Eddie Cliff

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...

Viewpoint: The reintroduction of the most favored nation pricing policy aims to curb high US drug prices but faces legal and operational challenges.

ja.ma/4lXJcYs

Just out @jama.com, led by Ian Liu we review 10 years of nononcology accelerated approvals

12/50 vaccines
10 nonmalignant haem
11 neurology
5 nonvaccine ID

>60% conversions to regular approval based on surrogate endpoints
jamanetwork.com/journals/jam... @portalresearch.org @akesselheim.bsky.social

Regulatory and Clinical Outcomes of Nononcology Accelerated Approvals

The US FDA accelerated approval pathway spans many nononcologic diseases, especially nonmalignant hematology and neurology, with 25% for infectious disease vaccines.

https://ja.ma/4lRpuge

Currently at #EHA2025: @broeckelmann.bsky.social presenting our recent @thelancethaem.bsky.social commission on adverse events, starting with our paper (with @biostatgirl.bsky.social) on advancing the measurement & dissemination of AE data HT @eddiecliff.bsky.social #EHA25

🔍Presenting at #ASCO25 as a #poster and now LIVE on our website

Predictors of withdrawal of anticancer drug indications granted accelerated approval: a retrospective cohort study

Read the whole paper here: www.thelancet.com/journals/ecl...
#TheLancet #Oncology #OncologyResearch #MedSky

Announcing the 1st paper of ‪@thelancethaem.bsky.social‬ Commission on Adverse Events, with Drs. @biostatgirl.bsky.social‬ & Thanarajasingam.

We review advances in measuring & reporting newly-described AEs and provide analytic & AE visualization tools for dissemination.

buff.ly/SchRHhq
Thread ⬇️🧵

What steps can trialists, regulators, journals, editors, reviewers, sponsors & academics take to improve toxicity reporting & identification?

👇 check out this figure from our @thelancethaem.bsky.social adverse event commission

www.thelancet.com/journals/lan... @broeckelmann.bsky.social

For the third (open access) paper, I was humbled to coordinate an international author panel to comprehensively summarize challenges, lessons learned and outline future strategies for tolerability assessment with novel, targeted therapeutic approaches: doi.org/10.1016/S235...

Non-relapse mortality with bispecific antibodies: A systematic review and meta-analysis in lymphoma and multiple myeloma This systematic review and meta-analysis examined non-relapse mortality, referring to death unrelated to cancer relapse/progression, in patients with lymphoma and myeloma treated with bispecific antib...

www.cell.com/molecular-th...

The latest in a trio of meta-analyses by Tobias, David & Kai just out at Molecular Therapy, on non-relapse mortality after bispecific antibodies in lymphoma & myeloma.

>70% of non-relapse deaths are due to infection.

Need to prioritise measurement, reporting, prophylaxis, early intervention.

Just out @jama.com

Led by Dr Hwang we show when oncology drugs withdrawn due to negative trials are still accessible off-abel, prescribing plummets anyway

Romidepsin a notable exception, unsurprising to lymphoma docs who use it in TFH lymphomas

jamanetwork.com/journals/jam... @portalresearch.org

Delighted Piers Blombery joined us to discuss CAR transgenic T-cell lymphoproliferative neoplasms & all things post-CAR-T malignancies on Blood Cancer Talks, with a side helping of molecular haematology. We discuss Piers' recent NEJM paper plus recent MSKCC case w transgene integration into TP53.

Blood Cancer Talks Education Podcast · 57 Episodes · Updated Semimonthly

A real honour to have Dr Hagop Kantarjian, M.D. on the podcast to talk all things CML, including the recent ASCEMBL trial - a really enjoyable hour packed full of wisdom!

podcasts.apple.com/us/podcast/b...

Check out Blood Cancer Talks on your favourite podcast platform. #leusm #leukemia #cml

Circulating Tumor DNA as Measurable Residual Disease in Aggressive B-Cell Lymphoma This narrative review explores how the identification of measurable residual disease through methods of detecting circulating tumor DNA contributes to outcomes for B-cell lymphomas.

Helpful review on ctDNA in aggressive B-cell lymphomas just out in @jama.com oncology jamanetwork.com/journals/jam... #lymsm #lymphoma

Enticing data for axi-cel in high risk upfront DLBCL in ZUMA-12 3 year followup @BloodJournal

75% 3-year progression free survival

ashpublications.org/blood/articl...

Randomised ZUMA-23 data eagerly awaited

#lymsm #lymphoma

Outcomes Among Adult Recipients of CAR T-cell Therapy for Burkitt Lymphoma Key Points. Despite having relatively favorable disease kinetics, patients with relapsed/refractory BL who receive CAR T-cells have poor outcomes.Future tr

Disappointing outcomes for CAR T cells in 31 patients with relapsed/refractory Burkitt lymphoma

Tricky disease to treat. Perhaps combo of chemo and bispecific might offer better long term control

ashpublications.org/blood/articl... #lymsm #lymphoma

SYMPATICO trial - RCT of venetoclax + ibrutinib vs ibr+placebo in R/R mantle cell lymphoma just out in Lancet Oncology

www.sciencedirect.com/science/arti... #lymphoma #lymsm

Diagnosis and treatment of Burkitt lymphoma in adults: clinical practice guidelines from ERN-EuroBloodNet Burkitt lymphoma is a rare lymphoma entity that represents less than 5% of adult lymphomas. Although prognosis has improved with dose-dense therapy, Burkitt lymphoma remains an area of clinical and bi...

Updated European guideline on Burkitt lymphoma just out in Lancet Haem - www.thelancet.com/journals/lan... #lymsm #lymphoma #burkitt

How to protect HHS, FDA, NIH, and other health agencies from political interference When politicians subordinate scientific institutions to electoral interests, they undermine immediate public health efforts and inflict lasting damage on institutional credibility.

New piece led by Anushka Bhaskar @portalresearch.org in STAT First Opinion on protecting public health agencies from damaging political interference -- even the threat of which can greatly affect people's behavior: www.statnews.com/2025/01/31/p...

Will The New Administration’s FDA Be A Threat Or An Opportunity For The Public's Health? | Health Affairs Forefront As various reform ideas are proposed, the organized medical and scientific community will need to work with the new leadership at the FDA to promote positive change–and oppose initiatives that undermine the agency, its workforce, and its mission.

The new administration's FDA -- threat or opportunity for public health? A piece in Health Affairs Forefront with @akesselheim.bsky.social

www.healthaffairs.org/content/fore...

AI Devices in Neurology—Moving From Diagnosis to Prognosis This Viewpoint describes considerations for regulatory oversight in the implementation of artificial intelligence–enabled prognostic devices.

Check out important new Viewpoint from @portalresearch.org collaborators @eddiecliff.bsky.social and Kerstin Vokinger on regulatory oversight of AI-enabled medical devices in JAMA Neurology: jamanetwork.com/journals/jam...

Financial challenges of being on long-term, high-cost medications Abstract. The isocitrate dehydrogenase (IDH) inhibitor, vorasidenib, may offer a promising new treatment option for patients with IDH-mutant gliomas. Howev

Financial toxicity in cancer meds: @portalresearch.org's collaborator @eddiecliff.bsky.social and others review the potential financial implications of receiving vorasidenib for glioma and how different countries manage the high cost: academic.oup.com/nop/advance-...

Also the importance of actually assessing clinical endpoints in confirmatory studies (pubmed.ncbi.nlm.nih.gov/38583175/) ... and completing them in a timely fashion (pubmed.ncbi.nlm.nih.gov/39373384/) - studies from @eddiecliff.bsky.social Ian Liu Joseph Daval at @portalresearch.org

Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment Many cancer drugs approved through the FDA's accelerated approval pathway do not offer any survival benefit to patients. In this study, individuals expressed strong preferences for certainty that a ca...

Relevant to accelerated approval, new DCE from former @portalresearch.org fellow Huseyin Naci et al examined patient views on survival benefit for cancer drugs: "individuals expressed strong preferences for certainty that a cancer drug would offer survival benefit" www.thelancet.com/journals/lan...

Just out at JAMA Oncology, led by Parsa Erfani

We review why many efforts to improve access to oncology medicines around the world have failed so far, especially compared to infectious diseases, & offer potential strategies to improve global pharmacoequity

jamanetwork.com/journals/jam...

Agree needs a core biopsy - don’t want to miss lymphoma! (But then I would say that wouldn’t I?)

Just out in Nature Reviews Clinical Oncology: we explain why ibrutinib's mantle cell lymphoma indication should *not* have been withdrawn, dissect SHINE & TRIANGLE trial results & suggest what the FDA could have done instead rdcu.be/dmGJu
#healthpolicy #lymsm #mmsm