Archive for Mifeprex

Group vows to defy FDA, continues dispensing abortion pills illegally

Posted in Abortion pill, Abortion Pill Connections, Abortion Pill Horrors, Abortion Pills Illegal, DANCO, FDA, Illegal abortion, Population Control with tags , , , , , , , , on June 1, 2019 by saynsumthn

abortion pill

Just days after 100 lawmakers sent a letter to the Food and Drug Administration (FDA) — which oversees drug safety — requesting that the FDA monitor abortion group Aid Access for illegally dispensing abortion pills, Aid Access announced its intent to defy the FDA’s warnings to “immediately cease” dispension of the drugs.

Aid Access founder Rebecca Gomperts published her response on Aid Access’s website as well as on Women on Waves, another organization Gomperts founded in 1999. Gomperts claims, “Last year, I prescribed 2,581 medical abortions out of 11,108 women who consulted me.”

Gomperts states in part:

On March 8, 2019, I received a letter from the FDA ordering my new (since 2018) organization, Aid Access, to stop providing telemedical abortion services to women who cannot otherwise access safe abortions because of costs, domestic violence, distance, or other reasons, and who do not have access to other doctors willing or able to prescribe misoprostol and mifepristone.

This letter was applauded by Republican members of Congress, of whom 92 percent are male.

But I will not be deterred. When U.S. women seeking to terminate their pregnancies prior to 9 weeks consult me, I will not turn them away. I will continue to protect the human and constitutional right of my patients to access safe abortion services.

Notably, the Congressional letter was signed by a number of women in Congress, including Reps. Martha Roby, Carol D. Miller, Virginia Foxx, Liz Cheney, Ann Wagner, Jenniffer González Colón, Debbie Lesko, and several medical doctors who also serve in the House of Representatives, among many others.

Rebecca Gomperts founder of Aid Access defiant to offer illegal abortion pills online

In a statement to Live Action News, the FDA wrote:

As noted in the FDA warning letter to AidAccess issued on March 8, 2019, failure to correct the violations of the law may result in FDA regulatory action, including seizure or injunction, without further notice. We cannot comment on a potential future action at this time, but we remain very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet, because this bypasses important safeguards designed to protect women’s health. Unapproved drugs purchased from foreign internet sources are not the FDA-approved versions of the drugs, and therefore, they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.

The statement went on to say that “The FDA’s regulation and oversight of the drug approval process and drug distribution helps to protect patients by applying rigorous scientific and safety standards, requiring labeling review for accuracy and completeness, and working to ensure that counterfeit and unsafe medicines do not enter the U.S. drug supply. When these requirements are not met, FDA can step in to help protect consumers.” The FDA reiterated that it has warned AidAccess.org and Rablon that they are in violation of the Federal Food, Drug, and Cosmetic Act for causing the introduction of unapproved new drugs into U.S. commerce.

Drugs are tightly regulated by the FDA for a reason, and under current requirements, the abortion pill — also known as Mifeprex or Mifepristone — is only permitted to be dispensed in hospitals or clinics by medical personal who are approved prescribers of the pill. FDA placed Mifeprex under a tighter regulatory system known by the acronym 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.”

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 FDA has warned women against purchasing these dangerous pills online: “Do Not Buy Mifeprex Over the Internet.

FDA warns consumers to not buy abortion pills over the internet

The FDA adds, “You should not buy Mifeprex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others). Mifeprex has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.”

READ: AWFUL: Abortion groups tell women to lie about abortion pill, claim miscarriage

Weeks ago, the FDA updated its adverse events report through 2018, documenting “24 deaths of women associated with Mifeprex since the product was approved in September 2000….” The FDA also noted at least 4,200 additional adverse effects. Under 2016 changes, the drug’s manufacturer, Dancono longer has to report non-fatal adverse effects, so we can only imagine what the number really is.

Abortion Pill Deaths December 2018

Dec 2018 abortion pill deaths FDA

Live Action News previously documented a larger push by pro-abortion organizations to lift the FDA’s REMS requirements, to expand abortion pill dispension to mail order and online sales, via self-managed abortions. And we also documented the secretive history of Danco’s investors, which include organizations such as the Packard Foundation and other abortion philanthropists, who appear to stand to gain financially from a broad abortion pill expansion. The original drug, Mifeprex, was approved in 2000 after being brought to the U.S. by the eugenics-founded Population Council.

The defiance by Aid Access comes on the heels of multiple pro-life bills being passed in several states. Pro-abortion organizations, who used to claim that self-abortions injure and even kill women, now appear willing to place them in harm’s way. In addition, when these same women experience serious complications from these dangerous pills, they are instructed to present to the ER and lie, claiming they had a miscarriage. Ironically, while the abortion lobby shows support to Aid Access, they simultaneously want to discredit the science behind abortion pill reversal.

Editor’s Note 5/17/19: This article was edited to include a statement from the FDA.

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

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.

Abortion industry responsible for women dying from home use/ self managed abortions – here’s why!

Posted in Abortion death, Abortion pill, Abortionist, ACOG, Gynuity, Home Use Abortion, Planned Parenthood, Planned Parenthood Clinical Trials, RU-486, Self Managed Abortion with tags , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , on September 27, 2018 by saynsumthn

The abortion industry is now pushing dangerous home abortions

By  |  Via LiveActionNews.org

abortion

When the abortion industry speaks about women dying from “home abortions”, they leave out the fact that historically, they were the ones lined up to assist women in obtaining illegal abortions. Today, the trend seems to be continuing. “Abortion AMA: Can I give myself an abortion?” published weeks ago by Bustle and written by Danielle Campoamor, points out that even though abortion is legal in the US, groups like Women Help Women are advising women on “self managed abortions.”

Image: Bustle promotes self abortions

Bustle promotes self abortions

A June 2018 BBC article reported, “By buying pills online and sharing medical advice through WhatsApp groups, women are increasingly turning to technology to sidestep legal barriers to abortion.” Women on Web, an international group that helps women obtain illegal abortions, suggests women lie about complications and tell the doctors they had a miscarriage instead. Despite warnings against purchasing drugs online, activists Francine Coeytaux and Victoria Nichols created the website, PlanC, to push dangerous home abortions.

Joanna Erdman, assistant professor at Dalhousie University’s Schulich School of Law in Halifax, told the New York Times that Plan C is the “same feminist ideology of ‘self-help’ that guided the many safe-abortion initiatives before it, including, most notably, the Abortion Counseling Service of Women’s Liberation, or Jane.”

Image: Plan C pushes home abortions

Plan C pushes home abortions

Today, despite Roe v. Wade remaining firmly in place, the industry is pushing a legal version of “home use” abortion.

The move, being tested in clinical trials, would allow the drug Mifeprex to be mailed to women, or obtained over-the-counter at a local pharmacy. Mifeprex is regulated by the FDA under Approved Risk Evaluation and Mitigation Strategies (REMS), which ensures that Mifeprex is only dispensed in certain healthcare settings by or under the supervision of a certified prescriber.

The abortion-inducing regimen is made up of two pills: Mifeprex, also known as mifepristone, and misoprostol, which, according to the FDA, will end “an early pregnancy (70 days or less since the first day of the last menstrual period).” Of course, “the pregnancy” is a term for ending the life of a preborn child in the womb. But sometimes these chemicals also claim the lives of their mothers. This process is explained by Dr. Anthony Levatino in the video below:

 

Between May 2009 and February 2011, Clinical Trials “to assess the acceptability of home-use mifepristone” were conducted and reviewed in the United States, Moldova, and the Republic of Nepal, sponsored by Gynuity Health Projects. The sponsor sought to recruit 615 women between 18 to 55 to enroll in the non-randomized study, Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion. The trial within the USA included locations in three states — Georgia, New York and Pennsylvania:

Image: Feminist Women's Health Center home use abortion

Feminist Women’s Health Center home use abortion

Gynuity was founded in 2003 by Beverly Winikoff, M.D., M.P.H, and according to the website, “Winikoff was employed… at the Population Council.. Prior to joining the Council in 1978, she was Assistant Director for Health Sciences, The Rockefeller Foundation.”

Image: Gynuity Home Use Abortion

Senior Clinical Adviser Paul Blumenthal also currently serves as a member of the Board of Directors of the National Abortion Federation (NAF).

Gynuity is funded by organizations known for their support of abortion and population control, including:

  • The Bill and Melinda Gates Foundation
  • The David and Lucile Packard Foundation
  • The John D. and Catherine T. MacArthur Foundation
  • Planned Parenthood Global
  • Population Council
  • Society for Family Planning
  • The Rockefeller Foundation
  • The William and Flora Hewlett Foundation
Image: Abortion by Mail (Screen: The Atlantic)

Abortion by Mail (Screen: The Atlantic)

A report published by the pro-abortion journal ContraceptionAcceptability of Home-use of Mifepristone for Medical Abortion, reviewed a trial conducted from May 2009 through November 2010 at “four urban, demographically diverse clinical sites in New York City, Philadelphia and Atlanta…” which reported, “Four women in the home-use group and five women in the office-use group reported visiting the emergency room (ER) for care related to their abortion.”

Image: Home Use abortions send women to ER (Image: Journal Contraception)

Home Use abortions send women to ER (Image: Journal Contraception)

white paper overview written by authors at the Jacobs Institute of Women’s Health at George Washington University states, “More recent studies include one involving 400 women who received care at six US Planned Parenthood centers.” The Planned Parenthood home use study was conducted between April 2013 and June 2014, and results were published in Contraception, titled A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S, in 2015.

Abortion promoters are currently recruiting for a study at sites in California and Washington, where women will obtain the abortion pill regimen from the pharmacy instead of in the facility itself. Gynuity is also conducting clinical trials for the “Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine,” or “mail order” abortion pills at select locations, including Planned Parenthood.

website, Teleabortion, has even been created to recruit for this experiment.

Image: Telabortion website

Telabortion website

While activists in favor of Roe and their complicit media allies claim abortion is safe, recent FDA reports indicate that almost a dozen women, who obtained pills at medical facilities, have died from it, and a thousand have been hospitalized.

Image: RU486 abortion pill deaths updated 2017

RU486 abortion pill deaths updated 2017

The real numbers may be difficult to track since, as Live Action News has previously documented, nearly half of all states do not require complications be reported. In addition, women suffering complications may present to the emergency room claiming they are suffering a miscarriage, without telling the truth about what has really happened.

In the years leading up to Roe v. Wade, advocates openly admitted that a majority of “illegal abortions” were being performed by “reputable physicians.” Past Planned Parenthood president Alan Guttmacher admitted to the Harvard Crimson in 1967 that “Seventy per cent of the illegal abortions in the country are performed by reputable physicians, each thinking himself a knight in white armor.”

Underground groups are already being formed to help commit “cheap, safe” abortions. There are also legal groups dedicated to “liberating” women who commit self-induced abortions. ACOG, which has shown itself to be pro-abortion, has also called for women to not be prosecuted for any self-induced abortions.

Regardless of the legal status of Roe v. Wade, women will continue to die, and the blame should be placed solely at the feet of the people who enable the killing to keep happening.

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

Dying for birth control?

Posted in Abortion, Abortion death, Abortion injury, Abortion pill, birth control, Birth Control Dangers with tags , , , , , , , , , , , , , , , , , , , on August 24, 2010 by saynsumthn

Birth Control Death
Aired: 2/17/2010 10:13PM CST

Vodpod videos no longer available.

Birth Control Death, posted with vodpod

Symptoms

Symptoms of gallbladder problems could include:

* Pain or discomfort in the upper right side of the abdomen
* Nausea
* Diarrhea
* Abdominal Bloating
* Jaundice

Symptoms of blood clots could include:

* sudden severe headaches
* unusual swelling or pain in the legs or arms
* sharp or crushing chest pain or coughing blood
* eye problems such as blurred or double vision or complete loss of vision
* pain in the back of the lower leg

YAZ/Yasmin

NPR: With Birth Control Pills, New Isn’t Always Better
by Richard Knox
Bayer HealthCare, the leading maker of birth control pills, is coming out with a brand new pill.

Natazia, as it’s called, contains a form of estrogen that’s never been used in an oral contraceptive. It also has a novel dosing regimen. Women on Natazia will take four different combinations and doses of hormones or sugar pills each month.

The new launch coincides with growing problems for Bayer’s last new contraceptive, Yaz.

Beyond Birth Control

After Yaz came out in 2006, it quickly became America’s No. 1 birth control pill, bringing Bayer $800 million last year. But now thousands of women are suing Bayer because they say Yaz caused them serious harm. Sales have dropped 15 percent in the past year.

It’s a good time to look at the Yaz saga and see if it has anything to teach women and their doctors when they choose a contraceptive.

Yaz was something entirely new in the long history of birth control pills — and not just in its chemical formulation. It was the first pill to be marketed for multiple purposes. Bayer promoted it heavily as going “beyond birth control.”

A centerpiece TV ad noted that “all birth control pills are 99 percent effective and can give you shorter, lighter periods. But there’s one pill that goes beyond the rest. It’s Yaz.”

On the screen, brightly colored balloons floated upward. Each balloon had a label — moodiness, irritability, feeling anxious, increased appetite, bloating, fatigue, headaches, muscle aches, acne. In the background, The Veronicas sang “Goodbye to You.”

A Cautionary Tale
Those ads caught the attention of a 16-year-old in Maryland named Katie Anderson.

“I do remember going to the gynecologist and asking for Yaz because I had seen the commercials,” says Anderson, who’s now 19. “That was the one I wanted.”
Anderson hoped Yaz would even out her irregular periods. She liked the implication that Yaz could treat premenstrual syndrome. And, of course, the idea of clear skin appealed to her, too.

“What girl would not fall for something that says, you know, it’s going to help with moderate or mild acne?” she says. “That’s great! That’s just a perk, that’s a plus.”
So she got her doctor to write a prescription for Yaz. It’s a choice she’d live to regret.

Misleading Ads
We’ll come back to Katie Anderson’s story. But first, let’s hear from professor Ruth Day of Duke University. She advises the Food and Drug Administration on “medical cognition” — people’s comprehension and use of medical information in advertising and drug labels.

Day says she’d never seen a campaign that made such sweeping claims as those Yaz ads. She showed the “balloon” ad to dozens of young women and asked what they thought.

“Most people thought it was going to prevent all those symptoms, period,” Days says.

For instance, 97 percent thought Yaz can treat ordinary PMS.

“It does not,” Day says, noting that the FDA approved Yaz for treating a more serious and less common condition called PMDD — premenstrual dysphoric disorder.
What girl wouldn’t fall for something that says it’s going to help with acne? That’s great. That’s a perk, a plus!

– Katie Anderson
Day also asked her research subjects if they thought Yaz treats mild acne. “Sixty-four percent said, ‘Yes, it does.’ But the truth is, it does not treat mild acne,” she says. “So people were getting this idea that Yaz ‘goes beyond.’ But they were getting the wrong message.”

The FDA agreed. Officials declared the ads misleading and ordered Bayer to run a corrective commercial. But Day found the corrective ad still left a lot of misconceptions about what Yaz can and can’t do.

But there’s no question Bayer’s aggressive ad campaign worked. Yaz catapulted past all other birth control pills — and became Bayer’s top-selling drug.

So one lesson from the Yaz saga is: Be wary of claims that a potent pill will solve all your problems — it’s probably not true. And as Day’s research has found out, all those claimed benefits tend to cloud people’s appreciation of the potential risks.

Consider The Risks
Katie Anderson learned that the hard way. She began having persistent leg pains within a month of starting on Yaz.

“I started developing this kind of pinching, twinging, numbing kind of feeling in my left butt cheek,” she recalls. She thought it was a pinched nerve.
Then a couple of weeks later, she was awakened with terrible chest pain.

“She tells me she woke up about 5 o’clock in the morning,” says Beth Anderson, Katie’s mom. “She sat bolt upright in bed — couldn’t move, couldn’t talk, was trying to cry as silently as possible because it hurt to breathe.”

When she didn’t leave for school on time, Beth went to check on her. “I found her sitting in a puddle of tears saying, ‘Mommy, I can’t breathe! Mommy, I can’t breathe! I couldn’t even reach my cell phone!’ ”

Her doctor diagnosed pleurisy, an inflammation of the chest lining that isn’t serious, and prescribed Motrin. That helped for a while, but over the next few days, Katie developed shortness of breath. And her left leg went totally numb and cold.

“My left leg was completely purple,” she says.

It turns out an enormous blood clot had formed in her leg. A piece of it had broken off and lodged in her lung. Doctors call that a pulmonary embolism, and it can be deadly.

At the emergency room, Beth recalls, “the doctor came in and he took one look at Katie’s cold, blue leg, and he said, ‘Wow! That’s a big blood clot! You’re on birth control, aren’t you?’ “

The link between birth control pills and blood clots isn’t new. It’s been known for decades. Every year a few thousand U.S. women suffer clots because they’re on the pill.
It’s possible that Yaz and Yasmin, a similar pill, carry a higher than usual risk of clotting.

Newest Pills Not Necessarily Safest

Danish researchers decided to compare the experience of millions of women taking different contraceptives. “Denmark is the only country in the world with national registration of all women with thrombotic events [blood clots], whether in public or private hospitals,” says Ojvind Lidegaard of Copenhagen University. “We also have a detailed record of women’s medication history.”

Lidegaard’s group found that women taking Yaz or Yasmin had a 64 percent higher risk of blood clots than women taking pills that have been around for decades. Their study was published late last year in the British Medical Journal.

A 64 percent higher risk is not dramatic. But it’s worrisome, given the fact that millions of women are taking the pills.

“The safest is still, surprisingly, one of the oldest pills,” says Dr. Frits Rosendaal, an expert in clotting disorders at Leiden University in Holland.

Rosendaal led another study that also found that women taking Yaz have a higher risk of clotting than those on older birth control pills — about twice as high. That paper also appeared in the British Medical Journal.

“There are convincing indications this pill is less safe than other pills,” Rosendaal says, adding that there’s really no difference in Yaz’s effect on other menstrual symptoms.

Bayer strongly disagrees. The company wouldn’t make a spokesman available to talk about these issues. In a statement, it said that studies the company funded show its pills are no riskier than other contraceptives.

For its part, the FDA looked at all the studies. It found flaws in the Danish and Dutch results. The agency has commissioned its own study, due out sometime next year. The leader of that study, Dr. Stephen Sidney of Kaiser Permanente Health Care, says his reading of the data so far is that “it’s a bit of a mix,” and that the relative risk of Yaz and Yasmin “is an open question.”

Some Women At Higher Risk

On one point, there’s no controversy. Some women have a much higher risk of clotting and death when they take birth control pills. And most of them don’t know they’re at risk.

Katie Anderson was one of these. She has a “superclotting” gene called Factor V Leiden. In fact, Rosendaal’s group in Leiden discovered it.

The gene makes her 35 times more likely to develop a blood clot when she takes any oral contraceptive. With Yaz, her odds might have been even higher.

Factor V Leiden isn’t rare. Rosendaal says about 1 in 5 Caucasians has it, but it’s not routinely tested for. It turns out Katie’s father has the gene. Beth Anderson says she pointed that out to Katie’s doctor before she went on birth control pills.

“I wanted to make sure that wasn’t going to be an issue,” Beth Anderson says. The doctor, she reports, “said she was not aware there was any specific problem with that.”

The leaflets inside all packets of birth control pills warn women not to take them if they have a family history of clotting. But that’s often not mentioned in TV ads. The ads for Yaz simply warned that women over 35 shouldn’t smoke because that increases the risk of blood clots.

“Both Katie and I assumed that since she was well under 35, she wasn’t overweight, and she had never smoked, that it would be safe,” Beth says. “We assumed wrong.”
Katie is now one of 2,700 or so women suing Bayer over Yaz. Three years later, she’s left with a massive clot in her leg that requires her to wear a compression stocking to prevent swelling. She can’t do many of the things she loved to do, and can’t be on her feet for long. The clot may never go away.

“I have to be patient with myself,” she says. “Maybe I can’t run and I can’t hike for very long, but at least I have my legs. At least I can walk.”
So another lesson is: Women and girls thinking of taking the pill should pay attention to the fine print. Their parents, too, if they’re in the picture. And especially their doctors.

As Katie Anderson puts it: “I want people to understand it’s not just a little pill. I want people to understand the risks, understand what the symptoms of a blood clot are like, and really to take it seriously.”

New Pill On Market
So now, Bayer’s introducing another birth control pill.

This happens over and over again. It’s the way the pharmaceutical business works, especially when there’s an enormous market like the one for birth control pills. (About 13 million American women take them, and 100 million around the world.) To garner market share, companies regularly come up with new formulations and market them as new and improved.

The pressure’s even greater when lawsuits have dimmed the luster of a previous drug, or when a company faces competition from generic versions, as is now true of Yaz.
Dr. Edio Zampaglione, senior director of medical affairs for women’s health care at Bayer, and the official in charge of the company’s latest new pill, says its launch has nothing to do with these economic factors. He says Bayer developed Natazia because women need more contraceptive options.

“Each woman is different, and each woman will feel differently on these different types of hormones and will react differently to them,” Zampaglione says.

To some, that might be an argument for caution. When a new birth control pill comes out, no one really knows how millions of women will react to it. Pre-market studies of Natazia involved only about 3,000 women. The unknowns are even greater when a contraceptive contains hormones and combinations never used before.
Beth Anderson says Katie’s story contains a final lesson for women tempted to take the new pill.

“Really, the moral of the story is that you shouldn’t use the latest and greatest drugs unless there’s some reason that the ones that have been around don’t work for you,” she says.

That’s the philosophy of Rosendaal, the Dutch clotting expert.

“Personally, I would not start using a new drug unless it’s proven to be better,” Rosendaal says. “Because we know that all drugs have side effects, and we also know that for newer ones which have not yet been used by millions of people, the side effects are generally unknown.”

Bayer is monitoring how its new pill is doing in up to 70,000 women. But results of those studies won’t be available for at least five years.

ABC News- Birth Control and Blood Clots (Video here )

READ: After 2 More Deaths, Planned Parenthood Alters Method for Abortion Pill

FDA Says 2 More Women Have Died After Taking Abortion Pill
Agency Is Investigating; 7 Fatalities Now Tied to RU-486

By Marc Kaufman
Washington Post Staff Writer
Saturday, March 18, 2006

The Food and Drug Administration reported yesterday that two more women have died after taking the RU-486 abortion pill, bringing to seven the number of fatalities associated with the drug since it was approved for use in 2000.

The agency said that it was investigating the new reports, provided by the manufacturer of the drug, but so far was not able to confirm any cause of death. In four earlier fatalities of California women who had undergone medical abortions, the victims died of a form of blood poisoning caused by Clostridium sordellii , a common but rarely fatal bacterium.

Opponents of abortion quickly described the FDA advisory as another reason to ban the abortion pill, sold as Mifeprex.

“RU-486 is a deadly drug that is killing pregnant women,” Sen. Jim DeMint (R-S.C.), who has co-sponsored a bill to take the drug off the market pending a review, said in a statement. “This drug should never have been approved, and it must be suspended immediately.”

But supporters said that the pill, which has been used worldwide for years, remains safe.

“To put this in context . . . 560,000 medication abortions have occurred in the United States. We know of seven reported deaths of women who had medication abortions in North America,” Vanessa Cullins, vice president for medical affairs of the Planned Parenthood Federation of America, said in a statement. “At this time, none of those deaths have been directly attributed” to the abortion pill, she said.

Though commonly known as RU-486, this medical abortion actually entails taking two pills. The first, an antiprogestin, binds itself to the wall of the uterus, triggering the shedding of the uterine wall and not allowing the embryo to become implanted. One or two days later, the woman takes another drug — misoprostol — that causes her cervix to soften and dilate so the embryo can be expelled.

As a precaution, Cullins said, Planned Parenthood is changing its policy on how medical abortions should be administered. In the past, many women received misoprostol vaginally, although the FDA had never reviewed or approved that method. Vaginal use is considered to be more effective and has fewer side effects, but Cullins said that her organization would no longer recommend that method.

In its advisory, the FDA pointedly said that the safety and effectiveness of vaginal use of the second drug “has not been established.” It also said that providers of medical abortion and emergency-room staffs should investigate the possibility of blood poisoning whenever women who have taken the drugs come in complaining of nausea, vomiting or weakness unassociated with fever or other signs of infection.

The FDA said yesterday that it did not know whether the clostridium bacteria played any role in the most recent deaths, but the agency did establish that it was present in four earlier fatalities. One other death related to medical abortion was in a woman who had an ectopic pregnancy — a condition where RU-486 is not considered appropriate.

The issue of clostridium infection will be discussed at a public workshop in May hosted by the FDA and the Centers for Disease Control and Prevention. The bacterium has been associated with a small number of deaths and more hospitalizations involving both medical abortions and skin grafts.

The agency’s handling of the seven deaths of women who had undergone medical abortion was criticized by opponents of the drug.

“The FDA has pulled other drugs that have caused fewer deaths and less severe complications than RU-486,” Wendy Wright, president of Concerned Women for America, said in a statement. “Why the double-standard for an abortion drug that is now linked to the deaths of seven healthy women and over 800 other reported complications?”

Opponents of medical abortion filed a citizen’s petition with the FDA soon after the drug was approved for use, but the FDA has never acted on it. In addition, Rep. Roscoe G. Bartlett (R-Md.) introduced a bill in 2003 — called Holly’s Law, after Holly Patterson, an 18-year-old California woman who died following a medical abortion — that would ban use of RU-486. The bill has 79 co-sponsors.

Bartlett said yesterday that the maker of Mifeprex, Danco Laboratories LLC, should pull the drug from the market. If it refuses, he said, the FDA should force its withdrawal.