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  1. 1

    Report to Congress pursuant to the Federal Cigarette Labeling and Advertising Act for the years 1982-1983.

    United States. Federal Trade Commission [FTC]

    [Unpublished] 1985 Jun. 50 p.

    This report is the most recent in a series of reports on cigarette advertising that the Federal Trade Commission (FTC) has submitted annually to the US Congress since 1967 pursuant to the Federal Cigarette Labeling and Advertising Act. On September 26, 1984, Congress passed and on October 12, 1984, the President signed into law the Comprehensive Smoking Education Act. This Act amends the Federal Cigarette Labeling and Advertising Act. It provides for establishment of a Committee on Smoking and Health in the Department of Health and Human Services to coordinate federal and private efforts in educating the public on the adverse health effects of smoking. Additionally, Section 4 of the Act amends the Federal Cigarette Labeling and Advertising Act by requiring all manufacturers and importers to display on a quarterly rotating basis 4 specified health warnings on all cigarette packages and advertisements other than outdoor billboards. In 1983 the Commission sued successfully in the US District Court for the District of Columbia to enjoin Brown & Williamson Tobacco Company from advertising its Barclay cigarettes as a 1 mg "tar" cigarette or from using any "tar" number not specifically approved by the FTC. Brown & Williamson appealed, and the argument was heard on October 2, 1984, but no decision has been issued. Advertising expenditures for US cigarette manufacturers reached nearly $2 billion in 1982. By the end of 1983, the figure was almost $2.65 billion. Cigarette manufacturers led all other national advertisers in newspaper advertising and ranked second in magazine advertising. Associating smoking with high-style living, economic and social success, and healthy activities were the prevailing messages sent by the industry to consumers. In 1985, there was a marked increase in the market share of generic brands that were first introduced in late 1982. In 1983, R.J. Reynolds introduced the 25-cigarette pack. There have been numerous efforts to reformulate brands that failed achieve sales success when first introduced but were regarded positively in market surveys. Cigarettes sales are believed to have been affected by the increased cost of cigarettes due to an increased cost of cigarettes due to an increase in the excise tax and the continued reports on the health consequences associated with both active and passive smoking. Some of the major findings of the Surgeon General about the health consequences of smoking since initial consideration by the Congress of the rotational health warning legislation are summarized. The Surgeon General's reports on the health consequences of smoking have provided a significant stimulus to make the public aware of the adverse effects of tobacco usage. The most recent of these have dealt particularly with with the impact of cigarette smoking on cancer, chronic obstructive lung disease, and coronary heart disease. A table shows the totals of US cigarettes sold for the years 1963 and 1983.
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  2. 2

    Triphasics: have they fulfilled their promise? [editorial]

    Weisberg E

    CURRENT THERAPEUTICS. 1992 Jan; 33(1):11-6.

    Triphasic oral contraceptives (OCs) were designed to use the least amount of drugs for the desired effect and to imitate the physiology of the menstrual cycle, resulting in good cycle control and minimal side effects. Yet, studies indicate that triphasic OCs cause only marginally better cycle control than monophasic OCs with reduced frequency of withdrawal bleeding. In fact, the triphasic OCs in Australia do not mimic the normal menstrual cycle. Theoretically, the lowered total steroid doses more gently inhibits the hypothalamic-pituitary function via the absence of a midcycle surge of estradiol and luteinizing hormone and the absence of a rise in luteal progesterone, allowing a more rapid return to functional fertility. 2 triphasic OCs contain the progestogen norethisterone, and the other one contains levonorgestrel. Triphasic OCs appear to have a somewhat lower effect on lipid and carbohydrate metabolism than do current monophasic OCs. Clinicians have not conducted longterm prospective studies on triphasic OCs, so no evidence exists to support the contention that they are less likely to have cardiovascular effects than monophasic OCs. Further, triphasic and monophasic OCs have basically the same effect on blood coagulation factors. OCs have basically the same effect on blood coagulation factors. Many large-scale clinical trials show that the pregnancy rate is around .06. The low dose of levonorgestrel in the beginning of the cycle may reduce effectiveness, however, if women make mistakes. Further, the more complicated packaging of triphasic OCs may make it easier for women to make a mistake. Triphasic OCs may reduce the severity of acne. Most women find triphasic OCs to be quite acceptable, but, in a small group of women, its phasic formulation causes some side effects, including premenstrual syndrome, breast tenderness, excessive bleeding, or painful menstruation.
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  3. 3

    Public version: Federal Trade Commission staff report on the cigarette advertising investigation.

    Myers ML; Iscoe C; Jennings C; Lenox W; Minsky E; Sacks A

    [Washington, D.C.], Federal Trade Commission, 1981 May. [308] p.

    In its present investigation the Federal Trade Commission staff focused on 5 major issues: in light of the substantial growth of medical information in recent years, what are the known health consequences of smoking; what health information does cigarette advertising promotion contain about the nature, probability, and severity of the dangers of smoking; does the public already know these facts or does a substantial portion of the population lack knowledge of or hold false beliefs about the dangers of smoking; is the current warning effective in alerting the public about the health hazards of smoking; and is remedial action necessary. The issues presented by the current investigation emerge as more complex than when the Commission initially took action in 1964. In 1964, the Surgeon General had published his 1st comprehensive report on smoking and health, and cigarette packages and advertisements contained no health warnings. Similarly, in 1969 and 1971, cigarette advertisements contained no health warnings. The past efforts on the part of the Commission along with the efforts of Congress and other governmental agencies and private organizations to increase the amount of health information available to consumers have had an important impact. Many more consumers now are aware that smoking is hazardous to their health than in 1964. The percentage of Americans who smoke cigarettes has declined significantly over the same time period, and a substantially larger number of those who do smoke now smoke cigarettes with lower levels of "tar" and nicotine. Yet, many consumers do not know enough about the health effects of smoking to know how dangerous smoking is and desire more information about the specific hazards of smoking. Over 30% of the public remains unaware of the relationship between smoking and heart disease. Nearly 50% of all women do not know that smoking during pregnancy increases the risk of stillbirth and miscarriage. Approximately 30% of those polled do not know about the relationship between smoking, oral contraceptives, and the risk of heart attack. Many more consumers seriously underestimate the severity or increased risk of dying from the smoking-related illnesses. The health consequences of smoking are summarized in detail as are recommendations. Commission staff believes the following actions are likely to be most effective: additional funding for expanded educational efforts, such as public service announcements; changing the shape and increasing the size of the current warning; and replacing the current warning with a system of short rotational warnings. Expanded educational efforts would reach millions of consumers.
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  4. 4

    Questions and answers of the Fertility and Maternal Health Drugs Advisory Committee.

    Gregoire AT; Sobel S; Weiner A; Bennett R; Bilstad J; McCann D; Carter L; Price P; Lamar J; Millstein L

    [Unpublished] 1984 Feb. 4 p.

    A recent publication in "Lancet" by Pike et al. concluded that women who used oral contraceptives (OCs) for extended periods of time before age 25 were at an increased risk for the development of breast carcinoma. The authors also suggested that OCs with high progestational activity, as determined by a delay of menses test, accounted for this elevated risk. Other studies have addressed the issue of the relationship of OCs and breast carcinoma and the findings have been presented to the Fertility and Maternal Health Drugs Advisory Committee. The Committee, after a careful review of the paper by Pike et al. and a number of other recent studies relevant to OC use and breast cancer, concludes that a significant increase in risk for development of breast cancer has not been demonstrated in any subgroup of OC users or with any particular OC. The Agency is increasingly concerned about several studies which have shown an increased incidence of cervical carcinoma in patients using OCs. Probably a major problem in interpreting the results of these studies is the inability to eliminate with certainty the possible confounding effects of sexual activity. The Committee believes the changes suggested in the labeling reviewed 2 years ago under the heading "carcinoma" will answer the question regarding cervical cancer and no other changes need to be considered. The Agency has favored the use of OCs with lower steroidal content. In regard to the estrogen component, a clear recommendation has been made for the use of the low estrogenic dose. At this time there is no specific recommendation in regard to progestin content. This is due in part to an uncertainty of the ranking of progestational potencies of the various progestins. There is a less clear association of progestin with cardiovascular events. Recently, there is increased concern about the possible contribution of the progestin content to cardiovascular morbidity and mortality. This contribution may be mediated by effects on blood pressure, lipids, and perhaps blood clotting. The statement in the proposed changes in the current labeling under "Dose related risk of vascular disease from oral contraceptives" is believed to answer the question regarding risk and labeling. There are possible additional risks that may be associated with the inclusion of progestational agents in the estrogen replacement regimen. The potential risks include adverse effects on carbohydrate and lipid metabolism and possibly on coagulation factors. The Committee does not feel that labeling for progestin in estrogen replacement therapy is necessary at this time because of uncertainty about their safety.
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  5. 5

    Present and future of oral rehydration therapy for diarrhoeal diseases with special reference to health care delivery.

    Mahalanabis D; Jalan KN; Ohatterjee A; Maitra TK; Agarwal SK

    Indian Journal of Preventive and Social Medicine. 1975 Dec; 6:286-90.

    Oral rehydration therapy has changed the course of treatment for diarrheal diseases over the last decade and is now applied to all types of diarrhea in all age groups. Cost is minimal, administration is simple, and it is safe and effective. With a liberal intake of this fluid, adults and children both can replace volume and electrolytes lost due to diarrheal dehydration. 1 problem with the therapy, however, has been due to volume measure of the ingredients. Based on volume measures which were worked out, a standard 3 cc spoon has now been used adequately to measure the ingredients. Measurements have proven to be reasonably accurate and with little variation. A syringe barrel has also been used and with either method, only a few precautions must be observed. Problems with the prepackaging of ingredients were eliminated through a simple packaging system which involved weighing all 3 salts into 1 polyethylene bag and heat sealing the end, weighing the glucose into another bag and putting the 1st sealed bag into the 2nd, and heat sealing the 2nd bag containing the glucose and the sealed salt packet. These packets, called Kangaroo packets, can be kept for up to 9 months without any detectable change in components. Figures are included which demonstrate methods of preparation and prepackaging and a detailed description of the preparation, measurement, and packaging are included.
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  6. 6

    Report of the Committee set up by the Executive of the Irish Medical Association to advise on the hazards and side-effects of ovulation suppressants.

    Irish Medical Association

    Journal of the Irish Medical Association 71(2, Suppl.):1-10. February 17, 1978.

    Approximately 5% of the 48,000 women in the Republic of Ireland who use oral contraceptives were prescribed 1 of the 8 combined preparations which contain 75-100 mcg of estrogen. Since estrogen has been linked to the hazards of oral contraceptive use, all preparations prescribed or marketed in the Republic of Ireland should contain no more than 50 mcg of estrogen. The absolute and relative counterindications to oral contraceptive use are given as is a recommended supervision protocol for current users. Results of studies of cardiovascular mortality associated with oral contraceptive use are summarized, and mortality rates are compared with death rates from various other causes. The association between oral contraceptives and venous thromboembolism and hypertension is discussed as are the effects of this contraceptive method on subsequent fertility and pregnancy. Reasons for discontinuation of this method are explored, and carbohydrate and lipid metabolic changes are outlined. The effects of oral contraceptive use on the liver, the gall bladder, the breasts, the skin, the urogenital system, the eyes and vision, the oral cavity, and the use of certain drugs are reported. It is recommended that physicians receive full information on the contraindications, hazards, and side effects of oral contraceptives and that users be made award of these sequelae and of their symptoms via an explanatory package insert. The 24 preparations currently in use in the Republic of Ireland and their estrogen dosages are listed, and a sample of appropriate user information is given.
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  7. 7

    Oral contraceptive labeling.

    FDA Drug Bulletin. 1978 Mar-Apr; 8(2):12-13.

    A warning against smoking has been added to patent labeling of oral contraceptives. The warning is directed particularly to women over 35 who may suffer cardiovascular or circulatory disease. The new patient and physician labeling went into effect in the spring of 1978. A brochure and summary leaflet is included with every package of contraceptives dispensed which warn against possible side effects, chemicals, and birth defects. IUDs and other forms of contraception are mentioned in this first use of comparative labeling.
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