Positive Results From Hydroxychloroquine Study

[josie_L]

And why can’t I blame the Chinese government for covid-19?

It is a way to indirectly blame China.

 

[Boatswain2PA]

No more EXTREMELY ignorant than you must be about FDA approval process from Phase I through approval and the rational behind clinical trials for safety and efficacy before use.

Nope. I understand the FDA approval process as it was covered it pretty well when I was getting my Masters in Public Health. And as I practice Emergency Medicine I get to live the difference between FDA approval and various uses of drugs.

BTW - Phase I is really to just see if a new drug isn’t overly harmful to people so it is tested on a few people to see if there are any overwhelming safety issues. Then the Phase II is when the give it to a moderate number (maybe a few hundred) of volunteers to see if it might actually work, while carefully tracking for side effects. If it looks like it works, and no major adverse effects noted, then it goes to phase three for larger studies before approved for manufacture, and for use for a specific symptom/disease.

But, fortunately, we are not required to only prescribe medications for FDA approved usage. This leads to find, and study, of drugs for many more studies.

For example: Azithromycin has been FDA approved as an antibiotic for decades. Few years ago the FDA put out a warning about a “new” side effect of it called QT prolongation, a malfunction in how the heart recharges itself between beats that, theoretically, can lead to a dangerous pattern called Torsades that can be fatal. However there have been BILLIONS of doses of Azithromycin prescribed, and nobody in medicine really cares about that warning (unless our patient has history of QT prolongation and/or Torsades). But over the decades science has studied Azithromycin and has learned that it has pulmonary anti-inflammatory properties as well, and non-FDA studies have shown that if we give it to people with COPD exacerbations they have reduced risk of hospitalizations & death, so we give it pretty liberally to those people. All NON-FDA approved reason, but one that is well established in scientific/medical literature.

So, along comes COVID-19 that causes inflammation in some people’s lungs. We don’t need FDA approval before we prescribe Azith because it passed FDA approval years ago. However we don’t KNOW if it will work for COVID-19 at all, or which COVID-19 patients it will work on.

So we start using it on the really sick as we throw the kitchen sink at them to try to keep them from dying. Write up case reports, and eventually someone does a retrospective study to see if it looks like it works, or who it might work on. Eventually, if there is enough of a demand (and someone can find the money to do the study) someone will get around to doing a prospective blinded study on it and give us the best (but oftentimes still not clear) evidence.

There, now maybe you won’t be so ignorant on the subject.

 

[dscath]

There, now maybe you won’t be so ignorant on the subject.

Thanks…but you lost me at:

I understand the FDA approval process as it was covered it pretty well when I was getting my Masters in Public Health. And as I practice Emergency Medicine I get to live the difference between FDA approval and various uses of drugs.

I have 23 years experience at the directorate level in Regulatory Affairs and pharmacovigilance and a boy scout merit badge in first aid, so we seem to be on equal footing.

 

[josie_L]

Alright, I can agree to an extent with what you’re saying.

Oh, you can and they deserve blame, but, in the United States, many on the right are trying to shift the blame entirely on others as a way to take blame away from the pathetic response of the Trump administration.

But as a Canadian and someone who is of Italian descent I’m extremely angered by the Chinese government for allowing millions of Chinese citizens to travel abroad during a pandemic.

I live in the hardest hit region of Canada.

 

[Cathoholic]

Thbolt . . .

What did you say yesterday when I asked you about what Trump had done on abortion?

I replied the same way anyone else would who has already put up dozens of posts about Trump success stories about abortion, then gets asked about it, as though it is a conundrum.

But you on the other hand, have never expounded the pathophysiology of a corona virus infection here.

Look. If you don’t want to answer, I’m fine with that.
I knew you probably would have to punt on that anyway.

But I did not punt on Trump. I just wasn’t willing to repeat myself when I have already posted the answers to your “question” numerous times.

Politics over substance.

 

[Boatswain2PA]

I have 23 years experience at the directorate level in Regulatory Affairs and pharmacovigilance

Some would call a government functionary with utter contempt for the President a part of the deep state.

Kind of makes sense now. Maybe your “tik tok” is the end of the Trump Presidency so you are safe in an overpaid cushy little guv’ment job. Maybe its the tick of time before team Trump finds another useless guv’ment billet to delete.

And we are not on equal footing. A bureaucrat at your desk in “pharmacovigilence” is not on equal footing with the guy trying to explain to patients and their families the limitations of our knowledge, what we can try, and comisserating with them at the bedside when we run out of options.

 

[dscath]

So you are a government functionary,

In your never ending eagerness to off as an expert. you’ve made yet another erroneous assumption. I worked in the bio pharma industry…not there is anything wrong with it, but is a fireman a government functionary?

 

[Boatswain2PA]

In your eagerness to show your knowledge you’ve made yet another erroneous assumption. I work in the bio pharma industry

In “Regulatory affairs and ‘pharmacovigilance.’”. Huh. Those are some big titles. Congrats on getting those! Gotta be careful with those titles though, I’m guessing with Big Pharma that is a mid-six figure income…although I wonder if it fits with the bourgeoisie with their historical torches.

If you are in “Regulatory affairs” do you focus more on actually getting medications past the regulatory approval so they care covered by CMS? Or more with actual effectiveness of the medications?

And I don’t try to “come off as an expert”, but I’m a lot more of an expert on medicine than some guy sitting at a desk.

 

[dscath]

but I’m a lot more of an expert on medicine than some guy sitting at a desk

A guy performing first aid in back of a truck to stabilize a patient for care from a doctor and staff is hardly an expert on medicine Than a community college instructor is a college professor!

 

[Boatswain2PA]

Well, at least you got that right. I’ve done that in the past as well. Of course, now Im the guy the in the Emergency Department that the ambulance brings the patient TO.

But back to the OP - This isnt earth shattering news, but it is good news. Now if we could just get those rich guys in Big Pharma to make Hydroxychloroquine faster…but not enough money in it for them as it is a cheap drug.