Showing posts with label EllaOne. Show all posts
Showing posts with label EllaOne. Show all posts

Friday, 4 August 2017

College climbs down over ban on Christian doctors and nurses training in sexual and reproductive health

Doctors and nurses wishing to practise in sexual and reproductive health have been granted more liberty to exercise freedom of conscience under new guidelines published earlier this year.

The Faculty of Sexual and Reproductive Healthcare (FSRH), a faculty of the Royal College of Obstetricians and Gynaecologists (RCOG), has relaxed its stance on conscience in new guidelines issued in April so that those with an ethical objection to certain procedures can now obtain qualifications which they were previously excluded from.

Christian doctors and nurses in the UK are practising in an environment that is increasingly hostile to their beliefs and values. We have accordingly come to expect new constraints on our freedom of conscience almost as a matter of course. So this is a refreshing backtrack by the College.

In April 2014 I highlighted the fact that the FRSH was barring doctors and nurses with pro-life views from receiving its degrees and diplomas and may also be breaking the law (see also here). The story was later picked up by the Telegraph.

Under the previous guidelines, now removed from the FSRH website but still accessible in the Telegraph, doctors and nurses who had a moral objection to prescribing ‘contraceptives’ which can act by killing human embryos (levonelle, ellaOne, IUCDs etc) were barred from receiving diplomas in sexual and reproductive health even if they undertook the necessary training.

The wording was as follows (emphasis mine):

‘Completing the syllabus means willingness during training to prescribe all forms of hormonal contraception, including emergency, and willingness to counsel and refer, if appropriate, for all intrauterine methods…Failure to complete the syllabus renders candidates ineligible for the award of a FSRH Diploma.’

It added:

‘Doctors who hold moral or religious reservations about any contraceptive methods will be unable to fulfil the syllabus for the membership … or speciality training…This will render them ineligible for the award of the examination or completion of training certificates.

However, the new guidance grants much more freedom.

It begins by underlining the faculty’s commitment to diversity:

‘The FSRH welcomes and values having a diverse membership, representing a wide range of personal, religious and non-religious views and beliefs.’

It then underlines the fact that there is already statutory protection for healthcare professionals (HCPs) to opt out of abortions and procedures authorised under the Human Fertilisation and Embryology Act (HFEA):

‘There are currently two specific statutory protections for HCPs who have a conscientious objection 1) to participating in abortion (Abortion Act 1967, s.4) 2) to technological procedures to achieve conception and pregnancy (Human Fertilisation and Embryology Act 1990, s.38) .’  

But it also recognises that both the Human Rights Act 1998 and Equality Act 2010 offer some conscience protection in areas other than abortion and IVF:

‘The Human Rights Act 1998 incorporates the European Convention on Human Rights (ECHR) into UK law. Article 9 of the ECHR protects “the freedom of thought, conscience and religion; this right includes … to manifest his religion or belief, in worship, teaching, practice and observance.”’

‘Part 5 of the Equality Act 2010 sets out provisions for non-discrimination in employment. Specifically, s.39 prohibits employers from discriminating against individuals on the basis of “protected characteristics” (of which religious belief is one) and places an obligation on employers to make ‘reasonable adjustments’ to accommodate religious beliefs.’

The guidance recognises that the rights to ‘freedom of thought, conscience and religion’ and to ‘religious beliefs’ are not absolute, but qualified, and also that NHS employers may interpret these in different ways than the faculty, but this is nonetheless a significant step forward.

The guidance says that it applies to all FSRH qualifications and training, but a closer reading suggests that those seeking to sit the membership examination of the Faculty of Sexual & Reproductive Healthcare (MFSRH) will need to undergo ‘practical assessment of the provision of contraception (all methods including emergency contraception)’ and those seeking a Letter of Competence in Intrauterine Techniques (LoC IUT) will need to demonstrate ‘practical competence in the relevant live procedures’.

However, with respect to the Diploma of the Faculty of Sexual & Reproductive Healthcare (DFSRH and NDFSRH), holder must simply be ‘competent and willing to advise on all forms of contraception and manage SRH consultations, including providing evidence-based information on the options for unplanned pregnancy’. But there is no duty actually to provide all treatments.

‘The FSRH requires all Diplomates to provide patients with the full range of contraception choices, including emergency contraception and support of a woman with an unplanned pregnancy and appropriate onward referral. HCPs who plan to opt out of providing aspects of care because of their personal beliefs may still be awarded the Diploma, or recertified, if they can demonstrate commitment in their practice to the principles of care in section 5 of this document. For example, if a HCP chooses not to prescribe emergency contraception because of their personal beliefs, she/he has a personal responsibility to ensure that arrangements are made for a prescription to be issued by a colleague without delay, ensuring that the care and outcomes of the patient are never compromised or delayed.’

Although some would see referral to another doctor or nurse as a form of complicity, this is nonetheless a big improvement on the previous guidance.

Previously doctors or nurses who refused to fit coils or prescribe the morning after pill (MAP) were also barred from receiving the diploma signifying expertise in the management of infertility, cervical cancer or sexually transmitted infections. This effectively meant that many thousands of doctors and nurses were not able to obtain qualifications to pursue a career in gynaecology and sexual health.

This is no longer the case.

Quite why the faculty has relaxed its guidance is not clear, but I wonder if they have been conferring with the General Pharmaceutical Council (GPhC) who also similarly relaxed their guidance on dispensing drugs after receiving submissions from Christian Medical Fellowship and the Christian Institute earlier this year.

The GPhC’s attention was drawn to the fact that their proposed new guidance might well be illegal under Equality legislation (I made the same point about the FSRH in 2014).

The GPhC backtracked after the Christian Institute made it clear, in pre-action legal correspondence exchanged with the Council’s lawyers, that they ‘were fully prepared to litigate’.

Perhaps the FSRH also, on reflection, thought it wise to protect themselves by erring on the side of caution and taking themselves out of the legal firing line.

However, whatever the reason, the climb down is most welcome and will enable many more doctors and nurses to obtain diplomas in sexual and reproductive health. That can only be good for patient care. 

Thursday, 4 November 2010

UK retailers are not being honest about the mode of action of new morning-after-pill ellaOne (ulipristal acetate)

Earlier this week the news broke that a new ‘morning-after pill’ was being sold online in Britain by a London-based company called HealthExpress.

In fact ellaOne (Ulipristal acetate) has been available on prescription in the UK since May 2009. It was granted marketing authorisation by the European Medicines Agency (EMEA) in March 2009 and the FDA in the US approved the drug on 13 August 2010.

According to the UK EllaOne website the drug can actually be bought from at least four UK sources by filling out a simple on-line questionnaire. Prices vary from £21.36 up to £129.99.

This in itself has fuelled controversy as there is no way of knowing whether the personal or health information supplied by anyone buying ellaOne on line is actually true. What would prevent underage girls buying it or, for that matter, a man intending to cover up sexual abuse?

But the specific concern I wish to raise is that retailers are being dishonest about the mechanism of action of the drug.

Hormonal contraceptives prevent pregnancy by one of three mechanisms – by suppressing ovulation (the release of the egg form the ovary), by preventing fertilisation (the union of egg and sperm – usually by interfering with egg and/or sperm transport) and by preventing the implantation of the early embryo in the lining of the womb.

Some women only choose to use those hormonal contraceptives which they know act before rather than after fertilisation. Stopping egg and sperm coming together is one thing. Causing the death of an early embryo is quite another.

How then does Ellaone act? If we rely simply on what the retailers of the drug are saying we might conclude that its action is solely directed at suppressing ovulation and preventing fertilisation.

Typical amongst these is HealthExpress who describe it as follows:

‘(EllaOne) delays the release of the egg, preventing pregnancy. In the event that an egg has already been released, ellaOne works by increasing thickness of the mucus at the cervix. This additional effect reduces the chances of sperm entering the womb and also reduces the chances of pregnancy.’

Similarly 121doc claims that ‘ellaOne works by altering the activity of the body’s natural hormone progesterone, which can stop your ovaries from releasing an egg and prevent pregnancy.’

Pharmaplex Direct and Online Clinic give no information about mode of action at all.

However if we look at the scientific literature on the drug it is very clear that ellaOne also acts by preventing the implantation of the early human embryo. In other words it is embryocidal, or abortifacient.

This simple fact is not mentioned by any of the UK retailers but was made powerfully by Donna Harrison, President of the American Association of Pro Life Obstetricians & Gynecologists (AAPLOG) in evidence presented to the FDA’s Advisory Committee for Reproductive Health Drugs in June 2010. AAPLOG’s full submission goes into much more detail.

This embryocidal mode of action accounts for ellOne’s 98% effectiveness in preventing pregnancy even up to 120 hours (5 days) after intercourse and also explains why it is contraindicated in pregnancy – because of the chance that it might cause an early abortion.

By contrast Levonelle, the emergency contraceptive pill is 95% effective within 24 hours of unprotected sex, 85% between 25 - 48 hours and 58% if taken between 49 - 72 hours.

Unlike the morning-after pill Levonelle (levonorgestrel), but like the abortion drug mifepristone (RU 486), ellaOne is embryotoxic in animal studies. In practice it is actually very unlikely that ellaOne could be used to cause abortions, since it is used in much lower doses (30 mg) than the roughly equipotent mifepristone (600 mg). But killing early embryos is another matter entirely.

According to Wikipedia the EMEA proposed to avoid any allusion to a possible use as an abortifacient in the package insert in order to stop people misusing the drug.

EMEA’s wording is slightly more honest than the UK retailers but again lacks full transparency:

‘For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb. The sex hormone progesterone plays a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg… Through its actions on the progesterone receptors, ellaOne prevents pregnancies mainly by preventing or delaying ovulation.’

One has to read carefully between the lines to understand that this is actually saying that the drug could act by preventing an embryo implanting.

The Faculty of Sexual and Reproductive Healthcare (FSRH) of the UK’s Royal College of Obstetricians and Gynaecologists (RCOG) also hints at this mode of action.

The NHS is a little less ambiguous:

‘EllaOne stops or delays ovulation and makes it more difficult for a fertilised egg to be implanted into your womb.’

Most honest is ‘Netdoctor’ which simply and clearly states:

‘Ulipristal is also thought to alter the lining of the womb, preventing it from being prepared for a fertilised egg. This means that if an egg is released from the ovaries and is fertilised, it cannot implant into the womb and therefore pregnancy is avoided.’

EllaOne’s significantly higher cost than levonelle means in effect that in practice it will only be used in circumstances where there is a high risk that levonelle will not work – that is 2-5 days after sexual intercourse. At this stage it will almost certainly be acting almost exclusively by killing embryos rather than by preventing fertilisation.

Many women believe that life begins at fertilisation and may think twice if told that a drug worked by killing embryos. But how is properly informed consent even possible if retailers and the EMEA itself will simply not tell the truth about how ellaOne actually works?

We have to accept that EllaOne is already legal and available in the UK. But we can nonetheless insist that retailers are honest about its real mechanism of action.