iiinova — where your digital self keeps evolving

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/12/2025

7/8 This isn't just theory. We also discuss logistical pathways: 🏭 Decentralized manufacturing (hub-and-spoke models). 📜 Regional regulatory frameworks (e.g., West African Health Organization). 💊 Managing survivorship and long-term side effects locally.

130

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/12/2025

6/8 The Process > The Outcome 🗳️ We propose using community boards (e.g., representing regions in Ghana) to: 🔥Deliberate. 🔥Assess disease burden. 🔥Weigh opportunity costs. 🔥Vote on prioritization. Legitimacy comes from collective deliberation, not external mandates.

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/12/2025

5/8 The Trade-offs ⚖️ Prioritizing CGTs for a few could divert resources from: ❌ Maternal/Child health ❌ Malaria/HIV/TB treatments ❌ Clean water/sanitation An exclusive focus on the "individual patient" can obscure these broader social obligations.

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/12/2025

4/8 Why does this matter for CGTs? In LMICs, funding a CAR-T program is a zero-sum game. The Communitarian framework forces a hard conversation: Does prioritizing high-cost CGTs align with the community's best interests right now?

120

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/12/2025

3/8 We propose a different path: Communitarian Ethics. 🤝 This approach asserts that an individual’s well-being is entwined with the well-being of the community. Instead of rigid rules, it promotes a flexible, context-driven approach where the community defines what is "good."

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/12/2025

2/8 In high-income countries, we usually rely on standard ethical frameworks like: 💡Deontology: The duty to care for the individual patient. 💡Utilitarianism: The greatest good for the greatest number. But in resource-constrained settings, these can feel externally imposed ...

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/12/2025

1/8 Cell and gene therapies (CGT) offer cures, but they are incredibly resource-intensive 🌍 As we consider how to expand access to these therapies to low- and middle-income countries (LMICs), how do we do so ethically and sustainably? 🧵👇 @thelancethaem.bsky.social www.thelancet.com/journals/lan...

thelancet.com

A communitarian approach to cell therapy and gene therapy access in low-income and middle-income countries

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/11/2025

Health care decisions belong with patients and their physicians, not in politics. Grateful for the AMA & @ameracadpeds.bsky.social strong statement affirming evidence-based, gender-affirming care and rejecting harmful misinformation. www.aap.org/en/news-room...

aap.org

AMA and AAP Joint Statement on Evidence-Based Health Care

The American Medical Association (AMA) and the American Academy of Pediatrics (AAP) represent hundreds of thousands of physicians nationwide. Our members provide evidence-based care with a clear, sing...

Amar Kelkar MD MPH @amarkelkar.bsky.social · 06/08/2025

There’s a lot of pushback in Congress and the agencies against health technology assessment tools (like cost-utility analysis) that would facilitate value-based negotiations. The IRA functionally disallowed QALY analyses so we have some work to do educating Congress on this and reversing that …

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 02/08/2025

Our article was one of a few recent @jama.com articles on "Most Favored Nation" drug pricing and Medicare drug price negotiation by @dusetzinas.bsky.social @thomasmd.bsky.social @benro.me and others that help explain the current state of the US drug pricing landscape. bsky.app/profile/jama...

121

Amar Kelkar MD MPH @amarkelkar.bsky.social · 02/08/2025

The urgency is real—but the “Most Favored Nation” drug pricing policy is unlikely to deliver lasting reform. In @jama.com, @eddiecliff.bsky.social and I propose accelerating and strengthening Medicare drug price negotiation to align prices with value. 🔗 jamanetwork.com/journals/jam...

Reducing Drug Prices—The Most Favored Nation Policy vs Price Negotiation

This Viewpoint discusses the most favored nation policy vs price negotiation for reducing drug prices.

241

Reposted by Amar Kelkar MD MPH

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

New in @jama.com: The 2025 “Most Favored Nation” (MFN) drug pricing policy rightly captures the necessary urgency in lowering US drug costs—but is likely to face fierce opposition. We propose accelerating & improving on Medicare drug price negotiation. jamanetwork.com/journals/jam...

Reducing Drug Prices—The Most Favored Nation Policy vs Price Negotiation

This Viewpoint discusses the most favored nation policy vs price negotiation for reducing drug prices.

152

Amar Kelkar MD MPH @amarkelkar.bsky.social · 30/07/2025

Absolutely-it is horrible that the pricing system has been gamed to maintain such high prices, especially for off patent drugs like lenalidomide!

020

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

10/ The MFN policy reflects urgency—but not durability or long-term strategy. With the right reforms, Medicare negotiation can do better: lower prices faster, fairer, and without derailing innovation. @eddiecliff.bsky.social 📰 Full Viewpoint at @jama.com: jamanetwork.com/journals/jam...

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

9/ These changes would: • Lower prices sooner • Improve equity and access • Support innovation responsibly • Strengthen Medicare and help private insurers who benchmark to Medicare rates

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

8/ Our proposal: ✔️ Let Medicare start negotiation 1 year after approval (like Germany) ✔️ Use independent cost-effectiveness assessments ✔️ Delink provider reimbursement from drug prices to align incentives

media.tenor.com

a netflix ad with a girl and the words of course i have a plan on the bottom

ALT: a netflix ad with a girl and the words of course i have a plan on the bottom

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

7/ But the IRA has a critical delay: negotiation only begins 9 years after launch (13 for biologics). During that gap, taxpayers and patients foot the bill for high prices at peak sales volume.

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

6/ We already have a better tool: Medicare drug price negotiation, passed in the 2022 Inflation Reduction Act. First-year results (which go into effect in 2026)? 📉 >50% reductions in negotiated drug prices 💸 ~$100B in projected savings over 10 years

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

5/ What’s worse, MFN could become self-defeating. If other countries raise their list prices in response, US prices would go up too, undermining the very goal of the policy.

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

4/ The 2025 order threatens to revoke FDA approvals or sue companies that resist. It also gives HHS just 30 days to set prices without specifying how. That’s a recipe for legal gridlock, not real reform.

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

3/ But MFN’s approach is deeply flawed: ❌ Legal and constitutional vulnerabilities ❌ Opaque global pricing benchmarks (obscured by secretive rebates) ❌ Risk to rare disease innovation ❌ Possible retaliation or unsafe drug imports ❌ Could unintentionally raise US prices

100

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

2/ The US pays 2–3x more for prescription drugs than peer nations. MFN aims to fix this by capping Medicare prices to the lowest paid abroad. For example: $17,000/month ➝ $900/month for a cancer drug like lenalidomide.

media.tenor.com

patrick star and squidward from spongebob squarepants are standing next to each other and asking why does cost so much

ALT: patrick star and squidward from spongebob squarepants are standing next to each other and asking why does cost so much

210

Amar Kelkar MD MPH @amarkelkar.bsky.social · 29/07/2025

Reducing Drug Prices—The Most Favored Nation Policy vs Price Negotiation

This Viewpoint discusses the most favored nation policy vs price negotiation for reducing drug prices.

152

Amar Kelkar MD MPH @amarkelkar.bsky.social · 03/07/2025

Even if you personally won't lose health insurance with this law, it will result in MANY hospital and clinic closures that will affect the quality of healthcare (including available doctors) that you receive.

000

Amar Kelkar MD MPH @amarkelkar.bsky.social · 03/07/2025

The House of Representatives is voting into the night on a massive House Resolution (HR) 1 that will result in 16 million losing healthcare coverage (~11 million on Medicaid, and ~5 million from ACA marketplaces). Call your Congressperson's office tonight and tell them to vote NO!

221

Reposted by Amar Kelkar MD MPH

🦋Dr. Natalia🕊🌻🪬 @solnatamd.medsky.social · 03/07/2025

The American Medical Association President Dr. Bobby Mukkamala. @ama-assn.org 💥Medicaid patients will lose access to care if the OBBBA is adopted.💥

411243

Reposted by Amar Kelkar MD MPH

Laurence H. Tribe @tribelaw.bsky.social · 20/06/2025

We are facing a serious threat to democracy, law, and liberty. The abuse of prosecutorial power to intimidate, investigate, and detain political opponents is upon us. It is a constitutional crisis. I will keep speaking out until public outrage overflows. I just hope it’s not too little, too late.

637170265644

Reposted by Amar Kelkar MD MPH

Jack Resneck MD @jackresneckmd.bsky.social · 07/03/2025

A coalition of all 50 state medical associations, representing hundreds of thousands of physicians and their 80 million Medicaid patients, joined to demand that Congress protect #Medicaid from the devastating $880 billion proposed cuts. (link to letter below) www.cmadocs.org/Portals/CMA/...

cmadocs.org

041

Amar Kelkar MD MPH @amarkelkar.bsky.social · 20/06/2025

Nice to see the AMA finally off the sidelines fighting for #Medicaid! Proposed changes (work reqs, cuts, red tape) threaten coverage for millions—esp in rural & underserved areas. Lawmakers must hear us: these cuts would be devastating! #MedicaidIsHealthCare searchlf.ama-assn.org/letter/docum...

searchlf.ama-assn.org

000

Reposted by Amar Kelkar MD MPH

Sherry Pagoto, PhD @drsherrypagoto.bsky.social · 30/05/2025

Viewpoint in JAMA details the consequences of the proposed cuts to NIH: ❌15% reduction in new therapies ❌reduction in life expectancy by 83M life years in the US = $8.2T ❌loss of $51B in economic output annually All to save $20B annually. The math ain't mathin.' jamanetwork.com/journals/jam...

Cutting the NIH—The $8 Trillion Health Care Catastrophe

This JAMA Forum discusses the recent budget cuts to National Institutes of Health (NIH), the effects of these cuts on scientific research and health of individuals in the US, and the prospects for cha...

17665

Reposted by Amar Kelkar MD MPH

Dana-Farber News @danafarbernews.bsky.social · 09/05/2025

In a new @bloodadvances.bsky.social study, @danafarber.bsky.social researchers led by @amarkelkar.bsky.social outline an ethical framework to allocate scarce gene therapies in blood cancers—aiming to balance fairness, need and outcomes. bit.ly/3YBdpTr

bit.ly

Amar Kelkar, MD, MPH

Dana-Farber Cancer Institute

051

Amar Kelkar MD MPH @amarkelkar.bsky.social · 08/05/2025

We need responsible reform of NIH funding (streamlining regulations!), NOT devastating cuts. Let's protect the engine of US medical innovation. 🇺🇸🔬 #ResearchMatters 6/6

Amar Kelkar MD MPH @amarkelkar.bsky.social · 08/05/2025

Reduced #NIH funding risks: ➡️ forcing institutions to downsize/close depts. ➡️ driving talent away from academia ➡️ harming long-term exploratory research (where major breakthroughs happen!💡) ➡️ potentially increasing drug prices. 💊💸 4/6 www.nejm.org/doi/full/10....

nejm.org

U.S. Research Leadership at a Crossroads — The Impact of Reducing NIH Indirect-Cost Coverage | NEJM

The Trump administration’s proposed 15% cap on indirect-cost rates for National Institutes of Health grants risks upending the paradigm that underpins American leadership in medical research.

Amar Kelkar MD MPH @amarkelkar.bsky.social · 08/05/2025

The proposed 15% ICR cap is a drastic cut 📉, much deeper than it appears due to how ICRs are actually calculated (ICR=indirect/direct) that come out to 50-60% in practice at many major institutions! This will lead to significant funding losses for institutions. 💰➡️0 3/6

Amar Kelkar MD MPH @amarkelkar.bsky.social · 08/05/2025

Indirect costs in federal grants aren't just "overhead"! They cover essential research infrastructure: labs 🧪, equipment 🔬, admin support 🧑‍💼, compliance, safety & tech transfer. These are INTEGRAL to responsible research. 2/6