Association of American Physicians & Surgeons Sues the FDA over Restrictions on Hydroxychloroquine

So, old news? Correct! That's why I put it up today so all can read the tea leaves and judge it for what it is. No one else here put it out there. Especially after a "gentile" reporter from CNN wrote a piece trashing a group of First Line Doctors whom held a press conference several days ago on the steps of the Supreme Court. Their viral videos were banned by the trusted sources of social media such as Facebook, YouTube, Twitter. They aren't the only group being banned or simply not being discussed. Read on.

So why doesn't the White House talk about the Association of American Physicians & Surgeons lawsuit on ban of Hydroxychloroquine? Why doesn't the White House talk about SEMOS findings on Hydroxychloroquine?

Here's the CNN piece to discredit the President. Do we have a Julius Caesar on deck surrounded by assassins?

Trump walks out of briefing after CNN question about hydroxychloroquine


Association of American Physicians & Surgeons

"It is shocking that medical workers in Brazil will have access to HCQ as a prophylaxis while Americans are blocked by the FDA from accessing the same medication for the same use," observes AAPS Executive Director Jane Orient, M.D. "There is no legal or factual basis for the FDA to limit use of HCQ," states AAPS General Counsel Andrew Schlafly. "The FDA's restrictions on HCQ for Americans are completely indefensible in court." Many foreign nations, including China, India, South Korea, Costa Rica, United Arab Emirates, and Turkey, use HCQ for early treatment and prevention of COVID-19, AAPS points out. "Entrenched, politically biased officials at the FDA should not be allowed to interfere with Americans' right to access medication donated to the federal government for public use," Schlafly says. "By preventing Americans' use of HCQ as a prophylaxis, the FDA is infringing on First Amendment rights to attend religious services or participate in political events such as political conventions, town halls, and rallies in an important election year."

SERMO is as SERMO does:

SERMO

So ATS, Why, why, why?

originally posted by: Waterglass
So why doesn't the White House talk about the Association of American Physicians & Surgeons lawsuit on ban of Hydroxychloroquine? Why doesn't the White House talk about SEMOS findings on Hydroxychloroquine?

Probably because they're smart enough to not associate themselves with a group that promotes creationism.

a reply to: AugustusMasonicus

Which group is that?

a reply to: Waterglass

The one in your post. Who else would it be.

originally posted by: Waterglass
So why doesn't the White House talk about the Association of American Physicians & Surgeons lawsuit on ban of Hydroxychloroquine? Why doesn't the White House talk about SEMOS findings on Hydroxychloroquine?

They come across as a mite biased, wouldn't you say? Association of American Physicians and Surgeons

a reply to: AugustusMasonicus

Well all of the Federal Agents I know say to pray and believe in God. I cant speak for the NSA

a reply to: Waterglass

Uh, okay.

a reply to: AugustusMasonicus

So wassup with dis:

WHO: Tuberculosis is the world’s deadliest infectious disease

As the coronavirus death toll mounts, global health authorities are reminding that tuberculosis is deadliest infectious disease in the world. Over a million deaths are reported every year.

Plus I am here to save er "help" you. As an older gentlemen you need to followup on your aerosols:

Dangers of COVID-19 aerosols are underestimated

You inspire me Auggie

Why are they removing the videos and not discrediting the treatment itself and the credentials of the group so much? The FDA seems to be censoring instead of arguing the information. Why is this? Could it be that they are right and the FDA has no real argument against the treatment?

Let them take it. What happens later can be blamed on the dems!

In fact trump should remove the fda and free us from the tyranny of scientific methods

originally posted by: Waterglass
So wassup with dis:

WHO: Tuberculosis is the world’s deadliest infectious disease

Nothing in regards the kooks in your Original Post.

Plus I am here to save er "help" you. As an older gentlemen you need to followup on your aerosols:

You must be getting me confused with your Boomer ass, you probably have 20-30 years on me.

a reply to: AugustusMasonicus

Thanks and ha, just like the good old days. I'll have another thread coming your way .

Some People at the top of the FDA have their hands in the donation basket of the Pharma companies. Hydroxychloraquine is too cheap. Same with Heparin vs remdesivir.....Heparin from seaweeds works better at thirty bucks than remdesivir at three thousand bucks. Less side effects too.

a reply to: Waterglass

"By preventing Americans' use of HCQ as a prophylaxis, the FDA is infringing on First Amendment rights to attend religious services or participate in political events such as political conventions, town halls, and rallies in an important election year."

Hmmmmm.... how about the right to LIFE??? How about the right to informed consent? How about the right to try? Why are the more concerned on the political hot topics than actually keeping their patients ALIVE to enjoy those First Amendments rights??? Call me cynical (or whatever), but it seems to me they are more interested in protecting their professional and/or political interests than the health and rights of the people.

I am very disturbed at this laser focus on one pharmaceutical -- no matter how effective -- that requires the expense of doctor's visits and a doctor's prescription, presumably after symptoms are present, and the inevitable adverse side effects for many who take it... while not a word is said about simple nutritional supplements like Zinc and Vitamins C and D3, easily obtained without any doctor's visits or prescriptions, minimal side effects, and maximum benefits. Anyone so motivated can go to Pubmed.com and search for the studies themselves; for example, "Vitamin D3 + antiviral." All three are known antivirals and known to be effective against ARDS (Acute respiratory distress syndrome) in and of themselves. All three alone can prevent severe symptoms and complications.

I am also concerned that the very high death rates initially will be blamed on the lack of chloroquine, rather than the insane Draconian measures imposed. We know that many patients were put on ventilators unnecessarily because health professionals were too cowardly to treat them properly with less invasive methods, such as CPAPs and BiPAPs. We also know that sick patients were turned away from doctors and hospitals until they were "turning blue". In other words, they were forsaken until they were on death's door. We also know that nursing homes were a freaking germ fest thanks to CoVid positive patients being locked in -- yes, LOCKED IN! -- with non CoVid patients... at least, they weren't CoVid positive.

I don't doubt that chloroquine has some positive benefits fighting CoVid. But I don't believe for a minute that it's the end-all-be-all. Nor do I believe that it's our best option, much less our only option.

originally posted by: AugustusMasonicus
Probably because they're smart enough to not associate themselves with a group that promotes creationism.

Yeah, those silly creationists. It make so much more sense to believe that the entire perfectly ordered and structured cosmos just accidently and purposelessly farted itself into existence out of the great void of nothingness.

I mean, creationists ... believing by some line of observation and reason that some higher intelligence created the incredible order and structure that is evident in this meaningless, purposeless, happenstancical jumble of perfectly order molecules and infinitely complex physical laws that hold them together! Talk about blind faith!
:

a reply to: Waterglass

Since Hydroxychloroquine has been working safely for over 50 years, with millions of people having used it safely for Malaria, why is it so hard to get?

originally posted by: incoserv
Yeah, those silly creationists. It make so much more sense to believe that the entire perfectly ordered and structured cosmos just accidently and purposelessly farted itself into existence out of the great void of nothingness.

I mean, creationists ... believing by some line of observation and reason that some higher intelligence created the incredible order and structure that is evident in this meaningless, purposeless, happenstancical jumble of perfectly order molecules and infinitely complex physical laws that hold them together! Talk about blind faith!

:

None of that belongs in a medical journal.

AAPS v FDA Legal Claim, Pdf

Plaintiff’s members and the entire public are being denied early access to safe, inexpensive HCQ, a medication which is conquering COVID-19 in other countries. Countries with underdeveloped health care systems are using HCQ early and attaining far lower mortality than in the United States.

FDA’s recommendations are really schizophrenic. We used HCQ in pregnant women. We used it in children. We use it without monitoring in countries for malaria prophylaxis. Defendants do not address the numerous public statements by eminent professors and others which emphasize the proven safety of hydroxychloroquine for 65 years. Defendants do not and cannot dispute any of this. Defendants fail to submit affidavits or any other evidence, thereby essentially defaulting on Plaintiff’s motion.

Defendants do not deny their own political and financial conflicts of interest which result in their wrongful interference with HCQ access.

The medical science at issue here is simple and less complex than what courts decide every day in medical malpractice cases. Indeed, if a physician failed to recommend HCQ use early for treatment of COVID-19, then a patient harmed by that lack of treatment might have a valid cause of action for malpractice which a court would decide without deference to FDA officials, none of whom are practicing medical doctors themselves.

Defendants initially limited the use of HCQ from the Stockpile to patients only after they have been hospitalized, which is unnecessarily late in the progression of the disease. Delaying use of an anti-viral until late in the disease progression obviously reduces its effectiveness.

Defendants perpetuate their interference by falsely stating and implying that HCQ should not be used at any time to treat COVID, upon which States rely in blocking access. Defendants have been devastatingly tragic to the American people and our constitutional rights.

Defendants blithely insist that this Court has no cause to interfere with decisions of public health officials and scientists responding to COVID-19. Defendants argue that this Court must defer to interference by a handful of bureaucrats in Washington, D.C., regardless of their demonstrated political bias against our President and financial conflicts-of-interest in preferring rivals to hydroxychloroquine.

Because there is no possible justification for Defendants’ conduct, they resort to procedural attempts to avert a substantive ruling. Countries such as in Western Europe having more liberal views about the sanctity of life have been more likely to block access to HCQ.

Defendants’ primary argument is to assert that Plaintiff AAPS somehow lacks standing. But amid the COVID-19 pandemic, is there anyone who lacks standing to object to interference with medication for it? It is difficult to imagine an issue for which more universal standing exists, and AAPS has both standing and a valid cause of action.

Defendants’ first argument is that AAPS and its members assert generalized grievances against FDA’s actions. The injuries here are literally life-and-death issues, as well as core constitutional rights like the freedom to practice medicine and to associate; these are not “abstract” or “intellectual”interests. FDA’s actions have caused redressable injuries to doctors and patients.

Defendants falsely pretend that they do not interfere with the distribution of HCQ, Defendants do prohibit any access by Dr. Doe and his patients to the HCQ in the Stockpile, despite the donors’ intent for it to be used in treating COVID-19 patients.

Defendants instead insist on prohibiting all access by Dr. Doe and his patients, and millions of others in similar situations, from having any access to the HCQ Stockpile. Defendants’ own improper statements in revoking their EUA reinforce how they intend to interfere with access to HCQ.

Defendants’ own opposition brief broadly credits Defendants for directing the Nation amid the coronavirus pandemic. Defendants imply near the end of their brief that they alone have “the background, competence, and expertise to assess public health,” and that the Court should defer to them on that basis. But in arguing against standing, Defendants try to downplay their significance and influence. Which is it?

Defendants also argue that AAPS cannot assert standing for patients. AAPS physician members are themselves subject to COVID-19, and thus are themselves patients. This Court has jurisdiction for “declaratory, injunctive or mandamus relief” against Defendants, notwithstanding their status as federal officers and offices.

Defendants argue that FDA’s rescission of the EUA moots this litigation. Nothing in the relevant statutes even arguably prevents judicial review of agency actions outside of EUA actions.

Defendants devote more than a third of their of their argument to insisting that Plaintiff AAPS has not stated a cause of action. Under Defendants’ reasoning, they can falsely disparage HCQ with impunity, deny access to HCQ in the Stockpile while it wastes away amid a pandemic, issue an irrational EUA and a senseless revocation, without any cause of action against it.

Defendants do not argue that there is anything implausible about AAPS’s allegations. Defendants do not dispute in any way the allegations by AAPS of their political bias against President Trump, and their conflicts of interest with respect to more expensive medications which are rivals to HCQ.

Defendants make an incorrect argument that their conduct is somehow “excepted by statute from judicial review” under the Administrative Procedure Act. Defendants resort to factual arguments about whether it committed an equal protection violation by prohibiting use of HCQ outside of hospitals.

Defendants argue that the relevant statutes commit FDA’s EUA actions to agency discretion. They are wrong under the APA, under pre-APA review, and under constitutional review.

Defendants argue repeatedly that HCQ remains commercially available. These repeated claims of commercial availability ignore the fact that FDA’s false, statutorily unauthorized, and reviewable statements – which are not backed by any data – have created a legal impediment to commercial use of HCQ.

Defendants implicitly concede that FDA’s safety-for-COVID argument makes no sense for prophylactic use of HCQ because the patient does not have COVID-19. FDA disparaged the safety and efficacy of HCQ for COVID-19 without any data.

Defendants cannot justify their arbitrary actions in interfering with access to HCQ. Defendants cannot explain why they limited use of HCQ until after hospitalization, when anti-viral medication is most effective when given soon after exposure to the virus. Instead, Defendants make a cut-and-paste type argument that they supposedly acted within their discretion

Defendants say they should never be enjoined, no matter how badly they behave. Discretionary authority in the hands of Defendants does not justify their irrational interference with access to HCQ.

Defendants are simply wrong in implying that they can do whatever they want, and even waste a stockpile of lifesaving medication, without any accountability in court.

COVID mortality correlates with the countries’ interference with public access to HCQ. Interference with HCQ access is itself correlated with countries skeptical about the sanctity of life.

originally posted by: AugustusMasonicus

originally posted by: Waterglass
So why doesn't the White House talk about the Association of American Physicians & Surgeons lawsuit on ban of Hydroxychloroquine? Why doesn't the White House talk about SEMOS findings on Hydroxychloroquine?

Probably because they're smart enough to not associate themselves with a group that promotes creationism.

Logical Fallacy 101. Classic ATS.

Because person believes in A we can't believe them about B.

If you practiced that same logic for everyone then no one would be believed. Everyone disagrees on some topics. If a practicing Dr believes and has evidence that A works, then it doesn't matter if they believe in ghosts or Sasquatch or that the moon landing was faked.

originally posted by: jjkenobi
Because person believes in A we can't believe them about B.

No, but I can certainly take them a whole lot less seriously.


Which of course I do.