Now out in
@NEJM
is a piece from
@jsross119
,
@berg_karina
, & me on how
@US_FDA
's recent accelerated approval of
#lecanemab
highlights the agency's expanded use of the expedited review pathway & concerns this raises for patients, caregivers, & clinicians:
Chevron has been overruled by
#SCOTUS
. This is a dark day for public health & agencies like the
@US_FDA
. Here's why this decision is devastating for federal agencies with scientific & technical expertise that will now face challenges in the courts to their regulatory authority.
This Viewpoint from
@YaleLawSch
Sahil Agrawal, MD, PhD,
@jsross119
,
@reshmagar
describes implications for medicine and public health if the US Supreme Court decides to overturn or narrow Chevron deference.
So many issues with this piece in
@JAMAInternalMed
from
@US_FDA
officials (Dunn, Stein, & Cavazzoni) attempting to justify their poor choice in approving
#aducanumab
- don't bother reading it unless you want your blood to boil. I'll summarize instead: 1/
Essential reading from
@SenSanders
@HELPCmteDems
on US taxpayers' immense contributions through
@NIH
to the development of new treatments; despite this, median price is $111,000 & US taxpayers almost always pay more than other countries for these publicly-funded treatments.
🚨Now out in
@JAMA_current
,
@cmorten2
@jsross119
& I outline how the
@US_FDA
should strengthen its enforcement of the legal requirements for sponsors to submit clinical trial results to under the FDA Amendments Act (
#FDAAA
): 1/
So thrilled to see
@zainrizvi
joining
@SenSanders
team as
@HELPCmteDems
' new Senior Health Counsel. Looking forward to seeing what he does with this team to ensure that medicines are affordable and accessible for everyone. 🎉🎉🎉
Under
@US_FDA
accelerated approval, sponsors receive early drug approval in exchange for confirming clinical benefit.
@FDACBER
Director Peter Marks' decision today to overrule his own staff & approve
#Elevidys
despite the drug failing to confirm clinical benefit is a new low.
This year's
@nytimes
investigations of non-profit hospitals have been outstanding - the facade that they've built in claiming they're serving the community in exchange for multimillion tax breaks & other financial benefits while fostering such disparities is hopefully crumbling.
🚨 NEW: NYU Langone's emergency room has been secretly allowing the rich, even those with minor complaints, to jump ahead of everyone else.
Meanwhile, the poor sometimes struggle to be seen.
@sarahkliff
and I dug into this two-tiered system of care.
With
@rgupta729
, we write in the
@nytimes
today how the hasty approval of
#remdesivir
resulted from years of assailing
@FDAgov
standards. Especially now, our patients must not be left with options for
#COVID19
that are too costly & not very effective.
Happy, happy birthday to one of my favorite people, one of my favorite lawyers, one of my favorite co-authors, and one of my favorite people to fight injustice with.
@cmorten2
, you truly are the best. ❤️🥳🎉
So this is going to get personal...
A 🧵:
As folks might know, my mom is a professor at Miami Dade College (
@MDCollege
). Next Monday, she will be forced to go back to the classroom and lab to teach IN PERSON.
I think this is a really, really bad idea. I'm terrified. 1/
@ZLThill
& I are in the
@thenation
today, calling on our healthcare colleagues not only to post their inspirational photos of receiving the
#COVID19
vaccines, but also to call them what they really are - the
#PeoplesVaccine
. 1/n
The consequences of
@POTUS
allowing
@moderna
to fleece the American people & commercialize without safeguards a publicly-funded & jointly
@NIH
developed
#COVID19
vaccine - hike up the price to $130 per dose, setting a new floor to continued price hikes.
Next Monday (9/20), I'll be joining colleagues & advocates just outside of the
#UNGA76
in NYC to call on
@POTUS
to make good on his promises for
#VaccinEquity
& taken action to implement the policies he & his admin have claimed to support.
Please join me:
😲🤯😲🤯
Be right back as I figure out a way to get my parents (especially my mother who has taught in person at
@MDCollege
over the past year without any sort of protection from the administration and where masks are only "encouraged") the heck of out of Florida.
I'm speechless. I attended medical school with Dr. Joseph Ladapo and to say I'm shocked by his opposition to mask and vaccine mandates is an understatement. I could have never imagined this news.
Truly honored to be invited by
@SenSanders
to be a witness at this upcoming
@HELPCmteDems
@GOPHELP
hearing to discuss lessons learned from the
#COVID19
pandemic response toward ensuring equitable access to medical countermeasures developed for future public health emergencies.
Still on ☁️ 9 after hanging with two of my favorite people yesterday - thank you so much, Professor
@cmorten2
for inviting me &
@zainrizvi
to your Science, Health, and Information Clinic seminar as well as the Health Law Association lunch at
@ColumbiaLaw
.
Para 5: After all that, says this: "we concluded, as did the [Advisory Committee] that the clinical trial data were not adequate on their own to convincingly demonstrate a clinical benefit in reducing clinical decline in patients with Alzheimer disease." Cool, cool, cool. 5/
"...425 of 1,029 patients, or 41%, who received the high dose of the drug — the dose that the
@US_FDA
later approved — experienced either brain swelling or bleeding. 64 patients had to stop participating in the trials because of swelling or bleeding."
New study out in
@JAMAInternalMed
on how frequently
@US_FDA
approves new drugs with missed primary efficacy endpoints, their rationale when they do, & whether they require postapproval studies when this occurs to address patient/clinician uncertainty around these approvals.
A true masterclass in testifying & answering Congressional questions steeped in evidence from Dr.
@mellabarb
who did an incredible job today before
@EnergyCommerce
outlining why we need data-driven, coordinated, & targeted ways to address drug shortages:
Thank you
@endpts
for this honor and to
@leilei_wuu
for writing a great piece summarizing our conversation on how I became engaged in efforts to study & advocate on behalf of my patients for affordable access to treatments that are truly safe and effective.
We are so proud of Yale NCSP alum and current faculty member Reshma Ramachandran
@reshmagar
for being named as one of the 20 under 40 “next generation” of biotech leaders by Endpoint News! Reshma is a
#HealthPolicy
powerhouse!
Watching the
@HELPCmteDems
@GOPHELP
led by
@SenSanders
hearing with my newest coworker who's looking forward to hearing how in the future, publicly-funded health technologies like the
@NIH
-
@moderna_tx
#Covid19
vaccine will be made affordable & accessible to all incl taxpayers.
ICYMI:
@SkydelJ
@jsross119
& I are in
@thehill
speaking about the financial & clinical impacts of allowing unproven drugs to remain on the market & what reforms to the accelerated approval pathway should be included in the
@US_FDA
user fee legislation.
It's my birthday! I have everything I need but too many of my patients still do not have access to the medicines I prescribe. Help me change that by supporting
@uaem
& the student leaders who are working to change that unacceptable reality:
#birthdaywish
Super duper congratulations to
@pritikrishtel
, health justice lawyer extraordinaire and founder/co-ED of
@IMAKglobal
for receiving the 2022 MacArthur Fellowship! So very lucky to be inspired by you and work alongside you. 👏👏👏 cc:
@uaem
Meet the 2022 MacArthur Fellows: 25 exceptionally creative people who push the boundaries of their fields and challenge us to imagine new possibilities.
#MacFellow
.
Who inspires you?
One more thing, which I can't believe I forgot. They also left out what
@US_FDA
's own statisticians said and essentially contradicts everything that Dunn, Stein, & Cavazzoni claim in the
@JAMAInternalMed
piece. THIS is what should be required reading:
Great deep dive by
@By_CJewett
in the
@nytimes
on
@US_FDA
user fee process reauthorized by Congress every 5 years by which FDA receives funding to continue its critical regulatory work..from the same industry it is meant to regulate with strings attached:
🚨 Now out in
@JAMANetworkOpen
,
@millerbioethics
@jsross119
& I examine access to
@WHO
-recommended
#COVID19
vaccines in countries hosting clinical trials as of early Sept, defining access in terms of authorization/approval as well as delivery of doses.
1/
ICYMI:
@Public_Citizen
released an incredible report & interactive map of
@PhRMA
& its members' extensive network of funding (ie. patterns of buying influence or silence) universities, patient advocacy organizations, & professional societies, among others.
Pharmaceuticals company Merck will stop supplying a vaccine to West Africa for a virus that kills 200,000 children a year. It cited "supply constraints."
@NPR
reports it will instead start selling the vaccine in China, where it fetches 10 times the price.
These extraordinary times and circumstances of call for extraordinary measures.
The US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and we’ll actively participate in
@WTO
negotiations to make that happen.
Great to see & long overdue. Looking forward to seeing
@AmerMedicalAssn
now channel their multimillion dollar lobbying budget towards protecting this right across states & in Congress in addition to halting any political donations to anti-abortion legislators. cc:
@AAFP_advocacy
Saying
#aducanumab
was a "sound approval" & that the marketplace works ignores that
#Pharma
has gamed the market to mislead patients, clinicians (sometimes intentionally so via kickbacks of all kinds), &
@US_FDA
to sell us pricey drugs that we're not sure work or could harm us.
"I think FDA should have approved this drug, I think it was a sound approval,"
@ScottGottliebMD
says of Biogen's Alzheimer's drug. "But it's up to the marketplace whether or not they think the drug's providing sufficient value...and this is the marketplace working."
A short 🧵of gratitude & hopefully, a bright, motivating light amid the darkness. Today is my last day as an
@NCSP_Yale
fellow, which has been one of the best decisions I've made. Here's why you should apply (& come join us) too - applications due 7/15:
@zainrizvi
@gregggonsalves
in
@USATODAY
: "Promoting equitable access to vaccines is an act of self-interest. Limited vaccine access could allow the virus to establish deeper roots in more countries, increasing the risk of new outbreaks for years to come."
"If instead, the approval had been delayed, we could make sure that the next drug approved for Alzheimer's disease is a true treatment or cure rather than peddling false hope to patients & clinicians looking to us to protect them."
It's time for new leadership
@US_FDA
. /FIN
The controversy about this poor approval decision shouldn't be "lower" even if Medicare can (& should) negotiate prices. At any price, this approval is a failure of the
@US_FDA
to uphold science & its mission to protect patients instead of Pharma profits.
The controversy about the Alzheimer’s drug would be a lot lower if the company couldn’t unilaterally decide to price the drug to make $100 BILLION on it annually.
Medicare needs the power to negotiate.
Thank you
@gregggonsalves
@akapczynski
@thehowie
& so many others for this statement from
@Yale
faculty on the dangers of propagating misinfo on HCQ for
#COVID19
& pointing out the high opportunity cost of focusing on this drug instead of real treatment.
Nor do many [doctors] recognize the pressure the drug industry exerts on
@US_FDA
to meet approval decision deadlines. "And that just seems like the wrong metric to care about. It should be: ‘Are patients healthier? Are patients safe?’ And that just seems like an afterthought.”
What an afternoon. Grateful for the opportunity to testify today before
@EnergyCommerce
on what reforms should be in proposed user fee legislation to ensure a strong, independent
@US_FDA
that protects patients. Stay tuned for a 🧵on what else I would add to my answers.
#PDUFA
Stellar testimony from
@cmorten2
responding directly to
@moderna_tx
CEO claims including noting that their own board member said that
@NIH
held the company's hand every step of the way & CEO's net worth could fund its entire 2023 R&D budget.
@HELPCmteDems
@GOPHELP
Thrilled to have
@DanaMarinBrown
&
@cmorten2
presenting to student leaders on the capabilities of and current happenings around public pharma at the
@uaem
North America Leadership Workshop at the OG stomping grounds of
@YaleLawSch
.
This title is misleading -
@moderna_tx
hasn't backed away from upcharging the
@NIH
#COVID19
vaccine they market by 400% but instead will set up patient assistance programs for uninsured & rely on payers including
@CMSgov
to cover the price hike.
A personal story highlighting why it is so critical that agencies like
@US_FDA
remain independent and not have their mission to protect the American public derailed by the industries they're meant to regulate.
Just over 2 years ago, my baby's life depended on access to formula.
ICYMI: Big announcement from
@NIH
proposing that licenses for agency-owned invention require an access plan within 3 months of entering into a pivotal trial outlining how the product will be made affordable & accessible for patient populations: cc:
@uaem
If you're going to read a paper today, read this one from
@mellabarb
& co on how much lower cost-based prices for life-saving diabetes (& anti-obesity) drugs (not just insulin - the new, outrageously expensive SGLT2is & GLP1as ones too!) would be compared to what pharma charges.
1 in 4 people with diabetes in the US ration their insulin because it is unaffordable. GLP-1s could cost Medicare > $100bn.
In a study out today in
@JAMANetworkOpen
, we analyze how much
#diabetes
medicines actually cost to manufacture. 🧵1/
Following
@LillyPad
's recent announcement to cut prices for some insulins,
@SkydelJ
& I call on
@POTUS
in the
@baltimoresun
to "finish the job" of lowering prescription drug prices by ending patent abuse through meaningful
@US_FDA
&
@uspto
collaboration:
There's a lot more crap in this, but glaringly missing is an admission from
@US_FDA
that the Aβ plaque biomarker that this whole accelerated approval for
#aducanumab
is hinged on has not been proven to work multiple times over in multiple clinical trials. 8/
If you want to "make it easier for large industries to be able to compete" that means having a strong
@FTC
that addresses consolidation & monopolies. Some of the most popular policies for everyday people are from the Biden/Harris FTC stopping "transactions" that hike prices.
Maryland Governor Wes Moore - who is a close ally of Harris - was asked on CNBC about what Kamala Harris will do about antitrust/regulation. And his answer is that she is going to change it from the Biden framework towards a more friendly partnership between government and big
What do I think (as a non-lawyer) are the impacts of
#SCOTUS
overturning
#Chevron
on federal agencies like
@US_FDA
?
1) serious delays or even a chill on issuing regulations based not on scientific uncertainty, but legal review to determine if they have explicit authority from...
One year ago today, this little munchkin came with me across country as I started the best fellowship at
@NCSP_Yale
. It's been a terrific year even amid the chaos - 💯 would choose it again.
Come join us
@NationalCSP
! Deadline to apply is soon on 7/15:
Looking forward to discussing how universities can be key levers of change in ensuring global equitable access to health technologies, which has been made all the more apparent during
#COVID19
. Also will be highlighting the incredible work of
@uaem
including at Cal in this talk!
This is just absurd that
@US_FDA
would even consider relying on a company's promise to voluntarily withdraw a drug from the market if the study is negative - we've seen how (not so) well that has worked for the agency with plenty of accelerated approval drugs. Not to mention...
@PinkSheetSutter
WOW ...Dunn is asking company to be clear that it would voluntarily pull the drug (AMX0035) if approved and the Phase III Phoenix study fails -- not saying this means FDA will approve now, he says but seems to think getting this assurance matters alot. $AMLX
Excited to hear Dr.
@mellabarb
of
@Yale_CRRIT
testify tomorrow morning in front of
@EnergyCommerce
on drug shortages and the need for coordinated, targeted policy solutions that address the contributing complex & varied factors:
Glad to hear
@POTUS
noting how much our patients are suffering from not being able to access their prescription drugs due to their price in his
#JointAddress
and how we must empower
#Medicare
& other health plans to negotiate fair prices.
Let's do it via
#AmericanFamiliesPlan
!
Thank you
@NCSP_UCSF
for hosting a wonderful
#NCSP2022
Annual Meeting in such a pretty place. Thought provoking talks (esp the closing from
@JAMA_current
EIC Dr.
@KBibbinsDomingo
) & incredible scholar presentations/posters. Looking forward to seeing everyone next year
@NCSP_Yale
!
And here's
@US_FDA
statistician Dr. Massie again, expressing "uncertainty whether the treatment (
#lecanemab
) effect on amyloid is reasonably likely to predict change on the clinical outcome" & cautioning that even the surrogate endpoint results should be considered "exploratory."
Three (!) teams of FDA experts & their supervisors recommended against accelerated approval of Sarepta's new gene therapy, Elevidys for the treatment of Duchenne's muscular dystrophy after careful review of the evidence & were overridden by a one person:
I was in my third trimester of pregnancy admitting patients when
#COVID
first hit & held onto a mask for a week at a time. We were told repeatedly that we did not have enough
#PPE
. I saw
@realDonaldTrump
promise
#PPE
, but instead got donations from family & friends.
#VoteHealth
We must do everything in our power to better prepare for future public health emergencies. The Senate HELP Committee is LIVE holding a hearing on reauthorizing the Pandemic and All-Hazards Preparedness Act.
So Mr.
@POTUS
, we urge you to fully re-engage back with
@WHO
by laying claim on the vaccine tech that you, me, & taxpayers already paid for & share it with
#CTAP
. It's time to
#FreeTheVaccine
so that we all can truly see the light at the end of this long, dark tunnel. 10/n
As you can see from my expression, this was a real treat. Grateful for the opportunity to ask Dr. Fauci about how
@NIH
could ensure equitable global access to publicly-funded health technologies & for his wisdom across several areas. Thanks
@gregggonsalves
for facilitating this!
The
@NCSP_Yale
was very fortunate to spend a bit of time with THE Dr Fauci this morning, talking COVID, public health, equity, & the role of NIH in discovery and advancing health. Major lesson learned: don’t abide the normalization of outright lies, which has hurt so many
Exactly, the ongoing corporation driven inequity in vaccine access is a nightmarish situation especially for our loved ones in the Global South. When will
@POTUS
@JeffreyZients
@WHCOVIDResponse
finally do something to ensure access to the publicly funded
@NIH
-
@moderna_tx
vaccine?
@MSF
must reconsider this ill-advised decision. As far as I can remember, the
@MSF_access
Campaign & its incredible team of experts have been key role models for me on how to effectively bring in the voice of clinicians and the patients they care of to the forefront of advocacy.
🚨In a blow to stellar medicine access activism work (law, science, price)
@MSF
bosses decide to foolishly close off MSF ACCESS CAMPAIGN
@MSF_access
Bizzare own goal for Global South access work. The most dedicated, encyclopedic knowledge team I ever worked with. A privilege.
🙏🏽
Appalling from
@alzassociation
-
@biogen
didn't even care to test if the drug works or is safe for POC when seeking
@US_FDA
approval, but
@CMSGov
in asking for such evidence before subjecting POCs to a costly, maybe ineffective, & unsafe drug is exacerbating health inequities?!
Perhaps fate that our piece comes out on the same day
@kkariko
&
@WeissmanLab
deservedly receive the Nobel Prize for Medicine where we discuss the other lessons learned for the U.S. government to ensure that public investment supporting such discoveries also yields public power.
New piece in
@bostonreview
today, with
@reshmagar
&
@akapczynski
.
"As the future of industrial policy is being written, we need to talk in the same breath about how public investment must yield public infrastructure, public rights, and public power."
And so it begins -
@biogen
starts peddling
#aducanumab
through the
@nytimes
via a $100K+ ad & a hosted website to bring awareness to a possible unknown diagnosis of mild cognitive impairment leading folks to be *magically* connected to a specialist who will offer their drug.
The Aduhelm advertising cascade. First I've seen. Back of the NYT mag, leads to a bit of sponsored content. Not about the drug, but about signs of/encouraging screening for mild cognitive impairment. Will be curious to see if that's most of what they do. $BIIB
At the upcoming
@UN
General Assembly next month, we urge
@POTUS
to step up as a world leader and put action behind his administration's statements of support to make
#VaccinEquity
not just a lost hope, but a reality. FIN
We live in a global village. As long as
#COVID19
circulates somewhere, it’s still a threat everywhere. We can’t put out half a fire.
That’s why we need
#VaccinEquity
:
-Share doses
-Share know-how
-Share technology
-Waive intellectual property
Proud to sign this letter with over 100 organizations and over 200 individuals, many of whom are the leading advocates and experts on pharmaceutical and regulatory policy calling on
@MSF
to reverse its decision to effectively dismantle the
@MSF_access
campaign.
#WeStandWithAC
In 1999,
@MSF
used
@NobelPrize
money to found
@MSF_access
bc they knew humanitarians needed to tackle drug inaccess at the source.
Last week,
@MSF
announced its closure.
108 orgs & 208 folks explain 🔽 why
#WeStandWithAC
and ask
@MSF
to reconsider. 🧵1/
Excellent piece in
@statnews
from
@DanaMarinBrown
&
@cmorten2
calling for a public option for pharmaceutical production & distribution to effectively address generic drug shortages, noting that it's been done before (e.g.
@MassBiologics
, Walter Reed, etc)
This from Billy Dunn of
@US_FDA
is misleading - beta-amyloid, the surrogate marker that
#lecanemab
's approval is based on has not been proven to be predictive, much less reasonably predictive of
#Alzeimher
's disease progression after over 2 dozen studies trying to show this.
As
@SenSanders
asks the
@NIH
Director nominee if she would commit to reinstating reasonable pricing requirements to taxpayer-funded treatments, here's what
@nikchaudhry_
& I wrote on why this is a critical step for ensuring affordability & accessibility, one of her stated goals.
Here's the promised 🧵 - again, incredibly grateful for the opportunity to testify before E&C
#SubHealth
on
#PDUFA
,
#BsUFA
, &
#GDUFA
to speak on
@US_FDA
reforms that Congress should implement as part of these agreements to protect patients. Lots of thoughts since, so here goes...
This just hasn't worked - expecting companies to do the right thing by just telling them to. If we "shouldn't underestimate the resolve of the U.S. government", then why isn't
@POTUS
taking control of
@NIH
-
@moderna_tx
vaccine & invest in public manufacturing incl
@WHO
mRNA hub?
Whoa,
@novonordisk
is discontinuing Levemir (long-acting insulin) because they're "confident that [U.S. patients] will be able to find alternative treatments." Alternative but more costly like Wegovy (also Novo product)? And by killing insulin competition? 🫠 h/t
@klipskaMD
Must-read piece by
@ChelseaClinton
& Achal Prabhala on how
@POTUS
can ensure everyone, everywhere access to
#COVID19
vaccines w/ identified manufacturers around the world available to make them -- but only if he allows them to do so.
#FreeTheVaccine
Did he mistakenly skip the word "failed" before blueprint and "un" before "fair allocation"? This is some crazy PR spin to a program that sucked up global resources, attention, & effort while ignoring equity at its core:
With
#COVAX
the world now has a blueprint of how to deliver vaccines at scale in an emergency to low-income countries, guided by a fair allocation framework developed with the
@WHO
to prioritise those most at-risk.
@cmorten2
on how
@GileadSciences
gamed the patent system &
@uspto
at the expense of patients: “There’s something profoundly wrong that happened here. The patent system actually encouraged Gilead to delay the development and launch of a new product.”
To end this global pandemic, we need global access to the vaccine. And there is a way to make this wish a reality - through the
@WHO
Coronavirus Technology Access Pool, which Dr.
#Fauci
has already heartily endorsed.
9/n
The U.S.'s top
#COVID19
doctor is right: scarcity won't suffice. We CAN produce enough vaccines and COVID treatments for everyone globally, and the U.S. has the power to make it happen.
#PeoplesVaccine
In response to
@SenBillCassidy
, I noted that the US govt had already successfully included reasonable pricing provisions in contracts with pharma during
#COVID19
. Universities like
@UCBerkeley
are US access clauses in their licenses too so why not
@NIH
?
These figures are awful, a nightmare made reality because of the cowardice of our rich nation leaders & greed of pharmaceutical companies who happily take billions from taxpayers but deliver doses to only a few, both refusing repeatedly to share tech that could've prevented this.
NEW: probably the most important Covid chart I’ve made
As Delta goes global, it’s a tale of two pandemics, as the heavily-vaccinated Western world talks of reopening while deaths across Africa and Asia soar to record highs
My story with
@davidpilling
Resonated with
@_Eric_Reinhart
's
@nytopinion
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."