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Monday, June 23, 2025

Is Robotic Surgery Safe in Older Patients With Lung Cancer?

 Robotic-assisted thoracic surgery (RATS) was safe in patients aged 80 years or older with lung cancer and demonstrated comparable postoperative outcomes to younger patients, a retrospective study found. After propensity score matching, researchers found no significant differences in complications, hospital stay duration, and 90-day mortality between the two age groups.

METHODOLOGY:

  • Researchers conducted a retrospective analysis of 340 patients who underwent major lung resections using RATS between 2015 and 2022 in Italy.
  • They divided patients into very elderly patients (VEPs; ≥ 80 years; n = 28) and non-elderly patients (NEPs; < 80 years; n = 312). Patients were characterised according to demographic variables, comorbidities, forced expiratory volume in 1 second (FEV1), and clinical and pathological stage.
  • Propensity score matching at a 1:3 ratio was performed to balance the two groups, resulting in 26 VEPs and 71 NEPs, using clinically relevant variables that were significantly different at baseline.
  • The primary endpoint was the assessment of complications; secondary endpoints were the comparison of the complications according to the Clavien-Dindo classification, postoperative stay, and mortality rate between VEP and NEP groups.

TAKEAWAY:

  • After propensity matching, complication rates did not differ significantly between VEP and NEP groups (46.2% vs 32.4%; P = .21).
  • The mean hospital stay was 4 days for both age groups (P = .85), and the 90-day mortality was low and not significantly different between VEP and NEP groups (3.9% vs 0%).
  • Pathological stage I disease was associated with a lower risk for complications (odds ratio [OR], 0.23; P = .006), and lobectomy was linked to a decreased risk for complications (OR, 0.29; P = .033); however, FEV1 continued to demonstrate a protective effect (OR, 0.97; P = .025).

IN PRACTICE:

"This study provides strong evidence supporting the safety and feasibility of RATS in patients aged 80 years and older, demonstrating comparable postoperative outcomes to younger patients after propensity score matching. FEV1, smoking history, and ASA [American Society of Anesthesiologists] score were the most significant predictors of postoperative complications, while age itself was not an independent risk factor," the authors of the study wrote.

SOURCE:

This study was led by Pierluigi Novellis, IRCCS San Raffaele Scientific Institute, Milan, Italy. It was published online on June 17, 2025, in the Journal of Clinical Medicine.

LIMITATIONS:

This study was limited by the retrospective nature of the analysis and the difference in the sample size between the two groups.

DISCLOSURES:

This study did not receive any external funding. Several authors reported receiving honoraria or having other ties with various sources.

https://www.medscape.com/viewarticle/robotic-surgery-safe-older-patients-lung-cancer-2025a1000gdm

Daiichi-Astrazeneca Datroway Gains Second FDA Nod With NSCLC Approval

 The FDA has granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for certain patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.

Specifically, the Trop-2-directed antibody and topoisomerase inhibitor conjugate

was approved for adults previously treated with an EGFR-directed therapy and platinum-based chemotherapy, according to the approval notice

The approval marks the second for the antibody drug conjugate, which was discovered by Daiichi Sankyo and is being jointly developed with AstraZeneca. Initial approval was granted in January for previously treated patients with unresectable or metastatic HR-positive, HER2-negative breast cancer, as reported by Medscape.

The new approval was based on efficacy demonstrated in a pooled subgroup of 114 patients treated with datopotamab deruxtecan in the TROPION-Lung05 and TROPION-Lung01 trials. The confirmed overall response rate among the patients was 45%, and the median duration of response was 6.5 months.

Patients in the two trials were treated at the recommended dose of 6 mg/kg, up to a maximum of 540 mg for patients weighing 90 kg or more, given as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity.

Last year, AstraZeneca voluntarily withdrew its marketing authorization application with the EU's medicines regulator for the antibody drug conjugate for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer based on the TROPION-Lung01 phase 3 trial.

The decision “was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency,” the drug company said in a press release.

Reuters previously reported that data from TROPION-Lung01 “has repeatedly knocked [AstraZeneca’s] shares, most recently in September when results showed that the drug did not significantly improve overall survival results for patients.”

Full prescribing information for datopotamab deruxtecan, which will be posted on Drugs@FDA, includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity. 

https://www.medscape.com/viewarticle/datroway-gains-second-fda-nod-nsclc-approval-2025a1000gpw

Supreme Court Hands Trump Huge Win On Deporting 'Worst Of The Worst' Illegals

 The US Supreme Court just lifted a lower court's order that required the Trump administration to give people 10 days' notice and a chance to object before deporting them to a third country.

The United States is facing a crisis of illegal immigration, in no small part because many aliens most deserving of removal are often the hardest to remove,” Solicitor General John Saur wrote in an emergency application to the court in May.

“When illegal aliens commit crimes in this country, they are typically ordered removed. But when those crimes are especially heinous, their countries of origin are often unwilling to take them back. As a result, criminal aliens are often allowed to stay in the United States for years on end, victimizing law-abiding Americans in the meantime.”

The brief unsigned order came in the case known as Department of Homeland Security v. D.V.D. with (surprise, surprise) Justices Sonia Sotomayor, Ketanji Brown Jackson and Elena Kagan dissenting from the decision, who said they "cannot join so gross an abuse" of the high court’s authority.

“Apparently, the Court finds the idea that thousands will suffer violence in farflung locales more palatable than the remote possibility that a District Court exceeded its remedial powers when it ordered the Government to provide notice and process to which the plaintiffs are constitutionally and statutorily entitled,” Sotomayor wrote.

“That use of discretion is as incomprehensible as it is inexcusable.”

The government has tried to speed up the deportation process “by removing aliens to third countries that have agreed to accept them.”

“Convincing third countries to accept some of the most undesirable aliens requires sensitive diplomacy, which involves negotiation and the balancing of other foreign-policy interests,” it stated.

Now, the administration can proceed with fast-track deportations of “some of the worst of the worst illegal aliens” to countries it has made deals with, such as South Sudan.

Of course, not everyone is happy.

“The ramifications of the Supreme Court’s order will be horrifying,” said Trina Realmuto, executive director of the National Immigration Litigation Alliance.

“It strips away critical due process protections..."

We look forward to seeing President Trump's response.

https://www.zerohedge.com/political/supreme-court-hands-trump-huge-win-deporting-worst-worst-illegals

DHS Alerts US Public On Iran Retaliation Threat: Just Some 'Low-Level' Cyberattacks?

 The latest Department of Homeland (DHS) alerts are telling the American public to expect some form of Iranian retaliation in response to this weekend's major US bombing raids targeting three key Iranian nuclear energy and uranium enrichment sites.

And the Pentagon is preparing for potential attack on US bases in the Middle East, whether in Iraq or Syria where reduced troop presences still remain, or in the Gulf Arab countries - home to major naval and air bases.

Via Shutterstock

But the latest DHS warnings speak of a not-so-new threat (which gets repeated just about every year) of stepped-up Iranian cyber threat activity.

A fresh terrorism advisory bulletin from DHS warns that Iran’s response could include violent actions on US soil as well as increased cyber operations.

The supposed heightened threat environment predicts likely low-level cyberattacks from pro-Iranian hacktivists, but also more serious threats from state-backed Iranian hackers:

“The ongoing Iran conflict is causing a heightened threat environment in the United States,” the DHS said. “Low-level cyber attacks against US networks by pro-Iranian hacktivists are likely, and cyber actors affiliated with the Iranian government may conduct attacks against US networks.”

But behind the headlines, the reality is that the fear-mongering from US officials will front-run the actual threats and 'attacks' - and likely grow louder, according to the all too familiar playbook of the Bush-Cheney era...

But markets have been responding positively to the 'cyberthreat' headlines from Bloomberg and others, given a mere few minor cyberattacks against US infrastructure or interests will be a far cry from a massive hot war in the Middle East.

Of more concern will be the question of where is all that enriched uranium? following the US bombings at Fordow, Natanz, and Isfahan. Without doubt, the Iranians are busy moving it, or have moved it. The 'unknowns' (cue Rumsfeld) surrounding this, and whether the US goes up the escalation ladder, remain probably the biggest danger

A fresh Goldman Sachs report has cited Richard Nephew, a former senior US official, who says: "On the basis of what we’ve seen at this point, we don’t know where the material is. We don’t have any real confidence that we’ve got the ability to get it any time soon." 

https://www.zerohedge.com/geopolitical/dhs-alerts-public-iran-retaliation-threat-just-some-low-level-cyberattacks

Peer-to-Peer Prior Authorization: Is Physician Participation Ethical?

 Over the past few months, Austin-based breast reconstruction surgeon Elisabeth Potter, MD,

opens in a new tab or window has become notable for her social media videos giving insight into the real-world interactions of physicians with health insurance companies. Potter has highlighted the prior authorization process and even posted a videoopens in a new tab or window of her phone call with a fellow physician serving as a peer-to-peer (P2P) reviewer for a large insurance company. The P2P reviewing physician states two things on this call that stand out: (1) they are not a breast reconstruction surgeon (and therefore not intimately familiar with the nerve-sparing mastectomy at question that was meant to preserve sensation), and (2) they are bound by company policy to not reveal their name (ostensibly for security reasons).

There are reasonable economic argumentsopens in a new tab or window for some level of prior authorization being a mechanism for reducing low-value care and therefore ensuring healthcare dollars are spent prudently. However, this phone call -- and many other documented instancesopens in a new tab or window of the challenges physicians face in overcoming prior authorization burdens -- raises important questions: is it ethical for physicians to actively participate in denials of medical care? Or could an argument instead be made that they have a moral imperative to do so?

The American Medical Association (AMA)'s Principles of Medical Ethicsopens in a new tab or window explicitly state, "A physician shall support access to medical care for all people." This presumably means that the ethical physician has a responsibility to ensure that any care in a patient's best interest that can be provided, is provided. These AMA principles suggest that physicians shouldn't act as P2P reviewers. In another frameworkopens in a new tab or window, Tom Beauchamp, PhD, and James Childress's, PhD, famous 1979 Four Principles (of bioethics) reason that the ethical physician has respect for patient autonomy, is non-maleficent in their care, treats patients in a beneficial manner, and acts in a manner rooted in justice. Two of these principles are perhaps the most salient here. First, non-maleficence implies not engaging in activities that harm patients -- to most, denying care falls in that bucket. And second, beneficence implies only acting in the patient's best interest. These principles thus signify that physicians engaging in prior authorization denials are not acting in accord with bioethical principles.

But those are not the only principles at play here. Justice matters too.

"Justice" has myriad definitions. Indeed, philosophers across the centuries have devoted their lives to arriving at a single meaning. In this context, however, Beauchamp and Childress state that justice in medicine follows equality: "equals ought to be treated equally and unequals unequally." In other words, a medical system is just if two patients with the same medical circumstances receive the same care, without regard for extraneous factors -- presumably this would include ability to pay. However, they also argue that the "notion of distributive justice refers to fair, equitable, and appropriate distribution in society."

It is perhaps up to each individual physician how they interpret these definitions. Yet, no society is perfectly just. Ours has limited medical resources. Couldn't an argument be made that a physician serving as a P2P reviewer is upholding their responsibility to reduce low-value care? Following this logic, aren't P2P reviewers doing their part to ensure equitable "distribution [of medical resources] in society"?

What if instead of relying on the somewhat esoteric notion of justice, we conceptualize P2P reviewers as serving a harm reduction role? In other contexts -- for instance, opioid use disorder (OUD) -- harm reductionopens in a new tab or window has grown in popularity as an evidence-based mechanism for limiting the most devastating consequences of an activity. In OUD, harm reduction may manifest as supervised injection facilities, where persons suffering from addiction can find sterile needles that limit transmission of serious diseases. In prior authorization, by serving as P2P reviewers couldn't one argue that physicians are reducing the harm that might come from a potentially amoral artificial intelligence platform taking the role instead?

Irrespective of arguments for or against physician participation in P2P review, we can all agree that the prior authorization process needs reformopens in a new tab or window. Increasing prior authorization burdens are detracting from clinical timeopens in a new tab or window and causing burnout. Lack of appropriate clinical expertiseopens in a new tab or window among some P2P reviewers is leading to unclear conversations that frustrate care. Lack of personal liability for the downstream patient health outcomes caused by care denials, in consort with the anonymity many are afforded, gives P2P reviewers little accountabilityopens in a new tab or window for their decisions. Continued prior authorization burdens on physicians with proven track records of high value care serve almost no purpose for scarce resource allocation, yet exacerbate consternation and inefficiency (some statesopens in a new tab or windowpayorsopens in a new tab or window, and federal lawmakersopens in a new tab or window have tried addressing this issue through "gold card" laws). Provider frustration has given rise to a growing industry of "profit enhancing middlemenopens in a new tab or window" extracting funds from the healthcare system by attempting to reduce administrative burdens.

At the end of the day, our central question goes beyond whether physicians should serve as P2P reviewers. Rather, our crucial struggle is how to best align allocation of our society's limited resources with the fundamental aim of medicine: care for patients. There is a palpable tension between prudent spending of healthcare dollars and independent medical decisions. This challenge is unlikely to disappear any time soon. Yet, as we debate it, it is essential that reforms are grounded in ethical principles. Whether one views P2P reviewers as barriers to appropriate care or as necessary stewards of limited resources, our guiding principle must remain the same: decisions should serve patients' -- all patients' -- best interests. I refuse to let go of the hope that achieving a system that supports both fiscal responsibility and the profound doctor-patient relationship we so ardently cherish and seek is one day possible.

Manav Midhaopens in a new tab or window is an MD candidate at the Icahn School of Medicine at Mount Sinai and a researcher at the USC Schaeffer Center for Health Policy & Economics. All views are his own.

https://www.medpagetoday.com/opinion/second-opinions/116162

Number of Abortions Kept Rising in 2024 Due to Telehealth Scripts, Report Says

 The number of abortions in the U.S. rose again in 2024, with women continuing to find ways to get them despite bans and restrictions in many states, according to a report

opens in a new tab or window out Monday.

The latest report from the WeCount project of the Society of Family Planning, which supports abortion access, was released a day before the third anniversary of the U.S. Supreme Court's ruling that overturned Roe v. Wadeopens in a new tab or window and ended nearly 50 years of legal abortion nationally.

Currently, 12 states are enforcing bans on abortion at all stages of pregnancy, with limited exceptions, and four have bans that kick in at or about 6 weeks into pregnancy -- often before women realize they are pregnant.

While the total number of abortions has risen gradually over those 3 years, the number has dropped to near zero in some states, while abortions using pills obtained through telehealth appointments have become more common in nearly all states.

Pills are used in the majority of abortions and are also prescribed in person.

The Overall Number of Abortions Has Risen, but It Is Below Historic Highs

The latest survey, released Monday, tallied about 1.1 million abortions nationally last year, or about 95,000 a month. That is up from about 88,000 monthly in 2023 and 80,000 a month between April and December of 2022. WeCount began after Roe was overturned, and the 2022 numbers don't include January through March, when abortions are traditionally at their highest.

The number is still well below the historic peak in the U.S. of nearly 1.6 million a year in the late 1990s.

The Society of Family Planning relies primarily on surveys of abortion providers and uses estimates.

Pills Prescribed by Telehealth Now Account for One-Fourth of U.S. Abortions

WeCount found that in the months before the Dobbs ruling was handed down, about one in 20 abortions was accessed by telehealth.

But during the last 3 months of 2024, it was up to one in four.

The biggest jump over that time came in the middle of 2023, when laws in some Democratic-controlled states took effect with provisions intended to protect medical professionals who use telehealth to prescribe pills to patients in states where abortion is banned or where there are laws restricting telehealth abortion.

WeCount found that about half of the telehealth abortions last year were facilitated by the shield laws. The number of telehealth abortions also grew for those in states without bans.

WeCount is the only nationwide public source of information about the pills prescribed to women in states with bans. One key caveat is that it is not clear how many of the prescriptions result in abortion. Some women may change their minds, access in-person abortion, or be seeking pills to save for future use.

The WeCount data could help explain data from a separate survey from the Guttmacher Institute, which found the number of people crossing state linesopens in a new tab or window for abortion declined last year.

Anti-Abortion Efforts Are Focused on Pills

Anti-abortion efforts are zeroing in on pills, along with barring federal funds for Planned Parenthoodopens in a new tab or window and undoing ballot measuresopens in a new tab or window that provided for abortion access.

Three states have sued to try to get courts to limit telehealth prescriptions of mifepristone, one of the two drugs usually used in combination for medication abortions. President Donald Trump's administration last month told a judge it does not believe the states have legal standing to make that case.

The U.S. Supreme Court last yearopens in a new tab or window found that anti-abortion doctors and their organizations didn't have standing, either.

Meanwhile, officials in Louisiana are using criminal lawsopens in a new tab or window, and there is an effort in Texas to use civil penaltiesopens in a new tab or window against a New York doctor accused of prescribing abortion pills to women in their states. Louisiana lawmakersopens in a new tab or window have also sent the governor a bill to further restrict access to the pills.

Susan B. Anthony Pro-Life America President Marjorie Dannenfelser said on a call with reporters Monday that it's a priority for her group to keep pushing U.S. Health Secretary Robert F. Kennedy Jr. and other officials to investigate the safety of abortion pills -- and to require that they be dispensed only in person.

https://www.medpagetoday.com/obgyn/abortion/116205

CMS Tightens Reins on Obamacare Access

 The Trump administration announced a plan to curb Affordable Care Act (ACA)-related spending by beefing up income verification for subsidies, tightening open enrollment periods, and eliminating access for some young immigrants.

"We are strengthening health insurance markets for American families and protecting taxpayer dollars from waste, fraud, and abuse," said HHS Secretary Robert F. Kennedy Jr. in a statementopens in a new tab or window regarding the new guidance, known as the "Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability Final Rule.opens in a new tab or window"

During the COVID-19 pandemic, eligibility for ACA premium subsidies extended to cover the entire premium for those with incomes between 100% to 150% of the federal poverty level. "CMS believes this temporary expansion of premium subsidies resulted in conditions that were exploited to improperly gain access to fully-subsidized coverage," the agency noted in a fact sheetopens in a new tab or window.

Some 5 million people might have been improperly enrolledopens in a new tab or window, costing the healthcare system as much as $20 billion, the agency said, citing research from the Paragon Health Instituteopens in a new tab or window.

Under the final rule, CMS said it is taking the following steps to address these enrollment issues:

  • Eliminating the monthly special enrollment period (SEP) for those whose estimated household income is at or below 150% of the federal poverty level
  • Requiring income verification to ensure people are eligible for premium subsidies they receive
  • Enacting eligibility verifications for most enrollments during SEPs and getting rid of avenues that let people enroll in plans only after they need care
  • Requiring a $5 premium from anyone receiving the advanced payments of the premium tax credits who is auto-enrolled in fully-subsidized plans on the federal exchange

By implementing a "$5 premium responsibility," CMS argued it can reduce improper enrollments in the marketplace and prevent marketplace coverage from continuing for anyone unaware of their enrollments.

With regard to income eligibility, CMS plans to reinstate a 2015 policy that calls for the exchanges to deem an individual ineligible for premium tax credits if that individual, or person filing their taxes, did not file their income taxes and "reconcile" those tax credits for 1 year, rather than 2 years, as specified in a 2024 payment notice.

Additionally, the final rule seeks to standardize and shorten the annual open enrollment period (OEP), with the exchanges having flexibility to determine their own enrollment periods within certain limits.

"Each OEP must start no later than November 1 and end no later than December 31, and the OEP may not exceed 9 calendar weeks," a CMS fact sheet said. Open enrollment previously extended from November 1 to January 15 in most states.

By standardizing the open enrollment period, CMS hopes to encourage consumers to maintain year-round coverage, the agency said. And by "closing loopholes" that let people enroll when they decide they need care, the administration believes it can lower premiums for middle-class families due to the healthier risk pool, the press release stated.

The final rule announced on Friday, which goes into effect in the 2026 plan year, excludes Deferred Action for Childhood Arrivals (DACA) recipients, also known as "Dreamers," from enrollment in ACA coverage by amending the definition of "lawfully present" for eligibility and enrollment in exchanges and basic health programs to exclude them, undoing provisions of the 2024 DACA Ruleopens in a new tab or window, the fact sheet noted.

DACA recipients across nearly half of the country were already barred from enrolling in ACA coverage or accessing ACA subsidies. In December, a federal judge in North Dakota blocked accessopens in a new tab or window to ACA enrollment for Dreamers when he sided with the 19 states that sued the Biden administration over the rule.

An estimated 725,000 to 1.8 million people could lose coverage as a result of the rule's provisions, the agency said.

Many of the policies aimed at stopping improper enrollments are temporary and will sunset at the end of the 2026 plan year, CMS noted.

CMS Administrator Mehmet Oz, MD, praised the administration and his own agency's efforts.

"This is about putting patients first, stopping exploitation of the system, and realigning the program with the values of personal responsibility and fiscal discipline," he said.

https://www.medpagetoday.com/washington-watch/washington-watch/116208