Program On Regulation, Therapeutics, And Law (PORTAL)
@portalresearch.org
Academic research center at Brigham and Women's Hospital & Harvard Medical School studying the clinical, economic, and legal aspects of medication use.
RETHINKING MEDICATIONS by Jerry Avorn - Out Now! https://rethinkmeds.info/
RETHINKING MEDICATIONS by Jerry Avorn - Out Now! https://rethinkmeds.info/
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
Lots of talk about international reference pricing today. With that in mind, sharing this great article by @leah-rand.bsky.social and @akesselheim.bsky.social from @portalresearch.org!
www.valueinhealthjournal.com/article/S109...
www.valueinhealthjournal.com/article/S109...
International Reference Pricing for Prescription Drugs in the United States: Administrative Limitations and Collateral Effects
Many countries use international (or external) reference pricing—benchmarking prices
against those in other countries—to manage spending on prescription drugs. By contrast,
the United States (US) allo...
www.valueinhealthjournal.com
May 12, 2025 at 4:51 PM
Lots of talk about international reference pricing today. With that in mind, sharing this great article by @leah-rand.bsky.social and @akesselheim.bsky.social from @portalresearch.org!
www.valueinhealthjournal.com/article/S109...
www.valueinhealthjournal.com/article/S109...
⭐Out now from Dr. Jerry Avorn— RETHINKING MEDICATIONS: Truth, Power, and the Drugs You Take
In his new book, Dr. Avorn explains why some of the medications we take are poorly evaluated, overpriced, or pose unwarranted risks—and how we fix that.
📖 Grab a copy today: rethinkmeds.info
In his new book, Dr. Avorn explains why some of the medications we take are poorly evaluated, overpriced, or pose unwarranted risks—and how we fix that.
📖 Grab a copy today: rethinkmeds.info
Home
Truth, Power, and the Drugs You Take
rethinkmeds.info
April 30, 2025 at 6:58 PM
⭐Out now from Dr. Jerry Avorn— RETHINKING MEDICATIONS: Truth, Power, and the Drugs You Take
In his new book, Dr. Avorn explains why some of the medications we take are poorly evaluated, overpriced, or pose unwarranted risks—and how we fix that.
📖 Grab a copy today: rethinkmeds.info
In his new book, Dr. Avorn explains why some of the medications we take are poorly evaluated, overpriced, or pose unwarranted risks—and how we fix that.
📖 Grab a copy today: rethinkmeds.info
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
New op-ed with @drjoshs.bsky.social and Peter Lurie about the agenda-driven reality of 'radical transparency' -- www.washingtonpost.com/opinions/202...
Opinion | It’s not hard to see through RFK Jr.’s ‘radical transparency’ pledge
So far, what’s been released is little more than tactics in pursuit of Kennedy’s own agenda.
www.washingtonpost.com
April 24, 2025 at 1:10 PM
New op-ed with @drjoshs.bsky.social and Peter Lurie about the agenda-driven reality of 'radical transparency' -- www.washingtonpost.com/opinions/202...
WATCH: @akesselheim.bsky.social testifies before @waysmeanscmte.bsky.social
On NIH cuts - "...the next generation will look back at this moment & ask what we were doing while the Trump administration systematically disposed of 1000s of research projects that could've helped patients."
On NIH cuts - "...the next generation will look back at this moment & ask what we were doing while the Trump administration systematically disposed of 1000s of research projects that could've helped patients."
April 9, 2025 at 1:57 PM
WATCH: @akesselheim.bsky.social testifies before @waysmeanscmte.bsky.social
On NIH cuts - "...the next generation will look back at this moment & ask what we were doing while the Trump administration systematically disposed of 1000s of research projects that could've helped patients."
On NIH cuts - "...the next generation will look back at this moment & ask what we were doing while the Trump administration systematically disposed of 1000s of research projects that could've helped patients."
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
At 10am Eastern Time, watch as our Editor-in-Chief, @akesselheim.bsky.social , gives testimony to the House Ways and Means Committee on "Lowering Costs for Patients: The Health of the Biosimilar Market." www.youtube.com/watch?v=x_rh...
Health Subcommittee Hearing on Lowering Costs for Patients: The Health of the Biosimilar Market
YouTube video by Ways and Means Committee Republicans
www.youtube.com
April 8, 2025 at 1:25 PM
At 10am Eastern Time, watch as our Editor-in-Chief, @akesselheim.bsky.social , gives testimony to the House Ways and Means Committee on "Lowering Costs for Patients: The Health of the Biosimilar Market." www.youtube.com/watch?v=x_rh...
Tune in TODAY at 10am ET as PORTAL Director Aaron Kesselheim @akesselheim.bsky.social testifies before the House Ways & Means Health Subcommittee:
He'll discuss the biosimilar market, threats to US biomedical research funding, & the need to protect & expand Medicare drug price negotiation.
He'll discuss the biosimilar market, threats to US biomedical research funding, & the need to protect & expand Medicare drug price negotiation.
Health Subcommittee Hearing on Lowering Costs for Patients: The Health of the Biosimilar Market
YouTube video by Ways and Means Committee Republicans
youtu.be
April 8, 2025 at 1:52 PM
Tune in TODAY at 10am ET as PORTAL Director Aaron Kesselheim @akesselheim.bsky.social testifies before the House Ways & Means Health Subcommittee:
He'll discuss the biosimilar market, threats to US biomedical research funding, & the need to protect & expand Medicare drug price negotiation.
He'll discuss the biosimilar market, threats to US biomedical research funding, & the need to protect & expand Medicare drug price negotiation.
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
Starting in January 2025, various government health datasets were removed, restored, manipulated, or not posted as planned. The authors of a new Perspective write that the consequences of these changes could be far-reaching. Read the full Perspective: nej.md/4bYvujL
#MedSky #HealthPolicy
#MedSky #HealthPolicy
March 26, 2025 at 9:10 PM
Starting in January 2025, various government health datasets were removed, restored, manipulated, or not posted as planned. The authors of a new Perspective write that the consequences of these changes could be far-reaching. Read the full Perspective: nej.md/4bYvujL
#MedSky #HealthPolicy
#MedSky #HealthPolicy
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
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
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
April 6, 2025 at 9:34 AM
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
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
Check out the latest research from the PORTAL team in the April edition of our newsletter, featuring analysis on generic drug 'skinny labeling,' the expansion of the 340B program, a new form of product hopping, and much more! 🛟🧪
mailchi.mp/57ccd5e0b342...
mailchi.mp/57ccd5e0b342...
PORTAL Post | April 2025
Skinny labeling, 340B expansion, patent games, and more analysis from the PORTAL team.
mailchi.mp
April 3, 2025 at 2:11 PM
Check out the latest research from the PORTAL team in the April edition of our newsletter, featuring analysis on generic drug 'skinny labeling,' the expansion of the 340B program, a new form of product hopping, and much more! 🛟🧪
mailchi.mp/57ccd5e0b342...
mailchi.mp/57ccd5e0b342...
NEW in @nejm.org: Janet Freilich & couthors discuss the sudden removal of critical health datasets by US federal health agencies—undermining research, public health, & policy-making. Though lawsuits have restored some data, the authors call for broader action to keep taxpayer-funded data public. 🛟
Disappearing Data at the U.S. Federal Government | NEJM
Starting in January 2025, various government health datasets were removed, restored,
manipulated, or not posted as planned. The consequences of these changes could be
far-reaching.
www.nejm.org
March 28, 2025 at 2:57 PM
NEW in @nejm.org: Janet Freilich & couthors discuss the sudden removal of critical health datasets by US federal health agencies—undermining research, public health, & policy-making. Though lawsuits have restored some data, the authors call for broader action to keep taxpayer-funded data public. 🛟
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
Our latest in @nejm.org on the dilemmas of treating patients with chronic lung disease.
www.nejm.org/doi/full/10....
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?
www.nejm.org
February 22, 2025 at 12:47 PM
Our latest in @nejm.org on the dilemmas of treating patients with chronic lung disease.
www.nejm.org/doi/full/10....
www.nejm.org/doi/full/10....
New perspective in @nejm.org from Peter Ubel, Astrid Grouls, & @akesselheim.bsky.social on the financial toxicity patients face from high-cost drugs with uncertain clinical benefits, & the remedies available to policymakers to mitigate financial harms while drugs undergo further review.
Out of Pocket Getting Out of Hand — Reducing the Financial Toxicity of Rapidly Approved Drugs | NEJM
The FDA often exercises flexibility in deciding whether to approve highly promising
drugs for patients in desperate need of treatment options. But it doesn’t consider
a drug’s likely financial toxi...
www.nejm.org
February 17, 2025 at 8:21 PM
New perspective in @nejm.org from Peter Ubel, Astrid Grouls, & @akesselheim.bsky.social on the financial toxicity patients face from high-cost drugs with uncertain clinical benefits, & the remedies available to policymakers to mitigate financial harms while drugs undergo further review.
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
Analysis from former @portalresearch.org fellow Catherine Hwang and @benro.me showing the extent of out-of-pocket costs associated with starting brand-name Entresto over ACEI/ARB for heart failure and implications for overall spending: jamanetwork.com/journals/jam...
Spending After Sacubitril-Valsartan vs Renin-Angiotensin System Blockers for Heart Failure
This cohort study assesses health care costs after initiating sacubitril-valsartan compared to an angiotensin-converting enzyme inhibitor or an angiotensin II receptor-blocker in Medicare patients bei...
jamanetwork.com
February 16, 2025 at 4:15 PM
Analysis from former @portalresearch.org fellow Catherine Hwang and @benro.me showing the extent of out-of-pocket costs associated with starting brand-name Entresto over ACEI/ARB for heart failure and implications for overall spending: jamanetwork.com/journals/jam...
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
Survey of clozapine prescribers shows satisfaction with the REMS but desire for more educational info, led by @asarpatwari.bsky.social & team at @portalresearch.org in collab with FDA, where world class scientists are sadly being censored and forced out of their jobs: jamanetwork.com/journals/jam...
Physician Experiences With and Perspectives on Clozapine Prescribing
This survey study examines physician-prescriber experiences with and perspectives on the clozapine risk evaluation and mitigation strategy.
jamanetwork.com
February 14, 2025 at 3:48 PM
Survey of clozapine prescribers shows satisfaction with the REMS but desire for more educational info, led by @asarpatwari.bsky.social & team at @portalresearch.org in collab with FDA, where world class scientists are sadly being censored and forced out of their jobs: jamanetwork.com/journals/jam...
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
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/
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
February 14, 2025 at 2:03 AM
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/
pubmed.ncbi.nlm.nih.gov/39937634/
🔎 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...
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...
February 11, 2025 at 4:12 PM
🔎 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...
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...
Check out the February edition of the PORTAL Post, featuring analysis on:
- the promise and risk of drug repurposing,
- drug importation to address shortages,
- use of subgroup analysis in cost-effectiveness studies
- biosimilar patent litigation,
- and much more!
#medsky #healthpolicy
- the promise and risk of drug repurposing,
- drug importation to address shortages,
- use of subgroup analysis in cost-effectiveness studies
- biosimilar patent litigation,
- and much more!
#medsky #healthpolicy
PORTAL Post | February 2025
Protecting health agency independence, drug repurposing, academic detailing, and more from the PORTAL team.
mailchi.mp
February 6, 2025 at 3:53 PM
Check out the February edition of the PORTAL Post, featuring analysis on:
- the promise and risk of drug repurposing,
- drug importation to address shortages,
- use of subgroup analysis in cost-effectiveness studies
- biosimilar patent litigation,
- and much more!
#medsky #healthpolicy
- the promise and risk of drug repurposing,
- drug importation to address shortages,
- use of subgroup analysis in cost-effectiveness studies
- biosimilar patent litigation,
- and much more!
#medsky #healthpolicy
New from Chris Cai, @akesselheim.bsky.social and @benro.me in JAMA:
Despite having gone off patent decades ago, repurposing the antidepressant doxepin for insomnia has led to persistent high prices even though generics are available, highlighting the need for policy reform in drug repurposing.
Despite having gone off patent decades ago, repurposing the antidepressant doxepin for insomnia has led to persistent high prices even though generics are available, highlighting the need for policy reform in drug repurposing.
Despite the availability of generic low-dose doxepin for insomnia, the medication remains costly and less frequently used compared to other insomnia treatments.
ja.ma/4aLCKid
#MedSky
ja.ma/4aLCKid
#MedSky
February 3, 2025 at 9:52 PM
New from Chris Cai, @akesselheim.bsky.social and @benro.me in JAMA:
Despite having gone off patent decades ago, repurposing the antidepressant doxepin for insomnia has led to persistent high prices even though generics are available, highlighting the need for policy reform in drug repurposing.
Despite having gone off patent decades ago, repurposing the antidepressant doxepin for insomnia has led to persistent high prices even though generics are available, highlighting the need for policy reform in drug repurposing.
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
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...
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.
www.statnews.com
January 31, 2025 at 2:27 PM
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...
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
From Rosa Ahn-Horst @portalresearch.org -- psychiatric drug innovation over the last decade shows widespread use of clinical endpoints but few new mechanisms of action and 3/16 drugs for which < half the trials submitted to FDA were positive (in JAMA Network Open): jamanetwork.com/journals/jam...
Trials Preceding FDA Approval of Novel Psychiatric Drugs
This cross-sectional study reports on the study design characteristics of clinical trials for novel psychiatric drugs approved by the US Food and Drug Administration.
jamanetwork.com
January 29, 2025 at 3:50 PM
From Rosa Ahn-Horst @portalresearch.org -- psychiatric drug innovation over the last decade shows widespread use of clinical endpoints but few new mechanisms of action and 3/16 drugs for which < half the trials submitted to FDA were positive (in JAMA Network Open): jamanetwork.com/journals/jam...
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
🚨 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.
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.
January 31, 2025 at 8:11 PM
🚨 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.
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.
📣 Check out the latest in @nejm.org from PORTAL and collaborators at @cfr.org on the role of importation in alleviating generic drug shortages in the short term, particularly for generic sterile injectable drugs.
US shortages of critical generic drugs are a decades-old problem that has gotten worse
A more rational regulatory approach to importation could help prevent or shorten those shortages
@akesselheim.bsky.social, S. Nagar, Chloe Searchinger
& I explain how in @nejm.org
www.nejm.org/doi/full/10....
A more rational regulatory approach to importation could help prevent or shorten those shortages
@akesselheim.bsky.social, S. Nagar, Chloe Searchinger
& I explain how in @nejm.org
www.nejm.org/doi/full/10....
The Role of Importation in Remediating U.S. Generic Drug Shortages | NEJM
U.S. shortages of critical drugs are a worsening problem, and the FDA has been too slow to authorize temporary importation of drugs from other well-regulated markets to meet pressing U.S. needs.
www.nejm.org
January 15, 2025 at 4:32 PM
📣Tune in tomorrow, January 16 at 5pm GMT/12pm ET for a Consilium Scientific webinar led by PORTAL collaborator Ariadna Tibau!
This talk will discuss efforts to identify & prioritize cancer treatments with meaningful clinical benefit & value to patients.
Register here: mailchi.mp/consilium-sc...
This talk will discuss efforts to identify & prioritize cancer treatments with meaningful clinical benefit & value to patients.
Register here: mailchi.mp/consilium-sc...
January 15, 2025 at 3:16 PM
📣Tune in tomorrow, January 16 at 5pm GMT/12pm ET for a Consilium Scientific webinar led by PORTAL collaborator Ariadna Tibau!
This talk will discuss efforts to identify & prioritize cancer treatments with meaningful clinical benefit & value to patients.
Register here: mailchi.mp/consilium-sc...
This talk will discuss efforts to identify & prioritize cancer treatments with meaningful clinical benefit & value to patients.
Register here: mailchi.mp/consilium-sc...
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
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/...
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,...
www.bmj.com
December 30, 2024 at 2:31 PM
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/...
Brief thread below!
www.bmj.com/content/387/...
Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)
Nice @nytimes.com summary of some GOOD recommendations for reforming the #FDA… from experts including from @portalresearch.org director @akesselheim.bsky.social. 🩺📊🛟
www.nytimes.com/2024/12/22/w...
www.nytimes.com/2024/12/22/w...
R.F.K. Jr. Wants to Overhaul the F.D.A. How Would Scientists Change It?
While some agree with Robert F. Kennedy Jr. that the agency needs reform, their ideas for fixing it are very different from his.
www.nytimes.com
December 22, 2024 at 1:06 PM
Nice @nytimes.com summary of some GOOD recommendations for reforming the #FDA… from experts including from @portalresearch.org director @akesselheim.bsky.social. 🩺📊🛟
www.nytimes.com/2024/12/22/w...
www.nytimes.com/2024/12/22/w...