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DISSECTING REPUBLIC ACT NO. 10354
AN ACT PPROVIDING FOR A NATIONAL POLICY
    ON RESPONSIBLE PARENTHOOD AND
          REPRODUCTIVE HEALTH

   Medical & Public Health Issues

                               Dr. Liza C. Manalo, MSc.
           Department of Family & Community Medicine
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         • How Not to Be Poor:
   are the poor:
                                        • Stay in School
• High school drop-outs
                                        • Get a Job
• Staying single
                                        • Get Married
• Having children without a
                                        • Don't Have Children
   spouse
                                          Out of Wedlock
• Working only part time or             - National Center for Policy
   not working at all                     Analysis, Jan, 2003
                                          http://www.ncpa.org/pub/ba428/
           - 2001 U.S. Census data
Improve
Maternal Health
Everyday another 10 Filipino women die of
    complications due to pregnancy and childbirth
•   Birth attendance by
    skilled personnel, a proxy              Type of Assistance During Delivery
    indicator for MMR, has
    only slightly increased                70
    from 58.8% in 1990 to                  60
                                                                                59.8
                                                                                              62.3
    62.3% in 2006 (FPS)                    50   52.8
                                                              56.4




                                 Percent
•   Most women in rural                    40          45.3
                                                                     41.3
                                                                                       37.1
    areas prefer hilots (TBAs)             30                                                        34.5


•   Non skilled birth                      20
                                           10
    attendance is worst
                                           0
    among the poor with the                     1993          1998               2003         2006
    rich more likely to have
    skilled attendance at                                      SBA          Non-SBA

    delivery than the poor

           Many women still deliver without
                medical attendance
The main causes of maternal deaths
could have been avoided




Source: Wagner and Claeson. 2004
Crucial to reducing maternal deaths is having a
   skilled attendant present during a delivery
• Only 60 percent of the births in the Philippines
  are supervised by a skilled birth attendant.
• In the Philippine Framework for Maternal
  Mortality Reduction, health workers are
  identified as playing an integral part in achieving
  a lower MMR in the country.
• Giving midwives access to further training in life-
  saving skills could prevent up to 80 percent of
  maternal deaths in the Philippines, says Rosalie
  Paje, division chief of the Family Health Office
  under the Department of Health (DOH).
  – http://www.pogsinc.org/v2/index.php/component/content/art
    icle/10/58-philippines-ranks--48-in-maternal-mortality
Eliminating maternal deaths is POSSIBLE
Zero maternal mortality from 1994 up to 2004
Gattaran-Cagayan, 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                    DELAY # 2                  DELAY # 3
    Deciding to seek             Reaching an               Receiving EmOC
        EmOC                    EmOC Facility                 at Facility

• Educate on danger       • Improve access to         • Ensure availability of
  signs and location of     transport and               skilled birth attendant
  EmOC facility             communication
                                                      • Provide adequate drugs,
                            systems
• Provide alternatives                                  equipment, blood
  for financing           • Prepare delivery plan       transfusion
  (Social/Community         during antenatal visits
                                                      • Improve quality of
  Health Insurance)
                                                        services for the poor,
• Establish                                             less educated, and
  Community support                                     women who had
  group (e.g.. TBA,                                     undergone abortion
  BHW)
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
REPUBLIC ACT NO. 10354
  AN ACT PPROVIDING FOR A NATIONAL POLICY
      ON RESPONSIBLE PARENTHOOD AND
           REPRODUCTIVE HEALTH
                  is about:
• The State shall promote and provide information and
  access, without bias, to all methods of family planning,
  including effective natural and modern methods which
  have been proven medically safe, legal, non-
  abortifacient and effective in accordance with scientific
  and evidence-based medical research standards such as
  those registered and approved by the Food and Drug
  Administration (FDA).
V 1.1 What is wrongcontraceptives? and the use of
                                     with “safe sex”

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

i • 1.1 is no absolute guarantee that one will not get
                                  contraceptives?

     There
o sexually transmitted diseases (STDs) and HIV even when
     condom is used.
l – Most experts believe that the risk of getting HIV/AIDS
a       and other sexually transmitted diseases can be greatly
        reduced if a condom is used consistently and correctly.
t – In other words, sexrisky"condoms isn't totally "safe
        sex," but it is "less
                              with
                                   sex.
i – The most reliable ways to avoid transmission of STDs are
        to abstain from sexual activity, or to be in a long-term
o       mutually monogamous relationship with an uninfected
        partner.
n            - Centers for Disease Control (CDC) & US FDA
What is wrong with “safe sex” and the use of
V      1.1                   contraceptives?
    • There is no absolute guarantee that one will not get
i     genital HPV, the most common sexually transmitted
o     infection, even when condom is used.
       – For those who choose to be sexually active, condoms may
l        lower the risk of HPV. To be most effective, they should be
         used with every sex act, from start to finish. Condoms may
a        also lower the risk of developing HPV-related diseases, such
         as genital warts and cervical cancer. But HPV can infect areas
t        that are not covered by a condom - so condoms may not
         fully protect against HPV.
i      – People can also lower their chances of getting HPV by being
o        in a faithful relationship with one partner; limiting their
         number of sex partners; and choosing a partner who has
n        had no or few prior sex partners.
                - Centers for Disease Control and Prevention (CDC)
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 sperm-
               egg 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: McGraw-Hill, 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
o • Some contraceptives have post-fertilization
    effects
l – Although the primary mechanism of oral
a contraceptives (OC) is inhibition ofinovulation,
       other alterations include changes the cervical
t mucus, which uterus, and changes inof sperm
       entry into the
                      increase the difficulty
                                              the
i endometrium, which reduce the likelihood of
       implantation.
o          - Physicians’ Desk Reference & Drug Facts and
n            Comparisons
V 1.1             What is wrong with “safe sex” and the use
                             of contraceptives?
i Some contraceptives have post-fertilization
o effects
  • “In IUD users, the low recovery of ova from the
l uterus, as well as the lack of hCG rise in more recent
    studies of IUD users, suggest that the major
a postfertilization effect is destruction of the early
t embryo in prefertilizationtube, inis likely to be that
    the major
                  the Fallopian
                                      effect
                                               the same way

i destruction of sperm and ova.
o • Stanford andGynecology, December Journal of
       Obstetrics &
                    Mikolajczyk, American
                                          2002
n
V 1.1               What is wrong with “safe sex” and the use
                               of contraceptives?
i Some contraceptives have post-fertilization
o effects
l • For theofcopper IUD, thisand direct toxicity, whereas with the
    result inflammation
                              embryocidal effect may be more a

    progestin IUDs it may result more from inhibition of transport
a through the Fallopian tube, along with prevention of
    implantation, preventing long-term viability of the embryo.”
t                                                       Copper IUD
     • Stanford and Mikolajczyk, American Journal
i      of Obstetrics & Gynecology, December 2002

o
n
The Philippine National Drug Formulary System and
V   Family Planning Supplies. - the National Drug Formulary
    shall include hormonal contraceptives, intrauterine
i   devices, injectables and other safe, legal, non-
    abortifacient and effective family planning products
o   and supplies.
l   For the purpose of this act, any product or supply included or to be
    included in the essential drug list must have a certification from the
a   FDA that said products and supply is made available on the condition
    that it is not to be used as an abortifacient.
t
    These products and supplies shall also be included in the regular
i   purchase of essential medicines and supplies of all national hospitals.
    Provided, further, That the foregoing offices shall not purchase or
o   acquire by any means emergency contraceptive pills, postcoital pills,
    abortifacients that will be used for such purpose and their other
n   forms or equivalent.
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     Indicated in the treatment of prevalent diseases
  Efficacy and safety     Based on adequate pharmacologic studies especially
                             among Filipinos
       Quality            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                 What is wrong with classifying family
                planning supplies as essential medicines?
i
o   • Most normal, low-risk pregnancy, per se, is not a
      disease, and as such does not need medicines,
l     except for iron and folic acid supplementation.
a      – Hence, the only “essential” medicines during
t        pregnancy would be ferrous sulfate and
         multivitamins.
i
o
n
What is wrong with classifying family
V                planning supplies as essential medicines?
i •   Combined Oral Contraceptives (COC) are not safe, as they are

o     classified as carcinogenic to humans by the World Health
      Organization
l         • The International Agency for Research on Cancer (IARC),
            the cancer research agency of WHO, in its press release
a           of the 29th of July 2005, informed of the publication of a
            monograph on the carcinogenicity of combined estrogen-
t           progestogen oral contraceptives (COC) and combined
            estrogen-progestogen menopausal therapy (HRT), based
i           on the conclusions of an international Working Group of
            21 scientists from 8 countries.
o                » http://www.who.int/reproductivehealth/publications/agein
                   g/cocs_hrt_statement.pdf
n                » http://www.iarc.fr/en/media-centre/pr/2005/pr167.html
What is wrong with classifying family
V                  planning supplies as essential medicines?
i•   Combined Oral Contraceptives (COC) are not safe, as there is
o    sufficient evidence in humans for their carcinogenicity
     – Estrogen-progestogen oral contraceptives were classified in
l      the Group 1 of carcinogenic agents, after a thorough review
       of the published scientific evidence.
a    – This evaluation was made on the basis of increased risks for
       cancer of the breast among current and recent users only,
t      for cancer of the cervix and for cancer of the liver in
       populations that are at low risk for hepatitis B viral infection.
i               » IARC Monographs on the Evaluation of Carcinogenic Risks to
                  Humans Volume 91 (2007)
                  http://monographs.iarc.fr/ENG/Monographs/vol91/mono91-
o                 6E.pdf
                » The Lancet Oncology, Vol 6 August 2005

n                  http://oncology.thelancet.com
What is wrong with classifying family
V                  planning supplies as essential medicines?
i•   Combined Oral Contraceptives (COC) are not
o    safe, as women who were current or recent
l    users of birth control pills had a slightly
a    elevated risk of developing breast cancer.
     – from the analysis of 54 epidemiological studies conducted by
t      the Collaborative Group on Hormonal Factors in Breast
       Cancer on 53,297 women with breast cancer and 100,239
i      women without breast cancer
o       • The risk was highest for women who started using OCs as teenagers.
                » Lancet 1996; 347:1713–1727.
n
V                    What is wrong with classifying family
                   planning supplies as essential medicines?
i
o •   Combined Oral Contraceptives (COC) are not
      safe, as the risk for breast cancer was highest
l     for women who used OCs within 5 years prior
a     to diagnosis, particularly in the younger group
         • From the National Cancer Institute (NCI)-sponsored study
t          among women ages 20 to 34 compared with women ages
           35 to 54.
i               » Althuis MD, Brogan DD, Coates RJ, et al. Breast cancers among very
                  young premenopausal women (United States). Cancer Causes and
o                 Control 2003; 14(2):151–160.
                » http://www.cancer.gov/cancertopics/factsheet/Risk/oral-

n                 contraceptives
V                     What is wrong with classifying family
                    planning supplies as essential medicines?
i •   Contraceptive hormone use is linked to
o     cardiovascular disease.
      – Newer generation oral contraceptives (OC) indicate a persistent
l       increased risk of venous thromboembolism (VTE or blood clots)
        for current users.
a     – Current guidelines indicate that, as with all medication,
t       contraceptive hormones should be selected and initiated by
        weighing risks and benefits for the individual patient.
i     – Women 35 years and older should be assessed for cardiovascular
        risk factors including hypertension, smoking, diabetes,
o       nephropathy, and other vascular diseases, including migraines,
        prior to OC use.
n            – Shufelt & Bairey Merz, J Am Coll Cardiol. 2009 Jan
V                      What is wrong with classifying family
                     planning supplies as essential medicines?
i •   FDA Drug Safety Communication: Updated information
      about the risk of blood clots in women taking birth
o     control pills containing drospirenone.
l •   [4-10-2012] Based on its review of recent observational
      (epidemiologic) studies, the U.S. FDA has concluded that
a     drospirenone-containing birth control pills may be
      associated with a higher risk for blood clots than other
t     progestin-containing pills.
i         • The re drug labels (Beyaz, Safyral, Yasmin and Yaz) report that some
            epidemiologic studies reported as high as a three-fold increase in
            the risk of blood clots for drospirenone-containing products when
o           compared to products containing levonorgestrel or some other
            progestins.
n             • http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm
Women Sue Bayer Over Yaz Birth
     Control Side Effects
• In June 2012, Bayer announced that it had
  begun settling some of the approximately
  11,000 Yaz lawsuits filed on behalf of women
  who allegedly suffered severe side effects
  after taking the drug.

     • http://www.jdsupra.com/legalnews/women-sue-bayer-
       over-yaz-birth-control-s-57418/
What is wrong with classifying family
V                     planning supplies as essential medicines?
i Safety Labeling Changes Approved By FDA Center for
    Drug Evaluation and Research (CDER) , May 2008
o Mirena (Levonorgestrel-releasing Intrauterine Device)
l WARNINGS: Ectopic Pregnancy
a • ...Up to half of pregnancies that occur with Mirena in
    place are ectopic (incidence: about 1 ectopic
t pregnancy per 1000 users per year.)
     – Tell women who choose Mirena about the risks of ectopic
i       pregnancy, including the loss of fertility. Teach them to
        recognize and report to their physician promptly any
o       symptoms of ectopic pregnancy...
         • http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-
n          RelatedDrugLabelingChanges/ucm119274.htm
V                     What is wrong with classifying family
                    planning supplies as essential medicines?
i
    Mirena (levonorgestrel-releasing IUD) - WARNINGS
o   Sepsis
l   • ...In some cases, severe pain occurred within
      hours of insertion followed by sepsis within days...
a   Perforation
t   • Perforation or penetration of the uterine wall or
      cervix may occur during insertion although the
i     perforation may not be detected until some time
      later...
o
n      – http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-
         RelatedDrugLabelingChanges/ucm119274.htm
V                     What is wrong with classifying family
                    planning supplies as essential medicines?
i
o   Mirena (levonorgestrel-releasing IUD) - WARNINGS
l   Ovarian Cysts
    • ...Surgical intervention is not usually required.
a
    Breast Cancer
t   • ...Two observational studies have not provided
      evidence of an increased risk of breast cancer
i     during the use of Mirena.
o
       – http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-
n        RelatedDrugLabelingChanges/ucm119274.htm
V                    What is wrong with classifying family
                   planning supplies as essential medicines?
i•   IUDs are not safe
o    – During the use of a copper IUD, menstruation tends to be
       longer with a greater loss of blood; in 70% of women who
l      use a hormonal IUD oligomenorrhea or even amenorrhoea
       develops. In the first weeks after IUD insertion, there is an
a      increased risk of pelvic inflammatory disease (PID).
         • Summary of the practice guideline 'The intrauterine
t          device' from the Dutch College of General Practitioners,
           2009
i    – A World Health Organization multi-centre study established
       that pelvic inflammatory disease (PID) risk is temporally
o      related to IUD insertion procedures.
n           – Shapiro, Reprod Health Matters. 2004 May
What is wrong with classifying family
V                    planning supplies as essential medicines?
i • IUDs are not safe
o • In 15 studieswomen, nulliparous women had higher rates of
    nulliparous
                  comparing IUD performance in parous vs.

l expulsion and removals due to bleeding and pain.
     – Hubacher, Contraception. 2007 Jun
a • Uterine perforation is a rare yet serious complication and is
    usually seen during insertion of the IUD.
t – Koltan et al, J Chin Med Assoc. 2010 Jun
  • There are about 70 cases in the literature of IUDs that have
i migrated into the bladder. The resulting bladder perforation can
    be complete or partial.
o – Istanbulluoglu et al, J Chin Med Assoc. 2008 Apr
  • There is a reported case of a colon penetration by a copper IUD.
n – Arslan et al, Arch Gynecol Obstet. 2009
Mirena: Lawsuits & FDA warning
• Mirena, manufactured by Bayer Pharmaceuticals, has
  come under scrutiny for its dangerous side effects
  and has led to many lawsuits claiming the product is
  “defective and unreasonably dangerous.” Among
  the many claims of negligence, Bayer is accused of
  intentionally selling a dangerous product, deceptive
  advertising and concealing the risk of complications.
• In reviewing the manufacturer’s script for advertising
  for the product, the FDA warned Bayer in a Dec. 30,
  2009, letter that the company was in violation of the
  Federal Food, Drug, and Cosmetic Act. The agency
  further stated that the advertising included false or
  misleading presentations and misbranded the drug.
      • http://www.drugwatch.com/mirena/lawsuit/
Unjust
V      Distribution of Benefits & Burdens
i   REPUBLIC ACT NO. 10354
o   AN ACT PPROVIDING FOR A NATIONAL
    POLICY ON RESPONSIBLE PARENTHOOD AND
l   REPRODUCTIVE HEALTH
a   about promoting a program to “achieve
    equitable allocation of resources” when
t   problems pertaining to lack of “reproductive
i   health” is not as prevalent nor as life-
    threatening as our other health problems.
o
n
Top Ten Leading Causes of Morbidity and
         Mortality in Low-Income Countries
                                    (WHO, 2004)
                                          Deaths in millions
                                                               % of deaths

     Lower respiratory infections               2.94              11.2
        Coronary heart disease                  2.47               9.4
          Diarrheal diseases                    1.81               6.9
               HIV/AIDS                         1.51               5.7
Stroke & other cerebrovascular diseases         1.48               5.6

Chronic obstructive pulmonary disease           0.94               3.6
             Tuberculosis                       0.91               3.5
          Neonatal infections                   0.90               3.4
               Malaria                          0.86               3.3
   Prematurity and low birth weight             0.84               3.2
What is wrong with giving priority
V          to reproductive health ?
i •   “Eight of the 10 leading causes of morbidity in the
      Philippines are caused by infections:
o      – Acute lower respiratory tract infection and pneumonia
       – Acute watery diarrhea
l      – Bronchitis/ bronchiolitis
       – Influenza
a      – Tuberculosis
       – Malaria
t      – Acute febrile illness
       – Dengue fever
i •   Among these communicable diseases, pneumonia and
      tuberculosis continue to be among the 10 leading causes of
o     mortality, causing a significant number of deaths across the
      country.”
n             -World Health Organization (WHO) Western Pacific Region Report
What is wrong with giving priority to
V              reproductive health ?
i•   “Financial resources allotted by foreign donors to
o    assist the Philippine Government’s programs could
     actually be better spent in other pursuits than
l    purchasing contraceptives.”
a•   “It is also of value to demystify our perceptions about
     the role of contraceptives in women’s health, women’s
t    rights, and healthy families. To equate access to
i    contraceptives with the reduction in maternal
     morbidity and mortality is simplistic.”
o    - former Department of Health (DOH) Secretary Manuel M. Dayrit, MD, MSc
n               Philippine Daily Inquirer, 9/20/04
V
i   No person shall be denied information
o   and access to family planning services,
    whether natural or artificial: Provided,
l   that minors will not be allowed access to
a   modem methods of family planning
    without written consent from their
t   parents or guardian/s except when the
i   minor is already a parent or has had a
    miscarriage
o
n
V      What is wrong with access to reproductive
              health goods and services?
i
  •   Indiscriminate access to reproductive health
o     goods and services without full disclosure of
l     the potential for post-fertilization effects of
      hormonal contraceptives constitute a
a     violation of informed consent.
      – The available evidence supports the hypothesis that when ovulation
t       and fertilization occur in women taking oral contraceptives (OCs),
        post-fertilization effects are operative on occasion to prevent clinically
        recognized pregnancy.
i              Oral contraceptives directly affect the endometrium. These effects
                have been presumed to render the endometrium relatively
o               inhospitable to implantation or to the maintenance of the
                preembryo or embryo prior to clinically recognized pregnancy.
                   » Larimore & Stanford, Archive of Family
n                    Medicine, Feb 2000
What is wrong with access to reproductive
V              health goods and services?
i
  •   Women who believe that human life begins at
o     fertilization and those who consider it is
      important to distinguish between natural and
l     induced embryo loss are less likely to consider
      the use of a method with post-fertilization
a     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
t          consider using a method that may work after fertilization but before
           implantation and 57% would not consider using one that may work
           after implantation.
i                 » 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,
o          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
n
A                Fertility control should…
l
    • Be reliable
t   • Be harmless
e   • Be immediately reversible
    • Be inexpensive
r   • Not detract from the pleasure of sexual intercourse
n   • Encourage a good emotional and sexual
      relationship between partners
a   • Be due to the existence of a serious motive for
t     avoiding the birth of another child e.g., illness in
      the mother or children (genetic disorders),
i     extreme poverty, etc.
    • Be respectful of the Moral Law, while searching for
v     the most adequate means of avoiding births
e
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 AN ACT PPROVIDING FOR A NATIONAL
     POLICY ON RESPONSIBLE PARENTHOOD AND
     REPRODUCTIVE HEALTH

 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...
What an abortifacient is -- and what it isn't
                      by Jamie Manson | Feb. 20, 2012
• The reality is that there is overwhelming scientific evidence that the
  IUD and Plan B work only as contraceptives.
• When church officials argue that the IUD could be an abortifacient,
  they are relying on research from the 1970s that indicated that the
  IUD could affect an embryo's ability to implant. Decades of research
  since has demonstrated that the IUD actually works much earlier in
  the reproductive process than once thought. It does not destroy an
  implanted embryo.
• The most important point that emerges from all of this research is
  that, so far, there is no scientific evidence that any FDA-approved
  contraception is capable of destroying an embryo. To say that any of
  these drugs are abortifacient is not only misleading…
   – http://ncronline.org/blogs/grace-margins/what-abortifacient-and-what-it-isnt

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Dissecting the Philippines Reproductive Health Law

  • 1. DISSECTING REPUBLIC ACT NO. 10354 AN ACT PPROVIDING FOR A NATIONAL POLICY ON RESPONSIBLE PARENTHOOD AND REPRODUCTIVE HEALTH Medical & Public Health Issues Dr. Liza C. Manalo, MSc. Department of Family & Community Medicine
  • 2. 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
  • 3. 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
  • 4. 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 • How Not to Be Poor: are the poor: • Stay in School • High school drop-outs • Get a Job • Staying single • Get Married • Having children without a • Don't Have Children spouse Out of Wedlock • Working only part time or - National Center for Policy not working at all Analysis, Jan, 2003 http://www.ncpa.org/pub/ba428/ - 2001 U.S. Census data
  • 6. Everyday another 10 Filipino women die of complications due to pregnancy and childbirth • Birth attendance by skilled personnel, a proxy Type of Assistance During Delivery indicator for MMR, has only slightly increased 70 from 58.8% in 1990 to 60 59.8 62.3 62.3% in 2006 (FPS) 50 52.8 56.4 Percent • Most women in rural 40 45.3 41.3 37.1 areas prefer hilots (TBAs) 30 34.5 • Non skilled birth 20 10 attendance is worst 0 among the poor with the 1993 1998 2003 2006 rich more likely to have skilled attendance at SBA Non-SBA delivery than the poor Many women still deliver without medical attendance
  • 7. The main causes of maternal deaths could have been avoided Source: Wagner and Claeson. 2004
  • 8. Crucial to reducing maternal deaths is having a skilled attendant present during a delivery • Only 60 percent of the births in the Philippines are supervised by a skilled birth attendant. • In the Philippine Framework for Maternal Mortality Reduction, health workers are identified as playing an integral part in achieving a lower MMR in the country. • Giving midwives access to further training in life- saving skills could prevent up to 80 percent of maternal deaths in the Philippines, says Rosalie Paje, division chief of the Family Health Office under the Department of Health (DOH). – http://www.pogsinc.org/v2/index.php/component/content/art icle/10/58-philippines-ranks--48-in-maternal-mortality
  • 9. Eliminating maternal deaths is POSSIBLE Zero maternal mortality from 1994 up to 2004 Gattaran-Cagayan, 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
  • 10. Priority interventions on the ground DELAY # 1 DELAY # 2 DELAY # 3 Deciding to seek Reaching an Receiving EmOC EmOC EmOC Facility at Facility • Educate on danger • Improve access to • Ensure availability of signs and location of transport and skilled birth attendant EmOC facility communication • Provide adequate drugs, systems • Provide alternatives equipment, blood for financing • Prepare delivery plan transfusion (Social/Community during antenatal visits • Improve quality of Health Insurance) services for the poor, • Establish less educated, and Community support women who had group (e.g.. TBA, undergone abortion BHW)
  • 11. 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
  • 12. REPUBLIC ACT NO. 10354 AN ACT PPROVIDING FOR A NATIONAL POLICY ON RESPONSIBLE PARENTHOOD AND REPRODUCTIVE HEALTH is about: • The State shall promote and provide information and access, without bias, to all methods of family planning, including effective natural and modern methods which have been proven medically safe, legal, non- abortifacient and effective in accordance with scientific and evidence-based medical research standards such as those registered and approved by the Food and Drug Administration (FDA).
  • 13. V 1.1 What is wrongcontraceptives? and the use of with “safe sex” 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
  • 14. V What is wrong with “safe sex” and the use of i • 1.1 is no absolute guarantee that one will not get contraceptives? There o sexually transmitted diseases (STDs) and HIV even when condom is used. l – Most experts believe that the risk of getting HIV/AIDS a and other sexually transmitted diseases can be greatly reduced if a condom is used consistently and correctly. t – In other words, sexrisky"condoms isn't totally "safe sex," but it is "less with sex. i – The most reliable ways to avoid transmission of STDs are to abstain from sexual activity, or to be in a long-term o mutually monogamous relationship with an uninfected partner. n - Centers for Disease Control (CDC) & US FDA
  • 15. What is wrong with “safe sex” and the use of V 1.1 contraceptives? • There is no absolute guarantee that one will not get i genital HPV, the most common sexually transmitted o infection, even when condom is used. – For those who choose to be sexually active, condoms may l lower the risk of HPV. To be most effective, they should be used with every sex act, from start to finish. Condoms may a also lower the risk of developing HPV-related diseases, such as genital warts and cervical cancer. But HPV can infect areas t that are not covered by a condom - so condoms may not fully protect against HPV. i – People can also lower their chances of getting HPV by being o in a faithful relationship with one partner; limiting their number of sex partners; and choosing a partner who has n had no or few prior sex partners. - Centers for Disease Control and Prevention (CDC)
  • 16. 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 sperm- egg 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
  • 17. 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: McGraw-Hill, 1996, p. 3 • http://www.clinicquotes.com/site/story.php?id=28
  • 18. 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
  • 19. V 1.1 What is wrong with “safe sex” and the use of contraceptives? i o • Some contraceptives have post-fertilization effects l – Although the primary mechanism of oral a contraceptives (OC) is inhibition ofinovulation, other alterations include changes the cervical t mucus, which uterus, and changes inof sperm entry into the increase the difficulty the i endometrium, which reduce the likelihood of implantation. o - Physicians’ Desk Reference & Drug Facts and n Comparisons
  • 20. V 1.1 What is wrong with “safe sex” and the use of contraceptives? i Some contraceptives have post-fertilization o effects • “In IUD users, the low recovery of ova from the l uterus, as well as the lack of hCG rise in more recent studies of IUD users, suggest that the major a postfertilization effect is destruction of the early t embryo in prefertilizationtube, inis likely to be that the major the Fallopian effect the same way i destruction of sperm and ova. o • Stanford andGynecology, December Journal of Obstetrics & Mikolajczyk, American 2002 n
  • 21. V 1.1 What is wrong with “safe sex” and the use of contraceptives? i Some contraceptives have post-fertilization o effects l • For theofcopper IUD, thisand direct toxicity, whereas with the result inflammation embryocidal effect may be more a progestin IUDs it may result more from inhibition of transport a through the Fallopian tube, along with prevention of implantation, preventing long-term viability of the embryo.” t Copper IUD • Stanford and Mikolajczyk, American Journal i of Obstetrics & Gynecology, December 2002 o n
  • 22. The Philippine National Drug Formulary System and V Family Planning Supplies. - the National Drug Formulary shall include hormonal contraceptives, intrauterine i devices, injectables and other safe, legal, non- abortifacient and effective family planning products o and supplies. l For the purpose of this act, any product or supply included or to be included in the essential drug list must have a certification from the a FDA that said products and supply is made available on the condition that it is not to be used as an abortifacient. t These products and supplies shall also be included in the regular i purchase of essential medicines and supplies of all national hospitals. Provided, further, That the foregoing offices shall not purchase or o acquire by any means emergency contraceptive pills, postcoital pills, abortifacients that will be used for such purpose and their other n forms or equivalent.
  • 23. 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 Indicated in the treatment of prevalent diseases Efficacy and safety Based on adequate pharmacologic studies especially among Filipinos Quality 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
  • 24. V What is wrong with classifying family planning supplies as essential medicines? i o • Most normal, low-risk pregnancy, per se, is not a disease, and as such does not need medicines, l except for iron and folic acid supplementation. a – Hence, the only “essential” medicines during t pregnancy would be ferrous sulfate and multivitamins. i o n
  • 25. What is wrong with classifying family V planning supplies as essential medicines? i • Combined Oral Contraceptives (COC) are not safe, as they are o classified as carcinogenic to humans by the World Health Organization l • The International Agency for Research on Cancer (IARC), the cancer research agency of WHO, in its press release a of the 29th of July 2005, informed of the publication of a monograph on the carcinogenicity of combined estrogen- t progestogen oral contraceptives (COC) and combined estrogen-progestogen menopausal therapy (HRT), based i on the conclusions of an international Working Group of 21 scientists from 8 countries. o » http://www.who.int/reproductivehealth/publications/agein g/cocs_hrt_statement.pdf n » http://www.iarc.fr/en/media-centre/pr/2005/pr167.html
  • 26. What is wrong with classifying family V planning supplies as essential medicines? i• Combined Oral Contraceptives (COC) are not safe, as there is o sufficient evidence in humans for their carcinogenicity – Estrogen-progestogen oral contraceptives were classified in l the Group 1 of carcinogenic agents, after a thorough review of the published scientific evidence. a – This evaluation was made on the basis of increased risks for cancer of the breast among current and recent users only, t for cancer of the cervix and for cancer of the liver in populations that are at low risk for hepatitis B viral infection. i » IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 91 (2007) http://monographs.iarc.fr/ENG/Monographs/vol91/mono91- o 6E.pdf » The Lancet Oncology, Vol 6 August 2005 n http://oncology.thelancet.com
  • 27. What is wrong with classifying family V planning supplies as essential medicines? i• Combined Oral Contraceptives (COC) are not o safe, as women who were current or recent l users of birth control pills had a slightly a elevated risk of developing breast cancer. – from the analysis of 54 epidemiological studies conducted by t the Collaborative Group on Hormonal Factors in Breast Cancer on 53,297 women with breast cancer and 100,239 i women without breast cancer o • The risk was highest for women who started using OCs as teenagers. » Lancet 1996; 347:1713–1727. n
  • 28. V What is wrong with classifying family planning supplies as essential medicines? i o • Combined Oral Contraceptives (COC) are not safe, as the risk for breast cancer was highest l for women who used OCs within 5 years prior a to diagnosis, particularly in the younger group • From the National Cancer Institute (NCI)-sponsored study t among women ages 20 to 34 compared with women ages 35 to 54. i » Althuis MD, Brogan DD, Coates RJ, et al. Breast cancers among very young premenopausal women (United States). Cancer Causes and o Control 2003; 14(2):151–160. » http://www.cancer.gov/cancertopics/factsheet/Risk/oral- n contraceptives
  • 29. V What is wrong with classifying family planning supplies as essential medicines? i • Contraceptive hormone use is linked to o cardiovascular disease. – Newer generation oral contraceptives (OC) indicate a persistent l increased risk of venous thromboembolism (VTE or blood clots) for current users. a – Current guidelines indicate that, as with all medication, t contraceptive hormones should be selected and initiated by weighing risks and benefits for the individual patient. i – Women 35 years and older should be assessed for cardiovascular risk factors including hypertension, smoking, diabetes, o nephropathy, and other vascular diseases, including migraines, prior to OC use. n – Shufelt & Bairey Merz, J Am Coll Cardiol. 2009 Jan
  • 30. V What is wrong with classifying family planning supplies as essential medicines? i • FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth o control pills containing drospirenone. l • [4-10-2012] Based on its review of recent observational (epidemiologic) studies, the U.S. FDA has concluded that a drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other t progestin-containing pills. i • The re drug labels (Beyaz, Safyral, Yasmin and Yaz) report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when o compared to products containing levonorgestrel or some other progestins. n • http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm
  • 31. Women Sue Bayer Over Yaz Birth Control Side Effects • In June 2012, Bayer announced that it had begun settling some of the approximately 11,000 Yaz lawsuits filed on behalf of women who allegedly suffered severe side effects after taking the drug. • http://www.jdsupra.com/legalnews/women-sue-bayer- over-yaz-birth-control-s-57418/
  • 32. What is wrong with classifying family V planning supplies as essential medicines? i Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) , May 2008 o Mirena (Levonorgestrel-releasing Intrauterine Device) l WARNINGS: Ectopic Pregnancy a • ...Up to half of pregnancies that occur with Mirena in place are ectopic (incidence: about 1 ectopic t pregnancy per 1000 users per year.) – Tell women who choose Mirena about the risks of ectopic i pregnancy, including the loss of fertility. Teach them to recognize and report to their physician promptly any o symptoms of ectopic pregnancy... • http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety- n RelatedDrugLabelingChanges/ucm119274.htm
  • 33. V What is wrong with classifying family planning supplies as essential medicines? i Mirena (levonorgestrel-releasing IUD) - WARNINGS o Sepsis l • ...In some cases, severe pain occurred within hours of insertion followed by sepsis within days... a Perforation t • Perforation or penetration of the uterine wall or cervix may occur during insertion although the i perforation may not be detected until some time later... o n – http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety- RelatedDrugLabelingChanges/ucm119274.htm
  • 34. V What is wrong with classifying family planning supplies as essential medicines? i o Mirena (levonorgestrel-releasing IUD) - WARNINGS l Ovarian Cysts • ...Surgical intervention is not usually required. a Breast Cancer t • ...Two observational studies have not provided evidence of an increased risk of breast cancer i during the use of Mirena. o – http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety- n RelatedDrugLabelingChanges/ucm119274.htm
  • 35. V What is wrong with classifying family planning supplies as essential medicines? i• IUDs are not safe o – During the use of a copper IUD, menstruation tends to be longer with a greater loss of blood; in 70% of women who l use a hormonal IUD oligomenorrhea or even amenorrhoea develops. In the first weeks after IUD insertion, there is an a increased risk of pelvic inflammatory disease (PID). • Summary of the practice guideline 'The intrauterine t device' from the Dutch College of General Practitioners, 2009 i – A World Health Organization multi-centre study established that pelvic inflammatory disease (PID) risk is temporally o related to IUD insertion procedures. n – Shapiro, Reprod Health Matters. 2004 May
  • 36. What is wrong with classifying family V planning supplies as essential medicines? i • IUDs are not safe o • In 15 studieswomen, nulliparous women had higher rates of nulliparous comparing IUD performance in parous vs. l expulsion and removals due to bleeding and pain. – Hubacher, Contraception. 2007 Jun a • Uterine perforation is a rare yet serious complication and is usually seen during insertion of the IUD. t – Koltan et al, J Chin Med Assoc. 2010 Jun • There are about 70 cases in the literature of IUDs that have i migrated into the bladder. The resulting bladder perforation can be complete or partial. o – Istanbulluoglu et al, J Chin Med Assoc. 2008 Apr • There is a reported case of a colon penetration by a copper IUD. n – Arslan et al, Arch Gynecol Obstet. 2009
  • 37. Mirena: Lawsuits & FDA warning • Mirena, manufactured by Bayer Pharmaceuticals, has come under scrutiny for its dangerous side effects and has led to many lawsuits claiming the product is “defective and unreasonably dangerous.” Among the many claims of negligence, Bayer is accused of intentionally selling a dangerous product, deceptive advertising and concealing the risk of complications. • In reviewing the manufacturer’s script for advertising for the product, the FDA warned Bayer in a Dec. 30, 2009, letter that the company was in violation of the Federal Food, Drug, and Cosmetic Act. The agency further stated that the advertising included false or misleading presentations and misbranded the drug. • http://www.drugwatch.com/mirena/lawsuit/
  • 38. Unjust V Distribution of Benefits & Burdens i REPUBLIC ACT NO. 10354 o AN ACT PPROVIDING FOR A NATIONAL POLICY ON RESPONSIBLE PARENTHOOD AND l REPRODUCTIVE HEALTH a about promoting a program to “achieve equitable allocation of resources” when t problems pertaining to lack of “reproductive i health” is not as prevalent nor as life- threatening as our other health problems. o n
  • 39. Top Ten Leading Causes of Morbidity and Mortality in Low-Income Countries (WHO, 2004) Deaths in millions % of deaths Lower respiratory infections 2.94 11.2 Coronary heart disease 2.47 9.4 Diarrheal diseases 1.81 6.9 HIV/AIDS 1.51 5.7 Stroke & other cerebrovascular diseases 1.48 5.6 Chronic obstructive pulmonary disease 0.94 3.6 Tuberculosis 0.91 3.5 Neonatal infections 0.90 3.4 Malaria 0.86 3.3 Prematurity and low birth weight 0.84 3.2
  • 40. What is wrong with giving priority V to reproductive health ? i • “Eight of the 10 leading causes of morbidity in the Philippines are caused by infections: o – Acute lower respiratory tract infection and pneumonia – Acute watery diarrhea l – Bronchitis/ bronchiolitis – Influenza a – Tuberculosis – Malaria t – Acute febrile illness – Dengue fever i • Among these communicable diseases, pneumonia and tuberculosis continue to be among the 10 leading causes of o mortality, causing a significant number of deaths across the country.” n -World Health Organization (WHO) Western Pacific Region Report
  • 41. What is wrong with giving priority to V reproductive health ? i• “Financial resources allotted by foreign donors to o assist the Philippine Government’s programs could actually be better spent in other pursuits than l purchasing contraceptives.” a• “It is also of value to demystify our perceptions about the role of contraceptives in women’s health, women’s t rights, and healthy families. To equate access to i contraceptives with the reduction in maternal morbidity and mortality is simplistic.” o - former Department of Health (DOH) Secretary Manuel M. Dayrit, MD, MSc n Philippine Daily Inquirer, 9/20/04
  • 42. V i No person shall be denied information o and access to family planning services, whether natural or artificial: Provided, l that minors will not be allowed access to a modem methods of family planning without written consent from their t parents or guardian/s except when the i minor is already a parent or has had a miscarriage o n
  • 43. V What is wrong with access to reproductive health goods and services? i • Indiscriminate access to reproductive health o goods and services without full disclosure of l the potential for post-fertilization effects of hormonal contraceptives constitute a a violation of informed consent. – The available evidence supports the hypothesis that when ovulation t and fertilization occur in women taking oral contraceptives (OCs), post-fertilization effects are operative on occasion to prevent clinically recognized pregnancy. i Oral contraceptives directly affect the endometrium. These effects have been presumed to render the endometrium relatively o inhospitable to implantation or to the maintenance of the preembryo or embryo prior to clinically recognized pregnancy. » Larimore & Stanford, Archive of Family n Medicine, Feb 2000
  • 44. What is wrong with access to reproductive V health goods and services? i • Women who believe that human life begins at o fertilization and those who consider it is important to distinguish between natural and l induced embryo loss are less likely to consider the use of a method with post-fertilization a 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 t consider using a method that may work after fertilization but before implantation and 57% would not consider using one that may work after implantation. i » 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, o 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 n
  • 45. A Fertility control should… l • Be reliable t • Be harmless e • Be immediately reversible • Be inexpensive r • Not detract from the pleasure of sexual intercourse n • Encourage a good emotional and sexual relationship between partners a • Be due to the existence of a serious motive for t avoiding the birth of another child e.g., illness in the mother or children (genetic disorders), i extreme poverty, etc. • Be respectful of the Moral Law, while searching for v the most adequate means of avoiding births e
  • 46. 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
  • 47. 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
  • 48. Based on the presented evidence, it is hereby recommended… NO TO AN ACT PPROVIDING FOR A NATIONAL POLICY ON RESPONSIBLE PARENTHOOD AND REPRODUCTIVE HEALTH 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
  • 49. The youth is the hope of the fatherland. -Jose Rizal This is no longer a statement. It has become a challenge...
  • 50. What an abortifacient is -- and what it isn't by Jamie Manson | Feb. 20, 2012 • The reality is that there is overwhelming scientific evidence that the IUD and Plan B work only as contraceptives. • When church officials argue that the IUD could be an abortifacient, they are relying on research from the 1970s that indicated that the IUD could affect an embryo's ability to implant. Decades of research since has demonstrated that the IUD actually works much earlier in the reproductive process than once thought. It does not destroy an implanted embryo. • The most important point that emerges from all of this research is that, so far, there is no scientific evidence that any FDA-approved contraception is capable of destroying an embryo. To say that any of these drugs are abortifacient is not only misleading… – http://ncronline.org/blogs/grace-margins/what-abortifacient-and-what-it-isnt