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Thursday, August 28, 2025

Ether ETFs Capture 10x More Inflows Than Bitcoin In Last 5 Days

 Spot Ether exchange-traded funds are selling like hot cakes in the US, attracting more than 10 times the inflows of their spot Bitcoin counterparts over the past five trading days. 

Since Aug. 21, spot Ether ETFs have seen a whopping $1.83 billion in inflows, while Bitcoin funds took only a 10th of that with $171 million, according to CoinGlass. 

The latest trading day on Wednesday continued the trend, with nine Ether funds reaching $310.3 million in inflows, while the 11 spot Bitcoin funds saw just $81.1 million. 

Ether has recovered faster than Bitcoin this week, with ETH prices climbing 5% from their Tuesday low, whereas Bitcoin only managed to gain 2.8% over the same period. 

As CoinTelegraph's Martin Young reports, the massive shift to Ether was not missed by industry observers such as Ethereum educator and investor Anthony Sassano, who described it as “brutal.” 

Source: Anthony Sassano

Meanwhile, NovaDius Wealth Management president Nate Geraci added that spot Ether ETFs are now close to $10 billion in inflows since the start of July.

Spot Ether ETFs have been trading for 13 months and have seen $13.6 billion in total aggregate inflows, the majority of which has come in the last couple of months.

Spot Bitcoin ETFs have been around longer, trading for 20 months with an aggregate AUM of $54BN. However, just looking at the largest BTC ETF (IBIT), we can see it is rapidly catching up with the total AUM of the Gold ETF GLD...

 

The Wall Street token

The momentum has seemingly been shifting to Ethereum following the passing of the GENIUS Act stablecoin legislation in July, as the network has the largest market share of stablecoins and tokenized real-world assets. 

“It’s very much what I call the Wall Street token,” said VanEck CEO Jan van Eck, speaking on Fox Business this week. 

Meanwhile, Bloomberg ETF analyst James Seyffart reported that investment advisers were the top holders of Ether ETFs with $1.3 billion in exposure.

According to SEC filings, Goldman Sachs is the top holder with $712 million in exposure. 

https://www.zerohedge.com/crypto/ether-etfs-capture-10x-more-inflows-bitcoin-last-5-days

US Natural Gas Consumption To Hit New Record In 2025

 by Naveen Athrappully via The Epoch Times,

Natural gas consumption in the United States is forecast to increase 1 percent and set a record of 91.4 billion cubic feet per day (Bcf/d) on average in 2025, according to an Aug. 25 statement from the Energy Information Administration (EIA).

The EIA expects “natural gas consumption to increase across all sectors except for electric power, which had been the source of most natural gas consumption growth in the previous decade” in its latest Short-Term Energy Outlook report.

At the start of 2025, natural gas consumption hit a record of 126.8 Bcf/d, which is 5 percent more than in January 2024.

Consumption typically peaks in the colder months of January and February when demand for residential and commercial heating is highest.

“Natural gas remains the most prevalent source of electricity generation in the United States, but so far in 2025 natural gas has lost market share in the electric power sector to coal, solar, and wind,” said the EIA.

According to EIA numbers, gas accounted for a 40 percent share of U.S. electricity generation, with coal making up 17 percent, renewables 24 percent, and nuclear 18 percent in 2025. Two years back, natural gas made up 42 percent, and renewables 22 percent.

Electricity demand growth is expected to rise about 3 percent in 2025 and 4.5 percent in 2026, owing to the expansion of new data centers and artificial intelligence (AI) infrastructure in the country.

AI industry leaders such as Google are turning to nuclear reactors as part of their efforts to ensure energy sufficiency.

Energy consumption increases coincide with higher prices for end users, along with grid stability concerns.

American Energy Usage

The EIA forecasted in a May 14 statement that residential electricity prices this year are expected to rise by 13 percent from 2022 prices.

“Parts of the country with relatively high electricity prices may experience greater price increases than those with relatively low electricity prices,” the EIA stated.

In a June 12 report, the North American Electric Reliability Corp (NERC) warned that large data centers pose a “significant near-term reliability challenge” for the U.S. power grid stability.

The Trump administration has promoted the discovery and usage of natural gas in the country as part of ensuring the generation of reliable and affordable electricity.

In a Jan. 20 executive order, President Donald Trump directed all agencies to remove unnecessary regulatory burdens on energy sources such as natural gas and expand their exploration.

Stemming from the One Big Beautiful Bill Act, the Department of the Interior (DOI) unveiled a long-term schedule for at least 30 offshore oil and gas lease sales in the Gulf of America, which will account for roughly 14–15 percent of U.S. crude oil production and offshore energy output, according to an Aug. 19 press release.

“The One Big Beautiful Bill Act is a landmark step toward unleashing America’s energy potential,” said Interior Secretary Doug Burgum.

“Under President Trump’s leadership, we’re putting in place a bold, long-term program that strengthens American Energy Dominance, creates good-paying jobs and ensures we continue to responsibly develop our offshore resources.”

The department is also removing some of the regulatory hurdles in energy generation to lower costs.

“Under the One Big Beautiful Bill Act, Bureau of Safety and Environmental Enforcement ... must approve commingling requests unless safety or resource recovery would be harmed,” said an Aug. 22 report from the DOI.

“Downhole commingling is the production of oil or natural gas from multiple reservoirs through a single well. The process allows for more efficient and cost-effective production.”

Environmental group Sierra Club criticized the administration for reversing the prior administration’s focus on renewable energy sources such as wind and solar and shifting toward conventional sources like gas and oil. Holly Bender, chief program officer at the organization, said energy prices are going up because of the Trump administration’s “pro-fossil fuel policies.”

https://www.zerohedge.com/energy/us-natural-gas-consumption-hit-new-record-2025

Antivaccine Voices Topple Italy’s Vaccine Advisory Panel

 Italy is likely to remain without a NITAG for some time — potentially for the duration of the current government. The Italian Ministry of Health’s attempt to renew the composition of the independent vaccination advisory group, originally appointed in September 2021 and expired about a year ago, has failed. Italy’s Health Minister, Orazio Schillaci, was forced to dissolve the group just over a week after issuing the appointment decree, following a public outcry over at least two nominees whose antivaccine positions were deemed unacceptable by much of the medical and scientific community.

Strong Opposition

Calls for the minister to revoke his appointments came from diverse but united voices demanding a firm stance: from the Italian National Federation of Orders of Surgeons and Dentists to several scientific societies — including the Italian Society of Hygiene, Preventive Medicine, and Public Health; the Italian Society of Pediatrics; and the Italian Society of Neonatology — as well as associations such as the Italian Committee for the Investigation of Claims on Pseudoscience and the Transversal Pact for Science, which collected over 35,000 signatures. Numerous experts, science communicators, and journalists also spoke out personally, including myself.

Francesca Russo, head of interregional prevention coordination at the Health Commission of the Conference of Regions and Autonomous Provinces, declined the appointment following an assessment of the group’s composition, which includes members who, in the past, have repeatedly publicly expressed positions inconsistent with scientific evidence on vaccinations, in some cases promoting messages contrary to national vaccination strategies. Even The BMJ reported the news with concern.

The dispute also reflects tensions within Italy’s governing majority. Prime Minister Giorgia Meloni expressed irritation at Schillaci’s reversal, which was criticized by some members of Fratelli d’Italia (Brothers of Italy, Meloni’s right-wing party) and the Lega (a right-wing populist party), who had pushed for the inclusion of individuals with critical views on vaccines in the name of pluralism and freedom of debate. Forza Italia, a center-right party founded by former Prime Minister Silvio Berlusconi, praised the minister’s decision to backtrack and reaffirm his confidence — as a physician — in these essential preventive measures.

Some observers speculated, and others feared, that the minister might resign over the issue, opening a highly coveted post. Instead, in a last-minute move described as choosing the lesser evil, Schillaci dissolved the entire NITAG, a body recommended by the World Health Organization but which has never significantly influenced vaccination campaign decisions in Italy.

The episode dominated Italian news during Ferragosto, the national mid‑August holiday when much of the country is on vacation, for those following prevention, public health, and the delicate interface between science and politics.

Among the 22 technical experts selected to advise the ministry on vaccination policy were Paolo Bellavite, a retired professor of general pathology at the University of Padua, and Eugenio Serravalle, a Tuscan pediatrician specializing in homeopathy. Both are influential figures among Italians with vaccine concerns. For those studying vaccine hesitancy and antivaccine movements in Italy, the appointments initially seemed almost like a dark joke. But the decree was signed, and within hours the news was confirmed. Whether a political maneuver or an oversight, it raised serious questions, even though the minister has consistently affirmed his support for vaccines.

Vaccines and Anti-Vax Sentiment

Bellavite and Serravalle do not identify as antivaccine — a label they find offensive — but their skeptical positions, expressed in books, public appearances, and social media, resonate strongly with those who refuse to vaccinate their children. What both frame as freedom of debate and opinion on vaccines often concludes with a categorical assessment against the risk-benefit profile of vaccines, even when scientific evidence strongly supports the opposite.

According to some tweets by Bellavite, the magic serum kills because it intoxicates and overstimulates the body's reactions; inoculating children with 10 useless and harmful vaccines should be a crime; and it's better to risk measles than the vaccine.

Serravalle is a founder of the Italian Coordination Movement for Vaccination Freedom and president of the Association for Health Studies and Information, two major Italian organizations around which dissent revolves. While these movements claim to oppose mandatory vaccination — an issue open to legitimate debate — they also buy advertising and disseminate online content questioning vaccine safety and utility.

Among Serravalle’s recent publications is a claim linking mRNA COVID-19 vaccines to increased childhood cancers — unsupported by Italian data. According to the 2024 report I Numeri del Cancro, by the Italian Association of Medical Oncology, data extend only through 2021, and projections do not indicate warning signs. Serravalle cited rising US cancer diagnoses after 2021, linking them to COVID-19 vaccination. If vaccines were truly the causal factor, a similar or stronger effect would be expected in Italy, where vaccination coverage has been more comprehensive than in many US regions. Therefore, other factors are probably responsible.

A Problem Across the Atlantic

Concerns about mRNA products — also contradicted by data from millions of people — are shared by US Health and Human Services Secretary Robert F. Kennedy, Jr, known for promoting vaccine misinformation, including false links between measles vaccines and autism. Kennedy has even withdrawn government support for research into new infectious disease vaccines using mRNA technology, which Serravalle also believes should be regulated under gene therapy laws. The alignment between the two is reinforced by Serravalle having signed the introduction to the Italian edition of Kennedy's book, Vax-Unvax: Let the Science Speak. Across 288 pages, the book omits the long-established scientific conclusion: Vaccinated children are much healthier than unvaccinated children.

Serravalle has also coauthored books with Roberto Gava, a physician expelled from the Italian medical registry, questioning vaccination in their titles: Vaccinare contro il tetano? and Vaccinare contro il Papillomavirus?

For those familiar with vaccine safety, efficacy, and the consequences of preventable diseases, the answer is clear: Vaccination is essential. Yet, Bellavite and Serravalle continue to stoke parental doubts and fears. As someone who has at times expressed cautious or critical positions — particularly regarding mandatory vaccination during the pandemic — I want to be clear: Citizens can only make truly informed choices for themselves and their children if they have access to accurate information. Confusing them with fear and doubt undermines any notion of empowerment.

The turmoil unfolding in Rome this August is not just about ideologic clashes or political maneuvering for positions, votes, or influence. It reflects a broader, persistent challenge in Italy: the complex relationship between science and politics. As often happens in any system, cooperation becomes difficult when roles and responsibilities are unclear.

This tension was evident during the COVID‑19 pandemic. Politicians demanded certainty from scientists and grew frustrated when epidemiologic models produced unexpected results. Meanwhile, technical experts were accused of ignoring political realities, and politicians were criticized for deferring decisions to scientists.

In areas requiring technical or scientific judgment, truly independent advisory committees are essential to provide evidence that political authorities can responsibly act upon. Achieving this, however, requires reform in how such bodies are appointed — currently, political authorities control the selection — and a reconsideration of their mandate.

Many opponents of the previous NITAG, as well as Schillaci in his dissolution statement, have advocated for a committee that represents all relevant stakeholders. The Italian Ministry of Health emphasized the importance of initiating a new appointment procedure for NITAG members to involve all relevant categories and stakeholders.

Yet, this approach runs counter to NITAG’s original purpose: to provide independent scientific expertise to inform policy, free from competing interests. Because the primary focus — protecting public health — is often overshadowed by stakeholder conflicts, achieving a concrete, evidence-based solution is likely to remain difficult.

https://www.medscape.com/viewarticle/antivaccine-voices-topple-italys-vaccine-advisory-panel-2025a1000mon

Gene Therapy 'Transformed Lives' for Patients With Blood Disorders

 

  • Exagamglogene autotemcel resulted in significant improvements in quality of life for patients with severe sickle cell disease or transfusion-dependent beta-thalassemia.
  • Patients reported clinically meaningful improvements in overall quality of life, including physical, social/family, functional, and emotional well-being.
  • The gene therapy was previously shown to reduce vaso-occlusive crises in sickle cell disease, and lead to transfusion independence in beta-thalassemia.

Treatment with the gene therapy exagamglogene autotemcel (exa-cel; Casgevy) led to significant improvements in quality of life for patients with severe sickle cell disease or transfusion-dependent beta-thalassemia, data from two phase III trials showed.

Patients with sickle cell diseaseopens in a new tab or window and transfusion-dependent beta-thalassemiaopens in a new tab or window reported clinically meaningful improvements in overall quality of life, including physical, social/family, functional, and emotional well-being, with these improvements beginning as early as 6 months following exa-cel infusion, as noted in the two studies that were published in Blood Advances.

"This treatment has transformed lives and its impact was evident as we followed up with patients in our clinic," said Haydar Frangoul, MD, of the Sarah Cannon Research Institute and TriStar Centennial Children's Hospital in Nashville, Tennessee, who was an author on both studies, in a press releaseopens in a new tab or window. "Patients are returning to school, back to work, and overall spending more time with their families and less time in the hospital. It's a powerful example of how clinical research drives real-world impact."

A prespecified interim analysis of the sickle cell disease trial, known as CLIMB SCD-121opens in a new tab or window, showed that exa-cel, a one-time ex vivo CRISPR/Cas9 gene-edited cell therapy, eliminated vaso-occlusive crises in 97% of participants with severe sickle cell disease. These results led to exa-cel's FDA approval in December 2023opens in a new tab or window for patients ages 12 and older with sickle cell disease.

The next month, the FDA expanded exa-cel's approvalopens in a new tab or window to include patients ages 12 and older with transfusion-dependent beta thalassemia. A prespecified interim analysis of the CLIMB THAL-111opens in a new tab or window trial showed that among 54 evaluable patients (those with at least 16 months of follow-up), 53 achieved transfusion independence for at least 12 consecutive months with a weighted average hemoglobin of at least 9 g/dL.

Participants who completed the CLIMB SCD-121 and CLIMB THAL-111 trials were offered to enroll in the 13-year extension study CLIMB-131opens in a new tab or window.

Sickle Cell Disease

Using three quality-of-life assessments and one pain scale for 30 adult patients, and two quality-of-life assessments along with one pain scale for 12 adolescents, Frangoul and colleagues reported that scores across all domains surpassed thresholds for minimal clinically important differences after exa-cell infusion.

For adults, the ASCQ-Me quality-of-life scale -- designed to assess multiple domains of health-related quality of life in adults with sickle cell disease -- showed improvements at 36 months, including:

  • Pain impact (mean change from baseline 8.1 points)
  • Emotional impact (8.5 points)
  • Social functioning impact (16.5 points)
  • Stiffness impact (5.1 points)
  • Sleep impact (5.7 points)
  • Pain episode frequency (-21.0 points)
  • Pain episode severity (-5.1 points)

For adolescent patients, the mean change from baseline in PedsQL total score (a measure of health-related quality of life in children or adolescents with chronic diseases) was 23 points by month 6, which was maintained through month 24, with improvements seen across all subcomponents and subscales, including school functioning (+45.0 points), social functioning (+18.3 points), and emotional functioning (+16.7 points).

"Taken together, these results, which represent the largest patient-reported outcome dataset for patients with sickle cell disease following hematopoietic stem cell transplantation or gene therapy, show exa-cel infusion leads to clinically meaningful improvements in quality of life in patients with severe [disease]," Frangoul and colleagues wrote.

Transfusion-Dependent Beta-Thalassemia

Using the EuroQol Quality of Life Scale-5 dimensions-5 levels of severity (EQ-5D-5L) -- a quantitative measure of overall health through five dimensions of health and ability, adults had a mean score improvement of 14.0 points from a baseline of 82.2 at 48 months after exa-cel infusion, reported Franco Locatelli, MD, PhD, of the IRCCS Ospedale Pediatrico Bambino Gesù in Rome, and colleagues.

For adolescents, the baseline score at infusion was 81.3, with a mean score improvement of 6.1 points at month 24.

For both adults and adolescents, treatment with exa-cel led to clinically meaningful improvements and surpassed thresholds for minimal clinically important differences.

All participants also reported less fatigue following exa-cel infusion.

Disclosures

The CLIMB trials were sponsored by Vertex Pharmaceuticals.

Frangoul has received consulting fees from Vertex Pharmaceuticals, Editas Medicine, and Rocket Pharmaceuticals; honoraria from Jazz Pharmaceuticals; advisory fees from Rocket Pharmaceuticals; and served in a leadership or fiduciary position for Vertex Pharmaceuticals.

Locatelli is on the advisory board for Amgen, Neovii, Novartis, Sanofi, and Vertex, and the speaker's bureau for Amgen, Bluebird Bio, Gilead, Jazz Pharmaceuticals, Medac, Miltenyi, Neovii, Novartis, and SOBI.

Co-authors reported multiple relationships with industry.

Menopause Is Not a Disability — Why Rhode Island's new law misses the mark

 When I went through perimenopause, I experienced many of the symptoms that countless women report: insomnia that left me exhausted, weight gain that felt out of my control, and brain fog that made it harder to stay sharp at work. These were not minor inconveniences -- they were disruptive, daily challenges. But what I needed was treatment, not workplace accommodation. With the right medical care, my symptoms became manageable, and I was able to continue working productively in the prime of my career.

That's why I worry about Rhode Island's new lawopens in a new tab or window requiring employers to provide "reasonable accommodations" for menopause symptoms. The law goes beyond simply barring discrimination; it obligates employers to treat menopause as a condition akin to disability. Most concerning, the statute requires employees to notify their employer that they are experiencing menopause or related conditions in order to access accommodations, and requires the employer to provide a written notice of rights within 10 days of that disclosure.

While this may sound like progress, it sets a dangerous precedent.

Every woman will experience menopause -- this is not a niche issue. Symptoms can persist for a decade or moreopens in a new tab or window, often overlapping with women's most important leadership and career years. By folding menopause into frameworks designed for disabilities, we risk creating the very bias we seek to eliminate. Employers may see women in their 40s and 50s as "burdens" requiring special accommodations, just as these women are stepping into their most experienced and productive roles.

Perhaps most concerning, the law effectively requires women to disclose deeply personal health information to their employers in order to request accommodations. This means a woman struggling with hot flashes, insomnia, or brain fog may need to sit down with her manager or human resources representative and explicitly say she is going through menopause. That disclosure is not benign -- it risks reinforcing stereotypes about women being less capable, and it could subtly or explicitly influence hiring, promotions, and leadership opportunities, despite the law barring discrimination.

Research underscores the stubbornness of workplace bias. A 2022 Harvard Business Review studyopens in a new tab or window found that when participants were told that a woman's symptoms were due to menopause -- but explained by a colleague rather than the woman herself -- they still rated her as less leader-like, even though they knew the symptoms' cause. The takeaway: simply educating others about menopause does not erase bias, and disclosure often backfires unless it is fully in a woman's own control. Requiring women to "out" themselves to employers risks entrenching, not dismantling, workplace stigma.

This approach also pathologizes instead of treats. The core problem is not that women need special workplace carve-outs -- it's that they are not getting the medical care they need. Only around 5%opens in a new tab or window of U.S. women take hormone therapy, even though it is regarded as the most effective treatmentopens in a new tab or window for most. For women who cannot take hormones -- due to breast cancer or other conditions -- effective non-hormonal medicationsopens in a new tab or window exist, from selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) to gabapentin (Neurontin) and fezolinetant (Veozah). With proper treatment, the vast majority of women are able to thrive in their careers.

The stakes are high. Research shows that nearly 11% of womenopens in a new tab or window reported missing work due to menopause symptoms and 13% reported at least one adverse work outcome. This is generally not because employers fail to offer accommodations, but because women lack access to appropriate care. The result is a silent talent drain at a time when businesses can least afford to lose skilled, experienced leaders.

The solution lies in access to care, education, and inclusive workplace cultures -- not in labeling menopause as a disability. Employers can support all employees with flexible policies, comprehensive health coverage, and open acknowledgment that menopause is a normal stage of life. The healthcare system must do its part by training clinicians and expanding access to evidence-based treatments.

Women navigating menopause are not broken; the systems around them are. With the right care, we can sleep better, think clearly, and continue to contribute at the highest levels. I know this personally -- I lived it. That's why we must be careful not to turn menopause into a legal disability when the real solution is already in our hands: better healthcare, not workplace accommodations.

Joanna Strober, JD,opens in a new tab or window is CEO of Midi Health, the largest virtual-care platform for women in perimenopause and menopause covered by insurance. She has been recognized by the 2025 Time Healthcare 100 list, Forbes50over50, CNBC Changemakers, and more.

https://www.medpagetoday.com/opinion/second-opinions/117179

Can a Keto Diet be the GLP-1 of Psychiatry?

 Glucagon-like peptide-1 (GLP-1) agonist medications such as semaglutide (Ozempic, Wegovy) and tirzepatide (Zepbound, Mounjaro) have taken the world by storm over the past few years. People are losing tremendous amounts of weight and improving certain chronic medical conditions when all else has failed to help. Yet, it was an accident that GLP-1s were rediscovered as a tool

opens in a new tab or window for weight loss.

We have had GLP-1 medications on the market for a long time now, such as in the form of liraglutide (Saxenda). Liraglutide was first approved by the FDA in 2010 to improve blood glucose in patients with type 2 diabetes, but studies of the drug hinted at the weight loss potential offered by GLP-1s via its 5 and 10% weight lossopens in a new tab or window compared with placebo. However, only more recently was that potential taken seriously as an intervention in and of itself. Today, GLP-1s are seen as a game-changer for the world's growing obesity problem.

This brings us to the ketogenic, or "keto" diet, which has traditionally been used for weight loss and fitnessopens in a new tab or window. It has taken the health and fitness sector by storm in waves over the years, and routinely stirs controversyopens in a new tab or window. The keto diet is highest in fats, moderate in protein, and extremely low in carbohydrates. While exact amounts of each macronutrient can differ and there are multiple variations, a general rule is to keep carbohydrate intake extremely low (as low as 20 grams of net carbohydrate intakeopens in a new tab or window daily in some cases).

What is less well-known are the promising results of the keto diet in the medical literature across a variety of specialties. Beyond its effectiveness in weight loss, it has also shown risk reduction benefits for heart health, canceropens in a new tab or window, and even epilepsy. Even less well known is that in psychiatry, there is emerging research showing its impact on schizophrenia and bipolar disorderopens in a new tab or window, and more recently in obsessive-compulsive disorderopens in a new tab or window. Remarkably, some patients even claim the diet has brought to complete remissionopens in a new tab or window cases of the most treatment-resistant psychiatric conditions -- a claim actively sought by pharmaceutical companies for their drugs.

One case series showed success of the ketogenic diet for patients with a serious treatment-resistant psychiatric condition: anorexia nervosa. This is a condition in which patients will restrict eating for prolonged periods of time, which leads to it being the deadliest psychiatric conditionopens in a new tab or window. Patients with severe anorexia nervosa can routinely spend years pursuing treatments in inpatient medical and psychiatric units, eating disorder-specific units, structured outpatient group programs for eating disorders, and outpatient care with multiple individual specialists from various specialties, including psychiatry and adolescent medicine.

Published in the Journal of Metabolic Healthopens in a new tab or window, the case series follows three patients with anorexia nervosa who developed sustained improvements in their condition over the course of multiple years after starting the keto diet intervention. Over 1, 2, and 5 years, these three patients each ultimately gained at least 20 kilograms (about 44 pounds) of weight, with sustained weight restoration over those time frames. It is important to note that these were severe, treatment-resistant cases -- they suffered with anorexia for many years, and because of their conditions, these patients had developed multiple medical problems that directly resulted from food restriction, including osteoporosis, hypogonadism, and multiple organ prolapses treated with surgical interventions.

As a psychiatry resident, I am naturally fascinated by this promising potential of the keto diet. This may be a true disease-modifying interventionopens in a new tab or window -- perhaps comparable to the likes of a medication such as lithium for bipolar disorderopens in a new tab or window. Despite this, keto has long been overlooked.

So, how does it work? Theories point toopens in a new tab or window ketones' effects in improving the health and functioningopens in a new tab or window of mitochondriaopens in a new tab or window, brain neural energy metabolism, and immune response throughout the body.

However, we will need more than case reports and series in order to determine true efficacyopens in a new tab or window and for this intervention to gain traction. Some groups are already working on clinical trialsopens in a new tab or window.

I believe the keto diet has the potential to become one of the most serious breakthrough treatments in psychiatry. It could entirely redefine psychiatric "treatment-resistance" as we know it. Of course, there are certainly weaknesses to the keto diet, such as with stigma, lifestyle change, and long-term adherence -- especially within populations that face significant socioeconomic barriers. But I believe the keto diet can completely change lives if it were to be adopted more readilyopens in a new tab or window in psychiatric practice.

It is only a matter of time before the keto diet takes the world by storm as GLP-1s recently have, to potentially spur a new revolution as the "Ozempic" or "Zepbound" of psychiatry.

Zane Kaleem, MD,opens in a new tab or window is a fourth-year psychiatry resident at Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania. 

https://www.medpagetoday.com/opinion/second-opinions/117199

Prothena’s Alzheimer’s Drug Comes With Familiar Side Effect in Phase I

 

In another blow to Prothena’s neurodegenerative disease portfolio, anti-amyloid candidate PRX012 has run into the same problem that larger peers Biogen and Eli Lilly have battled: high rates of swelling in the brain.

Following the May failure of AL amyloidosis drug birtamimab, Prothena is facing more bad news for its Alzheimer’s porfolio. Like Biogen and Eli Lilly have seen with their approved anti-amyloid antibodies, Prothena’s anti-amyloid beta therapy PRX012 elicited high rates of amyloid-related imaging abnormality edema (ARIA-E), or swelling in the brain, in the Phase I ASCENT trials.

While the trio of studies showed proof of concept for PRX012 with dose dependent reductions in amyloid plaque observed, the results revealed “a non-competitive ARIA-E profile,” Prothena said in a Wednesday afternoon release.

Both ARIA-E and ARIA-H, or small brain bleeds, became key concerns as Biogen and Eisai’s Leqembi and Lilly’s Kisunla reached the market.

Heading into the readout, Jefferies analyst Michael Yee was “cautious at best given [the] high bar from current drugs Leqembi and [Kisunla],” according to a June note. Prothena’s shares have declined 61% year to date, with a slight dip as the markets opened Thursday. The stock is sitting at $8.30.

The news marks the second stumble for Prothena this year after birtamimab failed to improve all-cause mortality in patients with AL amyloidosis in a Phase III trial. The failure pushed Prothena into crisis mode, with the board promising to slash spending and consider business options that are in the best interest of shareholders. Birtamimab was discontinued.

In June, Prothena announced a restructuring that saw a 63% reduction in its workforce to support the wholly owned programs.

Next Steps

Prothena said the ASCENT studies, which featured those with early symptomatic Alzheimer’s, showed higher rates of ARIA-E as compared to approved amyloid drugs. Therefore, PRX012 is “less appropriate” for the patients in the ASCENT program, who were at the early stages of their disease.

Overall rates of ARIA ranged from 16% in the low dose group to 42% in the highest dose, compared to 7% in the placebo arm. ARIA-E had the highest percentage, ranging from 12% to 42%.

The biotech will now seek a partner for the program and turn its attention to a preclinical wholly owned Aβ-transferrin receptor antibody surrogate, PRX123.

“Prothena believes this approach may represent an opportunity to significantly lower the risk of ARIA and quickly reduce amyloid plaque with a once-monthly subcutaneous administration,” the company said in a statement.

Yee noted in June that Prothena had already indicated a desire to partner the PRX012 program given the high cost of capital. But the mixed results in the Phase I trial put the program’s future up in the air.

PRX012 was one of Prothena’s two wholly owned programs besides PRX123. The rest of the biotech’s portfolio includes multiple neurodegenerative programs with Bristol Myers Squibb, a Parkinson’s disease program with Roche and an ATTR amyloidosis therapy with Novo Nordisk. The latter two are in the Big Pharmas’ hands to initiate Phase III development.

https://www.biospace.com/drug-development/prothenas-alzheimers-drug-comes-with-familiar-side-effect-in-phase-i-test