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MLX 263

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Student LifeNet’s comments on the proposed amendments to the prescription only (human use) order 1997.

Consultation letter MLX 263

We would very much have liked to look at the evidence on which the Committee for the Safety of Medicines based their recommendation to change the status of Levonorgestrel 0.75mg, which unfortunately was not made available on request.

This, we feel, has seriously undermined the validity of the consultation, and we condemn such a lack of openness and transparency.

Our concerns regarding the proposal to reclassify Levonorgestrel 0.75mg as a Pharmacy available medication can be summarised as following:

Abortion One of the ways Levonorgestrel works is to cause an abortion, which is illegal.

Consent. Users of this pill are misled about the true action of Levonorgestrel 0.75mg.

Health concerns. Extensive research on the health effects of Levonorgestrel 0.75mg, has not been conducted in this country.

No evidence. There is no evidence that the ‘morning after’ pill, has reduced the number of recorded abortions in the UK, thus negating one of the proposed reasons for reclassification.

More abortions. Reclassifying this drug is contrary to the Department of Health’s comprehensive health strategy, as this action is likely to result in more abortions.

(i) Easier availability of Levonorgestrel 0.75mg, will reduce the patient’s risk perception of this drug, at the expense of other forms of oral contraception.

(ii) Advertising of Levonorgestrel 0.75mg will result in less use of other oral contraceptive methods, which can not be advertised.

ABORTION

Although, there are three ways in which Levonorgestrel 0.75mg can work, we find one method so objectionable that this is in itself a good enough reason not to change the status of Levonorgestrel 0.75mg to a Pharmacy available medication.

It is an accepted biological fact that human life begins at conception. Levonorgestrel 0.75mg can work post-conceptually and procure the miscarriage of an early human embryo. Procuring a miscarriage without adhering to the conditions laid down in the Abortion Act (1967), contravenes the Offences Against the Person Act (1861).

‘Morning after’ pills are a unique category of medicine, in that they treat no illness, cure no disease and alleviate no symptoms. As such they should be treated differently from all other medications and should definitely not be available as a Pharmacy medicine.

 

CONSENT

A number of studies into the post-fertilisation effects of oral ‘contraceptives’ have concluded that women should be explicitly informed of this abortifacient action. ‘On a physician patient level these are more than mere issues of semantics: they are ones of morality, personal choice and informed consent. Informed consent requires patient comprehension, the disclosure of information, and a sharing of interpretations with the patient to permit an informed choice.’

The post-conceptual action of Levonorgestrel is an issue that is currently being sidelined by providers of this drug, post conceptual effects are not even mentioned in the ‘Patient information booklet’ (Schering 1999), which is provided with Levonelle-2 the brand name of Levonorgestrel 0.75mg.

Full disclosure of information is rarely available under current protocols; it is even more unlikely to be available in busy chemist shops.

 

NO REDUCTION IN ABORTION RATES

The claim that increased access to the ‘morning after’ pill will reduce the number of ‘unwanted’ pregnancies and consequently abortions, is based on scattered anecdotal information, has no empirical basis and is not supported by statistics recorded by the Office for National Statistics. In fact, since the ‘morning after’ pill has been available there has been no decline in the number of abortions, in fact the overall abortion rate for every age group has increased.

 

HEALTH CONCERNS

There have been very few studies into the long-term health effects and consequences of repeated use of Levonorgestrel 0.75mg. As we have demonstrated ready access to this drug has not reduced abortion rates, and is, therefore, not in line with the Department of Health’s comprehensive health strategy, there is no valid reason to rush ahead and change the status of Levonorgestrel 0.75mg. Furthermore, it is imperative that extensive studies and research into the health effects of using Levonorgestrel 0.75mg are completed.

 

LEADING TO MORE ABORTIONS

a) Less effective

Changing the status of Levonorgestrel 0.75mg while other contraceptives are distributed as a prescription only medication will affect public perception of the relative safety of oral contraceptives. This could lead to a perception that using Levonorgestrel 0.75mg, on the ‘rare’ occasion that the condom fails, or when no contraception was used at all, is in fact safer or better for a woman's health than constantly using oral contraceptives.

It is widely held that emergency ‘contraception’ is not as effective as regular oral contraception. "It would be unwise to use ECPs routinely because they are not as effective as other contraceptive methods" The consequences of any change in status, could be an increase in the unplanned pregnancy and abortion rates.

b) Advertising & promotion

At the present time, it is expressly prohibited to advertise or promote Levonorgestrel 0.75mg and other forms of oral contraceptives. However, if this drug is reclassified advertising will be permitted. If providers and manufacturers are allowed to advertise and promote Levonorgestrel 0.75mg but are not permitted to promote or advertise more effective use of oral contraceptives, the result will be that more people will use the less effective product which is advertised. Once again, reclassification is likely to increase the number of unplanned pregnancies and abortions.

 

CONCLUSION

We recommend that Option 1, of the options presented should be adopted, that Levonorgestrel 0.75mg should not be made available as a prescription only medication

[1] Spinnato J, Am J Obstet Gynecol, 1997;176:503-6
[2] pp 55, Health Statistics Quartely, Winter 1999, Office for National Statistics
[3]  Emergency Contraceptive pills, British Pregnancy Advisory Service pamphlet 6/99

Student LifeNet
June 2000

 

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This Page was Last Updated on Tuesday, 11 July 2000.