Screwed, We Are Not So / a.k.a France to the Rescue

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Oct 7, 2016
2,451
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Except in cases of 'compassionate use' I wouldn't trust my family's health to anything that is relatively untested.
My hypothetical was very precise, I thought. A family member will die without a ventilator that isn’t available. If that isn’t compassionate use, what is?
 

greeneyes

Lifer
Jun 5, 2018
2,151
12,253
My hypothetical was very precise, I thought. A family member will die without a ventilator that isn’t available. If that isn’t compassionate use, what is?
Put another way, if I had my choice, I probably wouldn't choose hydroxychloroquine.
A very recent Chinese study found no effect with hydroxychloroquine alone, in a patient study with a larger size than the French study [1,2]. Also there's a potential for harmful synergistic drug interaction affecting the heart between hydroxychloroquine and azithromycin [3]. The Minnesota study is having a hard time getting people enrolled, but their target 1500 patient size should be fairly conclusive. My brother-in-law is extremely nervous about the outbreak and he bought several tablets of hydroxychloroquine overseas. He's particularly concerned about his father (my father-in-law) who is high-risk and particularly frail. I had to try to convince him that the treatment is inconclusive and potentially dangerous. It's difficult convincing people that overeager politicians and health professionals without evidence are acting irresponsibly when they suggest that this might be "the cure," since they are figures of authority.

[1] Chloroquine Use For COVID-19 Coronavirus Shows No Benefit In First Small—But Limited—Controlled Trial - https://www.forbes.com/sites/tarahaelle/2020/03/25/chloroquine-use-for-covid-19-shows-no-benefit-in-first-small-but-limited-controlled-trial/#7347ff404c86
[2] http://subject.med.wanfangdata.com.cn/UpLoad/Files/202003/43f8625d4dc74e42bbcf24795de1c77c.pdf
[3] Plaquenil (hydroxychloroquine sulfate) dose, indications, adverse effects, interactions... from PDR.net - https://www.pdr.net/drug-summary/Plaquenil-hydroxychloroquine-sulfate-1911
 
Oct 7, 2016
2,451
5,195
Put another way, if I had my choice, I probably wouldn't choose hydroxychloroquine.
A very recent Chinese study found no effect with hydroxychloroquine alone, in a patient study with a larger size than the French study [1,2]. Also there's a potential for harmful synergistic drug interaction affecting the heart between hydroxychloroquine and azithromycin [3]. The Minnesota study is having a hard time getting people enrolled, but their target 1500 patient size should be fairly conclusive. My brother-in-law is extremely nervous about the outbreak and he bought several tablets of hydroxychloroquine overseas. He's particularly concerned about his father (my father-in-law) who is high-risk and particularly frail. I had to try to convince him that the treatment is inconclusive and potentially dangerous. It's difficult convincing people that overeager politicians and health professionals without evidence are acting irresponsibly when they suggest that this might be "the cure," since they are figures of authority.

[1] Chloroquine Use For COVID-19 Coronavirus Shows No Benefit In First Small—But Limited—Controlled Trial - https://www.forbes.com/sites/tarahaelle/2020/03/25/chloroquine-use-for-covid-19-shows-no-benefit-in-first-small-but-limited-controlled-trial/#7347ff404c86
[2] http://subject.med.wanfangdata.com.cn/UpLoad/Files/202003/43f8625d4dc74e42bbcf24795de1c77c.pdf
[3] Plaquenil (hydroxychloroquine sulfate) dose, indications, adverse effects, interactions... from PDR.net - https://www.pdr.net/drug-summary/Plaquenil-hydroxychloroquine-sulfate-1911
Is there any amount of clinical experience that would be sufficient for you in the absence of a randomized trial? Apparently penicillin was accepted and used for at least two fatal conditions without clinical trials unless my source that I quoted a few posts back is incorrect. I don’t think it is, as I grew up hearing from my mother how her mother passed away from bacterial endocarditis about a year before anyone knew to use penicillin. She was sad about that. She would have been absolutely livid if she had learned that the drug was out there but couldn’t have been used without waiting for trials.

These drugs might or might not be of any benefit whatsoever. But keep what Eisenhower warned about in his Farewell Address in mind:
“The prospect of domination of the nation's scholars by Federal employment, project allocations, and the power of money is ever present and is gravely to be regarded.

Yet, in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientific-technological elite.”

Science is not apolitical. Too much money coming from the government, directly through grants or indirectly through government procurement, is involved. If science wants to be walled off from politics, stop taking the money. Or else find a way to accept that the public, in all its messiness, is going to be involved and deal with it other than by telling us to get lost. That is not directed at you personally, but I think it does reflect the attitude of much of your “community”
 

olkofri

Lifer
Sep 9, 2017
8,048
14,666
The Arm of Orion
Oldgeezersmoker, I agree with you, but as you obliquely pointed out with your quote from Eisenhower, we are, unfortunately, no longer 'back in the day', but in a highly-regulated scientifico-political morass in which a doctor simply can't prescribe stuff that he knows, or has a strong hunch, it works or can help if said stuff hasn't been given the 'blessing' of the FDA without fear of being sued, jailed, or have his licence revoked –or a combination of those three. Very sad state of affairs, considering that the FDA is in bed with all kind of powerful and greedy bedbugs, er, bedfellows.
 

condorlover1

Lifer
Dec 22, 2013
8,051
27,176
New York
It all boils down to tort reform. Sadly in the U.S we have a legal system that is predicated on the concept that all non-criminal wrongs can be put right by someone coughing up some money. Since the U.S has more flange ferrets aka lawyers than other country relative to population density and a legal system geared to positively encouraging litigation (i.e) no win no fee and 33% contingency fees the result is no one wants to take a risk. That being said the Pure Food & Drug Act did get rid of the crazy patent medicine market as a noisy third wheel to medical science but it also gave us the FDA who share a similar mindset to the U.K's Health Safety people. Rule by committee has always resulted in collective failure.
 

greeneyes

Lifer
Jun 5, 2018
2,151
12,253
Is there any amount of clinical experience that would be sufficient for you in the absence of a randomized trial?
Well it's a bit of a "canary in a coal mine" scenario. I'd be very wary of subjecting my family to unproven treatments. And as 'condorlover1' and 'olkolfri' rightly state above, we live in a very litigious society. To "take a leap of faith" in a medical-professional sense is to open yourself up to significant liability. Patients themselves are potential litigants.

These drugs might or might not be of any benefit whatsoever. But keep what Eisenhower warned about in his Farewell Address in mind:
“The prospect of domination of the nation's scholars by Federal employment, project allocations, and the power of money is ever present and is gravely to be regarded.
I agree. For example, the current administration is silencing scientists who, in agreement with the worldwide scientific consensus, argue that climate change is real. It's a perfect example of your statement. But I'm unclear how this applies to the drug in question. Are you suggesting that the government is somehow suppressing results or trying to hoard the drug for itself?

Yet, in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientific-technological elite.”
I understand this is a fear of many people. Being "ruled" by a "scientific-technological elite." I have to say that we've done a pretty outstanding job of ignoring science in this country, and the beautiful mess we're in at the moment is a direct consequence of that. My fear is the exact opposite: being ruled by unqualified people who surround themselves by other equally unqualified individuals. Prayer and bravado is no substitute for informed planning and preparedness. In the present situation public policy is in fact the captive of Wall Street, and science is an inconvenience if it stands in the way of profit and public safety.

Science is not apolitical. Too much money coming from the government, directly through grants or indirectly through government procurement, is involved. If science wants to be walled off from politics, stop taking the money. Or else find a way to accept that the public, in all its messiness, is going to be involved and deal with it other than by telling us to get lost. That is not directed at you personally, but I think it does reflect the attitude of much of your “community”
I have no problem with the public getting involved. There are clinical trials that people can enroll in. Then there are people like the Arizona fellow who poisoned himself and his wife with chloroquine aquarium cleaner [1]. This is what people are trying to avoid happening on a larger scale. If people want to advocate self-experimentation with potentially unsafe treatments they do so at their own risk. You have to assume at some point that medical professionals have your health and safety in mind when they make rules like this. If people have the attitude that they're an elite that's suppressing the truth or somehow trying to control them it becomes very difficult to create policy that people will adhere to. The pharmaceutical industry, on the other hand, has as a motive profits. That's a different animal altogether. I'm talking about public health officials and health care workers.


[1] Man Dies, Woman Hospitalized After Taking Form Of Chloroquine To Prevent COVID-19 - https://www.npr.org/sections/coronavirus-live-updates/2020/03/24/820512107/man-dies-woman-hospitalized-after-taking-form-of-chloroquine-to-prevent-covid-19
 

pappymac

Lifer
Feb 26, 2015
3,295
4,327
It all boils down to tort reform. Sadly in the U.S we have a legal system that is predicated on the concept that all non-criminal wrongs can be put right by someone coughing up some money. Since the U.S has more flange ferrets aka lawyers than other country relative to population density and a legal system geared to positively encouraging litigation (i.e) no win no fee and 33% contingency fees the result is no one wants to take a risk. That being said the Pure Food & Drug Act did get rid of the crazy patent medicine market as a noisy third wheel to medical science but it also gave us the FDA who share a similar mindset to the U.K's Health Safety people. Rule by committee has always resulted in collective failure.
You definitely got this right. You want to drive down healthcare costs? Institute tort reform. People just don't realize how much doctors and hospitals are having to pay out in malpractice insurance because of lawsuits.
 

docpierce

Can't Leave
Feb 17, 2020
479
1,379
Yeah, there have been some reports since Friday of last week of it helping and others saying it isn't. Speculation has spread enough that people are buying this up and pharmacies are running out.

If this isn't it, I am hopeful that there will be a breakthrough like this with some existing treatment or medicine. There is also speculation that warmer weather might slow this down. If this is true, it might also help with keeping the spread at bay in nations at the equator that have already struggling medical systems. (i.e. west Africa)
The French coming to the rescue. Now that's a first.
tic
I seem to remember the small matter of Lafayette and the French supplying troops and financial support during the American Revolutionary War.
 
Oct 7, 2016
2,451
5,195
Oldgeezersmoker, I agree with you, but as you obliquely pointed out with your quote from Eisenhower, we are, unfortunately, no longer 'back in the day', but in a highly-regulated scientifico-political morass in which a doctor simply can't prescribe stuff that he knows, or has a strong hunch, it works or can help if said stuff hasn't been given the 'blessing' of the FDA without fear of being sued, jailed, or have his licence revoked –or a combination of those three. Very sad state of affairs, considering that the FDA is in bed with all kind of powerful and greedy bedbugs, er, bedfellows.
In the hypothetical that started all this, I specified that @greeneyes was being asked to sign a release. I spent a career as a lawyer and am well aware of the litigation risks.
 
Oct 7, 2016
2,451
5,195
Well it's a bit of a "canary in a coal mine" scenario. I'd be very wary of subjecting my family to unproven treatments. And as 'condorlover1' and 'olkolfri' rightly state above, we live in a very litigious society. To "take a leap of faith" in a medical-professional sense is to open yourself up to significant liability. Patients themselves are potential litigants.


I agree. For example, the current administration is silencing scientists who, in agreement with the worldwide scientific consensus, argue that climate change is real. It's a perfect example of your statement. But I'm unclear how this applies to the drug in question. Are you suggesting that the government is somehow suppressing results or trying to hoard the drug for itself?


I understand this is a fear of many people. Being "ruled" by a "scientific-technological elite." I have to say that we've done a pretty outstanding job of ignoring science in this country, and the beautiful mess we're in at the moment is a direct consequence of that. My fear is the exact opposite: being ruled by unqualified people who surround themselves by other equally unqualified individuals. Prayer and bravado is no substitute for informed planning and preparedness. In the present situation public policy is in fact the captive of Wall Street, and science is an inconvenience if it stands in the way of profit and public safety.


I have no problem with the public getting involved. There are clinical trials that people can enroll in. Then there are people like the Arizona fellow who poisoned himself and his wife with chloroquine aquarium cleaner [1]. This is what people are trying to avoid happening on a larger scale. If people want to advocate self-experimentation with potentially unsafe treatments they do so at their own risk. You have to assume at some point that medical professionals have your health and safety in mind when they make rules like this. If people have the attitude that they're an elite that's suppressing the truth or somehow trying to control them it becomes very difficult to create policy that people will adhere to. The pharmaceutical industry, on the other hand, has as a motive profits. That's a different animal altogether. I'm talking about public health officials and health care workers.


[1] Man Dies, Woman Hospitalized After Taking Form Of Chloroquine To Prevent COVID-19 - https://www.npr.org/sections/coronavirus-live-updates/2020/03/24/820512107/man-dies-woman-hospitalized-after-taking-form-of-chloroquine-to-prevent-covid-19
I am not a conspiracy theorist. But I believe, and have for decades, that people act according to their interests. That includes, but is not limited to, their economic interests. Scientists also, for example,want to be considered as members in good standing of what has been termed the Republic of Science, so there is a sociological element, involved, too.

I notice that Larry Ellison of Oracle is designing software to collect and analyze clinical experience with this class of drugs. Whether they prove to be useful or not, shouldn’t it be exciting that we just might be able to use our knowledge of mega data, artificial intelligence, etc. in drug development? Might there be a time in the not too distant future when the clinical trial methodology is viewed like the horse and buggy? Will the present day gatekeepers be open to such a change? Do pigs fly?
 

trouttimes

Lifer
Nov 26, 2018
5,232
21,657
Lake Martin, AL
This is a discussion that has few answers. As far as people using aquarium cleaner or drinking bleach, Darwin at work. If I'm sick, I spend my money and take my chance. I would go see a witch doc in the jungle and drink bat piss if "modern medicine " had no cure. My choice. Lawsuits and HIPPA has done little to help us in my opinion.
 
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