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T**********e
发帖数: 29576 | 1 NYT:
Barriers to Testing
Dr. Stephen Hahn’s first day as F.D.A. commissioner came just six weeks
before Mr. Azar declared a public health emergency on Jan. 31. A radiation
oncologist and researcher who helped turn around MD Anderson in Houston, one
of the nation’s leading cancer centers, Dr. Hahn had come to Washington to
oversee a sprawling federal agency that regulates everything from
lifesaving therapies to dog food.
But overnight, his mission — to manage 15,000 employees in a culture
defined by precision and caution — was upended. A pathogen that Mr. Trump
would later call the “invisible enemy” was hurtling toward the United
States. It would fall to the newly arrived Dr. Hahn to help build a huge
national capacity for testing by academic and private labs.
Instead, under his leadership, the F.D.A. became a significant roadblock,
according to current and former officials as well as researchers and doctors
at laboratories around the country.
Private-sector tests were supposed to be the next tier after the C.D.C.
fulfilled its obligation to jump-start screening at public labs. In other
countries hit hard by the coronavirus, governments acted quickly to speed
tests to their populations. In South Korea, for example, regulators in early
February summoned executives from 20 medical manufacturers, easing rules as
they demanded tests.
But Dr. Hahn took a cautious approach. He was not proactive in reaching out
to manufacturers, and instead deferred to his scientists, following the F.D.
A.’s often cumbersome methods for approving medical screening.
Continue reading the main story
Even the nation’s public health labs were looking for the F.D.A.’s help.
“We are now many weeks into the response with still no diagnostic or
surveillance test available outside of C.D.C. for the vast majority of our
member laboratories,” Scott Becker, chief executive of the Association of
Public Health Laboratories, wrote to Mr. Hahn in late February. “We believe
a more expeditious route is needed at this time.”
Ironically, it was Mr. Azar’s emergency declaration that established the
rules Dr. Hahn insisted on following. Designed to make it easier for
drugmakers to pursue vaccines and other therapies during a crisis, such a
declaration lets the F.D.A. speed approvals that could otherwise take a year
or more.
But the emergency announcement created a new barrier for hospitals and
laboratories that wanted to create their own tests to diagnose the
coronavirus. Usually, they faced minimal federal regulation. But once Mr.
Azar took action, they were subject to an F.D.A. process called an “
emergency use authorization.”
Even though researchers around the country quickly began creating tests that
could diagnose Covid-19, many said they were hindered by the F.D.A.’s
approval process. The new tests sat unused at labs around the country.
Stanford was one of them. Researchers at the world-renowned university had a
working test by February, based on protocols published by the W.H.O. The
organization had already delivered more than 250,000 of the German-designed
tests to 70 laboratories around the world, and doctors at the Stanford lab
wanted to be prepared for a pandemic.
“Even if it didn’t come, it would be better to be ready than not to be
ready,” said Dr. Benjamin Pinsky, the lab’s medical director.
But in the face of what he called “relatively tight” rules at the F.D.A.,
Dr. Pinsky and his colleagues decided against even trying to win permission.
The Stanford clinical lab would not begin testing coronavirus samples until
early March, when Dr. Hahn finally relaxed the rules.
Continue reading the main story
Executives at bioMérieux, a French diagnostics company, had a similar
experience. The company makes a countertop testing system, BioFire, that is
routinely used to check for the flu and other respiratory illnesses in 1,700
hospitals around the country. It can provide results in about 45 minutes.
“A lot of us said, you know, your typical E.U.A. is just much too demanding
,” said Dr. Mark Miller, the company’s chief medical officer, referring to
the emergency approval. “It’s going to take much too much time. And can’
t you do something to shorten that?”
Officials at the F.D.A. tried to be responsive, Dr. Miller said. But rather
than throw out the rules, the agency only modified the regulatory
requirements, still requiring weeks of discussions and negotiations.
After conversations with the F.D.A. in mid-February, the company received
emergency approval for its BioFire test on March 24. (The company also began
talking to the F.D.A. in January about another type of test, but decided
not to pursue it in the United States for now.) Dr. Miller said that while
he was ultimately satisfied with the F.D.A.’s actions, the overall response
by the government was too slow, especially when it came to logistical
questions like getting enough testing supplies to those who needed them.
“You’ve got other countries — and I’m sorry, unfortunately, the U.S. is
one of those — where they’ve been slow, disorganized,” he said. “There
are still not enough tests available there to test everybody who needs it.”
In an emailed statement, Dr. Hahn maintained that his agency had moved as
quickly as it safely could to ensure that tests would be accurate. “Since
the early days of this pandemic,” he said, “the F.D.A.’s doors have
always been and still remain open to test developers.” | r***i
发帖数: 9780 | 2 cdc是罪魁
fda一直都这吊样
另外猪党很大可能有助攻 | T**********e
发帖数: 29576 | 3 cdc虽然不中用，但没fda卡着，各州医院自己测要快的多。
: cdc是罪魁
: fda一直都这吊样
: 另外猪党很大可能有助攻
【在 r***i 的大作中提到】
: cdc是罪魁
: fda一直都这吊样
: 另外猪党很大可能有助攻
| T**********1
发帖数: 2406 | 4 Time to abolish FDA.
one
to
【在 T**********e 的大作中提到】
: NYT:
: Barriers to Testing
: Dr. Stephen Hahn’s first day as F.D.A. commissioner came just six weeks
: before Mr. Azar declared a public health emergency on Jan. 31. A radiation
: oncologist and researcher who helped turn around MD Anderson in Houston, one
: of the nation’s leading cancer centers, Dr. Hahn had come to Washington to
: oversee a sprawling federal agency that regulates everything from
: lifesaving therapies to dog food.
: But overnight, his mission — to manage 15,000 employees in a culture
: defined by precision and caution — was upended. A pathogen that Mr. Trump
| d*********1
发帖数: 1 | 5 fda当然不让你测，主要这个口子一开，保险公司要多付多少钱，这些fda,cdc,nih的大
爷都等着退休以后去药厂和保险公司把存在那里的贿赂拿回来呢
【在 T**********e 的大作中提到】
: cdc虽然不中用，但没fda卡着，各州医院自己测要快的多。
:
:
: cdc是罪魁
:
: fda一直都这吊样
:
: 另外猪党很大可能有助攻
:
| f*********1
发帖数: 2518 | 6 疾病防控当然是首位的，要等到检测都已经晚了。所以罪魁祸首肯定是第一时间跳出来
篆长文要大家不戴口罩的CDC。
: cdc虽然不中用，但没fda卡着，各州医院自己测要快的多。
【在 T**********e 的大作中提到】
: cdc虽然不中用，但没fda卡着，各州医院自己测要快的多。
:
:
: cdc是罪魁
:
: fda一直都这吊样
:
: 另外猪党很大可能有助攻
:
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