ASK Your Pharmacist to NOT STOCK ELLA… http://downloads.frc.org/EF/EF10I20.pdf
Chemical Abortion Twins: Mifepristone & Ella
Pro-lifers recognize surgical abortion as killing humans, but not all of them recognize the scope of the problem presenting as chemical abortion.
Generally we recognize mifepristone, the chemical formerly known as RU-486. The initial name of the drug stayed with us, (the same as with the Artist formerly known as Prince).
Mifepristone is best known in the U.S. for its function to kill unborn humans during the embryonic stage, up to 49 days of pregnancy, although it has other investigational uses.
Meet the TWINS! Ulipristal acetate and Mifepristone. As you can see, they’re not quite identical, but very close. Both are selective progesterone receptor modulators.
[For these diagrams, visit http://themorningafter.us/chemical-abortion/ ]
Mifepristone, RU-486 is the most regulated drug in the U.S. Pharmacists don’t dispense it. It’s supposed to be dispensed only by physicians, directly to patients. In China and other countries it has been used as a morning after pill, as well as a killer of later embryos and early fetuses.
Those astute drug companies knew that this drug would not sell as a morning after pill in the U.S. That’s why we have it’s TWIN, Ulipristal Acetate, approved by the FDA in August , 2010, and brought to us in by Watson Pharmaceuticals in December of the same year. Watson also distributes Next Choice, generic of the original form of Plan B.
At 0.5mg/kg, Ulipristal Acetate, marketed as ELLA, is usable as a morning after pill. It’s marketed as an inhibitor of ovulation, but the manufacturer admits that the operative mechanism depends on the timing of its use. Like RU-486, Ulipristone is an anti-progesterone. It stops the action of that hormone in the reproductive tract, inhibits proliferation of the endometrium, inhibits implantation, and kills the embryo.
When used as a morning after pill Ella accomplishes this very early, before implantation. At higher doses, this drug can kill later embryos and fetuses just like its twin mifepristone.
In many states, pharmacists and hospitals will be required to distribute Ulipristal acetate, in the same way that they are now forced to dispense Plan B, levonorgestrel, the other morning after pill. Ella is among the drugs recommended for free distribution under the upcoming Obamacare, which will exacerbate complicity of all tax payers with chemical abortion, and add to the problems of conscientiously objecting health care workers.
Women can also visit ella-kwikmed.com to get Ella.
It’s possible for them to fill out a questionnaire for ONLINE PRESCRIBING, (allowed by Utah state law) then have the drug dispensed to them. They can dial 855-2ELLARX and accomplish the same thing.
Ulipristal acetate is available for market as 30 mg tablets. This supplies 0.5mg per kg for women up to 60 kg, or 132 lbs. As you know, many ladies are bigger than that, (including the author) and so the drug cannot expected to be uniformly effective throughout the American female population. A 120mg dose is required to reliably inhibit ovulation according to the CHMP assessment report. 300mg is needed to kill more developed embryos and fetuses.
The convenience of obtaining Ulipristal acetate online allows the accumulation of doses needed to perform home chemical abortions which may be completed at hospitals if necessary. Abortionist James Pendergraft supplied a model of initiating procedures by injecting the fetus, and allowing hospitals to complete the job. All of this has been done before.
Even in medical journals you will see claims that the mechanism of Ella is to prevent ovulation, even when the data shows otherwise.
However the CHMP assessment available from Europe, where they do not have to lie to sell the drug, is much more matter of fact regarding the pharmacology of this drug.
Ulipristal acetate prevents progesterone from occupying its receptor, thus the gene transcription normally turned on by progesterone is blocked, and the proteins necessary to begin and maintain pregnancy are not synthesized.”
The quality of ulipristal acetate which brought it under consideration for drug development as a morning after pill is candidly given in the same report:
“Since progesterone is critical for implantation, it was thought that ulipristal acetate may have promise as a contraceptive agent.”
First born twin, Mifepristone, can only be obtained directly from Danco Laboratories by clicking HERE, or by dialing 877-432-7596. Only physicians may distribute this drug, and there are specific requirements to adequately inform patients concerning this form of abortion procedure, use a patient consent form, and keep records.
The FDA approved usage of mifepristone involves an oral dose of three 200mg tablets. Planned Parenthood apparently likes variety, and has experimented with cost containment by using lower doses, and the vaginal route of delivery. Deaths from Clostridium sordellii infection have inspired a return to oral administration of the drug. The procedure requires an initial physician visit for dispensing the drug, a return visit in three days to receive 400mcg of misoprostil to cause expulsion of the dead human embryo, and a third visit at 14 days to ensure success. About 8 percent of patients require a followup surgical abortion.
Methotrexate is used in chemical abortion at a dose of 50mg /square meter, injected intramuscularly. Alternatively a 50mg dose can be given orally. This dose is followed on day 3 up to day 7 by a 800mcg vaginal dose of misoprostil to expel the dead embryo. A followup visit with the physician is needed to determine if the abortion is successful. There are multiple possbilities for followup treatment should the abortion not be complete at the second visit, some involving a second dose of misoprostil, others involving surgical abortion.
Methotrexate is usually used as an anti-cancer drug. It’s mechanism is to interrupt folic acid metabolism (by dihydrofolate reductase) to the active form, which serves to block thymidine production, thereby inhibiting DNA synthesis and cell division. As an abortion drug, it causes degeneration of the trophoblast, the tissue surrounding the embryo which produces the placenta. The production of HCG stops, which leads to a decline in progesterone production by the corpus luteum. The uterine lining degenerates, and nutritional support for the embryo ceases.
Plan B One-Step, the over-the-counter morning after pill is 1.5mg of levonorgestrel, a synthetic progestin.
From the Prescribing information of Plan B One-Step:
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Emergency contraceptive pills are not effective if a woman is already pregnant. Plan B One-Step is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal
transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.
Note the fact that levonorgestrel affects the endometrium and may act to inhibit implantation. This stops the life of a human embryo at the blastocyst stage of development, and is one of the bases for controversy concerning dispensing and use of this form of birth control. Unmentioned in the package insert is that effect on tubal transport also influences the transport of the very early embryo prior to implantation.
Here’s the quote of the year concerning Plan B:
“It has more than doubled since the last time the data were collected,” said Megan L. Kavanaugh, a senior research associate at the Guttmacher Institute in New York who worked on the study.
However, she said in an interview, “its use still seems relatively low, given that it’s easy to access. So there’s room for improvement.”
Somehow, in the fevered brain of Ms. Kavanaugh it represents an improvement to fail in the more reliable forms of preventing pregnancy, and require the use of the LEAST reliable modality, the morning after pill, tossed over the counter by the local pharmacist, who could be censured for attempting to ascertain clinically appropriate application of the drug. Kavanaugh credits the media, and not health care professionals, for stimulating the increase in this dependency. (A tiny silver lining in this cloud.)
Neither Plan B One-Step nor Ella One are very effective.
In actual use, expect a failure rate of about 40 percent, in round numbers.
Cumulative failure rate for repeat users guarantees good business for the abortionists, and this helps to fulfill the marketing plans of of such entities as Planned Parenthood.
Discouraging the use of chemical abortifacients by means of legal regulation is a difficult and expensive task. The proposed legislation to require reporting of mifepristone adverse events is a good start, and opposition from the abortion industry is certain. One might evaluate the potential efficacy of this and future regulations by how loudly the abortion providers protest.
Overall the abortion problem is most efficiently tackled by prohibiting government funds for both chemical and surgical abortions, requiring full disclosure of drug information to the patients, and protecting the option of all health care employees to refuse participation.
It should be remembered that all hormonal birth control forms have the possibility to act in a manner that causes inhibition of implantation. As with Plan B, this information can be found in the prescribing information for each drug.
The availability of artificial birth control has not produced a decrease in demand for abortion.
[ http://www.ncbi.nlm.nih.gov/pubmed/21134508 ]
It is a failed social experiment.
Innovation and invention are largely in response to filling human needs and alleviating suffering. The practice of killing unwanted or disabled human beings will impede further medical and technological advances, and lead to a DEvolution of civilization and the human species.
It’s heartening to see the recent pro-life legislative efforts in Indiana, and this pharmacist remains available to provide information and assistance if needed.
Useful Links
NOTE: Visit original link — http://themorningafter.us/chemical-abortion/ — for all the links below:
The European Medicines Agency CHMP Assessment Report for Ulipristal acetate – contains the most useful information from the manufacturer on the scientific basis and rationale for developing this compound as a morning after pill.
New Morning After Pill Works When Taken 5 Days After Intercourse … SOMEWHAT.
Useful Information About Ella from Tech News Site
http://themorningafter.us/new-5-day-morning-after-pill-tested-for-u-s-approval/
Revelations from the European CHMP Report on Ulipristal Acetate
FDA Approves Ulipristal Acetate as expected
Updated FDA summary of mifepristone related adverse events
http://downloads.frc.org/EF/EF11G29.pdf
An Unethical Model for the Ulipristal Acetate Abortions
http://themorningafter.us/let-abortionist-james-pendergraft-show-you-why-the-fda-approved-ella-ulipristal-acetate/
Prescriber information for Mifeprex (RU486)
Methotrexate abortion protocol from National Abortion Federation
Methotrexate plus misoprostil efficacy
Prescriber information for Plan B One-Step
Emergency Contraception does not reduce abortion rates.
Failed Social Experiment
Spanish study: trends in use of contraception and voluntary abortion 1997-2007
Selling the Pill
Indiana House Bill 1258, regulation of RU-486. Introduced by Rep. Bob Morris.
Indiana Senate Bill 72 this version lacks requirements for the reporting of adverse events arising from use of abortion drugs. This further enables misrepresentation of the risk of pregnancy vs abortion, as there is no impetus for an abortionist to report adverse events associated with abortion surgery or drugs.
Indiana House Bill 1228, Conscience protection for health professionals, introduced by Steve Davisson,
Planned Parenthood Financial Report 2010: Your Tax Dollars at Work
FDA summary of Mifepristone (RU486) Adverse events — http://downloads.frc.org/EF/EF11G29.pdf
[http://themorningafter.us/chemical-abortion/]
The Stealth Abortion Pill
The so-called “week-after pill” is an abortion drug hidden under the guise of contraception.
On August 13th, 2010, the Food and Drug Administration (FDA) approved the drug “ella” (ulipristal acetate) for prescription use as emergency contraception (EC).
The agency recommended it for “occasional” use up to five days following either unprotected intercourse or contraceptive failure, causing the Drudge Report to name it the “week-after pill.”
The innocently named 'ella' has the potential to do far more than merely prevent ovulation or even prevent embryonic implantation: there is good reason to believe it primarily acts as an “abortion drug” in the vein of RU-486, interfering with and indeed ending implanted pregnancies. [Ella is related to/in the chemical family of 'RU-486', more accurately known as mifepristone.]
As such, the approval of ella rightly ought to have involved more than antiseptic scientific data, institutional reviews, and clinical trials: ella’s approval and use raises fundamental questions of life, death, and ethics that our regulatory system is ill-equipped to answer.
Given the probable
usefulness of ella as an abortion pill, the FDA’s approval of the drug for EC prescription is only the beginning of the controversy surrounding ulipristal. A newly approved abortion drug for EC purposes will warrant future regulatory battles over the drug’s labeling, disputes over abortion funding, and, ultimately, demonstrate the inadequacy of our current pharmaceutical regulatory regime in controlling the “off-label” use of drugs. (“Off-label” use of drugs, of course, refers to the use of drugs for purposes outside of their FDA marketing approval. The possibilities for the “off-label” use of ella are obvious.)
News reports on the approval of ella note that it is an improvement over the previous form of emergency contraception “Plan B” (levonorgestrel), which purports to work only seventy-two hours after unprotected sex or contraceptive failure. Levonorgestrel has been used in hormonal contraceptives for decades, and Plan B simply uses a large dose of it to prevent pregnancy by preventing a woman’s ovulation. (Plan B’s label, however, also notes that it can work by obstructing fertilization of the ovum or by preventing the fertilized embryo from implanting in the womb.)
The ulipristal in ella works in a similar manner according to its label: “When taken immediately before ovulation is to occur, ella postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.” While the operation of the drugs as EC might be similar, ella can boast that it is approved for use up to two days longer than Plan B.
In all likelihood, however, ulipristal does more than simply prevent ovulation or implantation like levonorgestrel.
As the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) pointed out in their submission to the FDA prior to ella’s approval, ulipristal acts as a “selective progesterone receptor modulator” (SPRM). An SPRM acts to block receptors of the hormone progesterone throughout the body. AAPLOG described three ways this could possibly kill the developing child:
1. Ulipristal blocks progesterone at the level of the endometrial glands, and destroys the receptivity of the endometrium so that the embryo cannot implant;
2. Ulipristal destroys the capacity of the corpus luteum granulose cells to produce progesterone; production of progesterone at the corpus luteum level supports the implanted embryo throughout the first 10 weeks of pregnancy; absent this corpus luteal progesterone production, the placenta which feeds the embryo will die; this mechanism of action is identical to the action of [abortion drug] RU-486 on the corpus luteum;
3. Ulipristal directly blocks progesterone receptors in the endometrial stromal tissue, identical to the mechanism of action of mifepristone (RU-486) which kills the implanted embryo by directly destroying the maternal component of the placenta.
AAPLOG notes that the second and third abortifacient mechanisms, similar to those of mifepristone, distinguish ulipristal from levonorgestrel, which does not interfere with an implanted embryo. So while ella has been approved for marketing as contraception in the same vein as Plan B, it has the capacity to operate like the (more tightly regulated and more controversial) abortion pill RU-486.
AAPLOG, in its submission to the FDA, suggested that ella should have a “black box” warning on its label about its abortifacient properties, not unlike the drug Cytotec (misoprostol)—a drug approved for the treatment of certain ulcers that also moonlights as the abortion drug of choice in places where RU-486 is not available. As it stands, the ella label does note that “use of ella is contraindicated during an existing or suspected pregnancy.” This notice to users, however, is practically meaningless in the world of drug regulation, as the approved use of a drug by the FDA has more to do with marketing than with use.
FDA approval is a notoriously costly and laborious process, and when a drug company submits a “new drug application,” the drug undergoes no fewer than three phases of clinical testing for a specific population (e.g. “adults”), with specific administration criteria (e.g. “by prescription”) for a specific condition (e.g. the treatment of NSAID-induced gastric ulcers). When the FDA approves a drug, it can be marketed by the drug company under the conditions set forth—so the manufacturer can market misoprostol to adults to take the drug by prescription to treat NSAID ulcers. This marketing takes the form of marketing to “learned intermediaries” (physicians) who then recommend and prescribe the drug to patients, or, more recently “direct to consumer” (DTC) marketing, alerting consumers directly what their options are so they inquire with their physicians about the possibility of taking a drug. (The myriad commercials ending with, “Ask your physician if [drug X] is right for you,” following a comically long list of horrible side effects are examples of DTC marketing.) The FDA approval process bears directly on how drug companies can market drugs, not on how physicians can prescribe them.
It is an established fact of law that the FDA does not regulate the practice of medicine. As such, physicians are free to prescribe drugs as the practice of medicine dictates, not as the FDA has approved them. This “off-label” prescription of drugs is so commonplace that in some specialties a physician’s failure to prescribe a drug in an “unapproved” manner can open her up to malpractice liability. In many ways, this makes sense: in fields such as oncology, time is of the essence in treatment, so the cutting edge of the specialty might rely on accumulated knowledge and academic studies in lieu of plodding regulatory approval in Washington; in pediatrics, most drugs are approved already for adult populations, but getting them approved with a supplemental new drug application for children would be prohibitively costly (leaving aside the ethical problems with conducting clinical trials on children). Thus the current FDA regulatory framework does not constrain “unapproved” uses of drugs.
In the case of ella, this means that its labeled contraindication for pregnant women is wholly irrelevant to how it can be prescribed. While the label professes agnosticism as to how ulipristal might interact with an implanted pregnancy, the science of SPRMs like mifepristone is well established. A physician who is aware of ulipristal’s embryocidal properties has nothing to prevent him from prescribing ella to a patient in the early stages of pregnancy, regardless of what the FDA label indicates. Indeed, the main constraint on a physician doing so would be the fear of malpractice liability in the case of an adverse event.
In a sense, ella’s manufacturers do not need the FDA to approve ulipristal for anything more than EC. If they were to get it approved as an abortion drug, that would simply allow them to market it as such, and the political and commercial realities of contemporary America make DTC (or even learned intermediary) marketing of an abortion drug a dubious goal for a corporation. With or without FDA approval, the sorts of physicians who prescribe abortion drugs will be able to prescribe ulipristal to terminate a pregnancy.
Herein lies an immediate problem: If ella is labeled for use
as emergency contraception, but can be prescribed to effect an abortion, what is to prevent Federal monies from subsidizing it as contraception, only to have it used as an abortifacient? Congressman Chris Smith has concluded that coverage of the drug is probably mandated under the recent healthcare reform act, and has called on President Obama to issue an Executive Order clarifying that federal agencies and affected insurance plans are not to fund the drug. Given the already blurry line between contraceptive family planning and abortion, executive clarification is certainly in order.
…The possibilities of public funding for ella, its switch to over-the-counter availability, and its usefulness as an abortion drug implicate more than just “scientific evidence,” and necessarily involve politics. Drugs like ulipristal further blur the line between contraception and abortion, and lawmakers like Congressman Smith are right to demand that those lines remain bright when it comes to appropriations, regardless of the confusion caused by FDA labeling. More generally, the relatively quiet approval of an abortion drug as contraception should cause us all to step back and consider whether our current regulatory framework is in the best interests not only of Big Pharma, physicians, and patients, but also those of the body politic.
Michael Fragoso, formerly a policy analyst at the Family Research Council, is a law student at the University of Notre Dame.
[Michael Fragoso, August 17, 2010, http://www.thepublicdiscourse.com/2010/08/1515