MESSAGE
| DATE | 2020-11-19 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout - NYLXS] Elli Lilly FDA citations
|
https://www.forbes.com/sites/williamhaseltine/2020/10/20/eli-lilly-plant-set-to-manufacture-covid-19-therapy-cited-for-breaching-fda-regulations/
forbes.com
Eli Lilly Plant Set To Manufacture Covid-19 Therapy Cited For Breaching
FDA Regulations
William A. Haseltine
5-6 minutes
Eli Lilly Logo
FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego
REUTERS - Mike Blake
An Eli Lilly pharmaceutical plant set to manufacture a Covid-19
treatment has been cited by the Food and Drug Administration (FDA) for
quality control issues, according to Reuters. Sources close to the
situation told Reuters that Eli Lilly had falsified records pertaining
to FDA manufacturing standards.
The Covid-19 treatment Eli Lilly is set to produce is an antibody
therapy similar to a Regeneron therapy taken by the president during his
infection. The President has called for the authorization of both
treatments immediately.
The discovery of falsified records stems from a November inspection of
the Eli Lilly plant. Following the inspection, the FDA granted the plant
an “Official Action Indicated” notice, which means that “the violations
are serious enough and have a significant enough impact on the public
health that something needs to be fixed” noted Patricia Zettler, a law
professor at Ohio State University and former FDA official.
This report confirms our concerns from the start with fast-tracked
Covid-19 therapies: beware of lower safety standards. Undue speed
compromises manufacturing and distribution as well as efficacy and
safety. Fast-tracked Covid-19 treatments already present health risks
because nobody knows the long-term dangers of quickly approved and
unstudied drugs and vaccines. Some health effects may occur over a
period of many months to a year or more and cannot be evaluated in
accelerated trials. The chance that undue speed may compromise safety is
real, as the Lilly citation underscores.
Under normal circumstances, the FDA requires several batches of drugs to
be made, all meeting the same safety, consistency, stability, and
potency standards using the same facilities used to eventually sell the
drug. This safeguard was discarded in the rush to move drugs and
vaccines to market, imperiling patients.
We have seen EUAs for “miracle drugs” before after being highly touted
by the administration. The EUA for hydroxychloroquine released in March
was quickly revoked a few months later. The authorization letter cited
only a limited French study of thirty-six participants. Despite only
minimal evidence, the drug was allowed to proceed. After just three
months, there was little evidence suggesting the drug effectively
reduced Covid-19 symptoms, even provoking heart risks in some users, and
was promptly revoked of its authorization status.
The dangers of premature EUA are two-fold. The first is the health
dangers of approving a drug that does not work. Fast-tracked drugs and
vaccines are at risk of harming participants in drug trials in the short
term or the greater population in the long term. There have already been
pauses in vaccine and drug trials due to patient development of severe
unknown illnesses.
The second is the assurance that drugs will be safely and consistently
produced. Production standards for drugs and vaccines are in place
ultimately to protect the well-being of the nation. Someone hospitalized
with severe Covid-19 symptoms is not concerned with the safety standards
of some production plant. If their doctor tells them about an EUA
approved drug, they will want it. It is the responsibility of the FDA to
ensure that standards are being adhered to in order to protect those
most at risk.
The issues with drugs tested in the US raises the question of the
potential safety and efficacy of vaccines approved in both China and
Russia. Might they have similar undisclosed issues? Both of the vaccines
on pause in the US are broadly similar to those approved in China and
Russia. We know little to nothing of the quality and safety standards
applied. There are reports that the Chinese vaccine has been given to
“hundreds of thousands” and that the Russian vaccine is also widely
administered. The recent clinical development pauses of two Covid-19
vaccines in the US are currently paused as is the trial of the Lilly
monoclonal antibody therapy, data on the safety and efficacy of the
Russian and Chinese trials are overdue.
Covid-19 treatments have the potential to save thousands of lives as the
United States approaches 220,000 deaths from the disease. To ensure a
drug is successful, however, there must be regulations in place. The
short-term protection from Covid-19 does not outweigh the long-term side
effects of a defective drug. I hope that Eli Lilly is an aberration, not
a trend.
--
So many immigrant groups have swept through our town
that Brooklyn, like Atlantis, reaches mythological
proportions in the mind of the world - RI Safir 1998
http://www.mrbrklyn.com
DRM is THEFT - We are the STAKEHOLDERS - RI Safir 2002
http://www.nylxs.com - Leadership Development in Free Software
http://www.brooklyn-living.com
Being so tracked is for FARM ANIMALS and extermination camps,
but incompatible with living as a free human being. -RI Safir 2013
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