To fight coronavirus, and other diseases,
we need new drugs.
But the government’s approval process
for that takes so long!
Once it’s approved for trials,
researchers say the drug will be about ten years away
from hitting the market.
This year’s pandemic got
regulators to speed some approvals,
but the process still takes a long time.
I think it’s optimistically 12 to 18 months,
under normal circumstances it takes 5 to 10 years
to develop a vaccine.
It is a process designed to be slow.
I think about the FDA’s rules more lately because
My brother Tom, a medical researcher,
discovered something that might save a lot of lives.
It's mine, get off of me!
Tom and I often fought as kids
Our mother drew this picture.
We eventually stopped fighting,
and Tom helped raise me.
I trusted him because he was so smart.
[Pomp and Circumstance]
He went to Princeton and Harvard,
and did such top notch science
that when our government feared
Soviet microwaves were beamed at the US embassy
The State Department shipped
Tom to Moscow to investigate.
When Algeria’s dictator got sick,
they tapped Tom to treat him
And then, studying blood,
Tom discovered an unusual protein.
He named it gelsolin.
It turns out that gelsolin reduces excess inflammation.
Now some inflammation is useful.
Our own immune system creates it to fight off diseases.
But too much inflammation is a killer.
In COVID-19 what usually kills the patient
is not the virus.
In fact, as the patients get sicker,
often the virus is disappearing anyway.
It's the overexuberant, highly excessive
immune reaction that's destroying the lung.
Dr. Mark DiNubile was once Tom’s
assistant and protégé.
Now he speaks for Tom because several months ago,
Tom had a sudden heart attack and died.
A few year before he’d
come on my television show and pointed out
The vast predominance of what gets products
to patients comes from the private sector.
Only the private sector has the resources
and the skill sets to get the job done.
Now this company, BioAegis
is trying to get the FDA’s permission to
give Tom’s protein to people with diseases
like pneumonia, sepsis, and coronavirus,
because when you’re very sick,
gelsolin levels go down,
and inflammation gets worse.
We are not helpless here.
The gelsolin that's depleted can be replaced.
Will replacing gelsolin save lives
by reducing inflammation?
It did when BioAegis gave some to sick mice.
The mice treated with some extra gelsolin got better.
More animals live,
but it also improves what their lungs look like.
That improved lung function
should help human coronavirus patients.
And protect the lung from injury
and allow the patient to recover
and get off the respirator and go back home and
hopefully live a normal life.
BioAegis spent millions
getting through the FDA’s first layers of tests.
After the animal tests succeeded,
they spent more millions more studying
its safety in hospital patients.
They gave them big doses of gelsolin,
and the patients did fine.
That was expected,
gelsolin’s a natural protein after all,
it’s already in our blood.
Now BioAegis is trying to raise more millions
to fund tests that would convince the FDA
that gelsolin improves outcomes for sick people.
We were initially doing this before COVID-19.
Now that COVID-19 is broken,
it’s very possible, God willing,
that we will get some approval
from the Spanish agency in the next couple of weeks.
Spain, because those fast approvals
promised by our government
so far haven’t helped gelsolin.
Go give it to them.
I don't get why it takes years.
Why you have to beg for permission.
Just find some sick people
who are willing to try something.
Well, we legally cannot do that until we get approval.
The first rule of medicine is first do no harm.
Aren't a lot of diseases
caused by too much inflammation?
This could be a big deal.
The potential benefit is enormous.
This could be a major step,
a miracle drug like antibiotics were.
I hope they succeed.
I've invested in BioAegis.
I’ll probably lose that money because most
new drugs never make it to market.
We do want to make sure new drugs are safe,
but in a pandemic,
shouldn't there be a faster way
to get promising treatments,
ones that have already been proven safe,
to people who might benefit? There ought to be!
Hope you like our videos.
If you have interest or expertise in drug development,
maybe you can help me with gelsolin.
I’m in way over my head.
Just email me at john@johnstossel.com.
