Transcription – English – Brook Jackson

08. Brook Jackson.mp4: Video automatically transcribed by Sonix

08. Brook Jackson.mp4: this mp4 video file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Trish Wood:
So I guess the best place to start is is at the beginning. You got a gig at this place called Ventavia. We're doing clinical trials for the Pfizer vaccine. Maybe. Tell us, what was your role and when did you start noticing that things were not maybe as they should be, in your opinion, as someone who has clinical trials experience?

Brook Jackson:
Yeah. Almost 20 years of that. And I hate to say it because I feel like it ages me so much, but I was hired at Ventavia Research Group in September of 2020 as their regional director. I was hired specifically for that role in overseeing the day to day operations, the clinical trial staff, specifically for for Pfizer's COVID 19 vaccine study.

Trish Wood:
And so what what did that entail? In other words, how involved were you actually with the trials themselves? You weren't sort of distant. You were right there, weren't you?

Brook Jackson:
I was, yes. I wasn't patient facing. I was more in a senior position overseeing their research stuff and their activities and just ensuring the data integrity of the study, the quality assurance auditing of of the study that was going on up until the.

Trish Wood:
And what exactly was the clinical trial and what were they trying to to achieve very specifically with it.

Brook Jackson:
So I started up until we again in September of 2024 for my role specifically. Again, I was hired to oversee Pfizer's vaccine trial, which at that point, when I when I began working, there was about two months into enrollment. So this was their pivotal their phase three trial and what eventually led to their emergency use authorization being given by the US Food and Drug Administration in December of 2020.

Trish Wood:
And if you could just explain for people who might not know this, this was what they call a placebo controlled, double blind, right? Can you just say what it actually is.

Brook Jackson:
Called.

Trish Wood:
And what it is and why it is that way? Because that's really germane to what happened. Is that. Sure.

Brook Jackson:
Sure. So in clinical trials, randomized placebo control, that's really the gold standard for this particular study. It was actually observer blind, not double blind. And what that meant for this, the study is that the person that was vaccinating are given the injection to the clinical trial participants should have been the only one that was aware of of the treatment assignment or whether the patient was receiving the actual product or if the patient was receiving placebo, which in this case would have been just a saline injection.

Trish Wood:
And that's important because.

Brook Jackson:
It's important because it prevents a bias from being injected into into the trial. And by that, I always give a little example of if the study doctor or principal investigator, the physician that's overseeing your participation in the study, is looking over your health, the safety of you, it gosh, it's kind of hard to explain on the spot, but it it prevents a bias from being injected so.

Trish Wood:
So.

Brook Jackson:
Doctor doesn't treat you're.

Trish Wood:
Just go ahead so go ahead.

Brook Jackson:
Sorry. So that physician knowledge of what treatment you're on does not affect his course of treatment for you. Does that make.

Trish Wood:
Sense? It absolutely makes sense. Keep going.

Brook Jackson:
So back to my time there from from day one, I really recognized. A real lack of one space to enroll the number of patients that we were actually looking to enroll. We were understaffed. We did not have the infrastructure to to conduct this type of study. There was there was a real direct push from Pfizer directly to enroll more patients than than they knew we were capable capable of of safely overseeing. So that was really the first thing that I noticed in my first day on the job. I took an opportunity to obviously meet the staff that I was going to be managing and decided that I was going to kind of just shadow one of the research staff who were performing a consent on a new patient that wanted to enroll in the study. And I just I'm sure I made her a little nervous, but I just wanted to get an understanding for the clinical flow and also to make sure that we were following our own standard operating procedures in terms of providing informed consent. But when I watched her give this informed consent, it, in my opinion, was not a full informed consent. The coordinator understood that this patient wanted to participate in the trial, and it was it was quickly the informed consent form was quickly gone over with the patient and basically assign here, date here. Let's get let's get you injected.

Trish Wood:
Yeah. So you're suggesting it wasn't particularly thorough.

Brook Jackson:
Oh it wasn't at all. No. And research and nurses on on the call may be able to appreciate this, but there's a saying if you didn't document it, it didn't happen. And in research we, we document quite, quite a lot. And, you know, if there's ever a question that's that's asked by a potential participant, you know, we document that question. We document our response to that question. You know, we can quote, you know, the protocol and how we were able to give give that answer to the question. So it's a very it's a very thorough it's a continuing a continual process. It's not just a moment in time when you sign a document. It is, in my mind, the most important part of of. The research study.

Trish Wood:
So I know in the the original story. There. There was kind of a list of things that you discovered with varying degrees of seriousness, but but in your view, adding up to a pretty serious problem with the way that the trials were run. In your opinion, can you just give me that list and describe for me why each of those things was important going all the way up, I think, to the study becoming unblinded, in your view, right at one point?

Brook Jackson:
Yes, absolutely. So I from September 8th was was my first my first day at Ventavia. I was only there for 18 days before before I was fired. But but during those 18 days, I recognized these deficiencies and this misconduct. And so I started documenting everything I was I was bringing what I was finding to the attention of my leadership, the leadership team, and kept being told to put everything on a list. So I started documenting these these things that I was finding, and a lot of it was just sloppy. But a lot of it, you know, the data integrity I knew was was so important and the safety, obviously, of the patients, their welfare was important. So just documenting these things, I mean, the first the first one I've already talked about the lack of informed consent. And in my audit of these documents, these clinical trial documents, these individual patient documents, I was I was finding that some of the informed consent forms were and what I've been trained to find looked like they were forged. We collect a government issued ID card or driver's license as part of the entry into the study. And a lot of the signatures on the informed consent form did not match that on the government issued identification card. So I was documenting that. Fabrication of data, falsification of data, lack of timely reporting of adverse events, and those included those serious adverse events. Sometimes the staff were not reporting them at all. And this goes back to just our structure. We at sometimes only had 4 to 5 research staff where we needed triple that number, you know, to to safely monitor these patients that were volunteering themselves to science.

Trish Wood:
And so could you just I just want you to follow up on the on the not reporting of adverse events attached to the people in this trial of a vaccine, because that seems to be a key point. Right. If they're not reporting adverse events in the trial, then how can we have confidence in the numbers submitted later to go with the emergency use authorization? Right.

Brook Jackson:
That's you can't you can't that was my point to the FDA when I when I sent in my my complaint, when I realized and it was on the 17th of September when when I realized that Vince Harvey and my former company had inadvertently I don't think this was purposeful, but had had potentially unblinded every one of the enrolled patients in the study. I became aware that we were not storing the product at the temperature that was required by Pfizer's protocol, which which speaks directly to the stability of the product, the adverse events. There was a real confusion and an understanding that my staff had versus how the protocol was written, so they just were not sure what needed to be captured as adverse events. Obviously serious adverse events have a have a standard definition, but those adverse events, for example, during day one through seven post-vaccination were those those systemic reactions, the the headaches, maybe the body aches, the fevers or those to be captured as adverse events. So I feel, you know, when I think about the root cause of this misconduct, why did it happen? Why did Pfizer allow it to happen? It was really just just the rush the rush there for Pfizer especially to be first to market, I feel like for my company, because they were paid mainly on a per patient basis, that that money was was a driving factor. They had no regard for for these patients at all. And and that was what ultimately led me to to file the complaint with the FDA and and what got me fired.

Trish Wood:
I know the panel is going to want to drill down. I'll just get the I'll get the rest that kind of the outline of it because it's not just what happened to Ventavia, but then you went to the FDA and what happened with your complaint there?

Brook Jackson:
Sure. So on the 25th of September of 2020, after those 18 days of documenting, I think in my FDA complaint, I listed just 14 things off the top of my head. I had my son, I had a doctor's appointment. It was a Friday after Friday morning when I made this complaint. I chose to stay home this day and use it as a my administrative day to kind of catch up on emails and just other things. And on top of that, again, my son was sick, but I just I was sitting there, I was thinking, gosh, all these things that I've that I've noted, if this is happening at Ventavia, a few sites in the Dallas-Fort Worth area or is this happening elsewhere? So I, I emailed a complaint. So the FDA listed 14 things that were just on my mind at that moment. And about 6 hours later, I received a call from the Chief Operating Officer at Ventavia and was terminated on the spot and under the pretext that I was not a good fit.

Trish Wood:
Right. And so there's two ways we can go here. So so you you contacted the FDA. Were they responsive to the complaints you you made?

Brook Jackson:
So I called the FDA first and was directed to their their website, where I completed an online form and just copy and pasted an email that I'd kind of pre drafted. And I got their basically canned response back. Thank you for your concern. But on the 29th of September, I actually spoke to an investigator, an inspector with with the FDA and her and I spoke for a little over an hour. I, I went over my complaints. Our conversation basically mirrored that maybe a little more detail. And she was very, very sympathetic to the fact that I was I was fired and I felt good when when our conversation ended, and I had confidence that based on my credibility and the things that I was reporting and that they were going to go in and at least inspect Ventavia.

Trish Wood:
Did they?

Brook Jackson:
No. They did not.

Trish Wood:
No.

Brook Jackson:
And as a matter of fact, when when the initial emergency authorization was given to those that were 16 and older and that was given on December 11th, I, I saw a a release that the FDA had only inspected six clinical trial sites.

Trish Wood:
Out of how many? How many are there? Do you know?

Brook Jackson:
Well, there's a little bit of, I guess, debate about that. The FDA has reported that there are 153 sites. I have evidence that there's 154 that that's going to be discussed in my court case. Excuse me. But but 150 153 is what the FDA has reported to the FDA.

Trish Wood:
So I'm going to pass this to the panel and just say that you have. A stack of documents. Oh, yeah. You have audio tapes because they initially tried to say you hadn't even worked on the trial. Right.

Brook Jackson:
That was their first response.

Trish Wood:
Yeah. So just I'm just saying that this is a credible report that was published by the BMJ, well documented. Paul Thacker was the journalist. So I'm going to hand it to the to the panel because I'm sure they have questions for you.

Preston Manning:
Well, thank you for doing this. Just two questions. One, if you hadn't done what you've done, was there some other place in the system where this might have still come up and the company held accountable if you hadn't done what you've done? Is there still some safeguard somewhere else that might have triggered there's something wrong?

Brook Jackson:
Well, that that would have come hopefully maybe from another whistleblower, but but should have come from the Food and Drug Administration. The FDA. The FDA will tell you on its own website that they rely on the sponsor of a trial to provide the data, which is used to determine whether a product device, a biologic therapeutic, is approved or not. So unless the FDA actually goes to the clinical trial sites. They will they will never know unless it's reported by a whistleblower or maybe potentially the sponsor. Pfizer can do their own internal audits and there are reporting guidelines. So there are other ways. But I, I feel like I gave Pfizer, I let them know about the obvious conduct as well. Although I did that anonymously. I alerted the FDA and I gave them until January of 2021 to at least inspect and investigate my allegations. And nothing ever, ever happens.

Preston Manning:
Yeah, maybe you've answered this, but maybe you could elaborate. So if you could change the system so that this defect did not exist, are there any particular things that you would do or recommend?

Brook Jackson:
Yeah, I think that's that's a great question. Obviously, more more oversight from the regulatory body that that governs clinical trials. They they sometimes inspect as few as 1% of clinical trial sites that are participating in trials. So there's that I mean, gosh, there's there's a ton of ways that I think that we can find this type of misconduct. But but I think that really has to begin at the regulatory authorities direction. That's that's that's their job is to protect people that are participating in research. And they fail to do that very frequently. Okay.

Dr. Susan Natsheh:
Thank you, Brook. That was sure. So thanks for taking the time to be here. I have a few quick questions for you. You mentioned that there was a rush to get the trials finished. There was a marked understaffing at your facility to accommodate the number of participants they wanted. How would you comment on the training of the staff? Do you think that was an issue as well?

Brook Jackson:
Insufficient training, we were. Not prepared to run a trial of the size and the staff that was was hired to conduct these studies. And I'll give you a perfect example at one of my locations, the unblinded vaccinator. So the one that would be in charge of prepping the vaccine, ensuring that it was diluted properly and the one that was in charge of actually giving the vaccine product to the patient. When I when I looked at her resume or her CV, she only had restaurants and retail experience. That was one of probably one of the most surprising things that I found during during my short 18 days. But no medical experience, not a medical assistant level. Nothing. Just retail and restaurant experience.

Dr. Susan Natsheh:
Okay. Thank you. With the adverse events that were recorded, was there a pre or was there a list of pre accepted adverse events or would they accept any complaint or symptom that people mentioned?

Brook Jackson:
Sure. Any anything that changes from the moment you sign informed consent in your health and your the medications that you take regularly, we document that and. So so, yes, there there certainly should have been collected and captured. And because of just how busy, how overworked the staff was, I remember approving a time card for one of my one of my staff that in a two week time period, she had over 70 hours of overtime. They were frequently missing their their lunch breaks and their two daily breaks that they were offered. It was just the only way that I have to describe the conduct of the study at Ventavia was was pure chaos, chaotic.

Dr. Susan Natsheh:
Just one more quick question. I was hoping you'd be able to articulate for us how what you think the overall integrity or quality of the final results of the study based on what you saw at your center? How could they how would you quantify the results of the final study?

Brook Jackson:
Well, I think based on the number of clinical trial sites that the FDA inspected six prior to granting emergency use authorization and 16 and older that that to me speaks speaks volumes. And even actually I'm going to pull up this document just so I can read from it, if that's okay. I'm sure that. Am I close to it, actually? But even in the inspection reports of those six sites that that they did go to, the FDA tells you that they didn't even weren't able to fully complete the inspection as as they normally would have because of the restrictions that of COVID, for example, not being able to and because the trial had not had not been completed, there were documents, obviously, that that wouldn't have been finished. But, you know, in terms of data integrity. I know. Based on what I saw at Ventavia. I know that that data integrity didn't matter to them. I knew that it didn't matter to Pfizer. There were red flags just everywhere. And I still I still ask the question of myself all the time. Why if if Pfizer knew. Why would they allow that data to be included in the overall analysis when they knew that it was flawed in the ways that it was? That just is a question that I have. And if if this type of misconduct happens eventually, I'm sure that it happened somewhere else. But we will we will never know.

Dr. Susan Natsheh:
Thank you.

David Ross:
Thank you, Brook, for your testimony here. It's very interesting. Did I understand you to say that you've had nearly two decades of experience in in your career so far? And is it all in clinical trials or what portion of it would be in clinical trial administration?

Brook Jackson:
It is all in clinical research. The first ten years of of those were spent at the clinical research coordinator level. My experience is in gastroenterology, transplant hepatology, immunology and infectious disease. The next ten years of that, or eight plus years of that has been at more of a director level and managing the the studies at the clinical trial site level.

David Ross:
So so that's that, that's what I surmise. But I just wanted to be sure. So in in and that's that's that's pretty respectable experience. Have you seen parallels throughout your career to what you saw here at Fantasia? Or is this would you say this is an anomaly in your or is it maybe representative of a trend?

Brook Jackson:
No, I have never seen the type of misconduct. And we hear about it. We learn about it in our in our annual trainings. But I've never seen research conducted in this manner ever.

David Ross:
Okay. All right. That's helpful. And and you clearly have compassion for trial participants, which is which is heartwarming. That's for sure. We'd all like to think that that everyone shares that. What would be the key controls that you would design into a quality control process for for clinical trial administration? What are the what are the really big things? Like three or four or five major items and.

Brook Jackson:
Yeah, I think I think it depends on the complexity of the trial that that any particular site is running. I think. There is no there's no standardization and clinical research. And I think that's something that I would like to see change, obviously, regulatory oversight. But my experience is at the clinical trial excuse me, I have a little gnat flying around. He's been bothering me for two days. But my experience is, is at that clinical trial site level. And what I think a lot of people do not understand is that the data that's collected on these clinical trial participants is collected at the site. We then either manually or it's automatically transcribed into a sponsor's database. So in this instance, Pfizer. So Ventavia, my former company, collects the data. We transfer that data manually over to Pfizer's database. And there is an it's common terminology in my industry. There is a data cleaning process that takes place prior to the information going to the FDA. And what happens in between there is what I've found is disturbing. You know, through the Freedom of Information Act, these requests to documents that have finally been released through through a lawsuit are showing in black and white, where we're Pfizer's scientists and their data managers are asking my clinical trial site to change data.

Brook Jackson:
I'll give you an example. A patient was hospitalized with an eye, a heart attack, and several days later, he develops a pneumonia. He's tested in a hospital for COVID 19 and his test results are negative. He's discharged from the hospital. And we're capturing all of this through self that him and his family self reporting, but also through his actual medical record, which we were able to obtain a copy of in his medical discharge paperwork. It's a hospital discharge paperwork. It says, you know, describes his his heart attack and his stent failure and his progression to pneumonia, his negative COVID test. And so we put all that information again manually. We transcribe it into Pfizer's database. So he has a severe adverse event of pneumonia. And that's how it was captured in the discharge paperwork as pneumonia. Pfizer asks my clinical trial site, and you see this through an audit trail in this database I'm talking about. You see where Pfizer asks Ventavia to change his diagnosis of pneumonia to COVID 19 pneumonia. And I actually can applaud my my former company for for not doing this, but they refused to change that data because that's not what was documented in his his medical record. It was COVID or excuse me, it was pneumonia. It wasn't COVID 19 related pneumonia.

David Ross:
Okay. Thank you. And so just just for sake of understanding, my understanding is, is that a data cleaning process is meant to to address small nits, as guess as what I would call them, maybe the patient, the clinical trial participants name is spelled wrong or or first names in place of last name. Or maybe their date of birth is mixed up. They were born on the 31st of February or something rather like that. It's not meant to to address serious medical information. Is that correct?

Brook Jackson:
That's correct. So I'll give you another good example, because we don't use patient names in these databases database, the database. But for example, if we collect a blood pressure, we we write down or in his medical record is 120 over 80. But when it's transcribed into Pfizer's database, there is an error and it's 120 over zero eight. There's a process, the monitoring process that that would would catch that transcription error. And again, there's an audit trail. We would see that the Pfizer would see that then they would request the site to update that information. And what I'm seeing in these documents that have been released, that there's there's again, I call it misconduct, where they're asking clinical trial sites to change data. That that clearly benefits.

David Ross:
Thank you very, very much. I just commend your courage. Whistle blowers are a unique, uniquely beautiful form of humanity, that's for sure. And so thank you very, very much.

Brook Jackson:
Sure.

Dr. Susan Natsheh:
Brook, I just have one quick question about the story you just revealed. Do you have any way of knowing if that patient was in the placebo group or the treatment group?

Brook Jackson:
I don't know. I could certainly find out and let you know. I don't recall right off the top of my head. I want to say I don't want to say, but I can just find out.

Dr. Susan Natsheh:
Well, I was just wondering if it would have been unblinded. Would that have been known? Do you see what I'm getting at?

Brook Jackson:
And I'm thinking about when when his hospitalization was I don't want to misspeak. So I can I can certainly find out. And I'm happy to respond back to to someone there so they can get that information to you.

Dr. Susan Natsheh:
No, that's okay.

Brook Jackson:
Thank you. But that's that's just one instance. I've I've found many, many others of very similar conduct.

Max Daigle (CAERS):
Quick question, Brook. First, thanks for your courage.

Brook Jackson:
Thank you.

Max Daigle (CAERS):
Have you noticed before I'm planning trials. Is is is it something you've seen before?

Brook Jackson:
What? That a trial is blinded?

Max Daigle (CAERS):
Unblinded.

Brook Jackson:
Oh, unblinded. That's typically done in the case of an emergency. For example, if a patient is hospitalized and in order to treat that patient, we need to know what therapy they were on. You can certainly there's unblinding procedures that that can take place. So I have seen it happen, but never in this manner. And when I talk about obvious inadvertent unblinding, this happened prior to the emergency use authorization being given and those patients being unblinded by Pfizer directly. This happened prior. Thanks.

Trish Wood:
Okay. Thanks very much, Brook. I just want to say one thing that you've kind of come out the other end of this and you're doing well. But I know that there were some trials and tribulations there for you as well, and also that you have a lawsuit going forward that's passed a hurdle, has it not, with the courts, as I understand it.

Brook Jackson:
Yeah. So when I when I realized that there was going to be no inspection, the emergency use authorization came in December of 2020. I made the decision to file a False Claims Act lawsuit, and that was done January 8th of 21. And the False Claims Act allows private citizens to file suit on behalf of the United States government who against against those who have defrauded the government. And I did that again in January of 21. And in January of 22 this year, the Department of Justice declined to intervene or take over the case. They were not interested in taking any action investigating my claims. So in February, the case became unsealed. So for that year that the Department of Justice was determining whether or not they wanted to get involved in this action. The case was under seal, so I was not able to. Reveal or disclose that there was a pending court case. I was allowed to talk about the facts about my case, which is why I took them to the British Medical Journal. I felt at that point people around the world needed to know how this clinical trial was conducted. So.

Trish Wood:
So is the lawsuit proceeding now or is that it?

Brook Jackson:
It is proceeding, yes. The DOJ declined to intervene, but I was allowed to move forward with the case. I served the defendants in April of this year. All of them have motion to dismiss and we have August 6th is our, I guess, due date for our amended complaint, which will be we'll be filing soon. So that's where the case stands at this point.

Trish Wood:
And the article in the BMJ is nominated for a British Science Writers Prize. So that just happened, right. Okay. Good luck to you, Brook. Thanks for doing.

Brook Jackson:
This. Thank you so much. I appreciate it.

Trish Wood:
Super grateful. Thanks. Thank you. Bye.