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← The past, present and future of nicotine addiction

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Showing Revision 6 created 01/06/2020 by Erin Gregory.

  1. I'm going to tell you a story.
  2. I'm going to tell you a story
  3. about how the deadliest
    consumer product imaginable
  4. came to be.
  5. It's the cigarette.
  6. The cigarette is the only consumer product
  7. that, when used as intended,
  8. will kill half of all long-term users
    prematurely, later in life.
  9. But this is also a story
  10. about the work that we're doing
    at the Food and Drug Administration,
  11. and specifically,
    the work that we're doing
  12. to create the cigarette of the future,
  13. that is no longer capable
    of creating or sustaining addiction.
  14. A lot of people think that
    the tobacco problem or the smoking problem

  15. has been solved in the United States
  16. because of the great progress
    that's been made
  17. over the last 40, 50 years,
  18. when it comes to both
    consumption and prevalence.
  19. And it's true;
  20. smoking rates are at historic lows.
  21. It's true for both adults and for kids.
  22. And it's true that those
    who continue to smoke
  23. are smoking far fewer cigarettes per day
  24. than at any time in history.
  25. But what if I told you
    that tobacco use,

  26. primarily because of firsthand
    and secondhand exposure
  27. to the smoke in cigarettes,
  28. remains the leading cause of completely
    preventable disease and death
  29. in this country?
  30. Well, that's true.
  31. And what if I told you
    that it's actually killing more people
  32. than we thought
    to be the case ever before?
  33. That's true, too.
  34. Smoking kills more people each year
    than alcohol, AIDS, car accidents,
  35. illegal drugs, murders
    and suicides combined.
  36. Year in and year out.
  37. In 2014,

  38. Dr. Adams's predecessor released
  39. the 50th anniversary
    Surgeon General's report
  40. on smoking and health.
  41. And that report upped the annual
    death toll from smoking,
  42. because the list
    of smoking-related illnesses
  43. got bigger.
  44. And so it is now conservatively estimated
  45. that smoking kills
    480,000 Americans every year.
  46. These are completely preventable deaths.
  47. How do we wrap our heads around
    a statistic like this?

  48. So much of what we've heard
    at this conference
  49. is about individual experiences
    and personal experiences.
  50. How do we deal with this
    at a population level,
  51. when there are 480,000 moms,
  52. dads, sisters, brothers, aunts and uncles
  53. dying unnecessary deaths
    every year from tobacco?
  54. And then what happens
    when you think about this trajectory

  55. for the future?
  56. And just do the simple math:
  57. from the time of the 50th anniversary
    Surgeon General's report five years ago,
  58. when this horrible statistic was raised,
  59. just through mid-century --
  60. that's more than 17 million
    avoidable deaths in the United States
  61. from tobacco use,
  62. primarily because of cigarettes.
  63. The Surgeon General concluded
  64. that 5.6 million children
    alive in the United States in 2014
  65. will die prematurely later in life
    because of cigarettes.
  66. Five point six million children.
  67. So this is an enormous
    public health problem for all of us

  68. but especially for us as regulators
  69. at the Food and Drug Administration
    and the Center for Tobacco Products.
  70. What can we do about it?
  71. What can we do to reverse this trajectory
    of disease and death?
  72. Well, we have an interesting guide
    to help unravel issues

  73. like: How did the cigarette
    as we know it come to be?
  74. What is the true nature
    of the tobacco and cigarette business?
  75. How did the industry behave
  76. in the historically
    unregulated marketplace?
  77. And our guide
  78. is previously secret internal documents
    from the tobacco industry.
  79. Come with me
  80. in a tobacco industry
    document time machine.
  81. Nineteen sixty-three

  82. was 25 years before the Surgeon General
    was finally able to conclude
  83. that the nicotine
    and cigarettes was addictive.
  84. That did not happen until
    the Surgeon General's report in 1998.
  85. Nineteen sixty-three
  86. was one year before the first-ever
    Surgeon General's report in 1964.
  87. I remember 1964.

  88. I don't remember
    the Surgeon General's report,
  89. but I remember 1964.
  90. I was a kid growing up
    in Brooklyn, New York.
  91. This was at a time
  92. when almost one in two adults
    in the United States smoked.
  93. Both of my parents
    were heavy smokers at the time.
  94. Tobacco use was so incredibly normalized
  95. that -- and this wasn't North Carolina,
    Virginia or Kentucky,
  96. this was Brooklyn --
  97. we made ashtrays for our parents
    in arts and crafts class.
  98. (Laughter)

  99. The ashtrays I made were pretty awful,
    but they were ashtrays.

  100. (Laughter)

  101. So normalized that I remember seeing
    a bowl of loose cigarettes in the foyer

  102. of our house and other houses
  103. as a welcoming gesture
    when friends came over for a visit.
  104. OK, we're back in 1963.

  105. The top lawyer for Brown and Williamson,
  106. which was then the third-largest
    cigarette company in the United States,
  107. wrote the following:
  108. "Nicotine is addictive.
  109. We are, then, in the business
    of selling nicotine -- an addictive drug."
  110. It's a remarkable statement,
  111. as much for what it doesn't say
    as for what it does say.
  112. He didn't say they were
    in the cigarette business.
  113. He didn't say they were
    in the tobacco business.
  114. He said they were in the business
    of selling nicotine.
  115. Philip Morris in 1972:

  116. "The cigarette isn't a product,
  117. it's a package.
  118. The product is nicotine.
  119. The pack is a storage container
    for a day's supply of nicotine.
  120. The cigarette, a dispenser
    for a dose unit of nicotine."
  121. We'll come back to this
    dose unit notion later.
  122. And R.J. Reynolds in 1972:

  123. "In a sense, the tobacco industry
    may be thought of as being a specialized,
  124. highly ritualized and stylized segment
    of the pharmaceutical industry.
  125. Tobacco products uniquely
    contain and deliver nicotine,
  126. a potent drug with a variety
    of physiological effects."
  127. At the time, and for many
    decades, publicly,

  128. the industry completely denied addiction
  129. and completely denied causality.
  130. But they knew the true nature
    of their business.
  131. And from time to time,
  132. there have been health scares
    made public about cigarettes,
  133. going back many decades.
  134. How did the industry respond?
  135. And how did they respond
  136. in this historically
    unregulated marketplace?
  137. Going back to the 1930s,

  138. it was with advertising
    that heavily featured imagery of doctors
  139. and other health care professionals
  140. sending messages of reassurance.
  141. This is an ad for Lucky Strikes,
  142. the popular cigarette
    of the time in the '30s:
  143. [20,679 physicians
    say "Luckies are less irritating."

  144. Your throat protection
    against irritation, against cough.]
  145. (Laughter)

  146. We laugh,

  147. but this was the kind of advertising
  148. that was there to send
    a health message of reassurance.
  149. Fast-forward to 1950s, '60s and '70s.

  150. And here, again,
    in the absence of regulation,
  151. what we're going to see
    is modifications to the product
  152. and product design
  153. to respond to the health
    concerns of the day.
  154. This is the Kent Micronite filter.

  155. And here, the innovation, if you will,
    was the filtered cigarette.
  156. [Full smoking pleasure ...

  157. plus proof of the greatest
    health protection ever.]
  158. What the smoker
    of this product didn't know,

  159. what their doctor didn't know,
  160. what the government didn't know,
  161. is that this was a filter
    that was lined with asbestos --
  162. (Gasps)

  163. so that when smokers
    were smoking this filtered cigarette
  164. and still inhaling the chemicals and smoke
  165. that we know are associated
    with cancer and lung disease
  166. and heart disease,
  167. they were also sucking down
    asbestos fibers.
  168. (Gasps)
  169. In the 1960s and the 1970s,

  170. the so-called innovation
    was the light cigarette.
  171. This is a typical brand
    of the day called True.
  172. And this is after the Surgeon General's
    reports have started coming out.
  173. And you see the look
    of concern on her face.
  174. [Considering all I'd heard,

  175. I decided to either quit
    or smoke True.
  176. I smoke True.]
  177. (Laughter)

  178. [The low tar, low nicotine cigarette.]

  179. And then it says, "Think about it."
  180. And then even below that
    in the small print
  181. are tar numbers and nicotine numbers.
  182. What was a light cigarette?
  183. How did it work?
  184. This is an illustration
    of the product modification

  185. known as "filter ventilation."
  186. That's not a real filter blown up.
  187. That's just a picture
  188. so that you could see the rows
    of laser-perforated ventilation holes
  189. that were put on the filter.
  190. When you look at a real cigarette,
  191. it's harder to see.
  192. Every patent for this product shows
  193. that the ventilation holes
    should be 12 millimeters
  194. from the lip end of the filter.
  195. How did it work?
  196. The cigarette got stuck into a machine.

  197. The machine started
    puffing away on the cigarette
  198. and recording tar and nicotine levels.
  199. As the machine smoked,
  200. outside air came through
    those ventilation holes
  201. and diluted the amount of smoke
    that was coming through the cigarette.
  202. So as the machine smoked,
  203. there really was less tar
    and nicotine being delivered
  204. compared to a regular cigarette.
  205. What the tobacco industry knew
  206. was that human beings
    don't smoke like machines.
  207. How do human beings smoke this?
  208. Where do the fingers go?
  209. (Murmurs)

  210. Where do the lips go?

  211. I told you that the patent said
  212. that the holes are 12 millimeters
    from the lip end.
  213. The smoker didn't even know
    they were there,
  214. but between fingers and lips,
    the holes get blocked.
  215. And when the holes get blocked,
    it's no longer a light cigarette.
  216. Turns out that there's actually
  217. basically as much nicotine
    inside a light cigarette
  218. as a regular cigarette.
  219. The difference was what's on the outside.
  220. But once you block what's on the outside,
  221. it's a regular cigarette.
  222. Congress put FDA in the business
    of regulating tobacco products

  223. 10 years ago this June.
  224. So you heard the statistics
    at the beginning
  225. about the extraordinary contribution
    to disease and death that cigarettes make.
  226. We've also been paying a lot of attention
  227. to how the cigarette works
    as a drug-delivery device
  228. and the remarkable efficiency
    with which it delivers nicotine.
  229. So let's take a look.
  230. When the smoker puffs on the cigarette,
  231. the nicotine from that puff
    gets up into the brain
  232. in less than 10 seconds.
  233. Less than 10 seconds.
  234. Up in the brain,
  235. there are these things
    called "nicotinic receptors."
  236. They're there ...
  237. waiting.
  238. They're waiting for, in the words
    of that Philip Morris document,
  239. the next "dose unit of nicotine."
  240. The smoker that you see outside,

  241. huddled with other smokers,
  242. in the cold,
  243. in the wind,
  244. in the rain,
  245. is experiencing craving
  246. and may be experiencing
    the symptoms of withdrawal.
  247. Those symptoms of withdrawal
    are a chemical message
  248. that these receptors
    are sending to the body,
  249. saying, "Feed me!"
  250. And a product that can deliver the drug
    in less than 10 seconds
  251. turns out to be an incredibly efficient
    and incredibly addictive product.
  252. We've spoken to so many
    addiction treatment experts
  253. over the years.
  254. And the story I hear is the same
    over and over again:
  255. "Long after I was able
    to get somebody off of heroin
  256. or cocaine or crack cocaine,
  257. I can't get them to quit cigarettes."
  258. A large part of the explanation
    is the 10-second thing.
  259. FDA has it within its regulatory reach

  260. to use the tools of product regulation
  261. to render cigarettes as we know them
    minimally or nonaddictive.
  262. We're working on this.
  263. And this could have a profound
    impact at a population level
  264. from this one policy.
  265. We did dynamic population-level
    modeling a year ago,
  266. and we published the results
    in "The New England Journal."
  267. And because of the generational
    effect of this policy,
  268. which I'll explain in a minute,
  269. here's what we project out
    through the end of the century:
  270. more than 33 million people
  271. who would otherwise have gone on
    to become regular smokers won't,
  272. because the cigarette
    that they'll be experimenting with
  273. can't create or sustain addiction.
  274. This would drive the adult smoking rate
    down to less than one and a half percent.
  275. And these two things combined
  276. would result in the saving of more than
    eight million cigarette-related deaths
  277. that would otherwise have occurred
  278. from the generational impact of this.
  279. Now, why am I saying "generational"?

  280. It's about kids.
  281. Ninety percent of adult smokers
    started smoking when they were kids.
  282. Half of them became regular smokers
  283. before they were legally old enough
    to buy a pack of cigarettes.
  284. Half of them became regular smokers
    before they were 18 years old.
  285. Experimentation.
  286. Regular smoking.
  287. Addiction.
  288. Decades of smoking.
  289. And then the illness,
  290. and that's why we're talking
    about a product
  291. that will kill half of all long-term users
    prematurely later in life.
  292. The generational impact
    of this nicotine-reduction policy
  293. is profound.
  294. Those old industry documents
    had a word for young people.
  295. They were described as
    "the replacement smokers."
  296. The replacement smokers
    for addicted adult smokers
  297. who died or quit.
  298. Future generations of kids,
    especially teens,

  299. are going to engage in risky behavior.
  300. We can't stop that.
  301. But what if the only cigarette
    that they could get their hands on
  302. could no longer create
    or sustain addiction?
  303. That's the public health
    return on investment
  304. at a population level over time.
  305. Haven't said anything about e-cigarettes.

  306. But I have to say something
    about e-cigarettes.
  307. (Laughter)

  308. We are dealing with an epidemic
    of kids' use of e-cigarettes.

  309. And what troubles us the most,
  310. in combination with the rising numbers
    when it comes to prevalence,
  311. is frequency.
  312. Not only are more kids using e-cigarettes,
  313. but more kids are using e-cigarettes
    20 or more days in the past 30 days
  314. than at any time since e-cigarettes
    came onto the market.
  315. And at FDA, we're doing
    everything that we can
  316. using program and policy,
  317. first to get the word out to kids
  318. that this is not a harmless product
  319. and to make sure that kids
    aren't initiating and experimenting
  320. on any tobacco product,
  321. whether combustion is present or not.
  322. But think about e-cigarettes
    in a properly regulated marketplace
  323. as something that could be of benefit
  324. to addicted adult cigarette smokers
  325. who are trying to transition
    away from cigarettes.
  326. So, I'll leave you with this vision:

  327. imagine a world
  328. where the only cigarette
    that future generations of kids
  329. could experiment with
  330. could no longer create
    or sustain addiction
  331. because of a single policy.
  332. Imagine a world
  333. where health-concerned cigarette smokers,
  334. especially if a policy goes into effect
  335. that takes the nicotine levels down
    to minimally or nonaddictive levels,
  336. could transition to alternative
    and less harmful forms
  337. of nicotine delivery,
  338. starting with FDA-approved
    nicotine medications,
  339. like the gum, patch and lozenge.
  340. And finally,

  341. imagine a world and a properly
    regulated marketplace,
  342. whether it's e-cigarettes
    or whatever the technology of the day,
  343. it's not the product developers
    and the marketers
  344. who decide which products come to market
  345. and what claims get made for them,
  346. it's review scientists at FDA,
  347. who look at applications
  348. and decide, using the standard
    that Congress has entrusted us
  349. to implement and enforce,
  350. whether a particular product
    should come to market,
  351. because the marketing of that product
    and the words of our law
  352. would be appropriate for the protection
    of the public health.
  353. These are the kinds
    of powerful regulatory tools
  354. that are within our reach
  355. to deal with what remains
  356. the leading cause of completely
    preventable disease and death
  357. in the country.
  358. If we get this right,
  359. that trajectory,
    those 5.6 million kids,
  360. is breakable.
  361. Thank you.

  362. (Applause)