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UCSF looking at a variety of drugs - Printable Version

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UCSF looking at a variety of drugs - akiddoc - 05-01-2020

https://theconversation.com/we-found-and-tested-47-old-drugs-that-might-treat-the-coronavirus-results-show-promising-leads-and-a-whole-new-way-to-fight-covid-19-136789


RE: UCSF looking at a variety of drugs - M T - 05-01-2020

Oh wow...  That will likely be in the news tomorrow.


RE: UCSF looking at a variety of drugs - stupac2 - 05-01-2020

That progesterone finding is fascinating to me. There's been a sex discrepancy in deaths virtually universally, right? And we've seen findings like the NYC pregnancy tests that could show pregnant women having a high incidence of asymptomatic infection (previously it had been interpreted as everyone having a high incidence, but perhaps their hormones are prophylactic).

Anyway, it's obviously super early research, but it would be great if some cocktail of those panned out. I have to imagine they already have trials going.


RE: UCSF looking at a variety of drugs - magnus - 05-01-2020

Also suggests that some cough medicines may do more harm than good...

Quote:Interestingly, a seventh compound – an ingredient commonly found in cough suppressants, called dextromethorphan – does the opposite: Its presence helps the virus. When our partners tested infected cells with this compound, the virus was able to replicate more easily, and more cells died.



RE: UCSF looking at a variety of drugs - BostonCard - 05-01-2020

Quote:Remember, all these interactions have so far only been observed in monkey cells in petri dishes.

I am happy that investigators are pursuing drug repurposing studies.  Evaluating drugs that have already been approved and have a well known safety record is much easier than finding a drug that targets SARS-CoV2 de novo, or even adapting a drug (like remdisivir) that is not yet approved.  However, I think it is important to point out that the world is littered with great sounding drug repurposing articles that, when tested clinically in humans, did not pan out.  As with everything else, this is more about more "shots on goal" than expecting any one of these to pan out, or even that any of them pan out.

BC


RE: UCSF looking at a variety of drugs - M T - 05-01-2020

A question for those MDs or medical researchers that might know: 

There was a finding of the one drug that might facilitate the infection by SARS-CoV-2.  How does that get handled? 

Does the FDA act on this (suggestive, but not sufficient) evidence or does it wait on further testing (human?)?
Does the FDA warn the manufacturers that the drug may lose its approval by some date, unless safety tests are done?
Does it become another paragraph in a 10,000 word insert?
How long might it take for the FDA to have enough evidence to warn users of the medication (assuming that the medication does facility infections of SARS-CoV-2)?


RE: UCSF looking at a variety of drugs - dabigv13 - 05-01-2020

BC probably has more relevant experience, but I don't think this finding would cause the FDA to do anything. Monkey cells in a dish have the barest relation to activity in human patients. Some researchers may take this up though and do follow up studies.

The FDA black box warnings and recalls I am familiar with have all been based on experience from human patients, not in vitro experiments.


RE: UCSF looking at a variety of drugs - Goose - 05-01-2020

The article states their is one ongoing clinical trial already and another one starting up. If anything better than a hint of efficacy is seen in these trials there will at a minimum be further trials. Safety is less of a consideration with drugs that are already approved for different indications, so that will help a lot. Still very early days here.


RE: UCSF looking at a variety of drugs - BostonCard - 05-01-2020

IF you want some insight into the way the FDA works up a safety signal, read this document:

https://www.fda.gov/media/137475/download?utm_campaign=SBIA%3A%20publishes%20MAPP%2C%20Collaborative%20Identification%2C%20Evaluation%2C%20and%20Resolution%20of%20a%20NISS.%20%20%284121.3%29&utm_medium=email&utm_source=Eloqua

If you go to table 1, attachment 1, it lists all the ways FDA can lead to the FDA opening a signal work-up (what they call a newly identified safety signal or NISS).  However, even after a signal is identified, there is a long road before it can be confirmed or refuted.

I am sure, however, that the FDA has someone combing through the COVID data looking to see if any medications put patients at increased risk of bad outcomes.

If you are really curious, the FDA makes their dashboard of publicly reported adverse drug reactions available here:

https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis

Unfortunately, COVID-19 is too new of a diagnosis to have entered the adverse event dictionary (new versions of the dictionary come out every six months, in May and November; the May edition will have COVID-19 as an event term).  But, filtering in 2020, there have been 366 reports (312 serious, and 34 deadly) of either "coronavirus test positive" or "coronavirus infection" reported to the FDA.  The tools available to the FDA epidemiologists are much more robust, and they are able to perform disproportionality analyses and keep a running tally of whether some drugs are over-represented in reports, such that they can initiate a more robust signal work-up once a certain drug/event pair reaches a predetermined level of significance.

BC


RE: UCSF looking at a variety of drugs - M T - 05-01-2020

Thanks, B C.


RE: UCSF looking at a variety of drugs - akiddoc - 05-06-2020

https://www.nytimes.com/2020/04/30/health/coronavirus-antiviral-drugs.html


RE: UCSF looking at a variety of drugs - BostonCard - 05-06-2020

Key statement:

“I’m going to be brutally honest with you: 95 to 98 percent of these are going to fail,” said Sumit K. Chanda, a virologist at Sanford Burnham Prebys Medical Discovery Institute in La Jolla, Calif. “But we only need one or two.”

BC


RE: UCSF looking at a variety of drugs - dabigv13 - 05-06-2020

I can't imagine the pressure on these researchers. Cell culture and animal experiments take time and can go wrong in so many different ways. To do good science while in a race against time against a global pandemic......whew. Hats off to these guys.