progestin – Down on the Pharm

Hospital Pharmacy – Volume 46 – Number 5 / May 2011 – RxLegal – Pharmacist Conscience Clauses: Continuing Debate – Journal Article.

When the “experts” are called upon to provide commentary in professional Journals, it would help if they research their work sufficiently to write something accurate and useful.

Michael Gabay, Pharm D, JD, BCPS, has attempted to present the topic of Pharmacists conscience clauses, which have led to legislation excusing pharmacists from dispensing drugs which may operate to kill a human organism.

Listed below are a few of the troubles with Gabay’s article:

1) The implication that RU-486 contributed to pharmacists’ conscientious objection conflicts. Mifepristone/misoprostil regimen was highly regulated, and dispensed by the abortion practitioners themselves, rather than pharmacists. The article gives no mention of ulipristal acetate, the new analog of mifepristone which is now approved as a morning after pill, doses of which may be accumulated to accomplish a later abortion. (Way to keep current, Dr. Gabay.)

2) Glaring omissions of significant, current, judicial decisions. Dr. Gabay is a Clinical Associate Professor in the Dept. of Pharmacy Practice, University of Illinois, Chicago. Yes, he is in Illinois, a member of the Chicago Bar Association, and inactive member of the Illinois Bar. His article failed to mention the group of lawsuits recently decided in his own state, involving conscientiously objecting pharmacists and pharmacy owners, Walgreens and former Gov. Blagojevich. It is possible that Dr. Gabay, JD, was not aware of these significant court decisions, or perhaps he did not approve of them.

3) Garbled facts of the K Mart controversy, which actually involved a refusal to dispense progestin-only birth control drugs, not all “oral contraceptives” as the article incorrectly states.

4) Attributing the statement that oral contraceptives can prevent “implantation of a fertilized ovum”, to a person who knew better than that. Embryology lesson begins here: Fertilization of the secondary oocyte, produces an evanescent form called the zygote, that immediately begins cellular division, and proceeds to the next stage. By the time the human organism reaches the uterus to begin implantation, its embryonic form has differentiated into a blastocyst. (Dr. Gabay forgot the basic anatomy/physiology stuff which should have been prerequisite to his Pharm D.)

5) Dr. Gabay still appears not to know what Ms. Brauer knew about the mechanisms of birth control drugs, and the progestin, norethindrone, in particular. The actual disagreement in the K Mart case is still readily visible on the net: Page 1 and Page 2.

6) The crux of ethical objection to dispensing drugs which act, to a significant extent, to stop the life of a human organism is just that. It is not tied up in the various newer concepts of “abortion” and “pregnancy” which exclude the early human embryo. Abusing these terms to obfuscate the issue violates the patients’ right to give informed consent. The law has established no cogent or consistent basis for determining which human organisms may be willfully killed and which may not.

The complimentary review and editorializing will end here, to prevent reader fatigue.

The take home lesson for users of the literature in science and medicine is to read critically. Much of it is incomplete and factually “challenged” whether it is primary literature, or review and commentary, as in the case of Dr. Gabay’s article.

The value of extensive, formal education (as currently supplied) is also called into question, as it increasingly appears not to be helping with the quality of intellectual output.

*Note: This commentary has not been subjected to editorial review.

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.

Tag: progestin

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