Wave Crashes Despite Successful RNA Editing in AATD Study

 

Wave’s RNA editor resulted in protein levels that were “exceedingly close” to what investors were expecting, but nevertheless fell short of that bar, according to analysts at Truist Securities.

Wave Life Sciences’ investigational RNA editor WVE-006 boosted levels of a target protein in an early-stage study of alpha-1antitrypsin deficiency—but the magnitude of its benefits left investors underwhelmed.

In a Phase Ib/IIa trial using repeat injections of 200 mg WVE-006—the lower dose the biotech tested, the other being 400 mg—the treatment resulted in 11.9uM of alpha-1 antitrypsin (AAT) protein, which Wave deemed “therapeutically relevant.”

In a Wednesday morning note, however, analysts at Truist Securities said the firm and investors it had consulted were hoping for a total AAT of greater than 12uM.

WVE-006’s results are “exceedingly close” to what investors had hoped for, Truist analysts wrote, adding that the 400-mg dose of the RNA editor “could drive total AAT well into the 13uM+ range based on SAD [single-ascending dose] data.” Wave on Wednesday reported that at 400 mg, a single dose of WVE-006 achieved 12.8 uM total AAT.

Though the trial regimen has ended for patients in the 200 mg dose, Wave continues to treat patients in the 400 mg multidose cohort with a monthly schedule. Data from this cohort are expected in the first quarter of 2026.

Shares of Wave dipped 16.8% at market close on Wednesday, trading at $8.00.

In its own note on Wednesday morning, analysts at William Blair took a broader view of Wave’s findings, writing that these data suggest that “oligonucleotide therapies for RNA editing are an applicable therapeutic modality to human diseases.” Other companies taking a similar approach to Wave, the analysts continued, could benefit from this.

In particular, the William Blair analysts wrote that Wave’s data update could pose a “best-of-both-worlds-scenario” for Korro Bio, which is advancing KRRO-110 for AATD, currently being evaluated in the Phase I/IIa REWRITE trial. “We see room for Korro, with best-in-class preclinical editing data,” the analysts wrote. The biotech was priced at $26.04 at market close on Wednesday, representing a 17% increase day-on-day.

Also benefiting from Wave’s readout is Beam Therapeutics, though its AATD aspirant BEAM-302 is an irreversible RNA editor—as opposed to WVE-006’s reversible mechanism—making it a less direct comparator to Wave’s asset. Still, the biotech jumped 15% on Wednesday and hit $18.76 at market close.

AATD is a genetic disorder stemming from a lack of alpha-1-antitrypsin protein and resulting in liver and lung conditions. Jaundice, cirrhosis, shortness of breath, wheezing as well as chronic obstructive pulmonary disease are common symptoms and related conditions.

https://www.biospace.com/drug-development/wave-crashes-despite-successful-rna-editing-in-aatd-study

Microsoft White House's AI Education Task Force new initiative

 Today, at the White House’s AI Education Task Force meeting, Microsoft announced a sweeping set of new commitments to support the Presidential AI Challenge and the AI Education Executive Order, marking a major step forward in bringing cutting-edge AI tools and training to classrooms across the US. 

Microsoft Chairman and CEO Satya Nadella joined the meeting and outlined our commitments to empower teachers and students, build AI skills, and create economic opportunity in a video.

YouTube Video

We believe delivering on the real promise of AI depends on how broadly it’s diffused. This requires investment and innovation in AI education, training, and job certification. We applaud the leadership of the First Lady and the White House’s AI Education Task Force. They’re helping to forge a national AI education strategy and partnering with companies across the tech sector and business community. 

As we think about this national priority, we think it comes down to three things.  

First, empowering teachers and students with the latest AI tools.  

Second, building AI skills. With AI moving faster than any technology in history, the only way to keep up is learning by doing and getting recognized for it.   

Third, creating economic opportunity by connecting these new skills to jobs. Every American should be able to showcase their AI skills and credentials to find new jobs and grow their career.  

Here’s what’s coming from Microsoft:  

• Free Copilot in Microsoft 365 for college students. Today, we are making Microsoft 365 Personal free for 12 months to every college student in the United States. This includes all students attending community colleges. Microsoft 365 Personal includes Word, Excel, PowerPoint, OneNote, and Outlook with Copilot, our AI assistant, built right in. College students can sign up to access this free offer beginning today through October 31, 2025 (valid university email address required). Learn more.  

• Expanded access to our AI tools in schools. Microsoft Elevate will soon build on today’s announcement with expanded access to Copilot to students and teachers in schools, keeping an eye on providing the right tools and education in a safe and age-appropriate manner. 

• $1.25 million in educator grants. To celebrate and elevate outstanding teachers, Microsoft Elevate is funding $1.25 million in prizes through the Presidential AI Challenge—recognizing top educators in every state who are leading the way in AI-powered learning.  

• Free LinkedIn Learning AI courses for students and teachers. We’re unlocking free access to LinkedIn Learning courses for teachers and students that guide learners from foundational AI concepts to advanced skills—culminating in LinkedIn certifications that can be added to profiles to boost resumes and open doors to future careers.  

• AI training for job seekers and certifications for community colleges. Through new and expanded partnerships with the American Association of Community Colleges and the National Applied AI Consortium, Microsoft Elevate will sponsor no-cost AI training and certifications for faculty and staff, who serve more than 10 million students nationwide, and is providing grants to more than 30 Community Colleges across 28 states to create a community of practice AI peer learning program. Faculty and staff can sign up for training at NAAIC. 

• Free LinkedIn Learning AI courses for job seekers. With 70% of AI-related skills expected to shift by 2030, Microsoft will also launch almost 100 AI courses in 15 new LinkedIn Learning paths and host a nationwide AI Learning Challenge to help job seekers build in-demand skills and address the critical skills gap facing today’s workforce. Starting September 29, LinkedIn Learning will host an AI Learning Challenge offering 5 days of intensive, free AI education featuring expert instructors and a list of top AI voices to follow to continue learning every day.

Together, these initiatives represent a powerful investment in America’s future—ensuring that students, teachers, and job seekers across the country have the tools to thrive in the age of AI. 

https://blogs.microsoft.com/on-the-issues/2025/09/04/new-white-house-commitments/

'West Coast States Form Health Alliance in Rebuke of Trump Admin'

 The Democratic governors of Washington, Oregon, and California announced Wednesday that they created an alliance to safeguard health policies, believing the Trump administration is putting Americans' health and safety at risk by politicizing

opens in a new tab or window the CDC.

The move comes with COVID-19 cases rising and as Health Secretary Robert F. Kennedy Jr. has restructured and downsizedopens in a new tab or window the CDC and attempted to advance anti-vaccine policiesopens in a new tab or window that are contradicted by decades of scientific research. Concerns about staffing and budget cuts were heightened after the White House sought to oustopens in a new tab or window the agency's director and some top CDC leaders resigned in protestopens in a new tab or window.

"The CDC has become a political tool that increasingly peddles ideology instead of science, ideology that will lead to severe health consequences," the governors said in a joint statement.

"The dismantling of public health and dismissal of experienced and respected health leaders and advisors, along with the lack of using science, data, and evidence to improve our nation's health are placing lives at risk," California State Health Officer Erica Pan, MD, MPH, said in the news release.

Washington state Health Secretary Dennis Worsham said public health is about prevention -- "preventing illness, preventing the spread of disease, and preventing early, avoidable deaths."

"Vaccines are among the most powerful tools in modern medicine; they have indisputably saved millions of lives," Oregon Health Director Sejal Hathi, MD, MBA, said. "But when guidance about their use becomes inconsistent or politicized, it undermines public trust at precisely the moment we need it most."

Partnership Seeks Expert Medical Advice

The partnership plans to coordinate health guidelines by aligning immunization plans based on recommendations from respected national medical organizations, said a joint statement from Gov. Bob Ferguson of Washington, Gov. Tina Kotek of Oregon, and Gov. Gavin Newsom of California.

HHS spokesman Andrew Nixon shot back in a statement Wednesday that "Democrat-run states that pushed unscientific school lockdowns, toddler mask mandates, and draconian vaccine passports during the COVID era completely eroded the American people's trust in public health agencies."

He said the administration's Advisory Committee on Immunization Practices "remains the scientific body guiding immunization recommendations in this country, and HHS will ensure policy is based on rigorous evidence and Gold Standard Science, not the failed politics of the pandemic."

Florida announced Wednesday that it plans to phase out all childhood vaccine mandatesopens in a new tab or window.

Public Health Agencies Across Nation Start Vaccine Efforts

Meanwhile, public health agencies across the country have started taking steps to ensure their states have access to vaccines after U.S. regulators came out with new policiesopens in a new tab or window that limited access to COVID-19 shotsopens in a new tab or window.

Illinois Gov. JB Pritzker's (D) health department said last week it is seeking advice from medical experts and its own Immunization Advisory Committee on COVID-19 vaccines and other immunizations for the fall respiratory season.

The health department plans to provide citizens "with specific guidance by the end of September to help Illinois healthcare providers and residents make informed decisions about vaccination and protecting themselves and their loved ones," Health Director Sameer Vohra, MD, JD, said in a statement.

The New Mexico Department of Health said it would work with the state's Board of Pharmacy to remove barriers and allow access to COVID vaccines at pharmacies across the state.

"It's important for New Mexicans to know the New Mexico Department of Health is committed to keeping residents safe as we enter the 2025-2026 respiratory virus season," Health Secretary Gina DeBlassie said in a statement. "This order will remove obstacles to vaccination access."

Last month, public officials from eight Northeast states met in Rhode Island to discuss coordinating vaccine recommendations. The group included all the New England states except for New Hampshire, as well as New York, New Jersey, and Pennsylvania.

Massachusetts Gov. Maura Healey (D), who has been critical of federal cuts to public health funding and restrictions on vaccines, said her state was leading the bipartisan coalition.

"We're going to make sure that people get the vaccines they need -- no matter what the Trump Administration does," she said in a statement.

A spokesperson for the Connecticut Department of Public Health said Wednesday that cross-border meetings "are nothing new."

"Public health challenges extend beyond state lines, making collaboration essential for effective response and prevention efforts," the agency said in a statement. Last month's meetings allowed the states to "share numerous public health best strategies to meet the needs of our states at a time of federal health restructuring and cuts."

States Have Come Together Before

The West Coast alliance isn't the first time Democratic-led states have banded together to coordinate policies related to public health.

In the first months of the coronavirus pandemic, states formed regional alliances to gain buying poweropens in a new tab or window for respirators, gloves, and other personal protective equipment for front-line workers and to coordinate reopeningopens in a new tab or window their largely shuttered economies.

Governors in the Northeast and West Coast -- all but one of them Democrats -- announced separate regional groups in 2020 hours after Trump said on social media that it would be his decision when to "open up the states."

https://www.medpagetoday.com/publichealthpolicy/publichealth/117289

Psychosis and Bipolar in Attention-Deficit/Hyperactivity Disorder Treated With Stimulants

 

Gonzalo Salazar de Pablo, PhD1,2,3; Claudia Aymerich, PhD1,4; Juan Pablo Chart-Pascual, MD1,5
et al

Key Points

Question  What is the occurrence of psychosis or bipolar disorder (BD) in individuals with attention-deficit/hyperactivity disorder (ADHD) following stimulant treatment?

Findings  This systematic review and meta-analysis of 16 studies encompassing 391 043 participants found that the risk of psychosis and BD was nonnegligible in individuals with ADHD treated with stimulants. Occurrence of psychosis was higher in those treated with amphetamines compared to methylphenidate.

Meaning  A heterogeneous but nonnegligible occurrence of psychosis and BD following stimulants warrants psychoeducation, systematic monitoring, and appropriate management strategies.

Abstract

Importance  Individuals with attention-deficit/hyperactivity disorder (ADHD) may present with psychosis or bipolar disorder (BD) following treatment with stimulants. The extent to which this occurs is currently unclear.

Objective  To meta-analytically quantify the occurrence of psychosis or BD after exposure to stimulants in individuals with ADHD and assess possible moderating factors.

Data Sources  PubMed, Web of Science, Ovid/PsycINFO, and Cochrane Central Register of Reviews were searched from inception until October 1, 2024, without language restrictions.

Study Selection  Studies of any design with DSM or International Classification of Diseases–defined ADHD populations exposed to stimulants, where psychosis or BD outcomes were evaluated.

Data Extraction and Synthesis  PRISMA Preferred Reporting Items for Systematic Reviews and Meta-analyses and MOOSE Meta-analysis of Observational Studies in Epidemiology guidelines were followed, the protocol was registered, and the Newcastle-Ottawa scale and Cochrane risk of bias-2 tool were used for quality appraisal. Random-effects meta-analysis, subgroup analyses, and meta-regressions were conducted.

Main Outcomes and Measures  For the proportion of individuals developing psychotic symptoms, psychotic disorders, and BD, effect sizes are reported as percentages with 95% CIs. For the comparison between amphetamines and methylphenidate, effect sizes are presented as odds ratios with 95% CIs.

Results  Sixteen studies (N = 391 043; mean [range] age, 12.6 [8.5-31.1] years; 288 199 [73.7%] male) were eligible. Among individuals with ADHD prescribed stimulants, 2.76% (95% CI, 0.73-9.88; k = 10; n = 237 035), 2.29% (95% CI, 1.52-3.40; k = 4; n = 91 437), and 3.72% (95% CI, 0.77-16.05; k = 4; n = 92 945) developed psychotic symptoms, a psychotic disorder, and BD, respectively. Heterogeneity across the studies was significant (I² > 95%). Psychosis occurrence risk was significantly higher in individuals exposed to amphetamines than to methylphenidate (odds ratio [OR], 1.57, 95% CI, 1.15-2.16; k = 3, n = 231 325). Subgroup analyses showed significantly higher prevalence of psychotic symptoms in studies from North America and in those with longer follow-up periods. Increased psychosis occurrence was associated with a higher proportion of female participants, smaller sample sizes, and higher dose of stimulants.

Conclusions and Relevance  This systematic review and meta-analysis found a nonnegligible occurrence of psychotic symptoms, psychotic disorders, or BD in individuals with ADHD treated with stimulants. Amphetamines were associated with higher occurrence compared to methylphenidate. The included studies cannot establish causality, highlighting the need for further research, including randomized clinical trials and mirror-image studies comparing individuals exposed and not exposed to stimulants. Nonetheless, clinicians should inform patients about the increased occurrence of psychosis or BD when discussing stimulant pharmacotherapy and systematically monitor for these conditions throughout treatment.

https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2838206

RFK Jr. Picks 7 New Members for CDC's Vaccine Panel

 HHS Secretary Robert F. Kennedy Jr. has chosen seven new members for the CDC's Advisory Committee on Immunization Practices (ACIP), according to information

opens in a new tab or window obtained by MedPage Today's editor-in-chief Jeremy Faust, MD.

ACIP's next meeting is set to take place Sept. 18-19, and the posted agendaopens in a new tab or window states that "recommendation votes may be scheduled" for immunizations against hepatitis B, COVID, and respiratory syncytial virus, as well as the measles, mumps, rubella, and varicella shot.

CDC leaders who left the agency last week after director Susan Monarez, PhD, was fired warned that there may be changes to certain vaccine recommendations. In addition, Monarez was reportedly removed in partopens in a new tab or window over disagreements with Kennedy about ACIP.

Earlier this year, Kennedy oustedopens in a new tab or window all 17 ACIP members ahead of its June meeting and replacedopens in a new tab or window them with eight new members. Like his last picks, some of the new selections have made controversial claims during the pandemic.

Joseph Fraiman, MD

Fraiman is an emergency physician in Louisiana who has previously questioned COVID vaccines.

Among his published research is a 2022 paperopens in a new tab or window on mRNA COVID-19 vaccines in the journal Vaccine that concluded that the excess risk of serious adverse events warranted the need for formal harm-benefit analyses. He also co-authored a letter to Pfizer and Moderna's CEOs that year calling for the companiesopens in a new tab or window to allow "independent scientists and physicians to see the original data" on their mRNA vaccines.

More recently, in a preprint articleopens in a new tab or window on medRxiv, Fraiman and colleagues reported a higher than expected number of fetal losses associated with COVID vaccination during early pregnancy.

Fraiman was part of a public health integrity committee convened in Florida to look into COVID vaccinesopens in a new tab or window.

Catherine Stein, PhD

Stein is a professor at Case Western Reserve University in Cleveland with a focus on tuberculosis. She teaches classes on infectious disease epidemiology and population health, among other topics, according to her profile pageopens in a new tab or window there.

During the COVID pandemic, Stein testified in support of bills allowing Ohio lawmakers to vote down public health orders and for a "Truth in COVID Statistics" bill, according to a report in the Ohio Capital Journalopens in a new tab or window.

She wrote in January 2021, when U.S. death totals from COVID had surpassed 350,000, that the virus is "not the scary killer the media and government portray it to be" and alleged the state health department inflated case counts, according to the article.

According to her LinkedIn profileopens in a new tab or window, Stein earned a bachelor's degree in biological sciences from John Carroll University, followed by a PhD in epidemiology and biostatistics from Case Western Reserve University in 2004.

John Gaitanis, MD

Gaitanis is a pediatric neurologist at Brown University Health's Hasbro Children'sopens in a new tab or window in Rhode Island. He's also part of the biomedical research leadership at Autism Discovery Coalitionopens in a new tab or window.

According to court records, he in one case billed more than $50,000 for his expertise as part of a vaccine injury lawsuitopens in a new tab or window launched by parents who alleged that pediatric vaccines caused their son's encephalopathy or febrile infection-related epilepsy syndrome.

According to his Brown profileopens in a new tab or window, Gaitanis attended Dartmouth Medical School and Brown Medical School in the 1990s and went on to residencies in pediatrics and neurology.

Evelyn Griffin, MD

Griffin is an ob/gyn who practices in Baton Rouge, Louisiana at Ochsner Healthopens in a new tab or window and Baton Rouge General Medical Centeropens in a new tab or window, according to the health systems' websites.

In 2023, Griffin testified against Louisiana's move to add COVID-19 vaccines to the school immunization schedule, the Lafourche Gazette reportedopens in a new tab or window. She said that "the average kid in Louisiana has a higher chance of getting struck by lightning than dying of COVID."

During a 2024 speech at "Health Freedom Dayopens in a new tab or window," an event organized by COVID contrarian Peter McCullough, MD, MPH, Griffin expressed vaccine skepticism and highlighted McCullough and ivermectin proponent Pierre Kory, MD, as doctors who did good work during the pandemic.

Griffin graduated in 2003 from Ross University School of Medicine in Dominica, West Indies, according to DocInfoopens in a new tab or window.

Kirk Milhoan, MD

Milhoan is a pediatric cardiologist from Hawaii, who reportedly has ties to Children's Health Defense, the anti-vaccine group founded by Kennedy. He has advocatedopens in a new tab or window against vaccinating children against COVID-19, saying he believed the shots caused cardiac issues, and supported using ivermectin and hydroxychloroquineopens in a new tab or window for COVID, treatments that failed to show effectiveness in multiple randomized trialsopens in a new tab or window.

He was investigatedopens in a new tab or window by the Hawaii Medical Board for disseminating medical misinformation, according to a 2022 report. The licensing agency eventually dropped charges for lack of evidence, and its website showsopens in a new tab or window his license is in good standing.

Milhoan is also listed as a senior fellowopens in a new tab or window with the Independent Medical Alliance, which has challenged COVID public health policies.

He identifies as a Christian doctor and is listed as a senior pastor of Calvary Chapel South Maui.

Raymond Pollak, MD

Pollak is semi-retired but has practiced as a transplant surgeon and has a background in immunology, according to Reutersopens in a new tab or window.

"I'm being considered pending the vetting process. If I was offered the position, I would think carefully about it," he told the outlet.

Web searches turned up nothing on his views about vaccines.

Hillary Blackburn, PharmD, MBA

Blackburn is a pharmacistopens in a new tab or window based in Tennessee. She currently serves as the director of pharmaceutical services at a national non-profit medication distributor hosted by Ascension, according to the site.

Web searches turned up little about her views on vaccination. It also could not be immediately determined that this Blackburn is the one expected to be named to the ACIP panel. She has not returned a media inquiry as of press time.

https://www.medpagetoday.com/washington-watch/washington-watch/117299

'Cassidy, Facing Primary Challengers, Proceeds Cautiously on CDC and RFK Jr.'

 Republican Sen. Bill Cassidy's support was crucial to Robert F. Kennedy Jr.'s confirmation as Secretary of HHS. With firings and resignations at the CDC now prompting concern about a leadership breakdown at the nation's leading public health agency, the Louisiana lawmaker and physician is in a tight spot.

The two-term senator -- who publicly expressed concern about Kennedy's anti-vaccination positions before voting to confirm him -- has worried aloud about "serious allegations" at the CDC and has called for oversight, without blaming Kennedy.

But he was choosing his words carefully as he returned to Washington this week after the Senate's August recess and was preparing to question Kennedy during a finance committee meeting scheduled for Thursday. Cassidy told reporters he hadn't yet decided what to ask Kennedy, saying, "I want to carefully frame the question."

The tension underscores competing pressures: A senator with oversight responsibility for a massive federal agency and a Republican seeking reelection next year. Cassidy, who voted to convict Donald Trump after his 2021 impeachment trial, already has a cool relationship with the president. And his reelection chances would worsen were Trump to oppose him publicly.

"He's in a pickle," Republican state Sen. Alan Seabaugh said of Cassidy, "And it's a box I don't think he can get out of."

Chaos at the CDC

The most recent turmoil at the CDCopens in a new tab or window was the forced departure of Susan Monarez, a longtime government scientist who had been the CDC director for less than a month. Her lawyers said she refused "to rubber-stamp unscientific, reckless directives and fire dedicated health experts." It came amid Kennedy's efforts to reshape the nation's vaccine policies to match his long-standing suspicions about the safety and effectiveness of long-established shots.

Last month, Cassidy voiced concern after Kennedy's June firingopens in a new tab or window of the CDC's Advisory Committee on Immunization Practices. Cassidy had noted "serious allegations" about the outside group of expertsopens in a new tab or window that has been reshaped by Kennedy, a leading anti-vaccine activist before becoming the nation's top health official.

Cassidy was asked Tuesday about what information he'll seek from Kennedy at Thursday's hearing.

"I want to carefully frame the question. The issue is about children's health. There's rumor and allegations that children's health, which is at issue here, might be in danger by some of the decisions that are purported to be made," Cassidy said in the Capitol.

"I don't know what's true. I'm not quite sure what I just told you is exactly how to phrase it. I know that we need to get there," he said.

On allegations from those who resigned that Kennedy put politics above science, Cassidy was equally careful.

"Shouldn't we find that out. You don't presuppose they are right. You don't presuppose they are wrong," he cautioned. "You go at it in a way in which both sides get a chance to say, and then we can judge."

Cassidy's public concern about immunization policy recalled his hesitation to vote to confirm Kennedy in February.

Cassidy told Kennedy during his January confirmation hearing that he was "struggling" with his nominationopens in a new tab or window. "Your past, undermining confidence in vaccines with unfounded or misleading arguments, concerns me," he told Kennedy during his confirmation hearing.

Still, Cassidy voted for Kennedy, later describing intense conversations with the nominee and Vice President J.D. Vance that yielded "serious commitments" from the administration.

Cassidy's 2026 Reelection Bid

Already facing a crowded field of Republican primary challengersopens in a new tab or window, Cassidy is operating with little wiggle room.

A group supporting Cassidy's candidacy has been airing ads promoting the senator's support for Trump's agenda, while Trump himself, famous for publicly condemning others who have voted to convict him, has been quiet.

Trump is treating Cassidy friendlier than others who have publicly opposed him previously because the president needs the vote in a narrowly Republican-controlled Senate, Louisiana state Rep. Mike Bayham said.

"He would be in a lot more hot water had he defied Trump. Had he torpedoed RFK, Trump would not be neutral but would be working overtly against Bill," Bayham said. "Cassidy, for his own political self-interest, has to vote Trump's way, and Trump doesn't even have to say thank you. The thanks is his silence."

Trump has indeed been quiet as a field of Republicans has begun to gather to challenge Cassidy in what would be the state's first closed party primary in 16 years, in light of legislation enacted this year. Louisiana State Treasurer John Fleming, state Sen. Blake Miguez, and Public Service Commissioner Eric Skrmetta have announced they are running for the seat.

Republican Gov. Jeff Landry has discussed with Trump the idea of U.S. Rep. Julia Letlow, who is considering a Senate campaign, as a possible Cassidy challenger.

Cassidy announced his candidacy for a third term last month, and reported having $9 million in his campaign account, while a super PAC supporting him reported having $2.5 million, a total far more than his combined competition.

Senate Majority Leader John Thune, a South Dakota Republican, and South Carolina Sen. Tim Scott, chairman of the National Republican Senatorial Committee, endorsed Cassidy for reelection last month.

But with a newly enacted election system, where only registered Republicans and politically unaffiliated voters can participate in the GOP primary, Cassidy will likely have a tougher time than he would have under the former system.

For the past 16 years, congressional candidates from all parties seeking the same office ran on the same ballot regardless of party affiliation. In these so-called jungle primaries, only a candidate who received 50% of the vote would win the office outright. If no one reached the threshold, the top two finishers would face each other in a runoff.

The partisan primary will create a more GOP-heavy electorate for the Senate primary in a state Trump carried with 60 percent of the vote in 2024.

"Cassidy has put himself in a situation for which there are really no wins," said Scott McKay, a Louisiana Republican who runs a conservative news website. "In all this, what he hasn't bought is the goodwill of Trump voters."

https://www.medpagetoday.com/washington-watch/washington-watch/117305

Separating Fact From Fiction in 'Mini IVF'

 When a patient requests a fertility procedure called minimal stimulation in vitro fertilization (IVF), also known as "mini IVF," explicitly because they've heard it offers a "better" quality egg, I know I have some explaining to do.

There are reasons mini IVF -- which involves a shorter course and lower dose of medication to stimulate egg production, along with the retrieval of fewer eggs -- may be reasonable to pursue as a fertility treatment. Higher quality eggs is not one of them.

Though the hope is always for better quality eggs, there are no clear data to support the commonly repeated, and too-often believed, claim that mini IVF will yield them. This type of promise highlights the informational uphill battle the fertility field faces, where marketing (over)promises can give patients false hope. Optimism should not replace facts when patients face serious, sensitive medical challenges.

As physicians working in an environment where egg freezing and IVF are becoming increasingly common, we must set the record straight for our patients who are beginning this journey.

The reality is that mini IVF is actually less effectiveopens in a new tab or window than conventional IVF for most people, and is only useful in a few circumstances. It's typically not a first-line treatment in my practice because the typical goal of IVF is to retrieve a high number of eggs to boost the chances of creating more embryos for implantation, and the expectation in mini IVF is that it stimulates the production of fewer eggs.

Sometimes, however, the standard doses of medication that stimulate egg production in conventional IVF aren't the most effective path.

Reasons to Pursue Mini IVF

One of the most common reasons to pursue mini IVF is because a patient has low ovarian reserve, or diminished ovarian reserveopens in a new tab or window. This medical condition refers to a lower-than-expected quantity of eggs that affects the ability to conceive. It can simply be the state of fertility for a particular patient, or a result of anythingopens in a new tab or window from autoimmune diseases and viral infections to treatments like chemotherapy. Some patients with very low ovarian reserve don't respond to conventional doses but will respond with gentler stimulation like mini-stimulation IVF.

Some patients struggle to tolerate the higher levels of medications used in conventional IVF. In about 1-5% of IVF cyclesopens in a new tab or window, ovarian hyperstimulation syndrome may occur, in which ovaries swell, become painful, develop cysts, and leak fluid, leading to abdominal bloating and pain. Sometimes it makes sense to switch to lower doses and shorter courses of medication if treatments such as leuprolide acetate-only trigger shotsopens in a new tab or window are ineffective.

Cost can be another reason patients pursue mini IVF. It can be less expensive than conventional therapy because it uses less medication, which is typically what's driving the variable cost. But costs for mini IVF can mount and become as expensive as traditional IVF (anywhere from $15,000 to $25,000 per roundopens in a new tab or window, sometimes more with a donor egg) if patients have to undergo multiple cycles.

Finally, ethical considerations abound in the fertility field for both patients and doctors. Some families express religious and/or ethical concerns about conventional IVF because they don't want to create an excess of embryos that eventually may have to be stored, adopted, or destroyed. They see mini IVF as an opportunity to create only as many embryos as they plan to use.

No 'Better' Embryos

Still, there are no guarantees about the quality of the eggs. We only know that mini IVF is more likely to produce fewer eggs, and conventional treatments may yield more. That message can be difficult for patients to hear when they've been told there are "better" embryos, that they can "optimizeopens in a new tab or window" embryos, or prioritizeopens in a new tab or window some embryo characteristics over others. It may seem a small linguistic step from "better" to "optimal," but it's a steep ethical slope.

Experienced fertility specialists understand how vulnerable fertility patients and their families can be as they navigate procedures, costs, and sometimes, disappointments. That vulnerability isn't the time for hard-sell promises, but instead, a moment to be up-front with hard truths about what to expect throughout their fertility journey.

IVF can be both medically and numerically complex, making it our duty to be data-driven, to clearly communicate what reliable studies show, and to be honest about the unknowns. Amid specious claims that the fertility process can be optimized, we specialists must separate the marketing from the evidence, and share that with patients responsibly so they can grow their families with healthy knowledge, and in good health.

Randi H. Goldman, MD, MBA,opens in a new tab or window is the program director of the Reproductive Endocrinology and Infertility Fellowship for the Northwell Health Department of Obstetrics & Gynecology.

https://www.medpagetoday.com/opinion/second-opinions/117306