First Opinion is STAT’s platform for fascinating, 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 obtained in response to them. You’ll be able to submit a Letter to the Editor right here, or discover the submission type 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 need to appropriate 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 exterior the U.S. within the brief time since our medication was accepted.
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 gradual. CAB LA for PrEP was first accepted in December 2021 by the U.S. FDA, underneath the model title Apretude. Solely 5 months later we introduced we have 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 growing CAB LA for PrEP to increase capability and enhance affordability in resource-limited settings.
We’re offering expertise switch help 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 top 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 give attention to SSA, the place the burden of HIV is best. These rollouts began with our world 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 out there in resource-limited settings. We’re proud to say that CAB LA for PrEP can be being rolled out in Zimbabwe, Malawi, Eswatini, and Ukraine; and 14 L&MICs are deliberate to have provide by the top of this yr. When put next with typical timelines, our strategy has resulted in one of many fastest-ever rollouts of a drugs as advanced as CAB LA for PrEP.
One other instance of our profitable entry to medicines strategy are the 24 million folks residing with HIV throughout 128 L&MICs who’re on generic formulations of our dolutegravir-based medicines — representing no less than 90% of individuals residing with HIV on antiretrovirals in these nations. Opposite to the authors’ suggestion, we conduct research in various populations that symbolize the populations most impacted by HIV and the place the necessity is best, and we proceed to help these communities after the medical 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 might considerably profit from larger selection 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 medical trial for CAB LA for PrEP for girls in SSA and why these nations have been amongst the primary to obtain it. We provide medical trial members entry to our medicines by post-trial entry applications and are doing that now for members within the part III registrational HPTN 083 and 084 PrEP research. Though there’s nonetheless work to be accomplished, ViiV Healthcare has been an business chief in medical trial range. In partnership with the HIV Prevention Trials Community, the united statesNIH, and Invoice & Melinda Gates Basis, we’ve carried out a few of the most various and complete HIV prevention trials to this point. HPTN 083 included a few 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 group, 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 residing with HIV — discovering methods to make medicines higher, serving to educate folks and preventing stigma. I’ve seen how advances in drugs, from day by 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 progressive, long-acting choices for HIV. ViiV Healthcare, majority owned by GSK, is the one pharmaceutical firm 100% targeted on HIV. We’re dedicated to ending the HIV epidemic. Crucial to that dedication is enabling entry to our medicines to learn folks residing with or impacted by HIV, no matter who they’re or the place they reside. We received’t cease till we finish HIV for good.
— Kimberly Smith, M.D., M.P.H, senior vice chairman and head of analysis & growth, ViiV Healthcare
the story
“Compounded semaglutide is an ill-defined public well being disaster,” by Vishal Khetpal
the response
Just lately my apply expanded GLP-1 prescribing to compounding pharmacies because of price points. The facility and effectiveness of the medicines in compounded type appeared nearly as good as business type. When caring for folks preventing tooth and nail for management of ailments like diabetes, weight problems, and compulsive issues, this class of medication is commonly very efficient. I’ve not used semaglitide because of its considerably extra GI unwanted effects. We at the moment 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 subsequent six months.
The manufacturing and management of offering the drugs shouldn’t be as burdensome as it’s. When hope is there and efficacy out there, why would docs not assist their sufferers in getting the drugs on the named value? Like pointing sufferers to GoodRx coupons, we apply in a contemporary speakeasy in America. Greed and roadblocks create boundaries to straight ahead caring for folks. Insurance coverage firms will increasingly more block entry to medicines as a result of it’s not worthwhile. Corporations doing the analysis will promote medication in manners to maximise income and now have to hunt approval with payers. All of the whereas the overwhelming majority of our insured populations is barred from getting the most effective drugs for his or her sicknesses.
— Adam Schwarz, non-public apply
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 check’ on mice for antidepressant analysis,” by Karen S. Greenberg
the response
Of be aware, these “checks” are “presumed” to imitate despair. Additionally, present psychiatrists are likely 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 spanking new medicines.
— Alfred Jonas, non-public apply
the response
Karen S. Greenberg’s piece in regards to the abject failure of the compelled swim check to yield therapies or cures for despair in people is spot on. My work includes urgent main pharmaceutical firms to desert pointless checks, together with this one — and I’m heartened by the numerous which have accomplished so after realizing their fruitlessness and cruelty. The compelled swim check 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 check secure and efficient in animals fail in human medical trials. Different animals really feel ache and concern simply as people do, however elementary 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 technique to propel science ahead by changing archaic experiments on animals with superior human-relevant strategies. These strategies — organs-on-chips, cell-based checks 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 long gone time to finish our reliance on crude experiments utilizing different species and embrace trendy, human-relevant strategies.
— Emily Trunnell, Folks for the Moral Remedy 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 degree of affected person care. Even Spock had bother actually connecting with others, and he was half human. As entertaining as it’s to examine and think about 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 won’t be able to successfully take off of suppliers’ shoulders.
The kindest of prompted phrases for synthetic “comfortable abilities” won’t ever have the identical impact as a human one that can empathize together with your state of affairs or no less than think about it. As an ophthalmologist, I’ve had the disagreeable function of getting to tell sufferers that their decline in eye operate is irreversible, and that they’ll by no means be capable of 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 expertise, we should proceed to instill the significance of soppy abilities 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 meet such roles. Whereas the numerous extra challenges to the doctor scarcity aren’t misplaced on me, as knowledgeable, a father, and a human being, improvements in AI needs to be targeted elsewhere, similar 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 respect the attitude that AI language fashions, when used appropriately, may 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 no less than thought-provoking.
This has led me to query whether or not the most effective resolution for robotic well being care professionals is a larger reliance on expertise. I acknowledge and agree with the potential worth of generative AI in drugs, however maybe we’re overlooking a extra elementary concern in well being care schooling. 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 that means hooked up. These exist and lengthen past knowledge and diagnoses. The idea of narrative drugs, though not new, is commonly underemphasized in apply. I consider well being care schooling should embrace extra coaching targeted on empathy, understanding, and self-awareness. These parts are important for enhancing affected person care and for addressing the rising downside of practitioner burnout.
Occupational remedy, as an example, deeply values the non-public narratives of sufferers, utilizing their life tales and experiences to information individualized interventions and to advertise significant engagement in day by day actions. When well being care suppliers be taught that therapeutic typically happens between the information factors, they turn into higher geared up to attach with sufferers and their households. A larger 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 may extra successfully mirror on their very own experiences as care suppliers. By weaving narrative drugs into well being care schooling, we interrupt the round dependency created by counting on AI to handle empathy deficits. Ultimately, actual human connection can’t be changed by expertise, and we should be sure that well being care staff are geared up with the talents to supply real care and understanding.
— Christopher Alterio, Rochester Institute of Know-how
the story
“Well being care value regulation is undemocratic,” by Ge Bai
the response
Earlier than entering into my considerations, I need to acknowledge that Dr. Bai raises necessary points with the U.S. well being care system, similar to affordability throughout 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 checks, and the undue affect of business in well being care policymaking. These, together with different subjects raised by Dr. Bai, require consideration.
That mentioned, Dr. Bai’s predominant competition — that value laws in well being care all the time represent a “internet damaging for sufferers and society” and represent “a lifeless finish” — flies within the face of serious proof on the contrary. Our financial peer nations spend considerably much less per capita towards their well being care programs, whereas sustaining excessive ranges of entry, and sometimes having fun with higher inhabitants well being outcomes for well being care-amenable situations. Additionally it is 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 applications) 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 programs to regulate prices, Dr. Bai recommends “selling competitors — the one time-tested strategy to ship optimum outcomes for customers.” Once more, there’s a sizable literature demonstrating the bounds to market-based pricing reforms. Steep data asymmetry between suppliers and sufferers, the lack of many sufferers (and notably weak ones) to navigate advanced programs in searching for care at a value they deem applicable, and the boundaries to entry that come up when sufferers are requested assume extra “pores and skin within the sport” by larger publicity to the price of their care; these are just some of the problems that come up from a market-based strategy to lowering costs. I wrestle to give you a single nation with a high-performing well being care system that takes a strictly market-based strategy to lowering well being care costs. Even the supposedly market-oriented Swiss system employs a world payment schedule on the nationwide degree 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 revealed 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 help authorities motion to regulate the costs of well being care providers, suggesting these insurance policies can be nicely throughout the expectations of the general public concerning applicable authorities motion. A ballot launched from the Kaiser Household Basis finds that 85% of voters help 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.
Slightly than relegating the dedication of costs to market forces, the U.S. authorities ought to take heed 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 comply with California’s lead on banning poisonous chemical compounds 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 know it. How can we encourage our medical professionals to make this alteration and comply with California? How can we get this data out to most of the people in order that they know what’s going on? I consider this alteration must happen and wish 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 therapy,” by Brian Hurley and Paul N. Samuels
the response
I used to be so comfortable to learn your article, and to see that a difficulty that I’m dealing with is being addressed in such a complete and strong style. You’ve accomplished a improbable job articulating an issue that’s near dwelling for me. I’m being denied entry to high quality habit therapy as a result of I’ve been compelled to enroll in Medicare. I’ve searched tirelessly for a therapy heart that may take me in, however to date it has been the identical with each place I’ve known as. No person desires to just accept Medicare because it exists at the moment, 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 therapy 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 needed to briefly share with you my expertise, and thanks on your improbable article.
— Isiah Doolen
