Tag: Centre for Substance Use Research

  • Ignorance Is Not Bliss

    Ignorance Is Not Bliss

    Photo: bongkarn

    Professional research institutions can help nicotine companies carry out surveys that they may be reluctant to conduct themselves.

    By Neil McKeganey and Gabe Barnard

    In the 2012 Hollywood action thriller Zero Dark Thirty documenting the hunt for Osama Bin-Laden, there is a scene in which a CIA lead outlines to the president’s national security advisor the agency’s latest intelligence identifying the occupant of a fortified compound within Pakistan as possibly being the Al-Qaeda leader. On leaving the meeting and fearing that the proposed raid on the compound will have been rejected because of the risks involved, the CIA lead asks the national security advisor a critical question: Alongside the risks of the operation itself, what, he asks, are the risks of doing nothing? That scene underlines a fundamental of public policy, namely the importance of addressing both the risks of interventions as well as the risks of failing to intervene.

    And so with the tobacco industry. When it comes to tobacco products, there are few more sensitive matters than youth use of the products involved. In the world of manufacturing, selling, studying, treating and preventing tobacco consumption, the simple fact that the use of these products typically starts in the teen or preteen years makes youth use of tobacco products a hugely impactful issue. For decades, the tobacco industry has been reluctant to initiate research on teenage and underage adult use of their products, fearing that they may be accused of harvesting sensitive data on young people that may, in time, be used to market their products. While the risks of industry-supported research on youth are understandable, the risks of not undertaking that research are increasingly important.

    The consequences of initiating tobacco product use in the teen and preteen years, and of embedding a behavior that may last many decades, resulting in serious adverse health consequences, are too serious to disregard. Those involved in tobacco control, those with an interest in regulatory action and those involved in the media are all hugely interested in the results of research reporting the extent and determinants of teenage tobacco product use.

    By removing itself from research in this area, the tobacco industry repeatedly finds itself having to respond to accusations that its products are indeed being widely used by young people. By failing to support research in this area, the impression may be conveyed that industry as such are either uninterested in teen use of their products or frightened at what that research might show. That fear is understandable. If there was any doubt about the potential impact of reports of teen use of tobacco products, then think only of the fate that has befallen Juul, Puff Bar and Elf Bar. Each of these companies have been characterized as a major driver of youth vaping, and each of them have paid the price as a result.

    The ground is now changing in relation to the tobacco industry studying or supporting research in this area. There is, for example, Altria’s Underage Tobacco Use Study, gathering data on youth and underage adult use of a range of tobacco products. Not only has Altria overcome their own anxiety around research in this area, but in an extraordinary act of transparency, they have opened up the data from this study to external agencies and researchers. Similarly, other major tobacco companies are now actively considering how to undertake or support research in this area. There are multiple benefits that are likely to flow from this change. By collecting data on which products are being used by youth and young adults, tobacco companies can make a contribution both to tackling teenage tobacco use and utilizing such information in their own applications for regulatory approval where the research identifies those tobacco products that are not being used by youth and underage adults. Research in this area can help companies by providing “early warning” data on which of their products are being used by youth in which parts of the country, thereby better equipping the companies with data that can help them tackle the problem of underage tobacco use.

    In the face of a growing willingness to support youth research, the tobacco industry will still face notable barriers. Along with the large cost of undertaking research involved, there is also the fact that few in the industry have experience of undertaking research with young people.

    In both these regards, the industry can benefit from the services of professional research institutions. The Centre for Substance Use Research in Glasgow, Scotland, for example, collects detailed information on the extent to which specific named tobacco products and brands are being used by young people in the U.S. through its Tobacco Product Prevalence Survey (TPPS).

    The results of this survey have already assisted a number of companies in their submissions under the premarket tobacco product application process in the U.S. Because the TPPS study is funded by the research center rather than tobacco companies, the accusation that industry is harvesting data on young people, or that commercial interests are biasing the results, cannot be applied.

    In time, we will see more of the output of industry-supported research, with the results of that research hopefully changing the perception of an industry that while profitable is reluctant to ask the question of how widely their products are being used by young people.

    Neil McKeganey is director of the Center for Substance Use Research in Glasgow, Scotland.
    Gabriel Barnard is a director of the Center for Substance Use Research in Glasgow, Scotland.
  • A Second Chance

    A Second Chance

    Photo: andranik123

    How companies can make the most of a recent court ruling requiring the FDA to reassess thousands of PMTA rejection notices.

    By Neil McKeganey

    It would be hard to overstate the threat that youth vaping in the United States poses to the use of e-cigarettes as a means of tobacco harm reduction. Respected national surveys have shown a rising trend in youth vaping, with the threat to the vaping industry as predictable as night following day.

    Former Food and Drug Administration Commissioner Scott Gottlieb could not have been clearer in signaling that threat when he said that the offramp to adult smoking could not be justifiably achieved at the cost of the on-ramp of teen vaping. If anybody was in any doubt about the risks that youth vaping poses to the entire e-cigarette industry, those doubts would have surely been extinguished in the recent ruling against Juul Labs, which required the company to pay in excess of $438 million to compensate states for the harms caused by past marketing practices increasing the likelihood of youth using their eponymously named vaping device.

    For vaping companies, the threat of youth vaping may have lifted slightly in a recent U.S. court ruling requiring the FDA to pay attention to what vapor companies are doing in trying to restrict youth access to their products. Odd as it may sound, after having encouraged vapor companies to pay attention to their marketing and sales practices in light of the rising trend in youth vaping, the FDA’s position appears to have been that those efforts were almost certainly doomed to fail, with youth accessing what are often easy-to-conceal vaping products with relatively little difficulty through their social networks.

    With vapor companies having invested heavily in age verification software, point-of-sale restrictions and in the removal of flavored e-liquids, it would have been a bitter pill to swallow to be told that the regulators had largely ignored those efforts to reduce youth access to their products.

    The logic behind the FDA’s decision seems to have been that it would be easier to expedite the large number of premarket tobacco product applications (PMTAs) by adopting a “Fatal Flaw” approach—rejecting those applications that did not present data from either longitudinal customer studies or randomized trial evaluations and simply ignoring what the companies were doing to lessen the likelihood that their products would be found in the hands of youth.

    By ruling against the FDA in legal action initiated by six vapor companies that had received marketing denial orders without the FDA even paying attention to their youth sales restriction efforts, the judges have effectively provided vapor companies with a second chance to have their PMTA applications reassessed.

    So, what should vapor companies do given the legal victory that has been dropped in their lap? Clearly, it is going to be important for companies to do all they can to restrict youth access to their vapor products. But actions taken by these companies is not the same thing as being able to present evidence to the FDA that their products are not being used by youth.

    To this end, research undertaken by the Centre for Substance Use Research (CSUR) in Scotland may help many of the companies concerned. For the last two years, the CSUR has been measuring the prevalence with which over 200 e-cigarette devices are being used by youth and adults within the United States. This ongoing research provides vapor companies with product-specific data showing the extent to which their products are being used, or more crucially, are not being used by youth.

    Valuable as the data from this study undoubtedly are, vapor companies also have to be able to show the benefit of their products to adult smokers. The fastest route to obtaining this data is through an actual use study in which adult smokers using a company’s vapor products are monitored over a number of weeks to determine how many smokers are able to quit or reduce their cigarette smoking through using the company’s vapor products.

    To obtain a marketing authorization, vapor companies have to be able to show two things—that their products are not being used by youth and that they can help adult smokers in quitting or reducing cigarette consumption. Succeed in these two things and vapor companies can have a bright future. Fail in either one and the future looks a lot bleaker.

    Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.