By: Cong. Karlo Alexei Nograles
Representative, Davao City, 1st District
(Privileged Speech delivered during the RH Bill Hearing, June 8, 2011)
Madam Speaker, Majority Leader, dear colleagues, good day.
I rise today on a subject that demands this august Chamber's gravest concern: the dismal failure of a major government agency to discharge its mandated function in law to protect and promote the health of Filipino mothers, shield and protect motherhood from peril, and safeguard their maternal functions.The regulation of providers of drugs and medicines is reposed by law, R.A. No. 3720, the Food, Drug, and Cosmetic Act in the Food and Drug Administration or FDA, a regulatory agency under the Department of Health. It is mandated to ensure the safety, efficacy and good quality of all food and drug products being made available to the general public pursuant to Section 2 which provides: “It is hereby declared the policy of the State to insure safe and good quality supply of food, drug and cosmetic, and to regulate the production, sale, and traffic of the same to protect the health of the people.”
On April 19, 1992, the Consumer Act of the Philippines, R.A. No. 7394, went into effect. According to Article II, “It is the policy of the State to protect the interests of the consumer, promote his general welfare and to establish standards of conduct for business and industry. Towards this end, the State shall implement measures to achieve the following objectives: a) Protection against hazards to health and safety.”
After all, there is a clear and express constitutional mandate that: “The State shall protect consumers from trade malpractices and from substandard or hazardous products,” Article XVI, Section 9 of our Constitution.
Pursuant to Article VI of the Consumer Act, it is the Department of Health, through the Food and Drug Administration, that is responsible to the public with respect to drugs, devices and substances.
Section 4 of the Consumer Act defines “drugs” to mean articles recognized in the current official United States Pharmacopeia-National Formulary, official Homeophatic Pharmacopeia of the United States, official National Drug Formulary, or any supplement to any of them; and number two, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals.
Among the drugs, Madam Speaker, that fall under this definition are the oral contraceptives administered to women and mothers, the injectible contraceptive Depo Provera and the so-called “morning-after pill”.
The same section defines a “device” as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similaror related article, including any component, part or accessory which is recognized in the official United States Pharmacopeia National Formulary or any supplement to them; two, intended for use in the diagnosis of disease or other condition or in the cure, mitigation, treatment or prevention of disease in man or other animals.
Among the devices administered to women and mothers as contraceptives are the Intra-Uterine Device or IUD, and in recent times, the suction device known as the Manual Vacuum Aspirator or MVA. Both are allowed to be used and actually form part of the family planning devices used by the Department of Health.
We shall now see, Madam Speaker, in what manner these contraceptive drugs, substances and devices are supposed to cure, mitigate, treat or prevent disease in women and mothers.
First, the oral contraceptives. The so-called high-dose contraceptive pills bring about changes in the environment of the endometrium, that is the uterine lining of the woman, making implantation more difficult. When the high-dose pill functions via this last mechanism, it is an abortifacient if the woman experienced a “breakthrough” ovulation.
These pills have, for the most part, been pulled from the United States market due to their dangerous side effects. Naturally, they are still dumped relentlessly on poor women in developing countries.
The low-dose biphasic and triphasic pills on the other hand function in essentially the same manner as the high-dose pill. However, a much higher percentage of ovulation occurs in women who use the low-dose pills. This means that women who use these pills frequently conceive,and that low-dose pills prevent implantation of the new human individual, thereby acting more often as true abortifacients.
The Mini-Combination Pill functions by inhibiting ovulation and causing changes in the cervical mucus. However, their primary mode of operation is abortifacient, because they prevent implantation by causing changes in the endometrium.
Then, of course, there is the Mini-Pill. The primary mechanism of these pills have not been pinpointed, although women who use them almost always ovulate. Therefore, these pills function primarily as abortifacients.It is known that pills which contain only progestin alter the cervical mucus. They also interfere with implantation by affecting the endometrium and suppressing ovulation in some patients by reducing the presence of follicle-stimulating hormone(FSH).
This mechanism, Madam Speaker, is confirmed by the United States Food and Drug Administration (FDA), which stated that “Progestin-only contraceptives are known to alter the cervical mucus, exert a progestinal effect on the endometrium, interfering with implantation, and, in some patients, suppress ovulation.”
The manufacturers of the minipills also acknowledge this mode of action. For example, Syntex Laboratory spokesman, Rush Wilks, announced that “its progestin-only pill “... did not interfere with ovulation... It seems to affect the endometrium so that a fertilized egg cannot be implanted.”
In other words, Madam Speaker, the pill is now truly “birth control” not conception control, as was originally intended.
According to United States Federal courts, the birth control pill has been classified as “unavoidably unsafe.” This means that, implicit in a woman's consent to use the pill, even if she is not entirely informed of its dangers, is an acknowledgment of physical risk.
This legal classification means that women damaged by the pill have a much harder time recovering damages. Dr. John Hildebrand, an expert in the field, estimates that more than 500 women die every year because of pill-induced effects. This startling number is confirmed by figures provided by the Alan Guttmacher Institute and one of the foremost abortionists in the United States, Warren Hern.
It is ironic, Madam Speaker, that the same pill pushed so hard as part of the supposed solution to “excessive illegal abortion deaths” now kills five times as many women per year as illegal abortions themselves did before Roe v Wade.
The most dangerous and well-documented side effects commonly associated with the pill are heart attacks and strokes. The eight-year Nurse's Health Study at Harvard Medical School found that pill users are 250% as likely to have heart attacks and strokes than those who do not use the pill because the pill excessively increases blood clotting ability.
Now, let us talk about breast cancer. The Fertility and Maternal Health Drugs Advisory Committee is a panel of medical experts that meet to advise the commissioner of the United States Food and Drug Administration.
The committee evaluated a study by Dr. Clifford R. Kay of the Royal College of General Practitioners of Manchester, England. Kay studied 46,000 women, half of which were pill users and half of which were non-users. He found that pill users were more than three times more likely to develop breast cancer than non-users between the ages of 30 and 34.
A second study by researchers at the Boston University School of Medicine, the University of Pennsylvania and New York's Memorial Sloan- Kettering Cancer Center completed in 1988, showed that the longer women took the pill, the greater their chances of contracting breast cancer. The risk of developing breast cancer was found to be twice as great by age 45 for women who had used the pill for less than 10 years and four times as great for women who had used the pill for more than 10 years.Now, another type of drug, Madam Speaker, is the morning-after pill or emergency contraception. Postinor Levonorgestrel believed to act to prevent ovulation, fertilization and implantation. This was approved for sale and distribution in the Philippines by the Bureau of Food and Drugs as an emergency contraceptive. By reason of its abortifacient action, Abay Pamilya Foundation asked the Department of Health on May 8, 2001 to cancel its product registration.
The public hearings conducted by the DOH revealed the following uncontroverted data about the morningafter pill, Postinor: Number one,Levonorgestrel has a high pre-implantation emergency abortifacient action.According to authorities cited by the petitioners in DOH and based on learned medical treatises, the Levonorgestrel approach clearly has an anti-developmental impact on the endometrium of the woman. Work by Kubba, et. al. (1986), specifically referred to Levonorgestrel noting its ability to change the nature of the hormonal receptors within the endometrium.
Dr. Rabone (1990), reported that Levonorgestrel caused a reduction on the number of estrogen and progesterone receptors within the endometrium. The concentration of these receptors is critical for the normal development of endometrium to a stage that will support implantation.
Simon and co-workers have also reported that altered estradiol/ progesterone ratios or E2/P which will occur with high doses of Levonorgestrel are associated with the impairment of endometrial receptivity.Number two, inhibition of implantation. The administration of relatively large doses of estrogen or “morning-after” pills for several days beginning shortly after unprotected sexual intercourse usually does not prevent fertilization but often prevents implantation of the blastocyst. Postconception administration of hormones prevent implantation of the blastocyst and is sometimes use in cases of sexual assault or leakage of a condom.
Number three, the abortifacient action of Levonorgestrel was not denied by its Philippine importer. The drugs inserts submitted by the importer-distributor, Euro-Generics International, Philippines, reads: Clinical Pharmacology, Levonorgestrel is believed to act to prevent ovulation, fertilization and prevent implantation.
Number four, Gedeon Ritcher Ltd., the drugs manufacturer, was aware of the moral and ethical implications of Levonorgestrel. The 2001 petition in the DOH, citing Thaler Gy, stated, “Gy. Thaler of Gedeon Richter, Limited, the manufacturer of Postinor (Levonorgestrel 0.75 milligrams), has unwittingly acknowledged the seriousness of this debate by noting that the promotion and use of the morning-after pill involves ethical and moral questions.”
Thus, the morning-after pill, Levonorgestrel, whether marketed as Postinor or some other brand, and any estrogen or progesterone with an abortifacient action is not registrable under Philippine law.
However, Madam Speaker, Levonorgestrel Mirena, as an IUD or intra- uterine device, can be ordered by an OB-gynecologist through the medrep. And Levonorgestrel is also available in several other names here in the Philippines, namely: Logynon, Nordet, Charlize, the Trust pill and Lady. These are all available in your local drugstore.
Now, Republic Act No. 5921, or an Act Regulating the Practice of Pharmacy and Setting Standards of Pharmaceutical Education in the Philippines, provides in Section 37 that “No drug or chemical product or device capable of provoking abortion or preventing conception as classified by the Food and Drug Administration shall be delivered or sold to any person without a proper prescription by a duly licensed physician.”
The reality, however, the reality, however, Madam Speaker, is this—contraceptive pills can be purchased by any person regardless of age, sex or civil status over the counter. I have personal experience purchasing contraceptive pills myself without prescription, Madam Speaker, when I purchased several birth control pills on May 25, 2011 and again on June 2, 2011 just to prove how easy it is to purchase these pills.
More dangerously, Madam Speaker, in the May 30, 2011 Senate committee hearing, last week, that discussed three Senate bills protecting the unborn, former DOH Secretary Alberto Romualdez stated, under oath, that contraceptive pills can also be ingested as emergency contraception by altering the dosage. Let me just say this, Madam Speaker, birth control pills, purchased very easily without prescription, can be used for abortion by just doubling the dosage for a period of five days.
Let me go to another drug, the Depo-Provera injectible. Depo-Provera was banned as a contraceptive in the US in 1978. While this is so, it is endorsed by agencies such as the International Planned Parenthood Federation and the World Health Organization for use in the Third World. But our Consumer Act, our Consumer Act states in Article XXXIII that “Banned or severely restricted drugs for health and safety reasons in their country of origin shall be banned and confiscated, or its uses severely restricted, whichever is appropriate, by the Department. The Department shall monitor the presence in the market of such drugs and cause the maintenance and regular publications of an updated consolidated list thereof.”
Madam Speaker, Depo-Provera is imported, available and administered widely in the Philippines.
But warnings on its safety are not unknown to the Department of Health: Loss of bone mineral density, thromboembolic disorders, cancer risks, ectopic pregnancy, anaphylaxis and anaphylactod reaction, convulsions, bleeding irregularities, excessive weight gain, fluid retention---these are among the drug's dangerous effects. Banned in the United States, Depo-Provera can be purchased in your favorite drugstore for P117.00. And it goes by the names, Depotrust, Lyndavel, and Provestin.
Apart from the drugs, let's now talk about devices; namely, the intrauterine device and the manual vacuum aspirator.
First, the IUD. What is an intrauterine device? The intrauterine device is a foreign body made of a non-reactive plastic such as polyehtylene inserted in the uterus of the woman to prevent implantation of the developing human being. Some IUDs include active chemicals such as progesterone or copper which slowly diffuse into the uterus for an enhanced abortifacient effect. How do IUDs work? The different IUDs have different modes of action. They prevent sperm from fertilizing ova, release ions, primarily copper, that interfere with fertilization. They thicken the cervical mucus and inhibits sperm capabilities. These are all contraceptive effects. But IUDs also irritate the endometrium or the lining of the uterus of the woman and make it inhospitable for the blastocyst or the very early developing human being. Thus, an abortifacient effect. There is some disagreement among medical authorities over the contraceptive effects of IUDs, but these experts do agree that IUDs prevent implantation.
The American Medical Association's Committee on Human Reproduction has said that, "The action of IUDs would seem to be a simple local phenomenon. That these devices prevent implantation of an already fertilized ovum has been accepted as the most likely mechanism of action." The U.S. Food and Drug Administration, FDA, which studies birth control methods before releasing them to the market, has observed that "IUDs seem to interfere in some manner with the implantation of the fertilized egg in the lining of the uterine cavity. The IUD does not prevent ovulation."
The other device as I mentioned, is the manual vacuum aspirator, known more popularly as the MVA. This is a device for uterine evacuation. Meaning, suction of the contents of the womb. The MVA uses an aspirator with a cylinder, a plunger, and a bulb attached to the cannula with one or two apertures. According to literature describing and marketing the device, the indications for uterine aspiration using this device are : number 1, endometrial biopsy; number 2, treatment of incomplete abortion; and number 3, Madam Speaker, first-trimester abortion.
If the device is an instrument to procure an abortion, then it falls under the definition of an imminently hazardous product defined in Section 4 of the Consumer Act Section 4 of the Consumer Act, to wit, and I quote: “Imminently hazardous product means a consumer product which presents an unreasonable risk of death, serious illness or severe personal injury.”
A device of death, the MVA is purchased by local DOH agencies in some local government units.
In a case study in the Philippines entitled: Planning for a Sustainable Supply of Manual Vacuum Aspiration Instruments, a Guide for Program Managers, it appears that in this country, the key partners in the importation and use on the abortive device MVA are the DOH, Pangasinan Province, the NGO EngenderHealth, the local commercial distributor, the Packcard Foundation, and U.L.S. A.I.D. The local direct contractor of the MVA in the Philippines is BDM Enterprises.
I therefore ask, Madam Speaker, do these oral contraceptives, the morning-after pill, depo-provera, the IUD and the manual vacuum aspirator, cure, mitigate, treat or prevent disease? Are they safe for women and mothers?
Madam Speaker, no government can bargain away the public health. The people themselves cannot do it, much less their servants. And as public officers, our health officials can only execute the law, not disobey it. How can our government officers, whose sworn duty is to protect and preserve the health of our countrymen, allow such hazardous drugs and devices, abortifacients and carcinogens to be openly sold and distributed in our country?
I therefore call on this House to initiate an immediate investigation on the serious failure of our health agencies in exercising its strict mandate to defend and safeguard the health of Filipinos, particularly our women, in accordance with the letter, spirit and intent of our laws.
Thank you, Madam Speaker. Thank you, dear colleague.