Dear Friends,

An application has been made to the National Drugs and Poisons Schedule Committee for the "Morning After Pill" to be sold over the counter at pharmacies. This drug is an abortifacient, used after sexual intercourse not to prevent an embryo forming, but to remove any created embryos from the womb. That is to say, it kills any newly-created human being.

Submissions have been called for from the public, but they must be in by 21st May 2003. I was informed of this situation last Monday evening.

I have attached a copy of the submission made by Richard Egan of the "Coalition for Defence of Human Life" in Western Australia. As you can see, Richard bases his argument on the use of the pill on health grounds rather than pro-life arguments, as good as these are. We should send a letter or submission which contains both the the very clear health risks, plus our belief that the deliberate taking of human life like this is something no society should condone. There is also no harm in expressing your faith too, but know that it may mitigate against serious consideration by the Committee. Major on the health reasons and express your stand for the sanctity of life.

I have set out below a summary of Richard Egan's submission which you can use in your letter/submission. The address to send written submissions is:

The Secretary, National Drugs and Poisons Schedule Committee P.O. Box 100, Woden A.C.T. 2606.

If you need help further, please contact me.

Reasons for refusing change of Postinor-2 (aka levonorgestrel and "Morning After Pill") from Schedule 4 to Schedule 3: A summary of Richard Egan's submission.

1. The treatment can fail (the British CMO's memo to all British doctors reporting 12 cases of ectopic pregnancy out of 201 unintended prgnancies) 2. Significantly increased risk of ectopic pregnancy through the use of levonorgestrel. (Ectopic pregnancy is one where the embryo is created in the fallopian tube, seriously endangering the health of the mother). 3. The fact that some of the advocates of rescheduling the drug are wanting to do a prospective study to ascertain the link between the drug and ectopic preganancies shows that the application should be withdrawn while the doubt remains. 4. The British and New Zealand authorites are treating seriously the possibility of ectopic pregnancies. 5. Workers in busy all-night pharmacies have no authority or training to explain the dangers and the necessary checks after use. 6. There could be other, unknown risks to health associated with the drug. 7. The effect on the foetus if the treatment fails, is unknown. 8. Because Postinor-2 is marketed as a contraceptive, those who use it so may not know about its abortifacient effect. This could bring later psychological trauma for those who value human life from conception. 9. There is potential for abuse of the drug, because pharmacists do not know if a woman is using the drug over a long period or not. Also, young women of 14-16 years may use it, and we don't know the effects it has on them. 10. The Royal College of Nursing (UK) questions whether privacy, confidentiality, and sufficient information about the drug can be found in a pharmacy environment.

Your brother in Christ, Geoffrey Bullock State Officer Festival of Light in Queensland

~~ The Secretary

National Drugs and Poisons Schedule Committee

Dear Secretary

Re: Application for rescheduling of Postinor-2 (levonorgestrel)

from Schedule 4 to Schedule 3.

We are opposed to this rescheduling application firstly because of the risks associated with the use of levonorgestrel in large doses (two tablets of 0.75 mg) as a so-called 'emergency contraceptive'.

These include a significantly increased risk of ectopic pregnancy.

At its meeting held on 20 June 2002 the Medicines Adverse Reactions Committee (New Zealand) considered 3 case reports of ectopic pregnancies in New Zealand after use of levonorgestrel as an 'emergency contraceptive' and the 12 reports of ectopic pregnancy associated with 0.75 mg levonorgestrel held in the WHO database. The Committee agreed that "Given that levonorgestrel can interfere with smooth muscle contraction, there is biological plausibility for the progestogen-only ECP to increase the likelihood of ectopic pregnancy. It was agreed that it was important that doctors are aware of the possible association with ectopic pregnancy'. (http://www.medsafe.govt.nz/Profs/adverse/Minutes110.htm)

In January 2003 the British Chief Medical Officer wrote to all British doctors informing them that 12 cases of ectopic pregnancy out of a total of 201 unintended pregnancies had been reported to the Committee on Safety of Medicines following use of Schering's Levonelle (levonorgestrel 0.75 mg). The Committee on Safety of Medicines has advised that women using levonorgestrel 0.75 mg as an 'emergency contraceptive' should be told that the treatment can fail and should be followed up in the event of a missed normal period so that the possibility of an ectopic pregnancy can be explored, particularly in women with a previous ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.

We understand that some advocates of rescheduling of levonorgestrel (0.75 mg) as a Schedule 3 medicine are seeking to minimise the seriousness of this risk of ectopic pregnancy. They are suggesting that the 6 per cent rate of ectopic pregnancy per all unintended pregnancies reported to the UK Committee on Safety of Medicines is an apparent rate, as it is possible that not all unintended pregnancies are reported. It appears that Schering is planning to conduct a prospective study to determine the true rate of unintended pregnancy and ectopic pregnancy in women who have taken this product.

If this is the case then it would seem to be premature to agree to the rescheduling application before this trial is concluded. The approved Australian product information for Postinor-2 (Approved 28/9/01; amended 22/3/02) states that "no ectopic pregnancies or congenital abnormalities were reported".

Given the seriousness with which both the New Zealand and British authorities are taking the risk of ectopic pregnancy, it would be reckless to make levonorgestrel (0.5 mg) available over the counter without a prescription. Pharmacists, especially in the busy all-night pharmacies which are most likely to be used by women seeking an 'emergency contraceptive' after unplanned casual sex, are simply not in a position to explain this risk to women and communicate effective strategies for the necessary follow-up.

It appears that little is known with certainty about the extent to which the various risks, such as venous thromobembolism, and contraindications for the regular contraceptive pill apply to the taking of levonorgestrel in high, but irregular, doses.

The teratogenic effects on a foetus in the event of Postinor-2 failing to prevent or terminate a pregnancy are unknown.

Another risk of Postinor-2 arises from the attempt to suppress information about its post-fertilization effects by presenting it as a "contraceptive' and explicitly denying that it has an 'abortifacient' effect. As reported in the Annals of Pharmacology March 2002, Kalhlenborn et al.(Postfertilization effect of hormonal emergency contraception) warn that there is "a potential for negative psychological impact on women who value human life from conception onward, and . later learn of the potential postfertilization effects. Their responses could include disappointment, guilt, sadness, anger, rage, depression, or a sense of having been violated by the provider." It would be more difficult for a pharmacist, than for a doctor during a consultation, to conduct the necessary sensitive discussions with a woman to make sure this potentially damaging psycholigical impact is avoided.

In relation to the potential for abuse of a substance, Postinor-2 is being marketed as an 'emergency contraceptive'. The existing Australian product information recommends that prescribing doctors should advise women that present for repeated courses of Postinor-2 should consider a "longer term method of contraception". Pharmacists are not in a position to know that a woman is using repeated courses of the medication nor to offer this sort of advice.

Teenagers in particular may resort to the regular use of Postinor-2. Postinor-2 is "not recommended for children". It is admitted that there is "limited data" on the specific health risks for young women aged 14-16 years when the female body is still developing. Even if the scheduling decision precludes direct sale by pharmacists to girls under 16, over the counter sales without prescription are more likely to result in a 'black market' or at least informal supply of the medicine to girls under 16 after its purchase by friends 16 or over.

It is for these reasons that the Royal College of Nursing (UK) at it recent annual conference voted 290-108 (72.86%0 in favour of a resolution "that this meeting of the Royal College of Nursing Congress supports the need for regulation of assessment for emergency contraception".

Speakers to the successful motion questioned whether privacy and confidentiality could be given in a pharmacy environment and whether patients have sufficient information when they buy over the counter emergency contraception.

This is a development which should be given considerable weight by the Committee as it represents the considered of a response of a respected body of health professionals after 16 months experience with over the counter sales of emergency contraceptives in Britain.

In conclusion, we are opposed to the rescheduling of levonorgestrel (2 tablets x 0.75 mg) to Schedule 3 due to the known potential risks, the lack of adequate risk data, the potential hazards of use and the potential for abuse.

Further in the event that the Committee does approve rescheduling we are opposed to allowing advertising of this product. Such advertising of its nature is going to exacerbate the potential for abuse through repeated recourse to this product highlighted above.

Sincerely

Richard Egan

Coalition for the Defence of Human Life

GPO Box S1369

Perth WA 6845