CONTROVERSIAL BIRTH CONTROL METHOD:
ENCARE OVAL UPDATE
The following item appeared in the Winter, 1978 edition of Healthright in the "Health News Briefs" column:
"New on the birth control scene is the Contraceptive Vaginal Suppository. Called Encare Oval, it is inserted into the vagina, where body heat causes it to effervesce and form a dense spermicidal barrier across the cervix. Effective ten minutes after insertion, this West German product allegedly provides two hours of protection, but only for one act of intercourse. Effectiveness: Tested for over four years in West Germany with 10,000 women, Encare Oval claimed a 99.14 percent effectiveness rate. Available without perscription, a dozen suppositories cost $3.75. Though some experts say the studies look good, they feel further research might be necessary.
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This Healthright news brief has prompted me to write what I know about this product. Eaton-Merz Laboratories, Inc., manufacturers of Encare Oval, has conducted a massive advertising campaign in the United States over the past 5 months, which coincides with many women's search for safer yet highly effective methods of birth control. The Free Clinic's Family Planning Program has received dozens of inquiries about Encare Oval over the past several months, and has seen many women who say they have been using this new form of contraception. Until February of 1978, the only information we were able to obtain about research on Encare Oval came from the pharmaceutical company, Eaton-Merz, and their salesman, who repeated the information contained in the product's patient brochure:
"While no contraceptive method is absolutely fool-proof, Encare Oval has shown a high order of efficacy in preventing pregnancy in a recent West German survey.
In this survey of 287 physicians prescribing Encare Oval, 10,017 patients completed 63,759 months of use and a total of 43 pregnancles were reported. This represents a pregnancy rate of approximately one per 100 woman-years. This is the number of women who would become pregnant in 1 year of use. It should be noted, however, that surveys of contraceptive effectiveness vary substantially based on compliance and characteristics of the study group."
We have always suggested to women using spermicidal foam that their partner simultaneously use a condom if they want maximum protection against pregnancy; we gave the same advice to women using Encare Oval.
The second bit of information we received from the manufacturers were the details of a study performed by 2 German physicians (H. Brehm and I. Albrecht, Fertility and Sterility," February, 1978, Vol. 29, No. 2). In this study, "Contraceptive Effi. cacy Determination by Postcoital Testing," on the use of Encare Oval, 23 women were examined 5 to 12 minutes after intercourse, and no motile spermatozoa were found in the vagina, on the external os, or in the cervical canal. In this test, instructions for use were followed correctly (e.g., 10 minute waiting period for dispersion allowed, suppository placed high in the vagina near the cervical os). This type of test would reflect "theoretical" or "method" effectiveness as opposed to "actual user" effectiveness.
In March, 1978 we received a copy of a highly critical memo from the Over the Counter Contraceptive and Other Vaginal Drug Product Review Panel, which was sent to FDA Commissioner Donald Kennedy, regarding Encare Oval. Most damaging in the panel's negative review were their comments on the survey used to determine Encare Oval's effectiveness:
The Panel is most disturbed about the apparent inadequacies of the survey which generated the effectiveness data used to support the labeling claim made for Encare Oval. It is the Panel's understanding that these data were obtained by a survey of physicians conducted by salesmen of Merz & Co., Chemische Fabrik, Frankfurt, West Germany, manufacturers of Patentex Oval, the name given to this product in Germany. Each physician reportedly received a fee for completing a single page form on a patient who had used Patentex Oval for three, six, twelve or more months. The salesmen who recruited this physician also received a fee for the completion of this form. The salesmen were directed to attempt to obtain only records reporting six, twelve or more months of use. The payment received by the salesman for such reports was 2-1/2 times higner than that received for a form covering only three months of use. The Panel believes that given the
financial pressure brought to bear on the salesmen to get reports on longterm users, the number of patients who might have become pregnant during the first few months of use might well have been underreported.. The Panel believes that the way in which the various incentives were offered would clearly make the dala resulting from the survey unacceptable to any scientific group or regulatory agency."
The Panel's memo stated that they had received no formal submission of data from Eaton-Merz; there were no comments on the above-mentioned study done by Drs. Brehm and Albrecht.
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Although the Over the Counter Panel, consisting mostly of MD's, may well have an interest in keeping contraception under the control of the medical profession and thus rnight prefer birth control pills, IUD's, or sterilization, their criticism of Encare Oval should be considered. Personally, I long to see safe, effective alternatives to oral hormonal contraceptives and intrauterine devices developed, especi ally ones that would put birth control into the hands of women. There are benefits to a product like Encare Oval its over-the-counter accessibility, small size, portability, ease of insertion without an applicator, and relatively low cost. However, these benefits must be balanced against its risks comparatively minor ones like the possibility of allergic reaction, increased vaginal discharge, and the most major one, pregnancy. Until they are more thoroughly tested and proven to be more effective in actual use, women should continue the use of backup systems to decrease the chances of failure when using Encare Oval, as they should when using any "barrier'' birth control methods.
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If anyone has any questions regarding Encare Oval specifically, birth control generally, pregnancy, sexually transmitted diseases, or vaginal infections, please call the Free Clinic (721-4010). Ask to talk with me, Gail Powers, Director of Family Planning Program/Women's Counseling Program, with Russell Gibson, R.N., Family Planing Nurse Practitioner, with Lyn Singer, R.N. Head Nurse, or with Suzy Pare, R.N.
-Gail R. Powers
This information sounds good, and by its implication would make most women reading this insert think they were receiving 99% protection against pregnancy. In fact, it sounded too good to us, so we continued to recommend to women that they exercise the same caution with Encare Oval as they would with other chemical barriers, based on the following reasoning: The active ingredient in Encare Oval is the spermicidal agent, nonoxynol-9, the same spermicide contained in currently marketed topical spermicidal products, such as aerosol spermicidal foam. (The "effervescent" vehicle that carries the active ingredient in Encare Oval is a combination of baking soda and cream of tartar, according to the Eaton-Merz salesman.) Spermicidal foam, according to Contraceptive Technology 1976-1977, 8th Revised Edition, has a "theoretical" or "method" effectiveness rate of 97% and an "actual user" effectiveness rate of 78% in preventing pregnancy. Page 8/June, 1978/What She Wants
Death and Deformity from Dow: Dioxin
Dioxin is the most toxic chemical ever manufactured. One drop can kill 1,200 persons; 30 gallons could kill every living thing on this earth!
Every spring, thousands of gallons of herbicides, 2,4,5-T and 2,4,D, containing dioxin, are sprayed over acres of land in America. These herbicides, originally developed by the military as biological warfare agents, were dropped on Viet Nam to defoliate it and 1971.
over 100 million pounds between 1961
The first public knowledge of the dangers of herbicides came from a report by Bionetics Research Laboratories in 1970. The study confirmed that 2,4,5-T was teratogenic (causing birth defects), carcinogenic (causing cancer), and fetotoxic (killing fetuses). In 1971, Nixon, responding to pressure from the scientific community and liberals, banned the use of 2,4,5-T by the military. Also, the Environmental Protection Agency banned its usage near domestic water sources in this country. A few months later, Dow and Monsanto Chemical Companies, the largest manufacturers of the chemicals, managed to get the bans lifted, and the manufacturing, selling and usage of these deadly chemicols continued.
In 1972, Jacqueline Verritt, chemist for the Food and Drug Administration, stated that 2,4,5-T was 100,000 to 1 million times more potent in its ability to cause birth defects than Thalidomide.
In July of 1976, a dioxin leak in Sevesco, Italy caused the evacuation of over 800 people, who developed an incurable skin disease, Chloracne, which attacks the entire nervous system. Chloracne was
the cause for the closing of an herbicide manufacturing plant in Midland, Michigan as well.
Dioxin, an ever-present agent in 2,4,5-T and 2,4,-D, is not fat soluable in the body. It accumulates until there is enough to kill.
In 1968, the Forest Service of Arizona dropped large quantities of 2,4,5-T on the Tonto National Forest. That morning Billee Shoecraft stood on her front porch and was saturated from head to foot with the herbicide. She had gone out to greet the sun. Later, reports began to come in: animals aborted; animal and human babies were born severely deformed; older women resumed their menstrual cycles; younger women hemorrhaged so badly that they were given hysterectomies; trees grew deformed; and all over the area the water was contaminated. Billee filed a 7 million-dollar lawsuit against the perpetrators of this crime: Dow, Monsanto, Hercules, Thompson-Hayward and the U.S. Forest Service. The case never appeared in court because of payoffs, threats, and political pressure.
This spring, Billee is gone. She died of 2,4,5-T poisoning. She died because of the greed of the chemical manufacturers who make over a billion dollars a year from herbicide sales. We must carry on Billee's fight.
We must womencott all the household products of the chemical companies: Corning Ware, Saran Wrap, Handi-Wrap, Dow Bathroom Cleaner, Dow Oven Cleaner, Ziploc Bags, Aztec Sun Car Products, Rifocin Antibiotics, Lirugen measles vaccine, Touch of Sweden, Plasil (digestant), and Equilid (antidepressant).