Catholic Health Care Advocates Papers
The Medical Hazards of the Birth Control Pill
Herbert Ratner, M.D.
To withdraw a drug once on the market is considerably more difficult than to get a drug on the market. FDA originally approved The Pill (Enovid) as safe for marketing on the basis of studies on only 132 women who had taken The Pill consecutively for 12 or more months. (Morton Mintz, By Prescription Only, Houghton Mifflin Co, Boston, 1967, p. 271.) Since The Pill has been on the market, the number of deaths reported in association with The Pill has far exceeded this number. In fact, it is safe to say that The Pill is the most dangerous drug ever introduced for use by the healthy in respect to lethality and major complications.
To admit mistakes is not characteristic of the American scene. Governmental agencies are no exceptions. In addition, the pressures and manipulations by drug firms-and the people they subsidize-to prevent a drug from being removed from the market can be extraordinary. This is especially true of The Pill. Everyone prefers to believe that The Pill is safe. The net result of propaganda which led to pronouncements of Pill safety out of so-called humanitarian considerations was that the real users of The Pill, the middle and upper classes of the U.S., were seduced away from well established and safe means of birth control.
Perhaps the most fallacious argument in defense of The Pill is that it prevents the hazards of pregnancy. How a Pill which places the woman in a continuous state of false pregnancy, which in turn reproduces the illnesses of occasional pregnancies, can be considered an advantage is beyond scientific comprehension. The English, in an attempt to water down their finding of 3 deaths per 100,000 women from thromboembolism by alleging that The Pill prevents 12 deaths per 100,000 from pregnancy ignore two essential facts. The first is that the alternative to The Pill is not pregnancy but other and safer means of conception control. The second is that prior poor health contributes to most of the deaths in pregnancy. Contrasting the death rate of healthy women on The Pill to healthy pregnant women results in an entirely different comparison.
In pregnancy, the vascular system of the body adjusts to accommodate a rapidly enlarging uterus. In false or Pill pseudopregnancy, the pelvic vascular system increases the blood supply, but there is no enlarging uterus to utilize the increase. This results in extensive pelvic venous congestion, a condition which has already caused distress to surgeons. Such unnatural congestion introduces a whole series of factors predisposing to thrombosis and embolic phenomena.
The second example relates to the hypercoaguable state of pregnancy. This state was described prior to the introduction of The Pill. (B. Alexander, M.D., et al. Increased Clotting Factors in Pregnancy, New England Journal of Medicine 256:10931097, Nov. 30, 1961.) "This (state) provides a means whereby rapid clotting may take place at the site of placental separation." (Louise L. Phillips, Ch. 12, "Modifications of the Coagulation Mechanism During Pregnancy," in Modern Trends in Human Reproductive Physiology, Ed. H. M. Carey, Butterworths, 1963.) The Pill duplicates the hypercoaguable state. Because it serves no function in false pregnancy, its only contribution is to make the "patient potentially more susceptible to intravascular thrombosis." (Ibid,) The Pill introduces the risk without compensatory advantage.
The third example relates to the well-known protection which pregnancy or embryonic tissue confers against certain induced cancers in the lower animal. In the absence of fetal tissue this protection is not conferred. Protecting this fetal-maternal relationship to human beings, we cannot assume in using The Pill contraceptively, via the mechanism of a false pregnancy, that the protection against cancer is present in the absence of the fetus. It would seem that if we had any respect for nature's economics, subtleties and the ordering of health, and any humility in respect to our multiple ignorances of the fetal-maternal relationship, we would more readily recognize that a state of false pregnancy is pathologic and a monstrosity of nature.
The first committee appointed to study the question of thromboembolism, was sponsored by the manufacturers of Enovid, not the government, and conducted by the American Medical Association. (Proceedings of a Conference: Thromboembolic Phenomena in Women, Sept. 10, 1962, Chicago ) The latter has a well known bias in favor of the pharmaceutical industry. Within several hours of convening this meeting, before participants had an adequate opportunity to study and discuss the data presented at the meeting, the Chairman called for a vote that would, in effect, be a whitewash of The Pill. He commented, ". . . so far there has not been a single shred of evidence that has been presented in any of these figures to suggest that it contributes to a greater incidence of this disease. . . Will everyone agree with that?" The Chairman ultimately got the vote he requested. That it was not unanimous is a tribute to Stanford Wessler, M.D. a leading authority on thrombosis, who with courage and perspicacity, was the single dissenting voice.
If, for reasons of its own, FDA feels it cannot remove The Pill from the market on the same basis as other drugs, we would urge the FDA to appoint another committee. If the safety of the public is paramount, such a committee should be sympathetic to a long established principle of medicine - Above All Do No Harm! Physician's Desk Reference 1997 - Excerpt from patient package insert
The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:
- Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body.
- Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.
- High blood pressure, although blood pressure usually returns to normal when the pill is stopped.
Third generation oral contraception and venous thromboembolism
British Medical Journal - April 1997 The published evidence confirms the Committee on Safety of Medicine's concerns. All studies indicated a statistically significant doubling of the adjusted odds ratios for venous thromboembolism in patients taking third rather than second generation oral contraceptive pills. These results are consistent with those from the transnational study published in this issue of the British Medical Journal. The increased risk cannot be explained by known or expected bias or confounding.
The first law of epidemiology is that if a causal effect is large enough, it will show up despite all the problems of performing, analyzing, and interpreting observational studies on real people. The doubling of risk of venous thromboembolism in users of third generation pills is important when the baseline risk in users of the pill is already three times greater than in non-users. Some studies have reported a relative risk of venous thromboembolism of about nine for users of third generation pills compared to women using non-hormonal contraception.
Oral Contraceptives and Risk for Breast Cancer in Young Woman
The following is text of a press release from the British National Cancer Institute Press Office. The research was reported in the June 7th issue of the Journal of the National Cancer Institute.
A new study headed by scientists at the National Cancer Institute (NCI) adds to the evidence that oral contraceptives increase the risk of breast cancer in women under age 35. - CancerNet News UK June 6, 1995 "While the findings are reason for caution, breast cancer is uncommon in this age group, and the pill appears to be responsible for only a minority of breast cancers in young women," said NCI's Louise A. Brinton, Ph.D., lead researcher of the study.
Sterility & Infertility
Progress in Contraception Control: The Sequential Regimen. Physicians' Conference, San Francisco, April 4, 1965. Mead Johnson & Co., 1965.
". . . our multiparous patients . . . want to know how long it will be after they discontinue the tablets before they can expect to conceive... We have six patients who as yet have not become pregnant. They have been trying to conceive from two months up to thirty months. Because all have previously had children, we felt there must be some reason for the delay in conceiving." - A. L. Banks, M.D. (University of Washington) "I now have eight patients who are experiencing amenorrhea after discontinuing the combined contraceptive regimen . . . hoping to get pregnant. . ." - Robert H. Hall, M.D. (University of Utah) "Dr. Hall, you strike a very important chord in this discussion. I think Dr. Banks made reference to this point. All of us have encountered amenorrheic episodes following termination of the combined form of therapy." - Robert B. Greenblatt, M.D. (Medical College of Georgia) Amenorrhea After Treatment With Oral Contraceptives. R. P. Shearman M.D. (University of Sydney. Australia).
"In a period of 6 months, 9 women with secondary amenorrhea of at least 12 months duration, gave a history of onset after stopping The Pill." - Lancet 2:1110-1111, Nov. 19, 1966. Syndrome of Anovulation Following Oral Contraceptives. O. I. Dodek, Jr., M.D. et al (Washington, D.C. Hospital Center).
"The anovulation syndrome is found in patients who have had amenorrhea or evidence of anovulation for three or more months after discontinuance of The Pill. Prolonged dysfunction of hypothalamic centers concerned with cyclic gonadotropin release is probably the cause." - Am. J. Ob. and Gyn. 98 :1065-1070, 1967. Clomiphene Citrate for Improvement of Ovarian Function Georgeanna Seegar Jones, M.D. and Maria D. de Moraes-Ruehsen, M.D. (Johns Hopkins University).
"There were four women with longstanding amenorrhea (sterility) following oral contraception therapy." - Am. J. Ob. & Gyn. 99:814-828, Nov. 15, 1967.
Irregular Menses, Amenorrhea and Infertility Following Synthetic Progestational Agents. M. James Whitelaw, M.D. et al.
"During the past year we have had occasion to see 24 patients with normal menstrual cycles, but who, following the use of synthetic progestational agents (The Pill), had one or more of the following conditions as their chief complaint: irregular menses, amenorrhea, and infertility." Communication with other clinics indicates that there are hundreds of such cases that are unreported. "Let's Be Honest About The Pill" and inform nulliparous women, and those with only one living child of the possibility of being relatively infertile for undeterminate periods of time following discontinuation of oral contraceptives." - JAMA 195:780-782, Feb. 28,1966.
Should Nullipara and Infertility Patients be Given Oral Contraceptives? M. James Whitelaw, M.D. (Chief of Infertility Clinic, Santa Clara County Medical Center).
"Nullipara and infertility patients should not be given The Pill." - New England Obstetrical and Gynecological Society, 39th Annual Meeting, Nov. 1, 1967.
National Center for Health Statistics , 1985
In 1988 a panel assembled by the Congressional Office of Technology Assessment presented the following statistics to the U.S. Congress. Twenty five percent of couples in their thirties are infertile, even though only 1% of teenagers are infertile.
Wall Street Journal, 1993 Self-made Swiss billionaire, Fabio Bertarelli, whose company Serono Laboratories, manufactures 70 percent of the world's gonadotrophic hormones to treat infertility (including Pergonal and Metrodin), confirms this. In 1993 Bertarelli told the Wall Street Journal, "Our usual customers are women over 30 who have been taking birth-control pills since they were teenagers or in their early 20s."The Couples' Guide to Infertility, 1995
In the 1995 revised edition, Dr. Gary S. Berger and his associates again confirm the observations of Maggie Humm and Fabio Bertareli. "Long-term pill users may not menstruate or ovulate after they stop using the pill. This condition, known as post-pill amenorrhea, occurs because the pill disrupts the natural rhythmic flow of hormones from the hypothalamus to the pituitary to the ovaries. This may post a special problem for older women who have been on the pill for many years because their ovaries may have become resistant to resuming ovulation."The Pro-Life Activist's Encyclopedia, published by. . . The American Life League. (Excerpts from Chapter 31)
Users of the "old" high-dosage birth control pills experienced relatively severe side effects. However, many of these pills were generally considered non-abortifacient in their two-fold ("biphasic") modes of action. The pills would thicken cervical mucus and inhibit ovulation, but they would generally not inhibit implantation of the blastocyst (the five-day old, 256-cell developing human being) in the uterine lining.
However, the new low-dosage pills are "triphasic." They have three modes of action; they thicken cervical mucus, inhibit ovulation, and block implantation. Therefore, the "new" Pills are all abortifacient in nature. These actions explain why the minipill works, as it generally does not suppress ovulation." Many women (including pro-lifers) who would never even consider a surgical abortion now use low-dose birth control pills that cause them to abort on an average of once or twice every year. A large number of pro-life women use these pills, and these are usually the women who cannot seem to make the connection between contraception and abortion in their minds.
Cardiovascular Impacts. The most dangerous and well-documented side effects commonly associated with the Pill are heart attacks and strokes. The eight-year Nurse's Health Study at Harvard Medical School found that Pill users are 250 percent as likely to have heart attacks and strokes than those who don't use the Pill, probably because the Pill excessively increases blood clotting ability.
However, one of the major findings of the study was that women who get off the Pill have rates of cardiovascular disease equal to that of the general population after a period of one year.
Dr. Meir J. Stampfer. New England Journal of Medicine, November 24, 1988. This study was based on an eight-year followup of 119,061 female nurses, ranging in age from 30 to 55 in 1980. 7,074 were current pill users and 49,269 were previous users. Overall, there was 380 heart attacks, 205 strokes, and 230 cardiovascular deaths among pill users.
"According to United States Federal Courts, the birth control pill has been classified as 'unavoidably unsafe.' This means that, implicit in a woman's consent to use the pill, even if she is not entirely informed of its dangers, is an acknowledgement of physical risk."Thomas P. Monaghan, Co-Chairman, Free Speech Advocates. "Unavoidably Unsafe." Fidelity Magazine, October 1987, pages 14 and 15.
Dr. Ojvind Lidepaard, et al., Hvidovre University Clinic of Copenhagen, reporting in the British Medical Journal (April 1993 cited Europe Today No. 23, May 3, 1993) revealed that in a study of 2400 women aged 15 to 44, who were using the Birth control Pill, 800 suffered some degree of cerebral thrombosis. although not all of the blood clots led to stroke.
For 30 years, Japan has rejected the "Pill" on the grounds that it is too dangerous. Although the Japanese Ministry of Health and Welfare has proposed legalizing the pill, a 1990 survey of Japanese women found that fewer than 10 percent of Japanese women would even consider using it. Nearly twice as many insisted that it remain illegal.
Additional References
- The Doctor's Case Against the Pill, Barbara Seaman, 1995 (original publication 1969), Hunter House.
- The Pill An Alarming Report, Morton Mintz, (Washington Post) 1969.
- The Medical Hazards of the Birth Control Pill, Herbert Ratner, M.D., (Child and Family) 1970.
- The Couples' Guide to Infertility, Dr. Gary S. Berger, 1995.
