Birth Control Pill Side Effects





ARTICLE #1 Oral Contraceptives :  Current Medical Diagnosis and Treatment 2002

ARTICLE #2 Oral Contraceptives May Cancel Some Bone-Building Benefits of Exercise

ARTICLE #3 Kinsey Study Finds Adverse Sexual, Emotional Side Effects of Birth Control Pill

ARTICLE #4 Unavoidably Dangerous

ARTICLE #5 How Does the Birth Control Pill Work?

ARTICLE #6 Breast Cancer: Its Link to Abortion and the Birth Control Pill

ARTICLE #7 Hormone Heresy

ARTICLE #8 Birth Control Patch Linked to Higher Fatality Rate

ARTICLE #9 Hormone Replacement Therapy

ARTILCE #10 Oral Contraceptives Increase Breast Cancer Risk





Oral Contraceptives

Contraindications and Adverse Effects

(taken from Current Medical Diagnosis and Treatment: a major medical text)


Oral contraceptives have been associated with many adverse effects; they are contraindicated in some situations and should be used with caution in others.

Absolute Contraindications
Pregnancy
Thrombophlebitis or thromboembolic disorders (past or present)
Stroke or coronary artery disease (past or present)
Cancer of the breast (known or suspected)
Undiagnosed abdominal vaginal bleeding
Estrogen-dependent cancer (known or suspected)
Benign or malignant tumor of the liver (past or present)


Relative Contraindications
Age over 35 years or heavy cigarette smoker (>15 cigarettes daily)
Migraine or recurrent persistent severe headache
Hypertension
Cardiac or renal disease
Diabetes
Gallbladder disease
Cholestasis during pregnancy
Active hepatitis or infectious mononucleosis
Sickle cell disease (S/S or S/C type)
Surgery, fracture, or severe injury
Lactation
Significant psychological depression



Myocardial Infarction (Heart Attack)

The risk of heart attack is higher with use of oral contraceptives, particularly with pills containing 50 micrograms of estrogen or more. Cigarette smoking, obesity, hypertension, diabetes, or hypercholesterolemia increase the risk even further. Young nonsmoking women have less increased risk of heart attack. Smokers over age 40 and women with other cardiovascular risk factors should use other methods of birth control.

Thromboembolic Disease

An increased rate of venous thromboembolism is found in oral contraceptive users, especially if the dose of estrogen is 50 micrograms or more. While the overall risk is very low (15 per 100,000 woman), several recent studies have reported a twofold increased risk in women using oral contraceptives containing the progestins gestodene or desogestrel compared with women using oral contraceptives with levonorgestrel and norethindrone. Women who develop thrombophlebitis should stop using this method, as should those at risk of thrombophlebitis because of surgery, fracture, serious injury, or immobilization.

Cerebrovascular Disease

Overall, a small increased risk of hemorrhagic stroke and subarachnoid hemorrhage and a somewhat greater increased risk of thrombotic stroke has been found; smoking, hypertension, and age over 35 years are associated with increased risk. Women who develop warning symptoms such as headache, blurred or lost vision, or other transient neurologic disorders should stop using oral contraceptives.

Carcinoma

A relationship between long-term (3-4 year) oral contraceptive use and occurrence of cervical dysplasia and cancer has been found in various studies. A recent study has suggested the possibility of an increased risk of breast cancer in women who have ever used oral contraceptives if they have first-degree relatives with breast cancer. Rarely, oral contraceptives have been associated with the development of benign or malignant hepatic (liver) tumors; this may lead to rupture of the liver, hemorrhage, and death. The risk increases with higher dosages, longer duration of use, and older age.

Metabolic Disorders

A decrease in glucose tolerance (diabetes) and an increase in triglyceride levels is seen in pill takers, and women with diabetes using this method should be carefully monitored.

Hypertension (High Blood Pressure)

Oral contraceptives may cause hypertension in some women; the risk is increased with longer duration of use and older age. Women who develop hypertension while using oral contraceptives should use other contraceptive methods.

Headache

Migraine or other vascular headaches may occur or worsen with pill use. If severe or frequent headaches develop while using this method, it should be discontinued.

Amenorrhea

Postpill amenorrhea lasting a year or longer occurs occasionally, sometimes with galactorrhea. Prolactin levels should be checked; if elevated, a pituitary prolactinoma may be present.

Disorders of Lactation

Combined oral contraceptives can impair the quantity and quality of breast milk.

Other Disorders

Depression may occur or be worsened with oral contraceptive use.



back to top





Oral Contraceptives May Cancel Some Bone-Building Benefits Of Exercise

Young women who take oral contraceptives and exercise may have increased risks of bone loss, according to recent research at Purdue University. A two-year study headed by Connie Weaver, head and distinguished professor of foods and nutrition, suggests women ages 18 to 30 who exercise while using oral contraceptives (the pill) may lose bone density in the hip and spine, even more than women who take the pill and are sedentary. This loss of density could make a women susceptible to bone fractures later in life. The study also indicates, however, that women in this group who get the minimum daily requirements for calcium may be able to ward off bone loss. "The study showed that, overall, exercise had positive affects on whole body bone mineral content for everyone," Weaver says. "Only the spine and hip were compromised if subjects who were on oral contraceptives exercised, and only then if calcium intakes were inadequate." The purpose of the study, funded through the U.S. National Institutes of Health, was to investigate the effects of exercise on bone mineral content and bone mineral density in women 18 to 30 years old who either were or were not taking birth control pills. The study started with 180 women. At the end of the two-year period, 55 women remained.


Kinsey study finds adverse sexual, emotional side effects of birth control pills

BLOOMINGTON, Ind. -- The birth control pill can have significant adverse effects on sexuality and mood in some women, increasing the likelihood of early discontinuation, according to a study by the Kinsey Institute for Research in Sex, Gender and Reproduction at Indiana University. Results of the study will be reported in the July issue of the journal Contraception. Stephanie Sanders, associate director of the Kinsey Institute and an IU faculty member in gender studies, directed the study of 80 women. The research team included John Bancroft and Jennifer Bass of the Kinsey Institute and Cynthia Graham of the IU Department of Psychology. Of the women in the study who started on the pill (randomly assigned to either orthocyclen or orthotricyclen), 38 percent were still taking it after one year, 47 percent had stopped, and 14 percent had switched to another pill. The women who stopped or changed to another pill were four times as likely to report adverse sexual, emotional and physical side effects as the women who continued with their oral contraceptive. Some of these effects included decrease in sexual thoughts, less frequent intercourse and negative mood changes.



back to top






Unavoidably Dangerous

book exerpts by Mayer Eisenstein, M.D., J.D., M.P.H.

No other drug in the Physician's Desk Reference has as long a description of side effects as the birth control "PILL". Breast cancer, cardiovascular disease, blood clots, liver tumors, high blood pressure, infertility, sterility, and abortion are some of the more serious problems associated with the "PILL". In fact, the new third generation "PILL" seems to be more dangerous than the previous ones. This is not surprising. The late Dr. Mendelsohn said, "Doctors don't let go of one medication until they find a more dangerous one to replace it." The dangers of the "PILL" are well documented. Doctors believe that no woman should be deprived of her "PILL" (a form of chemical steroids) so they prescribe the "PILL" for a list of completely contraindicated medical conditions such as: irregular periods, scanty periods, no periods, and ovarian cysts. When asked about the side effects of the "PILL" most doctors will tell you, "trust me, it's safer than being pregnant." This thinking reflects most doctor's views that pregnancy is a disease for which the "PILL" is the cure. As a blessed and proud father of six children and a doubly blessed grandfather of four grandchildren, I am proud that my wife, daughters, and daughter-in-law have never been on the "PILL". If you are a teenager don't take the "PILL"! If you are thinking about ever having children, don't take the "PILL"!! If you're not thinking of having children, don't take the "PILL"!!! The "PILL" is unavoidably dangerous. As a medical student in 1971, I met Dr. Herbert Ratner. This distinguished physician and mentor became one of the most inspiring people in my life. Not only did Dr. Ratner teach my wife Karen and I the importance of children and family, but among the important values he taught us he also pointed out to us the medical risks and hazards of the "PILL". It is with great pleasure that we have an editorial in this issue on the "PILL" written by Dr. Ratner.


The Medical Hazards of the Birth Control Pill

by Herbert Ratner, MD

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 US, 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, MD, 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 pregnancy or embryonic tissue confer 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.Ê.Ê. 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:

1. 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.

2. 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.

3. 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 StreetÊJournal, 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)

Http://hebron.ee.gannon.edu/~frezza/plae/encyc031.html


The "Pill" as Abortifacient

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 Impact

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.

Unavoidably Unsafe

"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.

Interesting Information ON the Pill

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.

Japan and the Pill

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.


back to top







How Does the Birth Control Pill Work?

By Chris Kahlenborn, M.D.

The birth control pill is currently being used by more than 10 million women in the U.S.1 A number of physicians and researchers have claimed that the birth control pill (BCP—also called the oral contraceptive) is actually an abortifacient. An abortifacient causes an early abortion , specifically the death of the zygote, embryo or fetus after conception has occurred. Others do not believe the BCP is an abortifacient as noted in a 1998 publication authored by several physicians: Hormonal Contraceptives: Are They Abortifacients? 2

Before 1930 all Christian denominations agreed that contraception was a sin.3 this paper will focus on the medical and technical aspects of the pill’s abortifacient qualities and refrain from comment on the morality of taking or prescribing the BCP.

To answer the question of whether the BCP causes early abortions a number of introductory questions must be addressed.

What is a birth control pill (BCP) and how does it work?

Normally the pituitary gland produces two hormones called FSH (Follicle Stimulating Hormone) and LH (Luteinizing Hormone). These hormones serve to stimulate the ovary to produce an egg each menstrual cycle (to ovulate). The ovary is also the production site for the woman’s two central female hormones: estradiol (EST), a type of estrogen, and progesterone (PRO), a type of progestin. BCPs are a combination of synthetic estrogen and progestin. BCPs "fool" the pituitary gland so that it produces less FSH and LH. By reducing the FSH and LH required for ovulation, BCPs suppress, but do not eliminate ovulation.

Birth control pills are acknowledged to have two other main effects:

They thin the inner lining of the uterus (called the endometrium), depleting it of glycogen (a type of sugar) and blood supply, and

BCPs may thicken the cervical mucus, making it more difficult for the sperm to travel up through the cervix.

Though this latter effect is claimed by BCP manufacturers, the evidence for it is weak 4,5 and not strongly supported by the rabbit model.6

Of course, BCPs could not cause abortions if they always stopped ovulation, so this needs to be the first issue raised. A clear indication that ovulation will occur in women taking the BCP is provided by noting what the BCP manufacturers state in the PDR (Physician’s Desk Reference, @1998).7 The "efficacy rate" table for each BCP claims a "typical failure rate" of about 3%. The PDR defines "typical failure rate" as the rate of annual pregnancy occurrence in "typical couples who initiate use of a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason."

This means that even couples who use the pill consistently over the course of a year will have an average pregnancy rate of 3% according to the BCP manufacturers, who might tend to underestimate this number. A 1996 paper by Potter8 gives an excellent overview of the matter. She notes that the most recent data point to a rate of pregnancy for "typical use" as being 7%, which is probably a more accurate statistic. This is especially true given the immediacy of her research data and the fact that today’s BCPs are lower dose and theoretically permit a higher rate of breakthrough ovulation. From these estimates of BCP failure and the common experience of on-pill pregnancies, it is clear that both ovulation and conception occur in couples who use the BCP.

Could you present the evidence that some physicians and researchers give to support their claim that the pill is indeed an abortifacient?

Before presenting that evidence, normal anatomy and histology (the study of the body’s tissues on a microscopic level) of the inner lining of the uterus needs to be explained.

The endometrium slowly builds up before ovulation (the proliferative phase) and then peaks in the secretory phase (shortly after ovulation and possible conception). The endometrium is thus "ready for the newly conceived child to implant" a few days after ovulation. The blood flow carrying oxygen and nutrients to the glandular cells of the endometrium increases through the cycle as the spiral arteries enlarge during the secretory phase. These glands contain important nutritional building blocks for the preborn child about to implant, including glycogen (a type of sugar), mucopolysaccharides (they supply certain building blocks for a cell’s growth), and lipids (fats).9

What does the phrase "ready for implantation" mean?

The author of a histology text designed for medical students states: "Thus, the various changes that take place in the endometrium during the second half of the menstrual cycle may be regarded as preparing the uterine lining for the nourishment and reception of the fertilized ovum (blastocyst)."10 It would appear that a woman’s body and lining of her uterus are "optimal for implantation" a few days after ovulation and conception have occurred.

Does the BCP cause changes in the lining of the uterus that could be detrimental to the newly conceived child’s ability to implant?

It would appear so. Since we know that the birth control pill sometimes allows ovulation and conception to occur, unfavorable changes in the endometrium could make it difficult for the preborn child to implant and would support the conclusion that the BCP is an abortifacient.

What are some of those changes?

The first change that the BCP makes is to markedly decrease the thickness of a woman’s endometrial lining. Women who take the pill know this because they can tell you that the volume of menstrual contents (flow) lost in their monthly cycles significantly decreases once they start taking the pill. Obviously, if a woman is losing less menstrual contents each month, the layer of endometrium that is being shed must be thinner and less well developed.

Is there a technical or quantitative way to measure how much thinner a woman’s endometrium becomes when she uses BCPs?

Yes, in 1991 researchers in the U.S. performed MRI scans (Magnetic Resonance Imaging) on the uteri of women, some of whom were taking BCPs and some of whom were not.11 The BCP users had endometrial linings that were almost two millimeters thinner than those of the non-pill users.

But is there really any evidence that a thinner endometrium makes it more difficult for implantation to occur?

Yes. Several research papers have studied this issue, and it has been widely described in the medical literature concerning in-vitro fertilization, where it has been noted that the newly conceived child is much less likely to implant in a thin uterine lining than a thick one. A small, older study [Fleisher, et all,12 1985] did not find the thickness of the endometrium playing an important role in in-vitro implantation rates. However, later studies found a positive trend 13,14 or a statistically significant effect,15 of decreasing endometrium thickness, thereby reducing the likelihood of implantation. Additional larger and more recent studies;16,17,18,19,20 have reaffirmed this important conclusion. Most studies have found that a decrease of even one millimeter in thickness substantially decreases the rate of implantation. Two studies showed that when the endometrial lining became critically thin, no implantation occurred.16,17

What does the actual endometrial-lining look like under a microscope for women who take BCPs?

When the uterine lining is at an "optimal state for implantation," the glands and uterine arteries are at their maximal size. This makes intuitive sense: after all, at this point the blood supply, glycogen and lipid levels that the tiny preborn child needs to survive are at their maximal state. Researchers who study the histology of the endometrium find that the BCP causes a number of changes to the endometrium.

First, the spiral arteries regress significantly to the point where they are much smaller and may even be difficult to find under a microscope.21-24 Of course, this is important, since an adequate blood supply is critical to the existence of the implanting preborn child. A loss of blood flow means a drastic curtailment in the food and oxygen supply needed for the child’s survival. The blood flow to the endometrium is so important that in 1996 Kupesic wrote directly about its relationship to a preborn child’s likelihood of implantation.25 She first discovered that the blood flow through the spiral arteries peaks at day 16 to 18 or the menstrual cycle, and then stated: "It seems that endometrial perfusion presents more accurate noninvasive assay of uterine receptivity than uterine artery perfusion alone.

Therefore, blood flow velocity waveform changes of spiral arteries may be used to predict implantation success rate to reveal unexplained infertility problems and to select patients for correction of endometrial perfusion abnormalities."26 (emphasis added). In layman’s language, Kupesic is stating that the likelihood of implantation correlates with the blood flow through the spiral arteries.

In addition to the reduced blood supply from the spiral arteries, what other microscopic level changes to the endometrium are caused by BCPs?

The second prominent effect is that the endometrial glands become much smaller and the "mitotic rate" (rate of cell division) of the cells of the glands decreases.21-24 Obviously, if the glands which supply the glycogen (sugar), mucopolysaccharides, or lipids (fats) are compromised, the preborn child who needs those nutrients will have a more difficult time implanting and/or surviving.

Many of the studies that examined the endometrial lining are older and were performed when the estrogen content of BCPs was much higher (100 micrograms or more). Would the same effect be occurring with the more recent BCPs?

Yes. First of all, it should be mentioned that if you ask a woman who is taking lower dose BCPs about the amount of monthly menstrual contents that she loses, she will note that she loses significantly less after she started taking the BCP. Obviously, if she is losing less menstrual contents, then she is shedding less because the lining of the uterus has become thinner. Even histologic studies for BCPs which contain 50 micrograms of estrogen (a medium dose) and 0.5 mg of a progestin (norgestrel) found that the spiral arteries and the endometrial glands "shrivel up."22, 23

Is there any new evidence that supports the argument that BCPs act by causing an early abortion?

Yes. In early 1996 researcher Stephen Somkuti published an article concerning the endometrium and a group of molecules called "integrins."27 Integrins are a group of adhesion molecules that have been implicated as playing an important role in fertilization and implantation. There are several different types of integrins, and it is believed that the endometrium is most receptive to implantation when it expresses certain types of integrins. Birth control pills change the type of integrins that the endometrial lining produces, theoretically making it more difficult for the preborn child to implant. In the words of Dr. Somkuti: "These alterations in epithelial and stromal integrin expression suggest that impaired uterine receptivity is one mechanism whereby BCPs exert their contraceptive action."28

Has anyone proven that the BCP causes early abortions?

In order to prove if and how often women are having abortions while taking BCPs, one needs to be able to measure how often women become pregnant while taking them. But early pregnancy tests are currently not accurate enough to confirm pregnancy within the first week, although some researchers have been able to detect the hormonal changes in pregnancy as early as four days after conception.29,30 Until a very early pregnancy test is developed or until researchers physically measure how many abortions are occurring in women who take BCPs, one cannot state with absolute certainty when and how often BCPs cause early abortions. The most accurate description of the current evidence is as follows:

All of the evidence, whether at a microscopic, a macroscopic, or an immunological level, strongly supports the argument that the BCP causes an early abortion at times. Until further studies are done, we should take heed and base our actions and pronouncements on the current evidence.

How frequently do BCPs cause an early abortion?

At this point, no one knows. There are many factors that influence the answer to this question and it is possible that as technology improves an accurate estimate will be made. One of the determining factors is how often BCPs allow ovulation to occur. If the rate of ovulation is documented to be substantially higher than the pregnancy rate, then one could start to make an estimate of the frequency of abortion in women who take the BCP.

But measuring a woman’s ability to ovulate is difficult. Researchers measure ovulation rates in women who are taking the pill by using several parameters, including:

Ultrasound measurements of the ovary, specifically the size of the largest (dominant) follicle, which contains the egg or oocyte; and

Hormonal assays of progesterone and estradiol levels.

Until now, many researchers have arbitrarily accepted that a pregnancy has occurred when the progesterone levels reach a certain threshold. But it is possible that BCPs depress the ovary’s ability to produce progesterone despite pregnancy, as noted as early as 1962 by Holmes, et al.31 It would seem more accurate to measure ovulation rates based on daily pelvic or vaginal ultrasound exams. In 1985, Ritchie32 wrote in his review of the role of ultrasound in the evaluation of normal and induced ovulation: "With daily scanning, ovulation can be demonstrated in >80% of cases." In a 1998 paper Petta et al 33commented on ultrasound in regard to ovulation: "Follicles that disappeared or that were abruptly reduced in size by >50% after reaching a diameter of 15 mm were considered to have ruptured."

There are a number of other reasons why determining the frequency of ovulation by such a method is important. First, studies of women who take the pill often show a high rate of "ovarian activity" in their dominant follicles which may reach a size that is consistent with those seen in non-BCP users who ovulate. In other words, the ultrasound measurements indicate that these women (the BCP users) are about to ovulate. But these same studies often conclude that ovulation has not occurred because the progesterone level has not reached a critical level.34,35 This is somewhat counter-intuitive in light of a recent study that found: "Patients using the lower-dose monophasic and multiphasic pills had follicular activity similar to that of those using nonsteroidal contraception, with the important exception that ovulation rarely occurred."35 This study, as almost all others, used the criteria that ovulation is confirmed when progesterone levels reach a certain point. This may not be accurate.

Ultrasonography may reveal that ovulation rates are higher than today’s commonly quoted rates of 3-5%.32 The two reasons for this are that today’s BCPs contain far less estrogen and progestin than the early BCPs did and therefore suppress ovarian activity less often. Second, many studies have examined the rate of breakthrough ovulation in women who have recently started taking the pill, but the question that must be asked is: "Does the rate of ovulation go up in women have taken BCPs for more than a year?

This phenomenon occurs with Norplant, where it was noted that the breakthrough ovulation rate in the first year was only 11%. This rate increased dramatically after that year, so that a seven-year average yielded an annual breakthrough ovulation rate of 44% (although part of the reason for this increase may have been declining Norplant hormone levels over time).36 Could a woman’s pituitary gland "compensate" or "reset itself" to adjust for the presence of the hormones in the BCP so that ovulation occurs more frequently with time? If so, future trials may show that the rate of breakthrough ovulation increases in women who take the low dose BCP for longer periods of time.

It seems likely that a study will be done in the future that measures the rate of ovulation based on serial ultrasounds (although some may claim that such a study might be unethical). If such a study is performed in women who have been taking low dose BCPs for longer than a year, it could yield information that leads to a more credible estimate of the abortion rate for women taking the pill.

Questions regarding Other Contraceptives

Does the intrauterine device (IUD) cause abortion?

Yes, the IUD does not prevent ovulation37 and works by changing the inner lining of a woman’s uterus so that the newly conceived child cannot implant in the womb.

Do groups who favor abortion admit that BCPs and the IUD work by causing an early abortion?

The most ardent pro-abortion supporters openly admit the abortifacient nature of the BCP and IUD. In his arguments before the Supreme Court in 1989, in the case of Webster v Reproductive Health Services, Mr. Frank Susman, arguing for the pro-abortion side, said to Justice Anthony Scalia: "If I may suggest the reasons in response to your question, Justice Scalia. The most common forms of what we generally in common parlance call contraception today, IUDs, and low-dose birth control pills, which are the safest type of birth control pills available, act as abortifacients. They are correctly labeled as both."38

Do other hormonal contraceptives such as the long-acting progestins cause early abortions?

Norplant, manufactured by Wyeth-Ayerst, and Depo-Provera, made by Pharmacia-Upjohn, are made of artificial progestins. Norplant is composed of levonorgestrel and Depo-Provera of medroxyprogesterone acetate.

Depo-Provera is a long-acting progestin that is injected every three months intramuscularly. It is used worldwide despite the fact that animal and human studies have all shown that it increases the risk of breast cancer by at least 190% in women who took it for more than two years before the age of 25.39

Norplant is an artificial progestin that consists of a series of Silastic (rubber-like) strips which are filled with levonorgestrel and implanted under the skin of a woman’s upper arm. These slowly release progestin into the woman’s body over a five-year time period. Norplant has been found to allow breakthrough ovulation in over 44% of a woman’s monthly cycles.36 In addition, a study of rabbits conducted by Chang40 has shown that sperm freely reached the rabbit’s fallopian tubes—even when given high doses of synthetic progestin. The combination of a high rate of breakthrough ovulation and documented sperm migration to the fallopian tubes in animals suggests that progestins such as Norplant and Depo-Provera allow a high rate of fertilization and subsequent abortion, most likely even higher than BCPs.

Does the "Morning After Pill" cause early abortions?

The "Morning After Pill" consists of a series of high dose BCPs that some women have taken one or two days after thinking that they have conceived. These high does hormones act as an abortifacient by thinning the lining of the uterus, thus preventing the newly-conceived child from implanting. The animal model described by Castro-Vasquez in 1971 demonstrated this effect in rats.41

Some emergency rooms give "hormones" to women who have recently been raped. Can this cause an early abortion?

The woman who comes to the emergency room within a few hours of being raped may or may not have already conceived. Some ER staff will give such a woman high dose estrogen and progestin hormones very similar to the "Morning After Pill." The exception is often found in Catholic hospitals, whose physicians may not give the "post-rape pill." For the woman who is raped near the time of ovulation, the hormones may indeed stop ovulation and prevent conception. But if ovulation and conception have occurred, the hormones will work by causing an early abortion in the same way as has been described for the "Morning After Pill."

Since there is no way to know whether conception has occurred, some physicians will not prescribe the "post-rape pill."

Does artificial fertilization cause early abortions?

Every method of artificial fertilization that this author is aware of, whether it be in vitro fertilization, or ZIFT (zygote intrafallopian transfer) or GIFT (gamete intrafallopian transfer), involves the death of many unborn children during the process. Fewer than one out of 20 conceived children "survive" the process of in vitro fertilization. Even GIFT involves the exposure of more than one egg to multiple sperm—a situation in which multiple early abortions are extremely likely to occur. In addition to these methods, it is possible that women who take fertility pills such as Clomid® (clomiphene citrate), which works by making the ovaries "super-ovulate," may be experiencing early abortions. Some studies,42-45 but not all,46 indicate that this drug thins the lining of the uterus, theoretically making it more difficult for the conceived child to implant.

Can the estrogens that women take "after menopause" cause an early abortion?

Often women are started on estrogen replacement near the time of menopause. This usually has a beneficial effect of reducing the risk of osteoporosis, which increasing the risk of uterine and breast cancer. Unfortunately, many women are now starting estrogen replacement before they have completely stopped ovulating. That is, they are not always in true menopause but are still having occasional cycles (perimenopausal). If a woman were to start estrogen at a time when she was having an occasional cycle, she could still conceive and have an early abortion. This is something to be aware of, and women who wish to avoid this effect should not start hormonal replacement therapy until they have not had a cycle for a one-year period.

Why was the term "contraceptive" place in quotations when referring to the various artificial hormones?

Oral contraceptives, Norplant, Depo-Provera, the IUD, the "Morning After Pill," and the "post-rape pill" all work by causing an early abortion at least part of the time. The word "contraceptive" was consistently placed in quotations because all of the evidence points to these hormones or procedures as being abortifacients. That is, they cause an early abortion some of the time. Contraception technically means "to prevent conception." Clearly, the hormones alluded to here cause the death of the preborn child after conception and cannot accurately be called solely "a contraceptive."

Appendix

Response to the Arguments Put Forth in the Brochure:

Hormonal Contraceptives: Are They Abortifacients?

In January 1998, a group of 22 physicians (almost all Ob/Gyns) wrote a collaborative report questioning the abortifacient nature of the pill.2 Their four main arguments and a corresponding rebuttal to each are presented here.

The statement claims: We know of no existing scientific studies that validate the ‘hormonal contraception is partly abortifacient’ theory. ‘On-pill’ pregnancy rates roughly parallel ‘on-pill’ ovulation rates (about 3-5 percent on 35 mcg pill). Increased spontaneous abortion of on-pill pregnancies is not noted."

Here the term ‘pregnancy rate’ refers to the rate of pregnancy as determined by a positive pregnancy test. We must acknowledge that a woman is actually pregnant directly after conception, before one can diagnose it by a simple pregnancy test. The claim that "on-pill" pregnancy rates roughly parallel "on-pill" ovulation rates may appear to be a satisfying argument, but on closer examination this contention actually bolsters the argument in favor of the pill acting as an abortifacient.

Why? If a woman is taking the pill, she will experience an artificially regulated cycle that lasts 28 days so she will have about 13 cycles per year (365 days divided by 28). Thus, a group of 100 women would be expected to have a total of 1300 cycles per year. If women taking the pill experience a breakthrough ovulation rate (on-pill ovulation rate) of between 3 and 5 percent, a group of 100 women would be expected to have between 39 and 65 breakthrough ovulation cycles in one year (1300 x 3-5%)

William’s Obstetrics notes that the average woman has a "natural fecundibility rate" of 28%.47 "Natural fecundibility rate," perhaps more accurately called the fertility rate, is defined in this section of William’s Obstetrics as "liveborn infants per ovarian cycle."

But William’s Obstetrics also notes that for every 600 liveborn children, 279 embryos or fetuses are miscarried, 176 of them after a positive pregnancy test, and 103 of them prior to being able to detect that a woman is pregnant. This means that the average couple will actually have a detectable pregnancy rate of 36.2% {28% + 176/600 x 0.28}. So, a group of 100 women who are sexually active and using the birth control pill might expect between 14 and 24 detectable pregnancies per year {(39-65) x 36.2%}.

But the PDR (Physicians Desk Reference) notes that a group of 100 women who are using the pill in a consistent manner will have about three pregnancies per year.7 A recent study by Potter yields an updated statistic of seven pregnancies per year.8 If it is true that "on-pill pregnancy rates roughly parallel on-pill ovulation rates," then the conclusion that the pill is not an abortifacient is highly suspect. If the breakthrough ovulation rate is 3 to 5%, we might expect the pregnancy rate to be 14 to 24%--that is, far higher than the ovulation rate.

Since we do not see this clinically, we must ask: Why is the clinically measurable pregnancy rate far lower than the theoretical rate based on the rate of breakthrough ovulation?

A number of explanations exist, including the failure of sperm to reach the egg due to thicker cervical mucus or a change in motility within the fallopian tubes, which the pill may cause. But one must also recognize that the difference in rates may be due to a failure of the zygote/embryo to implant due to the pill’s effects on the endometrial lining. In short, the observation that "on-pill pregnancy rates roughly parallel on-pill ovulation rates" serves, if anything, to support the argument that the pill is an abortifacient.

They write: "There is regular successful implantation of the invasive blastocyst on the surfaces a great deal more ‘hostile’ than ‘hostile endometrium’ (e.g., fallopian tube lining). ‘Hostile endometrium’ is not a demonstrated clinical reality."

This argument is specious. It has already been stated in the answers to questions above that the sum of the evidence, both recent and old, supports the argument that the pill changes the lining of the endometrium in a fashion unfavorable for implantation. The fact that the preborn child may attach to a structure such as the fallopian tube lining has little to do with the previous arguments.

Although one can make the argument that a rare occurrence or an exception disproves a theory, one cannot deduce the converse, namely, that the exception proves the theory. That is, noting that some preborn children do implant in the fallopian tube, or for that matter in the peritoneal cavity, merely proves that is it possible for this event to occur. If offers no evidence that justifies the claim that a favorable implantation site is just as good as an unfavorable one.

They write: he extremely rare reporting of ectopic pregnancies associated with hormonal contraception would indicate the rarity of actual conception by patients using these modalities."

Once again the noted physicians apparently were unaware that their statement serves the purpose of supporting the pill’s action as an abortifacient.

It should be stated that both women who take the pill and those who do not can and do become pregnant. The pregnancy can be an extrauterine pregnancy (EUP—usually a tubal pregnancy) or an intrauterine pregnancy (IUP—a normal pregnancy). One can measure the ratio of EUP to IUP in either group. What should happen to this ratio if one compares women who are not taking the pill to those who are?

The Ob/Gyns would argue that this ratio should remain constant, and if the reporting of ectopic pregnancy were "practically unreported," as the Ob/Gyns write, one might even expect the ratio to decrease, since the numerator would become smaller. On the contrary, if the pill caused more early abortions (fewer IUPs), one would expect the number of IUPs to decrease in comparison to the number of EUPs, and thus the ratio should increase. What does the literature say?

The studies to date show that women who take the pill have an increased ratio of EUP to IUP. They note that women who take the pill are far more likely to experience more EUPs per IUP than women who do not take the pill, which supports the argument that the pill is an abortifacient. The reported odds ratios of the increased risk of EUP/IUP in women taking the pill compared to women who were not taking the pill were as follows:

WHO48 found an odds ratio of 1.7 (1.1-2.5);

Mol et al49 found an odds ratio of 1.8 (0.9-3.4);

Job-Spira et al50 found an odds ratio of 4.3 (1.5-12.6);

Thorburn et al51 found an odds ratio of 4.5 (2.1-9.6); and

Coste et al52 found an odds ratio of 13.9 (1.8-108.3)

These clinical studies once again provide evidence that suggests that the pill acts as an abortifacient.

They write: "Many factors play a part in how a family plans and spaces their children. It is not the purpose of this paper to promote nor to oppose hormonal contraception.

As a physician, I know that it is common to use a medicine or a type of procedure because previous physicians have done so. It is simply impossible for each physician to "re-invent the wheel" when trying to decide if a particular drug or procedure is the optimal one. Unfortunately, once one becomes accustomed to particular ways of doing things, one tends to continue to do them in a particular fashion because "they have always been done that say," and "new thoughts" on a "standard procedure" are not always appreciated.

How do these statements pertain to the current argument? It has been stated that almost every physician who signed or helped write the booklet Hormonal Contraceptives: Are They Abortifacients? Is or was an obstetrician/gynecologist. It is common knowledge that virtually all Ob/Gyns prescribe the pill to their patients for contraception, in addition to other indications. Therefore, I assume (and would certainly issue a retraction were I proven wrong) that nearly every Ob/Gyn who signed or helped write the paper currently prescribes or has prescribed birth control pills for contraception.

The problem here is that self-proclaimed pro-life Ob/Gyns would have difficulty being unbiased in any argument about whether the pill causes early abortions, since these physicians most likely has written thousands of oral contraceptive prescriptions in their careers. If they were to admit that the pill is an abortifacient, they would be admitting that they had likely aborted hundreds of tiny children. Surely, it would be difficult for a pro-life obstetrician to fairly evaluate the abortifacient action of the pill given these circumstances?

Recently Decook et al53 have argued that if a breakthrough cycle does occur while a woman is taking the pill, her endometrial lining would become similar to that of the non-BCP user for that particular cycle. Is this an accurate statement?

To the best of this author’s knowledge, that statement has no support in the medical literature. If the above statement were true, it would mean that each time a woman had a breakthrough cycle while taking the BCP (if she does not become pregnant), she should experience as heavy a menstrual period as if she were not taking the pill. This phenomenon has not been described in the medical literature either.

Conclusion:

The arguments presented by the 22 physicians in the booklet Hormonal Contraceptives: Are They Abortifacient? Lack substance and actually serve to bolster the evidence that the birth control pill causes early abortions.

Footnotes

1. Faust JM. Image change for condoms. ABC News Report. [Internet E-mail]. 6/8/97.

2. DeCook JL, McIlhaney J, et al. Hormonal Contraceptives: Are they Abortifacients? (Sparta, MI: Frontlines Publ., 1998).

3. Smith, Janet. Contraception: Why Not? (Dayton, OH: One More Soul). Tele.:513-279-5433.

4. Elstein M, et al. Studies on low dose oral contraceptives: cervical and plasma hormone changes in relations to circulating d-norgestrel and 17 alpha-ethinyl estradiol concentrations. Fertility and Sterility. 27; 1;976: 892-899.

5. Wolf DP, et al. Human cervical mucus v. oral contraceptives and mucus rheologic properties. Fertility and Sterility. 32; 1979:166-169.

6. Chang MC, Hunt DM. Effects of various progestins and estrogen on the gamete transport and fertilization in the rabbit. Fertility and Sterility, 1970: 21:683-686.

7. Physicians’ Desk Reference: 1997 {The noted information can be found when looking up any oral contraceptive. Failure rate for "typical use" is noted to be 3 percent.}

8. Potter LA. How effective are contraceptives? The determination and measurement of pregnancy rates. Obstet Gynecol. 1996; 88:13S-23S.

9. Snell, Richard. Clinical and Functional Histology for the Medical Student. (Boston: Little, Brown & Co., 1984), 586-591.

10. Ibid.

11. Brown HK, et al. Uterine Junctional Zone: Correlation between Histologic Findings and MR Imaging. Radiology. 1991; 1798:409-413.

12. Fleischer AC, et al. Sonography of the endometrium during conception and nonception cycles of in vitro fertilization and embryo transfer. Fertility and Sterility. 1986; 46:442-447.

13. Rabinowitz R, et al. The value of ultrasonographic endometrial measurement in the prediction of pregnancy following in vitro fertilization. Fertility and Sterility. 1986; 45:824-826.

14. Ueno J, et al. Ultrasonographic appearance of the endometrium in natural and stimulated in vitro fertilization cycles and its correlation with outcome. Human Reproduction. 1991; 6:901-904.

15. Glissant A, et al. Ultrasound study of the endometrium during in vitro fertilization cycles. Fertility and Sterility. 1985; 44:786-789.

16. Abdalla HI, et al. Endometrial thickness: a predictor of implantation in ovum recipients? Human Reproduction. 1994; 9:363-365.

17. Dickey RP, et al. Relationship of endometrial thickness and pattern to fecundity in ovulation induction cycles: effect of clomiphene citrate along and with human menopausal gonadotropin. Fertility and Sterility. 1993; 59:756-760.

18. Gonen Y, et al. Endometrial thickness and growth during ovarian stimulation: a possible predictor of implantation in in vitro fertilization. Fertility and Sterility. 1989; 52:446-450.

19. Schwartz LB, et al. The embryo versus endometrium controversy revisited as it relates to predicting pregnancy outcome in in vitro fertilization embryo transfer cycles. Human Reproduction. 1997; 12:45-50.

20. Shoham Z, et al. It is possible to run a successful ovulation induction program based solely on ultrasound monitoring: The importance of endometrial measurements. Fertility and Sterility. 1991; 56:836-841.

21. Hilliard George D, Norris HJ, Pathological Effects of Oral Contraceptives, Recent Results in Cancer Research. 1979; 66:49-71.

22. Ober WB. The effects of oral and intrauterine administration of contraceptives on the uterus. Human Pathology. 1977; 8513-527.

23. Ober WB. Synthetic progestagen-oestrogen preparations and endometrial morphology. J. Clin. Path. 1966; 19:138.

24. Roland M, et al. Sequential endometrial alterations during one cycle of treatment with synthetic progestagen-estrogen eompounds. Fertility and Sterility. 1966; 17:339.

25. Kupesic S. The first three weeks assessed by tranvaginal color doppler. J. Perinat. Med. 1996; 24:301-317.

26. Ibid.

27. Somkuti SG, et al. The effect of oral contraceptive pills on markers of endometrial receptivity. Fertility and Sterility. 1996; 65:484-488.

28. Ibid.

29. Witt B, Wolf G, et al. Relaxin, CA-125, progesterone, estradiol, Schwnagerschaft protein, and human Chorionic Gonadotropin as predictors of outcome in threatened and nonthreatened pregnancies. Fertility and Sterility. 1996; 65:484-488.

30. Norman RJ, et al. Inhibin and relaxin concentration in early singleton, multiple, and failing pregnancy: relationship to gonadotropin and steroid profiles. Fertility and Sterility. 1993; 59: 130-137.

31. Holmes, et al. Oral contraceptives: An assessment of their mode of action. The Lancet. June 2, 1962; 1174-1178.

32. Ritchie WGM. Ultrasound in the evaluation of normal and induced ovulation. Fertility and Sterility. 1985; 43: 167-181.

33. Petta CA, et al. Timing of onset of contraceptive effectiveness in Depo-Provera users. II. Effects on ovarian function. Fertility and Sterility. 70: 817-820.

34. Van der Vange N. Ovarian activity during low dose oral contraceptives. Contemporary Obstetrics and Gynecology. G. Chamberlain. London, Butterworths, 1988, 315-326.

35. Grimes DA, et al. Ovulation and follicular development associated with three low-dose contraceptives: A randomized controlled trial. Obstetrics & Gynecology. 1994; 83: 29-34.

36. Croxatto HB, Diaz S, et al. Plasma gorgesterone levels during long-term treatment with levonorgestrel silastic implants. Acta Endocrinologica. 1982; 101: 307-311.

37. Ibid.

38. Alderson Reporting Company. Transcripts of oral arguments before court on abortion case. New York Times. April 27, 1989; B12.

39. Skegg DCG, Noonan EA, et al. Depot medroxyprogesterone acetate and breast cancer [A pooled analysis of the World Health Organization and New Zealand studies]. 1995; JAMA: 799-804.

40. Chang MC, Hunt DM. Effects of variious progestins and estrogen on the gamete transport and fertilization in the rabbit. Fertility and Sterility. 1970; 21: 683-686.

41. Castro-Vasquez, Macome JC, et al. On the mechanism of action of oral contraceptives. Effect of Lynestrenol on ovum implantation and ovidutal morphology in the rat. Fertility and Sterility. 1971; 22: 741-744.

42. Eden JA, et al. The effect of Clomiphene citrate on follicular phase increase in endometrial thickness and uterine volumne. Obstet. Gyn. 1989; 73: 187-190.

43. Yagel S, et al. The effect of ethinyl estradiol on endometrial thickness and uterine volume during ovulation induction by Clomiphene citrate. Fertility and Sterility. 1992; 57: 33-36.

44. Fleischer AC, et al. Sonographic depiction of endometrial changes occurring with ovulation induction. J. of Ultrasound Med. 1984; 3: 341-346.

45. Imodedemhe DA, et al. Ultrasound measurement of endometrial thickness on different ovarian simulation regimens during in vitro fertilization. Human Reproduction. 1987; 2: 545-547.

46. Dickey RP, et al. Relationship of endometrial thickness and pattern to fecundity in ovulation induction cycles: effect of clomiphene citrate alone and with human menopausal gonadotropin. Fertility and Sterility. 1993; 59: 756-760.

47. Cunningham, et al. Williams Obstetrics, 20th Edition (Standford, CT: Appleton and Lange, 1997), 580-581.

48. The WHO Task Force on intrauterine devices for fertility regulation. A multinational case-control study of ectopic pregnancy. Clin. Reprod. Fertil.1985; 3: 131-143.

49. Mol BWJ, Ankum WM, Bossuyt PMM, and Van der Veen F. Contraception and the risk of ectopic pregnancy: a meta-analysis. Contraception. 1995; 52: 337-341.

50. Job-Spira N, Fernandez H, Coste J, Papiernik E, Spira A. Risk of Chlamydia PID and oral contraceptives. JAMA. 1990; 264: 2072-2074.

51. Thornburn J, Berntsson C, Philipson M, Lindbolm B. Background factors of ectopic pregnancy. I. Frequency distribution in a case-control study. Eur. J. Obstet. Gynecol. Reprod. Biol. 1985; 23: 321-331.

52. Coste J, Job-Spira N, Fernandez H, Papiernik E, Spira A. Risk factors for ectopic pregnancy: a case-control study in France, with special focus on infectious factors. A. J. Epidemiol. 1991; 133: 839-849.

53. DeCook J, et al. Hormonal Contraceptives, Controversies and Clarification. Feb. 1999. Pro-Life Obstetrician. P.O. Box 81, Fennville, MI 49408.

54. Dr. Chris Kahlenborn specializes in internal medicine and practices in Altoona, Pennsylvania. Dr. Kahlenborn has studied the epidemiology of breast cancer in relation to abortion and oral contraceptives for the past six years and has lectured in Canada, Russia, the Philippines, and China, in addition to testifying before the Food and Drug Administration.



back to top







Breast Cancer: Its Link to Abortion and the Birth Control Pill

a book by By Chris Kahlenborn, M.D.

this is a review of that book.


Intensively researched, full of clear explanations and convincing detail, Breast Cancer: Its Link to Abortion and the Birth Control Pill cuts to the heart of the current breast cancer epidemic and gives clear, workable strategies for reducing women's cancer risk.

Breast cancer has become epidemic in the United States in recent years, with the published expectation that one of eight women in this country will incur this disease during her lifetime. Each year more than 175,000 U.S. women develop breast cancer and more than 43,000 die from it.

This is a vast change from the status 50 years ago when breast cancer was quite rare and mostly affected women who had never been pregnant or given birth. Lifestyle changes apparently account for much of this change, particularly the adoption of contraception and abortion as principal tools for fertility management.

It is a very common experience for a woman today to use contraceptive pills for several years, have an unplanned pregnancy, and abort that pregnancy. Effects on breast tissue from these events can be disastrous.

Contraceptive hormones and normal pregnancy cause breast tissue cells to multiply, resulting in new immature (undifferentiated) breast cells. A complete pregnancy would cause these cells to mature completely, but abortion and contraceptive hormones leave them immature and prone to cancer.

Significant increases of breast cancer risk due to abortion and to use of contraceptive hormones have been clearly defined in research studies as early as 1981. The impact of these findings has been obscured, however, by controversy among the researchers, tendentious reporting in the media, and resistance from government agencies and medical organizations. The material presented here gives a clear opportunity to promote a culture of health for women, using natural means to manage fertility, and to develop a healthier environment for them and their families.

Many research studies have examined the connection between abortion and breast cancer. One study in 1957 found that women who had abortions had double the risk of breast cancer compared to women who had not aborted.

A study in 1981 found that women who had an abortion before having a full-term pregnancy had a 140% increased risk of breast cancer, while another major study in 1994 found a 40% increased risk for the same category of women. For women in this category who were less than 18 years old and had a pregnancy of over 8 weeks, the increase found was 800%!

In 1996 a meta-analysis was done on this topic, a statistical combination of all previous studies into one set of results. The combined conclusion was that women who experience an induced abortion before having a full-term pregnancy incur at least a 50% increased risk of breast cancer. These findings have not been well publicized, however, because great attention has been given to certain faulty studies with less alarming conclusions.

Concerns about contraceptive hormones causing breast cancer were raised beginning in 1972 when a series of animal research studies showed this connection. A major study on humans in 1981 showed a 125% increased risk of breast cancer for women who used hormonal contraceptives for 4 or more years before having a full-term pregnancy. Other studies since then have confirmed an increased risk for this category of at least 40%. These risks are likely understated because most of the large studies had clear design flaws that would tend to depress the calculation of risk percent.

A meta-analysis done in 1990 found that, overall, the studies up to that time confirmed an increased risk of breast cancer of 72% for women under age 45 who took oral contraceptive pills for 4 or more years before having a full-term pregnancy. Use of these contraceptives for longer periods appears to carry an even higher risk. Again these findings were not well publicized because of excessive attention given to certain faulty studies whose design errors tended to understate the risk.

The risks identified in these studies increase the likelihood that a woman will suffer breast cancer. This means that women who have a higher than ordinary breast cancer risk due to well known risk factors such as nulliparity (childlessness), faulty "protective" genes such as BRCA1 and BRCA2, or being a black American, have even higher risk when affected by abortion or hormonal contraceptives.

Calculations based on the available studies indicate that in the United States more than 46,800 women will develop breast cancer yearly due to contraceptive hormone exposure and more than 10,000 will die.

Besides the effect of hormonal contraceptives in increasing the risk of breast cancer, these chemicals have also been found to significantly increase the risk of cervical cancer, liver cancer, some types of endometrial cancer and for transmission of AIDS. These hormones reduce the risk of ovarian cancer and the most common type of endometrial cancer, but these protective effects are greatly outweighed by the added risks just mentioned.

A number of highly effective strategies for controlling breast cancer risk (and some other risks as well) are identified in the book. Use of Natural Family Planning instead of hormonal contraceptives would evidently reduce risk factors significantly, as would avoidance of abortion, childbirth early in a woman's life, extended breastfeeding, multiple childbirth, moderation of alcohol use, and weight loss (in obese women). Some protective benefit may also be obtained by use of Vitamin A.

To adopt these strategies would involve a significant change in our current culture, but would result in many lives saved and avert a huge amount of suffering.

The author of this book, Chris Kahlenborn, is an internal medicine specialist practicing in Altoona, PA. The book is the fruit of more than 6 years spent collecting and analyzing the available research on this topic. What sparked this search was a presentation in 1993 in which the speaker described an increase in breast cancer risk due to abortion, apparently caused by hormonal changes in the woman's body.

This led Dr. Kahlenborn to wonder whether contraceptive hormones might have the same effect. He then began an exhaustive review of the research covering breast cancer's connection to both contraceptives and abortion.

Employing a highly user-friendly question and answer format, the author gives a detailed, yet understandable presentation of the major research findings to date. Technical information is interpreted in clear non-technical language, making the subject matter very accessible for the layperson and medical professional alike. There is also a clear, well-documented, presentation of the factors which have unfortunately operated to suppress this crucial information. A number of effective preventative strategies are identified and explained.

The author strongly challenges physicians, medical organizations, the research establishment, and government agencies to live up to their responsibilities for protecting women's health in this area. A final challenge is given to women themselves to take action to protect their health in the absence of effective action from responsible organizations.



back to top




Hormone Heresy

Estrogen's Deadly Truth, Part 1

by Sherrill Sellman


Women are misinformed about their hormones, to the detriment of their health,

while drug companies reap huge profits at their expense.

For over 300 years, beginning in the 13th century and continuing well into the 16th century, the Inquisition was a reign of terror for the vast majority of people living throughout Europe and Scandinavia. The political, economic and religious forces of that time joined together to consolidate their power by eliminating those whom they perceived as impeding their ultimate objectives.

The unfortunate target of their efforts were the keepers of the healing arts and the ancient spiritual and cultural wisdoms. Historians debate the exact toll of such a hellish time - whether it was several hundreds of thousands or as many as nine million people - but what is undebatable is that the vast majority of the victims were women. In fact, the Inquisition is now regarded as a period of genocide against women, which successfully divested women of their power, self-respect, wealth, healing arts, and prominence and influence in their communities.

The Inquisition guaranteed that the Church fathers were the indisputable spiritual authorities. It was also successful in enshrining medical knowledge securely in the realm of men, since the Inquisition decreed that only trained medical doctors could now practice the healing arts and, needless to say, medical schools were barred to women (for that matter, so was any form of education).

What a relief that such a violent and misogynous era ended long ago. Or did it? Unfortunately, it appears that some traditions linger on. Women of today are still prey to vast political and economic interests, with dire consequences to their health, financial independence and personal power. Perhaps the Inquisition didn't end at all but just took on a more subtle and devious form.

Women are certainly big business to the medical and pharmaceutical interests. According to John Archer, author of Bad Medicine, about 600,000 hysterectomies are performed every year in the USA, and about 45,000 in Australia. (1) In 1994, it was estimated that 45,000 Australian women were taking hormone replacement therapy (HRT). (2) Many women are presently encouraged to remain on HRT for the rest of their post-menopausal lives.

According to Dr. Stanley West, noted infertility specialist, chief of reproductive endocrinology at St. Vincent's Hospital, New York, and author of The Hysterectomy Hoax, about 90 per cent of all hysterectomies are unnecessary. Gynecological consultants to Ralph Nader's Public Health Research Group reached a similar conclusion in 1991 in their book, Women's Health Alert. According to Dr. West, the only 100 percent appropriate reason for performing an hysterectomy is for treating cancer of the reproductive organs. (3) However, hysterectomies are all too frequently offered as treatment for a variety of conditions including endometriosis, fibroids, ovarian cysts, pelvic inflammatory disease and uterine prolapse.

It is no accident that gynecologists happen to be the highest earners of all specialists. Throughout their lives, women are encouraged to be subjected continuously to various medical treatments and procedures. Natural female functions, from menstruation through childbirth and into menopause, are taken over by medical and pharmaceutical interventions. Barraged by misinformation, myths, propaganda and, in some cases, downright lies, it's no wonder that so many women are thoroughly confused about matters relating to their own bodies and their health.


The History of Hormone Replacement Therapy

Perhaps there's no topic of greater confusion to women than the highly publicized introduction of HRT for the menopausal woman. It is touted as the best thing for liberating women since the discovery of oral contraceptives - even though the statistics now show that the wide use of the Pill has given rise to health hazards such as breast cancer, high blood pressure and cardiovascular disease on a scale previously unknown in medicine. (4)

Investigation into the theory of hormone replacement goes all the way back to the 1930s with the research of Dr. Serge Voronoff. His research involved implanting fresh monkey's testicles into men's scrotums, with limited effectiveness. Offshoots of his research led to the grafting of monkey ovaries in women, with rather dire consequences. After several fatalities (to both monkeys and women), the search was redirected to the use of synthetic estrogen. With the advent of World War II, research was put on hold.

Menopause didn't really come into vogue as a topic of concern for the medical profession until the 1960s. In 1966 a New York gynecologist, Dr. Robert Wilson, wrote a best seller called Feminine Forever, extolling the virtues of estrogen replacement to save women from the "tragedy of menopause which often destroys her character as well as her health." His book sold over 100,000 copies in the first year. Wilson energetically promoted menopause as a condition of "living decay." According to him, estrogen replacement was a kind of long sought after youth pill that would save poor, fading women from the horrors of age. He popularized the erroneous belief that menopause is a deficiency disease.

Women's magazines eagerly seized upon his ideas and extensively promoted his concepts. This pleased Wilson no end, since he had earlier set up The Wilson Foundation for the sole purpose of promoting the use of estrogen drugs. The pharmaceutical industry generously contributed over US$1.3 million to his Foundation. Each year he received funds from such companies as Searle, Wyeth-Ayerst Laboratories and Upjohn which made hormone products that Wilson claimed were effective in treating and preventing menopause. Pharmaceutical companies jumped on the bandwagon with aggressive promotions and advertising campaigns. His message hit a receptive chord: mid-life women need hormone drugs to be rescued from the inevitable horrors and decrepitude of this terrible deficiency disease called menopause.

Wilson pioneered the use of unopposed estrogen. However, there had been no formal assessment of the safety of estrogen therapy or its long term effects. Unopposed estrogen went out of vogue when it became obviously apparent that it shortened the lifetime of its users. In 1975, The New England Journal of Medicine examined the rates of endometrial cancer for estrogen consumers, concluding that the risk was seven and a half times greater for estrogen users. Women who had used estrogen for seven years or longer were 14 times more likely to develop cancer. (5)

As the popularity of unopposed estrogen therapy waned, new approaches were sought. The focus was also directed away from the false claims of preserving feminine beauty and youthfulness and towards more urgent health matters. The pharmaceutical industry resurrected estrogen replacement therapy with the new 'safe' hormone replacement therapy - a combination of synthetic progesterone and estrogen which would supposedly protect menopausal women not only from cardiovascular disease but also from the ravages of osteoporosis.

While the so-called 'experts' on women's health are reassuring women that there are no, or at least only very minor, unpleasant side effects, Dr. Lynette J. Dumble, Senior Research Fellow at the University of Melbourne's Department of Surgery at the Royal Melbourne Hospital, believes that "the sole basis of HRT is to create a commercial market that is highly profitable for the pharmaceutical companies and doctors. The supposed benefits of HRT are totally unproven." She believes that HRT not only exacerbates the presenting health problems but also contributes to the acceleration of the aging process of women. It either hastens the onset of other medical conditions or worsens the existing ones.

This perspective seems to be validated by the recent findings from a landmark study, published in The New England Journal of Medicine in 1995, involving 121,700 women, which revealed startling effects from HRT. It warned that women who used HRT to offset the symptoms of menopause also increased their chance of developing breast cancer by 30 to 40 per cent by taking the hormone for more than five years. In women aged between 60 and 64, the risk of breast cancer rose to 70 per cent after five years of HRT. Finally, the study concluded that women using HRT were 45 per cent more likely to die from breast cancer than those who chose not to use HRT or used it for less than five years. (6)

According to Leslie Kenton, author of Passage to Power, "everybody who is anybody will tell you that menopause is an estrogen-deficiency disease and that you will need to take more estrogen as you approach mid-life. What may surprise you is this: not only is most of such commonly given advice on menopause wrong, a great deal of it can be positively dangerous."

Fortunately there is another side to the hormone story - a perspective that not only can assist women of all ages to attain greater health but also to reclaim a greater sense of power, responsibility and dignity in their lives.


A Brief Gynecological Tour of a Woman's Body

In order to understand the HRT debate, it is important, first, to have a rudimentary knowledge of a woman's cyclic nature. Until recently, doctors thought that menopause began when all the eggs in the ovaries had been used up. However, recent work has shown that menopause is probably not triggered by the ovaries but by the brain. It seems that both puberty and menopause are brain-driven events.

Menstruation depends on a complex network of hormonal communications between the ovary, the hypothalamus and the pituitary gland in the brain. The hypothalamus secretes gonadotropin releasing hormone (GnRH) which triggers the production of follicle stimulating hormone (FSH) by the pituitary gland. The FSH then stimulates the growth of the egg follicles (a small excretory sac or gland) in the ovaries to trigger ovulation. As the egg follicles grow, estrogen is manufactured and released into the blood.

This chain reaction is not just one way. Estradiol, one of the ovarian estrogens in the bloodstream, also acts on the hypothalamus, causing a change in GnRH. Next, this altered hormone stimulates the pituitary to produce luteinising hormone (LH) which causes the egg follicles to burst and the ovum to be released. After the egg is expelled, progesterone is also manufactured by the collapsed egg follicle which develops into the corpus luteum.

All the hormones released during the menstrual cycle are secreted not in a constant, steady way but at dramatically different rates during different parts of the 28 day cycle.

For the first eight to 11 days of the menstrual cycle, a woman's ovaries make lots of estrogen. Estrogen prepares the follicles for the release of one of the eggs. It is estrogen which proliferates the changes that take place at puberty: the growth of breasts, the development of the reproductive system and the shape of a woman's body.

The rate of estrogen secretion begins to fall off on about day 13, one day before ovulation occurs. As estrogen falls, progesterone begins to rise, stimulating very rapid growth of the follicle. Beginning with this secretion of progesterone, ovulation occurs too. After the egg has been released from the follicle (known as the luteal stage of a woman's cycle), the follicle begins to change, enlarging and becoming a unique organ known as the corpus luteum. Progesterone is secreted from the corpus luteum, this tiny organ with a huge capacity for hormone production. The surge of progesterone at the time of ovulation is the source of libido - not estrogen, as is commonly believed.

After 10 or 12 days, if fertilization does not occur, ovarian production of progesterone falls dramatically. It is this sudden decline in progesterone levels that triggers the shedding of the secretory endometrium (the menses), leading to a renewal of the entire menstrual cycle.

Ovarian estrogen and progesterone stimulate the growth of the endometrium, or lining of the uterus, in preparation for fertilization. Estrogen proliferates the growth of endometrial tissue, and progesterone facilitates the secretory lining of the uterus so the fertilized egg can implant successfully. Adequate progesterone, therefore, is the hormone most essential to the survival of the fertilized egg and the fetus.

At around 40 years of age, the interaction between hormones alters, eventually leading to menopause. It is still not clear how. Menopause may start with changes in the hypothalamus and the pituitary gland rather than in the ovaries. Scientists have conducted experiments where young mice have had their ovaries replaced with those from aged animals no longer capable of reproducing. The young mice can mate and give birth. This shows that old ovaries placed in a young environment are capable of responding. On the other hand, when young ovaries are put into old mice, these mice cannot reproduce. (7)

Whatever the mechanism triggering menopause, as fewer egg follicles are stimulated, the amount of estrogen and progesterone being produced by the ovaries declines although other hormones continue to be produced. By no means do the ovaries shrivel up and cease functioning, as is popularly believed. With the reduction of these hormones, menstruation becomes scantier and erratic and eventually ceases.

However, other body sites such as the adrenal glands, skin, muscle, brain, pineal gland, hair follicles and body fat are capable of making these same hormones, enabling the female body to make healthy adjustments in hormonal balance after menopause - provided a woman has taken good care of herself during the pre-menopausal years with proper lifestyle, diet and attention to mental and emotional health.

Menopausal women have the opportunity to enter this phase of life empowered in their wisdom and creativity as never before. They have access to profound inner knowing. The renowned sociologist Margaret Mead said, "There is nothing more powerful than a menopausal woman with zest!" In many cultures around the world, menopause is a transition and an initiation into the fulfillment of a woman's power, totally symptom-free. She is held in the highest regard in her community as a wise, respected elder.


The Myth of Estrogen and Synthetic Progestins

The earlier research that led to the synthesis of estrogen made possible the development of the oral contraceptive by 1960. With consent of the US Food and Drug Administration (FDA), the Pill was widely marketed as an effective, convenient method of birth control. True sexual liberation for women was at hand at last.

However, the entire basis for the FDA's consent was the result of clinical studies conducted on 132 Puerto Rican women who had taken the Pill for one year or longer. (8) (Never mind the fact that there were five women who died during the study without any investigation into the cause of their deaths.)

By the mid-1970s the death toll of women from heart attacks and strokes began to attract public notice. A newer, supposedly safer Pill was then created with a lower dose of estrogen. But, in fact, there has never been any valid scientific proof that the Pill is safe - nor, for that matter, that any of the other forms of contraception presently available are safe. Women are only now discovering the price they have been paying for their sexual freedom: by altering their hormonal balance, many varied and devastating emotional and physiological dysfunctions have been created.

It is now 35 years on from the introduction of oral contraception and there are presently about 60 million women worldwide who are, in effect, 'trial-ing' the Pill. Its safety and long term effects have still not been established conclusively. It is interesting to note, however, that it has produced a wide assortment of adverse effects and side effects and has a significant link to breast cancer, high blood pressure and, in particular, cardiovascular disease - the major cause of female deaths in Australia. In 1992, 27,833 women died from heart disease and strokes, compared to 2,438 from breast cancer. (9) Is this merely a coincidence, or do these statistics indicate, perhaps, the harmful side effects of tampering with hormones?

While proclaimed also as the primary missing ingredient for the menopausal woman, estrogen is strongly recommended by the medical and pharmaceutical industries for the prevention of cardiovascular disease and osteoporosis. Just about any doctor's surgery you walk into these days will warn women of the inherent risks of going through menopause and, for that matter, the post-menopausal years without the protection of estrogen. Women are further reminded, once again, that menopause is a deficiency disease, which supposedly means that they are lacking estrogen and therefore must have supplemental doses to maintain their health.

As Dr. Lynette Dumble has noted, "Broadly speaking, cardiovascular prevention in women has overwhelmingly focused on hormone replacement. Yet, as Elizabeth Barrett-Connor emphasizes, the Big Trial, the Coronary Drug Project of 1973 that included two estrogen regimens, was conducted in men. As part of the Big Trial design, estrogen doses extravagantly in excess of physiological levels were deliberately administered to men in order to induce gynaecomastia [enlargement of male breasts] as an indicator of successful feminisation. This resulted in thrombosis and impotence and ultimately led to research failure because of treatment discontinuations amongst the study's participants." (10)

According to medical practitioner, independent researcher and author Dr. John Lee, the one notable study (known as the Boston Health Study, conducted with a large sampling of nurses) which formed the entire basis of the positive estrogen-cardiovascular link, was radically flawed. Although there is ample evidence from numerous other studies showing that, indeed, the opposite is true - i.e., estrogen is a significant factor in creating heart disease - these findings have been virtually ignored in the frenzy for profits. He goes on to say that the pharmaceutical advertisements also neglected to mention the fact that stroke death incidence from that study was 50 per cent higher among the estrogen users.

Dr. Lee has compiled a list of side effects and physiological impairments which result from taking estrogen. They include increased risk of endometrial cancer, increased body fat, salt and fluid retention, depression and headaches, impaired blood sugar control (hypoglycemia), loss of zinc and retention of copper, reduced oxygen levels in all cells, thickened bile and promoted gall bladder disease, increased likelihood of breast fibrocysts and uterine fibroids, interference with thyroid activity, decreased sex drive, excessive blood-clotting, reduced vascular tone, endometriosis, uterine cramping, infertility, and restraint of osteoclast function.

With so many side effects and dangerous complications, a woman must think very carefully about the HRT decision. Unfortunately, most doctors will tell her that there is no other alternative. While certainly most doctors are well-meaning and sincerely concerned about their patients, their primary source of education and product information comes directly from the pharmaceutical companies. Since most women also lack essential education and understanding about their options, menopause can be perceived as a rather frightening and perilous time.


Enter Natural Progesterone

For the past 15 years, Dr. Lee has conducted independent research into a natural, plant derived form of progesterone. His non-pharmaceutically-funded research presents a much broader understanding of a woman's hormonal options and offers a totally safe, effective alternative that is free of all side effects. He has found that this natural hormone - used in conjunction with a good diet and lifestyle changes - is capable of eliminating much of the suffering associated both with premenstrual syndrome (PMS) and menopause. Thousands of women in the Western world now use natural progesterone - generally in the form of a non-prescription cream which is rubbed into the body. They claim that they not only have relief from female symptoms but experience increased vitality, better skin and renewed emotional balance.

Natural progesterone seems to have been totally overlooked by medical science while the erroneous focus has been on estrogen. Considering that it is non-patentable and inexpensive, it not surprising that this is so. It is important, however, to have a much greater understanding and appreciation for this remarkable hormone.

As was previously mentioned, it is progesterone that is responsible for maintaining the secretory endometrium which is necessary for the survival of the embryo as well as the developing fetus throughout gestation. It is little realized, however, that progesterone is the mother of all hormones. Progesterone is the important precursor in the biosynthesis of adrenal corticosteroids (hormones that protect against stress) and of all sex hormones (testosterone and estrogen). This means that progesterone has the capacity to be turned into other hormones further down the pathways as and when the body needs them. The point needs to be emphasized that estrogen and testosterone are end metabolic products made from progesterone. Without adequate progesterone, estrogen and testosterone will not be sufficiently available to the body. Besides being a precursor to sex hormones, progesterone also facilitates many other important, intrinsic physiological functions (which will be discussed later).


The Estrogen Dominance Effect

Female problems seem to be on the rise. Between 40 and 60 per cent of all women in the West suffer from PMS. In addition, women also suffer from a plethora of symptoms, some menopausal and others not. Something quite alarming certainly seems to be happening to women. There is indication that proper hormonal balance necessary for a woman's body to function healthily is being interfered with by a number of factors. Research has revealed that a good portion of women in their 30s (and some even younger), long before the onset of menopause, on occasion will not ovulate during their menstrual month. (11) Without ovulation, no corpus luteum results and no progesterone is made. A progesterone deficiency ensues.

Several problems can result from this deficiency. One is the month long presence of unopposed estrogen with all its attendant side effects, as already mentioned. Another is the generally unrecognized problem of progesterone's role in osteoporosis. Contemporary medicine is still unaware that progesterone stimulates osteoblast-mediated new bone formation. Actually, it is progesterone that stimulates new bone tissue and is capable of reversing osteoporosis at any age. Lack of progesterone means that new osteoblasts are not created and osteoporosis can arise. (12) A third major problem results from the interrelationship between progesterone loss and stress. Stress combined with a bad diet can induce anovulatory cycles. The consequent lack of progesterone interferes with the production of the stress-combating hormones, exacerbating stress conditions that give rise to further anovulatory cycles. And so the vicious cycle continues.

Another major factor contributing to this imbalance between estrogen and progesterone is environmental in nature. We in the industrialized world now live immersed in a rising sea of petrochemical derivatives. They are in our air, food and water. These chemicals include pesticides and herbicides (such as DDT, dieldrin, heptachlor, etc.) as well as various plastics (polycarbonated plastics found in babies bottles and water jugs) and PCBs. These estrogen-mimics are highly fat-soluble, not biodegradable or well excreted, and accumulate in fat tissue of animals and humans. These chemicals have an uncanny ability to mimic natural estrogen. They are given the name "xeno-estrogens" since, although they are foreign chemicals, they are taken up by the estrogen receptor sites in the body, seriously interfering with natural biochemical changes.

Mounting research is now revealing an alarming situation worldwide created by the inundation of these hormone-mimics. In a recently released book, Our Stolen Future, authors Theo Colburn of the World Wildlife Fund, Dianne Dumanoski of The Boston Globe and John Peterson Meyers, a zoologist, have identified 51 hormone mimics, each able to unleash a torrent of effects such as reduced sperm production, cell division and sculpting of the developing brain. These mimics are not only linked to the recent discovery that human sperm counts worldwide have plunged by 50 per cent between 1938 and 1990 but also to genital deformities, breast, prostate and testicular cancer, and neurological disorders. (10)

Dr. Lee has discovered a consistent theme running through women's complaints of the distressing and often debilitating symptoms of PMS, peri-menopause and menopause: too much estrogen, or, as he has termed it, "estrogen dominance".

Now, instead of estrogen playing its essential role within the well balanced symphony of steroid hormones in a woman's body, it has begun to overshadow the other players, creating biochemical dissonance. The last thing in the world a woman's body needs is more estrogen - either in the form of contraceptives or HRT. Then, when the estrogen-dominant symptoms appear, guess what is prescribed? More estrogen! The delicate natural estrogen/progesterone balance is radically altered due to too much estrogen. Progesterone deficiency is then exacerbated even more.

Dr. Lee has been able to balance the estrogen-dominance effect through the use of transdermal natural progesterone cream. Natural progesterone, a cholesterol derivative, is made from wild Mexican yams or soybeans whose active ingredients are an exact molecular match of the body's own progesterone. It is interesting to note that in countries in Asia and South America where women eat either the wild yams or soybeans, the term "hot flush" doesn't even exist in their languages. They also rarely suffer from the host of female problems presently plaguing Western women.

Supplementation with natural progesterone corrects the real problem: progesterone deficiency. Natural progesterone is not known to have any side effects; nor have any toxic levels been found to date. Natural progesterone increases libido, prevents cancer of the womb, protects against fibrocystic breast disease, helps protect against breast cancer, maintains the uterus lining, hydrates and oxygenates the skin, reverses facial hair growth and hair thinning, acts as a natural diuretic, helps eliminate depression and increase a sense of well being, encourages fat burning and the use of stored energy, normalizes blood clotting, and is a precursor to other important stress and sex hormones. Even the two most prevalent menopausal symptoms - hot flushes and vaginal dryness - quickly disappear with applications of natural progesterone.

There is one other very significant benefit of natural progesterone that deserves a bit more attention. While most people are under the assumption that estrogen protects against osteoporosis - one of the biggest selling points for which a woman is encouraged to take HRT - this is definitely not the case.

The early studies on which the estrogen protection assumption was based had gross scientific defects. Canadian researcher Jerilyn Prior, chief endocrinologist at the University of British Columbia in Vancouver, and her colleagues, reporting in The New England Journal of Medicine, confirmed that estrogen's role in osteoporosis is only a minor one. In their studies of female athletes, they found that osteoporosis occurs to the degree that they become progesterone-deficient, even though their estrogen levels seem to remain normal. Prior continued her research with non-athletic women. They showed the same results. While both these groups of women were menstruating, they had anovulatory cycles and, therefore, were progesterone-deficient.

Prior then went on to discover that anovulation and a short phase cycle now occur in up to 50 per cent of North American women's menstrual cycles during the final reproductive years. (14) Unfortunately, these major findings went relatively unnoticed in the medical community.

As a result of her extensive review of published scientific evidence in this area, Prior confirmed that it is not estrogen but progesterone which is the bone-trophic hormone; that is, the bone builder. She was even able to identify progesterone receptor sites on osteoblast cells (bone tissue building cells). Nobody has ever found osteoblast receptors for estrogen. The bottom line is that it is in women with progesterone deficiency that bone loss occurs. (15)

These results were verified by a three year study of 63 post-menopausal women with osteoporosis. Women using transdermal progesterone cream experienced an average 7 to 8 per cent bone mass density increase in the first year, 4 to 5 per cent the second year, and 3 to 4 per cent in the third year! Untreated women in this age category typically lose 1.5 per cent bone mass density per year! These results have not been found with any other form of hormone replacement therapy or dietary supplementation. (16)

Dr. Lee believes that the use of natural progesterone in conjunction with dietary and lifestyle change can not only stop osteoporosis but can actually reverse it - even in women aged 70 or more.

At this point, it is important to make the distinction between the natural progesterone that is produced by the body and the synthetic progesterone analogues classified as progestins, such as Provera, Duphaston and Primulut. As you will learn, there is a big difference between the two in their effect in the body, although doctors most often use their names interchangeably. Since natural progesterone is not a patentable product, the pharmaceutical companies have molecularly altered it to produce synthetic progestins commonly used in contraceptives and HRT.

Synthetic progestins, because they are not exact replicas of the body's natural progesterone, unfortunately create a long list of side effects, some of which are quite severe. A partial list includes headaches, depression, fluid retention, increased risk of birth defects and early abortion, liver dysfunction, breast tenderness, breakthrough bleeding, acne, hirsutism (hair growth), insomnia, edema, weight changes, pulmonary embolism and premenstrual-like syndrome. (17)

Most importantly, progestins lack the intrinsic physiological benefits of progesterone, thus they cannot function in the major biosynthetic pathways as progesterone does and they disrupt many fundamental processes in the body. Progesterone is an essential hormone that also plays a part in the development of healthy nerve cells and brain and thyroid function. Progestins tend to block the body's ability to produce and utilize natural progesterone to maintain these life promoting functions.

The hormone story is certainly a very complicated one. Up until now, only one version of the story has been available to the majority of Western women, especially Australian women. Serious doubt has been cast on the efficacy and appropriateness of estrogen and progestins in all the forms they take. Women are certainly suffering from a wide variety of female complaints.

What complicates the hormone story is that the prescribed treatments for these complaints are actually making the problem worse. Without understanding the far reaching side effects of estrogen dominance and progestin, doctors are misdiagnosing the cause of these aggravated conditions. Often, other drugs are then prescribed with disastrous side effects, as the spiral of unnecessary medication increases. What is the ultimate toll, not only on a woman's deteriorating health and emotional well being but also on her financial situation, her relationships and her career?

Without adequate knowledge, education and access to natural products, women have been easy prey to the powerful campaigns of the multinational drug companies that have convinced doctors as well as governments of their claims. It is becoming more evident that women's interests are not always best met through such a biased approach. It is also not unusual for profits to take precedence over health and well being. The last thing a woman needs is to have her natural bodily functions denigrated to deficiency diseases - thus necessitating ongoing medical attention.

It is indeed time for women to take even greater responsibility for their health, their choices and their lifestyles. The greatest weapon against compliance and ignorance is knowledge. It's time to ask poignant questions of your health provider, to demand answers and to be willing to investigate safe, alternative approaches. It is apparent that women will need to participate in educating their doctors about the other choices that exist as well as the ones that they prefer.

Certainly, women have it well within their own power not only to find safe, natural and effective ways to heal themselves but to live long, full lives, preserving their vitality, youthfulness and health. Women deserve the right to appreciate themselves and their bodies through all the stages of life. As women find the way to return to a greater balance within themselves, they will know profoundly the truth of what Dr. Deepak Chopra has said about women: "Feminine wisdom is the intelligence at the heart of creation."

Effects of Estrogen Dominance

When estrogen is not balanced by progesterone, it can produce weight gain, headaches, bad temper, chronic fatigue and loss of interest in sex - all of which are part of the clinically recognized premenstrual syndrome.

Not only has it been well established that estrogen dominance encourages the development of breast cancer thanks to estrogen's proliferative actions, it also stimulates breast tissue and can, in time, trigger fibrocystic breast disease - a condition which wanes when natural progesterone is introduced to balance the estrogen.

By definition, excess estrogen implies a progesterone deficiency. This, in turn, leads to a decrease in the rate of new bone formation in a woman's body by the osteoblasts - the cells responsible for doing this job. Although most doctors are not yet aware of it, this is the prime cause of osteoporosis.

Estrogen dominance increases the risk of fibroids. One of the interesting facts about fibroids - often remarked on by doctors - is that, regardless of the size, fibroids commonly atrophy once menopause arrives and a woman's ovaries are no longer making estrogen. Doctors who commonly use progesterone with their patients have discovered that giving a woman natural progesterone will also cause fibroids to atrophy.

In estrogen dominant menstruating women where progesterone is not peaking and falling in a normal way each month, the ordered shedding of the womb lining doesn't take place. Menstruation becomes irregular. This condition can usually be corrected by making lifestyle changes and using a natural progesterone product. It is easy to diagnose by having a doctor measure the level of progesterone in the blood at certain times of the month.

Endometrial cancer (cancer of the womb) develops only where there is estrogen dominance or unopposed estrogen. This, too, can be prevented by the use of natural progesterone. The use of the synthetic progestins may also help prevent it, which is why a growing number of doctors no longer give estrogen without combining it with a progesterone drug during HRT. However, all synthetic progestins have side effects.

Water logging of the cells and an increase in intercellular sodium, which predispose a woman to high blood pressure or hypertension, frequently occur with estrogen dominance. These can also be side effects of taking synthetic progestogen [progestins]. A natural progesterone cream usually clears it up.

The risk of stroke and heart disease is increased dramatically when a woman is estrogen-dominant.

(Source: Leslie Kenton, Passage to Power, Random House, UK, 1995)



Anti-aging Benefits of Natural Progesterone

Progesterone is a primary precursor in the biosynthesis of the adrenal corticosteroids. Without adequate progesterone, synthesis of the cortisones is impaired and the body turns to alternate pathways. These alternate pathways have masculine-producing side effects such as long facial hairs and thinning of scalp hair. Further impaired corticosteroid production results in a decrease in the ability to handle stress, e.g., surgery, trauma or emotional stress.

Many peri- or post-menopausal women with clinical signs of hypothyroidism, such as fatigue, lack of energy, intolerance to cold, are actually suffering from unrecognized estrogen dominance and will benefit from supplementation with natural progesterone.

Estrogen and most of the synthetic progestins increase intracellular sodium and water uptake. The effect of this is hypertension. Natural progesterone is a natural diuretic and prevents the cell's uptake of sodium and water, thus preventing hypertension.

Whereas estrogen impairs homeostatic control of glucose levels, natural progesterone stabilizes them. Thus, natural progesterone can be beneficial to both those with diabetes and those with reactive hypoglycemia. Estrogen should be contraindicated in patients with diabetes.

Thinning and wrinkled skin is a sign of lack of hydration in the skin. It is common in peri- and post-menopausal women and is a sure sign of hormone depletion. Transdermal natural progesterone is a skin moisturizer which restores skin hydration.

Progesterone serves a role in keeping brain cells healthy. A disorder such as premature senility (Alzheimer's disease) may be, at least in part, another example of disease secondary to progesterone deficiency.

Progesterone is essential for the healthy development of the myelin sheath which protects the nerve cells. Low progesterone levels lead to recurring aches and pains.

Progesterone creates and promotes an enhanced sense of emotional well being and psychological self-sufficiency.

Progesterone is responsible for enhancing the libido.


(Source: John R. Lee, M.D., Slowing the Aging Process with Natural Progesterone, BLL Publishing, CA, USA, 1994, p. 14)


End notes:

Archer, John, Bad Medicine, Simon & Schuster, Australia, 1995, p. 191.

Op. cit., p. 217.

Op. cit., p. 192.

Op. cit., p. 211.

Coney, Sandra, The Menopause Industry, Spinifex Press Pty Ltd., Australia, 1991, pp. 164-165.

The Sydney Morning Herald, 24 June 1995.

Coney, Sandra, op. cit., p. 584.

Archer, John, op. cit., p. 210.

Archer, John, op. cit., p. 211.

(a) Dumble, Lynette J., Ph.D., M.Sc., "Odds Against Women with Heart Disease", presented at Health Sharing Women's Forum, Royal College of Surgeons, Melbourne, Victoria, Australia, 14 September 1995. (b) Barrett-Connor, Elizabeth, "Heart Disease in Women", Fertility and Sterility (1994), 62(2):127S-132S.

Lee, John R., M.D., Natural Progesterone: The Multiple Role of a Remarkable Hormone, BLL Publishing, California, USA, 1993, p. 29.

Ibid.

Newsweek, 18 March 1996.

Kenton, Leslie, Passage to Power, Random House, UK, 1995, pp. 19-20.

Ibid.

Lee, John R., M.D., "Osteoporosis Reversal: The Role of Progesterone", International Clinical Nutrition Review (1990), 10:384-391.

Lee, John R., M.D., Slowing the Aging Process with Natural Progesterone, BLL Publishing, California, USA, 1994, p. 12.


back to top




Birth Control Patch Linked to Higher Fatality Rate

Report: Device has three times greater risk of stroke, blood clot than pill

Gingerly, Kathleen Thoren’s family gathered around her in the intensive care unit, unable to speak to their beloved sister, daughter, wife, or even stroke her hands. The slightest stimulation might create a fatal amount of pressure on the 25-year-old woman’s swollen brain, warned the doctors.

“We were horrified, but we tried to just quietly be with her,” said her sister Erika Klein. “In the end, it didn’t help.”

The mother of three died last fall, just after Thanksgiving, after days of agonizing headaches that the coroner’s report said were brought on by hormones released into her system by Ortho Evra, a birth control patch she had started using a few weeks earlier.

She was among about a dozen women, most in their late teens and early 20s, who died last year from blood clots believed to be related to the birth control patch. Dozens more survived strokes and other clot-related problems, according to federal drug safety reports obtained by The Associated Press under a Freedom of Information Act request.

Several lawsuits have already been filed by families of women who died or suffered blood clots while using the patch, and lawyers said more are planned.

Risk three times higher

Though the Food and Drug Administration and patch-maker Ortho McNeil saw warning signs of possible problems with the patch well before it reached the market, both maintain that the patch is as safe as the pill.


However, the reports obtained by the AP appear to indicate that in 2004 — when 800,000 women were on the patch — the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.

The women who died were young and apparently at low risk for clots — women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station last April. Or Sasha Webber, a 25-year-old mother of two from Baychester, N.Y., who died of a heart attack after six weeks on the patch last March.

Some doctors, reviewing the Food and Drug Administration reports at the request of The AP, were alarmed. “I was shocked,” said Dr. Alan DeCherney, editor-in-chief of Fertility and Sterility and a UCLA professor of obstetrics and gynecology.

But other doctors said they would have expected some deaths and no investigation is warranted. They point to more than 4 million women who have safely used the patch and note that the FDA reports are called in voluntarily, rather than gathered scientifically.

“It doesn’t jump out at me to say, 'Let’s look at this any further,”’ agreed Dr. Steven J. Sondheimer, professor of obstetrics and gynecology at the University of Pennsylvania. “I don’t feel that these need to be looked at in any detail.”

No cause for alarm?

Ortho McNeil, a subsidiary of Johnson & Johnson, says none of the deaths can be directly attributed to the patch.

“Although we are investigating each and every one of the reports that we get, we have not drawn any causal relationships to the medication,” said Dr. Katherine LaGuardia, Ortho McNeil’s director of women’s health care.

Not one? “Right,” she said. “It’s difficult to reach a definitive answer, and privacy laws prevent us from investigating as thoroughly as we wish.”

Blood clots are an accepted risk from hormonal birth control because estrogen promotes blood coagulation.

But how many clots are too many?

The AP found that before the patch was approved, the FDA had already noticed nonfatal blood clots from the patch were three times that of the pill. The AP then examined what has actually happened since the patch came on the market and found that deaths also appear to be at least three times as high.

If you are a woman taking the pill who doesn’t smoke and is under 35, the chance that you are going to have a blood clot that doesn’t kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is about 1 in 200,000.

By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 out of 200,000.

Clots usually form in the legs, and become serious problems if they travel to a woman’s heart, lungs or brain.

Early warning signs

In 2000, doctors at the FDA reviewing clinical trials of the wafer-thin, plastic patch warned that blood clots could be a problem if it was approved.

In those trials, two of the 3,300 women using the patch were treated for blood clots that traveled to their lungs. Ortho McNeil says one of those women shouldn’t be counted because she had undergone surgery. But an FDA reviewer, using capital letters and underscoring his comments, took issue with Ortho McNeil.

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases ...,” said the report. “The incidence rates quoted by the sponsor may be misleading.”

The reviewer said “the label should clearly reflect this reviewer’s safety concern about a potential increased risk.” It would be important to study users after the patch came on the market for clot problems, he wrote.

But when the patch was approved in the U.S. in 2001, there were no requirements for follow-up studies beyond routine FDA reviews of reports called in by consumers, doctors and manufacturers.

The label’s safety warning says two different and seemingly contradictory things: First, it says the patch is expected to be associated with similar risks as the pill. Then, it says it is unknown if the risk of blood clots from the patch is different from the pill.

The AP reviewed what has happened since the patch came on the market in 2002.

Hormones enter bloodstream directly

The FDA responded to a FOIA request by providing the AP with a database that contained about 16,000 different reports of adverse reactions associated with the patch.

These ranged from mild rashes to deaths, and there were many duplicate reports. Within this collection of reports, the AP found 23 different deaths associated with the patch. The primary cause of death in those reports isn’t always clear — some mention suicide, others abortion. Doctors who reviewed the 23 cases found about 17 that appeared to be clot-related, including 12 from last year.

“That number of deaths certainly sounds suspicious,” said Dr. Pamela Berens, associate professor of obstetrics and gynecology at the University of Texas Medical School at Houston. “There may be something about the way the drug is metabolized that could increase the risk for clots.”

Although the estrogen levels are similar in the patch and the pill, the hormones in a pill must be processed through the intestinal tract before they enter the blood stream. Hormones in the patch, on the other hand, go directly into the bloodstream.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, a consumer advocacy organization founded by Ralph Nader, said that the deaths and high rate of clots are “worrisome” and should be investigated.

“These days, more often than not the problems with a drug show up after they’re approved,” he said.

But Dr. Daniel Shames, the FDA’s director of the Division of Reproductive and Urological Drug Products, who approved the agency’s medical review, said he has reviewed cases of women who died using the patch and saw no cause for alarm.

“We think the death rate here is of concern, but it’s not different than what we expect,” he said. “As of right now we still believe there’s nothing that would precipitate our doing anything additional to follow up on these reports.”

And other doctors who prescribe the patch warned that women should not overreact to news of deaths. It is more risky to remove the patch and become pregnant, several pointed out.

'You can use a patch safely'

Dr. Philip Darney, a professor of obstetrics and gynecology at the University of California, San Francisco, and a leading contraceptive researcher, cautioned that the FDA’s adverse event reports tend to be inflated for newer products like the patch.

Patients and doctors are more likely to contact the FDA when they have a bad reaction to a new drug than for something that has been on the market for a long time, he said. In addition, women using the patch are likely to either be new to hormonal birth control or have reacted poorly to the pill and are looking for a change. The result is that the pool of women using the patch are at higher risk than birth control users at large.

He tells patients, “If you can use a pill safely, you can use a patch safely, and we’re going to know a lot more later as more women use patches,” he said.

Ortho McNeil recommended that the AP speak to two doctors, Dr. Hilda Hutcherson, co-director of the NY Center for Women’s Sexual Health and a professor at Columbia University Medical Center, and Dr. Vanessa Cullins, vice president of medical affairs at Planned Parenthood Federation of America. Both doctors have served in the past as paid advisers to Ortho McNeil.

Hutcherson said the risks of blood clots from hormones are well known, and that “what has happened with the patch is consistent.”

Cullins said she did her own comparison of data for the pill and patch and found the patch is safer than expected.

“My research was to determine whether or not the expected number of deaths from the pill was lower than what was seen with the number of deaths reported with Ortho Evra. I found the opposite,” said Cullins, who has done research, consulted for and been a speaker for Ortho McNeil and other drug companies.

Cullins said she reviewed the deaths looking at “women years” rather than current users. Women years is a measure that takes into account that different people use a particular contraceptive for different periods of time. For example, if three women each used a patch for four months, that would count as one woman year rather than three current users.

Cullins reviewed patch users from 2002, when the patch came on the market, until late 2003. For that period, Cullins said she would have expected 22 deaths and found only 6.

The AP reviewed the deaths looking at both women years and current users, but used more recent data, focusing on 2004 when the patch had been much more widely adopted.




back to top




Oral Contraceptives Increase Breast Cancer Risk


According to a meta-analysis published in the Mayo Clinic Proceedings¸ but virtually ignored in the mainstream press, use of oral contraceptives increases risk of premenopausal breast cancer, writes Dennis Byrne (Chicago Tribune 12/3/07). The greatest increase in risk, 52%, was in parous women who used oral contraceptives for four or more years before their first full-term pregnancy (Kahlenborn C, et al. Mayo Clinic Proc 2006;81:1290-1302, 2006).

READ ENTIRE STORY: http://www.aapsonline.org/newsoftheday/006