“My brother-in-law went home and googled ‘Zoloft’ and ‘suicide,’ and we were shocked. There were hearings in 1991, when it was just Prozac on the market, with the exact same issue.”
After being happily married for almost 10 years, Kim Witczak’s husband shockingly committed suicide, shortly after he was prescribed an anti-depressant off-label for insomnia.
“I intuitively, at the deepest part of me, knew there was no way that Woody … would take his own life,” says Witczak.
For almost 20 years now, Witczak has been an advocate for pharmaceutical drug safety and reform, most recently taking on the fight for transparency and accountability surrounding COVID-19 vaccines.
“There are more injuries and deaths that have been reported with this vaccine alone than any of the other ones. Right there, that should be a signal,” says Witczak.
Interview trailer:
Watch the full interview: https://www.theepochtimes.com/are-covid-vaccines-just-the-tip-of-the-iceberg-kim-witczak-on-the-spider-web-of-corruption-in-the-drug-safety-system_4786393.html
Jan Jekielek:
Kim Witczak, such a pleasure to have you on American Thought Leaders.
Kim Witczak:
Thanks for having me. I’m excited to be here.
Mr. Jekielek:
So Kim, you’ve been a drug safety advocate now for almost 20 years, and I absolutely want to figure out how you got to be doing this very, very interesting work. Before we go there, I want to read a headline from the Epoch Times from yesterday and get your commentary. “Hundreds of thousands of Americans sought medical care after COVID-19 vaccination, CDC data says.” And I’ll read a quote from Aaron Siri, the lawyer on the case, representing the Informed Consent Action Network. “It took numerous legal demands, appeals, and two lawsuits and over a year, but the CDC finally capitulated and agreed to a court order requiring them to do what they should have done from day one, release the v-safe data to the public. So tell me about what v-safe data is. This is exactly in your wheelhouse?
Ms. Witczak:
Yes.
Mr. Jekielek:
And what this is all about.
Ms. Witczak:
Well, first of all, I’m so happy that we were able to finally get this data because this data actually should have been out and made public many, many months ago. So v-safe was actually, it was going to capture any kind of safety side effects that a person had at the time they actually got vaccinated. So there were little cards that they gave the individuals that were getting the shot. If they were experiencing any side effects they could actually write in and it would go to the CDC. So to me, when you have rushed to market vaccines, this was a really exciting thing for me to see that there was maybe an opportunity to capture safety in real time as it was happening. But as we know, it didn’t exactly get disclosed to the public until months and over a year later.
Mr. Jekielek:
So it’s like the very purpose of this system was kind of subverted from within what happened?
Ms. Witczak:
Yes, that would be a good question for the FDA and the CDC. I would like to know why. What were they going to do with the data? Imagine if Aaron Siri had not sued to get this data, would we ever get this? Would the public ever know what was being reported in real time when the vaccine program originally rolled out back in early… What was it? Late 2020, early 2021.
Mr. Jekielek:
And there were 800,000 reports, or almost 800,000 reports from what I understand. That seems like a lot.
Ms. Witczak:
It is a lot because that is people who took their time to actually put in their information because in some ways they wanted it to be used for other people going forward, right? So 800,000 is a lot, but I can see the other side saying, “But not compared to the millions and millions of people who have taken it.” But we always have to remember any of these safety systems, whether it’s v-safe or VAERS or the FDA MedWatch that a small percent of people actually take the time to report. So you always wonder, is this just the iceberg and there’s a lot more underneath who did not take the time to actually report?
Mr. Jekielek:
You actually have a difficult story of how you actually got into this. This was not your wheelhouse by any manner, shape, or form in the past.
Ms. Witczak:
Yes, I like to call myself the accidental advocate because I would never have chosen this as my advocacy work. So I was married to my husband Woody for almost 10 years. We were just starting to think about having kids. And August 6th, 2003, I got a call from my dad who told me, “Woody’s dead.” I’m like, “What? Woody’s dead?” And they’re like, “He’s hanging.” I’m like, “Hanging?” The whole thing made no sense.
Woody wasn’t depressed. Woody had no history of depression or any other mental illness. He had just started his dream job with a startup company and was having trouble sleeping. So five weeks earlier, he went to his doctor. The doctor told him he wasn’t sleeping. He sent him home with a prescription of Zoloft, which is an antidepressant, and told him it would take the edge off and help him sleep. And Woody did what most people did—trust. Woody was an athlete, he was kind of Humpty Dumpty. He got hurt, they fixed him. Broke his leg, they fixed him. So he trusted his doctor. And truthfully, there’s no reason why at that time we wouldn’t have trusted.
So that night when I got that call, I was out of town. I remember the coroner asked me a question. He asked if Woody was taking any medication, and I said, “Yes.” And I go, “I didn’t even really know what it was,” but she goes, “Oh, there’s a bottle of Zoloft sitting on the kitchen counter.” And I said, “Yes, that’s it.” She goes, “We’re going to take it with us. It might have something to do with his death.” So that was his only medication he was on. Then ironically, the front page of our newspaper had an article that said the UK finds link between antidepressants and suicide in teens that exact same day.
So Woody did not leave a message or there was no note. I was trying to figure out how to get home. I was out of town when this happened. My brother-in-law went home and googled Zoloft and suicide. And we were shocked. There were hearings in 1991 when it was just Prozac on the market with the exact same issue. There were advisory committee meetings talking about the link between suicide and violence. We had no idea. Truthfully, we never questioned the drug. Why would we? It was given to him by his doctor. It was sold and advertised safe and effective, and it was FDA approved. And at that moment, I intuitively at the deepest part of me knew there was no way that Woody, this guy who loved life, would take his own life. So that became kind of trying to research and figure out what happened. And so that really was the start of it.
And then from there, I like to call it the battle for Woody. It took shape in many forms. We did a lot of media, told Woody’s story. We had a lawsuit against Pfizer, a wrongful death failure to warn. I came out to DC and met with a lot of members of Congress and the FDA. And eventually there were FDA hearings to get black box suicide warnings put on, as well as congressional hearings that wanted to know what the drug companies knew about the link between suicide and antidepressants.
Mr. Jekielek:
Okay. You said one thing that might not be obvious to everyone, that’s black box warnings. What is that?
Ms. Witczak:
Black box warnings are the most serious of an FDA warning. That means that there could be deaths associated with it; but it is the most stringent warning. If you ever look at the inserts that come in your prescriptions, it is literally in a black box on the top of your prescription. And it alerts you and should alert your provider that there is a serious risk with this medication so that you can be informed and know. At the time of Woody’s death, there was no warning. That didn’t exist. And a black box warning also affects how you advertise the product. And if you also look at print ads or if you look at any of the social media ads, again, it’s in a black box.
Mr. Jekielek:
And that is going to basically tell the user presumably that they should seriously think about taking this. Is it worth it? Is that the idea?
Ms. Witczak:
Well, for me it should be something that you actually disclose and tell a person, like that this has a serious adverse event or a potential for it, so that you can actually have a conversation with your doctor, with the pharmacist, with your loved one. I look back and go, “Woody went in because he couldn’t sleep. Should that have been really what he should have been given?” No. And if he would’ve actually would’ve been told like it’s an antidepressant, if you start feeling a certain way, we could have maybe done something.
So I remember one situation with Woody when he came home. I was out of town for my job and I was excited to see him. He comes walking through our back door. He had a blue dress shirt on white t-shirt, completely sweat through, dropped to the floor with his hands around his head like a vice. He’s like, “Kim, you got to help me. I don’t know what’s happening to me. It looks like my head’s outside my body looking in.” He’s just rocking back and forth bawling. We had no idea what was going on. We called the doctor and the doctor said, You have to give it four to six weeks to kick in. He was having an adverse reaction, which had turned out to be one of the side effects that the company kept from the public and the doctors.
But that is the importance of warnings. It’s the importance of having conversations. But it starts from the top. The company knows, the FDA knows, CDC in this case, then it goes to the doctor. But if we’re the last to find out, we’re the ones that live with this decision from keeping it from us.
Mr. Jekielek:
So it sounds like you played an important role in at least getting these sorts of warnings being more publicized and available. Give me a picture of how you view the health industry prior to COVID. How do you see it functioning?
Ms. Witczak:
Well, it’s funny, when I look at what we initially got done with the antidepressants, I thought, “Oh good, I did my job. I’m going back to my old life” because I thought it was just an isolated incident with just the antidepressants. But what I quickly realized, it’s actually a larger systemic problem with our whole drug safety system. And then I started finding the ties. It’s almost, I like to call it a spider web where you start seeing how the industry is really a business. And I think that is a promise that I start from… I also look at our patients as customers. My patient safety groups aren’t always happy when I say that. They’re like, “No, but we’re patients.” I’m like, “We are, but the industry needs patients to do the business.” So it is a big business that is full of conflicts of interest. It’s set up to sell products. And even the approval process at the FDA, there’s so much focus on getting things to market and not so much after and looking at the harms of medication.
Mr. Jekielek:
And so what did you see when essentially COVID is coming onto the scene? There’s reporting on it. It looks like it’s going to be very bad. This is what the media is saying. What are you seeing when all this starts happening?
Ms. Witczak:
So of course I was nervous too. We don’t know what this is. It was always focusing on, “Death. Death. Fear. Death. Fear.” I’m in marketing and advertising as my profession. So fear sells, hope sells, and so I saw a lot of that and it creates panic, right? Then there’s a new vaccine that was going to be rushed through Operation Warp Speed, and it was going to be on the market by the end of the year. Vaccines were never my advocacy focus. But the fact that something was rushed to market and was going to be available and with a short amount of clinical trials, all drugs have risks, but not this one. It was told that it was completely safe and effective and started seeing celebrities and social media influencers all telling us that we had to get it. And I started to see that the media that I worked with all the time quickly became part of the PR firm, the extended PR department of the drug industry to help sell and get these into every arm.
Mr. Jekielek:
So the drug industry and the government, because it was a strong government push as well.
Ms. Witczak:
Yes, it’s very much. Right.
Mr. Jekielek:
Right. So let’s talk about that for a moment. So there’s all these people that you’ve been working with over the last 20 years to talk about these issues, for example, of psychiatric drugs and safety related to psychiatric drugs. So what happened to these journalists that have been helping you expose this?
Ms. Witczak:
I’ve worked for years with a lot of mainstream journalists from around the world, from ABC, CBS, CNN, BBC. They were my friends, as well as the Fortunes and the newspapers. When I go back to the initial trials that they used to get authorization, the fact that it was only a couple months worth of data and then we lost the placebo control group, the companies and the government said it was for ethical reasons, “We’re in a pandemic, so we got to let the people in the placebo group get it.” But my feeling is that is what a clinical trial is. So if you sign up for a clinical trial, as if I signed up for one, that is part of my job. I may get it, I may not get it. That’s part of the risk of being in a trial. But when you took away the placebo group, we now have lost a huge part of the ability to look at efficacy and safety.
So I would’ve loved to have seen that being reported on, right? Instead, we had… I remember right after December of 2020, we had the Times reporting 100 percent effective, 99 percent effective. And so that tells a very different picture than the idea that, “Well, but we don’t know about the safety.” That is where people get their news. And truthfully, a lot of doctors also, they’re people too, and that’s where they’re hearing their news. And so if you’re only getting the one side that’s coming from the pharma and the government, you’re not getting the full story.
Mr. Jekielek:
Well, I want to briefly talk about this v-safe data. Right from the beginning the CDC is collecting this v-safe data. But these journalists that you’re speaking with, that you’ve been speaking with all these years, one would think that if this data isn’t coming out, you might want to investigate that and find out. Even given the number of people that were vaccinated, 800,000, it’s still a pretty large number of adverse effects reported, right? So I’m trying to understand. Given this scenario with these v-safe data now coming out, which can and should be done in your mind with this?
Ms. Witczak:
Well, we should have been pushing the media, like what is the safety? Now we’re putting this in so many arms, we’re mandating, what does it look like? But you know what, they would just keep going to the same talking heads at CDC, the FDA, and we’d be like, “Nope, we have no safety signals,” right? If you were a true journalist, you should have been pushing that question a little bit more and asking, “Where is safety?” Or when there’s other reports and other studies and other experts that are coming out that maybe have a different view of what’s happening or they’re seeing data coming out of Israel or data coming out of the UK, why aren’t you curious to go find out what they’re finding, what they’re seeing?
I’m really thankful for Epoch Times because they are doing investigative journalism, going in and asking the tough questions. And it’s the alternative media that’s doing it, right? But the average person doesn’t know. So if you say, “Hey, did you know that the FDA’s not going to release Pfizer’s data for 75 years?” They look at you like you’re a crazy conspiracy theorist. I’m like, “No, it was because of lawsuits again by Aaron Siri that was able to get that data made public,” right? And so they started releasing the safety data. Same thing with the v-safe out of the CDC. But along the way they kept telling us it was safe. Nope, we just see no signals. And so I think when you don’t have that piece of the puzzle, when you’re having just everyday conversations with your friends or people in the community, that isn’t there so it’s creating a divide. And I think that division-
Mr. Jekielek:
Just to be clear, you mean some people are skeptical of the drug or just simply don’t like taking drugs or whatever, but the rest of the population has this perception, “This is something perfectly safe and in fact valuable for the community. So what’s your problem?” Right?
Ms. Witczak:
Yes. And I think that was part of what’s happened too in the last couple years. We’re becoming divisive people. We should be having conversations. But when everybody’s telling you that, “Do your duty. You’re going to save grandma. This is about somebody else. This is not about you” and yet that there’s all this other story that’s not being told, you start having people that don’t disagree… People have lost friendships. Families have divided up over this. And just the fact of what is science now too, right? Even science can’t be debated.
Mr. Jekielek:
So some people, like the folks at the Academy for Scientific Freedom for example, would say that, “Well, science is always just one thing. And it’s this kind of search for the empirical truth, empirical reality through various tests and hypotheses and so forth.” And then there’s also scientism, which is edict and the science is settled and this sort of thing. I’m paraphrasing here what they would say. So it’s not really that science that’s divided, it’s more like there’s some kind of establishment view that may or may not be science-based. And then there’s actual science.
Ms. Witczak:
That was another observation I had, is the idea of questioning, right? There was no debate. It was like, “This is the science.” And how can it be settled when it was just such new and we’re still in the process and we’re still learning and you’re asking for the public’s input by using the v-safe or we’ve got the VAERS. How is it settled? And especially when there’s all of these reports and studies coming in from other parts of the world, you would think they’d be curious about, “Well, what are you learning? We should have a debate.” And I saw that with antidepressants where the same thing, because remember it was the front page where it said the UK found link between antidepressants and suicide. There was somebody over there that had all this information. And when the FDA hearings were happening, he should have been one of the invited presentations, I would think, right? Instead, he was given three minutes like I was given three minutes to tell our story.
And then now fast forward sitting on one of the FDA advisory committees, there was a drug that we were reviewing. It got pulled off out of the UK, but they wanted to get it put on the market in the U.S. So I remember asking the question, “Are we going to hear from why the UK pulled the drug? Because we’re trying to approve it.” To me, that whole idea is that tension and that is what science should be, like we should want to learn and ask and tease it out to see especially when you have something novel like this, a novel platform, a novel delivery mechanism. We should want to see and learn and ask questions and have other scientists, not just the one that’s coming out of Fauci and the NIH and his camp of science.
Mr. Jekielek:
So what’s been coming out with this disclosure of the v-safe system of the Pfizer disclosures and frankly a lot of grassroots work that’s been doing is that there are a lot of vaccine harms associated with these genetic vaccines.
Ms. Witczak:
Well, we got to go back and remember that these companies were given complete legal immunity. So with this fast track product, even if it didn’t work or it caused some harms, they’re completely immune from being liable for any harms or future harms down the road. So that right there should be a flag for people. I’ve met a lot of vaxxed injured now who are trying to be heard, get their stories told, but what they’re doing is things are being quickly censored. So these people aren’t even being acknowledged. And they were doing what the government asked. They were doing their part. And now that they’re injured, they’re like an uncomfortable truth, an inconvenient truth. “Let’s not acknowledge them.” And they have no recourse for harms. They can’t sue.
I was able to take on Pfizer, right? There is no avenue and there is a special… The Vaccine Compensation Program, the countermeasure program, there are all these people that have applied for it. There’s been no distribution of any funds. And so again, the government’s going to be paying for any harms. First, there has to be acknowledgement of harms. But there’s been an intentional silencing. We need acknowledgement for the vaccine injured.
Mr. Jekielek:
There’s clearly sizable number of them just in this cataloged in this v-safe data and the CDC’s own database. So isn’t that an acknowledgement?
Ms. Witczak:
Sure, the data might be there, but we need the CDC, the FDA to come out and acknowledge it—that it exists. The people who approve your products at the FDA are the same people that review safety. So it’s the same people. And for a long time we’ve been advocating, they should be completely separate departments. The people who approve the drugs are not the same people who should be looking at safety.
Mr. Jekielek:
Or not beholden to them, right?
Ms. Witczak:
Yes, there should be not having anybody crossing over. And so this group over here can be curious when they start seeing all these reports that have come into VEARS at the FDA, which is our system for tracking vaccine safety, right? And of course we’ve heard for a long time, there’s so many limitations, but this is the best we’ve got. This is what we’ve got. There are more injuries and deaths that have been reported with this vaccine alone than any of the other ones. Right there that should be a signal. And it also should be a, “Should we put a pause on it?” Or at least tell the public, “Hey, we’re looking at the data that’s coming in. Here are some of the things we’re seeing.”
Mr. Jekielek:
So how is it that you sit on an FDA board? What does that even mean?
Ms. Witczak:
It is funny. I’m the consumer rep, so I represent the public on the FDA’s Psychopharmacologic Drugs Advisory Committee. It is the advisory board just like the ones that were reviewing the vaccine. This one is for all the psychiatric drugs. And it is a place where the FDA, if they have questions or if there’s something that they want to tease out, they convene a board of, a lot of them are researchers or academia that are looking at science. And then I’m the consumer rep.
It’s a great opportunity. It’s been a really big eye opening experience to see drugs coming to market. How they’re using fast tracking mechanisms, which is kind of what the emergency use authorization was, right? But there’s been a whole slew of new drugs that are coming using accelerated approval, which you think is an innovation breakthrough. But what it really means is less rigorous clinical trials and less focus on safety. And I take my job really serious on this committee, because I look back at the 1991 advisory committee that I now am a member of. Every one of those people took funds from pharma when they said, “Nope, we don’t see any length between antidepressants and violence and suicide.”
[Sound bite/Speaker X]:
I’ll ask the committee to vote on the following statement. “There is credible evidence to support a conclusion that antidepressant drugs cause the emergence and/or intensification of suicidality and or other violent behaviors.” Those in favor of that statement vote yes. Those opposed to that statement no. And Dr. Dunner has left a proxy which makes a unanimous of 10-0.
Ms. Witczak:
So if they had done their job, I probably wouldn’t be here, right?
And so I do take the safety perspective, I take the real world perspective because I’m seeing so many of the drugs coming in with small clinical trials, right? So I do care about what happens when it gets on the market. Our system is really set up to bring products on the market we love more in America. We want to sell everything. And so we want more drugs on the market, but we need to be really careful because there’s real life consequences to these decisions. So I still laugh that I’m actually on this board with being as vocal as I am about safety, but I think it’s a really important place to be.
Mr. Jekielek:
Do you ever find yourself in a situation where you have all these industry or revolving door people on one of these advisory boards and they just want to be able to say, “Hey, we have Kim Witczak on the board. Witczak. So we’re all good here. Everything’s legit and above board because Kim is around.” What do you think?
Ms. Witczak:
Well, sometimes I do wonder if I’m the token safety person. But again, if it’s being used or not, I know the role that I play and sometimes it may just be something that’s on the record that comes down the road that there was somebody who actually did question these medications.
Being on this role, to me it’s more than just the trials, it’s also having a background in marketing and advertising and how I just see the world. So when I get a new project, we have to go do a full 360 investigation with the good, bad, the ugly to take on a new product. And so my mind just naturally thinks that way. So I think I love being on the committee, although it’s very frustrating at times because I may be the only no vote. And I often tell people, if you’ve never observed an FDA advisory board meeting of any kind of drug, you should actually go back and listen.
So the first part of the day, the sponsors give their presentation of their data. The FDA will do their analysis of the data and the committee gets to question. There’s an open public hearing where members of the public can come and give their perspective. And then there are the questions at hand that the FDA wants to know, like, “Do you think the efficacy is there, the safety?” And then we get to vote. And I always say, go back and listen to the explanation, not the vote. And this is what I’m also trying to get the mainstream media. Don’t just report that 17-2 approved it. Go back and listen to the explanations. Because often you’ll find the person who voted yes, they’ll say, “I voted yes for this product. I don’t think safety is as good as it should be, but I think we need it on the market.” And then they’ll come to me. “Well, I voted no, I don’t think safety’s there.”
And so that explanation’s really important and I would highly recommend people just go, it’s a very interesting educational process. And it’s also where you learn how much pharma actually influences things that you don’t think are obvious. The patient groups that show up at these FDA meetings and where they get their funding.
Mr. Jekielek:
Okay, so let’s explore that, right? You’re talking about what are ostensibly non-profits or something in that vein are supposed to be independent groups that are looking at patient outcomes?
Ms. Witczak:
Yes. So they might be representing a group of patients, right? They might be like the Parkinson’s Association or the American Heart Society or National Alliance for Mentally Ill, they’re all nonprofits representing the disease or the disease group. And you could go to any of these hearings and they have become almost mouthpieces for pharmaceutical industry where they’re like, “We need this for our patients.” There’s the work that gets done for the people, but then you go and look at the funding. Two different parts of the business, right? Go look at the funding and it’s almost all pharmaceutical funding. And I think it’s really important with anything that we do, whether it’s patients groups who are the fact checkers, where’s funding coming from it? So that was a big aha. We like to call them astroturf groups because they seem like they’re real. And they are, they do good legitimate work, but you have to take that with a grain of salt. So that is one of those other areas that I have learned where pharma’s influence is pretty deep.
Mr. Jekielek:
Basically you’re talking about a situation where they’re strongly motivated arguably to give the outcome that the pharma would like because pharma provides some large portion of their funds. That’s the idea.
Ms. Witczak:
Yes.
Mr. Jekielek:
That’s what you would call a conflict of interest, right?
Ms. Witczak:
It seems like a conflict of interest to me. So they’ll sometimes have people who are in the clinical trials that would show up, but the funding, all their travel, everything’s paid for. And of course they’re going to say that this drug could have saved my loved one’s life if it was available now. You could see how things can get easily manipulated.
I don’t know if you had a chance to listen to any of the FDA or CDC advisory committee meetings that they’ve had during the last two years to do with the vaccines. It’s very interesting to listen. Now, I wish that they were in person and I wish that the cameras were on, but the cameras were not on so you can’t actually see the emotional [expressions].
But there were people that were researchers that came, but they were under the guise of mom. “Or I worked for the company, but I have no conflict. I’m coming here as a mom.” It was very interesting when you start looking at the number of people who were actually talking during the open public hearing. And it seemed like there was some selection, particular selection that was happening. And we’ll never know because everything was Zoom, digital. And unlike back in the day of previous, of many of the advisory committees, you had to actually show up.
When you do everything remotely, there’s something that you’re missing, you’re not getting the emotion of the people that are actually the injured that would’ve showed up to tell their story. But instead, during these last two years with the advisory committees, the cameras have been off.
Mr. Jekielek:
So you’re saying basically you think that there’s people who would’ve shown up to a hearing maybe uninvited or something like that, whereas on these Zoom meetings they just simply never get a say because they get edited out by someone who does that?
Ms. Witczak:
Yes, it’s somebody at the FDA that selects, say maybe it will only let 25 people, right? So I go back and I think about those hearings to do with antidepressants. I mean, even if you were not selected to speak, but they had a hundred and some people that would speak, families were lined up and the entire auditorium at the FDA was packed.
Mr. Jekielek:
Okay, what I’m hearing from you is that there’s some sense of accountability maybe of the people that are there, like, “Okay. There’s a lot of people that are interested. This is serious.” Whereas in the virtual world…
Ms. Witczak:
Yes, I think you know what? That’s a good way of saying accountability and transparency too. Then the media couldn’t ignore it. Imagine if all of these people came on to the FDA because they were going to discuss whatever vaccine and they are like, “Whoa, whoa, whoa. Before you do that, look at us. Here, I’m a healthy person. Now I’m in a wheelchair.” It would’ve been an entirely different outcome. I believe it all my heart. When I think back to antidepressants, there were so many, there were security guards with armed guards with guns. All the mainstream media was full with cameras. And it was all because people… Whether they got to tell their story or not, it was every row, every seat was full and it was also overflow. And so they had to have overflow rooms. And I think that same thing would happen with the vaxxed injured if we would’ve had in-person meetings. And I think we should be demanding in-person meetings as well.
Mr. Jekielek:
What is the level based on your experience of pharmaceutical industry capture of these institutions?
Ms. Witczak:
Well, again, I go back to follow the money. Most people, I learned a concept that I had no idea, it’s called the User Fee program, where basically it was back in I think ’97 that was established by Congress, that with every application the drug company pays a fee. So now I think it’s over 50 percent, 50 or more of the FDA budget actually comes from the pharmaceutical industry. This one’s Prescription Drug User Fee Act, PDUFA. And there’s MDUFA. We like all of our acronyms. And that’s a must pass legislation every five years. In fact, it’s just being authorized again. And mostly pharma decides what they want in, “Besides, we’re going to be paying you FDA, here are our demands.” And the consumer perspective doesn’t really get a say in that. So that’s one way.
Mr. Jekielek:
The consumer interest doesn’t have a say? How is that possible? Isn’t that the main interest?
Ms. Witczak:
So the initial negotiations happen behind closed doors, and it should never happen behind closed doors. My feeling is, we, the people that represent the public interests should be a part of these meetings. Again, everything is always about privacy. It’s always about the business and the privacy. I’ve heard that privacy thing forever. But at least there needs to be an opportunity where we can have a seat at the table and not the kids’ table at the Thanksgiving dinner. I want to be at the dinner table with the adults. But the times that we’ve maybe got to say what we want, we’re at the kids’ table. And so it really then goes back to Congress. But this congress, there hasn’t been a whole lot of interest in putting the safety measures in like there has been in past PDUFA negotiations.
So that’s one where there’s the captured kind of the ties between pharma and the FDA and industry. But then there are all the others like the rotating doors where they go from the FDA to the company, the company back to the FDA. I just read Google has a new business. Califf, our current FDA commissioner came from there, now who’s inside the FDA and a couple of his people are now over at the company. On the one hand, sure you get in, you understand how the system works, but I feel like there should be some rules against that as well because there’s been some damage that has been done because of that rotating door for consumers when getting into litigation. So that’s something that I think that we need to take a look at as well.
Mr. Jekielek:
What would be an example of that damage, just to be clear?
Ms. Witczak:
So one of them is a preemption brief, which is basically the government, the FDA was intervening in a bunch of private lawsuits against some of the companies. But the person who actually created it came from outside, got money from one of the drug companies when they came into the FDA. And then they started intervening on behalf of the FDA in private lawsuits. And it was to do with a lot with the antidepressants and suicides.
Mr. Jekielek:
On the side of the companies?
Ms. Witczak:
Yes.
Mr. Jekielek:
Right.
Ms. Witczak:
The FDA was intervening on behalf of the company, let’s say when there was the Pfizer litigation. And they actually said, the brief was basically, “Even if they wanted to warn, we wouldn’t let them because we’re the ones that watch the warnings and we didn’t see a sign.” So that was basically the essence of the brief, and a lot of judges around the country threw them out. And that’s intentionally what it was meant to do. It was the harm that it did. And the consumer lost out again because these suits were often thrown out.
I can give you another example of the rotating door problem. Prior to his appointment, Dan Troy, who became the FDA chief counsel which did not need to have congressional approval, it was presidential appointment, this guy took $300,000 from Pfizer and went into the FDA and started to intervene in these private lawsuits, suicide lawsuits against Pfizer and the other drug companies with the creation of this preemption brief. We were able to help expose this with one of the members of Congress, Representative Maurice Hinchey. And eventually Dan Troy left his position at the FDA as chief counsel and went back into industry, a law firm, private law firm, and then ultimately ended up as global chief council at GlaxoSmithKline, which is another huge drug company.
So right there, we lose out, the public loses out. All of this has been documented because it was in the “New York Times.” It was covered quite extensively back then. But see, that’s the difference. I look back at things that happened in the past and it had a lot of interest by the media and it was covered by the media. All of a sudden with the vaccines, it was like this behavior doesn’t exist anymore because this is all for the greater good. It’s this really bizarre thing that’s happened with the media, the ones that actually used to do really great reporting.
How much has changed just in the hypocrisy and the messaging that has come from top down and no one seems to be wanting to go back and go, “Well, do you remember when you said this Fauci? Remember when you said this? Do you remember when you said this?” And it’s like they’ve completely given him and the whole changing narrative a free pass. Maybe the good thing that’s going to come out of this is it’s going to shake up everything, shake up the traditional healthcare system, the FDA, government, the media system. And maybe we needed this to show the craziness of what has happened in the last couple years.
Mr. Jekielek:
Is there any good resource out there to basically understand how all these different relationships between pharma and government and patient advocates and so forth work?
Ms. Witczak:
Well, it’s funny you should ask. I’m actually working on something right now. I call it the spider web—the spider web of pharma’s influence on the whole medical ecosystem. It really started building it one by one as I’m learning about it through my years of doing this work. And I go back to where do our doctors get educated, right? The medical schools. Who owns medical education? So when you start seeing pharma’s influence on medical education, when I’ve asked doctors, “Have you ever learned anything about how the FDA works?” They were like, “No.” If you educate the doctors and you’re putting your monies into the programs and a lot of the academic institutions that do the research who the researchers also need the pharma money, well then that also influences what gets taught, how it gets taught, how it gets positioned, right?
So there’s the education part, then there’s medical journals. So one of the things that came out of my lawsuit was this whole document that was the publication plan for social anxiety disorder. And it was basically listing all the places it was going to run, when it was going to run, who the authors were. And then there were a few that said, “Dr. TBD, Dr. TBD, Dr. TBD.” And I was like, “Who’s Dr. TBD? It’s pretty famous.” But it’s because they haven’t put a doctor in there.
Mr. Jekielek:
They already had the material ready to go.
Ms. Witczak:
The material was already committed to run on this date, here’s what it was going to be about, but they didn’t have the doctor who was going to be writing the journal.
Mr. Jekielek:
Ostensibly. Right. Yeah.
Ms. Witczak:
Yes. That’s when I started learning about the concept of ghost writing and medical journals and really understanding key opinion leaders. It’s a term that’s used [for those] that have written papers. It is that doctors who actually are out being spokespersons about their research, but they’re actually getting funding from-
Mr. Jekielek:
People who shift opinions of others basically.
Ms. Witczak:
Yes, exactly. So that key opinion leader, which was a new concept for me. Then you look at the PR department, like PR, how it’s working. They hire to write to do shifting of public perception about a problem, right? So they might be putting op-eds, even though it wasn’t really from the company. It might have been from an average person, but it’s intentionally well coordinated. Then you learn about fact checkers and who’s, again, funding fact checkers, who’s behind the fact checkers. Then you look at who’s running clinical trials, where are the clinical trial sites and who’s influencing it. That’s a whole nother area. And you start seeing it everywhere. It is-
Mr. Jekielek:
And when you say it, you mean big pharma?
Ms. Witczak:
Yes. Big pharma’s money.
Mr. Jekielek:
Right.
Ms. Witczak:
Then you have Congress, and then you have the FDA and you have advertising. Again, that’s a little bit more obvious, right? We’re one of the only two countries in the world that allows direct to consumer advertising. But also there’s all the marketing that goes to the doctors and through journals. And so it’s not just to consumers, it’s the back end. So their hand prints, fingerprints are everywhere. And it’s not to say that you don’t trust them, you just have to take everything with a grain of salt. It’s just about being aware. You know the kind of questions that you might want to ask.
Mr. Jekielek:
Sp we’ve had you on as an expert on trying to get access to some of the FDA data. For example, we have a headline, “FDA is withholding autopsy results on people who died after getting COVID-19 vaccines. It’s refusing to provide key COVID-19 vaccine safety analyses.” That’s another headline, something that where we got your feedback on this. A little bit earlier, we have White House health officials making very clearly false claims about COVID-19 vaccines, again related to safety. At the moment this just seems to keep happening again and again, this withholding of information, especially anything that would be related to safety and create questions about that.
Ms. Witczak:
I will keep saying the same thing. I sound like a broken record. But when there’s safety signals, it belongs to the public. And if somebody sends in, takes the time, whether it’s the individual, their family member or the healthcare provider, takes their time to send in reports into the VAERS system or the MedWatch, which is prescription drugs, they want to be investigated, they want to be contacted, they want it to be looked at and serve as a signal.
But the idea that we’re intentionally keeping it and hiding it, I just don’t get it when people’s lives need this information and it could be the difference between life and death for somebody. Like the autopsy, we always hear, “Well, privacy. Privacy of data.” No, all you have to do, literally I’m… You redact everything else. So you redact their name, any personal information, but the information about what happened to them is not identifiable. It doesn’t say Kim Witczak, my age, where I came from. None of that, that’s all redacted.
But take my experience and go investigate it. But I will never understand when you are a public health agency why you would ever withhold data around safety from the public. Are we going to trust them? Are we going to trust our public health officials? Are we going to trust our regulatory agencies? Will people trust who’s in charge?
Mr. Jekielek:
Well, and with this new bill in California, which Governor Newsom just signed, right now there’s essentially doctors, individual doctors are being told what they can or cannot talk about in a blanket way as far as I can tell. Do you have any thoughts on that bill?
Ms. Witczak:
Well, first of all, who’s playing the decision maker on “This is misinformation. This is disinformation,” it goes back to who holds the science, the cards of science. And so I thought practice of medicines between me and my doctor. My doctor has a feeling that we’ve discussed, but now he or she could actually lose their license. And who’s deciding it? The medical boards that are a political position anyways? I’ve been doing a lot of work with other safety advocates that have done work around medical boards and when patients who have reported their doctors and the medical boards look the other way. And so the idea that now we’re going to give all this power to the medical boards as well, that’s political position, who wants to practice in that kind of environment? If you really go in wanting to do this work and you have a different opinion than what is coming out of Washington because it’s between me and my patient, who wants to practice in that environment.
Mr. Jekielek:
I kind of, in my head, called it the prevent doctors from Doctoring Act. I’m not a medical professional, but there’s a Hippocratic Oath that you vow. You make a vow. And if there’s somebody that’s telling you a blanket how to deal with a patient that obviously they can have no idea about the reality of that particular patient, it seems like that would violate that oath. I’ll have to talk to maybe Aaron Kheriaty, the medical ethicist about this in more detail, but it strikes me as unbelievably problematic.
Ms. Witczak:
Yes, I think, first, do no harm, right? It also impacts the informed consent. If they have to say that they’re completely safe, that is problematic. It sure seems that it would be a very difficult environment to practice in. And I could see really good doctors that don’t want to practice in that and leave and go somewhere else.
Mr. Jekielek:
Well, Kim, I love seeing you referenced as an expert in our articles and some of our investigative work. Any final thoughts as we finish up?
Ms. Witczak:
Well, first of all, I will continue to do this work. It’s very thankless work sometimes, but it means a lot that you are having somebody like me. So I do this work because I don’t want any other family to have to learn the hard way. Stop. Pause. Ask questions. Don’t be afraid to ask questions. Do research. Listen to programs like this, educate yourself, because it could be the difference between life and death.
Mr. Jekielek:
Well, Kim Witczak, it’s such a pleasure to have you on the show.
Ms. Witczak:
Thank you so much.
Mr. Jekielek:
Thank you all for joining Kim Witczak and me on this episode of American Thought Leaders. I’m your host, Jan Jekielek.
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