FDA, HHS Sued by Doctors Over Controversial Drug Ivermectin

[+OverSword]

Quote

 

In a press release, Bowden said, “Since the pandemic began, I have had one mission - help my patients. I provided access to testing when testing was hard to find. I provided treatment when other doctors told my patients to stay home. I have kept over 3,900 patients out of the hospital, but it hasn’t been easy. Sadly, fighting the system has been a much bigger challenge than fighting the disease. Despite my excellent track record treating COVID patients, the FDA’s smear campaign against ivermectin continues to be a daily hurdle to overcome. I am fighting back - the public needs to understand what the FDA has done is illegal, and I hope this suit will prevent them from continuing to interfere in the doctor-patient relationship.”

Marik, whose degrees (MBBch, MMed) are from the University of the Witwatersrand, Johannesburg, South Africa, stated, “The FDA’s public statements on ivermectin have been misleading and raised unwarranted concern over a critical drug in preventing and treating COVID-19. The agency felt compelled to use language to discourage any discourse and interest in using ivermectin as a front-line treatment of COVID-19. To do this is to ignore both statutory limits on the FDA’s authority and the significant body of scientific evidence from peer-reviewed research, over 80 medical trials, and results from ivermectin’s use in medical settings worldwide, showing the safe and effective use of the drug in fighting COVID-19.”

The Texas Department of State Health Services had issued poison warnings about the drug. In 2020 the Texas State Board of Pharmacy also tried to prohibit prescriptions for hydroxychloroquine dispensed without a diagnosis, but that only lasted six weeks.

Apter indicates she is being investigated by three state medical boards, “each threatening my medical license based on complaints from pharmacists that I have prescribed ivermectin for COVID-19. In all these cases the patients did very well.”

 

The excerpt is from the middle of the article, please click the link for the rest;

Link

[+Desertrat56]

If Ivermectin is useful to help covid patients where are the peer reviewed articles?   All we get is this tripe.   The FDA in the U.S. is not an honorable institution however, re-purposing drugs is rampant and has been going on as long as pharmacuetical companies have been able to tell doctors lies about the drugs they are selling.  The first time I encountered it was when I went to a quack who called himself a gynocologist and instead of giving me tests to find out what my problem was he prescribed prozac saying "This drug has been proven to alleviate the symptom you are complaining of."   Alleviate the symptom but who cares whether one finds out what actually causes the symptom!    Of course I did not fill the prescription and I never went back to that useless quack.    

Ivermectin was designed for a specific purpose and that is what it should be used for.  Just because some president of a country claims it works on national tv (or rather he suggested trying it) does not make it a useful optoion.   The same people who are using ivermectin for covid are the same ones complaining that the vaccine was not thoroughly tested!

Isn't Merk the one who owns the patent on Ivermectin?   I know Merk has a lot of questionalble business practices as do most of the large pharmacuetical companies.

[+OverSword]

54 minutes ago, Desertrat56 said:

Ivermectin was designed for a specific purpose and that is what it should be used for.

It's already been used successfully to treat things besides it's original purpose.  The lawsuit is possibly more about the FDA overstepping it's bounds than the effectiveness treating covid with ivermectin.  One of the doctors, Paul Marik, from his bio:

Quote

 

Prior to co-founding the FLCCC, Dr. Marik was best known for his revolutionary work in developing a lifesaving protocol for sepsis, a condition that causes more than 250,000 deaths yearly in the U.S. alone.

Dr. Marik is an accomplished physician with special knowledge in a diverse set of medical fields, with specific training in Internal Medicine, Critical Care, Neurocritical Care, Pharmacology, Anesthesia, Nutrition, and Tropical Medicine and Hygiene. He is a former tenured Professor of Medicine and Chief of the Division of Pulmonary and Critical Care Medicine at Eastern Virginia Medical School (EVMS) in Norfolk, Virginia. As part of his commitment to research and education, Dr. Marik has written over 500 peer-reviewed journal articles, 80 book chapters and authored four critical care books. His efforts have provided him the distinction of the second most published critical care physician in the world. He has been cited over 43,000 times in peer-reviewed publications and has an H-index of 77. He has delivered over 350 lectures at international conferences and visiting professorships. As a result of his contributions, he has been the recipient of numerous teaching awards, including the National Teacher of the Year award by the American College of Physicians in 2017.

In January 2022 Dr. Marik retired from EVMS to focus on continuing his leadership of the FLCCC and has already co-authored over 10 papers on therapeutic aspects of treating COVID-19. In March 2022 Dr. Marik received a commendation by unanimous vote by the Virginia House of Delegates for “his courageous treatment of critically ill COVID-19 patients and his philanthropic efforts to share his effective treatment protocols with physicians around the world.”

 

https://covid19criticalcare.com/experts/paul-e-marik/

Pretty good credentials I think.

 

Edited November 22, 2022 by OverSword

[+and-then]

Those who invested themselves and their credibility into toeing the party line on Covid and all of its facets, will rarely if ever, admit they were wrong.  No matter how much evidence is produced and laid before them, they'll stubbornly stick to the programming.  

[+Liquid Gardens]

1 hour ago, OverSword said:

It's already been used successfully to treat things besides it's original purpose. 

The main question is whether it is effective at treating covid I think.  Other experts disagree with Marik and the FLCCC and the effectiveness of ivermectin for covid:

https://www.respectfulinsolence.com/2022/09/02/mikki-willis-has-expanded-from-plandemic-to-ivermectin-conspiracy-theories/

Quote

There’s a whole section on the supposed “evidence” base for ivermectin that I won’t spend a lot of time on given how much I’ve discussed how weak this evidence base is, how fraudulent some of it is, and how newer studies demonstrate rather conclusively that ivermectin doesn’t work against COVID-19. It’s all the usual suspects, and Willis features Marik and others claiming that the ivermectin trials were “designed to fail”—by pharmaceutical companies, naturally!—and that ivermectin really is a miracle cure. Of course, if clinical trials can be “designed to fail,” they can also be “designed to succeed,” which was part of the problem with most of the examples cited by Willis. They were crappy trials, almost guaranteed to produce seemingly “positive” results. The real issue is that, the more rigorous the ivermectin trial, the more likely it was to be negative, rather like acupuncture trials. None of that stops Willis from claiming that the media ginned up coverage of every negative ivermectin study, while ignoring how right wing media ginned up every poorly designed or even fraudulent positive study of ivermectin.

Also, according to Willis, the NIH is in on it too, because of course it is. Also, to Willis, ivermectin is the “single greatest public health achievement” in our history.

 

[+OverSword]

11 minutes ago, Liquid Gardens said:

The main question is whether it is effective at treating covid I think.  Other experts disagree with Marik and the FLCCC and the effectiveness of ivermectin for covid:

 

The main question in this lawsuit is if the FDA exceeded their legal mission I think.  

[Katniss]

Oh my, haven't we been here before? Why yes, I think we have.

So to reiterate;

Quote

February 4, 2021 11:45 am ET

KENILWORTH, N.J., Feb. 4, 2021 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today affirmed its position regarding use of ivermectin during the COVID-19 pandemic. Company scientists continue to carefully examine the findings of all available and emerging studies of ivermectin for the treatment of COVID-19 for evidence of efficacy and safety. It is important to note that, to-date, our analysis has identified:

• No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; 
• No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and; 
• A concerning lack of safety data in the majority of studies.

We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.

Indications and Usage for STROMECTOL® (ivermectin)

Merck Statement on Ivermectin use During the COVID-19 Pandemic

 

Did you hear that Merck? A doctor thinks you are wrong about your own product and is suing the FDA instead of you and poster here believes;

Quote

Those who invested themselves and their credibility into toeing the party line on Covid and all of its facets, will rarely if ever, admit they were wrong.  No matter how much evidence is produced and laid before them, they'll stubbornly stick to the programming.  

Shame on you Merck! They all know better than you, then you do about your own product.

Edited November 22, 2022 by Katniss

[Knob Oddy]

Countries which didnt have mass (forced) vaccinations had a lower covid case rate then those who did. Also a lower death rate, and they prescribed Ivermectin.

India and Japan for example. I'm sure there were many others.

What i loved most about the Ivermectin conversations we were having in the west was the "horse de-wormer" narrative. The creator of Ivermectin won the Nobel Prize for creating Ivermectin. If it was only good for de-worming horses, i'm not sure why the Nobel committee made their decision...... 

Maybe because its safe and effective in humans for a variety of uses

[+OverSword]

26 minutes ago, Katniss said:

Oh my, haven't we been here before? Why yes, I think we have.

So to reiterate;

Merck Statement on Ivermectin use During the COVID-19 Pandemic

 

Did you hear that Merck? A doctor thinks you are wrong about your own product and is suing the FDA instead of you and poster here believes;

Shame on you Merck! They all know better than you, then you do about your own product.

Did you read the article?   This isn't really about the benefits or otherwise of ivermectin.  It's about the FDA operating within it's legal scope and their interfering with physicians ability to practice medicine as qualified. 

 

Edited November 22, 2022 by OverSword

[Katniss]

17 minutes ago, OverSword said:

Did you read the article?   This isn't really about the benefits or otherwise of ivermectin.  It's about the FDA operating within it's legal scope and their interfering with physicians ability to practice medicine as qualified.  

It doesn't matter because the point is, lawsuit or no lawsuit, these doctors are wrong about ivermectin anyway. Merck are the ones that are saying their product does not stop covid infections. So their lawsuit is moot, honey.

Edited November 22, 2022 by Katniss

[+OverSword]

17 minutes ago, Katniss said:

It doesn't matter because the point is, lawsuit or no lawsuit, these doctors are wrong about ivermectin anyway. Merck are the ones that are saying their product does not stop covid infections. So their lawsuit is moot, honey.

Are you more qualified than this guy, do you think for one second? https://covid19criticalcare.com/experts/paul-e-marik/  He's on the lawsuit.  Honey. 

Edited November 22, 2022 by OverSword

[+Desertrat56]

17 minutes ago, Katniss said:

It doesn't matter because the point is, lawsuit or no lawsuit, these doctors are wrong about ivermectin anyway. Merck are the ones that are saying their product does not stop covid infections. So their lawsuit is moot, honey.

The fact that Merck has it on their front page at the top means they are afraid someone is going to sue them for a death of overuse of ivermectin.   But even so, it is correct.  If the pharma company is not selling it as a cure for covid then it isn't and what ever the FDA did was to protect idiots, not ruin some doctor's life.

Edited November 22, 2022 by Desertrat56

[Katniss]

2 minutes ago, OverSword said:

Are you more qualified than this guy, do you think for one second? https://covid19criticalcare.com/experts/paul-e-marik/  He's on the lawsuit.  Honey. 

Lame reply, OverSword, It's not me that has say about it, I am relaying the message, it's what the pharm company Merck said about their own product.on their webpage. Not Paul E. Marik, not me, and not you insinuating certain things by posting this thread. What Merck said trumps them all. Because for all we know, Paul E. Marik could have investments in stocks that have to do with the sales of ivermectin and is peddling BS to raise stock prices.

[+OverSword]

15 minutes ago, Katniss said:

Lame reply, OverSword, It's not me that has say about it, I am relaying the message, it's what the pharm company Merck said about their own product.on their webpage. Not Paul E. Marik, not me, and not you insinuating certain things by posting this thread. What Merck said trumps them all. Because for all we know, Paul E. Marik could have investments in stocks that have to do with the sales of ivermectin and is peddling BS to raise stock prices.

No.  It's about a lawsuit alleging a government agency overstepping their mandate. Ivermectin is a secondary consideration at best here if even that high.  If you haven't investigated the particulars in the lawsuit it's tough to even have an opinion about it's merit.  You're just triggered by preconceptions.

Edited November 22, 2022 by OverSword

[Katniss]

6 minutes ago, OverSword said:

No.  It's about a lawsuit alleging a government agency overstepping their mandate. Ivermectin is a secondary consideration at best here if even that high.  If you haven't investigated the particulars in the lawsuit it's tough to even have an opinion about it's merit.  You're just triggered by preconceptions.

So now you are switching back to the lawsuit and the particulars involved in that lawsuit and so now you are admitting it's only about the lawsuit, but as I said before;

51 minutes ago, Katniss said:

It doesn't matter because the point is, lawsuit or no lawsuit, these doctors are wrong about ivermectin anyway. Merck are the ones that are saying their product does not stop covid infections. So their lawsuit is moot, honey.

 Circular arguments anyone?

[OpenMindedSceptic]

Ah, yet more covid fallout. The last stand against invermectin and the covid fanfare of lockdowns and mass vaccination is likely to be on these pages. So much egg on their faces while they maintain that the scientists in collusion with government responses knew best, that they still cannot see the truth. 

[+OverSword]

16 minutes ago, Katniss said:

So now you are switching back to the lawsuit and the particulars involved in that lawsuit and so now you are admitting it's only about the lawsuit, but as I said before;

1 hour ago, Katniss said:

Switching back???  No, never switched from

16 minutes ago, Katniss said:

 Circular arguments anyone?

Exactly what you're doing. 

The lawsuit and the thread are concerning the possibly wrong actions of a government agency and their over zealousness during covid mania.   Before you blindly defend the FDA consider that nearly 1/3 of the drugs and devices approved by them have problems and 1/4 are recalled annually.  Pretty ridiculous numbers, a private company with that record would go bankrupt.

[+Liquid Gardens]

21 minutes ago, OverSword said:

It's about a lawsuit alleging a government agency overstepping their mandate.  Ivermectin is a secondary consideration at best here if even that high. 

That's kinda like saying the Civil War was fought over 'state's rights'.  A government agency has overstepped their mandate concerning what?  The 'concerning what' I think makes all the difference, as it does apparently if you follow your links:

https://www.biospace.com/article/releases/doctors-sue-fda-over-unlawful-attempts-to-prohibit-ivermectin-use/

Quote

Today, a group of doctors filed a lawsuit against the Department of Health and Human Services, Xavier Becerra in his official capacity as Secretary of Health and Human Services, the Food and Drug Administration, and Robert M. Califf in his official capacity as Commissioner of Food and Drugs, over the FDA's unlawful attempts to prohibit the use of ivermectin to treat COVID-19.

I did see the actual lawsuit on one of the links and it also tries to argue that ivermectin is irrelevant but that is the only thing that is really that interesting here, or at least it's far more interesting (as we can see from the headlines and comments of people promoting it who are definitely bringing up the covid connection) than legal questions about federalism and the commerce clause, etc if that's really all you think this is about.

27 minutes ago, OverSword said:

It's about a lawsuit alleging a government agency overstepping their mandate.

Okay, how do you know they overstepped their mandate, which is of course to protect the population?

56 minutes ago, OverSword said:

Are you more qualified than this guy, do you think for one second? https://covid19criticalcare.com/experts/paul-e-marik/  He's on the lawsuit.  Honey. 

So? If that's relevant then have you determined that he is more qualified than the other experts who disagree with him?  I don't know what the point of this or your posting his bio from a site that is promoting him, there aren't any epidemiologists posting here so no one is really arguing from their own expertise.

[Katniss]

2 minutes ago, OverSword said:

Switching back???  No, never switched from

 

 

Sure you did. You think Paul E. Marik knows more about ivermectin than Merck. The maker of ivermectin.

Quote

Exactly what you're doing. 

As you just did.

Quote

The lawsuit and the thread are concerning the possibly wrong actions of a government agency and their over zealousness during covid mania.

And yet, Merck says their own product doesn't stop covid infections. So how lubricious is this stupid lawsuit when Merck says that? Imagine that.

Quote

Before you blindly defend the FDA consider that nearly 1/3 of the drugs and devices approved by them have problems and 1/4 are recalled annually.  Pretty ridiculous numbers, a private company with that record would go bankrupt.

Oh so now you want me to defend the FDA? When I only posted what Merck said, and not the FDA. Aren't you a tricky one.

[+Liquid Gardens]

5 minutes ago, OverSword said:

Before you blindly defend the FDA consider that nearly 1/3 of the drugs and devices approved by them have problems and 1/4 are recalled annually.  Pretty ridiculous numbers, a private company with that record would go bankrupt.

Those numbers are not obviously ridiculous at all if they are even accurate.  Think for a second, try to imagine all the possible diseases and syndromes out there amongst billions of people, and the sheer quantity of tests that would need to be done, and how difficult it is to perform those tests and studies.  Some problems only show up over time, and these are new treatments.  Now calculate how long it would take to ever approve any drug if we really wanted to bring these numbers down given the amount of effort it would take.  Risks vs benefits, acceptable danger thresholds, all pretty complicated stuff on top of the science itself that I don't know why you aren't factoring into your criticism.  

[+and-then]

53 minutes ago, OverSword said:

You're just triggered by preconceptions.

I rest my case.  They will become increasingly strident if cases like this encourage a deeper look into the entire question of efficacy of some of the therapeutics their heroes at FDA, CDC, and WHO utterly rejected and actively suppressed without proof in the form of long-term studies.  Bottom line, they will NEVER ADMIT THEY EVEN MIGHT HAVE BEEN WRONG...

[+OverSword]

11 minutes ago, Liquid Gardens said:

Okay, how do you know they overstepped their mandate, which is of course to protect the population?

Well first of all I doubt that's in their mandate per se'.  Second, I don't know that they overstepped their mandate and until the lawsuit plays out neither will the rest of us. 
 

Quote

 

I don't know what the point of this or your posting his bio from a site that is promoting him

 

His being qualified as an expert of Pulmonary and Critical Care Medicine and likely knowing what the limits of the FDA to regulate, not drugs or devices, but how and for what they are utilized probably is the basis of the law suit.

[+OverSword]

9 minutes ago, Katniss said:

Sure you did. You think Paul E. Marik knows more about ivermectin than Merck. The maker of ivermectin.

Quote

Well that's a stupid thing to say that I said, since I didn't say it.  You're really reaching here.  Just admit you were running down the wrong path as I never argued the merits of ivermectin.  Factually you could remove the word Ivermectin and just say an FDA approved drug for the purposes of this lawsuit as it's not about the drug it's about the FDA.

[+OverSword]

59 minutes ago, Liquid Gardens said:

Those numbers are not obviously ridiculous at all if they are even accurate.  Think for a second, try to imagine all the possible diseases and syndromes out there amongst billions of people, and the sheer quantity of tests that would need to be done, and how difficult it is to perform those tests and studies.  Some problems only show up over time, and these are new treatments.  Now calculate how long it would take to ever approve any drug if we really wanted to bring these numbers down given the amount of effort it would take.  Risks vs benefits, acceptable danger thresholds, all pretty complicated stuff on top of the science itself that I don't know why you aren't factoring into your criticism.  

Which is why the trials for new vaccines tends to be more than a decade, right?  But tell that to all the people that got cancer recently from Zantac or whatever the over the counter heartburn drug was called.  I wonder what the risks vs benefits was to someone's wallet in that case 

Edited November 23, 2022 by OverSword

[+OverSword]

12 minutes ago, and-then said:

I rest my case.  They will become increasingly strident if cases like this encourage a deeper look into the entire question of efficacy of some of the therapeutics their heroes at FDA, CDC, and WHO utterly rejected and actively suppressed without proof in the form of long-term studies.  Bottom line, they will NEVER ADMIT THEY EVEN MIGHT HAVE BEEN WRONG...

Even to the point of the legal (or otherwise) practices of a government agency with a mediocre at best record.