Eric Feigl-Ding Profile picture
Sep 21, 2020 17 tweets 5 min read Read on X
OH CHRIST—Trump HHS just did full “power grab” takeover of all drug/vaccines. Via “stunning declaration” of authority, HHS Secretary Azar barred FDA from signing any new rules—power now “is reserved to the Secretary.” Trump now controls all of it. #COVID19 nytimes.com/2020/09/19/hea…
2) “Outside observers were alarmed by the new memo and worried that it could contribute to a public perception of political meddling in science-based regulatory decisions. Dr. Mark McClellan, who formerly headed the F.D.A. For Bush said the policy change was ill-timed...
3) “We’re in the midst of a pandemic, when trust in the public health agency is needed more than ever,” he said. “So, I’m not sure what is to be gained with a management change with respect to F.D.A. when they are doing such critical work.”
4) “Dr. Peter Lurie, of the @CSPI and a former associate commissioner of FDA, called the new policy “a power grab.”
Many rules issued by federal health agencies are signed by lawyers or by heads of agencies. The new memo requires Trump’s political HHS secretary to sign them. 🔥
5) What this means is that Trump HHS secretary now wields to power to approve/reject a drug or vaccine with an EUA (emergency use authorization). Many problem w/ vaccine EUA is once it’s approved—some: a) people hesitant, b) not want to be part of trial anymore / other trials...
6) ...which makes future vaccines much harder. Let’s say first generation vaccine maybe only 40% effective. But next generation vaccine maybe 80% effective. Instead of just proving 80% vs placebo, they also have to prove 80% is better than the 1st gen 40% vaccine. MUCH HARDER!!!
7) Which unless they invest in 2-3x the people in next gen trials, we might get actually stuck with the first gen vaccine, which we don’t know even enough about if they EUA approve it and then get murky data afterwards. And the new stopping rules are super weak...
8) as Dr Topol points out, the EUA is criteria is set so weak that HHS can declare EUA if it just “may be effective”! Which means they would only need just 26 infections to “fulfill stopping rule and support efficacy”. 26 is not many at all!
9) This weird stopping rule is deemed “unusual” and “aggressive”.
10) How weak and usual is it? It’s so weak that it’s basically something a small Phase 2 trials can do. Dr Topol even equates it to “Russian vaccine approval and roll out”. Yes. You read that right.
11) this minimal “may be effective” criteria is a frigging “rush job” says Topol.
12) And the difference isn’t like waiting months and months, to hit a good threshold for data confidence with 150-160 infection events, we only need to wait a few more weeks longer that the rushed criteria to get the better data. Just a few extra weeks. No political rush job!
13) We ultimately need rigorous data. “There are ways to accelerate that process, but it is important not to cut corners, lest the public lose confidence and refuse a vaccine. But that doesn’t mean compromising robust data to prove safety and efficacy.” wsj.com/articles/a-fas…
14) Bottomline: the trial thresholds just seems so rushed and with a super low bar. And with FDA no longer the ultimate approver — Trump HHS now holding the power to approve drugs/vaccines via a power grab — it’s quite worrying that science will lose to Trump HHS politics.
15) Clarifying non-inferiority trials—yes it is expected next gen drug need proof it’s better than the old drug—but what an early stoppage of trial for a LOW/WEAK threshold is that we don’t know what 1st gen efficacy actually is. We won’t then know 2nd gen is really 80% either.
16) Also note, @ScottGottliebMD, who preceded Dr. Hahn as FDA commissioner, “spent much of his nearly two years as head of the agency fending off the new policy, which has been on the conservative agenda for many years.”
17) “former senior officials with the F.D.A. & H.H.S. speculated that the intent was to remove rule-making power from Dr. Stephen Hahn, the F.D.A. commissioner and to send a signal to President Trump that no surprises would come from the agency in the weeks before the election.”

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More from @DrEricDing

Jun 16
📍 THE 17 FIRED MEMBERS OF CDC’s VACCINE ADVISORY COMMITTEE (ACIP) speak out…

📍“As former ACIP members, we are deeply concerned that these destabilizing decisions, made without clear rationale, may roll back the achievements of US immunization policy, impact people’s access to lifesaving vaccines, and ultimately put US families at risk of dangerous and preventable illnesses.” 🔥

Full text:

Vaccines are one of the greatest global public health achievements. Vaccine recommendations have been critical to the global eradication of smallpox and the elimination of polio, measles, rubella, and congenital rubella syndrome in the US. They have also dramatically decreased cases of hepatitis, meningitis, mumps, pertussis (whooping cough), pneumonia, tetanus, and varicella (chickenpox), and prevented cancers caused by hepatitis B virus and human papillomaviruses.1 Recent scientific advancements enabled the accelerated development, production, and evaluation of COVID-19 vaccines, leveraging novel technologies that are estimated to have prevented approximately 1.6 million hospitalizations and 235 000 deaths in the US alone.2
For more than 60 years, the Advisory Committee on Immunization Practices (ACIP)—codified in the federal regulations (42 USC 217a: advisory councils or committees)—has served as a panel of experts that reviews the most up-to-date evidence on vaccines and monoclonal antibodies (eg, against respiratory syncytial virus [RSV]), providing sound recommendations to the US Centers for Disease Control and Prevention (CDC) regarding how vaccines should be used. ACIP recommendations are the cornerstone of the immunization program in this country. First, they serve as guidance and are the national standard for the use of Food and Drug Administration (FDA) authorized and licensed vaccines, providing a unified and trusted approach to vaccinations for the diverse array of immunization providers across the US. Second, they ensure science-based and tested immunization schedules that are optimized for well-timed protection against serious diseases. Third, the recommendations affect insurance coverage and safeguard broad access for vaccines. Fourth, ACIP’s continued monitoring of disease epidemiology and scrutiny of vaccine safety inform timely updates to recommendations that have maintained the trust and protection of the population. This transparent and ongoing surveillance of vaccines is one of the most stringent around the world, historically making the deliberations and decisions of this committee a beacon for immunization programs globally, while also serving as the foundation for recommendations harmonized with leading medical organizations in the US.3,4
ACIP committee members have always been selected through a rigorous process based on their expertise in immunology, epidemiology, pediatrics, obstetrics, internal and family medicine, geriatrics, infectious diseases, and public health. Historically, committee members were chosen because they worked at hospitals, clinics, health departments, universities, and other organizations where they dedicated themselves to caring for patients, conducting research, and helping to prevent and treat infectious diseases. Members’ deep understanding of immunization issues ensured that vaccine policies were grounded in scientific evidence, aligned with the needs of economically, socially, and medically diverse US communities, and always considered the public value, trust, and acceptability of vaccines.
Despite recent suggestions to the contrary, health care providers and the US public trust ACIP. For the past 18 years, the National Immunization Survey has shown that 99 of every 100 children in the US have received at least some recommended vaccines by 2 years of age, consistent with acceptance of ACIP recommendations implemented by trusted clinicians (National Immunization Survey - Childof Healthy People 2030).…Image
2) Full text part 2:

This does not suggest the population is so distrustful that it warrants dismantling the process by which vaccines have been recommended. ACIP standard procedures have minimized the risk of alleged conflicts of interest and biases. For decades, members of ACIP have undergone a thorough application and review process to participate. Proposed members submitted letters of support from other known experts and peers, completed an interview process, underwent a background check, and disclosed financial interests that might be considered a conflict, including any professional or financial relationships of immediate family members. Historically, it has taken up to 2 years for nominees to be approved to join ACIP.
Once part of the committee, ACIP members spent significant time preparing for meetings, reviewing the scientific evidence, and chairing work groups that, along with many CDC public health officials, led to the final recommendations that were determined during public meetings, which also included opportunities for public comment. Recordings of these meetings, agendas, and presentations were publicly available. Additionally, members agreed to ongoing monitoring and disclosure throughout their tenure. For example, potential conflicts of interest were reviewed throughout their time on the committee. Statements about potential conflicts were required during each meeting and before each vote, and members recused themselves from voting if any conflicts were identified. These disclosures have also recently been posted on the CDC website for public scrutiny. ACIP was among the most stringent and transparent of the federal committees, and we hope those criteria will apply to any new members joining the committee.
The abrupt dismissal of the entire membership of the ACIP, along with its executive secretary, on June 9, 2025, the appointment of 8 new ACIP members just 2 days later, and the recent reduction of CDC staff dedicated to immunizations have left the US vaccine program critically weakened.5,6 These actions have stripped the program of the institutional knowledge and continuity that have been essential to its success over decades. Notably, the ACIP charter specifies that committee members serve overlapping terms to ensure continuity and avoid precisely the disruption that will now ensue. The termination of all members and its leadership in a single action undermines the committee’s capacity to operate effectively and efficiently, aside from raising questions about competence.
Compounding these concerns, recent changes to COVID-19 vaccine policy, made directly by the HHS secretary and released on social media, appear to have bypassed the standard, transparent, and evidence-based review process.7 Such actions reflect a troubling disregard for the scientific integrity that has historically guided US immunization strategy. The newly stated strategy to replace ACIP members with individuals who will “exercise independent judgment, refuse to serve as a rubber stamp, and foster a culture of critical inquiry” is already leading to warnings by academic and scientific institutions, professional organizations, and the public who for decades have known well that these sought-after qualities precisely characterized the now-dismissed members of the ACIP.5
3) Part 3:

As former ACIP members, we are deeply concerned that these destabilizing decisions, made without clear rationale, may roll back the achievements of US immunization policy, impact people’s access to lifesaving vaccines, and ultimately put US families at risk of dangerous and preventable illnesses. Vaccines and the anti-RSV monoclonal antibodies are lifesaving, and people in the US deserve to have recommendations and broad access to use them to prevent serious diseases. In this age of government efficiency, the US public needs to know that the routine vaccination of approximately 117 million children from 1994-2023 likely prevented around 508 million lifetime cases of illness, 32 million hospitalizations, and 1 129 000 deaths, at a net savings of $540 billion in direct costs and $2.7 trillion in societal costs.8Finally, as individuals, we remain committed to evidence-based vaccine policy, both through our ongoing work in immunization science, public health, and medical education, and by supporting future efforts to keep America healthy that uphold scientific rigor and the public’s trust.
Read 4 tweets
May 8
⚠️Tariffs On Medications Will Make America Sick

We might soon see the Trump WH impose tariffs on pharmaceuticals—patients will suffer and die.

During the past few weeks, President Trump’s on-again, off-again tariff wars have rattled the stock market, decimated many Americans’ retirement funds, and promised to send grocery prices soaring—and his administration hasn’t even gotten to critical pharmaceutical tariffs yet. But that will likely be the next shoe to drop.
Trump exempted pharmaceuticals from his first round of tariffs in early April, but recently declared that he intends to impose “a major tariff” on imported medicines “very shortly.” These tariffs, he claims, will prompt pharmaceutical companies to leave countries including China and India and begin “opening up their plants all over the place.”
Commerce Secretary Howard Lutnick said in a television interview in mid-April that these tariffs are coming in the “next month or two.”

What will this mean? 

Read on:
progressive.org/op-eds/tariffs…Image
2) The majority of brand name drugs used in the United States are imported. Even generic drugs often rely on ingredients and direct imports from China, including pain relievers and cardiovascular drugs used by millions.
3) The United States was already facing a drug shortage crisis before Trump’s tariff announcement. Now, his policies will drive upnot only the cost of medicines, but also other health care items such as X-ray machines and medical instruments.
Read 8 tweets
Apr 10
It’s a trap: CATCH 22—if you register, ICE will deport you. If you don’t register, you’ve now committed a crime for the first time, and ICE will deport you. Trump doesn’t care if you’ve paid all taxes and followed all laws—ICE will deport you.

apnews.com/article/illega…Image
2) The Department of Homeland Security announced that it was mandating that all people in the United States illegally register with the federal government, and said those who didn’t self-report could face fines or prosecution. ***Failure to register is considered a crime***
3) Registration will be mandatory for everyone 14 and older without legal status. People registering have to provide their fingerprints and address, and parents and guardians of anyone under age 14 must ensure they registered. The registration process also applies to Canadians who are in the U.S. for more than 30 days, such as so-called snowbirds who spend winter months in places like Florida.
Read 4 tweets
Apr 3
Now economists know how scientists felt back when he pushed “hydroxychloroquine”
2) HCQ preventing COVID deaths has been debunked— and it’s now been linked with deaths.

@JoshuaPCohen1
forbes.com/sites/joshuaco…Image
@JoshuaPCohen1 3) JPMorgan on Trump Tariffs: “The largest tax increase since 1968” Image
Read 6 tweets
Mar 28
My god—Earthquake (a Richter ~7.7) causes a skyscraper to collapse in Bangkok. Hope all the construction workers made it out.
2) this skyscraper collapse was captured from a distant car’s dashcam while on a highway

3) another view of the collapse. For those who lived through 9/11, this collapse is a bit triggering.
Read 5 tweets
Mar 27
Welp—kiss public health & medical research infrastructure in America goodbye for the next 4 years. RFK Jr plans to cut 10,000 jobs from Trump HHS. Image
2) this will not make America healthy again… not by a long shot. So dangerous and irresponsible.
3) “Kennedy is set to announce Thursday the planned changes, which include axing 10,000 full-time employees spread across departments tasked with responding to disease outbreaks, approving new drugs, providing insurance for the poorest Americans and more”.
Read 5 tweets

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