Hahn

Desperate To Look Like a Winner


Reading time – 1:44  .  .  .

Trump gambles with American lives so he can brag

As suggested in an interview with Dr. Stephen Hahn, head of the Food and Drug Administration, he was under extreme pressure from our “Public Health”First” president to issue emergency use authorization for treatments and preventives for Covid-19. Emergency use authorization (“EUA”) means giving the okay to meds or procedures that have not been fully vetted to ensure they are safe to use (i.e. won’t kill the patient) and that they actually do some good (efficacy). And now it’s happened.

The FDA has issued an EUA for convalescent plasma therapy. That’s a procedure where the blood plasma from a person who has had Covid-19 and recovered is injected into a patient suffering from the disease. The theory is that the antibodies in the plasma from the donor will fight the disease in the recipient. There was a statistically small beneficial effect for a narrow band of patients from this procedure in a trial at Mayo Clinic. So far it appears to be safe, but that’s not proven, and its efficacy has not been fully tested. In other words, according to the FDA’s guidelines, it isn’t ready for prime time. But it’s approved now, thanks to Dr. Trump’s manipulation. Recall his success in prescribing hydroxychloroquin and how that worked out for patients.

In the face of the scientific clarity that this procedure is chancy at best, Trump has pressured Dr. Hahn into authorizing this procedure right before the Republican National Convention. Without reality to support her, White House press secretary Kayleigh McEnany has already announced that this procedure is a “major therapeutic breakthrough.”

Expect to hear waves of superlatives from Trump about himself as the protector of the people and some form of “Only I can beat this pandemic.” Expect this treatment to be described by Trump as “like nothing you’ve ever seen before,” “the greatest thing medicine has ever developed,” “We’re now winning the battle against the pandemic thanks to my strong leadership,” and more.

How odd, then, that over the weekend Trump tweeted that the FDA is part of the “deep state” that only he can crush. Odd, too, that economist Peter Navarro, Assistant to the President, Director of Trade and Manufacturing Policy, would confront FDA officials, pressuring them with, “You are all Deep State and you need to get on Trump Time.” Exactly how would he know a thing about what it takes to ensure safe and effective meds? Would you trust your life to Peter Navarro?

Don’t expect to hear from the FDA about its abandoning its own rules and ethics, as yet another department of government caves in to Trump in yet another of his epic tantrums to make the entire world about him and to get what he wants.

Too bad for the Covid-19 patients who learn that they were given false hope in Trump’s campaign to manipulate the election.

Be sure to read this post from Mike Murphy, a sane, formerly Republican consultant, on what can happen.

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Ed. note: We need to spread the word so that we make a critical difference, so

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The Fine Print:

  1. Writings quoted or linked from my posts reflect a point I want to make, at least in part. That does not mean that I endorse or agree with everything in such writings, so don’t bug me about it.
  2. Sometimes I change my opinions because I’ve learned more about an issue. So, educate me. That’s what the Comments section is for.
  3. Errors in fact, grammar, spelling and punctuation are all embarrassingly mine. Glad to have your corrections.
  4. Responsibility for the content of these posts is unequivocally, totally, unavoidably mine.

JA


Copyright 2022 by Jack Altschuler
Reproduction and sharing are encouraged, providing proper attribution is given.

I’m No Anti-Vaxxer


Reading time – 6:14  .  .  .

Conspiracy theories about vaccines abound. As well, reasonable, science based objections have made solid challenges to vaccines, too. Regardless, history tells us that blind acceptance of vaccines probably isn’t a good idea.

Take, for instance, the recent comments of FDA Commissioner Stephen Hahn. He insisted that any Covid-19 vaccine would have to “adhere to standards” for safety and efficacy. Perfect. We want to know that a vaccine or med we take to protect us both works and is safe. That’s especially important reassurance now, given the enormous political pressure being applied to develop a vaccine by election day. That’s where this story grows dark.

Dr. Stephen Hahn, Commissioner, FDA

Trump is making fantastical claims that we’ll have a vaccine by the election. Sometimes he makes solid promises – “We’ll have 100 million doses by November.” Sometimes they’re typical Trump vacuous teasers – “might be,” “very soon,” “like you’ve never seen before,”  “I think in some cases, yes possibly before [the November election], but right around that time,” “It will be unbelievable,” etc. Side note: He uses the word “unbelievable” like a circus sideshow barker to describe nearly everything he is promoting or claiming as a victory for himself. When he does that I know that he is at last speaking truth: it probably is unbelievable; i.e. not worthy of our belief. Back to the main point.

Nearly every time Trump speaks about the pandemic, fiction comes from his mouth in an avalanche, as he struggles to paper over his abject failure to meet the challenge. Note that when he at last admitted in March that the pandemic is here and is a big deal, he said we’re fighting a war and that he’s a wartime president. If that’s so, then it’s fair to say that he’s lost nearly every battle and the enemy is winning this war decisively. That’s why he’s desperate to have a vaccine before the election. His eagerness has nothing to do with your health.

So, Trump is leaning hard on the doctors, scientists, epidemiologists, researchers and pharma company CEOs to bail out his sinking wartime command ship. The good news is what Hahn said about adhering to standards. What you probably didn’t hear is that he left the door open to “emergency use authorization” of vaccines that haven’t yet “adhered to standards.” It’s a bit like chancey, off-label use of a drug; for example, hydroxychloroquine.

As you likely know, it’s a drug used to treat patients with malaria. That, lupus and rheumatoid arthritis are the sole FDA authorized uses of this drug. Fairly early in this pandemic somebody decided to try using it to treat Covid-19. In fact it was given FDA off-label authorization for that use – right up until our VA hospitals realized that they were killing our vets with hydroxychloroquine. That’s when the FDA rescinded the off-label use of the drug.

To be fair, there are reputable criticisms that suggest that hydroxychloroquine wasn’t used properly, in that it wasn’t used in conjunction with medically significant adjunctive treatments. Regardless, it was the government/FDA’s authorization that caused the problems.

Oddly, our president continued to recommend the use of hydroxychloroquine. He even said that he was taking it prophylactically, although he didn’t use that big word. The result was that there was enormous demand for the drug. People stockpiled it in case they got sick. There were two problems with that. First, people who had malaria, lupus and rheumatoid arthritis couldn’t get their meds on time because production couldn’t keep up with the Trump-caused, artificially inflated demand. Second, hydroxychloroquine just might kill the stockpilers if they were to use it to treat their Covid-19 and did so improperly. Nevertheless, Trump continues to either promote the use of hydroxychloroquine to treat Covid-19 or allows his prior nonsensical rah-rah for it to linger because he is incapable of admitting he made a mistake. And we pay the price for his limitations with our health and our lives. The key point is that the FDA allowed off-label use of hydroxychloroquine and that killed people.

Follow the money: Who benefits from the increased demand for hydroxychloroquine and why is Trump so invested in that?

Again, while Dr. Hahn promised that the FDA and manufacturers would “adhere to standards” for a Covid-19 vaccine, he left the door open for emergency use authorization of these as-yet unproven vaccines. That is expressly, intentionally not adhering to standards.

In other words, Hahn and his agency might succumb to political pressure and roll the dice with the lives of granny, your children and you so that Trump can get reelected. Wild guess: That probably doesn’t sound too good to you and you’re already doubting Covid-19 vaccines. It turns out this story gets worse.

AstraZeneca is one of the key players in Covid-19 vaccine development and their drug is in a phase 3 trial. They have selected 30,000 people to be vaccinated and then watch to see if they become protected from the virus or if they get sick and perhaps die. I’m wondering if they intentionally expose these human Guinea pigs to the virus to test the vaccine. How else would they know if the vaccine had successfully protected them against the virus unless they knew test subjects had been exposed to it? That makes me think of the infamous Tuskegee Syphilis Study.

There are two efficacy problems with the trial. The first is that they are only testing healthy, relatively young people. That means that if you have any underlying health issue, especially hypertension, diabetes or obesity, or are older or a child – any condition that is substantially different from the test group  – whatever the phase 3 trial shows, you won’t know if the vaccine will work for you as it did for those phase 3 trial subjects.

The second issue is that this phase 3 trial is being run without a placebo comparison; i.e. this isn’t a blind, much less double-blind test. That means that there will be no way to determine the true efficacy of the drug – whether it actually works. And we are expected to trust this vaccine with our lives.

The FDA’s mission is to protect the public health by assuring the safety, efficacy and security of human drugs and more (taken from the FDA’s Mission Statement). That’s why they have protocols and standards. And President Trump is leaning hard on Mr. Hahn to abandon those protocols and standards in order to win his election. Frighteningly, Hahn may be willing to cave in to the pressure and issue “emergency use authorization” of these non-adhering-to-standards vaccines before the election.

“Do you feel lucky, punk?” Click the pic.

This looks to me like they’re giving the anti-vaxxers big gun ammunition at a time when we desperately need confidence in something to protect all of us and stop the Covid-19 rampage.

I’m no anti-vaxxer, but as I said, blind acceptance of vaccines – especially a proposed, new generation, emergency-use-authorization vaccine, the use of which is entirely politically motivated – probably isn’t a good idea.

Makes me think of Dirty Harry. Like the guy in the car, my answer is no. Click the pic to the right and you’ll understand.

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Post Office Update

Stopping by the post office to mail a letter just in time for the last pickup of the day brought me face-to-face with Lizzy (not her real name), a postal service worker who was emptying the collection box. We chatted for a bit and I asked her about the reported slow down of the mail system orchestrated by the new Postmaster General, Louis DeJoy. He is a big Trump contributor and a complete postal system know-nothing. He has eliminated overtime, slowed the sorting process and done other things, which have resulted in reported mountains of undelivered mail, especially at the big sorting centers. That’s what I asked Lizzy about.

“Oh, yeah, everything’s slowed down,” she said. “We hate that – we care about service.”

DeJoy claims to be a logistics expert and declares that he’s reducing costs. Sounds good. But our most mailed-in election balloting in history is already underway and he’s clogging the system. What do you suppose Donald Trump will say about the election when it appears he’s lost big and those mountains of undelivered mail are highlighted by him on November 4? Decide for yourself how much Trump election conspiracy to assign to that and let Professor Laurence Tribe be your guide:

Key Impact Point: Go to your secretary of state’s website, register to vote and request a mail-in ballot. The clock is ticking and soon you may run out of time to do that and make your vote count. Especially with DeJoy screwing up the system, you better move on this.
 

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Conservative Corner

Have you noticed how many things have gone on in the Trump era, like what’s covered in this post, that aren’t remotely conservative? As I’ve written so many times, we need the traditional Republican party to come back, to saddle up and hit the trail for America. Where are you guys?

Another 4 years of Trump won’t bring back conservatism. In fact, Trump will crush under his heel everything that conservatives hold dear and which he hasn’t already destroyed. It goes without saying that the things liberals/progressives hold dear are terminal, too.

Have you always voted Republican and cannot even imagine pulling the lever for a Democrat (I have such relatives and friends)? Now’s the time to imagine something bigger and for you to dare to go where you haven’t gone before while you still can. Remember that Trump has repeatedly threatened to cancel elections. That ain’t conservative.

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Finally

Leonard Cohen in 1988. Click the pic for his biography.

From poet and songwriter Leonard Cohen:

Ring the bells that still can ring.
Forget your perfect offering.
There is a crack in everything.
That’s how the light gets in.

These are hard times and it’s difficult to know what to do and where to start. What is important is simply that we start. That we ring the bells that still can ring. Follow Leonard Cohen’s advice. Today is a good day for that.

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Ed. note: We need to spread the word so that we make a critical difference, so

  1. Pass this along to three people, encouraging them to subscribe (IT’S A FREEBIE!).
  2. Engage in the Comments section below to help us all to be better informed.

Thanks!

The Fine Print:

  1. Writings quoted or linked from my posts reflect a point I want to make, at least in part. That does not mean that I endorse or agree with everything in such writings, so don’t bug me about it.
  2. Sometimes I change my opinions because I’ve learned more about an issue. So, educate me. That’s what the Comments section is for.
  3. Errors in fact, grammar, spelling and punctuation are all embarrassingly mine. Glad to have your corrections.
  4. Responsibility for the content of these posts is unequivocally, totally, unavoidably mine.

JA


Copyright 2022 by Jack Altschuler
Reproduction and sharing are encouraged, providing proper attribution is given.

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