The most important person in a pharmaceutical company may be the one willing to say no (timecodes below).
That is what I took from my latest conversation with Susan F. Langlois, a retired vaccine-industry regulatory affairs specialist with approximately 45 years across regulatory approvals, quality, clinical trials and biotechnology strategy.
I invited Susan back because two contemporaneous records can now be placed side by side. Her pandemic diary records what she was seeing, hearing and questioning in Canada as events unfolded. Anthony Fauci’s diary records what occupied one of the most influential public-health figures inside the United States response.
The NIH-Moderna patent relationship was the obvious point of contact. But the more consequential question was not who held intellectual property or who received a royalty. It was this: when financial, political and public-health pressures converge, who inside a pharmaceutical company is responsible for asking the question nobody wants asked?
Susan’s answer was clear. That is part of the regulatory professional’s job. The hard question does not only protect the public. Asked early enough, it protects the company.
The Patent Record Needs Precision
NIAID’s Vaccine Research Center and Moderna had a documented scientific collaboration on the SARS-CoV-2 vaccine in January 2020. Fauci’s diary entries of 14 and 28 April 2021 record a dispute over whether Vaccine Research Center scientists should be named as inventors on a Moderna patent associated with the vaccine. Moderna’s public filing states that in December 2022 it entered a non-exclusive licence with NIAID for certain patent rights concerning stabilised prefusion coronavirus spike proteins, and records a $400 million catch-up royalty payment to NIAID with low single-digit royalties on future net sales.
Those are documented facts. They establish an institutional intellectual-property and financial relationship that deserves transparent governance. They do not establish that Anthony Fauci personally received royalties. They do not prove that the patent interest determined vaccine policy, or that scientific concerns were suppressed to preserve income.
The defensible question is narrower and more useful. What conflict-management rules, disclosures and organisational separations were in place when an institute involved in vaccine research and intellectual property was also central to the public-health response? Were those safeguards visible enough to sustain public confidence?
A Regulatory Professional Is Not a Sales Department
The pivotal moment came at 32:59. Susan said,
“I wouldn’t have filed the submission the way it was.”
Her point was not that emergency access is never justified. She has worked with emergency product releases. Her point was that urgency does not erase uncertainty. If evidence is incomplete, the incompleteness must travel with the product, appearing not only in technical documents but in the language used by governments, clinicians and the media.
She focused on pregnancy, fertility and the limits of the original clinical programme, and returned to the distinction between preventing symptomatic disease and proving that a product prevents infection or onward transmission. The pivotal Moderna trial was designed primarily around symptomatic COVID-19. That does not prove the vaccine had no effect on transmission. It means a categorical transmission claim required evidence beyond that primary endpoint.
This is where regulatory affairs becomes a protective function. It tests whether the claim matches the evidence, whether the intended population matches the data, whether known unknowns are disclosed, and whether a new signal changes the balance. It makes enthusiasm more accurate before enthusiasm becomes exposure.
A company may experience that as delay or obstruction. It is an early-warning system. The uncomfortable meeting today may prevent the product withdrawal, lawsuit, reputational collapse or loss of an entire platform tomorrow.
Emergency Authorisation Changes the Threshold, Not the Duty
Susan accepted that a severe emergency can justify acting with less information than usual. But a lower evidentiary threshold creates a greater disclosure obligation, not a smaller one.
Patients should know what has been demonstrated, what remains uncertain, which populations were studied and how long follow-up has lasted. Clinicians need the same clarity, because they are the final interpreters of the product for the person sitting in front of them.
Formal regulatory documents did contain qualifications and evolving safety information. Susan’s challenge is that public messaging often sounded more certain than the underlying record. That is a testable claim, and the test is a dated timeline: authorisation documents, approved indications, trial endpoints, public statements and subsequent label changes, placed side by side.
That is more useful than accusing one institution of misconduct. It shows where wording outran evidence, when uncertainty was corrected, and whether the correction reached the public with the same force as the original claim.
A Signal Is Not Causation. It Is a Responsibility.
At 49:58, Susan stated the most important pharmacovigilance principle in the discussion:
“A signal means you need to start investigating that.”
A safety signal is not proof that a medicine or vaccine caused an event. A spontaneous report is not a confirmed adverse reaction. Regulators make this distinction explicitly. But uncertainty about causation is not a reason to stop. It is the reason to begin a structured evaluation.
That evaluation may require clinical review, observed-versus-expected analysis, linked health records, targeted epidemiology, additional animal work or another clinical study. The method depends on the signal. The duty does not.
This is where much of the public discussion went wrong. One side treated every report as proof. The other treated the absence of immediate causal certainty as reassurance. Both collapse the middle of the scientific process, where a clue is tested and either strengthened, narrowed or dismissed.
Susan’s principle is stronger: do not call the signal causation, but do not leave it unanswered.
What Happens When Liability Is Blunted?
Susan explained that company leaders normally expect regulatory and clinical teams to identify a problem quickly, because unresolved signals create future liability. In her words, the instruction would be:
“You need to protect us from future liability.”
Her concern is that broad emergency protections may weaken one of the incentives that normally gives the internal challenge function its authority. If a company expects government to carry much of the legal and promotional burden, who owns the risk that remains?
Legal protection does not remove scientific responsibility, professional responsibility or reputational risk. It makes governance more important. A protected company still needs an internal group empowered to contradict commercial optimism. A government acting as promoter still needs a regulator empowered to contradict political messaging.
Without that separation, everybody can be described as responsible while nobody is clearly accountable.
Where the Hard Question Can Die
Susan described risk-management meetings in which regulatory, clinical and financial staff would discuss emerging problems. In large organisations, she said, difficult information may travel through several layers before it reaches senior executives or the board.
That creates a familiar hazard. The people closest to the evidence may lack the authority to act. The people with authority may be insulated from the evidence. And the messenger understands that escalation may end a career.
Susan was careful to correct herself here. She does not know what individual regulatory employees at Pfizer or Moderna said internally. They may have raised objections. They may have been overruled, marginalised or removed. The record supplied for this article cannot settle it.
The answer requires documents rather than assumptions: contemporaneous safety reviews, risk-management minutes, escalation logs, internal objections, regulator correspondence and records showing how disputed claims were resolved. Silence in public is a clue about governance. It is not proof that nobody spoke inside the company.
The Doctor Is the Final Trust Bridge
The discussion eventually reached clinicians, and this is where I felt the weight of Susan’s argument most clearly.
A doctor cannot independently reconstruct the full regulatory history of every product. Clinical practice depends on trusted summaries: the approved indication, the product monograph, regulator guidance, professional recommendations and post-market updates. The public then relies on the doctor who relies on that system.
If uncertainty is filtered out upstream, the doctor becomes the visible face of a decision made elsewhere. When confidence breaks, patients do not direct their anger towards an abstract governance chart. They turn to the person who recommended or administered the product.
This is why hard questions inside industry and government are not hostile to medicine. They protect the doctor-patient relationship from carrying claims it was never equipped to verify.
The Diary Is an Audit Trail, Not a Verdict
Susan’s diary matters because memory is easily reshaped by later narratives. A dated record shows what was said at the time, when recommendations changed, and which uncertainties were visible before they were publicly acknowledged.
Fauci’s diary serves a complementary purpose, showing internal priorities, conversations and disputes from inside a central institution. Neither diary proves every interpretation attached to it. Together they identify dates, contradictions and questions that can be checked against the formal record.
That is the correct use of a diary in serious analysis. It is not a substitute for trial data, regulatory files or causal evidence. It is a map showing where to look.
Surviving the Covid Pandemic: Contents of a Diary >
by Susan Langlois
What Would Proper Protection Look Like?
The reforms suggested by this conversation are practical. Patent and royalty interests should be disclosed alongside public recommendations. Intellectual-property and licensing functions should be visibly separated from clinical guidance and product oversight. Public claims should be mapped to the endpoints that support them. Major safety signals should trigger a published investigation plan, with dates, methods and a closure decision.
Inside companies, regulatory objections should be recorded and escalated through a channel that no single commercial layer can block. Boards should receive unresolved safety and indication disputes directly. After an emergency, an independent retrospective audit should compare what was known, what was said and what action followed.
None of this assumes that a disputed product is unsafe or that a conflicted institution acted corruptly. It recognises a simpler truth: systems deserve trust when they make challenge visible.
The Question We Should Ask Now
The patent question remains important. The public deserves a precise account of the NIH-Moderna intellectual-property relationship, the inventorship dispute, the royalty arrangements and the conflict-management safeguards around decision-making.
But Susan’s larger point travels beyond one patent, one company and one pandemic.
A regulatory professional does not protect a company by helping it avoid the difficult question. The protection comes from asking that question early, documenting the answer and changing course when the evidence demands it.
That is how patients are protected. It is how clinicians are protected. It is how a pharmaceutical company protects its licence to be trusted.
The hard question is not an act of disloyalty. It may be the last act of loyalty before scientific uncertainty becomes a corporate crisis.
Timecodes
00:00 Opening title
01:03 Why compare the pandemic diaries?
02:26 Susan Langlois’s regulatory background
04:18 Why she kept a daily pandemic diary
06:15 The China footage that shaped public fear
09:08 Protecting the diaries as a historical record
10:55 Inside the book: dated entries and verification
13:27 Fauci’s diary and the NIH-Moderna patent question
17:03 A past example of an undisclosed conflict
18:51 Could financial incentives influence platform choices?
21:17 From a high-risk rollout to broad mandates
23:32 Trial endpoints, infection and transmission
25:31 Patents, policy and public pressure
28:41 What if nobody had pushed back?
31:27 The regulatory professional’s personal responsibility
32:59 “I wouldn’t have filed the submission that way”
38:02 Ethics, liability and missing oversight
42:59 Why experienced people deferred to authority
44:49 Grandfathering mRNA technology into future vaccines
47:37 Post-market surveillance after liability protections
50:56 Risk-management meetings and escalation barriers
53:40 When trust moves from pharma to doctors
57:09 The professional cost of questioning
60:24 A real-world lesson in indication and informed choice
64:58 Reading the diary’s regulatory warning
68:44 Where to find Susan’s book
69:25 Closing remarks
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