As I noted in Sensible Medicine, it is absolutely unclear whether long covid exists and if so whether it is any different from the post-any-virus syndromes/symptoms people have had for decades.
The list of long covid symptoms now numbers 200. That is virtually anything felt by anybody. Not surprisingly, it is virtually the same as the list of symptoms for fibromyalgia/CFS -- and affecting primarily similar populations. One learns in medical school that when there is a disease with 200 drugs to treat it, the only thing known for sure is that none of them work. Similarly, a disease with 200 symptoms is likely non-existent or improperly characterized and certainly not understood.
Rob spent his off time between his two FDA stints at Google. But this is even unexpected behavior from him. Completely unsupported and even worse, unsupportable.
Pretty hard after reading this about Califf not to say the following: "We nominate and appoint Vinay to be the FDA Commissioner effective tomorrow morning at 0800 hours Eastern time. The incumbent is to hand in office keys, turn in his ID badge, put his stuff in the single cardboard box provided, and be off Federal property before 1200 hours Eastern Time".
Breaking News: Pfizer and Moderna fires everyone in Marketing. And asked why the sudden firing, Bourla responded by saying "Who needs a marketing dept when I have the CDC, FDA and the POTUS of US Gov acting as my megaphone. This is LIT!!!!"
Tell me where the lie is? What a horrific and tragic turn of events. And the MSM just standing aside and cheering it all on. Where have the sane people gone?
This seems to be a trend. Just yesterday the FDA released this statement about the new drug Teplizumab, the WHOLESALE price of which is $194,000 for one brief course: “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
Is it really the job of an FDA regulator to breathlessly promote new drugs? Especially those on which the evidence of benefit over harm is slim, and which barely squeaked by in an advisory-commission vote?
Much further down in the article we learn that it's not all roses with this drug either. "The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache. The use of Tzield comes with warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Tzield; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Tzield."
The FDA approved Theranos tests 🤪 The Dropout on Hulu is a must watch. The mRNA is even more Fraud...Fraud by the regulators. Peak Fraud. FTX/SBF up next!
I'm confused about whether I should be a paid subscriber for this Substack or Sensible Medicine. My main goal is to read whatever you write without having to subscribe to both. Thanks
This comment isn’t related to the post, but I’m hoping Vinay Prasad reads and responds. Whenever I read about vaccines, there is always the conclusion that they are worthwhile, regardless of effectiveness in limiting transmission or infection rates, because “vaccines limit severity’. Is this currently true? It’s a stated reason why boosters were needed, but documentation that the boosters reduced severity beyond what was obtained with original dosage didn’t seem to be proven.
And now, there is a new variant XBB. Yet despite its recent appearance, the same vaccine claim is being made. From MSN today, “When it comes to evasion of vaccine protection, it’s important to recognize that vaccine protection is not all or none,” Dr. Adalja says. “Even with immune-evasive variants, vaccine protection against what matters most—severe disease—remains intact.” Is it true that a booster will reduce disease severity more effectively than if someone was vaccinated with the original dosage? Is the answer different for XBB versus Omicron? I’ve only seen the nursing home study, which didn’t seem to be persuasive.
I have only one objection. Each year, a "new" influenza vaccine is produced WITHOUT undergoing new clinical trials. The reason is that the vaccine platform is the same with new antigens included. Why is the bivalent vaccine not exactly the same -- the identical platform with new antigens. As a 74 year old, I have taken the bivalent vaccine as well as the initial vaccine and boosters. Although irrelevant in the grand analysis, neither my wife nor I have had a syndrome suggestive of or any clinical evidence of COVID infection. We have gone out to dinner regularly since June 2020, choosing well protocoled restaurants and generally eat in early evening.
I agree about FDA commissioner not endorsing specific meds in any situation. Let the data speak for itself.
As I noted in Sensible Medicine, it is absolutely unclear whether long covid exists and if so whether it is any different from the post-any-virus syndromes/symptoms people have had for decades.
The list of long covid symptoms now numbers 200. That is virtually anything felt by anybody. Not surprisingly, it is virtually the same as the list of symptoms for fibromyalgia/CFS -- and affecting primarily similar populations. One learns in medical school that when there is a disease with 200 drugs to treat it, the only thing known for sure is that none of them work. Similarly, a disease with 200 symptoms is likely non-existent or improperly characterized and certainly not understood.
Rob spent his off time between his two FDA stints at Google. But this is even unexpected behavior from him. Completely unsupported and even worse, unsupportable.
Pretty hard after reading this about Califf not to say the following: "We nominate and appoint Vinay to be the FDA Commissioner effective tomorrow morning at 0800 hours Eastern time. The incumbent is to hand in office keys, turn in his ID badge, put his stuff in the single cardboard box provided, and be off Federal property before 1200 hours Eastern Time".
Breaking News: Pfizer and Moderna fires everyone in Marketing. And asked why the sudden firing, Bourla responded by saying "Who needs a marketing dept when I have the CDC, FDA and the POTUS of US Gov acting as my megaphone. This is LIT!!!!"
Tell me where the lie is? What a horrific and tragic turn of events. And the MSM just standing aside and cheering it all on. Where have the sane people gone?
This seems to be a trend. Just yesterday the FDA released this statement about the new drug Teplizumab, the WHOLESALE price of which is $194,000 for one brief course: “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
Is it really the job of an FDA regulator to breathlessly promote new drugs? Especially those on which the evidence of benefit over harm is slim, and which barely squeaked by in an advisory-commission vote?
Much further down in the article we learn that it's not all roses with this drug either. "The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache. The use of Tzield comes with warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Tzield; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Tzield."
The FDA approved Theranos tests 🤪 The Dropout on Hulu is a must watch. The mRNA is even more Fraud...Fraud by the regulators. Peak Fraud. FTX/SBF up next!
A new low and more evidence of agency capture at work. Show us the data!!!
Hi Vinay,
I'm confused about whether I should be a paid subscriber for this Substack or Sensible Medicine. My main goal is to read whatever you write without having to subscribe to both. Thanks
“Off with his head!”….
And Third: Long Covid might not even exist.
Hi, I cross-posted this on Sensible Medicine.
This comment isn’t related to the post, but I’m hoping Vinay Prasad reads and responds. Whenever I read about vaccines, there is always the conclusion that they are worthwhile, regardless of effectiveness in limiting transmission or infection rates, because “vaccines limit severity’. Is this currently true? It’s a stated reason why boosters were needed, but documentation that the boosters reduced severity beyond what was obtained with original dosage didn’t seem to be proven.
And now, there is a new variant XBB. Yet despite its recent appearance, the same vaccine claim is being made. From MSN today, “When it comes to evasion of vaccine protection, it’s important to recognize that vaccine protection is not all or none,” Dr. Adalja says. “Even with immune-evasive variants, vaccine protection against what matters most—severe disease—remains intact.” Is it true that a booster will reduce disease severity more effectively than if someone was vaccinated with the original dosage? Is the answer different for XBB versus Omicron? I’ve only seen the nursing home study, which didn’t seem to be persuasive.
Follow the money.
I have only one objection. Each year, a "new" influenza vaccine is produced WITHOUT undergoing new clinical trials. The reason is that the vaccine platform is the same with new antigens included. Why is the bivalent vaccine not exactly the same -- the identical platform with new antigens. As a 74 year old, I have taken the bivalent vaccine as well as the initial vaccine and boosters. Although irrelevant in the grand analysis, neither my wife nor I have had a syndrome suggestive of or any clinical evidence of COVID infection. We have gone out to dinner regularly since June 2020, choosing well protocoled restaurants and generally eat in early evening.
I agree about FDA commissioner not endorsing specific meds in any situation. Let the data speak for itself.
What an asshole!
I.Can't.Even.Imagine.The.Uproar if ___________
finish that sentence!!
Bob needs a cell right next to Richard Sackler - oh, sorry, Richard never went to jail - imagine that!
Great post, Vinay. How is this not being more widely reported???
(Actually, don’t answer that.)