The Science Sleuth Holding Fraudulent Research Accountable
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.
Introduction by Mary Inman, Whistleblower Attorney
For most people, when they see the word "whistleblower," the image that leaps to mind is a lone individual bravely stepping forward to shine a light on misconduct she has witnessed first-hand. Meryl Streep as Karen Silkwood exposing safety violations observed while working the line at the Kerr-McGee plutonium plant. Matt Damon as Mark Whitacre in The Informant!, capturing on his pocket recorder clandestine meetings between his employer and its competitors to fix the price of lysine. However, a new breed of whistleblower is emerging who isn't at the scene of the crime but instead figures it out after the fact through laborious review of publicly available information and expert analysis. Elisabeth Bik belongs to this new class of whistleblower.
"There's this delicate balance where on one hand we want to spread results really fast as scientists, but on the other hand, we know it's incomplete, it's rushed and it's not great."
Using her expertise as a microbiologist and her trained eye, Bik studies publicly available scientific papers to sniff out potential irregularities in the images that suggest research fraud, later seeking retraction of the offending paper from the journal's publisher. There's no smoking gun, no first-hand account of any kind. Just countless hours spent reviewing scores of scientific papers and Bik's skills and dedication as a science fraud sleuth.
While Bik's story may not as readily lend itself to the big screen, her work is nonetheless equally heroic. By tirelessly combing scientific papers to expose research fraud, Bik is playing a vital role in holding the scientific publishing process accountable and ensuring that misleading information does not spread unchecked. This is important work in any age, but particularly so in the time of COVID, where we can ill afford the setbacks and delays of scientists building on false science. In the present climate, where science is politicized and scientific principles are under attack, strong voices like Bik's must rise above the din to ensure the scientific information we receive, and our governments act upon, is accurate. Our health and wellbeing depend on it.
Whistleblower outsiders like Bik are challenging the traditional concept of what it means to be a whistleblower. Fortunately for us, the whistleblower community is a broad church. As with most ecosystems, we all benefit from a diversity of voices —whistleblower insiders and outsiders alike. What follows is an illuminating conversation between Bik, and Ivan Oransky, the co-founder of Retraction Watch, an influential blog that reports on retractions of scientific papers and related topics. (Conversation facilitated by LeapsMag Editor-in-Chief Kira Peikoff)
Elisabeth Bik and Ivan Oransky.
(Photo credits Michel & Co Photography, San Jose, CA and Elizabeth Solaka)
Ivan
I'd like to hear your thoughts, Elisabeth, on an L.A. Times story, which was picking up a preprint about mutations and the novel coronavirus, alleging that the virus is mutating to become more infectious – even though this conclusion wasn't actually warranted.
Elisabeth
A lot of the news around it is picking up on one particular side of the story that is maybe not that much exaggerated by the scientists. I don't think this paper really showed that the mutations were causing the virus to be more virulent. Some of these viruses continuously mutate and mutate and mutate, and that doesn't necessarily make a strain more virulent. I think in many cases, a lot of people want to read something in a paper that is not actually there.
Ivan
The tone level, everything that's being published now, it's problematic. It's being rushed, here it wasn't even peer-reviewed. But even when they are peer-reviewed, they're being peer-reviewed by people who often aren't really an expert in that particular area.
Elisabeth
That's right.
Ivan
To me, it's all problematic. At the same time, it's all really good that it's all getting out there. I think that five or 10 years ago, or if we weren't in a pandemic, maybe that paper wouldn't have appeared at all. It would have maybe been submitted to a top-ranked journal and not have been accepted, or maybe it would have been improved during peer review and bounced down the ladder a bit to a lower-level journal.
Yet, now, because it's about coronavirus, it's in a major newspaper and, in fact, it's getting critiqued immediately.
Maybe it's too Pollyanna-ish, but I actually think that quick uploading is a good thing. The fear people have about preprint servers is based on this idea that the peer-reviewed literature is perfect. Once it is in a peer-reviewed journal, they think it must have gone through this incredible process. You're laughing because-
Elisabeth
I am laughing.
Ivan
You know it's not true.
Elisabeth
Yes, we both know that. I agree and I think in this particular situation, a pandemic that is unlike something our generation has seen before, there is a great, great need for fast dissemination of science.
If you have new findings, it is great that there is a thing called a preprint server where scientists can quickly share their results, with, of course, the caveat that it's not peer-reviewed yet.
It's unlike the traditional way of publishing papers, which can take months or years. Preprint publishing is a very fast way of spreading your results in a good way so that is what the world needs right now.
On the other hand, of course, there's the caveat that these are brand new results and a good scientist usually thinks about their results to really interpret it well. You have to look at it from all sides and I think with the rushed publication of preprint papers, there is no such thing as carefully thinking about what results might mean.
So there's this delicate balance where on one hand we want to spread results really fast as scientists, but on the other hand, we know it's incomplete, it's rushed and it's not great. This might be hard for the general audience to understand.
Ivan
I still think the benefits of that dissemination are more positive than negative.
Elisabeth
Right. But there's also so many papers that come out now on preprint servers and most of them are not that great, but there are some really good studies in there. It's hard to find those nuggets of really great papers. There's just a lot of papers that come out now.
Ivan
Well, you've made more than a habit of finding problems in papers. These are mostly, of course, until now published papers that you examined, but what is this time like for you? How is it different?
Elisabeth
It's different because in the beginning I looked at several COVID-19-related papers that came out and wrote some critiques about it. I did experience a lot of backlash because of that. So I felt I had to take a break from social media and from writing about COVID-19.
I focused a little bit more on other work because I just felt that a lot of these papers on COVID-19 became so politically divisive that if you tried to be a scientist and think critically about a paper, you were actually assigned to a particular political party or to be against other political parties. It's hard for me to be sucked into the political discussion and to the way that our society now is so completely divided into two camps that seem to be not listening to each other.
Ivan
I was curious about that because I've followed your work for a number of years, as you know, and certainly you have had critics before. I'm thinking of the case in China that you uncovered, the leading figure in the Chinese Academy who was really a powerful political figure in addition to being a scientist.
Elisabeth
So that was a case in which I found a couple of papers at first from a particular group in China, and I was just posting on a website called PubPeer, where you can post comments, concerns about papers. And in this case, these were image duplication issues, which is my specialty.
I did not realize that the group I was looking at at that moment was led by one of the highest ranked scientists in China. If I had known that, I would probably not have posted that under my full name, but under a pseudonym. Since I had already posted, some people were starting to send me direct messages on Twitter like, "OMG, the guy you're posting about now is the top scientist in China so you're going to have a lot of backlash."
Then I decided I'll just continue doing this. I found a total of around 50 papers from this group and posted all of them on PubPeer. That story quickly became a very popular story in China: number two on Sina Weibo, a social media site in China.
I was surprised it wasn't suppressed by the Chinese government, it was actually allowed by journalists that were writing about it, and I didn't experience a lot of backlash because of that.
Actually the Chinese doctor wrote me an email saying that he appreciated my feedback and that he would look into these cases. He sent a very polite email so I sent him back that I appreciated that he would look into these cases and left it there.
Ivan
There are certain subjects that I know when we write about them in Retraction Watch, they have tended in the past to really draw a lot of ire. I'm thinking anything about vaccines and autism, anything about climate change, stem cell research.
For a while that last subject has sort of died down. But now it's become a highly politically charged atmosphere. Do you feel that this pandemic has raised the profile of people such as yourself who we refer to as scientific sleuths, people who look critically and analytically at new research?
Elisabeth
Yeah, some people. But I'm also worried that some people who are great scientists and have shown a lot of critical thinking are being attacked because of that. If you just look at what happened to Dr. Fauci, I think that's a prime example. Where somebody who actually is very knowledgeable and very cautious of new science has not been widely accepted as a great leader, in our country at least. It's sad to see that. I'm just worried how long he will be at his position, to be honest.
Ivan
We noticed a big uptick in our traffic in the last few days to Retraction Watch and it turns out it was because someone we wrote about a number of years ago has really hopped on the bandwagon to try and discredit and even try to have Dr. Fauci fired.
It's one of these reminders that the way people think about scientists has, in many cases, far more to do with their own history or their own perspective going in than with any reality or anything about the science. It's pretty disturbing, but it's not a new thing. This has been happening for a while.
You can go back and read sociologists of science from 50-60 years ago and see the same thing, but I just don't think that it's in the same way that it is now, maybe in part because of social media.
Elisabeth
I've been personally very critical about several studies, but this is the first time I've experienced being attacked by trolls and having some nasty websites written about me. It is very disturbing to read.
"I don't think that something that's been peer-reviewed is perfect and something that hasn't been peer reviewed, you should never bother reading it."
Ivan
It is. Yet you have been a fearless and vocal critic of some very high-profile papers, like the infamous French study about hydroxychloroquine.
Elisabeth
Right, the paper that came out was immediately tweeted by the President of the United States. At first I thought it was great that our President tweeted about science! I thought that was a major breakthrough. I took a look at this paper.
It had just come out that day, I believe. The first thing I noticed is that it was accepted within 24 hours of being submitted to the journal. It was actually published in a journal where one of the authors is the editor-in-chief, which is a huge conflict of interest, but it happens.
But in this particular case, there were also a lot of flaws with the study and that, I think, should have been caught during peer review. The paper was first published on a preprint server and then within 24 hours or so it was published in that paper, supposedly after peer review.
There were very few changes between the preprint version and the peer review paper. There were just a couple of extra lines, extra sentences added here and there, but it wasn't really, I think, critically looked at. Because there were a lot of things that I thought were flaws.
Just to go over a couple of them. This paper showed supposedly that people who were treated with hydroxychloroquine and azithromycin were doing much better by clearing their virus much faster than people who were not treated with these drugs.
But if you look carefully at the paper there were a couple of people who were left out of the study. So they were treated with hydroxychloroquine, but they were not shown in the end results of the paper. All six people who were treated with the drug combination were clearing the virus within six days, but there were a couple of others who were left out of the study. They also started the drug combination, but they stopped taking the drugs for several reasons and three of them were admitted to the intensive care, one died, one had some side effects and one apparently walked out of the hospital.
They were left out of the study but they were actually not doing very well with the drug combination. It's not very good science if you leave out people who don't do very well with your drug combination in your study. That was one of my biggest critiques of the paper.
Ivan
What struck us about that case was, in addition to what you, of course, mentioned, the fact that Trump tweeted it and was talking about hydroxychloroquine, was that it seemed to be a perfect example of, "well, it was in a peer review journal." Yeah, it was a preprint first, but, well, it's a peer review journal. And yet, as you point out, when you look at the history of the paper, it was accepted in 24 hours.
If you talk to most scientists, the actual act of a peer review, once you sit down to do it and can concentrate, a good one takes, again, these are averages, but four hours, a half a day is not unreasonable. So you had to find three people who could suddenly review this paper. As you pointed out, it was in a journal where one of the authors was editor.
Then some strange things also happened, right? The society that actually publishes the journal, they came out with a statement saying this wasn't up to our standards, which is odd. Then Elsevier came in, they're the ones who are actually contracted to publish the journal for the society. They said, basically, "Oh, we're going to look into this now too."
It just makes you wonder what happened before the paper was actually published. All the people who were supposed to have been involved in doing the peer review or checking on it are clearly very distraught about what actually happened. It's that scene from Casablanca, "I'm shocked, shocked there's gambling going on here." And then, "Your winnings, sir."
Elisabeth
Yes.
Ivan
And I don't actually blame the public, I don't blame reporters for getting a bit confused about what it all means and what they should trust. I don't think trust is a binary any more than anything else is a binary. I don't think that something that's been peer-reviewed is perfect and something that hasn't been peer reviewed, you should never bother reading it. I think everything is much more gray.
Yet we've turned things into a binary. Even if you go back before coronavirus, coffee is good for you, coffee is bad for you, red wine, chocolate, all the rest of it. A lot of that is because of this sort of binary construct of the world for journalists, frankly, for scientists that need to get their next grants. And certainly for the general public, they want answers.
On the one hand, if I had to choose what group of experts, or what field of human endeavor would I trust with finding the answer to a pandemic like this, or to any crisis, it would absolutely be scientists. Hands down. This is coming from someone who writes about scientific fraud.
But on the other hand, that means that if scientists aren't clear about what they don't know and about the nuances and about what the scientific method actually allows us to do and learn, that just sets them up for failure. It sets people like Dr. Fauci up for failure.
Elisabeth
Right.
Ivan
It sets up any public health official who has a discussion about models. There's a famous saying: "All models are wrong, but some are useful."
Just because the projections change, it's not proof of wrongness, it's not proof that the model is fatally flawed. In fact, I'd be really concerned if the projections didn't change based on new information. I would love it if this whole episode did lead to a better understanding of the scientific process and how scientific publishing fits into that — and doesn't fit into it.
Elisabeth
Yes, I'm with you. I'm very worried that the general audience's perspective is based on maybe watching too many movies where the scientist comes up with a conclusion one hour into the movie when everything is about to fail. Like that scene in Contagion where somebody injects, I think, eight monkeys, and one of the monkeys survives and boom we have the vaccine. That's not really how science works. Everything takes many, many years and many, many applications where usually your first ideas and your first hypothesis turn out to be completely wrong.
Then you go back to the drawing board, you develop another hypothesis and this is a very reiterative process that usually takes years. Most of the people who watch the movie might have a very wrong idea and wrong expectations about how science works. We're living in the movie Contagion and by September, we'll all be vaccinated and we can go on and live our lives. But that's not what is going to happen. It's going to take much, much longer and we're going to have to change the models every time and change our expectations. Just because we don't know all the numbers and all the facts yet.
Ivan
Generally it takes a fairly long time to change medical practice. A lot of times people see that as a bad thing. What I think that ignores, or at least doesn't take into as much account as I would, is that you don't want doctors and other health care professionals to turn on a dime and suddenly switch. Unless, of course, it turns out there was no evidence for what you were looking at.
It's a complicated situation.
Everybody wants scientists to be engineers, right?
Elisabeth
Right.
Ivan
I'm not saying engineering isn't scientific, nor am I saying that science is just completely whimsical, but there's a different process. It's a different way of looking at things and you can't just throw all the data into a big supercomputer, which is what I think a lot of people seem to want us to do, and then the obvious answer will come out on the other side.
Elisabeth
No. It's true and a lot of engineers suddenly feel their inherent need to solve this as a problem. They're not scientists and it's not building a bridge over a big river. But we're dealing with something that is very hard to solve because we don't understand the problem yet. I think scientists are usually first analyzing the problem and trying to understand what the problem actually is before you can even think about a solution.
Ivan
I think we're still at the understanding the problem phase.
Elisabeth
Exactly. And going back to the French group paper, that promised such a result and that was interpreted as such by a lot of people including presidents, but it's a very rare thing to find a medication that will have a 100% curation rate. That's something that I wish the people would understand better. We all want that to happen, but it's very unlikely and very unprecedented in the best of times.
Ivan
I would second that and also say that the world needs to better value the work that people like Elisabeth and others are doing. Because we're not going to get to a better answer if we're not rigorous about scrutinizing the literature and scrutinizing the methodology and scrutinizing the results.
"I quit my job to be able to do this work."
It's a relatively new phenomenon that you're able to do this at any scale at all, and even now it's at a very small scale. Elisabeth mentioned PubPeer and I'm a big fan — also full disclosure, I'm on their board of directors as a volunteer — it's a very powerful engine for readers and journal editors and other scientists to discuss issues.
And Elisabeth has used it really, really well. I think we need to start giving credit to people like that. And, also creating incentives for that kind of work in a way that science hasn't yet.
Elisabeth
Yeah. I quit my job to be able to do this work. It's really hard to combine it with a job either in academia or industry because we're looking for or criticizing papers and it's hard when you are still employed to do that.
I try to make it about the papers and do it in a polite way, but still it's a very hard job to do if you have a daytime job and a position and a career to worry about. Because if you're critical of other academics, that could actually mean the end of your career and that's sad. They should be more open to polite criticism.
Ivan
And for the general public, if you're reading a newspaper story or something online about a single study and it doesn't mention any other studies that have said the same thing or similar, or frankly, if it doesn't say anything about any studies that contradicted it, that's probably also telling you something.
Say you're looking at a huge painting of a shoreline, a beach, and a forest. Any single study is just a one-centimeter-by-one-centimeter square of any part of that canvas. If you just look at that, you would either think it was a painting of the sea, of a beach, or of the forest. It's actually all three of those things.
We just need to be patient, and that's very challenging to us as human beings, but we need to take the time to look at the whole picture.
DISCLAIMER: Neither Elisabeth Bik nor Ivan Oransky was compensated for participation in The Pandemic Issue. While the magazine's editors suggested broad topics for discussion, consistent with Bik's and Oransky's work, neither they nor the magazine's underwriters had any influence on their conversation.
[Editor's Note: This article was originally published on June 8th, 2020 as part of a standalone magazine called GOOD10: The Pandemic Issue. Produced as a partnership among LeapsMag, The Aspen Institute, and GOOD, the magazine is available for free online.]
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.
It looked like only good things were ahead of Taylor Schreiber in 2010.
Schreiber had just finished his PhD in cancer biology and was preparing to return to medical school to complete his degree. He also had been married a year, and, like any young newlyweds up for adventure, he and his wife Nicki decided to go backpacking in the Costa Rican rainforest.
He was 31, and it was April Fool's Day—but no joke.
During the trip, he experienced a series of night sweats and didn't think too much about it. Schreiber hadn't been feeling right for a few weeks and assumed he had a respiratory infection. Besides, they were sleeping outdoors in a hot, tropical jungle.
But the night sweats continued even after he got home, leaving his mattress so soaked in the morning it was if a bucket of water had been dumped on him overnight. On instinct, he called one of his thesis advisors at the Sylvester Comprehensive Cancer Center in Florida and described his symptoms.
Dr. Joseph Rosenblatt didn't hesitate. "It sounds like Hodgkins. Come see me tomorrow," he said.
The next day, Schreiber was diagnosed with Stage 3b Hodgkin Lymphoma, which meant the disease was advanced. He was 31, and it was April Fool's Day—but no joke.
"I was scared to death," he recalls. "[Thank] goodness it's one of those cancers that is highly treatable. But being 31 years old and all of a sudden being told that you have a 30 percent of mortality within the next two years wasn't anything that I was relieved about."
For Schreiber, the diagnosis was a personal and professional game-changer. He couldn't work in the hospital as a medical student while undergoing chemotherapy, so he wound up remaining in his post-doctorate lab for another two years. The experience also solidified his decision to apply his scientific and medical knowledge to drug development.
Today, now 39, Schreiber is co-founder, director and chief scientific officer of Shattuck Labs, an immuno-oncology startup, and the developer of several important research breakthroughs in the field of immunotherapy.
After his diagnosis, he continued working full-time as a postdoc, while undergoing an aggressive chemotherapy regimen.
"These days, I look back on [my cancer] and think it was one of the luckiest things that ever happened to me," he says. "In medical school, you learn what it is to treat people and learn about the disease. But there is nothing like being a patient to teach you another side of medicine."
Medicine first called to Schreiber when his maternal grandfather was dying from lung cancer complications. Schreiber's uncle, a radiologist at the medical center where his grandfather was being treated, took him on a tour of his department and showed him images of the insides of his body on an ultrasound machine.
Schreiber was mesmerized. His mother was a teacher and his dad sold windows, so medicine was not something to which he had been routinely exposed.
"This weird device was like looking through jelly, and I thought that was the coolest thing ever," he says.
The experience led him to his first real job at the Catholic Medical Center in Manchester, NH, then to a semester-long internship program during his senior year in high school in Concord Hospital's radiology department.
"This was a great experience, but it also made clear that there was not any meaningful way to learn or contribute to medicine before you obtained a medical degree," says Schreiber, who enrolled in Bucknell College to study biology.
Bench science appealed to him, and he volunteered in Dr. Jing Zhou's nephrology department lab at the Harvard Institutes of Medicine. Under the mentorship of one of her post-docs, Lei Guo, he learned a range of critical techniques in molecular biology, leading to their discovery of a new gene related to human polycystic kidney disease and his first published paper.
Before his cancer diagnosis, Schreiber also volunteered in the lab of Dr. Robert "Doc" Sackstein, a world-renowned bone marrow transplant physician and biomedical researcher, and his interests began to shift towards immunology.
"He was just one of those dynamic people who has a real knack for teaching, first of all, and for inspiring people to want to learn more and ask hard questions and understand experimental medicine," Schreiber says.
It was there that he learned the scientific method and the importance of incorporating the right controls in experiments—a simple idea, but difficult to perform well. He also made what Sackstein calls "a startling discovery" about chemokines, which are signaling proteins that can activate an immune response.
As immune cells travel around our bodies looking for potential sources of infection or disease, they latch onto blood vessel walls and "sniff around" for specific chemical cues that indicate a source of infection. Schreiber and his colleagues designed a system that mimics the blood vessel wall, allowing them to define which chemical cues efficiently drive immune cell migration from the blood into tissues.
Schreiber received the best overall research award in 2008 from the National Student Research Foundation. But even as Schreiber's expertise about immunology grew, his own immune system was about to fight its hardest battle.
After his diagnosis, he continued working full-time as a postdoc in the lab of Eckhard Podack, then chair of the microbiology and immunology department at the University of Miami's Leonard M. Miller School of Medicine.
At the same time, Schreiber began an aggressive intravenous chemotherapy regimen of adriamycin, bleomycin, vincristine and dacarbazine, every two weeks, for 6 months. His wife Nicki, an obgyn, transferred her residency from Emory University in Atlanta to Miami so they could be together.
"It was a weird period. I mean, it made me feel good to keep doing things and not just lay idle," he said. "But by the second cycle of chemo, I was immunosuppressed and losing my hair and wore a face mask walking around the lab, which I was certainly self-conscious. But everyone around me didn't make me feel like an alien so I just went about my business."
The experience reinforced his desire to stay in immunology, especially after having taken the most toxic chemotherapies.
He stayed home the day after chemo when he felt his worst, then rested his body and timed exercise to give the drugs the best shot of targeting sick cells (a strategy, he says, that "could have been voodoo"). He also drank "an incredible" amount of fluids to help flush the toxins out of his system.
Side effects of the chemo, besides hair loss, included intense nausea, diarrhea, a loss of appetite, some severe lung toxicities that eventually resolved, and incredible fatigue.
"I've always been a runner, and I would even try to run while I was doing chemo," he said. "After I finished treatment, I would go literally 150 yards and just have to stop, and it took a lot of effort to work through it."
The experience reinforced his desire to stay in immunology, especially after having taken the most toxic chemotherapies.
"They worked, and I could tolerate them because I was young, but people who are older can't," Schreiber said. "The whole field of immunotherapy has really demonstrated that there are effective therapies out there that don't come with all of the same toxicities as the original chemo, so it was galvanizing to imagine contributing to finding some of those."
Schreiber went on to complete his MD and PhD degrees from the Sheila and David Fuente Program in Cancer Biology at the Miller School of Medicine and was nominated in 2011 as a Future Leader in Cancer Research by the American Association for Cancer Research. He also has numerous publications in the fields of tumor immunology and immunotherapy.
Sackstein, who was struck by Schreiber's enthusiasm and "boundless energy," predicts he will be a "major player in the world of therapeutics."
"The future for Taylor is amazing because he has the capacity to synthesize current knowledge and understand the gaps and then ask the right questions to establish new paradigms," said Sackstein, currently dean of the Herbert Wertheim College of Medicine at Florida International University. "It's a very unusual talent."
Since then, he has devoted his career to developing innovative techniques aimed at unleashing the immune system to attack cancer with less toxicity than chemotherapy and better clinical results—first, at a company called Heat Biologics and then at Pelican Therapeutics.
His primary work at Austin, Texas-based Shattuck is aimed at combining two functions in a single therapy for cancer and inflammatory diseases, blocking molecules that put a brake on the immune system (checkpoint inhibitors) while also stimulating the immune system's cancer-killing T cells.
The company has one drug in clinical testing as part of its Agonist Redirected Checkpoint (ARC) platform, which represents a new class of biological medicine. Two others are expected within the next year, with a pipeline of more than 250 drug candidates spanning cancer, inflammatory, and metabolic diseases.
Nine years after his own cancer diagnosis, Schreiber says it remains a huge part of his life, though his chances of a cancer recurrence today are about the same as his chances of getting newly diagnosed with any other cancer.
"I feel blessed to be in a position to help cancer patients live longer and could not imagine a more fulfilling way to spend my life," he says.
The Stunning Comeback of a Top Transplant Surgeon Who Got a New Heart at His Own Hospital
Having spent my working life as a transplant surgeon, it is the ultimate irony that I have now become a heart transplant patient. I knew this was a possibility since 1987, when I was 27 years old and I received a phone call from my sister-in-law telling me that my 35-year-old brother, Rich, had just died suddenly while water skiing.
Living from one heartbeat to the next I knew I had to get it right and nail my life—and in that regard my disease was a blessing.
After his autopsy, dots were connected and it was clear that the mysterious heart disease my father had died from when I was 15 years old was genetic. I was evaluated and it was clear that I too had inherited cardiomyopathy, a progressive weakening condition of the heart muscle that often leads to dangerous rhythm disturbances and sudden death. My doctors urged me to have a newly developed device called an implantable cardioverter-defibrillator (ICD) surgically placed in my abdomen and chest to monitor and shock my heart back into normal rhythm should I have a sudden cardiac arrest.
They also told me I was the first surgeon in the world to undergo an ICD implant and that having one of these devices would not be compatible with the life of a surgeon and I should change careers to something less rigorous. With the support of a mentor and armed with what the British refer to as my "bloody-mindedness," I refused to give up this dream of becoming a transplant surgeon. I completed my surgical training and embarked on my career.
What followed were periods of stability punctuated by near-death experiences. I had a family, was productive in my work, and got on with life, knowing that this was a fragile situation that could turn on its head in a moment. In a way, it made my decisions about how to spend my time and focus my efforts more deliberate and purposeful. Living from one heartbeat to the next I knew I had to get it right and nail my life—and in that regard my disease was a blessing.
In 2017 while pursuing my passion for the outdoors in a remote part of Patagonia, I collapsed from bacterial pneumonia and sepsis. Unknowingly, I had brought in my lungs one of those super-bugs that you read about from the hospital where I worked. Several days into the trip, the bacteria entered my blood stream and brought me as close to death as a human can get.
I lay for nearly 3 weeks in a coma on a stretcher in a tiny hospital in Argentina, septic and in cardiogenic shock before stabilizing enough to be evaced to NYU Langone Hospital, where I was on staff. I awoke helpless, unable to walk, talk, or swallow food or drink. It was a long shot but I managed to recover completely from this episode; after 3 months, I returned to work and the operating room. My heart rebounded, but never back to where it had been.
Then, on the eve of my mother's funeral, I arrested while watching a Broadway show, and this time my ICD failed to revive me. There was prolonged CPR that broke my ribs and spine and a final shock that recaptured my heart. It was literally a show stopper and I awoke to a standing ovation from the New York theatre audience who were stunned by my modern recreation of the biblical story of Lazarus, or for the more hip among them, my real-life rendition of the resurrection of Jon Snow at the end of season 5 of Game of Thrones.
Against the advice of my doctors, I attended my mom's funeral and again tried to regain some sense of normalcy. We discussed a transplant at this point but, believe it or not, there is such a scarcity of organs I was not yet "sick enough" to get enough priority to receive a heart. I had more surgery to supercharge my ICD so it would be more likely to save my life the next time -- and there would be a next time, I knew.
As a transplant surgeon, I have been involved in some important innovations to expand the number of organs available for transplantation.
Months later in Matera, Italy, where I was attending a medical meeting, I developed what is referred to as ventricular tachycardia storm. I had 4 cardiac arrests over a 3-hour period. With the first one, I fell on to a stone floor and split my forehead open. When I arrived at the small hospital it seemed like Patagonia all over again. One of the first people I met was a Catholic priest who gave me the Last Rights.
I knew now was the moment and so with the help of one of my colleagues who was at the meeting with me and the compassion of the Italian doctors who supplied my friend with resuscitation medications and left my IV in place, I signed out of the hospital against medical advice and boarded a commercial flight back to New York. I was admitted to the NYU intensive care unit and received a heart transplant 3 weeks later.
Now, what I haven't said is that as a transplant surgeon, I have been involved in some important innovations to expand the number of organs available for transplantation. I came to NYU in 2016 to start a new Transplant Institute which included inaugurating a heart transplant program. We hired heart transplant surgeons, cardiologists, and put together a team that unbeknownst to me at the time, would save my life a year later.
It gets even more interesting. One of the innovations that I had been involved in from its inception in the 1990s was using organs from donors at risk for transmitting viruses like HIV and Hepatitis C (Hep C). We popularized new ways to detect these viruses in donors and ensure that the risk was minimized as much as possible so patients in need of a life-saving transplant could utilize these organs.
When the opioid crisis hit hard about four years ago, there were suddenly a lot of potential donors who were IV drug users and 25 percent of them were known to be infected with Hep C (which is spread by needles). In 2018, 49,000 people died in the U.S. from drug overdoses. There were many more donors with Hep C than potential recipients who had previously been exposed to Hep C, and so more than half of these otherwise perfectly good organs were being discarded. At the same time, a new class of drugs was being tested that could cure Hep C.
I was at Johns Hopkins at the time and our team developed a protocol for using these Hep C positive organs for Hep C negative recipients who were willing to take them, even knowing that they were likely to become infected with the virus. We would then treat them after the transplant with this new class of drugs and in all likelihood, cure them. I brought this protocol with me to NYU.
When my own time came, I accepted a Hep C heart from a donor who overdosed on heroin. I became infected with Hep C and it was then eliminated from my body with 2 months of anti-viral therapy. All along this unlikely journey, I was seemingly making decisions that would converge upon that moment in time when I would arise to catch the heart that was meant for me.
Dr. Montgomery with his wife Denyce Graves, September 2019.
(Courtesy Montgomery)
Today, I am almost exactly one year post-transplant, back to work, operating, traveling, enjoying the outdoors, and giving lectures. My heart disease is gone; gone when my heart was removed. Gone also is my ICD. I am no longer at risk for a sudden cardiac death. I traded all that for the life of a transplant patient, which has its own set of challenges, but I clearly traded up. It is cliché, I know, but I enjoy every moment of every day. It is a miracle I am still here.