EPISODE 5: KIM WITCZAK (PART 2)
This is Andy Miles, host of Akathisia Stories. We recently released the podcast's fourth episode with guest Kim Witczak. Along with that episode, I prepared three podcast extras that were, and still are, available from the Akathisia Stories web page, at studiocchicago.com/akathisia-stories. I've since received a request for those extras to be included in a bonus episode, and that's just what this is.
As noted in Episode 4, Kim Witczak is a leading international drug safety advocate and speaker with over 25 years professional experience in advertising and marketing communications. Kim co-founded Woody Matters, a nonprofit dedicated to advocating for a stronger FDA and drug safety system. She also co-created and organized the international, multi-disciplinary conference Selling Sickness, in Washington, D.C. In 2016 Kim was appointed Consumer Representative on the FDA Psychopharmacologic Drugs Advisory Committee and is on the Board of Directors of the National Physicians Alliance and MISSD. She is also an active member of the D.C.-based Patient, Consumer, and Public Health Coalition, making sure the voice of non-conflicted patients and consumers is represented in FDA-related legislative issues. And she is a founding alliance member of the Know More About Drugs campaign started by Nancy Cartwright, best known for her work as the voice of Bart Simpson.
Kim recently talked to me via Skype from her home in Minneapolis. These are segments of our interview that didn't make it into the episode proper. In them Kim talks about the legal battle she waged in the courts; her work producing the Selling Sickness conference; more about her work with the FDA panel and its involvement with the drug Chantix; and becoming involved with MISSD and the first time she met MISSD founder Wendy Dolin.
KW Funny. Wendy – well, obviously, Wendy has the same attorneys. And Wendy is – she wanted to make good with what happened out of her life, and so her attorney’s like, “Oh, you need to go meet Kim in Minneapolis.” And somebody else that – a completely unrelated connection in Washington, D.C., who sits on a board of somebody that I work with out there, said, “Oh, you need to meet Kim Witczak.” So she had two people that said that. And I’ll never forget: Wendy, like, emailed me and she’s like, “I’d like to come meet with you.” It was a January morning and she literally – I’m like, “If you really want to come to Minneapolis in January” — it was, like, freezing cold, but, now, knowing Wendy, she’s a force. And she’s like, “Yep, I’m coming,” but she brought a friend because she didn’t know if I was going to be safe enough, or something. We laugh about it today. And so we came and we sat and we were like talking, and I remember saying: “You know what? If I were you, I would focus on the word akathisia. Nobody knows that word. So if you could make that a household name, that would be amazing.” And so that’s really where she, you know, started akathisia, because I think that’s really – you know, it’s more than just, you know, the antidepressants.
So I love what MISSD’s focus is, because I think it’s such a huge undertaking, but it’s a singular focus that I think we need to make it a household name. And if anybody can do it, I think MISSD, you know, can do it, and all the people. And getting more and more — like, when we start hearing about it in the media, getting them connected for them to understand, you know, like, akathisia. So I think it’s going to be slow-moving, but I think definitely MISSD is making a huge contribution to exposing the word akathisia.
AM So you’ve been talking a bit about the lawsuit that you pursued. So let’s get into that. You took Pfizer to court, asserting that they knew Zoloft was unsafe and had pursued aggressive marketing practices and defrauded the public. And you won. Can you talk about that?
KW Sure. I would say, I don’t know if “won” is the right word. Our case was resolved. And you have to understand what was happening during that time, as well.
So we did go through a lot of the process, but what was happening is there’s a thing called – Pfizer had been – they had already been in several lawsuits for suicide-induced, failure-to-warn lawsuits against Pfizer for their drug Zoloft. And remember, there were no black box warnings. So the difference now, once they put the warnings on in 2004 for kids and 2006, is they could now say the warning exists, but back then there was no warning, so it was failure to warn, as well as wrongful death.
But during that time I was also going out to D.C. and doing a lot – taking all my documents that would get from under seal. I would take articles. I would go meet with members of Congress because they were investigating the kids and antidepressant issue in the House. There were all kinds of FDA hearings. So all of that was happening at the same time as the lawsuit. But what was happening also behind the scenes is that there was a guy who became chief counsel at the FDA. His name is Dan Troy, who now is global – he’s the head attorney for GSK. But at the time, he was – he had formally worked for a firm that represented Pfizer and then got put into a position at the FDA as chief counsel that did not need to be Senate-approved. So he got, you know, slid in during that time. And he started intervening in all these private lawsuits against Pfizer, saying that even if Pfizer wanted to warn, the FDA wouldn’t have allowed them to warn because they didn’t see the link between suicide and antidepressants. Right? So it was a legal maneuver that has now really wreaked havoc on a lot of the lawsuits, including [Wendy] Dolin’s, to do with preemption.
So what we were able to find out is that Dan Troy took $300,000 from Pfizer before he got appointed into that position at the FDA, so we held – there were some press events that one of the representatives in D.C. – his name was Maurice Hinchey out of New York – he was the one that actually held it, and we were able to expose that Dan Troy took this money from Pfizer. And from there, eventually Dan Troy resigned from the FDA, went back into private practice representing the companies and ultimately at GSK. But the damage was already done, so the preemption brief, and what was happening is a lot of these lawsuits that were in different courts, both state and federal, were getting thrown out. The judges were throwing it out for this preemption brief, saying that even if Pfizer wanted to, we wouldn’t let them.
So what happened – so that was the landscape that was happening legally with multiple lawsuits. Then, with our case, it was in federal court in Minneapolis. We actually had a hearing and days before we were able to get the attorney general of Minnesota to intervene on our behalf, where they were saying, even if – states have stronger – like, states’ rights and states also have stronger legal requirements than national, which is kind of the low bar, so they intervened and we had a big hearing. It was like a wedding that only one side really wanted people to be there. We had it packed with all of our friends, and there was, like, Pfizer and their couple attorneys up in the front arguing it. It came back and the judge ruled against Pfizer, and it was one of the first preemption briefs that were beat. And then Pfizer tried it again, because another – they won it in another court where another court ruled against the plaintiff and the victim and supported Pfizer. So they tried it again, and literally, the judge was like, it is so denied. That was his – literally his, like, three words that he wrote. And at that point, Pfizer – because they had already done the investigations; they had me for eight hours; they had investigated, you know, to see if there were – literally, again, there was no financial, marital, so they went through it all. But really, so there wasn’t going to be a win on their end.
And I also believe that when they had me under the – you know, they got me for eight hours of interrogation, where they could ask me anything. The first half of all of my eight hours, nine hours, whatever it ended up being, was all about what I had told people out in D.C. It was all information-gathering to know who – it was almost like damage control of what was happening in D.C., so that they knew who knew what, so they could start figuring out that play, because it was a really big – that time, because, you know, they were trying to put the warnings on there, they wanted to know where all the information was coming from. So that – and then I remember, finally after, like, four hours and I had just gotten back from a trip to Germany for one of my shoots and I was really tired and crabby, and then I remember, like, looking at her and I go, “Can I ask you a question?” And she goes, “Uh, no, we’re asking the questions.” And I’m like, “All right, then I just want this on the record: I don’t know what any of this line of questioning has to do with my husband’s death. Like, you haven’t even asked me one question about Woody.” And I was so frustrated because I felt like all they were doing was trying to – like, which senator knew; how did the attorney general happen; how did [Senator Chuck] Grassley get involved? So it was a very different kind of – I think it was, again, damage control. And now I see their game, years down the road, where I’m working at the FDA and see other things that are happening. But – so eventually it did resolved, and I think it’s because they couldn’t win at that preemption game.
AM I think I saw that one of the results of that lawsuit was that you were able to go public with discovery documents? Is that right?
KW Well, they were all were – so they weren’t necessarily documents that were discovered in my lawsuit, because, remember, my lawyers had represented their clients against, you know, GSK and Eli Lilly and Zoloft. So they had all these documents. But what happened in my lawsuit is that the judge released them, so for many years and many other cases with other judges, Pfizer has always argued those as trade secret. And the judge in this case said these are not trade secret. So once they became declassified, we were able to – I took them and brought them out to everyone in – you know, anybody who would listen. But, you know, all the senators and Congress, because they were, again, looking at it. I met with FDA. I met with Tommy Thompson personally when he was at HHS, and gave it to all the media, because, you know, those documents – to be honest with you, those documents belong to the public, because they – and the FDA should really want them. And they’re – you know, I personally believe, and this is, again, going forward, I know; we’ll probably get to it, but I think the FDA, if there are lawsuits, they should be getting no – these company documents should not be sitting under seal when there’s public health consequences occurring with the drugs. Period. Period.
AM Did you want to talk about Selling Sickness, the conference that you created?
KW So I did do the Selling Sickness conference in 2013. But it’s funny to me, and I’m actually — I work — and I get invited and I’m working a lot globally, and I just had a conference call this morning, “rethinking our health system.” And it’s interesting because when I – and how Selling Sickness came to the U.S. was born out of a conference that I attended in Amsterdam in 2010 called Selling Sickness. And at the time, it was put on by the Dutch government and another nonprofit, and it was mostly a lot of people from the EU, but all the continents were represented. And really, there was a couple people from the U.S., but every example that they were using was from the U.S. And I remember thinking, why isn’t this conference and this conversation happening in the U.S.? Because we are clearly the ones that are with the commercial and how our health system is, we’re driving this. Right? And it’s really about, like, expanding the boundaries; it’s, you know, selling sickness; it’s creating disease-awareness campaigns before the drug surprisingly gets approved, so that, you know, it’s really about the economic and follow the money and connecting the dots. So that became – and I remember, like, talking to the organizers, hey, you know, let’s do this in the U.S., and they’re like, nope. So it became something that I brought over and really changed it a little bit because most of the time – and it was from – a lot of the conferences I go to, which I love going to because I love to learn and whatnot, but one of the things that I’ve noticed is — and I’ve met so many amazing advocates that have taken their tragic experience or their family’s experiences and have done and made real change, and then there’s the academics that have the information, but it’s like, what if those two got together so you could actually move the ball forward with information? Because, you know, a lot of advocates take it and because it’s a personal drive and they push things.
So it became — and then I also saw the power of working with attorneys and the importance of the media and whistle blowers. And so it became this multidisciplinary conference that brought everybody together in one place. And also one of the insights is that a lot of times I’d go to these conferences and it’s pretty intimidating when everybody’s walking around with their name badge and it says, you know, like “Kim Witczak, Ph.D., M.D.,” like a zillion letters behind your name. And I just have plain old “Kim,” you know, “Kim Witczak.” It’s almost like they can size me up like “I will have nothing” – “it doesn’t even have an academic institution behind it, so I don’t need to talk to her.” And so one of the things that we did with this conference is that we had just first and last names and what city you were from. And we had people from all over the world. So you actually had to talk to somebody, and again, it was like rethinking how do we have conversations, and if we’re going to make change, you know, it has to be all of us working together, not just somebody sharing an idea. It takes all of us to make change.
So that was in 2013. It was a success. But now I want to take the idea of selling sickness and do it more like a docu-series and really go after the marketing of pieces and by target markets and show the follow-the-money sides of things and how people can get educated but also maybe have some information, you know. So I feel like there’s a lot more that we can do around this theme.
We are a global world now that we need to think globally, but a lot of things are still being driven by our system. And I just heard today that — I think it was India that’s going to now – something’s approved FDA, they’re just going to use that as kind of their guidance, and I’m like, oh, my god. So it really does need us – meaning Americans and people pushing from the outside – not in the system. I do know that I sit on the — inside the system, but that’s not where the change is going to happen. Change is going to happen by people doing what you’re doing and listening and being educated and informed and wanting to get involved.
AM And you say “oh, my god” in that story because you see the FDA as a broken system?
KW Oh, hundred percent, and I’m like, we want to – this is going to be what you guys are using? But yet, is this the best that we can have globally? Like, I don’t think so.
You know what? It’s funny. So, you know, I told you I sit on the FDA panels, and, you know, I totally do not talk — I would never talk to the media if I’m getting ready to review a drug, but, after the fact, I think it’s OK. Right? But I’ve been told by several of the media that other advisory members are afraid to talk to the media. And I don’t — you know, to me it’s not – and I had a really funny situation when I talked about Pfizer.
Do you know the drug Chantix, the anti-smoking drug?
OK, so it had a black box warning on it. So Pfizer, after – so I believe that Pfizer learned after all the antidepressant — you know, getting the warnings and the lawsuits and all of that, and all of us people, like regular families who were talking to the media, that they learned a lot, like, “We’re going to shut everybody up.” So they had all these lawsuits, like 3,000, almost 3,000 lawsuits that were individual lawsuits for psychiatric events, whether it’s suicide, violence from Chantix. Well, they settled all those lawsuits. They literally shut everybody up, so even if I had a website, like Woody Matters, I would have to take it down. So nobody could ever come to an FDA hearing to publicly talk about their story, nor could they tell the media, because it was all part of the settlement. All the documents, they are completely locked up, you know, never going to see the light of day.
Then Pfizer goes to the FDA with a new study, saying that the drugs don’t cause psychiatric – so they were able to get the FDA to reverse the black box warning. It’s never happened – well, I guess, technically that’s not true. There’s one, like, small drug for cancer, rare drug, but for a big drug and a big sales drug like Chantix, it was the first time a black box warning has ever been removed by the FDA.
So about – so I was excited because I knew all this and I had done some work on it, and I was excited to be on the committee, so I could – like I said earlier, I could ask the hard questions. You know, like, how come we’re not hearing from the victims here? What about all those documents? Like, those are some of the questions I would have wanted to know, because I think if you’re going to remove a black box warning, you better have all your information, FDA, and that means all the information that’s in those files. And I want to know about those lawsuits, because, unfortunately, there’s a — when a lawsuit happens, it’s not the lawyers that want to create something; something bad had to have happened before there were lawsuits.
So anyways, days before the FDA advisory panel had all the information, and it was a Thursday, I get a call from the FDA saying that it had been brought to their attention that I have an “intellectual bias,” and I was removed. I was recused from serving on the committee. And that happened like – it was a Thursday, and the hearing – I was supposed to fly out on a Monday and the hearing was Tuesday. And I remember – I said, well, I’d like to have a conversation with people because I want to understand why. And so I think there was like 10 people from the FDA on the – I wish I was in the room to watch it all, but one of the things I said is, “OK, well, if I can’t come and be a part of the advisory panel, I would like to have a slot during the open public hearing and be able to ask, you know, just get my three minutes,” which everybody should – you know, especially our doctors should know how these FDA hearings work. And I said I’d like to come and speak and I’ll pay my own way, but it’s really important that I’m there. And they said, you know, they put me on hold, they talked for like three minutes, then they came back and they said, “All right, we’re going to start the meeting in the morning saying there was one member that is not on the committee today that was recused for having an ‘intellectual bias,’ but we’ll let you speak.” So I was able to still go, but I did not have the same impact as I would have if I had been on the committee.
That intellectual bias argument has been used against me as well as Sid Wolfe, who started Public Citizen. And I think, you know, when the FDA said I had an intellectual bias, I remember saying, what do you consider an intellectual bias? Because if you consider safety — if you consider me and asking all the questions from a safety point of view, I will always have an intellectual bias because that is where I’m coming from. It’s safety that matters to me, once it’s on the market. And, you know, in my mind, a lot of the physicians as well as the other members on the committee, you know, who believe that drugs – the first, you know, line of treatment is drugs — isn’t that an intellectual bias, as well? So I think it got used selectively because of Pfizer and all of the stuff that I knew.
So anyways, it goes back to the advisory committees and challenging the FDA, and I think I’m fine doing it, for whatever reason. (Laughs.) Maybe I’m not very smart doing it, but I just feel like that’s what I should be doing.
[Andy Miles] If you'd like to find out more and get the best information about this important topic of akathisia, the MISSD website is a great place to start.
[Wendy Dolin] "If you go to our website, the section that says What Is Akathisia? you will see the two MISSD videos, as well as we have an educational PDF that you can print off. We also are on Facebook and Twitter. If you like this podcast, learn more about akathisia and just send it to your contacts."
That's MISSD founder Wendy Dolin.
You've been listening to the Akathisia Stories podcast. We'll have another episode next month. If you'd like to share your own story for this podcast, please email studio.c.chicago@gmail.com, and please share this podcast and subscribe. I'm Andy Miles and I'd like to thank Kim Witczak for her time and candor, and I'd like to thank you for listening.