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Rep. b. H. Fountain Page 55 and'scientific communities have not.agxeed on the hazards. or safety of pill taking and cigarette smoking eitter individually or in com- bination. I suggest, therefore, that the Congress cannot and should. not presume to find, in H:R_ 565.3' or anywhere else,. that "women who take birth control pills and smoke are more likely to suffer heart attack or stroke than women who d!on"t smoke". Zn fact, I know of no evidence to justify the Congresss in pre- suming or concluding that mere cigarette smoking per se is harmful to one's health. Common sense tells us that the effect of cigarette smoking upon anyone depends upon the person smoking and' the extent to which such person smokes. There are a number of items, many of them food, which are harmful to some people--in fact to most people if consumed to excess. Each person in a free society has the responsibility and the right to make his.or her own decisions in.connection w9:th, the con- sumptiion of,any legal item. Thank you Mr. Chairman and.biembers of the Subcommittee for giving me the privilege of presenting my statement in opposition to H..R. 5'653. . 4

Rep. L. H. Fountain • ~. Page 4 attached to my own statement.My reading of Professor Gibbons" evaluation of the current literature is,that not much has changed since 1978. Confusion and controversy still prevail on.the use of oral contraceptives in general and, on the alleged effect of cigarette smoking, on the users. Two, studies reported in the American Journal of Epidemiology in 1979 and 198D suggest an absence o.f increased risk.ofheart,attacks among women who smoke and take the pill. A third, believe it or not, in the New England Journal of.Mediicine in, 1981 suggests a.decreaseda risk of h,eart.attack among women who smoke and.take the pill! Professor Gibbons' own evaluation of those studies concluded as follows: "My primary overall conclusion; is that Congressional fi'nding. (5) in bill H...R. 4957 is at present groundless because the statistical evidence on which it is based is limited, weak, controversial, and subject to severe criticism by impartial experts." As recently as. 1978'., the year of my subcommittee's hearings on this subject, Dr. Donald Kennedy, Commissioner of'the Food and Drug Administration, was quoted as saying that even if'smoking were not a factor, he would~ not recommend the pill as a form of contra~- ception for members of,his own family. Yet at the very same time a report in World Health entitled Q W "'How Safe is the Pill", c,ras saying "Millions of women throughout M OA the world fin~l' the Hill effective:and acceptable; the overwhelming C,U go majority experience no ill-health as a result." 0 This subcormnittee should be aware of the fact that the medical

Rep. L. H. Fountain Page•, 2 have included testimony from witnesses., expert in this. specific area of health and medicine, who are prepared to present contrary evidence, based on their own research and on the research of others. A full and fair hearing on the subject.of.oral.contraceptives and smoking would have included testimony' of expert witnesses who testified on thisr subject not so many months ago before another sub- committee.of the House. As the Chairman may recall, the subject of oral contraceptives and smoking was taken up in 1978 at hearings of the Subcommittee on Intergovernmental Relations and' Human Re- sources during the second session of the 95th Congress, when the Chairman was a.member of that committee, and a very good member he was. I am attaching a copy of'those hearings which.I call to the attention of all of the members of this subcommittee, especially, the distinguishediChairman_. As a member of'that subcommittee Mr. waxman participated with me and others in hearings and deliberations, and' took that opportunity to question some of the distinguished scientists who had been called as expert witnesses. One of these witnesses was Dr. Jean Dickinson Gibbons,, Professor of Statistics and Mathematics at the University of Alabama. When asked by Mr. R7axman if'certain studiies justify that women increase their risk of heart disease by smoking while using the pill, Pro- fessor Gibbons replied.that these studies did not "'j,us,tify the presumption of risk". O . . ~,J The principal purpose of those hearings was to. examine the M , scientific basis:for the Food.and DrugiAdministration's order ~i . ~ requiring an antismoking warning in the labeling ofloral contra- m' ceptive pills. Our subcommittee investigation lent support to

~.Statement by Rep. L. H. Fountain before the Subcommittee on Health and.the Environment Committee on Energy and Commerce March 12., 19'8'2 Mr. Chairman, and Members of the SuIScommittee, I am grateful for the opportunity to express my views on the proposed "'Comprehensive Smoking Prevention Education Act of 19'8I2"'. Though I find myself in disagreement with many aspects.of this legislation, I will address only those "'findings" that are,directed specifically at women. Mor,e than ever before, the women of this country are.working outside,the home. ^ In fact,, statistics on both.the percentage of women who work and the percentage of.women in the overall work, force are,as dramatic as they are enlightening. One reason for the substantial increase of working,women is the,desire to have their own careers. Another is economic necessity. There is a~ real need for two incomes in one family. And this need shouldbe appreciated, understood and encouraged by the legislators of our great country. Instead women are con- tinually cautioned and warned and frightenedabout the impliication.s of their newly assumed'roTe. When they engage in pursuits that have been characterized in. the past as: purely male, such as smoking,. they are advised by officials in government that "Women who smoke like men will die like men". I suggest to my colleagues on this subcommittee that whereas government may'have a role in educating its citizens., it should'© W not,engage in scare tactics to~accomplish.tkiish purpose. 0 IMA LS And in that regasd I have reason to question the findings in H.R. 5653 that pregnant women who smoke have a higher risk for ~ abortion, stillbirths, premature births, and childweight deficiencies. A full and!fair, hearing on this subject by this committee would!

""r , Repl. L,. H. Fountain r w . Page 3 the suggestion thatthe scientific evidence relied upon by the FDA had been inconclusive and of questionable quality, and that the FDA had based its decisiion wholly on those questionable data. Indeed,, the suspicions of.the subcommittee staff were confirmed. - by internal FDA memoranda which said: (1) that one could not infer from the data."that the increased risk of myoca'rdial'infarction associated with the current use of oral contraceptives:is greater among smokers than among non-smokers"; (2) "that there are insufficient data to evaluate effects o.f individual risk factors for non-fatal myocardial infarction and almost no data.for fatali myocardial infarction",. (i3) and that at least one bit of scientific evidence was, no more than "ruminations in the absence,of facts". Additional studies have been reported in the scientific litera- ture since the 19:78:hearings were conducted. And'many of the important points made in 1978 by the non-government, expert witnesses concerning the weaknesses of the earlier studies are reiterated in the results of the more recent studies.. Because of my enduring interest in.this subject, I have asked'Professor Gibbons to review a number of the more recent studies and report to my Government Opera- tions Subcommittee on her findings. She was kind enough to comply with my request on such short notice and has sent me a copy of her C' , 4a GJ ~ report, a summary ot which, I understand, she was prepa.red to present, in person, to the subcommittee. I ask that herfull written report be included in the record of these hearings. A,copy of it is