In his new book, “No More Tears: The Dark Secrets of Johnson & Johnson,” Gardiner Harris, who was previously the public health and pharmaceutical business reporter for The New York Times, talks about the history of the overuse of red blood cell growth factors in oncology.
This episode is available on Spotify, Apple Podcasts, and YouTube.
In conversation with The Cancer Letter editor and publisher Paul Goldberg, Harris and Goldberg discuss their parallel coverage of ESAs—erythropoiesis-stimulating agents.
Harris’s book, released last April, is a New York Times bestseller.
“EPO is the largest cancer drug disaster in American history. There is no one who was more important in revealing that disaster than Paul Goldberg,” Harris said.
Goldberg and Harris go way back. “Just by way of disclosure, Gardiner and I had regular lunches at the Martin’s Tavern in Georgetown for most of the time that Gardiner was in Washington,” Goldberg said.
Goldberg and Harris tell the story about how this class of drugs was approved, aggressively marketed in oncology, and widely used in ways not supported by data. As sales of these products reached record-setting levels, data started to show that overprescribing was causing harm to cancer patients.
As data emerged (in part as a result of reporting by Harris and Goldberg), FDA stepped in with black box warnings and a risk evaluation and mitigation strategy. It’s a complicated story with many moving parts, and in this episode Goldberg and Harris spar over who knew what when, what could have been done better, and what has been learned.
This episode was transcribed using AI transcription services. It has been reviewed by our editorial staff, but the transcript may be imperfect.
The following is a transcript of this week’s In the Headlines, a weekly series on The Cancer Letter podcast:
Jacquelyn Cobb: This week on the Cancer Letter Podcast,
Gardiner Harris: EPO is the largest cancer drug disaster in American history. There is no one who was more important in revealing that disaster than Paul Goldberg. I mean, you were like, The New York Times wrote about it. The Wall Street Journal wrote about it. There were some pretty good stories about how oncologists were doubling their income on the back of just their EPO prescriptions, which of course, you know, is why this really exploded in use in the United States. It, you know, it is worth mentioning that American oncologists used three times as much EPO as oncologists in Europe, almost certainly, because American oncologists, as we all know, make about half of their income on drug markups because they serve both as physician and pharmacist in the cancer space.
Paul Goldberg: You are listening to the Cancer Letter podcast. The Cancer Letter is a weekly independent magazine covering oncology since 1973. I’m your host, Paul Goldberg, editor and publisher of The Cancer Letter.
Jacquelyn Cobb: And I’m your host, Jacquelyn Cobb, associate editor of The Cancer Letter. We’ll be bringing you the latest stories, groundbreaking research and critical conversations shaping oncology.
Paul Goldberg: So let’s get going. Welcome to the Cancer Letter podcast. With us today, we are fortunate to have Gardiner Harris a noted writer whose book about Johnson & Johnson is on the New York Times Bestseller list. And in fact, he happens to have a copy of it right here. Gardiner, do you have a copy of it?
Gardiner Harris: I do. I, I crazily I do happen to, oh—
Paul Goldberg: My God, this is upside-down, Gardiner.
Gardiner Harris: Yeah.
Paul Goldberg: No, right side-up: “The Dark Secrets of Johnson & Johnson.”
Gardiner Harris: There we go.
Paul Goldberg: Yep. And before we get to your book, yeah, yeah. Yes, that’s beautiful. In case anybody missed it, we can lift it up a few more times, just…
Gardiner Harris: Yeah. There we go.
Paul Goldberg: Yeah. That’s very nice. So before we go any further since we’ve got Gardiner here I’ll trap him into telling me, telling us all what he thinks about Prasad coming back to FDA.
Do you have deep thoughts about this? I mean, first he was brought in—that brought on some deep thought—then he was fired and “Loomered” and or fired, or not fired, whatever. He left, went to California, couldn’t stand it in California, presumably, for a few days, being there for a few days, you can see that. And then he’s back. Thoughts?
Gardiner Harris: I think the MAGA world is endlessly fascinating and interesting. Who’s in, who’s out, why they’re in, why they’re out? I mean, I think the sense, obviously that I got it, it, what’s interesting about the Trump administration is this battle, constant battle between traditional conservative republicanism and this populous strain that Trump represents.
And there’s a great kind of battle within the Trump movement between populism on the one hand and traditional conservatism on the other. And Vinay Prasad definitely kind of comes from that populous strain. and even though it was Laura Loomer who did him in, she did him in from sort of, I think, a very traditional Republican notion that he was not as pro pharma as he needed to be particularly his actions around these Duchenne muscular dystrophy drugs.
So I mean, I sort of, the message of his firing was, I think that traditional conservative ideas were, were, were going to come to the fore and would, you know, come back and dominate the FDA.
His return suggests, I think, that the populists have not entirely given up or been defeated. So I think it’s a fascinating battle within the movement writ large. And I think we will have to continue to watch how this plays out within the FDA, the, you know, under Makary, the FDA has done a few things that are clearly anti-corporate. And, you know, some of these have direct call outs within my book.
One of the big ones, of course, they had an expert advisory committee hearing on talc. The first big story I tell in my book is the Johnson’s baby powder and talc story, and how Johnson & Johnson knew for 50 years that talc contained small amounts of asbestos. And that Johnson’s baby powder thus contained this poisonous substance.
And Makary, led by now the head of FDA’s Drug Center, George Tidmarsh, went to an advisory committee hearing where he declared without any qualifiers that science has clearly shown that talc is carcinogenic since the early 1990s, which means that Johnson & Johnson was knowingly selling a consumer product Johnson’s baby powder that everyone knew was carcinogenic for nearly 30 years.
So it was something in which the FDA threw under the bus, one of the largest healthcare products conglomerate in the world. It’s not something the FDA would previously have done. That comes from that populist side of the MAHA/MAGA movement.
We’re going to have to see if there are gonna be more of those strains that become apparent, or whether the traditional conservative alignment with big pharma continues.
Paul Goldberg: Yeah, it’s interesting because it’s a subplot in your book. A big subplot of how some of the skeptics, and we are skeptics, by the way, as journalists in case you need that reminder. But we, you don’t, actually, neither one of us does. But, but you know, we are both skeptics on this, and we both probably should be more aligned with seeing this kind of an anti-pharma view.
But it’s also interesting that, you know, Vinay Prasad was a fellow at NIH, at NCI when I, the only time I’ve actually seen him in person, and the only time I’ve spoken with him. And he was, he’d identified himself, I would think, and I’ve seen him identifying himself as a liberal Democrat. And Makary, I believe, is a Democrat and so is Kennedy. So it’s kind of an interesting thing.
And here I am. I’m actually looking at pharma as a place that might want to have more of a sense of order, because in the sense of order you make money, you have to have stable rules. So it’s, it’s kind of, everything has shifted the right, the left. And then there’s also this feeling I’m having that if this is ever over and if the Dems come in we will not be, we will still be seeing this kind of—
Gardiner Harris: What’s interesting, Paul, and you and I have been following, obviously this stuff for now 30 some odd years,and I wanna tell your listeners, I was arguably the top FDA reporter in the country. You know, I was, I covered it for the New York Times, and I, unlike some reporters at the Times in that job, I actively covered it and really tried to penetrate the agency.
And one of the people who helped me the most was Paul Goldberg who is one of the great reporters in this space of the generation. And I just want people who, I think most of your listeners already know this, but Paul and I were partners on some of the most important, you know, disclosures and news stories of the 2000s really.
You and I, you would often find out something, you would come to me I would gratefully accept the information that you provided.
I would do my own reporting. And, you know, because I had the New York Times imprimatur, I could sometimes get stuff that you didn’t, and we would often partner together and release stories at the same time. That would have profound impacts.
And I think part of our discussion is gonna be about EPO, which again, you broke some of the most important stories on EPO that came out, EPO at the time being the most important drug in cancer. And you know, at some point, we’re gonna be able to say this in your obituary, but I think it’s—
Paul Goldberg: Not soon, I hope, Gardiner.
Gardiner Harris: Yeah, exactly. I think it’s important to say now just how extraordinary your career as a journalist has been. And I had a front row seat to that at The New York Times, arguably the most important media organization, certainly in this space during those years. And I just, I want your listeners, I mean, one of the reasons I was eager to have this conversation with you, Paul, is first of all, there’s no one on the planet who knows some of these stories better than you do.
And second of all I actually cite you in the book in multiple places to say, you know, Paul Goldberg then disclosed X and that changed the world. And so, you know, in the notes section of my book, I’m not sure I could count up the number of times I cite The Cancer Letter as, you know, the foundation for the stories that I’m telling.
So I, I just, I think it’s, I just wanna sort of tell your listeners who I think already know this, just how extraordinary you have been over such a long period of time and the book, I think the book is original in a lot of ways, but one way it’s not original is in telling some of these stories that you yourself told incredibly well and, and was, you were the first person to tell those stories.
Paul Goldberg: Well, you know, thank you again. Just by way of disclosure, Gardiner and I had regular lunches at the Martin’s Tavern in Georgetown for most of the time that Gardiner was in Washington, so covering and…
Gardiner Harris: Which is about 20 years. Including when I was a White House correspondent, although we had, we did far less business in those years, I would say.
Paul Goldberg: Yeah, Martin’s is a great place for this kind of lunch where you just essentially so much business is conducted at
Gardiner Harris: Oh, soft shell crabs, when they’re in season, are just… it’s killer.
Paul Goldberg: Absolutely. So, what would happen is looking back at that, at your book it’s what’s fascinating about this chapter on EPO, maybe if you want to focus on EPO…
Gardiner Harris: Sure. Let’s talk about it.
Paul Goldberg: It’s just how difficult it is to report it and, and how it actually doesn’t even lend itself to normal reporting. Like New York Times covered EPO before you, you didn’t really do a whole lot of EPO.
Gardiner Harris: It was Andy Pollack, who did a lot of the stories for the Times.
Paul Goldberg: Yeah. And if you look at those stories, you really would not be able to understand precisely what was happening because there were just so many moving parts. Yeah, I think that’s right. And you needed to have institutional commitment to be able to, to tell the story. And, and looking at your book, you are telling the story.
Gardiner Harris: Well, that’s, I mean, books in, in many ways, I mean, my book is a little unusual because I do tell, I have a lot of original work in the book. I, as you know, Paul, I have grand jury files that I cite that have never been seen anywhere else. usually almost invariably, in fact, books tell stories that have already been, it’s just they tell the full story.
They tell it a little bit better. I mean, if you think of Patrick Radden Keefe’s book, “Empire of Pain,” which was so well thought of, he tells the opioid story, but there’s really nothing in his book that hadn’t been said 20 years earlier by my colleague Barry Meier in the New York Times. It’s just, he does a really good job, you know, telling the narrative over a long period of time.
And I do that a little bit in EPO. I also have the grand jury records from the EPO investigation that not even you have seen, no one has seen. And one of the good things about seeing those records is that I can talk about just how widespread EPO was, a criminal conspiracy of vast scope both Johnson & Johnson and Amgen that pleaded guilty to criminal charges in the EPO investigation.
But both of those companies clearly engaged in criminal behavior, in how they sold EPO, how they marketed EPO. And frankly, much of the community that subscribes to your newsletter were either unconsciously or consciously participants in this vast criminal conspiracy. And I actually argue in my book that most of them engaged in this criminal conspiracy consciously, because as you know, both Amgen and Johnson & Johnson boosted sales by increasing the amount of content in each EPO vial that they gave sort of somewhere between 15 and 20% extra in the EPO vials that they didn’t tell the government about.
In the overfill issue, both Johnson & Johnson and Amgen increased sales of EPO by overfilling the containers and teaching doctors and cancer hospitals how to bill Medicare for the free extra that they got and bill them as if they paid full freight for that free extra. And nearly all of your listeners engaged in what is, was clearly insurance fraud.
And I know this because the grand jury files clearly show that cancer hospitals across the country hired compounding pharmacies to repackage their EPO vials so that they could more efficiently capture this overfill extra and charge the government for it.
The only reason to hire a compounding pharmacy to repackage EPO was to engage in insurance fraud. And nearly every cancer hospital did that.
Paul Goldberg: So there are all kinds of gimmicks here that, the marketing gimmicks and but, but let’s talk a little bit about what was known scientifically about this product and, and on what basis it was approved. It was approved based on reduction of risk of needing a blood transfusion. And nobody happened to look at any of the harder endpoints like time to progression of disease, treatment, failure, overall survival, whatever. One was done initially.
Gardiner Harris: Of course, they subsequently looked at that.
Paul Goldberg: Subsequently, but it got on the market with this, and nobody really knew it. Yeah, there’s anemia, but if you correct anemia, do people feel better? So, the original “Feel Better” campaign that that J&J did… Is that the right term? I’m going by memory.
Gardiner Harris: Yeah. I mean, it was something
Paul Goldberg: Like that.
Gardiner Harris: Yeah. Feel better was certainly—you can summarize it that way. Yeah.
Paul Goldberg: So there’s that campaign that was run, but, but really the main question was on what basis were the drugs approved? Is that, how did they become more marketed, be really beyond what was, what was found to work?
And then there was this really amazing and bold idea, and here you and I are in somewhat of a disagreement but there was this bold idea somebody had that if you forget about cancer and just treat the anemia, people will do better. And life will be good. And there is a kind of a kind of a bold idea again. And that Henke is a part of it, though, with a little bit of a nuance.
The question is how do you target the hemoglobin and hematocrit to the point where it goes to a normal level, and you do that by, you know, boosting people up to, you know, 14 or whatever and then surely they’ll do better.
Well, those studies, and J&J did those studies showed that that would not be the case. And then J&J had the good sense to get out of it.
Gardiner Harris: So what happened was that Johnson & Johnson came up with this idea to sell EPO to cancer patients as a general pick me up, because cancer patients take chemotherapeutic regimens feel bad, often become anemic. Now that anemia and that feeling of feeling poorly self-corrects usually after, directly after the regimen is stopped. But Johnson & Johnson’s idea was, why wait for that? Let’s give them this drug that will correct their anemia, make them feel better, and never prove that. Make them feel better, and they can perhaps take even stronger chemotherapeutic regimens.
It’s not a bad idea, but while Johnson & Johnson is coming up with this idea, there is this entire cancer research direction that you know a lot about, which is about anti-angiogenesis, right? This theory that if you starve tumors of blood, you will slow or stop their growth. And Johnson & Johnson realized that EPO was perhaps very important in the proliferation of capillaries around tumors that fed them with blood.
So, Johnson & Johnson, at the same time that it is proposing that EPO could be used in cancer, has launched a research program to create an anti EPO compound, because it feels that that anti anti EPO compound might actually be a very good anti-angiogenesis drug. So within Johnson & Johnson, there is real awareness that not only might EPO not be helpful for cancer patients, but that EPO might actually lead cancer tumors to grow more rapidly. And that is evidenced by this anti EPO research program. So, as you said, they were able to get the FDA to approve EPO for cancer use on the flimsiest of justifications, which is that cancer patients who used EPO had fewer blood transfusions. And this had come in the wake of this whole controversy around Genentech’s, tPA, where the FDA had refused to approve tPA in the use against strokes, because Genentech had not proven that tPA actually saved lives.
This caused this huge tumult in the political world. Everybody said the FDA had made a huge mistake. FDA ends up reversing itself, approving tPA. A later FDA’s worries about whether tPA was actually helpful would come true. T and tPAs use sort of declined or disappeared. But what Johnson & Johnson, what FDA learned from the tPA scandal is that biotech drugs are seen widely as very different. And you don’t ask for all that information. So, FDA approved EPO for cancer on the basis of very little information, but asked Johnson & Johnson to confirm that those cancer patients who got EPO survived longer than cancer patients who didn’t.
Both Johnson & Johnson and Amgen launched large clinical trials to show this. And what happened, these trials consistently showed that patients who got EPO died sooner and at a more rapid clip than patients who didn’t get EPO.
Paul Goldberg: But also to kind of, yes, everything you’ve said is absolutely there, but
Gardiner Harris: Wait, wait. I just wanna finish one more thought. Okay. What Johnson & Johnson did with those results is that it never disclosed them either publicly or it didn’t even send them to the FDA, which is against the law. This would come out subsequently in two FDA advisory committee hearings in which FDA officials publicly said that Johnson & Johnson never shared the results of a half a dozen clinical trials showing that EPO was deadly.
So, you know, yes, Amgen clearly was badly behaved, as we will talk about. And your reporting was crucial in showing that Amgen was hiding important clinical trial results from the public and from investors and all the rest.
But Johnson & Johnson had been doing the same for years and years and years. And there are hundreds of researchers, MD, PhD people out there who were either part of these clinical trials or were on this data safety monitoring board of each of these clinical trials, who kept all of this information, secret information, that showed that hundreds of thousands of Americans were being killed needlessly because of the widespread use of this drug.
And these people decided to, to put their, you know, legal requirements and their NDAs above the public health requirement of saving lives. And, and that is one of the great black marks for the cancer community in the United States. And that’s why I thought it was incredibly important to tell this story in a book, because the cancer community in the United States is made up of people you and I have known forever. Many of these people are seen as, you know, humanitarians of the year, when in fact, many of the top people in this world were actively engaged in a criminal conspiracy that I estimate cost 500,000 American lives.
Paul Goldberg: That’s, that’s a large number. Going back to the beginning and the rationale, one of the reasons these drugs got on the market was also concerned about blood supply during the AIDS pandemic—epidemic. The original. And then, so J&J as far as I’m concerned, got out of then pushing the hemoglobin to normal level trials.
Gardiner Harris: Well, sort of endlessly increasing doses Yeah. That, you know, before,
Paul Goldberg: And Amgen continued, but they, what Amgen did was they launched these pharmacovigilance studies, and that’s kind of your second EPO chapter in the book which is fascinating. and the first of them was the Henke study that came out and the German study that basically showed that that people who received EPO did worse in head neck cancer.
Gardiner Harris: And just to be clear, that was a Roche sponsored trial, not Amgen, but—
Paul Goldberg: Absolutely.
Gardiner Harris: You and I have talked about this forever. Amgen were idiots, right?
I mean, and Johnson & Johnson, frankly, was smarter about this terrible disaster that engulfed the American cancer community, because what Amgen did, as you point out, is they continue these trials in which they are bumping the dose of EPO up to correct people at hematocrit levels of, as, you know, 14 and 15, instead of keeping it, you know, at sort of reasonable levels at 10, 11, 12. And as a result, once they made the fact that these trials were coming out and, very publicly, and after the 2004 FDA advisory committee hearing, both of these companies were then on the record that they were launching these trials. And so they couldn’t hide them as easily.
Amgen ended up trying to hide one of the most important trials, and you were the guy who disclosed that this trial had finished and had shown that high levels of EPO were associated with more greater mortality.
And, and the reason that was so important was not only a public health reason, but EPO was such a huge part of Amgen’s profit, that it was a clearly material event to Amgen’s profits. And thus, securities laws required Amgen to disclose it. They didn’t even disclose it during their annual meeting. Their CEO subsequently—subsequent to your story—ended up disclosing this, admitting that they probably should have.
What is clear in the grand jury records I found is that that CEO was a target of a potential criminal charges that prosecutors considered for quite some time whether to charge him, and in the end decided not to, as they nearly always do in pharma cases, because it’s just gonna take too much work on their part. And they know that pharmaceutical companies have endless amounts of money to hire the best lawyers and the best PR people that will make the prosecutor’s lives difficult. And as I point out in this other case if you go after executives, if you’re a prosecutor and you go after executives at Johnson & Johnson in particular, your job prospects after leaving government service are seriously harmed because Johnson & Johnson hires nearly all of the top corporate law firms in the country.
Paul Goldberg: Yeah. It’s interesting because I view this as somewhat of an illustration of how well FDA can work and how much we need a strong regulatory system.
And so I see the first episode in this first data point is the data comes out that shows that gets J&J out of this business. and then comes this study from Germany and head and neck cancer. And that’s 2003, 2004. FDA holds that ODAC that you’re referring to, in which it signals that, Hey, we care about this issue a lot. Right?
And we are going to look at these pharmacovigilance studies. So there is no way out for anybody but to get the answer. And the answer did come, and then the label was restricted. You’re saying that it took a long time and that some people were not necessarily done well, mean,
Gardiner Harris: I mean, read the transcript of the subsequent ODAC hearing in 2007.
Paul Goldberg: I was there.
Gardiner Harris: And in the subsequent you were there. I know. And in the subsequent hearing, it’s, we, we all forget this FDA officials said again that Johnson & Johnson had refused to share until the until the, just that hearing, just before that hearing that Johnson & Johnson had not forwarded to the FDA, the results of six different clinical trials that Johnson & Johnson had had launched to answer this question. Now, of course, the company’s response was that the myriad studies that they had launched to answer the question about whether EPO killed people were then uninterpretable. And again, to FDA officials credit, they made a lot of hay with this, which is you told us in 2003 that you were going to launch a series of studies that would conclusively tell us whether EPO was deadly or not. You did launch those studies. Now you are telling us that we can’t use those studies because they’re uninterpretable. So I don’t, I don’t think that there was a single moment in this cancer disaster when you can say that Johnson & Johnson or Amgen acted appropriately. Oh, ’cause of course. Oh, no, no, I wasn’t. and they would not come out with the clinical trial that they promised to do in 1993 would only be published in 2016, like, you know, 20, what is that?
Paul Goldberg: A long time,
Gardiner Harris: 21 years later. I mean, it’s ludicrous that this company took that long to confirm. And why was that? It’s because it was by far the company’s most profitable product.
And it was 10% of Johnson & Johnson’s revenue. And because it was so profitable, it was somewhere on the order of 15 to 20% of its profits.
Paul Goldberg: Mm-hmm. Well, it was, it was the number one category of drugs in oncology until Amgen stepped in and basically pushed them out of the way because they also had white blood cell growth factors. So, but that’s a, that’s a conversation for another day.
Gardiner Harris: Yeah. The, the, as you used to love to say, the white juice and the red juice,
Paul Goldberg: Yes. And you, you mix them up just so, and it was quite something for me, this was, I mean, the reason I got involved in this story was years ago, I might as well just mention it, is I was talking to my friend Howard Ozer, who was at the time at the University of Illinois in Chicago. I think he was, no, actually at that point, he was at Oklahoma. So Howard told me, “You know, I don’t understand this, I shouldn’t believe it, but I’m seeing these Johnson & Johnson studies reporting worse outcomes, like the BEST study in England or, and that was published in Lancet Oncology, I believe.
And that’s what got me going. And then he mentioned, he was the first one to mention Henke to me and which is why I called Henke with his Roche study—which was actually not Roche before. Well, there
Gardiner Harris: Was, it was originally Boehringer Ingelheim.
Paul Goldberg: Yeah. Boehringer Ingelheim.
Gardiner Harris: Before Roche…
Paul Goldberg: Yeah. Which was a somewhat different, but it was, it was just a very interesting thing. But, but really what, what I’m taking back from that whole experience was how well how well how important FDA is a free, independent, scientifically-driven and powerful, and the FDA is to regulation of drugs and to stopping these situations where you’re having these uncontrolled population wide experiments that Americans are famous for.
Gardiner Harris: I think that, that, you know, this is always the problem with FDA, and you and I talk about FDA a lot. It’s sort of too hot, too cold, right? There is all kinds of evidence that both of these companies, Amgen and Johnson & Johnson were engaged in all kinds of criminal conduct.
You know, in talking to the prosecutors and the investigators they found so much criminal conduct across the cancer system that they kind of threw up their hands and said, you know, we can’t prosecute absolutely everyone. but it was clear that both companies were lying to the FDA, lying to the FDA is a crime.
And yet, in case after case, after case after case, the FDA declined to launch criminal investigations, you know, the FDA has, oh, and a cadre of criminal investigators with guns and shields, and they can start these investigations should they choose to do so. And clearly the FDA is really uncomfortable with that police operation within itself. I think all kinds of FDA officials and medical officers really see themselves as partners as, you know, FDA officials in speeches, in countless trade association venues will talk about industry being its most important customer, not the American public.
So, yes, while I think you can tell the story by saying that FDA eventually made these companies do the right thing, that extraordinary 15 year delay, the 500,000 deaths that resulted, I don’t think is a particularly good story for FDA.
Paul Goldberg: Oh, I wasn’t really. Yeah. The speed was not optimal. But it does take a while to actually sort through it. And, and I guess
Gardiner Harris: Unless, well, certainly when, when companies are lying to you, it, it, it takes longer when companies are refusing to forward clinical trial results that they’re required to forward rapidly to the FDA, it takes longer.
Paul Goldberg: Yeah. Do you remember back in 2007, I believe FDA finally allowed J&J to put in a claim, a health claim onto Procrit, stating that this may make you feel better.
Gardiner Harris: Yeah. This is the strength. Mm-hmm. Well, they allowed it and then they disallowed it, you’ll recall
Paul Goldberg: Oh, yes. But it was allowed for a bit of time. It was kind of fascinating to watch that happen just as this controversy was swirling. So yeah, FDA is suboptimal, but to me, it was a story that was given to me by an academic oncologist as part of my company. Yeah.
Gardiner Harris: I remember you telling that story at the time!
Paul Goldberg: Yeah, yeah. And it led me to do all of this. It also caused FDA to do the right things. And I think…
Gardiner Harris: That’s right. You know, I think the EPO story, the reason why I really wanted to have this conversation with you, Paul, I tell the story of nine different products, but I think one of the most important things that I feel like I can say is that EPO is the largest cancer drug disaster in American history.
There is no one who was more important in revealing that disaster than Paul Goldberg. I mean, you were, like, the New York Times wrote about it, the Wall Street Journal wrote about it. There were some pretty good stories about how oncologists were doubling their income on the back of just their EPO prescriptions, which of course, you know, is why this really exploded in use in the United States.
It is worth mentioning that American oncologists used three times as much EPO as oncologists in Europe, almost certainly, because American oncologists, as we all know, make about half of their income on drug markups.
They serve both as physician and pharmacist in the cancer space, which I think, and I think you believe this as well, tremendously distorts the practice of medicine in the United States. It’s why cancer patients at large cancer hospitals spend on average instead of months week, you know, their time on hospice is measured instead of being measured in months, weeks, or even days, their time on hospice is measured in hours because both the hospital and the oncologist make about half of their money from pumping patients, even when they are clearly near death, pumping patients with these incredibly expensive curative drugs up until the very end oncologists blame patients for saying that they, you know, don’t see reality until the very end. But I think it’s clearly because their oncologist has these financial incentives to use these very expensive drugs. And EPO was a classic example of that.
And you, Paul Goldberg, you were by far the most important reporter on that incredibly important story.
Paul Goldberg: Well, thank you. It was actually, thank you. That was one of the stories, probably the most important story of my career, but it received no awards because nobody could understand it.
Gardiner Harris: Exactly right. And no one knows it to this day. You know, when you and I talk about this, even in groups of oncologists, people who know cancer, I will say something like, well, of course the biggest cancer disaster in American history is the EPO one. And people who are MD PhDs in the oncology setting will look at me and go, wait, what?
They have no idea. That story, the story that I tell about EPO in this book, you know along with the Risperdal story, those two stories, I think are the two most important story among the two most important stories in American healthcare history. And the fact that no one knows those stories is unbelievable to me, because together those two stories have cost 1.5 million Americans their lives—more than all the deaths in all of the American wars in all of American history.
Going back to the Revolutionary War.
Paul Goldberg: I’d love to know your numbers.
I don’t understand your numbers, but I’d love to sit down and try to get them ’cause I don’t know how you would, you would count that, but one thing that was also interesting with that story is that it led to a Supreme Court decision that was based on my reporting, which was kind of fun. And I say this as a refugee that, that a former refugee—not recently, and I hope not anytime soon again. Yeah.
Gardiner Harris: Yeah. We’re, we’re, we’re gonna find a way to send you back to Russia if you keep this up, Paul.
Paul Goldberg: Yeah. That would not be good for a whole variety of reasons, but and I don’t think they want me either, but I, I don’t think actually too much. I’m, I’m pretty well, I feel very much at home and happy here, but, and, and patriotic, as I was saying, it ended up being Amgen securities litigation case at the Supreme Court. And that, how
Gardiner Harris: Much did you spend on that, by the way?
Paul Goldberg: many, many, many, many, many thousands of dollars, because I think, not one,
Gardiner Harris: Yeah. It was tens of thousands as I recall.
Paul Goldberg: Yeah. I got a lot of it back from first Amendment organization. But essentially they tried to depose me and Amgen did. And in order when, when the case went down from the Supreme Court, and my lawyer said, no. And that led to a really wonderful decision in the DC circuit.
Gardiner Harris: Your lawyer was Steve Lieberman, wasn’t he?
Paul Goldberg: Indeed.
Gardiner Harris: Yes.
Paul Goldberg: His view was no reporters don’t testify in situations like this. Yeah. It’s one of the great, I had nothing to hide, by the way.
Gardiner Harris: Yeah.
Paul Goldberg: I just didn’t wanna really discuss my sourcing at all. And even though I had no sources that really…
Gardiner Harris: You had the best sources on the planet. But
Paul Goldberg: Oh, no, well, not on that story, on that story, my source was, was someone who sent me a letter that informed the Danish group, cooperative group, about the outcome of this thing, and that that led to a huge, huge crash of [Amgen] stock. But that’s, like, two old guys. I think what we should do if we haven’t put everybody to sleep yet is do this again and maybe take it on the road, because that could be a very interesting debate.
Gardiner Harris: That’d be very fun.
Paul Goldberg: Because we’re, we’re not really in agreement with a lot of it. And although we are probably 90% in agreement.
Gardiner Harris: I think we’re probably 95%,
Paul Goldberg: 95.
Gardiner Harris: To me, I think you make, you know, Amgen sued you, Amgen—
Paul Goldberg: They did not sue me. They wanted to depose me.
Gardiner Harris: Oh, they wanted, right. Anyway, there was legal Sturm und Drang. You had to hire lawyers. Amgen clearly behaved badly. They pleaded guilty to criminal charges. I think you distinguish between Amgen and J&J’s behavior in this, in a way that I don’t, I think you’re slicing the onion, like extremely finely.
Paul Goldberg: I am.
Gardiner Harris: Both companies, you know, let’s recall that it was J&J’s original idea to sell EPO in cancer, despite knowing that EPO might actually, that an anti-EPO compound might work in that whole anti-angiogenesis field. So, you know, the company from day one behaved badly. Amgen subsequently sort of came along, really took over this marketplace with Aranesp. And as you said Neupogen, the combination between the two—
Paul Goldberg: Neulasta.
Gardiner Harris: But I, Neulasta, sorry.
Paul Goldberg: Both.
Gardiner Harris: Yeah. And, and you know, I think clearly behaved badly as well, but I don’t, I think you and I disagree that Johnson & Johnson deserves kudos for not going quite as far as Amgen at the end of this story.
Paul Goldberg: No, I think, I think that’s not kudos.
Gardiner Harris: J&J was that much more sophisticated.
Paul Goldberg: I’m not, I’m not, I’m not dispensing kudos here. What I was trying to dispense is that once they saw that this was not the place to go, they stopped the pharmacovigilance trials that they were doing, and they did.
And that’s my first story where I first looked at it after Howard told me about this crazy story—Howard Ozer—I looked and I called and they told me, we aren’t doing these anymore because of BEST study. And, you know, that is definitely what my experience is.
Gardiner Harris: Yeah. And that’s because they knew that the results were gonna be so terrible that they didn’t wanna publish them. Right. I mean, they subsequently did sick. You know, again, in that 2007 ODAC meeting, FDA talks about seven different trials that, or six or seven different trials that J&J did and did not provide the data to FDA,
Paul Goldberg: Did they stop them early? I think they stopped them early. That was the case.
Gardiner Harris: I, I don’t—
Paul Goldberg: Beause when they [J&J] told me they were done, they were done. I believe that,
Gardiner Harris: I think they, they promised in the 2004 ODAC to conduct a series of trials to confirm that EPO, in their view, did not increase mortality. Those trials were conducted.
Paul Goldberg: And by Amgen mostly,
Gardiner Harris: Well, Johnson & Johnson had its own series of trials and its own promises to FDA, they fulfilled those promises. They just refused to follow through and provide the subsequent data. And of course, that landmark study that came out in 2016, that, you know, ended up proving the hazard ratio of what was at 1.33. That again was a Johnson & Johnson study.
So, I don’t, I mean, again, I wrote the EPO part of my book maybe four years ago. I’m losing some of these very fine details. And you did your writing about much of this, oh, longer, 15 years ago. So you and I might be getting some of these details. Right. I just, I don’t agree that, that, you know, that any of these companies behaved well or appropriately and almost any part of the EPO saga. I mean, remember to this day, oncologists in small towns in the country prescribe large amounts of appropriate to patients who are hoping for cures. it, you know, there is inappropriate use of EPO that is endemic in the cancer system in the United States, and no one is doing anything about it.
Paul Goldberg: Well, it’s interesting also because the label says it should not be used except in curative settings where it—
Gardiner Harris: Should not be used in curative settings.
Paul Goldberg: Right. It should not be used in curative settings. Which is sort of an interesting question because—
Gardiner Harris: Well then why use it, right?
Paul Goldberg: Well, no, because there’s more tumor to stimulate and the not-curative settings a lot of the time.
Gardiner Harris: Exactly.
Paul Goldberg: So it kind of becomes a little bit odd, but most of, I do not see. What I see is the need for FDA—strong FDA and independent in the FDA and FDA… yeah. And that’s our point of agreement. And thank you very much for getting into this fight with me publicly.
Gardiner Harris: Yay.
As always, Paul, I mean, I’m, I so admire the work that you do, that you have done for so long. You have known and loved this cancer community for most of your adult life. They love you right back appropriately.
And I didn’t even go into the other areas where you’re reporting, particularly on the NCI and elsewhere has, has moved the ball where you have been the first to disclose any number of many scandals and other things that publications like the ones I used to work for, Wall Street Journal and New York Times subsequently follow, that’s extremely unusual for any kind of trade journal, which is what the kind of The Cancer Letter is.
So you are a unique figure, I think, in this space. And I’m thrilled to have been able to work with you and be your friend through the many of these years of your work.
Paul Goldberg: And of course, that’s mutual. And thank you very much.
Jacquelyn Cobb: Thank you for joining us on The Cancer Letter Podcast, where we explore the stories shaping the future of oncology. For more in-depth reporting and analysis, visit us at cancerletter.com. With over 200 site license subscriptions, you may already have access through your workplace. If you found this episode valuable, don’t forget to subscribe, rate and share together, we’ll keep the conversation going.
Paul Goldberg: Until next time, stay informed, stay engaged, and thank you for listening.
