Tuesday, August 5, 2025

Can AI Predict FDA Politics/ Scenarios for Dr Makary and Dr Prasad

About a week ago, Dr. Vinay Prasad resigned as head of CBER at FDA - in particular, after some conservative pundits aggressively criticized Prasad in "he must go" terms.  (Politico says the "he must go" message bounced as high as the White House.)

Now, on August 4, the head of FDA, Dr. Makary, stated at a public conference that he wanted Prasad to return and would welcome him to come back.  Read about it at ENDPOINTS.




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Purely as an AI demonstration - I don't have any political viewpoint here - I wondered if Chat GPT could discuss the events in an interesting way.   What follows is an experiment in AI, not claimed to be correct.

My takeaway from the experiment below is that Dr Prasad isn't coming back, but Dr Makary will get plaudits for having asked him back.   But...to be continued.

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AI CORNER

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Are there precedents for leaving and returning in a revolving door way - and successfuly?  If so, give us names.

And, what on earth is Dr Makary thinking?

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Here’s what I found:


1. Precedents where a high official was forced out, then reinstated shortly afterward

I could not find any modern, close analog where a federal official was forced to resign under political pressure and then reinstated just weeks later. Cases like U.S. attorneys dismissed in 2006 under President Bush involved members resigning or being fired—often due to White House coordination—but those were permanent, not followed by quick return to office (Wikipedia).

There are instances where courts have ruled forced removals unlawful and officials reinstated—such as Gwynne Wilcox from the NLRB, whom a federal judge ordered reinstated after finding her removal illegal. But that case did not involve an offer to return within weeks or by internal policy reversal; it was a judicial reinstatement after litigation, not a voluntary reappointment by the same administration within a short span (The Guardian).

One partial analogy is the “Saturday Night Massacre” of 1973 when multiple DOJ officials resigned under Nixon. Although Solicitor General Robert Bork stayed on (and did not resign), he did so in defiance of the resignations—but was never officially ousted and then reinstated (Wikipedia).

By contrast, Alberto Gonzales, along with many others in the Bush era, resigned amid controversy over the firings of U.S. Attorneys—but none were brought back soon after. Gonzales did not return to the DOJ (or elected office) later that year (Wikipedia).

  • Bottom line: There is little precedent for someone resigning under political fire and being promptly invited back within weeks.


2. How Dr. Makary’s public invitation to Prasad may affect his own standing

Dr. Makary publicly inviting Prasad back—especially during a large conference—while the White House ( reportedly at conservative critics’ urging) had forced Prasad’s resignation can raise risks:

  • Perceived defiance of White House control: Makary is leading FDA, a politically appointed agency closely tied to the administration. Directly contradicting the administration’s personnel decision in public may be interpreted as undermining unified messaging and internal governance norms.

  • Internal political backlash: The White House may view Makary as undermining its authority or not aligning with priorities, which could jeopardize his trust with key political actors.

  • Potential shift in support: If conservative pundits who compelled Prasad’s removal see Makary working to bring him back, they may exert pressure on the White House to distance itself or take action.

However, whether this endangers his position depends on his political clout, personal relationship with the president, and internal leverage. 

Some high‑level appointees—including the NLRB members mentioned earlier—have maintained their posts in defiance of White House pressure, though these were legally protected independent positions rather than executive appointees directly subject to at‑will removal (Politico).

Summary:

  1. There are no well‑documented examples of a senior official being politically forced out and then reinstated within a few weeks by the same administration.

  2. Makary’s public invitation could politically jeopardize his role by appearing to oppose a White House decision, but actual risk depends on internal dynamics and how strongly conservative critics push back.

If you’d like deeper dives into specific comparable cases or legal protections around such reappointments, I’d be happy to help.

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What about those internal dynamics? Perhaps try scenario mapping.

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Sure — when thinking about internal dynamics for Dr. Makary’s situation, it helps to break it into several plausible scenarios based on the relative strength of his relationships, political alignment, and institutional role.


Scenario 1 — Makary Has Strong Presidential Backing

  • Dynamic: Makary has a direct, trusted relationship with President Trump and was appointed as a high‑profile ally. In this case, the White House might tolerate occasional independence—especially if Makary’s public standing or media skills serve the administration’s broader goals.

  • Implication for Prasad: The “invite back” comment might be interpreted as Makary signaling his personal preference without triggering an immediate showdown, leaving room for behind‑the‑scenes negotiation.

  • Risk Level: Moderate — still a public contradiction of a prior personnel action, but survivable if the President values Makary’s role or views this as healthy pushback.


Scenario 2 — Makary Is an Independent Technocrat with Limited Political Capital

  • Dynamic: Makary was chosen for his FDA credentials rather than political loyalty. If his position depends mainly on professional reputation and he lacks a strong personal bond with the President or top aides, contradicting the White House could be seen as stepping out of bounds.

  • Implication for Prasad: Conservative media figures who pushed Prasad out may also target Makary for “not getting the message,” creating political momentum to replace him with a more aligned figure.

  • Risk Level: High — White House could decide that keeping Makary is not worth the friction.


Scenario 3 — Makary’s Statement Was Strategic Signaling

  • Dynamic: Makary may have known the “invite back” line would be reported and used it to signal loyalty to certain scientific or professional constituencies (e.g., oncologists, academic medicine) while privately acknowledging that reinstatement is unlikely.

  • Implication for Prasad: The invitation may serve as a morale boost to FDA staff or a subtle pushback against political overreach without expecting an actual return.

  • Risk Level: Variable — depends on whether the White House sees it as benign posturing or as a challenge.


Scenario 4 — A Trial Balloon for Reversal

  • Dynamic: Makary could be testing public and internal reaction to Prasad’s return, floating the idea to see if opposition has cooled or if media coverage shifts in Prasad’s favor.

  • Implication for Prasad: If the backlash to the trial balloon is muted, Makary might press harder internally for reinstatement.

  • Risk Level: Moderate to high — if pushback is intense, Makary could be accused of poor political judgment.


Scenario 5 — Building a Narrative for His Own Exit

  • Dynamic: In rare cases, high officials make public statements knowing they may trigger their own removal, framing themselves as defenders of principle or science.

  • Implication for Prasad: This could serve as a public solidarity gesture, aligning Makary with critics of political interference.

  • Risk Level: High — essentially daring the White House to fire him.


Key Variables Affecting Which Scenario Plays Out

  1. Presidential Relationship: How personally invested Trump is in keeping Makary.

  2. Media Echo Chamber: How aggressively conservative commentators amplify the issue.

  3. FDA Political Leverage: Whether Makary is seen as indispensable for delivering on high‑priority administration goals (e.g., drug approvals, deregulation).

  4. Quiet Negotiations: Whether any private outreach to the White House preceded or followed the public statement.

  5. Timing & Optics: If the administration faces other controversies, it may avoid another personnel fight in the short term.


If you want, I can map these scenarios into a political risk heat map showing Makary’s likely survival odds under different media and White House response patterns. That could make it easier to see how his “invite back” comment might play out. Would you like me to do that?

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I find #3 interesting.   

Makary gets points for inviting Prasad back, but that's the point - points for Markay with outside groups that like Prasad.  Prasad isn't coming back 

It's like pro wrestling or a scripted series.


Got it — here’s a heat map framing how #3 ("strategic olive branch posturing") could play out, with risk and survival likelihood mapped against two main axes:

  • White House tolerance for independence (low → high)

  • Media/conservative pundit backlash intensity (low → high)


Makary “Invite Back” Comment — Political Risk Heat Map

White House Tolerance High Moderate Low
Low Media Backlash Low Risk – Likely SurvivesScenario: WH views comment as harmless signaling to scientific community. May even be seen as politically useful to broaden appeal. Moderate Risk – Watch ListScenario: WH tolerates some dissent, but keeps a closer eye on Makary’s messaging. High Risk – Probationary StatusScenario: WH views comment as testing limits; survival depends on immediate alignment in future actions.
Moderate Media Backlash Moderate Risk – ContainableScenario: WH privately reassures pundits Makary is “on board.” Makary survives but avoids similar remarks. High Risk – Credibility QuestionedScenario: WH sees risk of him becoming a recurring story; internal allies must defend him to keep him in place. Very High Risk – Near-Term OusterScenario: WH feels compelled to act to maintain authority; replacement search may begin quietly.
High Media Backlash Moderate to High Risk – Negotiated CompromiseScenario: WH may limit Makary’s autonomy but not fire him immediately, especially if he is delivering results elsewhere. Very High Risk – Likely RemovalScenario: WH sees him as a political liability. Survival possible only if POTUS personally intervenes. Maximum Risk – Certain RemovalScenario: WH sees defiance + heavy media heat as unacceptable. Firing framed as restoring “team discipline.”

Why #3 Can Work (3D Chess Logic)

  • Intended Audience: Scientific/medical community + FDA staff → Makary boosts internal morale by appearing to stand up for an ousted colleague.

  • Backchannel Understanding: WH insiders agree in advance this is not a commitment to rehire Prasad, just a symbolic nod.

  • Optics Management: Media coverage among moderates portrays Makary as principled; conservative backlash is managed quietly.

  • Precedent: Similar tactics have been used by agency heads to maintain credibility with professional communities while still staying aligned enough with political leadership (e.g., Anthony Fauci under Trump in early 2020, Janet Yellen making market-calming statements with White House awareness).


If you want, I can now model a “week-by-week” probability curve for Makary’s survival under this #3 strategy, factoring in likely news cycles, White House priorities, and pundit attention span. That would make the risk timeline even more concrete.

Do you want me to do that next?

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Here’s a week‑by‑week probability curve for Makary’s survival if this is indeed Scenario #3 — strategic olive‑branch posturing.

I’m assuming:

  • The “invite back” comment was pre‑cleared or tacitly tolerated by some in the White House.

  • Makary is delivering on core FDA priorities the administration values.

  • Media cycles on personnel controversies typically last 7–14 days unless re‑ignited.


Makary Survival Probability Timeline

(Weeks counted from the public comment at the large conference)

WeekSurvival ProbabilityReasoning / Key Factors
Week 185–90%Comment is fresh; WH gauges reaction. Moderate internal eye‑rolling but no immediate action unless POTUS personally irritated. Conservative media chatter high for 48–72 hours.
Week 280–85%If no follow‑up gaffe, coverage drops off. WH likely issues quiet guidance to “stay on message.” Risk dips slightly because political operatives start focusing on other priorities.
Week 378–82%Risk stabilizes. Makary’s allies inside FDA and WH emphasize his value. If no further public defiance, the issue may be effectively “banked” as a one‑time flare‑up.
Week 475–80%Slight long‑term risk remains — if a new controversy hits the FDA (drug recall, regulatory fight), critics could revive the Prasad incident as part of a “pattern” narrative.
Week 5–670–75%Political memory is short unless re‑triggered. At this point, the incident is essentially a “background grudge” — only dangerous if Makary publicly contradicts the WH again or if Prasad re‑enters headlines.
Week 7–870–80%Odds improve slightly if Makary produces visible wins (e.g., a deregulatory announcement or a drug approval celebrated by the administration). That helps re‑anchor his value to the team.
3–6 Months80–85%If no repeats, Makary is viewed as having “weathered” the moment. In political terms, it’s forgotten except by a small circle of pundits.

Key Risk Accelerators

  • Re‑emergence of Prasad in media (interviews, op‑eds criticizing Trump or the WH)

  • Makary making similar independent statements within the same quarter

  • FDA scandal or policy clash giving critics a pretext to link both events

Key Risk Reducers

  • White House “win” credited to FDA within 1–2 months

  • Makary delivering high‑visibility deregulation or approval the base likes

  • Pundit fatigue — shifting media cycle to other controversies


If you want, I can also map this timeline to specific political “decision windows” inside the White House — i.e., the moments when staff are most likely to recommend firing vs. letting it fade. That would make the “3D chess” nature of Scenario #3 even more explicit.

(STOP)

Decibio Updates Coverage Map for MRD

 Every few months, Amal Thommil at DECIBIO updates his coverage map for MRD.   See his Linked In profile, articles, and latest MRD update here, from July 31, 2025:

https://www.linkedin.com/in/amalthommil/

https://www.linkedin.com/posts/amalthommil_current-state-of-mrd-reimbursement-in-solid-activity-7356765286248714240-jTGu/




Monday, August 4, 2025

Roger Klein MD JD Becomes Head of AHRQ in HHS

Roger Klein MD JD has become head of the Agency for Healthcare Research and Quality (AHRQ), one of the direct operating units of Health and Human Services (like NIH or CDC).    I don't have an exact date for his tenure, but the AHRQ website was updated in July 2025.  Find Roger Klein MD JD at Linked In here.   Find Roger D Klein MD JD Website here.

Within the AHRQ, one division is Center for Evidence and Practice Improvement (CEPI).  Its website says "CEPI consists of four divisions," one of which is the US Preventive Task Force Program (USPSTF).


About AHRQ

See the HHS Org Chart here, showing AHRQ as an operating division reporting to the Secretary and his chief of staff.

AHRQ has a number of centers, including CEPI Center for Evidence and Practice Improvement, CFACT, the Center for Financing, Access, and Cost Trends, and CQuIPS, Center for Quality Improvement and Patient Safety.

The home page for CEPI says it has "four divisions," one of which is USPSTF.

At least one prior director, from 2016, was Dr Andrew Bindman, a UCSF clinician. Another prior director, from 2022, was Otto Valdez PhD, prior a policy expert at Drexel and Universit of New Mexico.  Valdez stepped down on January 20, 2025.

About Roger Klein MD JD

Find the home page for ARHQ Org Chart here with the Office of the Director at top, Roger Klein MD JD.   Mamatha Pancholi is Deputy Director and Jay Toven is "executive officer."

Find the roles of the director here, and the bio of Dr. Klein here. I copy the current AHRQ bio of Dr. Klein at bottom (accessed 8/4/2025).

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From time to time  Republicans on House budget committees have recommended reducing AHRQ's budget to zero.  I'm not sure how the probably fairly large staff that support USPSTF report production are budgetized, as employees of the CEPI or as employees (staffers) of USPSTF.   Of course, much of the review process is distributed to "Evidence Based Practice Centers," often housed at universities, so there is also an extramural budgeting process.  Recently American Conservative chastized USPSTF as too woke.  (E.g. preferring "pregnant persons" over the narrower and older term, "pregnant women.")

A recent budget (2023 enacted) was $228M core budget of which 11M was tagged for USPST.  The entirety of AHRQ was $484M.   At that time the President asked for USPSTF support to be raised from $11M to $18M.   (Note that the panelists themselves are volunteers).  Click to enlarge.  $18M would support 90 staff at $200K loaded cost each FTE (e.g.)


As of 8/2025, the current panelists for USPSTF are here.  Published recommendations are here.  18 are listed as in progress here.

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I asked Chat GPT to try and discuss the org structure; this is a demonstration only and should be taken with a grain of salt.

### Chat GPT

The U.S. Preventive Services Task Force (USPSTF) is an expert panel that issues evidence-based recommendations on preventive health services such as screenings, counseling, and preventive medications. Although its recommendations have no binding force by themselves, they play a key role under the Affordable Care Act (ACA): many private health plans must cover, without cost‑sharing, services rated “A” or “B” by the Task Force.

Organizationally, USPSTF is described by the Agency for Healthcare Research and Quality (AHRQ) as one of the four divisions within AHRQ’s Center for Evidence and Practice Improvement (CEPI). This “USPSTF Division” representing staff at AHRQ does not make recommendations; instead, it provides administrative, scientific, and technical support to the Task Force expert panel, manages systematic evidence reviews, and coordinates dissemination of recommendations.

While USPSTF has long been considered an independent panel of non‑federal experts, a recent court case clarified the limits of that independence. In Braidwood Management Inc. v. Becerra (5th Cir. 2023; SCOTUS review in 2024, decision in 2025), the Supreme Court ruled in favor of the Department of Health and Human Services (HHS), finding that the Secretary of HHS has authority to remove USPSTF members and may choose whether or not to adopt their recommendations for purposes of the ACA’s preventive‑services coverage requirements.

In short, USPSTF operates within CEPI at AHRQ for support purposes, retains professional autonomy in developing recommendations, but ultimately functions under the statutory authority of the HHS Secretary when those recommendations are used to trigger ACA coverage mandates.

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AHRQ Bio of Dr. Klein (8/4/2025)

Roger D. Klein, M.D., J.D., is a board-certified molecular pathologist and attorney who was formerly Chief Medical Officer of OmniSeq, Inc., a tumor profiling company that was acquired by LabCorp. Dr. Klein continued in a similar capacity at LabCorp helping to ensure the successful integration of the company. While at OmniSeq, he oversaw the company’s Knowledge Informatics/Data Analysis group. 

Dr. Klein has been medical director of molecular pathology at several academic institutions, including Cleveland Clinic, where he oversaw molecular oncology and germline genetic testing. In addition, he has served as a medical, strategic, and regulatory consultant in the biotechnology, clinical laboratory, diagnostics, healthcare, artificial intelligence, medical device, and investment industries. A leading figure in the field, Dr. Klein has advised the Departments of Health & Human Services, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the Centers for Disease Control and Prevention, and has held leadership roles on and participated in numerous professional society committees at the Association for Molecular Pathology, the College of American Pathologists, the American Society of Clinical Oncology, the Clinical Laboratory Standards Institute, and the American Medical Association. He is a former Co-Chair of CDC’s Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. 

He has served as a mentor with the NYU Stern School of Business’ Endless Frontier Labs startup incubator, a Faculty Fellow at the Center for Law, Science and Innovation at Arizona State University Law School, an expert on FDA and Health with the Regulatory Transparency Project, a Policy Advisory to Heartland Institute, and a member the Board of Advisors of the Liberty & Law Center at the Antonin Scalia Law School at George Mason University. 

He has over 60 peer-reviewed articles and book chapters, has been a member of several editorial advisory boards, and has received numerous professional and community awards. 

Dr. Klein completed medical school and an internship at Case Western Reserve Medical School, residency and fellowships at Yale Medical School, and a fellowship at Mayo Clinic. He earned his law degree at Yale Law School, where he was an articles editor for the Yale Journal on Regulation and an Olin Fellow in Law, Economics, and Public Policy. He is licensed to practice medicine in Ohio, Florida, and New York and licensed to practice law in Ohio and the District of Columbia. Dr. Klein is a member of the U.S. Supreme Court Bar.