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.
If any malady proves the fragile grace of the human genome, it is sickle cell disease.
If experimental treatments receive regulatory approval, it would be a watershed breakthrough for tens of thousands of Americans.
It occurs because of a single "misspelled" letter of DNA, causing red blood cells to run low on oxygen and transforming the hemoglobin in each cell into a stiff rod. Normally round cells become rigid crescents that hamper the flow of blood throughout the body, like leaves clumping in a drain.
Strokes in toddlers are merely the beginning of the circulatory calamities this disease may inflict. Most sickled cells cannot carry oxygen through the body, causing anemia as well as excruciating chronic pain. Older patients are at risk of kidney failure, heart disease and all the other collateral damage caused by poor circulation. Few live beyond middle age.
The only way to cure it has been through a bone marrow transplant from a donor, which requires not only a closely matching volunteer, but bouts of chemotherapy to allow new stem cells to take root, as well as rounds of immunosuppressive drugs that may last for years.
Recent advances in genomic medicine may soon alter the disease's outlook, although many obstacles remain.
In one treatment under development, patient's skin cells are converted into stem cells, allowing them to be inserted into the bone marrow without the need for a donor. Another treatment known as gene therapy involves replacing the aberrant gene in the patient's body with new genetic material.
Although both remain in clinical trials -- and also require at least chemotherapy -- they have shown promise. Matthew Hsieh, a hematologist and staff scientist with the National Heart Lung and Blood Institute in Maryland, has performed about 10 gene therapy procedures over the past three years as part of a clinical trial. Ongoing tweaks in the procedure have led to the blood in more recent patients showing sickle cell trait -- not a perfect outcome, but one that leaves patients with far fewer symptoms than if they have the full-blown disease.
If one or both treatments receive regulatory approval, it would be a watershed breakthrough for the tens of thousands of Americans who suffer from the disease.
Yet it is entirely possible many patients may decline the cure.
A Painful History
The vast majority of sickle cell sufferers in the U.S. -- well beyond 90 percent -- are African-American, a population with a historically uneasy relationship toward healthcare.
"There is a lot of data on distrust between African-Americans and American medical institutions," says J. Corey Williams, a psychiatrist with the Children's Hospital of Philadelphia who has written extensively on racial disparities in healthcare. "It comes from a long legacy of feeling victimized by medicine."
"What you hear from many patients is 'I am not going to be your guinea pig, and I am not going to be experimented on.'"
As a result, Williams is among several clinicians interviewed for this story who believe a cure for sickle cell disease would be embraced reluctantly.
"What you hear from many patients is 'I am not going to be your guinea pig, and I am not going to be experimented on.' And so the history of African-Americans and research will manifest as we develop gene therapies for [these] patients," says Christopher L. Edwards, a clinical psychologist and researcher with the Maya Angelou Center for Health Equity at the Wake Forest University School of Medicine.
Fear among African-Americans of becoming guinea pigs is well-founded. The first c-sections and fistula repairs occurring in North America were performed on enslaved women -- all without consent and virtually none with anesthesia.
Modern 20th century medicine led to the Tuskegee syphilis experiments conducted by the U.S. Public Health Service. Researchers withheld treatment from some 400 African-American men from the 1930s well into the 1970s to observe how they reacted to the disease -- even though curative antibiotics had been around for decades. Only news reports ended the experiment.
The long-standing distrust of American healthcare in the African-American community is also baked into the care provided to sickle cell patients. Despite affecting one in 365 African-Americans, there is no disease registry to assist clinical trials, according to Mary Hulihan, a blood disorders epidemiologist with the Centers for Disease Control and Prevention. Edwards says many sufferers are suspicious of being monitored.
Meanwhile, only two drugs are available to alleviate the worst symptoms. The first one, hydroxyurea, received FDA approval only in 1998 -- nearly 90 years after the disease was first diagnosed. Moreover, Edwards says that some sufferers shy away from using hydroxyurea because it is also used to treat cancer. It's part of what he calls the "myth and folklore" in the African-American community about sickle cell disease.
Economics plays a role as well in the often-fragmented care such patients receive. According to CDC data, many patients rely extensively on public insurance programs such as Medicaid, whose coverage varies from state to state.
A Tough Transition
Edwards notes that sickle cell sufferers usually receive good care when they're children because of support provided by family members. But that often breaks down in adulthood. According to CDC data, an adult sickle cell patient visits a hospital emergency room three times as often as a child patient.
The consensus is that the path to a medical cure for sickle cell will first need to be smoothed over with a talk cure.
Modupe Idowu, a hematologist with the University of Texas Health system, estimates that there are perhaps a dozen comprehensive care centers for the estimated 100,000 sickle cell patients in the U.S., including the one she operates in Houston. That means a significant proportion of those afflicted are on their own to procure care.
And since many patients are on Medicaid, "a lot of hematologists that train to take care of blood disorders, many are not interested in treating [sickle cell disease] because the reimbursement for providers is not great," Idowu says.
Hsieh acknowledges that many of his patients can be suspicious about the care they are receiving. Frustration with fragmented care is usually the biggest driver, he adds.
Meanwhile, the skepticism that patients have about the treatments they seek is often reciprocated by their caregivers.
"The patients have experiences with medication and know what works at a very young age (for their pain)," Edwards says. Such expertise demonstrated by an African-American patient often leads to them being labeled as narcotics seekers.
The Correct Path
This all begs the question of how to deploy a cure. Idowu, who regularly holds town hall-style meetings with Houston-area patients, often must allay anxieties. For example, the gene therapy approach uses a harmless virus to transport new genetic material into cells. That virus happens to be a benign version of HIV, and convincing patients they won't be infected with HIV is a fraught issue.
The consensus is that the path to a medical cure for sickle cell will first need to be smoothed over with a talk cure.
Idowu tries to hammer home the fact that patients are afforded vastly more protections than in the past. "There are a lot of committees and investigational review boards that keep track of clinical trials; things just don't happen anymore as they did in the past," she says. She also believes it helps if more providers of color communicate to patients.
Hsieh is very straightforward with his patients. He informs them about the HIV vector but assures them no one has ever tested positive for the virus as a result of its use.
Edwards notes that since many patients suffer psychosocial trauma as a result of their chronic pain, there already is some counseling infrastructure in place to help them cope. He believes such resources will have to be stretched further as a cure looms closer.
In the absence of formal mental health services, straight talk may be the best way to overcome wariness.
"If patients have misgivings, we try our best to address them, and let them know at the end of the day it is their decision to make," Hsieh says. "And even the patients who have gone through the gene therapy and it didn't work well -- they're still glad they took the chance."
Probiotics seem to be everywhere these days. They are marketed for numerous health issues, from irritable bowel syndrome and vaginal yeast infections to life-threatening disorders like the bacterial infection Clostridium difficile.
The new probiotic drink is made of genetically engineered bacteria meant to help people feel better the day after drinking.
While the probiotic gummies that you'll find in supermarkets may not do much for you, good clinical evidence does support the C. difficile treatment, known as a fecal transplant, despite a recent setback, and there are always new probiotic regimens entering the scene. One emerging such treatment targets the hangover.
The Lowdown
You read that right – although "hangover" is a loaded term, according to ZBiotics, the company that's developing the product. The popular understanding of a hangover implies a collection of symptoms like a headache and fatigue, many of which result simply from dehydration and low-quality sleep. But those aren't the problems that the new product, a genetically engineered form of a common bacterial species, was developed to confront.
"Dehydration and poor sleep have actually always been pretty simple to deal with by having a good breakfast and some caffeine," notes ZBiotics founder and microbiologist Zack Abbott. Instead, the product targets acetaldehyde, a chemical that accumulates in the body if more than small amounts of alcohol are consumed.
Normally, body cells produce an enzyme that converts acetaldehyde into harmless acetic acid. But the enzyme becomes overwhelmed if you drink more than a little alcohol, or if you have a certain genetic deficiency.
A new probiotic drink aims to neutralize a chemical that builds up in the body after drinking alcohol.
(Zbiotics)
"I started ZBiotics with the hypothesis that if we used edible probiotic bacteria to make enzymes, and chose applications in which the enzymes these microbes make would be useful directly in the gut after you eat them, we could create all sorts of beneficial products," says Abbott. "I started with alcohol with the idea that we can augment the body's natural ability to digest its nasty byproduct, acetaldehyde, helping people feel better the day after drinking."
Next Steps
Based on the premise that the engineered bacteria augments a natural body function, ZBiotics had the product "sampled by thousands of beta-testers," including ZBiotics personnel, with "almost unanimously positive feedback," says Abbott.
"We are working on future scientifically controlled testing for publication."
ZBiotics is to set to launch on the market next week as a probiotic supplement, a category that does not require FDA approval. But some observers are troubled over whether the new product is attempting to serve a medical function without going through the standard drug testing process.
"I am skeptical of any new alternative product that is not FDA approved, has not undergone rigorous double-blind placebo control testing and adverse effects evaluation, and cites anecdotes as evidence of its efficacy," warns Heather Berlin, a cognitive neuroscientist and assistant professor of psychiatry at Icahn School of Medicine at Mount Sinai, in New York.
Abbott acknowledges that his product still needs to undergo rigorous study. "We are working on future scientifically controlled testing for publication," he says, noting that the company was "founded and [is] run by people with backgrounds in academic research."
Open Questions
Moving beyond the need for proper testing, Berlin has an additional concern: will a "hangover"-blocking substance cause people to drink more alcohol, or mask important physiological sensations like thirst?
"If that negative feeling is obscured, they may not [rehydrate], which can cause numerous adverse effects," Berlin says.
As for excessive drinking, there is a treatment on the market that does the opposite of Zbiotics. Disulfiram, commonly given to alcohol abusers, inhibits the very enzyme that ZBiotics supplements, causing acetaldehyde to accumulate especially fast. This makes drinking a pretty miserable experience.
But Abbott says his product would not interfere with disulfiram.
"[Zbiotics] is about enjoying the special moments in life where alcohol happens to be involved, but isn't the main focus."
"Disulfiram globally inhibits the enzyme throughout the entire body, including the liver, creating a massive amount of acetaldehyde at once, making the person ill immediately and forcing them to stop drinking right away," Abbott explains, whereas his product exerts its effects in the gut, and is really only helpful the next day. Thus, timing is everything; the probiotic would not change the experience at the moment of drinking.
"ZBiotics isn't about going out and ripping shots all night," Abbott says. "It's about enjoying the special moments in life where alcohol happens to be involved, but isn't the main focus. Weddings, celebrations, weekends with friends. And wanting to do that enjoyably while being safe and responsible at the same time."