Chemical Birth Control:
Short and Long-Term Side Effects
The Australian pharmacist John Wilks has published a book recently, entitled "A Consumer's guide to the Pill and other drugs."
It includes a discussion of the long term effects of hormones on women's health.
He tells us that studies have shown a 370% increase in cervical pre-malignant conditions compared with non-users.
He also describes a study by Brock et al in Sydney which shows a 130% increased risk of cervical cancer with use of the pill for more than six years. MJA 1989.
The use of the pill at an early age is particularly dangerous. Olssen, (JNat Cancer Institute 1989) reported that for a teenager taking the pill, the risk of breast cancer is 480% higher than in never users. He reaffirmed his conclusion s in 1991.
There is also a 1000% risk of thrombo-embolism (blood clots) in pill users compared with non-users. (1973 Boston collaborative drug programme.)
The more modern low dose pill appears to carry similar risks, as the British government warned users of the new generation pills in 1995.
Fact Sheet - Contraceptive Pill Side-Effects
1) Breast Cancer
~ For those women starting the pill before 20yrs old, the risk of dying from breast cancer was 820% higher than for healthy non-users of the same age.(1) *p61
~ For women starting pill between 20-25 years, relative risk was 180% higher than healthy non-users (1) *p61
~ Other researchers cite the risk of breast cancer for young women(<20 yrs old) is 200-480% higher than for non-pill users(2,3,4) *p53,219,223
Therefore the range these studies cite for breast cancer is 200-820%
~ In one study of 918 Dutch women diagnosed with invasive breast cancer, 85% had used the pill at some time (4a)
~ Even 3 months use of the pill has been reported to be associated with 100% increase in breast cancer (4b) *p49
~ For more than ten years use, breast cancer risk increased by 310% (4b) *p49
~ "women with breast cancer, who at an early age have used OC, have larger breast tumoursand a worst prognosis compared with later (pill users) and never users(5) *p60
~ ie a x3 fold reduction in Japan. Australia/USA have a pill history of 30 years with identical breast cancer statistics. Industrialized Japan, has no pill use, reports one third the rate (5a)
(Note: With use of Depo-Provera (DMPA) - "Use for two years or longer before age 25 was associated with a significantly increased risk of breast cancer" (ie 360% increase) (6) *p100
2) Cervical Cancer
~ Pill use in women <20years old means 280% higher risk of cervical cancer
In women 20-24 years, its 70 % higher
In women 25-29 years its 40% higher (7) *p26, 219
~ Another study cites increased risk of 250% for cervical cancer amongst pill users (8) *p21
~ Longer term users(6-12 years) 100-340% increased risk of non-users cervical cancer(9,10) *p24,25
~ However, one of these studies showed women who used the pill for only 1-6 months had a 190% increase in cervical cancer than non-users (9) *p24
~ Clinical evidence cites the pill's role in activation of and enhancing HPV (Human Papilloma Virus) in initiation of cervical cancer. (11,12) *p36
3) Deep Vein Thrombosis (DVT)
~ Risk of DVT increased by 600-900%(ie 5-8 fold) compared to non-users in users of 3rd generation progestagen pills (eg containing gestodene - eg Femodene, Minulet, Tri-minulet, or containing desogestrel - eg Marvelon) (13,14) *p219
~ Across all age groups, use of the 3rd generation pill brands had a 770% greater DVT risk than non-pill users (15) *p80
~ Second generation progestagens (levonorgestrel,norethisterone) have 120-280% increase risk of DVT (16,17) *p80,82
~ For teenagers aged 15-19yrs risk of DVT " for the desogestrel-containing OC was 7-fold higher than that of the levo-norgestrel containing products; among women aged 20-24 the risk was 4-fold higher" (18) *p81 IMPORTANT! Note that this x7 increase was relative to 2nd generation users not non-users!!
Therefore, by computation, risk for 15-19yr olds compared to non-users is
(120%-280%) x 7 = x 15-26 fold risk!!
~ A x50 fold increase risk of DVT for users carrying a blood clotting factor V Leiden mutation (19) *p81 This occurs in 3-5%of Dutch/Swedish women *p77
~ Note mechanism - gestodene causes decreased oestrogen metabolism in liver leading to accumulation in body leading to increased DVT risk *p74
4) Infertility after pill-use
~ Women may not conceive for up to 48 months or longer depending on age (19,20) *p93
This is due to atrophy of the mucus secreting glands thus preventing sperm transport *p94-95
5) Teratogenicity
~ Birth defects/chromosomal abnormalities in children conceived right after pill cessation (21,22) *p92
COMMENT
Fertility drugs cause hyperstimulation of the ovaries, leading to increased ovarian cancer of the ovary due to increased minor trauma of the covering epilthelium *p141
The pill, and pregnancy, and breast feeding cause a rest in ovulation, thus associated with a decreased incidence of ovarian cancer. Some family planning advocates defend or advocate pill use because of the associated decrease in ovarian cancer rates(0.2% risk). To do so in light of the magnitude of the side-effects of the pill documented is a woeful ignorance of the facts or a deliberate and cynical act of injustice to women.
All references from - A Consumer's Guide to the Pill by John Wilks B Pharm
MPS 2nd Ed1997 ALL Publications
Available from HLI (Ireland) £14 which includes p & p
References
1) Olsson H, Borg A, Ferno M, Moller TR, Ranstam J. Early oral contraceptive use and premenopausal breast cancer - a review of studies performed in South Sweden Cancer Detection and Prevention 1991:15 (4): 265-271 Table IV.
2) Olsson H & ML, Moller TR, Ranstam J, Holm P. Lancet(letter) 1985 March 30, 748-49
3) Olsson H, Moller TR, Ranstam J. Early oral contraceptive use and breast cancer among premenopausal women: Final report from a study in Southern Sweden. Journal of the National Cancer Institute. 1989;81(12):1000-4
4) Johnson JH, Weighing the evidence on the pill and breast cancer Family Planning Perspectives 1989: 21 (2): 89-92
4a) Rookus & Van Leeuwen. Oral Contraceptives and risk of Breast Cancer women aged 20-54 years. Lancet 1994 ; 344; p844-51
4b) Millar DR, Rosenberg L, et al Breast Cancer before age 45 and oral
contraceptive use ; new findings. American J of Epidemiology 1989;129
(2):269- 80,
5) Olsson H, Borg A, ferno M, Moller T, Ranstam J. Early oral contraceptive use and breast cancer in Southern Sweden. Proc. Annu Meet Am Soc Clin Oncol. 1989: A367, Ma
5a) WHO Cancer Mortality database 1994 Breast Cancer Rates by Country.
6) Paul C, Depo medroxyprogesterone (Depo-Provera) and risk of breast cancer Br Med J 1989; 299: p762
7) Thomas DB, Ray RM. Oral contraceptives and invasive adenocarcinomas and adenosquamous carcinomas of the uterine cervix Am J Epid 1996;144:p284 table 2.,
8) Kohler U, Wuttke P. results of a case control study of the current effect of various factors of cervical cancer risk . 2) Contraceptive behaviour and the smoking factor. Zentralblatt fur gynakologie 1994;116 (7): 405- 9 (Ma)
9) Ursin G, Peters RK, Henderson BE, d'Ablaing G, Monroe KR, Pike MC. Oral contraceptive use and adenocarcinoma of cervix. Lancet 1994; 344; 1390-1394
10) Brisson J et al Risk factors for cervical Intraepithelial Neoplasia: differences between low and high-grade lesions American J of Epidemiology 1994;140:700-710
11) Chen Y-H, Huang L-H, Chen T-M. Differential effects of progestins and estrogens on long control regions of human papilloma virus types 16 and 18. Biochemical and Biophysical Research Communications 1996;224:p654
12) Kenney JAW. Risk Factors associated with genital HPV infection. Cancer Nurse 1996 (Oct);19:5, p353
13) Vandebrouke JP, Rosendaal FR. End of the line for "third-generation pill" controversy? Lancet 1997; 349:1113-1114
14) Vandenbrouke JP et al Increased risk of venous thrombosis in oral contraceptive users who are carriers of factor V Leiden mutation. Lancet 1994;344:p 1454
15) Bloemenkamp KW, Rosendal FR, Helmerhorst FM, Bauller HR, Vandenbroche JP. Enhancement by factor V Leiden mutation of deep vein thrombosis associated with oral contraceptives containing third generation progestogen. Lancet 1995;346:8990:1593-6
16) Ref 15 p1594, table 1
17) Spitzer WO, Lewis MA, Heineman LAJ et al. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study Br Med J 1996;312:83-8
18) Bloemenkamp et al p1595
19) APPG 24th Ed Microgynon 30 monograph 1995 p1508
20) Micromedex vol 89 Oral contraceptives monograph
21) Wade ME, McCarthy PM et al. Am J Obstet Gynaecol 1995; 172: p698
22) Rahwan R, Prof Pharmacology & Toxicology, College of Pharmacy Ohio State University. Chemical Contraceptives, Interceptives and Abortifacients 1995
Infromation is from Patrick McCrystal
Human Life International (Ireland)
Jan 1999
ORAL CONTRACEPTIVES TIED TO FOCAL NODULAR HYPERPLASIA OF THE LIVER
Confirming previous studies, a new report by Italian researchers provides a quantitative estimate of the association between oral contraceptive use and the risk of developing focal nodular
hyperplasia of the liver.
Reuters Health Information 2002
http://www.medscape.com/viewarticle/429217?srcmp=wh-030102
DRUG FIRM SAYS ORAL CONTRACEPTIVE'S THROMBOTIC RISK WELL KNOWN
A leading drug company said that the use of its third-generation oral contraceptive pills carried a higher thrombotic risk than the use of other agents, but the risk was well known and was included in
the packaging information.
Reuters Health Information 2002
http://www.medscape.com/viewarticle/429492?srcmp=wh-030802
CLASS-ACTION TRIAL ON THIRD-GENERATION OC SET IN UK
One hundred women who claim they were seriously injured by third-generation oral contraceptives will seek 'substantial damages' from manufacturers in a court case starting in Britain next
week, their lawyers said.
Reuters Health Information 2002
http://www.medscape.com/viewarticle/429303?srcmp=wh-030102
From the book "What Your Doctor May NOT Tell You About Premenopause" by John Lee list of side affects consistently noticed in women taking all combinations of birth control pills (and depo shots etc)
~ six times greater risk of thrombosis (blood clot in a blood vessel)
~ four times greater risk of dying from a stroke (blood clot or broken blood vessel in the brain)
~ four times the risk of heart attack
~ three times greater risk of headaches
~ double the risk of migraine headaches
~ double the risk of high blood pressure
~ double the risk of death from an accident or violence
~ double the risk of dying from cancer, especially cervical, breast, and endometrial cancer, in women 25 to 50 years old
~ increased risk of ovarian cancer
~ increased cancer risk in smokers, especially melanoma and lung cancer
~ more thyroid and liver cancers
~ altered immune function
~ reduction of antioxidant levels, especially in the liver
~ a higher rate of birth defects and birthmarks in the children of women who have used oral contraceptives
~ increased risk of osteoporosis caused by blood vessel abnormalities in the bone
~ increased risk of ovarian cysts, infections, urinary tract problems, cervical erosion (dysplasia), allergies, gallbladder disease, sinus infections, ulcerative colitis, Crohn's disease, lung disease, epilepsy, loss of libido, infertility, pituitary tumors, and schizophrenia
~ higher rates of antianxiety drug, antidepressant, or sleeping pill usage
~ higher likelihood of having their uterus and/or ovaries removed
Contraception: Five Important Facts That You Need to Know
By Dr. Joseph Mercola
with Rachael Droege
Close to 39 million U.S. women use some form of contraception with female sterilization, the birth control pill and the condom being the most widely used methods in the United States. Other methods include hormonal injections, implants, intrauterine devices (IUDs) and the birth control patch.
The different contraception methods act in very different ways and can be broken down as follows:
Barrier Methods: This method works by physically preventing the sperm from reaching the egg. It includes condoms (and female condoms), the diaphragm, the cervical cap and the sponge, which is not currently on the market.
Hormonal Methods: Typically, hormonal birth control methods work by releasing estrogen and progestin into the body, preventing the ovaries from releasing eggs. They also thicken cervical mucus, making it harder for sperm to enter the uterus. There are a wide variety of hormonal methods on the market including oral birth control pills, implants (Norplant), hormone shots like Depo-Provera, a vaginal ring called NuvaRing, and a contraceptive hormone patch worn on the skin.
Spermicides: This method involves a chemical that kills or disables sperm so that it cannot cause pregnancy. It comes in many different forms: foam, jelly, cream, film, and suppositories.
Intrauterine Devices (IUDs): This is a small, plastic, T-shaped stick with a string attached to the end. The IUD is placed inside the uterus and prevents sperm from joining with an egg. It does this by making the sperm unable to go into the egg and by changing the lining of the uterus.
Natural Family Planning: In this method, a woman uses various techniques to determine when she is fertile during the month. By avoiding sexual intimacy, or using a backup method, during the window of fertility, pregnancy can be avoided. Techniques include the ovulation method, the symptothermal method, which is a combination of the ovulation method and monitoring of body temperature, and monitoring saliva with the Ovu-Tech magnification lens.
If you use contraception, the decision of which method to use can be overwhelming and it seems that most women are not adequately informed of their options. For instance, most doctors who see women about contraceptive concerns underestimate the effectiveness of natural family planning options and rarely or never mention them . Many women--more than 16 million U.S. women choose birth control pills as their preferred method--turn to birth control pills as a result because they are not aware that there are safer options available.
Below I’ve included five important facts that you can use to make an informed contraception decision for yourself.
1. Hormonal contraceptives are SYNTHETIC hormones.
The body is not designed to be exposed to these synthetic hormones, and long-term use will invariably increase the user's risk of developing serious chronic illness. In my view, there is no medical justification for using birth control pills or other hormonal methods. The benefits simply do not outweigh the tremendous risks.
Side effects of the pill Side effects of the patch
Increased risk of breast cancer
Increased risk of cervical cancer
Increased risk of endometrial cancer
Increased risk of ovarian cancer
Liver tumors
Blood clots
High blood pressure
Cycle irregularities
Miscarriages
Headaches
Migraines
Cramps
Bloating
Nausea
Vaginal infections
Gall bladder disease
Mental depression
Loss of sexual drive
Raised risk of heart attack and stroke
Irregular bleeding
Problems wearing contact lenses
Fluid retention or raised blood pressure
Nausea
Headache
Breast tenderness
Mood changes
Menstrual cramps
Abdominal pain
Skin irritation or rashes at site of patch
2. Birth control pills can deplete important nutrients.
Aside from the long list of potential side effects, birth control pills can deplete your body of nutrients. These nutrients include:
Vitamin B2
Vitamin B6
Vitamin B12
Folic Acid
Vitamin C
Magnesium
Zinc
3. There are much safer options to using hormonal contraceptives.
Barrier methods and natural family planning (NFP) offer much safer, albeit less convenient, options than hormonal contraceptives. With NFP, there are no side effects and no toxic substances to put in your body and women often feel empowered as they become aware of their fertility cycle. I do recommend that you learn the method from a reliable source and if preventing pregnancy is an absolute must you may want to use a backup barrier method. Because these other safer options exist, I ask ALL of my patients to stop hormonal contraceptives like birth control pills as soon as possible.
4. Depo-Provera hormone shots are fraught with complications.
A study in the May 2004 issue of the journal Obstetrics and Gynecology found that Depo-Provera users had declines in bone mineral density averaging 3 percent each year. Those on the shot for two years had losses in bone mineral density of roughly 6 percent, compared with a loss of 2.6 percent among women on birth control pills. Comparatively, women using no hormonal contraceptives had, on average, a 2 percent increase in bone density during the same period.
Aside from bone loss, the Depo-Provera shot is associated with a long list of additional side effects.
Side effects of the Depo-Provera
Weight gain
Headaches
Breast swelling and tenderness
Decreased sexual desire
Depression
Bloating
Swelling of the hands and feet
Nervousness
Abdominal cramps
Dizziness
Weakness of fatigue
Leg cramps
Nausea
Vaginal discharge or irritation
Backache
Insomnia
Acne
Pelvic pain
Lack of hair growth or excessive hair loss
Rashes
Hot flashes
Joint pain
Convulsions
Jaundice
Urinary tract infections
Allergic reactions
Fainting
Paralysis
Osteoporosis
Lack of return to fertility
Deep vein thrombosis
Pulmonary embolus
Breast and cervical cancers
Abnormal menstrual bleeding
Unexpected breast milk production
Changes in speech, coordination, or vision
Swelling of face, ankles or feet
Mood changes
Unusual fatigue
5. Spermicides can promote urinary tract and yeast infections.
Spermicides are essentially chemicals (usually nonoxynol-9 (N-9)) that kill sperm by dissolving their outer membrane. However, they also kill beneficial bacteria and skin cells. Disrupting the beneficial bacteria in the vagina can leave women more susceptible to urinary tract infections and yeast infections.
Further, according to a 2001 report from the World Health Organization, there is no evidence that condoms lubricated with nonoxynol-9 are any more effective in preventing pregnancy or infection than condoms lubricated with silicone, and such condoms should no longer be promoted.
Birth Control Pills Linked to Thinner Bones
Women who are taking birth control pills have lower bone mineral density (BMD) than women who have never used oral contraceptives.
Past studies in postmenopausal women have found that supplementation with the hormones estrogen and progestin actually helps maintain bone density. But few have looked at the effect of hormones on premenopausal women.
After adjusting for age, body mass index and height, BMD in oral contraceptive users was 2.3% to 3.7% lower than in women who had never used oral contraceptives, especially in the spine and the upper part of the thigh bone.
Canadian Medical Association Journal October 16, 2001;165:1023-1029
Birth Control Pill Increases Risk of Fatal Embolism
Further reinforcing results of previous studies, new research from New Zealand suggests that the use of oral contraceptives may cause a nearly 10-fold increase the risk of developing a fatal pulmonary embolism.
Several previous case-control studies had found that their use was associated with an increased risk of deep-vein thromboses and nonfatal pulmonary embolism.
The incidence was somewhat higher than we expected" stated one on the study's authors, who found that 65% of women who died from pulmonary embolisms were current oral contraceptive users.
The risk of death from pulmonary embolism in oral contraceptive users was estimated at 10.5 deaths per 1 million woman-years, which is much higher than previous estimates, which had put the annual incidence at 1 or 2 per 10,000 women, with a fatality rate of only 1-2%.
Risk factors for pulmonary embolism includes a past history of deep venous thrombosis, being extremely overweight, or prolonged immobility.
Lancet 2000; 355: 2133-2134
Birth Control Pills Increase Blood Clot Risk
"Third generation" oral contraceptives are linked to a more than doubled risk of potentially fatal blood clots known as venous thromboembolisms.
The research from Boston University School of Medicine in Massachusetts indicates that oral contraceptives containing desogestrel or gestodene increased the risk of blood clots by a factor of 2.3 compared to older birth control pills containing levonorgestrel.
The findings support earlier research about the potential danger of the "third-generation" pills that caused a scare in 1995 and resulted in a warning to doctors and pharmacists about the potential dangers. Since the warning, the number of women taking the "third generation" pill, have dropped by about 80%.
The researchers estimated that if women had not switched after the warning there would have been about 26% more cases of blood clots.
In an emailed response to the study, Anthony Griffiths points out that the "third-generation" pills might me of use to women in certain situations, such as women suffering from the androgenic effects of polycystic ovarian disease syndrome (PCOS) and women at an increased risk of heart disease.
Women with PCOS would benefit from the greater estrogenic effects of the "third generation" pills.
Women at increased risk of heart disease would be better off avoiding the levonorgestrel pills which can lower the levels of cardio-protective HDL cholesterol.
British Medical Journal November 11, 2000;321:1190-1195
Birth Control Pills Increase Risk of Breast Cancer
Older generation birth-control pills may have significantly increased breast cancer risk among women with a family history of the disease.
In a study of 426 families, investigators found that oral contraceptive use tripled breast cancer risk among women with sisters or mothers who had the disease.
The risk was confined to women who used "the pill" prior to 1975.
Since then, birth control pills have evolved to include lower doses of estrogen and progestin, which may make them safer in terms of breast cancer, researchers suggest, although this will likely not be definitively known for years to come.
The breast cancer link was strongest among women with five or more cases of breast or ovarian cancer in their families. In these women, birth control pill use was linked to an 11-fold increase in breast cancer risk.
An editorial accompanying the study notes that "the use of oral contraceptives needs to be considered on an individual basis," taking into account all of a woman's health concerns.
The Journal of the American Medical Association October 11, 2000;284:1791-1798, 1837-1838
Oral Contraceptives and Low HDL Increase Stroke Risk
This study analyzed the relationship between various blood lipid parameters and the risk of ischemic stroke in patients under 45 years of age.
There was no relation found between risk of ischemic stroke and total cholesterol, LDL cholesterol, or triglycerides.
Only low HDL cholesterol levels were shown to increase risk.
Other increased risk factors included the use of oral contraceptives, high blood pressure, smoking, and male sex.
These risk factors remained, regardless of any apparent atherosclerosis. The authors state that although the relation between serum lipids and ischemic stroke remains controversial, low HDL cholesterol should be considered in the care of young patients regardless of the detectable presence of atherosclerosis.
Journal of Neurology and Neurosurgical Psychiatry June 2000;69:29-33.
Can Depo-Provera Destroy Your Sex Life?
Tom Grant
Turning Off Libido
Just how many women are affected by loss of libido is unclear. Pharmacia, the drug company that markets Depo-Provera, says that between one percent and five percent (1 in 20) of the users experience "decreased sexual desire," as they benignly describe the side effect.
But an Australian study said that one of the most common side effects of the drug was "dyspareunia" (meaning painful sex) or loss of libido, which affected eight percent (1 in 12) of the women.
One Internet survey conducted by a woman in Great Britain suggests that loss of sexual desire is common among women who have complaints.
Teresa Campbell solicited responses from more than 3,000 users of Depo-Provera and copyrighted the results. Campbell complains about serious side effects from Depo-Provera herself, so those attracted to her survey undoubtedly tend to have worries about the drug.
The number one complaint was weight gain (68%), but the number two complaint was loss of libido.
Nearly six out of ten women (58%) complained of it. The number three and four complaints were aggression (56%) and depression (54%).
Among those new to the drug (less than three months), complaints of depression, aggression and loss of libido were even higher than complaints of weight gain.
The Hormone Doctor
Dr. John Lee, a medical doctor and author of two best-selling books on female hormones, believes that Depo-Provera has adverse affects on the sexuality of nearly every woman.
"It's given to sex offenders as a chemical castration to kill their sex appetite," Lee said. He sees that as a hint about what it does to women. "Depo-Provera is the worst possible way to provide birth control. It's a long-term continuous release form of Provera. It lasts three months. There's a terrible incidence of side effects and it should not be used."
Dr. Lee, author of What Your Doctor May Not Tell You About Menopause, was a physician in general practice in the mid-1970s when he became interested in the effect on women of the hormone progesterone. Progesterone is one of three hormones controlling sexuality, the others being estrogen and testosterone.
Lee pointed out that Depo-Provera is synthetic progesterone. "Provera is a terrible thing," Lee said.
He complained that the drug companies take natural progesterone, change the molecule so that it can be patented, and then sell the synthetic as if it were as good as the real thing. Lee believes the change in the molecule is what leads to the drug's side effects.
Dr. David Zava, a biochemist with ZRT Laboratory in Portland, Oregon, who specializes in hormonal research, agrees with Lee. He describes progesterone as a "master key" that unlocks about ten different bodily functions. "Depo-Provera has a limited function and only opens about two of them," Zava says.
Zava says the synthetic progesterone does some things well, such as shut down the ovaries, which creates one set of side effects, and it does other things very poorly. He says Depo-Provera does not provide natural progesterone's calming effect in the brain nor its stabilizing effect on the cardiovascular system. "Women feel rotten on it," Zava says.
"Get a Physician's Desk Reference and look up Provera," Lee says. "You'll see there's about six columns of side effects. And it really doesn't have any benefits."
When Weight Gain Is the Least of Your Worries
Pharmacia acknowledges a number of potential side effects, the most prominent of which is weight gain. The company says women who remain on Depo for one year gain an average of five pounds. They gain eight pounds in two years. Six years adds 16 pounds.
Dr. Jerilynn Prior, a professor of medicine at the University of British Columbia in Vancouver, said that doses of progesterone actually raise core temperatures of the body and increase the number of calories a person can eat by about 300 per day.
But high-dose Depo-Provera may cause a reverse effect by shutting down the ovaries, where estrogen and testosterone are produced.
Lee and Zava believe Depo-Provera creates a hormonal imbalance in the body so estrogen becomes the dominant hormone. Subsequent weight gain is not the woman's fault, Lee maintains.
Depo-Provera is also known to cause irregularities in menstrual bleeding for most women. Repeated injections of the drug often stop women from having periods at all.
According to Pharmacia's literature, the drug has also been associated with complaints of headaches, breast swelling and tenderness, decreased sexual desire, depression, bloating, swelling of the hands and feet, nervousness, abdominal cramps, dizziness, weakness of fatigue, leg cramps, nausea, vaginal discharge or irritation, backache, insomnia, acne, pelvic pain, lack of hair growth or excessive hair loss, rashes, hot flashes and joint pain.
The drug company says a few women also complained of convulsions, jaundice, urinary tract infections, allergic reactions, fainting, paralysis, osteoporosis, lack of return to fertility, deep vein thrombosis, pulmonary embolus, breast cancer or cervical cancer.
The list of possible side effects for Depo-Provera seems almost ludicrous.
This is a drug given to millions of women. Men rip off the condom because sex won't feel as good for the next twelve minutes or so. But millions of women take a drug that may make them feel horrible all the time.
Depo-Provera and Murder
Some women blame Depo-Provera for sending them to the deepest depths of depression and even psychosis. Constance Lynn Baugh was jailed last February in St. Clair County, Illinois, on a charge of murdering her newborn baby. She's now awaiting trial.
Baugh's mother, Nancy Hedrick, believes Depo-Provera played a significant role in what happened. Baugh had a child at age 17 and immediately went on Depo-Provera to prevent another pregnancy. The drug is known to be more than 99 percent effective at preventing pregnancy, but it's not perfect.
Medical records show that even though Baugh maintained her shots every three months for the next two years, she got pregnant again in the summer of 2000.
However, Hedrick says that Baugh continued to deny being pregnant, even to her mother, even though they lived together.
"I walked in on her one time and saw she couldn't get her jeans up. One side effect of Depo is she gains weight. She said she felt fat and ugly," Hedrick said. "I said, 'Constance, are you pregnant?' And she said, 'No. I'm not pregnant." It was like her body and mind went in different directions." Baugh gained only ten pounds. She had no prenatal care.
Of course, Baugh did not have the number one sign of pregnancy, a cessation of normal menstrual periods. Her periods had been erratic since she went on Depo-Provera. She generally had no periods, but in July of 2000, a month before she was told she was pregnant, she had significant bleeding, so significant that a cop from the carnival had to give her a ride home.
In late January of 2001, Baugh complained to Hedrick that she'd started a period and was bleeding heavily. Hedrick gave her some pads and Motrin. Baugh went to bed. Hedrick let Baugh's two-year-old daughter, Angel, sleep in her bedroom.
"The next morning, I found Constance on her knees in a fetal position," Hedrick said. "She said she was fine and I helped her to bed."
But Baugh was bleeding badly. Hedrick's husband called 911. Hedrick cleared Angel's toys from the floor of Baugh's room, tossing them in the closet so the ambulance crew could get in and take care of Baugh.
At the hospital, while Baugh was taken to intensive care to be treated for internal hemorrhaging, officials called Hedrick into a private room. "I thought they were calling me into the room to tell me my daughter had died. They said she'd given birth to a baby and where was the baby? I said they were liars."
By the time Hedrick got back to her home, police had already found the body of Baugh's newborn child wrapped in a blanket in the closet. The child lay among the toys Hedrick had tossed there.
"They're saying she had the baby in the bedroom," Hedrick said, based on what she heard at the baby's death inquest. "They're saying the baby felt cold, so Constance wrapped up the baby in a blanket and then passed out. For that they're saying she suffocated the baby."
Hedrick believes Baugh was depressed and perhaps even psychotic when she gave birth. She blames the Depo-Provera. "From what I've read, any woman with a mental illness history in the family should not be on Depo," Hedrick said.
Hedrick says Baugh has a history of depression in her family. She said Hedrick became so depressed while she was on Depo-Provera that she tried to overdose on Tylenol. Hedrick says Baugh told doctors she was depressed.
"I've got pictures. I've got video tape," Hedrick says, "but there are times I can't even watch them they make me feel so emotional. To see her how she was before she got on that Depo is heartbreaking."
A Long Fight
Cindy Pearson, executive director of the National Women's Health Network, worked against Food and Drug Administration approval of Depo-Provera in the mid-1990s and continues to be concerned about potentially adverse effects on women.
She points out that hormonal contraceptives have side effects that can vary tremendously from woman to woman.
"For every woman who has a problem there are many women who have nothing like that and can be happy on the same product," Pearson said. "The problem with Depo is that once you're on it there's no way out except waiting it out." And the wait may be longer than three months.
"People who love the drug are not lying when they say it has minor side effects but they're only telling part of the story. We've tried to bring the other part of the story to women's awareness, so they know they face a range of side effects and not just the rosy picture in the brochure," she said.
Depo-Provera has what Pearson calls a "quirky history" of approval. The FDA rejected it in the 1970s because tests on beagles and monkeys showed increased rates of cancer. In addition, no long-term study on women had been done.
But in the 1990s, the World Health Organization financed long-term studies in women that showed no clear risk of cancer. There was a hint, Pearson says, but only a hint, that it may be related to an increased risk of breast cancer in young women.
In addition, the FDA changed its rules to accept testing with rats and mice instead of dogs and monkeys. Depo-Provera passed the rat and mice tests.
The side effects of Depo-Provera drew little notice, said Pearson. "Why below the radar?" she asked rhetorically. "People who are trying to provide contraceptives to women and men who want to postpone children think on the bottom line about postponing pregnancy, and they don't think what's it like living with it."
That angers her. "What gets me mad is mention the word 'condoms' and every man has something to say about what an inconvenient thing it is to use condoms. But here we've got a method that can really be a drag for women all day long. If they rated men's and women's experience of birth control we'd be describing Depo with the same disagreement as men's condoms."
Damage to Relationships
As many people testify, Depo-Provera can end up being as big a drag for men as for women, especially if the side effects damage the relationship. Pearson believes the evidence supports blaming the drug.
"Acne. That's a slam-dunk. It's in all the literature for birth control clinicians," Pearson said. "Lack of lubrication is absolutely hormonally related." In addition, weight gain and irregular menstrual bleeding, which are strongly linked to Depo-Provera, are also know to be sexual turnoffs for some people. Then there are the hormones.
"There's not an absolute link that if you turn off women's hormones you turn off women's interest in sex, but it is not unrelated," she said. "Depo-Provera turns off the ovaries with large does of progestin [synthetic progesterone]. Theoretically, it makes sense that it turns off normal hormone levels. There's a logical theory there about why Depo-Provera could cause loss of libido in some women."
Local Planet December 14, 2001
A study found that a hormone commonly used in hormone replacement therapy and as a form of contraceptive could increase levels of aggression and anxiety and decrease libidos in women who take the hormone.
Researchers believe the hormone, medroxyprogesterone (MPA), could explain the symptoms of mood swings, depression and loss of sex drive described by some of the women who took the MPA for contraception purposes and hormone replacement therapy.
In a study, three separate hormone treatments were used to evaluate any behavioral changes in six female monkeys.
The three treatments were estrogen only, estrogen with natural progesterone and estrogen with MPA. The researchers focused on changes in aggression, anxiety and sexual behavior.
Results of the Study
The monkeys treated with estrogen plus MPA exhibited distinctly higher levels of aggression and restless behaviors compared to the monkeys who received estrogen alone or estrogen with progesterone.
There appeared to be a significant decrease in sexual behaviors among the monkeys who were treated with the MPA plus estrogen combination.
From these findings, researchers concluded that MPA with estrogen might produce a greater affect on the brain’s stress system than the treatment of natural progesterone.
In order to study the behavioral changes over an extended period of time, researchers have conducted studies involving observing aggression, anxiety and sexual behavior changes in monkeys over the course of 21 days, which is comparable to the monthly cycle for women taking contraceptives.
Journal of Clinical Endocrinology and Metabolism June 2004;89(6):2963-72
Contraceptive is linked to high STD risk
Depo Provera increases risk more than the pill
By Rita Rubin
USA TODAY
http://news.yahoo.com/news?tmpl=story&u=/nm/20040823/hl_nm/health_contraceptive_dc_3
Use of the contraceptive Depo Provera appears to triple women's risk of infection with chlamydia and gonorrhea, a study reports today.
An estimated 20 million to 30 million women worldwide use Depo Provera, which is injected into the arm or buttocks every three months.
“It's popular among young women particularly,” says Christine Mauck of the Contraceptive Research and Development Program in Arlington, Va. Not only is it convenient and effective, says Mauck, who wasn't involved in the new study, “it can't be found by your mother.”
But other studies have suggested that Depo Provera, as well as oral contraceptives, raise users' risk of contracting chlamydia and gonorrhea, two common sexually transmitted diseases.
The study, which appears in the journal Sexually Transmitted Diseases, focused on 819 women ages 15 to 45 who were just starting birth control prescribed at two Baltimore-area Planned Parenthood clinics. About three-quarters were single. Of the women, 354 chose the pill, 114 chose Depo Provera and 351 opted for a non-hormonal contraceptive. The women were tested for chlamydia and gonorrhea after three, six and 12 months.
By the end, 45 women had contracted chlamydia or gonorrhea. Women using Depo Provera were about three and a half times more likely to develop one of the infections than women using non-hormonal contraceptives. The researchers say they can't yet explain their finding.
They also found that pill users were 50% more likely to become infected than users of non-hormonal contraceptives, but there were so few cases that could have been due to chance, says lead author Charles Morrison of Family Health International in Research Triangle Park, N.C.
Morrison says one or two more high-quality studies are needed to confirm his findings. But, he says, the study does highlight the need for hormonal contraceptive users to also use condoms if they aren't in mutually monogamous relationships. Hormonal contraceptives alone don't protect against STDs, and, as this study suggests, Depo Provera might raise the risk of infection.
Because researchers didn't randomly assign women to contraceptive methods, they can't be absolutely sure whether the Depo Provera itself or some characteristic of women who opted for it raised the infection risk, Mauck says. But the authors say it's unlikely that differences in the women led to the finding.
The study was paid for by the National Institute of Child Health and Human Development and the U.S. Agency for International Development.
Estrogen Therapy for Tall Teens Linked to Fertility Problems
Thu Oct 21,11:48 PM ET Health - HealthDay
http://story.news.yahoo.com/news?tmpl=story&u=/hsn/20041022/hl_hsn/estrogentherapyfortallteenslinkedtofertilityproblems
THURSDAY, Oct. 21 (HealthDayNews) -- Tall girls who receive estrogen therapy during adolescence to reduce their adult height are more likely to have fertility problems later in life.
That's the conclusion of an Australian study in this week's issue of The Lancet.
This form of treatment has been available since the 1950s. Estrogen therapy alters the development of the long bones in adolescents and can reduce adult height by 2 centimeters to 10 centimeters.
The study researchers examined fertility information from 780 women. Half of them had received estrogen therapy during adolescence and half did not.
The study found that women who received estrogen therapy were 80 percent more likely than those in the control group to have tried for a year or more to become pregnant without success. The women in the estrogen group were also 80 percent more likely to have seen a doctor because they were having difficulty getting pregnant, and were twice as likely to have taken fertility drugs, the researchers said.
"Although the possibility of adverse reproductive effects of estrogen treatment for tall stature in girls has been acknowledged for many years, we believe ours is the first study to report long-term follow-up of the reproductive experiences of a large cohort of treated girls," lead investigator Alison Venn, of the University of Tasmania, said in a prepared statement.
"Our findings indicate that exposure to high-dose estrogens in adolescence is associated with impaired fertility in later life. This effect was seen as both a reduced per cycle rate of conception in those who conceived, and as an increase in the risk of experiencing infertility. The availability of infertility treatments is likely to have contributed to the finding that women who were treated for tall stature had only a small decrease in the probability of eventually conceiving and having a live birth compared with untreated women," Venn said.
Syphilis Through Oral Sex on the Rise
Thu Oct 21, 1:26 PM ET Health - Reuters
http://story.news.yahoo.com/news?tmpl=story&u=/nm/20041021/hl_nm/syphillis_oralsex_dc
NEW YORK (Reuters Health) - Many people mistakenly believe that oral sex is safe, unaware that they can readily catch or pass on syphilis in this manner, according to a report put out by Centers for Disease Control and Prevention (news - web sites).
Moreover, syphilitic sores in the mouth may in turn increase the risk of HIV (news - web sites) infection.
Dr. C. Ciesielski and colleagues from the Chicago Department of Public Health (news - web sites) found that syphilis is increasingly being spread through oral sex.
"Persons who are not in a long-term monogamous relationship and who engage in oral sex should use barrier protection (e.g., male condoms or other barrier methods) to reduce the risk for sexually transmitted disease (STD) transmission," the team advises.
Ciesielski's group saw that patterns of syphilis transmission changed substantially over the period from 1998 to 2002. During the 1990s, they report in the CDC's Morbidity and Mortality Weekly Report, syphilis occurred almost exclusively among heterosexuals. Since 2001, men who have sex with men account for nearly 60 percent of people with syphilis.
To account for these findings, they began interviewing persons with syphilis during 2000 to 2002. In almost 14 percent of cases, oral sex was the subjects' only sexual exposure during the time they were infected; this was reported by 20 percent of gay men with syphilis, and 6 to 7 percent of heterosexual men and women.
These figures don't include possible infection through oral sex when sexual intercourse also took place.
People with syphilis in the mouth may not have any symptoms, or the sores may be mistaken for aphthous ulcers or herpes, the authors point out.
The lesions may carry high concentrations of the germ that causes syphilis, and are thus highly infectious. Also, oral lesions may increase the risk of being infected with HIV.
"These data underscore the need for educating sexually active persons regarding the risk for syphilis transmission through oral sex," the investigators write.
U.N. Says Fertility Rate Declining
Wed Jan 26, 9:44 PM ET
By NICK WADHAMS, Associated Press Writer
UNITED NATIONS - Following a trend among rich nations, the fertility rate in developing countries has dropped below three children per women for the first time, a United Nations (news - web sites) report says.
The findings reflect trends, common among many researchers including the U.S. Census Bureau (news - web sites), that suggest the world population boom that had been feared in recent decades would not come to pass. A key factor has been the unexpected drop in the fertility rate.
The U.N. report, released Tuesday, said the fertility rate of 2.9 came as people across developing nations are waiting longer to marry and have children, and are using family planning including contraception more often.
"Women and men in developing countries are marrying later, having fewer children and having them later," a summary of the report said.
The report said that with the fertility rate in 20 developed countries now below the replacement rate, the world was seeing "a major and unprecedented reduction in fertility levels."
Among key findings of the report: In the world's 192 countries, the number of women between the ages of 25 and 29 who are single rose from 15 percent in the 1970s to 24 percent in the 1990s. For men, the increase was from 32 percent to 44 percent.
The report, "World Fertility 2003," said government policies had played a central role in changing reproductive behavior. It cited support by 92 percent of all governments for family planning, and widespread backing for the distribution of contraceptives.
According to the report, the use of contraceptives rose from 38 percent to 52 percent of women. In the developing world, the numbers also rose, from 27 percent to 40 percent.
The report was issued by the U.N. Department of Economic and Social Affairs' Population Division.
Cipro-Resistant Gonorrhea on the Rise
NEW YORK (Reuters Health) - In Hawaii, the proportion of cases of gonorrhea that are resistant to treatment with the antibiotic Cipro increased nearly sevenfold between 1997 and 2000, new findings show.
So-called fluoroquinolones like Cipro have been first-line treatment for gonorrhea infections since 1993, according to an article in the medical journal Sexually Transmitted Diseases, but fluoroquinolone-resistant infections were first identified in Hawaii as early as 1991.
An increase in such cases in 1999 prompted Dr. Christopher J. Iverson and colleagues from the Centers for Disease Control and Prevention (news - web sites), Atlanta, and the Hawaii Department of Health, Honolulu, to look into the situation.
They found that after declining steadily during the early 1990s, the overall number of gonorrhea cases reported to the Hawaii STD Program remained constant at approximately 500 cases per year from 1996 to 2000.
The percentage of infections that were resistant to Cipro increased from less than 1.5 percent in 1996 to 6.3 percent in 1998 and 10.4 percent by 2000, the investigators report.
Most of the Cipro-resistant infections were also resistant to penicillin, and 28 percent were also resistant to tetracycline. Nevertheless, all were susceptible to several other antibiotics.
Cipro-resistant cases were more common among patients who had recently traveled in Asia or had a sex partner who had done so.
Based on these findings, Iverson's team concludes that fluoroquinolones "are no longer recommended treatment for gonorrhea infections acquired in Hawaii, Asia, or the Pacific Islands."
SOURCE: Sexually Transmitted Diseases, December 2004.
Excess Weight Can Compromise Birth Control Pills
Excess Weight Can Compromise Birth Control Pills
Heavier women likelier to become pregnant while using them, study finds
By Amanda Gardner
HealthDay Reporter
WEDNESDAY, Dec. 29 (HealthDayNews) -- Women who are overweight or obese are more likely to get pregnant while taking birth control pills than women of normal weight are, new research finds.
In the group of women studied, 5 percent of overweight women taking the Pill got pregnant each year vs. 3 percent of normal weight women, said study author Victoria Holt.
The study, which the researchers believe is the first of its kind, was funded by the National Institute of Child Health and Human Development. It appears in the January issue of Obstetrics and Gynecology.
The finding is potentially significant because overweight women have a higher chance of complications while pregnant, including gestational diabetes and high blood pressure.
But while obese or overweight women in the study were 60 percent to 70 percent more likely to get pregnant while on the Pill, other experts emphasized that the actual chances of conceiving were not alarming.
"The absolute risk is low," said Dr. Ralph Dauterive, head of obstetrics and gynecology at the Ochsner Clinic Foundation in New Orleans. "Who knows why this is occurring. The solution is to add condoms, an IUD or no sex."
Oral contraceptive trials have reported pregnancy rates of 0.5 percent or lower, but national surveys have put the actual number much higher. There are more than 400,000 pregnancies among users of oral contraceptives in the United States each year, the study said.
In the 40 years since the first birth control pills hit the market, the amount of the hormone estrogen they contain has decreased fivefold.
"Maybe we're at a point that it's not enough for some women," said Holt, who is a member of the Public Health Sciences Division at Fred Hutchinson Cancer Research Center in Seattle.
The genesis of the new study reaches back several years to a meeting of a U.S. Food and Drug Administration panel convened to discuss the possibility of removing higher-dose birth control pills from the market. At the meeting, one of the new study's co-authors overheard another panel member, who was also a physician, say, "Don't do that. All of my overweight patients are going to get pregnant.'"
Holt is a former pediatric nurse who knows from experience that the dosage of virtually every drug administered is determined by patient weight. "It made perfect sense to me," Holt said. "We also knew that obesity is getting to be more common, so there is a bigger variation in adult women's weight, from 100 pounds to 300 pounds."
Holt and her colleagues compared the weight and body mass index (BMI) of 248 women who became pregnant while using birth control pills between 1998 and 2001, to 533 control subjects who used oral contraceptives but did not become pregnant. All the participants were enrolled with a health maintenance organization in Seattle.
The risk of pregnancy was nearly 60 percent higher in women with a BMI greater than 27.3, and more than 70 percent higher in those with a BMI in excess of 32.2.
A BMI of 27.3 or more is roughly equivalent to a 5-foot, 4-inch woman weighing 160 pounds or more. A person with a BMI greater than 25 is considered overweight; a BMI above 30 is obese.
Among consistent birth control pill users, the risk of pregnancy was more than 70 percent higher in women weighing more than 165 pounds and nearly double in women weighing more than 190 pounds.
The researchers said there are several possible explanations -- though none proven -- for the findings.
First, overweight and obese people have a higher metabolism, which means it's possible the Pill is "used up" more quickly in these women, Holt said.
Also, overweight women have more liver enzymes, which help metabolize the hormones in birth control pills. "That would also cause the pills to be used up more quickly," Holt said.
The final possible explanation has to do with body composition. "Women with high BMI are more likely to have more fat and the hormones in birth control pills are fat-soluble," Holt explained. "The hormones may get trapped in the fat rather than entering the bloodstream."
Since the study authors found a stronger connection between BMI and pregnancy than weight and pregnancy, they tend to gravitate toward the last two explanations.
However, Holt added, the answer isn't for heavy women to take high-dose pills. "Heavier women have cardiovascular risk factors and a higher dose might increase that risk further," she said.
Women who have completed their families might consider a permanent birth control method, such as tubal sterilization. And, as Dauterive noted, women still considering more children should think about adding a back-up method such as a condom or IUD.
And all women should make sure they take birth control pills as directed and without skipping any doses. "We know that increases the risk of pregnancy," Holt said.
SOURCES: Victoria Holt, Ph.D., member, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, and professor, epidemiology, University of Washington School of Public Health and Community Medicine, both in Seattle; Ralph Dauterive, M.D., head, obstetrics and gynecology, Ochsner Clinic Foundation, New Orleans; January 2005 Obstetrics and Gynecology
Depo-Provera to Get Tough Safety Warning
The U.S. Food and Drug Administration on Wednesday announced that the strongest possible warning will appear on packages of the contraceptive Depo-Provera, citing the risk of lost bone density after long-term use.
The move marks the second time in three days that the agency has put a so-called black box warning on a reproductive health drug used by women. On Monday, a similar warning was added to RU-486, the morning-after pill, after reports of rare occurrences of infection in users.
Although the FDA said that Depo-Provera, an injectable contraceptive, has been used safely for decades, it added that "the drug may result in significant loss of bone density, and that the loss is greater the longer the drug is administered," the agency said in a statement. Moreover, the FDA added, the bone loss may not be reversible once a woman stops using the drug.
The black-box warning, designed to point out serious effects of the drug, said that women should use Depo-Provera for two years or longer only if other methods of birth control are inadequate.
Substantial Bone Loss Seen with Depo-Provera Use
By Megan Rauscher
NEW YORK (Reuters Health) - The results of a new study confirm that using the contraceptive Depo-Provera is associated with bone loss.
Depo-Provera, also known as DMPA, is a long-lasting contraceptive hormone that is injected every three months.
Dr. M. Kathleen Clark and colleagues at the University of Iowa in Iowa City compared changes in bone mineral density in 178 women starting on Depo-Provera for the first time and 145 women not using hormonal contraception.
Average bone density at the hip fell 2.8 percent one year after starting Depo-Provera and 5.8 percent after two years. Loss of bone density in the spine was similar.
In contrast, average bone loss at the hip and spine was less than 0.9 percent among the comparison group of women, the team reports in the medical journal Fertility and Sterility.
"We clearly show that bone density is lost with DMPA use," Clark told Reuters Health.
She also noted that in mid-November, the U.S. Food and Drug Administration (news - web sites) issued a black box warning on Depo-Provera stating, in essence, that bone density is lost and may not be regained, particularly when it is used for more than two years.
"Without information on the magnitude of bone mineral density loss, clinicians cannot weigh the potential benefits of a highly effective method of contraception to the potential problems associated with bone loss. Our study provides this information," Clark said.
She emphasized that most women between the ages of 18 and 35 who are using Depo-Provera for contraception will not have immediate problems related to osteoporosis. However, whether there are long-term problems following menopause will depend on whether lost bone is regained when Depo-Provera is discontinued.
Clark's team is close to completing the phase of their study that is looking at what happens to bone density when women stop using the contraceptive. "It is hard to speculate on recovery without complete data," she said.
The results of a study released in 2002 hint that bone density returns to normal about 15 months following discontinuation.
However, Clark sees a problem with that study. "Most of the women were enrolled after they had been on DMPA for a while, so they did not have baseline data and would have no way of knowing what the true bone loss was since beginning DMPA," she commented.
SOURCE: Fertility and Sterility, December 2004.
Male Birth Control Moves Closer to Reality
By E.J. Mundell
HealthDay Reporter
SUNDAY, Dec. 12 (HealthDayNews) -- The day when men can take a pill or rely on an implant to keep them from fathering a child may only be a few years away, experts say.
Even now, "China may actually have a male hormonal contraceptive soon, we just don't know what that 'soon' is -- one to two years, perhaps, we just don't know," said Dr. Vanessa Cullins, vice president for medical affairs at the Planned Parenthood (news - web sites) Federation of America.
She said most experts believe that a reliable, reversible hormone-based male contraceptive, similar to what's been available to women for more than 40 years, could be achieved in five to 10 years.
And, contrary to popular belief, most men say they would welcome some form of long-term but easily reversible contraception.
"It may be easier for men to leave contraception up to women, but there have been some recent surveys that suggest the majority of men are willing to share in the responsibility for family planning," Cullins said. "And I think if you talk to men who are in situations where they didn't want to have a child, I think some of those men would tell you they definitely would've wanted to have had either shared in, or made, that decision themselves."
Unfortunately, men's physiology is working against the rapid development of a male Pill. While women usually produce one egg per cycle, men carry approximately 100 million sperm, any one of which can help create new life.
"It's a much tougher challenge," said Robert Spirtas, chief of the contraception and reproductive health branch at the National Institute of Child Health and Development (NICHD).
But he said researchers around the world are tackling the problem from different angles. According to a new report from the U.S. Institute of Medicine (news - web sites), some of those efforts include:
Testosterone undecanoate (TU). This is the hormone-based research in China that's already shown good results in human trials. Like other hormonal therapies currently under development, TU halts sperm production in the testes, in this case by suppressing gonadotropin-releasing hormone. One drawback with hormonal approaches: The complete shutdown of sperm production can take months.
Lonidamine. This non-hormonal, non-steroid drug was first developed as an anti-cancer drug, but researchers soon noticed it also shut down sperm production. Lonidamine does have toxic effects on the liver and kidney, but similar compounds currently under development appear to be much less toxic.
MENT (7-alpha-methyl-19-nortestosterone). Implants containing MENT, a synthetic hormone resembling testosterone, are being developed by the European drug company Schering AG, along with the Population Council, and they are currently in the U.S. Food and Drug Administration (news - web sites) pipeline. In a recent trial, nine of 11 men achieved zero sperm counts after receiving four MENT implants.
Eppin. Dubbed an "immuno-contraceptive," it has proven effective in primates and works by stimulating the immune system to shut down an enzyme crucial to sperm maturation.
Alkylated sugars. In mouse studies, ingestion of these compounds produced sperm with misshapen heads, poor mobility, and other problems. After three weeks, the mice became sterile, but regained their fertility a month after discontinuing use of the drug.
According to Spirtas, "there's a continuum of effort in terms of what's going on, from large-scale clinical trials, through the NICHD's own effort to start a clinical trials group, to the development of compounds that seem to work in animals, right down to the basic biology" of male reproduction.
The vast majority of this research is publicly funded, Spirtas noted. Despite that fact that men make up half the population, drug companies "simply don't put a lot of money into this research," he said.
"They didn't believe the oral contraceptive would work in the 1950s," Spirtas added. "Until someone actually showed that it would work they weren't interested. When someone showed that it did work, then they all jumped on it." He believes a similar scenario will occur after the launch of the first male equivalent of the Pill.
For family planning experts, as well as many women, the idea of a long-term male contraceptive implant may be particularly appealing.
"For a man to take a Pill, if he forgets a couple times and the woman gets pregnant, well, too often it's 'her problem,'" Spirtas said. "But if there's something right there in a man's arm that's continually releasing that kind of a drug, that might offer real comfort to a woman."
Another concern is that a pill or implant might cause men to ignore the condom, the best protection against HIV (news - web sites) and other sexually transmitted diseases. But Cullins said sexually active individuals need to remember that contraception and the prevention of sexually transmitted infection are two separate issues.
"Regardless of what contraceptive method is being used, one should minimize exposure to sexually transmitted infection," she said. "And if you're sexually active, the best way to do that is through use of a condom."
Laptops May Threaten Male Fertility
By Ed Edelson
HealthDay Reporter
THURSDAY, Dec. 9 (HealthDayNews) -- Laptop computers pose a long-term threat to the fertility of young men who use them because they can reduce sperm formation by raising temperatures in the genital area, a small new study says.
Keep the laptop on a desk, not on the lap, is the advice of Dr. Yefim Sheynkin, an associate professor of urology at the State University of New York at Stony Brook and lead author of what is described as the first study of the effect of heat from the computers on the genital region.
But the warning drew a quick rebuttal from another fertility expert, Dr. Steven J. Sondheimer of the University of Pennsylvania, who said "it is not clear that it [the warming effect] is clinically important."
High scrotal temperature is "definitely a well-known risk factor for infertility," Sheynkin said. "We have known for years that it can affect male fertility and sperm production."
Men who are trying to become fathers are routinely advised to avoid saunas and hot baths, he said, and the new warning is "quite important because millions of young men and boys are using laptop computers on a regular basis now."
The study of 29 men in their 20s and 30s by the Stony Brook group found that keeping a laptop on the lap for an hour can raise scrotal temperatures by more than 2.5 degrees Celsius, enough to affect fertility significantly, said a report in the Dec. 9 issue of the European journal Human Reproduction.
But Sondheimer, a professor of obstetrics and gynecology, said there's little for men to worry about. "We've known for a long time that anything that warms the testicles lowers the sperm count, but whether this translates into infertility is not clear," he said. "Most likely it does not lead to infertility. We don't translate this information into clinical practice."
Previous studies have raised alarms about other factors that could affect male fertility by raising scrotal temperatures. French researchers reported in 2000 that driving a car for two hours raised the temperature by more than 2 degrees Celsius. A report from doctors in Kiel, Germany, that same year warned about the possible danger of plastic-lined disposable diapers, which were found to raise temperatures more than cotton diapers.
A 1999 study in the United States found that even seasonal temperature changes had a major effect on male fertility. Sperm production dropped by 41 percent in the summer as compared to winter, the study found, while sperm speed decreased and the number of defective sperm increased as the weather got hotter.
That effect was noted in the Cole Porter song Too Darn Hot, whose lyrics say in part, "According to the Kinsey Report, the average man you know, must prefer to play his favorite sport when the temperature is low."
The new study was "not designed to look at fertility issues," Sheynkin said, but merely to measure temperature effects. It found that the surface temperature of the Pentium 4 computers used in the study rose from 31 degrees Celsius (87 degrees Fahrenheit) to nearly 40 degrees Celsius (104 degrees Fahrenheit) after an hour of use.
Scrotal temperatures of the men rose by an average of 2.1 degrees Celsius when they sat with their thighs together to keep the computers centered. Temperatures went up more than 2.5 degrees Celsius when the computers sat on one leg or the other.
Many studies have shown that an increase of just 1 degree Celsius can affect sperm formation, Sheynkin said. Just 15 minutes of laptop use produced that temperature rise in the study.
If a user can't put the computer on a desk, laptop use should be limited to just a few minutes at a time, Sheynkin said. But even then, frequent laptop use can be damaging, he said.
"The effect of short-term exposure can be reversible," he said. "But if men don't give themselves time to recover, if they use laptop computers on a daily basis for years, it can take from three months to a year to recover. And the effect can be irreversible, which is very difficult to treat."
Sheynkin said he now plans a study to measure the physical effects of laptop use. "We will identify a group of men who are using laptop computers on a regular basis and see to what extent it affects fertility," he said.
By MARILYNN MARCHIONE, AP Medical Writer
A study concluding that birth control pills slightly lowered the risk of heart disease has now been called into question by federal officials who say it was flawed and wasn't properly reviewed before it was presented at a major medical meeting in October.
Doctors from Wayne State University in Detroit had presented two studies at a reproductive medicine meeting in Philadelphia claiming that oral contraceptives lowered heart risks and did not increase the risk of breast cancer.
That got a lot of attention because the conclusions were opposite what previous studies had found. The new information also came from the largest women's health study ever done in the United States.
But on Wednesday, Dr. Barbara Alving of the National Heart, Lung and Blood Institute, which funds and oversees the national study, said these particular analyses hadn't been properly reviewed, and that a new analysis by senior statisticians had determined that the heart findings were flawed.
Once age and other factors were considered, they "could not find a relationship" between pill use and heart disease, Alving said.
The breast cancer findings also are suspect now, she said.
The research was from the Women's Health Initiative, best known for its landmark finding in 2002 that taking hormones after menopause raised the risk of certain cancers and heart problems. But it is not the best kind of study for determining risks of oral contraceptives, Alving said.
That's because it relies on women's memories of what drugs they used in previous years rather than actual hospital or medical records.
Previous studies that were more scientifically sound have found that pill-users have a small increased risk of blood clots, heart attacks and stroke, she said. The Detroit researchers reported a small benefit — pill users reportedly had 8 percent less risk of cardiovascular disease and 7 percent less risk of developing any form of cancer.
But those findings were based on information women gave about whether they'd ever had heart problems or cancer, and were not verified with medical records as other WHI findings have been, Alving said.
"There is room for a lot of bias to be introduced," she said.
John Oliver, vice president for research at Wayne State, said the scientists were reviewing their work and would have no comment now.
"They want to look at the data. They're in contact with the Women's Health Initiative about how to proceed," he said.
The university also issued a statement apologizing for any confusion caused by the studies, which it now calls preliminary, and pledged to publish full results when they are available.
Major Warnings on Injectable Birth Control
While doctors prescribe various methods of birth control, women taking such contraceptives need to be aware of what they are putting inside their bodies.
Studies have shown that the prolonged use of an injectable contraceptive, Depo-Provera, is associated with bone density loss. Depo-Provera works by stopping ovaries from releasing eggs, which results in a thin uterine lining or no lining at all.
One injection of the drug can last up to three weeks. The longer the drug is used the greater the losses are. Unfortunately, it may not be possible to reverse bone density loss completely, even if one discontinues the use of the drug. However, a spokesman for the drug maker claimed bone density loss has been "at least partially reversible" in girls and adult women who have used this birth control method.
Along with lowering bone mass, women being injected with Depo-Provera are at an increased risk of developing osteoporosis.
This discovery has motivated the Food and Drug Administration (FDA) to place a "black box" warning -- the strongest warning that can be issued -- on the drug's label. In addition, the label will explain how Depo-Provera should be used only as a last resort, when all other methods have failed.
The label currently includes severe cautions of using the drug for women who suffer from:
Breast cancer
Liver problems
History of stroke
Blood clots in the legs
Despite these risks, the drug's manufacturer, Pfizer, and the FDA continue to claim Depo-Provera is a safe and effective method of birth control.
News & Observer November 18, 2004
