Cipro -- Fluoroquinolone associated disability -
>>> “The Cost of Being a David,” a conversation with Dr. Charles Bennett
https://www.knowrisks.org/episode6
On this episode Dr. Charles Bennett joins Heather and Lee to discuss the forthcoming book, Taking On Big Pharma: Dr. Bennett’s Battle; black box warnings; citizens petitions; and his recent journal article, “Davids versus Goliaths,” where he talks about his story and that of 26 others and how they were retaliated against for reporting on drug safety, effectiveness, and data integrity concerns.
LEE: Awareness is power.
HEATHER: And it can save your life.
LEE: Welcome to our podcast, “Know Risks.”
HEATHER: I’m Heather.
LEE: And I’m Lee. We’re two moms, a lawyer and a nurse, who were brought together by a misfortune. Both our children were harmed by adverse drug reactions.
HEATHER: The purpose of this podcast is to educate people on the risk of any health treatments you put in or on your body.
LEE: We feel if we’d been properly informed and been our own experts, our children would not have been harmed.
HEATHER: In today’s world, with medicines being incentivized for profits, you need to educate yourself. Know the risk of health treatments and it can protect yourself and your loved ones from being harmed.
LEE: Thank you for joining us today on our episode, “The Cost of Being a David.” We are honored to have Dr. Charles Bennett with us to discuss his new book, Taking On Big Pharma, black box warnings, citizens petitions, and his publication, “Davids versus Goliaths,” where he talks about his story and that of 26 others and how they were retaliated against for reporting on drug safety, effectiveness, and data integrity concerns.
Here is Heather to tell us a little bit more about Dr. Charles Bennett.
HEATHER: Thanks, Lee.
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Dr. Charles Bennett, M.D., Ph.D., MPP
Charles L Bennett M.D., Ph.D., MPP, is the Frank P. and Josie M. Fletcher Chair, and the SmartState Chair and Director of the SmartState Center for Medication Safety and Efficacy at the University of South Carolina. Dr. Bennett was the first physician to hold the A.C. Buehler Chair of Economics and Medicine at the Northwestern University Kellogg School of Management and the Feinberg School of Medicine. He has led seven R01-funded research grants on pharmaceutical safety, with the initial decade funding the Research on Adverse Drug Events and Reports — also known as RADAR — at Northwestern University, and for the past six years, the R01 funding has supported the Southern Network on Adverse Reactions — also known as SONAR — at the University of South Carolina. The SONAR project includes active collaboration with clinicians and researchers throughout the United States, Europe, Canada, and Asia.
Dr. Bennett is an academic hematologist/oncologist who has been the principal investigator for over $15 million dollars in peer-reviewed grant support from the NIH, the American Cancer Society, and the Pfizer Foundation. Dr. Bennett is a Phi Beta Kappa and High Honors graduate of Swarthmore College (in 1977), a 1981 graduate of the University of Pennsylvania School of Medicine, and a 1989 recipient of a Ph.D. and Masters in Public Policy from the RAND Graduate School in Santa Monica, for which he received honors in social science research. He has published over 450 articles in peer-reviewed medical journals, including first-authored papers in the NEJM, JAMA, Lancet, Blood, and Journal of Clinical Oncology, and Lancet Oncology.
Dr. Bennett is currently the principal investigator of the American Cancer Society Institutional Research Grant at the University of South Carolina, which is now in its seventh year of funding. His current paper, “Davids and Goliaths: Scientists versus Pharma,” is published in The Journal of Scientific Practice and Integrity. He also has a book, Taking On Big Pharma: Dr. Charles Bennett's Battle, which will be out in January 2023. Dr. Bennett will touch on both of these most recent publications in our interview today.
LEE: Thank you so much. We are just honored to have you here with us today, Dr. Bennett. I know that you’ve had lots of contact with Heather but, for me, I’m just so pleased to finally put a face to the name, a name that helped me so much through my journey with my daughter, Charlie. The work that you have done on fluroquinolones has just been hugely instrumental in helping to get the black box warnings on that medication, that medication that just has such horrific side effects. And I know that as a community, survivors, fluoroquinolone survivors and loved ones of people harmed by fluoroquinolones, we almost consider you saint-like for the work that you’ve done and we just so greatly appreciate it.
I think it might be nice today if we could perhaps talk about these black box warnings. I know the fluoroquinolones have had several of them added over a period of years. And perhaps you could just walk us through that process, like what’s involved in trying to get those black box warning attached to these medications.
DR. BENNETT: Just to be clear, we tracked black box warnings, safety advisories, communications, side effects, adverse events. They have seven different sections on the label. And as Heather knows, very intimately, when you get to a package label, which is often attached to the product that you give to the pharmacy, you should set aside a couple days worth of reading time because the labels are – I’ve been up to places where they do product review for quality up in New York and Underwriters Laboratory and what they did was they printed one of the labels out in a font that you could actually see and the label went for 42 feet.
HEATHER: Oh, my gosh.
DR. BENNETT: Nobody could read it. And so, as you can imagine, the labels are primarily for lawyer protection. Heather, maybe you’ll agree with me –
HEATHER: Yes.
DR. BENNETT: – because Heather’s clearly a lawyer. And then they claim that it provides some insight into side effects of a drug and you would need to have a whole day worth of reading to do it. We have on the labels what used to be called black box warnings. The FDA, in their infinite wisdom, thought the color black was too sinister so they made them box warnings now; they took away the black box warnings because black box warnings – you could almost imagine somebody might want to read it. But a box warning, you can really get past and say there’s nothing different because the color’s not different. Box warning, by definition, to the FDA, is there’s no regulatory requirement of what gets you to a black box warning, so it’s sort of like they say at the Supreme Court, you know it when you get there, and there’s no – say if you have X, Y, Z, A, B, and C you’re in a black box. No such thing X, Y, and Z, A, B, C. The box warning is the hope that the patient who gets the label might read at least the box warning, which should have three to four major concerns, and that’s it. And that way they don’t have to read 57 pages in the warning and the four major concerns in the black box warning. So that’s what we’ve done over time. And in 2006 the box warning, black box at that time, was for Achilles’ tendon rupture, and I’ve known several people who have taken one or two doses of the quinolone – Cipro, Levaquin – and they end up with a bilateral or unilateral Achilles’ tendon rupture. Also shoulder rupture. You can rupture any tendon in the body. My lawyer came from his biopsy of his prostate where he got a dose of Cipro they said would be good to protect against infection, and then the parking lot at the place where he got it his biopsy, he fell down because both Achilles’ tendons ruptured about an hour after he took the biopsy.
Those black box warnings, 2006, weren’t easy to get black box. Ralph Nader’s group, which Sidney Wolfe led, helped petition and they were not – they being Johnson & Johnson and Cipro. FDA supported Johnson & Johnson/Cipro – (inaudible) – no black box. In the meantime, I had tried a clever idea that I had never thought about except for Richard Blumenthal, currently Senator Blumenthal of Connecticut. Then-attorney general of Connecticut said to me he liked one of my concerns on a different drug and wanted a black box warning on it and so he and I collaboratively – first collaborative black box warning from an attorney general. He was Connecticut attorney general at the time – on it, and we got a year later – one year later we got the first ever black box warning collaboratively from an attorney general and a public citizen, myself. And Sidney Wolfe read about that and he replicated that and attorney general of Illinois, Lisa Madigan, joined him and they got a black box warning for Cipro and Levaquin for Achilles’ tendon rupture. It did not come easy because they had to file a lawsuit in court – (inaudible). Besides the petition you had to do lawsuit in court. There have actually been only six citizen petitions ever accepted, in part or in total, by citizens. Citizen petitions, just to let you understand, are really misnamed because they’re meant to be competitive drug company petitions and they’re primarily there to make sure that competitors do not market the drug, and 95 to 98 percent of all citizen petitions are written by drug companies trying to prevent another drug company from competing against them. It’s very rare.
HEATHER: Wait, so the drug companies – just to understand this because this is just fascinating to me – so the drug companies are doing citizens petitions against competitor drugs?
DR. BENNETT: Right. And it would be primarily a generic drug and a branded drug. The branded drug will say the generic drug is not up to quality; it should not be allowed on the market, and regulation is generic drug companies being brought against by the brand. The courts have six months to adjudicate so it puts a six-month halt on a generic company from manufacturing and competing. So these become a huge game and a way to slow down your competitors. On the other hand, a poor citizen like me trying to write a citizen petition, they have no – there’s no law there. Only six of us have done it besides Ralph Nader, and two of the six that have ever been accepted, two of the six that have been submitted by people other than Ralph Nader are Sidney Wolfe. Two of the six are by me. And they both were partially accepted. I’ve had two rejections. But I have the most citizen petitions in the country that are partially accepted.
HEATHER: Excellent. And I know I was with you – I believe that was in 2016 for the citizens petition that you submitted in regard to the fluoroquinolone-associated disability. And just to back up, for some our listeners who are maybe just joining in, I know a lot of our listeners will see Dr. Bennet’s name and they know quite a bit about fluoroquinolones, either from being damaged by them or having a loved one hurt by them, but in this particular citizens petition, was that – that was one of the ones you’re referring to that was – resulted in a black box warning for the associated disability?
DR. BENNETT: So to bring things clearer, Linda Martin, who’s very active with me and Heather, has worked with me hand in hand on citizens petitions and we felt filing a petition just like a piece of paper over the transom would be unlikely to be successful and needed some more oomph. So Linda and I and Terry Aston, we flew in 2014 to Washington, D.C., to the Rayburn Building and we met with 19 senators, policymakers about a petition that we wanted to write in 2014, which we wanted them to include issues related to fluoroquinolone-associated disability, long-term neuropsychiatric disability. We had 19 senators; 18 of them kicked us out of the office with the boot. And one of them had – the aide to Patty Murray, he was very subtle, called Terry at home many nights after that saying that he was talking to Senator Patty Murray, liked our petition, was unlike the others, and lo and behold, in 2015, we had an FDA Advisory Committee meeting, which Heather attended, and the advisory committee meeting talked about fluoroquinolones. It had came as a shock to us – maybe not to Heather; maybe you were able to lobby for it, but we had no idea they were going to have that. But when we went to citizen petition review in 2015, November 5th at the FDA, there were many patients, many family members. There was an armed guard. There was a rope line. There was CNN, Wall Street Journal, New York Times, there were a bunch of lawyers, there were a bunch of investment bankers looking to see which way the stock went, and then – (inaudible) – was the fact that 21 advisers of the FDA and on two sides people in suits on the left side with the suits I can’t afford to buy; those are called – businesspeople at Johnson & Johnson and Bayer, and then on the right side was the FDA people, and at that meeting they discussed fluoroquinolone-associated disability and one FDA employee, Debra Boxwell, said that she had read through notes of people like Heather’s son and others; she had read about 80 of them; she felt that despite it not being statistically significant – which maybe David Healy might have addressed in his podcast – that she had never seen such visceral and such real pain at these narratives, which were never before used by the FDA to define an adverse event were in fact for her definitive. She called it FQAD. We left the meeting with a 21-1, 18-2 and 19-1 approval that all three uses – uses would be sinusitis, COPD, and also UTI – that quinolones should go first-line drug to last-line drug. We left that meeting with The Wall Street Journal supporting us, and as you can imagine, the next day nothing happened. It was an advisory committee meeting. They decided to disregard our advice – 19-2, 18-1, 20-1. Nothing happened. A year later, Johnson & Johnson and Cipro said that they had reconsidered their thinking and these drugs were now last-line drugs in 2016. 2018, I get a letter in my office in a brown envelope, no FedEx, no nothing. I open it up; it’s from FDA, at that time Janet Woodcock, the interim director of the FDA, and she said she thought that the suggestions that I made in 2014 she could live with for half of them, and the black box warning became a reality in 2018. So to remind you of the timeline, it was not a year; it’s four years – (inaudible).
LEE: That’s just terrible when you – well, Heather and I both know how many people’s lives have been affected by this category of medications and to just know how much effort and convincing it takes, and then the time, so in that time, how many other people have been harmed? And then you brought up – and Dr. Healy did touch on – that it’s only a very small percentage – I think it’s 1 percent of the people that actually the adverse drug reactions get reported. Is that right?
DR. BENNETT: We published in different journals that we could empirically document only 1 percent get reported because we had a way of getting two sources of documents – what was reported and, secondly, what was reported in clinical trials, and we showed only 1 percent were ever reported. In 2019, after we were frustrated that the black box warning did not actually have the effect of actually warning anybody about the side effect, I filed my third citizens petition related to the quinolones and this time I asked if there could be a signature required by patients and doctors before they received the drug, going through the side effects that people like you, both of you, who have experienced these side effects would know about them in real time because you’d signed a consent form and your doctor signed the consent form and the pharmacy signed the consent form, which is not unusual – it’s severe but not unusual; it’s done for retinal gas. It is done for acne drugs. I mean, you can’t imagine. They also do it for drugs they use for anemia, for cancer patients. And we’re just asking to have some really strong way to make sure that you don’t bypass something that might come back to really affect lives, your daughter and her son.
LEE: Yeah, I think what that – well, what you’re asking for is really documentation of informed consent.
DR. BENNETT: Exactly. And if you don’t document it, don’t get the drug. And we got a letter, a terse letter back in six months from the FDA saying this will never happen in my lifetime.
LEE: Wow.
HEATHER: Now, can we – yeah, I’m just still kind of – I just want to go back for a second because you said it was two – the black box warning label for the FQAD actually was done because the two pharmaceutical makers, Johnson & Johnson being one of them, two years later they decided that was important? What would have been the motivation behind that in 2018?
DR. BENNETT: I think what happened (beyond ?) that is to have an advisory committee meet, make a recommendation, and nothing happened, it must mean there must be ongoing, behind-the-scenes conversations between the FDA and the company, and finally they convinced them that this is the right thing to do. So there’s no real event. But I will say, it was interesting that we found in 2015, you had in 2014 – the meeting was held in 2015. And the other important event was in 2018; the European Medical Association asked me and asked others and they flew patients in from 27 European Union countries and each of them talked about their own personal experience with fluoroquinolone-associated disability. Now, the FDA and every country in the world has refused to call it fluoroquinolone-associated disability. The term that they’ve used is called long-term disability or long-term neuropsychiatric disability. They do not call it fluoroquinolone-associated disability because I don’t think they want another name to be used in the ICD-10 nomenclature and the name would require possibly (meaning ?) that there will be money. Fluoroquinolone-associated disability might mean that there should be a claim for disability –
HEATHER: Correct.
DR. BENNETT: – from the government and you would be entitled to some disability payments. So they have purposely not gone with it. But the Europeans voted 28-0 – 27 now because of Brexit – that what we had found in the U.S. was exactly correct and they also moved it from first-line to last-line in Europe, and that also may have been somewhat of a trigger for the change because the Europeans were moving on it. Japan followed, Australia followed, New Zealand followed, and Canada followed. Those four countries I just mentioned at the end did not change placement of the quinolones from first-line to third-line; they just made an announcement that these drugs to them were too important to move around and that people could occasionally – and they wrote rarely – have permanent neuropsychiatric damage. They were uniquely different from the 28/27 European Union and the U.S. in terms of that. The Japanese, for instance, said that they only saw it with Levaquin in only one or two cases so they really wouldn’t even put much on their label about it, and only on Levaquin and not all quinolones.
LEE: But one would think potentially that the motivation of Johnson & Johnson to want to help change the labeling could be the – were they under a lot of legal, like, lawsuits as well?
DR. BENNETT: Lawsuits do not work in this case because the Supreme Court has, in its infinite wisdom, ruled in the Atkins case in 2013 that if a drug is generic the manufacturer cannot be sued for anything, and so if you take generic Levaquin or generic Cipro and had a terrible outcome like Heather’s son or your daughter being ill, none of that can be sued by anybody. So the reason – put on a label is not because of anything related to lawsuits; it is about just trying to get the label to be complete.
LEE: Well, yeah, and subsequently prevent people from being harmed because it’s, you know, the health care professionals should be aware –
DR. BENNETT: I think that in the perfect world they’d be aware. The reason why I filed the last petition is because I don’t think they are aware and that’s why I asked for the consent form. I don’t think – and I have many, many friends who tell me routinely, I’ve used Cipro and Levaquin for at least three decades. Now, don’t forget these drugs came to market in 1986 and the only one who started raising concern besides concerned patients and family members was me in 2011 and (Jay Cohen?) who died in 2011. And so this concern lasted 11 and 14, 25 years before some initial concern happens, and after 25 years the label gets changed, in 2018 with the black box warning, which is 14, 18 – 32 years after these drugs hit the market.
HEATHER: Yeah, and, I mean, we know how many people were harmed. I believe – who was the journalist – I think that was in the late ’90s – Stephen Fried, who wrote Bitter Pills. I mean, that was almost identical situation what happened to his wife, although she survived, and my son. You know, having the neuropsychiatric issues, being diagnosed with bipolar, landing in the mental health system. So, I mean, essentially, it just sounds like, to me, that for the industry, anyways, and for our regulatory agencies, it’s just not really about patient safety but more about navigating a system to kind of slow down any type of negativity associated with the drug. In the meantime, the pharmaceutical industry is just reaping the profits from it. I mean, is that kind of what’s happening here?
DR. BENNETT: I don’t think so, actually.
HEATHER: No?
DR. BENNETT: I think what’s happened since Stephen Fried’s case, his wife was very sick and mentally ill for a year, and he wrote a long book, as you – (inaudible) – Bitter Pills. Now if you talk to Stephen Fried, he hardly brings it up in a conversation.
HEATHER: Really?
DR. BENNETT: Yes. So Heather, you know – and you, Lee – you’re committed, long-time, lifetime advocates. You’ll be there. Stephen Fried, you call him up, he’s writing a different book now. He’s moved on in his life. His wife is a little better, a lot better, and this is all a bump in the road that he hardly remembers.
Now, I would like to say that, make it clear that this is not a rare side effect.
HEATHER: Exactly.
DR. BENNETT: People blow us off all the time and say it’s a rare side effect. And the reason why they do that is because a side effect that causes a heart attack or Achilles’ tendon rupture, it’s easy to see and feel. Tendon goes out, you get tendon repair; your heart attack goes out, you go to the hospital. But when you get a brain attack or brain injury, then they talk to you about drinking too much, having poor sex life, not accommodating, and millions of things, and it does not include – and this is why – that’s why almost the majority of these actual events occur in isolation. You’ll go see at least 10 doctors who would tell you that everything that has happened is in your mind, it can’t be this drug that’s been on the market since 1986 or we would have heard more about it. And it’s true.
HEATHER: Yeah, exactly. And, you know, to kind of go along with that, I mean, in my son’s case, you had a patient who was telling his doctors, even though he was experiencing these neuropsychiatric issues, that this is from this drug, this is from this – he’s, you know, connecting it, and again, none of the many, many doctors, you know, wanted to give any validity to that. And I think that that’s kind of a good lead-in because the system really has a way of shutting down these type of complaints from patients or giving them the attention that they need. And I know you have an article that will be published soon in The Journal of Scientific Practice and Integrity that kind of deals with – we talked a little bit about the low number of reports, such as FAERS reports, the FDA Adverse Event Reporting System, from doctors and also from patients. You can’t really, you know, criticize a patient for not knowing to report because it’s hard to know that information and if you’re scared and you’re having a bad reaction to a drug, especially one that might affect your perception and your ability to function and your mind, more likely than not, that’s not going to happen. And we don’t have a lot of doctors reporting either for exactly the issues that you just discussed, Dr. Bennett. But I kind of want to go back because I know Dr. Healy, I know you have been a victim of this, and it’s just this total maligning of anyone especially in the medical field or scientists who come out and speak about – you know, advocate for the patients or try to warn about potential effects of drugs. I just was wondering if you could talk a little bit about that.
DR. BENNETT: One of the most important things about a drug side effect (potentially ?) is an animal model, and my thinking is that deep in the woodwork at Johnson & Johnson and at Bayer their animal model data exists and it says that when you gave mice this drug, they produced long-term and short-term neuropsychiatric illness, because you would not get a drug to market without animal testing. And what we did in 2014 and 2012 and ’13 is with Dr. Raja Fayad. We gave mice increasing doses of Cipro, which apparently – in the laboratory setting, and we generated the exact same side effects we talk about now, in the mice, which is a really clearly convincing argument that the mice are – that this is a toxic drug, and why – the basic path of physiology is – and we identified it in a second set of series that my son led, who is now at Oxford in pharmacology. We did a series where we got blood samples from 25 people with neuropsychiatric illness, with quinolones, and 55 percent had a genetic abnormality to cytochrome P450 gene, which led them to mis-metabolize, under-metabolize the drug, which means the reason why it’s causing these psychiatric effects is many people have a genetic defect that leads them to poorly metabolize the drug and leads to tremendously large CNS-brain accumulation of drug. And then when Raja did the work with the mice to generate the exact same symptomatology, he called me up on a Monday and he says Charlie, I have it, I’ve nailed it, it is “this.” I went to see the mice and they were depressed, they couldn’t – (inaudible) – they couldn’t go through a maze, and as increasing dosages we had neuro-psychiatrically damaged mice from Cipro. That was on a Monday. Thursday I got an email at the University of South Carolina where I worked, and there had been a murder on campus and Raja was dead with the papers – with his dead body lying over his research. And his wife and he had had a fight and she shot him eight times and killed herself. So I was able to get his research and it was published – that was completed three days before his untimely murder.
HEATHER: Oh, my goodness.
DR. BENNETT: And so I call the work that I do Raja’s legacy –
HEATHER: Yes.
DR. BENNETT: – because he had just gotten tenure as an academic, and this was the first tenured project. He had just received tenure at 42 and then he was dead. And so I felt – the work that he would have continued to do with me on the Cipro, we would have just continued to find more and more, but because of his untimely murder, we had to shorten it. And then the – (I guess ?) the other effects that I said – besides Raja, my son’s findings on the genetics were stark, startling. We filed a provisional patent on that genetic test, and with some additional help we hope some day to market that test so before you take Cipro or Levaquin you take the gene test and if your genes aren’t going to metabolize the drug, they’re going to end up with a CNS (blast ?). Don’t take the drug.
LEE: Well, we’re not researchers but just through the journey with my daughter, you know, we’ve connected with thousands and thousands of people that have been harmed, and there is a commonality in that a lot of them seem to have what they call this – where they don’t methylate or they don’t detox. But the research that you’re saying, which, you know, is not, whatever, published or – but do you feel that it’s specific to the fluoroquinolones or that’s already sort of a harmful enough drug that that’s one of the ones that makes it worse? Would other medications be a factor with this genetic –
DR. BENNETT: There are – (inaudible) – drugs that have cytochrome P450 metabolic issues and this is just one of many.
LEE: OK.
DR. BENNETT: But what it accounts for is the fact that this side effect is undoubtedly not rare. The cytochrome P450, out of 25 people we tested, or 54, we had 55 percent with the genetic – (inaudible). So the reason why people are not being protected is not because this is rare but because doctors won’t listen to it and won’t report it and won’t say anything about it and won’t count this. So we 100 percent believe this is a fairly common side effect, and if you walk around the world and talk to people you meet socially on the plane or at a restaurant or anywhere else, they say, this happened to me, happened to my aunt, my grandma, my mother, my brother.
LEE: I agree and I think, too, that part of the problem is – well, the doctors aren’t aware of the warnings, they don’t listen to you when you complain because one of the things that I heard – we must have seen over 12 different doctors. They thought well, the drug’s out of the system so it wouldn’t keep causing harm. It is a little bit of a delay and these symptoms can keep developing. And then it’s given – a lot of the time, people are elderly, so if you have – you know, they just categorize you, oh, you’re, you know, feeling depressed; you know, they’re associating it with age a lot of the time or just –
DR. BENNETT: But as you know, from your own personal experience with your daughter, and Heather knows from prior experience with her son, there’s nothing about this that is protected by age.
LEE: No.
DR. BENNETT: Young people – at the FDA meeting, Heather, that you were at, the 17-year-old girl from Seattle, Washington, came in a wheelchair; she’d found her way to Harvard before she took this drug for a bladder infection and she wasn’t going to Harvard. She was going down a wheelchair to the FDA.
LEE: Yeah. And I think that’s why we were – our cases were successful in that we had – like, they told me, my daughter was a high-level athlete in perfect health and then within 10, you know, 10 days, she could barely move her arms, like, and had all these issues, which I didn’t even realize the anxiety and all those other things were actually related until afterwards when those warnings came out, thanks to you. I didn’t even connect those ones, but it was because she was so young and healthy that it was like textbook, almost.
DR. BENNETT: I’d like – you mentioned in your preamble in that conversation that Heather and you were successful for a reason. Could you define to me and to the audience what you mean by successful?
HEATHER: Well, that’s interesting – (laughs) – because what’s successful, you know, you think you’re – when something like this happens to you in your family, your first inclination is to try to, you know, get the word out. First of all, you’re – in my case, I’m mourning the loss of a child and also not wanting this to happen to someone else. In terms of success, I would term success in this in having broad knowledge amongst patients of the dangers of these drugs, which, you know, signed informed consent? Yes. That’s extremely important. In terms of court cases, I think Lee and I can both attest: It’s a long process and you think in doing so you’re trying to achieve some type of acknowledgment for the wrong that’s been done either by a doctor or by the pharmaceutical industry, but the result of those, if it’s with the pharmaceutical industry, is going to be a settlement with a nondisclosure, or a gag order, so the goal of talking about it’s not really going to happen. And even in a basic law case, it’s just not – the courts aren’t suited to make the type of broad change that’s needed in this. So when you speak about success, it’s just – it becomes very frustrating as you start to move forward down these different paths of what you think are your recourse for the type of damage that’s done to people, you know, only to find out that the impact of what you’re doing is very small. And I think that’s what you’re getting at, Dr. Bennett. Is that correct?
LEE: I think so too. I’d just add to that before he answers is that that’s a really great – that made me think, just right on the spot, I actually don’t think that we were successful and I think that’s one of the reasons for our podcast is that our individual kids’ cases were not about trying to get financial compensation. You could put no money on – I’d give up everything I had to go backwards in time and not have that happen, and I know Heather would give probably 10 times that. So we got acknowledgment, which you seem to want after being told over and over and over that this is in your head, that this isn’t happening. So that I felt successful in. But in getting a broad audience reached, we’re hoping to do more with the podcast. But obviously the work that you’ve done trying to get some labeling, and hopefully that there will be this one where they have to actually sign, that’s going to make way more of a difference because it’s going to reach way more people.
DR. BENNETT: Well, my citizens petition is out there in the web and anybody who wants to sign on to it, you just sign on to it through the website and people put a note supporting it. You can talk to – Heather knows some political people in her neighborhood. You can chat those people up and try to get – (inaudible) – the more political agenda you have, the more political influence you have, the more likely it is to happen. Bart Stupak, who used to be a congressman from Michigan, his son died of Accutane-induced suicide. He put the black box warning and the patient consent on Accutane. He’d be all over trying to get this for a similar story.
I will make a mention to this and I haven’t given you my journey in full. I have two pieces – three pieces of information to provide you. Besides the article coming out, my – a biography of me has been accepted and will be published – distributed by Simon & Schuster.
HEATHER: Oh, congratulations.
DR. BENNETT: And so a lawyer who went to Harvard Law School, taught at Yale and Stanford, University of Chicago, University of Texas, 93 years old, has spent six years detailing my journey with the Cipro and Levaquin, and they also added another journey that we did on Epo, a drug that’s used for anemia made by the largest biotech company. When Epo came up, in 2006, the result was the University of Northwestern, where I worked for 24 years as a stellar researcher with the most grants, resulted in them saying that I stole my research, I stole my money, I created no new research, and they took all my grants and gave them to people that did not do the research. They took my academic position away and I have been unable to return to a (pharmacy ?) medical school for 13 – since 2008. It’s now 15 years that I’m unable to get a job at a medical school, which I’ve applied for almost every year and sometimes twice, three times a year. And the important thing about that is they have a note on the internet you can read yourself, by Mort Schapiro at Northwestern, saying that, in his opinion, as the president of the university and the provost, dean of the medical school, Charlie Bennett is an unfit researcher and has developed and has propagated research that is not replicable and stolen money in the meanwhile. And that letter, which is on the internet today, this minute, is still there and I’ve never had a meeting in my life with Schapiro or Linzer or the dean, Neilson, in my life. But they did say – and I heard this from somebody else – is that somebody who knew the inside of the case was told by the university if he could sign a sheet that said that I was all those things the university could blame all their troubles on their mismanagement of my grants on me and I would pay the university’s $2.9 million fine. The end is they were able to give me a $475,000 fine on my “mismanagement,” quote/unquote, of grants, which I don’t manage because I’m a researcher, not a grant administrator, and I paid the $475,000, which required me to sell my house, empty out my retirement accounts, and as part of that – shortly after that, two, three years later, they took away all my research grants, gave them away to people who don’t know how to do the research. Research became pro-pharma. They took it from anti-pharma pharma oversight to a pharma booster, and that research then dissolved, and then they tried to take my medical license away and said that I could not practice medicine, (collected ?) $50,000 (to get ?) the license away. And the university just last week had Sidley Austin, a rather large law firm – said that while the note about me is not – is meant to be harmful that unless they can find a fault in it, it’s a lie, it needs to stay up there for the rest of the life of the world and no reason to take it out because history is history. And they make a point in the letter that no employee at Northwestern currently – when they wrote the letter in 2013 – had ever mismanaged my grants. Well, I left in 2010 and the woman that mismanaged my grants in 2009 was fined, criminal fine, sentenced to jail, quit her job for cause, and paid a penalty, and the reason why in 2013 she wasn’t considered a current employee four years after I left is because she wasn’t a current employee; they fired her four years ago. And so it shows you, at the end of the day, they would not – and they will not – this letter is used by every medical center that I’ve applied to, by their lawyers, for reason not to allow me to work as an oncologist in the medical school where I have spent 14 years of training and 20 years of research to do my work.
The only good side, the silver lining of that, is because of that effort I moved to South Carolina with a brand new slate because I lost all my research. I went to an FDA meeting in 2011. At that meeting I met (John ?) Bradee (ph) who has a very severe case of quinolone-associated neuropsychiatric damage, and it was because I met him at that meeting, shook his hand, listened to him, that I spent the next 10 years of my life on Cipro- and Levaquin-associated disability.
LEE: It’s a hard journey and tragic, but, I mean, us quinolone-affected –
HEATHER: We’re grateful. (Laughs.)
LEE: We’re grateful, not that that’s any consolation for what you had to go through.
DR. BENNETT: And we’re not done. As Heather knows, I’ve filed a whistleblower lawsuit personally against Johnson & Johnson and Bayer, saying what they’ve done is not (disseminate ?) the safety issues, and we’ve gone – we’re in the public domain now. It’s in the public domain; you can just google it. But we’re in a very positive stream of decisions. Judge Salas, who’s the judge in New Jersey whose son was shot by the FedEx driver and then her husband was shot by the FedEx driver but not killed, son was killed, and she is our judge – (federal ?) court – and we are publicly out there, and if the decisions continue to go our way, it will be a $2 billion payment from Johnson & Johnson related to the the side effect.
LEE: So we’re going put some of – just for our listeners, we’re going to have – you mentioned at the FDA there’s somewhere that they can go to – can you just –
DR. BENNETT: They can do it on the FDA website. There’s a citizen petition website where you can sign up. But they should also – and Heather knows this – they can talk to their local political people. And they can read my citizens petition; it’s also on the website. And I’ve had two congressmen from St. Louis, Missouri, both Republicans, in this case, support me, and the more political support we can get for those petitions to require the consent, the more likely they will actually be enacted. So you go to the website, you can sign your name up and say you agree with the petition, but you can really talk to your congressman and say it’s – I have a personal reason why this must be so; it’s my son and my daughter that I believe in personally, are important to me, as you know – Heather with a lost son and you, Lee, with a damaged daughter. There’s a reason to be there. And your congressman is only meant to help you and that’s why I think going through congressmen would be something terrifically important.
HEATHER: And this whole – like, the retaliation that was taken against you, Dr. Bennett – I mean, I briefly mentioned an article that will soon be published by you; it will be published by the time we air this podcast – but this is common. I mean, this is just common for –
DR. BENNETT: No, let me clarify this.
HEATHER: Yeah.
DR. BENNETT: No, I’m not saying it’s common.
HEATHER: No?
DR. BENNETT: I want to talk to you about icebergs. Some people ask me if this is the tip of the iceberg. What do you think? Is this the tip of the iceberg? Heather, what do you think?
HEATHER: A very small tip, I would say. (Laughs.)
DR. BENNETT: OK, I’m going to tell you this is the iceberg.
HEATHER: This is the iceberg?
DR. BENNETT: This is the iceberg. And why do I mean that? In my paper, we have 26 Davids and Goliaths. The paper’s called Davids and Goliaths. If you look on Google under Davids and Goliaths, you’ll see a total of zero articles called Davids and Goliaths. You’ll see a thousand called David and Goliath, because Erin Brockovich, she’s a David, the guy from the Insider was a David. People are Davids. Like David Healy is a David. The 26 Davids are never in one paper. Everybody fights a very lonesome fight where they get slaughtered by the company and by the university and, in my case, the Department of Justice on top of it.
HEATHER: Yeah, unbelievable.
DR. BENNETT: You know, to fight the university was hard, but I could get through it. To fight the drug company was hard but I realized I would get through it. The Department of Justice Assistant U.S. Attorney Kurt Lindland said to me in 2013, he goes, Charlie, let me just tell you the three most evil people in Chicago ever: those are Rob Blagojevich, the governor who was in jail; Scooter Libby, who worked for Ronald Reagan, was in jail; and Charlie Bennett. And he said, I will do everything in my power to make sure all three of those people go to jail. Can you imagine that? And then he wrote, he said, you know, I’m going to write a press release about you, it’s going to cost you your job, and I don’t have to be accurate; nobody vets my press releases. And so he wrote one parallel to the Northwestern one where he talked about nobody at the university was involved because the woman who was involved had been fired because she was in jail. Surely she was not employed by Northwestern when she was in jail. And he said I can say anything I want and I will have your career in three months’ time and you’ll be broke and I can take your family’s incomes too, so there’ll be nothing left for you. He said, you will learn what it’s like to work for Starbucks.
LEE: Wow. Oh, my god.
DR. BENNETT: Can you imagine getting that from the Department of Justice?
LEE: No.
DR. BENNETT: When all you’re doing is research. As my old boss said, I’ve saved more lives in American medicine than anybody ever in the history of the United States. People can save lives by generating new drugs. (Inaudible.) The amount of lives I’ve saved on safety is at least millions of lives, and more than anybody would do on 50 drugs like Cipro and Levaquin. As my mother said to me before she died three years ago, she said, they will kill you, but when they do kill you, you won’t know who did it. So the 26 Davids in my paper, the reason why I say, Heather, it’s not the tip of the iceberg, of the 26 people – and I personally interviewed almost all of them, went all over the country and the world to visit with them; I sat down with them; we had lunch. Many of them had hidden these stories inside their bodies, inside their heart, inside their heads for decades because the pain of losing their job and the fight they had was so real that they never wanted to talk about it again. And I’m coming in there bringing it up again and everyone I have in my paper on Davids and Goliaths is named. The 26 Davids are named in my paper. And more than that, I have a quote from each of them in their own words that have been published in Senate hearings, FDA hearings, New York Times, “60 Minutes,” in their own words about the pain that they went through. So I didn’t ask them to tell me something. I just looked through this published literature for the words that they’ve used to describe their own personal experiences. So when I cited the paper, I said, you want to find the words? I give you the actual page number of the Senate testimony. Let me give you an example of one piece of words. Tyrone Hayes, who’s been in the New Yorker magazine, had a very tremendous negative experience at UC Berkeley. Graduated from Harvard undergrad, Berkeley Ph.D., chairman of the department. His department is on animal biology. And he found that when you gave frogs a pesticide, the male frogs became feminized, much to the disappointment of Monsanto – Syngenta at that time. And they – as he presented his talk – (inaudible) – at a lecture, Syngenta vice president said Tyrone, we knew – Tyrone’s an African-American chap, about 5’3”, his wife’s Korean or Asian – guy said to Tyrone, he says, you’re going to give a very important talk and you should say what you believe. He says, I just want you to know that we’re not above murdering people; we’re not above raping your wife; we’re not above lynching your kids. And Tyrone said to the guy, his name is in the book, my book, he said to him, that is the most disgusting thing I’ve ever heard in my life but fortunately I have my tape recorder on. And he has that on and he’s presented that around the world and he has that tape – that’s a real tape. (Inaudible) – to do that. Tyrone – they have an internet site called Tyrone Hayes, which is owned by Syngenta, calls him a pedophile, and when you go look up at Google “Tyrone Hayes,” you find the most mean things about Tyrone Hayes that the drug companies populated with inaccuracies, terrible things about Tyrone. A hundred counties sued Syngenta for the water was poisoned and hundred counties were fined or settled for $100 million the amount of money it takes to clean that water up and the damage it’s doing to the kids in those neighborhoods. That’s just one of the other 26 of me. Every story is as powerful as that.
We monetize – what does these 26 stories mean? The 26 stories – here’s the thing we found. This is even worse besides the stories. All those companies, they were eventually asked to pay criminal fines or settle civil lawsuits. The total amount of money involved in those lawsuits was $27 billion so that’s why I say it’s not the tip of the iceberg because if it were – the tip of the iceberg is 1 percent. That would mean that would be $2.7 trillion involved in this kind of work, which would be far more than COVID. We wouldn’t even talk about COVID today if this were $2.7 trillion. We showed a million lives lost from these drugs from the harm that they did, either very severely damaged or dead. We also showed 13 of the companies that we evaluated of the 26 – 27 companies evaluated, 26 people – 13 of them, when they were identified by the Davids as submitting fraudulent data to the FDA for approval, 13 of them submitted fraudulent data to the FDA for approval and the Davids in our stories pointed that out. When they pointed it out, the Davids lost their jobs and the FDA data went through and the drugs got approved. So the answer to what happened there is the messenger lost their jobs. The people who were actual culprits got these drugs through the FDA and sold – total sales of these drugs are trillions of dollars we’re talking about here. And we asked in the paper, in the conclusion, that the just answer for this work should be not destroy 26 people like me who have been unable to work for several decades, and I’ve gone through the best medical school, college, graduate school, Ph.D. programs in the country and I’ve been sidelined except for the quinolones for the last 15 years and I don’t see patients for the last two years. And I went to – I didn’t go to average schools; I went to Penn, I went to – I work at Johns Hopkins now, I went to UCLA, I went to University of Chicago, I went to Duke University, Northwestern University. We’re talking about schools – Swarthmore College – that you could never imagine anybody getting into all five or six of those schools ever in their lifetime, and to have that kind of training and that kind of education not being put to use –
LEE: It’s a tragedy.
DR. BENNETT: It’s a crime.
HEATHER: It’s criminal. It’s criminal. There should be charges against all of them. And, I mean, just the 26 – how many – I mean, scientists, doctors like you are few and far between of what we’re seeing now. We see that more than ever now with this recent pandemic is most are just going to go along with the program; they’re not going to speak up. And how many lives are lost there?
DR. BENNETT: You wouldn’t want to lose your job, your career, your reputation, your friends. How many of my friends have deserted me? I can’t even go see 99 percent of my friends. The job getting pushed away from me, losing my house, my retirement plan. Every time my son goes to school, when he was in high school, looks up the internet; all they have is a Department of Justice press release about me. He said, dad, I didn’t know you were a criminal.
HEATHER: Amazing. Well, if it’s any consolation, you know, the result of the system that silences those who have integrity and have a commitment to science and speaking out, I mean, this system – there’s so much blood on its hands. I am not the only one – I lost a child. I mean, my son should be here today, but for, you know, the refusal to speak out on behalf of a whole lot of people – certainly not you, Dr. Bennett. But it’s just – it’s horrific what you have to go through for doing what is the right thing, what is the human thing. I mean, the result of this system is families like mine, you know? A bright young man who lost his life over this, you know, for profits. So it seems to me at the very core of this is they just want to preserve the income and the money, and paying off a few people is probably just chump change for a lot of, you know, those in the industry. But it’s just so difficult to wrap your head around such an unconscionable system. I mean, just the violence of the health care system and medicine system itself – it’s – you know, I commend you and I know Lee does too, but it’s just so sickening to hear this.
DR. BENNETT: You know, the point is there is no way forward for somebody to follow behind me. I can’t, in good faith, tell my son, I hope you save as many lives as I did and I hope you don’t mind being put out of work before you ever complete your life mission and I hope you don’t mind losing all your friends and your house, part of your medical license and all your grants and everything you worked for. If you’re willing to give all that up to save people’s lives, then go at it. There’s nobody in their right mind who will follow behind me.
HEATHER: I pray there are people who will. (Laughs.) I pray there are.
LEE: If we lose all the Davids because of the way that they’re treated and destroying your life, just to speak up and do the right thing, then where does that leave all of the public and the safety? Like, it’s a really, really scary thing to think about.
DR. BENNETT: That’s why my current lawsuit is important and it has to be won. If that lawsuit is won, Johnson & Johnson will pay $2 billion. And that would provide an opportunity for young Davids to see a path forward.
LEE: Yes.
DR. BENNETT: I’ll be the first ever in the history of the United States to take my research, which started in 2011, file it as a false claims lawsuit with the government. I’ve been certified by the court as the finder and relater, the person with unique non-public information, so other people who can do research, who want to do research do what I do which is I file my work, I do citizens petitions, I filed the Qui Tam lawsuits, and that is a whole package of things that are nontraditional. Nobody files – (inaudible). I did. Nobody files a whistleblower lawsuit. I did. I’ve been certified that way. In a year and half or two, before the next presidential election, it is our goal and our hope that that money would come forward and then people who want to do the right thing may have spent a lot of years suffering, but at the end of the day, $300 million, $600 million comes back to us, there will at least be some financial gain for the work that’s happened. The book is very important for my effort as well. I hope it’s called Resilience, because that’s what it is. We have been talking with Hollywood producers. Al Ruddy, who just did the movie – 50-year anniversary of “The Godfather,” which he and Francis Ford Coppola got the Academy Award for, has done a 10-part series on how he made “The Godfather.” He’s 93 as well and he wants to co-produce my movie about this work. We have a singer, Carol Connors, who got the Academy – not the Academy Award – she wrote the song for “Rocky,” “Up and Away” (sic/”Gonna Fly Now”). She did not get the Academy Award because Barbra Streisand won the award that year for “The Way We Were,” 1977, the year that Elvis Presley died. But that song is by far the most downloaded song on any song ever from a movie, and she’s agreed, in person when I’ve seen her, to make my movie. So we feel that between the book, the movie, the court case, citizens petition, some of the work that you’ll follow on, people like that, this will be an enterprise. If you all take a chance to look at on Hulu TV, there’s a TV show called “The Resident” you may or may not have seen. It’s “The Resident.” On Hulu you can buy it for a buck or two bucks. It’s made by Amy Holden Jones, who’s a partner of Martin Scorsese. It’s been on Fox for seven years, but Season 3, Episode 7 is called “Woman Down,” Season 3, Episode 10 is called “The Whistleblower,” and both episodes are about my work, so we’ve been able to get it into Fox TV, we hope the movie, the book. So I – as Heather knows, you can’t just take one avenue; you’ve got to take multiple avenues and you have to be persistent. I don’t sleep ever. This is something I believe in day or night – and night. Tim Robbins is going to play me, just to let you know, 6 foot 2 –
LEE: Oh, wow.
HEATHER: (Laughs.) Oh, gosh, that would be just spectacular.
DR. BENNETT: His hair is a little bit neater than my hair.
HEATHER: (Laughs.) That would be spectacular.
I am just – Dr. Bennett, you’re so impressive. And no, I know that you’ve had to go through quite a bit over the past decade, longer than that. But it’s people like you who give us the energy to push forward in doing the small parts that we are and trying to address these issues.
LEE: You have been instrumental. Our children were harmed. Heather did lose her son but my daughter is here today because of those warnings, because if I did not have those black box warnings and just the information and the petitions that you guys did at the FDA, I would have no credibility and I would not – her symptoms, everything – we would have been down a completely different path.
DR. BENNETT: Let me say this: I got a call from a husband from Tampa maybe five months ago. His wife, she had no prior medical, psychiatric history. She had, like, a sinus infection or a pulmonary infection. Her internist gave her Cipro; she took the first dose and she felt foggy. She looked at the package insert; it says on page one it can cause CNS toxicity. She wondered to herself, what does CNS toxicity mean? He says, if you want to learn about it, go to page 42 of the 72-page – I think, Heather, you’ve already done it – going deeper on this. And then it says, some people have committed suicide after one or two doses. She took a screenshot of those statements and sent it to her doctor, her internist. He told her not to worry because it’s overblown. She tied herself to a chair in a swimming pool area in Tampa, she moved the chair into the swimming pool; when her husband came home from the store she was under water and she was dead.
HEATHER: Yep.
DR. BENNETT: And that’s only one dose.
HEATHER: And no history, no mental health history –
DR. BENNETT: No history.
HEATHER: – no history of depression.
DR. BENNETT: As with Heather’s son, they’re not talking about immediate – that’s only like this.
HEATHER: No.
DR. BENNETT: People can get psychiatrically damaged over months and then they throw you on a bunch of different psychiatric medications which can only damage you even more –
HEATHER: Yes.
DR. BENNETT: – and then months later the person can be dead. So we’re not talking about just immediate death.
HEATHER: It was a very slow walk with Shea. He knew – he connected the dots but it was a slow walk. And, you know, ironically he was put on more drugs by Johnson & Johnson, more drugs that are similarly as dangerous, Risperdal, which resulted in numerous lawsuits. It’s just this slow unraveling in a perfect storm of destructive treatments when you’re already experiencing a toxic reaction to another drug.
So this has just been a wonderful interview, Dr. Bennett. I appreciate you so much. I want to highlight this article again, and we’ll have it – a link to it on our website. It’s “Davids and Goliaths: Scientists vs. Pharma.” It’s going to be in The Journal of Scientific Practice and Integrity. Just so appreciative. We’ll get that petition going for you, most definitely, for all that you’ve done for all of us and all the victims out there. We surely want to support you and let you know we appreciate you, and your work has been lifesaving for many people, and life-changing for others. I know for me I can’t bring my son back. The result of this system and the result of the incentivizing treatments and prioritizing profits, you know, results in death. That is the result.
DR. BENNETT: Instead of destroying the messenger, we want the corporate executives who do this fraudulent work to end up in jail.
HEATHER: To be accountable. Yeah.
DR. BENNETT: To end up in jail. That’s simple.
HEATHER: Yeah, that’s where they belong.
DR. BENNETT: And they will stop that as a company and as a system and as an industry once five or 10 of these corporates find themselves in a one- or two- or three-year vacation.
HEATHER: Hopefully longer than that. (Laughs.) Hopefully longer than that.
LEE: Well, thank you again. We hope you’ll join us on another episode, and as Heather mentioned, we will post all your links and we’ll also have your information on our website.
DR. BENNETT: Again, I appreciate so much support that you all have given me for the last 10, 12 years that I’ve been doing this journey. But I will say that Linda and I and a couple others, one from Britain, a woman in the U.S., and a student, we have collaborated on an update on the Cipro- and Levaquin-associated toxicities which will be published in eClinicalMedicine, which is a Lancet journal, as soon as they go through the last round of reviews, which it seems to me that they’ll take, and then a copy edit, so we’ll have a very informative paper. That paper reviews how the various toxicities from fluoroquinolones have been reviewed and analyzed in six different geographic regions – the U.S., Canada, Australia, Japan, New Zealand, and I forgot one in there. But the thing that’s amazing – that U.S. – oh, Great Britain; it’s separate because it’s no longer part of the EU – the U.S. and the EU and now Great Britain have made strongly definitive statements, these drugs are not first-line therapies. The other three regions – Australia, Japan, and New Zealand – do not make similar concerns. And the more recent side effects that have been known is aortic aneurysms, aortic valve rupture. And again, there’s not complete agreement on this but there’s been a “dear doctor” letter sent out in Europe; in the U.S., no “dear doctor” letter. We want to harmonize these safety messages for the entire world, not just the U.S., and that’s what we want to harmonize. People shouldn’t have to read six different labels and get six different opinions, especially on this, and particularly on this worldwide, terrible and life-threatening and life-ending side effect.
HEATHER: Well, thank you so much. Just really appreciate you, and know that the work you’ve done has just impacted us and our lives and we thank you.
DR. BENNETT: My pleasure.
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