Archive for Home Use abortion pill

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.

Conflicts of interest? Abortion pill investor funds study claiming women want expanded distribution

Posted in Abortion pill, DANCO, David and Lucile Packard Foundation, George Soros, Journal Contraception, Population Council, RU-486, self-managed abortion, Warren Buffet with tags , , , , , , , , , , , , , , , , , , , , , on November 30, 2018 by saynsumthn

EXPOSED: Massive conflicts of interest found in new abortion pill study

abortion pill

Abortion industry insiders insist that there is a large public interest in expanding distribution of the abortion pill by lifting safety requirements for the drug regimen. Now, right on cue, a study done by abortion industry insiders and funded by a large investor of the abortion pill’s manufacturer purports to show that women want “alternative models” for obtaining the abortion pill. But the move is anything but organic and is being strategically driven by abortion industry insiders.

Published by the Journal Contraception, the study claims that women support obtaining abortion pills “(1) in advance from a doctor for future use, (2) over-the-counter (OTC) from a drugstore and (3) online without a prescription.” But there is more beneath the surface at play here. Not only are the Journal and its authors deeply embedded in the abortion industry, but the funding for this study also came from the David and Lucile Packard Foundation, a major investor in Danco, the manufacturer of the abortion pill.

In 1998, according to reports, Packard seeded Danco with $10 million, and Packard also currently funds Gynuity Health Projects, which conducts abortion pill clinical trials. Packard’s investment in Danco included a $14 million loan as early as 1996 to bring the drug to the US, as well as additional grants made in 2000, 2004, and 2009. And yet, the Journal claims there are no conflicts of interest.

Image: Packard Foundation self managed abortion pill study (Image: 2018 study from Journal Contraception)

Packard Foundation self managed abortion pill study (Image: 2018 study from Journal Contraception

Additional investors in Danco include George Soros (Open Society), Warren Buffet (Buffet Foundation) and the California-based Kaiser Family Foundation.

Image: Packard Foundation invested in abortion pill manufacturer DANCO (Image: David and Lucile Packard Foundation )

Packard Foundation invested in abortion pill manufacturer DANCO (Image: David and Lucile Packard Foundation )

Journal Contraception  

Authors

Image: Journal Contraception 2018 study on self managed abortion

Journal Contraception 2018 study on self managed abortion

 

Image: Author Sarah Raifman Tweet June 2018 SB320 (Image: Twitter)

Author Sarah Raifman Tweet June 2018 SB320 (Image: Twitter)

  • Author Diana G. Foster is another ANSIRH staffer who opposes late-term abortion restrictions. She sits on the board of the Later Abortion Initiative (LAI), a group with the mission of “increas[ing] the number of sites where later abortion is available” and “expand[ing] the number of physicians who can perform later abortion, especially at 20 weeks’ gestation and beyond.” Foster has been applauded by the abortion advocacy group, NARAL.
Image: Author Diana G Foster applauded by NARAL 2016 tweet

Author Diana G Foster applauded by NARAL 2016 tweet

READ: Amazing: Over 500 babies saved thanks to abortion pill reversal

The abortion pill regimen, RU486, is made up of two drugs: Misoprostol and Mifeprex. This regimen is currently regulated by the FDA under a system known as REMS. As Live Action News previously explained, taking the abortion pill regimen isn’t just a simple thing — if a woman is too far along or if her pregnancy is ectopic, these factors put women at additional risk. There have been 22 reported deaths and thousands of hospitalizations since the abortion pill’s approval in 2000.

Live Action News has previously documented how:

  • Abortion insiders brought RU486 to the US.
  • Abortion insiders are conducting clinical trials for “home-use” and “self managed” abortions.
  • Abortion insiders collaborated to push “home use” abortions.
  • Abortion insiders recently coordinated a Tweetfest to promote “self-managed” abortions.
  • And now, abortion insiders conveniently roll out a study claiming women support “alternative models of medication abortion provision.”

Despite the clear conflicts of interest surrounding this study about the abortion pill, it and other studies like it are likely to go unchallenged by the mainstream media, just as abortion industry leader Planned Parenthood’s claims continue to go unchallenged. This does a grave disservice to women.

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.

TARA Health Foundation funds abortion pills on college campuses in California

Posted in Abortion pill, Home Use Abortion, TARA Health Foundation, Telemed with tags , , , , , , , , , , , , , , on September 6, 2018 by saynsumthn

Abortion groups pledge $20M for abortion pills on California college campuses

UPDATE: SB320 passed and is on the way to the Governor’s desk

abortion pill

The push to force California colleges to provide deadly abortion pills via legislative mandate (SB320) is a dangerous idea. But it’s not being funded primarily by the state. Instead, two pro-abortion philanthropic organizations have pledged their support to the tune of nearly $20 million. According to the website StateofReform.com, SB320 needed at least $9.6 million in private funding “made available to a state fund January 1, 2019,” to move forward. As the bill is moving forward, it is relevant to ask who is behind those funds: “[T]he Funders’ Collaborative, led by the Tara Health Foundation and The Women’s Foundation of California, committed just under $20 million in funds to ensure that it will move forward at no cost to the state.”

According to a letter from TARA to the Chair of the California Appropriations Committee, TARA and The Womens Foundation “have collectively committed to just under $20 million dollars in implementation funds ready to be deployed as soon as this important bill becomes law. All of the funders will make donations to a California nonprofit organization that will be responsible for providing the $9.6 million to the California Commission”:

  • $200,000 grants to each of 34 public university student health centers
  • $200,000 grants to each of the 2 public university systems (UC and CSU)
  • $2.4 million to CCSWG for administering the fund

An additional $9.875 million dollars will be provided directly to appropriate technical assistance
advisors, and an evaluation team, as well as directly funding grants of $200,000 each for any
community colleges or private universities that wish to become ready to provide medication
abortion at their student health center.

Image: TARA Health Foundation letter to fund abortion pills

TARA Health Foundation letter to fund abortion pills

TARA Health Foundation was founded by Ruth Shaber, an OB/GYN who held research positions at Kaiser Permanente. According to her online bio, she sits on the Medical Advisory Committee for Planned Parenthood Federation of America. Shaber is also the chairman of the board of TARA’s Reproductive Health Investors Alliance, which partners with abortion organizations like Planned Parenthood, and has granted them $3.35 million.

Shaber claims the mission of TARA consists of “engaging peers to join in piloting and demonstrating the use of creative philanthropic capital to drive social and financial returns.” Those “social” returns include abortion on demand. According to its website, in 2014, Shaber named the foundation “after the goddess Tara in order to invoke the strength and compassion of a powerful female deity. Tara, a Hindu goddess later adopted in Buddhism, embodies both fierceness and maternal protection for all beings. She represents creation, wisdom, oneness and strength to overcome obstacles.”

How, exactly, does killing children via the abortion pill square with “maternal protection for all beings”?

Image: Ruth Shaber founder TARA Health Foundation (Image credit: LinkedIn)

Ruth Shaber founder TARA Health Foundation (Image credit: LinkedIn)

The Women’s Foundation is led by Surina Khan, a previous staffer at the Ford Foundation and the International Gay and Lesbian Human Rights Commission. Though on paper, the Women’s Foundation advocates for a number of causes impacting women, the Foundation also gives grants to nonprofits that advance “reproductive rights” — code for abortion on demand.

Image: Womens Foundation California funds abortion pill on college campus (Image credit: Twitter)

Womens Foundation California funds abortion pill on college campus (Image credit: Twitter)

According to Marj Plumb, DrPH, Chief Strategist of Policy Advocacy and Training at The Women’s Foundation, SB 320 came out of a training program called the Women’s Policy Institute. Plumb told StateofReform.com:

One of our teams a couple years ago had heard of the UC Berkeley effort [to petition the University to offer medication abortions at the campus health center] and felt that there needed to be a state law that required the state university health centers to provide medication abortion. So they partnered with Senator Leyva who helped to write the bill language and do the advocacy…

Primarily, The Women’s Foundation of California and Tera Health Foundation…helped to implement both medication and other types of abortion at Kaiser and at other facilities. Then we have other funders who are participating with us, several of whom wish to remain anonymous.

TARA’S philanthropy was recently used to prop up the abortion chain Whole Woman’s Health (WWH) while they raised legal challenges to Texas’s abortion laws, taking it all the way to the Supreme Court. An interview Shaber conducted with the Wharton School at the University of Pennsylvania, Shaber explained:

One example of how we’re using capital in an integrated fashion and creatively is in how we’ve supported Whole Woman’s Health, an organization of clinics led by Amy Hagstrom Miller… because of the burden of the litigation, they needed to open and close their clinics multiple times. As a result, they had a large amount of debt, and the only place they were able to get capital from was high-interest credit card debt. When we got involved in supporting them…giving them a grant, we were able to do this private debt. It’s giving us a 3% return over five years.

Recent FDA reports indicate that almost a dozen women have died from the abortion pill and a thousand have been hospitalized. Women suffering adverse effects of the abortion pill may claim to hospital emergency rooms that they are experiencing miscarriages rather than medication abortion complications — and this can skew the real numbers of reported complications, which may have a tremendous impact on the safety of vulnerable young women.

College campuses should not be partners in killing off future generations. And no matter how much money is raised, abortion will never be a good solution for women.