What’s Really Happening at the CDC? | Dr. Robert Malone

[RUSH TRANSCRIPT BELOW] With President Donald Trump recently challenging pharmaceutical companies to “justify success” of their COVID-19 products, I’m sitting down with scientist, physician, and author Dr. Robert Malone to get his insights into what’s going on behind the scenes.

Dr. Malone is currently serving as a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) and also as a medical advisor for MAHA Action.

The recent firing of CDC director Susan Monarez was followed by the resignations of several top CDC officials. At the same time, Robert F. Kennedy Jr. has also announced that the emergency-use authorization for the COVID-19 vaccine products has been rescinded.

Is Trump’s recent Truth Social post a turning point in his stance on the COVID-19 vaccines and the success of Operation Warp Speed?

What does the future hold for the ACIP? What will they be evaluating in upcoming meetings? And what challenges and major opportunities does Dr. Malone see?

Views expressed in this video are opinions of the host and the guest, and do not necessarily reflect the views of The Epoch Times.

RUSH TRANSCRIPT

Jan Jekielek:

Dr. Robert Malone, so good to have you on American Thought Leaders.

Dr. Robert Malone:

Thank you for having me back, Jan. These are interesting times.

Mr. Jekielek:

Well, incredibly interesting times. Over the weekend, President Trump had a Truth Social post that, when I looked at it, I thought to myself, my goodness, has the world changed? What was your reaction? You said, hmm, very interesting, but I know there was a lot of thought behind that.

Dr. Malone:

Well, of course, it’s a little bit tongue-in-cheek having to do, if you’re of a certain age, with Rowan and Martin’s Laugh-In, where there was a character that always had that tagline, very interesting,when various interesting things were occurring on the show. In this case, what we’ve got is President Trump putting out a very thoughtful post on Truth Social, his home platform, in which he is taking the position that he has questions about the safety and effectiveness of the COVID products, medical products in particular. He never says vaccines. 

And he’s apparently perplexed that the information that has been shared with him from Pfizer and others about the success of Operation Warp Speed is not universally shared by others. And he is in a very cautious way laying down a challenge to the pharmaceutical manufacturing industry that they make public the information that they’ve been sharing privately with him. And one can infer that the logic here is that this will be made public and subjected to public scrutiny. 

And Jan, you know as well as anybody that there was an attempt to not make any of the information available, having to do with the clinical trial data and post-marketing data acquired by Pfizer in particular for decades, that this was all going to be sequestered. And it required a court determination, a federal court determination, to insist that the FDA go ahead and make those data public. These are the data that were summarized and analyzed by various groups, but notoriously by Naomi Wolf and the Steve Bannon MAGA posse that resulted in Naomi’s book, The Pfizer Papers. 

And so the president here, for the first time, I think, is publicly questioning whether or not the narrative that he has been provided and the information that he’s been shown is aligned with or fully transparent and is insisting that with data that’s otherwise available and insisting that the manufacturers provide the data that they’ve been showing him because the inference is it’s discordant with the data that others throughout the world, including in other regulatory agencies, have been identifying and disclosing publicly. And that comes on the heels of years of his insistence that Operation Warp Speed was a huge success, a major breakthrough. 

And I don’t think you can question that bureaucratically Operation Warp Speed achieved far in excess of what anybody would have expected would come out of the U.S. federal bureaucracy in terms of timelines, in terms of overcoming bureaucratic obstacles, and really pioneering a whole government approach to a health care crisis, a public health policy crisis.  But the question is, were too many corners cut? And were people mandated and otherwise persuaded, enticed, compelled to accept a medical product that wasn’t as safe and effective as they were told? 

This is particularly important in that most, if not all, of the major criteria that underpin modern biomedical ethics were breached in that response. And informed consent was not only not required or enabled, but it was actively suppressed. What the current data indicates is that the communications, both from the sponsors and from the federal government, actively suppressed information about potential adverse events in particular. And that’s just not acceptable in terms of modern medical bioethics. 

But it became a huge event that President Trump, on his Truth Social platform, raised these questions that he has really avoided asking in the past. And that’s been perhaps the largest reservation that his base has had about him. And certainly to make America healthy again, grassroots movements have had about President Trump is his insistence that this program was a spectacular success.  

Mr. Jekielek:

The president talks about the CDC [Centers for Disease Control and Preventation] being ripped apart over the question, indeed, of what was the effect of these products. And maybe why don’t you chart for me a little bit of the process of getting here? Because this didn’t come out of the blue. There was a whole lot of activity, I mean, almost too much to cover as a media company, frankly, or as yourself on your platform. But why don’t we start with where this actually came from? What catalyzed this?

Dr. Malone:

I agree. Those were remarkably strong words from the president, ripped apart. Let’s walk back over the last three weeks. Three Fridays ago in the evening at about 5 pm, an unhinged young gentleman decided to open fire. The term has been used as a spray of bullets on the outside of the CDC building. Unfortunately, a police protection security personnel assigned to the CDC, who is a father of a young family, lost his life in this attack. No one else did. 

The facility itself was not breached. And by the way, ever since that event three Fridays ago, virtually the entire CDC staff has been on paid leave, which they will need to return to work on September 15th. So five weeks of paid leave for the traumatic event of bullets being sprayed in downtown Atlanta against their workplace. 

That was followed by various statements from Senator Blumenthal that were a little personal for me, in which he reacted to my Friday Funnies meme roundup and called for Senator Kennedy to fire me from the volunteer position at the ACIP [Advisory Committee on Immunization Practices], which I wouldn’t mind if I didn’t. I’m doing this because Bobby wanted me to. Then that happened in the context of what’s been about seven weeks of slow walking of the ACIP subcommittee working group on the coronavirus vaccines, attempting to get CDC senior leadership to authorize what’s called a terms of reference statement, which for those of you that are not federal bureaucrats, you might just call it a scope of work. 

But terms of reference is the terminology that is approved within the CDC, as well as authorization to query the FDA for the data that was used to support the CBER [Center for Biologics Evaluation and Research] director Vinay Prasad’s decision to authorize the Moderna product for high-risk children and adolescents, which is still pending, that authorization. But they had to go through CDC approval, vetting, lawyers, etc. And there was a concerted effort to control what that agenda would be. And it finally came to the point last Monday, apparently.  

By the way, I just need to give the disclaimer, Jan, I’m speaking in my personal capacity, not as a member of the Centers for Disease Control and Prevention, or the Advisory Committee on Immunization Practices, or as a special government employee, or as a representative of the U.S. government. My opinions are my own in this interview. And I haven’t spoken to Bobby directly or Stephanie about this cascade, just to be clear. 

What I’ve learned from reading tidbits from the likes of Stat News and the Washington Post, etc., and then a little bit of chatter from insiders, not Bobby or Stephanie, was that last Monday, so two Mondays ago, the secretary called in the newly confirmed, only been on the job for about a month, director of the Centers for Disease Control. And there was a discussion that apparently included the issue of the letting go of certain CDC senior staff. I infer those senior staff may have been involved in the slow walking of the ACIP terms of reference document. 

And I know that in prior statements in the context of her confirmation, the director had made a statement to the effect that she would not terminate any of the existing CDC senior staff. It appears that the secretary asked the director of CDC to terminate some of these senior long-term staff that were insisting on basically controlling the agenda for the upcoming ACIP COVID subcommittee workgroup and what they would be allowed to consider as they would investigate and make recommendations to the director of the CDC concerning the three COVID vaccine products that are currently on the agenda for discussion at the upcoming ACIP meeting, which Bobby has insisted occur in September and is now finally scheduled for the 18th and 19th of this month. So stay tuned. 

If you’re enjoying the last week, you’ll enjoy the week of the 17th and the 18th even more. And with the decision apparently by the secretary coming out of the meeting with the director to ask the director to vacate her position. And then last Wednesday, the Washington Post came out with a brief breaking news article that, in fact, the director had been asked to leave. The director apparently had already engaged attorneys to work to neutralize, claiming that the secretary didn’t have the authority to terminate the director of the CDC that reports to him. 

Somewhere in there, apparently, I’m not clear on the dates, but the director of the CDC apparently spoke to Senator Cassidy and complained that the secretary for HHS, RFK Jr., was politically interfering with the processes, the science occurring at the CDC. Then almost within an hour, it’s been a pretty compressed news cycle, as you say, the Washington Post came out with this immediately after that announcement. And in the resignation letters asserted again the narrative that the secretary was politically interfering with the science at the CDC.  

I infer that the science at the CDC that they’re referring to, their claiming had to do with these terms of reference at the ACIP working group. The person who is functionally serving as a spokesperson for this group of people that resigned has denied that that’s the case, that there’s a cause and effect having to do with the terms of reference, and that his objection was that there were policy decisions being made. It’s unclear what policy decisions he’s referring to.

The chairperson of the working group, Dr. Retsef Levy, has given an interview, with authorization from Andrew Nixon of HHS Communications with Dr. Maryanne Demasi, who writes a substack. There, Dr. Levy, a full professor of risk management and identification at MIT, so no small chops there academically and scientifically, makes it very clear that there were absolutely no policy discussions between himself and the individual or individuals who have resigned that are claiming that this was a policy dispute, but that, in fact, the only subject of dispute and discussion was the scope of what the ACIP working group for COVID vaccines would be allowed to investigate. 

The position taken by the senior CDC staff that resigned was that the CDC has already done all the necessary investigations about, for instance, the adverse events. The only adverse event that is occurring with the COVID vaccine mRNA products is myocarditis. There are others that have not met statistical significance. That’s a different nuanced question of how they’re determining that. What this teaches, in my opinion, is that historically, what has been observed by many and complained about by many is that the ACIP seems to be a rubber stamp organization. This has often been attributed to financial conflicts of interest, and certainly, those have existed. 

Many of the ACIP members and the working group subcommittee members have been drawn from various medical professional societies, which have been documented as pretty much universally receiving major funding from the pharmaceutical industry. So the secretary, in deciding to retire the former ACIP committee, that’s his words, had indicated that there was this chronic financial conflict of interest that had characterized many of the prior ACIP members and that it was necessary to start over. So those were the claims. They were reinforced through a number of venues. 

First off, there was a protest at the CDC that was apparently a previously scheduled rally. It was composed mostly of the approximately 600 full-time employee personnel that had been made redundant by the DOGE effort when Elon Musk was still functioning as a special government employee. Their termination had been delayed because they had filed a court case seeking an injunction against their termination. They just lost it. They just lost the court case, so they were officially fired. 

You read in the headlines that Bobby Kennedy has fired over 600 full time employees at the CDC.  Actually, that happened weeks ago. It’s just that the courts finally allowed it to happen. A lot of these people had a rally protest in front of the CDC. Apparently, they’re not worried about shooters. In that context, some CDC personnel walked out and joined them, including the chief medical officer and another individual who has really become a bit of a media darling recently, been on ABC News, etc. Speaking about the narrative that they’ve resigned because the secretary, RFK, has politicized the CDC and so on. 

Also introduced was the narrative, why this person did this, that they feared that the next thing that was going to happen was that the ACIP was going to recommend that the hepatitis B vaccination policy would be changed. What a tragedy this would be. I think if you polled American parents, most American parents would disagree with this senior bureaucrat from the CDC that has resigned. But that created a whole new narrative that Ron Paul felt he had to address. 

Senator Cassidy endorsed that. Ron Paul, who is actually a physician, as is Senator Cassidy, contradicted Senator Cassidy and said, no, there isn’t a good justification for hepatitis B vaccination of the newborn. The president then dropped this post that we’ve discussed, and that set off another whole round of social media turmoil. I haven’t encountered that level of hate directed at me, oh, at least for about three weeks since I was appointed to the ACIP. There was a whole round of media posts about me. 

Clearly, there is a concerted effort to attack the secretary, delegitimize him, and accuse him of interfering in public policy positions of the CDC, which to my eyes has no merit. This then reaches this point where we’re at today, where, you know, this morning I had conference calls with the other members of the ACIP COVID working group, but we have four meetings scheduled because we have to jam all of our hearings in between now and when we have a slide deck available for the other ACIP members and draft recommendations that’ll be rolled out during the 18th and the 19th. Everything is compressed, as usual. It all got delayed because of the slow walking. Now it all has to be done in a very short time frame, and we’re not going to be able to do a very comprehensive job on that. 

Last week, the Secretary also announced that the emergency use authorization for the COVID products had finally, finally been rescinded. The medical emergency had been declared ended months ago, but they managed to kind of retain the EUA [Emergency Use Authorization] for these products, even though there was no longer a medical emergency, and that’s finally ended. 

Now we have a termination of that and three products authorized, Moderna, Pfizer, and Novavax, you know, in short, for limited indications of basically elderly and populations at high risk of at least one high-risk factor, undefined by the FDA what that meant, which is part of the remit now that’s been tossed into the lap of the AC following any FDA determination about a vaccine. The FDA basically took this hot potato and threw it straight in their lap in the midst of all this other chaos, and there we are.

Mr. Jekielek:

Robert, from what Dr. Levy said, it seems like they wanted to keep any discussion of COVID vaccine injury out of the scope of the work that the subcommittee was going to do? Now, explain that to me.

Dr. Malone:

I’m also perplexed that the subcommittee is supposed to be independent of the agency. This is fundamental to FACA [Federal Advisory Committee Act], to independently assess and advise key personnel and decision-makers within the federal government. The position taken by these individuals that have resigned, apparently, was that, in fact, they were the ones that were authorized to determine what the scope would be for the ACIP’s investigations and decision-making, and that the CDC had gathered all the necessary data concerning adverse events and effectiveness of these products, and that those data from the CDC were available for the ACIP to evaluate, and that it was out of scope for the ACIP to consider other sources of information. 

That, I think, is a perverse interpretation of the charter, but it is the clearest indication of how we got to this point where the ACIP had basically become a mouthpiece for the interests of both the CDC bureaucracy and the pharmaceutical industry. Because, as opposed to a check, you know, on the system, that’s really supposed to be an independent assessment and advisory to the director, which is what the charter is.

Mr. Jekielek:

So where does that leave Dr. Levy and the subgroup, which I understand is going to be meeting soon?

Dr. Malone:

Our first meeting, I think, is tomorrow and then another one on Friday and then two next week. Now those folks that were obstructing and insisting on controlling the process and the scope are no longer there. New people have stepped into those roles. As Dr. Levy, elaborated in this notable interview, currently all indications are that we will be able to move forward as partners with these CDC personnel. That is absolutely our approach to this. There are those who insist that there should be some accountability for these actions. 

But from the standpoint of the committee, it’s not our job. We’re not in charge of accountability, nor is it within our mission to assess or do fact-finding on any things that might have occurred over the last few years. Our focus is going forward. Our focus is on the current circulating strains of SARS-CoV-2, on the currently available products, and advising the director of the CDC on what the data show as the safety, effectiveness, and utility of these products should be, and to follow the data wherever it should lead. Current discussions include all of those that will be testifying to the subcommittee, and may well include some members of the prior subcommittee that was terminated under the Secretary’s order when the ACIP was retired and the new one rolled in. 

We’re absolutely on board with having a full diversity of opinion and commentary. It may well be looking forward; I speculate that there may be a presentation to the general ACIP and the public that has bullet points for those that are advocating current policy and those that have testified about things that might cause reservations about current policy. What’s on the table is what would be recommended. 

The recommendation range of options for ACIP is really pretty constrained. Sorry, MAHA base, it doesn’t include throwing them in jail. It’s very straightforward. We can recommend that these vaccines be administered. in alignment with what the FDA is authorized to do. We can recommend what’s called shared decision-making, in which there must be a discussion and informed consent between a physician and the patient or the caregiver responsible for the patient. So, father, mother, etc., for the child. And then there is the option of no recommendation. 

If, for instance, our request to the director of CBER is to share with the ACIP data he and his staff used to support the decision to authorize these products for these populations, it’s reasonable that the ACIP should receive the same information that the FDA used in their decision-making. Otherwise, we can’t really know what was the basis of the decision. We also, you might imagine, would very much need to receive the documentation about what constitutes a special population or a population at high risk. 

It’s not good enough to just say anybody that is high risk or has one risk factor; well, define what that is and what the data are to support that. Not all risk factors are the same. Somebody that’s recovering from cancer or has certain conditions, let’s say cystic fibrosis, may not be the same as a child who is just moderately obese.

So what is that data? What are those criteria that support that? And if those data aren’t aligned or aren’t made available, then one can reasonably infer that it’s not possible for the committee to formulate a recommendation. If we don’t have the data and our charter is to follow the data, then how can we make a recommendation when the data doesn’t exist? Just in good faith? Sorry, I can’t do that anymore. So that’s a hot topic. 

And then another one looking forward, if the committee were to make a recommendation here, there, or anywhere about shared decision-making, that implies that there must be a dialogue and informed consent between the patient or patient representative and the prescribing physician. It also implies that these products would be available by prescription, but not necessarily that you can just walk up to Walmart and get a jab in the butt or in the shoulder or whatever. So already a lot of the reports are that CVS and Walmart, etc., are pulling back from their campaigns for administering these various products. So if there’s going to be shared decision-making, there has to be informed consent. 

Why there doesn’t have to be informed consent in the case of what is functionally a standard of care mandate, if the ACIP recommends and the CDC director endorses use for a particular indication is beyond me, as somebody schooled in medical ethics. Informed consent is the cornerstone of all medicine, but that’s how it’s been interpreted. That’s the system we have. 

But if we’re going to move towards shared decision-making, which the pediatricians hate, by the way. They just want a cut-and-dried, if you’re 36 months and you’re overweight or whatever the risk factor is, then you get it. That’s the cut-and-dried world of modern corporate medicine. So they don’t like the idea of shared decision-making where they’re going to have to have a discussion with a patient and justify why this particular child or that particular elderly person should receive the product. 

We believe that it’s necessary. It’s the responsibility of the ACIP to provide the physician with guidance about the information that must be shared with the patient. So we can’t just say, well, you have to have informed consent and it’s shared decision-making, but it’s up to you to figure out what you have to discuss with the patient. Now, that doesn’t really work. It doesn’t help anybody. 

Part of what we’re going to seek to do is to provide clear guidance. It’s a fact-based document that, in fact, A, B, C, or D are known risks and F, G, H, and I are potential risks. And I’m pretty sure that one of those risks is going to be death. So stay tuned on that. But the database is being independently examined, I think, for the first time.

Mr. Jekielek:

Robert, the last time you were on the show with Dr. Retsef Levy, one of the topics we covered was the difference in your vote and Dr. Levy’s when ACIP was voting on authorizing these RSV [respiratory syncytial virus] monoclonal antibodies. And since you’ve actually seemed to have some second thoughts about your decision and actually have been asking questions about whether you are going to be trusting CDC presentations to ACIP going forward, I’m wondering if you could just unpack that for me, please. 

Dr. Malone:

This illuminates one of the key problems in relying on a bureaucratic structure to assess data without peer review. And in the case of the ACIP, which ostensibly might function as a peer review structure, being presented with the data the day before the meeting, actually the night before, so no chance to evaluate it or ask questions. In the case of the RSV products, it was a very strange presentation that was made in which information about other RSV products was more prominent than that of the monoclonal antibody that was actually the subject for discussion. So a lot of kind of ancillary information that wasn’t specifically relevant to the question at hand was presented. And the information that was presented now, in retrospect, appears to have been incomplete. 

And the claim advanced most clearly once again by this PhD investigative reporter, and her PhD is not in English literature or women’s studies, it’s directly relevant to this topic of immunology. Dr. Maryanne DeMasi, working with others, evaluated in particular two of the signals that were present in the data, but not entirely clear in the presentations at that ACIP meeting having to do with the new RSV monoclonal antibody that we collectively ended up endorsing for virtually all newborns, much like the hepatitis B vaccine. 

But we had a couple of dissenters in that vote who voted not to recommend, one of whom was the same Retsef Levy. And there was a particular issue that raised Retsef’s intuitive sense that something wasn’t right. Was data having to do with deaths in clinical trials? Deaths are a rare event in this case, fortunately, post-inoculation with these monoclonal antibodies, which are not vaccines. But there was an imbalance. There’s never a proper negative control with the vaccine products. 

But in these studies, there were proper negative controls. And there was an imbalance in deaths, with slightly more deaths in the inoculated group compared to the control group. Furthermore, that trend of statistically not significant, but still numerically split with the same trend was present in the studies involving the other marketed monoclonal antibody product. As I recall, Retsef’s particular objection was that there were these trends in the data about excess deaths that were in, I guess this gets back to another nuance in clinical trials. 

A death is a severe adverse event, full stop, and usually will trigger a stop a clinical trial enrollment. And someone has to adjudicate the decision whether that death was associated with the product or not associated with the basics. And the person who gets to make that determination is the principal investigator for the study. The principal investigator for the study is often working for a contract research organization that gets its money from the sponsor, say Merck. 

So the principal investigator, one might infer, might not be entirely objective about, or there might be some even unintentional bias towards making a determination that a death is unrelated to the product. Because if the death was related to the product, then there is a huge cascade involving disruption of the study, major revisions, delaying timelines, which means delaying when you’re going to get paid. 

A lot of structural disincentives in clinical research make it difficult for a principal investigator to make a determination that a death was related to the product. In all of these cases in the treatment group, the principal investigators made the determination that the deaths were unrelated to the product. Now, there are historical examples where this was the case. 

For instance, in some of the cholesterol-lowering drugs that are particularly potent, there’s a notorious example of suicides, deaths being higher in the treatment group than the untreated group, and yet the determination that it’s unrelated because they were suicides. But it turns out that when you draw down cholesterol, you draw down cholesterol out of the brain, people get depressed, and then they have more suicides. So it actually is related. 

But at first blush, when you just look at the data, oh, come on, they’re taking a cholesterol-lowering drug and they commit suicide. Clearly, that’s unrelated, right? And historically, that has just been the way the system works. And the FDA blesses that and endorses it. And it’s the way things are. 

I think that what this death signal teaches, and I suspect we’ve had some informal discussions. I think that there’s support for this. When we have death data like that, the ACIP is going to need to require that we get our hands on the primary clinical records associated with those events so we can make our own assessment of whether those were related or unrelated. Clearly, we need to do something more than just accepting what comes at us from the pharmaceutical industry. 

The other signal that was worrisome had to do with seizures. And in particular, there was a timeline that appears on the surface to have been arbitrary, wherein seizures that happened after that timeline were determined to be unrelated to the product, whereas seizures before that timeline were. And once again, there’s an imbalance. There’s more seizures in the inoculated group than the un-inoculated group, but it didn’t rise to significant statistical significance. It’s just under the threshold of predetermined statistical significance. But there’s this, what appears to be an arbitrary cutoff. In fact, there were one or more additional seizures after that timeline. 

When you take those data and wrap them together with the seizures prior to the cutoff date, that is not justified. It wasn’t justified in the presentation. I’m sure they have a reason; they haven’t shared it with us. If you lump that, suddenly the seizure signal is statistically significant compared to the comparison group. The appearance is that, at a minimum, the data presented to the ACIP on very short notice has the potential appearance, I’m choosing my words, of having been, let’s say, selectively reported and that it, with just a slight turn of the knob, the interpretation would have been very different. And on the basis of that, we’re making a decision. 

I voted for universal administration of this product to the newborns during RSV season whose mothers were not previously vaccinated. Hence, my objection and my sense of, frankly, betrayal is that I made a very public vote on a rather sensitive issue at a time in which the ACIP was, this new ACIP, was under intense fire. I was under intense fire from corporate media, calling me an unqualified, crazy anti-vaxxer, that whole media characterization that is promoted about me. 

Yes, I am an anti-vaxxer if you define anti-vaxxer as somebody who’s against vaccine mandates, which is how Webster’s defines it. So I’m guilty as charged of not being for vaccine mandates, which is defined by Webster’s as an anti-vaxxer, but they don’t put all that context in. They just say, that guy Malone, he’s crazy. He’s an anti-vaxxer. So all this was coming down. We were under direction from leadership to be gentlemanly, I think is one word, in our initial interactions with the ACIP. The press was on us like flies all the way through that.

They were staying at the Emory Hotel. The long lenses were out focusing on each one of us. You can see the photographs of me asking questions, and they were looking for us to make a misstep and to do something that would fit into their narrative of being a bunch of rabid, now and was a member of the RSV subgroup, who very carefully walked me through the logic of what the prior working group had determined as it related to these products. I trusted how the data were presented. 

What I said in reposting the Demasi substack was that I no longer feel comfortable assuming good faith and transparency and integrity in the presentations. In this case, the presentation was provided by a contractor, not actually CDC personnel, that works for one of the large HMOs, I believe it was Kaiser Family Foundation. So it wasn’t CDC personnel making the presentation. And so nobody within CDC can actually directly be held responsible for that. 

But not to say that CDC personnel are liars, but we’ve all heard the saying that, you know, statistics can lie. They can be used to distort information. That statistical analysis of clinical data can be manipulated through choosing the analysis window so that if you’re right at the threshold of something being statistically significant, you can shift the results by very carefully choosing how you analyze the data. If you’re going to choose a particular cutoff in a sensitive situation like this, our position now is that you have to have clear justification for why you did that. 

We’re now insisting that there be a lot more transparency about what has been done to validate these findings. We are seeking to have more independent scrutiny and review of the information presented to the public and the ACIP in these presentations. And that’s consistent with the Secretary’s mandate that we follow the data. In order to follow the data, the data have to have integrity. The analysis has to have integrity because we don’t have the time, nor does the public, to go through line listings of clinical trial data and reevaluate them. We have to have summary statistics. 

The position of the CDC, as it relates to, for instance, the adverse events associated with COVID products, is if it doesn’t meet statistical significance, functionally it didn’t happen. So if you have signals that are rare and they don’t rise to the level of a sufficient number of signals to meet a statistical test, then the position is essentially that they didn’t happen. That’s not valid. That’s a distortion. It’s a distortion that is common in epidemiologic public health analysis, that basically the position of modern public health is, of course, the greatest good for the greatest number. 

Functionally, what their position is, is that the only truth in a world in which truth has become based on feelings and subjective criteria, the only truth that they will endorse is that truth, which is validated through statistical significance and their particular epidemiologic assessments. Any other data are anecdotal and irrelevant. And that’s just not OK. It flies in the face of experienced, firsthand or secondhand in most cases, adverse events associated with these products that are more than just myocarditis. But the CDC denies that that’s the case. Hence, you have a public that, for this and other reasons, no longer trusts the CDC. 

Of course, I’m getting back to the amazing cascade of the news cycle about the CDC over the last three weeks. The positions taken by those that have resigned and their backgrounds have raised even more questions about the CDC’s integrity, caused other authors to go back and look at the history of the Tuskegee experiment, which is a very dark time in CDC history, and many of those that have been doing the media circus right now and calling for the secretary’s resignation appreciated the Streisand effect, wherein if you go and try to cover things up and make excuses, all you do is you get more public scrutiny and have your own house in order because it’s going to get examined. That is pretty much what’s happened over the last three days.

Mr. Jekielek:

The bottom line here is ACIP has been tasked with looking at the safety and efficacy of vaccines and other products, of course. It seems like the CDC was basically resisting your ability to do that, in fact. Am I reading that right?

Dr. Malone:

That’s certainly my impression. There absolutely have been a lot of barriers to moving forward as a fully independent organization, as opposed to one that is very dependent on the opinions, structures, agendas, and subcommittee membership advocated by CDC senior administrators. I believe that Dr. Levy and the committee are well within the committee charter to seek to function independently, but there has been enormous resistance to that idea. 

It’s very strange for myself and for anybody on the outside to grapple with why CDC personnel would be so actively resisting asking the independent advisory committee questions about issues such as the safety and effectiveness of these products and the wisdom of the current childhood vaccine schedule for many of these products, for example. It seems, I think, for the average person, self-evident that an independent advisory committee would need to ask independent questions about the safety and effectiveness of these products and the underlying immunology associated with how they’re working or not working, interactions, potential effects in terms of class switching, which is functionally a form of immunosuppression, something I’ve been attacked for saying is occurring, and yet the data are very clear. 

This is functionally a version of an acquired immunodeficiency. It’s not AIDS, but it is an acquired immunodeficiency, which is the formal definition of that category of diseases, acquired immunodeficiency syndrome. It doesn’t mean that it’s triggering HIV disease, but the press is not very good with nuance. In particular, this grassroots movement of Make America Healthy Again that has gained so much momentum and interest on the part of the public is insistent that these questions be asked. They have lost confidence for good reason in the decisions that have been promoted by the CDC and in particular by some of these staff.

The MDMPH investigator that has resigned so publicly was specifically brought on to be Rochelle Walensky’s specialist. It was the same person that advocated for universal American vaccination against monkeypox. This is somebody who is intimately involved in the decisions about social distancing, mask use, lockdowns, and the pivot within the CDC under the influence of the Teachers Union away from a historically more rational position on children and schooling and lockdowns that was involved in the decision-making to pivot to advocate for these harsher measures. 

The data is quite clear that major harms have occurred; financial harms, learning harms, socialization harms, and educational harms. There are discussions about this being a lost generation educationally, consequent to what are fundamentally CDC positions. So we have entered a new era. 

When we first started this interview talking about the president’s statement, this has changed the entire landscape. And the CDC is receiving a lot more scrutiny. And again, let me emphasize, the CDC has a lot of good people there. There are some folks that have advanced questionable policy that is being challenged, but the ones that are remaining, who are working with Retsef Levy, a subcommittee, and the ACIP in general, are fully committed to working in an open, transparent, cooperative way with the appointees that are currently participating in the Advisory Committee on Immunization Practices.

We at the ACIP and the workgroups serve at the pleasure of the secretary. If the secretary decides that it’s time for all of us to retire, or just for me to retire, or whoever, it’s his call. And likewise, the secretary serves from the manufacturers concerning the data that had been presented to him, which appears to me to be tacit support and acknowledgment of the Secretary’s position that we deserve to get to the bottom of this data. 

He doesn’t want the news cycle dominated, you know, compared to stopping the Israeli-Palestinian conflict or Iranian nuclear weapons or trade policy. For some of us, this is important. But if you think about the president’s portfolio, he’s basically put his foot down and said, guys, I’m tired of this. Let’s get to the bottom of it, get it cleaned up, and move on. And I fully support the president in that. That is where we’re coming from at ACIP: show me the data.

Mr. Jekielek:

Well, I think that’s the thing that really struck me here. This administration, part of its mandate, or part of its promise, was that it would provide some transparency. It seems to me that this particular post is a demand for that kind of transparency.

Dr. Malone:

Another thing that people overlook, and I’m often asked the question, what is the bond between the secretary and the president? They both have a firm bedrock commitment to families and children in America. If you look at what’s going on with the MAHA Commission, you look at the president’s statement with the rollout of the first commission report in which he emphasized that if we don’t change something, we’re on track for our children to live shorter, sicker lives than their parents. That’s where Bobby and the president have a strong shared commitment: over American children. All of this relates directly to that issue. 

Are American children being well served in federal vaccine policy or not? I know that the secretary is committed to having that question addressed. I’ve heard through back channels that the president is also personally committed to having that issue addressed comprehensively. It’s our intention at the ACIP, in my opinion, not speaking for the ACIP, that we meet this mandate in an open, transparent, open-minded fashion, despite all of the horrible things the press is saying about me and my colleagues. 

If it turns out that I was wrong about the data having to do with adverse events, deaths, etc., stratified by age and risk factor associated with these products, I will say so, just like I said that I was wrong in my vote with the RSV until proven otherwise. If the data show that I was wrong on COVID products, I’ll be glad. I’ll be the first one to announce that I was wrong and my detractors were correct. I don’t think that’s going to happen, but time will tell.

Mr. Jekielek:

Dr. Robert Malone, it’s such a pleasure to have you on the show.

Dr. Malone:

Thanks for having me on, Jan, and thanks for the opportunity to help your listeners navigate these challenging news cycles.

This interview has been partially edited for clarity and brevity.