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Health experts want FDA safety review of fast-tracked Alzheimer's drug

reviewed Phase 2 study for this accelerated approval that missed primary clinical endpoint but met unvalidated surrogate & agency had yet to review Phase 3 study at the time. Features

@drsforamerica

statement on approval as well: doctorsforamerica.org/press-release-

Nice deep dive from

around call for

to convene an expert AdCom for #lecanemab ahead of traditional approval given significant safety concerns & uncertainty of true benefit. Also really appreciate the disclosure at the end!

axios.com

Health experts worry that the FDA has not properly evaluated the risks and benefits of Eisai's lecanemab.

Resonated with

piece esp on how the hidden curriculum/apprenticeship nature of medicine contributes to "[rationalizing] a deeply unequal health care system that emphasizes personal, rather than public, moral responsibility for protecting health."

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Gregg Gonsalves

@gregggonsalves

15h

An op-ed for the ages by ⁦@_Eric_Reinhart⁩. Unless we organize against this extractive system together, there is little medicine can do to fix what truly ails us. There will be push-back on this piece from the usual suspects. Ignore them. nytimes.com/2023/02/05/opi

Joseph Ross

Humira Rivals Set to Try to Drive Down Cost of Blockbuster Drug

Feb 2

Wow, this is absolutely bonkers. FDA is now recommending antiviral treatment for COVID for patients who TEST NEGATIVE! Just in case. What are we doing here?

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FDA says it’s removed the positive test requirement for prescribing of Covid antiviral drugs bc “in rare instances,” people with recent exposure & symptoms may be diagnosed w Covid even w negative test result

Today a biosimilar to #Humira was launched & more are expected soon. Here's hoping this is the catalyst for more systemic changes to the patent system as

@IMAKglobal

& others have called for, not just a one-off bad example with little lessons learned:

news.bloomberglaw.com

An alternative to AbbVie Inc.‘s blockbuster drug Humira officially launched Tuesday, the first in a wave of therapies that will put to the test whether market competition is enough to bring patients...

wrote in the

on the egregious (but not first) case of

@abbvie

's exploitation of the US patent system & ~30 price hikes for #Humira allowing it to reap an additional $114B after its key patent in 2016 was expected to expire.

nytimes.com

How a Drug Company Made $114 Billion by Gaming the U.S. Patent System

AbbVie for years delayed competition for its blockbuster drug Humira, at the expense of patients and taxpayers. The monopoly is about to end.

call on Congress to end patent abuse by raising the patent bar, provide oversight to enable competition, expand public participation in patent system, & ensure better ROI on publicly-funded drugs.

thehill.com

Patent reform and lower drug prices should be bipartisan priorities

Patent system reform is not a partisan issue; it’s an American issue.

ICYMI: There were 2 excellent pieces on the patent games that drug manufacturers play to bar patient access to affordable options highlighting the incredible work of advocates & academics in the #access2meds movement which have made a once obscure legal construct a known barrier.

As recommended by several experts these past 2 days at

@theNASEM

workshop on accelerated approval & hinted at by

@CMSGov

, Medicare may (& should) pay less for accelerated approval drugs with pending confirmation of clinical benefit to move companies to complete those key studies.

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John Wilkerson

@john_wilkerson

Jan 31

Medicare may test policy of paying less for accelerated approval drugs statnews.com/2023/01/31/med via @statnews

Yale School of Public Health

@YaleSPH

Jan 31

Dr. Megan L. Ranney (

@meganranney

), an internationally recognized public health leader, investigator, advocate, and clinician-scientist, will become dean of the Yale School of Public Health on July 1, President Peter Salovey announced today. More: news.yale.edu/2023/01/31/meg

read image description

ALT

492

487

3,683

An Underused Covid Treatment

Disagree with

's framing of the problem. Asserts that Paxlovid is underused, but story starts by saying 45% of recorded COVID cases are associated with an Rx. If physicians are preferentially prescribing to high-risk only, ... (1/3)

nytimes.com

Doctors are now a major barrier to Paxlovid.

Also looks like

abandoned its standard risk development program for Paxlovid after pivoting from enrolling only vaccinated patients in EPIC-SR to enrolling those who're unvaccinated after FDA granted broader indication EUA (including kids > 12): twitter.com/MaxGelman/stat

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Joseph Ross

Effect of reductions in amyloid levels on cognitive change in randomized trials: instrumental...

Jan 31

and all unvaccinated, that seems about right and no data is presented to the contrary. More frustrating, blame is laid on physicians for "wanting more data" but never on Pfizer for not conducting an RCT in vaccinated patients, only subgroup analyses (2/3) pfizer.com/news/press-rel

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on tools available

to make confirmatory trials for accelerated approval drugs more robust including engaging independent expert AdComs on the design of studies including ensuring a placebo arm instead of different doses of the drug & more robust endpoints.

Is there a list that

maintains of failed surrogates that were once thought to be reasonably likely to predict clinical benefit and the agency's rationale for removing them from lists of accepted surrogates? FDA says that such a publicly available list does not exist.

Grateful for the strong efforts of student advocates from

@uaem

@ColumbiaLaw

's Science, Health, & Information Clinic under

working with

Ranking Member

to hold

accountable for lax enforcement of clinical trial transparency.

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TranspariMED

@TranspariMED

Jan 30

US congress committee calls for tougher action on trial sponsors who fail to meet reporting deadlines bmj.com/content/380/bm @NC4HR @uaem @reshmagar @cmorten2 @DeborahZarin @EnergyCommerce @NLM_NIH

Reshma Ramachandran

@reshmagar

Jan 30

Dr. Emerson highlights

@bmj_latest

meta-analysis from

@SFAckley

@MariaGlymour

et al where pooled data across trials reporting both amyloid level reduction & cognitive change shows that amyloid reduction does not seem to substantially improve cognition.

bmj.com

Objective To evaluate trials of drugs that target amyloid to determine whether reductions in amyloid levels are likely to improve cognition. Design Instrumental variable meta-analysis. Setting 14...

committee reminds us that accelerated approvals are not based on validated surrogate endpoints, but rather those that are "reasonably likely to predict clinical benefit" making the confirmatory trials & their completion critical to know these drugs work meaningfully.

Tuning in now - next panel up is on surrogates & then

speaking on confirmatory trials. Interested to hear about

's efforts to validate surrogate endpoints & make clear to public. As a reminder, despite FDA saying otherwise, beta-amyloid has not been validated.

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Yale_CRRIT

@Yale_CRRIT

Jan 23

Next Monday, CRRIT co-Director @jsross119 will be speaking on a panel about required confirmatory trials for @US_FDA accelerated approval drugs during @theNASEM’s workshop on “The FDA’s Accelerated Approval Process for New Pharmaceuticals.” To register: nationalacademies.org/event/01-30-20

's work featured on the front page of

@nytimes

today!

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From 2018 to 2023

cc:

👀

What would this mean? Medicaid could apply similar CED restrictions to limit coverage of costly, unproven drugs like #aducanumab further incentivizing companies prove that the drugs work. Before Medicaid had to fully cover the drugs to receive a modest rebate from companies.

👏🏾

voting almost unanimously recommending that Congress allow states to exclude or otherwise restrict coverage for outpatient drugs based on Medicare CED decisions & to require Medicaid managed care contracts include those coverage restrictions. insidehealthpolicy.com/daily-news/mac

Holly Fernandez Lynch

@HollyLynchez

Jan 27

Great new paper from

@MahnumShahzad

, Huseyin Naci, and Anita Wagner showing what a difference it makes to start confirmatory trials *before* drug approval is granted. 1/ jamanetwork.com/journals/jama/

Robert Weissman

@Rob_Weissman

Jan 24

Why do we ration access to medicines and health care? Why do we force people into medical bankruptcies? Why does the US rank at the bottom of rich countries for health care access, efficiency, equity and outcomes? See below.

New Lawsuit Challenges State Bans on Abortion Pills

Greer Donley

@GreerDonley

Jan 25

🚨🚨🚨 Here we go!!! The first preemption lawsuits challenging state abortion bans have been filed -- one by Genbiopro in West Virginia and one by a provider in North Carolina!! Short thread on what's coming:

nytimes.com

The case, brought by GenBioPro, a company that makes one of two abortion drugs, argues that it is unconstitutional for a state to bar access to a medication approved by the federal government.

195

364

Joseph Ross

Jan 24

Interesting analysis in

@PharmaPinkSheet

@dgingery

showing how FDA Advisory Committee disagreements with eventual FDA decisions are becoming increasingly rare (none in 2022!). Adds data to our seminal study, led by

@AudreyDZhang

@jasonlschwartz

(1/2) pink.pharmaintelligence.informa.com/articles/2023/

Also, the book is available online for free! #OpenAccess 🎉

Excited for tomorrow's

@LPE_Project

@yalelpe

's event at

@YaleLawSch

with Victor about his insightful & timely book in conversation with

@akapczynski

@lenorepalladino

. Join us if you're in New Haven or tune in virtually - to register: lpeproject.org/events/capital

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It’s finally here - book launch day! Excited to share Capitalizing a Cure: How Finance Controls the Price and Value of Medicines, available open-access (can download now) and paperback with @ucpress. bit.ly/3HnMXUQ. A brief

(1/11)

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Atheendar Venkataramani

@atheendar

Jan 24

1/ If you are going to do a subgroup analysis (or ask for one), there needs to be a strong reason why. Increasingly, people equate studying #healthequity with taking some exposure and stratifying by race. These knee jerk tendencies can set off some weird dynamics.

Now out in

is Dr. Maryam Mooghali's study with

@laurarglick

@reshmagar

Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a...

examining the prevalence & accuracy of industry-related financial conflict of interest (#COI) disclosures among US physician authors of 2020

@CMSSmed

guidelines.

bmjopen.bmj.com

Objective To evaluate the prevalence and accuracy of industry-related financial conflict of interest (COI) disclosures among US physician guideline authors. Design Cross-sectional study. Setting...

Insightful comments from @a_kaltonboeck

@MarkMiller_DC

@igisci

's Melinda Kleigman on complexity & need for new payment models tied with further evidence generation for novel & very expensive gene therapies in this

@BLaw

piece from

@cecelou18

news.bloomberglaw.com

World’s Most Expensive Drug Revives Push for New Payment Models

A gene therapy considered to be the world’s most expensive drug raises questions about how to pay for it, and the federal agency overseeing Medicare and Medicaid could play a central role in ensuring...

Dear

We found 43 clinical trials involving >3,000 children that have never made their results public - not on ClinicalTrials-gov and not in the literature. Parents and doctors need this evidence - now. Please enforce the law. transparimed.org/single-post/fd

Yale_CRRIT

@Yale_CRRIT

Jan 23

Next Monday, CRRIT co-Director

will be speaking on a panel about required confirmatory trials for

accelerated approval drugs during

@theNASEM

’s workshop on “The FDA’s Accelerated Approval Process for New Pharmaceuticals.” To register: nationalacademies.org/event/01-30-20

What The Inflation Reduction Act’s Reforms To Medicare Part D Mean For Prescription Drug Prices |...

Anna Kaltenboeck

@a_kaltenboeck

Jan 20

Misconceptions about how the #InflationReducationAct works abound. Here's my attempt to clarify 💊💉💵 👉

healthaffairs.org

Much has been written about the Inflation Reduction Act’s individual provisions, but little has been said about how they fit together as a whole. In fact, these seemingly standalone reforms act...

Glad to see our

#transparency research cited by

@EnergyCommerce

today in its letter to

@NIHDirector

over universities' noncompliance w/ federal law and the lack of enforcement by

@NIH

Trial transparency is necessary for patient safety and minimizing research waste

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UAEM

@uaem

Jan 19

Following our Transparency Team’s FOIA investigation w/@ColumbiaLaw SHIC (@cmorten2), Ranking Member @FrankPallone wrote today to @US_FDA & @NIH, concerned about limited enforcement of the FDA Amendments Act requiring clinical trials results reporting: twitter.com/EnergyCommerce

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Energy & Commerce Democrats

UAEM

@uaem

Jan 19

Following our Transparency Team’s FOIA investigation w/

SHIC (

), Ranking Member

wrote today to

, concerned about limited enforcement of the FDA Amendments Act requiring clinical trials results reporting:

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@EnergyCommerce

Jan 19

NEW: Ranking Member @FrankPallone wrote to @DrCaliff_FDA and @NIHDirector to raise questions about the practices of FDA and NIH to enforce ClinicalTrials.gov reporting requirements. Read the full letter here

democrats-energycommerce.house.gov/newsroom/press

Tanvee Varma

@TanveeVarma

Jan 18

So excited to see our recent

@BMJMedicine

article on clinical trial diversity covered in

Future Pulse 💊

Clinical trials on trial

pink.pharmaintelligence.informa.com

Sarah Karlin-Smith

@SarahKarlin

Jan 17

ICMYI Friday: Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax pink.pharmaintelligence.informa.com/PS147582/Reass $PFE $BNTX

Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax

US vaccine surveillance systems were triggered, but so far further investigation clears the bivalent COVID vaccine of any new safety concern. CDC and FDA’s attempt to control the narrative appears to...