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 While Esmya for fibroid treatment has been revoked because of severe liver-injuries, the emergency-contraceptive EllaOne is allowed in repeated self-administrations possibly exceeding UPA toxic-dosing with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

View in Article 

  1.  
  • Meunier L.
  • Meszaros M.
  • Pageaux G.P.
  • Delay J.M.
  • Herrero A.
  • Pinzani V.
  • et al.

Case Report. Acute liver failure requiring transplantation caused by ulipristal acetate.

Clin Res Hepatol Gastroenterol. 2020; 44 (Epub 2020 Mar 4): e45-e49https://doi.org/10.1016/j.clinre.2020.02.008

View in Article 

  1. EMEA/261787/2009 – https://www.ema.europa.eu/en/documents/assessment-report/ellaone-epar-public-assessment-report_en.pdf

View in Article 

  1. EMA/73099/2015 – https://www.ema.europa.eu/en/documents/variation-report/ellaone-h-c-1027-ii-0021-epar-assessment-report-variation_en.pdf

View in Article 

  1.  
  • Pohl O.
  • Osterloh I.
  • Gotteland J.P.

Ulipristal acetate – safety and pharmacokinetics following multiple doses of 10–50 mg per day.

Journal of Clinical Pharmacy and Therapeutics. 2013; 38: 314-320

View in Article 

  1.  
  • Gatti M.
  • Poluzzi E.
  • De Ponti F.
  • Raschi E.

Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis.

Drug Saf. 2020 Aug 3; (Online ahead of print)https://doi.org/10.1007/s40264-020-00975-8

View in Article 

  1.  
  • Raschi E.
  • De Ponti F.

Strategies for Early Prediction and Timely Recognition of Drug-Induced Liver Injury: The Case of Cyclin- Dependent Kinase 4/6 Inhibitors.

Front. Pharmacol. 2019; 10: 1235https://doi.org/10.3389/fphar.2019.01235

View in Article 

  1.  
  • 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

View in Article 

Article Info

Publication History

Accepted: November 24, 2020

Received in revised form: November 23, 2020

Received: September 23, 2020

Publication stage

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.

ScienceDirect

Access this article on ScienceDirect

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

Ara kif tista’ tagħmel differenza b’dan il-kalendarju

Ara kif tista’ tagħmel differenza b’dan il-kalendarju

Il-Fondazzjoni LifeNetwork Malta b’appell għal kalendarju tal-avvent

Diċembru huwa sinonimu mal-kalendarju tal-avvent, kalendarju li ta’ kuljum jagħtik rigal. X’taħseb li kieku din is-sena minflok tirċievi, tkun inti li tagħti rigal ċkejken kuljum? LifeNetwork Malta qiegħda toffrilek din l-opportunità.

Din l-organizzazzjoni volontarja, li tiddependi ħafna fuq il-ġenerożità tal-poplu Malti, tgħin lil tfajliet u nisa li jsibu ruħhom f’diffikultà waqt it-tqala billi toffri pariri professjonali u sapport.

Din is-sena minħabba l-pandemija, LifeNetwork Malta għandha bżonn iżjed għajnuna minn qatt qabel. Inti, flimkien mal-membri tal-familja tiegħek jew anke sħabek tista’ tagħmel differenza billi kuljum tpoġġi ġo kaxxa oġġett mil-lista ta’ hawn taħt. Wara l-25 jum, il-kaxxa tkun imtliet b’25 prodott u tistgħu tmorru biha fl-uffiċċju ta’ LifeNetwork Malta l-Belt Valletta jew inkella d-Dar Tgħanniqa t’Omm il-Mosta.

Bħala ringrazzjament, għal kull kaxxa li inti tagħti bħala donazzjoni, tingħata kalendarju tal-LifeNetwork Malta għas-sena 2021. Għal aktar informazzjoni tista’ ċċempel fuq 77115433.

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

Ref: https://newsbook.com.mt/ara-kif-tista-taghmel-differenza-bdan-il-kalendarju/?fbclid=IwAR0Jo0KdeIeGlDZm2sZtu51SjY7yjaQaPAfdlTzEp4Pj0sWTCqvVlh5PVTY

The Truth About Emergency Contraception (MAP)

The Truth About Emergency Contraception (MAP)

We have a duty as scientists and healthcare professionals – and as humans – to expose the fallacy that emergency contraception (EC) – the “morning-after pill” – is not abortifacient. To do this I have drawn up the following write-up, which is also a synopsis of a previous piece, which, also rests on the evidence given by other scientists and medical professionals who have contributed in this field, in scientific, medical, legal and ethical research and literature.

Two of the reasons why I am writing again is because it is disquieting that we are faced with misinformation again and that pharmacists might be obliged to sell ECs, even if it goes against their conscience and morals. It is not equality at all to be ok with offending the sentiments of a particular group in order not to offend those of another category. It is evident that this is exactly the opposite.

Despite all considerable evidence regarding the abortifacient effect of ECs, some continue to deride those who maintain that ECs are abortifacient. Their arguments can hold water, only if one accepts the definition of conception, that is, the implantation of a fertilized ovum, adopted by the American College of Obstetricians and Gynecologists (ACOG) in the 1960. For the rest of the world, or at least most of it, fertilization and conception are synonymous and mark the beginning of a new living organism.  (Charlotte Lozier Institute 2014, Sadler and Langman 2010, O’Rahilly and Müller 1996, Moore and Persaud 1993). 

However, our modern abortionists have become past masters of double-talk and the art of equivocation. For example, they substitute product of conception for pre-born child or by using the word choice instead of abortion. A word like abortion is too ugly and violent and sends negative messages. Indeed, all abortionists see red when one insists on conscience rights and conscientious objection. They are the most belligerent votaries of the cult of “the politically correct”. Serious scientific and scholarly research has proved that most popular emergency “contraceptives” can cause the death of embryos. For the sake of intellectual honesty, this truth must be accepted and acknowledged. Only thus, can we take informed decisions. But even if we refuse to look at the scientific truth in the face, as humans, we ought to feel prickly pangs of conscience when terminating the joy of a new birth.

However, our modern abortionists have managed to find a way to numb conscience. The equivocation is camouflaged in the prefix “pre“:  so, they have invented pre-pregnancy, pre-fertilization, pre-embryo and even such a meaningless word as pre-life when life exists already. Therefore, it is best to stick to scientific facts and base our arguments on empirical surveys. In case of EC we must stress clarity and follow the American maxim and say, “It walks like a duck, it quacks like a duck, it is a duck”. To start with, following are a few (of the multitude) scientific definitions on the beginning of life:

  • “Human development begins at fertilization, when a sperm fuses with an oocyte to form a single cell, the zygote(one cell embryo). This highly specialised, totipotent cell (capable of giving rise to any cell type) marks the beginning of each of us as a unique individual.” (The Developing Human: Clinically Oriented Embryology, Saunders 2016).
  • “Human pregnancy begins with the fusion of an egg and a sperm within the female reproductive tract.” (Human Embryology and Developmental Biology. Elsevier, Saunders, 2014).
  • “The seminal question in modern developmental biology is the origins of new life arising from the unification of sperm and egg.” (Gene expression during the oocyte-to-embryo transition in mammals. Evsikov AV, Marín de Evsikova C. Molecular Reproduction and Development, 2009).

 

The above quotations from scientific and medical sources prove that fertilization is synonymous with the very first instance of human life. So, it follows that any artefact terminating the result of fertilization is indeed an abortifacient. Therefore, whether ECs can induce abortion depends upon when a new human life begins. The scientific reality is that when a human egg and sperm unite (fertilization), the newly formed being contains the full genome in which hair and eye colour, gender and all physical characteristics are determined.

In the first hours of existence, the embryo signals the mother to lower her immune system, prompting her body mechanism to release the Early Pregnancy Factor and this protein is detectable in maternal blood as early as 24 hours after fertilization (Charlotte Lozier Institute 2014). During its journey down the fallopian tube, the fertilized egg is actively growing and dividing itself. It will implant in the uterine lining where it will continue to grow. One of the ways ECs may work is to alter the uterine lining so that a fertilized egg (the embryo) may not be able to implant and grow (Kahleborn, Stanford, Larimore 2002, Kahlenborn, Peck, Severs, 2014, Mozzanega and Cosmi 2010, Peck and Vélez 2013, Morris and van Wagenen 1973, Rabone, 1990, Stratton et al 2010, Turlock Pregnancy Center 2016).

Also, certain ECs have inferior effect on ovulation than other ECs (Brache, Cochon, Deniaud, and Croxatto, 2013). So other mechanisms of action would prevail to stop the process of life. What are these?

An interesting fact is that mifepristone, which is marketed (in various countries) as an abortion pill, is also used (at lower doses) as an EC. Mifepristone effectively kills embryos in approximately six weeks after implantation. Mifepristone is also molecularly very similar to ulipristal acetate, the active ingredient of mainstream EC. It may be taken within 120 hours (five days) of unprotected sex or contraceptive failure (such as a tear in a condom during sex)!

So, the term “Morning-After pill” is also a misnomer! In the 2010 study of Stratton et al mifepristone and ulipristal acetate were compared. The following is a self-explanatory excerpt. (Here, one has to keep in view that mifepristone has also an abortive effect because it causes reduction in molecular markers for implantation, progesterone action and endometrial thickness): “….either effect of CDB-2914 [ulipristal acetate], endometrial atrophy or combined proliferation (endometrial hyperplasia – tissue growth), however, may hamper implantation. 

Single dose of CDB-2914 given to normal women at other times of the cycle have yielded effects similar to mifepristone’s on the endometrium, ovary and menstrual cycle.

In the luteal phase, a single 200mg mid-luteal dose of CDB-2914 caused early menses and less frequently functional luteolyses, as did 200mg of mifepristone [as an abortifacient it is marketed as 200mg tablets]. Lower amounts of mifepristone (10mg) administered twice in the mid-luteal phase induced stormal edema and delayed glandular development without changes in the cycle length. With a single late-follicular dose, luteal phase endometrial maturation was delayed in 70% of the biopsies at each dose of CDB-2914 (10, 50 and 100mg) compared with 17% in the placebo group. A delay in ovulation and suppression of estradiol levels was less frequently observed and was dose dependent. Similarly, 100mg of mifepristone administered from days 10 to 17 delayed both ovulation and endometrial maturation… In contrast to histologic dating, molecular markings of implantation and progressive action and decreased endometrial thickness were reduced by CDB-2914 in a dose dependent fashion.”

In Destroying unwanted embryos in Research: Talking Point on morality and human embryo research, Thomas Douglas and Julian Savulescu of EMBO (European Molecular Biology Organisation 2009), estimate that more than 50% of embryos die within eight weeks of conception, even if no direct actions are taken to end their lives. This vulnerability has also been unbelievably posited as a justification for considering implantation as the beginning of pregnancy, even the beginning of Life. So, here, the reasoning is that the phase following fertilization until implantation is a pre-pregnancy phase. By this reasoning even lethal experiments could be performed on pre-implantation human embryos. Yet, this fragile creature is indisputably human. His or her vulnerability should rather be a call for greater care than for annihilation (European Molecular Biology Organisation 2009). In plain language, we are aware of the vulnerability of embryos and yet, instead of striving to protect them even more, we use it as a prime justification for destroying them. But abortionists are not destroying life, it is a thing called pre-“something”. Abortionists seek excuses to terminate Life and to distort facts, they insult in their faces those parents who have lost a child, be it through a miscarriage or at a later stage in life.

I have gone into perhaps fastidious details to prove that the Morning After Pill is an abortifacient by any other name, but we are free to refuse to listen to reason and science and continue on the way to oblivion. Even at this late hour, it is not too late. All stakeholders must step forward to convince that it is both inhuman and self-defeating to terminate the unborn. Nice words can never hide ugly deeds.

 

Jean Pierre Fava holds a B.Sc. (Hons.) and M.Sc. in Health Science

This is a independent.com.mt opinion piece

Ref: https://www.independent.com.mt/articles/2020-11-29/newspaper-opinions/The-truth-about-emergency-contraception-6736229001

Abortions in the U.S. Hit All-Time Low

Abortions in the U.S. Hit All-Time Low, More Babies Saved From Abortion Than Ever

Americans have another reason to give thanks this week. A new report from the Centers for Disease Control shows abortions have once again hit an all-time low as more babies are being saved from abortion than ever before.

The new CDC report covers the year 2018 and confirms America’s abortion decline continues. The report indicates the number of babies killed in abortions has declined 1.4% from 2016-2018 and the abortion rate — the percentage of women having an abortion or choosing life for their baby — has declined 2.% as more women opt against abortion.

The abortion decline was widespread. Not every state reports its abortion data to the CDC, but of the states that do 29 of them saw declines in their abortion rates. California, Maryland, and New Hampshire did not report abortion statistics to the CDC and, as a result, the actual number of babies killed in abortions is higher — usually estimated to be around 900,000 a year.

Looking at the data more historically, the number of babies killed in abortions has dropped 21.8% since 2009 and the abortion rate has declined 24.2 percent, making it clear that lifesaving efforts such as pregnancy centers across the nation have helped and supported more women as they give birth instead of having abortions. The abortion rate has declined over 50% since 1980.

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From 2009 to 2018, the total number of reported abortions, abortion rate, and abortion ratio decreased 22% (from 786,621), 24% (from 14.9 abortions per 1,000 women aged 15–44 years), and 16% (from 224 abortions per 1,000 live births), respectively.

Despite the decline and more babies saved, the number of children killed in abortions is still staggering, as the CDC indicated 619,591 babies had their lives ended by abortion in 2018. And despite the overall decline from its last report covering 2016 to this one covering 2018, the number of abortions in 2018 increased slightly by 1% from the 2017 levels.

The CDC indicates young women continue to have more abortions than other age groups.

In 2018, women in their 20s accounted for more than half of abortions (57.7%). In 2018 and during 2009–2018, women aged 20–24 and 25–29 years accounted for the highest percentages of abortions; in 2018, they accounted for 28.3% and 29.4% of abortions, respectively, and had the highest abortion rates (19.1 and 18.5 per 1,000 women aged 20–24 and 25–29 years, respectively). By contrast, adolescents aged <15 years and women aged ≥40 years accounted for the lowest percentages of abortions (0.2% and 3.6%, respectively) and had the lowest abortion rates (0.4 and 2.6 per 1,000 women aged <15 and ≥40 years, respectively). However, abortion ratios in 2018 and throughout 2009–2018 were highest among adolescents (aged ≤19 years) and lowest among women aged 25–39 years.

But the good news is “Abortion rates decreased from 2009 to 2018 for all women, regardless of age.”

The decrease in abortion rate was highest among adolescents compared with women in any other age group. From 2009 to 2013, the abortion rates decreased for all age groups and from 2014 to 2018, the abortion rates decreased for all age groups, except for women aged 30–34 years and those aged ≥40 years. In addition, from 2017 to 2018, abortion rates did not change or decreased among women aged ≤24 and ≥40 years; however, the abortion rate increased among women aged 25–39 years. Abortion ratios also decreased from 2009 to 2018 among all women, except adolescents aged <15 years. The decrease in abortion ratio was highest among women aged ≥40 years compared with women in any other age group. The abortion ratio decreased for all age groups from 2009 to 2013; however, from 2014 to 2018, abortion ratios only decreased for women aged ≥35 years. From 2017 to 2018, abortion ratios increased for all age groups, except women aged ≥40 years.

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Most all abortions involved killing babies between 7 and 13 weeks of age, but 9% of all abortions involved killing older babies past 13 weeks. And 1% of abortions killed babies at or after viability, meaning abortions killed over 6,100 viable babies.

The CDC also indicated that half of abortions now involve the dangerous mifepristone abortion drug while the other half remain surgical abortions. When it comes to later abortions, the CDC report shows more surgical abortions are done to end babies’ lives than abortions with the pills.

The abortion industry continues to target black women and, as a result, they continue having abortion at much higher rates than women of other ethnicity.

“Among the 31 areas that reported race/ethnicity data for 2018, non-Hispanic White women and non-Hispanic Black women accounted for the largest percentages of all abortions (38.7% and 33.6%, respectively), and Hispanic women and non-Hispanic women in the other race category accounted for smaller percentages (20.0% and 7.7%, respectively),” the CDC reports. “Non-Hispanic White women had the lowest abortion rate (6.3 abortions per 1,000 women) and ratio (110 abortions per 1,000 live births), and non-Hispanic Black women had the highest abortion rate (21.2 abortions per 1,000 women) and ratio (335 abortions per 1,000 live births).”

Abortion also continues to be used as a method of birth control as 23.9% of women having an abortion had previously had one abortion, 9.9% had previously had two abortions, and 6.4% had previously had three or more abortions.

Overall, the news is encouraging for pro-life advocates who are working to empower pregnant mothers to choose life and to restore legal protections to unborn babies.

From providing free diapers and ultrasounds to educating parenting students about their rights on campus, to sidewalk counseling to laws that protect unborn babies from brutal dismemberment abortions, pro-life leaders are making a difference in the lives of countless families every single day.

Not since the U.S. Supreme Court allowed abortion on demand in 1973 through Roe v. Wade have abortion numbers been so low. An estimated 62 million unborn babies have been aborted since the infamous case was handed down.

This is a LifeNews.com opinion piece

Ref: https://www.lifenews.com/2020/11/25/abortions-in-the-u-s-hit-all-time-low-more-babies-saved-from-abortion-than-ever/

Pope Francis Opposes Argentina Bill Legalizing Abortions: Don’t “Eliminate Human Life to Solve a Problem”

Pope Francis Opposes Argentina Bill Legalizing Abortions: Don’t “Eliminate Human Life to Solve a Problem”

Pope Francis, answering the pleas of Argentine women who are fighting for the rights of unborn babies, wrote a public letter to his home country this week urging its leaders not to legalize abortions.

According to the National Catholic Register, the grassroots group of pro-life women recently wrote to the pope, urging him to “help us by making our voice heard” in opposition to a new pro-abortion bill. Their letter and the pope’s response both appeared in the newspaper La Nacion on Wednesday.

“Is it fair to eliminate a human life to solve a problem? Is it fair to hire a hitman to solve a problem?” the pope wrote, adding that the pro-life women “know what life is.”

Argentina is facing renewed pressure to abandon its protections for unborn babies and legalize abortion on demand. Earlier this month, President Alberto Fernandez announced plans to introduce a bill to legalize abortions up to 14 weeks of pregnancy, according to the Buenos Aires Times.

Wide-spread public opposition stopped a similar bill from passing in 2018, and pro-life advocates hope to do so again.

In his letter Wednesday, Pope Francis praised the women who have been fighting for years to prevent the violence of abortion in Argentina.

“The country is proud to have such women,” he wrote. “Please tell them for me that I admire their work and their testimony; that I thank them from the bottom of my heart for what they do, and that they keep going.”

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The women who wrote to Pope Francis began meeting in 2018 to fight pro-abortion misinformation and advocate for the lives of women and babies in their country. One survey that they conducted found that 80 percent of Argentines oppose abortion, according to the report.

They told the pope that poor women and their children will be hurt the most if the pro-abortion bill passes.

Here’s more from the report:

The women told Pope Francis about being filled with “cold terror” after the abortion bill was introduced to the legislature last week, “just thinking that this project is aimed at adolescents in our neighborhoods.”

“Not so much because in the villa [shanty town] culture abortion is thought of as a solution to an unexpected pregnancy (Your Holiness knows well our way of assuming motherhood between aunts, grandmothers and neighbors),” the women wrote, “but because [the law] is oriented to cultivate the idea that abortion is one more possibility within the range of contraceptive methods and that even the main users must be poor women.”

They urged Pope Francis to use his voice to help them fight against the idea that “our life is the unwanted one and that we do not have the right to have children because we are poor.”

Currently, Argentina protects unborn babies from being killed in abortions. Exceptions are allowed in cases of rape or threats to the mother’s life. Most countries in Central and South America protect unborn babies from abortion, but Fernández wants Argentina to change that.

“Legalizing abortion saves women’s lives and preserves their reproductive capabilities, which are often affected by unsafe abortions, but it does not increase the number of abortions or promote them,” he said earlier this month.

None of this is true. Abortions destroy lives, they do not save them, and pro-abortion laws jeopardize the lives of more unborn babies by putting the government’s approval on killing them. Pro-abortion groups often overestimate the number of illegal and unsafe abortions that occur in countries across the world, and some have admitted to lying about the numbers. Growing research also indicates that access to basic health care, not abortion, is what really helps improve women’s lives.

Pro-lifers have been making their voices heard to lawmakers. In 2019, approximately 2 million Argentines participated in the country’s March for Life in Buenos Aires. Thousands more protested in March after Fernandez first announced his plans to legalize abortion on demand.

A similar proposal to legalize the killing of unborn babies in Argentina failed in 2018 because of strong public opposition. But pro-abortion groups, backed by some of the richest men in the world, continue to put intense pressure on Argentina and other countries to legalize abortion on demand.

This is a Righttolife.org.uk opinion piece

Ref: https://www.lifenews.com/2020/11/25/pope-francis-opposes-argentina-bill-legalizing-abortions-dont-eliminate-human-life-to-solve-a-problem/

 

President urged to safeguard right to conscientious objection

President urged to safeguard right to conscientious objection

The Chamber of Pharmacists has written to President George Vella asking for his intervention to safeguard the right to conscientious objection for pharmacists and other health care professionals.

The request was made in view of the current debate in parliament on the Equality Bill which the chamber views as breaching this right.  It did not specify any examples, but over the past weeks Parliamentary Secretary Rosianne Cutajar insisted that every pharmacy in Malta should sell the morning-after pill.

In September, fourteen associations representing various medical specialities in a statement also called for the inclusion of a conscientious objection clause in the Bill, endorsing a draft amendment proposed by the Medical Council.

“Doctors should not be faced with clinical situations where they are forced to act against their ethical convictions or be deemed liable if they exert their freedom of conscience,” the associations said.

They argued that doctors should be allowed to refuse to prescribe treatment or perform procedures that violate their ethical convictions, even if such interventions are deemed legal by the state.

Malta’s bishops in a statement in September had also warned that the proposed law aimed at achieving equality and eradicating discrimination would have serious implications on individual freedom.

The Chamber of Pharmacists said on Sunday it had also written to the prime minister, the Minister for Health, the Minister for Justice and the Parliamentary Secretary for Equality and Reforms.

“The Kamra reiterates that under the watch of these persons who serve the Constitution and the people, pharmacists and other health care professionals must not be stripped of their right to freedom of thought and conscience in the context of legal health care.

“The Kamra which is a professional association and also a trade union takes a serious view of this matter and expects the State to be a guarantor of this right,” it said.

Click to view the letter to the President

This is a timesofmalta.com opinion piece

Ref: https://timesofmalta.com/articles/view/president-urged-to-safeguard-right-to-conscientious-objection.833725