Consolidated RH Bill HB4244

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Dissecting the Consolidated RH Bill Medical, Public Health, & Bioethical Issues

Dr. Liza C. Manalo, MSc. Department of Family & Community Medicine

R H B I L L S

Human Dignity Beneficence Non-Maleficence

Justice
Allocation of scarce resources

Autonomy
Bioethical Principles in Medical Practice

Success can be taught
• The process starts with making people understand that each of us choose to be victims or victors. • Poverty is more than a lack of income. It is also the consequence of specific behaviors and decisions. • The real long term solution to poverty is not achieved by mere luck and circumstance. It is achieved by a string of decisions. • Set backs in life happen, but there is no special formula that magically brings prosperity and wealth. • It is the core belief that we, the people, have the power to overcome wrongs, injustices, and disasters. • It is the fundamental knowledge that we ultimately have power over ourselves, our lives, and our pursuit of happiness.
- Reese, Nov, 2008 http://www.digitaljournal.com/article/262211

The real answer to poverty is a two step process :
• 1st step in helping people rise from despair: instill self worth.
• There is no self worth or self dignity found in a dole-out.
• This does not mean that we don't lend a helping hand; this means that the helping hand must be accompanied by true compassion that is not attached to our own personal agenda for the individuals we claim we want to help.

• The first step is by far the toughest. Victory over victim-hood does not occur overnight, and people have to want that personal victory before they can find the will to fight for personal success.
- Reese, Nov, 2008 http://www.digitaljournal.com/article/262211

The real answer to poverty is a two step process :
2nd: Simply teach the odds to people each year, from 3rd grade through high school graduation, as to who are are the poor: • High school drop-outs • Staying single • Having children without a spouse • Working only part time or not working at all - 2001 U.S. Census data

• How Not to Be Poor: • Stay in School • Get a Job • Get Married • Don't Have Children Out of Wedlock
- National

Center for Policy Analysis, Jan, 2003
http://www.ncpa.org/pub/ba428/

Importance of Having Children to Filipinos
• The Filipinos strive to expand the power of his family and in turn enhance their welfare through procreation. • Many children would mean more people supporting the members of it as a whole.
• In the farming families in the provinces, more children means more hands to help in harvesting the crops. • In a typical home, more children would mean more help to do the household chores. • When it comes to family protection, the saying "blood is thicker than water", runs true to Filipinos, the more family members, the more protection one gets against attacks, to defend them against their enemies. Certainly an example of "strength in numbers".

• The bigger the family, the better and the prouder their members are especially when there are family members who are accomplished in their own fields.
- http://www.western-asian.com/marriage/44marriage/103-importance-ofhaving-children-to-filipinos

Improve Maternal Health

Many women still deliver without medical attendance
• Birth attendance by skilled personnel, a proxy indicator for MMR, has only slightly increased from 58.8% in 1990 to 62.3% in 2006 (FPS) Most women in rural areas prefer hilots (TBAs) Non skilled birth attendance is worst among the poor with the rich more likely to have skilled attendance at delivery than the poor
Type of Assistance During Delivery
70 60 50 Percent 40 30 20 10 0 1993 1998
SBA
52.8 45.3 56.4 41.3 37.1 34.5 59.8 62.3

• •

2003
Non-SBA

2006

Everyday another 10 Filipino women die of complications due to pregnancy and childbirth.

The main causes of maternal deaths could have been avoided

Source: Wagner and Claeson. 2004

Eliminating maternal deaths is POSSIBLE
Zero maternal mortality from 1994 up to 2004 GattaranCagayan, Ara-asan-Surigao del Sur and Isulan, Sultan Kudarat
• Key elements • Pregnancy Watch • Prepaid Perinatal Services • Upgraded Birthing Centers • Botica sa Birthing (Pharmacy) • Walking Blood Bank • Tambayan sa Birthing (Waiting Home) • Male Motivators

Priority interventions on the ground
DELAY # 1 Deciding to seek EmOC • Educate on danger signs and location of EmOC facility • Provide alternatives for financing (Social/Community Health Insurance) • Establish Community support group (e.g.. TBA, BHW) DELAY # 2 Reaching an EmOC Facility • Improve access to transport and communication systems • Prepare delivery plan during antenatal visits DELAY # 3 Receiving EmOC at Facility • Ensure availability of skilled birth attendant • Provide adequate drugs, equipment, blood transfusion • Improve quality of services for the poor, less educated, and women who had undergone abortion

At the service level Increase Demand and Utilization for Emergency Obstetric Care (EmOC)
• Improve quality of antenatal services • Information on danger signs and where to go when complications arise • Ensure provision of iron and folic acid supplementation • Rice biofortification • Distribution in workplace-based settings • Prepare delivery plans that include options for transport and financing • Network with traditional birth attendants (TBAs) to identify danger signs, plan referrals

CONSOLIDATED REPRODUCTIVE HEALTH BILL (HB 4244) is about:
• Education & promotion of safe sex and use of modern contraceptive devises. (Sec. 13, Mandatory Age-Appropriate Reproductive
Health and Sexuality Education, HB 96 )

• Classifying making family planning supplies as essential medicine (Sec. 9, Family Planning Supplies as Essential Medicines, HB 96 ) • Promoting a program to “achieve equitable allocation of resources” when problems pertaining to lack of “reproductive health” is not as prevalent nor as lifethreatening as our other health problems. (Sec. 3, Guiding
Principles, HB 96)

• Mandatory age-appropriate reproductive health and sexuality education (Sec. 13, HB 96)

V i 1.1 o l a t i o n

Reproductive Health and Population and Development Act of 2010 is about education & promotion of safe sex and use of modern contraceptive devises.
See Sec. 13, Mandatory Age-Appropriate Reproductive Health and Sexuality Education, HB 96

V 1.1 What is wrong with “safe sex” and the use of contraceptives? i • Contraceptives are not effective in blocking out STDs. o • The inherent naturally occurring flaws in natural rubber (latex) are up to 5 microns inches in size. The average l sperm is about 50 microns in diameter, and the average AIDS virus is about 0.1 micron in size. An AIDS virus can a pass through a latex flaw. t i - Dr. C. Michael Roland of the U.S. Naval Research Lab, o Washington D.C, Rubber World, June, 1993 n

What is wrong with “safe sex” and the use V 1.1 of contraceptives? i • There is no absolute guarantee that one will not get sexually o transmitted diseases (STDs) and HIV even when condom is used. getting HIV/AIDS and l • Most experts believe that the risk of can be greatly reduced other sexually transmitted diseases if a condom is used consistently and correctly. a • In other words, sex with condoms isn't totally "safe sex," but it is "less risky" sex. t • The most reliable ways to avoid transmission of STDs are to abstain from sexual activity, or to be in a long-term mutually i partner. monogamous relationship with an uninfected - Centers for Disease Control (CDC) & US FDA o n

V 1.1 i • There is no absolute guarantee that one will not get genital HPV, the most common sexually transmitted infection, even o when condom is used. • For those who choose to be sexually active, condoms l may lower the risk of HPV. To be most effective, they should be used with every sex act, from start to finish. Condoms may also lower the risk of developing HPVa related diseases, such as genital warts and cervical cancer. But HPV can infect areas that are not covered t by a condom - so condoms may not fully protect against HPV. i • People can also lower their chances of getting HPV by being in a faithful relationship with one partner; limiting their number of sex partners; and choosing a partner o who has had no or few prior sex partners. n
- Centers for Disease Control and Prevention (CDC)

What is wrong with “safe sex” and the use of contraceptives?

When Does Human Life Begin? A Scientific Perspective
• The scientific evidence supports the conclusion that a zygote is a human organism and that the life of a new human being commences at a scientifically well defined “moment of conception.” • Based on universally accepted scientific criteria, a new cell, the human zygote, comes into existence at the moment of spermegg fusion, an event that occurs in less than a second. • Upon formation, the zygote immediately initiates a complex sequence of events that establish the molecular conditions required for continued embryonic development. • The behavior of the zygote is radically unlike that of either sperm or egg separately and is characteristic of a human organism.
• Condic M, 2008, The Westchester Institute For Ethics & the Human Person

When Does Human Life Begin? At Fertilization
• • • • • • Keith L. Moore, Before We Are Born: Essentials of Embryology, 7th edition. Philadelphia, PA: Saunders, 2008. p. 2. T.W. Sadler, Langman's Medical Embryology, 10th edition. Philadelphia, PA: Lippincott Williams & Wilkins, 2006. p. 11. Keith L. Moore, The Developing Human: Clinically Oriented Embryology, 7th edition. Philadelphia, PA: Saunders, 2003. pp. 16, 2. Ronan O'Rahilly and Fabiola Miller, Human Embryology and Teratology, 3rd edition. New York: Wiley-Liss, 2001. p. 8. Essentials of Human Embryology, William J. Larsen, (New York: Churchill Livingstone, 1998), 1-17. Carlson, Bruce M. Patten's Foundations of Embryology. 6th edition. New York: McGrawHill, 1996, p. 3 • http://www.clinicquotes.com/site/story.php?id=28

When Does Human Life Begin?
From the Pro-choice side: Acknowledgments of life before birth
• "A facet that makes the obstetrician's burden unique in the whole field of medicine is his double obligation; he simultaneously cares for two patients, the mother and the infant...The essential step in the initiation of life is by fertilization, the penetration of the ovum by a spermatozoa and the fusion of the two cells into a single cell." - Dr. Alan Guttmacher, Pregnancy and Birth: A Book for Expectant Parents New American Library, Jan, 1962. He was the president of Planned Parenthood "Let me say something shocking. I am perfectly willing to grant that life begins at conception...let's not pretend it [abortion] is not a form of killing." - Pro-Choice activist and supporter Norman Mailer to David Frost on PBS "Fertilization, then, has taken place. A baby has been conceived." - Planned Parenthood's former medical director Mary Calderone, M.D. (Quoted by pro-choice author Magda Denes. Appears in "The Zero People: Essays on Life" by Jeffrey Hensley, Servant Publications (March 1983) p 9.
• http://www.clinicquotes.com/site/story.php?id=28





V 1.1 What is wrong with “safe sex” and the use of contraceptives? i • Some contraceptives have post-fertilization effects. o Although the primary mechanism of oral contraceptives l • (OC) is inhibition of ovulation, other alterations include changes in the cervical mucus, which increase the a difficulty of sperm entry into the uterus, and changes in the endometrium, which reduce the likelihood of implantation. t - Physicians’ Desk Reference & Drug Facts and Comparisons i o n

What is wrong with “safe sex” and the use V of contraceptives? 1.1 i Some contraceptives have post-fertilization effects • o l a t i o n


“In IUD users, the low recovery of ova from the uterus, as well as the lack of hCG rise in more recent studies of IUD users, suggest that the major postfertilization effect is destruction of the early embryo in the Fallopian tube, in the same way that the major prefertilization effect is likely to be destruction of sperm and ova. • For the copper IUD, this embryocidal effect may be more a result of inflammation and direct toxicity, whereas with the progestin IUDs it may result more from inhibition of transport through the Fallopian tube, along with prevention of implantation, preventing long-term viability of the embryo.”
• Stanford and Mikolajczyk, American Journal of Obstetrics & Gynecology, December 2002

V i o l a t i o n

Reproductive Health and Population and Development Act of 2010 is about classifying making family planning supplies as essential medicine
See Sec. 9, Family Planning Supplies as Essential Medicines, HB 96

Criteria for Drug Selection into the Essential Drug List and the National Drug Formulary
(WHO Technical Report Series No.825, The Use of Essential Drugs)
Relevance to disease Efficacy and safety Quality Indicated in the treatment of prevalent diseases Based on adequate pharmacologic studies especially among Filipinos Must meet adequate quality control standard including stability &, when necessary, bioavailability Compliance with WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

Cost of treatment regimen Appropriateness to the capability of health workers at different levels of health care Local health problems Benefit/Risk ratio

V i o l a t i o n

What is wrong with classifying family planning supplies as essential medicines?
• Most normal, low-risk pregnancy, per se, is not a disease, and as such does not need medicines, except for iron and folic acid supplementation. • Hence, the only “essential” medicines during pregnancy would be ferrous sulfate and multivitamins.

V i o• l a t i o n

What is wrong with classifying family planning supplies as essential medicines?
Combined Oral Contraceptives (COC) are not safe, as they are classified as carcinogenic to humans by the World Health Organization • The International Agency for Research on Cancer (IARC), the cancer research agency of WHO, in its press release of the 29th of July 2005, informed of the publication of a monograph on the carcinogenicity of combined estrogenprogestogen oral contraceptives (COC) and combined estrogen-progestogen menopausal therapy (HRT), based on the conclusions of an international Working Group of 21 scientists from 8 countries.
• http://www.who.int/reproductivehealth/publications/agein g/cocs_hrt_statement.pdf • http://www.iarc.fr/en/media-centre/pr/2005/pr167.html

V i• o l a t i o n

What is wrong with classifying family planning supplies as essential medicines?
Combined Oral Contraceptives (COC) are not safe, as there is sufficient evidence in humans for their carcinogenicity • Estrogen-progestogen oral contraceptives were classified in the Group 1 of carcinogenic agents, after a thorough review of the published scientific evidence. • This evaluation was made on the basis of increased risks for cancer of the breast among current and recent users only, for cancer of the cervix and for cancer of the liver in populations that are at low risk for hepatitis B viral infection.
• IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 91 (2007) http://monographs.iarc.fr/ENG/Monographs/vol91/mono91-6E.pdf • The Lancet Oncology, Vol 6 August 2005 http://oncology.thelancet.com

V i• o l a t i o n

What is wrong with classifying family planning supplies as essential medicines?
Combined Oral Contraceptives (COC) are not safe, as women who were current or recent users of birth control pills had a slightly elevated risk of developing breast cancer.
• from the analysis of 54 epidemiological studies conducted by the Collaborative Group on Hormonal Factors in Breast Cancer on 53,297 women with breast cancer and 100,239 women without breast cancer
• The risk was highest for women who started using OCs as teenagers. • Lancet 1996; 347:1713–1727.

V i • o l a t i o n

What is wrong with classifying family planning supplies as essential medicines?
Combined Oral Contraceptives (COC) are not safe, as the risk for breast cancer was highest for women who used OCs within 5 years prior to diagnosis, particularly in the younger group
• From the National Cancer Institute (NCI)-sponsored study among women ages 20 to 34 compared with women ages 35 to 54.
• Althuis MD, Brogan DD, Coates RJ, et al. Breast cancers among very young premenopausal women (United States). Cancer Causes and Control 2003; 14(2):151–160. • http://www.cancer.gov/cancertopics/factsheet/Risk/oralcontraceptives

V i o• l a t i o n

What is wrong with classifying family planning supplies as essential medicines?
Contraceptive hormone use is linked to cardiovascular disease.
• Newer generation oral contraceptives (OC) indicate a persistent increased risk of venous thromboembolism for current users. • Current guidelines indicate that, as with all medication, contraceptive hormones should be selected and initiated by weighing risks and benefits for the individual patient. • Women 35 years and older should be assessed for cardiovascular risk factors including hypertension, smoking, diabetes, nephropathy, and other vascular diseases, including migraines, prior to OC use. • Shufelt & Bairey Merz, J Am Coll Cardiol. 2009 Jan

V i o• l a t i o n

What is wrong with classifying family planning supplies as essential medicines?
Intrauterine devices (IUDs) are not safe
• During the use of a copper IUD, menstruation tends to be longer with a greater loss of blood; in 70% of women who use a hormonal IUD oligomenorrhea or even amenorrhoea develops. In the first weeks after IUD insertion, there is an increased risk of pelvic inflammatory disease (PID). • Summary of the practice guideline 'The intrauterine device' from the Dutch College of General Practitioners, 2009 • A World Health Organization multi-centre study established that pelvic inflammatory disease (PID) risk is temporally related to IUD insertion procedures. • Shapiro, Reprod Health Matters. 2004 May

V i o• l a t i o n

What is wrong with classifying family planning supplies as essential medicines?
Intrauterine devices (IUDs) are not safe
• In 15 studies comparing IUD performance in parous vs. nulliparous women, nulliparous women had higher rates of expulsion and removals due to bleeding and pain.
• Hubacher, Contraception. 2007 Jun

• Uterine perforation is a rare yet serious complication and is usually seen during insertion of the IUD.
• Koltan et al, J Chin Med Assoc. 2010 Jun

• There are about 70 cases in the literature of IUDs that have migrated into the bladder. The resulting bladder perforation can be complete or partial.
• Istanbulluoglu et al, J Chin Med Assoc. 2008 Apr

• There is a reported case of a colon penetration by a copper IUD.
• Arslan et al, Arch Gynecol Obstet. 2009

V i o l a t i o n

Unjust Distribution of Benefits & Burdens

Reproductive Health and Population and Development Act of 2010 is about promoting a program to “achieve equitable allocation of resources” when problems pertaining to lack of “reproductive health” is not as prevalent nor as life-threatening as our other health problems.
See Sec. 3, Guiding Principles, HB 96

Top Ten Leading Causes of Morbidity and Mortality in Low-Income Countries
(WHO, 2004)
Deaths in millions
Lower respiratory infections Coronary heart disease Diarrheal diseases HIV/AIDS Stroke & other cerebrovascular diseases Chronic obstructive pulmonary disease Tuberculosis Neonatal infections Malaria Prematurity and low birth weight

% of deaths

2.94 2.47 1.81 1.51 1.48 0.94 0.91 0.90 0.86 0.84

11.2 9.4 6.9 5.7 5.6 3.6 3.5 3.4 3.3 3.2

V i • o l a t i o n


What is wrong with giving priority to reproductive health ?
“Eight of the 10 leading causes of morbidity in the Philippines are caused by infections: • Acute lower respiratory tract infection and pneumonia • Acute watery diarrhea • Bronchitis/ bronchiolitis • Influenza • Tuberculosis • Malaria • Acute febrile illness • Dengue fever
Among these communicable diseases, pneumonia and tuberculosis continue to be among the 10 leading causes of mortality, causing a significant number of deaths across the country.”
-World Health Organization (WHO) Western Pacific Region Report

V i o• l • a t i o n

What is wrong with giving priority to reproductive health ?
“Financial resources allotted by foreign donors to assist the Philippine Government’s programs could actually be better spent in other pursuits than purchasing contraceptives.” “It is also of value to demystify our perceptions about the role of contraceptives in women’s health, women’s rights, and healthy families. To equate access to contraceptives with the reduction in maternal morbidity and mortality is simplistic.” - former Department of Health (DOH) Secretary Manuel M. Dayrit, MD, MSc
Philippine Daily Inquirer, 9/20/04

V i o l a t i o n

Reproductive Health Population and Development Act of 2010 is about ensuring people’s access to medically safe, legal, effective, quality and affordable reproductive health goods and services .
See Sec. 20, Implementing Mechanisms, HB 96

V i • o l a t i o n

What is wrong with access to reproductive health goods and services?
Indiscriminate access to reproductive health goods and services without full disclosure of the potential for postfertilization effects of hormonal contraceptives constitute a violation of informed consent.
• The available evidence supports the hypothesis that when ovulation and fertilization occur in women taking oral contraceptives (OCs), post-fertilization effects are operative on occasion to prevent clinically recognized pregnancy.
Oral contraceptives directly affect the endometrium. These effects have been presumed to render the endometrium relatively inhospitable to implantation or to the maintenance of the preembryo or embryo prior to clinically recognized pregnancy. • Larimore & Stanford, Archive of Family Medicine, Feb 2000

V i • o l a t i o n

What is wrong with access to reproductive health goods and services?
Women who believe that human life begins at fertilization and those who consider it is important to distinguish between natural and induced embryo loss are less likely to consider the use of a method with post-fertilization effects.
• In a cross-sectional survey of 755 women, aged 18-49, from Primary Care Health Centers in Pamplona, Spain, 40% of women would not consider using a method that may work after fertilization but before implantation and 57% would not consider using one that may work after implantation. • de Irala et al, Biomed Central Women's Health 2007 • Among 618 women ages 18–50 in family practice and obstetrics and gynecology clinics in Salt Lake City, Utah, and Tulsa, Oklahoma, USA, 34% reported they believed that life begins at fertilization and would not use any birth control method that acts after fertilization. • Dye et al, Biomed Central Women's Health 2005

A l t e r n a t i v e

Fertility control should…
• • • • • • Be reliable Be harmless Be immediately reversible Be inexpensive Not detract from the pleasure of sexual intercourse Encourage a good emotional and sexual relationship between partners • Be due to the existence of a serious motive for avoiding the birth of another child e.g., illness in the mother or children (genetic disorders), extreme poverty, etc. • Be respectful of the Moral Law, while searching for the most adequate means of avoiding births

Evaluation of the Effectiveness of 12-month Multi-center Natural Fertility Regulation Program in China
• Women of different social/education status, strata and ethnic groups in rural and urban China readily understand the meaning of the mucus patterns described in the Billings books and all of them accept the method. • The method-related pregnancy rate of the Billings Ovulation Method™ user group was zero and their continuation rate was significantly higher than those in the IUD group. • • • • • 37,000 BOM teachers trained 2.7 Million fertile couples in regular use Success rate 99% Abortion rate dramatically reduced 32% of infertile couples give birth

Shao-Zhen QIAN et al, 2003

Use-effectiveness of fertility awareness (Billings' Ovulation Method) among the urban poor in Delhi slums
• The continuation rate of 91.86% for 12 months with a standard error of 0.67% was surprisingly high for a sample with low literacy and occupational status, low female work participation rates, small family size and a preference for sons with low motivation to use other methods. • The 1 year efficacy rate (life table analysis) was 99.86%. • The 1-year use-effectiveness rate was 97.43% for the 5,752 cohort.
• Dorairaj, Soc Action, 1984

Based on the presented evidence, it is hereby recommended…

NO to RH Bills!!!
The end does not justify the proposed means which are: Not reliable Not harmless Not immediately reversible Not inexpensive Not respectful of every Filipino’s beliefs and moral values

The youth is the hope of the fatherland. -Jose Rizal
This is no longer a statement. It has become a challenge...

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