FDA Commissioner Gottlieb Resigns

Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, has resigned after about 2 years (1). Gottlieb was a controversial appointee by the Trump administration due to his ties to the pharmaceutical industry. However, he stood out in the anti-regulatory Trump administration, where some officials such as Scott Pruitt, the former head of the Environmental Protection Agency, appeared intent on reducing the clout of the departments and agencies they headed. For nearly two years, Gottlieb has avidly promoted the FDA, inserting the agency into important health issues and sometimes taking on industries regulated by the agency.

Under Gottlieb’s leadership the FDA has made sweeping moves to lower smoking and vaping amongst minors. Gottlieb’s departure could throw into question other controversial tobacco initiatives he championed that have not yet emerged from the FDA, including proposals to ban menthol cigarettes and to reduce nicotine levels in cigarettes. In his resignation letter to Health and Human Services Secretary, Alex Azar, Gottlieb listed his accomplishments, including accelerating the approval of generic drugs and modernizing the process for handling novel gene and precision therapies to treat those with cancer.

The resignation took some senior FDA officials by surprise, and came as Gottlieb’s signature issue – youth vaping – is being reviewed by the White House Office of Management and Budget. The plan, detailed by Gottlieb last fall, would sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping, which he argues could lead to a whole new generation addicted to nicotine.

Gottlieb, who has been commuting weekly to Washington from his home in Connecticut, said he wants to spend more time with his family. The resignation was apparently not sought by the White House. A senior White House official said Gottlieb had spoken to President Trump, and that the president liked the FDA chief and did not want him to leave. While Gottlieb had some policy disagreements with the White House, he is well respected, and could even be asked to take another post, said two officials. Gottlieb declined to comment on that possibility.

Most praised Gottlieb including his predecessor, Robert Califf, and Friends of Cancer Research and Tobacco Free Kids (1). However, he was not without his critics. Pieter Cohen, an associate professor at Harvard Medical School who conducts research into the safety of dietary supplements, faulted Gottlieb for not taking significant action on major safety problems involving dietary supplements. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, criticized Gottlieb’s opioid policy. “I am concerned, because he seems to have a tendency to spend most of his time talking and very little of his time implementing policy.” The advocacy group Public Citizen said that Gottlieb’s time as the agency's head "was marked by regulatory decision making regarding medications and medical devices that tilted further in favor of industry's financial interests rather than the interests of public health (2).” The group cited the controversial approval in April of an opioid called Dsuvia, which is 10 times more powerful than fentanyl.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Laurie McGinley L, Bernstein L, Dawsey J.  FDA Commissioner Gottlieb, who raised alarms about teen vaping, resigns. Washington Post. March 5, 2019. Available at: https://www.washingtonpost.com/health/2019/03/05/fda-commissioner-gottlieb-who-raised-alarms-about-teen-vaping-resigns/?utm_term=.b50dd0bbb2ae (accessed 3-6-19).
2. Scutti S, Diamond J, Goldschmidt D. FDA Commissioner Dr. Scott Gottlieb to resign next month. CNN Politics. March 5, 2019. Available at: https://www.cnn.com/2019/03/05/politics/gottlieb-resigning-fda-health-bn/index.html (accessed 3-6-19).

Cite as: Robbins RA. FDA commissioner Gottlieb resigns. Southwest J Pulm Crit Care. 2019;18(3):65-6. doi: https://doi.org/10.13175/swjpcc012-19 PDF 

Younger Smokers Continue to Smoke as Adults: Implications for Raising the Smoking Age to 21

A review article published in Pediatrics assesses the evidence that smoking is particularly harmful the younger a smoker begins (1). Not only do youths tend to accumulate more pack-years but they have more difficulty quitting. The recent shift in smoking trends from tobacco cigarettes to e-cigarettes may not be helpful since both contain the addictive component, nicotine. Although e-cigarettes are marketed as a smoking cessation tool, there is no strong evidence to support these claims, the authors report.

"I think most people realize nicotine is addictive, but I don't know if there's an understanding of just how addictive it is – particularly for youths," said Lorena M. Siqueira, MD, MSPH, lead author of the report (2).

Evidence shows that the earlier in life a person is exposed to nicotine, the more likely they will consume greater quantities and the less likely they will be able to quit (1,2). The vast majority of tobacco-dependent adults (>99%) started smoking before age 26 years. Approximately two thirds of children who smoke in sixth grade, become regular smokers as adults. In comparison, 46% of youth who begin smoking in the eleventh grade go on to become regular smokers as adults. Youths require more attempts to quit smoking before being successful compared to adults. Only about 4% of smokers aged 12 to 19 years have been shown to successfully quit each year.

"There are now seven published longitudinal studies showing that youths who initiate smoking with e-cigarettes are about three times more likely to be smoking conventional cigarettes a year later," said Stanton A. Glantz, PhD, of the Center for Tobacco Research and Education at the University of California and a coauthor of the review (2). Instead of making quitting easier, e-cigarettes make it harder, Dr. Glantz added.

An Institute of Medicine report notes that the age of initiation of smoking is critical (3). The report estimates that that raising the minimum age for the sale of tobacco products to 21 will, over time, reduce the smoking rate by about 12 percent. This reduction is estimated to result in reducing smoking-related deaths by 10 percent, which translates into 223,000 fewer premature deaths, 50,000 fewer deaths from lung cancer, and 4.2 million fewer years of life lost (3).

These data may prove valuable in evaluating the potential health impact of this legislation.  California became the second state to raise the tobacco sale age to 21 in 2016, joining Hawaii (3). At least 210 localities have raised the tobacco age to 21, including New York City, Chicago, Boston, Cleveland, Kansas City and Cottonwood, Arizona. Statewide legislation to do so is being considered in several other states and will probably be introduced in Arizona during this legislative session.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Siqueira LM; Committee on Substance Use and Prevention. Nicotine and tobacco as substances of abuse in children and adolescents. Pediatrics. 2017 Jan;139(1):e20163436. [CrossRef] [PubMed]
2. Melville NA. Nicotine's highly addictive impact on youth underestimated. Medscape. January 3, 2017. Available at: http://www.medscape.com/viewarticle/873955?nlid=111769_2863&src=wnl_dne_170104_mscpedit&uac=9273DT&impID=1266832&faf=1 (accessed 1/5/17).
3. Campaign for Tobacco Free Kids. Increasing the minimum legal sale age for tobacco products to 21. Available at: https://www.tobaccofreekids.org/research/factsheets/pdf/0376.pdf (accessed 1/5/17).

Cite as: Robbins RA. Younger smokers continue to smoke as adults: implications for raising the smoking age to 21. Southwest J Pulm Crit Care. 2017;14(1):24-5. doi: https://doi.org/10.13175/swjpcc002-17 PDF

Smoking Rates Low in Southwest

The Gallup survey confirms that smoking rates in the US are declining and that smoking rates are lower in the Southwest than the US as a whole (1). Nationally, the smoking rate fell to 19.7% in 2013 from 21.1% in 2008. Among the Southwest states California ranked second (15.0%), Colorado ninth (17.4%), and Arizona tenth (17.5%). Only New Mexico was above the Nation's average at 20.0%. Utah remains the state with the lowest percentage of smokers, 12.2 percent, and Kentucky the highest, 30.2 percent.

Nine of the 10 states with the lowest smoking rates have outright bans on smoking in private worksites, restaurants, and bars, with California allowing for ventilated rooms. Bans are significantly less common in the 10 states with the highest smoking rates. Kentucky, West Virginia, and Mississippi -- the states with the three highest smoking rates -- do not have statewide smoking bans. In addition, these three states have some of the lowest average cost of a pack of cigarettes (2).

The Campaign for Tobacco-Free Kids has identified access to tobacco as a major factor in youth smoking (3). However, tobacco products still remain readily accessible. Recently, CVS, the National chain of pharmacies, announced that it will no longer sell cigarettes (4). A recent New York Times op-ed called for Walgreen’s to do the same (5).

Richard A. Robbins, MD

Editor

References

1. McCarthy J. In U.S., Smoking Rate Lowest in Utah, Highest in Kentucky. Available at: http://www.gallup.com/poll/167771/smoking-rate-lowest-utah-highest-kentucky.aspx?utm_source=rss&utm_medium=rss&utm_campaign=in-u-s-smoking-rate-lowest-in-utah-highest-in-kentucky-smoking-rate-in-alaska-has-dropped-the-most-since-2008 (accessed 4/12/14).
2. Boonn A. Campaign for tobacco-free kids. Available at: https://www.tobaccofreekids.org/research/factsheets/pdf/0202.pdf (accessed 4/12/14).
3. Campaign for tobacco-free kids. Enforcing laws prohibiting cigarette sales to kids reduces youth smoking. Available at: http://www.tobaccofreekids.org/research/factsheets/pdf/0049.pdf (accessed 4/12/14).
4. CVS quits for good. Available at: http://info.cvscaremark.com/cvs-insights/cvs-quits (accessed 4/12/14).
5. Bach PS. The tobacco ties that bind. New York Times. 4/10/14. Available at: http://www.nytimes.com/2014/04/11/opinion/the-tobacco-ties-that-bind.html?_r=0 (accessed 4/12/14).

Reference as: Robbins RA. Smoking rates low in southwest. Southwest J Pulm Crit Care. 2014;8(4):233. doi: http://dx.doi.org/10.13175/swjpcc051-14 PDF