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Antivaccine nonsense Bioethics Medicine

To unblind or not to unblind COVID-19 vaccine trials?

Antivaccine alternative health tycoon Joe Mercola claims that the unblinding of participants in the clinical trials of Moderna and Pfizer COVID-19 vaccines was intended to “blow up the trials” and undermine the science, making it impossible ever to identify long term adverse events. What he’s really doing is deceptively oversimplifying complex ethical and scientific issues surrounding these trials in the middle of a deadly pandemic, all in the service of his grift.

One longstanding tactic of the antivaccine movement has been the oversimplification of complex questions of science and ethics in such a way as to imply nefarious intent on the part of vaccine manufacturers, public health officials, physicians, and vaccine advocates. The idea, of course, is that somehow we are all “sabotaging” the science in order to cover up evidence of massive harm due to vaccines. This tactic has, in particular, been weaponized in the era of the COVID-19 pandemic, largely because of uncertainty in the science and the fast pace of scientific discovery. More importantly, the fast pace of vaccine development has left open a door to this tactic of oversimplification. An excellent example of this tactic comes in the form of an article published by one of the foremost promoters of antivaccine disinformation and COVID-19 quackery and crankery, “alternative health” tycoon Joe Mercola. His talking point comes in the form of an article entitled “Vaccine Makers Destroy COVID Vaccine Safety Studies”.  His objection? That Pfizer and Moderna going to unblind the clinical studies that led to the emergency use approvals (EUAs) issued for their vaccines.

Basically, if you listen to Mercola, Pfizer and Moderna are “sabotaging” clinical trials and/or denying antivaxxers The One True Vaccine Safety Study that they insist to be absolutely essential. Before I discuss Mercola’s article, though, I think it’s useful to discuss how this antivaccine trope existed before COVID-19. Then, I’ll discuss how Mercola, as antivaxxers so frequently do, takes what is really a very complicated question of science, clinical trials, and ethics, and oversimplifies it in order to feed a conspiracy theory.

In brief, he’s trying to argue that the ethical imperative to “unblind” subjects in COVID-19 vaccine clinical trials or to convert currently ongoing trials into a crossover design (I’ll explain what that is later) come not from an earnest discussion of the complex ethics of clinical trials during a pandemic balancing the potential for harm to clinical trial subjects against the need for the most rigorous clinical trial design, but rather the intent to sabotage the science in order to prevent the finding of any potential adverse effects from COVID-19 vaccines. This question was rarely considered (but not unheard of) before the pandemic, mainly because the risks involved in not unblinding participants in clinical trials as to who received the placebo control and who received the vaccine was much lower. In other words, whether or not to unblind vaccine clinical trial participants and give the control group the actual vaccine was much less commonly a major issue. In the middle of a global pandemic, in which remaining unvaccinated against COVID-19 carries much more risk and more consequences, the science and ethics are not nearly as clear as Mercola would have you believe, as I will discuss. First, let’s see what Mercola is claiming.

Mercola oversimplifies massively, in order to deceive

So what is the third variant of the “No True Clinical Trial” gambit that “Dr.” Mercola is using? Last week, I saw him claiming that we’ll “never know” if COVID-19 vaccines are safe because of the “sabotage” of the clinical trials by Pfizer and Moderna:

While reports of side effects from COVID-19 gene therapies, including life-threatening effects and deaths, continue to climb at breakneck speed,1 a one-sided narrative of safety and effectiveness permeates mainstream media and medical news.

These “vaccines” are so safe and so effective, according to this narrative, that keeping control groups intact for long-term study and comparison of outcomes is now being derided as “unethical,” despite the fact that there is absolutely no non-fraudulent data to support their perverse assertions. Truly, what we’re watching is the active destruction of basic medical science in a surreal dystopian nightmare.

First of all, no, the vaccines are not “gene therapy”. They are vaccines. I will concede, though, that we’re in a surreal dystopian nightmare, but not for the reasons Mercola claims. Instead, it’s because so many people are denying science in a manner that can facilitate the spread of a deadly disease in the middle of a pandemic that has claimed the lives of millions already and is threatening to cause the total collapse of health care systems in countries such as Brazil and India.

In any event, I’ve discussed these reports to the Vaccine Adverse Events Reporting System (VAERS) database before multiple times, specifically how they are being weaponized by antivaxxers, particularly Mercola himself, to spread fear, uncertainty, and doubt (and loathing) about COVID-19 vaccines by implying causation of death and destruction where none has been demonstrated.

My goodness! How on earth are nefarious pharmaceutical companies accomplishing this evil trick to sell governments hundreds of millions of doses of their product without safety testing? Glad you asked! Mercola is more than happy to explain. I’ll quote at length, so that antivaxxers can’t say that I’m taking him out of context:

Consider this report in JAMA by Rita Rubin, senior writer for JAMA medical news and perspectives, for example.2 According to Rubin, the launch of “two highly efficacious” COVID-19 vaccines has “spurred debate about the ethics, let alone the feasibility, of continuing or launching blinded, placebo-controlled trials …”

Rubin recounts how Moderna representatives told a Food and Drug Administration advisory panel that rather than letting thousands of vaccine doses to go to waste, they planned to offer them to trial participants who had received placebo.

Pfizer representatives made a similar announcement to the advisory panel. According to a news analysis published in The BMJ,3 the FDA and U.S. Centers for Disease Control and Prevention are both onboard with this plan, as is the World Health Organization.4

In the JAMA report by Rubin, Moncref Slaoui, Ph.D., chief scientific adviser for Operation Warp Speed, is quoted saying he thinks “it’s very important that we unblind the trial at once and offer the placebo group vaccines” because trial participants “should be rewarded” for their participation.

All of these statements violate the very basics of what a safety trial needs, which is a control group against which you can compare the effects of the drug or vaccine in question over the long term. I find it inconceivable that unblinding is even a consideration at this point, seeing how the core studies have not even concluded yet. The only purpose of this unblinding is to conceal the fraud that these vaccines are safe.

This is the key passage of Mercola’s article. As you can see, the hubris is epic, the arrogance of ignorance incredible. Here is a person who has never designed (or even participated in the design of) a clinical trial, much less a massive vaccine trial. I’d be willing to bet that he’s never even enrolled a single patient on a legitimate clinical trial himself. Never mind all that! Mercola nonetheless considers himself qualified to expound on the ethics of vaccine clinical trials.

So is it “unethical” to unblind clinical trial participants after a vaccine trial? Will it forever sabotage the science behind COVID-19 vaccines? Let’s just say that the answer is much more complicated than Mercola describes. As antivaxxers do, Mercola has selectively quoted experts to make it seem as though it is clearly unscientific and unethical not to unblind the studies and give the vaccine to the clinical trial participants who received the placebo control. What he ignores is the unprecedented nature of the situation we are in with respect to COVID-19 vaccines and the pandemic.

To unblind or not to unblind…?

Let me describe the dilemma faced by scientists in a manner different than how Mercola describes it, which is to portray unblinding as a nefarious attempt to undermine science in the name of ethics. It is not. In fact, the question of whether it’s even ethical to do randomized placebo-controlled clinical trials of vaccines for serious diseases that affect large numbers of people dates back at least to Jonas Salk, as Carl Zimmer and Noah Weiland noted in a December New York Times article:

Yet the prospect of giving people something useless in the face of a life-threatening disease has always been fraught. Even Jonas Salk balked at the idea of giving people placebos when researchers designed a trial to test his new polio vaccine in 1953.

“I would feel that every child who is injected with a placebo and becomes paralyzed will do so at my hands,” he complained. The study, Dr. Salk declared, “would make Hippocrates turn over in his grave.”

But Dr. Salk lost that fight, and the placebo-controlled trial went forward. It clearly demonstrated that the polio vaccine was safe and effective. Only when the trial was over did the children who received the placebo get the vaccine — along with millions of other children.

Given the stakes of the Covid-19 pandemic, the F.D.A. has agreed to consider a faster, but limited approval, known as an emergency use authorization, based on early results from clinical trials. The agency said in new vaccine guidelines published in October that such an authorization would not necessarily be grounds for unblinding a trial.

Yet the problem with unblinding such clinical trials is, as a February JAMA article described it, the possibility of “blowing up” trials, or, as the WHO put it:

Conversely, there was concern that observational data obtained from nonrandomized studies after vaccine deployment could yield unreliable answers. Observational studies are subject to substantial biases and are much less amenable to unambiguous interpretation. Their limitations are of particular concern during this public health emergency, because vaccinated and unvaccinated people will differ in their risk of exposure to infection and of serious disease, partly because of fluctuating attack rates and because during early phases of vaccine deployment, vaccinees may well be at particular risk of infection. In these circumstances, even carefully analyzed observational studies can yield misleading answers about safety and efficacy.2,3 In addition, unrelated events that occur by chance after vaccination may be incorrectly attributed to the vaccine, and such anecdotes may be deliberately promulgated by groups opposed to vaccination.

You know, I can’t help but emphasize that last part, in which premature unblinding might lead to unrelated adverse events that occur after vaccination being attributed to the vaccine. The problems with unblinding cut both ways, and Mercola ought to be salivating over the possibility of attributing any and every adverse event to the vaccine, but no one said consistency was a feature of antivax rhetoric.

Leaving these issues aside, try to imagine that you are a clinical trial participant in one of the major vaccine trials, be it for the Moderna, Pfizer/BioNTech, AstraZeneca, Johnson & Johnson, or the Novavax vaccines. The initial clinical trial results have been announced and demonstrate that the vaccine is highly effective in preventing COVID-19 with no major safety concerns. As a result, the vaccine has been issued an emergency use authorization (EUA) and is now being deployed widely, first being administered to high-risk individuals and now being administered to almost any adult who wants it. Thus far, hundreds of millions of people have received a dose. Now imagine that you strongly suspect that you were in the placebo control arm. Wouldn’t you really want to know which group you were in and, if you were in the placebo group, be given the opportunity to receive the real vaccine? Imagine, now, that you are the scientist in charge of this clinical trial and ask yourself: Is it ethical to keep the tens of thousands of people in the placebo arm of your clinical trial in the dark and leave them susceptible to COVID-19, as millions of people are receiving the vaccine from the clinical trial that they had agreed to participate in?

Just think about this dilemma for a minute. An intellectually honest person will quickly realize that the answer is not simple or obvious. It involves the balancing of the ethical imperative to minimize harm to the individuals in the clinical trial versus the scientific imperative to complete the trial to make the science as rigorous as possible. Not unblinding and allowing the control group participants to “cross over” to the vaccine arm leaves them susceptible to a potentially deadly disease against which millions are being vaccinated (as millions have died and thousands are dying of it each day) against using the very same vaccine in the clinical trial these people agreed to participate in. On the other hand, unblinding them and allowing them to receive the vaccine could make data on any longer term effects of the vaccines much harder to interpret. Imagine you’re in charge of this massive clinical trial. What do you do? Again, it’s not an easy or straightforward question. Before you answer, consider two other issues, one of which was cited by Mercola from a MedPageToday article on self-unblinding of participants in the Novavax trial:

On social media, participants in Novavax’s ongoing trial have been hotly debating whether it’s a good idea — or ethical — to unblind themselves by taking commercially available antibody tests. Many say they’ve already done so and used the results to help them decide whether to drop out and get a definitely active vaccine.

And:

The self-unblinding of participants spells trouble even if they stay in the trial, geneticist and cardiologist Elizabeth McNally, MD, PhD, of Northwestern University, told MedPage Today.

“The purpose of blinding the participants is so that they don’t change their behavior and decide to take more risks in terms of getting COVID,” she said. “We know vaccination will cause some people to take more risks. For example, it’s possible that vaccinated people are less likely to wear a mask and not social distance. If one group of people is more likely to get COVID than the placebo group, this will skew the results. It could make the vaccine look less effective than it is.”

Goodman, the Stanford University epidemiologist, said that those who unblind themselves via antibody tests “undermine the contributions of fellow trial participants and make this behavior seem acceptable by violating the trust within the trial, potentially weakening the ability to do other trials in a scientifically valid way as well.”

Mercola portrays this concern about “self-unblinding” not as due to concern about the scientific rigor of the clinical trial but rather being due to nefarious intent (of course):

So, whether vaccine scientists agree with unblinding or not, unblinding really only has to do with whether it will skew results in their favor.

Trial participants unblinding themselves might make the vaccine appear less effective if they alter their behavior as a consequence, whereas vaccine makers unblinding the entire control group will allow them to hide side effects, even if participants alter their behavior.

Actually, it’s a question of what people will do now that the cat is out of the bag and the horse has left the stable, so to speak, and multiple antibody tests are available. It is, after all, human nature to be curious. It is also not about “hiding adverse events” to unblind the entire control group. It’s about balancing potential harms of leaving them vulnerable to COVID-19 versus the scientific rigor of letting the trial run to its planned end. (I’ll discuss that more in a moment.)

That’s not all, though. Before you answer the question of whether unblinding is a good idea or not, consider also that more and more doses of multiple vaccines have become available, meaning that clinical trial participants who suspect they received placebo could easily just go and get vaccinated with one of the other vaccines—or even the vaccine whose clinical trial they participated in! Ask yourself if it is ethical to require those participants to remain in the dark and unvaccinated in the context of nearly 300 million doses of, for example, the Moderna and Pfizer/BioNTech vaccines alone having been distributed in the US.

Moreover, it’s not as though there isn’t substantial literature on the ethics and science of unblinding clinical trials. It is an issue that is not at all unique to vaccine clinical trials but occurs in clinical trials of, for example, new anticancer drugs. If you really want to get into the weeds of the issue of unblinding, here’s a video of an interview between the Editor-in-Chief of JAMA Journal of Ethics and Steven Goodman, MD, MHS, PhD, Associate Dean of Clinical and Translational Research and Professor of Medicine and of Epidemiology and Population Health at Stanford School of Medicine from January 27. Mercola selectively quoted Goodman in his article, but if you go to the interview, you will find that the issues involve far more than whether the two groups in a COVID-19 vaccine trial will behave the same with respect to risky activity:

If you watch the 22-minute video you’ll quickly see just how complex the issues involved are. Indeed, just look at how Dr. Goodman hesitates when asked what the implications of the decisions by Pfizer and Moderna to unblind the clinical trial participants in their trials. He also notes that there is a data monitoring committee that follows the data in real time. Indeed, these committees are the reason why some clinical trials are ended early, and it can go both ways. Such trials can be ended early because the treatment arm does a lot better than the control or because it does a lot worse. Either way, when the data safety monitoring committee finds a clear difference between the groups in a clinical trial, there is an ethical dilemma: Stop the trial and potentially knowingly harm one group or continue the trial to get the most rigorous science. Often, it is considered unethical to continue a study once a clear difference is noted, because there is no longer clinical equipoise, which I’ve discussed before. Stated briefly, for purposes of clinical trials, clinical equipoise demands that at the time a clinical trial is being carried out there be a state of genuine scientific uncertainty in the medical community over which of the drugs or treatments being tested is more efficacious and safer, an issue that pops up fairly frequently in clinical trials of cancer therapeutics.

Echoing what I said above, Dr. Goodman also points out that the question of whether to unblind or not is only a question in the context of a global pandemic. Under normal circumstances, there would be little pressure or ethical imperative to unblind a vaccine trial because the risk to the control group would be very small. In the case of COVID-19 trials, what information might we lose by unblinding? As Dr. Goodman recounts, we could lose information on how long the protection from the vaccine lasts. We could also lose information regarding which groups respond the best to the vaccine. The World Health Organization stated in a New England Journal of Medicine Perspective piece in January:

After relatively short follow-up in phase 3 trials, even when vaccine efficacy appears to be high, reliable information will still be needed on longer-term safety and duration of protection. Other information gaps will include more comprehensive assessments of short-term safety, knowledge of whether waning of vaccine-induced protection may lead to vaccine-enhanced disease if a vaccinee becomes infected on exposure to SARS-CoV-2, information on protection against clinically severe forms of Covid-19, and knowledge of any associations between the degree of protection and the recipient’s age or coexisting conditions. Even after the first vaccines become available, it will still be important to evaluate additional vaccines to meet worldwide needs.1

There’s another aspect to this problem as well, as Goodman also points out. Once the vaccine is offered outside of a clinical trial there is no way to prevent participants in the trial from “walking away from the trial” and getting vaccinated, thus adding a practical element to the dilemma of what to do, in addition to the ethical and scientific elements. Why is that?

One of the bedrock features of ethics in clinical trials is voluntariness. Participants must voluntarily agree to participate without any coercion. In addition, they must always be free to leave the trial at any time for any reason. Good clinical trial investigators try to design their trials in a manner that minimizes this “dropout” rate or at least tries to make sure that any dropouts are distributed as equally between all arms of the study as feasible. Who when designing COVID-19 vaccine trials many months ago could have anticipated that the vaccines would demonstrate themselves to be so effective so early and that governments would issue EUAs to distribute many millions of doses in a short period of time? Basically no one. Again, this is an unprecedented situation with respect to vaccine clinical trials that Mercola is massively oversimplifying and using to impute nefarious intent to the clinical trialists, the vaccine manufacturers, and the regulatory agencies that allowed these vaccines to be distributed.

That brings up yet another concern. Once there are a number of vaccines that haven’t been full approved yet but are available under various emergency use authorizations to combat the pandemic, will it even be ethical or possible to do true placebo-controlled randomized clinical trials of new vaccine candidates? After all, again, clinical equipoise demands that there be genuine uncertainty about which is better, placebo or experimental treatment, and that equipoise will be gone once governments have decided that these vaccines are sufficiently safe and effective to use on a large scale in the context of a pandemic killing millions. Given the realities on the ground, it is likely that most new vaccines from here on out will have to be tested against an existing vaccine, as we do now for new vaccines against diseases for which there is already a vaccine. The idea is to demonstrate that the new vaccine is at least as effective and safe as the old vaccine.

There’s one last wrinkle to consider before you answer. The question doesn’t have to be, “To unblind or not to unblind?” There also exists a compromise: The crossover trial. It’s a compromise that leaves participants blinded but has both groups ultimately getting the vaccine. Goodman discusses it, and Hilda Bastian wrote an excellent blog post about it on her PLoS blog Absolutely Maybe.

To cross over or not to cross over…?

So what is a crossover trial? It turns out that crossover trials are quite common in oncology clinical trials. For example, in this trial patients in the placebo group whose cancers progressed could “cross over” to the treatment arm. Some trials are designed so that cross-over is automatic and the only way that the groups in the trial differ is in what order they receive experimental drug or placebo.

Unlike Pfizer and Moderna, Novavax has done just this:

Novavax has added crossover arms to late-phase clinical trials of its COVID-19 vaccine. The action will enable participants in the placebo cohorts of the original trials to get vaccinated without unblinding the studies.

Participants in the 15,000-subject U.K. trial and 30,000-subject U.S.-Mexico study, which is yet to post data, will be offered the chance to get an additional round of injections. People who originally got a placebo will get two doses of the vaccine, and people who originally got the vaccine will receive two doses of placebo. 

Novavax has taken a different approach to the South African phase 2b, where the prevalence of the B.1.351 variant contributed to weaker efficacy data than in the U.K. Placebo participants will still get the vaccine, but subjects in the original vaccine arm will also get a booster dose of NVX-CoV2373.

The design of the South African crossover trial will enable Novavax to evaluate whether an additional dose of its vaccine improves protection against B.1.351. The variant makes up a far smaller proportion of all COVID-19 cases in the U.K. and U.S.

Across all three trials, Novavax will conduct the crossover stages without unblinding the studies. The approach enables Novavax to address the ethical concern about leaving people unprotected during a pandemic while retaining the ability to assess efficacy. Novavax plans to follow participants for up to two years to assess the durability of protection. Participants have the option to become unblinded and receive a vaccine through their national immunization campaigns.

Here is a diagram, borrowed from Hilda Bastian’s article:

Crossover trial: The answer to unblinding
A typical cross-over design for a clinical trial.

Interestingly, Mercola doesn’t even mention the possibility of cross-over studies. To him it’s all “to unblind or not to unblind,” without any other options, because, as usual, he selectively cites articles and studies to make it look as though the decision to unblind the Pfizer and Moderna clinical trial participants is all about hiding adverse events, not about making a defensible decision that others might disagree with regarding how most fairly to balance the risk of harm to the placebo group in the clinical trials versus the potential loss of finer grain information that would come from keeping the groups blinded for the full length of the trial coupled with the likely increasing rate of self-unblinding or dropouts the longer the trial remained unblinded.

There is a problem with a cross-over trial, though, as discussed by Hilda Bastian:

Now, this has real limits. And it’s not what you expect from vaccine trials. It’s done for treatments with effects that fade away – “wash out” – before you cross over. Turns out, vaccine crossover trials are not completely unheard of, though. I quickly found a couple from the 1990s – one tested a single-dose live cholera vaccine against placebo, and the other assessed the effects of influenza vaccination on asthma symptoms. Still, the scale of this – and the information we’re relying on them for – makes the first Covid vaccine crossover trial a real landmark.

She also notes, however:

I first saw this possibility discussed in early December last year, in a New York Timesarticle by Carl Zimmer and Noah Weiland. Anthony Fauci proposed it as a way to get large-scale randomized data on how long immunity lasted, without leaving people on only placebos. The idea was if the group that was vaccinated earlier starting to get Covid-19 while the later-vaccinated group didn’t, you’d get the signal that immunity in the first group was waning. (Immunity is expected to wane, because immunity to coronaviruses generally does – though it’s not guaranteed, of course.)

(Yes, that’s the same article that I cited to point out Jonas Salk’s misgivings about a randomized trial of the polio vaccine.)

Bastian also cites Goodman:

A few days later, statistician Steven Goodman presented on this – peer review, really – at an FDA meeting discussing it. Here’s what we could learn from a Covid vaccine trial crossing over to crossover:
  • Large-scale data on duration of immunity (as already mentioned);
  • More data will be gathered on subgroups of people, like elderly people and racial/ethnic groups;
  • There are very few vaccinated people who got Covid-19 in the early results – with more, the theoretical risk that some could experience what’s called vaccine associated enhanced respiratory disease (VAERD or VAED) could be better assessed;
  • Assessing the impact of boosters on people who already in a trial and ready to go would be quicker and easier; and
  • More vaccinated people who got Covid-19 would help with the across-trials exercise of trying to establish correlates of immunity – we need to know if you can detect a difference in laboratory tests between the vaccinated people who were protected and those who still got sick (called “breakthrough cases”).

She also notes that, in addition to the Novavax trial, a 30,000 subject phase 3 clinical trial of a COVID-19 vaccine by the Canadian company, Medicago is a cross-over trial, while a French company, Valneva, is reportedly considering it, when their inactivated vaccine gets to phase 3.

The bottom line is that whether or not to unblind studies of COVID-19 vaccines and/or convert them to a cross-over design is a devilishly difficult question, given the uncertainties and the practicalities of doing so versus continuing until the completion of the trials. From my perspective, I highly doubt that it is any longer feasible to keep from doing one or the other with existing trials, at least for very much longer.

Mercola: Oversimplifying incredibly complex ethical and scientific questions and misrepresenting science to spread fear

Given all that information, now what would you do if you were a participant in one of these clinical trials? If you were a scientist running such a trial? The question isn’t as easy as Mercola would have you believe, is it?

This is especially true given how antivaxxers, especially Robert F. Kennedy, Jr. but also Mercola himself have weaponized reports to the Vaccine Adverse Events Reporting System (VAERS) database in order to strongly imply causation by vaccines of adverse events where none has been demonstrated. Remember, Mercola and his fellow antivaxxers are not about nuance, except when it can be twisted to spread fear about vaccines. That’s why they have no compunction about taking a complex issue like this and simplifying it beyond the recognition of reasonable scientists.

Don’t believe me? As is usual for him, Mercola just couldn’t help himself. He gives the game away in the very same article by saying this about reports of adverse reactions to VAERS:

Keep in mind that we still do not know the percentage of adverse effects being reported. Is it between 1%12 and 10%13 as past inquiries into VAERS reporting have shown, or is it higher?

If only 10% are reported, we may be looking at 23,420 deaths, but if it is as low as 1%, it jumps to more than 230,000 deaths. We will never know because there are major attempts to suppress this information, as we have already witnessed with the deaths of sport celebrities Hank Aaron and Marvin Hagler, both of whom died shortly after COVID vaccinations.

Regardless, it’s hard to justify even a single death of an otherwise healthy individual, seeing how the survival rate for COVID-19 across all age groups is 99.74%. If you’re younger than 40, your survival rate is 99.99%.14

First, as Dr. Vincent Iannelli has noted, it is completely untrue that “only 1%” of adverse events are reported to VAERS. That’s a cherry picked couple of studies there! In fact, I can’t help but counter by pointing out how VAERS data for the Johnson & Johnson vaccine led to the real time detection of an adverse event that was literally one in a million and led to a week and a half “pause” in the use of the vaccine while the CDC’s Advisory Committee on Immunization Practices (ACIP) evaluated the data, a pause that was lifted a couple of weeks later. If VAERS underreporting were as extreme as claimed by Mercola, detecting such a rare form of adverse event would have been impossible. It’s also about as innumerate and fantasy-inspired as can be to imagine that there could have been 230,000 people in four months dying after receiving a COVID-19 vaccine and nobody noticed (or the government “covered it up”), as that is almost as many as the number of people who died of COVID-19 itself in the same four month period since the first vaccine (the Pfizer/BioNTech vaccine) was authorized. He then does his best to minimize the seriousness of COVID-19 by listing only the fatality rate and ignoring the hospitalization rate and the rate of having long term serious sequelae from the infection.

Then he pivots to the quackery:

If you’re concerned about vaccine side effects, please understand there are several prevention strategies and treatments readily available that have been shown to be highly effective, which means the need for a vaccine in the first place is nearly moot.

For example, nebulized hydrogen peroxide with iodine, which I’ve written about in previous articles, works very well. For a refresher, see “How Nebulized Peroxide Helps Against Respiratory Infections.” Other treatments include hydroxychloroquine with zinc, ivermectin and the iMASK and MATH+ protocols, which you can learn more about in the linked articles.

No, there’s no evidence that nebulized peroxide works, nor is there any good evidence that hydroxychloroquineivermectin, or zinc works, no matter how much quacks try to convince you otherwise. It does amuse me, however, how Mercola just can’t help but pivot to the grift, which he then doubles down on:

In closing, if you got the vaccine and now regret it, you may be able to address your symptoms using the same strategies you’d use to treat actual SARS-CoV-2 infection. I’ve written many articles over the past year detailing simple strategies to improve your immune system, and with a healthy immune system, you’ll get through COVID-19 without incident. Below, I’ll summarize some of the strategies you can use both to prevent COVID-19 and address any side effects you may encounter from the vaccine.
  • Eat a “clean,” ideally organic diet. Avoid processed foods of all kinds, especially vegetable oils, as they are loaded with damaging omega-6 linoleic acid that wrecks your mitochondrial function. Linoleic acid has been shown to increase mortality from COVID-19.
  • Consider nutritional ketosis and a time-restricted eating window of six to eight hours with no food at least three hours before bed. These strategies will help you optimize your metabolic machinery and mitochondrial function.
  • Implement a detoxification program to get rid of heavy metals and glyphosate. This is important as these toxins contribute to inflammation. To improve detoxification, I recommend activating your natural glutathione production with molecular hydrogen tablets.
  • A simple way to block glyphosate uptake is to take glycine. Approximately 3 grams, about half a teaspoon, a few times a day should be sufficient, along with an organic diet, so that you’re not adding more glyphosate with each meal.
  • Maintain a neutral pH to improve the resiliency of your immune system. You want your pH to be right around 7, which you can measure with an inexpensive urine strip. The lower your pH, the more acidic you are. A simple way to raise your pH if it’s too acidic (and most people are) is to take one-fourth teaspoon of sodium bicarbonate (baking soda) or potassium bicarbonate in water a few times a day.

Again, none of these interventions work, in particular the “detoxification” and the baking soda. Sure, it won’t hurt to eat an organic diet and minimize processed foods, but there’s no good evidence that doing so will prevent or treat COVID-19.

When considering anything Mercola writes, remember two things. It’s all about the quackery and the grift. Always. In this article, he started out with a clever ploy, to oversimplify the complex issues behind the ethics and science of clinical trials in a way to cast doubt on the efficacy of COVID-19 vaccines and the motives of the vaccine manufacturers, who are portrayed as trying to “betray science”. If he had been able to restrain himself a bit when it comes to pushing quackery and conspiracy theories, he might have been much more effective and not so obviously given the game away. He wants to sell his book on COVID-19, though, and so can’t help but make the grift behind his fear mongering obvious.

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]

25 replies on “To unblind or not to unblind COVID-19 vaccine trials?”

Apart from all the anti-vaccine nonsense, which I expect from Mercola, I also expect him to be not in tune with medical ethics. Which alternative health tycoon is? If they understood anything about medical ethics, they would not be an alternative health tycoon.

The simple fact of the matter, as explained, is when you identify a treatment in a trial that has the potential to massively decrease morbidity or death from a very serious disease, it is unethical not to unblind the trial at the end and offer the effective treatment to all participants.

An excellent deconstruction of the propaganda – but unwinding the deceit of the concoction of lies, cherry-picked comments of experts and statistics is far more complicated (and esoteric) than the message of fear and mistrust that Mercola illogically delivers.

I’m reminded of the huge effort, the vast resources, that the tobacco industry put into the flashy propaganda campaign that it waged against the pronouncements of health authorities about serious health dangers associated with smoking. Here in Australia cigarette advertising has been banned: the cheapest packet of 25 cigarettes costs about AUD$30: cigarette packets are emblazoned with horrific pictures of pathology associated with smoking – but there is still a significant market for tobacco products.

Maybe further progress could be made if the scare tactics were set aside to focus on the profiteering of the multinationals and their disdain for health consequences for smokers.

So, I believe that dangerous anti-science, anti-medical science, propaganda could be better countered if the public was alerted to the profiteering, the quest for celebrity, behind the snake-oil salesmen who would undermine rigorous, reputable medical research with their antisocial, self-serving bull-shit.

” .. if the public was alerted to the profiteering, the quest for celebrity, behind the snake-oil salesmen…”

Orac wrote about Mercola’s vast fortune ( 100 million USD; Dec 20, 2019). Some of us try to illustrate how alt med prevaricators/ anti-vaxxers live in luxury, running empires selling BS and hiring staffs of IT specialists and lawyers.by leading readers to websites showing estates, warehouses/ packaging facilities and lists of jobs available. Woo is Big Business .
HOWEVER, I think that when these entrepreneurs unabashedly brag about their businesses and RE interests, followers applaud their success perhaps taking it as proof of being their right.
They got rich because they help people whereas SBM/ pharma get rich because of plotting, avarice and malfeasance.

But there is great wealth as evidenced by internet photos of their estates. Mercola had a large mansion in Illinois and now has re-located to Ormond Beach, Florida.

Thank you, Denice.

I certainly gave the wrong impression with my previous comment.

Orac, undoubtedly, recognises the profit motives in the spreading of fraudulent health claims, and in this, he is fearless and passionate.
So, my comment was meant to encourage and promote others to emphasise this greed aspect when arguing about the dishonesty of quacks.

Orac provides us with all of the ammunition, so we should carry the complete message to others (blogs etc).

I agree with you that woo propaganda might be better countered by focusing on the greed, manipulation, and disregard for the customers’ well-being. But Orac is operating on his turf — the medical science angle. The more muckraking-type material isn’t his wheelhouse. That’s really up to other folks [I sometimes try to contribute little bits in that direction in the comments]. There may be folks somewhere on the Web doing that, and maybe Orac could offer brief references and links, but the thrust of his posts here is always going to be how the quacks’ claims are wrong on the science.

@ sadmar:

There is so much that I don’t know where to begin!
— Rational Wiki and Wikipedia have details about scandals, wealth and MOs by name of culprit
— often business sites like Manta, Spokeo have money/ staff details
— Quackwatch has a few stories about Mercola’s brush with the FTC fraud,,fines etc
— there is material about Mercola’s wife’s past but I’ll leave that alone and only refer to her enablement of him via Health Nut News, fraudulent advertising photos
— Encyclopaedia of American Loons by name
–HealthWyze on Adams’ various scams; Orac on his libelous articles
— Wikipedia, Rational Wiki, Quackwatch, Lee Phillips, Orac, me on Null’s schemes, frauds, dangerous products, faux CV
— google Dr Oz’s houses ( Cliffside Park, Palm Beach)

Often, their own websites contain telling material on their wealth and MOs e.g bios, employment ads. images of business properties, homes

But Orac is operating on his turf — the medical science angle. The more muckraking-type material isn’t his wheelhouse. That’s really up to other folks

I agree – and I should have made that clear in my comments.

Orac as a professional medical scientist is an expert at refuting deceptive, fraudulent and misguided claims regarding medical science, medical treatments, and medical ethics. And , as a someone who was formerly engaged (as a scientist) in research in medical science fields I enjoy his rigorous, and logical arguments against quackery. But, I feel quite sure that his message (through this website) is avoided by those who don’t want to be told the truth, is not “sexy’ enough for major news outlets, and is a powerful , insightful resource that is seemingly neglected. Bearing in mind that my perception about neglect arises from my distant view from Australia.

I also have the impression that this website is mainly used by supporters of Orac, – that is, from the general run of comments to articles, it is preaching to the converted.

For my part, I find that Orac’s robust, and passionate analysis is the best resource available to use as reference material for people who may be confused and disturbed by the quackery dispensers, and it is ideal material for debunking the claims of quacks. However, I make sure that I emphasise the profiteering, the fraudulence, the parasitic motives of the quack crew.

We owe a great debt of gratitude to Orac for the time, energy and passion that he devotes to what is often a matter of just bashing his head against the wall. But, he keeps trying, he never gives up in the thankless task of discrediting the quacks, the purveyors of lies, harm and mistrust.

@ Chris H

Right but he knows the secret of eternal youth, longevity and strength through diet that he teaches to his admiring followers for a price.
I think I’ll stick to cupcakes, iced tea and gin.( Joking:)

Another safety challenge to consider, is that some of the subjects in the trials who opt to discontinue and get a vaccine might be exposing themselves to a double dose. The safety of that isn’t known. So, unblinding and offering vaccine to the placebo recipients potentially reduces risk for participants who were randomized to the active vaccine group.

In related news, one of Cuba’s vaccine trials is using the waiting list as the control group.

“We always have three times as many people lined up to participate in clinical trials as we need.”

It’s not a very good control group, is it? How many elevators do they have in Cuba? They don’t have that crap on their cars so there is no 5G, 4G, GSM, they have BlueLight.

The big bang happened out of nowhere for noreason. Or maybe God set it all into motion who knows? But, then, like the dinosaurs died because a meteor hit earth in the exact worst spot imaginable…. And volcanoes erupt and drunk drivers drive and sinkholes collapse and sometimes people explode. And, I guess, that just means bad shit’s gonna happen…

I don’t know what’s gonna happen next. I hope it’s cool. All I know is I could die any second now. Hell, so could you… Fuck else can you do?

@ EVERYONE

I was actually a volunteer in the phase 3 clinical trial for the Moderna mRNA vaccine. Before volunteering I got out my textbooks on molecular biology and genetics and read carefully sections on mRNA. I then did thorough search of PubMed, Google Scholar, etc for any and all research on mRNA vaccines and/or corona virus vaccines. Though there are NO guarantees in life, based on my thorough reading, I volunteered.

To volunteer I had to sign an agreement to participate for 25 months, to come into lab every so often for blood tests, to answer a weekly questionnaire and once monthly phone call, to contact them if I had any from a list of symptoms and signs, if had two, to either come to lab or they would send someone to my home, to give permission to access my medical records and to contact my primary care physician. The latter enabled them, in case I was hospitalized or died, to access severe COVID.

Note, that Mercola isn’t the only one promoting false information. Peter Doshi, senior editor of the BMJ, wrote an opinion piece that the COVID mRNA trials protocol only looked at mild adverse events. Absolutely false.

Since the Moderna study began in August 2020, prior to the unblinding in January they had over 3 months of data which was published online, December 30, 2020: Baden et al. Efficacy and Safety of the mRNA-1273 SARS-Cov-2 Vaccine. New England Journal of Medicine:

“Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001) . . . Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group.”

We were called into the lab in January and unblinded. I then received the first and a month later the second shot. On both occasions they took blood and asked a number of questions. I then returned again for blood tests. And I continue to fill out the weekly questionnaire and monthly phone calls and will return again for blood tests.

While anything is possible, having studied vaccines for over 40 years, highly unlikely that adverse events will show up after more than three months; however, as Orac points out, other factors could result in what the vaccine recipient may think is vaccine related. And as he has made clear on both this blog and its sister blog, Respectful Insolence, VAERs reports of serious adverse events are thoroughly investigated, including obtaining the patients actual medical records. There are dedicated teams at CDC that monitor VAERS and, yep, mild adverse events, e.g., sore arm, mild fever, are only reported about 1% of times; but serious adverse events are reported at much higher rates, for instance with intussusception from first rotavirus vaccine, only a few reports led to withdrawal from market. Other medicines and medical devices with even higher rates of serious adverse events can take up to a decade to withdraw from markets. Quite simply, the FDA requirements for vaccines are much much more stringent than anything else and the post-market surveillance with multiple systems as well.

I have been a blood donor for most of my life, donating whole blood; but since receiving the Moderna mRNA vaccine I have become a convalescent plasma donor every four weeks. And the blood bank informed me that my titers for COVID antibodies was HIGH. Which means I am helping up to four hospitalized COVID patients every time I donate.

So, besides that cross-over designs work quite well, I don’t live in a perfect world, that over 3-month follow-up with thorough reporting of adverse events to vaccine and possible infection with COVID, and continued follow-up, and my ability to help others with convalescent plasma donations, anyone with an open mind will understand that Mercola and others literally are not trustworthy. And their preventive and treatment measures for COVID have NO basis in reality. By the way, I am a longtime vegetarian and vegan for over 10 years, take a few supplements, never megadoses, vitamin B-12 (can’t get from vegan diet), iron (because blood donor), and vitamin D3 twice daily 1,000 iu, 25 mg (seldom out in sun and as we get older bodies ability to convert from sunlight diminished). So, I lead a very health life, including diet. But, antibodies take up to 10 days to recognize and attack a new invader, regardless of how healthy someone is. Whereas, vaccines, HARMLESS versions of the invader, alert the specific antibodies that will target it and, thus, they act immediately, often so well that we don’t even know we have been invaded.
By analogy, our military often have war-games, everything as real as possible, except no live ammunition, or, maybe some shot way above heads?

Just one reference that does a good job summarizing what is currently known about vitamin D and COVID. Just Google title:

Will Stone (2021 Apr 14). A Year In, Here’s What We Know About Vitamin D For Preventing COVID.

So I’ve posted once before about the excesses of a few poster on this site and their inability to stick to the topic.

I was chastised for my position that people should stick to the topic presented and that I would possibly leave ‘respectful insolence and sbm’ and others would leave or only visit once as well.
I was even criticized by ORAC for that statement.

I know ORAC and his position on anti vaccination and his purpose of this and SBM is to present evidence and factual data to fight mis information. I maybe presuming that his goal is to reach as many ‘fence sitters’ as possible in an effort to come to his way of thinking.

I also know that ORAC was a fan of Rush Limbaugh at one time, so is familiar with Limbaugh’s hook .

Mr. Limbaugh was a showman and attempted to obtain the largest audience as possible and to entertain them first and foremost, then educate/enlighten/persuade them to his way of thinking. Early in the start of his career (or through out his shows) he would not allow callers who wanted to talked about gun control, the holocaust (or related topics) or abortion. He stated on many occasions that these were audience killers and that people would quit listening to the show and if they didn’t listen to his show they could not be persuaded to his way of thinking.

So despite my reservations and after the admonishment by the host, I continued to come to this site and SBM.

On the 19th of April 2021 the topic of ‘Antivaxxers don’t want COVID-19 vaccines to ‘impurfy’ their ‘purity of essence’.

I was introduced to 4 people who just wanted to argue about Jews/theHolocaust/Hitler/NAZI’s, gun control, abortions and about 90,000 words of non related stuff, and one person who repeated the the line ‘woo-misters’.

A friend told me that less than 35 unique IP addresses were responsible for the 375 plus posts, several posters had used the same IP address with different names and by day 2 of the post the unique IP addresses of visitors had stopped. Seriously who has time to read this may posts and sort the garbage out.

Even ORAC had had his fill by the 3rd of May.

ORAC if you want and echo chamber of 30-40 people, it is your website. or do you want to persuade people to visit your websites and be educated about science/vaccines well…..

“I also know that ORAC was a fan of Rush Limbaugh at one time”

Good. Now go away before he mindfucks you a second time.

A logorrhoeic complaint about posts that are too long.

“We may be entering a singularity, Marvin”

Who would have guessed?

@ Prohias

“A friend told me that less than 35 unique IP addresses were responsible for the 375 plus posts, several posters had used the same IP address with different names”

Not me on that post.

“ORAC if you want and echo chamber of 30-40 people, it is your website. or do you want to persuade people to visit your websites and be educated about science/vaccines well…..”

It’s his choice. But as to myself, when Aelxa steps in with her hubris of galactic proportions, I can’t resist. Poking a balloon of hubris the size of a galaxy is irresistible. Way too tempting.

Mercola lying again:
https://infiniteunknown.net/2021/05/01/dr-joseph-mercola-why-im-removing-all-articles-related-to-vitamin-d-c-and-zinc-and-covid-19/
I use the above kooksite because it reproduces the article at Mercola.com which requires registration to read.
Merde-ola explaining why he’s removing his articles about Vit.C, Vit.D, and COVID-19:
Why I’m Removing All Articles Related to Vitamin D, C and Zinc and COVID-19

Over the past year, I’ve been researching and writing as much as I can to help you take control of your health, as fearmongering media and corrupt politicians have destroyed lives and livelihoods to establish global control of the world’s population, using the COVID-19 pandemic as their justification
Through it all, I have refused to succumb to these relentless attacks. I have been confident and willing to defend myself in the court of law
Unfortunately, threats have now become very personal and have intensified to the point I can no longer preserve much of the information and research I’ve provided to you thus far. So, effective immediately, much of the information on my website will be permanently removed

Unfortunately, threats have now become very personal and have intensified to the point I can no longer preserve much of the information and research I’ve provided to you thus far. These threats are not legal in nature [lying liar], but if you can imagine what upset billionaires and their front groups are capable of, I can assure you they’ve deployed assets to get creative and force me to remove this content.

I cannot elaborate about these events in detail at the moment,…”
.
Oh!
He’s he’s doing it because he’s being threatened by teh ebil med. billionaires…

Hmmmm…
I think Merde-ola is telling porkies again:
Gee, it couldn’t be because Merde-ola has been doing something that is illegal on his website promotions and the FDA is calling him on it, could it?
The FDA can shut him down and lock the doors if he doesn’t comply and Merde-ola didn’t become worth $100+ million by not selling worthless supplements using lies and fairy-tales to the gullible worried well.
Here’s his latest warning letter from the FDA about illegally advertising Vit. C, Vit. D, and Quercetin and Pterostilbene Advanced products as cures or treatments for COVID-19:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mercolacom-llc-607133-02182021
Note – He had 48 hours to respond to the FDA “describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction.”
He apparently couldn’t defend his claims for his worthless products so rather than being shut down he has decided to remove the lying articles.
It isn’t some mysterious billionaire med cartel that is threatening him… It is the FDA that will seize his property and shut him down if he doesn’t remedy the situation of his lying about cures/treatments for COVID-19.
Mercola is a lying sleazy internet marketeer ripping morons off.

@Reality

If 100 million dollars impresses you, what about billion-dollar fines?
https://www.dmlawfirm.com/crimes-of-covid-vaccine-maker-pfizer-well-documented/
mercola is small-time.
Pfizer received the biggest fine in U.S. history as part of a $2.3 Billion plea deal with federal prosecutors for mis-promoting medicines (Bextra, Celebrex) and paying kickbacks to compliant doctors. Pfizer pleaded guilty to mis-branding the painkiller Bextra by promoting the drug for uses for which it was not approved.

I trust Mercola, because the big money is not in making supplements for money, but getting bribes for money.

@ Prohias

You write: “So I’ve posted once before about the excesses of a few poster on this site and their inability to stick to the topic. I was chastised for my position that people should stick to the topic presented and that I would possibly leave ‘respectful insolence and sbm’ and others would leave or only visit once as well. I was even criticized by ORAC for that statement. . . I was introduced to 4 people who just wanted to argue about Jews/theHolocaust/Hitler/NAZI’s, gun control, abortions and about 90,000 words of non related stuff, and one person who repeated the the line ‘woo-misters’.”

As for “Jews/theHolocaust/Hitler/NAZI’s, gun control,” I didn’t start it; but given my entire life affected by the Holocaust, nightmares, etc, having met at least 50 survivors, sole survivors of extended families and known dozen or more closely, plus having read massively on it since my youth I wasn’t going to allow anyone to write BS. As for 90,000 words, wow, your really know how to exaggerate. And since a good colleague years ago did collaborative work with CDC on guns and violence, I became interested and have read extensively on it.

Yep, you were chastised by my refuting point by point your various claims.

You wrote:

“Prohias
says:
April 25, 2021 at 7:31 pm
Joel I have never commented here before nor will I ever again and after this last month of you endless post, will probably give up on SBM as well.

I guess you can’t be trusted to keep you word about never commenting here again. So, just so anyone who missed what I wrote, here’s a repeat that shows just how dishonest Protias is:

Joel A. Harrison, PhD, MPH
says:
April 26, 2021 at 1:03 pm
@ Prohias

You write: “You on the other hand are retired, you walk your dog, which pretty much leaves you to post stuff here (and other places)(if you type 40 words a minute it has got to take you hours just to type your responses to Scott, Natalie, Kay, Charles, Narad, Denice et al.) which has the unintended consequences of making the rest of the readers of these blogs spend time reading your stuff, which quite frankly is boring retelling of things in your life. There are 7 Billion people in the world all with stories of their life, and probably a lot more interesting than yours.”

Yep, I am retired; but currently, as I’ve mentioned in several comments, proof-reading and making editorial suggestions for a colleague’s over 800 page next edition of a best-selling undergraduate microbiology book. And, yep, in high school I was one of only two boys in a typing class, so I do type 40 words or probably more per minute, though I have now have arthritis in my hands. Since most of my comments are under 2,000 words, takes less than an hour, except I also devote considerable effort in obtaining actual scientific papers for references. And I regret not also having taken high school course in short-hand, would have been great when taking notes in university courses.

As for retelling my life, two reasons: a. as an example of a point I am making and b. to explain my life-time passion with science and my education and training. While education and training don’t necessarily mean what someone writes is correct, when I’ve, for instance, asked several antivax commenters if they have read anything on immunology, microbiology, epidemiology, infectious diseases, they answer no and don’t need to. If one doesn’t understand the basics of immunology, then impossible to understand how a vaccine works. If one doesn’t understand the basics of epidemiology, then impossible to understand how vaccines are approved, etc. And if one doesn’t understand critical thinking, well . . .

You write: “But as an outsider I will try to show you what the rest of the visitors to this site see.”

Actually a number of commented positively on my comments. So, how do you know what the “rest of visitors to this site see?” Do you have ESP? Or are you delusional? A number have actually posted positive comments regarding what I write.

You write: “Now you post comments that are profanity laden, sexist, demeaning, condescending, long winded, boastful and sometimes just fake information. This does have the tendency of people to ignore your post (some which may contain useful information).”

Yep, sometimes I really get angry when someone, like you, attacks me without even addressing what I write, e.g., totally ignoring, making up things I said, taking out of context, etc. Sexist? Nope. The fact that I rebut what several women write doesn’t make me a sexist. I devoted a lot of time and effort into rebutting men as well, e.g., Scott Allen. And losing my temper doesn’t depend on gender, just simply tired of attacks based on lies. As for “fake information”, give a few examples. Bet you can’t. As for “long winded,” even in college on exams we had essay questions requiring 1,000 words. As opposed to people like you, I actually carefully explain my position, including examples, and with numerous references, a nuanced position, not simply absurd dichotomous positions ignoring the real world, the world of science based on probabilities, not absolutes. Sorry if you have a short attention-span or simply are incapable of absorbing a nuanced developed argument.

You write: “Now for the next part you need to sit down with your favorite beverage and get into your zen mode and think about this.”

If you are referring to an alcoholic beverage, don’t indulge. Except for a few episodes where barely tasted in my youth, have been a teetotaler my entire life. I do like a cup of decaf with half water and half vanilla soy milk.

You write: “First Denice tries to dissuade you from responding to Scott, to the point of you launching an attack against Denice. Then Orac tries to dissuade you by posting this On April 19 at 0918: “As longtime readers know, I definitely do not like pedants, but in this case I’ll allow it.” Now I know you haven’t had any real military training but one of the first things that happens in an offensive is the distraction/diversion.”

Military training. Well, as I’ve written I was in Army ROTC Freshman and Sophomore years of college, which included classes in military strategy. Also, spent two years aboard U.S. Naval Ships in Western Pacific teaching in PACE Program (Program for Afloat Continuous Education). When draft ended to get recruits Navy offered chance to earn college credits, even at sea. And when not teaching or tutoring, observed, interacted with officers and crew,etc. So, nope, not expert; but not exactly uninformed.

As for Denise, following is my exchange with her, not an attack by any standards; but a respectful exchange of ideas. Again, are you delusional?

Denice Walter
says:
April 3, 2021 at 1:08 pm
Joel:
I notice that scott quotes me a few times, edited, as if to imply that I am critiquing you but nothing could be further from the truth.
I believe degrees ALONE are not enough and that WOO-MEISTERS frequently parade their faux credentials and crappy degrees to disguise their lack of data
..
Your degrees reflect a lifetime of learning and originate from respectable institutions. I often observe that we have areas of overlapping studies in psychology and biology. Educatiis a start but doesn’t mean that you automatically have carte blanche to say whatever you will but most times, you learn – especially in SB fields like those mentioned- how to cite research, understand statistical analyses and come to conclusions.
I don’t respect Orac ONLY because of his degrees but because of how he utilises them .: he criticises people who have medical degrees but who fall prey to unsubstantiated hypotheses and misuse of research data.”

Joel A. Harrison, PhD, MPH
says:
April 3, 2021 at 9:48 pm
@ Denice Walter
Scott doesn’t just misquote us, he ignores most of what we write and just cherry picks stuff taken out of context. He also makes stuff up, attacking based on “facts not in evidence.” And, as I over and over pointed out to him, it isn’t my degrees, it isn’t who I am, it is simply my use of critical thinking, my willingness to look at all sides and to explain why I disagree with some, it is what I write. Does it make sense? Do I back it up with references?

Denice Walter
says:
March 30, 2021 at 10:49 am
@ Joel:
” What matters is what I write.” Amen.
As sceptics we should always remember that degrees aren’t the final word if we do not ground our assertions in evidence- although in some cases, acquiring the degrees involved learning how to support your position adequately.

Joel A. Harrison, PhD, MPH
says:
April 16, 2021 at 1:19 pm
@ Denice Walter
You write: “A few observations: scott just likes to argue. I suggest that you shepherd him away from general topics ( war, politics, prejudice) because those have a tendency to spread beyond their original boundaries. SBM topics are easier to manage- we can stick to data. I’ve read lots of what he writes and I can’t tell if he is predominantly SB or not. Maybe he really likes you as a sparring partner, take it as a compliment.”
Maybe; but some of his comments indicate more than just sparring, much more. I don’t know if you continued to follow our exchange at “WTF happened to John Ioannidis?” but if not read the last dozen comments or so. Some of his comments just go way to far over the line of any type of human decency. And, though science-based medicine allows for databased discussion, other topics certainly allow for applying critical thinking.
And Christine refuses to even consider that she cannot possibly be absolutely certain that a vaccine was responsible for her infants tragic death. And she continues on her Gish Gallup of finding studies that she believes support her anti vaccination stand as, once more, I point out in the previous comment.

And just plain dishonest when you write: “Then Orac tries to dissuade you by posting this On April 19 at 0918: “As longtime readers know, I definitely do not like pedants, but in this case I’ll allow it.”

Notice that Orac’s comment was directed to F68.10 not me concerning his comment about Scott Allen:
F68.10
says:
April 19, 2021 at 6:15 am
@ Scott Allen
“Actually the Greeks invented napalm, it was called “Greek fire”.”
Wouldn’t call that napalm. But would you call mysorean rockets rockets ?
Pedantism is a scourge.
Orac
says:
April 19, 2021 at 9:18 am
As longtime readers know, I definitely do not like pedants, but in this case I’ll allow it.

So, why don’t you keep your word and NOT comment anymore on this blog?

Interestingly, ORAC you never write about the miracle drug ivermectin, despite writing bout mercola alot

As the genius BIPOC/Jew surgeon Mercola explains in the fact-checked article:

https://articles.mercola.com/sites/articles/archive/2021/05/05/human-prescription-ivermectin.aspx

Multiple studies have demonstrated successful treatment of COVID-19 with ivermectin, which lowered mortality rates, shortened hospital stays and limited viral spread
Although billions of doses have been used in the last 30 years, Merck now says there is a concerning lack of safety data and the WHO is concerned it may create “false confidence”
The WHO ignored their own commissioned report that found using ivermectin could cut COVID-19 deaths by 75% and instead cherry-picked data to support the subsequent recommendation that the drug be used only in clinical trials
The unsubstantiated war against ivermectin has followed in the footsteps of the hydroxychloroquine story and bears a strong resemblance to the lies perpetrated by the tobacco and sugar industries

https://journals.lww.com/americantherapeutics/Fulltext/2021/00000/Review_of_the_Emerging_Evidence_Demonstrating_the.4.aspx

Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance. Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin. Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of COVID-19 has been identified.

The science is incontrovertible. Since you ignore it, it must be the best drug for covid. But obviously it cant get approved cuz then EUA for vaccines would have to be removed, As always money>science

@Narad

thats not me, I always reference my stuff, its legit, I do facts, not drama.

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