Recently it has been reported that women on hormone replacement therapy (HRT) had acquired a 26% increased risk of developing breast cancer.  So dramatic was this finding it precipitated the early closure of the study. Worldwide media attention brought this and other findings onto the front page of major national newspapers. In Australia, the Therapeutic Goods Administration, charged with the regulation of all drugs prescribed in Australia, responded to this study by tightening the indications for HRT use.

  As a result of this controversy over the safety of HRT, questions have arisen as to the safety of the birth control pill. Like HRT the birth control pill uses artificial hormones to alter the natural physiological characteristics of a woman's endocrine system, using pharmaceutically similar drugs. To help clarify this debate, the following citations and accompanying explanation will be, I trust, instructive.

  "Historically, conjugated estrogens have been the most common agents for postmenopausal use, and 0.625mg/day is effective in most women (although 1.25mg is needed is some patients). In contrast most combined oral contraceptives in use employ 20 to 35mcg/day of ethinyl estradiol. Conjugated estrogens and ethinyl estradiol differ widely in their oral potencies: for example, a dose of 0.625mg of conjugated estrogens generally is considered equivalent to 5 to 10mcg of ethinyl estradiol.

  It is important to recognize that the dose of estrogen used for postmenopausal hormone replacement therapy is substantially less than that used in oral contraception, taking into account the different potencies of the drugs normally employed in the two settings."

  A number of aspects of the above quote require clarification. First, conjugated estrogens are found in Premarin®, the brand at the centre of the current controversy. The hormone is obtained from the urine of pregnant horses. Ethinyl estradiol is the artificial estrogen commonly found in the birth control pill, and is manufactured in the laboratory.

  Second, "mg" is an abbreviation for milligram, being one thousandth of a gram. Also, "mcg" is shorthand for microgram, being one millionth of a gram. Some texts use the Greek letter mu (which cannot be received properly by some e- mail browsers) with the letter "g" instead of "mcg" as an abbreviation for microgram, but they are synonymous terms.

  Hence, a dose of 0.625mg of conjugated estrogens is 0.625 thousands of a gram. This, according to Goodman and Gilman's text, is considered to be the bio- equivalent of 5- 10 mcg of ethinyl estradiol. In pharmacology, bio- equivalence refers "to a drug that has the same effect on the body as another drug, usually one nearly identical in its chemical formulation."

  Modern forms of the birth control pill contain, on a cyclical basis, between 30 and 40 mcg (micrograms) of ethinyl estradiol. Hence, one birth control pill, at 40mcg, is at least four times stronger than the dose equivalent of 10mcg, which was previously indicated as begin equal to one Premarin 0.625mg tablet. Stated another way, the average dose of hormone in the birth control pill is, conservatively, four times stronger per dose than HRT. In the extreme (based upon the lowest strength comparison of ethinyl estradiol of 5mcg), the birth control pill is eight times stronger per tablet than a dose of HRT.

  Similar, though slightly lower dose equivalent data is provided by Lange's Basic and Clinical Pharmacology. This text indicates that one birth control pill is the dose equivalent of 2- 4 HRT tablets, depending on whether one calculates conservatively or extremely.

  Hence it is biologically and pharmacologically plausible to expect that the birth control pill would have at least the same rate of breast cancer in its users as than seen in HRT uses. According to the most recent research, this is exactly the case. Data presented at the third European Breast Cancer Conference reported that the risk of breast cancer was 26% higher in pill users compared to non- users.  This finding is in harmony with more than 15 papers published since the mid- 80s which have all indicated the birth control pill use in women, notably young women, causes an increase in the risk of developing breast cancer. To be consistent one would hope that the media will act to inform women of the dangers of the birth control pill also.

Healthy Behaviors Lower Overall Breast Cancer Risk CME

High Dietary Fat Intake Associated With Low Sperm Quality

October 20, 2010 —  Engaging in "breast- healthy" behaviors — drinking alcohol in moderation, exercising regularly, and watching weight — appear to reduce a woman's risk for the development of invasive breast cancer after menopause. However, healthy behaviors do not seem to modify risk attributable to a family history of later- onset breast cancer (FHLBC), according to a study published online October 12 in Breast Cancer Research.

An analysis of follow- up data on nearly 86,000 postmenopausal women enrolled in a large observational study indicated that rates of invasive breast cancer among women who reported taking part in all 3 behaviors at baseline (moderate alcohol, regular exercise, weight management) were lower than those of women who said they did not participate in any of the behaviors, report Robert E. Gramling, MD, from the Department of Family Medicine at the University of Rochester, in Rochester, New York, and colleagues from 7 other centers in the United States and Denmark.

However, the benefit of breast- healthy behaviors was seen both in women with an FHLBC (breast cancer in a mother or full sister at 45 years or older) and in women with no affected first- degree relatives, and the degree of benefit did not differ significantly between the groups, the study authors note.

"This study suggests to both public health and office- based clinicians that adherence to breast- healthy behaviors (regular exercise, weight management and alcohol moderation) benefits women with or without a family history of later- onset breast cancer but does not function to reduce family history of later- onset breast cancer- attributable risk," the study authors write.

October 29, 2010 (Denver, Colorado) — A high intake of saturated and monounsaturated fat is associated with significantly low sperm concentration, whereas a high intake of healthier polyunsaturated fatty acids is associated with improved sperm motility and morphology, according to research presented here at the American Society for Reproductive Medicine 66th Annual Meeting.

Researchers evaluating the semen quality and dietary fat intake of 91 men attending the Massachusetts General Hospital Fertility Center, in Boston, found that men with the highest intake of saturated fat had as much as 41% fewer sperm than those with the lowest intake, and those with the highest levels of monounsaturated fat had 46% fewer sperm than those with the lowest intake.

Participants in the study ranged in age from 18 to 55 years, had a mean age of 36 years, and were generally overweight, with body mass indexes ranging from 26 to 27 kg/m².

For the complete study go to; Breast Cancer Res. Published online October 12, 2010.

Women May Not Need to Delay Pregnancy After an Initial Miscarriage

NBC Investigates Ortho Evra – The Birth Control Patch 

August 11, 2010 — Women may not need to delay pregnancy after an initial miscarriage, according to the results of a retrospective, Scottish population–based cohort study reported Online First August 5 in the British Medical Journal..

Current guidelines from the World Health Organization recommend that women should wait for at least six months before trying again, whereas others suggest a delay of up to 18 months, based on reports that interpregnancy intervals of 18- 23 months after a live birth can enhance maternal and perinatal outcomes in the next pregnancy."

Compared with an interval of 6 to 12 months between the miscarriage and second conception, an interval less than 6 months was associated with lower risks for repeated miscarriage "Women who conceive within six months of an initial miscarriage have the best reproductive outcomes and lowest complication rates in a subsequent pregnancy," the study authors write.

"Our research shows that it is unnecessary for women to delay conception after a miscarriage," the study authors conclude. "As such the current WHO [World Health Organization] guidelines may need to be reconsidered. In accordance with our results, women wanting to become pregnant soon after a miscarriage should not be discouraged."

According to a study reported on the Today show in late September of 2010, there is growing evidence that the birth control patch named Ortho Evra leads to strokes and even death. NBC has found evidence to suggest that the product manufacturer, Johnson and Johnson, has known about the risks since the patch received FDA approval but have kept their findings private.

Since the patch went to market in 2002, over 2400 women have filed complaints about the product, claiming that they had either had a stroke or blood clots. And there are two dozen law suits pending because of death caused by the patch.

The patch is considered more dangerous than the pill because it delivers 60% more estrogen to the woman than the regular birth control pill (BCP). When a woman takes a BCP, she gets a quick hit of hormones that dissipate. The patch, on the other hand, delivers a consistent dose of estrogen that does not dissipate. This on- going dose of estrogen is the likely culprit behind blood clot formation which can result in a stroke or death.

The investigation reported that the patch is twelve times more likely to cause strokes and eighteen times more likely to cause blood clots than the BCP. 

Quick Response to Study of Abstinence Education 

A study of middle- school students that found for the first time that abstinence- only education helped to delay their sexual initiation is already beginning to shake up the longstanding debate over how best to prevent teenage pregnancy and sexually transmitted diseases. 

“This is a rigorous study that means we can now say that it’s possible for an abstinence- only intervention to be effective,” Dr. John B. Jemmott III, the University of Pennsylvania professor who led the study, said Tuesday, hours after results of the study were released. “That’s important, because for some populations, abstinence is the only acceptable message.” 

In Dr. Jemmott’s research, only about a third of the students who participated in a weekend abstinence- only class started having sex within the next 24 months, compared with about half who were randomly assigned instead to general health information classes, or classes teaching only safer sex. Among those assigned to comprehensive sex- education classes, covering both abstinence and safer sex, about 42 percent began having sex.

Dr. Jemmott’s research followed 662 African- American students at urban middle schools, who were paid $20 a session to attend the classes, plus follow- up and evaluation sessions. The abstinence- only classes covered HIV, abstinence and ways to resist the pressure to have sex. 

“Because African- Americans tend to have a higher rate of early sexual initiation than others, we thought that within two years, a reasonable number would start having sex,” Dr. Jemmott said. “If we went younger, we couldn’t show that intervention works.”

The research, published in the Archives of Pediatric & Adolescent Medicine, appears just as the Obama administration is eliminating federal financing for abstinence- only programs, and starting a pregnancy- prevention initiative that will finance programs that have been shown in scientific studies to be effective. 

Recognizing the political sensitivity of the research, and how unexpected are its results, the journal ran an accompanying editorial cautioning that public policy should not be based on the results of a single study and that policy makers should not “selectively use scientific literature to formulate a policy that meets preconceived ideologies.”

“The results may be surprising to some in that the theory- based abstinence- only curriculum appeared to be as effective as a combined course and more effective than the safer- sex only curriculum in delaying sexual activity,” the editorial said. “None of the curricula had any effect on the prevalence of unprotected sexual intercourse or consistent condom use.” 

The executive director of the National Abstinence Education Association, Valerie Huber, said she hoped that the new study would lead to restored federal support for abstinence programs. 

“The current recommendation before Congress in the 2011 budget zeroes out abstinence education, and puts all the money into broader comprehensive education,” Ms. Huber said. “I hope that either the White House amends their request or Congress acts upon this, reinstating abstinence education.”

Ms. Huber also said she found it especially interesting that African- Americans were the focus of Dr. Jemmott’s study since, she said, “our critics would contend that the abstinence message would be least effective with the most at- risk youth.”

Even longtime advocates of comprehensive sex education heralded the findings.

“This new study is game- changing,” said Sarah Brown of the National Campaign to Prevent Teen and Unplanned Pregnancy, in a statement. “For the first time, there is strong evidence that an abstinence- only intervention can help very young teens delay sex and reduce their recent sexual activity as well. Importantly, the study also shows that this particular abstinence- only program did not reduce condom use among the young teens who did have sex.” 

Ms. Brown noted that the abstinence- only classes in the Jemmott study centered on people with an average age of 12 and that unlike the federally supported abstinence programs now in use, did not advocate abstinence until marriage.

The classes also did not portray sex negatively or suggest that condoms are ineffective, and contained only medically accurate information. Dr. Jemmott’s abstinence- only course was designed for the research, and is not in current use in schools. 

Hormone Therapy Linked to Ovarian Cancer 

November 11, 2010 —  Postmenopausal women who use hormone replacement therapy face a 29% increased risk of ovarian cancer, according to a study.

Researchers at the Cancer Epidemiology Unit at the University of Oxford in England analyzed data from the European Prospective Investigation Into Cancer and Nutrition to evaluate the relationship between hormone therapy use during the postmenopausal years and ovarian cancer risk.

Investigators led by Konstantinos Tsilidis, PhD, looked at data on 126,920 postmenopausal women who did not have a history of cancer and who had not had their ovaries removed. During nine years of follow- up, there were 424 cases of ovarian cancer diagnosed.

The women were also asked about their height and weight, whether they smoked, use of oral contraceptives, number of pregnancies, and what age  they started menstruating.

After accounting for other factors, the research team found that:

45% of the group had used hormone therapy at some point.
30% were current users of hormone therapy when the study started.
69% of the group that used hormone therapy took an estrogen- progestin combination, 18% used estrogen- only hormone therapy, 3% used tibolone, and 2% used other preparations of hormone therapy; 8% had missing information on type of hormone use.
Current use of any hormone therapy was significantly associated with a 29% increased risk of ovarian cancer compared to women who had never used hormone therapy.
Current use of estrogen- only therapy was associated with a 63% increased risk of ovarian cancer.
Current use of estrogen- progestin combination therapy was not significantly associated with risk.
Women who had ever used some form of hormone therapy for five or more years had a 45% higher risk for ovarian cancer compared with women who had never used hormone therapy.

 “This study is consistent with previous recommendations that say if women are going to take hormones they should only take them in the short term,” Tsilidis says in a prepared statement.

Previous research has shown an association between hormone replacement therapy and an increased risk for breast cancer.  A study published last month in The Journal of the American Medical Association found that postmenopausal women who take a combination of estrogen and progestin therapy face a greater risk for developing a more advanced form of breast cancer and an increased risk for dying from the disease. The findings were based on the ongoing Women’s Health Initiative, a major research program launched in 1991 by the National Institutes of Health.

In the United States, ovarian cancer is the fifth leading cause of cancer death. According to 2006 data from the CDC, 19,994 women in the U.S. were diagnosed with ovarian cancer and 14,857 women died from the disease. 

September 24, 2010 — The US Food and Drug Administration (FDA) today approved an oral contraceptive —  the first of its kind — that is intended both to prevent pregnancy and reduce the risk for neural tube defects in newborns if and when users of the pill give birth.

The new contraceptive, Beyaz (Bayer HealthCare Pharmaceuticals), contains levomefolate calcium, a metabolite of folic acid that helps produce and maintain new cells in the body. Low folate levels in women have been linked with neural tube defects in their children such as spina bifida, resulting in recommendations that women of childbearing age supplement their diet with folate.

"Combining an oral contraceptive with folate is important, because women may become pregnant during [oral contraceptive] use or shortly after discontinuation, possibly before seeking preconception counseling from their healthcare provider," said Dr. Anita Nelson, professor of obstetrics and gynecology at the Harbor–University of California at Los Angeles Medical Center, Torrance, California, in a company press release. "For women who want to use an oral contraceptive, Beyaz offers a new option for women to receive daily folate supplementation." 

November 5, 2010   An estimated 6.4 million pregnancies occurred in the United States in 2001. Half of these pregnancies were unintended; 44% of the unintended pregnancies ended in births, whereas 42% ended in induced abortions (a total of 1.3 million, or one fifth of all pregnancies). Half of the unintended pregnancies were conceived in cycles when some type of contraception was used. The rate of unintended pregnancy is highest in the 18- to 24- year- old population, which is twice as high in comparison with other age groups.

A 2006 study reported a rate of 16.1 abortions per 1000 reproductive- aged women. According to the same report, 236 abortions were performed for each 1000 live births. Almost 60% of the abortions were performed in women aged 20- 29 years (29.9 per 1000 women). Slightly more than 60% of the pregnancy terminations were at a gestational age of less than 8 weeks, and almost 88% were surgical procedures.

Author’s Comment: The article struck me as odd; why would you put an additive in a pill primarily designed to prevent pregnancy that will improve a newly conceived baby’s neural development? 

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