trointestinal absorption of antibiotics by measuring their concentration in serum (or by using the less standardized and more cumbersome test of serum bactericidal activity) is not burdensome or costly and can detect the occasional patient who requires ad-justment in dosage and the rare patient who has slow, incomplete absorption of drug and is not a suitable candidate for oral therapy. There should be no rigid duration of antibiotic therapy; each case is evaluated individually. Prolongation of antibiotic treatment beyond 3 to 4 weeks is often needed if there has been delayed or incomplete surgical evac-uation of pus or if there are other foci of infection in disseminated staphylococcal disease. In my opinion, the “cookbook” approach of standardized manage-ment is not appropriate in a disease with varied manifestations and variable course.
John D. Nelson, MD Department of Pediatrics
University of Texas Southwestern Medical Center Dallas, TX 75235-9063
REFERENCES
1. Nelson JD. Oral antibiotic therapy for serious infections in hospitalized patients. J Pediatr. 1978;92:175–176
2. Peltola H, Unkila-Kallio L, Kallio MJT, Finnish Study Group. Simplified treatment of acute staphylococcal osteomyelitis of childhood. Pediatrics. 1997;99:846 – 850
3. Nelson JD. Osteomyelitis. In: Krugman S, Katz SL, Gershon AA, Wilfert CM, eds. Infectious Diseases of Children. 9th ed. St. Louis, MO: Mosby Year Book; 1992:273–284
4. Syriopoulu VPh, Smith AL. Osteomyelitis and septic arthritis. In: Feigin RD, Cherry JD, eds. Textbook of Pediatric Infectious Diseases. 3rd ed. Philadelphia, PA: Harcourt Brace Jovanovitch; 1992:727–740 5. Aronoff SC. Osteomyelitis. In: Jenson HB, Baltimore RS, eds. Pediatric
Infectious Diseases. Principles and Practice. Norwalk, CT: Appleton & Lange; 1995:1277–1285
6. Gutierrez KM. Osteomyelitis. In: Long SS, Pickering LK, Prober CG, eds. Principles and Practice of Pediatric Infectious Diseases. New York, NY: Churchill Livingstone; 1997:528 –537
7. Tetzlaff TR, McCracken Jr GH, Nelson JD. Oral antibiotic therapy for skeletal infections of children II. Therapy of osteomyelitis and suppu-rative arthritis. J Pediatr. 1978;92:485– 490
8. Syrogiannopoulos GA, Nelson JD. Duration of antimicrobial therapy for acute suppurative osteoarticular infections. Lancet. 1988;1:37– 40
The Food and Drug
Administration’s Rule on Tobacco:
Blending Science and Law
In February 1997, the first provisions of the Food and Drug Administration’s (FDA’s) regulation of the sale and advertising of tobacco products went into effect. The rule, based on a more than 2-year investigation and published in August 1996,1–3is a careful blend of
sci-ence, public health policy, and relevant law.aDesigned to keep cigarettes and smokeless tobacco out of the hands of minors, the FDA’s rule could prevent millions of premature deaths from tobacco-caused disease.
Although no single factor produced the FDA’s tobacco rule, science was the key starting point. The FDA’s examination of the scientific literature on nic-otine’s addictiveness and drug-like effects, as well as previously private tobacco industry documents showing that the companies understood nicotine’s pharmacological impact, led the FDA to conclude that nicotine-containing tobacco products are subject to its jurisdiction under the federal Food, Drug and Cosmetic Act.4
Once the FDA found, based on the evidence before it, that it had jurisdiction, the agency faced a simple, yet difficult, public health question: What should it do? The agency concluded that an out-right ban would cause serious problems. Studies suggest that 77% to 92% of the more than 50 mil-lion Americans who currently smoke cigarettes5
are addicted to nicotine.6 – 8 Abruptly depriving
them of nicotine would cause significant health problems and would likely lead to a black market for tobacco products.
Epidemiologic studies suggested that the real fo-cus should be on adolescents. New smokers primar-ily come from the ranks of the young. Every day, nearly 3000 young people start smoking; that’s more than 1 million annually.9 Eighty-two percent of
adults who ever smoked had their first cigarette before age 18, and more than half of them had al-ready become regular smokers by that age.10Only a
few percent of smokers began after they reached adulthood.
The studies strongly suggest that if children can be guided through their teenage years without becom-ing addicted to nicotine, the likelihood of becombecom-ing life-long tobacco users drops dramatically. Conse-quently, the FDA focused its rule-making on adoles-cents with the goal of reducing by half the number of teenagers who begin using tobacco products.
When the FDA calculated the tobacco rule’s long-term benefit, the results were impressive. If the num-ber of new teenage tobacco users is cut in half, the agency predicts that 60 000 smoking-related deaths would be prevented annually, and more than 900 000 future-life years would be saved for each year’s co-hort of teenagers who would otherwise begin to smoke.
Although it is impossible to put an absolute value on human life, the financial impact from the rule could be substantial. In economic terms, this im-proved health and life-years saved is valued at from $28 to $43 billion per year.bEven if these regulations achieved only a minimal reduction in the number of
Received for publication Mar 5, 1997; accepted Mar 21, 1997.
Reprint requests to (L.J.T.) Food and Drug Administration, 5600 Fishers Lane, Room 14-57, Rockville, MD 20857.
PEDIATRICS (ISSN 0031 4005). Copyright © 1997 by the American Acad-emy of Pediatrics.
aThe tobacco industry, and others, have filed suit in Federal District Court
in North Carolina challenging the regulation.
b“Willingness to pay” provides a means to value the amount that society
teenagers who begin to smoke, say only 1 out of 20, it would still produce a significant benefit of between $2.8 billion and $4.3 billion.
Achieving these results, however, will require more than the access restrictions that went into effect in February 1997. They only prohibit retailers from selling cigarettes or smokeless tobacco products to anyone younger than age 18. Retailers are required to ask for photo identification from anyone younger than age 27.
Every state, however, already prohibits tobacco sales to minors, yet these laws have done little to reduce teenage tobacco use. In August 1997 the FDA will further restrict access by banning vending ma-chines in locations where adolescents can access them, eliminating free samples, and removing self-service displays from retail outlets.
Because the FDA also seeks to reduce demand for tobacco products by young people, the rule includes a comprehensive set of restrictions on tobacco adver-tising and promotion. The reason is simple: tobacco products are among the most heavily advertised products in this countryc and studies show that young people are particularly susceptible to the mes-sages. Children as young as 3 recognize the tobacco icon Joe Camel, and know that he sells cigarettes.11,12
(Research conducted for Reynolds by Mizerski found that the recognition rate of Joe Camel by 3- to 6-year-olds exceeded their recognition rate of Ronald Mc-Donald, an icon of fast food). What’s more, the mes-sages are everywhere: in print media, on billboards, at point of sale, by direct mail, on items such as hats, tee shirts, at concerts and sporting events, on race cars, at sponsored events on television, and in other media. The ubiquity creates a “friendly familiarity” that makes smoking seem respectable and “fosters an environment in which experimentation by youth is expected, if not implicitly encouraged.13
Advertising appears to be disproportionately ef-fective with young people. Although 86% of young smokers prefer the three most heavily advertised brands (Marlboro, Camel, Newport), the most pop-ular “brands” among adults are the “price value” or generic brands that are not supported by major ad-vertising campaigns, but appeal through low price.14,15
Experts in adolescent behavior and tobacco indus-try documents describe how advertising can affect young people’s tobacco use. Young people begin using tobacco for a complex set of reasons that in-clude the “interplay of sociodemographic, environ-mental, behavioral and personal factors.16
Adoles-cence is a time of “identity formation.” Young people carefully try to control the image they present as they strive for the dual goals of social acceptance and individual autonomy.17
Tobacco advertising plays on these needs. The Marlboro Man, Joe Camel, and the Virginia Slim woman exude romance, success, sophistication, pop-ularity, adventure, and risk-taking that advertising associates with particular brands of cigarettes. Young people use these product images as badges to define themselves.18The tobacco industry itself
con-curred in this description of the role of advertising in comments to the FDA:
The personal display of products with commercial logo— through dress and other forms of expression—is a form of participation in American popular culture. It is a way to register a group identity to signal one’s place in the social fabric.19
In a previously nonpublic company document, a researcher from one of the major tobacco companies described the role advertising plays for a young per-son:
The causes of initial brand selection relate directly to the reasons a young person smokes. The more closely a brand meets the psychological “support” needs (advertising or oth-erwise communicated brand or physiological needs. . . , the more likely it is that a given brand will be selected. . . . To some extent young smokers “wear” their cigarettes and it becomes an important part of the “I” they wish to be, along with their clothing and the way they style their hair.20
Together, marketing theory and social psychology theory explain why tobacco advertising has such a powerful effect on young people. For example, the “elaboration-likelihood model of persuasion” exam-ines how people viewing an advertisement process the information it contains and how it affects their behavior.21The model states that people process
per-suasive messages in one of two ways: directly or indirectly.22 When people process information
di-rectly, they read the message, or information, and think carefully about it. This type of processing re-quires motivation, knowledge, and ability.23
On the other hand, when people process indi-rectly, they are not really trying to understand the content of the messages but are persuaded by cues. People will process indirectly if they are not paying careful attention or are unmotivated or unable to carefully consider the arguments in a message. They are more likely to be influenced by the imagery or the color that attracts their attention.24
Young people process tobacco messages primarily through an indirect mechanism.25 According to the
American Psychological Association, children and adolescents react differently to tobacco advertising than adults.26 Children generally have less
informa-tion-processing ability than adults, and they are less able or less willing to pay attention to the factual information in advertisements.
Empirical studies and surveys of tobacco advertis-ing27 show that children are exposed to substantial
and unavoidable tobacco advertising, that exposure to tobacco advertising leads to favorable beliefs about tobacco use,28 –35 and that advertising plays a
role in leading young people to overestimate the
cThe FTC reported that for the year 1993 more than $6 billion was spent by
the cigarette and smokeless tobacco industry on advertising and promo-tion.—Report to Congress for 1993, Pursuant to the Federal Cigarette Labeling and Advertising Act. Federal Trade Commission Table 3 and 3D, 1995; Federal Trade Commission Report to Congress: Pursuant to the Comprehensive Smokeless Tobacco Health Education Act of 1986. 1995;25–35. The FTC reported that for 1994, the cigarette industry spent $4.83 billion on advertising and promo-tion, almost a 20 percent decline from the previous year. This is the first such decline since 1986. Almost the entire decline is accounted for by a drastic cut in expenditures for coupons and retail value added (price incentives). Report to Congress for 1994, Pursuant to the Federal Cigarette Labeling and Advertising Act, Federal Trade Commission Table 3 and 3E, page 8, 1996.
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prevalence of tobacco use.36 – 41 Moreover, individual
empirical studies42– 45and a large, multi-country
sur-vey46have found that advertising is related to young
people’s tobacco use and that advertising can and does increase tobacco consumption.
Several countries have restricted tobacco advertis-ing, and studies show that such restrictions, when fully implemented, do reduce tobacco use among children and adolescents.47–51
The FDA’s regulations will restrict tobacco adver-tising seen by young people to black-and-white text only.dThis will affect magazines with significant ad-olescent readership, in-store advertising, and bill-boards. Outdoor tobacco advertising within 1000 feet of schools and playgrounds will be prohibited.
In addition to traditional advertising media, evi-dence has shown that nontraditional forms of adver-tising and promotion are instrumental in affecting young people’s attitudes towards and use of tobacco. Several surveys document the popularity of specialty items such as hats, sporting goods and tee shirts that carry tobacco brand logos with young people.52,53
One of these studies found that about half of young smokers and one quarter of nonsmokers owned at least one of these items.54 Another recent study
re-ported that participation in tobacco company promo-tions (owning an item, collecting coupons for gifts, or owning a catalog) by 12- to 17-year-olds is more predictive of “susceptibility of tobacco use” than if a friend or relative smokes.55 Therefore, the agency
determined that hats, tee shirts, and other specialty items bearing brand names or logos must be prohibited.
The agency also determined that tobacco compa-nies’ sponsorship of events, such as NASCAR or rodeos, must be carried out only in the corporate name of the company (ie, RJ Reynolds Cup NASCAR Series instead of the Winston Cup). Four separate studies found that sponsored events are attended, and seen on television, by a substantial number of young people, and that the effect of the exposure is to increase brand awareness and association between the brand and the event.56 –59 The sponsorship of an
event in a brand name associates adventure, risk-taking, and hero worship with the brand and con-tributes to a perception that tobacco use is acceptable and commonplace.
The agency has indicated that it may also seek a company-funded education campaign to teach young people about the risks of tobacco and how those risks apply to them.e
Studies show that young people know that tobacco
use can cause disease, but do not believe they them-selves will face any long-term risks or tend to dis-count these risks. In one study, only half of high school seniors who smoke, compared with three-quarters of those who do not smoke, said that smok-ing 1 pack or more per day is a serious health risk.60
In addition, although young people say that nicotine is addicting, those who smoke believe that they themselves will quit; unfortunately, many do not.61
The antismoking messages on television, man-dated by the Federal Communications Commission during the late 1960s, provide a good example of an education program that had the desired effect. At that time, broadcasters were required to air such messages to counter the cigarette advertising then permitted on television. For several years, the Amer-ican public was exposed to both pro- and antismok-ing messages. Durantismok-ing this time, per capita cigarette consumption declined 7%, from 4280 in 1967 to 3985 in 1970.62 Most of the this decline (4.5% was
attrib-utable to the antismoking messages.63When the
an-tismoking messages ended on television and radio, per capita cigarette consumption began to rise.64
More recently, researchers at the University of Vermont conducted a 5-year, multistate demonstra-tion project using a mass-media, antismoking cam-paign specifically aimed at young people.65,66 The
study’s intervention combined school-based smok-ing prevention programs with a mass media pro-gram that used more than 50 different television and radio spots over a 4-year period, and compared that to a school-only program.67By the end of the study,
the group exposed to television ads in addition to the school-based curriculum had an approximately 35% lower smoking rate and smoked 41% fewer ciga-rettes.68
The FDA has based its regulation of tobacco on strong empirical evidence that effective efforts must focus on children and adolescents. The agency be-lieves that its regulation will have a profound public health impact in the years to come, saving many individuals from premature death, and saving soci-ety considerable expense in treating tobacco-caused disease.
David A. Kessler, MD
Commissioner of Food and Drugs Food and Drug Administration Rockville, MD 20857
Judith P. Wilkenfeld, JD Office of the Commissioner Food and Drug Administration Rockville, MD 20857
Larry J. Thompson, MS Office of the Commissioner Office of Public Affairs Food and Drug Administration Rockville, MD 20857
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1. US Food and Drug Administration. Regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents; final rule. Fed Reg. 1996;61:44396
2. Kessler DA, Witt AM, Barnett PS, et al. The Food and Drug Adminis-tration’s regulation of tobacco products. N Engl J Med. 1996;335:988 –994 3. US Food and Drug Administration. Regulations restricting the sale and
dUnrestricted advertising can appear in publications that have adult
read-ership and in locations which are inaccessible to young people at all times. An adult publication is one which has a readership of adults 18 years of age and older that is at least 15% and which has fewer than 2 million underage readers.
eUnder section 518(a) (21 U.S.C. 360h(a)) of the act, if the agency finds that
distribution of cigarettes and smokeless tobacco to protect children and adolescents: final rule. Fed Reg. 1996;61:44396
4. Kessler D, Barnett PS, Witt A, et al. The legal and scientific basis for FDA’s assertion of jurisdiction over cigarettes and smokeless tobacco. JAMA. 1997;277:1–5
5. US Dept of Health and Human Services. National household survey on drug abuse: population estimate 1993. Rockville, MD: Substance and Mental Health Services Administration, Office of Applied Studies; 1994; SMA-94-3017:89 –95
6. Cottler LB. Comparing DSM-III-R and ICD-10 substance use disorders. Addiction. 1993;88:689 – 696
7. Hughes JR, Gust SW, Pechacek TF. Prevalence of tobacco dependence and withdrawal. Am J Psychiatry. 1987;144:205–208
8. Woody GE, Cottler LB, Cacciola J. Severity of dependence: data from the DSM-IV field trials. Addiction. 1993;88:1573–1579
9. Pierce JP, Fiore MC, Novotny TE, Hatziandreu EJ, Davis RM. Trends in cigarette smoking in the United States: projections to the year 2000. JAMA. 1989;261:161–165
10. US Dept of Health and Human Services. Preventing tobacco use among young people: Surgeon General’s Report. Washington, DC: GPO; 1994:65. (DHHS Publication No. 017-001-00491-0). Referred to as 1994 SGR 11. Fischer PM, et al. Brand logo recognition of children aged 3 to 6 years:
Mickey Mouse and Old Joe the Camel. JAMA. 1991;266:3145–3148 12. Mizerski R. The relationship between cartoon trade character
recogni-tion and product category in young children. Presented at Marketing and Public Policy Conference; May 13–14, 1994
13. Lynch BRJ. Time to up the ante in the war on smoking. Iss Sci Technol. 1994;11:33–37
14. Teinowitz J. Current trends: changes in the cigarette brand preferences of adolescent smokers—United States, 1989 –1993. MMWR. 1994:43: 577–581
15. Add RJR to list of cigarette price cuts. Advertising Age. 1993;April:43, 46 16. Surgeon General’s Report. 1994:123
17. Nichter M, Cartwright E. Saving the children for the tobacco industry. Med Anthropol Q. 1991;5:236 –256
18. Stacey BG. American Psychological Association comment, economic socialization in the pre-adult years, Br J Soc Psychol. 1982;21:159 –173 19. US Food and Drug Administration. Comment to FDA’s rulemaking by
the major cigarette companies and the Tobacco Institute. Fed Reg. 1996; 61:44396, 44485
20. Tredennich DW. RJ Reynolds Marketing Research Department memo dated July 3, 1974 reported by Schwarz J. RJ Reynolds marketing memo discusses young smokers ‘‘brand image.’ Washington Post, A03, April 23, 1996, Fed Reg. 1996;61:44396 – 44485
21. Petty RE, Cacioppo JT. Communication and Persuasion: Central and Pe-ripheral Routes to Attitude Change. New York, NY: Springer-Verlag; 1986:3
22. Petty RE, Cacioppo JT. Labeled the two routes: central (directly) or peripheral (indirectly).
23. Petty, Cacioppo, op cit 24. Ibid
25. APA comment. Fed Reg. 1996;61:44396 – 44468 26. Ibid
27. US Food and Drug Administration. A complete discussion of the evi-dence underlying FDA’s conclusions. Fed Reg. 1996;61:44396, 44465– 44538
28. Chapman S, Fitzgerald B. Brand preference and advertising recall in adolescent smokers: some implications for health promotion. Am J Public Health. 1982;72:491– 494
29. Aitken PP, Eadie DR. Reinforcing effects of cigarette advertising on under-age smoking. Br J Addiction. 1990;85:399 – 412
30. Goldstein AO, Fischer PM, Richards JW, Cretan D. Relationship be-tween high school student smoking and recognition of cigarette adver-tisements. J Pediatr. 1987;110:488 – 491
31. Botvin GL, Goldberg CJ, Botvin EM, Dusenbury L. Smoking behavior of adolescents exposed to cigarette advertising. Public Health Rep. 1993;108: 217–224
32. Klitzner MP, Gruenewald PJ, Bamberger E. Cigarette advertising and adolescent experimentation with Smoking. Br J Addiction. 1991;86: 287–298
33. Aitken PP, Eadie DR, Hastings GB, Haywood AJ. Predisposing effects of cigarette advertising on children’s intention to smoke when older. Br J Addiction. 1991;86:383–390
34. O’Connell DL, Alexander HM, Dobson AJ, et al. Cigarette smoking and drug use in schoolchildren. II. Factors associated with smoking. Int J Epidemiol. 1981;10:223–231
35. Alexander HM, Calcott R, Dobson AJ, et al. Cigarette smoking and drug use in schoolchildren: IV. Factors associated with changes in smoking
behavior. Int J Epidemiol. 1983;12:59 – 66
36. Chassin L, Presson CC, Sherman SJ, Corty E, Olshavsky RW. Predicting the onset of cigarette smoking in adolescents. A longitudinal study. J Appl Soc Psychol. 1984;14:224 –243
37. Collins LM, Sussman S, Mestel Rauch J, et al. Psychosocial predictors of young adolescent cigarette smoking: a sixteen-month, three-wave lon-gitudinal study. J Appl Psychol. 1987;17:54 –57
38. Sussman SC, Dent CW, Merstel-Rauch JJ, Johnson A, Hansen WB, Flay BR. Adolescent nonsmokers, triers, and regular smokers’ estimates of cigarette smoking prevalence: when do overestimations occur and by whom? J Appl Soc Psychol. 1988;18:537–551
39. Burton, et al. Surgeon General’s Report. 1994:192–195
40. Sherman SJ, Presson CC, Chassin L, Corty E, Olshavsky R. The LA/ Finland study. The false consensus effect in estimates of smoking prevalence: underlying mechanisms. Personality Soc Psychol Bull. 1983; 9:197–207
41. Botvin CJ, Goldberg CJ, Botvin EM, Dusenbury L. Smoking behavior of adolescents exposed to cigarette advertising. Public Health Rep. 1993;108: 217–224
42. Pierce J, et al. Does tobacco advertising target young people to start smoking? Evidence from California. JAMA. 1991;266:3154 –3158 43. Pierce JP, Lee L, Gilpin EA. Smoking initiation by adolescent girls, 1944
through 1988, an association with targeted advertising. JAMA. 1994;271: 608 – 611
44. Laugesen M, Meads C. Advertising, price, income, and publicity effects on weekly cigarette sales in New Zealand supermarkets. Br J Addiction. 1991;86:83– 89
45. Roberts MJ, Samuelson L. An empirical analysis of dynamic, nonprice competition in an oligopolistic industry. Rand J Economics. 1988;19: 200 –220
46. Smee C. Effect of tobacco advertising on tobacco consumption—a dis-cussion document reviewing the evidence. London, England: Dept. of Health, Economics and Operational Research Division; 1992 47. Ibid
48. Bjartveit K. The effects of an advertising ban—who has the burden of proof. Norway: National Health Screening Service; 1994
49. Rimpela M, Aaro LE, Rimpela AH. The effect of tobacco sales promo-tion on initiating of smoking. Scand J Soc Med. 1994;49:1–23
50. Van Reek J, Adriaanse H, Aaro L. Smoking by schoolchildren in eleven European countries. Presented at Proceedings of the 7th World Conference on Tobacco and Health; April 1–5, 1990
51. Lund K. Tobacco advertising and how to measure its effect on smoking behavior. In: Slama K, ed. Tobacco and Health. New York, NY: Plenum Press; 1995:294
52. Teenage Attitudes and Behavior Concerning Tobacco: Report of the Findings. Princeton, NJ: The George H Gallup International Institute; 1992;17:59 53. Slade J, et al. Teenagers participate in tobacco promotion. Presented at
the 9th World Conference on Tobacco and Health; October 10 –14, 1994 54. Gallup International Institute, op cit, 59
55. Evans N, et al. Influence of tobacco marketing and exposure to smokers on adolescent susceptibility to smoking. J Nat Cancer Inst. 1995;87: 1538 –1545
56. Slade J. Tobacco product advertising during motorsports broadcasts: a quantitative assessment. 9th World Conference on Tobacco and Health; October 10 –14, 1994
57. Aitken PP, Leathar DS, Squair SI. Children’s awareness of cigarette brand sponsorship of sports and games in the UK. Health Educ Res Theory Pract. 1986;1:203–211
58. Ledworth F. Does tobacco sports sponsorship on television act as ad-vertising to children? Health Educ J. 1984;43:4
59. Hock J, Gendall P, Stockdale M. Some effects of tobacco sponsorship advertisements on young males. Int J Adv. 1993;12:25–35
60. Dept of Health and Human Services. Preventing tobacco use among young people. Surgeon General’s Report. 1994:80. DHHS Publication No. 017-001-00491-0
61. Surgeon General’s Report. 1994:84 – 87
62. Simonich WL. Government Antismokng Policies. Peter Lang Publishing, Inc; 1991
63. Ibid.
64. Federal Trade Commission. Pursuant to the federal cigarette labeling and advertising act. Report to Congress. Washington, DC: Federal Trade Commission;1994:Table 2
65. Flynn BS, et al. Prevention of cigarette smoking through mass media intervention and school programs. Am J Public Health. 1992;82:827– 829 66. Ibid.
67. Ibid.
68. Flynn BS, et al. Prevention of cigarette smoking through mass media intervention and school programs. Am J Public Health. 1992;827– 829
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DOI: 10.1542/peds.99.6.884
1997;99;884
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David A. Kessler, Judith P. Wilkenfeld and Larry J. Thompson
Law
The Food and Drug Administration's Rule on Tobacco: Blending Science and
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