Posted on 12/22/2004 3:10:18 PM PST by nickcarraway
Teenwire - "Ask the Experts"...
Question...
Dear Experts,
How can I get Mifeprex — RU486, the abortion pill? Does Planned Parenthood provide it? I can't let my parents know that I want to get it.
EffeJr
Answer...
Dear EffeJr,
Many Planned Parenthood affiliates recently started providing Mifeprex. Mifeprex is the brand name of a drug called mifepristone, which was just approved by the FDA to use for early medical abortions that can be done without surgery and before a fetus develops. Mifepristone, formerly called RU-486, can be used during the first seven weeks of pregnancy.
The law in many states requires a minor to inform a parent, or to receive parental consent, prior to an abortion. The laws vary from state to state. Sometimes another adult is allowed to give the necessary consent. The Supreme Court has ruled, however, that there must be another option to parental notification or consent for a minor. It is called "judicial bypass." In judicial bypass, a judge can either rule that the young woman is mature enough to make this decision without her parents or that she is not mature enough to make this decision without informing them.
To find out more about mifepristone and medical abortion, contact Planned Parenthood at 1-800-230-PLAN, other women's health care centers, or your private clinician. Planned Parenthood centers that do not provide medical abortion may be able to refer you to someone who does.
For more information, check out Medical Abortion.
Hope this information helps!
Take care,
Teenwire® Editors
http://www.teenwire.com/index.asp?taStrona=http://www.teenwire.com/ask/articles/as_20001213p129.asp
Q. What is the "abortion pill," or mifepristone?
A. Most people have heard of the abortion pill, RU-486. Mifepristone is the generic name for RU-486, which was developed in 1980 by the French pharmaceutical company Roussel Uclaf. Mifepristone is the first in a two-drug chemical abortion technique given to women who are up to 7 weeks (or 49 days gestational age) pregnant. First, a woman is given mifepristone, which acts to block progesterone-a hormone necessary to maintain pregnancy. Mifepristone causes the uterine lining to shed, disconnecting (and in essence starving to death) the developing unborn child. A second drug, misoprostol, is taken a day or two later and causes the womb to expel the now-dead embryo. Taken in tandem, the two drugs cause an induced abortion.
On September 28, 2000, mifepristone was approved by the U.S. Food and Drug Administration (FDA) for use in chemical abortion under the brand name Mifeprex®. The companion drug, misoprostol, was already available in the U.S. as a treatment for ulcers. Misoprostol is manufactured by Searle Pharmaceuticals under the brand name Cytotec®. In July 2002, the FDA approved a generic version of misoprostol distributed by IVAX Pharmaceuticals.
The FDA recommends misoprostol for use in conjunction with mifepristone. However, one month before FDA approval for the abortion drug combination, Searle issued an alert to physicians, warning that misoprostol was not approved for use in pregnant women and that using the drug can cause "rupture or perforation requiring uterine surgical repair, hysterectomy," "severe vaginal bleeding" and "maternal death." 1 Despite this warning, the drug is often used by physicians to induce childbirth. The FDA reports 35 uterine ruptures and 10 infant deaths linked to misoprostol between 1988 and 2000.2 Since 1997, misoprostol is blamed for the deaths of two women who received the drug and then died during or after childbirth.3 Searle, a subsidiary of Pharmacia Corporation, has not studied or approved Cytotec for use in labor induction or abortion.
Mifepristone is the first drug legally prescribed in the U.S. for the sole purpose of ending a human life. It is not a contraceptive, as it is used after the mother knows she is pregnant and the unborn baby is developing in her womb.
Q. What are the risks to women to take mifepristone?
A. On November 15, 2004, the FDA announced labeling changes to highlight the risks and complications associated with mifepristone, including "serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death." 4 The most recent death involved a California woman who died in January 2004 after taking the drug. 5
Officials with the FDA are also reportedly investigating the September 17, 2003 death of 18-year old Holly Patterson. The Livermore, California resident died at a local hospital seven days after receiving mifepristone and misoprostol at the Hayward Planned Parenthood affiliate. According to local press reports, ValleyCare Health System officials are calling on the FDA to pull mifepristone from the U.S. market until a safety review can be conducted, describing the drug combination as having "a controversial and an extensive history of problems." 6 The California state health department is also investigating Patterson's death.
According to the FDA, mifepristone-in conjunction with misoprostol-is linked to two additional abortion-related deaths between June 1998 and November 2001. The FDA data also reports another 22 women who required hospitalization or another "intervention to prevent permanent impairment or damage" after taking mifepristone during the same time period.7
In Tennessee, the family of 38-year old Brenda Vise filed a medical malpractice lawsuit against the abortion clinic that gave Vise mifepristone, alleging that failure to correctly diagnose her ectopic (or tubal) pregnancy caused her death five days after taking the drug.8
The drug manufacturer, the New York-based Population Council, reported the deaths and hospitalizations to the FDA in accordance with federal law. Critics, however, say that the negative side effects of mifepristone are probably under-reported, as physicians are not required to report problems to drug manufacturers. 9
Even before the February 2002 release of this data, supporters of mifepristone acknowledged that the chemical abortion it triggers is not a quick and easy process. Common side effects are potentially serious and include abdominal pain, nausea, vomiting, diarrhea and vaginal bleeding. Five to 8 percent of women require a follow-up surgical abortion because the chemical abortion fails.10 During the U.S. clinical trials, at least one woman who used the drug hemorrhaged so severely that she lost one-half of her blood and nearly died. 11
One published study based on the U.S. clinical trials of mifepristone found that "[E]xcessive bleeding necessitated blood transfusions in four women and accounted for 25 of 27 hospitalizations (including emergency-room visits), 56 of 59 surgical interventions, and 22 of 49 administrations of intravenous fluid." The study reported that one in 100 women participating in the trials were hospitalized with complications ranging from bleeding to abdominal pain and vomiting, which women described as severe and incapacitating.12
Byron C. Calhoun, M.D., of the American Association of Pro-Life Obstetricians and Gynecologists, states, "We can foresee many significant problems that women will encounter should medical abortion become an accepted standard of care. From the clinical trials, we have a generally good idea of the complication rates, which we believe are unacceptably high. One can only imagine the thousands of young women who have taken mifepristone who will be sitting at home wondering how much bleeding is too much."13
Q. What is the history of the FDA's approval of the drug?
A. Clinical trials conducted to receive FDA approval for a new drug can take from seven to 10 years. U.S. trials for approving mifepristone were conducted in about one year, beginning in 1994 and ending in 1995.
The FDA approved mifepristone under a set of rules often referred to as the "Fast Track" process. This approval process was created in 1992 to expedite the approval of drugs for serious or life-threatening illnesses and allows the FDA to put drugs on the market after less testing than other medicines. FDA officials indicate that this accelerated path was chosen for mifepristone because it gives authorities increased control over how the drug is prescribed and how quickly it can be pulled from the market. However, critics accuse the FDA of misapplying the approval option to expedite what amounts to illegal approval of Mifeprex.
Q. Was the FDA decision to "fast track" mifepristone influenced by politics?
A. Initially, Roussel Uclaf was hesitant to bring mifepristone to the United States. Both the Reagan and (first) Bush Administrations were hostile to the idea, and U.S. pro-life leaders were vocal in their opposition, declaring their intention to boycott Roussel Uclaf or any other company involved in bringing mifepristone to the U.S. The Clinton Administration, however, took a different view and pressured Roussel Uclaf to help bring the drug to the U.S., which resulted in the patent donation to the Population Council.
The Population Council experienced major difficulties in its attempts to identify a manufacturer to make the drug, a distributor to make it available to physicians and pharmacists, and investors to fund the venture. Once these necessary steps were accomplished, the 2000 presidential election was fast approaching and with it the potential (and eventual) election of George W. Bush, who opposed the use of the drug for chemical abortion. Based on then-candidate Bush's opposition, critics believe the FDA was urged to quickly approve the drug while the Clinton Administration was still in office.
Q. Who is manufacturing the drug for U.S. markets?
A. The Population Council and Danco Laboratories, the U.S. company formed to distribute mifepristone, were unable to identify a U.S.-based pharmaceutical company willing to manufacture the drug. So, they turned overseas to Communist China, where Danco signed a contract with the state-owned Shanghai Hua Lian Pharmaceutical Co., Ltd. Congressional investigators say the Chinese company and its Shanghai plant have been cited by federal regulators for bringing mislabeled and impure drugs into the United States.14
Q. Did the FDA put adequate "safeguards" in place to protect women's health when approving Mifeprex?
A. No. According to FDA documents, physicians prescribing mifepristone must meet specific qualifications. However, in its position statement regarding mifepristone, the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) points to several areas of concern where physicians say the FDA did not go far enough to protect women's health.
http://64.233.161.104/search?q=cache:IaHTF4jsmGsJ:www.family.org/cforum/fosi/bioethics/faqs/a0027731.cfm+Mifeprex&hl=en
I don't dismiss her bad choices. My commentary is about the FDA approval of this harmful procedure - which actually takes place outside a doctor's perview. If ever there was a case of product liability, this is one. Certainly that is true if we have a media that goes bananas over something far less lethal like Naproxen in Aleve. I blame the FDA's willingness to be manipulated by the Clinton administration and their feminist/abortion-industry compatriots. No one deserves bad medicine - especially when peddled by folks with a political agenda.
..with a deadly drug the Right-to-Life folks have been fighting against for years!...
...They saw this coming.....knew it would happen...but were unable to prevent it.
Now, this young woman's parents have come forward and might...might be able to do exactly that.....Stop it!
Because, money talks......money gets attention.....and drug companies don't want to face years of litigation & loss of revenue IF...these parents succeed with their lawsuit.
That's what it's about.
No reason to take RU-46 off the market while Tylenol is still available. Tylenol doesn't even require a prescription, and any kid can take buy and take as much as they want -- and not everybody who needs a liver transplant gets one in time, even if they go straight to the doctor at the first sign of serious liver damage. There's probably not a single drug on the market that hasn't killed at least one person, in most cases due to the patient ignoring symptoms of serious complications from either the drug or the underlying condition, or not bothering to read and follow dosage and "do not mix with" instructions.
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