Hydroxychloroquinine updates (and other potential treatments)

[jesmu84]

remdesivir has been mentioned a few (bunch of...) times - and seems like it may have some good characteristics in treating this.  Now...hopefully not too many bad characteristics. 

And it's free for now!
https://www.bloomberg.com/news/articles/2020-04-04/gilead-to-donate-experimental-coronavirus-drug-for-140-000-cases

Don't get me wrong - it was already in clinical trials - and if GIlead can get it approved faster - they have everything to gain.  But hey - if it helps a few (or a bunch) of people in these trials - for free - great!

And don't tell the WHO haters that they've been on this since January -

Has the White House talked about this one?

[JWags85]

Has the White House talked about this one?

Yes. I remember cause Trump mispronounced it once and i remember Fauci fielding questions about it two different times

[rocky_warrior]

For sure - although in the same breath as his favorite:

https://www.usatoday.com/story/news/2020/03/19/trump-touts-chloroquine-remdesevir-possible-coronavirus-treatments/2875965001/

[Lennys Tap]

For sure - although in the same breath as his favorite:

https://www.usatoday.com/story/news/2020/03/19/trump-touts-chloroquine-remdesevir-possible-coronavirus-treatments/2875965001/

So of the two drug he touted as promising, one may prove to be a game changer. This is a bad thing?

[jesmu84]

So of the two drug he touted as promising, one may prove to be a game changer. This is a bad thing?

I guess I just assumed one this promising would be pushed as much as others

[rocky_warrior]

So of the two drug he touted as promising, one may prove to be a game changer. This is a bad thing?

Mentioning remdesivir, as well as other potential drugs, not horrible.  I was actually just answering the question in a factual way.

Now, one could also argue the droning on about Hydroxychloroquinine was potentially dangerous. Could also say politicians shouldn't make medical recommendations. But that's a whole different story.

[rocky_warrior]

remdesivir has been mentioned a few (bunch of...) times - and seems like it may have some good characteristics in treating this.  Now...hopefully not too many bad characteristics. 

Doing more reading, I think there's irrational exuberance about remdesivir right now.   These results were leaked, and even Gilead is cautioning about reading too much into them.

Another article a couple days ago.
https://www.biospace.com/article/data-from-gilead-s-compassionate-use-of-remdesivir-for-covid-19-looks-promising/

Significant side effects:

about 25% of patients receiving it have severe side effects, including multiple-organ dysfunction syndrome, septic shock, acute kidney injury and low blood pressure. Another 23% demonstrated evidence of liver damage on lab tests.

Yikes.

[Frenns Liquor Depot]

So of the two drug he touted as promising, one may prove to be a game changer. This is a bad thing?

Personally I think both instances are, yes. The doctors should lead the promotion of a therapy. 

However if the docs are recommending and the president compels the company to license the tech immediately in the US or globally to flood the world with supply—full speed ahead.  Or if the president wants the govt to prioritize more covid therapies, he can take all the credit in the world. 

[TSmith34, Inc.]

So of the two drug he touted as promising, one may prove to be a game changer. This is a bad thing?

One he has mentioned, one he has continually touted (after he saw Oz talk about it on Fox as a wonder drug).

[MU Fan in Connecticut]

Interesting to hear a doctor on the radio this morning, basically saying he sees people dying in his hospital, and there is no known treatment of Cornoavirus and Hydroxychloroquinine has been around 60 years and may work so it's worth a shot to give to patients with no other options.

Didn't know enough about remdesivir, but said the same thing.

[D'Lo Brown]

remdesivir has been mentioned a few (bunch of...) times - and seems like it may have some good characteristics in treating this.  Now...hopefully not too many bad characteristics. 

And it's free for now!
https://www.bloomberg.com/news/articles/2020-04-04/gilead-to-donate-experimental-coronavirus-drug-for-140-000-cases

Don't get me wrong - it was already in clinical trials - and if GIlead can get it approved faster - they have everything to gain.  But hey - if it helps a few (or a bunch) of people in these trials - for free - great!

And don't tell the WHO haters that they've been on this since January -

Thanks for sharing... Smacks of an ingenious nontraditional advertising campaign to me, but it's absolutely worth considering anyway. I have concerns about any company looking to corner/consolidate the market with a new drug in short order, especially in this environment. My assumption is that the real sales pitch isn't going to be to individuals, at all, & that giving out some free doses is likely just a "free 14 day trial" for the feds.

There is little incentive for a boatload of $ to be spent on researching drugs that have already been around forever, and IMO we'd be better off focusing on that. It's less of a risk, & cheaper.

[forgetful]

Interesting to hear a doctor on the radio this morning, basically saying he sees people dying in his hospital, and there is no known treatment of Cornoavirus and Hydroxychloroquinine has been around 60 years and may work so it's worth a shot to give to patients with no other options.

Didn't know enough about remdesivir, but said the same thing.

To me, the big difference is there was no biochemical reason hydroxychloroquine should work (as I mentioned before, it wouldn't be the first time something worked and we didn't know why). That coupled with the fact that the initial trial results were weak at best was a warning sign.

There are biochemical reasons why remdesivir may be a good option. There are reasons why plasma may be a good option. The initial results were as or more promising for these.

They should have been being pushed as hard, or harder. They weren't. Instead we couldn't go 2-minutes without the president, or his media, touting it as a miracle cure, despite study after study showing it didn't work. Governors were attacked for not being aggressive enough using this treatment, or for not going out and buying millions of doses.

Shows great incompetence and malfeasance.

No one ever said don't try hydroxychloroquine. It was the exuberance that was grossly inappropriate. 11 died in a trial in Brazil, that likely would have never been given such dosages if it wasn't for our president pushing this so hard.

[Coleman]

Doing more reading, I think there's irrational exuberance about remdesivir right now.   These results were leaked, and even Gilead is cautioning about reading too much into them.

Another article a couple days ago.
https://www.biospace.com/article/data-from-gilead-s-compassionate-use-of-remdesivir-for-covid-19-looks-promising/

Significant side effects:
Yikes.

Not great - but initial results so far bring mortality rates down for people already on ventilators to something like 20%. Which is a HUGE improvement.

[forgetful]

https://www.politico.com/news/2020/04/17/drug-makes-coronavirus-cure-trump-193174

This outlines the basis for one of my fears with how everything is proceeding. The leaked data on Remdesivir was quite odd in how things are usually done, especially given that the full results from this trial will be ready soon.

We see the same thing with unapproved tests (antibody or rapid tests) being used and press releases being put out with sensational headlines before FDA approval or validation.

I fear, this is all to create press, and create community pressure that they need these drugs/tests, pressuring the FDA to approve things that may never be approved otherwise. Essentially, creating such a positive story publicly, before the problems can be observed. That would not be good for the population or treatment of the disease. Essentially taking Trumps hydroxychloroquine sensationalism and commercializing it.

The Remdesivir results showed promise, but the leak left out all the harmful side effects (e.g. apparent organ damage). My fear is they know under typical scenarios, the risks may block actual approval, but they can selectively leak results to drive pressure to get things approved anyway.

Hopefully Remdesivir is a magic bullet, but right now the model of how to manipulate public opinion and push things through the FDA is known. People will take advantage of that.

[TSmith34, Inc.]

"Microsoft is launching a 'plasmabot' to encourage people who recovered from the virus to donate their plasma as a possible treatment"
https://www.cnbc.com/2020/04/18/microsoft-plasmabot-encourages-covid-19-survivors-to-donate-plasma.html

[Frenns Liquor Depot]

Interesting discussion of pneumonia onset.  A potential way to screen for this much earlier to improve outcome.

https://www.nytimes.com/2020/04/20/opinion/coronavirus-testing-pneumonia.html

[forgetful]

Interesting discussion of pneumonia onset.  A potential way to screen for this much earlier to improve outcome.

https://www.nytimes.com/2020/04/20/opinion/coronavirus-testing-pneumonia.html

It would be nice if these articles would give some guidance on O2 sat levels that should be cause for concern.

[MU Fan in Connecticut]

Another drug being tested.



Alexion testing blood disease drug for coronavirus treatment
By Luther Turmelle

Boston-based Alexion Pharmaceuticals, which has research and development operations in New Haven, has announced plans to launch a large-scale clinical study to determine whether one of the drugs the company already has approved by the federal Food and Drug Administration can be used to treat COVID-19.

Megan Goulart, a company spokeswoman, said Monday that Alexion officials already have approval to begin a Phase 3 study of Ultomiris to treat COVID-19. The study will begin next month and is expected to enroll about 270 patients across countries with high numbers of diagnosed cases, according to Goulart.

The study will focus on individuals with COVID-19 who are hospitalized with severe pneumonia or acute respiratory distress syndrome, company officials said. Ultomiris will be evaluated on survival rate, duration of mechanical ventilation, and hospital stay compared to best supportive care.

Phase 3 is the last step in the drug development process before FDA officials evaluate a drug candidate for commercial use.

Ultomiris was approved by the FDA in late 2018 for use in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria, which is a rare, acquired, life-threatening disease of the blood. It is characterized by destruction of red blood cells, increased incidents of clots and impaired bone marrow function.

Dr. John Orloff, executive vice president and head of research and development at Alexion, said that "based on early anecdotal information available from compassionate use cases in multiple countries, we are launching a controlled clinical trial to evaluate the potential of Ultomiris in mitigating the severe pneumonia and lung injury caused by the virus."

Ultomiris, with its weight-based dosing, is a good fit to treat COVID-19, according to company officials, who said it can reduce the burden on hospital systems. The drug requires less frequent dosing and can be manufactured at a higher capacity, providing the opportunity to better meet future supply demands.

Alexion also has launched efforts in the United States to evaluate another one of the company's FDA-approved drugs, Soliris, for severe cases of COVID-19-related pneumonia. The company's emergency Expanded Access Programs, also known as compassionate use programs, provide expanded access and a potential pathway for a patient with an immediately life-threatening condition to gain access to an investigational medical product, according to the FDA.

All requests for a hospital to be included in the expanded acccess programs must be made by a treating physician and can be submitted to the company.

luther.turmelle@hearstmediact.com

[BM1090]

Apologies if already posted.

https://apnews.com/a5077c7227b8eb8b0dc23423c0bbe2b2

"A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals. There were more deaths among those given hydroxychloroquine versus standard care, researchers reported"

[TSmith34, Inc.]

Apologies if already posted.

https://apnews.com/a5077c7227b8eb8b0dc23423c0bbe2b2

"A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals. There were more deaths among those given hydroxychloroquine versus standard care, researchers reported"

[Jockey]

Apologies if already posted.

https://apnews.com/a5077c7227b8eb8b0dc23423c0bbe2b2

"A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals. There were more deaths among those given hydroxychloroquine versus standard care, researchers reported"

But... but rocket brain and the orangutan said it was the answer.

[Frenns Liquor Depot]

Jockey - In my opinion there is no need for this.

[jesmu84]

But... but rocket brain and the orangutan said it was the answer.

Not a great look here for you

[TSmith34, Inc.]

Head of vaccine agency says he was ousted for resisting hydroxychloroquine

https://www.axios.com/hydroxychloroquine-coronavirus-vaccine-doctor-02f1430c-6c44-43fc-abab-56f2716c6d5a.html

Rick Bright, former director of the U.S. Biomedical Advanced Research and Development Authority, said in a statement Wednesday that he believes he was removed from his role this week after clashing with HHS leadership over his attempts to limit the use of chloroquine and hydroxychloroquine to treat the coronavirus. The news was first reported by the New York Times.

"I believe this transfer was in response to my insistence that the government invest the billions of dollars allocated by Congress to address the Covid-19 pandemic into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit. I am speaking out because to combat this deadly virus, science — not politics or cronyism — has to lead the way. ...

"My professional background has prepared me for a moment like this — to confront and defeat a deadly virus that threatens Americans and people around the globe. To this point, I have led the government's efforts to invest in the best science available to combat the Covid-19 pandemic.

"Unfortunately, this resulted in clashes with H.H.S. political leadership, including criticism for my proactive efforts to invest early into vaccines and supplies critical to saving American lives. I also resisted efforts to fund potentially dangerous drugs promoted by those with political connections.

"Specifically, and contrary to misguided directives, I limited the broad use of chloroquine and hydroxychloroquine, promoted by the administration as a panacea, but which clearly lack scientific merit.

"While I am prepared to look at all options and to think 'outside the box' for effective treatments, I rightly resisted efforts to provide an unproven drug on demand to the American public. I insisted that these drugs be provided only to hospitalized patients with confirmed Covid-19 while under the supervision of a physician.

"These drugs have potentially serious risks associated with them, including increased mortality observed in some recent studies in patients with Covid-19.

"Sidelining me in the middle of this pandemic and placing politics and cronyism ahead of science puts lives at risk and stunts national efforts to safely and effectively address this urgent public health crisis.

"I will request that the inspector general of the Department of Health and Human Services investigate the manner in which this administration has politicized the work of BARDA and has pressured me and other conscientious scientists to fund companies with political connections and efforts that lack scientific merit.

"Rushing blindly towards unproven drugs can be disastrous and result in countless more deaths. Science, in service to the health and safety of the American people, must always trump politics."

[tower912]

I appreciate his delicate subtlety.