Aaron Kesselheim
@akesselheim.bsky.social
Professor of Medicine, Brigham and Women's Hospital/Harvard Medical School; Director, Program On Regulation, Therapeutics, And Law (PORTAL)
Reposted by Aaron Kesselheim
Stigma, Scarcity & the Price of Legitimacy: Chronic Pain Advocacy & the Politics of Pharmaceutical Partnerships in Canada
Daniel Eisenkraft Klein, Benjamin Hawkins, Quinn Grundy, Robert Schwartz
onlinelibrary.wiley.com/doi/full/10....
I think findings here potentially transferable to obesity...
Daniel Eisenkraft Klein, Benjamin Hawkins, Quinn Grundy, Robert Schwartz
onlinelibrary.wiley.com/doi/full/10....
I think findings here potentially transferable to obesity...
Stigma, Scarcity and the Price of Legitimacy: Chronic Pain Advocacy and the Politics of Pharmaceutical Partnerships in Canada
This study examines how chronic pain advocates in Canada navigated fraught relationships with pharmaceutical companies amid escalating concerns about the adverse public health impacts of opioids. Dra...
onlinelibrary.wiley.com
January 8, 2026 at 2:44 PM
Stigma, Scarcity & the Price of Legitimacy: Chronic Pain Advocacy & the Politics of Pharmaceutical Partnerships in Canada
Daniel Eisenkraft Klein, Benjamin Hawkins, Quinn Grundy, Robert Schwartz
onlinelibrary.wiley.com/doi/full/10....
I think findings here potentially transferable to obesity...
Daniel Eisenkraft Klein, Benjamin Hawkins, Quinn Grundy, Robert Schwartz
onlinelibrary.wiley.com/doi/full/10....
I think findings here potentially transferable to obesity...
Pitfall…had a sequel?! What more to the story was there?
December 26, 2025 at 2:51 AM
Pitfall…had a sequel?! What more to the story was there?
With the problematic national priority review voucher in the news again today (FDA staff not involved in decisionmaking? Really?), here’s our overview of how it opens the FDA up to corruption and moves us further and further away from “gold standard” reviews: www.statnews.com/2025/11/21/f...
The Trump administration is turning drug review into make-a-deal
“FDA decision-making may be reduced to a sequence of ‘make-a-deals’ with Trump, his FDA, or even political allies,” experts warn.
www.statnews.com
November 21, 2025 at 10:44 PM
With the problematic national priority review voucher in the news again today (FDA staff not involved in decisionmaking? Really?), here’s our overview of how it opens the FDA up to corruption and moves us further and further away from “gold standard” reviews: www.statnews.com/2025/11/21/f...
What he said
Gutting funding for key health agencies & terminating thousands of workers does nothing to ensure the future of the biotech industry, experts & Democratic lawmakers argued during a Senate health committee hearing on Wednesday. @akesselheim.bsky.social
Read more: www.medpagetoday.com/washington-w...
Read more: www.medpagetoday.com/washington-w...
October 31, 2025 at 10:22 PM
What he said
Reposted by Aaron Kesselheim
I filed an amicus brief on behalf of 24 professors challenging the interim PTO director's illegal policy of blocking IPRs for any patent that is more than a few years old.
drive.google.com/file/d/1NhrG...
drive.google.com/file/d/1NhrG...
drive.google.com
September 22, 2025 at 8:38 PM
I filed an amicus brief on behalf of 24 professors challenging the interim PTO director's illegal policy of blocking IPRs for any patent that is more than a few years old.
drive.google.com/file/d/1NhrG...
drive.google.com/file/d/1NhrG...
Reprint of my Substack with @ylepidemiologist.bsky.social today in @statnews.com. Check it out if you’re interested in recent “moves” the FDA is making on drug ads. As with most claims this admin makes … IBIWISI: www.statnews.com/2025/09/13/p...
9 answers to burning questions about pharmaceutical ads
Got questions about the FDA’s new plans around pharmaceutical ads? We’ve got answers.
www.statnews.com
September 13, 2025 at 7:55 PM
Reprint of my Substack with @ylepidemiologist.bsky.social today in @statnews.com. Check it out if you’re interested in recent “moves” the FDA is making on drug ads. As with most claims this admin makes … IBIWISI: www.statnews.com/2025/09/13/p...
Another fun collaboration with @ylepidemiologist.bsky.social in Substack with a post on DTC drug ads and the new administration announcement claiming to seek greater enforcement: yourlocalepidemiologist.substack.com/p/pharmaceut...
Pharmaceutical ads in the U.S.: Top questions answered
The Administration's order and what can actually be done
yourlocalepidemiologist.substack.com
September 10, 2025 at 2:58 PM
Another fun collaboration with @ylepidemiologist.bsky.social in Substack with a post on DTC drug ads and the new administration announcement claiming to seek greater enforcement: yourlocalepidemiologist.substack.com/p/pharmaceut...
CBER bein’ like
homer simpson says that 's bad in front of a bookshelf
ALT: homer simpson says that 's bad in front of a bookshelf
media.tenor.com
August 9, 2025 at 3:49 PM
CBER bein’ like
Reposted by Aaron Kesselheim
High brand-name drug prices fall once a generic enters the market. In a new @journalgim.bsky.social article, Ravi Gupta, CRRIT Co-Director @jsross119.bsky.social, and colleagues from @portalresearch.org assess associations between patents, revenue, and generic competition.
July 21, 2025 at 3:35 PM
High brand-name drug prices fall once a generic enters the market. In a new @journalgim.bsky.social article, Ravi Gupta, CRRIT Co-Director @jsross119.bsky.social, and colleagues from @portalresearch.org assess associations between patents, revenue, and generic competition.
Superman. See it.
July 13, 2025 at 1:59 AM
Superman. See it.
<10% of these were not previously published (via STAT). Remember Sniglets? What term can we create for something that is self-promoted as a major step forward but is not really in reality even close to that?
www.statnews.com/2025/07/10/f...
www.statnews.com/2025/07/10/f...
FDA publishes rejection letters sent to drugmakers, with a big caveat
The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.
www.statnews.com
July 11, 2025 at 3:21 PM
<10% of these were not previously published (via STAT). Remember Sniglets? What term can we create for something that is self-promoted as a major step forward but is not really in reality even close to that?
www.statnews.com/2025/07/10/f...
www.statnews.com/2025/07/10/f...
New @healthaffairs.bsky.social Forefront covering the recent EOs on drug prices and tariffs -- little good news for prices or access -- www.healthaffairs.org/content/fore...
Trump’s Ongoing Tariff Chaos Will Make Medications Less Affordable And Harder To Find | Health Affairs Forefront
In his first term, Trump made a lot of noise about lowering drug prices but accomplished little of consequence. The noise continues, but it is now accompanied by new ill-conceived initiatives, includi...
www.healthaffairs.org
July 4, 2025 at 10:40 AM
New @healthaffairs.bsky.social Forefront covering the recent EOs on drug prices and tariffs -- little good news for prices or access -- www.healthaffairs.org/content/fore...
New PORTAL Post from @portalresearch.org for June. Sign up to receive these directly to your inbox!
mailchi.mp/eb7d1808132b...
mailchi.mp/eb7d1808132b...
PORTAL Post | July 2025
New faculty members, the ORPHAN Cures Act, “hyaluronidase hopping,” and more from PORTAL
mailchi.mp
July 4, 2025 at 10:37 AM
New PORTAL Post from @portalresearch.org for June. Sign up to receive these directly to your inbox!
mailchi.mp/eb7d1808132b...
mailchi.mp/eb7d1808132b...
Unrecorded manipulation of large datasets has been common in the US government since Trump's election -- bad for science, trust, and transparency -- in @thelancet.com from Janet Freilich and myself: www.thelancet.com/journals/lan...
Data manipulation within the US Federal Government
A US Department of Veterans Affairs dataset compiling veteran health-care use in 2021
was quietly amended on March 5, 2025. A column titled gender was renamed sex, and
the words were also switched in ...
www.thelancet.com
July 4, 2025 at 9:44 AM
Unrecorded manipulation of large datasets has been common in the US government since Trump's election -- bad for science, trust, and transparency -- in @thelancet.com from Janet Freilich and myself: www.thelancet.com/journals/lan...
Language is now back in the Senate version of the OBBA that would undermine Medicare price negotiation for drugs with Orphan Drug Act designation. Here's our HA Forefront published yesterday (!) from Helen Mooney and @benro.me on why it is a very bad idea:
www.healthaffairs.org/do/10.1377/f...
www.healthaffairs.org/do/10.1377/f...
Congress Should Remove The Rare Disease Carve-Out From Medicare Drug Price Negotiation, Not Expand It | Health Affairs Forefront
Expansion of the Medicare drug price negotiation rare disease drug carve-out would unnecessarily limit the number of drugs eligible for negotiation, allow for continued high drug prices for products that earn billions of dollars in Medicare, and introduce a new set of misaligned incentives.
www.healthaffairs.org
June 28, 2025 at 4:55 PM
Language is now back in the Senate version of the OBBA that would undermine Medicare price negotiation for drugs with Orphan Drug Act designation. Here's our HA Forefront published yesterday (!) from Helen Mooney and @benro.me on why it is a very bad idea:
www.healthaffairs.org/do/10.1377/f...
www.healthaffairs.org/do/10.1377/f...
New in @jama.com, Joseph Daval and I discuss legal issues surrounding ACIP including its role in setting government policy and dealing with politically-motivated agendas arising from its new membership: jamanetwork.com/journals/jam...
Legal Challenges for the Advisory Committee on Immunization Practices
This Perspective offers an analysis of the legal foundations in the context of these and other challenges to the role of the Advisory Committee on Immunization Practices.
jamanetwork.com
June 26, 2025 at 7:51 PM
New in @jama.com, Joseph Daval and I discuss legal issues surrounding ACIP including its role in setting government policy and dealing with politically-motivated agendas arising from its new membership: jamanetwork.com/journals/jam...
Thanks to the 2024 peer reviewers for @jlme-journal.bsky.social, with a list here: www.cambridge.org/core/journal...
Thank You to Our 2024 Peer Reviewers | Journal of Law, Medicine & Ethics | Cambridge Core
Thank You to Our 2024 Peer Reviewers
www.cambridge.org
June 11, 2025 at 6:05 PM
Thanks to the 2024 peer reviewers for @jlme-journal.bsky.social, with a list here: www.cambridge.org/core/journal...
I helped Your Local Epidemiologist answer some of her pressing Substack subscriber questions on drug prices. yourlocalepidemiologist.substack.com/p/your-top-1...
Your top 10 FAQ on drug prices
Some clarity for this wildly confusing topic.
yourlocalepidemiologist.substack.com
May 15, 2025 at 6:31 PM
I helped Your Local Epidemiologist answer some of her pressing Substack subscriber questions on drug prices. yourlocalepidemiologist.substack.com/p/your-top-1...
New Health Affairs Forefront post on the Medicare negotiation "biologic bonus" and the massive financial hit to patients and the health care system of delaying small molecule negotiation from 9 to 13 years, led by Chris Cai and @benro.me: www.healthaffairs.org/content/fore...
www.healthaffairs.org
May 8, 2025 at 4:57 PM
New Health Affairs Forefront post on the Medicare negotiation "biologic bonus" and the massive financial hit to patients and the health care system of delaying small molecule negotiation from 9 to 13 years, led by Chris Cai and @benro.me: www.healthaffairs.org/content/fore...
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...
Interesting new op-ed! Very proud of Max: thehill.com/opinion/5180...
thehill.com
March 7, 2025 at 6:20 PM
Interesting new op-ed! Very proud of Max: thehill.com/opinion/5180...
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...
New in @nejm.org from Peter Ubel, Astrid Grouls and myself on "financial toxicity" and how to consider it in the context of new drugs @portalresearch.org: www.nejm.org/doi/abs/10.1...
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 16, 2025 at 4:13 PM
New in @nejm.org from Peter Ubel, Astrid Grouls and myself on "financial toxicity" and how to consider it in the context of new drugs @portalresearch.org: www.nejm.org/doi/abs/10.1...
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...