Prominent House of Lords Member Speaks Out Against Dangerous DIY Abortion

Prominent peer speaks out against ‘dangerous’ DIY home abortion scheme

A prominent member of the House of Lords has called on the Government to stop the provision of ‘DIY’ home abortions, which she says have “proven to be so dangerous”.

In a recent article, Baroness Philippa Stroud criticised the Government for introducing a dangerous and harmful ‘DIY’ home abortion concession as part of efforts to ‘Protect the NHS’ during the COVID-19 pandemic. She said that the decision to allow ‘pills-by-post’ or ‘at home’ abortion represents “the largest change to abortion law since 1967 and was done without any parliamentary scrutiny or public consultation”.

“The measures allow consultations with a single doctor or nurse over the phone, after which both sets of abortion pills (one mifepristone/six misoprostol) are sent to the patient’s home for a woman to effectively perform a DIY abortion, up until 10 weeks gestation”.

In March, just a week after the beginning of lockdown, Secretary of State for Health, Matt Hancock confirmed that there were no plans to change the abortion law as part of the COVID-19 response. However, as Baroness Stroud points out, these reassurances were quickly forgotten as the Government U-turned to allow ‘DIY’ home abortion throughout the pandemic, despite the Health Minister Lord Bethell admitting in the House of Lords that “it is not right to rush through this type of change in a sensitive area such as abortion without adequate parliamentary scrutiny.”

 Unintended consequences

“It is difficult to quantify the number of complications that have arisen from these pills, such as incomplete abortion and continued bleeding, due to insufficient data collection of patients receiving the pills, but Freedom of Information (FOI) requests have revealed the aftermath from the pills-by-post process to include sepsis, hemorrhaging, embolisms, renal failure and trauma to pelvic organs, among other medical complications”, she said.

The limit for ‘DIY’ home abortion is supposed to be 10 weeks gestation. As the abortion provider BPAS states, one week’s difference, from less than 9 weeks gestation to a 9-10 week gestational age more than doubles the risk of an incomplete abortion from 3% to 7%.

Baroness Stroud highlighted that “there are at least 52 cases officially reported to the Department of Health and Social Care of women who were provided pills-by-post beyond 10 weeks gestation, including one case where the unborn child was at 28 weeks gestation (beyond the legal limit)”.

A leaked email from a Regional Chief Midwife at NHS England and NHS Improvement concerning the “escalating risks” around ‘DIY’ home abortion revealed that one woman was able to receive abortion pills at 32 weeks pregnant and mentions “3 police investigations […] linked to these incidents”, one of which is a murder investigation “as there is a concern that the baby was live born” after a woman used the ‘DIY’ home abortion service.

 “Threat to vulnerable women and girls”

Alongside the medical complications of ‘DIY’ home abortion, the Baroness decried the potential for abuse and coercion, which becomes difficult to detect without in-person consultation.

She noted: “This poses a threat to vulnerable women and girls who are at risk from an abusive partner, sex-trafficking or child-sex abuse, as the home abortion could be used by their abusers as a means to more easily cover up trafficking or abuse scandals”.

 “Proven to be so dangerous”

Despite Government guidance encouraging people to attend medical appointments in person during lockdown, such access to physical healthcare has not been applied to ‘DIY’ home abortion, thereby leaving vulnerable women and girls to fend for themselves in their own homes.

As Baroness Stroud powerfully concludes, “it is crucial that the Government reverses these damaging concessions that were made at the beginning of the pandemic that have proven to be so dangerous, and restores protections for women during these unprecedented times, and reverses the concessions for at-home abortions”.

Right To Life UK’s spokesperson, Catherine Robinson said:

“The pre-COVID abortion law in England and Wales, although certainly a very bad and dangerous law, did at least provide some minimal protections against forced abortions and ensured at least a minimum of post-abortion care. Once abortion pills are sent in the post, no one can be certain who takes them and at what stage of pregnancy. The potential for complications and abuse is extensive especially considering that thousands of  women have procured an abortion via this method”.

“Baroness Stroud is absolutely right to call on the Government to rescind this appalling law, which was introduced with no parliamentary scrutiny and next to no discussion. The concern that abortion access be expanded at all costs is once again on clear display. The abortion providers distributing this pill and knowing the many risks involved are showing how little they actually care for women, let alone their unborn children”.

 

This is a www.righttolife.org.uk opinion piece

Ref: https://righttolife.org.uk/news/prominent-peer-speaks-out-against-dangerous-diy-home-abortion-scheme

Brave pregnant mother with cancer refuses abortion and delays treatment

Brave mother with cancer refuses abortion and delays treatment, given all clear

A 21-year-old mum who delayed cancer treatment rather than have an abortion has now been given the all clear.

Ellie Whittaker from Chesterfield was diagnosed with Hodgkin’s Lymphoma in October 2019 while she was also 16 weeks pregnant. Ellie was told that chemotherapy to treat the cancer could harm her unborn baby, so her doctors told her she should have an abortion.

 “I don’t regret my decision and I’d make the same one again given the choice.”

Ellie refused to have an abortion and decided to delay chemotherapy until after her daughter was born.

‘The doctor advised I have an abortion because cancer treatment could cause problems for the baby. There was no way I was going to give her up so I chose to delay it.’

‘I pushed the cancer as far from my mind and focused on Connie – I couldn’t wait to be a mum.

Her daughter, Connie, was born on 18th March 2020, and by that time the cancer had progressed. Ellie started treatment almost immediately after the birth.

She said: ‘I tried to spend as much time with Connie as I could before I started. I remember crying and thinking I wouldn’t be able to be there for her.

‘I knew the chemotherapy would take its toll.

‘But when they scanned me the cancer had progressed to stage three – it had spread to my stomach and spleen.’

The all clear

Ellie underwent 12 gruelling rounds of chemotherapy between March and September before doctors finally gave her the all clear in October 2020.

“I’m so pleased it’s gone and I can focus on being a mum.”

“Connie’s an amazing baby – she started teething and trying to sit-up. She’s the quietest baby and sleeps through the night. I wouldn’t change her for the world.”

 Pressured to have an abortion

Women are advised or even pressured to have abortions for many different reasons. They are often pressured to have an abortion if doctors think their child might be disabled

In 2017, a damning report from the UK’s Care Quality Commission (CQC) accused Marie Stopes International (now MSI Reproductive Choices) of paying staff bonuses for persuading women to have abortions.

In October of this year, a nurse in the UK said she was left fearing for her life and needing emergency surgery after MSI Reproductive Choices denied her proper counselling and pressured her to take abortion pills at home, rather than under the supervision of a doctor in a clinic.

Right To Life UK’s spokesperson, Catherine Robinson, said: “It’s wonderful that Ellie is now free of chemotherapy and her daughter is healthy. It’s so encouraging to see this brave mother refuse an abortion despite potential risks to her own health.”

“Sadly, in this case the doctors are endorsing a form of twisted logic that says: ‘Better to have an abortion than risk harming the baby.’ In reality of course, nothing could harm the baby more than ending his or her life through abortion.”

 

This is a www.righttolife.org.uk opinion piece

Ref: https://righttolife.org.uk/news/brave-mother-with-cancer-refuses-abortion-and-delays-treatment-given-all-clear?fbclid=IwAR1DS2aIqPo-6-QmpjP7X964swO_YdBSY5lQr8HBZehW8Cg87wySXRcaa88

Pro-Life People Will Sing Christmas Carols at Abortion Clinics to Save Babies, Share Christ

Pro-Life People Will Sing Christmas Carols at Abortion Clinics to Save Babies, Share Christ

With messages of hope and life, pro-life advocates plan to sing Christmas carols outside abortion facilities all across the country this December.

The Christian Post reports the “Peace in the Womb” caroling project has been going on for seven years, and, through their singing and encouragement, pro-lifers have helped save unborn babies from abortion.

“More than any other factor, it’s fear that drives a woman to seek abortion. Fear for her future, fear of giving birth, even fear over her partners’ reaction to her pregnancy,” said Eric Scheidler, executive director of the Pro-Life Action League, in a statement. “These fears have been compounded by the COVID pandemic and resulting economic downturn.”

Though participation in pro-life sidewalk advocacy is down due to the coronavirus, Scheidler said pro-lifers in dozens of cities still plan to participate this year.

“So far, the number of locations is a little bit down this year because some places, particularly hard-hit states, we’ve had some of our leaders decide to either scale down the event or postpone it or wait until next year,” he told the Christian Post.

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He said they hope the Christmas carols will plant a seed in women’s minds that there is hope for them and their babies and there is forgiveness for those seeking abortions.

“It’s particularly sort of horrifying to think of a woman seeking an abortion at this time of year, when all of us are putting together Christmas lists and praying in preparation for Christmas and reflecting on the beauty of Mary and Joseph saying yes to our Lord and becoming parents, even in trying circumstances,” Scheidler told One News Now.

“Our mission is to bring the light of the incarnation, the light of the birth of Christ to this place of despair,” he added.

Though the carolers sometimes face “very aggressive” pro-abortion counter-protesters, he said they know that they are making a difference for life. He told the Post that, during one event in Jacksonville, Florida, a mother and daughter who came for an abortion heard the Christmas carols and had a change of heart.

“ … when they heard that we were there singing Christmas carols trying to appeal to the moms to choose life, the mom and daughter left the abortion clinic and then the pro-lifers followed up and found out that the girl had absolutely chosen to keep her baby,” Scheidler said.

Find a list of events here.

 

This is a www.lifenews.com opinion piece

Ref: https://www.lifenews.com/2020/12/11/pro-life-people-will-sing-christmas-carols-outside-abortion-clinics-to-save-babies/

Morning After Pill Charades

Morning After Pill Charades

The morning after pill can be abortifacient and women need to know the truth.

I read the article by Isabel Stabile, published on TMIS of Sunday, 6 December, and as a researcher and gynecologist in the field, I must answer in the interest of correct consumer information to the Maltese citizens.

I base my reply quoting the Official Assessment Reports on EllaOne by the European Medicines Agency (EMA) itself. It is pertinent to note that we are speaking of two very different drugs mentioned as Morning after pill, each having a completely different mode of action. These are Levonogestrel (morning after pill) and Ella One (five days after pill).

From the studies presented, it is clear that Levonogestrel (LNG) is unable to prevent or delay ovulation; however, it leads to a shortened or inadequate corpus luteum that does not allow the endometrium to prepare for implantation. The diagram below, from a study by Brache et al, confirms that compared to the placebo, Levonogestrel does not prevent ovulation. The data is presented and shared by EMA itself in its EPAR (European Public Assessment Report) on EllaOne page 9 and updated yearly; last update being on 20 May.

The EMA shows officially that LNG does not work by affecting ovulation and is placebo-like in the fertile days, when fertilization is possible. In spite of this, the EMA presents LNG as an ovulation-inhibitor. Why?

EllaOne (ulipristal acetate, UPA) can prevent implantation and also terminate ongoing pregnancies. “Ulipristal acetate prevents progesterone from occupying its receptor, thus the gene transcription normally turned on by progesterone is blocked, and the proteins necessary to begin and maintain pregnancy are not synthesized.” (EMEA 2617/87/2009, Page 8: 2.3). On page 10 of the same document, it goes on to say that: “The ability of Ulipristal Acetate (UPA) to terminate pregnancy was investigated. Ulipristal, mifepristone and lilopristone were approximately equipotent” further confirming that it can terminate an ongoing pregnancy.

The science and the marketing of the morning after pill (MAPs) are diametrically opposed. The consumer can easily be misled into thinking that the MAPs are “normal” contraceptives when in fact they can be and are anti-implantation drugs and EllaOne can likely interrupt ongoing pregnancies.

Women who would be reluctant to take any medicinal that could endanger their embryo’s life should have access to the correct information and biological processes taking place in their body. The law in Malta protects the embryo from conception. Professionals can also have a conscientious objection to referral and/or supply of such medicinals.

In her article, Stabile also emphasised the relevance of the SPC. Have a look at the image below taken from page 41 of the same 2009 EMA Assessment Report: the highlighted sentences: “Omit any sentence in the SPC and the PL suggesting that the product could be used as an abortifacient”, “Pregnancy should be excluded before EllaOne is administered” and “Contraindication: Pregnancy”, speak volumes.

Furthermore, the European Medicines Authority in the Assessment Report EMA/73099/2015 on page 35, reports that during the evaluation process of the ellaOne registration dossier, the company, HRA-Pharma, was “requested to study any potential off-label use of ellaOne, in particular during pregnancy, possibly as an abortifacient. No such clinical studies were performed with Ulipristal-Acetate and it is therefore left as an unknown, whether it is possible to use it for abortion”. This notwithstanding, at the end of the 2015 AR, EMA presented ellaOne once again as an anti-ovulatory drug and made it “not subject to medical prescription”.

EllaOne does not prevent ovulation in the most fertile days and yet over 80% of expected pregnancies do not appear clinically. The drug does not allow endometrial maturation, so necessary for the embryo to implant. This leads to the embryo losing his or her life.

EllaOne and Levonogestrel are being sold over the counter and without prescription to young adults and women who think that they are using contraceptives that are safe. No advice is obligatory as to the side effects that these medicinals can have on their health, especially with recurrent use of EllaOne. In fact, Esmya, a medicine containing the same active ingredient, ulipristal acetate, has been withdrawn from clinical use due to a direct relationship between UPA and severe liver injuries, including liver transplantation. A case of severe DILI (Drug Induced Liver Injury) occurred after an UPA consumption, not greater than the dosage in one-two tablets of EllaOne, and EllaOne, unlike Esmya, can be self-administered repeatedly, without any medical surveillance.

The scientifically correct information regarding the mechanism of action of these drugs must be available to our politicians, decision-makers, doctors, chemists and other professionals and last but not least to the women consuming these pills. Their rights and freedom of informed choice are being deliberately thwarted. Women are being deceived. They are being informed that ovulation will be prevented after taking Emergency Contraceptives, but, on the contrary, they can ovulate and can conceive, but their offspring dies as these drugs inhibit implantation. Healthwise they are completely unaware of the severe drug induced liver injury (DILI) potentially due to Ulipristal acetate.

For further information on toxicity and on the mechanism of action, please see, respectively: Ulipristal Acetate and liver-injuries: while Esmya is revoked, EllaOne is allowed in repeated self-administrations possibly exceeding UPA toxic-dosing with Esmya. Mozzanega B. J Hepatol 2020 Nov. 30; S0168-8278(20)33828-9. doi: 10.1016/j.jhep.2020.11.041. 

UPA and LNG in emergency contraception: the information by EMA and the scientific evidences indicate a prevalent anti-implantation effect. Mozzanega B, Nardelli GB. Eur J Contracept Reprod Health Care 2019; 24(1):4-10. doi: 10.1080/13625187.2018.1555662. Epub 2019 Jan. 18

Further scientific papers are available on http://www.sipre.eu in Italian or English

Related article – http://staging-lifenetwork.stagingcloud.co/ulipristal-acetate-and-liver-injuries-by-bruno-mozzanega-md/

Bruno Mozzanega, Dept SDB (Woman’s and Child’s Health), University of Padua (I)

 

This is a www.independent.com.mt opinion piece

Ref: https://www.independent.com.mt/articles/2020-12-13/newspaper-opinions/Morning-After-Pill-charades-6736229383

 

Ectopic Pregnancy: The Truth

Ectopic Pregnancy: The Truth

by Klaus Vella Bardon 

In their increasingly aggressive campaign to promote abortion, Doctors for Choice again claimed that the criminal code has no provision for abortion under any circumstance, not even when a woman’s life is imminently at risk of death as a result of a pregnancy.

To prove their point, they stoop to any level and are now exploiting a relatively recent case of ectopic pregnancy.

An ectopic pregnancy is a non-viable pregnancy that occurs outside of the uterine cavity, most commonly in the fallopian tube.

As a pro-life activist, I checked the facts with the help of an expert of how this condition is treated in Malta

I was informed that there are basically three ways to deal with an ectopic pregnancy and that saving the mother is the top priority.

One either waits, or one treats the case medically, or, thirdly, as a last resort, it is removed surgically.

As in all sound medical practice, invasive treatment is kept to a minimum in the interest of the patient’s well-being.

Usually, unless otherwise indicated, the mother is kept under strict observation and, often, the body solves the problem on its own, unassisted medically.

The second line of treatment is the medical option where the drug methotrexate, that cuts short the pregnancy, is administered.

The use of methotrexate is also not so straightforward as its side effects and contraindications have to be taken into account. Yet, even here, one has to weigh the risks of taking methotrexate when the risk of surgery is higher.

Once the specialist treating the mother decides medically that the patient needs methotrexate, the decision is final.

There are formulary drugs and non-formulary drugs. Formulary are easily accessible, one just needs to prescribe them, like paracetamol or certain antibiotics.

Non-formulary are more difficult to access, not for ethical reasons but because of logistical and safety issues.

Being a dangerous non-formulary drug, methotrexate needs to be signed off by the specialist/consultant and head of department, then sent to the pharmacy where the drug is prepared and finally forwarded for its administration. The whole process takes time and some delay is inevitable as the use of drugs that carry certain grave risks must be controlled.

It is about time that the pro-abortion lobbyists make a serious attempt to respect the facts. We all have a very serious obligation to ensure that the public is given the truth, especially about such life and death matters.

Sadly, again and again, ethics is not the forte of the so called ‘pro-choice’ brigade.

It is profoundly unjust and dishonest that they grasp and manipulate any extreme case they can find in order to justify their false claim that anti-abortion laws place pregnant women at risk.

Klaus Vella Bardon – Balzan

_________________________________________________________________

It is disingenuous and entirely wrong for the self-styled “doctors for choice” to use the case of an unfortunate woman who suffered the traumas of an ectopic pregnancy as a “trojan horse” attempt at changing Malta’s abortion laws.

This poor lady (assuming the account in the Times of Malta is accurate) appears to have suffered additional distress as a result of what appears to have been bureaucratic delay in being given the correct treatment for her serious and potentially life-threatening problem, which is always to end the pregnancy. This case, in itself, establishes the fact that Malta’s abortion laws have nothing to do with the difficulties encountered and I cannot fathom how anyone could claim otherwise.

It should be evident that the solution to prevention of a similar future occurrence of this most regrettable incident must surely lie in modifying or speeding up the procedures already in place to ensure expeditious delivery of necessary treatment. I fail to see why the laborious process of parliamentary legislation should be required to achieve this desirable outcome.

There has never been any controversy about the need to terminate ectopic pregnancies. No pro-life institution, government or Church has ever challenged this fact.

Abortion, on the other hand, almost invariably involves the deliberate ending of a healthy, viable pregnancy. It is rarely carried out for what might be termed ‘good medical reasons’, the usual situations being ‘domestic arrangements’ or ‘economic hardship’. The minority associated with abuse/assault/foetal abnormality create tremendous difficulty all round as they are, inevitably, tragic situations to which there is no ‘happy or easy’ solution.

Malta’s would-be abortionists might like to ask themselves to explain the schizophrenic approach like-minded clinicians adopt towards pregnancy. If the baby is wanted, the foetus is happily referred to as ‘your baby/little boy/little girl’; on the other hand, if unwanted, it remains an ‘it’ and is treated like an unwanted wart, to be disposed of expeditiously.

Whither the Hippocratic oath, which, for thousands of years, included the line “I will not administer a pessary to a woman to induce an abortion”, until the evermore utilitarian approach the human race has adopted towards life led to its removal in around 1970?

Anton Borg – Gloucestershire, UK

 

This is a www.timesofmalta.com opinion piece

Ref: https://timesofmalta.com/articles/view/letters-to-the-editor-december-10-2020.837920

Ulipristal Acetate and liver-injuries by Bruno Mozzanega MD

Ulipristal Acetate and liver-injuries:

while Esmya is revoked, EllaOne is allowed in repeated self-administrations possibly exceeding UPA toxic-dosing with Esmya. – Bruno Mozzanega, MD – Assistant Professor Dept Woman’s and Child’s Health, University of Padua (Italy)

To the Editor of Journal of Hepatology,

Ulipristal Acetate (UPA), an antagonistic Selective Progesterone-Receptor Modulator (SPRM), is the active-principle of two drugs: Esmya and ellaOne. While Esmya for fibroid treatment has been revoked because of severe liver-injuries, the emergency-contraceptive EllaOne is allowed in repeated self-administrations possibly exceeding UPA toxic-dosing with Esmya.

ESMYA – Micronized-UPA, 5mg-tablets in blisters of 28. It was taken daily for three to six months to treat uterine fibroids, after EMA (European Medicines Agency) authorization in 2012. It needed medical prescription and treatment was supervised by experienced doctors. It reduced progesterone-induced fibroid growth.

Due to the appearance of serious liver injuries in 8 Esmya-treated patients, the EMA Pharmacovigilance-Risk-Assessment-Committee (PRAC) started an evaluation (EMA/791062/2017) [1] that concluded that UPA had a possible role in injuries. EMA recommended measures to minimize the risk (EMA/355940/2018) [2]: contraindication if liver problems; information to patients; liver-tests before, during and after treatment; repeated courses only to inoperable women.

On September 4th 2020, a further review by EMA-PRAC confirmed that UPA 5mg can cause liver injury, including the need for liver transplantation. Since it was not possible to identify which patients were most at risk or measures that could reduce the risk, the PRAC concluded that the risks outweighed its benefits and Esmya should not be marketed in the EU (EMA/455818/2020) [3].

The strict post-marketing surveillance made it possible to link Esmya-administration to side-effects. The time from Esmya first-intake to hepatic failure ranged from few days to six months [4].

ELLAONE – Micronized-UPA, 30mg single-dose tablets, authorized for emergency contraception.

Both the 2018 and 2020 EMA-PRAC Reports on Esmya-related risk 2,3 specify that with ellaOne there is no concern about liver injury.

When the Members of EMA-CHMP (Committee-Human-Medicinal-Products) recommended ellaOne for marketing-authorization in 2009, they acknowledged that UPA accumulates in tissues, with a high tissue-to-plasma ratio (EMEA/261787/2009,page 13) [5]. They acknowledged that repeated UPA-administrations (even scheduled monthly) lead to a progressive accumulation in the liver, eventually resulting in liver-toxicity. Consequently, EMA-CHMP authorized single-dose administration and warned against repeated self-administration.

However, in 2015 this scenario changed: the EMA-CHMP removed the warning against repeated self-administration and made ellaOne-supply “not subject to medical prescription” (EMA/73099/2015) [6]. Since then, the repeated self-administration of ellaOne in the same cycle is allowed and suggested as safe, without any medical supervision.

Up-to-date, no cases of hepatotoxicity have been reported after single-dose administration of ellaOne; however, the patient 2 in Meunier’s series [4] evidenced severe liver injury after taking Esmya (UPA 5mg) for 3 days (15mg=half ellaOne) to 26 days. Women on Esmya-treatment were strictly surveilled, while those taking ellaOne are unidentified: eventual adverse events could hardly be attributable to an undocumented drug-self-administration.

Indeed, liver-toxicity seems due to UPA-accumulation, while circulating levels of either UPA or its metabolites [7] have no impact on safety. The life-threatening DILI (drug-induced-liver-injury), including autoimmune hepatitis, associated with UPA in post-marketing surveillance may be partially explained by UPA physiochemical (high lipophilicity) and pharmacokinetic (hepatic metabolism, long half-life, inhibition of liver transporters, reactive metabolite formation) features [8].

The most challenging form of DILI is the so-called idiosyncratic one: it is unpredictable, usually unrelated to the dose and is characterized by a variable onset-time. DILI is an important public health issue: not only it strengthens the importance of the post-marketing phase, when urgent withdrawal sometimes occurs for rare unanticipated liver-toxicity, but also shows the imperfect predictivity of pre-clinical models and the lack of validated biomarkers beyond traditional, non-specific, liver-function tests [9].

The removal of the warning against repeated use was requested and obtained by HRA-Pharma, basing on HRA2914-554 Study (Report-pages 6-9) [6] that examined the effect of repeated administration of ellaOne on ovulation, menstrual cycle and safety. EllaOne was given weekly (Q7D, twelve women) or every 5 days (Q5D, eleven women) for 8 consecutive weeks since the first day of the menstrual cycle. No safety-issues emerged for those 23 women, suggesting that, should ellaOne be used more than once in the same cycle, the safety profile is similar to that for a single administration [6]. The repeated self-administration of EllaOne in the same cycle was authorized as safe [6].

Overlooking the fact that almost every woman had normal ovulations during the repeated self-administration of ellaOne, officially presented as anti-ovulatory [10], the total UPA-dosing for women was 270mg in Q7D and 360mg in Q5D. These amounts are presented as safe, but are equal to or greater than Esmya-dosing in the same 8 weeks, UPA 280mg: the UPA-dosing leading two patients to liver transplantation [4]; besides, the single UPA-bolus to liver was six time-higher than with Esmya.

The burden of DILI is likely underestimated: clinical trials are usually underpowered to identify rare idiosyncratic events and most data come from post-marketing retrospective studies. DILI occurs only in a small fraction of exposed-subjects [9]: with UPA the percentage was 1/10.000: 8 out of 80.0000 Esmya-patients, but ellaOne is taken by millions of women every year and repeated-self-administration cannot be quantified. EllaOne is not subject to medical prescription, so no data are available for post-marketing evaluation.

Liver-toxicity due to Esmya-administration were still unreported in 2015, when the EMA-CHPM removed the warning against the repeated self-administration of ellaOne, but nowadays it seems difficult to state that ellaOne-self-administration is always safe. The PRAC-EMA assessed definitively that UPA has a direct responsibility in inducing liver-injuries 2,3. Besides, it is commonly known that ellaOne can be taken repeatedly by millions of women whenever unprotected-sex-intercourse recurs, in whichever period of the cycle (ellaOne Package-Leaflet). In the light of the above, it is easy to argue that repeated self-administration can lead to a total UPA-intake even exceeding the UPA-amounts responsible of the dramatic DILI officially 2,3 attributed to Esmya. As well, it is easy to argue that nothing can either discourage or only restrict ellaOne-repeated self-administration: not only women are not informed about its risks, but, furthermore, they are reassured that even closely-repeated self-administrations are as safe as a single-tablet self-administration [6].

The overall metabolic impact of Ulipristal and/or its side-effects are still unknown. EllaOne frequent self-administration for subsequent contraceptive-emergencies is authorized as a correct and safe behaviour, but is likely to present a danger, in the absence of medical supervision, due to the progressive UPA-accumulation in the liver.

CONCLUSIONS

The repeated-self-administration of ellaOne, micronized-UPA 30mg, likely can be associated with hepatotoxicity in unaware women. However, further investigations are required to understand the underlying pharmacological mechanisms, to define the UPA-toxic-thresholds and to assure women the best protection.

Information to women and to the Medical Community seems mandatory to preserve women’s health.

REFERENCES

  1. EMA/791062/2017 – https://www.ema.europa.eu/en/documents/referral/esmya-article-20-procedure-review-started_en.pdf

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  1. EMA/355940/2018 – https://www.ema.europa.eu/en/documents/referral/esmya-article-20-procedure-esmya-new-measures-minimise-risk-rare-serious-liver-injury_en.pdf

View in Article 

  1. EMA/455818/2020 – https://www.ema.europa.eu/en/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-prac-recommends-revoking-marketing_en.pdf

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  • Mozzanega B.
  • Nardelli G.B.

UPA and LNG in Emergency Contraception: the information by EMA and the Scientific Evidences indicate a prevalent anti-implantation effect.

Eur J Contracept Reprod Health Care. 2019; 24 (10.1080/13625187.2018.1555662. Epub 2019 Jan 18): 4-10

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Article Info

Publication History

Accepted: November 24, 2020

Received in revised form: November 23, 2020

Received: September 23, 2020

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In Press Journal Pre-Proof

Footnotes

I declare no conflict of interest, neither any financial support

Identification

DOI: https://doi.org/10.1016/j.jhep.2020.11.041

Copyright

© 2020 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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This is a Journal-of-hepatology.eu letter to the editor piece  

Ref: https://www.journal-of-hepatology.eu/article/S0168-8278(20)33828-9/fulltext#%20

‘Covid-19 saved a lot of babies’: Women’s shelter

‘Covid-19 saved a lot of babies’: Women’s shelter

During the months when the Coronavirus pandemic was at its peak, Dar T’ghanniqa T’Omm (Mother’s Embrace Home) received a number of calls from both local and foreign women, overwhelmed and panicked when they found out they were pregnant.

To contain the spread of the pandemic, flights were suspended from 21 March up until 1 July, leaving women who found themselves in an unwanted pregnancy feeling concerned, panicked and alone.

During that period, the women’s shelter received nearly 80 calls from women coming from different backgrounds and situations needing support and reassurance. “We received all kinds of calls; including mothers who gave birth but had no more money because they had been made redundant, so we would provide them with food and support. There were also women who had unplanned pregnancies and were not sure what the next steps were,” said Christie.

She explained that, during COVID-19, many mothers felt stressed and in a state of shock when they found out they were pregnant. “We were there for these mothers every step of the way. We supported them, accompanied them to any appointments they had, we just wanted to make sure that the mothers felt safe.”

The helpline also received calls from women who were considering an abortion. “We always leave the decision up to the mother; we never tell them what to do or judge them. Our councillors speak to these women to see what they need and how we can help, but at the end it is always up to the mother to decide.”

She explained that some women, and also men, call the helpline after the abortion has taken place. “We have received calls from men, some of whom felt guilty for pushing their partner to have an abortion, or who needed support themselves after their partner had an abortion. Whatever the case, we support them, and our councillors help them to grieve and come to terms with their guilt.”

We go through the whole journey with these mothers

The shelter, which was set up back in 2018, is run by Life Network Malta, a pro-life NGO, which welcomes women and mothers experiencing crisis pregnancies. The shelter currently hosts five mothers.

Christie explained that the Foundation began receiving a number of calls from mothers who needed help and that at the time there was no specific shelter which helped homeless pregnant women who are more likely to have an abortion. “We had mothers who would want to carry out their pregnancy but were scared of losing their accommodation, or else mothers who were kicked out by their parents who disapproved of the pregnancy. We are there to help them and provide the support they and their child need.”

She said that mothers who come to the shelter not only find a roof over their head but also are provided with the support and information they need as new mothers. She explained that she, volunteers and councillors work together to provide the mothers with a caring support system. “We become a family, we help the mothers throughout their journey and the shelter is run in a household manner.”

The volunteers and councillors provide the mothers with the necessary life skills, such as time and money management. “We even help them send CVs … whatever we can do we help them as much as possible.”

Christie recalls how, during COVID-19, the mothers had to remain inside the shelter and how one mother had to go into labour on her own in the hospital. “Unfortunately, we had to cut down the amount of volunteers coming in but we continued counselling sessions online or over the phone; we never stopped.” She said that she kept going to the shelter because she realised that the mothers felt lonely at times and the staff came up with different activities to do inside during that time.

The shelter also donated to 38 families in need. It provided food, baby milk, nappies, clothes and other items which mothers might need.

Anti-human rights? We support a mother to give birth to her child

In recent news, Voice for Choice, a pro-choice NGO working for reproductive rights have expressed its disappointment that the government donated €130,000 to Dar Tghannieqa T’Omm. “By providing funds to LifeNetwork Malta, the government is supporting an anti-human rights agenda, and this is completely unacceptable,” it said.

When asked for her opinion on the comment, Christie asked how a Foundation which is supporting a mother can be anti-human rights. “All I can say is how am I, or the Foundation, who are supporting a mother to give birth to her child, anti-human rights? If that child is not born, then they are not obliged to any of the rights we keep fighting for.”

Christie highlighted that the extra funding donated by the government will help pay for care workers to come and stay at the home during the week. Funding will also help with keeping up maintenance of the house, and providing a better programme for the mothers.

This is a independent.com.mt opinion piece

Ref: https://www.independent.com.mt/articles/2020-07-12/local-news/Covid-19-saved-a-lot-of-babies-Women-s-shelter-6736225085

 

Protests across Ireland following late-term abortion report release

Protests across Ireland following late-term abortion report release

Pro-life protests have taken place across Ireland in response to the shocking revelations about the nature and extent of the late-term abortions now occurring in Ireland.

Published in the British Journal of Obstetrics and Gynaecology, September 2020, a report confirmed that babies are being aborted via foeticide, where the baby receives a lethal injection of potassium chloride into the heart. Doctors in the report described late-term abortion as “‘brutal’, ‘awful’ and ‘emotionally difficult’, referring to it as ‘stabbing the baby in the heart’, and held themselves responsible for the death of the baby”.

The shocking study was raised in a debate on Thursday 4th December in the Dáil (the Irish Parliament). The Minister for Health, Stephen Donnelly, failed to show up to answer questions from concerned TDs (Members of Parliament).

Niamh Uí Bhriain of the Life Institute, the group organising the pro-life vigils said: “There can be no cover-up in relation to these absolutely appalling revelations and the horrific treatment of babies in late-term abortions”.

“During the 2018 referendum, voters were assured that late-term abortions would not take place. They were told that in the case of an advanced pregnancy and where the baby had a severe anomaly, the baby would simply be delivered. This study has shown those claims to be untrue. The paper notes that ‘Ireland’s legislation is without gestational limits so creating opportunity for late TOP (termination of pregnancy) following FFA (fatal foetal anomaly)”. The horrific reality is that babies are being given lethal injections into the heart in late-term abortions and babies are also surviving abortions and not receiving care”.

“We will not allow the Health Minister to sweep this under the carpet. He must investigate and then he must take action to stop this barbaric practice from happening”.

Shocking and unspeakable

Independent TD for Tipperary, Mattie McGrath, said the report made for “grim reading”. He said what was revealed in the paper was shocking, unspeakable and had to end. He added that the Minister for Health during the time of the referendum, Simon Harris, dismissed concerns from TDs on this issue in 2018.

Carol Nolan, Independent TD for Laois Offaly, said TDs were assured that babies would never be born alive after abortion and left without care but that it was now happening. “What are you going to [do] about this?” she asked the government, adding that it was shameful that the Health Minister was not here to take questions. “It’s barbaric and shameful.” she said.

The pro-life protests took place in Carlow, Cork, Donegal, Dublin, Galway, Kerry, Kildare, Laois, Leitrim, Limerick, Mayo, Navan, Trim, Offaly, Roscommon, Sligo, Waterford, Wexford and other centres.

Late-term abortions in Ireland

Abortion legislation in Ireland permits abortion throughout all stages of pregnancy if the baby has a disability such that doctors can form a ‘reasonable opinion’ that the baby is likely to die within the first 28 days of his or her life.

Late-term abortions typically use a procedure known as ‘foeticide’, whereby the baby is killed in the womb, before inducing labour so that the mother gives birth to a dead child. This involves the injection of potassium chloride directly into the baby’s heart to end the baby’s life.

The Royal College of Obstetricians and Gynaecologists (RCOG) says that “failure to perform foeticide could result in live birth and survival, an outcome that contradicts the intention of the abortion”.

The administration of potassium chloride in executions in the USA is considered so painful that it is necessary to first administer an anaesthetic before its use. There is, however, no such obligation to use painkillers in late-term abortions, despite the mounting evidence that the unborn baby is capable of experiencing pain and distress.

Spokesperson for Right To Life UK, Catherine Robinson, said: “Irish pro-lifers are absolutely right to protest against the extremity of abortion as revealed in this report. Through its interviews with those who actually perform abortions, the report shines a light on the total inhumanity of the whole process, and many people in Ireland are rightly disgusted”.

“It is particularly shameful that the former Minister for Health, Simon Harris, dismissed these kinds of concerns during the referendum and the current Minister for Health, Stephen Donnelly, has not presented himself to face questions on this”.

 

This is a Righttolife.org opinion piece

Ref: https://righttolife.org.uk/news/protests-across-ireland-following-late-term-abortion-report-release

 

UK Government rejects pressure from assisted suicide lobby to review law

UK Government rejects pressure from assisted suicide lobby to review law

The Government has announced it has no plans to review the law on assisted suicide or to issue a call for evidence.

In response to a Parliamentary question, the Government announced that “any change to the law in this area must be for individual Parliamentarians to consider as an issue of conscience, rather than a decision for Government”.

The announcement came after a question from assisted suicide supporter, Andrew Mitchell MP.

Assisted suicide campaigners have been putting pressure on the Government to undertake a review of the current law on assisted suicide.

The Government’s response is consistent with the continued Parliamentary rejection of assisted suicide legislation at the beginning of this year.

Through the courts

Parliament has consistently rejected attempts by the assisted suicide lobby to introduce assisted suicide. The Marris-Falconer Bill was defeated in 2015, with 330 to 118 voting against introducing assisted suicide.

Assisted suicide supporters have since attempted to pass assisted suicide legislation through the courts. All such attempts have so far failed. Last year, the high court said the courts were not the place to decide moral issues. In a ruling concerning a man with motor neurone disease who wanted to be assisted in suicide, the court said: “In our judgment the courts are not the venue for arguments that have failed to convince parliament”.

Similarly, at the beginning of this year, the Lord Chancellor Robert Buckland QC confirmed the Government has “no plans” to introduce assisted suicide legislation.

Support among Parliament, the courts and doctors for changes in assisted suicide legislation, which protects the most vulnerable, remain low. A recent BMA survey found that 84% of doctors in palliative medicine would not be willing to perform euthanasia on a patient should the law ever change.

Pushing the boundaries

Calls for the legalisation of assisted suicide come at the same time as a global pandemic and lockdowns, which are having an adverse effect on many people’s mental health. In October of this year in Canada, a 90-year-old woman was euthanised because she said she couldn’t cope with another lockdown.

Countries, like Canada, which have already legalised the practice, reveal that the motivations for assisted suicide are largely social and not medical. For example, in 2019 Canada reported that more than a third (34%) of those who opted for “medical assistance in dying” cited concerns of being a burden to family or carers. A further 13.7% cited “isolation or loneliness” as their reason for procuring an assisted suicide.

While proposed changes to assisted suicide legislation would likely not permit an assisted suicide under these circumstances, other countries which have introduced supposedly restricted assisted suicide and euthanasia legislation, have seen an expansion of their laws as medical professionals and activists push the boundaries of acceptable practice.

Euthanasia has been legal in the Netherlands since 2002. The law permits voluntary euthanasia for anyone over the age of 16, and children aged 13-15 can be euthanised with their parents’ consent. Earlier this year, the Dutch government said it would be changing the regulations to allow doctors to end the lives of terminally ill children between the ages of one and twelve. Non-voluntary euthanasia is already available for Dutch babies before the age of one.

Right To Life UK’s spokesperson, Catherine Robinson, said, “This latest Government rejection of calls to change the law on assisted suicide is welcome news. Throughout the COVID-19 restrictions, many people are suffering and sadly, some have ended their own lives. To introduce assisted suicide in England and Wales at this time would have particularly disastrous consequences for the most vulnerable in our society”.

 

This is a RightToLife.org opinion piece

Ref: https://righttolife.org.uk/news/government-rejects-pressure-from-assisted-suicide-lobby-to-review-law

Pregnant woman’s life never at risk says Head of obstetrics at Mater Dei Hospital

Treatment ‘delay’ is under review

Head of obstetrics at Mater Dei Hospital says pregnant woman’s life never at risk

The head of obstetrics and gynaecology at Mater Dei Hospital is looking into a woman’s claim that her life was “needlessly put at risk” because it took two days for her to receive authorization to use a medicine that would end her ectopic pregnancy, which can be fatal.

“The delay is not normal and the case is being looked into,” Yves Muscat Baron said. “The patient’s life was never put at risk as she was kept under continuous surveillance. We will, however, take the opportunity to look into how the system can be improved.” He said about one to two per cent of pregnancies are ectopic, amounting to 25-35 per year. These cases are treated either surgically, by removing the fallopian tube, or medically by administering a medicine called methotrexate, which has been available at Mater Dei since 2018.

The use of methotrexate is still not common. There have been about four cases this year, Muscat Baron said. “Surgical interventions impact fertility,” he said. There is no guarantee that methotrexate works. It may have to be repeated and, in some cases, surgery may still have to be resorted to as medical treatment may not be sufficient.”

“She was kept under continuous surveillance”

Muscat Baron stressed that the stage at which a patient goes to hospital is key in deciding on the type of treatment to administer.

The decision depends on the condition of the patient. “The decision-making process involves the specialist on call and the firm caring for the patient,” he said. The woman’s story was last week made available to the media by the NGO Doctors for Choice in Break the Taboo, a pro-choice collection of abortion experiences from Malta. An ectopic pregnancy occurs when an egg implants itself outside of the womb, usually in a fallopian tube.

Doctors for Choice have long insisted that the management of ectopic pregnancies is compromised by the country’s total legal ban on abortion. Methotrexate is technically illegal because the law criminalises all ways of inducing a miscarriage. The anonymous woman claimed it took two and a half days for methotrexate to be approved in her case, putting her life and fertility at risk. She said the scan and bloods showed she was a good candidate for the relatively new treatment without the need for surgery. Asked about the delay last week, the health ministry explained that, once the case fits the criteria, a request form for methotrexate medicine is signed by the consultant or a delegate and countersigned by the chairman or a delegate of the obstetrics and gynaecology department, in a procedure which “usually takes few hours”. Doctors for Life have pointed to the excellent track record of the hospital: no pregnant mother had lost her life in the last 10 years.

This is a timesofmalta.com article written by Claudia Calleja