Archive for mifepristone

FDA: 24 women die from abortion pill, thousands of serious complications

Posted in AAPLOG, Abortion death, Abortion pill, Abortion Pill Connections, Abortion Pill Horrors, DANCO, Daniel Grossman, Generic Abortion Pill, Inc., Packard Foundation with tags , , , , , , , , , , , , , , , , , , , , , , , , on April 23, 2019 by saynsumthn

As more women die from abortion pill, the FDA approves a generic version

abortion pill, emergency contraception

 

The FDA has approved a generic version of the abortion pill Mifeprex, at a time when more deaths are being reported and the abortion industry is pushing for the dangerous abortion inducing chemicals to be dispensed online or by mail. According to a notice from the FDA, the generic version is approved for use as an abortifacient. This news comes just a day before the FDA updated its adverse effects reports through 2018, stating, “As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal…” The FDA’s 2017 report put the number of deaths at 22.

This means that in 2018 alone, two more women died from taking the abortion pill. And yet, now a generic version is going to be made available.

Abortion Pill Deaths December 2018

Dec 2018 abortion pill deaths FDA

To date, the report documents nearly 4,200 reported adverse effects, including hospitalization and other serious complications.

On April 11, 2019, the FDA approved GenBioPro, Inc.’s abbreviated new drug application for a generic Mifeprex, which, when used with Misoprostol is approved as an abortion pill regimen. The FDA states (emphasis added), “This approval reflects FDA’s determination that GenBioPro’s product, Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation….”

READ: The secrecy surrounding the abortion pill’s maker and influential financial investors must end

Generic abortion pill by GenBioPro approved by FDA

The FDA also states clearly that although they modified the Mifeprex application to include “mifepristone products,” this change in no way removes the FDA’s REMS (Risk Evaluation and Mitigation Strategy), “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”

Of note, on April 11, 2019, FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products (including Mifeprex as well as the approved generic version of Mifeprex) for the medical termination of intrauterine pregnancy through 70 days gestation. In establishing the single, shared system REMS, no changes were made to the substantive elements of the REMS. This single, shared system REMS is known as the Mifepristone REMS Program.

Find approval information for this 2019 supplement here.

The approved generic version of Mifeprex generally has the same labeling as Mifeprex…Under the law, the approved generic version of Mifeprex is required to use a single, shared system REMS with the brand product, Mifeprex. This single, shared system REMS, known as the Mifepristone REMS Program, sets forth the distribution requirements that must be followed for both Mifeprex and the approved generic version of Mifeprex.

Requiring that the generic be subject to FDA’s REMS is good news for now, because, as Live Action News has previously reported, the abortion lobby is attempting to expand access to the abortion pills via mail order or pharmacy by pushing “self-managed abortion,” described by Guttmacher as ending a pregnancy “without direct supervision by a health care provider.” To accomplish this, REMS, must be eliminated.

READ: What you should know about the dangerous ‘self-managed’ abortion pill push

Dr. Donna Harrison, Executive Director American Association of Pro-Life Obstetricians and Gynecologists(AAPLOG), agreed, telling Live Action News (emphasis added):

Allowing a generic equivalent of Mifeprex basically means that the patent restrictions have run out. So, new drugs have a patent which is time limited… and in the case of Mifeprex, the patent was held by the Population Council. So, now that the patent has run out, generics are allowed. But this does not change the restrictions. REMS are still in place until FDA changes the restrictions. So, just to clarify, this does not mean that Mifeprex is OTC [over-the-counter]. It just changes how much quality control goes in to the pill manufacturing process and how much Danco can charge for the drug.

The move towards a generic drug is being hailed a victory by abortion advocates, specifically Dr. Daniel Grossman, who has deep tiesto the “self-managed” abortion pill push.

Image: FDA Approves generic abortion drug (Image Twitter Dr. Daniel Grossman)

FDA Approves generic abortion drug (Image Twitter Dr. Daniel Grossman)

Image: FDA Approves generic abortion drug NWHC (Image: Twitter)

FDA Approves generic abortion drug NWHC (Image: Twitter)

Under the Mifepristone REMS Program, the FDA states, “Mifeprex and the approved generic version of Mifeprex” may:

  • [O]nly be supplied directly to healthcare providers who are certified to prescribe the drug product and who meet certain qualifications.
  • [T]he products are only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber.
  • They are not available in retail pharmacies and are not legally available over the Internet.

The original drug (Mifeprex) was approved in 2000 after being brought to the U.S. by the eugenics-founded Population Council, and was seeded by the Packard Foundation among other pro-abortion philanthropy groups. They then set up a highly secretive company named Danco to manufacturer the drug.

The generic version is produced by GenBioPro, Inc., which also appears to have the financial support of abortion collaborators. In fact, Packard gave GenBioPro, Inc. $185,000 in 2016 and 100,000 in 2017. According to the Nevada Secretary of State, a 2007 filing for the company was permanently revoked. A new filing in 2011 is active and shows a registered agent of CSC Services of Nevada, Inc. and the only officer listed is E. Masingill.

The FDA warns consumers they should not buy Mifeprex or GenBioPro, Inc.’s approved generic version of Mifeprex, Mifepristone Tablets, 200 mg., over the Internet because they will bypass important safeguards designed to protect patient health.

    • This article is reprinted with permission. The original appeared here at Live Action News.

Media ignores profit motive of researcher attempting to discredit abortion pill reversal

Posted in Abortion pill, Abortion Pill Connections, Abortion Pill Study, Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Clinical Trial APR, Contraception Journal, DANCO, Daniel Grossman, Mitchell D. Creinin, Population Council, Reproductive Health Professionals (ARHP), RU-486, University o California San Francisco (UCSF), University of California, University of California Davis with tags , , , , , , , , , , , , , , , , , , , , , , , , , , , , , on April 23, 2019 by saynsumthn

abortion pill birth control

 

The principal investigator of a study seeking to disprove the legitimacy of abortion pill reversal has direct ties — including financial ties — to abortion pill manufacturer Danco, which was formed by the eugenics-founded Population Council. This potential conflict of interest should demand scrutiny from the media — but instead, the media willingly questions abortion pill reversal based upon a single “expert” that receives compensation from Danco. This “expert” is Mitchell D. Creinin, a professor at University of California, Davis, sponsor of the study.

Mitchell Creinin has long history with abortion. He is an abortionist who was involved in clinical trials of RU-486 at Magee-Women’s Hospital Dept. of OB/GYN Pittsburgh, PA. He was the previous medical and lab director of Planned Parenthood of Western Pennsylvania, as described by Oxford University Press. He worked on an abortion training publication for the National Abortion Federation (NAF). He has served on the Board of Directors for the Association for Reproductive Health Professionals (ARHP). He is also listed among the advisory counsel for the early abortion training guide published by Advancing New Standards in Reproductive Health (ANSIRH), part of UCSF’s Bixby Center for Global Reproductive Health.

As I detailed in a Twitter thread shown below, Creinin’s abortion history and connections to the abortion pill’s manufacturer are deep and worth mentioning. This calls into question the validity of his study into abortion pill reversal. Creinin has financial incentive to make sure the abortion pill remains in demand, as do the study’s sponsors. This is a blatant conflict of interest.

Carole Novielli@CaroleNovielli

Person behind “Clinical Trial” to attempt to disprove abortion pill reversal (APR) – connected to abortion and takes money from abortion pill manufacturer- can you say CONFLICT? https://www.liveaction.org/news/whos-who-abortion-pill-reversal-study/ 

The who’s who (and who not to trust) behind an abortion pill reversal study

Abortion advocates want broad access to the abortion pill, and are pushing studies funded by people who stand to gain financially from abortion pill sales.

liveaction.org

See Carole Novielli’s other Tweets

 

See Carole Novielli’s other Tweets

Carole Novielli@CaroleNovielli

3/ Mitchell D Creinin is Professor at University of California, Davis (UCD) – the anti-APR study’s sponsor more here https://www.liveaction.org/news/whos-who-abortion-pill-reversal-study/  pic.twitter.com/ceovZv7Uqr

See Carole Novielli’s other Tweets
View image on Twitter

Carole Novielli@CaroleNovielli

4/ Mitchell D Creinin is a consultant for abortion pill manufacturer, receiving consulting fees $$/ honorarium f/ DANCO https://www.liveaction.org/news/whos-who-abortion-pill-reversal-study/  pic.twitter.com/GZ4s3kfmSp

See Carole Novielli’s other Tweets

Carole Novielli@CaroleNovielli

5/ Mitchell D Creinin provided “third-party telephone consults,” for pill (Mifeprex or RU486) DANCO – formed by Population Council
More here https://www.liveaction.org/news/whos-who-abortion-pill-reversal-study/  pic.twitter.com/MsAH2mXW7v

See Carole Novielli’s other Tweets

Carole Novielli@CaroleNovielli

6/ Creinin founding member of Society of Family Planning (SFP) began w/ Packard Foundation $$ – which is funding abortion pill studies/ publications. SFP funding study- granted UC Davis $401,764. https://www.liveaction.org/news/whos-who-abortion-pill-reversal-study/  pic.twitter.com/FTtWWM90gm

See Carole Novielli’s other Tweets

Carole Novielli@CaroleNovielli

7/ Creinin, deputy editor SFP’s journal Contraception, publishes Packard-funded reports promoting self-managed abortion. Funds Gynuity which sponsors abortion pill expansion studies https://www.liveaction.org/news/exposed-conflicts-interest-abortion-pill/  more here https://www.liveaction.org/news/whos-who-abortion-pill-reversal-study/  pic.twitter.com/CarYNczMXg

See Carole Novielli’s other Tweets

Carole Novielli@CaroleNovielli

8/ Packard’s investment seeded abortion pill MFG, DANCO including a $14 million loan as early as 1996 to bring drug RU486 (Mifepristone) to US Packard funds UC Davis sponsor of study https://www.liveaction.org/news/secrecy-abortion-pill-maker-investors/  More here https://www.liveaction.org/news/whos-who-abortion-pill-reversal-study/  pic.twitter.com/SYzUaTfwHV

See Carole Novielli’s other Tweets

Carole Novielli@CaroleNovielli

9/ Creinin is Principal Investigator (PI) in another clinical trial by abortionist on pharmacy dispension of abortion pill https://www.liveaction.org/news/this-abortionist-claims-abortion-pill-doesnt-need-regulations-hes-wrong/ 
More here https://www.liveaction.org/news/whos-who-abortion-pill-reversal-study/ 

The who’s who (and who not to trust) behind an abortion pill reversal study

Abortion advocates want broad access to the abortion pill, and are pushing studies funded by people who stand to gain financially from abortion pill sales.

liveaction.org

See Carole Novielli’s other Tweets

Carole Novielli@CaroleNovielli

10/ Creinin previous medical/lab director Planned Parenthood of Western Pennsylvania – and an abortionist involved in original clinical trials of RU-486 abortion pill

See Carole Novielli’s other Tweets

Carole Novielli@CaroleNovielli

11/ In summary- FOLLOW THE MONEY – something this @VICE report FAILED to do – https://news.vice.com/en_us/article/j5wqqp/theres-no-proof-abortion-reversals-are-real-this-study-could-end-the-debate 
These abortion “studies” are tied together by $$ from / Danco support from

There’s no proof “abortion reversals” are real. This study could end the debate.

Four states already mandate that doctors advise women their abortions can be reversed.

news.vice.com

See Carole Novielli’s other Tweets

As shown in the Twitter thread above, Creinin serves as consultant for abortion pill (Mifeprex) manufacturer, Danco, and receives consulting fees and compensation from the company. In addition, he receives honorarium from Danco. Creinin also provides “third-party telephone consults” for Danco. Creinin’s study sponsor is financed by the Packard Foundation, one of Danco’s major financial investors.

If this all weren’t enough to show a major conflict of interest, Creinin is also a founding member of the Society of Family Planning, which is collaborating on the study. This organization’s mission is to support abortion research, it, too, is funded by the Packard Foundation. Creinin is also the deputy editor of SFP’s official journalContraceptionPackard-funded studies in this journal unsurprisingly support the pro-abortion cause, claiming self-managed abortion is safe, and urging the undoing of current FDA safety standards restricting dispensation of the abortion pill (known as REMS). The Journal’s editorial board has been stacked with abortion industry insiders, including a National Abortion Federation board member and members of the Population Council (responsible for bringing the abortion pill into the US and forming DANCO, the manufacturer of the pill).  Obviously, the journal is pro-abortion.

Creinin is also the principal investigator in another clinical trial run abortionist/researcher Daniel Grossman (professor at University of California, San Francisco) on pharmacy dispension of the abortion pill.

Despite the fact that this conflict exists between the study’s “investigator” and Danco, media outlets ignore it. Such was the case over at Vice, which published the latest attack against abortion pill reversal, highlighting Creinin’s study without drawing one line to his connections to the abortion pill’s manufacturer. Vice headlined their hit piece: “THERE’S NO PROOF ‘ABORTION REVERSALS’ ARE REAL. THIS STUDY COULD END THE DEBATE,” in spite of the fact that Creinin’s study is only at the recruiting stage, and hasn’t reached any conclusions yet.

Or has it?

Creinin makes no secret that he doesn’t believe in abortion pill reversal  — and his profitable relationship with Danco should give any critically thinking person reason to question the motivations behind this push to “test” the effectiveness of the abortion pill reversal protocol.

    • This article is reprinted with permission. The original appeared here at Live Action News.

Reducing abortions is there an abortion change?

Posted in Abortion decreasing, Abortion Numbers, Abortion pill, Abortion reporting, Abortion stats, AHA, CDC, Guttmacher, Medication Abortion, Morning After Pill, Non-Surgical abortion, Plan B, RU-486 with tags , , , , , , , , , , , , , , , , , , , on February 11, 2015 by saynsumthn

Anti-abortion activists who “claim” that abortions are not decreasing have neither the documentation nor the knowledge to prove their claims.

One such pro-life “claim” was refuted recently by Jill Stanek on her blog which you can read here.

The argument is that medical abortion as opposed to surgical abortion are somehow not counted in the overall abortion stats which then contradicts statements by pro-life leaders who say that abortions are decreasing in United States.

Mifeprex -ABORTION-PILL-082713

Of all the people I have heard use this bogus claim, no one offers a single study to back it up.

In addition, they fail to mention that medical abortions are counted in the overall abortion stats where abortion reporting is required.

It is important to note that medical abortions never went OTC because of popularity – this happened because of politics plain and simple.

The early medical abortion, RU486 or mifepristone was not approved for use in the US until Sept 2000.

So how do they account or the drop in abortions prior to those dates?

The chemical abortion, Plan B, regarded by the FDA as a “emergency contraction”, was first approved in July 2009 for use without a prescription for women age 17 and older and as a prescription-only option for women younger than age 17. In April 2013, the product was approved for nonprescription use for women as young as 15. In June of 2013, Plan B became available to women and girls of all ages.

Although, it might be true that some chemicals labeled “contraception” which are abortive, may not be included in the abortion numbers – it is also true that this has always been the case.

For example, if emergency contraception is counted as “birth control” and not “abortion” that does not negate the fact that abortions are on the decrease.

Because emergency contraception (also called “morning after pills” or “day after pills”) is only effective up to 5 days after having sex and Plan B must be taken within 72 hours of sexual intercourse to be effective, it may be true that some women who take EC or Plan B are pregnant – but- it may also be true that some are not pregnant – a fact we will never know.

Just as it is true that the birth control pill and other forms of “contraception” may also be abortive, their numbers have never been included in the overall abortion stats.

What we are looking at is “trends.”

Prior to Roe, women were not seeking abortions by the millions like they do today.

After abortion was legalized it is true that abortion numbers rose.

However, according to stats, abortions peaked in 1990 (around then) and after groups like Operation Rescue and others took to the streets – they went on a downward trend which continues to this day.

According to the CDC:

    following nationwide legalization of abortion in 1973, the total number, rate (number of abortions per 1,000 women aged 15–44 years), and ratio (number of abortions per 1,000 live births) of reported abortions increased rapidly, reaching the highest levels in the 1980s before decreasing at a slow yet steady pace . However, the incidence of abortion has varied considerably across demographic subpopulations (5–9). Moreover, during 2006–2008, an interruption occurred in the previously sustained pattern of decrease, but was then followed in subsequent years by even greater decreases.

We used to have almost 2200 abortion clinics in America and according to a 2014 analysis by Operation Rescue which tracks abortion clinics closures, the total number of all remaining abortion clinics in the US is currently 739. Surgical abortion facilities account for 551 of that total while the number of medication-only abortion facilities stands at 188.

How can the majority of abortions be medical when the majority of clinics are surgical?

Abortion restrictions limit abortion access and reduce abortion numbers.

Guttmacher ab restrictions

We know that legalization makes abortion “appear” acceptable – which in turn increases them. We know from studying trends that when abortion became legalized, for example the numbers of African American women who had abortions went way up. We also know from studies that if an abortion clinic is within certain miles of a woman seeking abortion that her decision to have the abortion increases. All those factors change when the abortion clinic is closed.

Trends for example in the African American community show that not only did legalization increase abortion so did access.

Studies from the CDC show that, prior to legalization, approximately 80% of all illegal abortions were done on white women. One study in New York even found that white women had five-times as many abortions as black women.

But, at the moment abortion became legal, that began to reverse.

In 1973, researchers within the abortion movements were documenting that easy access to abortion clinics produces higher abortion rates in the surrounding area. And at least one expert discovered that having a nearby clinic is a bigger factor in the black abortion rate than it is in the while abortion rate.

In a 1999 paper published by the American Journal of Public Health Phillip B. Levine, Douglas Staigei; along with Thomas J. Kane and David J. Zimnmerman, entitled, Roe v Wade and American Fertility, the group points out that when abortions are made legal, fertility rates drop with a reduction in births of teens and non-White women to be the largest.

Phillip B Levine Roe v Wade and American Fertility

Estimates show that births to non-White women in repeal states (vs states with no law change) fell by 12% just following repeal, more than 3 times the effect on White women’s fertility,” that paper states.

Effect of abortion on Black births

The group also concluded that there was an important connection between the fall of birth rates in states where abortion was accessible vs. states where it was not, “The results indicate that travel between states to obtain abortions was important. Births in repeal states fell by almost 11% relative to births in nonrepeal states more than 750 miles away but only by 4.5% relative to births in states less than 250 miles away and those in states between 250 and 750 miles away,” the authors write.

What this shows is the reverse is also true. Closing abortion clinics will reduce abortions overall.

Abortion advocates know that when abortion access i.e. the closing of local abortion clinics takes place- fewer women have abortions.

Many reasons for women NOT to get a medical abortion.

According to the American College of Obstetrics and Gynecology women prefer surgical abortions, “Generally, women are satisfied with the method they choose but, when randomized, prefer surgical abortion to medical abortion, ACOG says.

    When women choose medical abortion they choose them because of a desire to avoid surgery, a perception that medical abortion is safer than surgical abortion, and a belief that medical abortion is more natural and private than a surgical procedure.

    However, compared with surgical abortion, medical abortion takes longer to complete, requires more active patient participation, and is associated with higher reported rates of bleeding and cramping.

ACOG medical versus chemical abortion

    With medical abortion, expulsion of the products of conception [i.e. the unborn baby], most likely will occur at home, but a few women will still require surgical evacuation to complete the abortion. An early surgical abortion takes place most commonly in one visit and involves less waiting and less doubt about when the abortion occurs compared with medical abortion. In addition, women who undergo surgical abortion will not see any products of conception [or fetal body parts] or blood clots during the procedure.

Given this data, it is a marketing ploy by the for-profit abortion lobby to give an impression that many abortions are “non-cutting” or non-surgical. That is because “Surgery” scares clients.

However- the use of the term non-surgical abortion does not imply that they are medical as Randall K. O’Bannon, Ph.D at National Right to Life explains:

    Clinics are obviously trying to address and assuage these fears. On the one hand they explicitly try to argue in their descriptions of the procedures that “no cutting is involved” (Aaron’s Women’s Clinic, Houston TX). Or they can say that in a vacuum aspiration “There is NO cutting or scraping of the uterus” (Northside Women’s Clinic, Atlanta, GA).

    The South Jersey Women’s Center still calls these surgical abortions (which they are), but tries to distinguish these from ordinary surgical procedures. “No cutting or incision is necessary and the procedure takes only 5 to 7 minutes.”

    Planned Parenthood avoids the term “surgical” and tries to call these “In-Clinic Abortion Procedures.”

    New York OB/GYN AssociatesTM classifies these as “Non-Surgical Abortions” because they “do not involve any scraping or scarring of the uterus.” They say that “There is no cutting during an Aspiration Abortion.” They maintain that “There is no scraping, no scaring and no damage to the uterine wall.”
    Both the chemical and aspiration methods they advertise “are designed to naturally release a woman’s pregnancy in a gentle and safe way, which does not cause damage.”

    However there is more to this than just calming fears and apprehensions. The abortion industry has found it increasingly difficult to find doctors willing to perform abortions or to add abortion to their practices. By re-defining the abortion procedure as “non-surgical,” this opens up the performance of abortion to a whole new set of medical practitioners.

    Promoters of the idea that these are “non-surgical” try to employ the rationale that because they do not cut tissue to enter the woman’s body but enter through the birth canal, these are somehow, strictly speaking, not surgery.

What the increase of medical abortions show is that abortions are occurring earlier, not that more are happening.

As of 2008 medical abortions comprised around 15-16% of abortions.

In 2011, the CDC reported that at ≤8 weeks’ gestation, early medical abortion accounted for 28.5% of abortions, but at all subsequent points in gestation the use of medications to induce abortions through nonsurgical methods accounted for only 0.6%–5.3% of reported abortions.

CDC 2011 Surgical and Medical abortion state

A July 2014 report by Guttmacher said that in 2011, medication abortion accounted for 23% of all nonhospital abortions and 36% of abortions before nine weeks’ gestation a similar figure to the CDC.

Guttmacher Medical Abortions 2011

Early medication abortions have increased from 6% of all abortions in 2001 to 23% in 2011, even while the overall number of abortions continued to decline, Guttmacher reports.

(NOTE: Medication and nonsurgical abortions numbers are reflected in Guttmachers overall abortion totals.)

REPORTING

Having said all of that, I do agree that not all abortions are reported – but – as I document above- they never have been.

What we are using to determine that abortions are declining is stats that have been in place since the 1970’s.

An analogy by Troy Newman, president of Operation Rescue, reveals the nonsense of critics of the pro-life movement by comparing stats on abortion numbers to other statistics we commonly reference, “How do they know robbery and murder rates are down? Those are just stats also,” he told Saynsumthn.

Newman points out that there are many ways to steal online and those thefts may not get counted.

In addition, Newman says that people can be murdered in ways that don’t look like murder, “Does that mean that the “anti-murder” crowd and the “anti-robbery crowd” need to do a better job and stop quoting published crime stats?” he asked.

Take polls for example, they do not sample all people but are a proven indication of trends. If you do not use any source for your abortion stats how can you then make the claim from that – nothing has changed?

So, even though an argument can be made that every abortion is not reported, that does not prove that abortions are not decreasing in numbers.

Know this, that had it not been for pro-life legislation, pro-life counselors outside abortion clinics, undercover efforts to expose doctors and clinics the numbers would be much higher no matter how you look at it. This is not a complete victory – but it is a reason to push all the harder to banish abortion from our land.

No one has ever claimed that ALL abortions are reported however the baseline is consistent.

Whatever the real number – pro-lifers have the testimony of many women who have chosen life as a source as well.

I have been in this fight for 32 years and no person who is recently interested in the unborn will EVER convince me that we have not saved lives and made a difference.

You can try to re-write history if you want to, but some of us lived this history and until we are dead we will testify to the changes we have witnessed.

Dying for the abortion pill !

Posted in Abortion, Abortion complication, Abortion death, Abortion injury, Abortion pill, Morning After Pill, RU-486 with tags , , , , , , , , , , on July 18, 2011 by saynsumthn

This video is from 2005 – since then several more women have died….is abortion worth YOUR life?

Vodpod videos no longer available.

Abortion pill warning- too many deaths, posted with vodpod

The Truth About Chemical Abortion and Women’s Health: Updated FDA on RU486

by Jeanne Monahan
July 12, 2011

A summary of adverse event reports (AERS) recently released by the Food and Drug Administration (FDA) and obtained through Sen. Orrin Hatch’s office reveal that in the span of almost eleven years since the approval of the abortion drug, popularly known as RU-486, in the United States, at least 11 women have died as a result of complications related to taking the drug.[1] Internationally, the number of women who have died as a result of RU-486 is at least 17.[2]

That’s not all. The dangerous complications associated with this drug continue include hemorrhaging and infection. In the U.S., at least 612 women have been hospitalized after taking RU-486; and at least 339 women required blood transfusions as a result of serious blood loss after taking the abortion drug.

Clearly highlighting the need for more stringent medical oversight, the report also indicates that 58 women were prescribed RU-486 despite having ectopic pregnancies. Yet, “[a]dministration of mifepristone and misoprostol is contraindicated in patients with confirmed or suspected ectopic pregnancy.”[3] To state it more clearly, a woman who has an ectopic pregnancy and takes the RU486 regimen places her life in danger.

It is not only women in the U.S. who are suffering as a result of chemical abortion, it is a worldwide trend. A recent Australian health department audit of nearly 10,000 abortions performed in 2009 and 2010 compared the safety of RU-486 with surgical abortion, with the outcome being in the words of one major media outlet “The Abortion Pill ‘Less Safe than Surgery’”. The Australian report showed that 1 in 18 patients who used RU-486 had to be re-admitted to hospitals (a total of 5.7% of women vs. only .4% of surgical abortions.) The same study revealed that as many as 33% of women who had second trimester RU-486 abortions required some form of surgical intervention.[4]

Marketing the abortion drug as simple and painless, such as taking an aspirin, is dangerously misleading to women. RU-486 is in a class of drugs categorized as selective progesterone receptor modulators, which, in addition to blocking progesterone necessary for the developing baby, also suppresses a woman’s immune system. Additionally, it is sometimes the case that the remains of the pregnancy are not entirely expelled from a woman’s uterus, causing infection and other problems.

Despite the seriousness and intensity of adverse effects related to RU-486, use of this form of abortion is on the rise, and frequently the regimen is dispensed with less medical oversight than surgical abortion. Even more troubling, nationally and internationally, “telemed” dissemination of RU-486 is increasing.[5] Telemed abortions involved doctors proscribing RU-486 through skype or over the internet rather than during a patient visit.

The bottom line is that abortion drugs are not about improving women’s health but are more accurately about advancing a radical pro-abortion agenda regardless of the impact on women’s health, even when it proves deadly.

[1] Food and Drug Administration, “Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011” (http://downloads.frc.org/EF/EF11G29.pdf).

[2] Ibid.

[3] Jamie Walker, “Abortion pill ‘less safe than surgery’,” The Australian (May 7, 2011) (http://www.theaustralian.com.au/national-affairs/abortion-pill-less-safe-than-surgery/story-fn59niix-1226051434394).

[4] EA Mulligan, “Mifepristone in South Australia” Australian Family Physician Vol. 40, No. 5, May 2011 (http://www.frcblog.com/wp-content/uploads/2011/05/Australian-AERs_RU486_201105mulligan.pdf).

[5] Michel Martin (host), “Growing Controversy Surrounds ‘Telemed’ Abortions,” National Public Radio (January 24, 2011) (http://www.npr.org/2011/01/24/133182875/Growing-Controversy-Surrounds-Telemed-Abortions).

FRC and Lifenews report on 2 more RU486 abortion pill deaths

Posted in Abortion, abortion clinic safety, Abortion complication, Abortion death, Abortion pill, RU-486 with tags , , , , , , , , , on October 1, 2010 by saynsumthn

Pro-Life Groups Saddened by News of More Women Dying From Abortion Drug
by Steven Ertelt
LifeNews.com Editor
October 1, 2010

Washington, DC (LifeNews.com) — Reaction from the pro-life community to the news that the CDC is reporting two more women have died from using the RU 486 abortion drug is swift. Representatives of two organizations say the deaths are an indication the FDA and the abortion industry are ignoring women’s health and safety.

As LifeNews.com reported, new information about the deaths comes from a CDC report issued September 30 in the New England Journal of Medicine.

The two women died after developing a Clostridium sordellii infection after using the abortion drug, including the 2008 death of a 29-year-old Hispanic woman and the 2009 death of a 21-year-old Caucasian woman.

That brings the total number of deaths from the abortion drug of women in the United States to eight. Another five women have died in other nations, including Canada, the U.K., Sweden and France, and the European maker of the abortion drug suggests 29 women have died from using it.

“With this latest report, we see that, despite high profile government investigations and public assurances of the drug’s safety, women taking RU 486 continue to die,” National Right to Life education director Randy O’Bannon told LifeNews.com this morning. “It’s clearly a dangerous drug that kills unborn children and puts their mothers at risk.”

“We are told that these are extremely rare infections, supposedly unrelated to RU 486 or its accompanying prostaglandin, yet somehow they keep showing up with this specific group of women taking these abortifacients,” he said.

The Planned Parenthood abortion business had been telling women to use the abortion drug vaginally — until two published studies confirmed vaginal use contributed to lethal infects the women contracted that ultimately claimed their lives.

Although Planned Parenthood changed its protocol on the administration of the abortion drug, it still uses the drug in a smaller dosage than the FDA recommends in order to safe money, which O’Bannon says will continue until the abortion drug is no longer available.

“The abortion industry continues to thumb its nose at the FDA and its protocol, and now two more women are dead. Both women and their unborn children will be safer if this drug is pulled from the market,” he said.

Wendy Wright, whose organization Concerned Women for America has closely monitored the FDA’s approval process of the abortion drug and the deaths of and injuries to women that have resulted from it.

“Because RU-486 is a dangerous drug, I was sure there would be more deaths but expected they would go undetected and unreported,” Wright told LifeNews.com.
She says the Food and Drug Administration is taking a curious approach to the abortion pill — informing the public of dangers of other products and drugs but ignoring the problems associated with mifepristone.

“Just this week the FDA released a dire warning to stop using infant sleep positioners because 12 infants died in 13 years. RU-486 has caused at least 9 deaths in less than 10 years,” she said. “According to the FDA’s standards, it needs to warn people not to use RU-486. No respectable doctor would use it.”

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FRC’s Jeanne Monahan Responds to Two New Deaths from RU-486

WASHINGTON, Oct. 1 /PRNewswire-USNewswire/ — U.S. Centers for Disease Control and Prevention officials have disclosed that two mifepristone (RU-486)-induced deaths occurred in the past two years, bringing the total number of reported death related to RU-486 to 12. This announcement comes almost 10 years to the date after the Food and Drug Administration (FDA) approved the abortion drug, deeming it a major advancement for women’s health and safe for public use.

The news came in a letter to the editor of the New England Journal of Medicine on September 30, 2010. Both mifepristone-induced septic shock deaths were caused by c. sordellii, the bacteria linked to a number of RU-486 deaths from 2000-2006.

One woman who died was 29; the other was 21. The deaths occurred in 2008 and 2009, respectively. The public is only now learning of these deaths.

Of this announcement, Family Research Council’s Director of the Center for Human Dignity Jeanne Monahan, who formerly worked in the Office of the Secretary in the Department of Health and Human Services, made the following comments:

“Abortion proponents claim that abortions should be ‘safe, legal and rare.’ Yet RU-486 use is increasing and its safety record is entirely dubious, as these two deaths prove.

“Ten years ago, the FDA’s approval process for RU-486 was flawed, relying primarily on French data that the FDA admitted was marked by ‘carelessness,’ ‘fraud,’ and ‘evidence tampering.’ And while the abortion industry achieved a major victory with the approval of RU-486, women have been the victims of the abortion agenda.

“Other drugs with less extreme adverse affects have been pulled from the market quickly, but not RU-486, whose over 1,300 adverse affects on women using the drug – including 336 hospitalizations, 172 blood transfusions, and most gravely, 12 deaths – have been ignored. These two women are just the latest of many to pay a severe price.

“Ten years later, the FDA approved ulipristal acetate – ‘ella’ – as an emergency contraceptive, despite the fact that it shares an almost identical chemical make-up and identical modes of action with RU-486. Given the strong resemblance, there is reason to believe that the negative side effects will also be similar. Women should not be the ‘guinea pigs’ of the abortion industry or the government. These risks should not be taken,” Monahan concluded.
For more information on RU-486:
FRC Senior Fellow Chris Gacek on the FDA’s approval of RU-486: http://www.frc.org/content/politicized-science-the-manipulated-approval-of-ru-486-and-its-dangers-to-womens-health
Jeanne Monahan in Human Events regarding the tenth anniversary of RU-486: http://www.humanevents.com/article.php?id=39179

Pharmacists for Life- disgusted with FDA’s approval of abortion drug

Posted in Abortion, Abortion pill, Ella One, Warren Buffet with tags , , , , , , , , on August 16, 2010 by saynsumthn

PFLI Condemns FDA Approval of Chemical Cousin of Abortion Pill Mifepristone (RU 486)

MEDIA ADVISORY, Aug. 16 /Christian Newswire/ — Pharmacists For Life International releases the following statement:

In many places of employment a gigantic board is posted listing the shortages and outages of essential medications, such as antibiotics, pain relievers, anesthetics and drugs for sedation. This problem has been significant for years, and has worsened considerably in the last year, impeding pharmacists’ ability to provide vital care for our patients. The FDA has placed the approval of this “chemical cousin” analog of mifepristone (sometimes known by its antiquated experimental name, RU 486) ahead of the need to address this severe health care issue.

Our disgust for the deadly FDA action is profound and beyond the ability to verbalize. Ulipristal acetate, according to its own developers, can kill embryos and feti. It is marketed in Europe as EllaOne® . The low dose 30mg form of Ella®, has been prioritized for approval by the US FDA, which would have served the citizens of the US better by adequately addressing the current, rolling shortages of truly lifesaving and essential medications, rather than chemicals whose main intent is to snuff out a nascent life in the first few weeks of existence.

The embryocidal doses of ulipristal acetate may now be stockpiled and accumulated by prescribers or patients for “medical” chemical abortions at home, sidestepping the so-called regulation of mifepristone/misoprostil (the other abortion drug brought to the US in the 1990s by the Population Council and whose $4 million experimentation bill was entirely footed by mega-billionaire Warren Buffett). This will lead to additional life-endangering problems for the targeted adolescent girls and women, as well as giving continued cover for sexual predators of underage girls and incestuous abusive relationships.

The FDA is expected to continue in its long tradition of relegating females to lowest class health care status. PFLI rounded and vehemently denounces and condemns the FDA for this inappropriate use of its drug regulatory power to destroy life rather than approve and regulate medicines which actually are life-saving and preserve health.