05
Apr 13

Federal Judge Places Morning After Pill over the Counter Without Age Restriction

Your friendly Pharmer came home from work this morning to a message from a Reuter’s reporter, asking for comment on this story.   Lacking real information,  there was not much to do but comment on the inappropriateness of medically uneducated people, making decisions on matters  in that field, and give information on the liabilities of the drug, particularly in teens and adolescents. Naturally, the reporter garbled the message.

Naturally, Pharmer thinks that a judge has no business ruling on whether a drug should be considered safe enough for over the counter sales, (unless he would perhaps rule simply on whether the FDA should exist or not  ;-) .

It appears that Judge Edward Korman  of the Eastern NY division of the Federal court has made two decisions on this issue.  One of them impinged on dropping the age to 17 to obtain Plan B One-Step without a prescription.  The actual decision is HERE. 

The 2nd and current  decision,  which resembles a temper tantrum in style, further loosens the   restrictions, and has  countermanded Kathleen Sebelius’ Dec. 2011 decision to limit over the counter sales to girls under 17 years of age.  Now it appears that  the FDA is ordered to allow general sale of Plan B One-Step over the counter within the next 30 days, “without point of sale or age restrictions”.   Judge Edward Korman has made a pretty good argument for completely eliminating the FDA, since its decisions are moot, and may be overturned at any time by a medically uneducated Federal Judge.

So far,  only Plan B (levonorgestrel) is being addressed in this decision.  Ella is excluded from consideration.  Korman’s  one-man usurpation of FDA regulatory functions cedes only the label requirements and the  ability to regulate the sale of of the older 2-pill version,  Plan B, back to the agency.

The FDA will have to generate mega-reams of paperwork to address these  and other momentous decisions, such as whether to re-categorize  hydrocodone as a  CII controlled substance.   They have minutiae to manage, and certainly will not have time to appropriately address the rampant and unprecedented drug shortages which are causing medical errors and deaths in our hospitals and communities.


24
Sep 12

Birth Controlling the High School Herds in New York City

EXCLUSIVE: New York City high schools giving students morning-after pills and other birth control, without telling parents – NYPOST.com.

The Department of Education has expanded their “CATCH” Program (which involves giving birth control pills, Plan B and Depo-Provera to girls without parental consent) to 13 New York high schools. Parents can opt out of the program by FINDING a piece of paperwork allowing them to opt out, and signing it. The so-called information telling parents of this form has resulted in only a 1-2 percent response.

Prescriptions for the drugs are supplied by Health Department physicians. This can be obtained by seeing a school nurse, and taking a pregnancy test.
From the NY Post:
“We can’t give out a Tylenol without a doctor’ s order,” said a school staffer. “Why should we give out hormonal preparations with far more serious possible side effects, such as blood clots and hypertension?”

Last year, New York City boasted a 64% abortion rate among 7000 girls under 17 who got pregnant.
Watch and see if this program of giving out pills at high schools has any effect on the statistics.

Pharmer wonders who is the brainiac behind this new “CATCH-bugs” program, which is likely to boost the incidence of STDs in the area, now that girls will have less incentive to abstain or use barriers.

The following schools are listed by the NY Post as participating in the program to pass out birth control hormones to kids without parental consent. Adlai Stevenson and Grace Dodge in The Bronx; Boys and Girls, Clara Barton, W.H. Maxwell Career and Technical Education, Abraham Lincoln and Paul Robeson in Brooklyn; John Adams, Newcomers, Queens Vocational and Technical, and Voyagers in Queens; High School of Fasion Industries in Chelesa, and Port Richmond on Staten Island.
Seward Park Campus in lower Manhattan was dropped from the program because the school medical office couldn’t keep up with the business.


07
Jun 12

For NYT, Evaluating Birth Control Mechanisms is Classed as POLITICAL SCIENCE

Science at Issue in Debate on Morning-After Pill – NYTimes.com.

Pharmer is immensely amused by the NYT Political Science article purporting that Plan B, levonorgestrel (a progestin – synthetic progesterone analog) delays ovulation but has no effect upon post fertilization mechanisms. This claim certainly has a relationship to political ideology, but not to pharmacological science.

There is the suggestion that Plan B can operate to impede ovulation even when taken 72 hours after intercourse.

The usual life of sperm is 48 hours, and The usual lifespan of secondary oocytes (eggs) is 1 day. The most fertile time for a woman is the day of, and the day after ovulation.

Laughably entertaining is the suggestion that there is no time for levonorgestrel to affect thickness or receptivity of the uterine lining, but there is time for it to always work by delaying ovulation. Scroll back up to the lifespan of the gametes and THEN ponder that it takes about 7 days for the early human embryo to travel down the fallopian tubes into the uterus and implant in the uterine lining.

Seven days is not long enough for the morning after pill to affect feedback inhibition, transport, endometrial tissue, and implantation processes, yet 48 hours is claimed to be long enough to exert a perfect 100 percent mechanism for delaying ovulation so that sperm and ‘egg’ don’t meet.  (Remember when a woman is most fertile, the day of and the day after ovulation?)   It’s pathetic when leftist ideology replaces scientific analysis and inquiry in such a blatantly obvious manner.

James Trussell (population controller of Princeton) has changed his tune about the efficacy of Plan B. Now he wants to say that the pill is ridiculously ineffective, so that condoms, rhythm, and withdrawal are far superior in efficacy as birth control. This is what he needs to admit in order to claim that the Plan B doesn’t work if a woman has ovulated.

Progesterone hormones have multiple mechanisms of action. Progesterone receptors are found in various tissues, and their preponderance and activity undergo cyclic changes. These hormones largely affect gene expression. These effects are not instantaneous. The physiological effects of progestins on reproduction vary with the timing of their use. The morning after pill’s modes of action will vary depending on when in the cycle and how long after intercourse they are used.

One cannot prescribe progestins to patients to mitigate hypermenorrhea (excessive bleeding), and at the same time claim that they don’t affect the uterine lining.

Progestins given on a scheduled basis fail to prevent ovulation in about half of patients. This has been attached to the labeling of progestin only pills, which have been used to control excessive bleeding, as well as to prevent pregnancy.

Plan B is a progestin. Ella is a selective progesterone receptor blocker (like mifepristone, RU456). Each one will affect the reproductive processes in different, dose dependent and time dependent ways. Political Science author Pam Belluck needs to consider the drugs separately when attempting to evaluate them mechanistically.

Plan B, levonorgestrel, like ALL hormones, operates on many physiological processes, by many different means.

If the leftists ever manage to develop effective birth control drugs which operate ONLY by preventing the union of sperm and egg, we may proceed with the constitutional amendments to accurately define human life with no further impediments.

More at Jill Stanek’s place. and right HERE.


13
Mar 12

ACLU: Two More Pharmacies Refuse to Sell Morning After Pills to MEN

ACLU: Two More Pharmacies Refuse to Sell Emergency Contraception to Men.

The ACLU,  (defender of NAMBLA)  is so extremely concerned that men should be able to buy the morning after pill and  use it on their underage sex abuse victims, or on semi conscious date rape victims, or on their partners without consent.   Their mission is to harass and threaten any pharmacist who does not want to dispense the pill to anyone other than the final user, or those who wish not to dispense  it at all.

One right that the ACLU does NOT  defend is that of informed consent.


07
Feb 12

So the Frat Boys and Jocks Can Buy Plan-B For Their “Dates”

Shippensburg University To Offer Plan B Contraception From Vending Machine « CBS Philly.

You know….. those “Dates”, where several guys take advantage of a single intoxicated girl ( often of questionable age)? Now the guys can put a couple of different drugs into her drink and GET ER DONE!!!! Classy Shippensburg University in Pennsylvania will have Plan B One-Step in the health center vending machine, for the sake of privacy. Shippensburg is now the no-tell motel, and it vends the date-rape drug.

Parents might wish to check the plan B policies of universities and colleges before sending their kids out of town for school. The policy reflects an attitude towards how the female students, and underage females in the vicinity are to be utilized.

Shippensburg issued a statement dated 2/7/12  regarding their policy of vending Plan B.


07
Dec 11

Press Secretary Jay Carney Has Offended Peta

PETA sends letter to White House press secretary for taking bestiality question ‘lightly’ | The Cutline – Yahoo! News.

The latest defense authorization bill approved by the Senate includes repeal of military laws forbidding sodomy and bestiality.

Jay Carney dismissed questions on this from a reporter during his daily press briefing, merely saying, “Let’s get on to something more serious”.

This prompted a letter from PETA’s Director of Communications, Colleen O’Brien.   It points out that their office has been deluged with calls from people who are upset that bestiality is now permitted in the military.

From the letter:  “As we outlined in the attached letter sent yesterday to the secretary of defense, animal abuse does not affect animals only—it is also a matter of public safety, as people who abuse animals very often go on to abuse human beings.”

One of the rare bits of common sense coming from the People for Ethical Treatment of Animals  is going to fall on deaf ears, as the Obama Administration would not be sympathetic to these kinds of problems.

In fact, the FDA is again seeking to facilitate the sexual abuse of humans by putting the morning after pill, Plan B One-Step  out on store shelves with the condoms.

Ella, the new morning after pill which is chemically analogous to mifepristone (RU-486), is now distributed  through an on-line prescribing and dispensing  process.  Though it is more cumbersome, it allows  non-patients and  men to have access to the drug and accumulate doses for abortions.

By this means, the FDA has  facilitated the availability of  home abortions outside the supervision of medical personnel.  These processes are frequently completed at hospitals where the resultant, life-threatening infections are treated.

Sorry, PETA, this is one administration which is not concerned about the  abuse of  animals, (humans included).


17
Oct 11

Abortion Supporters Fear Legal Recognition of Biological Fact

Mississippi Abortion Amendment 26 Says Life Begins at Fertilization | Video | TheBlaze.com.

It’s in your developmental biology book, and your general biology text.   Life for an organism of sexually reproducing species begins when fertilization is complete.

Mississippi proposes to recognize this fact in law, amid objections from abortion supporters.

They complain that this amendment might affect the availability of many birth control pills.

This is an admission that birth control pills, which operate by multiple mechanisms, including interference with implantation, have been misbranded as contraceptives.

Maybe we can request a surgeon general warning on BC pill packs that says: WARNING: this pill may operate by stopping the life of an early human embryo.

The warning could be upgraded for Plan B, and especially for Ella, doses of which can be accumulated for use in home abortions.

It is feared that legal recognition of what developmental biologists have observed might hurt the pharmaceutical and abortion industry.   Maybe if they had been honest all along, such efforts as Mississippi amendment 26 would not have been necessary.


25
Sep 11

Stanek weekend question: Why would a group promoting emergency contraception encourage men to buy it? – Jill Stanek

Stanek weekend question: Why would a group promoting emergency contraception encourage men to buy it? – Jill Stanek.

Found at the backupyourbirthcontrol site was encouragement for males to buy emergency contraception for their sex partners.  There seems to be huge support and encouragement people to have sex with those whom they don’t really like.  Jill Stanek’s weekend question got right to the heart of the matter, and bears repeating.

Plan B One-step (levonorgestrel 150 mcg) is the form which is available over the counter, and which may be purchased by both males and females.
Here is a Blast from the Past from pharmacy academics who favored the availability of the original Plan B  for use in  underage females.  This was the intended result of bringing the drug over the counter.
(If you read the entirety of  THIS article, you can appreciate the utter incompetence of one of the academics referenced in the Blast from the past link.)

It’s  important to remember that these morning after pills are NOT very effective.  The efficacy  is about 60 percent per SINGLE use.   Used repeatedly, the drugs are an absolute joke for preventing pregnancy.  Encouraging reliance upon the morning after pills (Ella included) is really an efficient  way to sell surgical or later forms of chemical abortions.   Encouraging guys to believe that the pill can increase their access to sex is a smart marketing move for the abortionists.  It also places the health and well being of girls and women at risk, since males can give them the drug without their consent.

It is a public service for Jill Stanek to have asked this question about the marketing of morning after pills to males.  This question needs to be repeated whenever and wherever possible, to highlight the rationale behind the morning after pills.

Ella  (ulipristal acetate, analog of RU-486 mifepristone) is available for morning after use by an ONLINE PRESCRIBING process.   It’s easy to obtain fraudulently and doses can be accumulated for later chemical abortions initiated at home.   This mechanism was allowed by the FDA in order to make up for the shortfall of physicians willing to do surgical abortions.

The only positive aspect of this scenario is that it is ultimately self-limiting.  Enhanced by the immunosuppressive qualities of the progestins, Chlamydia trachomatis and other STD organisms can help to prevent further propagation of people with this socially destructive mindset.


21
Jul 11

Chemical Abortion

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.


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.

Click for MORE

 


28
Apr 11

Guttmacher Spokesperson: Use of Morning After Pill increasing but “there’s room for improvement”

More U.S. women using “morning-after” pill: study – Yahoo! News.

The above article purports a single mechanism of Plan B, levonorgestrel, to operate by stopping ovulation.  It is known that progestin-only (a class of hormone analogs)  pills perform this job very  poorly, or not at all if taken in the latter third of the fertile period of a human female.   The media claim that this is their only operative mechanism of action would hinge upon extremely poor performance,  a failure rate of  approximately 40 percent per use.

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 that it contradicts the above linked article by mentioning 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.)

The above article suggests that the number of women who require afterthought birth control is on the rise, since the levonorgestrel form of morning after pill has been given over the counter status, and that this is a positive development.   It is one more reason that women should not obtain medical information and advice from the mainstream media.

The prescriber info of Plan B One-Step admits to a failure rate of  16 percent, per use  (which corroborates  the multiple mechanisms of action), and admits to the cumulative problem of failure should a woman rely on the morning after pill  as her main form of birth control.

How does the Guttmacher institute spell “improvement”??  Birth control failure.   It sells abortion.