First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.
To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.
the story
“Tested in Africa, used in America,” by Mark Siedner and Rochelle Walensky
the response
We want to correct the record on ViiV Healthcare’s commitment to providing access to long-acting injectables for HIV prevention, or PrEP, to the communities that need it most, and our accomplishments outside the U.S. in the short time since our medicine was approved.
The authors incorrectly state that cabotegravir long-acting for HIV prevention, or CAB LA for PrEP, remains largely unavailable in sub-Saharan Africa (SSA) and that its rollout was slow. CAB LA for PrEP was first approved in December 2021 by the U.S. FDA, under the brand name Apretude. Only five months later we announced we were negotiating a voluntary license with the Medicines Patent Pool for patent rights. By July 2022, we announced the signing of that licensing agreement, enabling generic manufacturers to start developing CAB LA for PrEP to expand capacity and improve affordability in resource-limited settings.
We are providing technology transfer support to the manufacturers, but while that process is ongoing, ViiV is delivering CAB LA for PrEP to low-income and SSA countries at a not-for-profit price. By the end of 2023, we had committed to provide over 1 million doses of CAB LA for PrEP to lower- and middle-income countries (L&MICs) over 2024-2025, with a focus on SSA, where the burden of HIV is greatest. These rollouts started with our global health partners at a record pace. For example, in Zambia, we began providing CAB for PrEP in February 2024, which means that within two years of Apretude’s approval in the U.S., we’ve made long-acting CAB for PrEP available in resource-limited settings. We’re proud to say that CAB LA for PrEP is also being rolled out in Zimbabwe, Malawi, Eswatini, and Ukraine; and 14 L&MICs are planned to have supply by the end of this year. When compared with typical timelines, our approach has resulted in one of the fastest-ever rollouts of a medicine as complex as CAB LA for PrEP.
Another example of our successful access to medicines approach are the 24 million people living with HIV across 128 L&MICs who are on generic formulations of our dolutegravir-based medicines — representing at least 90% of people living with HIV on antiretrovirals in these countries. Contrary to the authors’ suggestion, we conduct studies in diverse populations that represent the populations most impacted by HIV and where the need is greatest, and we continue to support those communities after the clinical trials have concluded. As the authors point out, a key population at greatest risk in SSA is adolescent girls and young women — a group that could significantly benefit from greater choice in HIV prevention options. In some of these countries, young women are twice as likely to acquire HIV as their male counterparts, with more than 5,000 adolescent girls and young women acquiring HIV every week.
That great unmet need is precisely why we conducted our large clinical trial for CAB LA for PrEP for women in SSA and why these countries have been amongst the first to receive it. We offer clinical trial participants access to our medicines through post-trial access programs and are doing that now for participants in the phase III registrational HPTN 083 and 084 PrEP studies. Although there is still work to be done, ViiV Healthcare has been an industry leader in clinical trial diversity. In partnership with the HIV Prevention Trials Network, the U.S NIH, and Bill & Melinda Gates Foundation, we’ve conducted some of the most diverse and comprehensive HIV prevention trials to date. HPTN 083 included some of the largest numbers of transgender women and Black men having sex with men ever enrolled in a prevention trial. HPTN 084 included more than 3,000 cisgender women at 20 sites across seven African countries.
I’ve been working with the HIV community, treating patients, and doing HIV research since the early days of the AIDS epidemic. I’ve spent the better part of my life caring for and advocating on behalf of people living with HIV — finding ways to make medicines better, helping educate people and fighting stigma. I’ve seen how advances in medicine, from daily oral pills to long-acting injections, are changing lives. I’m proud to be part of ViiV Healthcare, the company that pioneered these innovative, long-acting options for HIV. ViiV Healthcare, majority owned by GSK, is the only pharmaceutical company 100% focused on HIV. We are committed to ending the HIV epidemic. Critical to that commitment is enabling access to our medicines to benefit people living with or impacted by HIV, regardless of who they are or where they live. We won’t stop until we end HIV for good.
— Kimberly Smith, M.D., M.P.H, senior vice president and head of research & development, ViiV Healthcare
the story
“Compounded semaglutide is an ill-defined public health crisis,” by Vishal Khetpal
the response
Recently my practice expanded GLP-1 prescribing to compounding pharmacies due to cost issues. The power and effectiveness of the medications in compounded form appeared as good as commercial form. When caring for people fighting tooth and nail for control of diseases like diabetes, obesity, and compulsive problems, this class of medicine is often very effective. I have not used semaglitide due to its significantly more GI side effects. We currently surveyed our 104 patients using GLP-1, and 68% receive the medication from compounding pharmacies. Sixty percent plan to use the medication for more than the next six months.
The production and control of providing the medicine should not be as burdensome as it is. When hope is there and efficacy available, why would doctors not aid their patients in getting the medicine at the named price? Like pointing patients to GoodRx coupons, we practice in a modern speakeasy in America. Greed and roadblocks create barriers to straight forward caring for people. Insurance companies will more and more block access to medications because it’s not profitable. Companies doing the research will promote drugs in manners to maximize profits and also have to seek approval with payers. All the while the vast majority of our insured populations is barred from getting the best medicine for their illnesses.
— Adam Schwarz, private practice
the response
Thank you for this article. Hopefully, initiatives will be taken now and not after untold issues arise as a result of the compounding of semaglutide.
— Jacqueline Dean-Shaw
the story
“End the ‘forced swim test’ on mice for antidepressant research,” by Karen S. Greenberg
the response
Of note, these “tests” are “presumed” to mimic depression. Also, current psychiatrists tend to rely on ineffective treatments (because they don’t know about the effective ones), which is why they’re suckers for new medications.
— Alfred Jonas, private practice
the response
Karen S. Greenberg’s piece about the abject failure of the forced swim test to yield treatments or cures for depression in humans is spot on. My work involves pressing major pharmaceutical companies to abandon pointless tests, including this one — and I’m heartened by the many that have done so after realizing their fruitlessness and cruelty. The forced swim test is just one example of how clinging to old, failed paradigms is stalling medical progress. Across the board, a staggering 90% of basic research, most of which involves animals, fails to lead to effective treatments for humans. And 95% of new drugs that test safe and effective in animals fail in human clinical trials. Other animals feel pain and fear just as humans do, but fundamental biological, immunological, and genetic differences make results from one species inapplicable to another. That’s why I’m also pushing for the adoption of PETA’s Research Modernization Deal, a strategy to propel science forward by replacing archaic experiments on animals with advanced human-relevant methods. These methods — organs-on-chips, cell-based tests and tissue models, advanced computer modeling, and more — are humane, accurate, and offer real hope of the breakthroughs we desperately need. For the sake of animals as well as humans suffering from debilitating and deadly diseases, it’s long past time to end our reliance on crude experiments using other species and embrace modern, human-relevant methods.
— Emily Trunnell, People for the Ethical Treatment of Animals
the story
“Can AI help ease medicine’s empathy problem?” by Evan Selinger and Thomas Carroll
the response
I shudder to think of the uncanny valley that future patients may experience if AI avatar doctors ever take the place of human doctors for any level of patient care. Even Spock had trouble truly connecting with others, and he was half human. As entertaining as it is to read about and consider where the future of AI in health care is headed, it behooves me to definitively answer the prompt: Empathy is one responsibility that AI will not be able to effectively take off of providers’ shoulders.
The kindest of prompted phrases for artificial “soft skills” will never have the same effect as a human person who can empathize with your situation or at least imagine it. As an ophthalmologist, I’ve had the unpleasant role of having to inform patients that their decline in eye function is irreversible, and that they’ll never be able to see like they once did or perhaps may lose their sight altogether — it’s a very different kind of eye dimming, a loss of hope that can only be picked up by another human. It’s situations like that where no one wants to be “alone” with an AI or even an empathy-trained robot.
When forging a path forward with technology, we must continue to instill the importance of soft skills in the new generations of physicians, and be diligent in educating them that they should not rely on the vague and distant potential of AI to fulfill such roles. While the many additional challenges to the physician shortage are not lost on me, as a professional, a father, and a human being, innovations in AI should be focused elsewhere, such as low-risk administrative and scheduling tasks and AI assistant tools for tackling paperwork. Removing the mundane from providers’ days can do wonders to revive passion for the industry.
— Michael B. Rivers, M.D., senior director of ophthalmology, ModMed
the response
I appreciate the perspective that AI language models, when used appropriately, could help facilitate more empathetic communication in health care. I also appreciated the final sentence of the essay: “[P]rematurely concluding that AI can’t help may unnecessarily contribute to preserving a dysfunctional system that leaves far too many patients seeing doctors as robotic.” It struck me as potentially ironic, or at least thought-provoking.
This has led me to question whether the best solution for robotic health care professionals is a greater reliance on technology. I recognize and agree with the potential value of generative AI in medicine, but perhaps we are overlooking a more fundamental issue in health care education. Training often prioritizes technical and scientific aspects of care, but the human body is not just a machine to be fixed. It has a soul and intention and purpose and meaning attached. These exist and extend beyond data and diagnoses. The concept of narrative medicine, although not new, is often underemphasized in practice. I believe health care education must include more training focused on empathy, understanding, and self-awareness. These elements are essential for improving patient care and for addressing the growing problem of practitioner burnout.
Occupational therapy, for instance, deeply values the personal narratives of patients, using their life stories and experiences to guide individualized interventions and to promote meaningful engagement in daily activities. When health care providers learn that healing often occurs between the data points, they become better equipped to connect with patients and their families. A greater emphasis on literature, the arts, and the broader human experience fosters empathy and enhances communication. Practitioners who are better listeners can tell their patients’ stories more effectively and can also more effectively reflect on their own experiences as care providers. By weaving narrative medicine into health care education, we interrupt the circular dependency created by relying on AI to address empathy deficits. In the end, real human connection cannot be replaced by technology, and we must ensure that health care workers are equipped with the skills to offer genuine care and understanding.
— Christopher Alterio, Rochester Institute of Technology
the story
“Health care price regulation is undemocratic,” by Ge Bai
the response
Before getting into my concerns, I want to acknowledge that Dr. Bai raises important issues with the U.S. health care system, such as affordability within the individual market, restrictions on physician-owned hospitals, the gaming by providers of site-based payments and the 340B drug pricing program, price transparency in the case of government payments for Covid-19 tests, and the undue influence of industry in health care policymaking. These, along with other topics raised by Dr. Bai, require attention.
That said, Dr. Bai’s main contention — that price regulations in health care always constitute a “net negative for patients and society” and constitute “a dead end” — flies in the face of significant evidence to the contrary. Our economic peer countries spend substantially less per capita toward their health care systems, while maintaining high levels of access, and often enjoying better population health outcomes for health care-amenable conditions. It is also the case that their principal mechanism for controlling costs is through setting (or acting as a strong negotiator over) the prices that government payers, or quasi-public ‘sickness funds’, reimburse for specific goods and services (i.e. a “fee schedule”). In fact, there is a sizable literature arguing convincingly that the primary driver of high health care costs in the U.S. are the high prices paid by third-party payers (both private insurers and public insurance programs) for medical goods and services — and the reason for these high prices is the absence of government-set/negotiated prices for these goods and services.
But rather than take the approach of other high-performing health care systems to control costs, Dr. Bai recommends “promoting competition — the only time-tested way to deliver optimal outcomes for consumers.” Again, there is a sizable literature demonstrating the limits to market-based pricing reforms. Steep information asymmetry between providers and patients, the inability of many patients (and particularly vulnerable ones) to navigate complex systems in seeking care at a cost they deem appropriate, and the barriers to access that arise when patients are asked assume more “skin in the game” through greater exposure to the cost of their care; these are just a few of the issues that arise from a market-based approach to reducing prices. I struggle to come up with a single country with a high-performing health care system that takes a strictly market-based approach to reducing health care prices. Even the supposedly market-oriented Swiss system employs a global fee schedule at the national level that serves as the basis for regional price negotiations between associations of providers (on one side) and of insurers (on the other).
Also, while I recognize that authors do not always have control over the title of their published articles, the claim that “health care price regulation is undemocratic” flies in the face of what we know from polling. Large majorities of Democrats, Republicans, and independents support government action to control the prices of health care services, suggesting those policies would be well within the expectations of the public regarding appropriate government action. A poll released from the Kaiser Family Foundation finds that 85% of voters support new efforts by Medicare to negotiate the price of prescription drugs. In a time of deep partisan divide, we need to look to these areas of consensus when crafting policies to reduce health care costs.
Rather than relegating the determination of prices to market forces, the U.S. government should listen to the American people and aggressively negotiate the prices for health care goods and services, with the goal of bringing them in line with prices paid in economic peer countries.
— Michael Harvey, Brown University School of Public Health
the story
“The U.S. should follow California’s lead on banning toxic chemicals in IV bags and tubes,” by Lisa Bailey
the response
Thank you so much for this eye-opening essay! As a retired NICU nurse, it is appalling that this is still going on, and I am sure not many people are aware of it. How can we encourage our medical professionals to make this change and follow California? How can we get this information out to the general public so that they know what is going on? I believe this change needs to take place and would like to be involved in making that happen. As the saying goes, it takes a village!
— Cynthia DeMo
the story
“Congress: Close Medicare’s dangerous gaps in coverage for addiction treatment,” by Brian Hurley and Paul N. Samuels
the response
I was so happy to read your article, and to see that an issue that I’m facing is being addressed in such a comprehensive and robust fashion. You’ve done a fantastic job articulating a problem that is close to home for me. I’m being denied access to quality addiction treatment because I have been forced to enroll in Medicare. I have searched tirelessly for a treatment center that will take me in, but so far it has been the same with every place I’ve called. Nobody wants to accept Medicare as it exists currently, and because I’m on disability retirement and receive SSDI, I’m classified as an annuitant, which makes Medicare my primary payer. With this being the case, this treatment centers are either unwilling or incapable of charging my federal health insurance, which is extremely frustrating. Most of these places have informed me that they would accept my insurance if not for the fact that it’s a secondary payer. I just wanted to briefly share with you my experience, and thank you for your fantastic article.
— Isiah Doolen