Tag: ulipristal

Let Abortionist James Pendergraft Show you WHY the FDA Approved Ella, Ulipristal Acetate.

~ Pharmer ~ 1 Comment

Unlicensed abortionist operating secret ‘lethal injection’ abortion facility in DC: watchdog group | LifeSiteNews.com.

Abortionist James S Pendergraft injected toxic doses of meds into the hearts of fetuses in utero, and told their moms to finish up the job at a legitimate hospital, or other facility.  This way the abortion would be counted as a fetal demise, miscarraige, etc., and the mom would avoid the abortion stigma as well as much of the cost.

Ella, (ulipristal acetate) was put on to the market as a morning after pill, but the abortionists will be doing a similar thing with this drug, using it off label, and in increased doses, to cause fetal demise.

It’s another abortion pill, but without the regulatory controls applied to mifepristone,  ru486, it’s chemical analog.

For the time being,  Pendergraft is in hot water for practicing with a suspended license in Washington DC.

FDA remembers the old days, when it used to do its job.

~ Pharmer

Dr. Gerard M. Nadal appropriately nails the non-functional FDA to the wall, noting it’s new Kelsey award, honoring a former FDA reviewer from back when the agency was worth something.

Frances O. Kelsey, now 96 years old, is the namesake and first recipient of the Kelsey award from the FDA for doing what she was supposed to do. She stopped distribution of Thalidomide, for morning sickness, in the USA, likely sparing countless kids the associated birth defect called phocomelia, severely shortened limbs.

Nadal notes that the present FDA commissioner, Margaret Hamburg has ushered in the new drug Ella, ulipristal acetate, without appropriate testing, and with next to zero study of its effects on the babies who survive its embryocidal effects. In addition, the FDA has misbranded this drug as a contraceptive, thus disrespecting female patients’ right of informed consent to treatment.

FDA Approves Ulipristal acetate as Expected

~ Pharmer

Watson is the generic drug manufacturer which is expected to distribute EllaOne in the US, now that the FDA has approved it for use as a morning after pill.

Headlining at Pharmacists for Life International is a low opinion of the FDA’s decision to spend time on this me-too analog of the abortive drug, mifepristone (RU486), and allow the marketing as a morning after pill.
Below is what Pharmer sent to Rob Stein of the Washington post, at his request. It’s possibly not translatable into language understandable by that newspaper’s readers.

On the sidebar and searchable on this blog is further information on Ulipristal acetate, coming soon to the US, for use in underage girls, (without parental consent) and by women who are ill-informed about the drug and its effects.

Reply to request for statement on the impending approval of Ulipristal:

Ulipristal Acetate, according to its developers, can kill embryos and fetuses, and is marketed in Europe as EllaOne. The low dose 30mg form, has been prioritized for approval by the FDA, which would have served us better by adequately addressing the current, rolling shortages of lifesaving and essential medications.

The embryocidal, ulipristal acetate doses may be accumulated by physicians or patients for medical abortions at home, sidestepping the so-called regulation of mifepristone/misoprostil (the other abortion drug). This will lead to additional life-endangering problems for the targeted adolescent girls and women.

The FDA is expected to continue in its long tradition of relegating females to bottom class health care status.

Reply when asked if pharmacists would refuse to dispense it:

Pharmacists were excused from handling mifepristone/misoprostil, and most were relieved to be sheltered from the ethical and legal liabilities.
The majority would not like providing information and dispensing ulipristal, since it is an analog of mifepristone. Expect attempts to force pharmacists to do so.

If you were to juxtapose the issue of severe drug shortages and the approval of this ‘me-too’, abortifacient in a survey of pharmacists, the majority would express the opinion that the FDA is nearly useless.

Personal note to Rob Stein concerning the FDA’s action:

In my place of employment is a gigantic board listing the shortages and outages of essential medications, such as antibiotics, pain relievers, anaesthetics and drugs for sedation.This problem has been significant for years, and has worsened considerably in the last year, impeding our ability to provide vital care for our patients.

The FDA has placed the approval of this duplicate analog of mifepristone ahead of need to address this severe health care issue. My disrespect for the FDA is profound and beyond the ability to verbalize.

NPR: Lost in the Weeds (As Usual) on EllaOne

~ Pharmer

NPR demonstrates why its listenership is really low and it needs public support to survive.

New ‘Morning After’ Pill Works Five Days Later, Too : NPR.

“Paul Fine would like to stop seeing emergency contraceptives referred to as “morning after pills”, the story opens.

Well, those interested in accuracy and honesty continue to use that term, since calling it “contraception” is misbranding.

All of the morning after pills can operate by interceptive  (post fertilization) mechanisms to stop the life of an early human embryo.

Not withstanding the similar words from Dr. Donna Harrison, a representative of the ob-gyn physicians who DON’T make money by prescribing these morning after pills,  NPR plods on with the latest apologetics.

The interceptive mechanisms are explained away by stating that the pills sometimes don’t work and claiming that the failures are post ovulatory.    It is fact that both Plan B and EllaOne have extremely high failure rate,  but this is not adequate evidence against  the action of interceptive mechanisms, the likelihood of which the manufacturer admits in the CHMP Assessment Report.

In fact, the interceptive mechanism of EllaOne, a drug closely related to mifepristone (RU-486) is much more obvious.   Efficacy of the drug in stopping pregnancy stays the same, (or perhaps even rises)  when used during the entire recommended 5 day period after intercourse.

The morning after pill dose is about 0.5mg/kg in an average size woman.  This is considerably LOWER  than the dose required to stop ovulation  (seen in animal studies).  This latter dose is  closer to the embryocidal, or fetocidal dose.

Think of it this way:

ulipristal acetate 30mg EllaOne morning after pill   ———-> ulipristal acetate 120mg higher dose needed  to stop ovulation——–>ulipristal acetate 300mg higher dose to kill more developed  embryos and fetuses.

Therefore, doses  of  EllaOne can be accumulated for home abortions, and one can be certain that this will happen when this morning after pill is placed over the counter.

It will become  another tool  in the armory of planned parenthood  along-side the tele-abortions offered  (in Iowa)  using mifepristone and misoprostil.

Below are tidbits from the CHMP Assessment Report,  (European Medicines Agency Evaluation of Medicines for Human Use)
which is linked here, and on the sidebar of this blog.  

1) “Ulipristal acetate (17α-Acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione, also known as CDB-2914, VA2914, HRP-2000 and RTI-3021-012) is a compound that is derived from 19-norprogesterone. It is a synthetic selective progesterone receptor modulator with antagonistic and partial agonistic effects at the progesterone receptor. It binds the human progesterone, but not the estrogen receptor3. 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.”

2) “In vitro, Ulipristal acetate binds competitively to the progesterone, glucocorticoid and androgen receptors, but has minimal affinity for the estrogen or mineralocorticoid receptors. Pre-clinical studies indicate that ulipristal acetate binds to the human progesterone, glucocorticoid and androgen receptors at approximately 6, 1.5 and 0.2 times the affinity of the endogenous ligands. The compound has antiprogestational activity in rats, rabbits and monkeys, with additional antiglucocorticoid and antiandrogen activity at doses ∼50 times higher than those needed for antiprogestational activity. Since progesterone is critical for implantation, it was thought that ulipristal acetate may have promise as a contraceptive agent.”  **

3)”The ability of ulipristal acetate to terminate pregnancies was investigated in the guinea-pig and monkey. Ulipristal, mifepristone and lilopristone were approximately equipotent at the dose levels of 10 and 30 mg/day in terminating pregnancies in guinea-pigs when the animals were treated on days 43 and 44 of gestation. Pregnant long-tailed macaques (5/group) were administered ulipristal acetate 0.5 or 5 mg/kg/day p.o. or 0.5 mg/kg/day i.m. on days 23-26 of gestation. Pregnant animals were assessed by ultrasound pretreatment (day 23) and then monitored on days 26-28, 30, 32, 35, 55, 80, 100, 130  and 145. At 0.5 mg/kg of ulipristal acetate there was no loss of foetuses, while at 5 mg/kg 2/5 foetuses were lost. When using intramuscular administration of 0.5 mg/kg 4/5 foetuses were lost in ulipristal acetate treated animals. In monkeys in which pregnancy continued and which were allowed to deliver normally, there was no evidence of structural or physiological abnormalities in foetuses.”

** note misuse of the word “contraceptive” for interceptive mechanism in tidbit number 2.

 

New 5-Day ‘Morning-After’ Pill Tested For U.S. Approval

~ Pharmer

New 5-Day ‘Morning-After’ Pill Tested For U.S. Approval.

Two useful bits of information in the above article, from  a tech news site (Physorg).

1) EllaOne, the new morning after pill from Europe is being tested for approval in the United States.

2) It’s efficacy in killing the early human embryo does not decrease over the 5 day period after sex, in which it is recommended for use.

Some  of the  Physorg  commentators  had sufficient education to recognize that the mechanism of EllaOne involves causing death of  the early human embryo.   Hat’s off to them.

Some  of the comments appended to the article are from those who  were unable to part from a religious notion that they could distinguish which humans had been ensouled by developmental stage.    These might  be drained  from the human gene pool  over time, by means of EllaOne, perhaps, despite Pharmer’s recommendations to the contrary.

As a progesterone receptor modulator with low glucocorticoid activity,   ulipristal   gained attractiveness as a birth control drug primarily due to its ability to cause endometrial atrophy.  That means, from a birth control standpoint :  no place for the human embryo to implant.

*** ulipristal  ellaone ella-one  ella one sprm

BOGUS Medical News: Novel ‘Morning-After’ Pill Works for Five Days – in OB/Gyn, Pregnancy from MedPage Today

~ Pharmer

Medical News: Novel ‘Morning-After’ Pill Works for Five Days – in OB/Gyn, Pregnancy from MedPage Today

More ineffective birth control is being marketed to women in Europe. This new morning after pill, Ella One, containing ulipristal 30mg, is said to be useful for up to 120 hours (5 days) AFTER intercourse.

The study (1241 women) mentioned in this article indicates that ulipristal reduces the pregnancy rate from the expected 5.5 percent down to 2.1 percent.

In this study, the women who used the pill later after intercourse had lower pregnancy rates than the earlier users, though the differences among the groups were not statistically significant. If a larger study were to replicate this trend within statistical significance it would add more evidence for the pill’s post fertilization effects. Those who understand the reproductive processes find it intuitively obvious that pills reducing pregnancy rate AFTER intercourse work to a significant degree by killing the embryo shortly after it is formed.

That ethical problem aside, women should be aware that a pill reducing the pregnancy rate from 5.5 percent to 2.1 percent should not be considered reliable.

The data here indicates that it fails to stop nearly 40 percent of the pregnancies, under study conditions with more education and oversight than usual circumstances.

*** ulipristal  ellaone ella-one  ella one sprm ella 1  ella1