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**SEPTEMBER 15, 2023**
On the Prospect website
* Jarod Facundo & Lee Harris track the latest developments as the UAW
strikes the Big Three automakers
* Thomas Keegan warns of ongoing human rights abuses
linked to Saudi Arabia's massive investment in pro sports
* Liz Rosenberg looks at a new documentary on the 1969 student uprising
that reshaped higher education
in New York City
Kuttner on TAP
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**How Do You Spell Relief?**
After an FDA finding that a popular decongestant is worthless, Biden
could direct that agency to fast-track approval of a miracle drug for
colds used all over the world.
This week, an advisory panel of the FDA unanimously concluded that a
widely used nasal decongestant is ineffective and basically worthless
. The ingredient,
phenylephrine, is found in numerous over-the-counter
remedies-including Mucinex, NyQuil, and Theraflu-in all, in some 250
different products worth $1.8 billion in sales last year.
Decongestants in general are not very good. There is a well-known
rebound effect
.
You get some relief for a while but then are more congested than ever.
As it happens, there is a near-miraculous generic cold medicine,
ambroxol, that is available over the counter all over the world, but not
in the United States. I stumbled on this medication last year when I was
in France and had a bad cold. I went to the local pharmacy and asked if
they carried something like Mucinex or Robitussin.
"We have something much better," the pharmacist said. As I wrote last
December in the
**Prospect**, ambroxol works on an entirely different biochemical
principle , to thin sputum and
facilitate productive coughing, and also operates as a pain reliever and
gentle decongestant with no rebound effect. My wife and I experienced it
as a miracle drug for coughs and colds. A box cost eight euros.
Why is ambroxol not available in the U.S.? A comprehensive review
published by NIH
in 2020 found it safe and effective.
But no drugmaker has ever sought FDA approval, a time-consuming process
requiring three stages of clinical trials. Why not? Because drugmakers
could not make enough money with a generic to justify the expense.
It's obviously crazy to require this laborious review process for a
generic that has been widely used in Europe since 1978, but this is how
our system works.
Here is where President Biden could come to the rescue of
cold-sufferers. He could direct the FDA to fast-track the approval of
ambroxol for sale in the U.S.
When the U.S. ran short of infant formula in 2022 due to the misfeasance
of a highly concentrated and profit-gouging industry, Biden ordered
agencies to cut red tape and increase imports of formula from several
countries , and we relied on their
regulators to certify that these products were safe.
In fact, we already rely on EU agencies to certify that exported foods
in general are safe and without toxic residues. European regulators are
trusted with many other reciprocal delegations of regulatory authority,
such as pollution standards in cars.
The European Medicines Agency, the counterpart of the FDA, has an
excellent record. Under a new fast-track process, it would take just a
few days for the FDA to review EMA records on the history of ambroxol in
Europe to confirm that it has been safe and effective for decades.
Biden could also direct the FDA to establish a new process to fast-track
approval in general for other generic drugs approved for sale in Europe
but not in the U.S. That would save consumers money and give us access
to beneficial medicines that we are now denied because of the
manipulative greed of Big Pharma combined with an antiquated and
captured FDA.
Al Gore was hailed as the man who helped bring us the internet. Joe
Biden could go him one better. He could bring Americans relief from the
common cold.
~ ROBERT KUTTNER
To receive this newsletter directly in your inbox, click here to
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Follow Robert Kuttner on Twitter
[link removed]
UAW Strikes at Select Plants
The 'Stand Up Strike' is intended to keep the Big Three automakers
off-balance. BY JAROD FACUNDO & LEE HARRIS
The Saudi Sports Grab Is a Humanitarian Disaster
Saudi Arabia's soccer revolution risks perpetrating a similar labor
crisis as seen in Qatar during the 2022 FIFA World Cup. BY THOMAS
KEEGAN
Demanding Equity in Higher Education
A new documentary, 'The Five Demands,' explores the 1969 student
campus takeover that reshaped college education in New York. BY LIZ
ROSENBERG
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