Tobacco Documents Online

t Inside: ACSH inquires; the Tobacco Institute evades : PAGE 4 Why isn't the U:S. immune to vaccine shortages? PAGE 5 The pros and cons of home pregnancy tests PAGE 10 Editorial: - Hold the regulatory PAGE 1 S hairspray . , Approxilnately one in five high school seniors smokes regularly. Do tobacco companies really wish they didn't? By Cathy Becker Popescu DO TDBACCO COMPANIPS WANT YOUNG PEOPLE TO SMOKE? Of course not, the indus- try protests with all the vehemence and indignation of the unjustly accused. In pub- lic appearances, interviews with the media and advertisements in large-circulation pub- lications, tobacco industry representatives do their best to convince the American pub- lic that "the people who make cigarettes do not want young people smoking them.^ The Tobacco Institute, the industry s trade and lobbying organization, informs us that the folks there believe that smoking is a purely adult custom. The Institute has attempted to substantiate this assertion by its collaboration with the National Associa- tion of State Boards of Education on a pub- CONTINUED CONTINUED ON BtGE 2 PUBLICATION OFTHE AMERICAN COUNCILON SCIENCE ANDHEALTH • 1995 BROADWAY - NEW YORK, NY 10023 (212) 362-7044 The Real Cost of Generic Drugs Consumers may lose more than they save on prescription drugs if the rise of the generic drug industry discourages the development ojnew medicines. By Roger P. Maickel THE U.S. CONSUMER HAS BEEN INUNDATED IN RECENT YEARS BY A "NEW" CONCEPT IN - . MARKET7NG -'GENERIC" PRODUCTS. Such products are often packagedin black-and- white or other non-unique and sometimes nondescriprcontainers, generally devoid of' any brand/manufacturer's name. The retail price is somewhat lower than the regular retail prices of branded competitors, and the quality of any given product may be equal to or less than that of its brand name competi- tors, based on comparative evaluation test- ing. The public, in general, feels that generic products offer a maximal saving in costs with a minimal reduction in quality. As a result, we now have generic canned foods, generic paper products, generic soda pop, generi¢ beer, generic cigarettes, generic aspi- rin, and generic prescription drugs. -- Itk clear that generic products offer con- sumers substantial savings. But do they pro- vide comparable quality? And do they have bidden costs? In the case of generic prescrip- tion drugs, the answer to one of these ques- tions is reassuring, but the other may give us cause for concern. - Generic Drugs in the 'Good Old Days' The concept of generic, (-e., non-brand name) pharmaceutical products is not reallyy new. Until the upsurge of prepackaged pre- scription drugs in the 1950s. many medicines were prepared by mixing bulk ingredients in the individual neighborhood pharmacy. 9- Geaeric products offer coasumerssubsluotial savings. Bot tlo they provide comp.nble quality? And do tbeyhavehiddeocostst. .. .-- ;--. . -.- - : ... . (Phaobylorcelona) While the component ingredients (active (compounded)byMr.Smith-thepharma- drugs, binders, solvents, flavors, etc.) were cist. The ingredients had to meet the stand- purehased~ by the pharmacist from manu- ards of the United States Pharmacopeia: the facturers, the actual product delivered to the final products were theoretically similar customer was produced in its final form from pharmacy to pharmacy but certainly Learn how a new drug is developed - Page 8 were not as uniform as the standardized products of a modern industrial production line. Some idea of the state of the pharma- txutical' industry in the United' States less than 50 years ago may be seen in the fact that - r. . CONTINUEDON MGE4

. ;k Tobacco Industry and Youth CONT[MUED FROM MGE t' - Introducing Viceroys to 'Starters' "For (young smokers], a cigarette, and the whole smoking process ts part of the illicit pleasure category. ... In the young smoker's mind a cigarette falls into the same eategory with wine, beer, shaving, wearing a bra (or purposely not wearing one), declaration of independence and striving for self-identity. For the young starter, a cigarette is associated' with introduction to sex life, with courtship, with smoking'pot' and keeping late study- inghours - • From a report summariring an advertising strategy for Viceroy Cigarettes,,1975. ~= 6catloatwhich advises parents how to tising agencies supports the contentions of children and teenagers in more subtle ways. V._;• encourage their children "to defer making a Dr. Magnus and others that tobacco com- For example, in the movie Superman Il, "~ decision on adult behaviors, such as smok- panies are targeting teens in their marketing which was seen by millions of children R. J. Reynolds Tobacco Company efforts. The 1975 document, which sets around the world, references to Marlboro ~s1 assures us that its executives don't think it's _ forth the development of an advertising cigarettes appear more than 20 times. Lois y;.a a good idea for young people to smoke and strategy for Viceroy cigarettes, includes a Lane smokes Marlboros throughout' the wouldn't dream of advertising to child'ren. `: chapter which focuses on introducing the film and a prominently labeled Marlboro If these reassurancesthat cigarette manu- brand to "starters." The report'states: ,4 van plays a starring role in some of Super- j' facturers aren't the least bit interested in :°For [young smokers], a cigarette, and man's fight scenes. - k. attracting kids seem reassuring, consider • the whole smoking process, is part' of the In the movie Starman, another film with y:_ this faet: 90 percenf of all adult male smo- illicit pleasure category... In the young widespread, appeal for children and teena- kers kers and 60 percent of all adult female smo- smoker's mind a cigarette falls into the same gers, an earthling offers a visiting alien a kers began smoking before the age of 21. - category with wine, beer, shaving, wearing a Winston cigarette. Later, a billboard adver- 1 And' according to Clarice Brown, statisti- bra (or purposely not wearing one), declara- tising the same cigarette brand fills the ; cian with the federal Office on Smoking and 'tion of independence and'striving for self- screen. I . Health, the percentage of smokers who takq '.identity. For the young starter, a cigarette is • The casting of readily identifiable ' up the habit as teenagers has been increasing associated with introduction to sex life, with cigarette brands in movies aimed at young > over the years. courtship, with smoking 'pot' and keeping audiences could hardly be construed as acci- "People are less likely to initiate smoking „late studying hours." , dental, given the growing number of agen- after the age of 20 than they ever were - The report goes on to recommend that cies that specialize in strategically placing before," says Ms. Brown. "Males have young starters could be attracted to smoking products in movies. '` always initiated smoking early, but when by presenting the cigarette as one of the few Candy and bubble gum cigarettes in pack- you look at the younger cohorts, females are ages similar or identical to those of popular " beginning to take up the habit at earlier ages, cigarette brands are another means by which too. Usually people who are smokers have Survey data indicate that' cigarette manufacturers can indirectlyy begun by the age of'20; a great percentage looking more mature is one of appealito young consumers. The fact that have started before the age of 17.° -- I cigarette producers have either given their " Smoking is not a habit which adults, who the major perLeiVed benef is of permission for use of their package design are apt to be more concerned'with the sub- Smo/Cing among adoleScentS. and brand name, or have generally failed to stantial health risks of smoking than with its Other perceived benef t5 include file lawsuits for trademark infringement• "cool" image, are likely to start. Obviously, appearing tougher, more SOcla- suggests that tobacco companies tacitly con- the crucial'time to recruit loyal, long-term ble and more like a leader, done the promotion of mock smoking customers is, thus, during the teenage years, atthibuteS which are often among young children+ no doubt with the ; since once a person becomes established as a emphasized in cigarette ads. ~~ hopes that it will'eventually lead to the real smoker chances are that the addictivenature thing.. of tobacco will keep him or her hooked Social Pressures - throughout life. -- :,; initiations into the adult world and as part - Despite the obvious indications that "To actively avoid marketing cigarettes to of the illicit pleasure category of products tobacco companies db„ and in fact must, teenagers or discourage them from smoking _ and activities; by creating advertising would be sheer business suicide," observes images that depict situations taken from the want young people to smoke, there is pres- ently no persuasive empirical evidence that Dr. Paul Magnus, Medical Associate with day to day life of the young smoker, while the industry's advertising and marketing the NationallOffice of Heart Research of touching upon basic symbols of growing up; strategies directly cause teenagers to smoke. Australia. "Yet, this is what the cigarette and by relating the cigarette to "pot", wine, It seems likely, however, that promotional manufacturers would have us believe: that beer, sex, et cetera. techniques which appeal to youth at least they bend over baekwards to avoid market- Such a strategy hardly appears to be reinforce other factors which encourage ing to the very group they most need, chil- geared toward the mature, responsible smoking among teens. dren; that smoking is an 'adult custom' and adults to whom the industry purports to that the industry not only does not want kids market its deadly wares. Social and peer pressures appear to be the mostt important factors in influencing to start smoking, but is even glad thaYfewer The creative . director of an advertising agency with hefty cigarette accounts also young people to begin smoking. Smoking by • According to the tobacco industry pub- " are.smokingthesedays. , - I "This is, in effect, asking us to believe implicated cigarette manufkcturers in they're deliberately trying to put them- keting n mar- to teenagers during , a discussion lication The Tobacco Observer, "a major which was published in the March 5 a 1983 cigarette manufacturer" has recently gone selves out of business. We can conclude that they're either stupid or lying. Few people issue of the Medical Journal of Austratia. to court to block a candy maker from selling would call them stupid." "The . entryy age for smokers, I recall, is confectionery cigarettes in packages that 14,"'said the ad executive. "When I worked resemble its products. Candy cigarettes have Targeting Teens for (the advertising agency] we were trying been sold in packages that9ook like the «al' very hard to influence kids who were 14 to thing for decades, however, and it's difficult A report obtained by the Federal Trade Commission from Brown and Williamson to believe that the tobacco companies just start to smoke." Cigarette manufacturers also appeal to Tobacco Corporation and one of its adver- J noticed it. ~

parents and friends is strongly related to the probability that a child will begin smoking. '' In one study conducted in an Iowa high ; rchool, onlq threepercent of students who _ ; reported both parents and best friends as • nonsmokers were themselves smokers, while _-` 80 percent had never smoked. Among stu- "-''dents whose parents and best friends smoked, however, 74 percent were frequent smokers and only 11 percent had never smoked. . v : Students who smoke tendKto come from lower socioeconomic groups; to have lower educational and occupational aspirations; and to participate less in school-related acti- vities than nonsmokers. It has been sug- _ gested thafthe former tend to express their •, emerging adult identities through indul- gence in immediate adult prerogatives, such as smoking, drinking, engaging in sexual activity etc., while the latter establish their adult identities through the performance of adult-like roles within the school and school- 1 ted cti "ti rca a v t a.• - . --I _-.obviouslythecruculllmeloreerultloyal,loog-rermeostomers4duringtheteenrgeyean,sieeeoaeea In support of [his hypothesis, survey data - b bli b d person ceome esta s e as a smoker cheeees are that the addxtilf tbill k him ,ve naure ooaeco weep II indicate that looking more mature is one of.f or her hooked throughout bre. __- fit (PbaabyJoyafooa) / th iv d be fi f i ng , % e major perce e ne ts o smok among adolescents. Other perceived bene- start smoking they can give it up whenever cally been unsuccessful in preventing smok- fits include appearing tougher, more socia- they wish. ing among young people. While such infor- ble and'more like a leader, attributes which ~M. ,. Attacking a Major Problem mational campaigns are capable of affecting are often emphasized'in cigarette ads. = students'' knowledge and attitudes about Accordin to national te v k' h h s t ll d d t established, setting the stage for life-long 'Itaditional educational approaches, adults, as teachers, and encouraging stu- ~ srnoking. Most young people, however, are which consist of lectures, films, pamphlets dents to make a public commitment not to z unaware of the problem of'tobacco depend- and other materials discussing the adverse smoke. _ ence, erroneously believing that once they health consequences of smoking, have typi- -' CONTINUED ON PAGE'4 ~ young person may or may not enter the "Obviously, cigarette smoking among logical inoculation in that students are experimentation phase. For some, the young people continues to bra major prob- exposed to arguments in favor of smoking . unpleasant sensations which accompany the lem;" says Dr. Patrick O'Malley, who was within a controlled situation, then taught to first cigarette will discourage furthetexperi- involved in conducting the survey. "It is refute them. For example, students may be mentation. For others, smoking the first especially serious because smoking is a truly encouraged to counter the argument cigarette may represent a more positive addictive behaviop which is very difficult to "You're a chicken if you don't smoke" with experience, especially if it engenders strong stop " the counter-argument "If I smoked because social'approval. Duringthe experimentation According to Dr. O'Malley, roughly half you want me to, that would just show that stage, smoking by family members may also of high school'seniors who smoke say that I'm afraid of you" or to respond to an ad ; promote the further use of cigarettes. _. they would like to stop if they could. "Only depicting a"liberated° female smoker by If experimentation continues for long one percent ofhigh school seniors definitely thinking "She's not really liberated'if she's enough, the young person will eventually plan to be smoking in five years, but in real- hooked on tobacco~" According to the the- r become a regular smoker. It has been ity, probably 25 percenn will be," says Dc ory, practice in countering pro-smoking ; reported that 85 to 90 percent of those who O'Malley. arguments will inoculate the studenCagainst g experiment with more than four cigarettes Given the relatively low rates of success in pressures to smoke which may subsequently T will graduate to the regular smoking stage• smoking cessation, prevention of the onset arise in real+life situations. Duringthecxperimentationandearlyreg- of regularamoking holds the most promise Other techniques employed in the social ~ ular smoking stages, physiological land psy, for halting our current epidemic of psychological smoking prevention pro- > chological dependence on tobacco become cigarette-related disease• grams include the use of peers rather than a Dependtng upon the experience assocr- percent of females reported smoking half a niques: ated with smoking the first' cigarette, a pack of cigarettes or more per day. "Social inoculation" is analogous to bio- smoktng at least once. .. - females did. Eleven percent of males and 13 generally using "social inoculation" tech- firsrcigarette af earlier ages, but eventually Sixteen percent of males reported smoking programs have stressed methods for dealing 80 to 90 percenr of adolescents will try daily, while slightly more than 20 percent of with social i and peer pressures to smoke, cigarettes are fust tried. Children who seek Research for the National Institute on Drug Programs which have incorporated social to improve their self-image or to gain social' Abuse indicated that 19 percent of high psychological approaches to smoking pre- acceptance may be more likely to try their school seniors were regular smokers in 1984. vention have met with greater success These „ smoker is a gradual one, involving,several The rates stabilized until 1984, when they tional smoking prevention programs has - distinct stages. The first step is preparation, again~showed'a decline. Although smoking been blamed on the fact that teenagers find in which the child becomes aware of and rates among teenage girls initially lagged it difficult to appreciate the importance of develops attitudes toward cigarettes. Family well behind those of teenage boys, by 1979 a health problems tharwill develop in middle influences may be the most important greater proportion of females than males or late adulthood, and that these programs during this stage. were smoking: fail to deal'with the powerful social and psy- Peer influences assume greater impor- A recent survey conducted by the Univer- chological factors which influence smoking tance during the initiation phase„ when sity of Michigan's Institute for Social behavior. e ur eys, n smo mg, ey ave gener y nofsuccee e a = Becoming a Smoker g smoking increased from 1975 through 1977, in preventing the onset of smoking. ' It'appears that the process of becoming a then declined' fairly sharply through 1980. The lack of success of'traditional'educa- 3 ;~: 4

E i suade most nonsmoking adults from taking up the deadly habirand to encourage a sig- nificant minority of adult smokers to quit- ~ Smoking prevention programs must, of regular smokers. 'Oventy-six percent of On the other hand, the perception that '' b initiatdlh if th ae those children with friends who smoked smoking imparts an image of maturity, course,ee eary enougeyr were experimcnters or regular smokers by toughness and' to have a significant impact on smoking sociability appears to be more salient to teens and preteens than con- ~ : oerns about long-term risks. In an attempt to bolster sagging sales, the tobacco companies have no choice but to take advantage of the vulnerability of youth: You can't really blame them - even an industry that sells death doesn't want to die. t i -- . - Cathy Berker Popeccu, M.S. is a Research Associate with ACSH. d behavior. Since the major increase in onset Sra e' of smoking occurs during junior high The Future of Smoking school this indicates that programs must , begin by the sixth or seventh grade. Experi- ence with a smoking prevention program conducted at the University of Waterloo (Ontario) has indicated that even this may be too late to prevent smoking among "high risk" students, i.e.,, those with parents or friends who smoke. Thirty-five percent of 4 Suspecting that the tobacco industry's avowed disapproval of~ smoking among young people was nothing more than another clever public relations ploy, ACSH Executive Director Dr. Elizabeth Whelan addressed the following questions to Tobacco Institute Chairman Horace Kornegay. The Tobacco Institute's reply was, shall we say, less than enlightening. William Kloepfera Jr., Senior Vice President for Public Relations, merely referred Dr. Whelan back to "Helping Youth Decide," which the Tobacco Institute published in collaboration with the National Association ofState Boards of Education, ostensi- bly to help parents encourage their children in makingg mature decisions on important adult issues such as smok- ing. As usual, this tobacco industry spokesman carefully avoided giving direct answers to direct questions. a +~~ ~~ Horace Kornegay Chairman TOBACCO INSTITUTE 1875 1 Street, NW Wazhington D C. 2O006 Dear Mr. Kornegay: . , - W ~,~fv W , I note that m a numbet of recent Tobacco Institute related pub- lications, induding :IIelping Youth Deade,°" the lnstitute states that the people who make etgarettes do no4 want young people smoking them" .-`~~ ~r.. ~tAs the mother of a school age child who may soon be facing the decision on whether or not to 4moke; I would be most apprecia- tive if you would supply me with the answers to a few questions ~ Howdoestbelnstttutedefne youngpeople?" 5~~~ If, ss the Institute has long maintained, smoking is nott harardaus, why shouldn't young people smoke? If smoking is not hazardous to onels health, why should the decision to smoke r not bepostponed to adult= - a , ' Why do you regard smo as an exclustvely adult ~. Given that~ few people ova the age of 21 beg`ut smoktng,' ~hur idieih owcan yonustry expect to suvtv wtout enwur- 'agingyout!SP~pte[osmoke~-`y".~5r-,~x~ 3]~~ y~,,3Yt'~ f. . ~ . z ~~W^'sl ta> . tteti° ` Thank you for your help in this ma Smarely, ~ ? M Elizabeth M. Whelan Executive Director ;As American Council on Science and Health ..Doaember18t1984 relative to this subject ~ Evasive Answers Circumvent the Truth ' There can be little doubt that today's youth (along with inhabitants of Third World countries) represent the tobacco industry's hope for the future. Public knowledge about the adverse health conse- quences of smoking, while far from being encyclopedic, is apparently sufficient to dis- ~ ,.. Ms. Elizabeth M. Whelan Executive Direetor - '` ~; American Council on Science and Health 1995 Broadway,l8th floor :_ New York, NY 10023 Dear Ms Whelan ~r ~ Mr. Kornegay asked me to reply to "theq ry you wrote on December 18 1984, as the parent of a child who as you noted, may soon face a decision about smokutg.~$ You aze o® of the scores of thousands of parents who have espressed interesrin the Helping Youth Decide project which was launched last year by the National Association of State Boards of Education with the support of The Tobacco Insti- tute I believe however, that you are the only parent who wrote on the letterhead of an antt smoking organuauon ?Sx. I am bnclosing for your information a copy of our, booklet, "Helping Youth Deelde," and I think it wiB help you toward better understanding of the answers to the questions you'have' azked For example 'we believe parents are better qualified_than any organization to judge whether their offspring are youung peo-' ple in terms of postponcment of decisions regarding adult life stylea +>i~~F#;;r~•~~~~T~r~~~ . -_ Nowhere in the~Ciooklet, or anywhere else for that matte ; is there any statement that it is the belief of The Tobacco Institute that smoking is not hazardous. Thrcomplieated question as to" whether smoking is hazardous [4 the essential reason: for our view that decisions about smoking should be made by mature persons Similar reasoning obviously applies to other kinds of denstons.' + ~. .~t ? ,~ ~~~ ~~~. Finally, your question about the survtval of the tobacco mdus- try does not appear to be relevant to the NASBE/fl public service project nor to the interest of parents in proper guidance of their youngsters I am not aware that it was a consideration by etther organization in tts decision to support the roject- ~ Cordially W illiam Kl ~ oepfer, Jr. Senior VicePresident-Public Relations_ The Tobacco Institute

i Why Isn't the U.S. Immune to Vaccine Shortages? i By Kathleen A. Meister To make this country immune to shortages of vaccines against' childhood diseases, a new system of compensation for vaccine injuries is urgently needed. PICIURE THIS. YOU BRING YOUR CHILD TO THE DOCTOR FOR A ROUTINE CHECKUP. The doctor says that your child'is scheduled to receive a shot to protect him or her from one of the major childhood diseases. However, the immunization yourchild needs can't be given because the vaccine is unavailable. This once-unthinkable scenario is now occurring in many parts of the country, due to a general nationwide shortage (and extreme spot shortages) of DPT vaccine, which protects children from diphtheria, pertussis (whooping cough), and tetanus. Last December, there were widespread fears of a prolonged nationwide shortage of whooping cough vaccine. That shortage has turned'out to be less severe than predicted. Howeveq it is causing significant problems, and more extreme shortages may occur in the near future. The probVemsthat1ed to the December panic still exist, and unless they are corrected; lengthy disruptions in vaccine supplies with resulting outbreaks of serious childhood diseases are likely. The Whooping Cough Vaccine Shortage The December panic over the supply of': whooping cough vaccine was prompted by Connaught Laboratories' announcement that it would stop selling this vaccine after it' fulfilled existing contracts. Earlier in 1984„ Wyeth Laboratories had stopped selling this vaccine to the public. The one remaining manufacturer, Lederle Laboratories, had experienced production problems, and some federal officials anticipated a major vaccine shortage until Lederle could increase its pro- duction. On December 13, the federal govern- ment's Centers for Disease Control'(CDC). recommended thaf doctors withhold whooping cough vaccine from all children more than a year old to conserve supplies for infants, who are most likely to die if they contract this disease. Health experts pre- dicted that even though this strategy would protect the most vulherable individuals, an increase in whooping cough cases, with some deaths, could be expected if the short- age was prolonged. W hooping cough is still; after all, a very dangerous disease, and immunization is our only real weapon against it, since it still can't be treated very effectively. Most Americans today have never seen a case of whooping cough, so they don't know what a child with this dis- ease goes through. If we had a whooping cough epidemic in this country, thousands of children would face many weeks of illness with a diseasetharacterized by long bouts of extremely painful, uncontrollable coughing. Many children would need long periods of hospitalization, some would suffer severe complications such as encephalitis and pneumonia, and sotne'would die or suffer permanent brain damage,' from the disease or its complications. ~" The CDC off icials whomade the unprece- dented'recommendation to ration whooping cough vaccine evidently did' not know, (although other federal officials did) that Wyeth is still making whooping cough vac- cine, although it is now'selling it only to Lederle and not to the public. Because the Wyeth/Lederle vaccine sup4ly is available, the current shortage is less eatreme than was originally anticipated. However, at a special conference in February of this year, repre- entatives of federal, state, and local health cies and physicians f-tr'me'd that the curr va tne supply sfi dem d: Many p recommendatip older"~drcn enough 1985 to shots. !Accordlri Wyeth, ls s3 t`r-dd has Lederk only for tlie agreement betweeii; extended, this vacdA eight manufacturers~' one. Measles, ttituni measles), and o produced by only, , Measles vaccine usia rubella and oral pi firms each. ' As manufacturq`ip the vaccine busined rganizations con- Wyeth cited high litigation costs when it stopped'selling whooping cough vaccine to the public. A sharp increase in liabilityy insurance rates prompted Connaught's deci- sion to discontinue selling this vaccine. As for the one remaining supplier of whooping cough vaccine, it may soon be faced with a difficult decision, and some observers believe that it' may be forced to withdraw from the market too. In February, Dr. James H. Sammons of the American Medical Association pointed out thar"there is a risk that the product liability coverage which is provided by a coalition of 25 companies will not be renewed when it is due for review in June of this year. If this occurs it is unlikelyy thatithe company will market vaccine." Unfortunately, a manufacturer cannot avoid lawsuits simply by doing an excellent job of producing vaccine. Most vaccine reactions are unavoidable; they are not caused by negligence or errors in produc- tion. Although the benefits of.all the stand- ard childhood vaccines in use todaysubstan- tially exceed their risks (see accompanying article, page 6) none of the vaccines are totally risk-free. In rare cases, they can cause serious, permanent side effects in pre- viously healthy children, even though theyy were manufactured and administered prop- erly. In most of these instances, there would have been no way to determine in advance that this partieularchild was likely to have a issed - bad reaction to the vaccine. Unfortunately, the American public ney of seetn~ unwilling to accept the fact that all ' 'vaccine to medic ocedures, and'vaecination in par- ars. If the ticular, invo some degree of risk. The panies is not very success of childhood immunizations produced by has helped to create this problem, and cur* ade by only a (German es are also urer apuece. bysix,and es by three rent'Ameriean attitudes toward unexpected misfortune have also contributed. "Many immunization programs are vic- tims of their own success," said Dr, Kenneth J. Bart, chief of the surveillance„investiga- tion and research branch of the CDC. "They have reduced diseases to such low levels that pped out of the very rare adverse effects become more ave gonee up prominen[.°' and fears of pro th-threatening "When our country was religious, we vaccine shortages ave tncreased, In oases tended to'aecept the will ofGod' when mis- where a vaccine has,only one producer, a fortune occurred," said Dr. SidneyShindell, strike, fire, accident, or bad batch of'vac- Professor and Chairman, Department of cine could lead to a public health crisis. And - Preventive Medicine, Medical College of if the last manufacturer stopped selling the Wisconsin, and a Scientific Advisor to a vaccine, there could be a lengthy shortage ACSH. "We are more litigious than reli'- ~ until someone - presumably the federal gious at the moment, and we take the view ~ government-took over. that someone should'pay for every misfor, A Causes of the Vaccine Gap The increasing cost of lawsuits brought by individuals who have suffered ads^erse reac- tions to vaccines is the principal reason why many companies have stopped making vac- cines and others have increased'prieesd tune. The price we all pay for this is to have ~ companies be unwilling or unablt to stay in 't the market and be liable forthis small risk." ~. Flaws in the System Z Diseouraging,manufacturers from mak- 6 CONTINUEDONMGE7: < 5

.:`;VACCINES: BALANCING RISKS AND BENEFITS with all the recent pub6cityabout adverse side effects from vac- tines, some parents have become understandably confused about 4 whether their children would be better off with or without the usual I I ' immunizations. Many wonder whether the risks of vaccines might . outweigh theG benefits. The scientific evidence indicates, however, thaTfor all of the stand- ard childhood vaccines - diphtheria, pertussis (whooping cough), tetanus, measles, mumps, rubella (German measles), and polio - the benefits of immunization substantially exceed the risks. All medical procedures have some degree of risk, and immuniza- tions are no exception. On rare occasions, they can cause serious or even permanent side effects. However, the diseases they protecr against are also dangeroust they can kill or permanently disable a child. This is true even for measles, mumps, and rubella, which most' laymen don't think of as potentially serious diseases. Measles and mumps both have rare but serious complications; before vaccines against these diseases were available, substaritial numbers ofchildren suffered these complications, since the diseases were practically uni- versal. Rubella is a mild'disease in children, but if a pregnant ~ woman catches it, it can cause miscarriage, stillbirth, or serious birth defects.. Thus, for all seven of the diseases against which children are routinely immunized, the risk of serious consequences from the disease is far geaterthan the risk of serious side effects from immunization. Polio Vaccine Public concern about side effects has focused on the vaccines against polio and whooping cough, The use of oral polio vaccine unavoidably causes about five cases of polio in the U.S. each year,, usually in unimmunized adults who come into contact with recently immunized children, This small risk must be weighed against the enor- mous benefits of pollo,vaccine: Before the vaccine was available, there were more than 20,000 cases of polio a year in this country. Today, the disease is almost unknown. However, polio still exists and immunization against it is still necessary, as a recent polio outbreak in an unvaccinated religious community tragically demonstrated. Whooping Cough Vaccine The "P"' component of DPT vaccine, which protects children against pcrtussis (whooping cough) has aroused'great concern in recent years. Its potential hazards were dramatized in TV documenta- ries in 1982 and 1985 and in the recently published book DPT.• A Shot in the Dark, by Harris L. Coulter and Barbara Loe Fisher. Both the programs and the book have been harshly criticized for presenting only one side of the story. They devoted extensive attention to descrip- tions ofichildren allegedly injured by the vaccine but almost ignored the disease, pertussis, that the vaccine prevents. Unfortunately, few parents could supply the missing pictures of the devastating effects of pertussis from their own memories, since most were born after this disease was nearly eliminated in the U.S. Pertussis vaccine is indeed the most toxic of the vaccines in current use, causing an estimated one case of brain damage per 310,000 doses. However, the disease that it prevents also causes brain damage. Dr. Paul E Wehrle of the American Academy of Pediatrics (AAP) notes that "pertussis, the disease, would potentially produce ten times the rate of,brain damage as the pertussis vaccine " Before pertussis vaccine was available, there were more than 250,000 cases of this disease each year„with more than 7,000 deaths. 7bday, only about 2,000 cases and five to 20 deaths are reported each year. Both DPT.• A Shot in the Dark and a recent episode of the TV pro- gram 20/20 have suggested that' pertussis vaccine causes sudden infant death syndrome (SIDS). This is not the case. A major nationwide.researeh study, administered by the National Institute of Child Health and Human Development and completed in 1982, showed no evidence of a link between SIDS'and DPT vaccine. The study analyzed more than 800 SIDS cases from all over the country. According to AAP president Dr. Robert J. Haggerty, "Although the entire medical community hopes the cause of SIDS is soon detected,, there is still no answer to this tragedy. What we do know, however, is that the pertussis vaceine-as well as anyoth'er childhood immuniza- tion- is not the cause." 6 Risk/BenefifDecisions Many people think that whenever science comes up with a new vac- cine„public health officials will automatically recommend it for the whole population. This is not true. Evaluations and reevaluations of risks and benefits are constantly being made, and when conditions change, recommendations may also change. For instance, in 1971', the U.S. Public Health Service advised~ that routine immunization of civilians against smallpox be discontinued, because the chance of con- tracting that disease in the U.S. had become remote, and the risks of vaccination had become greater than the benefits. Very, recently, an effective vaccine against chickenpox was developed. This vaccine has been lifesaving for children with leukemia, for whom chickenpox can be a fatal disease. However, it is still uncertain whether the vaccine will be recommended for all children. The risks of the vaccine will need to be carefully weighed against the benefit of preventing a dis- ease which is almost always mild in healthy children. Unlike smallpox, which has been eradicated worldwide, diphtheria, pertussis, and tetanus still exist, and when the DPT immunization rate drops, the rates of these diseases rise. Following adverse publicityy about the side effects of whooping cough vaccine, immunization rates fell in both England and Japan in the mid-I970s. Both countries have since experienced major epidemics of whooping cough, Healthier Lifestyles? , It has been argued tharbecause of today's healthier lifestyles and better medical treatment,,the need'for immunization against child- hood diseases has decreased. This argument is wrong. The experiences of England and7apan have shown that pertussis is still a deadly dis- ease and that epidemics of it can still occur, even in technologically developed countries. The same is true of the other major childhood diseases. Even long-forgotten diphtheria still,occurs occasionally in the UIS. in unvaccinated childten. There are still no specific antibiot- ics for any of the preventable childhood diseases. Thus, prevention of these diseases is preferable to treatment of them. . If Your Child Must Miss a Shot If your child is denied a booster shot of DPT vaccine during the current shortage, it is crucial to return to the doctor later this year so that he or she can receive the missed inoculation. Many physicians are keeping records on children who have missed shots, and they will be sending recall notices to parents when more vaccine becomes availa- ble. However, iowould be a good idea for parents to keep track of this as well, especially if you may be moving to another community and' switching physicians. Dr. Martin H. Smith, president-elect of the AAP,' who chaired a recent emergency meeting on the DPT vaccine shortage, warns "I want to emphasize the need for children to be pro- tected against diphtheria, tetanus, and pertussis. We need to ensure that doses which may be deferred at present are given as soon as possi- ble after adequate supply of the vaccine becomes available." Vaccines Are Not )usf Kid Stuff Adults need vaccinations too, and manydo not have the protection that they should. Although immunization to prevent disease is routine in children, "the medical community has lagged~in applying these same principles to adult diseases," according to Dr. Anthony S. Fauci, director of theNational'Institute of Allergy and Infectious Diseases. The American College of Physicians is currently conducting a cam- paign to promote adulfvaccination. All adults should be immunized against tetanus and diphtheria, and boosterdbses are needed every 10 years. if you can't remember when you had your last tetanus/diphthe- ria shot, you should consult your doctor. Other vaccines are impor- tantfor specific population groups. Adults who have never had mea- sles should be immunized against it. Women of childbearing age particularly need rubella vaccine. Health care workers and other peo- ple at risk of catching hepatitis B should receive this vaccine. Persons over age 65 and those with certain chronic health problems should be immunized against pneumococcal'pneumonia and influenza, since these diseases can be very serious in these individuals. K.A.M.

~ -~ Vaccine Shortages ' CONTINUEDFROMMGES 1,= ing vaccines is only one of the many disad- vantages of our current system of compen- sating people for vaccine injuries only through lawsuits. The court system is nei- ther swift nor equitable to the victims, according to Dr. Lawrence Miike, a physi- cian and'lawyer who directed a study of the vaccine compensation issue by the Congres- sional Office of Technology Assessment (OTA) in 1981. "The legal system is a terri- ble way to go," Dr. Miike said. "It takes years to get a settlemenrand only a few who push their cases get anything. (For those few]; it's a jackpot situation. The court sy£- tem doesn't award anything to most of the injured " The threat of litigation discourages physi- cians as well as manufacturers. At recent Congressional hearings on vaccine injuryy compensation, pediatricians testified that some of their colleagues no longer gave immunizations because they were afraid'of beingsued. An individual's chances of receiving com- pensation through the legal system depend on the state in which he lives, since liability laws differ greatly in different states. If a uniform national standard for producrlia- bility is established (as advocated in Dr. Sid- ney Shindellls article in the Nov/Dec 1984I ACSH NEWS & VIEWS), this inequity would be eliminated, bur the other disad- such a situation, can consent truly be volun- victims ended up in the hands of lawyers. mry? , r- Most of the current arguments about a An Alternative ComJensation S Stem compensation system for vaccine injuries p Y One of the most compelling arguments againsrthe current system is that it does not provide fair treatment for the few people who are harmed by a program designed to benefit many people. Dr. Martin H. Smith, chairman of the AAP's Task Force on Vac- cine Injury Compensation„put it this way, "If laws are in place for the public good which require that children be immunized before entering school and if some children are injured as a result of compliance with them{ it follows that the public should be responsible for providing adequate and expeditious compensation." 6 L The increasing cost of law- suits brought by individuals who have sujfered adverse reactions to vaccines is the principal rea- son why many companies have stopped making vaccines and others have increased vaccine prices. I ~ Many people believe that compensation for children injured'by mandatory child- hood vaccines could be provided most effec- tively by the federal government„through a program with an administrative rather than judicial basis. The principal argument t t f thi h i ld a sys em o s type - t at t wou L L As manufacturers have agatns constitute a "foot in the door" for those dropped out of the vaccine busi- who would like to replace lawsuits with ness, prices have gone u and administrativee compensation systems for . - fears of prolonged, health- injuries caused by everything from lipstick I i threatening vaccine shortages to lswn mowers -ts easily refuted. Manda- have increased. " : tory childhood vaccines are fundamentally different from most consumer products. No vantages of the adversarial judicial'process would remain. Vaccine injury cases do not fit comfort- ably into the torrsystem. Most vaccine inju- ries are unavoidable; no one is at fault, yet someone must pay. The courts have decided that the loss should be borne by the manu- facturer and then passed on to the consumer in the form of increased'prices. Lawsuits, the courts say, are a foreseeable cost of doing business. Unfortunately, the results of lawsuits are so unpredictable that manufac- turers have been unable to foresee these costs and adjust their prices appropriately: This is why many have dropped out of the vaccine market. According to some court decisions, man- ufacturefs can avoid liability if they have adequately discharged their "duty to warn" the person being vaccinated of the inherent risks of the vaccine. Yet the appropriateness of the "duty to warn" standard is question- ' able. A parent who signs an "informed con- sent" form was certainly "informed," but did he or she really "consent" to immuniia- tlonvoluntarily? Thechildhood vaccines are required for school admission in all states, and sch,ool attendance is required by law. In ..>.e..ie~.:._ one tells you to buy a lawn mower to protect the health of others, and no one will Idenyy you admission to school because you don'r have one. Unlike childhood vaccines, most consumer products are used voluntarily and for the benefit of the individual user only. The idea of an administrative compensa- tion system for vaccine injuries is not new. Denmark, France, Great Britain, Japan, West Germany and Switzerland already have such systems. A limited compensation program is now operating in California. And in 1976, in connection with the swine flu vaccination effort, the federal govern- ment went halfway toward a compensation program. When vaccine manufacturers were «luctantio produce swine flu vaccine in quantity because their insurers refused to provide liability coverage, the federal gov- ernment agreed to handle any lawsuits that did not involve negligence by the.drug com- panies. However, the system remained judi- cial rather than administrative. Victims sim- ply sued the government rather than the manufacturer. As a result, those injured by swine flu vaccine faced lengthy court pro- ceedings, many received nothing, a very few received'huge "jackpot" settlements, and a lot of money thaf might have compensated center around how such a system will be set up, rather than whether it should be estab- lished at all. Which injuries shouldbe com- pensated? Should compensation be limited to medical costs or should other costs involved in caring for a permanently dis- abled person (and'perhapseven lost wages) be included? Where should the funds for compensation-payments come from - a surcharge on vaccines or general tax reve- nues? Should!the compensation program be mandatory or should claimants have the choice of using it or bringing suit against vaccine manufacturers? Whan should be done in cases of truenegligence-an unsafe batch of vaccine or a case in which a health professional gave a vaccine to a child who should not have received it for medical rea- sons? All of these questions need to be answered, and none of them are simple. Identifying Vaccine Reactions For instance, determining whether an injury was actually caused by an immuniza- tion is far more difficult than it mighrseem at first glance. The CDC warns that'"events that follow vaceination are not necessarily caused bythevaecine.... Considerablecau- tion must be used'in interpreting reports of adverse events temporally associated' with immunization before inferring causality." f L Most vaccine reactions are unavoidabte;; they are not caused b}~ negligence or errors in pro- duction » This is particularly true for neurologic abnormalities and DPT vaccine. The vac- cine is given to children who are at an age when congenital neurological disorders often manifest themselves for the first time. In a 1984 report, the Ad Hoc Commission on Vaccine Injury Compensation of the American Medical Association (AMA) stated that "the medical community believes that it can, in fact, identify those persons who have had severe reactions to the man- dated pediatric vaccines. With less than severe, irreversible injuries, the causal con- nection that medicine can state may be less precise." Since severely injured persons are those most in need of compensation, this statemenrsounded hopeful. . More recently, however, the AMA has seemed less sure of itself. In February 1985, it announced that it was delaying p1ans to push for a compensation system until fur- ther study could be completed. One of the questions tharthe AMA wants to investigate further is whether the current reporting sys- tem is "accurately reflecting the number of adverse reactions and their severity." The National Vaccine Injury Compensation Act Perhaps the most' controversial issue is CONTINUED ON PAGE 12 7

THE DEVELOPMENT OF A NEW DRUG - ~ To get a better idea of~how new drugs are developed„let's take a typical new drug, an antihypertensive (one that lowers blood pressure), and trace its hypothetical history throughoutthe development process. While we describe the many developmental activities that are going on, we will also keep track ofithe approximate cumulative time elapsed and the approximate money spent to produce the new medicine. Cumulative Time (Years) Cumulative . Cost (Millions of Dollars) 0.5 0.25 . 0.35 1.5 0.75 2.5 2.5 10 Phase II Clinical Trials Stage of Development SynthesislIsolation/' Characterization - ~ 2 Primary Screening , Secondary Screening What's Happening Now Chemists are synthesizing a new molecule or extracting and purifying a substance from a natural source. . short-term effects of the drug in animals. Ifdhe ~' Intensive biological testing to dctermine the testing proceeds drug works and isn't too toxic , to the next stage. the drug works. Several species and strains of animals are used arthis stage. includes dose-response and time-response studies in animals, studies of absorption from the digestive tract and elimination of the dtug from the body, and efforts to figure out how characterize the drug in more detail. This - More extensive biological testing to Preliminary Toxicity Testing Animal experiments to determine if the drug is safe enough to be tested on people. Preparation/Submission of Reporting on all of the above to the Food and IND Drug Administration (FDA), in order to get the Animal Studies time. The subjects are healthy adult volunteers, (IND), meaning that it is now,legal to test it in people. drug classified as an Investigational New Drug Phase I:Clinical'IYials/Further The drug is administered to people for the first 5.5 Phase III iClinical Trials and the goal of the studies is to find out how the drug behaves in the human body. Meanwhile, animal studies, including chronic toxicity testing, continue. - First trials of the new drug in a limited number whether it really does lower blood pressure and of patients with hypertension to determine to develop information on side effects. 'IYials of the new drug in a large number of hypertensive patients. The drug is tested in the precise manner in which it is to be used in patients once it is on the market. Preparation for Marketing Preparation of labels„design of capsules or tablets, writing of package insert materials, developmentiof informational, training, sales, and advertising materials. Reporting on alliof the above to the FDA in the form of a New Drug Application (NDA). Waiting#or FDA approval, providing additional'information requested by FDA, preparing to produce the new product. R.P.M.

,,. Cost of Generic Drugs ie)1 the drug. After that; competitors who - CONt[NUED FROM MGE 1 wish to markett the drug as a generic can in 1940 not one manufacturer of ethical enter the picture. But it's important to (prescription) drugs in this country had an remember that new drugs are usually pat- annual sales volume larger than that of ented long before the date when they are Macyt department store in New York City. actually approved for sale by the Food and The onsetbf World War II brought a shift Drug Administration (FDA): Thus, the In the leadership of the pharmaceutical actual! opportunity for the company to industry from Europe to the United States regain the cost of developmenr(and some of with a concurrent increase in research and the cost of the aborted development of other development. The impetus of military prob- drugs that fell by the wayside during the long kmsatimulated research to develop new and development process) without market com- better vaccines and drugs; the use of these petition may be as little as five to seven agents in battlefield situations demanded years. Until very recently, it might have been new and better dosage forms and drug deliv- even shorter if the red tape of the FDA's ery systems. The concept of prepackaged„ review process for new drugs became more pre-measured, easily stored and readily dis- than usually tangled, thus delaying the pensed dosage systems was stimulated, and drug S final approval. by the late 1940s the days of the compound- ing pharmacist were rapidly nearing an end. As pharmaceutical companies became thee manufacturers of the final products used, their need to extend their efforts into new drug development became more pro- nounced; at the same time, scientists around the world began to develop newer approaches to the therapy of human dis- eases. A host of new drugs - many in thera- peutic classes previously unknown - were i L At the present time, the man- ufacturers of pioneer drugs return a significant portion of their proffts on marketed drugs to their in-house research efforts; much of this funding goes to support basic research into tne causes qi aisease as weft as into the development of com- pletely new therapeutic : .,, - approaches.95 .. born. For example, since 1945 (only four decades ago);,we have seen the development of antibiotics, tranquilizers, oral contracep- tives and manyothers. How a New Drug Is Born . Developing a new therapeutic agent is much like trying to breed pandas in captivity - a lengthy and expensive process with a very low, probability of success. Of every 1,000 chemical compounds prepared by a pharmaceutical company - either isolated from a natural source or synthesized in the chemical laboratory - one or two will actu- ally develop into marketable drugs. From the date a substance is first isolated or syn- thesized ia sufficient quantities for the start of testing to when that compound is actually sold in the marketplace, six to eight years generally elapse, and the cost may be any- where from 25 to 73 million dollars. (See box,pageS.) At some point during the process of drug development, often rather early, the manu- facturer files a patent application, From the date of issuance of the patent, the manufac- turer has a period of 17 years of sole rights to ..~: sive litigations and court tests to fully define the "new" procedures. In general terms, however, the law accomplishes the following two things. First, numerous parts of the new law con- cern extension of patent terms to allow for delays in review and/or approval of truly new drugs by the FDA. Such extensions may not exceed five years per se, nor may the time from the date of thedtug$ approval to the termination of the patent extension exceed 14 years.: - - - - Second, the new law establishes specific procedures which should facilitate the approval of;generic versions after a drug's patent expires. - Despite the extension of patent protection which it provides, the new law's overall New Lawfxtends Patents, Promotes impact is expected to be an increase in the Generics ., availability of generic drugs. This should Tvo decades of controversy over generic reduce the overall cost of health care in the United States by stimulating price competi- drugs culminated in the passage of the Drug tion for r ' tt' h ti escn on az l Wh t The developer of the generic drug oeed only prove a lal his product 6ets to ILs desttmtion In lhe body W as efficiently as the original drug does, and that u acts as effectively once it arrives.. -. Price Competition and Patent Term Resto- ration Act of 1984, signed into law by Presi- - dent Reagan on September 24, 1984. The controversy had'~focused on two issues, and the new law deals with both of them. One keyconcern was the decreasing incentive for manufacturers to develop new drugs, caused by the shortened patent pro- tection produced by stringent regulatory requirements and lengthy approval proc- esses. The other problem was the difficulty that manufacturers of generic drugs were having in getting their products approved by FDA, because of complex regulatory proce- dures. The new law covers a variety of aspects ot drug patenting and development. Indeed, mostexperts are of the opinion that various types of legal situations will require exten- p p p ca maceu , a s are some of the implications of this for the consumer? Benefits for the Consumer There is no question thara generic version of a drug can be sold for a lower price than the original'venion of the same drug, since the overall cost of development of the generic is considerably smaller. Unlike the developer of the truly new (pioneer) drug, ii In the long run, the real cost of generic drugs may be not'a saving fn dollars, but a reduction in the quality of research and development at'the frontiers of biomedical science. 99 the developer of the generic need not con- dua research to prove that the drug is safe and effective. He need only prove that his product has bioavailability and bioequiva- lency comparable to the original (i.e., that it geu to its destination in the body as effi- ciently as the original drug does, and that it acts as effectively once it arrives). The research required to demonstrate bioavaila- bility and bioequivalency is minimal in com- parison with the research required to develop a pioneer drug. - Because bioavailability and bioequiva- kncy must be demonstrated before a generic version of a drug is marketed, the generic drug is therapeutically the same as the pio- neer product. Therefore, consumers who take advantage of the generic's lower cost do not have to sacrifice therapeutic effective- ness to do so. FDA regulations ensure that they do not have to sacrifice quality either. All manufacturers of prescription pharma- ceuticals are required to maintain similar standards of quality by the FDA. Thus,,all must follow the requirements of t.,ood Man- ufacturing Practices and must exist within - CONTINUEDON PAGE 10 i

. Cost of Generic Drugs CONTINUED FROM MOE 9 similar constraints for quality control. '- While it may be tempting to curcorners in ," manufacturing procedures, any decrease in quality will lead to FDA- or manufacturer- initiated recalls with consequent financial losses to the manufacturer. LL The complez regulatory pro-' cedures for FDA approval of • generic drug products were addressed in the Drug Price Competition and Patent Term Restoration Act of 1984. 9 9 Long-Term Concerns What then are the concerns, if any, that need be expressed regarding the expected influx of generic prescription drugs into the marketplace? One major concern stands out. Afthepresent time, the manufacturers of pioneer drugs return a significant portion of their profits on marketed drugs to their in-house research efforts; much of this funding goes to support basic research into the causes of disease as well as into the devel- opment' of eompletely new therapeutic approaches. The generic manufacturers have, in general, no such in-house research capabilities. As a result, one might very well expect to see fewer and fewer truly new drugs being developed in this country. . While generic versions of a drug rarely achieve the lion's share of a market, a signi- frcant decrease in market share held by a pioneer manufacturer, coupled with a com- petition-induced selling price reduction, will lead to a reduction in company-available research and development funding. In the long run, this will be the real cost of generic drugs, not a saving in dollars but a reduction , in the quality of research and'development at the frontiers of biomedical science. Unless a manufacturer can foresee the rewards of an activereseareh program and can return those rewards to furthering development, the pharmaceutical industry in the U.S. may face a future thaf is charac- terized by a high degree of competition for lower prices rather than for new and better products. The tremendous improvements in pharmacotherapeutics(useof drugs in the treatmentof diseases) since the end of World War II havenmanated largely from research efforts ofthe "pioneer drug" pharmaceuti- cal industry; one must hope that the rise of generic drugs will not lead to a reversal'of this trend'. t ' Roger P Maickel; Ph.D., is a ProJessor in the DepartmenLof Pharrnacology and Toxi- cofogy. School of Pharmacy and Pharmacal sciences. Purdue fJniversity and a Scientfc Adviror to ACSH. xamining Home Pregnancy Tests By Cathy Becker Popescu W HEN A WOMAN IN ANCIENT EGYPT drops of first morning urine with a solution WANTED TO KNOW WHETHER OR NOT SHE WAS Of antibodies to HCG. If a sufficient qnan- I+REGNANT; she was advised to drink a mix- tity of HCG is present in her urine, it will ture of pounded watermelon and the milk of bond with the HCG antibodies. Next, cells a woman who had borne a son. If she vom- ited, she was considered pregnant. Since that time, pregnancy testing has become considerably more scientific and less unpleasant. The first laboratory test to detect pregnancy was the so.called "rabbit test"' dEveloped in 1927. This relatively expensive and tim"onsuming test, which was widely used until a generation agoi . involved injecting a rabbit with the urine of a woman who thought she might be preg- nant. If she was, indeed, pregnant, her urine would contain a special hormone called human chorionic gonadotrophin (HCG); which would cause changes in the rabbit's ovaries. Forty-eight hours afterinoculationa coated with HCG are added to the solution. If HCG in the woman's urine has already bonded with the HCG antibody, the HCG on the cells will have nothing to bond to and the cells will settle into a ring at the bottom of the container. This indicates pregnancy On the other hand, if there is no(or very little) HCG in a womans urine, the HCG antibodies will remain free to bond'with the HCG coated cells. The cells will then form clumps in the solution, forming a milky fluid, but no ring. This indicates thaf a woman is probably not pregnant. A couple of the newer home pregnancy tests, such as e.p.t. Plus' and Advancea, use a slightly different immunological technique iL When used appropriately, these tests are reasonably accurate, but they can't replace a doctor's expert diagnosis. » the rabbit was sacrificed and the ovaries to detect HCG and are simpler to perform. examined. If there was a large amount of With these tests, a color change in a special blood'presentinthebloodvesselsoftheova- solution or "colorstick" indicates preg- ries, pregnancy was diagnosed. I nancy ' . In the 1960s, scientists developed an The instruction booklets advise that home immunological test to detect' HCG in the pregnancy tests can be performed as early as urine which did not involve the use of labo- three to nine days after a missed period and ratory animals and gave much quicker results can be read'. in 30 minutes to two results. This test, which is used in laborato- hours, depending on the brand. The tests ries today, can be done on a glass slide or in a can be performed without scheduling an test tube and takes only a few minutes(for appointment or leaving home. They thus the slide test) or a couple of hours (for the fulfill claims of convenience and speed, but tube test). A slide test can detect pregnancy what about accuracy? as early as five days aftera missed menstrual period, while a tube test is accurate at three Accuracy and Error to nine days. Sinee results are sometimes dif- ficult to interpret in the very early part of All brands boast comparable accuracyy t Th ese ra es pregnancy, however, most doctors recom- rates of close to 100 percent. mend that a woman wait two weeks after the reflect testing under ideal laboratory condi- first day of her expected'period before com- tions, however, with rigid adherence to all ing in for a pregnancy test. instruetions and intepretation by experi- In 1978, women began to see advertise- enced personnel. Under conditions of actual ments for pregnancy tests which they could use. there is a ample room for error which perform themselves at home. The ads pro- can reduce substantiallythe tests"reliability. fessed that thetests were a quick, convenient If the testis performed'too early in preg- nancy (even within the period specified in and accurate way to determinepregnancy . The claims are impressive, but can home pregnancy tests really live up to all of them? The answer is a qualified yes. ' . Standard Techniques Home pregnancy tests on the market today are based on standard'immunological techniques used by laboratories to detect HCG and are regulated by the Food and Drug Administration. With most tests, the woman mixes a few the instructions)„there may not be enough HCG present to be detected. Although these products stress early detection of pregnancy, consumers should be aware that reported accuracy rates are based on tests performed 15 or so days after a missed period, nonthe three to nine days specified in the instruc- tions. Because of the rather high probability of a false negative result (i.e., the test results indicate a woman is not pregnant when she actually is), which may be around 20 percent on a f irst test, the instructions advise women