Tag: EllaOne

Pharmacy Owners Prevail in Court Decision on Blagojevich Edict

~ Pharmer

Illinois Pharmacy Owners have emerged victorious after six years of litigation against  the state of  Illinois edict compelling them to dispense the morning after pill.

This comes shortly after the approval of a new morning after pill, Ella, which is an analog of RU486, mifepristone.

Francis J Manion of the ACLJ, and Mark Rienzi, of Catholic University’s Columbus School of Law  teamed up as counsel to the pharmacy owners.

Deposed Governor Blagojevich’s original order addressing individual pharmacists had previously been overturned.

Judge Belz  noted that the government had made no effort to advance it’s supposed interest in supplying morning after pills to women prior to April 2010, and had specifically targeted pharmacists of conscience and their religious beliefs.

Pharmacists for Life International has stored the original letter from Blagojevich which threatened pharmacists  with loss of their license to practice if they did not dispense the morning after pill and all other  hormonal birth control products and contraceptives upon demand.

The coverage in the Chicago Tribune is very brief, does not mention the newest morning after pill, and does not mention that the original order to the pharmacists was for them to dispense all drugs labeled as “contraceptives” though most are misbranded.  It does mention an expected  (hoped for) appeal to the case.

 

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.

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