Archive for the Daniel Grossman Category

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.