Misoprostol (Cytotec)

Discussion in 'Pregnancy - Second Trimester' started by Hels_Bells, Mar 31, 2011.

  1. Hels_Bells

    Hels_Bells Bun in the Oven!!

    Mar 21, 2011
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    I am a biology major and currently taking a class called "Health, Contaminants, and the Environment". It deals a lot with the chemicals in food, cosmetics, water, drugs, etc.

    I recently had to write a research paper and after watching "Pregnant in America" (which I would recommend to anyone!) I decided to write about Cytotec. I don't want to explain too much what it's about as I am pasting the paper here. It's something I am really passionate about as the drug kills hundreds up babies and mothers each year. I just saw another woman post on this forum that was offered Cytotec when she went into labor. I was appalled and hope you guys read this!!

    Copyrighted 2011 Helena Davey. Not to be reused - in any form - without express permission. (I am writing a book about this and other issues)

    The purpose of the United States Food and Drugs Administration (FDA) is to evaluate products such as cosmetics, food, and drugs for their safety. According to the FDA’s website, when a drug company wishes to receive FDA approval in order to manufacture a product, they must first test the drug for safety. The drug company itself performs these tests, which include non-human and human-animal testing. The company then sends the FDA the results along with an application for approval. An important component of this application is the prototype of the label the company intends to use, which should display any warnings or possible side effects. The FDA bases its approval on this application (www.fda.gov ). Though FDA physicians review the scientific data, they do not conduct any experiments of their own to ensure the validity of the results. This lack of internal FDA experimentation, along with a lack of enforcement power, has allowed dangerous drugs such as Cytotec to be used improperly in the United States.
    The FDA is a government agency with limited funding and manpower, which corporations know and use to pressure the FDA for approval. For example, when Monsanto was vying for endorsement to use the growth hormone rbGH in its milk cows, it buried officials in a submission consisting of stacks of paper sixty-seven feet high (Smith 80). Shiv Chopra, one of the scientists working on the case, was quoted as saying “We have been pressured and coerced to pass drugs of questionable safety” (Smith 78). Further, the lack of regulatory power binds the hands of the FDA. Instead of giving clear directives, the FDA can only issue guidelines. For example, when asked what it was doing to stop the marketing of drugs that have not garnered approval, the FDA stated it “ issued a final guidance document outlining its approach to addressing medicines that are marketed without required FDA approval” (emphasis added) (www.fda.gov). Once a drug is approved and on the market, doctors are free to use it however they wish in an “off-label” way that the FDA is powerless to stop, says Dr. Marsden Wagner (www.midwiferytoday.com ). The very existence of the FDA creates a moral hazard in which people feel safe about the products they use. They are being made to believe that they are being protected, which is not the case. Over two million people are negatively affected by “safe” drugs every year, including 100,000 deaths (Fitzgerald 8).
    One of the drugs listed as safe when used according to directions is Cytotec. Cytotec was developed by Searle to treat gastric ulcers. It has also been used to cause abortions. The FDA warning label found at www.accessdata.fda.gov clearly states that the drug should not be used to treat ulcers in women of childbearing age unless a negative pregnancy test was obtained; pregnant women especially should never be administered the drug because of its “abortificiant properties”. Nine other organizations besides the FDA have declared this drug to be inappropriate for use in pregnant women, including the World Health Organization and Society of Obstetricians and Gynecologists of Canada, as well as the British Royal College of Obstetricians and Gynecologists. However, because it causes uterine contractions it has been endorsed by the American College of Obstetrics and Gynecology as a labor inducing drug (www.hollowayfoundation.org).
    The contractions induced by Cytotec can be so strong that the uterus ruptures, which may require an emergency hysterectomy; severe bleeding can lead to death of the mother, baby, or both. Even if both survive, Cytotec can leave the infant scarred or maimed for life – missing limbs or mentally handicapped. Such was the case with Samuel Spain, whose mother was brought into labor with Cytotec. Now nine years old, Samuel “has cerebral palsy, epilepsy, learning disabilities. … (There was) delay in walking, talking, motor function, hearing loss and lazy eye” (www.wsmv.com ). Other women have also reported heartbreaking stories of their experience with Cytotec. Tatia Oden French was one of these women who entered the hospital willingly, healthy, and expecting no complications in labor. As she was about two weeks over due, she was induced with Cytotec. She and her baby later died on the operating table after she suffered from an amniotic fluid embolism (www.cytotecadverseevents.com ). This is a serious condition in which parts of the fetus, such as fluids or hair, leave the uterus and enter the mother (www.emedicine.medscape.com). Such was the case when Tatia’s uterus ruptured, exploding inside of her. And yet the drug continues to be used as an induction agent on hundreds of women each year, many of them in good health.
    Safer alternatives such as Pitocin, the synthetic oxytocin, exist. But Pitocin sells for $150 dollars per pill, whereas Cytotec only costs about 25 cents per pill (www.hollowayfoundation.org ). There is a clear causal relationship here as to why the more dangerous drug is chosen. As for why women are induced even when it is not necessary, three factors come into play: lack of education, convenience for mother as well as doctors, and the lack of say mothers have in the decision making process.
    Women today are not very educated about what a normal pregnancy should look like, or even the length of term. It is commonly believed that 36 weeks is the normal gestation period; however, delivery before 39 weeks is considered unsafe. Induction is also seen as a more convenient way of giving birth. The mother is able to mark the day on her calendar with accuracy, and the doctor is in relative control of how long he will be in the hospital, and will likely make it home in time for dinner. The hospital also knows how many nurses will be needed that day. Shockingly, many women are induced with little or no knowledge as to why it is happening or the risks associated with induced labor (www.childbirthconnection.org ). The doctor does not share the decision making with the patient, as was the case when one mother was given Cytotec even after she specifically denied the physician the right to do so (www.cytotecadverseevents.com ). Doctors are able to exploit the mothers’ lack of knowledge, while women are influenced by the moral hazard created by a government agency powerless to protect them and often too manipulated by large companies to have the mothers’ best interest in mind.
    Instead of obeying and heeding Searle and FDA advice and warning, doctors continue to use the dangerous drug Cytotec in order to induce labor. They do this as a as a matter of convenience and cost-effectiveness. The United States Food and Drug Administration is powerless to stop the misuse of the drug, and the process of approving a product is near-to controlled by the companies seeking endorsement.

    Works Cited

    "Cytotec." Web. 24 Mar. 2011. <https://www.accessdata.fda.gov/>.

    "Cytotec (misoprostol)." The Ronald Andrew Holloway Foundation. Web. 24 Mar. 2011. <https://www.hollowayfoundation.org/>.

    Fitzgerald, Randall. The Hundred-year Lie: How to Protect Yourself from the Chemicals That Are Destroying Your Health. New York: Plume, 2007. Print.
    Index. Web. 24 Mar. 2011. <https://www.cytotecadverseevents.com/>.

    "Induction of Labor." Childbirth Connection: Helping Women and Families Make Decisions for Pregnancy, Childbirth, Labor Pain Relief, the Postpartum Period, and Other Maternity Care Issues. Web. 25 Mar. 2011. <https://www.childbirthconnection.org/>.

    Kalodimos, Demetria. "Controversial Drug Sometimes Used To Induce Labor." Nashville News, Tennessee News and Local Weather from WSMV Channel 4 News. Web. 25 Mar. 2011. <https://www.wsmv.com/>.

    Moore, Lisa L. "Amniotic Fluid Embolism." Web. 24 Mar. 2011. <https://emedicine.medscape.com/>.

    Smith, Jeffrey M. Seeds of Deception: Exposing Industry and Government Lies about the Safety of the Genetically Engineered Foods You're Eating. Fairfield, IA: Yes!, 2003. Print.

    U S Food and Drug Administration Home Page. Web. 24 Mar. 2011. <https://www.fda.gov/>.

    Wagner, Marsden. "Cytotec Induction and Off-Label Use." Midwifery Today - Pregnancy, Birth, Homebirth and Midwife Information. Web. 22 Mar. 2011. <https://www.midwiferytoday.com/>.

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