Friday, August 22, 2014

Contraceptive implants of DOH for 600,000 women: health risks, abortifacients, and business strategy


Woman holding her left shoulder with her right hand

DOH is planning to purchase contraceptive implants for 600,000 Filipina women at the cost of Php 5000 per implant, with the Gates Foundation shouldering Php 4,500/implant and the Philippine government Php 500.  But this is only for the first three years, because the implant must be removed after the third year:
“Young Family Planning Implant, maliit siya na mukhang toothpick. Sub-dermal lang, ibig sabihin sa ilalim ng balat (The Family Planning Implant is a small, toothpick-like thing. It is sub-dermal, meaning it will be placed under the skin),” DOH Undersecretary Janette Garin said. The implant prevents pregnancy by preventing ovaries from releasing eggs. It can be effective for up to three years. “It inhibits ovulation for three years, the eggs will not be released,” she explained in Filipino, adding that a woman will not have her menstrual flow while the implant is inserted. “For three years it is very effective. But after three years, bumababa ‘yong effect, may risk na mabuntis ka (It’s effectiveness wanes after three years, there is a risk that you’ll get pregnant),” the undersecretary added. (Manila Bulletin)

A.  Nexplanon, Etogestrel, and Venous Thrombosis

The toothpick contraceptive described by Garin is most likely Nexplanon manufactured by Merck:
Nexplanon / Implanon NXT, or the almost identical Implanon, is a single-rod subdermal contraceptive implant made by Merck & Co. that is inserted just under the skin of a woman's upper arm and contains etonogestrel. Nexplanon/Implanon are a type of long-acting reversible contraception, the most effective form of birth control.[2] Nexplanon and Implanon NXT are essentially identical to Implanon except Nexplanon and Implanon NXT have 15 mg of barium sulphate added to the core, so it is detectable by x-ray.[3] Nexplanon / Implanon NXT also has a pre-loaded applicator for easier insertion.[4] Implanon was first approved for use in Indonesia in 1998, then approved for use in the United States in 2006. Subdermal contraceptive implants are now used by 11 million women around the world and approved for use in over 60 countries as of 2003.[5]
Nexplanon/Implanon consists of a single rod made of ethylene vinylacetate copolymer that is 4cm long and 2mm in diameter.[6] It is similar to a matchstick in size. The rod contains 68 mg of etonogestrel (sometimes called 3-keto-destrogestrel), a type of progestin.[5] Peak serum etonogestrel concentrations have been found to reach 781–894 pg/mL in the first few weeks, gradually decreasing to 192–261 pg/mL after 1 year, 154–194 pg/mL after 2 years, and 156–177 pg/mL after 3 years, maintaining ovulation suppression and contraceptive efficacy.[7] Serum levels maintain relatively stable through 36 months, which implies that the method may be effective for longer than 3 years.[8] Although not formally approved by the manufacturer for more than 3 years, none of the 240 women in the 3 studies became pregnant in the 4th year.[9][10][11] (Wikipedia: Nexplanon)
What is etonogestrel?
Etonogestrel is a steroidal progestin used in hormonal contraceptives, most notably the subdermal implant Nexplanon and the vaginal ring NuvaRing. Etonogestrel is the active metabolite of the inactive prodrug desogestrel, one of two third-generation progestins found in some epidemiological studies of combined oral contraceptive pills to be associated with a higher risk of venous thrombosis than combined oral contraceptive pills containing certain second-generation progestins.  (Wikipedia: Etonogestrel)
A higher risk of venous thrombosis, a blot clot in the veins that can break free and travel to the lungs is not a sign of a woman's good health because it may cause death. If we require cigarette packs to declare "Cigarette smoking is dangerous to your health," these contraceptive implants should also have the same warning.

B.  Supreme Court, Hormonal Contraceptives, and Abortifacients

Notice that etonogestrel is a hormonal contraceptive, which makes it similar to the birth control pill:
The Birth Control Pill is the most popular and widely used method of hormonal contraception. It involves taking a month-long series of pills—three weeks of pills containing hormones, and one without. This allows the woman to have a menstrual period. The Pill contains two synthetic hormones, progestin and ethinyl estradiol and has three mechanisms: 1) it prevents ovulation, 2) thickens the cervical mucus, which makes it harder for sperm to enter the uterus and 3) affects the endometrium or lining of the womb to make it more hostile to implantation. This means the tiny developing baby (embryo) cannot attach to the uterine lining and dies, which is a very early abortion. Even so, they define this as "preventing pregnancy. (Life Issues)
That is, the third action of hormonal contraceptives is to affect the lining of the womb to make it hostile to implantation of the embryo, so that the embryo dies.  This is abortion.

In its Decision on the RH Law, the Supreme Court already ruled out the word "primarily" in the definition of contraceptives:
8. Section 3.0l a) and Section 3.01 G of the RH-IRR, which added the qualifier primarily in defining abortifacients and contraceptives, as they are ultra vires and, therefore, null and void for contravening Section 4(a) of the RH Law and violating Section 12, Article II of the Constitution.
 The Supreme Court explains its decision as follows:
Evidently, with the addition of the word primarily, in Section 3.0l(a) and G of the RH -I RR is indeed ultra vires t contravenes Section 4(a) of the RH Law and should, therefore, be declared invalid. There is danger that the insertion of the qualifier primarily will pave the way for the approval of contraceptives which may harm or destroy the life of the unborn from conception/fertilization in violation of Article II, Section 12 of the Constitution. With such qualification in the RH-IRR, it appears to insinuate that a contraceptive will only be considered as an a bortifacient if its sole known effect is abortion or, as pertinent here, the prevention of the implantation of the fertilized ovum. For the same reason, this definition of contraceptive would permit the approval of contraceptives which are actually abortifacients because of h . f: ·1 c: h . 174 t eir i -sa1e mec amsm. Also, as discussed earlier, Section 9 calls for the certification by the FDA that these contraceptives cannot act as abortive. With this, together with the definition of an abortifacient under Section 4 (a) of the RH Law and its declared policy against abortion, the undeniable conclusion is that contraceptives to be included in the PNDFS and the EDL will not only be those contraceptives that do not have the primary ction of causing abortion.
Thus, since the etanogestrel in Nexplanon is a hormonal contraceptive which may have a secondary action of abortion, then it should not be allowed by FDA.

B. Merck's Business Strategy

The DOH may think that paying Php 500/implant for the next three years for 600,000 women instead of Php 5,000/implant is a big savings for the government.  But think of it this way: what the Gates Foundation shall give as donation is actually advertising cost for Merck.  To advertise a product, you need to pay the TV and radio stations, and even newspapers and magazines.  In advertising, you lose money, for the prospect of gaining more money in the future.

It is possible that Merck gave Gates Foundation Php 4,500 x 600,000 = Php 2,700,000,000 or Php 2.7 billion to donate to the Philippine Government.  Or perhaps the Gates Foundation alone provided all this amount in support of its advocacy of controlling the world's population. The purpose of this fund is to establish demand for the contraceptive product.  Once the government sees that the contraceptive is effective in preventing pregnancy for the first three years, then the government becomes a consumer of the contraceptive good starting from the fourth year onward.  In the 4th to 6th years, the government would have bought the same number of contraceptive implants as in the first three years and Merck would already have a gross profit of Php 500 x 600,000 = Php 300,000,000 or Php 300 million (assuming it donated to Gates Foundation)--the same amount that the government paid in the first three years.  So it is essentially a get-now-pay-later program.  By 6th to 9th years, if the government's demand for the contraceptive implant is still the same, Merck would finally start making large money at Php 5,000 x 600,000 = Php 3,000,000,000 = Php 3 billion for 3 years or Php 1 billion per year.   And it is not really the government who pays for this, but we the tax payers.

Reproductive Politics: What Everyone Needs to Know®
Reproductive Politics: What Everyone Needs to Know®
Contraceptive Technology
Contraceptive Technology
The Doctor's Case Against the Pill: 25th Anniversary
The Doctor's Case Against the Pill: 25th Anniversary
The Nine: Inside the Secret World of the Supreme Court
The Nine: Inside the Secret World of the Supreme Court
The Supreme Court
The Supreme Court
The Secret Life of the Unborn Child: How You Can Prepare Your Baby for a Happy, Healthy Life
The Secret Life of the Unborn Child: How You Can Prepare Your Baby for a Happy, Healthy Life
The Merck Druggernaut: The Inside Story of a Pharmaceutical Giant
The Merck Druggernaut: The Inside Story of a Pharmaceutical Giant
Pills by the Billions