William Feldman
@wbfeldman.bsky.social
Lung & ICU doctor | Faculty @harvardmed & @PORTAL_Research | Ethics Co-Chair @BrighamWomens
New on FirstView: "Patent Thickets and Product Hops: Challenges and Opportunities for Legislative Reform" by @wbfeldman.bsky.social explains the strategies pharmaceutical manufacturers use to limit generic competition — and how to overcome them. #GenericDrugs www.cambridge.org/core/journal...
Key message here is that there is actually little conflict between good care and the environment. The most effective asthma care is also best for the environment. -reduces the need to use reliever medication -reduces the number of acute exacerbations www.nice.org.uk/news/article... #RespEd #LungSky
New joint guideline recommends prescribing combination treatments for people with newly diagnosed asthma
nice.org.uk
William Feldman@wbfeldman.bsky.social · 2y agoOur latest in @nejm.org on the dilemmas of treating patients with chronic lung disease. www.nejm.org/doi/full/10....
Our latest in @nejm.org on the dilemmas of treating patients with chronic lung disease. www.nejm.org/doi/full/10....
The Moral Injury of Inhaler Prescribing | NEJM
Many inhalers that are vital for patients with asthma or COPD are associated with societal harms that can worsen the very diseases the products are designed to treat. How can this dilemma be resolved?
nejm.org
Physicians who receive money from inhaler manufacturers prescribe more inhalers in the future. New findings from Hasan Nadeem, @wbfeldman.bsky.social &co: pubmed.ncbi.nlm.nih.gov/39937634/
Association Between Industry Payments and Prescription of Inhaled Medications - PubMed
Association Between Industry Payments and Prescription of Inhaled Medications
pubmed.ncbi.nlm.nih.gov
United Health Group’s pharmacy benefit manager, Optum Rx, stopped covering Cole Schmidtknecht’s “life-changing” inhaler, suit alleges.
Man dies of asthma attack after inhaler cost skyrockets to more than $500
United Health Group’s pharmacy benefit manager, Optum Rx, stopped covering Cole Schmidtknecht’s ‘life-changing’ inhaler, suit alleges.
washingtonpost.com
🔎 New in JAMA IM: Avik Ray, @wbfeldman.bsky.social & colleagues assess the comparative effectiveness of diabetes drugs in COPD patients. They find GLP-1s & SGLT-2s are associated with lower risks of moderate or severe COPD exacerbations vs. DPP-4s during follow-up: jamanetwork.com/journals/jam...
Democrats can win back some of the public’s trust by building an agenda around game-changing ideas *if* they address systemic issues like patent abuse at their root, rather than continuing to settle for legislation that is watered down and incremental at best. 1/8 🔗 www.nytimes.com/2025/02/01/o...
🚨 Just out today (online)! 🚨 Our results show that a common argument against #QALYs (based on the use of subgroup analyses) is not justified with empirical data. With co-authors: @leah-rand.bsky.social , @wbfeldman.bsky.social, & @akesselheim.bsky.social from @portalresearch.org.
Treating COPD with DPI triple therapy had slightly lower exacerbation rates than with MDI triple therapy (about 7-9% lower). Better for patients, better for planet! Mimms write up www.mims.co.uk/triple-inhal... and BMJ paper www.bmj.com/content/387/...
Triple inhalers in COPD: no outcome disadvantage with low-carbon option, study suggests
Patients using a triple combination dry powder inhaler had a slightly lower rate of COPD exacerbations than those using a high-carbon metered-dose inhaler, a retrospective study has found.
mims.co.uk
Dry powder inhaler shows similar effectiveness and safety to metered-dose inhaler, w numerous implications including that environmentally-friendly prescribing in this case is also clinically equivalent -- led by @wbfeldman.bsky.social of @portalresearch.org in BMJ: www.bmj.com/content/387/...
Comparative effectiveness and safety of single inhaler triple therapies for chronic obstructive pulmonary disease: new user cohort study
Objective To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once daily dry powder inhaler,...
bmj.com
I'm excited to share a new study out today in @bmj.com comparing the two single-inhaler triple therapies on the US market. Brief thread below! www.bmj.com/content/387/...
Comparative effectiveness and safety of single inhaler triple therapies for chronic obstructive pulmonary disease: new user cohort study
Objective To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once daily dry powder inhaler,...
bmj.com
Pre-holiday PPV: Fed Circuit in Teva v Amneal follows recommendation in amicus brief written by @wbfeldman.bsky.social and Sean Tu of @portalresearch.org, affirming delisting of improper inhaler patents from OB and helping promote timely generic competition: fedcircuitblog.com/wp-content/u...
fedcircuitblog.com
Important win today for the generic drug industry and patients with asthma and COPD. The Federal Circuit ruled that Teva's patents on the delivery device of its ProAir HFA inhaler were impermissibly listed in the Orange Book. patentlyo.com/patent/2024/...
Orange Book Device Patent Listings: Understanding Teva v. Amneal
by Dennis Crouch In a major decision clarifying the scope of Orange Book patent listings, the Federal Circuit has ruled …
patentlyo.com
The wrong ways and right ways to reform the FDA in the new administration - new in Health Affairs Forefront from me and Josh Sharfstein: www.healthaffairs.org/content/fore...
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 undermi...
healthaffairs.org
New Perspective in NEJM models the impact of recent proposals by USPTO and Congress to try to clear thickets of questionably innovative drug patents. Awesome graphics! With @portalresearch.org's Sean Tu, Bernard Chao, Ryan Whalen: www.nejm.org/doi/abs/10.1...
Clearing Dense Drug-Patent Thickets | NEJM
Proposed reforms from the U.S. Patent and Trademark Office and Congress could work in tandem to prevent patent thickets by targeting strategies that impede market entry of generic and biosimilar drugs.
nejm.org
Some really interesting bits here on med non-adherence and the pharmaceutical supply chain. Definitely worth a listen for the latest on what Amazon pharmacy is up to.
Dr. Vin Gupta@vinguptamd.bsky.social · 2y agoWishing you and your family a happy and healthy Thanksgiving! I joined @thehowie.bsky.social and Dr Harlan Krumholz on their podcast, Health and Veritas, to discuss a wide ranging of topics in healthcare today. Hope you’ll give it a listen! #medsky insights.som.yale.edu/podcasts/hea...
New in JGIM: Dongzhe Hong & coauthors discuss the results of a physician survey on antibiotic prescribing preferences. They find clinicians prioritize clinical outcomes over other factors like patient cost or risk of antibiotic resistance in deciding which antibiotic to prescribe. #idsky
National Survey of Factors Associated with Physician Antibiotic Prescribing Preferences - Journal of General Internal Medicine
Background The development of new infectious disease therapies has become a public health priority given the suboptimal efficacy and adverse effects with current drugs for some patients. Understanding...
doi.org
New from Dongzhe Hong, @wbfeldman.bsky.social, Metlay, Powers [@portalresearch.org]: Physicians considering new abx prioritize clear evidence of drug efficacy and safety over public health or econ factors like resistance or OOP costs: link.springer.com/article/10.1...
National Survey of Factors Associated with Physician Antibiotic Prescribing Preferences - Journal of General Internal Medicine
Background The development of new infectious disease therapies has become a public health priority given the suboptimal efficacy and adverse effects with current drugs for some patients. Understanding...
link.springer.com
New JAMA Special Communication from @ojwouters.bsky.social, Sean Tu, Matt Vogel and @wbfeldman.bsky.social at @portalresearch.org: comparison of small molecule and biologic drugs show no clear rationale for greater legal protections for biologic drugs: jamanetwork.com/journals/jam...
Legal Protections for Biologics vs Small-Molecule Drugs in the US
This Special Communication analyzes and compares development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment...
jamanetwork.com
New paper out at @jamacurrent.bsky.social led by @ojwouters.bsky.social on the empirical assumptions underlying differential protection for biologics & small-molecule drugs. Upshot: We found no good evidence supporting differential treatment by FDA (or under IRA). jamanetwork.com/journals/jam...
Legal Protections for Biologics vs Small-Molecule Drugs in the US
This Special Communication analyzes and compares development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment...
jamanetwork.com
We are hiring new fellows and faculty in PORTAL. Please reach out if interested! And spread the word.
Program On Regulation, Therapeutics, And Law (PORTAL)@handle.invalid · 2y ago📣PORTAL is hiring! 📣 There are less than 2 weeks left to apply for our Postdoctoral and General Medicine Fellowships, both with a focus on pharmaceutical law, health policy, and health services research. Apply by December 1, 2024. Learn more: mailchi.mp/3e02f38a708b/portal-hiring-2025
🎙️New NEJM audio interview recapping where we are with Medicare price negotiation and how to think about the results from the first 10 drugs. #healthpolicy #medsky @portalresearch.bsky.social www.nejm.org/do/10.1056/N...
Interview with Benjamin Rome on the results of the initial round of drug-price negotiation under the Inflation Reduction Act. | NEJM
Audio Interview from the New England Journal of Medicine — Interview with Benjamin Rome on the results of the initial round of drug-price negotiation under the Inflation Reduction Act.
nejm.org
I'm very much looking forward to serving on a panel at this event hosted by the FDA and Center for Research on Complex Generics focused on the transition to lower emission inhaler propellants. Registration still open! www.complexgenerics.org/education-tr...
Navigating the Transition to Low Global Warming Potential Propellants - The Center for Research on Complex Generics (CRCG)
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG) In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.
complexgenerics.org
Check out the new NEJM audio interview with @bnrome.bsky.social about the outcomes and future prospects of Medicare drug price negotiation under the Inflation Reduction Act after 1 year - from @portalresearch.bsky.social: www.nejm.org/do/10.1056/N...
Interview with Benjamin Rome on the results of the initial round of drug-price negotiation under the Inflation Reduction Act. | NEJM
Audio Interview from the New England Journal of Medicine — Interview with Benjamin Rome on the results of the initial round of drug-price negotiation under the Inflation Reduction Act.
nejm.org
New from @portalresearch.bsky.social incl Dan Carpenter and @wbfeldman.bsky.social: Reviewing how political actors can undermine public vaccine confidence by studying case of COVID19 vaccine roll-out...and how effects can persist. See doi.org/10.1215/0361...
Does Policy Uncertainty Boost Vaccine Hesitancy? Political Controversy, the FDA and COVID-19 Vaccine Hesitancy in Fall 2020 | Journal of Health Politics, Policy and Law | Duke University Press
doi.org