sample="quota" bates="517106095" isource="rjr" decade="1990" class="ui" date="19970919" IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS TEXARKANA DIVISION THE STATE OF TEXAS, Plaintiff VS THE AMERICAN TOBACCO COMPANY ET AL Defendants CIVIL ACTION NO. 5-96CV91 ORAL DEPOSITION OF CECIL R. REYNOLDS (ACCOMPANIES VIDEOTAPE) SEPTEMBER 19, 1997 COPY IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS TEXARKANA DIVISION THE STATE OF TEXAS, Plaintiff, VS. THE AMERICAN TOBACCO COMPANY, et al, Defendants NO. 5-96-CV91 JUDGE DAVID FOLSOM MAGISTRATE JUDGE WENDELL C. RADFORD JURY VIDEOTAPED ORAL DEPOSITION OF CECIL R. REYNOLDS ANSWERS AND DEPOSITION OF CECIL R. REYNOLDS, a witness called by the PLAINTIFF, taken before D'ANDRA FISHER, Certified Court Reporter for the State of Texas, on September 19, 1997, beginning at 10:16 a.m. and ending at 4:15 p.m., at the offices of Maroney, Crowley, Bankston, Richardson & Hull, 701 Brazos, Suite 1500, Austin, Texas 78701, pursuant to the Federal Rules of Civil Procedure. APPEARANCES For the Plaintiff: PROVOST UMPHREY By: Mr. Keith Hyde - and - Mr. Robert J. Giblin 490 Park Street P.O. Box 4905 Beaumont, Texas 77704 (409) 835-6000 For the Defendant R. J. Reynolds: JONES, DAY, REAVIS & POGUE By: Mr. Michael A. Nims North Point, 901 Lakeside Avenue Cleveland, Ohio 44114 (216) 5867208 For the Defendant Lorillard Tobacco Company: THOMPSON COBURN BY: Mr. Edward A. Cohen One Mercantile Center St. Louis, Missouri 63101 (314) 552-6000 Mr. Stephen Gonzalez, videographer LEGAL MEDIA INDEX CECIL R. REYNOLDS (Deposition Exhibits Nos. 1 and (2 marked for identification. CECIL C. REYNOLDS, Ph.D., was called as a witness and, having been first duly sworn, testified as follows: EXAMINATION BY MR. HYDE: Q. Good morning. Would you please state your name. A. Cecil R. Reynolds. Q. And that's Dr. Reynolds; is that correct? A. Yes. Q. What is your home address? A. Route 3, Box 390, Bastrop, Texas, 78602-9507. Q. And what is your telephone number? A. 512-321-4785. Q. Dr. Reynolds, what is your age? A. Gosh, you had to ask hard questions right away. 45. Q. Dr. Reynolds, you understand you're under oath to tell the truth today? A. Yes. Q. At any time I ask you a question that you don't understand, will you tell me that so that I can rephrase my question? A. To the best of my ability I will. Q. Have you brought with you today a report that you generated in this lawsuit? A. Yes. Q. And is that report the one that we've had marked as Exhibit 2? A. Yes, I believe it is. Q. Do you want to look through it and check? A. That looks like a copy, yes. Q. Do you have any other documents that were provided to you by any of the Defendants or their lawyers relative to this lawsuit? A. Yes, I do. Q. Would you identify those, please. A. I have depositions of Robert Woody, Robert Arrington, Robert Carpenter, and Percy, I'm not sure how to pronounce his last name, it's either Lucke, and several exhibits to those depositions. I have Woody Exhibit 7, Woody Exhibit 12, Woody Exhibit 2. The exhibit number on this one is illegible, but it's an exhibit to Arrington. Q. Would you read the title of that document, please. A. "Tree-based Risk Factor Analysis of Preterm Delivery in Small for Gestational Age Birth." And I have Woody Exhibit 20. Q. Have the lawyers of the Defendants or the Defendants themselves, any representatives of the Defendants, provided you with any internal tobacco documents concerning the health hazards associated with cigarette smoking? A. No. Q. Have you been provided any documents concerning any risk analysis concerning health effects of cigarette smoking? A. Well, not anything that's not published in the literature. I mean, some of these documents, I think, deal with those issues that I just named. So obviously, I have, but nothing that has not been published in the literature. Q. Have you been provided with any internal tobacco industry documents concerning smoking and its effect on pregnant women or the fetuses or babies? A. No, I don't believe so. Nothing I would recognize as an internal document and nothing that I have any reason to suspect is an internal document. Q. Now, I understand that you've testified in approximately 100 court appearances; is that correct? A. Over the years probably. Maybe more, maybe a little less. I don't keep count. Q. And you've also appeared in approximately 100 depositions and civil lawsuits; is that correct? A. Again, over -- since I started doing this around 1977, I don't keep track. I think that's a reasonable guess, but it is a guess. Q. It's your best estimate. Is that a fair statement? A. Again, with the qualification that it is -- I'm not even sure I'd call it an estimate. I think guess is probably better, but it's my best. Q. Well, you testified in the lawsuit involving the Attorney General of the State of Mississippi that you thought you testified in approximately 100 civil cases by deposition. Do you recall that testimony? A. I don't recall that exact number, but I recall giving that testimony and being asked. And I believe I qualified it also saying that that was -- that I don't keep count and that's not an exact number, but it's not an unreasonable number. Q. And in the civil cases in which you testify, I think you've testified before that 60 to 70 percent of the time that you've been called as a witness you've been called by the lawyers who represent the defense; is that correct? A. I think that's a reasonable estimate, yes. Q. And primarily those cases involve personal injury or medical malpractice; is that correct? A. Yes. Q. Are there any other documents that you've reviewed in preparation for your deposition today other than Exhibit 2 and the documents you told me little about a little bit earlier in the deposition? A. Well, in Mississippi I don't think we ever actually got to what I would consider a narrative report stage. We had all the tables made up and the statistical tables and things like that were ready. The case settled before we could write a report and it was no longer necessary to do that. In the Florida case we -- I don't even -- I wouldn't consider what we had to be a draft. It was a partial draft. And we had summary tables and statistical runs and those kind of things put together. But once the case settled there was no need to continue with that. Q. For Mississippi you had the tables made up from the natality data, and in Florida you had the tables made up and you had a partial draft. Is that a fair statement? A. Yes. Q. Well, I take it that in Texas you made the tables first, and then you put together a partial draft or a draft of the report which has been marked as Exhibit 2; is that correct? A. Yes. Q. Well, after you put together your tables, did you pass those tables by any of the tobacco lawyers who retained you in this matter? A. No. I didn't pass them by them, no. Q. Did you show them to them? A. yes. Q. When did you show them these tables from the State of Texas concerning the natality data? And I'm talking about the tobacco lawyers. When did you show them the data? A. I'm not sure. It was sometime in August. Q. Who did you show them to specifically? A. To Mr. Nims. Q. Where did you show them to him? Where were you at when you showed him these data? A. I'm not sure if we had those at a meeting in San Antonio or if we mailed them to him. I really don't remember. Q. And what tables did you send Mr. Nims, the lawyer from R. J. Reynolds? A. It would have been tables that are included in this report. Q. And did he send you back some information or a letter or a memo or anything? A. No. Q. Did he write on any of the reports and send them back to you, any of the tables? A. No. Q. Did he discuss them with you over the telephone? A. Yes. Q. Well, what did you-all talk about? A. Well, he wanted me to tell him what I thought they meant and I - you know, that's what I did so. Q. Then you wrote a draft; is that correct? A. Dr. Stone and I wrote a draft together. Q. And I take it that you passed the draft by Mr. Nims too; is that correct? A. Well, I don't like the connotation of passed it by. Q. You gave him a copy of the draft. Is that a fair statement? A. I don't know for sure if Mr. Nims ever saw a draft report of this or not. Q. Okay. Did you send any law firm or person a draft of your report which has been marked Exhibit 2? A. No. Q. Well, now I'm confused because I thought for a second you said, well, I may have, and now you're saying on. A. No, I said I don't know if he saw one. I did not send one to anybody. Q. Okay. So you wrote -- you and Dr. Stone wrote a draft of your report which is Exhibit 2. That much we've established, correct? A. Yes Q. Well, after you wrote the draft, what did you next do? I mean, I want to know the next thing you did after you had this draft completed. A. Oh, the next thing I did was sit down and go through it and rewrite it. Q. Did you talk with anyone after you wrote the draft concerning your rewrite of Exhibit 2, your report in this matter? A. Yes. Q. Who? A. Dr. Stone. Q. Anybody else other than Dr. Stone? A. I talked to Dr. Robert Brown about looking at it and commenting on it, but I did not get his comments back before the report had to be produced. Q. Who is Dr. Robert Brown? A. Dr. Brown is a developmental psychobiologist at the University of North Carolina in Wilmington. Q. And certainly you're aware that the tobacco companies have targeted adolescents for cigarette smoking, correct? A. Well, I read that in popular media. But beyond that, I don't have any knowledge of. Q. Well, you don't have any reason to disagree with that, do you? A. I don't have any reason to agree or disagree. All I'm telling you is I read it in the popular media. That's the extent of my knowledge about that. Q. With your stepson smoking, you haven't done anything more to research that issue of why adolescents smoke; is that correct? A. No, that's correct. Q. You agree that using movies and stars like John Travolta and Sylvester Stalone, that that's an effective way to promote the use of cigarettes amongst adolescents? A. I don't know if it is or not. Q. Hadn't studied that neither, huh? A. No. Q. Doctor, do you study things in a vacuum and only things you get paid for, or do you study things that may be of a health concern to the general public? A. Well, I study a great number of things that may or may not be of a health concern to the general public. I study a lot of things. And I have limited time, I can't study everything. I study things that pique my interest more than others. Q. Well, do you have an opinion whether tobacco companies should advertise in such a way as to attract adolescents to become smokers? A. Yes. Q. What's your opinion? A. My opinion is that they should not purposely attempt to attract underage individuals to smoke. Q. I was looking at the Austin American Statesman today and there was an article entitled "Morales: Tobacco ploy targeted kids." Did you have an opportunity to read that today in the paper? I did read that many today. Q. What did you think of the tobacco companies having root beer-flavored cigarettes or considering root beer-flavored cigarettes to attract adolescents or teenagers? Do you think that's a good idea? A. Well, do I think it's a good idea? No. And my reading of it is that they didn't do it either; that they considered doing it and they had the good sense not to. Q. Would you ever suggest to anyone that they intentionally try to have adolescents start smoking? A. No. Q. If the evidence is that the tobacco companies deliberately designed a study to attract teenagers to smoke, is that inappropriate in your mind? A. Is the evidence inappropriate or is the fact that they did it inappropriate? The fact that they did it. A. I would find that very inappropriate. I would go beyond that. I think when I was asked that in my Mississippi deposition that you have over there that I described as despicable behavior and I would stand by that description. Q. As a psychologist, do you have an opinion concerning the tobaccos if they even considered to manufacture and sell root beer-flavored cigarettes to teenagers whether that's inappropriate? A. Well, for an individual person in there to have come up with that idea -- to have ideas is neither appropriate nor inappropriate. I think in rejecting that idea the company acted appropriately. I don't think having an idea should be characterized as appropriate or inappropriate. Q. And once again, I hope this is the final question. You have not reviewed any tobacco company internal documents concerning advertisements aimed at teenagers, correct? A. That is correct. Q. Have you -- A. That must have been the wrong answer. Q. No. For the record, have you reviewed any tobacco company internal documents concerning any subject? A. I have reviewed absolutely nothing that to the best of my ability I could have recognized or would characterize as an internal tobacco company document, nor have I requested any. Q. Don't you care to know what research was conducted by the tobacco companies concerning cigarette smoking and low birth weight babies? A. I am interested in seeing peer-reviewed research in that area. I am interested in anything that's been done that I can evaluate properly. Anything that they have done in-house like that is done using sound scientific principles, sure, I'd like to see it. Q. But you just haven't? A. I have not seen it. Q. Have you asked the lawyers who represent the tobacco companies if they have any such documents? A. No. MR. HYDE: I think that's all the questions we have. MR. NIMS: You're done. CHANGES TO DEPOSITION No erasures or obliterations of any kind are to be made to the original testimony as transcribed by the deposition officer. Any changes in form or substance which the witness desires to make shall be furnished to the deposition officer by the witness, together with a statement of the reasons given by the witness for making such changes. Please enter the page number, line number, and the reason for such change or correction. Page/Line Correction Reason for Correction CECIL R. REYNOLDS WITNESS' SIGNATURE STATE OF ) COUNTY OF ) I HEREBY CERTIFY that I have read the foregoing deposition and that this deposition, together with my corrections, is a true record of my testimony given at this deposition. CECIL R. REYNOLDS SUBSCRIBED AND SWORN TO BEFORE ME this the day of , 19 . Notary Public in and for State of REPORTER'S CERTIFICATE IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS TEXARKANA DIVISION THE STATE OF TEXAS, Plaintiff, VS. THE AMERICAN TOBACCO COMPANY, et al, Defendants NO. 5-96-CV91 JUDGE DAVID FOLSOM MAGISTRATE JUDGE WENDELL C. RADFORD JURY VIDEOTAPED ORAL DEPOSITION OF CECIL R. REYNOLDS I, D'ANDRA FISHER, Certified Court Reporter for the State of Texas, do hereby certify that the facts stated by me in the caption hereof are true; that the said witness did make the above and foregoing answers in response to questions propounded as shown; that I did, in shorthand, report said proceedings, and that the above and foregoing typewritten pages contain a full, true and correct computer-aided transcription of my shorthand notes taken on said occasion. I further certify that I am not in any capacity a regular employee of the party in whose behalf this deposition is taken, nor in the regular employ of any attorney or record; and I certify that I am not interested in the cause, nor a kin or counsel to either of the parties. D'ANDRA FISHER, CSR Certified Court Reporter For the State of Texas CSR No. 4869 Expiration Date: 12-31-97 King & Fuller 400 West 15th Street, Suite 604 Austin, Texas 78701 (512) 478-7885 Job No. 107270 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS TEXARKANA DIVISION THE STATE OF TEXAS, Plaintiff VS THE AMERICAN TOBACCO COMPANY ET AL Defendants CIVIL ACTION NO. 5-96CV91 ORAL DEPOSITION OF CECIL R. REYNOLDS SEPTEMBER 19, 1997 EXHIBIT VOLUME (EXHIBITS 1 - 6 OF 6) COPY IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS TEXARKANA DIVISION THE STATE OF TEXAS, Plaintiff, v. THE AMERICAN TOBACCO COMPANY, et al., Defendants NO. 5:96CV91 JUDGE DAVID FOLSOM MAGISTRATE JUDGE WENDELL C. RADFORD JURY AMENDED NOTICE OF ORAL AND VIDEO DEPOSITION OF CECIL REYNOLDS ON SEPTEMBER 19, 1977 TO: Harold Waldrop, Administrative Liaison Counsel for Defendants Atchley, Russell, Waldrop & Hlavinka, L.L.P. 1710 Moore's Lane Texarkana, TX 77503 PLEASE TAKE NOTICE that, under Fed. R. Civ. P. 30, Plaintiff, State of Texas, will take the oral deposition of Cecil Reynolds on Friday, September 19, 1997, at 9:00 a.m. at Maroney, Crowley, Bankston, Richardson & Hull, L.L.P., 701 Brazos, Austin, Texas 78701. The deposition will continue from day to day until completed. 1. The deposition will be taken before a court reporter appointed or designated under Fed. R. Civ. P. 28. All parties are invited to attend and cross-examine. Reynolds Exhibit No. 1 9-19-97 D'Andra Fisher Respectfully submitted, DAN MORALES Texas Attorney General Texas Bar No. 14417450 JORGE VEGA First Assistant Attorney General Texas Bar No. 20533800 HARRY G. POTTER, III Special Assistant Attorney General Texas Bar No. 16175300 P. O. Box 12548 Austin, TX 78711-2548 512-463-2191 512.463.2063 WALTER UMPHREY, P.C. Texas Bar No. 20380000 490 Park Avenue Beaumont, TX 77701 409-835-6000 409.838.8811 ATTORNEY-IN-CHARGE GRANT KAISER KAISER & MORRISON, P.C. 801 Arkansas Blvd. Texarkana, TX 71854 409-774-7008 409.774.7311 By: GRANT KAISER, BY PERMISSION OF Walter Umphrey, Attorney-in-Charge Final Report of the Analysis of Natality and the Relationship of Smoking to Birth Weight By Dr. Cecil Reynolds and Dr. Brice M. Stone Data for infants in the state of Texas were examined for the years 1989 through 1993 to determine if maternal smoking factors relate to birth weight. The data were obtained from the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Center for Health Statistics. Particular series used for each year are detailed in Attachment 1. Several variables were created using the data contained in the natality series. Infants were divided into three groups based upon birth weight for analysis, Table 1. The groups were created as follows: Table 1. Birth Weight Groups Birth Weight (in grams) Low, Low Birth Weight 1,500g or less Low Birth Weight greater than 1,500g to 2,500g Normal Birth Weight greater than 2,500g Variables were also created for smoking and alcohol use during pregnancy, as well as for diseases or other complications which the mother of the infant identified. Demographic information concerning the mother was also used to create variables, such as age, race, education, income, and amount of prenatal care .All the variables used in the analysis are detailed in Attachment 2. Descriptive Statistics Birth weight for infants of smokers versus non-smokers were compared for the years 1989 through 1993 (Attachment 3 contains the output from the statistical program used to produce the descriptive statistics). Smokers are identified using the variable DTOBACCCO (smoked ruing pregnancy). On average approximately 10% of mothers reported smoking during pregnancy for each year examined. The number of smokers and non-smokers from the natality data is presented graphically in Figure 1. Average birth weight for smokers versus non-smokers was then compared. This comparison is presented in Table 2. The average birth weight of infants of smoking mothers was approximately 200g less than that of non-smokers. The average birth weight of all smokers was still within the normal birth weight range of greater than 2,500 grams. However, the association between smoking and birth weight was found to be discontinuous by birth weight group. i.e., the approximately 200 gram difference was not distributed evenly across birth weight group directly or as a proportion of weight. Average length of gestation was also examined for smokers and nonsmokers. It was found that 39 weeks was the average gestation for all mothers, smokers and non-smokers. The next analysis centered on the differences for smokers and non-smokers for infants in each of the three birth weight groups created. Table 3 presents the numbers of births by birth weight group for each years 1989 through 1993. As Table 3 shoes, low, low weight births are only a small portion of the number of births in the state of Texas each year. Low weight births represent a slightly larger portion of the births each year. Most births are in the normal birth weight group. The first birth weight group examined was low, low birth weight infant group. Table 4 presents the average birth weight for infants in this group for smokers versus non-smokers. Table 4 shows that in all years except 1992, for low, low birth weight infants (<=1500g), infants of smokers tended to weight slightly more than infants of non-smokers. However, only two fo the differences in average birth weight between smokers and non-smokers for low, low birth weight infants were statistically at the 99% confidence level. Next, average birth weights for infants in the low birth weight category were compared for smokers and non-smokers for each year. Table 5 contains these results. As Table 5 shows, there was little difference in the average birth weight for smokers and non-smokers in the low birth weight group. In fact, infants of smokers had slightly higher birth weights than infants of non-smokers. The difference in average birth weights for 1992 was statistically significant at the 99% level, with infants of smokers being 17g heavier on average than infants of non-smokers. Table 9 presents the number of low, low weight births and low weight births which occur with mothers who had medical or physical complications during labor or delivery such as excessive bleeding, cord prolapse, dysfunctional labor, seizures, abruptio placenta, placenta previa, etc. Table 9 presents the numbers for years 1993 while Attachment 5 provides the results for all years. The percentage of mothers with low, low weight births who had medical or physical complications during labor or delivery represent over 24 percent of the total low, low weight births in 1993. This percentage drops nearly half for low weight births, 15.55 percent. Thus, mothers who had medical or physical complications during labor or delivery compose a high percentage of low, low and low weight births compared to mothers who are not identified as having such labor or delivery complications. If the diseases of the of the mother are considered in conjunction with mothers who had medical or physical complications during labor or delivery, the numbers and percentage are quite large. Table 10 presents these figures for the year 1993. For low, low weight births in 1993, over 60 percent of the births were from mothers that either had a disease or medical or physical complications during labor or delivery. For low weight births in 1993, over 46 percent of the births were from mothers that either had a disease or medical or physical complications during labor or delivery. Thus, diseases of the mother or complications during labor or delivery appear to account for a substantial part of the low, low weight births and low weight births in the state of Texas. Regression Analysis of Birth Weight Explanatory equations were developed to explain the variation in the birth weight of infants in the natality data sets. Equations were developed for each birth weight group for each year 1989 through 1993 for the state of Texas. Birth weight was used as the dependent variable in the analysis. Three sets of equations were developed for each year, a low, low birth weight equation, a low birth weight equation, and a normal birth weight equation. Equations were estimated using ordinary least squares (regression) given the continuous nature of the dependant variable (Greene. 1990 and Kmenta, 1971). Variables in the equation included conditions which could have affected the mother during the pregnancy, as well as demographic information concerning the mother. Tobacco and alcohol were included in the equations as dichotomous variables (zero/one for no/yes responses). In addition, tobacco was intersected with four other variables: DALCOHOL. GESTAT. DECLAMP. and DINCERVI. Thus, the relationship of tobacco to birth weight must be considered directly, through DTOBACCO. and indirectly, through the interactions. All variables are defined in Attachment 2. The regression equation results are presented in Attachment 6. Low, Low Birth Weight Equations Of the four equations estimated for each year numerous variables were statistically significant at the 99º level in most equations and years. Variables which were tended to be significant and associated with a decreased born weight in the low, low birth weight group included: the mother being black, the mother having twins, triplets, or quadruplets, and the mother conditions such as hydramnios oligohydramnios, chronic hypertension, pregnancy associated hyptertension, eclampsia, incompetent cervic, abruptio placenta, excessive bleeding, seizures during labor, or dysfunctional labor. Conditions affecting the infant such as congenital abnormalities also decreased the birth weight of an infant in the low, low weight birth group. Variables which tended to increase birth weight within the low, low birth weight groups included infant begin male, longer gestation periods, increased number of prenatal visits, and the earlier prenatal care began in the pregnancy. Variables were included in the equation to account for the use of tobacco and alcohol during the pregnancy. Though alcohol use was not significant in most equations in this birth weight group, the association of alcohol and birth weight was consistently negative. The direct relationship of tobacco use with birth weight during pregnancy was associated with higher birth weights when statistically significant. The indirect relationships of tobacco use with birth weight through gestation, alcohol, eclampsia, and incompetent cervix were mixed, at best, and rarely statistically significant. Tobacco and alcohol use together tended to increase the birth weight of the child. Interaction of Tobacco and Gestation The interaction of tobacco use with gestation produces an interesting mathematical result. The partial derivative of birth weight with respect to tobacco use provides the opportunity to determine when during the gestation period that the positive direct relationship of tobacco use with birth weight is overcome by the negative indirect relationship of tobacco use, in conjunction with gestation period, on birth weight. Simply stated mathematically, formulaname Thus, the first derivative with respect to DTOBACCO can be written as formulaname If the above first derivative is set to zero and solved for GESTAT, the resulting value represents the gestation period at which the direct relationship of tobacco use on birth weight is offset by the interaction of tobacco use and gestation period. formulaname For example, if b is equal to 215.9117 and c is equal to -8.0293, the offset occurs at 26.8906 weeks of gestation. This would imply that the net relationship of tobacco use on birth weight prior to 26.8906 weeks results in a positive contribution to birth weight. The net relationship of tobacco use on birth weight would not become negative (reducing the birth weight of the child) until after the 26th week of gestation. DTOBACCO and DTOBGEST were not statistically significant in any of the low, low birth weight equations. In the regression equations for low weight births. DTOBACCO and DTOBGEST were statistically significant in two of the five years resulting in offset periods during the 34.89th and 35.29th weeks of gestation. The offset period ranges from 16 to 23 weeks for the normal birth weight group, though the issue is of minimal concern since the birth weights are normal. Analysis of Probability of Birth Weight Type One methodology for analyzing the relationship of tobacco smoking on birth weights of live births is to develop an explanatory equation or model which explains the variation in the probability of being a low, low weight birth versus a non-low, low weight births. This type of analysis can be applied to the other two classifications of birth weights: low weight births and normal weight births. The model which best fits this type of analysis is the logit model for a zero/one dependent variable. (Maddara, 1983). In the case of low, low weight births, the dependant variable is assigned the value of one if the birth weight falls in the range of the low, low weight birth and zero otherwise. The explanatory variables are the same factors which were used in the regression analysis of the birth weight within birth weight groups. See Attachment 8 for the results of the logit analysis. The mathematics presented above concerning the interaction of tobacco use and gestation period apply similarly for the logit analysis, with the exception that a negative sign for DTOBACCO implies that the net relationship of tobacco use on the probability of being a low, low weight birth is negative until the offset period is reached. DTOBACCO and DTOBGEST were statistically significant in four of the five years (exception. 1992). The offset period ranges from a low of 26.91 in 1989 to a high of 29.38 in 1991. Thus, tobacco use does not increase the probability of being a low, low weight birth until the gestation period is beyond the 26th week period. Conclusions Several conclusions can be drawn from the analyses performed using the natality data. One is that tobacco use does not appear to be associated with low and low, low weight births in infants. It appears from the analysis that other conditions, primarily gestation and medical conditions and risks associated with the mother appear to be the greatest determinant of the infant's birth weight. In addition, these conditions do not appear to be associated with tobacco use. These findings, especially when gestational period is considered, demonstrate a lack of association of smoking during pregnancy to weight reductions in infants that are know to be of any clinical concern. A plot of the interactions found would indicate, consistent with NIDA reports, that any association of smoking with lowered birth weight occurs after the fifth month of pregnancy (20th -week of gestation). In fact, very few birth weights of clinical concern appear in infants of non-diseased mothers. FROM :PROVOST & UMPHREY O 17868#99999*0000:5124549 1997 09-18 16:54 #475 P. 02/05 APA Resolution on Tobacco and Smoking The Council of Representatives of the American Psychological Association approved the following resolution: WHEREAS tobacco is a legally available consumer product that is demonstrably harmful to health when used as intended; WHEREAS tobacco is an established risk factor for morbidity and mortality; WHEREAS more than one million teenagers begin smoking each year, a rate of approximately 3,000 per day which has not declined appreciably over the last decade (1), and 90 percent of young smokers report that they become regular smokers before age 18 (2); WHEREAS psychological scientists study human and animal behavior, and our research domain encompasses the full spectrum of issues related to tobacco use, including: how people decide whether or not to use tobacco products and what are the different factors that enter into that decision (such as cultural factors, minors' access to tobacco products, tobacco industry advertising, cost); psychopharmacological aspects of nicotine, i.e., understanding modes of addiction and what changes it causes in the central nervous system; identifying ways to prevent people from engaging in risk-taking behaviors such as tobacco use; identifying effective community interventions for bringing about widespread changes in behavior; and treating tobacco addition individually and within the community; and WHEREAS psychological scientists have contributed substantially to the body of research knowledge in these areas; THEREFORE, BE IT RESOLVED that the American Psychological Association supports the tobacco and smoking objectives set forth in, "Healthy People 2000 - National Health Promotion and Disease Prevention Objectives for the Nation," and intends to encourage federal, state and local policies to minimize recruitment to, and facilitate abstinence from, the use of tobacco, including but are not limited to: 1) restricting illegal access of youth to tobacco products by supporting a range of direct and indirect mechanisms to discourage use and restrict access; and 2) fostering research on behavioral, psychological, pharmacological, and toxicological components of addiction, smoking prevention and intervention, and smoking cessation methods. Reynolds Exhibit No. 3 9-19-97 D'Andra Fisher Linked Birth/Infant Death Data Set Geographic Code Outline The following pages show the geographic codes used by the Division of Vital Statistics in the processing of fetal event data occurring in the United States. For the linked data set, counties and cities with a population of 250,000 or more are identified. Federal information Processing Standards (FIPS) State and County Codes: For the 1989 linked file, the county codes and the State code immediately preceding them are FIPS codes. These codes were effective with the 1989 data year and are based on the results of the 1980 Census. County and county equivalents (independent and coextensive cities) are numbered alphabetically within each State. When an event occurs to a nonresident of the United States, residence data are coded only to the "State" level, or to the remainder of the world. For an explanation of FIPS codes, reference should be made to various National Bureau of Standards (NBS) publications. NCHS State and City Codes: The city codes and the State codes immediately preceding them are NCHS codes. These codes were effective with the 1982 data year and are based on the results of the 1980 Census. Cities are numbered alphabetically within each State. When an event occurs to a nonresident of the United States, residence data are coded only to the "State" level; several western hemispheres countries or the remainder of the world are uniquely identified. Reynolds Exhibit No. 4 9-19-97 D'Andra Fisher Chapter 1 Introduction The Linked Birth/Infant Death Data Set, 1989 Birth Cohort consists of three separate data files. The first file includes linked records of live births and infant deaths for the 1989 birth cohort -- also referred to as the numerator file. The second file is the live birth file for 1989, with a few minor modifications -- referred to as the denominator-plus file. The files are offered as a numerator/denominator data set to give users the means to compute infant mortality rates. The third file contains information from the death certificate for all infant death records which could not be linked to their corresponding birth certificates -- referred to as the unlinked death file. The 1989 linked file is comprised of deaths to infants born in 1989 who died in 1989 or 1990 before their first birthday. Infant death records were extracted from the 1989 and 1990 National Center for Health Statistics (NCHS) mortality statistical files. Linked birth records were extracted from a denominator file that contained the 1989 NCHS natality statistical file and a small number of late-filled birth certificates. Refer to the Methodology section for a more detailed explanation of records added to the statistical file. The denominator file is not identical with the NCHS natality statistical file. The linked file of live births and infant deaths includes linked records for births and deaths that occurred in the United States to U.S. residents and to U.S. nonresidents. Excluded are deaths that occurred outside the United States to infants born in the U.S.; deaths that occurred in the United States to foreign-born infants; and births and deaths that occured outside the Untied States to U.S. residents. Sources for denominator data and for birth records included in the numerator file are described in detail in the 1989 Technical Appendix from the Natality Annual Volume; sources for death records included in the numerator files are described in detail in the 1989 Technical Appendix from the Mortality Annual volume, and in the 1990 Addendum. Copies of these Technical Appendices are included on the CD-ROM. Because of confidentiality concerns, only those counties of 250,000 or more population and only those cities of 250,000 or more population are identified in this data set. The population counts are based on the results of the 1980 census. Users should refer to the geographic code outline in this document for the list of available areas and codes. In tabulations of linked data and denominator data, events occurring in the United States to U.S. nonresidents are included in tabulations that are by place of occurrence, and excluded from tabulations by place of residence. For linked data, these exclusions are based on the usual place of residence. For linked data, these exclusions are based on the usual place of residence item of the mother. This item is contained in both the denominator file and the birth section of the numerator linked file. U.S. nonresidents are identified by a code 4 in location 11 of these files. Standard certificates and reports For many years, the U.S. Standard Certificate of Death and the U.S. Standard Report of Fetal Death, issued by the Public Health Service, have been used as the principle means to attain uniformity in the contents of documents used to collect information on these events. They have been modified in each State to the extent required by the particular needs of the State or by special provisions of the State vital statistics law. However, the certificates or reports of most States conform closely in content and arrangement to the standards. The first issue of the U.S. Standard Certificate of Death appeared in 1900. Since then, it has been revised periodically by the national vital statistics agency through consultation with State health officers and registrars; Federal agencies concerned with vital statistics; national, State, and county medical societies; and others working in such fields as public health, social welfare, demography, and insurance. This revision procedure has ensured careful evaluation of each item in terms of its current and future usefulness for legal, medical and health, demographic, and research purposes. New items have been added when necessary, and old items have been dropped when their usefulness appeared to be limited. New revisions of the U.S. Standard Certificate of Death and the U.S. Standard report of Fetal Death were recommended for State use beginning January 1, 1989. The U.S. Standard Certificate of Death and the U. S. Standard Report of Fetal Death are shown in figures 7-A and 7-B(1). Among the major challenges made were the addition of a new item on educational attainment and changes to improve the medical certification of cause of death. Additional lines to report causes of death were added as well as more complete instructions with examples for properly completing the cause of death. Also, for the first time, the U.S. Standard Certificate of Death includes a question on the Hispanic origin of the decedent. A number of States had included an Hispanic-origin identifier on their certificates, resulting in data shown in this volume for years before 1989. To obtain information on type of place of death, the format of the item was changed from an open-ended question to a checkbox. Chapter 8 Quality of Data Completeness of registration All States have adopted laws that require the registration of births and deaths and the reporting of fetal deaths. It is believed that more than 99 percent of the births and deaths occurring in this country are registered. Reporting requirements for fetal deaths vary somewhat from State to State (see "Comparability and completeness of data"). Overall reporting is not as complete for fetal deaths as for births and deaths, but it is believed to be relatively complete for fetal deaths at a gestation of 28 weeks or more. National statistical data on fetal deaths include only fetal deaths occurring at a stated or presumed gestation of 20 weeks or more. Massachusetts data The 1964 statistics for deaths exclude approximately 6,000 events registered in Massachusetts, primarily to residents of that State. Microfilm copies of these records were not received by NCHS. Figures of the United States and the New England Division are affected also. Alabama data The 1988 statistics for deaths show no deaths assigned to the City of Prattville in Autauga County. The death records that should have been assigned to this area were instead assigned to the Balance of County due to a processing error. Quality control procedures Demographic items on the death certificate--As previously indicated, for 1989 the mortality data for these items were obtained from two sources--photocopies of the original certificates furnished by the 50 States, the District of Columbia, New York City, and Puerto Rico. For the Virgin Islands and Guam, which sent only copies of the original certificates, the demographic items were coded for 100 percent of the death certificates. The demographic coding for 100 percent of the certificates was independently verified. Other central nervous system anomalies--Other specified anomalies of the brain, spinal cord, and nervous system. Hear malformations--Congenital anomalies of the heart. Other circulatory/respiratory anomalies--Other specified anomalies of the circulatory and respiratory systems. Rectal atresia/stenosis--Congenital absence, closure, or narrowing of the rectum. Tracheo-esophageal fistula/Esophageal artresia--An abnormal passage between the trachea and the esophagus; esophageal atresia is the congenital absence or closure of the esophagus. Omphalocele/gastroschisis--An omphalocele is a protrusion of variable amounts of abdominal viscera from a midline defect at the base of the umbilicus. In gastroschisis, the abdominal viscera protrude through an abdominal wall defect, usually on the right side of the umbilical cord insertion. Other gastrointestinal anomalies--Other specified congenital anomalies of the gastrointestinal system. Malformed genitalia--Congenital anomalies of the reproductive organs. Renal agenesis--One or both kidneys are completely absent. Other urogenital anomalies--Other specified congenital anomalies of the organs concerned in the production and excretion of urine, together with organs of reproduction. Cleft lip/palate--Cleft lips is a fissure of elongated opening of the lip; cleft palate is a fissure in the roof of the mouth. These are failures of embryonic development. Polydactyly/syndactyly/adactyly--Polyadactyly is the presence of more than five digits on either hands and/or feet; syndactyly is having fused or webbed fingers and/or toes; adactyly is the absence of fingers and/or toes. Club foot-Deformities of the foot, which is twisted out of shape or position. Diaphragmatic hernia--Herniation of the abdominal contents through the diaphragm into the thoracic cavity usually resulting in respiratory distress. Other muscoloskeletal/integumental anomalies--Other specified congenital anomalies of the muscles, skeleton, or skin. Down's syndrome--The most common chromosomal defect with most cases resulting from an extra chromosome (trisomy 21). Other chromosomal anomalies--All other chromosomal aberrations. Method of delivery The new birth certificate contains a checkbox item on method of delivery. The choices include vaginal delivery, with the additional options of forceps, vacuum, and vaginal birth after previous cesarean section (VBAC), as well as a choice of primary or repeat cesarean. When only forceps, vacuum, or VBAC is checked, a vaginal birth is assumed. In 1993 this information was collected from birth certificates of all States and the District of Columbia. Several rates are computed for method of delivery. The overall cesarean section rate or total cesarean rate is computed as the proportion of all births that were delivered by cesarean section. The primary cesarean rate is a measure that relates the number of women having a primary cesarean delivery to all women giving birth who have never had a cesarean delivery. The denominator for this rate includes all births, less those with method of delivery classified as repeat cesareans and vaginal birth after previous cesarean. The repeat cesarean rate is the proportion of all cesarean deliveries that were to women having their second (or subsequent) cesarean delivery. The rate for vaginal birth after previous cesarean (VBAC) delivery is computed by relating all VBAC deliveries to the sum of VBAC and repeat cesarean deliveries, that is, to women with a previous cesarean section. Repeat cesarean and VBAC rates for first births exist because the rates are computed on the basis of previous pregnancies, not just live births. Hispanic parentage The 1989 revision of the U.S. Standard Certificate of Live Births includes items to identify the Hispanic Origin of the parents. Concurrent with the 1978 revision of the U.S. Certificate of Live Birth, the NCHS recommended that items to identify the Hispanic or ethnic origin of the newborn's parents be included on birth certificates and has tabulated and evaluated these data from the reporting States. All 50 States and the District of Columbia reported Hispanic origin of the parents for 1993. In computing birth and fertility rates for the Hispanic population, births with origin of mother not stated are included with non-Hispanic births rather than being distributed. Thus, rates for the Hispanic population are underestimates of the true rates to the extent that the births with origin mother not stated (1.3 percent in 1993) were actually to Hispanic mothers. The population with origin not sated was imputed. The effect on the rates is believed to be small. ACOG TECHNICAL BULLETIN SMOKING AND WOMEN'S HEALTH Susan C. Hellerstein, MD, MPH Instructor in ObGyn And Reproductive Biology Benjamin P. Sachs, MBBS, DPH ObGyn in Chief Harvard Medical School 6/96 Beth Israel Hospital Boston, MA Reynolds Exhibit No. 6 9-19-97 D'Andra Fisher Smoking - 1996 Introduction Over 22 million American women smoke cigarettes despite the overwhelming medical evidence about the harmful effects of smoking. From 1963 to 1990 there was a 40% decline in the overall prevalence of smoking but since 1990 the prevalence has plateaued. Currently 22.5% of American women smoke. Among adolescent high school students the rate of cigarette smoking increased from 27% in 1991 to 35% in 1995. In the 1995 Youth Risk Behavior Survey, 34.4% of high school girls reported that they smoked cigarettes during the last 30 days. Adolescence is the critical period during which most women begin to smoke. 91% of all adult smokers had their first cigarette before age 20 and 77% became daily smokers by age 20. Very few women begin smoking after age 20. Physicians, nurses and medical staff can be instrumental in preventing the initiation of smoking among adolescents. Among women of reproductive age 29% smoke. There is a higher prevalence among women living in poverty and those with less than a high school education. Between 19-40% of pregnant women continue to smoke putting themselves and their fetuses at risk for a number of adverse reproductive events. From 1992-1993 restrictive worksite and public smoking policies helped transform a significant number of women from daily smokers into occasional smokers but the overall number of smokers did not change. Most American women who smoke want to the 1992-93 NHIS survey 12.5% of female smokers reported they wanted to quite, 34% attempt to quit each year but only 2.5% successfully stop each year. OBGyn practitioners can accurately inform women of the medical consequences of smoking and facilitate successful smoking cessation. Composition of Tobacco Smoke There are over 2,500 chemicals identified in tobacco smoke. Many constituents have not been evaluated for their effects on health. Two of the major components that are thought to be responsible for the adverse effects of cigarette smoke are nicotine and carbon monoxide . Both active and passive smoking involve the inhalation of smoke, with systemic absorption via the pulmonary vasculature. EFFECTS OF SMOKING ON WOMEN General Effects on Women Cigarette smoking is the largest preventable cause of death and disability among women in the United States. Cancer Smoking is responsible of approximately 30% of all cancer. Since 1987 lung cancer has been the leading cause of cancer deaths among women. In 1993 an estimated 56,000 died of lung cancer. Women who smoke are 12 times more likely to die from lung cancer than those who never smoked. By 10 years after smoking cessation the risk of lung cancer returns to that of a nonsmoker. In addition smoking increase the risks of cancer of the oropharynx, esophagus, kidney, bladder, pancreas, and cervix. Coronary Artery Disease Smoking is responsible for 55% of the cardiovascular deaths in women less than 65 years old. The Nurses Health Study respectively followed 117,906 female nurses aged 30-55 years. The relative risk (RR) of total coronary heart disease among smokers is four times higher compared to women who never smoked. The risk of coronary heart disease was highest among those who initiated smoking before 15 years old. (RR=9.25). Women who stopped smoking immediately decreased their relative risk of coronary heart disease to 1.5. Two years after smoking cessation risk of coronary heart disease declined to the level of those who had never smoked. Smoking is also a risk factor for coronary artery disease in women under 30 years old . Women older than 35 years old who use oral contraceptives and smoke have a higher risk of coronary artery disease, cerebrovascular accidents, myocardial infarction and deep venous thrombosis. Menopause At least 13 studies indicate that smokers cease menstruating 1-2 years earlier than nonsmokers. This effect is dose dependent, and the difference persists after controlling for subjects weight ( ) Female smokers have significantly reduced bone mineral density of the hip compared to nonsmokers . Smokers taking hormone replacement therapy have reduced levels of serum estrogens compared to nonsmokers on the same hormone replacement therapy. There is an inverse correlation between the number of cigarette smoked daily and the decreased serum estrogen levels on hormone replacement. This suggests increased hepatic metabolism of estrogens stimulated by smoking may contribute Large epidemiological studies of developed countries have demonstrated that smokers have 1.2 to 1.8 times as many spontaneous abortions as nonsmokers. Given a of approximately results in a miscarriage rate of 18-27% for smokers A study of in vitro fertilization studies that control for the number of eggs retrieved, fertilization rates, or implantation rates show the incidence of spontaneous abortion was 42.1% in smokers compared with 18.9% in nonsmokers . Kline et al evaluated 979 karyotyped spontaneous abortions . Spontaneous abortions of smokers were 39% more likely to be chromosomally normal than those of nonsmokers. This suggests a non-genetic mechanism. Male Reproductive Function In a number of studies, a consistent association between smoking and impaired sperm concentration, motility, and morphology has been found . Some evidence supports that cessation of smoking may improve sperm density and motility. Effects on Pregnancy Various effects of cigarette smoking on pregnancy have been studied. They include placental changes, pregnancy complications, and perinatal loss (Table 1). Carbon monoxide and nicotine are thought to be the main ingredients in cigarette smoke responsible for adverse fetal effects. These products cause decreased availability of oxygen to maternal tissues and the fetus. Placental changes found in smokers include hypertrophy, thickening of the truphoblastic basement membrane , and calcification changes typically seen in cases of chronic hypoxis and ischemia. The volume density of fetal vessels in terminal decreased signifying a loss in the exchange area of smokers' placentas Pregnancy Complications In the Collaborative Perinatal Project study, abruptio placentae was 1.5 times more common and was more likely to result in perinatal mortality in smokers than in nonsmokers. When women stopped smoking prior to their first prenatal visit, there were 50% fewer fetal and neonatal deaths due to abruptio placentae . In several recent studies, women who smoked cigarettes during pregnancy had placenta previa twice as often as nonsmokers Surprisingly, a number of studies suggest that maternal smoking decreases the risk of pregnancy-induced hypertension by 50% with a dose-dependent relationship . The proposed mechanism is nicotine inhibition of thromboxane A2 production. Low Birth Weight There is a consistent association between smoking and lower birth weight in the medical literature supporting a probably causal relationship. This is from a combination of preterm deliveries of appropriate-weight babies and intrauterine growth retardation of term babies. Recent studies have shown a consistent relationship between preterm PROM and smoking . Further studies controlling for differences in maternal sexual activity and in maternal genital tract pathogens are needed to assess the association between smoking and PROM. In a prospective study of 30.896 pregnant women , preterm births (delivered less than 37 weeks of gestation) were 20% more common in women smoking more than one pack a day while pregnant than in nonsmokers. The analysis controlled for maternal age, education, the time of initiation of prenatal care, and alcohol consumption, among other confounding variables. In a recent study attempting to characterize reasons for higher rates of preterm births in black women compared with white women, 10% of the excess risk in black women was attributed to cigarette smoking . Smokers also have a 3.5 - 4.0-fold increase in small-for-gestational-age infants compared with nonsmokers . Newborns of smokers are smaller at every gestational age. The women who stop smoking before 16 weeks of gestation have infants with birth weights similar to those of babies of women who never smoked . The mean birth weight of infants of women who smoke during pregnancy is 170-200 g less than that of infants of nonsmokers. This difference persists even after controlling for confounding variables such as maternal age, parity, maternal weight gain and energy intake, social class, level of education, and alcohol consumption. Perinatal Outcomes Multiple recent studies have demonstrated a clear association between maternal smoking and perinatal loss. Placenta previa, abruptio placentae, and preterm PROM were responsible for most of the perinatal losses in smokers. These epidemiological studies report an association between smoking and perinatal mortality but do not establish a causal relationship. Most studies have not found a relationship between smoking in pregnancy and birth defects, childhood cancer, or longterm neurologic sequelae . Several studies of maternal smoking in pregnancy to be an important risk factor (a) For women who smoke more than 10 cigarettes a day, the 21 mg patch should be the initial dose. After 1-2 months wean to successively lower dosages prescribing each for 2-4 weeks. (b) Patients who smoke 6-10 cigarettes per day should start with the mid-range transdermal doses. (c) For those who smoke 5 cigarettes or less are likely to have withdrawal symptoms and benefit from transdermal nicotine medication. Side effects may include skin reaction and sleep disturbance, which can be alleviated by removing the patch at night. Weight Gain Many smokers are concerned about weight gain associated with smoking cessation. Not all women who stop smoking will gain weight. In a recent study of stopped smoking gained significantly more weight than those who had never smoked or those who continued to smoke. Over a 10 year period of time the average amount of weight gain for women associated with smoking cessation was 5.0 kg. However, in the same time period only about 1/6 of the increase in prevalence of overweight in the USA can be attributed in smoking cessation. To equal the health risks of smoking patients would have to gain approximately 100 lbs. Patients who are worried about weight gain should be counseled to refrain from dieting at the same time they quit smoking. It is unrealistic to tackle both at once. A regular exercise program can help smokers cope with withdrawal symptoms and prevent weight gain. Vegetables (carrot sticks) and fruit are good snacks. Stress Management Many smokers are concerned about how to manage stress after stopping smoking. Some of the symptoms of restlessness and inability to concentrate are symptoms of nicotine withdrawal and will become less acute after 3 days and most disappear within a few weeks. After a few weeks of not smoking, most women actually feel less nervous. By knowing what to expect women can mobilize their personal resources, will power. family and friends to get through the particularly difficult first few weeks. Self Help Smoking Cessation Materials Many women smokers benefit from self-help written materials. The National Cancer Institute has of some available materials (See Table III) Smoking Cessation Pregnancy Approximately one third of women are smokers at the time they conceive. It has been estimated that if all pregnant women stopped smoking, a 10% reduction of infant and fetal deaths would be seen . Approximately 20% of smokers quit by the time of their first prenatal visit . Despite regular contact with health care providers who give current antismoking advice, however, only 6% give up smoking later in their pregnancy . The most successful efforts in smoking cessation during pregnancy involve interventions that emphasize how to stop smoking and to not just provide antismoking advice. Printed material should be directly targeted to pregnant women and not general smokers . A prospective, randomized, controlled clinical trial of an intensive smoking reduction program with substantial patient contact and supervision (initial visit plus telephone contact at least monthly) has been shown to aid in smoking cessation during pregnancy and to increase birth weights . Use of a smoking cessation chart may help health care providers to track patient contacts with the goal of achieving initial smoking cessation as well as reinforcing that behavior throughout the pregnancy. A recent metanalysis of 10 randomized controlled trials showed a 50% increase in smoking cessation between the 6th and 9th months with organized prenatal smoking interventions. In the third trimester smoking cessation rates up to 32% were achieved with the prenatal program. Two important points stood out about the successful programs studies smoking cessation geared toward pregnant women the absence of direct data concerning use of the patch and gum during pregnancy, it is appropriate to inform the patient about the presumed risks and benefits of this approach and to individualize therapeutic decision making. Conclusions Smoking tobacco increases cancer, cardiovascular and other health risks for all women. It is also associated with reproductive health problems, increased perinatal mortality, bleeding complications of pregnancy, decreased mean birth weight, and higher incidences of small-for-gestational-age babies, low-birth-weight babies, and preterm deliveries. The ultimate goal of the provider is to identify all women who smoke and counsel them to stop smoking. The support of providing a concrete smoking cessation plan, with nicotine replacement when indicated and arranging a follow-up can help avoid relapse.