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Tuesday, August 5, 2025

Social Justice Encroachment into Medicine

 Today, social justice imperatives are deeply entrenched in the medical profession. As a close observer of such trends, I have noted a concerted effort to transform the mission of medicine from improving health to advancing social justice and to morphing the identity of the physician from healer to an activist. Nowhere has this ethic been more aggressively pursued than within the realm of gender medicine and scholarship. I chaired the panel on Censorship Around Gender Research and Medicine with panelists Michael Bailey, Diana Blum, and Carole Hooven, held at the Censorship in the Sciences: Interdisciplinary Perspectives conference at the University of Southern California in early January. The speakers that followed me elaborated upon the forms of censorship manifest in treating gender dysphoria (in the context of human psychology and biology), and in studying its origins and expressions. In what follows I share my personal perspective on the ideological subversion of medicine.

For the past 25 years I have been chronicling the erosion of medical excellence and values under the weight of social justice ideology. After the death of George Floyd, the simmering problem became white hot.

One of the earliest post-Floyd examples entails an epidemiologist from the Johns Hopkins Bloomberg School of Public Health who felt moved to urge her Twitter followers to march in protest of police action against black men. “The public health risks of not protesting to demand an end to systemic racism greatly exceed the harms of the virus,” she exhorted [1].

Her imperative was scientifically incoherent—there is no way she could have quantified and predicted the benefit of marching. Yet days later, 1,200 health professionals cheered her on in an open letter [2].

Most troubling to me was not the hypocrisy—though you just know she never would have applied a similarly generous risk-benefit calculus to an outdoor pro-life rally— but the now-publicized fact that she blurred her professional role. And that 1,200 of her colleagues thought that was fine.

The job of epidemiologists is to inform the public about risks, not to tell others what risks are worth taking or what their moral prerogatives should be. The Johns Hopkins professor and her associates had allowed their own moral commitments, as opposed to objective metrics of risk, to shape their advice.

Within the weeks and months that followed, the American Association of Medical Colleges informed medical schools that they “must employ anti-racist and unconscious bias training and engage in interracial dialogues” [3]. In the spring of 2021, the American Medical Association, AMA, advocated “mandatory anti-racism [training]” as part of its vision that all physicians “confront inequities and dismantle white supremacy, racism, and other forms of exclusion and structured oppression” [4].

Clinical responses were influenced by anti-racism and equity agendas. One bioethicist argued in the New York Times that if hospitals needed to ration ventilators—a fleeting but major concern in the winter of 2020—they should prioritize black patients in the spirit of reparations [5].

When the COVID-19 vaccine became available, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) concluded that race should supersede age as a prioritization category. Why? Because the oldest cohort in America is whiter than the general population [6].

Thankfully the CDC never followed the Committee’s advice. The CDC scientists rightly recognized that the odds of serious illness in older people were far greater than in younger individuals. One CDC official even said that a race-based vaccine allocation plan would result in up to 6.5 percent more COVID-related deaths overall, many of them among black senior citizens [7].

Furthermore, the Committee’s proposal flies in the face of well-established laws of clinical triage, which depend upon patient need and prognosis. Schemes to distribute scarce resources on the basis of group identity deal a serious blow to public trust in the medical system.


More and more, I am seeing an effort to change the mission of medicine to serving social justice and to morph the identity of the physician to an activist, facts and hypothesis testing and forthright acknowledgement of uncertainty be damned.

Nowhere has the ethic of clinical care been more systematically tainted than in gender medicine and scholarship. In their talks, Michael Bailey and Carole Hooven—both of whom have devoted their careers to the biology and psychology of sexuality—and Dr. Diana Blum provided vivid details.

I had one memorable closer encounter. I like to call it a textbook case—literally—of social justice medicine run amok.

In the fall of 2023, the American Psychiatric Association, APA—I used to be a member—published Gender-Affirming Psychiatric Care [8]. The association’s publishing arm hailed it as “the first textbook in the field to provide an affirming, intersectional, and evidence-informed approach to caring for transgender, non-binary, and/or gender-expansive (TNG) people.”

The textbook should never have been published. Instead of providing even-handed analyses of the controversies within a still-evolving topic of gender dysphoric youth, the volume approaches it as a settled matter [9].

The volume, for example, instructs clinicians to take at face value a teen patient’s request (even a child’s request) for transition on its face. “Clinicians should … always allow patients autonomy in their care,” authors wrote. Accordingly, the editors and authors advocated for puberty blockers (chemicals that suppress the natural hormonal development and the appearance of secondary sexual traits) and then cross-sex hormones (estrogen or testosterone) to produce the physical characteristics aligned with the patient’s gender identity.

When it comes to gender-affirming surgery, some textbook authors cautioned that “the [mental health] clinician should never place barriers to surgery, only identify those that exist and assist with overcoming them.” (Emphasis added.)

As a practicing psychiatrist, I would have expected this volume to probe how to conduct productive interviews with all patients, especially children and young teens, who consider themselves candidates for a gender-affirming approach. After all, this book has the seal of approval from the American Psychiatric Association.

It should have advised clinicians to examine, over many sessions, young patients’ experiences and developmental struggles, to learn about their home lives and social worlds, as well as to treat them for the frequent co-occurring issues, such as depression, anxiety, and posttraumatic stress disorder, which sometimes manifest as gender dysphoria. Such foundational steps are ignored [10].

Gender-Affirming Psychiatric Care also fails to mention desistance—the phenomenon wherein gender dysphoria diminishes before transition—as a phenomenon worthy of high-quality studies. Lisa Littman (a physician who identified "rapid-onset gender dysphoria," ROGD) and colleagues suggest a straightforward analysis of desistance that entails selecting a random group of transgender-identified youth and following them over time, while assessing relevant factors (e.g., gender dysphoria, transition steps, current adjustment, and sexuality) repeatedly [11,12]. To counteract self-report bias, additional informants (e.g., parents and therapists) would be enlisted. This design would help identify predictive factors for many kinds of outcomes.

Nor does the textbook mention the robust debate surrounding ROGD. This term, which is not part of the DSM, refers to a young person’s sudden insistence, during or after puberty, that one is trans. The phenomenon seems to overwhelmingly affect girls. Some doctors recognize ROGD as real—bitter debate surrounds its existence—and regard it as the product of social contagion fostered by peers and social media.

Finally, a reader gets no sense that gender-affirming care is the subject of vigorous international scientific debate. Authors ignored the 2022 decision by Sweden’s National Board of Health and Welfare to suspend hormone therapy for minors except in very rare cases and limited mastectomies to research settings [13]. Nowhere mentioned is the fact that the Norwegian Healthcare Investigation Board now defines all medical and surgical interventions for youth as “experimental treatment” and that the French National Academy of Medicine advises caution in pediatric gender transition [14].

The textbook also failed to mention that, in 2020, the United Kingdom’s National Health Service commissioned a comprehensive review of puberty blockers and cross-sex hormones [15]. The interim review conducted by Hilary Cass, honorary Consultant Paediatrician at Evelina London Children’s Hospital, was published in 2022—two years before the textbook appeared. It concluded that “the available evidence was not strong enough to form the basis of a policy position” [16].

Several months after the textbook appeared, the National Health Service released the much-publicized Cass Review, formally known as the Independent Review of Gender Identity Services for Children and Young People [17]. The 2024 review, as foreshadowed by the 2022 interim report, concluded that medical gender transition interventions, such as puberty blockers and cross-sex hormone therapy, have not been shown to provide overall benefit. This is of special concern, given both known and unknown risks of those treatments.

The Cass Review’s 32 recommendations would bring the UK into greater alignment with the other European countries. For example, the report stipulated that although masculinizing and feminizing hormones will remain available to youth over 16 years of age, they should be undertaken only with “extreme caution. … There should be a clear clinical rationale for providing hormones at this stage rather than waiting until an individual reaches 18” [17].

The current policy climate for gender care is fraught. Contrary to the textbook’s full-speed-ahead approach, I subscribe to informed modesty about our understanding of these issues and restraint regarding both chemical and surgical interventions. I believe existing evidence isn’t strong enough to support an unhesitating, gender-affirming approach to youth. But neither do I think that state-imposed bans and limits on gender-affirming care should be endorsed when they apply to the care of adults or interrupt the treatment of youth already in progress [18].

At the same time, blanket denial of the reality of gender dysphoria is unacceptable. Legislation is too rigid to guide specific care—it is not credible to say that there are never instances of youth who might benefit from gender-affirming care—and it turns health issues into partisan battlefields. Conversely, it is hard to look to the usual advisers on clinical protocols, namely professional organizations and state medical boards, as they are mainly in sync with the orientation of this textbook.

Gender-dysphoric youth deserve a comprehensive and clinically judicious textbook from the country’s premiere psychiatric association, not a volume that omits essential facts and perspectives in the service of a political agenda.

The good news is that the plight of such youth has received enormous public attention—rightly so, as parents are deeply concerned about their teenage children, mostly girls, rushing into irreversible biological changes. High-profile stories of young women who regret their choice have brought lawsuits and get noticed [19].

And in October 2024, the New York Times reported the case of a researcher who withheld data on the impact of puberty blockers on adolescent mental health. [20] The researcher, who ran the country’s largest youth gender clinic at the Children’s Hospital Los Angeles, received a multimillion-dollar grant to study the effect of puberty blockers.

When the results showed negligible improvement in depression and suicidal ideation, she was reluctant to publish them, telling the Times that she worried that her “study’s results could be used in court to argue that ‘we shouldn’t use blockers [in adolescents] because it doesn’t impact them.’”

Outside of the transgender issue, troubled domains of medicine are not as well known. But they exist. Medical schools and professional organizations have also compromised standards in teaching, research, and even in clinical care in the name of equity and identity politics [21].

At present, the policy landscape has shifted. President Trump signed one of his earliest executive orders, eight days after his inauguration, aimed at cutting federal support for gender transitions for people under age 19. On June 18, the Supreme Court handed down a 6-to-3 decision upholding the ability of states to ban or limit gender affirming care for minors. As of mid-July, the Children’s Clinic in Los Angeles closed. Stanford Medicine, the University of Pittsburgh Medical Center and Children’s Hospital of Orange County, University of Chicago Medicine, and Children’s National Hospital in D.C. all announced they will end or dramatically scale back services for trans youth. (Incidentally, the kind of research proposed by Littman and colleagues may now be moot due to the administration’s cuts in federal research funding.)

The public needs to become as aware of these broader transgressions, as it is of the more circumscribed but high-profile debates and politics surrounding gender medicine in youth.

[with references]

Senior Fellow, American Enterprise Institute and Lecturer, Yale University School of Medicine

https://hxstem.substack.com/p/68e5f66d-21b7-44d6-bb57-7712ff0697e1

Noom expands its GLP-1 range with 'microdose' package

 Digital health company Noom has started offering lower doses of GLP-1 agonist semaglutide, the active ingredient in Novo Nordisk's weight-loss drug Wegovy, at a knock-down price.

The 'microdose' package costs $119 initially, then $199 per month thereafter, and is claimed to "unlock weight loss and long-term health benefits while minimising side effects" through "personalised" dosing.

Noom is basing its offering on a quarter dose of semaglutide – 0.6mg per injection versus 2.4mg for Wegovy – and said the rationale for the dose reduction comes from data gleaned from its members, as well as a couple of investigator-led studies published in The Lancet and New England Journal of Medicine.

The company started selling a compounded version of semaglutide last year, when the drug was still on the FDA's shortage list. While no longer in short supply – meaning that compounding should no longer be possible – some companies have continued to provide the drug to patients under exceptions for 'personalised' treatments under a framework known as Section 503A.

In a nutshell, that allows compounders to make compounds in small quantities for patients whose needs are not met by a standard formulation.

That interpretation of the rules is being challenged in the courts by Novo Nordisk and Eli Lilly, which makes rival weight-loss therapy tirzepatide, while the compounders have countersued, claiming that the FDA's removal of the drugs from the shortages list was premature.

Noom claims its microdose approach allows users to lose up to 11 pounds (around 5kg) in one month and up to 17 pounds in two months, with 70% of them reporting no side effects. At regular doses, semaglutide and tirzepatide are associated with tolerability issues in some patients, particularly gastrointestinal side effects.

Combining the low doses with Noom's GLP-1 Companion support app "helps more patients stay on the treatment, experience the full health benefits of these medications, and make real progress in reducing obesity and overweight rates in the US," said the company's chief medical officer, Dr Jeffrey Egler.

The company estimates that more than 50% of patients taking GLP-1 drugs stop because of costs, while more than a third do so because of side effects.

Novo Nordisk has launched its own telehealth programme for regular-dose semaglutide through its own channels, as well as other providers, for $499 per month, although a partnership with Hims & Hers quickly broke down due to what the company said were "concerns about […] illegal mass compounding and deceptive marketing."

Hims & Hers – which accused Novo Nordisk of 'anticompetitive' actions – is now offering a compounded version at $199 per month.

https://pharmaphorum.com/news/noom-expands-its-glp-1-range-microdose-package

Chipmaker TSMC uncovers potential trade secrets theft, three arrested in Taiwan

 Taiwan Semiconductor Manufacturing Company, the world’s largest chipmaker, said Tuesday it had discovered “unauthorized activities” of employees suspected of stealing trade secrets related to its most advanced computer chips.

TSMC, which makes chips for major firms like Apple and Nvidia, reportedly fired several workers after uncovering the security breach “during routine monitoring” and contacted Taiwanese authorities.

The Taiwan High Prosecutors Office said it had arrested three people involved in the alleged theft and had searched their homes, the Wall Street Journal reported. The probe began after TSMC observed them accessing secure company files.

“TSMC maintains a zero-tolerance policy toward any actions that compromise the protection of trade secrets or harm the company’s interests,” the company said in a statement.

“Such violations are dealt with strictly and pursued to the fullest extent of the law,” the company added. “We remain committed to safeguarding our core competitiveness and the shared interests of all our employees.”

Nikkei Asia earlier reported that the company had fired multiple employees suspected of trying to steal information related to its leading-edge 2-nanometer chips, which are set to enter mass production later this year.

TSMC did not provide further specifics since the case is still under judicial review.

US and Taiwanese officials have expressed growing alarm about the theft of trade secrets in recent years as tensions rise with China.

TSMC’s work is particularly sensitive due to its roster of top clients. The company once said it has more than 200,000 trade secrets stored in its internal systems.

Computer chips are in high demand because they are needed to power artificial intelligence models. Nvidia has become the world’s most valuable company with a market valuation of nearly $4.4 trillion.

The Trump administration has cultivated closer ties with TSMC since the president took office.

In March, TSMC pledged to invest $100 billion to boost production in the US as part of a four-year project.

https://www.msn.com/en-us/money/news/chipmaker-tsmc-uncovers-potential-trade-secrets-theft-three-arrested-in-taiwan/ar-AA1JXvph

'Scientists Behind Trial of Replimmune’s [sic] Tumor Destroyer Protest FDA’s Rejection'

 

In an open letter, 22 experts who designed and ran Replimmune’s Phase III IGNYTE trial answered the FDA’s issues, as outlined in the complete response letter for the melanoma candidate RP1.

On July 23, the FDA rejected Replimmune’s oncolytic immunotherapy RP1 for advanced melanoma. The researchers who designed and ran Replimmune’s Phase III IGNYTE study assessing the drug have urged the FDA to “re-review” the company’s application.

In an open letter sent on Friday—the full text of which was posted Monday on LinkedIn by the writers—22 experts responded to several issues outlined by the FDA in its complete response letter, leading to its refusal to approve RP1. The letter was spearheaded and organized by Michael Wong, physician in chief at the Roswell Park Cancer Institute and co-first author of the IGNYTE trial. Eric Whitman, who posted the letter and is a signatory, is the director of the Atlantic Melanoma Center. Twenty other melanoma and cancer experts have attached their names to the open letter.

In rejecting RP1, the FDA cited the “heterogeneity” of the IGYNTE patient population, flagging marked differences in participants’ prior exposure to therapies and severity of disease at baseline. But what the FDA sees as a methodological shortcoming, the experts consider representative of the real-world scenario. Current treatment guidelines, they argued, “show multiple treatment pathways in both the adjuvant and advanced disease setting funneling to the point of IGNYTE eligibility.”

“This means that this real-world population will be, by necessity, heterogeneous,” the open letter reads.

The FDA also raised questions about RP1’s efficacy, noting that given IGNYTE’s design—RP1 was tested in combination with Bristol Myers Squibb’s PD-1 blocker Opdivo (nivolumab)—it is difficult to establish RP1’s contribution to the documented response rate.

To address this concern, the experts argued, Replimmune would have to run a control arm with Opdivo monotherapy. But IGNYTE’s enrollment is already “rigorous,” they added, with patients receiving at least eight weeks of continuous anti-PD-1 therapy. Participants also need to stay on PD-1 treatment throughout the trial and have experienced disease progression on two occasions at least a month apart.

“A nivolumab monotherapy control arm would be impractical, unacceptable and borders on the unethical,” the researchers write.

In light of these clarifications, the experts “believe that reassessment” of IGNYTE is in order “to do right by our constituents and our patients.”

RP1, also known as vusolimogene oderparepvec, is composed of a proprietary and engineered strain of the herpes simplex virus carrying a fusion protein, according to Replimmune’s website. This construct attacks cancer cells and destroys them, while simultaneously altering the tumor’s microenvironment, in turn stimulating and activating the body’s anti-cancer immune response.

In IGNYTE, the combination of RP1 with Opdivo resulted in a 32.9% overall response rate in patients with melanoma who had previously failed anti-PD-1 therapy. Complete response rate was 15% and overall survival hit 54.8% at 3 years.

https://www.biospace.com/fda/scientists-behind-trial-of-replimmunes-tumor-destroyer-protest-fdas-rejection

Orthofix beats Q2 2025 forecasts

 Orthofix Medical Inc (OFIX) reported its second-quarter 2025 earnings, surpassing expectations with an EPS of -0.36 compared to the forecast of -0.41. Revenue reached $203.12 million, exceeding the anticipated $196.16 million. Following the earnings release, Orthofix’s stock surged 15.21% in pre-market trading, reflecting investor optimism. 

Key Takeaways

  • Orthofix reported better-than-expected EPS and revenue for Q2 2025.
  • The stock price increased by 15.21% in pre-market trading.
  • Significant growth was noted in US Orthopedics and Bone Growth Therapies segments.
  • New product launches and FDA clearances highlight innovation.
  • Positive free cash flow and improved gross margins were achieved.

Company Performance

Orthofix demonstrated robust performance in Q2 2025, with a 4% year-over-year increase in net sales to $200.7 million. The company continued to strengthen its position in the spine and fracture markets, benefiting from a 7% increase in US Spine Fixation procedure volume. Orthofix’s strategic focus on product innovation and market penetration has positioned it well against competitors.

Financial Highlights

  • Revenue: $203.12 million, a 4% increase YoY.
  • Earnings per share: -0.36, beating the forecast by 12.2%.
  • Gross margin: 72.7%, up by 140 basis points.
  • Adjusted EBITDA: $20.6 million, representing 10.3% of net sales.
  • Positive free cash flow of $4.5 million.

Earnings vs. Forecast

Orthofix exceeded earnings expectations with an EPS of -0.36 against a forecast of -0.41, a positive surprise of 12.2%. Revenue also surpassed forecasts, reaching $203.12 million compared to the expected $196.16 million, marking a 3.55% surprise.

https://za.investing.com/news/transcripts/earnings-call-transcript-orthofix-beats-q2-2025-forecasts-stock-surges-93CH-3820484

Pharma prepared to work with Trump on DTC drug sales: Pfizer CEO

 Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump’s demand that drugmakers make more of their medicines available direct to consumers in the U.S. at lower cost, Pfizer CEO Albert Bourla said Tuesday.

“We have serious discussions in the industry,” Bourla told investors on a conference call Pfizer held to discuss its earnings for the second quarter. “I’m connected very often individually with all the major companies and they are all ready to roll up their sleeves and execute something like that.”

Pfizer and partner Bristol Myers Squibb recently announced plans to offer their widely-used blood thinner Eliquis at a discounted cash price through an online service. The company previously launched a direct-to-consumer service that allows patients to book telehealth appointments, schedule vaccinations and fill prescriptions for certain medicines, such as those Pfizer sells for migraine and COVID-19.

“We think it is a fantastic way to go ahead, so we will work collaboratively to do it,” Bourla said. 

Obesity drugmakers Eli Lilly and Novo Nordisk have also recently opened up more ways for cash-paying patients to access their weight loss medicines directly. Other companies are signaling interest, too, in exploring ways to sidestep pharmacy benefit managers. These drug-purchasing middlemen extract from drugmakers rebates that insurers say they use to lower overall costs, but not necessarily in ways that are obvious to a prescription-filling patient.

Expanding direct-to-consumer options was one of four demands Trump made of the pharmaceutical industry last week in letters issued to 17 drugmakers, including Pfizer. 

In those letters, the president threatened to use “every tool” the U.S. government has available if the companies don’t take steps to lower the cost of their products to the prices paid in other industrialized countries. Such a “most favored nation” policy could be a major blow to the industry, although analysts are divided on how sweeping its impact would be if limited only to Medicaid, as Trump indicated.

On Tuesday’s call, Bourla said he is in “active discussions” at the “highest levels of the U.S. government,” including conversations with Trump, Health and Human Services Secretary Robert F. Kennedy Jr., and Centers for Medicare and Medicaid Services Administrator Mehmet Oz. In addition to leading Pfizer, Bourla is the current board chair of industry lobbying group PhRMA.

“The letter asks a lot from us,” Bourla added. “But we are engaged in productive discussion with them and in general I’m happy with the way that they listen to us.”

Pricing threats aren’t the only challenge drugmakers face in the U.S. The Commerce Department is nearing the end of an investigation into pharmaceutical imports expected to result in sector-specific tariffs. On Tuesday, Trump told CNBC that his administration will initially impose a small levy on pharmaceuticals that could later rise as high as 250% over time.

Such duties would be costly for drugmakers, but analysts believe a phase-in period would allow many companies to adjust their supply chains in such a way that the worst financial hit could be mitigated. Already, most of the largest drugmakers have announced major manufacturing investments in the U.S.

Pfizer anticipates that it can absorb the impact of tariffs this year, as well as any changes it makes to its products’ prices, while still meeting its financial forecast of $61 billion to $64 billion in revenue. On Tuesday, the company raised its guidance for adjusted diluted earnings per share by 10 cents.

https://www.biopharmadive.com/news/pharma-prepared-to-work-with-trump-on-dtc-drug-sales-pfizer-ceo/756783/