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Censorship, publication bans and integrity in scientific research

By Marina Murphy

In a recent commentary piece in the journal Addiction, professor Jim McCambridge from the University of York said that academic journals should not publish any e-cigarette research funded by the tobacco industry. But research and innovation—whether or not conducted or funded by industry—have the potential to immeasurably improve people’s lives. This is as true for the tobacco industry as any other industry and is particularly relevant given that with e-cigarettes, we now have potentially revolutionary products in tobacco harm reduction.

Many in the public health community believe that e-cigarettes represent a historic opportunity to save millions of lives and drastically reduce the public health burden of smoking-related diseases. We need to be able to trust the science and research that comes out of the industry driving this revolution, and the regulators that oversee it. Doesn’t this mean that we need to foster a culture of collaboration, cooperation and greater—not less— transparency? It therefore makes no sense to suggest that the science on which this innovation is based be censored or hidden from the scientific community, the public, consumers or regulators. It makes no sense that the science conducted by companies that research and manufacture e-cigarettes, or indeed any product we consume on a daily basis, be banned from publication. It is in everyone’s interest that scientific results are demonstrated to be based on research that is repeatable, traceable, and open for critique and comment by the scientific community. Censorship and publication bans are not the way to achieve this.

SCIENCE AND INDUSTRY

Industry plays a crucial role in the research process, which is not likely to change. Society in general expects that this research be tied to commercialism, and so much of the science supporting innovation, from green chemistry to new drugs, will happen in companies not universities. All of us depend on industry to put research results into practice—to feed us, clothe us, get us around and provide medicines when we are ill. Industry scientists outnumber academic research scientists, and industry funds more research than any government or noncommercial organization.

A common view is that industry scientists have conflicts of interest and that this conflict influences the integrity of the science—that these scientists are compromised and that the science should be viewed to some degree at least to be of suspect credibility or value. Regrettably, much of this debate mixes up bias and conflict; if all conflicts were banished forever, there would still be many sources of bias. But conflicts of interest are not, in themselves, determinants of bias.

You could argue that of course industry scientists are conflicted—of course they want the research to yield positive results, better products, advances in technology, etc. But it is not necessarily biased. If industry scientists were truly biased, how do we explain the marvelous innovations and advancements that have so successfully and so immeasurably enhanced all our daily lives?

BANS

Science students are more likely to end up working for an industrial organization than for a government or university. They can’t all be bad. That is not to say that mistakes have not been made in the past. But surely we can learn from these mistakes and work together to engender a culture of transparency and collaboration—to fulfill our duty of care and to ensure that society benefits from the immeasurable good possible through scientific and technical innovation and expertise.

In his commentary, McCambridge concedes that his proposal to ban the publishing of tobacco-funded e-cigarette research is not based on the evidence of any current misconduct on the part of the tobacco industry with regard to research it funds on e-cigarettes, but on evidence of decades-old misconduct. His proposal is based on his own belief that this misconduct occurs, and he suggests creating a register that does “not rely exclusively on self-disclosure,” a suggestion that one commentator called a “new McCarthyism in which allegation stands in place of evidence and where the appearance upon such a blacklist could destroy a researcher’s career.”

This commentator goes on to say, “Here is a real danger of creating an academic environment in which allegations have supplanted proof when it comes to scientific misconduct … suspicion has assumed primacy over evidence.”

It cannot be right to judge an industry based on incidents that happened many decades ago, in a different world, in a different century. Indeed, generations of scientists have passed through the doors of the research laboratories of the tobacco industry since then. The scientists in our laboratories believe in tobacco harm reduction and the potential of e-cigarettes and other next-generation products. We all accept that there is a huge public health benefit to be gained by reducing or eliminating the impact of tobacco-related disease. In our capacity as scientists, it is our role to create the science needed to develop products that are substantially reduced-risk compared to combustible cigarettes and that are acceptable to those who wish to continue to use nicotine.

INVESTMENT

In the past few years, hundreds of millions have been invested by the tobacco industry in e-cigarettes and other next-generation products. These products are now used by millions of consumers. Vaping represents a new subculture, with its own jargon and its own technology. High levels of investment means that this technology is evolving rapidly and is often the topic of conversation, controversy and debate. Almost every day, e-cigarettes appear in the mainstream media. Vaping is trending!

A clear advantage of this “trending” is that smoking cessation now enjoys a place on the news agenda like never before. Smoking cessation had not been covered in any depth until relatively recently. E-cigarettes may take the lead in much of the coverage, but smoking cessation and nicotine are both now routinely featured in mainstream science and health coverage. Another advantage to this is the fact that nicotine, once much maligned, is now widely understood not to be the cause of tobacco-related disease. This contrasts sharply with the situation just a few years ago, when a survey of general practitioners revealed that 40 percent of them thought that nicotine was the first or second riskiest component of tobacco smoke (see info box). It isn’t. It is the toxicants produced as a result of burning dried tobacco that are responsible for the development of tobacco-related diseases, from cardiovascular disease to cancer.

Research has shown e-cigarettes to be better than existing nicotine-replacement therapies or nothing at helping smokers quit smoking. That e-cigarettes are substantially less risky than conventional cigarettes is also a view endorsed by Public Health England, Cancer Research UK, Action on Smoking and Health and the British Heart Foundation.

There is much to be positive about when it comes to all this activity in e-cigarettes. The category is rapidly evolving. Smoking cessation is getting the attention it deserves, and nicotine is better understood than ever before. But this progress cannot and will not continue in a scientific vacuum, and much of that science does and will come from the industry. This science deserves to be reviewed, shared and debated. It is only in this way that the industry can show that it conducts research to the highest standard and demonstrate integrity and best practice. We need more transparency, not less.

There have been examples of scientific misconduct. The worse examples are plagiarism, double publishing of results and falsifying data. There have been a few cases (not in the tobacco industry) in the past decade, but in most cases the peer review system has successfully rooted out the small (though often potentially extremely high-impact cases) number of misconduct cases. Peer review is not perfect, but it is very effective. And if there are doubts about this effectiveness, that needs to be dealt with. It is, after all, an ancient system operating in a modern world.

Advances in science and technology over the last millennia have realized benefits in every facet of mankind’s existence, from shelter and food to health and mobility. No scientific bodies have driven this progress more so than industrial scientists as they apply fundamental science to deliver their products. It is imperative that industry science continues to be seen as a flagship for scientific integrity, and to this end, all science deserves the opportunity to be commented upon and critiqued objectively by the scientific community through continued engagement and peer review.

The potential that e-cigarettes and other products have to save millions of lives cannot be lost in a zeal that sees a desire to eliminate tobacco-related disease confused with a desire to eliminate an industry.

Nicotine misperceptions widespread

A 2013 survey of general practitioners (GPs) revealed that many then believed nicotine to be one of the most harmful components of cigarette smoke

A study of GPs in the U.K. and Sweden, published in Drugs and Alcohol Today, revealed that many hold the view that one of the greatest health risks from smoking is nicotine

The study participants (100 in the U.K., 120 in Sweden) were asked about the risks associated with tobacco and nicotine products, smoking cessation and tobacco harm reduction approaches, and influential sources of information.

The majority of survey respondents (96 percent in the U.K., 98 percent in Sweden) said that they regularly discussed smoking cessation with their patients, but less than half believe that long-term nicotine replacement therapy (NRT) is preferable to smoking (31 percent in the U.K., 48 percent in Sweden).

The survey findings show that a substantial proportion of GPs (40 percent) believe nicotine to be the first- or second-riskiest component of cigarettes, incorrectly identifying it as more harmful than smoke.

Many (44 percent in the U.K., 56 percent in Sweden) also wrongly believe that nicotine in tobacco products is associated with cancer, while 15 percent in the U.K. and 22 percent in Sweden believe the same for pharmaceutical nicotine.

Thoughts on the nicotine revolution

By David Sweanor

Imagine a time and place where the leading cause of cancer death was consumer consumption patterns, and where innovative technology was developed that allowed these consumers to change their behaviors to something greatly less hazardous. This new technology actually gave them something they preferred and that even cost them less than sticking with the old, deadly alternative. Imagine that businesses were allowed to promote and sell the new technology and competition and sensible regulation led to ever-better, more reliable and safer versions of this new technology. Well, stop imagining, because it has already happened, and we are using it every day.

It was refrigeration. As recently as the 1940s, stomach cancer was our largest cause of cancer deaths. But it was already declining steeply, it continued to fall rapidly, and it’s now thankfully rare. With the advent of refrigeration, diets changed. Out went the highly salted, pickled, smoked and easily contaminated foods, and in came more fresh fruits and vegetables. This huge public health breakthrough was led by entrepreneurs and consumers, and it was self-financing. So if you want to celebrate the ability of innovative technology to largely eliminate the leading cause of cancer death, send a fan letter to General Electric and go hug your refrigerator.

But refrigerators aren’t an anomaly in being an entrepreneurial intervention that saved lives. We can think of the Lambeth Waterworks Company, which opted to source water for its customers in London from upstream in the Thames when the competition was sourcing it downstream from the city’s sewer outlets and causing cholera epidemics. Or those who saw a competitive advantage in sanitary food manufacturing, or in science-based pharmaceuticals in place of snake oil, or in installing safety features in their cars. We live in a world made massively less hazardous through the work of visionaries and the workings of markets.

LEARNING LESSONS

Many business and public health breakthroughs look obvious, even inevitable, in retrospect. People deride the Royal Navy for taking decades to act on information showing citrus prevented scurvy, and decry the nearly 200 years from the time mankind knew how to prevent smallpox until the time we eliminated that horrible disease. So, how will history judge what we are doing about cigarette smoking?

Likely not favorably. We have known for decades that people smoke for the nicotine, but what kills them at such a horrendous rate is the inhalation of the smoke. Getting nicotine without the smoke, as we have seen with Swedish snus and medicinal nicotine, can eliminate the vast majority of all the harms. We also know that consumers are spending roughly $800 billion a year buying cigarettes, and being stuck with that product not through choice but because others have chosen to limit their access to viable alternatives. Given the ability, markets could meet consumer demand in a way that facilitates a breakthrough that could leave hundreds of millions of people with hugely improved health and numerous entrepreneurs having done well by doing good. With policies that actually facilitate market transformation rather than hindering it, the move away from lethal cigarettes could rival the pace of change in other areas of technology. We could make smoking history, and innovation could also facilitate those who are wishing to cease using nicotine altogether.

GETTING TO SENSIBLE

To get to such a breakthrough will require some deeper thinking about how best to deal with nicotine, and an abandonment of measures that treat nicotine use as if it were an immoral act rather than an issue of public health and consumer rights. Abstinence-focused campaigns based on imposing an absolutist morality on others intensify the evils they hope to destroy, as the historian Richard Hofstadter pointed out about alcohol prohibition. It has happened with Prohibition, the war on drugs, abstinence-only messages on sexual activity, blame-the-driver approaches to auto safety, and it’s happening now with the war on nicotine. When the stakes are high—and they are exceedingly so, with roughly 1.5 billion people getting their nicotine through inhalation of the products of combustion—pragmatism must win out over dogmatism.

“Getting to sensible” is often a serious public policy challenge, and it’s certainly a difficult task when there are vigorous efforts to create a moral panic about alternatives to cigarettes. Consumers have traditionally lost out in the battles over nicotine because others were able to impose choices on them. Products like medicinal nicotine were so heavily regulated as to not be viable alternatives to cigarettes. Many countries actually banned noncombustible alternatives like snus and moist snuff, thus protecting the much more deadly cigarette business. For decades, consumers desperately looking for safer alternatives were not just denied accurate information on and access to truly less hazardous products; they were also misled into believing that “light” cigarettes were safer.

But innovative technology has a way of disrupting markets, and the rapid transformation of electronics, combined with the role of the Internet for getting information and social media for sharing it, means that vapor products have acted much like Uber. Instead of seeking permission to exist, they simply showed up in the market, and when challenged under what were seen as outdated laws, the entrepreneurs fought back. The end result is that the technology became very widely used before those opposing its existence could stop it. Those who have a vested interest in the status quo must fight not only the innovators but a very broad swath of consumers who prefer the new product. It is hard to ban a product used by millions, just as it is hard to stop a civil rights march if enough people are marching.

The opposition to alternative nicotine products will not die easily. Among other things, major U.S. funding bodies adopted a moral-absolutist goal of a “tobacco-free America” rather than a pragmatic public health one of reducing the burden of disease. Then, in some truly twisted logic, they decided that tobacco-free vapor technology constituted a tobacco product. So we see a near-endless parade of funded studies aimed at furthering a moral panic, reminiscent of what was seen in the war on alcohol and the war on drugs. Studies that often betray rather than honor the goals of science. Studies that will often point to a “potential problem” without either specifying whether there is any actual risk to vapers or comparing any identified risk to that of continued smoking. Studies, in short, that deceive rather than inform.

BETTING ON INNOVATION

So, who is going to win this war on nicotine? Will an abstinence-only approach actually end up protecting the cigarette cartel? Or will a growing band of pragmatic revolutionaries fundamentally change the market and achieve not only a marketplace transformation but a public health breakthrough of historic proportions?

Were one to place a bet, go with the innovators. Matching their creativity, work ethic, personal drive, commitment and consumer support to that of the bureaucrats, moralists and cigarette companies wishing to preserve the status quo is (fortunately) a very uneven fight. We will soon see the market deliver a range of alternative products, some without vapor, some aimed at specific niches of the current cigarette market, some aimed at easing people off nicotine altogether. Many will be hugely better than anything seen to date. Innovation and competition does that. There are millions of lives to be saved and billions of dollars to be made replacing lethal cigarettes. There are simply too many bright people with too great an interest in a better future to believe that innovators will stop innovating and smokers will be denied access to and accurate information about alternatives. Sensible regulators, knowing they can’t defeat innovative technology, will opt to work with it to facilitate the rapid end of the cigarette epidemic.

Lung cancer is now our leading cause of cancer deaths. It dwarfs other types of cancer. Just 80 years ago, before cigarette smoking became the primary vehicle for obtaining nicotine, lung cancer was as rare as stomach cancer is now. Of course, smoking causes a broad array of other cancers and numerous other diseases. It is truly a totally unnecessary modern-day catastrophe, and on many levels—health, economics and consumer rights among them. But modern markets can change quickly, entrepreneurs can see opportunity when it occurs, and consumers with information and options for using it can change the course of history. So go show your refrigerator you are prescient. Tell it that it is about to have company in the annals of historic public health breakthroughs.

David Sweanor is an adjunct professor with the Faculty of Law at the University of Ottawa. He is also with the Centre for Health Law, Policy & Ethics at the University of Ottawa.

What the thaw in U.S.-Cuban relations means for the electronic nicotine delivery systems.

By Givi Topchishvili

As U.S. President Barack Obama is making his historic visit to Cuba—the first by sitting American president in almost 90 years—the business community is asking itself what the thawing in relationship means to it. Calumet Advisors recently concluded an assessment of risks and opportunities for the vaping sector in the South American market, with Cuba being a part of the study. While our findings show that the current environment in Cuba is not yet ripe for a serious market entry, we do see a number of opportunities and are happy to share some of these observations.

According to the 2015 revision of the World Population Prospects, the total population of Cuba stands at 11.39 million, and is projected to decrease by 9.2 percent to 10.34 million by 2050. By then Cuba is also projected to become the ninth oldest country in the world, with a median age of 51.9 years.

On the economic front, the Cuban government continues to balance the need for loosening its socialist economic system against a desire for firm political control. As the government has cut state-sector jobs as part of the reform process, it has opened up some retail services to “self-employment,” leading to the rise of so-called “cuentapropistas,” or entrepreneurs. Approximately 476,000 Cuban workers are currently registered as self-employed.

Yet despite the recent reforms, the average Cuban’s standard of living remains at a lower level than before the collapse of the Soviet Union and the resulting downturn of the 1990s, with an average income of just $300 per year. That means very limited buying power for most Cuban consumers, especially for non-essential goods and services.

At the same time, Cuba is home to some of the toughest anti-smoking laws in the region. In 2011 it conducted the Third Survey on Risk Factors of Non-Transmissible Diseases. It polled 9 million people and is recognized as the most important study on the issue to date. The study yielded significant results, such as the fact that 36.4 percent of those interviewed smoked at least once in their lives, and that two out of every 10 women and three out of every 10 men are addicted to cigarettes. As much as 53 percent of all black and mixed-raced people on the island claim to be smokers—a figure of more than double the rate of white Cubans who smoke (24 percent).

At the moment the Cuban authorities are working on new anti-tobacco legislation that would provide the framework for even tougher restrictions on smokers than exist today, and strengthen commercial limitations on tobacco-derived products. In addition to reiterating provisions that forbid smoking in closed spaces and the sale of tobacco products to people under 18, the proposed legislation would include restrictions on the promotion and sponsoring of tobacco products in the country, prohibit their sale at health, educational, and sporting institutions, and the sale of single units or packages with less than 20 cigarettes. It would also raise the prices of tobacco products.

Another important factor to consider is the fact that currently all tobacco products are tightly controlled by Tabacuba, the state tobacco monopoly, which will most likely seek authority over the future sale of e-cigarette and vapor products once the market begins to open up.

Interestingly enough, currently, there are no limitations or restrictions on sale or use of vaping products in Cuba, something that was confirmed by tourists and locals alike.  The actual current size of the electronic nicotine delivery systems (ENDS) market there is under $4 million a year, and to date there are no established local retail or online market for vape devices or e-liquid products.

It’s clear that the current economic and political environment in Cuba is not yet welcoming enough to make significant investments in market entry. One possible venue for entry that we identified is an exploration of a joint venture with, or becoming a supplier to Tabacuba. Working with government controlled monopolies comes with a price, but as we have seen in analogous places it carries less risk than attempts to bypass it.

However, the real opportunity for development and expansion of ENDS market at the moment is within the smoking-cessation campaign going on in Cuba. Now is the time to influence the public perception and legislative work pointing at Cuban antismoking environment. It is worth considering respective lobbying efforts, especially with the high number of U.S. and European tourists willing to visit Cuba in the future. It is noteworthy that the U.K. has just ruled on licensing BAT e-cigarettes as quit-smoking medicine, which was announced in January 2016. This U.K. ruling may pave the way for other countries to follow this route and should be closely monitored in general and in the context of entering the Cuban market in particular. With a population base of 11 million people and 3 million tourists annually, Cuba could, potentially, become a large player in the Caribbean vape market.

Givi Topchishvili is a co-founder of Calumet Advisors, an international strategic consulting company dedicated to the e-cigarette segment.

Gaïatrend, a leading vapor company in France, is expanding into the United States, where it will be launching its flagship brand, Alfaliquid.Industry veteran and executive Arnaud Dumas de Rauly will lead Gaïatrend USA’s development as president.

Currently commanding more than 50 percent of the e-liquid market in France, Alfaliquid’s early success in Europe can be attributed to the brand’s extensive variety of unique, quality e-liquid flavors and the company’s commitment to health and safety regulations for each stage of production.

Gaïatrend will initially be rolling out 15 flavors in the U.S. market across Alfaliquid’s three e-liquid collections, Heritage, Harvest and Reserve. Understanding the importance of transparency, particularly in an unregulated U.S. industry, Alfaliquid will also work to educate consumers about e-liquids and their ingredients as they have done successfully in France.

De Rauly is the former president of FIVAPE, a European vaping trade association. He currently serves as the organization’s Secretary General for International Relations and is also a board member of the Vapor Technology Association, currently serving as Treasurer.

De Rauly also plays an integral role in the development of industry standards as a founding member of the AFNOR (French Standards Body) technical committee on vaping and vapor products, current member of the CEN (European Standards Body), and current member of the ISO International Standards Organization.  He frequently serves as a keynote speaker at international vaping shows across the globe.

“We are thrilled to announce Gaïatrend’s expansion to the U.S.,” says De Rauly. “With the advent of a real vaping culture across the globe, we see tremendous opportunity for Alfaliquid in the U.S.  Alfaliquid has set the industry standard in Europe through quality and innovation, and we look forward to introducing our e-liquid products to adult consumers in the states.  With our expansion to the U.S., we will also work to educate adult consumers about e-liquids and their ingredients, as well as the importance of health and safety standards.”

Alfaliquid e-liquids are manufactured by Gaïatrend in the French region of Lorraine.

Tony Scanlan has been appointed CEO of Madvapes U.K. to lead the company’s business expansion strategy in the United Kingdom and the Republic of Ireland.

Scanlan is an experienced international manager who has spent his career building businesses in the tobacco, mobile phone and of late the e-cigarette sectors.

Having spent many years at Rothmans International, where he built brands and sales in Europe, the Middle East and Africa, Scanlan looked for business opportunities to suit his talent. He built a business in the emerging mobile phone e-transaction space, which grew to a turnover of €65 million ($71.93 million) within three years and sold to investors within five.

As e-cigarettes started to emerge as a serious option for consumers, he joined a fast-growing manufacturer and led it to become a leading brand in the U.K. market and No. 2 in Ireland.

The U.K. vaping market is growing at a tremendous pace as technology improves and more mainstream consumers are attracted to vaping, according to Madvapes.

The current retail environment is beginning to mature, giving ideal conditions for Madvapes to establish a chain of corporate owned and franchised stores across the country.

“Having owned a retail franchise myself I am fully aware of the success criteria and am confident the U.S. model will fit very well in the U.K. and Ireland,” said Scanlan.

“We welcome Tony to the Madvapes team, we have tremendous confidence in his experience and ability to lead our brand in the U.K. and beyond,” said Mark Kehaya, chairman of Madvapes Holdings.

 Innokin and Nerudia have established a strategic partnership to ensure that some of the world’s most popular vaporizers achieve compliance with the new EU Tobacco Products Directive.

Nerudia will begin work immediately on preparing a TPD notification for the Innokin Endura T18, which is a simple, high-performance device. The two companies will continue to update the market on the progress of this notification so as to ensure wholesalers and distributors can buy the product with confidence.

Nerudia will also audit Innokin’s manufacturing facilities and help the manufacturer ensure that its production meets the directive’s stringent requirements. It will also monitor Innokin’s compliance with the body of European law that already applies to vaping products.

“We are delighted to be working in partnership with Innokin, who have made some fantastic devices that have helped to shape the vaping industry as we know it,” says David Lawson, Nerudia chief regulatory officer.

“Nerudia looks forward to helping Innokin grow by making sure that they continue to lead the field when TPD comes into force”.

“When we chose our TPD Compliance partner Nerudia really stood out,” says James Li, general manager of Innokin. “They offer a service that is more robust than any other we have seen in the market, and we are confident that they will lead us to a successful future in this newly regulated market.”

Neil McKeganey and Christopher Russell of the Centre for Substance Use Research in Glasgow, Scotland, cautioned against a “new McCarthyism” in the area of e-cigarette research.

The scientists responded to a commentary in Addiction, in which Jim McCambridge of the University of York advocates a ban on industry-funded e-cigarette research and a creation of a register of financial and other disclosures that “does not rely exclusively upon self-disclosure,” with no statute of limitations.

McKeganey and Russell said McCambridge is effectively calling for a list that is “based on suspicion, innuendo, some level of detective work, and unsubstantiated allegation.”

McKeganey and Russell also said McCambridge’s proposal is a “new McCarthyism in which allegation stands in place of evidence and where the appearance upon such a blacklist could destroy a researcher’s career,” and risks undermining “the openness, and the free exchange of knowledge and understanding, that is at the very heart of the scientific enterprise.”