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.
“Young Blood” Transfusions Are Not Ready For Primetime – Yet
The world of dementia research erupted into cheers when news of the first real victory in a clinical trial against Alzheimer's Disease in over a decade was revealed last October.
By connecting the circulatory systems of a young and an old mouse, the regenerative potential of the young mouse decreased, and the old mouse became healthier.
Alzheimer's treatments have been famously difficult to develop; 99 percent of the 200-plus such clinical trials since 2000 have utterly failed. Even the few slight successes have failed to produce what is called 'disease modifying' agents that really help people with the disease. This makes the success, by the midsize Spanish pharma company Grifols, worthy of special attention.
However, the specifics of the Grifols treatment, a process called plasmapheresis, are atypical for another reason - they did not give patients a small molecule or an elaborate gene therapy, but rather simply the most common component of normal human blood plasma, a protein called albumin. A large portion of the patients' normal plasma was removed, and then a sterile solution of albumin was infused back into them to keep their overall blood volume relatively constant.
So why does replacing Alzheimer's patients' plasma with albumin seem to help their brains? One theory is that the action is direct. Alzheimer's patients have low levels of serum albumin, which is needed to clear out the plaques of amyloid that slowly build up in the brain. Supplementing those patients with extra albumin boosts their ability to clear the plaques and improves brain health. However, there is also evidence suggesting that the problem may be something present in the plasma of the sick person and pulling their plasma out and replacing it with a filler, like an albumin solution, may be what creates the purported benefit.
This scientific question is the tip of an iceberg that goes far beyond Alzheimer's Disease and albumin, to a debate that has been waged on the pages of scientific journals about the secrets of using young, healthy blood to extend youth and health.
This debate started long before the Grifols data was released, in 2014 when a group of researchers at Stanford found that by connecting the circulatory systems of a young and an old mouse, the regenerative potential of the young mouse decreased, and the old mouse became healthier. There was something either present in young blood that allowed tissues to regenerate, or something present in old blood that prevented regeneration. Whatever the biological reason, the effects in the experiment were extraordinary, providing a startling boost in health in the older mouse.
After the initial findings, multiple research groups got to work trying to identify the "active factor" of regeneration (or the inhibitor of that regeneration). They soon uncovered a variety of compounds such as insulin-like growth factor 1 (IGF1), CCL11, and GDF11, but none seemed to provide all the answers researchers were hoping for, with a number of high-profile retractions based on unsound experimental practices, or inconclusive data.
Years of research later, the simplest conclusion is that the story of plasma regeneration is not simple - there isn't a switch in our blood we can flip to turn back our biological clocks. That said, these hypotheses are far from dead, and many researchers continue to explore the possibility of using the rejuvenating ability of youthful plasma to treat a variety of diseases of aging.
But the bold claims of improved vigor thanks to young blood are so far unsupported by clinical evidence.
The data remain intriguing because of the astounding results from the conjoined circulatory system experiments. The current surge in interest in studying the biology of aging is likely to produce a new crop of interesting results in the next few years. Both CCL11 and GDF11 are being researched as potential drug targets by two startups, Alkahest and Elevian, respectively.
Without clarity on a single active factor driving rejuvenation, it's tempting to try a simpler approach: taking actual blood plasma provided by young people and infusing it into elderly subjects. This is what at least one startup company, Ambrosia, is now offering in five commercial clinics across the U.S. -- for $8,000 a liter.
By using whole plasma, the idea is to sidestep our ignorance, reaping the benefits of young plasma transfusion without knowing exactly what the active factors are that make the treatment work in mice. This space has attracted both established players in the plasmapheresis field – Alkahest and Grifols have teamed up to test fractions of whole plasma in Alzheimer's and Parkinson's – but also direct-to-consumer operations like Ambrosia that just want to offer patients access to treatments without regulatory oversight.
But the bold claims of improved vigor thanks to young blood are so far unsupported by clinical evidence. We simply haven't performed trials to test whether dosing a mostly healthy person with plasma can slow down aging, at least not yet. There is some evidence that plasma replacement works in mice, yes, but those experiments are all done in very different systems than what a human receiving young plasma might experience. To date, I have not seen any plasma transfusion clinic doing young blood plasmapheresis propose a clinical trial that is anything more than a shallow advertisement for their procedures.
The efforts I have seen to perform prophylactic plasmapheresis will fail to impact societal health. Without clearly defined endpoints and proper clinical trials, we won't know whether the procedure really lowers the risk of disease or helps with conditions of aging. So even if their hypothesis is correct, the lack of strong evidence to fall back on means that the procedure will never spread beyond the fringe groups willing to take the risk. If their hypothesis is wrong, then people are paying a huge amount of money for false hope, just as they do, sadly, at the phony stem cell clinics that started popping up all through the 2000s when stem cell hype was at its peak.
Until then, prophylactic plasma transfusions will be the domain of the optimistic and the gullible.
The real progress in the field will be made slowly, using carefully defined products either directly isolated from blood or targeting a bloodborne factor, just as the serious pharma and biotech players are doing already.
The field will progress in stages, first creating and carefully testing treatments for well-defined diseases, and only then will it progress to large-scale clinical trials in relatively healthy people to look for the prevention of disease. Most of us will choose to wait for this second stage of trials before undergoing any new treatments. Until then, prophylactic plasma transfusions will be the domain of the optimistic and the gullible.
Who’s Responsible for Curbing the Teen Vaping Epidemic?
E-cigarettes are big business. In 2017, American consumers bought more than $250 million in vapes and juice-filled pods, and spent $1 billion in 2018. By 2023, the global market could be worth $44 billion a year.
"My nine-year-old actually knows what Juuling is. In many cases the [school] bathroom is now referred to as 'the Juuling room.'"
Investors are trying to capitalize on the phenomenal growth. In July 2018, Juul Labs, the company that owns 70 percent of the U.S. e-cigarette market share, raised $1.25 billion at a $16 billion valuation, then sold a 35 percent stake to Phillip Morris USA owner Altria Group in December. The second transaction valued the company at $38 billion. While the traditional tobacco market remains much larger, it's projected to grow at less than two percent a year, making the attractiveness of the rapidly expanding e-cigarette market obvious.
While Juul and other e-cigarette manufacturers argue that their products help adults quit smoking – and there's some research to back this narrative up – much of the growth has been driven by children and teenagers. One CDC study showed a 48 percent rise in e-cigarette use by middle schoolers and a 78 percent increase by high schoolers between 2017 and 2018, a jump from 1.5 million kids to 3.6 million. In response to the study, F.D.A. Commissioner Scott Gottlieb said, "We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion."
Another study found that teenagers between 15 and 17 were 16 times more likely to use Juul than people aged 25-34. In December, Surgeon General Jerome Adams said, "My nine-year-old actually knows what Juuling is. In many cases the [school] bathroom is now referred to as 'the Juuling room.'"
And the product is seriously addictive. A single Juul pod contains as much nicotine as a pack of 20 regular cigarettes. Considering that 90 percent of smokers are addicted by 18 years old, it's clear that steps need to be taken to combat the growing epidemic.
But who should take the lead? Juul and other e-cigarette companies? The F.D.A. and other government regulators? Schools? Parents?
The Surgeon General's website has a list of earnest possible texts that parents can send to their teens to dissuade them from Juuling, like: "Hope none of your friends use e-cigarettes around you. Even breathing the cloud they exhale can expose you to nicotine and chemicals that can be dangerous to your health." While parents can attempt to police their teens, many experts believe that the primary push should come at a federal level.
The regulation battle has already begun. In September, the F.D.A. announced that Juul had 60 days to show a plan that would prevent youth from getting their hands on the product. The result was for the company to announce that it wouldn't sell flavored pods in retail stores except for tobacco, menthol, and mint; Juul also shuttered its Instagram and Facebook accounts. These regulations mirrored an F.D.A. mandate two days later that required flavored e-cigarettes to be sold in closed-off areas. "This policy will make sure the fruity flavors are no longer accessible to kids in retail sites, plan and simple," Commissioner Gottlieb said when announcing the moves. "That's where they're getting access to the e-cigs and we intend to end those sales."
"There isn't a great history of the tobacco industry acting responsibly and being able to in any way police itself."
While so far, Gottlieb – who drew concerns about conflict of interest due to his past position as a board member at e-cigarette company, Kure – has pleased anti-smoking advocates with his efforts, some observers also argue that it needs to go further. "Overall, we didn't know what to expect when a new commissioner came in, but it's been quite refreshing how much attention has been paid to the tobacco industry by the F.D.A.," Robin Koval, CEO and president of Truth Initiative, said a day after the F.D.A. announced the proposed regulations. "It's important to have a start. I certainly want to give credit for that. But we were really hoping and feel that what was announced...doesn't go far enough."
The issue is the industry's inability or unwillingness to police itself in the past. Juul, however, claims that it's now proactively working to prevent young people from taking up its product. "Juul Labs and F.D.A. share a common goal – preventing youth from initiating on nicotine," a company representative said in an email. "To paraphrase Commissioner Gottlieb, we want to be the off-ramp for adult smokers to switch from cigarettes, not an on-ramp for America's youth to initiate on nicotine. We won't be successful in our mission to serve adult smokers if we don't narrow the on-ramp... Our intent was never to have youth use Juul products. But intent is not enough, the numbers are what matter, and the numbers tell us underage use of e-cigarette products is a problem. We must solve it."
Juul argues that its products help adults quit – even offering a calculator on the website showing how much people will save – and that it didn't target youth. But studies show otherwise. Furthermore, the youth smoking prevention curriculum the company released was poorly received. "It's what Philip Morris did years ago," said Bonnie Halpern-Felsher, a professor of pediatrics at Stanford who helped author a study on the program's faults. "They aren't talking about their named product. They are talking about vapes or e-cigarettes. Youth don't consider Juuls to be vapes or e-cigarettes. [Teens] don't talk about flavors. They don't talk about marketing. They did it to look good. But if you look at what [Juul] put together, it's a pretty awful curriculum that was put together pretty quickly."
The American Lung Association gave the FDA an "F" for failing to take mint and menthol e-cigs off the market, since those flavors remain popular with teens.
Add this all up, and in the end, it's hard to see the industry being able to police itself, critics say. Neither the past examples of other tobacco companies nor the present self-imposed regulations indicate that this will succeed.
"There isn't a great history of the tobacco industry acting responsibly and being able to in any way police itself," Koval said. "That job is best left to the F.D.A., and to the states and localities in what they can regulate and legislate to protect young people."
Halpern-Felsher agreed. "I think we need independent bodies. I really don't think that a voluntary ban or a regulation on the part of the industry is a good idea, nor do I think it will work," she said. "It's pretty much the same story, of repeating itself."
Just last week, the American Association of Pediatrics issued a new policy statement calling for the F.D.A. to immediately ban the sale of e-cigarettes to anyone under age 21 and to prohibit the online sale of vaping products and solutions, among other measures. And in its annual report, the American Lung Association gave the F.D.A. an "F" for failing to take mint and menthol e-cigs off the market, since those flavors remain popular with teens.
Few, if any people involved, want more regulation from the federal government. In an ideal world, this wouldn't be necessary. But many experts agree that it is. Anything else is just blowing smoke.