Aquino's SONA

I didn't get the chance to catch it live, but the transcript of President Noynoy Aquino's 1st State of the Nation address is posted online here.

As expected, there were varied reactions. Some legislators pledged support. Some, like the militants, noted here that 'there was no mention of any concrete plans or policies to address the issue of human rights.". Forces loyal to the previous administration commented that "much of it was spent blaming the previous administration for the many problems, but...the figures that were mentioned were misleading”. They were actually preparing for a "counter-SONA" to refute Aquino.

At any rate it would be premature to judge the new administration's concrete plans on the basis of this SONA alone, and it is quite understandable that it is couched in general terms at this point. President Noynoy has been in the hot seat for only three weeks, and detailed action plans should take more time in the making. As far as the nitty-gritty is concerned, one should feel especially interested in the fiscal policy details. Aquino's SONA has hinted at a policy of "public-private partnerships" to deliver social services, which a solon found "dangerous". The president also talked about pushing a "Fiscal Responsibility Bill", which would require legislators to identify funding sources for bills. It has been noted that P104.1 billion is still needed for the many laws have already passed but whose implementation remains pending because of "lack of funds". Hmm, what's the point in expending legislative resources cranking out all those laws if there is no money to implement them.

The brief situationer is that Aquino's government has inherited a budget deficit of P325 billion for 2010, while the debt stock has already ballooned to P4.4 trillion. On this note I remember Noynoy's campaign promise not to impose new taxes while seeking to improve the delivery of social services. Already, DOH Secretary Ona has asked for an additional P9 billion to increase the reach of basic PhilHealth services for the poor. The other departments are expected to follow suit, noting urgent requirements. It is going to be a agonizing tightrope of belt-tightening, running after revenue, strictly prioritizing and controlling expenses while targeting the biggest bang in the bucket for every peso spent. Tough, very tough. It beats me why so many people are so eager to become president...

Meanwhile, congressman Lagman has re-filed the RH bill on the very, very first day of Congress. The bill seeks to appropriate gazillions of taxpayers money so that the government can buy and distribute the full range of contraceptives for free.

Tsk-tsk.

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Keep on knocking

"When nothing seems to help, I go and look at a stone cutter hammering away at his rock, perhaps a hundred times without as much as a crack showing in it. Yet at the hundred and first blow, it will split in two, and I know it was not that last blow that did it - but all that has gone before."
- Jacob Riis
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I just arrived late last night after a work-related, 3-day industry convention at the northern mountain city of Baguio. It was a very draining yet thankfully productive exercise. At one point in the workshop, our committee comprised of five were tasked to draw up IT strategic directions for the year, which we had to present to the plenary the next morning. Our group was basically discussing and intensely arguing on for about three hours during the night but we could not finalize anything. It was very frustrating and I was tempted to move for an adjournment. However, in the next 30 minutes our ideas suddenly jibed together and we were finally able to get a consensus on our presentation. Looking back, I knew it was not exactly the last 30 minutes that led to our results, but the previous 3 hours of continuous discussions that went before.

This Sunday's Gospel (Lk 11:1-13) teaches us the value of persistence when we lift up our petitions to God. Indeed we should keep knocking until the door is opened, yet the reality is we really need countless doors to be opened. We can never live meaningfully without continuously knocking because without Him, we can really do nothing. That is why St. Paul teaches us to pray unceasingly. We must never feel frustrated. He asks us to pray day and night, in joy and in sorrow, at work and at play, without intermissions or adjournments.

Here is an excerpt from Henri Nouwen's "Living a prayerful life", which relates beautifully why we need to maintain a constant, "fearless" conversation with God.

To pray unceasingly, as St.Paul asks us to do, would be completely impossible if it meant to think constantly about God...To pray, I think, does not mean to think about God in contrast to thinking about other things, or to spend time with God instead of spending time with other people. Rather, it means to think and live in the presence of God...

Although it is important and even indispensable for the spiritual life to set apart time for God and God alone, prayer can only become unceasing prayer when all our thoughts -- beautiful or ugly, high or low, proud or shameful, sorrowful or joyful -- can be thought of in the presence of God.Thus, converting our unceasing thinking into unceasing prayer moves as from a self-centered monologue into a God-centered dialogue...

So the next time I participate in a convention, I must remind myself that it is not "work-related". Instead, I've realized that when we consider everything we do as "God-related", every moment in our lives takes on a profound significance. It should make no difference whether it is 1 minute, 30 minutes, 3 hours, or even a lifetime. It just feels good to keep on knocking, because every knock counts.
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What was Martha preparing?

An old fisherman took a young man as a passenger in is boat. On one of the oars was written the word PRAY. On the other oar the word WORK. The young man said mockingly:

"You're out of date, uncle. What does anyone need with prayer, if he works?".

The old man said nothing, but he let go of the oar on which "pray" was written, and rowed with the other. He rowed and rowed, but they only turned round and round, and made no progress.

The young man understood.
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Lk 10:38-42 (at the home of Mary and Martha)

I understand that this story that occurred in Martha and Mary's home has sparked numerous discussions for proper interpretation since time immemorial. Spiritual or temporal? Which weighs more? Under what circumstances? It is worth noting that the story itself revolved around an argument when Martha complained to Jesus: "Lord, do you not care that my sister has left me by myself to do the serving?". Much has been said about proper priorities although I noticed that an interesting matter has been left out in all the discussions. What could Martha have been preparing in the house so much so that the texts say that she was "burdened with much serving"?

The common staple in those biblical times was bread, fish, lamb/goat's meat,and fruits. Meat would have required time-consuming tenderizing, so my bet goes with the bread and fish. Fish would be quick enough to broil or steam although it would require some cleaning preparations. I would say 30 minutes tops, although the serving itself would still be a separate daunting task. Take note from the texts that the disciples were with Jesus at the time, so there were at least 13 hungry people to serve, possibly even more. It was therefore a tall order.

Today, with the many choices of convenience food available, a similar situation would have been more manageable. For example when my kids' hordes of YFC friends suddenly drop by our house, we just order pizza. In our weekly prayer meetings with our charismatic group, I take charge of the snacks and I usually serve my personal version of easy-to-cook noodle dish like this "pancit luglog" with bread - the recipe of which I posted in my blog. I do have a passion for cooking and thankfully, my wife appreciates it (I think).

Anyway, such modern food conveniences were of course not options to Martha at the time. However, it is apparent there would have been ample time for everything. It leaves us no doubt when Jesus said "Mary has chosen the better part". Nothing suggests there was a dire need to eat pronto. We could glean however, that Jesus only admonished Martha gently in a sort of affectionate manner that is common among intimate fellowship: "Martha, Martha, you are anxious and worried about many things". In retrospect, Martha should have joined Mary at the feet of Jesus to listen to the Word first. There should be enough time later on to prepare the food. After all, when it comes to crunch time, we all know that Jesus can multiply food.

I would also like to share something from my 5-year old son when we ask him to pray before meals.

"God is good, bless the food. Bless the hands that made this food. Bless us O God, Amen".


Amen.
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Attacking the Church

Catholics angry as church puts female ordination on par with sex abuse

Uh-oh. The liberal press is having a field day gain. One just has to read the headlines to get
an idea where the rest of the article spins. Just who are those 'Catholics' mentioned in the article who are
angry?

Terry Sanderson, president of the National Secular Society, called the document "one of the most insulting and misogynistic pronouncements that the Vatican has made for a very long time.

Vivienne Hayes, the chief executive of the Women's Resource Centre, said the decision to raise women's ordination to the level of a serious crime was "appalling".

Ceri Goddard, chief executive of the Fawcett Society, said: "We are sure that the vast majority of the general public will share in our abject horror at the Vatican's decision to categorise the ordination of women as an 'offence' in the same category as paedophilia – deemed to be one of the 'gravest offences a priest can commit'.

Barbara Doris of the Survivors Network of those Abused by Priests (Snap) said it was tackling the issue the wrong way round. "Defrocking a predator, by definition, is too late," she said. "Severe harm has already been done.".

Oh you mean those 'Catholics'. I see.

Now let's see what the Vatican Document really says.

Modifications made in the Normae de gravioribus delictis

Norms

Delicta Graviora

"VATICAN CITY (CNS) -- The Vatican has revised its procedures for handling priestly sex abuse cases, streamlining disciplinary measures, extending the statute of limitations and defining child pornography as an act of sexual abuse of a minor.

Vatican officials said the changes allow the church to deal with such abuse more rapidly and effectively, often through dismissal of the offending cleric from the priesthood.

As expected, the Vatican also updated its list of the "more grave crimes" against church law, called "delicta graviora," including for the first time the "attempted sacred ordination of a woman." In such an act, it said, the cleric and the woman involved are automatically excommunicated, and the cleric can also be dismissed from the priesthood.

Vatican officials emphasized that simply because women's ordination was treated in the same document as priestly sex abuse did not mean the two acts were somehow equivalent in the eyes of the church.

"There are two types of 'delicta graviora': those concerning the celebration of the sacraments, and those concerning morals. The two types are essentially different and their gravity is on different levels," said Msgr. Charles Scicluna, an official of the Vatican's doctrinal congregation.

Sexual abuse of a minor by a priest was added to the classification of "delicta graviora" in 2001, and at that time the Vatican established norms to govern the handling of such cases, which were reserved to the Congregation for the Doctrine of the Faith. The norms affect how church law treats sex abuse cases; civil law deals with the crime separately.

The latest revisions, approved by Pope Benedict XVI May 21 and released July 15, for the most part codify practices that have been implemented through special permissions granted over the last nine years and make them part of universal law.

The Vatican spokesman, Jesuit Father Federico Lombardi, said publication of the revisions "makes a great contribution to the clarity and certainty of law in this field, a field in which the church is today strongly committed to proceeding with rigor and transparency."

The norms on sexual abuse of minors by priests now stipulate:

-- The church law's statute of limitations on accusations of sexual abuse has been extended, from 10 years after the alleged victim's 18th birthday to 20 years. For several years, Vatican officials have been routinely granting exceptions to the 10-year statute of limitations. Exceptions to the 20-year limit will be possible, too, but the Vatican rejected a suggestion to do away with the statute of limitations altogether, sources said...

etc, etc...

So there. At any rate, attempted ordination of women is already covered in canon law. Canons #1024, 1381-84. It merits latae sententiae - automatic excommunication. 'Attempted ordination' is a proper word, because any action of women ordination is just that: an attempt.

Fr Z, again, is right on the button:

...Another thing you will perhaps will see in the press, secular and Catholic, are criticisms of the list of crimes. They may complain that, for example, trying to ordain a woman is not nearly as horrible as abusing a minor and it shouldn’t simply be lumped in with other sins, as if they all did they same damage. In a sense, they are right, especially from the perspective of the victim of abuse. But they are wrong from another perspective. Critics might assert that pouring the Precious Blood down the sink or selling a Host or pretending to ordain a woman is a "victimless" crime, bad to be sure but really not that bad. They are wrong. There are still victims: the whole Church suffers because all the crimes involved attack who and what the Church is.

The crimes do belong together when seen in the correct perspective. All of the crimes here involve sacred things...

...and...

It is patently false that the Church didn’t see the abuse of children as a crime.

It must also be remembered that the Church regards abuse of children as a grave sin, and a heinous crime for that matter. As such, it places the unrepentant offender in a state of mortal sin, having automatically severed his communion with the Body of Christ. So is attempted ordination of women. In this sense Fr Z is right: they all involve attacking the Church. Sadly, attacking the Church seems to be a trendy pastime, in oh so many ways.
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Overpopulation: One more time

My good friend Manny Amador has posted an incisive piece in response to a recent editorial (propaganda, rather) in the Sun Star entitled: Two-pronged war against poverty.

Obsolete Thinking — Again!

Manny is spot on as usual.

His piece brings to mind the way Inquirer columnist Antonio Montalvan III debunked the overpopulation myth in his article.

They’re at Malthus again

This whole issue is getting to be boring (yawn).

But there is an interesting discussion going on at FB.
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Odds and Ends 7/15/10

Ateneo University appoints new president

MANILA, July 14, 2010— Jesuit-run Ateneo de Manila University has appointed a new president who is set to take over the helm of the academic institution early next year.

Fr. Jose Ramon Villarin, SJ was elected during a special meeting of the university’s board of trustees last June 29, 2010 as next president of the Ateneo de Manila, according to a memorandum circulated to the university community.

Villarin, who holds a doctorate in Atmospheric Physics from Georgia Institute of Technology completed his Bachelor degree in Physics magna cum laude at the Ateneo de Manila University in 1980 and M.S. in Physics in Marquette University, 1991. He finished his STB in Theology summa cum laude from Loyola School Theology, also in 1991. Ordained priest in April 1991, Villarin took his final vows as a Jesuit in January 2005.

Congratulations Fr Villarin. Such great credentials much worthy of a great Catholic institution. It remains to be seen however, whether such credentials are enough to crack the whip on Ateneo Theology professors who publicly advocate against Catholic Theology.
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Bishops tell DOH chief Ona: Avoid Onan's sorry fate in the Bible

MANILA, July 15, 2010— Two Catholic prelates have advised Health Secretary Enrique Ona to learn the lesson on Biblical character Onan, who was punished by God for practicing withdrawal to prevent conception...

Catholic bishops said that in the Church today, the practice of preejaculatory withdrawal during intercourse, which the church opposes, is also known as “Onanism.”
The reminded Ona that Onanism is against the Holy Teaching.
“So the better thing to do for Mr. Ona is to review (the Scripture). It’s clear that God don’t allow onanism,” said Oscar Cruz, retired archbishop of Lingayen-Dagupan...

Secretary Ona earlier expressed the government’s support for the use artificial contraceptives to prevent unwanted pregnancies and the spread of sexually-related diseases. The chief of the Department of Health also vowed a “population policy that prevents abortion and unwanted pregnancies."

Ona. Onan. Hmm, just one letter off. In the Scriptures, Onan was slain by God for his grievous misdeed, although I am certain the Bishops were not alluding that DOH Secretary Ona is bound to be physically slain if he leads his department to propagate millions of Filipino Onans. Definitely not. The bishops were alluding to a fate much worse.
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Singapore needs 100,000 workers as economy sizzles

SINGAPORE – Singapore will need 100,000 new foreign workers this year to keep on track an economy enjoying a stunning rebound, Prime Minister Lee Hsien Loong said in remarks published Thursday.

Rich but worker-starved Singapore has historically rolled out the welcome mat for foreigners, whose numbers rose dramatically in the boom of 2004-2007.

But with one in three of the five million people living on the tiny island now a foreigner and citizens complaining about competition for jobs, housing and medical care, the government has been looking anew at its open-door policy.

Nonetheless Lee said the need for more overseas labor was unavoidable despite efforts to slow the influx after complaints from citizens facing tougher jobs competition during last year's recession.

"If we don't allow the foreign workers in, you are going to have overheating," the Straits Times quoted him as telling Singaporean media during an ongoing visit to the United States.

Well, well. Mortality rate: 2.2. Total fertility rate: 1.22. What do you expect??
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POSTINOR BAN (2001)

Here is the BFAD position which led to the DOH delisting of the abortifacient drug POSTINOR in 2001. the light of recent developments, I am posting it here for reference purposes. It is quite lengthy bit to cut it down to the chaste, you can only disagree with the BFAD findings if:

1 - You disagree that life begins at conception, and;
2 - You choose to ignore the constitutional provision that "The State shall equally protect the life of the mother and the life of the unborn from conception." (sec. 12, Art. II)".
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BFAD vs Postinor

Republic of the Philippines Department of Health BUREAU OF FOOD AND DRUGS LEGAL DIVISION Filinvest Corporate City, Alabang, Muntinlupa City

10 October 2001

HON. MANUEL M. DAYRIT, MD, MSC

Secretary

Department of Health

Manila

Subject:

In the Matter of Levonorgestrel 750 mcg Tablet Brand: POSTINOR BFAD Registration No. DR-XY26140

Dear Mr. Secretary:

This is in response to your directive contained in your communication dated June 13, 2001, requiring this Office "to take all appropriate actions in the immediate recall of POSTINOR and the consequent cancellation of its CPR and to prohibit its further use, dispensing, sale and distribution in the local market," if proven to be abortifacient, following a letter-complaint of ABAYPAMILYA FOUNDATION through its President, Ramon A. Pedrosa dated May 08, 2001, seeking the recall of the above Certificate of Product Registration on the ground that Levonorgestrel 750 mcg Tablet is abortifacient, hence, illegal under existing laws and the Constitution.

By way of antecedents, this Office received on 23 April 1999 an application for registration for Levonorgestrel 750 mcg. Tablet filed by EURO GENERICS INT'L. PHILS., INC., the drug's importer. Among the documents included in the application is the printed drug insert which reads as follows:

LEVONORGESTREL

POSTINOR



DESCRIPTION

Each tablet contains 0.75 mg. Of Levonorgestrel [d)-)-13-beta-ethyl-
17-alpha-ethinyl-17-beta-hydroxygon-4en-3-one), a totally synthetic
progestogen.

The inactive ingredients present are lactose and starch.

CLINICAL PHARMACOLOGY

Levonorgestrel (Gedeon Ritcher LTD-EGIP) is believed to act to
prevent ovulation, fertilization and implantation. It is not effective
once the process of implantation has begun.

INDICATION

Levonorgestrel (Gedeon Ritcher LTD-EGIP) is an emergency
contraceptive which can be used to prevent pregnancy if taken within
72 hours (three days) following unprotected intercourse or a
contraceptive accident.

As an emergency contraceptive, Levonorgestrel (Gedeon Ritcher LTD-
EGIP) is indicated following any unprotected act of sexual intercourse,
including:

When no contraception has been used

When a contraceptive method may have failed, including

• 
  Condom rupture, slippage or misuse


• 
  Diaphragm or cap dislodgement, breakage or early removal


• 
  Failed coitus interruptus


• 
  
  Miscalculation of periodic abstinence method


• 
  IUD expulsion


• 
  missed regular oral contraceptive pills for three or more
  days in a cycle

In cases of sexual assault

The drug is manufactured by Gedeon Richter Ltd. of Hungary. It is licensed to Schwarz Pharma and is distributed in the Philippines by Zuellig Pharma Corporation.

Following the standard evaluation and testing procedures provided in BFAD rules and regulations, Certificate of Product Registration No. DR-XY26140 was issued for Levonorgestrel 750 mcg Tablet (Postinor) on April 24, 2000.

Pursuant to Par. 2.2.4, Section 2 of AO 66, S. 1989, we notified the following interested parties of the instant letter-complaint:

1. Drug Association of the Philippines (DSAP)


2. Chamber of Filipino Drug manufacturers & Distributors


3. Filipino Drug Association, Inc. (FIDA)



4. Philippine College of Pharmaceutical Medicine (PCPM)


5. Philippine Pharmaceutical Manufacturers Association (PPMA)


6. Pharmaceutical Healthcare Association of the Philippines (PHAP)


7. Association of Drug Industries of the Philippines (ADIP)


8. Philippine Association of Pharmacist in the Pharmaceutical Industry (PAPPI)


9. Philippine Medical Association (PMA)


10. Philippine Obstetrical & Gynecological Society



11. Philippine College of Surgeons

The above parties were invited to give this Office written submissions within thirty (30) days, on the issue of whether or not the above named drug should be recalled and delisted from the Bureau's registry of drug products, based on the grounds cited by ABAYPAMILYA FOUNDATION.

Of the parties notified, only the following sent position papers:

1. Schwarz Pharma Philippines, Inc., through its Country Manager,
   
   PEDRO D. MIRANDA, JR., on August 01, 2001;




2. Philippine Medical Association, through its President,
   
   
   GIL C. FERNANDEZ, M.D. , on August 20, 2001;




3. Philippine Obstetrical and Gynecological Society (Foundation), Inc., through its President, CORAZON T. LIM, M.D., on August 27, 2001; and




4. Philippine College of Pharmaceutical Medicine, through its President,
   
   NERISSA CINCO-CALIMON, on August 14, 2001; and

The complainant, ABAYPAMILYA, subsequently filed its own submission on September 28, 2001.

Discussion

In its letter-complaint, ABAYPAMILYA states:

"Studies about Levonorgestrel reveal that it is an abortifacient. Levonorgestrel operates to prevent a fertilized ovum from implanting into the uterus and thus aborts a pregnancy that has already began. It may be noted that implantation of the human embryo takes place around the 6^th day after fertilization, with the human embryo now being a multi-cellular structure known as a blastocyst."

Part I

The complaint dated May 8, 2001 included a paper written by JOHN WILKS (Annex "B" of letter-complaint) stating that "conception is the beginning of a pregnancy, taken to be the precise moment that a spermatozoon enters the female secondary oocyte, resulting in the formation of a viable human zygote."

The paper of WILKS cited the medical textbook of MOORE & PERSAUD which states that, "Human development begins at fertilization, the process during which a male gamete or sperm . . . unites with a female gamete or oocyte . . . to form a single cell called a zygote. This highly specialized, totipotent cell marks the beginning of each of us as a unique individual."

Citing the WILKS paper, complainant goes on to say that, "abortifacient drugs or devices are defined as those whose action is operative after conception has occurred."

The meaning of conception and fertilization is, we believe, the key in determining the legality of the registration of Levonorgestrel 750 mcg. Tablet. Stated another way, the answer to the question -- "When does human life begin?" determines the answer to the final question -- "Is the action of Levonorgestrel in the woman's reproductive system directed against a new human being as to characterize the drug as abortifacient?"

FIRST, on the question of "When does human life begin?".

1. Dr. CORAZON T. LIM, M.D. of the Philippine Obstetrical and Gynecological Society (POGS) wrote this Office:

"When does life begin? Majority believe that life begins at fertilization."

DR. LIM cited an article entitled "Life Begins at Conception," by PAUL A. BYRNE, M.D. (Neonatologist, American Board of Pediatrics, Sub-Board of Neonatal Prenatal medicine of the American Board of Pediatrics) published in VITAL SIGNS, September-October 1993, where Dr. Byrne wrote:

"Many textbooks on human embryology state that a new human life begins at conception (See e.g. Langman, Medical Embryology, p. 3 (1963): 'The development of a new individual commences with fertilization;' Thomas, Introduction to Human Embryology, p. 52 (1968); 'Fertilization is significant in that new life is created . . .'; O'Rahilly, Developmental Stages in human Embryos, p. 9 n. 1; 'the initiation of new life occurs at that moment when fertilization is completed by fusion of the two sets of chromosomes.'

"I have never read a medical text or heard of any doctor writing or stating that what exists at conception is not a new human life."

She also cited DR. JEROME LEJEUNE, (Medical Doctor, Doctor in Science, Professor of Fundamental Genetics for over 20 years, and discoverer of the genetic cause of Down's syndrome) who had stated that it is important to understand the meaning of fertilization as the beginning of a human being.

2. NERISA CINCO-CALIMON of the Philippine College of Pharmaceutical Medicine referred to the textbook by MOORE & PERSAUD, The Developing Human: Clinically Oriented Embryology (pp 2-18) which states that "a zygote is the beginning of a new human being (an embryo). Human development begins at fertilization, the process during which a male gamete or sperm . . . unites with a female gamete or oocyte . . . to form a single cell called zygote."

3. The product licensee, SCHWARZ PHARMA PHILS., INC. does not go by the above definitions of conception/fertilization. Instead, it cited Emergency Contraceptive Pills: Medical and Service Delivery Guidelines (Consortium for Emergency Contraception, October 2000) wherein it is written:

"Data from studies of high-dose oral contraceptives indicate that the two ECP regimens described in these guidelines do not cause abortion; that is, they do not interrupt or damage a pregnancy, defined as beginning after implantation has occurred."

Grounded on such "definition" of pregnancy, it is the position of SCHWARZ PHARMA PHILS. that when Levonorgestrel acts to prevent implantation, as it admittedly does, there is nothing interrupted because prior to implantation, pregnancy has not begun, that is, no human life has begun to exist.

4. Central to the submission of ABAYPAMILYA FOUNDATION is a letter dated August 28, 2001 (Annex "A") addressed to this Office by Prof. Dr. DIANNE NUTWELL IRVING, M.D., M.A., Ph. D. of the United States (with Curriculum Vitae included.)

Dr. IRVING wrote:

"The major issue concerns when a new living human being begins to exist. Scientifically, there is no question whatsoever that this occurs at fertilization - in vivo, or in vitro. By the time of implantation, the living human embryo is approximately already 5-7 days old. This is not a 'religious', 'prolife', or subjective 'belief' or 'opinion', but rather it is an objective scientific fact that has been known scientifically for over a hundred years, e.g., with the publication of Wilhelm His' (the 'Father of Human Embryology'), Anatomie menschlicher Embryonen (Leipzig: Vogel, 1880-1885).

Dr. IRVING also cited MOORE & PERSAUD (6^th ed.), "a zygote is the beginning of a new human being." She further cited LARSEN, Human Embryology (1997), "In this text, we begin our description of the developing human with the formation and differentiation of the male and female sex cells or gametes, which will unite at fertilization to initiate the embryonic development of a new individual . . ." ; O'RAHILLY & MULLER, HUMAN EMBRYOLOGY & TERATOLOGY, "Fertilization is an important landmark because, under ordinary circumstances, a new, genetically distinct human organism is thereby formed. The ill-defined and inaccurate term pre-embryo . . . is not used in this book"; and CARLSON, HUMAN EMBRYOLOGY AND DEVELOPMENTAL BIOLOGY, (1994) which states in particular that, "Human pregnancy begins with the fusion of an egg and a sperm."

We note Dr. Irving's statement that "the scientific experts who are the experts on the issue of when a human being begins to exist, and on subsequent early human development from fertilization on, are human embryologists. Although many attempt to cast even the scientific issue in 'subjective' terms, it needs to be realized that in the science of human embryology these scientific experts are professionally required to follow definitions of terms according to an International Nomina Embryologica Committee (INEC). This international committee meets every 3-5 years to examine, update and clarify which human embryological facts are scientifically demonstrated, accurate, and acceptable for human embryologists worldwide to employ in their own research, teaching and textbooks. In other words, these scientific definitions are not arbitrary, nor are they 'relative'. And among human embryologists globally there is 100% consensus on these objective scientific facts. If other scientists and physicians are not aware of these scientific facts, that is more a reflection of their lack of knowledge and/or credentials, rather than a reflection of any 'confusion' on these scientific facts."

5. Mr. JOHN WILKS, Pharmacist from Australia, as addressed to this Office a paper dated August 22, 2001 (Annex "B", with Currivulum Vitae) wherein he traces the historical perspective and origins of what he calls the "embryological error" which spawned the dissociation of conception from fertilization, and its re-association with implantation. He wrote:

The origins of this embryological error can be traced back to the text Obstetric-Gynecologic Terminology, published by the American College of Obstetrics and Gynecology (ACOG) in 1972.

In this text, conception was specified to be "the implantation of the blastocyst." Conception was not, according to this revised definition, one and the same with fertilization. Consequently, pregnancy was re-defined as "the state of a female after conception and until termination of the gestation."¹ As a consequence of this new definition, any interference with the viability of the human embryo, from the time of its creation until the time of implantation, was no longer an abortifacient action. According to this 'new' definition, no pregnancy (apparently) existed; hence no abortifacient actions are possible.

Having re-defined conception, which began the process of dismantling the continuum of fertilization, conception and pregnancy, a further reworking of pregnancy was initiated and approved at a meeting of the International Federation of Gynecology and Obstetrics (FIGO), in 1985. The Committee on Medical Aspects of Human Reproduction was asked by FIGO to "develop an accurate definition of pregnancy."

That --

As a consequence of the ACOG action in 1972, and the subsequent redefining of pregnancy in 1985, there has been an increasing trend in the deviations from definitional orthodoxy. Some examples of the re-defining of pregnancy are:

"The prevention of pregnancy before implantation is contraception and not abortion." ² (Glasier 1997)

Mr. WILKS emphasized that --

These statements are, in the strictest sense of the word, non-sense. A woman is pregnant because fertilization has been completed and conception has occurred, not because implantation has taken place. Implantation is, from both a time and developmental perspective, separate to conception/fertilization. Implantation of the human embryo takes place around the sixth day after fertilization³ with the human embryo now a multi-cellular structure known as a blastocyst. As Mosby's correctly states: "Pregnancy - the gestational process, comprising the growth and development within a woman of a new individual from conception through the embryonic and fetal periods to birth.⁴

I respectfully draw your attention to another example of meaning manipulation. Those who seek to promote postcoital birth control re-name the human embryo a "pre-embryo",⁵ a "fertilized ovum"⁶ or a "fertilized egg."⁷ Again, these are non-sense terms without any basis in science. They are ideological definitions only, fully in conflict with contemporary embryology. To recall: "Human development begins with fertilization, a process during which a sperm unites with an oocyte (ovum)." (Their emphasis).⁸ This distinction in terminology is critical. The full range of bioethical issues linked to the morning-after pill is centred upon this point."

This Office took time in going over the compendium of medical writings-standard textbooks and medical journals, including the submissions addressed to this Office by the above named resource persons both, Filipino and foreign authorities whose respective professional background in the medical and pharmaceutical community (See Currivulum Vitae, Annexes "A-1", "B-1" and "C-1") sufficiently qualify them to speak on this issue with authority. We likewise considered the paper cited by the SCWARZ PHARMA, product licensee.

This Office can only rely on the objective and scientific fact generally accepted in the medical profession that "life begins at conception and the moment of conception is when the ovum is fertilized by the sperm that there is human life." This fact was earlier recognized by the framers of the present 1987 Constitution, as gleaned from the Record of the Constitutional Commission (Vol. 4, p. 668, pointed out in Annex "B" of the letter of ABAYPAMILYA to the Secretary of Health dated May 08, 2001.) According to the Constitution:

"The State . . . shall equally protect the life of the mother

and the life of the unborn from conception . . . " (Article II, Sec. 12)

thus, expressly recognizing the right to life from the moment of conception.

According to noted Constitutional authority, FR. JOAQUIN BERNAS, S.J. who was part of the 1986 Constitutional Convention:

"The intention is to protect life from its beginning, and the assumption is that human life begins at conception, that conception takes place at fertilization." (IV RECORD of the Constitutional Commission 799, cited in Bernas, J., The 1987 Constitution of the Republic of the Philippines, Manila: 1996 ed., p. 78)

Part II

With the above fact in correct perspective, we now consider the question of whether or not Levonorgestrel 0.75 mg. has an abortifacient action.

The drug insert submitted to this Office by the applicant, EURO GENERICS INT'L. PHILS., INC. indicates that Levonorgestrel inhibits implantation:

"CLINICAL PHARMACOLOGY


Levonorgestrel (Gedeon Ritcher LTD-EGIP) is believed to act to
prevent ovulation, fertilization and implantation. "

So does the product literature attached by SHWARZ PHARMA to its written submission to this Office:

"INDICATIONS


Levonorgestrel is an emergency contraceptive preparation that can

prevent conception if it is taken within 72 hours following unprotected

intercourse. It is a progestogen inhibiting the implantation of the

ovum into the endometrium, stimulating the motility of the oviduct and

increasing the viscosity of the cervical mucus."

We note that standard medical textbooks already refer to the anti-implantation effect of certain drugs. This is pointed out by Dr. IRVING as follows:

"It is also an objective scientific fact that the use of many 'contraceptives' can be abortifacient, including the 'morning-after pill', or 'emergency contraception', as stated by Moore (a member of the INEC⁹):

"Keith Moore and T.V.N. Persaud,¹⁰ The Developing Human: Clinically Oriented Embryology (6^th ed. -- use this edition only) (Philadelphia: W.B. Saunders Company, 1998), pp. 45, 58, 59, 532)

"Inhibition of Implantation: The administration of relatively large doses of estrogens ('morning-after pills') for several days, beginning shortly after unprotected sexual intercourse, usually does not prevent fertilization but often prevents implantation of the blastocyst. Diethylstilbestrol, given daily in high dosage for 5 to 6 days, may also accelerate passage of the dividing zygote along the uterine tube (Kalant et al., 1990.) Normally, the endometrium progresses to the secretory phase of the menstrual cycle as the zygote forms, undergoes cleavage, and enters the uterus. The large amount of estrogen disturbs the normal balance between estrogen and progesterone that is necessary for preparation of the endometrium for implantation of the blastocyst. Postconception administration of hormones prevent implantation of the blastocyst is sometimes used in cases of sexual assault or leakage of a condom, but this treatment is contraindicated for routine contraceptive use. . ." (Annex "A", p. 3).

DR. CHRIS KAHLENBORN¹¹ confirms these facts in his paper, The Morning After Pill: Analysis of Mechanism of Action & Side Effects, (Annex "C" and "C-1"). Dr. KAHLENBORN writes:

"All the evidence to date supports the contention that emergency contraception does not always inhibit ovulation and that it unfavorably alters the endometrial in regard to implantation. In addition, the reduced rates of observable pregnancy over the expected rates in women who receive hormonal EC in the ovulatory or post-ovulatory phase point to an abortifacient effect. Thus, the available medical evidence suggests that an abortifacient effect is likely one of the significant mechanisms by which EC reduces rates, even if given prior to ovulation."

So does Pharmacist, Mr. WILKS, as follows:

" . . . the levonorgestrel [LNG] approach clearly has an anti-developmental impact on the endometrium.

"Work by Kubba et al (1986) specifically referred to levonorgestrel, noting its ability to change "the nature" of the hormonal receptors within the endometrium.¹² Dr Rabone (1990) reported that levonorgestrel caused a reduction in the number of estrogen and progesterone receptors within the endometrium. As Dr Rabone reported: "The concentration of these receptors is critical for the normal development of the endometrium to a stage that will support implantation.

"Simon and co-workers have also reported that altered estradiol/progesterone ratios (E2/P), which will occur with high doses of levonorgestrel, are associated with the impairment of endometrial receptivity." (Annex "B", pp. 8-9)

To us, what is of great concern is simple fact pointed out by Mr. WILKS that:

" . . . the levonorgestrel-only post-coital dose is equal to taking 40 to 50 standard once-a-daily progesterone-only birth control pills."

(Annex "B", pp. 9-10).

The same facts were presented to us by local medical doctors who submitted their written responses to this Office:

1. The Philippine Obstetrical and Gynecological Society Foundation, Inc. (POGS):

"These potent progestogens such as Postinor do not prevent fertilization but inhibits implantation by decidualizing the endometrium rendering it non-receptive to implantation. In this case the so called Postinor is considered abortifacient."

2. The Philippine College of Pharmaceutical Medicine:

"Human development begins at fertilization, when a sperm units with an oocyte to form a single cell, a zygote. A zygote is the beginning of new human being. When you prevent this new human being from being implanted in the uterus, pregnancy is terminated and ABORTION occurs.

"Postinor can therefore be considered as abortifacient. The use of abortifaciens is illegal and not allowed in the Philippines."

3. The Philippine Medical Association(PMA) :

"It is the firm view of the PMA that intentional abortion is or assisted abortion directly or indirectly or in any manner whatsoever is criminal in nature. In view henceforth, condemns the use of drugs or medicines or any device for purposes of inducing abortion.

"Henceforth, if Postinor is indeed found to be abortifacient, then the PMA supports the call for recall and delisting from BFAD's registry of drug products."

The Consumer Act of the Philippines (RA 7394), one of the laws enforced by this Office, prohibits the importation of drugs which are dangerous to health. It states:

ART. 89. Mislabeled Drugs and Devices. -- A drug or device shall be deemed to be mislabeled:
i) if it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labeling thereof;

ART. 15. Imported Products. --

a) Any consumer product offered for importation into the customs of the Philippine territory shall be refused admission if such product:


x x x
2) is or has been determined to be injurious, unsafe and dangerous.

x x x

ART. 18. Prohibited Acts. -- It shall be unlawful for any person to:

a) manufacture for sale, offer for sale, distribute in commerce, or import into the Philippines any consumer product which is not in conformity with an applicable consumer product quality or safety standard promulgated in this Act.

Conclusion

Even as this Office had notified interested parties and invited written submissions before resolving this issue pursuant to the procedural guidelines contained in Adm. Order No. 66, s. 1989, the same Administrative Order states in paragraph 2.3:

"2.3 -- This procedure of review and evaluation does not preclude however the BFAD from submitting a recommendation to immediately ban a drug and all products containing it in cases where there is a clear finding of serious or lethal toxicity constituting undue risk to public safety. In which cases, the BFAD shall submit its finding and recommendation, together with records of substantial evidence to the Secretary of Health for immediate action."

We therefore find that Levonorgestrel 750 mcg marketed as Postinor is not registrable in the Philippines. We recommend:

1. That Certificate of Product Registration No. DR-XY26140 dated April 24, 2000 issued to EURO GENERICS INT'L. PHILS., INC. be cancelled;

2. That the Department prohibit the further importation, use, dispensing, sale and distribution in the local market of Levonorgestrel 750 mcg - Postinor;

3. That all existing inventories of the drug in any warehouse, enclosure, pharmacy, whether public or private, be immediately reported and delivered to the Department, through the BFAD, for immediate proper disposition.

(SIGNED) WILLIAM TORRES, Ph. D.

Director (Sgd.) 1/10/01

---

NOTES:


¹
Tatum HJ, Connell EB. A decade of intrauterine contraception : 1976 to 1986. Fert Steril 1986; 46(2): 173-192



²
Glasier A. Emergency postcoital contraception. NEJM 1997; 337:1058-1064



³

Larsen, op.cit., p.19.



⁴
Mosby's, 5th ed., op.cit., p.1309



⁵
Grimes, loc. cit.



⁶
Harper C, Ellerston C. Knowledge and perceptions of emergency contraceptive pills among a college-age population: A qualitative approach. Family Planning Perspectives. 1995; 27:149-154



⁷
Ashraf H, McCarthy M. UK improves access to "morning after pill". Lancet 2000;356:2071



⁸

Moore, op.cit., pp. 14 & 531



⁹
International Nomina Embryologica Committee, an international committee that meets every 3-5 years to examine, update and clarify which human embryological facts are scientifically demonstrated, accurate, and acceptable for human embryologists worldwide. to employ in their own research, teaching and textbooks. In other words, these scientific definitions are not arbitrary, nor are they 'relative.' And among human embryologists globally, there is 100% consensus on these objective scientific facts. If other scientists and physicians are not aware of these scientific facts, that is more a reflection of their lack of knowledge and/or credentials, rather than a reflection of any 'confusion' on these scientific facts. (Dr. Dianne Irving, Annex "A", p. 1)




¹⁰
Annex "A-3" herein.



¹¹
Author, Breast Cancer: Its Link to Abortion and the Birth Control Pill, New Hope, Kentucky: 2000.



¹²
With reference citations detailed by Mr. WILKS in ANNEX "B."