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Can we trust the CDC and FDA any more?

Since the COVID-19 pandemic reached the US, increasing concern has been expressed about the politicization of the CDC and FDA due to pressure from the Trump administration to downplay the severity of the pandemic and push out treatments and a vaccine as fast as possible, potentially at the expense of safety. This has led me to a disturbing question: Can I trust the CDC and FDA any more?

[Orac note: Some of you might have seen a version of this post earlier this week elsewhere. This version is updated. I have a major grant deadline on Monday and that’s why there haven’t been any new posts since Monday. I anticipate resuming the Insolence on Tuesday or Wednesday, and hopefully I can get back to my regular schedule, at least until the next grant deadlines in early October. After that, things should be less hectic for a couple of months. In the meantime, I ask the question: Can we trust the CDC and FDA any more?]

Now that we’re at about the six month anniversary of the first lockdowns to combat the COVID-19 pandemic, I saw a story over the weekend that led me, at the risk of being too “political,” to ask a very disturbing (to me) question: Can we still trust the CDC and FDA (and other federal agencies, like the NIH, ostensibly dedicated to upholding policy based on good science)? Although the answer is still yes for most topics, for COVID-19 increasingly the answer is no. I fear that the list of topics on which the CDC and FDA can no longer be trusted will only grow if Donald Trump is reelected and that, even if he isn’t, some of the changes weakening the firewall between political appointees and the career scientific personnel of these agencies might be permanent and difficult for a President Biden to reverse. Let me explain.

Efforts to muzzle the CDC

My impression that the FDA and CDC have been co-opted by the Trump administration is one that’s been growing for a long time, ever since Trump’s inauguration, in fact, but the story that tweaked me to write this post appeared in Politico a week ago. It described efforts by officials in the Department of Health and Human Services (HHS) to water down a Morbidity and Mortality Weekly Reports (MMWR), the weekly publication of the CDC that has served as a science-based source for the agency to inform health care professionals, scientists, and the public about health topics ranging from vaccines to infectious disease to just about everything. Indeed, as mentioned in the story, one prominent example of how important MMWR has been was this June 1981 MMWR report describing five cases of Pneumocystis carinii pneumonia in five young homosexual men in Los Angeles that concluded that the “above observations suggest the possibility of a cellular-immune dysfunction related to a common exposure that predisposes individuals to opportunistic infections such as pneumocystosis and candidiasis. Although the role of CMV infection in the pathogenesis of pneumocystosis remains unknown, the possibility of P. carinii infection must be carefully considered in a differential diagnosis for previously healthy homosexual males with dyspnea and pneumonia.” This report was one of the early signals that revealed the AIDS epidemic.

This isn’t the first time the Trump administration has meddled in the CDC, but this time it seems different. According to Politico:

The health department’s politically appointed communications aides have demanded the right to review and seek changes to the Centers for Disease Control and Prevention’s weekly scientific reports charting the progress of the coronavirus pandemic, in what officials characterized as an attempt to intimidate the reports’ authors and water down their communications to health professionals.

In some cases, emails from communications aides to CDC Director Robert Redfield and other senior officials openly complained that the agency’s reports would undermine President Donald Trump’s optimistic messages about the outbreak, according to emails reviewed by POLITICO and three people familiar with the situation.

CDC officials have fought back against the most sweeping changes, but have increasingly agreed to allow the political officials to review the reports and, in a few cases, compromised on the wording, according to three people familiar with the exchanges. The communications aides’ efforts to change the language in the CDC’s reports have been constant across the summer and continued as recently as Friday afternoon.

It’s hard to overstate how disturbing this story has been to professionals trying to safeguard public health. The MMWR is a CDC publication compiled by CDC career scientists that is released week after week, usually with little or no fanfare (although certainly MMWR reports occasionally make the news, as has happened multiple times during measles outbreaks) and no interference from political appointees.

Political interference in the activities of the CDC is, of course, not unprecedented. There was political interference during the 1980s as the AIDS epidemic first blossomed, as well as during the 1990s, when Congress passed the Dickey Amendment, putting up a huge funding roadblock to the study of gun violence by the CDC and NIH. This is unsurprising history. Although the CDC, FDA, and National Institutes of Health (NIH) were meant to be as apolitical and science-based as possible, they are creations of the federal government. All of them are part of HHS, a cabinet-level department overseen by a political appointee, right now Alex Azar and earlier in the Trump Administration Tom Price. The budgets and laws creating and dictating what these agencies can and cannot do are written and passed by Congress. Some interjection of politics from the White House, Congress, and the HHS Director is inevitable, but there are statutory and regulatory roadblocks designed to insulate these agencies from political interference and, for the most part, they are largely effective, at least against gross meddling. What’s happening now, though, goes beyond the sorts of political interference we’ve seen before over the last 50 years. I certainly can’t recall ever having seen an account of direct interference in the activities of the CDC by the Executive Branch this blatant:

But since Michael Caputo, a former Trump campaign official with no medical or scientific background, was installed in April as the Health and Human Services department’s new spokesperson, there have been substantial efforts to align the reports with Trump’s statements, including the president’s claims that fears about the outbreak are overstated, or stop the reports altogether.

Caputo and his team have attempted to add caveats to the CDC’s findings, including an effort to retroactively change agency reports that they said wrongly inflated the risks of Covid-19 and should have made clear that Americans sickened by the virus may have been infected because of their own behavior, according to the individuals familiar with the situation and emails reviewed by POLITICO.

Caputo’s team also has tried to halt the release of some CDC reports, including delaying a report that addressed how doctors were prescribing hydroxychloroquine, the malaria drug favored by Trump as a coronavirus treatment despite scant evidence. The report, which was held for about a month after Caputo’s team raised questions about its authors’ political leanings, was finally published last week. It said that “the potential benefits of these drugs do not outweigh their risks.”

As I’ve written many times before, there was never particularly convincing scientific prior plausibility that hydroxychloroquine would be effective against COVID-19 and we have documented how the randomized controlled clinical trials of the drug have been resoundingly negative, which is why doctors have largely abandoned the drug as a potential promising treatment for coronavirus. Unfortunately, aided and abetted by President Trump himself (and Dr. Oz), there has been a major disinformation campaign promoting hydroxychloroquine as a miracle cure for COVID-19, an astroturf campaign that has at times gone to ridiculous lengths to sell the drug as effective. Similarly, there has been a concerted effort to portray SARS-CoV-2, the virus that causes COVID-19, as not a big deal, as lethal only to the elderly and those with comorbid conditions.

According to Politico, the pressure was quite intense. For example, Paul Alexander, MSc, MHSc, PhD, Caputo’s scientific advisor, acted as Caputo’s hammer, as shown in this incident involving Caputo (who also accused the CDC on August 8 of attempting to use the reports to “hurt the President”) triin to get the CDC to retroactively alter MMWR issues that, he claimed, “wrongly” inflated the risks of coronavirus to children and thereby undermined Trump’s push to reopen schools:

Alexander also called on Redfield to halt all future MMWR reports until the agency modified its years-old publication process so he could personally review the entire report prior to publication, rather than a brief synopsis. Alexander, an assistant professor of health research at McMaster University near Toronto whom Caputo recruited this spring to be his scientific adviser, added that CDC needed to allow him to make line edits — and demanded an “immediate stop” to the reports in the meantime.

“The reports must be read by someone outside of CDC like myself, and we cannot allow the reporting to go on as it has been, for it is outrageous. Its lunacy,” Alexander told Redfield and other officials. “Nothing to go out unless I read and agree with the findings how they [sic] CDC, wrote it and I tweak it to ensure it is fair and balanced and ‘complete.'”

“Fair and balanced”? Who is Alexander, a Fox News pundit? It also doesn’t help that Caputo has said things like:

Caputo also said that HHS was appropriately reviewing the CDC’s reports. “Our intention is to make sure that evidence, science-based data drives policy through this pandemic—not ulterior deep state motives in the bowels of CDC,” he said.

What a jarring juxtaposition of a claim that “science-based data” will drive policy with a claim that he’s protecting science against “ulterior deep state motives” and what can only be correctly described as raving conspiracy theories! Let’s just put it this way. If you have to appeal to a conspiracy theory to justify your policy, you are not practicing science-based medicine or medical policy.

Conspiracy theories a-go-go

The conspiracy mongering coming from the administration as a justification for directly trying to control the public messaging of the CDC and FDA is even worse than that, though. The most amazingly weird example showed up this morning, when the news was full of stories like this about Alexander’s boss Caputo, who comes across as just shy of a QAnon believer. The accounts were so amazing that I had to do a quick revision of this post in order to include this new development. Don’t believe me when I say that Caputo is just shy of a QAnon believer? Then take a look what the stories published on Monday morning reported:

A top communications official for the administration’s coronavirus response urged President Trump’s supporters to prepare for an armed insurrection after a contested election and accused government scientists of “sedition” in a Facebook Live chat that he described in detail to The Washington Post on Monday.

Michael Caputo, assistant secretary for public affairs at the Department of Health and Human Services, which is overseeing the coronavirus response, leveled the accusations and promoted other conspiracy theories in a Facebook Live event first reported by the New York Times. Caputo confirmed the authenticity of the video in comments he made to The Post.

Yes. you read that right. Caputo thinks the government scientists working for the CDC are seditious “deep state” operatives looking for any opportunity possible to take down President Trump, rather than career professionals, many of whom have served under Presidents of both parties, who are simply trying to do their job and communicate the current best scientific understanding of critical aspects of SARS-CoV-2 and the COVID-19 pandemic in order to guide policy. Under a normal administration, regardless of party, the President would listen to them, even if he ultimately didn’t heed their advice. He wouldn’t hire delusional conspiracy mongering sycophants, toadies, and lackeys like Michael Caputo to oversee them. I’m not saying that political interference in the CDC and FDA hasn’t occurred before. It’s just that I”m hard pressed to think of an example this blatant and disturbing, going back even to the emergence of the AIDS epidemic in the 1990s.

It gets even worse and more disturbing:

In the Facebook video, Caputo criticizes government career scientists, the media and Democrats, the Times reported and Caputo confirmed. He said he was under attack by the media and that his “mental health has definitely failed.”

Caputo also said the CDC, which is part of HHS, had a “resistance unit” that aimed to undermine Trump. Without offering any evidence, he also accused scientists “deep in the bowels of the CDC” of giving up on science and becoming “political animals.”

They “haven’t gotten out of their sweatpants except for meetings at coffee shops” to plot “how they’re going to attack Donald Trump next,” he said in the video. “There are scientists who work for this government who do not want America to get well, not until after Joe Biden is president.”

He also predicted that Trump would win the election but that Biden, the Democratic presidential nominee, would refuse to concede. “And when Donald Trump refuses to stand down at the inauguration, the shooting will begin,” he warned in the video. “The drills that you’ve seen are nothing. If you carry guns, buy ammunition, ladies and gentlemen, because it’s going to be hard to get.”

This is downright paranoid. It really is. The man in charge of messaging for the CDC and the government’s COVID-19 response is a raving conspiracy theorist who clearly has nothing contempt for scientists, given his sarcastic jibe about their not having “gotten out of their sweatpants except for meetings at coffee shops” to plot “how they’re going to attack” Trump next.

As this week wore on and the controversy over Caputo’s blatant attempts to “massage” the messaging coming out of the CDC ratcheted up, news reports surfaced that Caputo is planning to take a medical leave of absence from his job for “health reasons” for two months, which, conveniently, would mean that he’ll be out until after the election. As a reason, he cited a need to “pursue necessary screenings for a lymphatic issue discovered last week” due to unexplained weight loss. One can only hope that, whatever it is going on with Caputo, it’s nothing serious and also that Alexander will soon be on his way out of the door of HHS with him.

Kicking CDC scientists aside on testing

Unfortunately, this is far from the only example of interference from Azar’s office and appointees in CDC messaging, although it is the most “out there.” An equally disturbing example that didn’t involve an HHS official ranting about conspiracy theories against Donald Trump occurred last month, when the CDC issued revised guidance on who should be tested for COVID-19, in which the CDC recommended not testing people who have no symptoms of the disease, even if they’ve been recently exposed to coronavirus, alarming health experts. After all, as we’ve discussed before, asymptomatic transmission is a major issue with this virus, which can contribute to “super-spreader” events when large numbers of people are together indoors. At the time, experts had nearly universally urged more, not less, testing for COVID-19, especially to reach vulnerable and marginalized sectors of the population, in order to halt the rapid spread of the virus, leading many public health scientists to react with alarm.

The Trump administration tried to deny that it had influenced the CDC to make this revision, but let’s just say that its denials were not…persuasive:

Adm. Brett P. Giroir, the administration’s coronavirus testing czar, called it a “C.D.C. action,” written with input from the agency’s director, Dr. Robert R. Redfield. But he acknowledged that the revision came after a vigorous debate among members of the White House coronavirus task force — including its newest member, Dr. Scott W. Atlas, a frequent Fox News guest and a special adviser to President Trump.

“We all signed off on it, the docs, before it ever got to a place where the political leadership would have, you know, even seen it, and this document was approved by the task force by consensus,” Dr. Giroir said. “There was no weight on the scales by the president or the vice president or Secretary Azar,” he added, referring to Alex M. Azar II, the secretary of health and human services.

Of course, who appointed Admiral Giroir and Dr. Atlas, the latter of whom was specifically recruited because, even though he’s a radiologist with no special expertise in infectious disease, his beliefs align with those of the administration when it comes to COVID-19? These people know what their bosses want and strive to provide it. The task force also threw Dr. Fauci under the bus, but then it came out later:

In a brief interview, Dr. Fauci said he had seen an early iteration of the guidelines and did not object. But the final debate over the revisions took place at a task force meeting on Thursday, when Dr. Fauci was having surgery under general anesthesia to remove a polyp on his vocal cord. In retrospect, he said, he now had “some concerns” about advising people against getting tested, because the virus could be spread through asymptomatic contact.

“My concern is that it will be misinterpreted,” Dr. Fauci said.

So great was the outcry over this obvious attempt to game the CDC’s testing guidelines, that it wasn’t long at all before the CDC walked back its new guideline, “clarifying” it by saying that says “all close contacts of confirmed or probable COVID-19 patients” may consider testing.

Yesterday, we learned why these testing guidelines seemed so dissonant, so different from the CDC’s previous messaging on testing for COVID-19, when the New York Times published a story indicating that the testing guidance published by the CDC last month didn’t come from CDC scientists, but rather from HHS officials over the objections of CDC scientists:

A heavily criticized recommendation from the Centers for Disease Control and Prevention last month about who should be tested for the coronavirus was not written by C.D.C. scientists and was posted to the agency’s website despite their serious objections, according to several people familiar with the matter as well as internal documents obtained by The New York Times.

The guidance said it was not necessary to test people without symptoms of Covid-19 even if they had been exposed to the virus. It came at a time when public health experts were pushing for more testing rather than less, and administration officials told The Times that the document was a C.D.C. product and had been revised with input from the agency’s director, Dr. Robert Redfield.

But officials told The Times this week that the Department of Health and Human Services did the rewriting and then “dropped” it into the C.D.C.’s public website, flouting the agency’s strict scientific review process.

“That was a doc that came from the top down, from the H.H.S. and the task force,” said a federal official with knowledge of the matter, referring to the White House task force on the coronavirus. “That policy does not reflect what many people at the C.D.C. feel should be the policy.”

And, apparently, the interference is still occuring:

A new version of the testing guidance, expected to be posted Friday [today], has also not been cleared by the C.D.C.’s usual internal review for scientific documents and is being revised by officials at Health and Human Services, according to a federal official who was not authorized to speak to reporters about the matter.

Even after being caught meddling in the CDC’s scientific recommendations, the Trump administration just does it again.

Unfortunately, it’s not just the CDC. Alexander has reached beyond the CDC to try to muzzle Anthony Fauci:

Emails obtained by POLITICO show Paul Alexander — a senior adviser to Michael Caputo, HHS’s assistant secretary for public affairs — instructing press officers and others at the National Institutes of Health about what Fauci should say during media interviews. The Trump adviser weighed in on Fauci’s planned responses to outlets including Bloomberg News, BuzzFeed, Huffington Post and the science journal Cell.

Then there’s the FDA.

The FDA: Emergency use authorizations and “Operation Warp Speed”

My concern about the influence of the Trump administration on the FDA is nothing new. I’ve been writing about it since right after Trump won the 2016 election. Indeed, very early on I expressed concern that the new administration would move to fulfil a longtime right-wing goal of weakening the FDA’s regulatory authority over drug approval, a concern that became more acute not long after that when two of the finalists for the post of FDA Commissioner were cronies of libertarian Silicon Valley venture capitalist and founder of PayPal Peter Thiel, who holds the strong belief that government and the “progressive left” always impede scientific innovation with their cautiousness and lack of imagination.

The two finalists whose names were floated included Jim O’Neill, managing director of investment firm Mithril Capital Management, and Balaji Srinivasan, CEO of bitcoin start-up 21.co. O’Neill was notable for his prior proposal that the FDA give up vetting drugs for efficacy before they come to market. (He was also a free market fundamentalist into serious antiaging woo.) A direct quote:

“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety — and let people start using them, at their own risk, but not much risk of safety,” O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. “Let’s prove efficacy after they’ve been legalized.”

You get the idea.

Balaji Srinivasan was notable for his many utterances on Twitter attacking the FDA, which led him to hide his Twitter archive. Particularly disturbing was his idea that the FDA was not necessary to determine efficacy and safety when, according to him, the same could be done with online reviews, which some characterized as a “Yelp for drugs”. When asked, “But how do you prevent quacks?” Srinivasan’s answer was, “Scaled Internet reputation systems. Works at massive scale in other areas.” I explained in depth why this was an incredibly awful idea. Fortunately, it’s an idea that no FDA Commissioner could have implemented without first getting Congress to pass a law, given that the Kefauver-Harris Drug Amendments to the Federal Food, Drug, and Cosmetic Act, passed in the wake of the thalidomide scandal, mandates that the FDA demonstrate safety and efficacy before approving drugs.

Ultimately, Trump chose the “least bad” of his three finalists, Scott Gottleib. Because of his extensive history in pharma and his holding positions on the boards of directors of multiple pharmaceutical companies, I referred to him at the time as an “honest-to-goodness real pharma shill”. At least he was a reasonably competent pharma shill, though. While he was definitely biased in favor of pharma, he wasn’t interested in radically restructuring the FDA in the sort of ways that O’Neill and Srinivasan might have been, which made me think that maybe O’Neill and Srinivasan were thrown in there to make Gottleib seem reasonable.

Over the last four years, I intermittently expressed concern over the effects of the administration’s general hostility to regulation and commitment of this administration to speeding up drug approval, potentially at the cost of safety, and the effects these efforts might be having on the FDA, as well as how “right-to-try” laws were passed to weaken the FDA under the guise of helping terminally ill patients. The same issue has come up with COVID-19, where the FDA has allowed the sale of dubious lab tests without FDA review in the name of “speed”.

More recently, I was very disturbed by two emergency use approvals issued by the FDA. The first occurred in March and was for—you guessed it!—hydroxychloroquine to treat COVID-19. I already discussed how that EUA had to be reversed because increasingly evidence didn’t support using the drug to treat coronavirus. The second was just a couple of weeks ago and was an EUA for convalescent plasma to treat COVID-19. As I discussed at the time, although the use of plasma from recovered COVID-19 patients has biological plausibility, there was as yet no good RCT evidence to support its use.

Disturbingly:

It was the third week of August, the Republican National Convention was days away, and President Trump was impatient.

White House officials were anxious to showcase a step forward in the battle against the coronavirus: an expansion of the use of blood plasma from recovered patients to treat new ones. For nearly two weeks, however, the National Institutes of Health had held up emergency authorization for the treatment, citing lingering concerns over its effectiveness.

So on Wednesday, Aug. 19, Mr. Trump called Dr. Francis S. Collins, the director of the NIH, with a blunt message.

“Get it done by Friday,” he demanded.

It wasn’t done by Friday, and on Sunday, regulators at the Food and Drug Administration still had not finished a last-minute data review intended to ease N.I.H. doubts.

But on Sunday night, the eve of the convention, the president announced, with the FDA’s approval, that plasma therapy would be available for wider use, and he declared that it could reduce deaths by 35 percent, vastly overstating what the data had shown about the benefits.

Yes, it’s that bad, which brings us to Operation Warp Speed. This is, of course, the name that the Trump administration used to describe its program to rush a COVID-19 vaccine to market. Of particular concern is the suggestion by current FDA Commissioner Stephen Hahn (Dr. Gottleib left the FDA a year and a half ago) that a COVID-19 vaccine could be released under an EUA before phase 3 clinical trials are complete. While such a suggestion is not completely unreasonable if the bar is very high (for instance, the difference between the group receiving an experimental COVID-19 vaccine and the placebo control group is so great that the institutional review board overseeing the study decides that continuing to sign up subjects for the placebo group would be unethical), unsurprisingly, many doctors and scientists, including myself, are wary.

For instance:

Doctors have worried that just before Election Day, President Trump might pressure the FDA to approve a coronavirus vaccine before it’s ready as an “October surprise” to gain votes.

“This just cannot be allowed to happen,” Dr. Francis Collins told CNN this month.

He said if FDA’s Hahn approves a vaccine based on flimsy evidence, “he’s got a lot of people he’d have to answer to.”

Collins said he’d be one of those people, and so would Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases and a member of the White House Coronavirus Task Force.

Collins said he, Fauci, and others would “certainly make a big noise about not supporting [the vaccine]” if the FDA were to approve it prematurely, adding that the vaccine cannot be approved “on the basis of anything other than science.”

As I’ve said before, vaccines are different from therapeutics in that they are administered to huge numbers of people, in the case of a COVID-19 vaccine hundreds of millions to, eventually, billions. The standards for vaccines are very different from those for drugs in terms of safety in that the standard for vaccines is much higher. It has to be, because, in contrast to drugs, which are administered to treat disease, vaccines are administered to huge numbers of people without disease in order to prevent disease. The tolerance for adverse reactions in a vaccine is therefore much lower than it is for drugs, particularly drugs for serious illnesses. What that means is that even a phase 3 clinical trial is only the beginning of safety monitoring. As I’ve described many times before, we have multiple postmarketing safety monitoring systems for vaccines, including one passive (Vaccine Adverse Events Reporting System, or VAERS) and three active surveillance systems: the Vaccine Safety Datalink (VSD), the Post-licensure Rapid Immunization Safety Monitoring System (PRISM), and the Clinical Immunization Safety Assessment (CISA) Project. That doesn’t mean using an EUA to authorize the use of a COVID-19 vaccine might not be reasonable under certain circumstances. It’s also true that it is not unreasonable not to trust the current FDA leadership to make a science- and ethics-based decision in the face of unrelenting pressure from the White House.

Even pharma is doubtful

So unusual is the pressure for a vaccine coming from this administration that even big pharma is pushing back, with nine drug companies, three of which have COVID-19 vaccines nearing completion of their phase 3 trials, signed a joint pledge a week ago:

Nine pharmaceutical companies issued a joint pledge on Tuesday that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy.

The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved,” the companies said.

And:

Federal officials have been pushing back against Mr. Trump’s enthusiastic predictions. Late last week, Moncef Slaoui, the top scientist on Operation Warp Speed, the federal effort to quickly bring a vaccine to market, warned in an interview with National Public Radio that the chance of successful vaccine results by October was “very, very low.”

And on Tuesday, Dr. Anthony S. Fauci, the nation’s top infectious disease expert, said he believed that researchers would know whether the Moderna and Pfizer vaccines were effective by “November or December.”

This is actually good business and science as well as good PR. First, although beating all previous records for speed in developing a vaccine to make one for COVID-19 would be good for the reputation of pharma, equally true is that using an EUA to release a vaccine prematurely that ends up causing serious side effects could result in catastrophic damages to the reputation of any company that takes advantage of an EUA if the evidence isn’t good enough. As for business, any vaccine is approved under an EUA could make it dramatically more difficult for other drug companies, whose candidate vaccines not as far along in development might actually be safer and/or more efficacious, to get their vaccines approved. Why? Once a vaccine is issued an EUA, the ethics of continuing a placebo control group in other ongoing vaccine trials becomes problematic, as the EUA would result in a de facto standard of care, and clinical trials cannot ethically deliver care that is below the standard of care. It would thus become arguably unethical to continue to use a placebo control in clinical trials, meaning that the trials might have to be altered to compare the new vaccines versus the vaccine with the EUA. This would make it difficult to tell which vaccines are the safest and most efficacious.

Can we trust the FDA and CDC any more?

Regular readers know that I’ve long supported the CDC and FDA as the two federal agencies most aligned with science-based medical care. True, they aren’t perfect, and we at SBM have criticized them many times over the last 13 years when we thought they were falling short. We’ve also criticized the laws governing the FDA’s regulation of dietary supplements and homeopathy. Before this year, my answer to the question “Can we trust the FDA and CDC?” would have been an emphatic yes, even after three years of the Trump administration. Can I still say this? I don’t know.

Why? If you want to get an idea of how significant that pressure is, a New York Times article from Saturday gives an idea:

With Election Day just over seven weeks away, Washington is witnessing the collision of two worlds: a community of largely anonymous government scientists and doctors who operate in a culture guided by research, data sets and peer review, and a president famously disdainful of science, politically wounded by his failures to contain the coronavirus and now determined to cast himself as moving as fast as possible to provide Americans with vaccines and treatments.

The EUAs for hydroxychloroquine and convalescent plasma are two examples. Operation Warp Speed is another. All contribute to the reasons why I now fear my answer to the question is: I don’t know any more, at least not when it comes to anything having to do with the COVID-19 pandemic. The agencies have been politicized in a way I’ve never seen before, and that damage will be difficult to undo, even if Donald Trump fails to win reelection. Worse, in the age of the COVID-19 pandemic, we need more than ever a reliable FDA, CDC, and NIH, all strongly dedicated to science-based medical policy and resisting political pressure to deviate from science. I fear that, increasingly, we don’t have that anymore.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

137 replies on “Can we trust the CDC and FDA any more?”

This is beyond disturbing; the broad ramifications are downright dangerous. In addition to the points you raise, it just empowers the antivaxxers who say they don’t trust the CDC on vaccines. Once CDCs credibility is impaired on one thing, it all goes down the tubes, because then both sides accuse the other of just picking and choosing what suits them. So when mainstream medicine and orthodox science questions CDC, Trump just handed the anti-vaxxers a victory. Great.

Under the best case scenario, it will take decades to repair the harms the Trump administration did to our system. This is not about specific policies, Republican or Democrat. This is about the damage to the integrity and legitimacy of agencies and the functionality of the administrative state.

This is another part of undermining the foundations.

And over 200,000 Americans will still be dead when nowhere near that should have been.

@Peter,

It is interesting that 4 months after we already had SEM pictures of the SARS-CoV-2 virus, your German friends were posting this massive exercise in the Nirvana fallacy cloaked in a cloud of FUD.

https://www.niaid.nih.gov/news-events/novel-coronavirus-sarscov2-images

I think Jessica Watson spoke quite clearly for herself in May.

https://www.bmj.com/content/bmj/369/bmj.m1808.full.pdf

What you need to know
• Interpreting the result of a test for covid-19 depends on two things: the
accuracy of the test, and the pre-test probability or estimated risk of
disease before testing
• A positive RT-PCR test for covid-19 test has more weight than a negative
test because of the test’s high specificity but moderate sensitivity
• A single negative covid-19 test should not be used as a rule-out in
patients with strongly suggestive symptoms
• Clinicians should share information with patients about the accuracy of
covid-19 tests

These tests are not perfect, but they are still a useful diagnostic tool and play an important role in screening to identify and limit the spread of this virus and its subsequent disease.

I can almost predict at this point that once I’ve read any of the NYT articles you quote from, that I will see Orac addressing their content soon after. It’s a small comfort in light of the gravity of the outcome.

Oh, what a tangled web [ they} weave…

HOWEVER I take heart because so much of it is being revealed by standard news sources/ television like when Redfield spoke up about masks, Dr Fauci making appearances on television, social media to clear up misinformation or people quitting and going public as that woman did recently.

We know that blue partisans already have dismissed Donald but his faithful will not ever. How about the less partisan?
A few things make me fear less:( e.g. see 538/ first 3 statements)
— people over age 65- a group that supported him last time has shifted away from him- they’re scared of the illness as they should be, Woodward’s revelations will frighten them more
— projections show his opponent ahead in many polls
— these estimates have remained steady for weeks**
— AND all the manooeuvering his allies put forth such as tampering with mail service, changing figures about Covid and scoffing about masks show desperation: anything to win

** one of the warning signs in 2016 was that in the final weeks of the campaign poll estimates jumped around a lot in states that were close: I looked several times a day..

,

.

@ Orac

I must say, without saying anything about my personal opinion on the topic you mentionned, that I have on multiple occasions witnessed that you were willing to both defend science and not let taboos remain untouched.

This blog post is the latest example I can mention where I witnessed you doing so.

You really are trying to strike the best balance when it comes to tough issues, and I must therefore say: I deeply admire you.

@ F68.10:

That’s why we’re here!
The people I survey ( woo, anti-vax) portray sceptics/ SB supporters as being in “lock step”,regimentation, blindly following “orders” from their masters, as many scoffers here accuse: it’s a simplistic view of how people behave and how they advance ideas. One of the most valuable lessons I learned from my mentors/ profs was that controversies were not something to be eliminated but could be fuel for research AND we had to understand the complexity of certain issues which often involved reading huge tomes filled with myriad results of experiments in microscopic detail ( you wouldn’t believe that there are so many aspects in infants’ language development, LT verbal memory, the PFC or visual constancies but there are!)

It’s only cults that require absolute obedience and acquiescence. ( And there are cults everywhere as you know only too well)

IN OTHER NEWS…
I recently reported that Null was leaving WBAI but that has been cancelled, he’ll be back in a week. Can’t stick the flounce. They must need pledge money badly to tolerate his swill and grandiosity.

.

@ Denice Walter

“And there are cults everywhere as you know only too well.”

Indeed. Though I must say that the definition of cults can be rather worrying. I’m promoting the BITE model endlessly as a bunch of criteria for cults. I haven’t been happy seeing, for instance, catholics in my country jumping on the notion of cults, in the last decades, to wage their petty moral wars. Sad that the Miviludes, our institution in charge of battling cults, seems to have lent credibility to this approach.

The BITE model seems to me absolutely a foundational cornerstone as to how cults should institutionally be thought of and detected.

The heuristic “”criticism” of medicine” = “cult” as both a necessary and sufficient condition, as promoted under the direction of the Miviludes by Serge Blisko, seems to me to be both authoritarian and ineffective. It fits a not illegitimate purpose, though… as everyone here should know…

I am familiar with the model but not his personal story.

Many years ago, as a student in the great city of [redacted], I was approached by a slightly older guy who asked if I wanted to be in “research” where I could “learn about myself”: because the rented locale for this enterprise was EXACTLY equidistant between two major universities who conducted psych/ social research/ polls, I asked “Who is doing this, University A or B? Who is the experimenter? ” Of course, he didn’t answer because it was Scientology, who also set up “personality tests’ for dealing with stress control at busy transit stations trying to hook people into their web. In the subway corridors yet.

HBO is presenting a series about people who were involved into the NXIVM cult – a mix of sex, female slavery and multilevel marketing ( The Vow). Interestingly enough, I asked my cousin who lives in the area if she knew anything about it and YES! she even knew one of the principals, a nurse, who had worked for her husband, a doctor, and conducted hypnosis for patients- she’s now on charges of racketeering and divorced..

My other insight involves a less toxic form of cult- my classmate had a much older brother who became a yoga teacher and chosen leader for a well-known Indian guru. I attended yoga classes at different times and noticed how several of the participants were totally immersed in the group, I don’t think that there was major interference in personal freedom or living arrangements BUT they sure were persuaded into spending lots of money for classes and supplements from the attached health food store as well as sounding an awful lot like the leaders.. . .

Speaking of Maddow… This week she has argued that all the revelations from the past week or so – including, in addition to what Orac discussed, the Woodward tapes, internal WH documents uncovered by Jim Clyburn’s House committee, and Trump’s comments in his recent Town Hall on ABC – point to an even more disturbing conclusion: There actually is a Trumpian plan to deal with the virus, and it’s the one advocated by Scott Atlas: actually encouraging it’s spread by dropping mitigation measures in the hopes that survivors will create a “natural” (non-vaccine derived) state of herd immunity ASAP. She showed video of Atlas’s TV appearances claiming rising infection rates are a good thing, graphics of the WH recommendations to the States showing the mitigation recs went down as the infection rates went up, and Trump telling George Stephanopoulos the virus will “go away” without a vaccine due to “herd mentality… it’s going to be herd developed – and that’s going to happen. That will all happen,”

Maddow then went on to do the math, taking the % of the US population projected as necessary for herd immunity, multiplying that by current fatality rate, then giving the Trumpers a bunch of “benefit of the doubt” adjustments, ultimately calculating the Atlas plan would result in a minimum of over 2 million deaths. She did not include an adjustment for adding some measure of vaccine-derived immunity onto the mix, However, I have the feeling she was being too generous in the other fudge factors, and Atlas is indeed cheerleading the Trumpers, and us along with them, on toward 2million + deaths.

Maddow also helpfully pointed out that a rather long list of faculty at Stanford Medical School have essentially called out Atlas as a quack.

Yes, this is what they’ve decided on, and without doing the math, either. Trump likes to listen to Atlas, who apparently has the (need I say, false) idea that “herd immunity” is 100% achievable with any virus, just because it is with viruses that have been infecting humans for millenia. Sounds like a quack radiologist!

I had already decided that I was not going to get any vaccine (nor any treatment) that the CDC or FDA put out unless I saw statements about it from reputable scientists and doctors, or perhaps even read the peer-reviewed papers. Trump will move like lightning on anything that presents itself, anything that claims itself to be a vaccine. So, all these latest revelations, and Caputo’s apparent insanity, didn’t change anything for me.

This is not lost on the general population, either: my friend who sells real estate and is a personal trainer (i.e., no medical background) remarked that they were moving on this vaccine mighty fast and that she wasn’t anxious to be one of the first to receive it.

Redfield is another Trump appointee, isn’t he? (sorry, I don’t know.) He and Birx were said to be part of a new “Christian public health” movement (whatever that may be). But, Redfield seems to have done a gut check and threw down in front of congress. Wonder if he’ll keep his position for much longer? The FBI director just did the same in his area (i.e., Russia is trying to fix the election again), and apparently they’re got the short list out for his replacement already. Next CDC head will probably be Atlas! So, there goes the institution’s credibility.

Isn’t the herd immunity approach is the strategy which was applied in Sweden. I.mean , they officially do not refer to herd immunity as an outcome, but in practice , this is exactly what they have put in place.

The awful long term damage aside, there’s the immediate problems of what does a person do given the lack of trust this points to. For example: partake in vaccine or not? I understand people who say they will in no way accept any vaccine operating under the auspices of this administration. But that’s a gamble with pretty heavy stakes.

Well, this morning Moderna and Pfizer released their clinical trial protocols for their vaccines, so you can try reading those to see if their criteria and testing methods sound, well, sound.
At least one of them included a timeline that says they’ll be done and made a decision and ready to roll out if it works by 2021 (I think it was Moderna).

So that should give not just us as individuals but the science community in general a really good idea of what’s going on and what to expect (and where to be looking for issues) in the future.

The Pfizer one must be stored at -94F. If mass testing didn’t pan out after seven months then I don’t see mass refrigerator trucks with that capability rolling into a neighborhood near you anytime “soon”. Invest in dry ice??

“If Pfizer’s produces the best results, there will be pressure to distribute it as widely as possible, even if the cold chain freezes over.”

https://qz.com/1904638/covid-19-vaccine-states-are-hunting-for-medical-deep-freezers/

The Moderna one is at least stable for shipping at -4F.

@squirrelelite

They could have misspoke but from TFA:

<

blockquote>But there are more storage facilities capable of reaching that temperature than at -70°C.

The company is also partnering with UPS to build two freezer farms, one in Louisville, Kentucky and the other in the Netherlands, that can house 48,000 vials of vaccine at -80°C (-112°F.)

Once the vaccines have thawed, they can be kept in the fridge for five days—but this time can be quickly eaten up in the commute. “If the product’s only good for 10 days and it takes two or three to get to a rural community, you’ve already lost 30% of the time frame that product is viable,”

Most vaccines are transported along the cold chain network at 2° to 8°C (35° to 46°F)…

“There’s no precedent for vaccines to be stored at that low of a temperature,”

Did the TWiV podcast happen to mention why so south of just ‘chilly’ with these ones?

Although only tangentially relevant to the US this kind of development reverberates elsewhere, including my own country. It applies equally to FDA, CDC, FAA and other US government agencies. Testing drugs, vaccines, aircraft, etc for safety is expensive. Since well funded and competent US agencies are already doing it many governments reduce their own regulatory approvals to little more than reviews of the what those US agencies did and concluded. The result is faster access to new technology that is reliable and safe, and to do it at minimal cost. Every politician looks for opportunities to spend public funds on their own initiatives rather than on unavoidably important stuff.

Unfortunately the cost of the regulatory review is no cheaper or faster because of a smaller population or economy. The cost doesn’t scale. Yet these same politicians are increasingly being pressed to fund in-country approvals for these products and most can ill afford to do so. Trust in the US is suffering and the politicians know who to try and blame when faced with potential enormous regulatory costs. COVID is simply the latest crisis to erode that trust. A never ending string of unilateral US actions with international implications is accelerating the erosion.

The policy of US isolationism is creating a vacuum and the vacuum will be filled, although many of the candidates to fill that vacuum are not so admirable. Less international unity on important matters such as pandemics has broader implications that are not pleasant to contemplate. None of this seems to matter to many Americans and everyone else is scrambling to deal with the fallout. I doubt that your upcoming election will change much. For the time being all we can do is close our borders to Americans to reduce importation of the virus and wonder how this will conclude.

McMaster university has issued a statement which appears to distance itself from Dr Alexander. He is, they say, an assistant professor on contract who is not being paid by the university. It isn’t clear from the statement as reported in the paper whether he is not being paid at the moment because of his employment in the US, or whether he is on some non-tenure track with external funding. Apparently he was personally recruited by Caputo.

Contrary to a number of reports, McMaster is not in Toronto, but in Hamilton, a city of 600,000 where everyone sings a lot.

William Hyde

@ JDK

it can be hard to tell where the Greater Toronto Area ends and Hamilton begins

Even for a visitor, it’s difficult.
On my first road trip from Toronto to Ottawa, I felt like we spent more time driving on the highways through the GTA than on the countryside highway to Ottawa.

To be fair to the foreign press, it can be hard to tell where the Greater Toronto Area ends and Hamilton begins…

Hamilton has a very large envy of white collar Toronto. They have traditionally been very blue collar as much of the economy was in the steelworks (in many ways, the city was Ontario’s to old Pittsburgh). There is a rather nasty (at times) rivalry between out football teams, the Tiger Cats and Argonauts. Hamilton has been more than a little peeved that it hasn’t been able to land a NHL franchise.

Due to the changing economies of scale and expansion of the commuter bus and rail service out of Toronto, much to Hamilton’s chagrin, they are becoming a sleeper community for Toronto.

Alexander is listed by McMaster as a part-time Assistant Professor. “The assistant professorship is an unpaid position given to scholars working primarily outside the university.” So the association appears to be weak indeed, a title without any real substance, something I’m guessing McMaster readily hands out to its recent PhDs as mutual self-promotion. McMaster now can’t run away from the guy fast enough, and the coverage in the Canadian press reveals he quite the piece of work.

One respected expert who knows him… called him “the weakest person I’ve ever interacted with at McMaster.”…the source said Alexander “didn’t know basic epidemiology.” That included being unclear on the difference between odds ratios and relative risk, two similar but subtly different principles in epidemiology.

Nevertheless:

In a lengthy e-mail to The Globe and Mail on Wednesday and a subsequent interview, Dr. Alexander accused the CDC of “generating pseudo scientific reports” and said he was more qualified to analyze COVID-19 data than the 1,700 scientists at the agency. “None of those people have my skills,” Dr. Alexander said. “I make the judgment whether this is crap.”

Paul Alexander seems to have been a part-time assistant professor at McMaster (fancy title for adjunct?).

The Star has done a bit of a hatchet job on him.
From Oxford to Congress: McMaster prof embroiled in White House scandal ‘loyal’ … to a fault with the implication that he has decent science credentials but abases himself to authority.

Some comments from an Oxford prof.

He was also very loyal, she said. At times, to a fault.

“Paul was very deferential. I would tell students, ‘Get on your computers. Challenge me. Tell me that I’m wrong.’ And that was not his modus operandi,” Burls said.

He was also very loyal, she said. At times, to a fault.

“Paul was very deferential. I would tell students, ‘Get on your computers. Challenge me. Tell me that I’m wrong.’ And that was not his modus operandi,” Burls said.

He was also very loyal, she said. At times, to a fault.

“Paul was very deferential. I would tell students, ‘Get on your computers. Challenge me. Tell me that I’m wrong.’ And that was not his modus operandi,” Burls said.

Hamilton—isn’t that a Toronto suburb like Scarborough?

“And the credibility may take a generation to regain. Pissed away for nothing. The King Midas of Shit enpoopifies everything he touches.” <– this comment right here, officer.

https://arstechnica.com/science/2020/09/cdc-dramatically-restores-covid-19-testing-advice-marred-by-political-meddling/?comments=1&post=39248969#comment-39248969

Just one generation, though? It will fuel talk radio on both sides (CDC is seditious/CDC are chumps, pawns, pushovers) and instill in nextgen kids for decades, most likely.

@ Dangerous One:

PLEASE, don’t even think it.

But there are a few issues that may insulate the US from the horrors of an anti-vax political establishment developing soon.
1. I doubt that RFK jr would be amenable to right wing activists/ senators because he is (probably) NOT anti-abortion AND he has a history in the environmental movement SO he will protect rivers not the “un-born”, the inverse of their prime concerns
2. Trump himself may be getting the side eye from anti-vaxxers because he is supporting a Covid vaccine PLUS, he is rushing it through and will attempt to distribute it quickly..

HOWEVER anti-vaxxers can twist anything factual to suit their purpose: a few anti-vax leaders seem to disregard Trump’s position when he hawks a Covid vaccine. Selective in-attention, I suppose.

.

I think Junior has burned his bridges with any sensible person to the left of, say, Rush Limbaugh. He tried to suck up to Trump in an attempt to chair a so-called vaccine safety commission. Now he’s at Trump’s Doral trash palace schmoozing with the likes of Roger Stone and Dinesh D’Souza. He’s selling out what little environmental credibility and influence he has in pursuit of his antivax monomania.
Right-wing politicians and activists seem acceptable to him,and he seems to have become a useful idiot for the right-wing antivax/antiCDC/antiWHO side.

BTW, is he still cheating on his wife? (I know, cheap shot, but I hate the pathetic assclown).

@ Dangerous Bacon

Actually…
Not to downplay the importance of vaccination, but RFK Jr. may be a good pick for the Supreme Court. Comparatively.
As Denice pointed, he may not be fully on board with the main tenets of the GOP. And conversely, the other judges may not be full antivax. Yet. That I know of.
(This “yet” applies also to RFK Jr. The recent Berlin escapade has shown that he has… flexibility in his political views. If people were proposing him to get reach as well…)
I know, my argument is basically “someone far worse could be selected for the job”. I’m an incorrigible optimistic this way.

@ TBruce:
@ Athaic:

The Donald said he will probably nominate a woman and he has an extreme right-to-lifer in mind. And she’s young

Could she be worse that RFK jr? No,technically no one is worse than RFK jr.

He demonstrates something I’ve come to believe about anti-vaxxers:
if you accept their basic ideas and you are an adult who can read and has a reasonably good education there is something wrong with you:
it may be an emotional problem, motivated reasoning, a need to deny reality, blame an outside source for your misfortune or to sell an idea, product, service or your brand
BUT no one who can understand the written word and survey research can accept the crap put forth by anti-vax .

RFK jr attended Harvard and the LSE and later studied law, acquiring 2 degrees.
So he can read. I don’t think that he has a child with ASD – which often sets off immersion in anti-vax BUT he does have a law firm that can sue companies PLUS he wants to make a big splash- he has a crusade to lead. He styles himself as an expert but makes the most horrendous mistakes when discussing science as Orac has catalogued over the years ( see search above RFK jr), He indulges in histrionic speech to incite followers and will appear with anyone who agrees with him on vaccines despite their background including some dodgy operators, even DJT.

A college grad should be able to see through the bad science and blatant MO of anti-ivax.
which requires conspiracies to explain why their cutting edge science has never been adopted by the mainstream. It must be a plot..
They will enlighten and save the world Shift the entire paradigm like Galileo did…

Basic science explaining vaccines at the level of the NYT, WaPO, Time, BBC,CBC, or governmental information should be enough to educate people- even secondary school students. .RFK jr fails.
.

Orac writes,

“Can I trust the CDC and FDA any more?”

MJD says,

I’m assuming this is not a rhetorical question. Thus, “no’ is my response. Therefore, file a citizen petition to present your grievance, although, it may take over a decade to get a response. For example, it took 13 years for the FDA to respond to a citizen petition from MJD. Wait a minute, I’ve asked Orac many questions over the last decade without a single response.

@ Orac,

Please respond

Orac and Dorit (OD) fail to mention that no childhood vaccine has ever been tested against a true inert saline placebo, they are mostly compared to other vaccines; nor are they tested to see if they cause cancer or infertilities, and that most of the pre-licensing studies lasted from 2 weeks to 48 hours (Polio), as clearly stated in each manufacturers’ vaccine insert. See https://tinyurl.com/Insert-Placebo-Info.

OD also fail to mention that in the only study where a true placebo was used, in one particular Gardasil study, that no one in the placebo group had any Systemic Autoimmune Disorders, and that Merck merged that group with one that received aluminum (like in the Gardasil vaccine) and other of its ingredients, minus the virus. Here is revised Table 10 of the Gardasil insert showing such fraud. See https://tinyurl.com/Gardasil-Revised-Table.

The CDC and the FDA are infiltrated by Big Pharma operatives and it is my personal belief that people like Dr. (sic) David Gorski and Law Professor (sic) Dorit Reiss are helping perpetrate the vaccine-safety fraud and are knowingly conspiring to commit crimes against humanity, by promoting vaccines as safe, by attacking those against them as ignorant cranks, claiming that no therapeutic treatment helps to stop the spread and injury caused by COVID-19, that only a vaccine will help stop the alleged pandemic, and always telling us to fully and in no uncertain terms to trust HHS/FDA/CDS – until, of course, our President Trump starting talking of cures outside of the vaccine program.

When talking about whether hydroxychloroquine working for COVID-19, Dr. Fauci said that we would not know until we did the Gold Standard of tests, which he said was comparing it to a true placebo. Why has this never been done with vaccines, whose studies were never made in emergency situations like this alleged COVID-19 pandemic?

I challenge Dr. Gorski and Dorit Reiss to disprove any of the statements I make above and in my Analysis of Vaccine Safety Claims flowcharts, https://tinyurl.com/Vaccine-Flowchart-Summary, which proves that vaccines have never been proven to be safe, are in fact causing disease, and that the vaccine manufacturers, including their direct and/or indirect spokespersons, like Gorski and Reiss, are committing fraud and are therefore involved in Crimes Against Humanity. I am open to set up any forum for the discussion.

Sincerely,
Pastor Ricardo Beas

“until, of course, our President Trump starting talking of cures outside of the vaccine program.

Pastor, huu? The face is the image of god don’t hide it with a mask kinda mindfuck?? You have freedom of religion, not freedom of arcitecture — Jesus: All of God that would fit into a cum-shot into a twelve year old.

I guess my drunken inflammatory rhetoric has finally got me banned. Been fun all, keep it real.

I think I’ll purchase a bunch of Trumpy-bears as advertised on Fox, pile them around your house, and light them on fire. I declare as Antifa; Trump win, or not, Imma coming to your (yes, ‘your’ as in r/fuckyouinparticular) suburb. You won’t ever suspect a thing; Once the Trumpy-bears flair up, you won’t be able to see though the blaze to see who did you, and your family, your dog, your Simple Green guy in. /s {not really}

God damn, F68.10. Your measured rationality has caused me to to tell my peeps to consider to not burn down Trumpster’s houses with Trumpy bears. Are you controlled opposition??

I assumed it was a faith healing scam. Or maybe an attempt to use religion to gain either vaccine exemptions or a religious veneer to cloak otherwise actionable statements. The Natural Law Church of Health and Healing. Either way, it’ll be a money spinner.

@ Tim

I’m not controlled opposition. Merely speaking for myself. But see the whitey in that photo? That’s the school where I grew up. Maybe you now understand why I suggest people really should take a step back while they still can? What’s happening in the US is spiraling out of control. But maybe I think too much like a Swiss.

@ others

On the Raoult front, for French speakers, I really suggest this interview of Didier Raoult by Darius Rochebin.

Put bluntly: this interview is premeditated murder with silk gloves.

Darius Rochebin is a swiss journalist who has recently been hired by LCI in France. He asserted when joining LCI: “Seen from Switzerland, French people engage in rhetorical hubris.”

And he proved it. Premeditated murder of Raoult. With silk gloves.

A gem.

Aww, you’re a girl!! {I listened to that Byrds song about 15 times now, thx} (or possibly one of those super-cute black kids) .

Shine on, you crazy diamond:

Yes, ‘Merica –>Nazi.–> ‘Merica’ Why does it always have to be this??

@f68.10

I don’t understand why we as a collective are doing this. I’ll just surf on that it has been many genarations that forbid cannabis. We are not a rational people.

@ Tim

That’s a much more recent photo. The dress code hasn’t changed though… And I do not have the full blown aryan phenotype…

@ F68.10

On the Raoult front

To stay on this, I found out this morning that Fabrice Lucchini has floated the idea of playing Raoult’s role if a biopic was made about his life. Because maverick doctor.
I’m disappointed.

Rhetorical hubris, you said? I hate but have to admit, the shoe fits.
(to echo someone on Orac’s friend blog, we French are nuanced)
Although I don’t think we French have a monopoly on that. Other people may just be a little less nuanced.

@ Tim

Maybe it’s time for a foreign intervention from a more civilized country. Like South Africa. I lived in Lesotho, so I’m used to these…

p.s. Even though I use Ublock and Noscript, I’m still not clicking on preacher man’s link. Hiding behind ‘tinyurl’ more often than not means that the site has a free payload that it really, really thinks you should have.

“I use tiny addresses to simplify typing a link.”

Bullshit,. Just copy/paste the link. tinyurl is that + extra steps.

If people had recognized it as .pdf, most would not visit anyways. SumatraPDF may be safe but default browser is not for this guy’s offerings.

I don’t have the luxury of a thowayway machine right now or I would expose what you are trying to do.

WTF are you even saying. The cures outside vaccines “Our President Trump” has been talking about boil down to hydroxychloroquine and drinking bleach. Now that the former has been proven to be ineffective and the latter has been laughed out of the room, “Our President Trump” has only been talking about a vaccine and has been pinning all his hopes on it.

@ Addicted

“Our President Trump” has only been talking about a vaccine and has been pinning all his hopes on it.

Don’t forget what he recently said about “herd mentality”. Seems like, in his hurry to get something, anything before the US presidential election, he is now hoping, along with his new health advisors, that the virus will just go through everybody in the US, and natural immunity will be achieved.
And too bad for all the losers who will get the virus and be harmed or killed by it..
Well, it kinda was his master plan all along.

Pastor Beas (identified online as an “alternative artist” who runs something called the “Natural Law Church of Health and Healing”*) has been mentioned previously by Orac (2/19/20) in an article about antivaxers who attempt to use religion to justify their crank views.

A sample of Beas’ loonery, in which he proclaims that he and his disciples will:

“Defend ourselves from any corrupted evil human beings that, for whichever misguided purpose, (1) want to defile our body and corrupt our minds, God’s Temple, in any way, promoting and forcing supposed medications, orthodox medical treatments and vaccination upon us which are toxic and are contaminated with such things as aborted (dead and preserved alive) fetal cell lines; (2) are destroying the world through contamination of our natural resources, affecting air, land and sea; (3) are contaminating God’s natural foodstuffs through Genetically Modified Organisms (GMO’s); and (4) are discrediting, attacking, jailing and killing any person involved (as promoter, seller or user) in any unorthodox medical treatment, or who confirms that vaccines cause autism.”

The Church also warns against the Evil that would impose radiation on the flock (5G? Oo.) and, like Jesus, appears intent on suing various parties to get its way. Reminds me of the anti-EMF activist who sued his neighbor for $1.43 million, because she had an iPhone and used Wi-Fi (he lost, hopefully ordered to pay his victim’s court costs).

*Mr. Beas likes “scare quotes” so he’s welcome to more of them.

Fun reminder: Anyone who is anti-GMOs (like Mr Beas here) is also anti-insulin, because in the modern system insulin is made in GMO yeasts. Before that insulin was extracted from pig pancreases, and there aren’t enough pigs in the world to keep all the insulin-dependent people alive.

There are sane and reasonable conversations to be had about crops and monocultures. But just shouting “GMOs” isn’t it.

NumberWang, my church does not require any fees to join and never asks for donations or has it ever received any.

Interesting comments, except that no one is addressing the evidence I provided, you are all ignoring it, all comments are just an attack on me. Is it because you all know that what I say is true? I gave Tim the links to the true inserts, so there is no excuse for not viewing them (or he can look for them on the net on his own), but he believes it is better to attack me than to look at the truth.

So I ask each on of the persons that commented against me to address this: Let’s use another vaccine, for Pneumococcal, Prevenar 13: (1) There was not placebo test, the study compared Prevnar 13 with Prevnar; (2) two studies, on lasted 7 days and the other 4 days, (3) was not tested to see if it caused cancer, and (4) was not tested to see if it causes infertility. Here is the link to the insert: http://labeling.pfizer.com/ShowLabeling.aspx?format=PDF&id=501. You will find similar things with all the childhood vaccines.

Now look at the Gardasil inserts, compare table 4, on Injection-Site Adverse Reactions, which shows a vaccine group, an AAHS Control group (received aluminum+), and a placebo group, with table 10, Systemic Autoimmune Disorder. In this table they combined the AAHS group with the placebo group, hiding the zero problems in the vaccine group. That group, from ‘A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018), can be found here: https://clinicaltrials.gov/ct2/show/results/NCT00092547?view=results. And again here is the link to the Gardasil study: https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf. Here is the result of the placebo group, showing the disorder and the number of placebo recepients that showed such condition:

Blood and lymphatic system disorders
— Haemorrhagic anaemia 0
Gastrointestinal disorders
— Colitis ulcerative 0
General disorders
— Chest pain 0
Infections and infestations
— Appendicitis 0
— Localised infection 0
Injury, poisoning and procedural
complications
— Meniscus injury 0
— Road traffic accident 0
Metabolism and nutrition disorders
— Type 1 diabetes mellitus 0
Musculoskeletal and connective tissue
disorders
— Pain in extremity 0
Nervous system disorders
— VIIth nerve paralysis 0
— Tonic clonic movements 0
Renal and urinary disorders
— Acute kidney injury 0
Reproductive system and breast
disorders
— Dysfunctional uterine bleeding 0

Remember, don’t attack me, attack the facts I present, else you are just another spokesman for big pharma, whether you get paid directly or indirectly by them, like through their controlled government and private institutions, like NIH and other organizations, where Gorski gets his million dollar grants. Either that or you are simply ignorant and prefer staying that way.

I challenge Orac to address this comment and the facts I presented.

@ Beas

“Remember, don’t attack me, attack the facts I present, else you are just another spokesman for big pharma, whether you get paid directly or indirectly by them…”

I have a personal emotional relationship with the Zug canton in Switzerland, where Roche has a big building in Rotkreuz. Zug is a major major tax haven, and we all benefit from the presence of industries such as Roche, who pay very little taxes. But enough to make public finances swell like the Yellowstone geyser.

That’s why personal tax rates are so friggin’ low… And it made me extremely happy.

Does that make me a pharma shill?

Because if it does, I’ll gladly let other people answer…

By the way Orac, you are allowing and condoning, if not fueling (as you did in your attack on me and my church in a previous article) comments that result in harassment, hate speech and an attack on my religious beliefs and rights by your followers and people that comment here, like Tim, who is promoting and hoping that someone kills me and my family:

“I think I’ll purchase a bunch of Trumpy-bears as advertised on Fox, pile them around your house, and light them on fire. I declare as Antifa; Trump win, or not, Imma coming to your (yes, ‘your’ as in r/fuckyouinparticular) suburb. You won’t ever suspect a thing; Once the Trumpy-bears flair up, you won’t be able to see though the blaze to see who did you, and your family, your dog, your Simple Green guy in. /s {not really}”

Thus by not condeming it, you are supporting it and you and your site are acting as spreaders of hate speech, See 18 U.S. Code § 249, Offenses involving actual or perceived race, color, religion, or national origin. Further, A court can impose several possible penalties on someone who was convicted of making criminal threats. Depending on the state, a criminal threat can be charged as either a misdemeanor or felony offense. While felony offenses are more serious than misdemeanors, either of them can result in incarceration, fines, and other penalties. Anyone convicted of making a criminal threat faces a substantial time in jail or prison. A misdemeanor conviction can result in up to a year in county jail, while felony convictions can impose sentences of five years or more. In some instances, a terrorist threat can result in a sentence that lasts decades.

Aw, you poor triggered snowflake, no one threatened you. Pro tip: a sentence that ends with “/s” indicates that Tim was using satire because your words are very silly. You also missed he ended by saying “not really.”

I guess you think the First Amendment only works for the chosen people like you. Sorry, snowflake, it does not. Especially since Orac used your own words: https://respectfulinsolence.com/2020/02/19/latest-attempt-by-antivaccine-movement-to-invoke-religion/

Science does not care about your clueless opinions. We do not need to provide the silly stuff you “demanded” because it is idiotic. It is up to you to prove vaccines are dangerous. All you have to do is provide the PubMed indexed studies by reputable qualified researchers that any vaccine on the American pediatric schedule causes more harm than the disease. But you cannot because you have proved you reject actual science and will buy into any crazy pants idea out there.

I am now waiting for Beas to tell us: “I am going to tell AG Bill Barr that the people on Orac’s blog are being mean to me and Trump! That has to be sedition.”

From that article:

Both in 2019 and today, Hawley explicitly cited the supposed silencing of conservative speech as his motivation for the bills, claiming users have no recourse and adding, “Congress should act to ensure bad actors are not given a free pass to censor and silence their opponents.”

I am not surprised at that kind of whining, which is why they are special snowflakes. Then we have this insanity: https://www.seattletimes.com/opinion/sleepless-in-seattle-the-mayor-durkan-remake/

{well, I hit the wrong button on my tiny keyboard again so this may be a double-post}

It was essentially to say that the understanding of 230 is dumb as it was what allowed moderation/moderators in the first place. And that no site can afford the risk of litigious fucks (such as Mr. Beas??) to milk them every time someone leaves a bad review of some MLM crap.

These comment sections would be gone, if 230 is gutted as proposed.

My employer is very Trumpy. I warned him in 2017 what would start happening under Ajit’s policies — r/LeopardsAteMyFace

I’ve railed against Guardasil in 2006 when Rick Perry stood to make $$ by making it mandatory. I even passed out VCD’s on the matter. I’ve railed against certain GMO’s like rBGH because it lead to puss-filled milk, BT corn because I thought it messed up gut bacteria, and Roundup-resistant soybeans because the shit is litteraly in my backyard and the stuff is so saturated that on a foggy night my banana plants looked like wet paint streaking and dripping off. That, and the litigious nature of Monsanto* — suing everyone around.

But, false preacher man, you and yours have ruined it for me. Anyone who goes around here quoting “See 18 U.S. Code § 249” that is not also an expert in ferel cats is just a litigious fuck. The rest of your words just sound like any other copyright troll ever. You don’t “buy in” to any of that shit — But you are a proud manufacurer and distributor of it.

https://torrentfreak.com/prenda-copyright-trolls-arrested-and-charged-with-fraud-and-extortion-161216/

p.s. Trumpy bears don’t even burn; They smell of cheap naugahyde and don’t absorb accellerant. Red mercury, low-yeild mini-nukes, on the other hand…

*On this very blog, perhaps, I stated that it’s like they shit on your table, call the cops and the cops arrest you because that is obviously their shit on your table. {their product infecting your land and you get sued}

“it lead to puss-filled milk”

See, in my experience, milk just produces cats naturally. No hormones needed.

Like many of his fellow antivaxers, Beas has latched onto placebos in an effort to delegitimize vaccines. In addition to not understanding the purpose and proper use of placebos, he’s dead wrong in his claims.

For example, there have been multiple randomized, double-blind placebo-controlled trails of pneumococcal vaccine, including Prevnar13..

Further, there have been many vaccine studies using saline placebo.*

https://vaxopedia.org/2019/02/13/where-are-the-saline-placebos/

*Saline placebos aren’t always the optimal type of placebo to use in a vaccine study, but Beas can’t or won’t comprehend that either.

Meanwhile, back at the CDC, the Trumpers strike again:
“CDC removes statement on airborne virus transmission, claiming website error.
The agency had posted guidelines suggesting the virus can transmit over a distance larger than six feet and that indoor ventilation is key to protection against its spread.”(Wapo)
“In Another Reversal, C.D.C. Removes Guidance on How the Virus Is Transmitted
After posting on its website that the virus is transmitted mainly by tiny air particles, the agency withdrew the guidance days later.” (NYT)

What does it say that no one seemed to notice until it got changed back? Personally, I haven’t visited CDC official site in months. It’s cludgy and when I finally got to the page It danced around the whole ‘airborn thing’ stating “surfaces are not thought to be the main way the virus is spread, we’re not sure of the main way” or words to that effect.

This one’s a real toe-tapper but, I’ve not seen it on networks yet as they’re all over the CDC reversal and Trump’s self-given grade as A+ (but a D on PR because fake news) & Supreme Court machinations:

https://www.thedailybeast.com/redstate-covid-troll-streiff-is-actually-bill-crews-and-he-actually-works-for-dr-anthony-fauci {he bowed out of his position at NIAID hours after it was published}

At last we have real evidence of the “deep state” and they are not what Trump and his ilk have been claiming. Quelle surprise.

I saw a reference to claims made by an engineer that “aerosol” transmission is very important. Perhaps guidance was taken down because it was produced on work from an engineer only and had not been adequately evaluated in terms of biological plausibility. There has been an awful lot of sloppy mock science surrounding this disease. Without knowing what the work was it’s impossible to evaluate it. It may be excellent. It may be rubbish. It may have been that the language in the guidance was simply sloppy and terms such as “aerosol” not adequately defined.

Very early in the outbreak some researcher did some very limited work using mechanically generated aerosols and published that virions remained viable for some substantial time therein. This lead to a lot of jumping to the unsupported conclusion that airborne transmission was important.

Even with that transient appearance at the CDC,the anti-maskers jumped on it to shout about masks being useless because Mosquitoes! Chain link fences!

After posting on its website that the virus is transmitted mainly by tiny air particles,

Air particles? What in blue blazes are “air particles?” That is sloppy and meaningless language. But after that incompetent and harmful article about PCR, I don’t expect much of the NYT.

As I recall, CDC briefly mentioned work like this (particularly re: the Guangzhou restaurant and the Skagit Valley choir practice) to support airborne transmission of SARS-CoV-2:

https://www.medrxiv.org/content/10.1101/2020.04.16.20067728v1.full.pdf
https://www.medrxiv.org/content/10.1101/2020.06.15.20132027v2.full.pdf
https://www.medrxiv.org/content/10.1101/2020.07.13.20041632v2.full.pdf

CDC might have been influenced by the fact that evidence discussed in an open letter by over 200 scientists that study aerosols caused WHO to change its position, but there’s more like this:

https://www.medrxiv.org/content/10.1101/2020.07.13.20041632v2.full.pdf

Sorry if this is a double post. The first attempt produced an error message.)

Thanks for the links, Brian. There is one among them that I hadn’t seen before. I’ve only skimmed it so far but it looks pretty good.

One problem with this topic is that terminology tends to be inconsistent. The engineer I mentioned referred to “aerosols” which can be defined just about any way one chooses (I do draw the line at calling cheese goop in a pressure can “aerosol.”). “Airborne” has established meaning, though not totally consistent, in reference to transmission. The general public seems to largely regard direct droplet transmission as airborne though it is formally considered to be distinct. Of course there is a continuum and no sharp boundary.

A lot of this stuff would be much easier to evaluate were it not for the pesky ethical barrier to trying to deliberately infect people with a potentially deadly disease.

@ doug

“A lot of this stuff would be much easier to evaluate were it not for the pesky ethical barrier to trying to deliberately infect people with a potentially deadly disease.”

Just curious: aren’t there any kind of precautions or compensations that could make such trials ethical? This is not exactly a serious question, but I really wonder where the ethical limitations are really placed in such matters.

@f68.10

“Human challenge trials” are sometimes used in vaccine evaluation. People who have been vaccinated are deliberately exposed to the target pathogen. This of course can be very high risk and I suspect you really have to have your proposal extremely well constructed to get it past an ethical review panel. Somewhere along the line I saw a document discussing such trials. I think it was at the WHO website but it might have been at the US CDC site.

I suppose with serious diseases for which there are effective treatments it might be ethical to experimentally infect people.

I’m listening to the detailed, in depth presentations of ACIP on Covid-19 vaccines. They are doing massive work to assure safety. The fact that these political manipulations may undermine their credibility – when AcIP is actually relatively independent – and lead reasonable people to dismiss all that work is a very, very painful and real possibility.

These people are causing so much harm.

Here’s the link, if anyone wants to watch. https://www.ustream.tv/channel/VWBXKBR8af4

The fact that these political manipulations may undermine [ACIP’s] credibility and lead reasonable people to dismiss all that work is a very, very painful and real possibility.

More than a possibility I’m afraid. One question though is how much the work of such government bodies reaches reasonable lay people even w/o political interference. Information only reaches the majority of the public through a fairly heavily-mediated route, going not just through the press releases prepared by the agency’s communication staff, but through the additional layer of reportage in the mass media.

The result is that the Trumpers don’t have to purge the “Deep State” scientists from the agencies, they just have to purge politically inconvenient material from the press/PR releases and the web material designed for the masses. Actually, the don’t even have to purge all of it. If you look at typical public health messaging, it’s all pitched to a largely distracted unsophisticated public. KISS rules: distill the message down to one central idea and hammer it over and over again. More granular nuance can be a terminal glitch of confusion, much less actual contradiction.

So with just a few well-placed gatekeepers, like Caputo and “strieff” and, I guess now Azar, even if a bit of good info gets out, there’s always a reversal, a ‘well no, we didn’t mean THAT’, and that’s enough of forked-tongue speaking to screw the poochie as far as getting understanding of all that good work out there enough to do any good.

Orac wrote about the controversy concerning airborne transmission of Covid ( July 13).

These reversals at the CDC fuel the fires of scoffers like AoA ( today) who insist that we can’t believe them anyway because of they “created, exacerbated and ignored the autism epidemic”.

Unfortunately, as doug notes, even sources that were usually reliable like the NYT can publish sub-par material.
Of course, this enables woo-meisters and anti-vaxxers who can then claim that the ‘esteemed’ outlet agrees with them or that it is a rag and can’t be trusted for scientific information. A frequent rant by PRN’s chief super-spreader of misinformation maintains that the NYT’s Judith Miller was wrong about weapons of mass destruction so we shouldn’t believe anything they print. ever.

I think that sceptics should learn how to determine which sources are fact based and how alt med proselytisers manipulate their audiences through misquotes, omission, relying upon suspicious outlets or contributors and mis-interpretting standard material. Right now a few pseudo-scientists are trying to negate Wikipedia entries that discusse their qualifications and beliefs so as to disarm their critics and insist upon PR that props them up rather than outside sources that investigate their activities and beliefs.
Which leads me to ask, ” Did they ever have to write a university level paper, do research or write up current news for secondary school?” Doesn’t look like it.

In fact, a common trait of altie,,cult leaders** or trolls on RI is to dismiss standard news reporting, current science or academic consensus.

** I’m watching a television documentary about the inner workings of a NY State cult, NXIVM. that examines their efforts to silence critics and present themselves are the vanguard

AND as we at RI know only too well, alt med providers disputing Wikipedia bios, cult leaders disparaging reality based reporters and trolls attacking sceptics all attribute critics’/ mainstream media’s/ academic findings as being bought and paid for by nefarious international ,industrial cartels and thus, not to be trusted

Actually, the aforementioned cult leader paid a former news person to explain away how mainstream news is unusually opinionated, extremely judgmental and uses purely qualitative terminology… so it’s then correct to call a Master/ Slave secret society a “women’s group”.
A mail order degree mill a respected educational institution and Medical Hypotheses a peer reviewed scientific journal,.

Well, for the CDCs before Trump started bending their writings, there are some guidelines for oseltamivir prescription that are so so ..
Otherwise t’is a great institution with some branches being attacked

“Can we trust the CDC and FDA any more?” No. The conflicts of interests and revolving doors made me stop trusting them a LONG time ago.

@ Tim – Thanks for the link regarding William B. Crews. Lovin’ this guy and can’t wait to read all his posts as “streiff” on Red State. Woohoo!

Love JP too. https://www.youtube.com/watch?v=ZeCaYaG-ZRM

Good day.

You perhaps have noticed that Trump is pushing covid vaccine before elections. He would like minimise covid to better his chances to get elected. This is the reason why CDC is now unreliable, not supposed “conflicts of interest”. You are applying nice Orwellian crimestop here (stopping anti party line thinking without any thinking, by a standard device).

Continuing your reign as a disgusting sadistic child hating disease monger. You really don’t care how many people get sick with a high possibility of permanent damage and death. So there is blood on your hands too.

@ Chris:

Agreed. What’s 200 K? They would have died anyway eventually.

Why are so many alt med advocates/ anti-vaxxers/ libertarians strong denialists about Covid and SB ways to mitigate it?
–As I mention above, sources are very important ( see JP Sears Rational Wiki about his education, careers, politics) know what a reliable source is..
–A commenter at AoA ( Benedetta) relates that Dr Fauci and Bill Gates were in school together so of course, they stick together- Where did she learn that?
There is much more than a decade age difference between them and they went to different universities, studying different subject matters. Perhaps, I’m wrong and Gates was a premed student and classics major at age 5. You never know.
— twitter trending: Dr Fauci discusses Covid with Senator Paul today concerning herd immunity.

Where do scoffers get their “facts” and “data”? Rhetorical question, we already know that.

What saddens me is that it’s extremely political. Why would they do this [extra safety stringency] when we come back with these great results; and I think you will have these great results. Why would we, why would we be delaying it? But, ahh, we’re gonna look at it, we’re gonna take a look at it 🤗 and ultimately the White House has to approve it. And.. maybe we will and maybe we won’t but we’ll be taking a look. I ☝️ have to leave👌 for an emergency phone call, I’m gonna let 👉 Scott and Larry fininish up {with my incredible mindfuck proclimations}

— DJT

“I don’t think all those people are dying from the virus but to disrespect me.” — DJT, probably

“Once a vaccine is issued an EUA, the ethics of continuing a placebo control group in other ongoing vaccine trials becomes problematic, as the EUA would result in a de facto standard
of care, and clinical trials cannot ethically deliver care that is below the standard of care. It would thus become arguably unethical to continue to use a placebo control in clinical trials,
meaning that the trials might have to be altered to compare the new vaccines versus the vaccine with the EUA. This would make it difficult to tell which vaccines are the safest and
most efficacious.”

I have been told repeatedly on this blog that it would be unethical to use a placebo control in a clinical trial to determine if there is a correlation between the vaccines on the childhood immunization schedule & SIDS. Instead; those vaccines are compared to other vaccines. When I mention that there has never been a saline placebo controlled study to rule out if vaccines are associated with autism, I was told the same thing.

When I replied, in my own words, that “this made it difficult to tell which vaccines are the safest and most efficacious”; some said that it was an appropriate standard of care because it would be unethical to use a saline placebo. Why should the vaccine that YOU desire, be held to a higher standard than the vaccines my children receive?

Non-rhetorical question: If Trump is defeated in November, will you take the vaccine created during his administration, or will you require that they start all over again, so that you can have a Trump-free vaccine? I guess that could happen by maybe 2023?

This question suggests a misunderstanding. The claim “an already licensed, tested, used product has a problem we didn’t notice before” is fundamentally different than the claim “we still don’t know the risk/benefit profile of this new product and it needs to go through testing.”

When you claim vaccines cause autism and SIDS you’re claiming the former. RCTs on that raise the real question of depriving people of a product that previous data shows has benefits that outweigh its risks. That’s unethical. As much as you want a group of children to be given saline instead of being protected against diphtheria, tetanus and pertussis, for example, potentially fatal diseases, ethicists see a problem.

But studies were done on these questions – controlled studies all around the world – and they show vaccines don’t cause autism and SIDS.

An RCT is sometimes the right approach, but not always.

My decision whether to take the vaccine will depend on whether the existing, robust oversight process is allowed to work and what’s the data is from the trial. Though for full disclosure, I did sign up to the trial registry (haven’t heard back yet), so I’m clearly also willing to be part of the testing process.

@ Dorit,

Good news; the saline placebo trial could now be ethically done for the safety study of diphtheria, tetanus and pertussis vaccines.

We have other proven treatments; known as erythromycin, azithromycin & tetanus immune globulin.

Tetanus and diphtheria have a 5-10% mortality rate with best treatment. They both have other risks besides death, too. There isn’t a good treatment for harms from pertussis – antibiotics help if you catch that it’s pertussis early enough, but that’s really hard to do

I understand you think it’s still ethical to put children at that risk. People who understand the data and understand ethics don’t see it that way. “Good news! We can do an RCT and if the children that were not protected get the disease, their risk of death maybe – if we are lucky – can be brought down” isn’t a convincing statement for people who work with these things.

The fact that you, an anti-vaccine activist, can sincerely say it in the way you did is highly troubling.

How many times I have asked an antivaxxer to type “”saline placebo” vaccine” into Google Scholar search box. Perhaps you could do that ? Saline placebo is unethical when there is a working treatment, not when there is not one available
Trump free vaccine is of course not needed, what is needed is full set of clinical trials. Any of current vaccines are OK, if they pass these.

Almost all the vaccines on the schedule met or exceeded the standards for covid-19 vaccines.

Annual influenza is too often less effective, but because of the logistics of annual influenza epidemics, that can’t be tested in advance.

@cochristi
Go a step forward and type “”saline placebo” mmr vaccine” into Google Scholar search box. Simple, is it not ?

Concurring with Prof. Dorit Reiss. Measles results in encephalitis and pneumonia. In last year’s measles epidemic, hospitalization in Rockland county for measles was over 20% of cases. Additionally, measles causes immune amnesia – wiping out immunity children have already garnered for other diseases, and the rare disease, SubAcute Sclerosing Pan-encephalitis, a dismal condition which often results in death. And on top of that the public health costs needed to subdue a measles outbreak is astronomical, not just in dollars (NYC spent 6 million dollars) but personpower – 500 public health personnel were redeployed to deal with the outbreak, and vaccinate the unvaccinated that the anti-vax groups were stoking. Can you imagine if we had a measles outbreak (or Diphtheria, or pertusis) on top of CoVid?

@ Doctor Barbara,

I can’t seem to find any information on how many people died or were permanently disabled due to the Rockland outbreak?

Measles “outbreaks” used to result in lifelong immunity from measles; NY should have saved their 6 million.

Measles “outbreaks” used to result in lifelong immunity from measles

1) Only for those who survived.
2) Even those who survived suffered horrible consequences: deafness; blindness; brain damage; and measles disables immune memory, making you susceptible to diseases you’ve had before or were innoculated against.
3) Some people still don’t gain measles immunity from wild measles infection.

I’ve said this before, but it bears repeating. Catching a disease to gain immunity to it is like burning something to fireproof it.

Nor can I find any report of any autism cases or other severe cases associated with the tens of thousands of vaccines the Rockland County DOH (and the NYC DOH) administered to stop the outbreaks.

But in the Israeli outbreak (same year, same source of index exposure) 3 people died and one (a ten year old boy) was permanently disabled. (Permanent brain damage in extended coma) from the disease.

Does anyone know of a better source than the CDC to get regular, reliable information about coronavirus research and recommendations? Universities, or CDC-equivalents in other countries?

WHO, Johns Hopkins, Oxford, umm.. I know there is an equivalent to the FDA in the EU, but I don’t remember what it is called. I don’t know if the Australian/NZ information would be as useful, given the seasonal difference.

For vaccines specifically Moderna, Pfizer and Johnson and Johnson have all published their clinical trial protocols (though I will admit I haven’t read them yet), which are good for understanding what the metrics are/will be for those vaccines.

Also, Tim, please more /s tags when you’re being funny.

You have not learned anything about Google Scholar, it seems. About zero autism risk, would you like me cite Hviid’s paper (or Jain’s) again ? Tell me what is problem with these ?
Actually, paper stating there is zero autism risk would be suspicious. You must always cite error margin.

Her question is misleading, but your answer still shows her wrong. What she’s complaining is that the few trials that looked at MMR very saline placebo – few, because for a combination vaccine the main question is comparing it to the individual vaccines, not to saline, but it happens that there is a saline trial there – did not look at the risk of autism, something not alleged at the time.

Of course, if there was a strong link it should have come up without looking, but she’s complaining on the lack of focus.

You still answered her, because comparing children who got MMR to children who did not get MMR should capture the risk, if the observational study is good enough, and there were many on Mmr, with this Hviid just the last iteration.

@Tim:
/ And yet measles outbreaks continued to happen….why, exactly?

Because there are pockets of vaccine resistance, which are rising — in direct proportion to infiltration by the anti-vax community.

No less than four of the 6 major outbreaks in the last eleven years were in insular communities, one in the Somali, 3 in ultra Orthodox. Each of these sustained an earlier prodromal epidemic with in the five years prior. In each case the the community registered a vaccine uptake significantly lower than the general population at the time of the initial/prodromal attack. After that prodromal outbreak the anti-vax community targeted these groups with focused literature, robocalls and conferences – well documented, px and literature and interviews the the principles of these groups are on the web. And when the second epidemic hit- the vaccine resistance had more than doubled, in some cases increased by ten times.

So that’s why measles outbreaks happen – people aren’t being vaccinated. And the reason they are increasing in severity is because the anti-vax groups are spreading their message and increasing the percentage of unvaccinated.

You are of course, correct. There’s a reason that anti-vax proselytisers target insular communities**: they may be less attuned to standard informational sources and suspicious of the majority community. RFK jr tried to lecture Black people in Harlem who may be wary of governmental intervention because of their true history of oppression and medical malfeasance such as Tuskegee experimentation..

In addition,, anti-vax leaders actively avoid or deny any research which invalidates their beliefs no matter how well done: Arno mentions studies by Hviid and Jain, both which show no association between vaccination and autism and involved large numbers of subjects. Similarly, there is an entire of body of research that does show how autism develops that is denied or insulted by anti-vax thought leaders: genetic research, studies of early detection of autism and research into how the brain develops prenatally that show what occurs and makes autistic people’s brains different. including insults during gestation..

Anti-vax advocates such as Wright and Rossi scoff at “money wasted” by researching genetics, characteristics of the mother and early indicators like gaze. HOWEVER these studies show that ASDs can be detected in infants as young as 6 months ( Ozonoff) or even at 3 months ( UCLA, EEGs)
LONG before the vaccines that are generally indicted as harmful. Studies in brain research such as that of Courchesne, Miles and Aldridge provide additional data that illustrate how vaccines are not a likely cause of autism.
Yet I never hear the aforementioned well-known scientists or their colleagues mentioned by anti-vax luminaries. I wonder why that is. . .

** -btw- I live near several enclaves of the Ultra Orthodox/ Hasidim

i should add:
Ed Lein is another researcher of interest ( UWashington). Both Courchesne ( especially his 19 minute video) and Ozonoff have created detailed videos/ lectures that explain their results.. EASY to find.

Sorry, I should have been clearer in my reply. Historically, measles outbreaks occurred cyclically – i.e. lots of people would get sick & the threshold for herd immunity would be reached & the cases would taper off.

Then you get more “non-immune” people added to the population – the threshold for herd immunity is breached & the outbreaks happen again…this was the historical model.

It wasn’t until we could vaccinate that this threshold could be reached & maintained without the need for people to get sick, get crippled or in some cases, die.

Anti-vaxers seem to love seeing people get sick – I have no idea why, unless they are a bunch of sadists.

“You could, upfront, acknowledge the tragedy of responding poorly, apologize for what has happened and your role in acquiescing, set a course for how CDC would now lead the country if there was no political interference, give them the ability to report such interference to a neutral ombudsman, and assure them that you will defend their attempts to save this country,” he wrote. “Don’t shy away from the fact this has been an unacceptable toll on our country. It is a slaughter and not just political dispute.”

And as for Redfield’s own legacy in this historic pandemic, Foege cautions: “You don’t want to be seen in the future as forsaking your role as a servant to the public in order to become a servant to a corrupt president.”

https://arstechnica.com/science/2020/10/redfield-urged-to-leave-cdc-in-blaze-of-glory-or-forever-be-trumps-toady/

There were attempts to politicize and undermine the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention, the journal noted.
.
.
The editorial castigated the Trump administration’s rejection of science, writing, “Instead of relying on expertise, the administration has turned to uninformed ‘opinion leaders’ and charlatans who obscure the truth and facilitate the promulgation of outright lies.”

The uncharacteristically pungent editorial called for change: “When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.”

https://www.nytimes.com./2020/10/07/health/new-england-journal-trump.html

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