Comment by Cantbekhan | Hacker News Reader

Comment by Cantbekhan | Hacker News Reader

Parent Full thread

Several EU countries in addition to China are already actively using chloroquine and hydroxichloroquine to treat COVID19 patients. And I mean outside trials.

For instance:

Here are the Netherlands treatment guidelines (in Dutch): https://lci.rivm.nl/covid-19/bijlage/medicamenteuze-behandel...

Here are the Italy treatment guidelines (in Italian): http://www.simit.org/medias/1555-covid19-linee-guida-trattam...

I think the anecdote on how they found out about the effectiveness of chloroquine in China is fascinating and has nothing to do with the in vitro efficiency study nor with the malaria usage but solely with the immunomodulator effect. They just noticed that there were no lupus patients infected with Covid19. And after investigating with the dermatology dept, they confirmed that indeed there were no reported lupus patients of that hospital infected with covid19.

Their common treatment was chloroquine...

Source: https://www.jqknews.com/news/388543-The_novel_coronavirus_pn...

It should be noted that as far as the Chinese are concerned, it doesn't seem like there is any debate about chloroquine usefulness for COVID19.

Sources:

https://pubmed.ncbi.nlm.nih.gov/32075365-expert-consensus-on...

and https://pubmed.ncbi.nlm.nih.gov/32074550-breakthrough-chloro...

Why do these things take slowly in US but are much faster in the EU? Even though Italy and Netherlands are already using it, no patient in US is treated with chloroquine since it's not FDA approved. Why does FDA approval matter for a brand new disease, in an emergency situation like this?

It doesn't for many known medications. But, it's a factor for new and less well understood medications.

There is "on label" and "off label" usage of drugs. Just because this existing medication is being used in the EU, or has made its way into guidelines, does not mean that it would even make it through EU approvals. It's being used "off label" if it's used for a new condition.

I've personally been treated "off label" for a condition using a drug developed and FDA approved for a serious condition that you wouldn't immediately associate with my condition. It was weird being unable to find any substantive literature on that medication and my condition, but that's the nature of uncommon conditions, or being at the edge like we are with COVID-19.

US doctors will, based on the evidence available, make their own decision on whether to follow the treatments used by their colleagues in the EU and China. They are not going to be held up by FDA approval for off-label use, but they may find things that warrant FDA review and approval because they feel the outcome is not worth the risk. The impact on the US is trailing China and EU to some degree. This buys a little time for some very smart people to do some level of analyses of what's happening elsewhere. It'd be a little different if the early waves hit here first.

So a US doctor doesn't need FDA approval to be able to prescribe something like chloroquine or Remdesivir for a COVID19 patient as long as they believe it'll be helpful to patient, did I understand it correctly?

Yes, but in practice it is rarely the situation where a doctor is making this call on their own. The hierarchy from doctor to senior leadership should be involved in decisions like this because there are many more ramifications than just one patient.

From the doctor's perspective, at minimum this is a cover-your-ass move because they don't want to get blamed for an adverse event. The administration needs to manage the risk too, and find other experts to review the situation. They may also need to manage supplies, or costs. This is really no different from the usual medical bureaucracy in the US.

One item that I'll end with is that approval processes (FDA, EU, etc.) provide no guarantees. There are many drugs that have been approved and then removed from general use based on additional experience, or long-term clinical trials. It's obviously good to do more trials and get approvals, but patients and doctors really want the best possible outcome given the situation.

The good part of the answer: Because they need to make sure the treatment doesn't kill more people than the virus does.

The bad part of the answer: Overseas testing (e.g. the testing needed for EU approvals) usually does not count for this purpose for bureaucracy reasons.

Is there no hope to expedite it in this case? Are we gonna sit and watch dozens, maybe hundreds of Americans dying of a disease that has a medication in EU and China?

Yes, there's hope to expedite it in this case. There are people working on that. The Gates foundation, for one, is funding "development" of treatments per the article[1]. "Development" includes but is not limited to getting regulatory approval as quickly as possible.

[1]- I am not affiliated with them in any way, have no specific nonpublic information, and I don't know if they are looking at this specific treatment.

You’re definitely asking the right questions. The answer is because that’s how things are done.

Reply on news.ycombinator.com