First Opinion is STAT’s platform for attention-grabbing, illuminating, and provocative articles in regards to the life sciences writ massive, written by biotech insiders, well being care staff, 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’ll be able to submit a Letter to the Editor right here, or discover the submission kind on the finish of any First Opinion essay.
the story
“Examined in Africa, utilized in America,” by Mark Siedner and Rochelle Walensky
the response
We wish to right the document on ViiV Healthcare’s dedication to offering entry to long-acting injectables for HIV prevention, or PrEP, to the communities that want it most, and our accomplishments outdoors the U.S. within the quick time since our drugs was authorised.
The authors incorrectly state that cabotegravir long-acting for HIV prevention, or CAB LA for PrEP, stays largely unavailable in sub-Saharan Africa (SSA) and that its rollout was sluggish. CAB LA for PrEP was first authorised in December 2021 by the U.S. FDA, below the model identify Apretude. Solely 5 months later we introduced we had been negotiating a voluntary license with the Medicines Patent Pool for patent rights. By July 2022, we introduced the signing of that licensing settlement, enabling generic producers to start out creating CAB LA for PrEP to broaden capability and enhance affordability in resource-limited settings.
We’re offering know-how switch assist to the producers, however whereas that course of is ongoing, ViiV is delivering CAB LA for PrEP to low-income and SSA nations at a not-for-profit value. By the tip of 2023, we had dedicated to supply over 1 million doses of CAB LA for PrEP to lower- and middle-income nations (L&MICs) over 2024-2025, with a deal with SSA, the place the burden of HIV is best. These rollouts began with our international well being companions at a document tempo. For instance, in Zambia, we started offering CAB for PrEP in February 2024, which signifies that inside two years of Apretude’s approval within the U.S., we’ve made long-acting CAB for PrEP accessible in resource-limited settings. We’re proud to say that CAB LA for PrEP can also be being rolled out in Zimbabwe, Malawi, Eswatini, and Ukraine; and 14 L&MICs are deliberate to have provide by the tip of this 12 months. Compared with typical timelines, our strategy has resulted in one of many fastest-ever rollouts of a drugs as complicated as CAB LA for PrEP.
One other instance of our profitable entry to medicines strategy are the 24 million folks dwelling with HIV throughout 128 L&MICs who’re on generic formulations of our dolutegravir-based medicines — representing not less than 90% of individuals dwelling with HIV on antiretrovirals in these nations. Opposite to the authors’ suggestion, we conduct research in various populations that signify the populations most impacted by HIV and the place the necessity is best, and we proceed to assist these communities after the scientific trials have concluded. Because the authors level out, a key inhabitants at best threat in SSA is adolescent ladies and younger girls — a bunch that would considerably profit from higher alternative in HIV prevention choices. In a few of these nations, younger girls are twice as more likely to purchase HIV as their male counterparts, with greater than 5,000 adolescent ladies and younger girls buying HIV each week.
That nice unmet want is exactly why we carried out our massive scientific trial for CAB LA for PrEP for girls in SSA and why these nations have been amongst the primary to obtain it. We provide scientific trial individuals entry to our medicines via post-trial entry packages and are doing that now for individuals within the part III registrational HPTN 083 and 084 PrEP research. Though there may be nonetheless work to be performed, ViiV Healthcare has been an business chief in scientific trial range. In partnership with the HIV Prevention Trials Community, the usNIH, and Invoice & Melinda Gates Basis, we’ve carried out a number of the most various and complete HIV prevention trials so far. HPTN 083 included a number of the largest numbers of transgender girls and Black males having intercourse with males ever enrolled in a prevention trial. HPTN 084 included greater than 3,000 cisgender girls at 20 websites throughout seven African nations.
I’ve been working with the HIV neighborhood, treating sufferers, and doing HIV analysis for the reason that early days of the AIDS epidemic. I’ve spent the higher a part of my life caring for and advocating on behalf of individuals dwelling with HIV — discovering methods to make medicines higher, serving to educate folks and preventing stigma. I’ve seen how advances in drugs, from each day oral tablets to long-acting injections, are altering lives. I’m proud to be a part of ViiV Healthcare, the corporate that pioneered these revolutionary, long-acting choices for HIV. ViiV Healthcare, majority owned by GSK, is the one pharmaceutical firm 100% centered on HIV. We’re dedicated to ending the HIV epidemic. Crucial to that dedication is enabling entry to our medicines to learn folks dwelling with or impacted by HIV, no matter who they’re or the place they reside. We gained’t cease till we finish HIV for good.
— Kimberly Smith, M.D., M.P.H, senior vice chairman and head of analysis & improvement, ViiV Healthcare
the story
“Compounded semaglutide is an ill-defined public well being disaster,” by Vishal Khetpal
the response
Lately my observe expanded GLP-1 prescribing to compounding pharmacies as a result of price points. The facility and effectiveness of the drugs in compounded kind appeared nearly as good as industrial kind. When caring for folks preventing tooth and nail for management of ailments like diabetes, weight problems, and compulsive issues, this class of drugs is commonly very efficient. I’ve not used semaglitide as a result of its considerably extra GI uncomfortable side effects. We at present surveyed our 104 sufferers utilizing GLP-1, and 68% obtain the medicine from compounding pharmacies. Sixty p.c plan to make use of the medicine for greater than the following six months.
The manufacturing and management of offering the medication shouldn’t be as burdensome as it’s. When hope is there and efficacy accessible, why would docs not assist their sufferers in getting the medication on the named value? Like pointing sufferers to GoodRx coupons, we observe in a contemporary speakeasy in America. Greed and roadblocks create boundaries to straight ahead caring for folks. Insurance coverage corporations will an increasing number of block entry to drugs as a result of it’s not worthwhile. Firms doing the analysis will promote medication in manners to maximise earnings and still have to hunt approval with payers. All of the whereas the overwhelming majority of our insured populations is barred from getting the very best drugs for his or her diseases.
— Adam Schwarz, non-public observe
the response
Thanks for this text. Hopefully, initiatives can be taken now and never after untold points come up because of the compounding of semaglutide.
— Jacqueline Dean-Shaw
the story
“Finish the ‘compelled swim take a look at’ on mice for antidepressant analysis,” by Karen S. Greenberg
the response
Of word, these “assessments” are “presumed” to imitate despair. Additionally, present psychiatrists are inclined to depend on ineffective therapies (as a result of they don’t know in regards to the efficient ones), which is why they’re suckers for brand new drugs.
— Alfred Jonas, non-public observe
the response
Karen S. Greenberg’s piece in regards to the abject failure of the compelled swim take a look at to yield therapies or cures for despair in people is spot on. My work includes urgent main pharmaceutical corporations to desert pointless assessments, together with this one — and I’m heartened by the numerous which have performed so after realizing their fruitlessness and cruelty. The compelled swim take a look at is only one instance of how clinging to previous, failed paradigms is stalling medical progress. Throughout the board, a staggering 90% of fundamental analysis, most of which includes animals, fails to result in efficient therapies for people. And 95% of recent medication that take a look at secure and efficient in animals fail in human scientific trials. Different animals really feel ache and worry simply as people do, however basic organic, immunological, and genetic variations make outcomes from one species inapplicable to a different. That’s why I’m additionally pushing for the adoption of PETA’s Analysis Modernization Deal, a method to propel science ahead by changing archaic experiments on animals with superior human-relevant strategies. These strategies — organs-on-chips, cell-based assessments and tissue fashions, superior pc modeling, and extra — are humane, correct, and supply actual hope of the breakthroughs we desperately want. For the sake of animals in addition to people affected by debilitating and lethal ailments, it’s gone time to finish our reliance on crude experiments utilizing different species and embrace trendy, human-relevant strategies.
— Emily Trunnell, Folks for the Moral Therapy of Animals
the story
“Can AI assist ease drugs’s empathy downside?” by Evan Selinger and Thomas Carroll
the response
I shudder to think about the uncanny valley that future sufferers might expertise if AI avatar docs ever take the place of human docs for any stage of affected person care. Even Spock had hassle actually connecting with others, and he was half human. As entertaining as it’s to examine and take into account the place the way forward for AI in well being care is headed, it behooves me to definitively reply the immediate: Empathy is one accountability that AI will be unable to successfully take off of suppliers’ shoulders.
The kindest of prompted phrases for synthetic “gentle expertise” won’t ever have the identical impact as a human one that can empathize along with your state of affairs or not less than think about it. As an ophthalmologist, I’ve had the disagreeable position of getting to tell sufferers that their decline in eye perform is irreversible, and that they’ll by no means have the ability to see like they as soon as did or maybe might lose their sight altogether — it’s a really completely different form of eye dimming, a lack of hope that may solely be picked up by one other human. It’s conditions like that the place nobody desires to be “alone” with an AI and even an empathy-trained robotic.
When forging a path ahead with know-how, we should proceed to instill the significance of sentimental expertise within the new generations of physicians, and be diligent in educating them that they need to not depend on the obscure and distant potential of AI to satisfy such roles. Whereas the numerous extra challenges to the doctor scarcity will not be misplaced on me, as knowledgeable, a father, and a human being, improvements in AI ought to be centered elsewhere, corresponding to low-risk administrative and scheduling duties and AI assistant instruments for tackling paperwork. Eradicating the mundane from suppliers’ days can do wonders to revive ardour for the business.
— Michael B. Rivers, M.D., senior director of ophthalmology, ModMed
the response
I recognize the angle that AI language fashions, when used appropriately, might assist facilitate extra empathetic communication in well being care. I additionally appreciated the ultimate sentence of the essay: “[P]rematurely concluding that AI can’t assist might unnecessarily contribute to preserving a dysfunctional system that leaves far too many sufferers seeing docs as robotic.” It struck me as probably ironic, or not less than thought-provoking.
This has led me to query whether or not the very best resolution for robotic well being care professionals is a higher reliance on know-how. I acknowledge and agree with the potential worth of generative AI in drugs, however maybe we’re overlooking a extra basic difficulty in well being care training. Coaching typically prioritizes technical and scientific facets of care, however the human physique is not only a machine to be fastened. It has a soul and intention and goal and which means hooked up. These exist and lengthen past knowledge and diagnoses. The idea of narrative drugs, though not new, is commonly underemphasized in observe. I imagine well being care training should embody extra coaching centered on empathy, understanding, and self-awareness. These components are important for bettering affected person care and for addressing the rising downside of practitioner burnout.
Occupational remedy, as an illustration, deeply values the non-public narratives of sufferers, utilizing their life tales and experiences to information individualized interventions and to advertise significant engagement in each day actions. When well being care suppliers study that therapeutic typically happens between the information factors, they turn into higher outfitted to attach with sufferers and their households. A higher emphasis on literature, the humanities, and the broader human expertise fosters empathy and enhances communication. Practitioners who’re higher listeners can inform their sufferers’ tales extra successfully and also can extra successfully replicate on their very own experiences as care suppliers. By weaving narrative drugs into well being care training, we interrupt the round dependency created by counting on AI to handle empathy deficits. In the long run, actual human connection can’t be changed by know-how, and we should be sure that well being care staff are outfitted with the abilities to supply real care and understanding.
— Christopher Alterio, Rochester Institute of Expertise
the story
“Well being care value regulation is undemocratic,” by Ge Bai
the response
Earlier than entering into my issues, I wish to acknowledge that Dr. Bai raises necessary points with the U.S. well being care system, corresponding to affordability inside the particular person market, restrictions on physician-owned hospitals, the gaming by suppliers of site-based funds and the 340B drug pricing program, value transparency within the case of presidency funds for Covid-19 assessments, and the undue affect of business in well being care policymaking. These, together with different matters raised by Dr. Bai, require consideration.
That mentioned, Dr. Bai’s foremost competition — that value rules in well being care all the time represent a “web destructive for sufferers and society” and represent “a lifeless finish” — flies within the face of great proof on the contrary. Our financial peer nations spend considerably much less per capita towards their well being care methods, whereas sustaining excessive ranges of entry, and sometimes having fun with higher inhabitants well being outcomes for well being care-amenable situations. It’s also the case that their principal mechanism for controlling prices is thru setting (or appearing as a powerful negotiator over) the costs that authorities payers, or quasi-public ‘illness funds’, reimburse for particular items and providers (i.e. a “payment schedule”). Actually, there’s a sizable literature arguing convincingly that the first driver of excessive well being care prices within the U.S. are the excessive costs paid by third-party payers (each non-public insurers and public insurance coverage packages) for medical items and providers — and the rationale for these excessive costs is the absence of government-set/negotiated costs for these items and providers.
However slightly than take the strategy of different high-performing well being care methods to manage prices, Dr. Bai recommends “selling competitors — the one time-tested solution to ship optimum outcomes for shoppers.” Once more, there’s a sizable literature demonstrating the bounds to market-based pricing reforms. Steep info asymmetry between suppliers and sufferers, the shortcoming of many sufferers (and notably weak ones) to navigate complicated methods in searching for care at a price they deem acceptable, and the boundaries to entry that come up when sufferers are requested assume extra “pores and skin within the recreation” via higher publicity to the price of their care; these are only a few of the problems that come up from a market-based strategy to decreasing costs. I battle to give you a single nation with a high-performing well being care system that takes a strictly market-based strategy to decreasing well being care costs. Even the supposedly market-oriented Swiss system employs a worldwide payment schedule on the nationwide stage that serves as the idea for regional value negotiations between associations of suppliers (on one facet) and of insurers (on the opposite).
Additionally, whereas I acknowledge that authors don’t all the time have management over the title of their printed articles, the declare that “well being care value regulation is undemocratic” flies within the face of what we all know from polling. Massive majorities of Democrats, Republicans, and independents assist authorities motion to manage the costs of well being care providers, suggesting these insurance policies can be properly inside the expectations of the general public concerning acceptable authorities motion. A ballot launched from the Kaiser Household Basis finds that 85% of voters assist new efforts by Medicare to barter the value of prescribed drugs. In a time of deep partisan divide, we have to look to those areas of consensus when crafting insurance policies to scale back well being care prices.
Quite than relegating the willpower of costs to market forces, the U.S. authorities ought to hearken to the American folks and aggressively negotiate the costs for well being care items and providers, with the purpose of bringing them according to costs paid in financial peer nations.
— Michael Harvey, Brown College College of Public Well being
the story
“The U.S. ought to observe California’s lead on banning poisonous chemical substances in IV luggage and tubes,” by Lisa Bailey
the response
Thanks a lot for this eye-opening essay! As a retired NICU nurse, it’s appalling that that is nonetheless occurring, and I’m certain not many individuals comprehend it. How can we encourage our medical professionals to make this variation and observe California? How can we get this info out to most people in order that they know what’s going on? I imagine this variation must happen and want to be concerned in making that occur. Because the saying goes, it takes a village!
— Cynthia DeMo
the story
“Congress: Shut Medicare’s harmful gaps in protection for habit remedy,” by Brian Hurley and Paul N. Samuels
the response
I used to be so blissful to learn your article, and to see that a difficulty that I’m dealing with is being addressed in such a complete and strong vogue. You’ve performed a implausible job articulating an issue that’s near house for me. I’m being denied entry to high quality habit remedy as a result of I’ve been compelled to enroll in Medicare. I’ve searched tirelessly for a remedy heart that can take me in, however to date it has been the identical with each place I’ve known as. No one desires to just accept Medicare because it exists at present, and since I’m on incapacity retirement and obtain SSDI, I’m labeled as an annuitant, which makes Medicare my main payer. With this being the case, this remedy facilities are both unwilling or incapable of charging my federal medical insurance, which is extraordinarily irritating. Most of those locations have knowledgeable me that they’d settle for my insurance coverage if not for the truth that it’s a secondary payer. I simply wished to briefly share with you my expertise, and thanks to your implausible article.
— Isiah Doolen