First Opinion is STAT’s platform for fascinating, illuminating, and provocative articles concerning the life sciences writ giant, written by biotech insiders, well being care employees, researchers, and others.
To encourage strong, good-faith dialogue about points raised in First Opinion essays, STAT publishes chosen Letters to the Editor acquired in response to them. You possibly can submit a Letter to the Editor right here, or discover the submission kind on the finish of any First Opinion essay.
The story
“The NIH ordered me to cease my ‘harmful’ gain-of-function analysis. It isn’t harmful in any respect,” by Sarah Stanley
The response
I’ve been working for properly over a decade to boost consciousness about, and improve restrictions on, the small subset of microbiology analysis that might result in a big outbreak or pandemic, by way of accident or deliberate misuse. The sort of analysis, which has had totally different names by way of the years, known as “harmful gain-of-function” (DGOF) analysis in President Trump’s government order. It’s outlined as analysis “that might end in important societal penalties and that search or obtain” one in every of seven forms of modifications to infectious brokers like elevated transmissibility or virulence.
I stay in favor of tighter restrictions on such analysis and contend that there are solely very uncommon cases the place such work can justify the danger. Various, protected scientific approaches practically at all times exist that may obtain the general public well being objectives of proposed harmful gain-of-function research, and we must always assist these protected alternate options as an alternative of the DGOF approaches.
Sadly, Sarah Stanley is correct that the implementation of this government order has focused totally protected and vital analysis that doesn’t even meet the definition of DGOF within the government order. This implementation does little to make us protected. As a substitute, it has canceled experiments, together with hers, that pose no danger of widespread an infection even within the occasion of an accident, and that are a part of fundamental science that’s important for brand spanking new cures and prevention measures for tuberculosis.
Although I most likely favor tighter restrictions on some experiments than professor Stanley, I consider that arbitrarily limiting protected and productive scientific analysis will increase, moderately than reduces, the danger we face from infectious ailments. Restrictions needs to be centered on the tiny subset of analysis that really creates outbreak or pandemic danger, leaving the overwhelming majority of microbiology to proceed.
— Marc Lipsitch, Harvard T.H. Chan Faculty of Public Well being
The story
“The U.S. experiment with profit-driven well being care has failed,” by Steffie Woolhandler, David U. Himmelstein, Adam W. Gaffney, and Danny McCormick
The response
Whereas the authors make nice factors, they overlook the most important downside: the irrational expectations of the general public. We’re entitled to each attainable care possibility. And it shouldn’t price us something. Each different present well being system can be unacceptable to People as they apply cost-benefits constraints, particularly in late-stage care, which explains a number of our larger prices per capita vs. Europe. However we’ll scream “loss of life panels” and discover scapegoats to keep away from coping with realities of an unhealthy and getting older inhabitants with more and more costly methods of treating their situations.
— Robert Merold
The response
The authors are proper on course. The primary motive well being care within the U.S. is unaffordable and inaccessible is possession of hospitals, practices, and long-term care by disinterested traders. The revenue they earn needs to be going into well being care, not dividends. When one in every of us is sick, all of us are sick. We discovered that lesson painfully over the last pandemic and absolutely there will likely be one other one. The products of well being care are public items. They need to be allotted in keeping with want and paid for in keeping with capability. Our present well being care system (in case you can name it that) and the sources required to handle it are irrational, harmful and unjust. The issue is that we now have no operative notion of the widespread good in america. We favor to see every part by way of the lens of benefit and personal possession. If we don’t dump our present system and envision a brand new one by way of the lens of the widespread good, the issue will worsen and worse till it collapses totally.
— Father Charles Bouchard, Aquinas Institute of Theology
The response
The authors are appropriate in describing the failures the U.S. well being system and the position of company takeover in siphoning cash and priorities towards revenue moderately than enhancing care. Nevertheless, it’s in some ways worse that they’ve described. To say one instance: main care, the place we now have a nationwide scarcity and disaster in entry and value. At Mass Common Brigham we now have greater than 15,000 sufferers on the ready checklist for main care — sufferers of ours whose docs have left and there are not any PCP appointments accessible. I just lately discovered of a affected person who was simply discharged from the hospital and given the earliest accessible PCP follow-up appointment — December 2026! The issues have been properly documented and studied with a number of commissions in Massachusetts and from the Nationwide Academy of Drugs. However since it’s not worthwhile to put money into main care, the wants of sufferers (and PCPs to enhance their work processes) go unaddressed.
— Gordon Schiff, Brigham and Ladies’s Hospital
The story
“Company assist can not make up for threats to the NIH price range,” by Jerry Avorn
The response
Professor Avorn raises a vital subject — however reaches the incorrect conclusions. Between 2010-2019, 83% of Nationwide Institutes of Well being grants (totaling $156 billion) had been for fundamental analysis and 17% ($31 billion) had been for translational analysis.
How can we clarify this yawning chasm in program funding? The Occam’s razor clarification is that the NIH can solely approve grants that they’re requested to assessment. In different phrases, the overwhelming variety of grant requests are for fundamental science analysis. One other technique to outline “fundamental science analysis” is analysis that isn’t solely unique to tutorial researchers however that purposely excludes intramural cooperation with the biopharmaceutical business.
Such puritanical attitudes are churlish, outdated, and opposite to the scientific tenet of cooperation. Why aren’t extra tutorial researchers in search of extra translational program funding partnerships from potential business companions? One motive is that they haven’t needed to. Till just lately, with each doubling of the NIH price range, the incentives for translational business partnerships decreases. Teachers had been fishing the place the fishing was most plentiful.
Avorn fails to contemplate the broader ecosystem. Even when NIH funds grants for translational analysis, a lot of which embody human trials, they typically fail to achieve out to the FDA to vet the potential grantee’s technical assumptions — lowering the power to validate related findings and, probably, placing medical trial individuals in danger. Different areas of related however siloed information embody the FDA’s experience in biomarkers, actual world proof, and profit/danger evaluation.
Since interagency cooperation isn’t succeeding organically, it’s time for top-down initiatives led by a Well being and Human Companies “innovation czar.” Such cooperation will act as a drive multiplier, serving to to make the recipients of NIH grants extra prone to succeed.
An excellent first step can be for the NIH to contemplate necessary cross coaching for his or her inside groups and exterior grantees within the processes, procedures, and evidentiary requirements of the FDA. Doubtlessly fewer NIH-funded grants and decrease reimbursement charges for oblique prices are each very unsubtle indicators that tutorial researchers ought to look to sources aside from NIH for challenge funding.
The apparent alternative lies with increasingly common partnerships with the biopharmaceutical business. It must also drive revolutionary pondering contained in the NIH grant-making equipment. Maybe the NIH ought to create a class of “matching grants” whereby authorities assist is contingent on an applicant’s first receiving equal assist from personal sources (reminiscent of foundations and the biopharmaceutical business).
Such a paradigm shift requires abandoning the shibboleths of conventional analysis purity. It takes two to tango.
— Peter Pitts, Middle for Drugs within the Public Curiosity
The response
Thanks for this considerate and 100% correct opinion piece. Every thing you stated is what I do know to be true; is what I studied as a graduate scholar in a science, expertise, and public coverage program at George Washington College; and is what I skilled firsthand once I labored on the NIH/CC and the FDA and presently working for a pharmaceutical firm. Your phrases are compelling, however I worry solely to those that already perceive and worth how biomedical analysis is carried out in america.
Allow us to hope that individuals in positions of energy will acknowledge what’s at stake and take heed of your sage warning.
— Julie Zawisza
The story
“The origins of Covid and public well being’s uncertainty downside,” by Michaela Kerrissey and Richard J. Tofel
The response
Public well being students Michaela Kerrissey and Richard J. Tofel just lately argued in STAT that college students ought to research the unresolved debate over Covid-19’s origins as an train in grappling with uncertainty. Their impulse is admirable.
However there’s a hazard right here that echoes an earlier chapter in American science schooling: the “Educate the Controversy” marketing campaign of the early 2000s. That motion, led by advocates of clever design, urged faculties to “train each side” of evolution, presenting it as an open query moderately than a foundational reality of biology. Inside evolutionary virology, proof for a zoonotic spillover from the wildlife commerce in Wuhan stays far stronger than proof for a laboratory accident. The latter just isn’t unimaginable, however it’s extremely speculative and unsupported by information. Treating these as equal “scientific hypotheses” dangers reproducing the identical false-balance dynamic that when let pseudoscience sneak into biology curricula beneath the banner of equity. Uncertainty in science just isn’t the identical as controversy in politics. Each discipline of analysis incorporates unknowns; that’s why science progresses.
However not each unknown deserves to be framed as a dwell dispute between co-equal camps. When instructors or journalists collapse that distinction, they will inadvertently validate manufactured controversy and erode the general public’s sense of what counts as dependable information.
A greater technique to train the Covid-origin debate is to flip the body. As a substitute of asking college students to weigh “lab leak versus market spillover” as in the event that they had been symmetrical, ask them to look at why the lab-leak narrative unfold so powerfully regardless of restricted proof. What roles did media incentives, algorithmic amplification, and partisan polarization play? How did uncertainty grow to be political forex? These questions illuminate the sociology of data with out complicated it with the science itself. The purpose isn’t to suppress skepticism or shut debate. It’s to show the hierarchy of proof and the anatomy of misinformation on the similar time.
College students can and will learn the way scientists assign confidence to hypotheses, how peer assessment works, and the way information can overturn consensus. However they need to additionally see how disinformation campaigns exploit the traditional self-correction of science to recommend chaos or deceit the place there’s merely complexity. Framed that method, the Covid-origin dialogue turns into a lesson in epistemic literacy — find out how to know what is thought — moderately than one other installment of “train each side.” It arms future public-health professionals not simply with information, however with the mental instruments to acknowledge when an argument is real or manufactured.
— Philipp Markolin
The story
“The novel democratization of educational drugs,” by Jonathan Avery
The response
Jonathan Avery’s essay is strictly proper that the middle of gravity is shifting away from the previous guard. However let’s be trustworthy about why that shift is overdue. For many years, tutorial drugs has fetishized “R01 + NEJM” over real-world adoption metrics. The system has rewarded incrementalism, danger aversion, and gatekeeping disguised as rigor. NIH paylines usually vary from 10–12%. The median age for a primary R01 is 43.
That isn’t meritocracy. It’s a system optimized for endurance, not discovery. Those that got here up beneath that construction have huge mental funding in preserving it. They chair assessment panels, sit on promotion committees, and guard the strategies they had been educated in. However as Byrne Hobart and Tobias Huber argue in “Growth: Bubbles and the Finish of Stagnation,” and as Alexander Karp and Nicholas Zamiska warn in “The Technological Republic,” Western science has been trapped in a tradition of protected excellence. Sensible at refinement, timid in danger.
In the meantime, the following era is constructing in public: open-source datasets, synthetic intelligence instruments, instructional movies, and digital well being pilots that attain extra folks in every week than a print journal does in a decade. These usually are not distractions from “critical” scholarship. They’re fashionable expressions of it. I as soon as acquired a grant assessment that requested, “The place is your energy calculation?” for a pc imaginative and prescient proof-of-concept. That second captured the mismatch between our strategies of innovation and our strategies of validation. Democratization just isn’t dilution. It’s appropriate. Rigor nonetheless issues, however rigor immediately means reproducibility, transparency, and usefulness, not gatekeeping. The longer term tutorial doctor will publish instruments, information, and concepts that transfer quicker than paperwork. Tutorial drugs’s credibility downside just isn’t that it’s shedding its hierarchy, it’s that it mistook hierarchy for high quality. The brand new era of students just isn’t asking for permission. They’re rebuilding the structure of influence itself.
— Matthew Crowson, Mass Eye & Ear and Harvard Medical Faculty
The story
“The lengthy historical past of euphemisms round the usage of animals in lab analysis,” by Melanie D.G. Kaplan
The response
Melanie Kaplan’s current opinion piece, an excerpt from her new e book, “Lab Canine: A Beagle and His Human Examine the Shocking World of Animal Analysis,” raises an vital fact: Language shapes how the general public understands science. The analysis neighborhood hasn’t at all times completed sufficient to elucidate the phrases we use or the safeguards behind them.
Nevertheless, the excerpt’s declare that this language “hides” actuality to be secretive overlooks vital context and should lead readers to misconceive its true goal. In animal analysis, terminology just isn’t about softening or “soothing” actuality; it’s about precision and accountability. Phrases like “euthanasia” and “animal mannequin” have particular scientific and authorized meanings that set off outlined welfare requirements, coaching necessities, and oversight mechanisms. As an illustration, when a protocol lists “euthanasia,” it prompts a sequence of mandated veterinary assessment, authorised strategies, and public documentation.
Removed from being euphemisms, these are phrases embedded in a regulatory framework designed to guard animals and guarantee constant, humane care. Animal analysis is among the many most scrutinized areas of science within the U.S. Establishments utilizing regulated species are inspected by the Division of Agriculture — typically unannounced — and people studies are posted publicly. Federal companies publish annual counts by species and ache class, and most main packages additionally endure voluntary Affiliation for Evaluation and Accreditation of Laboratory Animal Care accreditation, including yet one more unbiased welfare audit past what the legislation requires.
Specialised language isn’t distinctive to analysis or animal-related fields. In aviation, for instance, a pilot would possibly use phrases like “managed descent” or “runway incursion” — to not downplay an issue or keep away from plain phrases like “crash” or “close to miss,” however as a result of these phrases are standardized codes that exactly outline the danger and corrective course of. They allow consultants, inspectors, and regulators to speak successfully, permitting each occasion to be traced, measured, and corrected beneath federal oversight, guaranteeing the problem doesn’t occur once more. Animal analysis terminology works the identical method: it ensures that welfare and procedural requirements are met, not masked.
Nonetheless, the analysis neighborhood can and should do extra to speak transparently. Scientists, veterinarians, animal care professionals, and compliance consultants share an obligation to proactively clarify their work and the compassion behind it. Clearer dialogue that’s grounded in information, not worry, will strengthen public belief and safeguard the scientific progress that advantages each human and animal well being.
— Naomi Charalambakis, People for Medical Progress
The story
“Mother and father of youngsters with uncommon ailments ask: How lengthy till our CRISPR miracle?” by Celena Lozano
The response
Lozano’s perspective as each a scientist and a mom is a well timed reminder that progress in uncommon illness analysis requires urgency from researchers, policymakers, and the biotech business. Precision drugs ought to begin at beginning. Immediately, most households nonetheless endure diagnostic journeys that may final years, delaying care and inflicting emotional and monetary devastation. In response to the European Journal of Human Genetics, practically 70% of uncommon ailments start in childhood, with over 80% of these being genetic in origin. In the meantime, consultants estimate that uncommon ailments price the U.S. well being system roughly $1 trillion yearly.
Fortunately, we’re beginning to see progress that meets the urgency Lozano is asking for. BEACONS is the primary U.S. multistate genomic new child screening program, funded by a $14.4 million NIH award. This system will enroll as much as 30,000 newborns in an effort to find out how entire genome sequencing will be responsibly built-in into public well being new child screening packages. Analysis like this promotes a future the place each youngster has the possibility to dwell a more healthy life ranging from beginning, whereas arming dad and mom like Lozano with the knowledge they should advocate for his or her youngsters.
Early analysis is barely a part of the answer. The present ecosystem isn’t constructed for the tempo of genomic innovation or the urgency of excessive unmet medical wants for pediatric sufferers residing with uncommon ailments. There isn’t a motive households needs to be ready a long time for an correct analysis that might enhance a toddler’s well being outlook. Lozano and each uncommon illness dad or mum like her want our system to vary. Analysis like BEACONS is a vital step to find solutions and coverings our system wants.
— Katherine Stueland, GeneDX
The story
“What RFK Jr. will get incorrect about medical college and vitamin schooling,” by Tiffany Onyejiaka
The response
Bravo to Tiffany Onyejiaka for highlighting the big, science-based position that vitamin performs within the affected person’s prevention and remedy of many persistent ailments in addition to figuring out the registered dietitian nutritionist (RDN) as an vital member of the interdisciplinary well being crew. Whereas I welcome the next degree of vitamin schooling within the medical college curriculum, I’d advocate this for under one motive. Medical docs needs to be educated that RDNs are well-trained in personalised medical vitamin remedy so they need to refer their sufferers to those vitamin professionals.
An orthopedic surgeon is aware of the worth of bodily remedy within the pre- and post-treatment of their sufferers. They don’t, nevertheless, present this remedy. Fairly, they refer them to the professional bodily therapist. RDNs are the vitamin consultants and a useful member of the crew.
— Joan Salge Blake, Boston College
The story
“An insurance coverage firm is introducing a brand new risk to American drugs,” by Ryan Nadelson
The response
One side I respect about Ryan Nadelson’s article is that he cited a research to exhibit his viewpoint on doctor burnout and burdensome paperwork. His quotation makes his view credible. If Cigna cited any goal research to assist their view, that physicians are upcoding medical visits falsely, we don’t find out about such research on this article. I want to know what’s the supply that helps their claims.
In immediately’s political local weather, legislators will freely accuse reliable customers of presidency providers of fraud and different misdeeds, with out substantiating these claims. Cigna could not have adopted this web page from the conservative politicians’ playbook, but when they did, they’re importing weak authorities techniques into the world of well being care decision-making. Whether or not the group making these accusations justifies their assertions as efforts to save lots of taxpayers {dollars} or get traders a greater return, the general public who’s affected by the results of draconian insurance policies deserves higher documentation of the fraud they’re being accused of. If docs grow to be victims of unfastened claims of fraud, the general public has motive to view docs as untrustworthy. Cigna’s prices, substantiated or not, significantly undermine the bedrock relationship of belief between docs and their sufferers. I discover this subject to be very unsettling. Thanks for overlaying it.
— Marty Perry
The response
The ideas specified by this opinion piece are woefully one-sided. Sure, well being insurers are getting extra revolutionary. However guess what? So are suppliers — docs, caregivers, and many others. Simply for instance, increasingly suppliers are doing their medical coding and billing utilizing AI. After copious quantities of {dollars} misplaced (and upset shareholders), the insurers seemed to the claims they had been despatched and realized that there was a pattern of high-level submissions amongst sure docs. These docs coded and billed utilizing AI brokers and people submissions had been incorrect, bordering on fraud. Naturally, well being insurers are actually actively combing by way of claims, and as this text said, are downcoding the place relevant.
Simply wait till insurers begin the claims approval course of through AI to fight the AI generated submissions. The complications that may trigger the overall populace will likely be legendary.
— Christopher Aliprantis, medical health insurance IT professional
The response
I learn with concern your current reporting on Cigna’s new coverage to downgrade doctor billing primarily based on peer comparisons. As an unbiased doctor in a small follow, I’ve seen firsthand how insurers exert outsized management over reimbursement—with little transparency or accountability.
Starting this July, each Cigna and Aetna abruptly started paying me about two-thirds of the contracted fee I had been receiving, with out warning or clarification. At first, when my billing crew known as, we had been instructed: “Our mistake, we utilized the incorrect contract — submit an attraction and wait 30 days.” After a number of appeals, audits, and hours on the cellphone, the story shifted: Abruptly, these decrease funds had been supposedly the “appropriate contracted charges.” However that is mindless — particularly since reimbursements for a similar analysis and administration codes range extensively throughout claims, and this inconsistency solely began a yr into my new follow.
The fact is that insurers maintain all the facility. There isn’t a mechanism to carry them accountable for unexplained fee delays or underpayments — issues that may destabilize a small follow’s money movement in a single day. To maintain my follow afloat, I’ve needed to shorten appointment occasions once more, immediately impacting affected person care. When giant insurers like Cigna or Aetna can unilaterally alter doctor reimbursement with out oversight, sufferers finally lose. Transparency, consistency, and accountability are badly wanted if unbiased practices are to outlive — and if sufferers are to maintain entry to personalised care outdoors of enormous hospital programs.
— Gordon Hill, M.D.
The response
Good for Cigna! As a veteran medical neurologist and as a affected person I’ve witnessed extreme upcoding by too quite a few physicians to rely. I’ve seen physicians pop their head into an examination or hospital room whereas I’m doing a full examination on a affected person and cost them as a 4 or 5 degree go to. Disgusting! This has gone on for years. How can these physicians sleep at night time? Typically I’ve mentioned this with buddies after taking a look at their clarification of advantages after witnessing these temporary medical encounters after which later assessing the costs. I can personally say I’ve not been a perpetrator of med insurance coverage fraud like this.
In some way these physicians rationalize it. Their pondering most likely goes like this: “Effectively, they aren’t paying me sufficient for a degree one or two go to so I’ll upcode.” I say to physicians on the market: Show it. Show you’ve got spent the time you spent with the affected person and show the complexity of your choice making and administration. Cigna wouldn’t have to do that if physicians had been trustworthy.
— Robert Feldman