Trump Pressed for a Plasma Treatment. Officials Worry,
Is a Vaccine Next?
New
details of how the president has demanded faster action from health agencies
help explain the intensifying concern that he could demand pre-Election Day
approval of a vaccine.
On Sunday night, the eve of the Republican National Convention,
President Trump announced, with the F.D.A.’s approval, that plasma therapy
would be available for wider use.
By Sharon LaFraniere, Noah Weiland and Michael D. Shear
·
Sept. 12, 2020, 12:09 p.m. ET
WASHINGTON — It was the third week of
August, the Republican National Convention was days away, and President Trump
was impatient.
White House officials were anxious to
showcase a step forward in the battle against the coronavirus: an expansion of
the use of blood plasma from recovered patients to treat new ones. For nearly
two weeks, however, the National Institutes of Health had held up emergency
authorization for the treatment, citing lingering concerns over its
effectiveness.
So on Wednesday, Aug. 19, Mr. Trump
called Dr. Francis S. Collins, the director of the N.I.H., with a blunt
message.
“Get it done by Friday,” he demanded.
It wasn’t done by
Friday, and on Sunday, regulators at the Food and Drug Administration still had
not finished a last-minute data review intended to ease N.I.H. doubts.
But on Sunday night, the eve of the
convention, the president announced, with the F.D.A.’s approval, that plasma
therapy would be available for wider use, and he declared that it could reduce
deaths by 35 percent, vastly overstating what the data had shown about the
benefits.
Mr. Trump’s call to Dr. Collins was a
flash point in a pressure campaign by the White House to bend the nation’s
public health agencies to his desire to show progress in the fight against a
pandemic that has killed more than 192,000 people in the United States.
And it was just one in a series of moments that have left scientists and
regulators across the public health bureaucracy increasingly worried that the
White House could exert greater pressure to approve a vaccine before Election
Day, even in the absence of agreement on its effectiveness and safety.
On the night of the plasma
announcement, Dr. Collins was told to show up at the White House, where he was
given a coronavirus test and then shunted to the Roosevelt Room as Mr. Trump
and others spoke to journalists in the briefing room.
There, Dr. Collins and Dr. Peter Marks,
one of the top regulators at the Food and Drug Administration and the person
most directly responsible for maintaining the independence and scientific rigor
of the vaccine approval process, watched helplessly as the president and other
top administration officials oversold plasma’s effectiveness, creating a public
relations debacle that reverberated for days.
Dr. Collins left the
White House after the announcement. But Dr. Marks, who had pushed for the
plasma approval, was escorted to the Oval Office to spend a few minutes with
Mr. Trump and his top aides, who were celebrating with cupcakes with white
icing. In an interview on Friday, Dr. Marks said he was “a little bit in a
state of shock” to find himself there being thanked by the president for his
work on the plasma approval.
Although he described it as “a brief
interaction that really didn’t have any substance,” health officials who had
heard about the encounter said they feared it could create the impression that
the guardrails between politics and science were being further eroded at a time
when the public is already concerned about
political pressure in assessing the safety of vaccines and treatments.
Some of those present
were taken aback when Mr. Trump, who a day earlier had tweeted about
a “deep state” at the Food and Drug Administration blocking quick
approvals of treatments and vaccines to hurt him politically, jokingly asked
whether Dr. Stephen M. Hahn, the F.D.A. commissioner, was doing a good job.
With Election Day just over seven weeks
away, Washington is witnessing the collision of two worlds: a community of
largely anonymous government scientists and doctors who operate in a culture guided
by research, data sets and peer review, and a president famously disdainful of science, politically wounded by his
failures to contain the coronavirus and now determined to cast himself as
moving as fast as possible to provide Americans with vaccines and treatments.
Government scientists and pharmaceutical companies have begun taking
extraordinary steps to counter any impression that they could sacrifice public
safety to political expediency, pledging publicly that
they are committed to impartial scientific decisions about fighting the
coronavirus.
Dr. Hahn has publicly committed to
vetting any vaccine approval through an advisory committee of outside experts.
In an attempt to add more rigor to the agency’s decision-making process, he
said this week that the Food and Drug Administration intended to issue new
guidance on the standards used to justify emergency use of a vaccine.
“We will not
jeopardize the public’s trust in our science-based, independent review of these
or any vaccines,” Dr. Hahn said on Twitter on Friday.
“There’s too much at stake.”
The administration has come under
withering criticism for not acting aggressively enough to confront the
virus and failing, for example, to push through bureaucratic red tape in the
pandemic’s early stages to develop diagnostic tests that would work. White
House officials say the president is now doing exactly what his opponents have
assailed him for not doing: exerting pressure to develop safe and effective
drugs and vaccines as quickly as possible because people are sick and dying,
not because of the timing of the election.
The rushed plasma approval rollout is
far from the only aspect of the government response to the virus that was
shaped by pressure from the White House. The Centers for Disease Control and
Prevention has repeatedly waffled on how much testing is recommended and for
whom, and political appointees at the Department of Health and Human Services
have repeatedly asked the agency to revise, delay and even scuttle reports on
the coronavirus they believed were unflattering to the president. The Food and
Drug Administration first gave emergency authorization for use of
hydroxychloroquine to treat Covid-19 after Mr. Trump promoted it, only to be
forced to reverse itself.
But the battle over approval of
convalescent plasma is particularly telling because it involves many of the
players who would figure in a far more momentous decision over whether to authorize
an emergency approval for a vaccine.
Over the summer, the debate over plasma
evolved from a purely scientific discussion about its merits to a kind of
political loyalty test, laid bare in presidential remarks in the days before
the announcement.
In a news briefing on Aug. 19, Mr.
Trump complained that “people over there” — an apparent reference to the Food
and Drug Administration — wanted to limit plasma treatment until after the
election. In a Twitter post three days later, he accused “deep state” officials
at the agency of slow-walking approvals of Covid-19 vaccines and treatments to
harm him politically.
Like other approaches to dealing with
the virus, convalescent plasma was a subject of scientific debate and
disagreement. The pale yellow liquid that remains after blood is stripped of
its red and white cells, it has been used since the 1890s to treat infectious diseases,
including the flu, SARS and Ebola.
Regulators at the
Food and Drug Administration, which approves new treatments, were willing to
evaluate convalescent plasma for emergency approval on the basis of tens of
thousands of case studies from a federally supported Mayo Clinic program. Dr.
Collins and other officials at the N.I.H. wanted its benefits tested with
randomized trials, for which scientists across the country had struggled to
recruit patients. Although N.I.H. did not have regulatory authority, the
administration wanted agreement among all the health agencies on moving ahead
with expanded use of plasma.
In June, Dr. Marks
alerted Dr. Deborah L. Birx, the White House coronavirus response coordinator,
that early data from the Mayo Clinic program looked promising. Mark Meadows,
the White House chief of staff, quickly began agitating for emergency approval,
senior administration officials said.
Throughout the summer, the White House
has kept a close eye on the Food and Drug Administration’s progress with
therapies and possible vaccines. The president himself calls Dr. Hahn on his
cellphone about once a week, according to a senior administration official.
Mr. Meadows is also in regular contact
with Dr. Hahn, who sometimes makes unscheduled visits to Mr. Meadows’s corner
suite in the West Wing.
Dr. John C. Fleming, a top adviser to
Mr. Meadows, holds a weekly meeting with Dr. Hahn, Dr. Marks, Dr. Janet
Woodcock, a top F.D.A. drug official, and Eric D. Hargan, the deputy health
secretary. Jared Kushner, the president’s senior adviser and son-in-law, was
also closely involved in tracking progress on vaccines and treatments.
For weeks, F.D.A. regulators, backed by
Dr. Hahn, insisted the data from the plasma research was not strong enough to
justify approving wider use. By Aug. 12, though, they were ready to move ahead,
deciding plasma met the comparatively low bar for emergency authorization in
which the potential benefits outweighed the risks.
N.I.H. officials were
still arguing for a clinical trial, but the scientists arrived at a compromise:
The Food and Drug Administration would analyze the data again with fresh
results from the Mayo Clinic program.
Frustrated by the delay, Mr. Trump
pressed his case with Alex M. Azar II, his health secretary.
Two allies of Mr. Kushner’s got involved:
Brad Smith, a deputy assistant to the president, and Adam Boehler, the chief
executive of the U.S. International Development Finance Corporation and a
former Trump administration health official.
They talked to Dr. Hahn and Mr. Azar
about data that they said showed that plasma from the Mayo Clinic program was
available to only three-fourths of the hospitals treating Covid-19 patients,
leaving 900 hospitals without access to the therapy. While emergency approval
was held up, they noted, Americans were dying.
Matters came to a head on Aug. 19 after
The New York Times published an article saying the plasma approval
was on hold because of the N.I.H. objections. F.D.A. and White House officials
were furious that N.I.H. officials had publicly aired their objections despite
negotiations to resolve the conflict over data. Mr. Trump called Dr. Collins
demanding that plasma be approved within two days.
Dr. Birx and other top health officials
also lashed out at Dr. Collins, asking him to publicly clarify his position,
according to senior administration officials with knowledge of one tense
meeting that week.
At the Food and Drug
Administration, officials were expecting to finish the new analysis for the
N.I.H. and to announce emergency approval of plasma as early as Monday, Aug.
24.
But on the preceding
Thursday, they were told that was too late: The decision had to be announced on
Sunday, the day before the start of the Republican National Convention,
ostensibly because making the announcement during the gathering would appear to
be politically driven.
Another obstacle emerged that weekend:
New Mayo Clinic data was missing key entries and could not be used, foiling the
reanalysis.
White House officials said they were
told by Mr. Azar and Dr. Hahn that they were ready to make the announcement on
Sunday. The president’s communications team quickly put together an event in
the White House briefing room, with Mr. Trump flanked by Dr. Hahn and Mr. Azar.
The F.D.A. called the approval “another achievement”
in the administration’s battle against the pandemic.
The rush contributed to serious
mistakes. Dr. Hahn misinterpreted agency data and claimed that plasma reduced
the mortality rate of Covid-19 patients by 35 percent — a substantial exaggeration of what the research
actually showed.
Immediately after the announcement,
however, the mood in the Oval Office was celebratory. Cupcakes were served.
Photographs were taken.
Before him on the Resolute Desk, the
president had multiple copies of that day’s Wall Street Journal. He noted with
pleasure a prominent article stating that he had forever changed the Republican
Party.