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It was approved for Emergency Use on December 23, 2021.

The pandemic hit the U.S. (officially) a year and a half earlier. Below, Tyrone's handlers are feeding him information to regurgitate comparing Paxlovid's effectiveness vs. the HCQ protocol. The problem with that is that NO ONE that I'm aware of is trying to claim that Paxlovid is inferior. But the reality is that it wasn't available for a loooooong time. If there was data that indicated that the HCQ protocol may be effective when used as an early intervention shortly after the onset of symptoms, why was there such a massive pushback against it? This wasn't a high-risk intervention to prescribe for patients, so why did so many do everything they could to discredit and block it?

I'm not a physician, and I don't have any claims about its effectiveness. But I absolutely recall that the "wrong" people were discussing it, and it became a political lightning rod when it shouldn't have.

and quite a few were undertaken (but no RCTs), so they certainly didn't try to block it...unfortunately, the results showed no benefit over not taking the drug combo...and there are always concerns for cardiac arrhythmias with HCQ, which go back many years before COVID-19.

It's unfortunate that really effective and well designed drugs, like Paxlovid, can take a long time to develop...thankfully, we got it early enough to have a positive effect.

There have NEVER been any concerns about HCQ and cardiac issues ... none. This is according to Dr. Risch and another prominent doctor (Dr. Davis Something) whose last name escapes me.

And once yet again, NOT ONE trial showing it to be ineffective was done correctly. Why is that so hard for you to understand???

....here's a summary response to the question of whether HCQ, in high doses, can cause cardiac problems...
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AI Overview
Yes, high doses of hydroxychloroquine (HCQ) can result in cardiac problems, especially with acute overdose or long-term use at higher doses.
Potential cardiac problems include:
QT prolongation: This is a lengthening of the QT interval on an electrocardiogram, which can increase the risk of developing dangerous arrhythmias like torsades de pointes.
Ventricular tachycardia and fibrillation: These are types of irregular heartbeats that can be life-threatening.
Cardiomyopathy: This is a condition where the heart muscle becomes thickened, stretched, or stiffened, impairing its ability to pump blood effectively. It can eventually lead to heart failure.
Heart failure: A condition where the heart cannot pump enough blood to meet the body's needs.
Conduction abnormalities: Disruptions in the heart's electrical system, such as atrioventricular (AV) block or bundle branch block.
The risk of these problems increases with higher doses and prolonged use. Additionally, combining HCQ with other medications that can also prolong the QT interval, such as the antibiotic azithromycin, further increases the risk.
It's important to note that hydroxychloroquine has a long half-life, meaning it stays in the body for an extended period, which allows for potential accumulation with repeated dosing, even at relatively low doses.
While hydroxychloroquine is prescribed for malaria treatment, it's crucial to follow your doctor's orders carefully regarding dosage and duration to minimize the risk of cardiac and other adverse effects. If you're taking hydroxychloroquine and experience any symptoms like irregular heartbeats, dizziness, or fainting, seek immediate medical attention.
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Given that no RCTs showed a benefit from HCQ+...and that some patients could experience cardiac problems from inappropriate doses...it was wise for the FDA and WHO to cancel their EUA for this potential treatment.

Also, no one ran a trial to demonstrate HCQ+'s ineffectiveness...no one ran an RCT according to Dr. Risch's protocol...sorry, but that's on him and his fellow proponents for not designing and conducting one....it's not the FDA's responsibility. I'm trying to be as charitable toward you as I can...someday, I'm hoping you'll get it...the "Sponsors" of HCQ+ have never provided evidence that their drug combo works in the way they said it should be.

btw, what would you do or say if I read Dr. Risch's paper?...what difference would it make for HCQ+?

The question must be asked, why in the world were the RCTs on HCQ+ not done correctly in the first place? There can be only three reasons: Too difficult to do it in the real world; ignorance of the protocol doctors out in the real world were using, or, the conspiracy reason, they wanted it to fail.

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And Trump was a vaccine cheerleader the entire time, so much so that Biden, Kamala and other Dems tried their best to create vaccine hesitancy. Then they forced people to take it.

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I'd guess you don't want to engage that.

RCT could? The good Doctor may be an excellent Family Physician, but he's not a Virologist or Epidemiologist who practices in those fields for a living. Those who are professionals in those fields like Dr. Risch's peers at Yale Medical School and the American Journal of Epidemiology have publicly gone on record denouncing HCQ+ as a treatment for COVID-19.

The fundamental reason why HCQ+ never got FDA approval is because Dr. Risch, Dr. Fareed, Dr. Tyson and other "Sponsors" of that drug treatment failed to provide data from an RCT that proved any benefit in the manner of usage they recommended. If they truly believed in it, they should have ponied up the money and conducted it...like Pfizer did with "Paxlovid"...a drug treatment that was so successful the FDA halted the trials early in order to get it out to the public asap.

Here's an AI summary to the question of whether or not proponents of HCQ+ had ever done an RCT for their recommended treatment...

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AI Overview

Submission of RCT data for FDA approval of hydroxychloroquine (HCQ) for COVID-19

While hydroxychloroquine (HCQ) was temporarily authorized for emergency use in hospitalized patients with COVID-19 based on limited evidence in 2020, the FDA later revoked this Emergency Use Authorization (EUA) in June 2020. This revocation was based on mounting evidence, including data from a large randomized controlled trial, indicating that the potential benefits did not outweigh the risks.

The FDA issued the EUA for HCQ for COVID-19 based on limited in-vitro and anecdotal clinical data available at the time. However, the EUA itself stated that the authorization was for the unapproved use of the drug in specific hospitalized patients where a clinical trial was not available or participation wasn't feasible.

The FDA recommends that the use of HCQ for COVID-19 should be limited to clinical trial settings or for treating certain hospitalized patients under the EUA (which has since been revoked). Healthcare professionals were advised to check ClinicalTrials.gov for suitable clinical trials and consider enrolling patients in such trials.

Therefore, to answer the question directly, sponsors of HCQ did not submit randomized controlled trial (RCT) data specifically for FDA approval of HCQ as a COVID-19 treatment. The EUA was based on limited data and was subsequently revoked after RCTs, like the RECOVERY trial, showed no evidence of benefit for mortality or other outcomes in hospitalized patients with COVID-19.
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Thankfully, the COVID-19 pandemic is behind us, so there's no need to keep beating this horse...but keep in mind the lesson learned when it comes to the next viral threat...which will definitely come some day...perhaps too soon with RFK Jr. at the helm of HHS...i.e. Conduct rigorous RCTs for any prospective drug that would be distributed to millions if not billions of human beings.

Your own link condemns your point of view and confirms the truth. The FDA only authorized use on ALREADY HOSPITALIZED PATIENTS. Read that again. And thus, that's why the RCTs were conducted that way, when it was far too late to be effective.

It wasn't just Dr. Fareed who used HCQ+ to great success. Dr. Zev Zelenko was a pioneer of this and had identical results. So did America's Frontline Doctors, who got a bad rep when Dr. Stella Immanuel turned out to have kooky beliefs and the media fixated on this.

Face it. This is one of the greatest failures in American medical history...and your boy the Great Fauchino is directly responsible.

effectiveness IN THE MANNER THEY PRESCRIBE...they didn't do it...end of story.

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Be free of conflicts of interest. It's a fucked up tangled web rife for corruption as is.

research, where a lot of new drugs and startups come from...

...here's an AI summary in answer to the question...Do all drugs on the market come from big pharmaceutical companies?

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AI Overview
No, not all drugs on the market are developed by "big pharma" companies, though they do play a significant role. While large pharmaceutical companies often handle the later stages of drug development, including manufacturing and marketing, a substantial amount of drug discovery originates in universities and smaller biotech companies. Additionally, public funding, particularly through institutions like the National Institutes of Health (NIH), plays a crucial role in foundational research that underpins many drug discoveries.
Here's a more detailed breakdown:
"Big Pharma" is a Misnomer:
While the term "Big Pharma" is often used, it's more accurate to think of it as a complex ecosystem involving various players.
Early-Stage Research:
Much of the foundational research that leads to new drugs originates in universities and academic centers.
Biotech Companies:
Small biotech companies often focus on specific areas of drug discovery and development, sometimes partnering with or being acquired by larger pharmaceutical companies.
Public Funding:
The NIH and other public institutions invest heavily in basic research that forms the basis for many new drugs.
Later-Stage Development:
Large pharmaceutical companies are typically involved in the later stages of drug development, including clinical trials, manufacturing, and marketing.
Collaboration:
Collaboration between universities, biotech companies, and large pharmaceutical companies is increasingly common, with each entity contributing its unique expertise.
Global Production:
While the US plays a significant role in drug development, global manufacturing is more geographically dispersed, with countries like India and China playing a large role in the production of active pharmaceutical ingredients (APIs) and finished drug products.
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The existing system can work quite when we have strong government oversight that is non-political...as well as government funding for Universities and BioTech startups, so that we're not totally dependent on Big Pharma. DJT seems to be 'Stacking the Deck' in favor of Big Pharma with all his cuts to Oversight and University/BioTech startups. Guess that's what his Plutocrat friends like Peter Theil would like to see.

AI Overview


+21
Yes, there can be conflicts of interest between the FDA and pharmaceutical companies. These arise when individuals involved in the FDA's drug approval process have financial or other relationships with pharmaceutical companies whose products they are reviewing.
Here's a breakdown of the potential conflicts:
1. Financial Ties:
Advisory Committee Members:
FDA advisory committees play a crucial role in drug approvals, and members may have financial relationships with pharmaceutical companies, including research grants, consulting fees, or stock ownership.
FDA Staff:
FDA employees, including reviewers, may also have financial ties to the pharmaceutical industry, creating a potential conflict of interest when they are involved in drug approvals.
"Revolving Door":
A concerning trend is the movement of former FDA employees into high-paying positions at pharmaceutical companies, particularly after involvement in drug approvals.

of Interest...the response was a firm "Yes"...which is why I mentioned DJT axing 17 of them...including the one for HHS. btw, I've also queried whether IGs have uncovered serious cases of COI and initiated criminal proceedings...the answer was YES.

Again, it is my belief that DJT is turning the U.S. government into a candy store for criminals...like himself. There is no justification for firing 17 IGs...none.

Are Inspectors General vulnerable to conflicts of interest?

AI Overview


+8
Yes, Inspectors General (IGs) can be subject to conflicts of interest, but their role is designed to minimize and mitigate these potential issues. The Inspector General Act explicitly aims to ensure independence and objectivity for IGs, which are crucial for maintaining public trust and the integrity of their work.
Here's why and how conflicts of interest are addressed:
Independence:
IGs are designed to be independent from the agencies they oversee. This means they report to the agency head or Congress, but not to lower-level officials who might be subject to their oversight.
Dual Reporting:
IGs have a dual reporting obligation, keeping both the agency head and Congress informed about program deficiencies.
Legal Counsel:
IGs have their own legal counsel, independent of the agency's legal team, to avoid potential conflicts of interest.
Objectivity:
The IG Act mandates that IGs operate with integrity, objectivity, and independence, all of which are essential for ethical conduct and avoiding conflicts.
Potential Conflicts:
The Department of Justice Office of the Inspector General (DOJ OIG) has identified potential conflicts of interest when employees within the same agency division conduct investigations, particularly when they have personal relationships with the subject of the investigation.
Addressing Conflicts:
If a potential conflict of interest arises, the IG's office will take steps to mitigate the issue, which may include recusal, reassignment, or other measures to ensure the integrity of the investigation.
Whistleblower Protection:
IGs also play a role in protecting whistleblowers and ensuring they are not retaliated against for reporting wrongdoing.

summary speaks to the low probability of IGs becoming compromised. Is it possible for an IG to have a conflict of interest?…Yes…is it likely?…No.

See how easy this is? Now if I were you I would make this thought into an unchangeable gospel. But then I'd be miserable.

Each year, ~4K Doctors and ~3K Attorneys are publicly disciplined by their state review boards…should we get rid of all our Doctors and Lawyers?

You have a perception problem along with an inability to make reasonable decisions…

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important as the rationale behind their firings. Take a look at the attached article for some insight into why Trump took this questionable action.

Link: https://campaignlegal.org/update/significance-firing-inspectors-general-explained su

Pfizer had a financial interest in Paxlovid - a drug "strangely" enough designed to mimic HCQ+, while the drugs in HCQ+ are generically made.

Pfizer wasn't stupid. They knew it had to be given within five days of symptom onset. And you likely will not remember this, but back in the day you put up a link to an "expert" who claimed the five-day requirement was bogus, because if HCQ+ was effective within five days, it would be good on already hospitalized patients. Okaaayyy...

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What a tiresome ass you are.

explain what I pointed out below, that no RCT was conducted properly? That not only Dr. Fareed but many other doctors had similar results? How do you explain that?

For an educator, you sure do have a closed mind and far too much trust in "expert" consensus.

By the way, have you ever bothered to email Dr. Risch? I gave you his email address once, here it is again: harvey.risch@yale.edu. If he's willing to answer me, a tiresome ass, I'm sure he'll be most happy to reply to a peer.

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Would you really tell Dr. Fareed he doesn't know what he's talking about? What about Dr. Risch, who actually took the time to review every trial, RCT or observational, on HCQ+?

big Pharma? Please my good man.

All the RCTs were conducted on already-hospitalized patients or they used hydroxychloroquine only without zinc and azithromycin. Since HCQ+ had to be used within 5-7 days of symptom onset, these trials were doomed to failure. Yet, doctors everywhere (most prominent Dr. Fareed and Dr. Zelenko) found almost none of their patients dying or even going to the hospital.

The Great Fauchino is on record as he considers all observational data as "anecdotal" as not valid, so the rest of the medical community went along. His outsized influence on this and other medical matters cannot be underestimated.

the protocol he recommended.

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It was foolish and political for people to ignore usefulness of a drug in every patient moiety.

HCQ+ is supposed to be used on vulnerable-aged patients within 5-7 days of symptom onset to be effective.

Not one RCT was conducted that way. (They used hydroxychloroquine only without zinc and azithromycin; they used HCQ+ on already-hospitalized patients well past the 5-7 day window.)

Every credible observational trial (such as Dr. Fareed's among many others, by the way) showed HCQ+ to be incredibly effective. But because the Great Fauchino has a personal medical philosophy of not accepting ANY observational data as valid - a philosophy that doesn't square with mainstream medical research thought - it was on that basis alone deemed "ineffective."

Now that you have been educated on the facts, you are now free to comment.

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Everything I said is factual, gleaned DIRECTLY from Dr. Risch.

Not one RCT showing HCQ+ to be ineffective was done correctly. What about that can't you understand?

Every credible gathering of observational data shows it reduced hospitalizations and deaths around 84% (Dr. Risch's research). What about that can't you understand?

And I understand that there would be NO resistance to using that drug if it worked. Most docs actually want to help their patients.

And i understand that you are a conspiratorial loon who thinks that Big Pharma is pulling strings here to keep a drug that works under wraps.

It was many. Let me ask you this, since at times you're reasonable, and Ty refuses to answer.

Dr. Risch took the time to research all available trial data and found exactly what I've been saying here (by the way, 100% of what I say came directly from him, either through email correspondence or his paper). He found all credible observational trials showed great success and that all RCTs showing it to be ineffective - the same RCTs Fauchino and other "experts" use to say it was ineffective - were not conducted correctly. Since that IS the case, what is the logical conclusion?

Can you not at least consider maybe this was a failure of the medical community?

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They disputed, not "refuted," his initial findings. He answered every criticism in his paper.

Once again, how do you explain Dr. Fareed's success?

...and here is the Yale Faculty letter criticizing/rebuking Dr. Risch's paper and advocacy for HCQ+ as a treatment for COVID-19...signed by 20 of his colleagues.

https://www.counterpunch.org/2020/08/04/statement-from-yale-faculty-on-hydroxychloroquine-and-its-use-in-covid-19/


Link: https://yaledailynews.com/blog/2020/08/16/ysph-professor-criticized-for-promoting-unproven-drug-to-treat-covid-19/

Paper and recommendation…and they have never changed their opinion. Face it, Mark…you’ve been suckered in by charlatans. I can only hope that you didn’t become financially involved.

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that will be given to billions of people...not questionable "Observational Studies" with little, if any, rigor.

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Is that the majority of the studies that were done finding the combo to be ineffective were not studying the use case Fareed and others are talking about. All the studies that were posted refuting that it was beneficial that I saw, were all end stage, usually on respirators and the like, where it proved to not be helpful. None of the supporters of the combo were saying it was helpful in that instance, so the studies didn't actual refute anything that they said.

Honestly though Mark, I would just drop it at this point. No matter what, you will not change his mind. Unless you just like arguing with him, then by all means, continue.

recommend...they didn't do it...Pfizer did, with its 'Paxlovid' product...results so obviously outstanding, the FDA halted trials in order to get the drug released asap.

btw, if you dig deeper into this issue, HCQ+ never had a chance of being effective given that the SARS-CoV-2 virus uses not just ACE2 receptors on human cells...which HCQ can inhibit...but also the FMPRSS2 transmembrane proteins...which HCQ doesn't touch. Paxlovid on the other hand does and it has an added drug that slows metabolism of it, thus making it effective longer. The initial HCQ studies were "in vitro" (i.e. in petri dishes) with Kidney tissues that don't have TMPRSS2 enzymes...like LUNG tissues do...BIG difference, as you can probably surmise...btw, there are videos available through Youtube by microbiologists who explain the phenomenon in layman (Me) teams.

Bottom Line...Trust the Professionals who do this work for the sole purpose of keeping you healthy and alive.

But azithromycin DOES work on this protein, which is why you have to combine it with the other two drugs

Look, be a real human being for once instead of some shill. How do you explain the success of Dr. Fareed? Dr. Zelenko? Dr. Herman of Savannah? How do you explain how a real Yale professor of medicine looked at every trial and concluded the reasoning behind claiming HCQ+ didn't work was flawed? These are real medical professionals. Instead of just parroting "it doesn't work" and avoiding my questions, do the right thing and directly answer my questions. Did Dr. Fareed, in your estimation, not have success with HCQ+? And if he did...again ... please explain in your estimation why.

...the quick answer is NO...and the FDA/WHO are wise not to risk the lives of billions of people on "Observational Studies"...

It's over, Mark...move on.

Dr. Fareed (and other doctors) found his patients were not dying or even going to the hospital, so why would he intentionally let some of his patients die just to conduct an RCT?

Risk lives? Really? You can't use logic to see the recommended alternative, to do nothing until you got so bad you had to go to the hospital, actually was worse?

Why, WHY do you continue to dodge the question...how do you explain a highly accomplished doctor like Fareed finding great success with HCQ+? Please, please give a direct answer.

The point was, that it wasn't test in any of the studies that were posted back then that I did read, in the manner that it was suggested that it would best work. I don't know or care who was at fault for that.

In regards to your post, there is a possibility, through anecdotal evidence of people getting this combo treatment during that time, that disruption of the ACE2 receptors could have helped, and per the anecdotal evidence, did seem to help during the early stages of COVID.

I would say to this that COVID in your body is like a fire in your kitchen. You might be able to smother it or use your fire extinguisher early on to keep it from getting out of hand (HCQ) but if you let it get going before you try to stop it, that just isn't going to work anymore (as noted by the studies).

He absolutely refuses to read Dr. Risch's paper, a paper I linked to several times, while telling others he is "open minded," "willing to hear your evidence," "provide your source or link," all the while demanding people read his endless links while he hypocritically refuses to return the favor.

Yes, this is more about his childish refusal to read Dr. Risch's paper. Until he does, I'm not dropping this.

I don't really care what his reasoning is behind it, calling the guy a hack, quack, or whatever, he should read it when he has time, and try to refute what he can if possible, since that is what he always says his game is.

I was more saying that beating your head against a wall that doesn't want to listen to you is not going to ever change anything, but if you want this to be your crusade, have at it sir lol.

and certainly not for years on end...i.e. I don't "Demand" that they do so...I lament it, but move on.

In this case regarding my not reading Dr. Risch's paper, if you want to get involved with Mark's complaint, you need to understand the context....to wit...

>This whole issue was debated and decided 3 months before I joined the UHND Open Forum (i.e. no HCQ approval
>Dr. Risch's peers at Yale Med School...including Virologists and Infectious Disease Specialists...plus, his fellow Epidemiologist Co-Editors at the journal which published his paper...all publicly denounced it...after spending many hours trying to show him why he was wrong. (I've posted their letters)
>I have the benefit of family Physicians who are Infectious Disease and Pulmonary/Critical Care Specialists who have followed the HCQ saga and termed it a "Joke within the Medical community"
>Dr. Risch didn't conduct any of the HCQ studies...he wrote, in the terms of his Co-Editors, an "Opinion Piece"...so I did some research on two of the five featured studies Dr. Risch references and found that each of them had to apologize for faulty conduct and results, thus causing Dr. Risch to do the same...a clear case of shoddy work on his part for not picking up on these failures himself.

I'm sorry that Mark has dug his heels in on such a poor choice...but reading and debating a paper that's already been rejected...long ago...by the best minds in this field is counter productive to getting him to see the truth. If he, and you, disagree with the outcome on HCQ, so be it...just move on for heaven's sake.

Oh, and if you've paid any attention, I've continued to engage with Mark and read scores, if not hundreds of his posts/links while responding with substantive arguments/links of my own...which very few others on this forum take the time to do. Also, he and I have exchanged several B-Mails...he knows I'm a friend and not trying to cause him any harm.

Ty, dude, you're coming into this battle in complete ignorance because you haven't read his paper. He answered and rebutted every claim his colleagues and others said about him and his position.

Let me try again.


Link: Dr. Risch paper

(Einstein?)...talk about being "Dense" ;-)

Because logic and reason don't work on you. And I'm still waiting for your answer on how Dr. Fareed was able to use HCQ+ to great effectiveness.