Posted on 04/29/2020 8:34:20 AM PDT by Kaslin
We need new drugs to fight COVID-19 and other diseases. But our government's approval process makes that too hard.
This year's pandemic got regulators to say they'll speed the approval process. The FDA adopted Emergency Use Authorization to speed up approval of some tests, medical equipment and ventilators.
But that's not enough.
I know about the FDA's rules because my older brother, Dr. Thomas Stossel, discovered something that might save a lot of lives.
Doing medical research at Harvard, he found a protein in our blood that helps reduce excess inflammation. He named the protein gelsolin.
Some inflammation is useful. Our own immune system creates it to fight off diseases.
But excess inflammation kills.
With COVID-19, "what usually kills the patient is not the virus," explains Dr. Mark DiNubile in my new video. "As the patients get sicker, often the virus is disappearing. It's the over-exuberant, excessive, immune reaction that's destroying the lung."
DiNubile was once my brother's student and partner. Now, he speaks for Tom because, several months ago, Tom died of a sudden heart attack. DiNubile will carry on Tom's work.
So will I. Suddenly, I'm an investor and on the board of their biotech company, BioAegis, which hopes to give supplemental gelsolin to people with diseases like pneumonia, sepsis and the coronavirus.
When we're very sick, gelsolin levels go down, and that often leads to deadly outcomes. But we're not helpless. BioAegis found a way to manufacture extra gelsolin. Now, the company hopes to get the FDA's permission to give some to coronavirus patients.
BioAegis already gave the protein to animals infected with pneumonia. They got good results. Animals that would have died, lived. "It also improves what their lungs look like," said DiNubile.
Improved lung function should certainly help human coronavirus patients, he adds, "allowing them to get off the respirator, go back home and, hopefully, live a normal life."
After BioAegis' successful animal tests, they did safety tests on people, giving hospital patients big doses of gelsolin. The patients did fine.
That was expected. Gelsolin is a natural protein, after all. It's already in our blood.
Now BioAegis is raising more money to fund tests that we hope will convince the FDA to allow us to restore gelsolin levels in COVID-19 patients -- and other very sick people.
But getting government approval takes so long!
It also costs, on average, hundreds of millions of dollars.
BioAegis and its partners already spent $50 million researching gelsolin. Yet, we still seem to be years away from getting permission to offer it to people.
I understand that the FDA's job is to protect us.
But I know some sick people would be willing to try the drug, even if it were risky, if it might save their life.
I asked DiNubile, rudely: "Why do you have to beg for permission? Just find some sick people who are willing to try something!"
"We legally cannot do that," he responded. "The first rule of medicine is: Do no harm. In the pandemic of 2009, a flu drug was approved that turned out not to work well. So, there is a possibility that you could subject patients to a risk -- for no gain."
But all drugs involve risk. I say: Leave it up to individuals, once we're adults, to make our own choices about those risks.
"Because so many diseases are caused by excess inflammation," says DiNubile, "Gelsolin's potential benefit is enormous. This could be a miracle drug like antibiotics were."
I sure hope he's right, and that BioAegis succeeds in bringing gelsolin to patients.
But the odds are against us. Most new drugs never get to the point where our government allows them to be given to patients.
Yes, of course, we want to make sure new drugs are safe.
But in dire situations like a pandemic, there ought to be a faster way to get promising treatments to people who might benefit.
Especially treatments like gelsolin that have been shown to be safe.
Given a chance, my brother's discovery -- and others like it -- could save a lot of lives.
President Trump’s “RIGHT TO TRY” act.
To quote him “What have you got to lose?”
good post.
and why did this corrupt agency remove the ability of the
USA to make HCQ before the DNC/Xi/Soros/Gates released
the viral Atrocity?
why?
why did the DOJ/FIB watch while the owners were MURDERED
in the DNC way, with belts around their necks?
“Alex, i’ll take they were just too busy attempting
to remove the ELECTED PRESIDENT.”
In all areas of government, government’s #1 job is to justify its own existence. This is as true with the FDA as it is with all the other alphabet agencies at the federal level - not to mention all the way down to state, county and local level.
I work on publicly-funded infrastructure projects for a living and have seen this first-hand since, well, forever. And it isn’t limited to this country. I’ve seen it on projects in Canada as well.
Very often, the consultants hired by the owner are just as guilty as the agencies themselves. Way too much obstruction of the project under the guise of looking out for owner’s interest when, in reality, it is self-serving and self-promoting.
It costs hundreds of millions (sometimes billions) of dollars to bring a new drug to market. And people wonder why the new drugs are so expensive.
Trump recommends people drink Gasoline. /s
How do we know it works?
If I get you right, you are saying HCQ production was stopped in the US before Covid. How close to its release was production stopped?
Second inference was that the “owners” were killed, what owners and what did they own?
if it’s just inflammation that is causing lung damage, then why wouldn’t prednisone work? It quickly reduces inflamation
However, it does it be clobbering the immune system.
which would, if it were a medication that coudl help, be good i would think because the virus is creating an overactive destructive immune system response- and we’re talking only a short course of high dose anti inflammatory- like 7-10 days or so- not long term- The person’s immune system would return to normal very quickly when the medicine is stopped- I think the goal is to clobber the immune system quickly- briefly-
Fuaci was just one discussing hte use of remsivider + an anti- inflamatory (Which he didn’t name unfortunately)
If it might work, try it. If it doesn’t work, stop using it. Why not let people try?
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