News ***NON-POLITICAL COVID-19 Discussion Thread*** - Page 2867

Originally Posted by Fish:
Statement from Yale Faculty on Hydroxychloroquine and its Use in COVID-19

We write with grave concern that too many are being distracted by the ardent advocacy of our Yale colleague, Dr. Harvey Risch, to promote the assertion that hydroxychloroquine (HCQ) when given with antibiotics is effective in treating COVID-19, in particular as an early therapeutic intervention for the disease. As his colleagues, we defend the right of Dr. Risch, a respected cancer epidemiologist, to voice his opinions. But he is not an expert in infectious disease epidemiology and he has not been swayed by the body of scientific evidence from rigorously conducted clinical trials, which refute the plausibility of his belief and arguments. Over the last few weeks, all of us have spent considerable time explaining the evidence behind HCQ research, as it applies to early and late stage COVID-19 patients to the scientific community and general public, and now are compelled to detail the evidence in this open letter.

Spoiler!

We are seriously alarmed for the safety of patients and the coherence and effectiveness of our national COVID-19 emergency response when misinformation about HCQ is spread and when rigorous scientific evidence and consensus produced by the community of expert researchers in infectious diseases, federal agencies and national and global health organizations are not heeded. Let us be clear: we are unanimous in our desire to see the development of therapies to treat COVID-19 and to prevent the transmission or acquisition of SARS-CoV-2. If HCQ was shown to be effective, even among subgroups of patients with COVID-19 in ongoing high quality trials, we would join our colleagues in promoting access to it for all who need it. However, the evidence thus far has been unambiguous in refuting the premise that HCQ is a potentially effective early therapy for COVID-19.

HCQ is used for the treatment of rheumatological diseases, such as lupus and rheumatoid arthritis. However, this does not ensure that the drug will be safe in patients with COVID-19 or in widespread use to treat early illness. In fact, rigorously-conducted clinical trials have found that HCQ is not effective as an early prophylactic therapy in preventing illness due to COVID-19 in people exposed to the virus. Furthermore, HCQ, alone or together with the antibiotic, azithromycin, has not been shown to be effective in improving the clinical status of patients with COVID-19. Moreover, clinical trials have found that treatment with HCQ may be associated with increased risk of adverse reactions. Taken together, the scientific evidence does not support the widespread use of this drug, alone or in combination with an antibiotic, as advocated by Dr. Risch and others, unless rigorous evidence from clinical trials demonstrates otherwise.

Finally, we point to the recent memorandum from the US Food and Drug Administration revoking the Emergency Use Authorization for HCQ that has assembled the data on the drug as of June 2020 (Food and Drug Administration Memorandum Explaining Basis for Revocation of Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate). The Infectious Diseases Society of America now advises against the drug alone or in combination with azithromycin in the setting of COVID-19 except in the context of ongoing clinical studies. If these trials do show a clinical benefit for HCQ, we would revise our views on its use in the management of COVID-19.

The disproportionate focus on treatment with HCQ, in addition to the lack of a strong scientific rationale for its use and the risk of its potentially harmful effects, has major opportunity costs. In a recent analysis of COVID-19 clinical trials, one in every six studies of treatments against SARSCoV-2 was designed to study HCQ or chloroquine. We understand the desperation of many to see an effective treatment for COVID-19 emerge that will stop the pandemic in its tracks or slow its relentless spread in the US. But investing our resources in HCQ after multiple studies have not shown it to be effective for COVID-19 has serious implications for more than just individual patients. The continuing advocacy on behalf of HCQ distracts us from advancing the science on COVID-19 and seeking more effective interventions in a time when more than 1000 people are dying per day of this disease. There are multiple approaches to expedite the evaluation and approval of drugs for serious and life-threatening diseases in the US that have existed for decades now, but they all still rely on data from rigorous, well-conducted clinical trials to guide us. In addition, this ongoing promotion of HCQ has global implications as well, as many countries in the global South only have access to HCQ and use of HCQ is still common in this setting despite the lack of evidence and potential risks.

It is critical that we follow the science and where the evidence leads us on a quest to treat and prevent COVID-19. In this climate, it�s important to rely on the data above all else when making clinical or regulatory decisions. Making these kinds of choices guided by personal endorsements outside of the context of the existing scientific evidence is medicine by testimonial and risks people�s lives. Randomized controlled trials are how we keep from fooling ourselves, test our assumptions about new drugs and new uses for old ones. For instance, flecainide was initially proposed as a drug to treat those at risk of severe arrhythmias after sudden myocardial infarction. However, the Cardiac Arrhythmia Suppression Trial showed for the first time that mortality was actually three times higher among persons receiving the drug for this purpose. Even though the drug was known to be effective in those experiencing severe arrhythmia, it ended up increasing mortality in those simply at risk. And no one noticed because sudden death after myocardial infarction was not a rare event and this tripling of the risk was not detected until a randomized, controlled trial was done. The FDA has rescinded the EUA for HCQ for a reason: the vast preponderance of the evidence suggests that the drug is without merit in clinical care for COVID-19 and presents real dangers to patients by its continued use.

In 1987, University of California at Berkeley Professor Peter Duesberg gained notoriety by expounding on his belief that AIDS was not caused by the human immunodeficiency virus, but by antiretroviral agents like azidothymidine (AZT) and recreational drugs. However, the data on antiretroviral therapy was clear: these drugs extended life and health and turned around the course of the AIDS epidemic worldwide. But Professor Duesberg persisted in his quest. Professor Duesberg�s thesis dissuaded many from taking antiretroviral therapy, and after the President of South Africa Thabo Mbeki endorsed these views, it led to delays in the roll-out of these life-saving drugs costing hundreds of thousands of lives in that country. While minority opinions, anecdotal evidence, novel interpretations and challenges to orthodoxies in a field can be important, at some point, the application of the scientific method generating evidence from multiple, well-designed clinical trials and observational studies does matter and should be heard over the noise of conspiracy theories, purported hoaxes, and the views of zealots.

Signed,
Jason Abaluck, PhD
Associate Professor of Economics
Yale School of Management
Amy Bei, PhD
Assistant Professor of Epidemiology (Microbial Diseases)
Yale School of Public Health
Theodore Cohen, MD, DPH
Professor of Epidemiology (Microbial Diseases)
Co-director, Public Health Modeling Concentration
Yale School of Public Health
Gary V. Desir, MD
Paul B. Beeson Professor of Medicine
Vice Provost, Faculty Development and Diversity
Chair, Internal Medicine, Yale School of Medicine
Chief, Internal Medicine, Yale New Haven Hospital
Gail D�Onofrio MD
Professor & Chair, Emergency Medicine
Yale School of Medicine
Yale School of Public Health
Howard P. Forman, MD, MBA
Professor of Radiology & Public Health (Health Policy)
Yale School of Public Health
Yale School of Medicine
Professor in the Practice of Management
Yale School of Management
Alison Galvani, PhD
Burnett and Stender Families Professor of Epidemiology (Microbial Diseases)
Director of the Center for Infectious Disease Modeling and Analysis (CIDMA)
Yale School of Public Health
Gregg Gonsalves, PhD
Assistant Professor of Epidemiology (Microbial Diseases)
Yale School of Public Health
Associate Professor (Adjunct) and Research Scholar
Yale Law School
Nathan D. Grubaugh, PhD
Assistant Professor of Epidemiology (Microbial Diseases)
Yale School of Public Health
Roberta Hines, MD
Nicholas M. Greene Professor & Chair of Anesthesiology
Yale School of Medicine
Valerie Horsley, PhD
Associate Professor of Molecular, Cellular & Developmental Biology
Yale University
Akiko Iwasaki, PhD
Waldemar Von Zedtwitz Professor of Immunobiology and Molecular, Cellular and Developmental Biology
Yale School of Medicine
Professor of Molecular Cellular and Developmental Biology
Yale University
Amy Kapczynski, JD
Professor of Law
Yale Law School
Trace Kershaw, PhD
Department Chair and Susan Dwight Bliss Professor of Public Health (Social and Behavioral Sciences)
Yale School of Public Health
Albert I. Ko, MD
Professor of Epidemiology and Medicine and Chair of Epidemiology of Microbial Diseases
Yale School of Public Health
Stephen R. Latham, JD, PhD
Director, Interdisciplinary Center for Bioethics
Yale University
Brett Lindenbach, PhD
Associate Professor, Microbial Pathogenesis
Yale School of Medicine
Fiona Scott Morton, PhD
Theodore Nierenberg Professor of Economics
Yale School of Management
Ruslan Medzhitov, PhD
Sterling Professor of Immunobiology
Yale School of Medicine
Saad B. Omer, MBBS MPH PhD FIDSA
Professor of Medicine (Infectious Diseases),Yale School of Medicine
Adjunct Professor, Yale School of Nursing
Susan Dwight Bliss Professor of Epidemiology of Microbial Diseases, Yale School of Public Health
A. David Paltiel, PhD
Professor of Health Policy & Management
Yale School of Public Health
Yale School of Management
Sunil Parikh, MD, MPH
Associate Professor of Epidemiology and Medicine
Yale School of Public Health
Yale School of Medicine
Karen Santucci, MD
Professor & Chief, Pediatric Emergency Medicine
Yale School of Medicine
Marcella Nunez Smith, MD, MHS
Associate Professor, General Internal Medicine, Public Health, and Management
Yale School of Medicine
Yale School of Public Health
Yale School of Management
Director, Equity Research and Innovation Center
Daniel Weinberger, PhD
Associate Professor of Epidemiology (Microbial Diseases)
Yale School of Public Health

Yeah but the demon-sperm doctor says they're wrong. So I guess it's a wash.

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Originally Posted by suzzer99:
Yeah but the demon-sperm doctor says they're wrong. So I guess it's a wash.

Weren't you calculating us at being like 2k-3k deaths a day at this point or something?
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Originally Posted by petegz28:
Don't have a tantrum, it's not a political article....

'It saved my life': Democratic councilman says hydroxychloroquine was key to recovering from COVID

https://justthenews.com/politics-pol...oquine-was-key

Must have been the Benadryl I got before my infusions that cured my cancer.
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Originally Posted by 'Hamas' Jenkins:
Must have been the Benadryl I got before my infusions that cured my cancer.

Benadryl is the awesome...don't even go there
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Originally Posted by Marcellus:
Frankly I don't have a "dog in the fight" either

Right.

Originally Posted by Marcellus:
other than I find it amazing people still dismiss it outright when all over the world its still being used as a treatment. That doesn't make sense with it being settled science.

How many of these all over the world treatments have been RCTs?
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Originally Posted by petegz28:
Benadryl is the awesome...don't even go there

Good in a lot of ways, really sucks in others. Benadryl ODs are interesting.

Interesting alliteration/mnemonic for toxicity:

Blind as a bat
Dry as a bone
Full as a flask (can’t urinate)
Hot as a Hades
Red as a beet
Mad as a hatter
Tacky as a leisure suit (fast heart rate)

Pro-tip: Don't give to people over 65, especially if they have dementia.
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UNC is shutting down in person classes just after 1 week because they had 130 positive cases and probably have much larger outbreak occurring. Who could have predicted that. :-)
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Originally Posted by dirk digler:
UNC is shutting down in person classes just after 1 week because they had 130 positive cases and probably have much larger outbreak occurring. Who could have predicted that. :-)

Anyone else have elementary school-aged kids?

How are you planning on handling the (almost certain) possibility of them being virtual for a large portion of the year?
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Originally Posted by dirk digler:
UNC is shutting down in person classes just after 1 week because they had 130 positive cases and probably have much larger outbreak occurring. Who could have predicted that. :-)

I wonder how many are symptomatic and/or hospitalized.
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Originally Posted by Marcellus:
Frankly I don't have a "dog in the fight" either other than I find it amazing people still dismiss it outright when all over the world its still being used as a treatment. That doesn't make sense with it being settled science.

Then the same people want to use these crazy outlier cases like the one random 22 year old healthy guy who got permanent heart damage from Covid as if that's a real statistical danger for anyone who gets Covid but want to outright ignore many many doctors who say HQC has worked for their patients.

:-)

i dunno seems a little hypcoritical.

Any healthcare practitioner has the ability to make choices for treatment, it’s just that some treatment options have scientific backing with supported data and some do not. You are asked as a provider to promote treatments within your scope of practice and those supported by research.

In my field I help people return swallow function from a variety of conditions. This may include strokes, head/neck cancer, Parkinson’s and dementia. I have an estim unit that sends electrical impulses to help improve muscular contraction and swallow function when paired with oral motor exercises. It’s been shown to improve function post stroke but does not have evidence in support of improving swallow function in people with Parkinson’s, as traditional compensatory swallow techniques are more beneficial for them. However, some therapists will give estim to people with Parkinson’s even though the data doesn’t support it’s use and traditional treatments are more effective. Does that make it wrong? No, but it cannot be stated to be a cure when data does not support this, especially when it’s paired with traditional treatments. Could we have achieved the same results, without risking side effects, just using traditional treatments?

This is similar to HCQ based on current research. Traditional treatments prove same/more effective without the possible known side effects from HCQ. Does that mean it can’t be used as last resort, maybe not. But drawing conclusions that it’s curing COVID cannot be drawn from any studies or literature.

There’s examples in all of healthcare about making decisions and making good/better decisions. It shouldn’t be a guessing game.

/typing on phone
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The doctor I know in Seattle was in one of the HCQ studies. He said he didn't think it did much, but some of the nurses thought it was a miracle drug. Point is the more emotionally involved you are, and you see the patient seem to miraculously get better the day they take something - you're going to believe in it. Which is exactly why you need placebos and double-blind studies.

These non-RCT HCQ studies seem to have taken patients who were probably going to get better anyway, and purposely excluded the really sick patients - at least the ones I've dived into.
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Originally Posted by dirk digler:
UNC is shutting down in person classes just after 1 week because they had 130 positive cases and probably have much larger outbreak occurring. Who could have predicted that. :-)

Predicted that they would shut down after something happened everyone knew would happen? Yeah that is pointless. If cases means you shut down then starting was pointless to begin with. As far as I can tell that�s not the debate though about in person schooling occurring.
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Originally Posted by 'Hamas' Jenkins:
Anyone else have elementary school-aged kids?

How are you planning on handling the (almost certain) possibility of them being virtual for a large portion of the year?

I have two. Luckily the wife works from home and was a teacher before, but I'm not looking forward to it. It really had an effect on my kindergartener last year psychologically. I am hopeful they can stay in school this year.

They're doing all they can to make it work.
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Getting a little hairy here in Greene county. Hospitalizations up by a fair amount over the weekend.
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Originally Posted by O.city:
Getting a little hairy here in Greene county. Hospitalizations up by a fair amount over the weekend.

We're seeing a small uptick here in Buchanan. We've had counties around us that don't have medical facilities that have had outbreaks in nursing homes, so I think this may have something to do with it.

Our cases per day have been steadily increasing around here though. We were averaging 4 or 5 a day for a while and now seem to be closer to 11-12 per day.
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