EDITORIALS
sold over-the-counter to women to facilitate the early diagnosis of pregnancy. Immunologic tests become positive as early as 3 weeks after conception, at least 2 weeks before consistently accurate diagnosis by pelvic examination is possible. The advantages of such early diagnoses should be obvious-for women desiring termination, a simpler and safer abortion procedure; for those desiring to be pregnant, the avoidance of deleterious physical and chemical agents during the most vulnerable period of embryonic life. Our own experience at the 78th Street Center in New York City has convinced us that a Do-It-Yourself Pregnancy Testing Program can be a major public health benefit, providing that an accurate simple test is used (2-Minute UCG or Dridot) and that each woman receives an instruction sheet advising her of the possibilities of error and of the confirmatory symptoms of pregnancy. Indeed, the costs of each test are so low (about $1.00) that questionable tests can easily be repeated.
We believe that all tests of biological materials should be evaluated by appropriate testing authorities and that the accuracy and limitations of the tests be clearly stated on the package inserts. We hope that in the not-too-distant future simple, inexpensive pregnancy test kits will become readily available to women who have missed their periods just as urine test paper strips are presently available to diabetics.
EDWARD M. STIM, MD Dr. Stim is Medical Director of the 78th Street Center, a consumeroriented women's health facility, 1120 Lexington Ave., New York, NY 10021.
REFERENCE 1. Baker, L. D., Yert, L. W., Chase, M. C., and Dale, E. Evaluation of a Do-It-Yourself Pregnancy Test, Am. J. Public Health, 66:166-167, 1976.
. . . Envoi At least three of the issues raised by this fascinating case study warrant further comment. The first is the judge's delightful opinion that pregnancy is not a disease. On the one hand, the health care system and those who work within it could profit by taking this refreshing viewpoint to heart. On the other hand, one doubts whether even the judge himself would want this particular physiological function to be identified inaccurately or monitored, supported, and culminated only by family and friends. All physiological functions have their pathology, and pregnancy has a good many. One hopes at least that the health care system and those who work within it strive to promote normal physiological functions (health) as well as treat pathological ones (disease). This leads to the second issue-protection of consumers from the marketing of drugs and medical devices that are unsafe, ineffective, or mislabeled. For a wry view of the federal agency involved, readers are referred to a recent commentary in a sister journal.1 Both the full authority to protect the public and the funds with which to exercise the authority already granted the agency appear to be lacking. Pending congressional legislation may or may not provide requisite authority, contingent upon the outcome of political compromise; given the turmoil surrounding the federal budget, adequate funding to enable the agency to exercise its authority seems unlikely for the present. The story is not a pleasant one. Ova II was a chemical test, and the Food and Drug Administration sought to take it out of circulation under its authority to control drugs. However, currently available pregnancy tests of accepted effectiveness depend upon the action of a biological product rather than a chemical or drug and, therefore, come under the purview of FDA authority to conAJPH February, 1976, Vol. 66, No. 2
trol biologicals. This is exercised by the Bureau of Biologics (recently transferred to FDA from the National Institutes of Health) under different laws from those governing drug and medical device regulation. For the purpose of this discussion, neither the authority to regulate biologicals nor the capability of implementing this authority will be questioned. We will assume that the consumer is adequately protected against unsafe, ineffective, or mislabeled biological products. This leads us to the third issue-over-the-counter sales of do-it-yourself pregnancy tests versus their sale by prescription only. For a comprehensive review of the status of pregnancy tests the reader is referred to a recent report from The George Washington University Medical Center.2 Pregnancy diagnostic kits are available to the consumer through over-the-counter sale in Canada and Western Europe but not in the United States. Granted that a diagnostic capability earlier than two weeks following a missed menstrual period (the limits of the available simple tests) would be desirable, and granted an effective test, what are the pros and cons? The pros seem self-evident. The prevention of late abortions, especially in teenagers, and perhaps the promotion of earlier prenatal supervision are clearly important public health objectives. There are several hypothetical contraarguments: I . The test may require use of perishable materials or unfamiliar equipment. However, this does not hold for at least one of the tests currently sold by prescription only in the U.S.A.2 2. The test results cannot be interpreted accurately by a lay person. However, anecdotal reports belie this assertion. Furthermore, as Baker and his colleagues have pointed out, 131
EDITORIALS
pre-market testing of "use-effectiveness" (a comparison of results read by women doing the test at home per instructions in the package with results read by a trained technologist) can and should be applied before such a test is released for over-the-counter sale. 3. False negatives can occur although rarely (as would be true with any test). However, if the pregnancy is a normal one, the falsity of the test will soon be evident. If it is an ectopic pregnancy or a threatened abortion (which may give false negatives) it seems doubtful that the false result would alter the behavioral course or outcome that would have occurred if the over-the-counter sale had not been made. Furth-ermore, appropriate labeling, which should advise both repeat testing and health care regardless of test result and should spell out the cautions and the meaning of false negatives, could well motivate more appropriate health behavior than would have occurred if the sale had been prohibited (whether the pregnancy is normal or abnormal). 4. False positives can occur although rarely (as would be true with any test). However, it must be assumed that the test would be repeated by the care provider before undertaking a legal abortion or initiating ante-natal care. 5. Finally, there are a series of arguments such as those of encouraging illegal abortions or asserting that any woman who questions whether or not she is pregnant should be counseled at the same time that she is tested. These are debatable points but given the holes in the health care system and the stigma attached to unwanted pregnancies one might
question whether the availability of over-the-counter sales would have any effect upon the current delivery status of either illegal abortions or counseling services. One might also speculate about the vested interests of those who raise such arguments. The outcome of this dialectic appears to support the view that over-the-counter sales of pregnancy tests of proven effectiveness and "use-effectiveness" are justified now, in the U.S.A. However, this Editor can claim no special familiarity with pregnancy testing, much less expertise in the field. The intent of the exercise was to raise the issue for debate and resolution in public, professional, and bureaucratic forums. One wonders why it has lain fallow for so long. Responsible professional groups have not addressed the issue. The manufacturers have initiated no action. There are no outcries from the women's liberation movement, the free clinics, the women's clinics, or the neighborhood samaritans who have used these simple tests for many years (on prescription of a friendly physician). Isn't it about time for someone to pick up the ball and move?
ALFRED YANKAUER, MD REFERENCES 1. Greenberg, D. S. The FDA Investigates Itself. New Eng. J. Med. 21:1157, 1975. 2. Pregnancy Tests-The Current Status. Pop. Reports, Series J, No. 7, Nov., 1975. Dept. Medical and Public Affairs, George Washington University Medical Center, Washington, D.C.
The Cigarette Smoking/Lung Cancer Hypothesis The persistent controversy regarding the role of smoking in lung cancer cannot be resolved merely by escalating the force of arguments pro and con. That these arguments are becoming increasingly sophisticated and more vigorous serves to demonstrate that the issue is hardly trivial. Let us, therefore, carefully examine the nature of the problems we confront and seek to identify means of approaching them in the best interests of both the scientific community and the general population. In a recent issue of this Journal, Sterling's critique of American Cancer Society and other studies challenged the apparent association between cigarette smoking and lung cancer.' In addition to insisting that uncontrolled selective factors bias the ACS findings, Sterling cited a number of epidemiologic observations which presumably cast doubt on the importance of smoking in the etiology of lung cancer. He emphasized that these observations demand further appraisal of current evidence about environmental and industrial factors in the complex causal web of cancer. Only by the most careful reading of Sterling's article can one avoid the impression that cigarette smoking should be discounted as a contribuiting cause in lung cancer. In the same issue of the Journal, however, Weiss states that 132
"... the evidence in favor of the smoking-lung cancer hypothesis is overwhelming."2 With reference to studies not included in Sterling's survey, Weiss cites further support for the smoking-lung cancer hypothesis: "No matter where we look, the association is consistent, strong, and specific. . ." In this month's issue of the Journal two communications constitute additional rebuttals to Sterling's charges of spuriousness.3 Sterling's reply to these communications also appears.5 Clearly, there is substantial interest in this debate, and the publication of this series of papers is intensely provocative-although more of heat than light! Study of the arguments from all sides reveals some common ground upon which we might proceed more dispassionately. While debating the relative importance of smoking, we, can, nevertheless, agree that cigarette smoking is at least included in the array of causal factors. A concern for appropriate public health policies and activities relevant to smoking and cancer follows from this agreement. Continued divisiveness around the precise contribution of smoking has potentially two tragic consequences for policy. On the one hand, to insist that smoking independently accounts for lung cancer is to construct an obstacle to future investigations and reappraisals of environmental carcinoAJPH February, 1976, Vol. 66, No. 2
sold over-the-counter to women to facilitate the early diagnosis of pregnancy. Immunologic tests become positive as early as 3 weeks after conception, at least 2 weeks before consistently accurate diagnosis by pelvic examination is possible. The advantages of such early diagnoses should be obvious-for women desiring termination, a simpler and safer abortion procedure; for those desiring to be pregnant, the avoidance of deleterious physical and chemical agents during the most vulnerable period of embryonic life. Our own experience at the 78th Street Center in New York City has convinced us that a Do-It-Yourself Pregnancy Testing Program can be a major public health benefit, providing that an accurate simple test is used (2-Minute UCG or Dridot) and that each woman receives an instruction sheet advising her of the possibilities of error and of the confirmatory symptoms of pregnancy. Indeed, the costs of each test are so low (about $1.00) that questionable tests can easily be repeated.
We believe that all tests of biological materials should be evaluated by appropriate testing authorities and that the accuracy and limitations of the tests be clearly stated on the package inserts. We hope that in the not-too-distant future simple, inexpensive pregnancy test kits will become readily available to women who have missed their periods just as urine test paper strips are presently available to diabetics.
EDWARD M. STIM, MD Dr. Stim is Medical Director of the 78th Street Center, a consumeroriented women's health facility, 1120 Lexington Ave., New York, NY 10021.
REFERENCE 1. Baker, L. D., Yert, L. W., Chase, M. C., and Dale, E. Evaluation of a Do-It-Yourself Pregnancy Test, Am. J. Public Health, 66:166-167, 1976.
. . . Envoi At least three of the issues raised by this fascinating case study warrant further comment. The first is the judge's delightful opinion that pregnancy is not a disease. On the one hand, the health care system and those who work within it could profit by taking this refreshing viewpoint to heart. On the other hand, one doubts whether even the judge himself would want this particular physiological function to be identified inaccurately or monitored, supported, and culminated only by family and friends. All physiological functions have their pathology, and pregnancy has a good many. One hopes at least that the health care system and those who work within it strive to promote normal physiological functions (health) as well as treat pathological ones (disease). This leads to the second issue-protection of consumers from the marketing of drugs and medical devices that are unsafe, ineffective, or mislabeled. For a wry view of the federal agency involved, readers are referred to a recent commentary in a sister journal.1 Both the full authority to protect the public and the funds with which to exercise the authority already granted the agency appear to be lacking. Pending congressional legislation may or may not provide requisite authority, contingent upon the outcome of political compromise; given the turmoil surrounding the federal budget, adequate funding to enable the agency to exercise its authority seems unlikely for the present. The story is not a pleasant one. Ova II was a chemical test, and the Food and Drug Administration sought to take it out of circulation under its authority to control drugs. However, currently available pregnancy tests of accepted effectiveness depend upon the action of a biological product rather than a chemical or drug and, therefore, come under the purview of FDA authority to conAJPH February, 1976, Vol. 66, No. 2
trol biologicals. This is exercised by the Bureau of Biologics (recently transferred to FDA from the National Institutes of Health) under different laws from those governing drug and medical device regulation. For the purpose of this discussion, neither the authority to regulate biologicals nor the capability of implementing this authority will be questioned. We will assume that the consumer is adequately protected against unsafe, ineffective, or mislabeled biological products. This leads us to the third issue-over-the-counter sales of do-it-yourself pregnancy tests versus their sale by prescription only. For a comprehensive review of the status of pregnancy tests the reader is referred to a recent report from The George Washington University Medical Center.2 Pregnancy diagnostic kits are available to the consumer through over-the-counter sale in Canada and Western Europe but not in the United States. Granted that a diagnostic capability earlier than two weeks following a missed menstrual period (the limits of the available simple tests) would be desirable, and granted an effective test, what are the pros and cons? The pros seem self-evident. The prevention of late abortions, especially in teenagers, and perhaps the promotion of earlier prenatal supervision are clearly important public health objectives. There are several hypothetical contraarguments: I . The test may require use of perishable materials or unfamiliar equipment. However, this does not hold for at least one of the tests currently sold by prescription only in the U.S.A.2 2. The test results cannot be interpreted accurately by a lay person. However, anecdotal reports belie this assertion. Furthermore, as Baker and his colleagues have pointed out, 131
EDITORIALS
pre-market testing of "use-effectiveness" (a comparison of results read by women doing the test at home per instructions in the package with results read by a trained technologist) can and should be applied before such a test is released for over-the-counter sale. 3. False negatives can occur although rarely (as would be true with any test). However, if the pregnancy is a normal one, the falsity of the test will soon be evident. If it is an ectopic pregnancy or a threatened abortion (which may give false negatives) it seems doubtful that the false result would alter the behavioral course or outcome that would have occurred if the over-the-counter sale had not been made. Furth-ermore, appropriate labeling, which should advise both repeat testing and health care regardless of test result and should spell out the cautions and the meaning of false negatives, could well motivate more appropriate health behavior than would have occurred if the sale had been prohibited (whether the pregnancy is normal or abnormal). 4. False positives can occur although rarely (as would be true with any test). However, it must be assumed that the test would be repeated by the care provider before undertaking a legal abortion or initiating ante-natal care. 5. Finally, there are a series of arguments such as those of encouraging illegal abortions or asserting that any woman who questions whether or not she is pregnant should be counseled at the same time that she is tested. These are debatable points but given the holes in the health care system and the stigma attached to unwanted pregnancies one might
question whether the availability of over-the-counter sales would have any effect upon the current delivery status of either illegal abortions or counseling services. One might also speculate about the vested interests of those who raise such arguments. The outcome of this dialectic appears to support the view that over-the-counter sales of pregnancy tests of proven effectiveness and "use-effectiveness" are justified now, in the U.S.A. However, this Editor can claim no special familiarity with pregnancy testing, much less expertise in the field. The intent of the exercise was to raise the issue for debate and resolution in public, professional, and bureaucratic forums. One wonders why it has lain fallow for so long. Responsible professional groups have not addressed the issue. The manufacturers have initiated no action. There are no outcries from the women's liberation movement, the free clinics, the women's clinics, or the neighborhood samaritans who have used these simple tests for many years (on prescription of a friendly physician). Isn't it about time for someone to pick up the ball and move?
ALFRED YANKAUER, MD REFERENCES 1. Greenberg, D. S. The FDA Investigates Itself. New Eng. J. Med. 21:1157, 1975. 2. Pregnancy Tests-The Current Status. Pop. Reports, Series J, No. 7, Nov., 1975. Dept. Medical and Public Affairs, George Washington University Medical Center, Washington, D.C.
The Cigarette Smoking/Lung Cancer Hypothesis The persistent controversy regarding the role of smoking in lung cancer cannot be resolved merely by escalating the force of arguments pro and con. That these arguments are becoming increasingly sophisticated and more vigorous serves to demonstrate that the issue is hardly trivial. Let us, therefore, carefully examine the nature of the problems we confront and seek to identify means of approaching them in the best interests of both the scientific community and the general population. In a recent issue of this Journal, Sterling's critique of American Cancer Society and other studies challenged the apparent association between cigarette smoking and lung cancer.' In addition to insisting that uncontrolled selective factors bias the ACS findings, Sterling cited a number of epidemiologic observations which presumably cast doubt on the importance of smoking in the etiology of lung cancer. He emphasized that these observations demand further appraisal of current evidence about environmental and industrial factors in the complex causal web of cancer. Only by the most careful reading of Sterling's article can one avoid the impression that cigarette smoking should be discounted as a contribuiting cause in lung cancer. In the same issue of the Journal, however, Weiss states that 132
"... the evidence in favor of the smoking-lung cancer hypothesis is overwhelming."2 With reference to studies not included in Sterling's survey, Weiss cites further support for the smoking-lung cancer hypothesis: "No matter where we look, the association is consistent, strong, and specific. . ." In this month's issue of the Journal two communications constitute additional rebuttals to Sterling's charges of spuriousness.3 Sterling's reply to these communications also appears.5 Clearly, there is substantial interest in this debate, and the publication of this series of papers is intensely provocative-although more of heat than light! Study of the arguments from all sides reveals some common ground upon which we might proceed more dispassionately. While debating the relative importance of smoking, we, can, nevertheless, agree that cigarette smoking is at least included in the array of causal factors. A concern for appropriate public health policies and activities relevant to smoking and cancer follows from this agreement. Continued divisiveness around the precise contribution of smoking has potentially two tragic consequences for policy. On the one hand, to insist that smoking independently accounts for lung cancer is to construct an obstacle to future investigations and reappraisals of environmental carcinoAJPH February, 1976, Vol. 66, No. 2
