BEGINNINGS
IN THIS ISSUE:
The abortifacient "emergency abortion" pill known by the trade name Preven was approved by the U.S. Food and Drug Administration on 2 September with much fanfare and free promotion from the pharmaco-medical and mainstream media. To be distributed by the "paper" corporation Gynetics (Belle Mead, New Jersey), Preven is actually going to be manufactured by Barr Laboratories (Pomona, New York), a generic manufacturer.
The high dose of steroids in Preven (0.25mg l-norgestrel and 0.05mg ethinyl estradiol per tablet) has been shown to be at least 75.4% effective in killing post-conception children.1 Based on the dosages recommended by the manufacturer, and as approved by the FDA, a woman using Preven will expose herself and her preborn child to 10-20 times greater progesterone exposure than found in the common OC, Triphasil. She will also expose both parties to 5.7 times the estrogen level found in Triphasil.
Gynetics has launched a $30 million advertising campaign in addition to all the free publicity afforded it by the various media. At an estimated $20 retail price, the four tablets in Preven fetch a price about 5 times the usual $20-30 per packet monthly users of OCs dish out when paying cash. The kit also includes a pregnancy test
Gynetics was founded in 1995 by ex-Johnson & Johnson / Ortho Pharmaceuticals president Roderick Mackenzie. Mackenzie also founded the front corporation, GynoPharma in 1989 for the express purpose of having a company with one product, a new IUD. Ortho took possession of the IUD last year, leaving GynoPharma with only a generic OC as its sole product.
Emergency abortion pills were actually first approved by the FDA in a sneak approval in June, 1996, just prior to that body's approval of mifepristone (formerly known as RU 486). The FDA had petitioned itself for EA approval since no drug company wished to step forward and be the lightening rod for pro-life opposition.
Part of the confusion and disinformation campaign for Preven makes pains to state it is a contraceptive, not an abortifacient like mifepristone. However, numerous studies document the abortifacient nature of the high dose, post coital OCs as are found in Preven. One clinical embryology text specifically addresses this concern, noting, "These hormones prevent implantation, not conception. Consequently, they should not be called contraceptive pills. Conception occurs but the blastocyst does not implant. It would be more appropriate to call them "contraimplantation pills". Because the term abortion refers to a premature stoppage of a pregnancy, the term abortion could be applied to such an early termination of pregnancy.2
It is unfortunate even some "pro-life" voices have decided to facilitate the disinformation campaign by Gynetics and the media by chiming in unison; examples would be spokeswomen for the National Right to Life Committee and the so-called DeCook statement of "pro-life" physicians circulating to pregnancy help centers, places where the truth about chemical abortion has been dispensed to women with regularity till now.
Many independent and some chain pharmacies have elected not to carry the Preven kit. Much to their credit, Wal-Mart wisely has taken the corporate position not to stock Preven. Such policies may affect areas like Washington state; the latter allows specially certified pharmacists to dispense emergency abortion without a doctor's prescription. In that state, as of July, over 2700 chemical abortion attempts were dispensed in the first 4 months of the program's operation.
Preven will increase, not lower, number of abortions
By Lloyd J DuPlantis Jr, PD, president PFLIFor the first time ever, a company has won government permission to advertise and sell birth control pills, known as so-called "Morning After Pills" (MAPs), for use as emergency abortifacients. The maker of the PREVEN kit, Gynetics Inc. of Somerville, New Jersey, claims that these pills work to prevent pregnancy by acting before pregnancy occurs.
These so-called "morning after pills" are simply large doses of birth control chemicals that have been on the market for years. Birth control pills, at regular dosage levels, have always been known to cause side effects such as nausea, vomiting, headaches, high blood pressure, changes in cholesterol levels, changes in menstrual flow patterns and, for some who have severe reactions, strokes and even death from blood clots and heart attacks (see below on news reports in this area). These MAPs are increased amounts of these chemicals--usually eight times the normal dose over a 24 hour period--taken to prevent a pregnancy.
Can a woman expect to experience some of the previously stated side effects from taking these extremely high levels of artificial hormones? Past experience would certainly indicate so. What will be the long-term effects on the woman and her offspring? Studies are not yet available.
Let's take a look at this preventing pregnancy function. Gynetics, Inc. states that these pills "will not interrupt an already established pregnancy." What in fact the company promoting these products has done is redefine pregnancy as beginning after successful implantation of the embryo in the woman's uterus which normally occurs seven to ten days after fertilization. Life begins at fertilization--at the time of the fusion of an egg and sperm--not after implantation. One of the major actions of these chemicals is to interfere with and prevent proper implantation.
Make no mistake: this is an abortifacient mechanism of action rather than a contraceptive one.
NOW AVAILABLE: John Wilks' groundbreaking book, A Consumer's Guide to the Pill and other Drugs, documenting hazards and mechanisms of OCs and other abortifacients. $13 post paid (add $2 extra for foreign destinations).
Methotrexate "A cytotoxic drug that can cause damage to the liver, bone marrow and lungs... It cannot be recommended as an adjuvant to medical [chemical] termination of pregnancy in the absence of any demonstrable beneficial effect on the pattern of menstrual bleeding."3
Mifepristone / Endometriosis Contrary to previous wild assertions by proponents, a recent study indicates that mifepristone is not effective for endometriosis. In a small study of 7 women over a 2-year period, no change in the endometrium was noted.4
Mifepristone / Abortion A recent study of mifepristone shows the abortifacient is effective as an abortifacient, especially among women 49 days or less pregnant. The 2015 women participating were given 600mg of mifepristone followed by 400mcg of misoprostol (Cytotec), a prostaglandin, 2 days later. Abortion took place in 762 of the 827 women pregnant 49 days or less who took mifepristone. Pregnancy was terminated in 49% of the women within 4 hours after taking the drug and 75% of the women within 24 hours. Side effects included nausea, vomiting, diarrhea and abdominal pain.5
Levlite The FDA has approved the new low dose OC Levlite by Berlex Laboratories. The product contains 20mcg of estrogen, joining Alesse and Loestrin as the very low dose estrogen OCs.6
Progestin-Only Emergency Abortion Women's Capital Corp, a Seattle-based privately held company, plans to shortly submit a New Drug Application to the FDA for approval of a new progestin-only emergency abortion pill (aka "morning after pill"). Currently available in Europe, the 0.75mg l-norgestrel tablet was the first chemical developed for emergency abortion. If approved, it would be the second such product in the USA. The progestin is the same one found in many OCs as well as Norplant and the IUD Progestasert.78
A new technique for killing an acardiac twin has been proposed in a medical journal.9 The use of an 18g needle along with a wire electrode was utilized at London Medical School to kill 4 preborn babies between the ages of 12-24 weeks gestation. They were suffering from no heart developing in one of the twins; one of the victims was conceived without a brain. The victim's umbilical cord was probed with an electrode, heating the cord blood and causing coagulation and, ultimately, demise of the baby.
Norplant: Around 250 women claiming to have serious side effects are suing Norplant's British supplier in the UK. Chief complaints are alopecia, weight gain, depression and paranoia.10
Spermicides: New research challenges the belief spermicides protect against the transmission of HIV. A study, published in the New England Journal of Medicine, was conducted with 1292 HIV-negative females in Cameroon between March, 1994 and December, 1996. The women were given condoms and either the spermicide nonoxynol-9, used in many spermicide products, or an inactive placebo film. Researchers found approximately 7% of women in both groups became infected with HIV during the study. Additionally, it was found the spermicide did not reduce the risk of contracting other STDs such as chlamydia and gonorrhea. The pro-abortion propaganda firm of Family Health International in Durham, North Carolina, led the investigation.11
The pill and stroke: German researchers studying women ages 16-44 found that "compared with non-users of OC without hypertension, women with hypertension who used OC had an almost 10-fold increased risk" for ischemic stroke. The author, a member of the UN Development Program, thinks women with hypertension in the third world should not be denied OCs nonetheless, as their blood pressure cannot often be checked.12
Oral contraceptives: While the U.S. market for OCs stands at $1.6 billion annually, they have lost market share to condoms and other "contraceptives" in recent years, reported the Wall Street Journal. According to the National Center for Health Statistics, the percentage of women using OCs has dropped from 31% in 1988 to 27% in 1995. Among teens the numbers plummeted from 59% to 44% in the same period. The numbers do not reflect OCs dispensed in clinics and at university health clinics. Ortho's campaign promoting Ortho Tri-Cyclen brand of OC as "anti-acne" has yielded it good results: prescriptions for the OC surged 73% to $3.8 million. Already that brand alone controls 12.1% of the U.S. OC market, making it the #1 brand OC in the US. American Home Products Wyeth-Ayerst division plans to seek FDA approval for Alesse for the anti-acne indication soon.13
Many young women killed by OC use: A number of British women have been reported in recent years to have died from causes related to their use of OCs. Caroline Bacon, started on OCs at 15, had a stroke and died 11 months later at age 16. Lisa Smith died at the age of 16 form a pulmonary embolism, four months after starting OCs. Dawn Watson, collapsed at the wheel of her car and died at the age of 19 from use of the OC Femodene. A blood clot in her leg broke off and went to her heart. Rachel Ashbronk, 22, fit and healthy, died four months after starting OCs. Denise Hossel, 25, was engaged to be married when she had a pulmonary embolism-an event almost always fatal-and died on Christmas, 1995. Over the past four years, doctors have reported at least 50 cases of women dying from OC use. Eleven brands of OCs and Norplant have been named in a class suit filed by 170 women so far.14
OCs and breast cancer: An Icelandic study of young women indicated "an association between beast cancer and oral contraceptive use at a young age." In women born between 1951 and 1967, the relative risk associated with OC use more than four years was 2.0. This means a 100% increased risk of contracting cancer versus similar women who did not use OCs. For women born between 1945-50, the risk was a more modest 10% greater risk of contracting cancer versus similar women non-OC users. Besides the steroid exposure OCs impose on a user, the well documented relationship of abortion and breast cancer may play a risk factor, since OCs are abortifacient at various times.15
OCs and venous thromboembolism: Recent studies have evaluated the use of OCs and venous thromboembolism (VTE). Results of these studies indicate a higher incidence of VTE with certain forms of OCs compared with others.16 The desogestrel formulation had a 2.2 fold increased risk of VTE compared with the 30g ethinyl estradiol/150g l-norgestrel combination. Overall, the desogestrel formulation was associated with a 2.5 fold increased risk compared to all other OCs in the study. Carriers of the Factor V Leiden mutation for blood clotting who used desogestrel, when the relative risk is added into the baseline risk from the mutation, have a combined 50-fold increase.17
OCs and cerebral vein thrombosis: Another study revealed that OC use in women with Factor V and prothrombin gene mutations greatly increased risk of a cerebral vein thrombosis (CVT), a situation which has a 30% mortality result.18 OC use was prevalent in women with CVT (96%) with an odds ratio of 22:1. In women with the prothrombin gene mutation and OC use, the odds ratio skyrocketed to 149:3. The mean age for women with CVT was 30 years old. A commentary by another publication noted, "This study suggests that oral contraceptive use in women with familial thrombophilia is hazardous..."19
OCs, MIs and Joe Camel: An analysis of recent studies linking OC use with cigarette smoking to MIs (myocardial infarctions)in women reveals striking examples of the dangers posed with use of these powerful steroids and concurrent smoking. The analysis found a risk up to 2.5 times in OC users who don't smoke compared to that of non-OC users, non-smokers (control group). For OC users smoking less than 15 per day, the maximum risk jumped to almost 10 times the control group. For women OC users smoking 15 or more per day, the maximum risk skyrocketed to 90 times the control group.20
Abortion vaccines: Worldwide Medical Corp. has announced its work on abortion vaccines has been accepted for an oral presentation and nominated for a major prize award that was presented at the 16th World Congress on Fertility and Sterility in San Francisco 4 October, 1998. The company intends to use its technology of detecting anti-sperm antibodies in the body which attach to sperm and prevent fertilization of ova, to be used as a vaccine against pregnancy. It seeks a major partner, such as its current one, Hitachi Chemical Research, to launch its costly and ambitious foray into abortion by vaccine.21
Vaginal rings: Both combination and progestin-only vaginal rings are now under advanced research, a pro-abortion newsletter reports. The research arm of the Population Council, a Rockefeller offspring, has spent 20 years developing so-called "contraceptive" vaginal rings which are as abortifacient as OCs, Norplant, etc. One contains a combination of 20g ethinyl estradiol (EE) + 1mg norethindrone acetate. It has been passed on to an undisclosed partner for market introduction. Another combines 15g EE and the new progestin Nesterone, patented by the PC. Organon is in Phase III trials with its ring of 15g EE and the progestin Etonogestrel. It expects to end research mid-1999.22
- Let's welcome 18 new members to PFLI! We encourage our present members to continue our goal of each member enlisting at least one new member per year.
- Included in this issue of BEGINNINGS is a form for the annual appeal PFLI puts out during the Christmas holy days. Please act on it to the best of your ability. As usual, we will pick a charity to fund from part of those proceeds not necessarily associated with the pro-life cause. This year's beneficiaries will be the victims of Hurricane Mitch in Honduras, where over 11,000 have been known to have died, thousands are missing and 1 million of the country's 6 million are displaced.
- PFLI President Lloyd J DuPlantis, Jr., PD was extensively interviewed in an article discussing the lobbying by the American College of Obstetricians and Gynecologists (ACOG) for mandatory insurance coverage of so-called contraceptives. He also wrote a letter to the editor explaining the truth behind the mechanism of action of Preven. See above, "Preven makes a bloody splash."
- Pro-life pharmacist Karen Brauer, MS, in Lawrenceburg, Indiana, wrote a letter to the editor of Drug Topics regarding coverage of the Conscience Clause (CC), explaining her own dismissal from a K-Mart pharmacy in Cincinnati in December, 1996 for having a conscience she followed. For more on her personal story visit the web site: http://www.gargaro.com/pharmacy.
- PFLI's Lynn McEldowney recently penned an update column on mifepristone (formerly RU 486) and misoprostol (Cytotec) for the West Virginians for Life newspaper, August, 1998.
- PFLI's Lloyd DuPlantis has published an insightful brochure describing how he discontinued selling OCs at the multiple store locations he manages. Discontinuing Contraceptives: One Pharmacist's Insights gives a practical outline for pro-life pharmacists wishing a "game plan" to stop dispensing OCs and other abortifacients. The brochure, published by One More Soul, is available from PFLI for 75 cents postpaid.
- It's not too early to think about PFLI elections which take place in the summer of 1999. All offices and board positions are up for nomination: president, vice president, secretary, treasurer, at least 5 but no more than 7 board members. Thinking about volunteering your talents? We need you! Committees which the new president will assign include: nominating (we need these before the election), continuing education, merit award, finance, professional affairs, publications, and membership/development.
- E-mail addresses needed: we'd like to have fellow members contact each other, and e-mail is a convenient way today. If you'd like to see your e-mail address here, send us an e-mail with "e-mail address" in the subject area. At the same time, let us know if you wish to receive our e-mail news, PharmFacts Update.
- Coming soon! You'll see some improvements in our web site including FAQs on abortifacients, recent news updates, PFLI's on-line catalog of publications and more!
- Mike Koelzer had an excellent letter to the editor in Drug Topics (10/19/98) re: the truth about Preven's abortifacient actions.
- PP fears a CC from PFLI! Ain't that a hoot! PP of NYC president and grandson of eugenics racist Margaret Sanger wrote a diatribe against any Conscience Clause (CC) for pharmacists who can think for themselves in a piece on his web site. There are so many factual errors in the piece, we'd thought you'd like to see it for yourself. Click on to http://www.prochoiceresource.org/html/news/issues_dangprac.htm. It's interesting. Those so vociferously for "choice" would deny a choice for pharmacists with a conscience.
- In Ontario, Canada, PFLI / Canada and many other groups with a conscience are fighting to get a significant and meaningful CC enacted into law. The diverse grassroots group, Coalition for Conscience, plans to have MPP (private member of parliament) Dave Boushy (PC, Sarnia) introduce a bill protecting the rights of conscience of health care workers this fall. CLC Director Steve Jalsevac, a key player in the clause's introduction, said that the CC is not just pharmacists and nurses refusing to take part in abortions and objectionable "services" but is also ensuring health care workers with the greatest commitment to quality care and healing not be pushed out of their chosen profession. For more info or petition forms, call 1-800-730-5358 (in Canada only) or +1-905-732-3139.
- CC passes in New Jersey, Pennsylvania with virtually no opposition. NJPhA passed the CC on 2 July at their state convention and will be working to implement it into the state's Pharmacy Practice Act. In Mars, Pennsylvania, the PPA passed the CC after overwhelming support from the Delaware County Pharmacists Association introduced the CC and encouraged its passage. The House of Delegates passed the CC on 18 July, including language in the resolution to get the CC incorporated into the Pharmacy Practice Act.
- Now we just need to work on backward Ohio whose out of touch leadership continues to resist a conscience clause by hook or by crook. The state association resisted the clause's introduction in 1997 and in 1998 made sure it would not even be brought up for consideration, tipping their un-democratic hand. The state board of pharmacy named many of the same "leaders" to its committees revamping the Pharmacy Practice Act.
FOOTNOTES
1) Reuters/Pathfinder Network, 10 September, 1998
2) Moore and Persaud. The Developing Human: Clinically oriented embryology, 6th edition, p. 532. London.
3) "A pilot study of the effect of methotrexate or combined oral contraceptive on bleeding patterns after induction of abortion with mifepristone and a prostaglandin pessary," Contraception, Volume 58, 1998, pp. 98-103.
4) Preliminary report on the treatment of endometriosis with low dose mifepristone. American Journal of Obstetrics and Gynecology, June, 1998, pp. 1151-6.
5) Spitz IM, Bardin CW, Benton L and Robbins A. "Early pregnancy termination with mifepristone and misoprostol in the United States," New England Journal of Medicine, 1998, 338:1241-7.
6) NewsPage Direct on-line Netcom, 15 July, 1998.
7) "Latelines," Drug Topics, 17 August, 1998, p. 11.
8) "Research," Health Care Business Daily, 7 August, 1998.
9) Rodeck C, Deans A and Jauniaux E. "Thermocoagulation for the early treatment of pregnancy with an acardiac twin," New England Journal of Medicine, 1998, 339(18):1293-5.
10) "Norplant," Communique,, 21 August, 1998, p. 21.
11) "Research," Health Care Business Daily, 24 August, 1998.
12) Meirik O. "Thromboembolic stroke in young women," Contraception, 1998, 57:29-37; "Cardiovascular safety and combined oral contraceptives," Contraception, 1998, 57:135-6.
13) "Oral contraceptives: anti-acne marketing raises questions," Kaiser Daily Reproductive Health Report (on line), 28 September, 1998.
14) Zimmerman A. "Deaths from the Pill in England," 12 October, 1998.
15) Tryggvadottir L, Tulinius H and Gudmundsdottir GB. "Oral contraceptive use at a young age and the risk of breast cancer: an Icelandic, population-based cohort study of the effect of birth year," British Journal of Cancer, 1997, 71:1, 139-43.
16) Erush SC. "Oral contraceptives and venous thromboembolism," P&T, August, 1997, pp. 393-4, 403.
17) Bloemenkamp KW, Rosendaal FR, Helkmerhorst FM et al. "Enhancement of Factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen," Lancet, 1995, 346:1593-6.
18) Martinelli I, et al. "High-risk of cerebral vein thrombosis in prothrombin gene mutation carriers and in oral contraceptive users," New England Journal of Medicine, 1998, 338:1793-7.
19) Berga SL. Ob/Gyn Clinical Alert, 1998, 15(7):49-50.
20) Grimes DA (ed.). "Oral contraceptives and the risk of myocardial infarction: an update," The Contraception Report, 1998, 9(3):4-11
21) PRNewswire on-line, 29 July, 1998.
22) Contraceptive Technology Update, May, 1998, 19(5):57-9.
DEAR FELLOW MEMBERS AND SUPPORTERS: PFLI's annual appeal is quite simply presented here. We continue to experience a great demand for our services, increased electronic presence, increased support for pregnancy services, increased expenses in running an all-volunteer international headquarters in a professional manner. Our expertise and clinical information and analyses are in ever-increasing demand as are the efforts many are providing for such important issues as the Conscience Clause here in the US and now in more fronts on the international level.
For all this we are most grateful and appreciative to almighty God, whose Hand ultimately directs all things good. Can you spare an extra $1000 this holy day season as we recall the Nativity of the Holy Infant? If not that, then how about $500, $250, $100? Pray and think on that, especially if you've been blessed in business or the markets this year. If you don't want to give a lump sum, how about a pledge of monthly $25, 20, 10 or even $5 amounts? Or if that stock or mutual fund has appreciated nicely, you can realize a bonanza tax deduction with a gift of transfer of shares (call us or your financial consultant to discuss that). Donations of $25 or more will receive our lovely logo clock. All donations over $10 will receive a special thank you gift from PFLI for 1999. God bless you this Christmas season and may you and yours have a blessed and prosperous 1999!
HOME
Pharmacists For Life International
1995-99 Officers
President Lloyd J DuPlantis Jr, PD Vice President Karen Brauer RPh Secretary / Treasurer Jim Penkala, RPh Executive Director Bogomir M Kuhar, PharmD Directors Sandra Fabregas
Andy Cocco
Mike Izzotti
Lynn McEldowney
Paul Weckenbrock
Communications
Snail Mail: PFLI
PO Box 1281
Powell, OH 43065-1281 USA
Phone:
Fax:740.881.5520
707.667.2447e-Mail: pfli@pfli.org Website http://www.pfli.org
BEGINNINGS, the official organ of Pharmacists For Life International (PFLI), is sent via third class mail (in the US; via surface abroad). It is a component of membership in PFLI, currently $40 pharmacists and $25 students/retirees/organizations/non-pharmacists. Please send change of address or membership request with a complete address, phone, fax, and e-mail, if applicable. Payment accepted as checks, money order, Visa, MasterCard and Discover.
PFLI is the only pharmacy association which is exclusively pro-life. Others may have that as a component of their mission, but it is PFLI's sole mission. Founded in May 1984, PFLI has spread throughout the US, Canada and worldwide with many affiliates abroad.