant finding: exercise seemed to matter more than diet in terms of epigenetic impact on future generations.

Ultimately, this sort of study offers a unique perspective that should be considered an asset for hopeful parents. We’re familiar with the need to avoid things to protect the health of an expected child, like alcohol, tobacco or fast food. But you can also actively seek out pursuits to enrich the health of that child, like running, hiking or cycling, which will bequeath a happier, healthier life for you along the way. That’s an intergenerational win-win-win.

https://www.insidehook.com/daily_brief/health-and-fitness/exercise-habits-affect-grandchildren-study

Florida health systems resuming operations in Ian's aftermath

 In the aftermath of Hurricane Ian, some health systems in the state are returning to normal operations, the Orlando Sentinel reported Sept. 30.

In a news release, Orlando Health said it suspended and rescheduled elective surgeries/procedures and physician practice appointments scheduled after 2 p.m. Sept. 28 and Sept. 29. The system resumed regular operating hours at all physician practices, outpatient ambulatory and medical group locations in Central Florida on Sept. 30.

AdventHealth Central Florida resumed elective procedures as well, after limiting operations Sept. 28 and Sept. 29, according to the Orlando Sentinel.

AdventHealth also closed Centra Care clinics in Central Florida for in-person visits Sept. 28 and Sept. 29. As of Sept. 30, most Centra Care, imaging and sports medicine and rehabilitation offices were open in Central Florida, according to the AdventHealth website.

The Orlando Sentinel reported that both systems in Central Florida no longer had emergency teams staying on site, and staff were commuting to work again as of Sept. 30. 

Additionally, Clearwater-based BayCare Health System's website states that its medical group offices are opening as able Sept. 30, including offering telehealth services. The system also said it expects medical group offices to be open as usual on Oct. 3.

Hurricane Ian made landfall Sept. 28 as a Category 4 hurricane near Cayo Costa, Fla. Ian made another landfall Sept. 30, this time on the South Carolina coast as a Category 1 hurricane, according to AccuWeather. At the time of publication, Ian had weakened to a tropical rainstorm.

https://www.beckershospitalreview.com/care-coordination/florida-health-systems-resuming-operations-in-ian-s-aftermath.html