Regulator’s proposal to remove pharmacists’ conscience rights is unethical, unnecessary and quite possibly illegal

Should pharmacists be forced to dispense drugs for what they consider to be unethical practices – like emergency contraception, gender reassignment, abortion and assisted suicide?

Or should they have the right to exercise freedom of conscience by either referring to a colleague or opting out?

The General Pharmaceutical Council (GPhC), the independent British regulator for pharmacists, pharmacy technicians and pharmacy premises, is proposing to replace the current ‘right to refer’ with a ‘duty to dispense’.

The Council calls this ‘person-centred’ care. 'Person-centred care' which puts the dignity and best interests of the client first is, of course, crucial and at the very heart of true professionalism.

But the Council then goes on to frame this care in terms of a universal right for clients to ‘access’ legally prescribed drugs and devices.  Pharmacists would thereby be pressured to comply or risk disciplinary procedures and/or possible loss of employment. Potential trainees could be dissuaded from pursuing a career in pharmacy altogether.

The consultation on the draft proposal is open until 7 March 2017 (background here; full consultation document here - the response form is on pages 23-30 and is summarised on p31).

Pharmacists who believe that human life should be respected from the time of fertilisation will generally object to dispensing potentially abortifacient drugs like levonelle and ellaOne.

Although marketed as ‘emergency contraception’ or the 'morning-after pill', these drugs are known in some cases to act by preventing the implantation of an early embryo and causing, in effect, an early abortion.

Currently pharmacists have a right to refer these cases to another pharmacy or colleague, but under the new draft guidance, which the GPhC admits represents ‘a significant change from the present position’ this right would be removed.

All health professionals are currently protected by a conscience clause in the Human Fertilisation Act 1990 from having to participate in ‘any activity’ governed by that Act. So, for example, if they have a moral objection to disposal of, or experimentation upon, human embryos, they do not have to take part.

But ironically, no such statutory conscience protection exists for those 'contraceptives' which act by killing embryos.

The Abortion Act 1967 has a conscience clause which allows health professionals to abstain from ‘participation’ in abortion. However, it also does not cover abortifacient contraceptives. Its scope has also recently been narrowed by a Supreme Court judgment so that it probably does not now protect pharmacists from being forced to supply drugs used in medical abortions either.

Highly contentious gender reassignment procedures, involving hormones to bock puberty in children, or to aid transsexuals to ‘transition’ to the opposite gender, are another area where the new regulations will put pharmacists under pressure to comply.

Assisted suicide and euthanasia are currently not legal in Britain, but were they to become so, this could be yet another situation where the new proposed guidance would leave pharmacists exposed.

Freedom of conscience has been a core ethical value, foundational to healthcare practice as a moral activity, from the Hippocratic Oath to the General Medical Council’s Good Medical Practice.

The right of conscientious objection is not a minor or peripheral issue. It goes to the heart of medical practice as a moral activity. It helps to preserve the moral integrity of the individual clinician, preserves the distinctive characteristics and reputation of medicine as a profession, acts as a safeguard against coercive state power, and provides protection from discrimination for those with minority ethical beliefs.

Most people can understand and respect the right of health professionals not to be involved in activities which they regard as abhorrent – obvious examples in other jurisdictions in which doctors have been complicit include female genital mutilation, punitive amputation, capital punishment or organ harvest from prisoners or street children.

But equally we need to recognise that many healthcare professionals in Britain regard such practices as abortion, assisted suicide, gender reassignment or embryo disposal or experimentation to be similarly morally wrong.

Pharmacists are healthcare professionals in their own right. Accordingly they deserve to be treated by their regulators with the respect due to their professional status. This latest proposal does not do that.

The contribution of community pharmacists to the provision of primary care is being actively promoted by the profession. Given that pharmacists are now taking on many of the roles once seen as the preserve of doctors, the GPhC should surely be protecting their freedom of conscience in a way commensurate with that shown to doctors by the GMC.

There are simply better ways in a democratic society to ensure that freedom of conscience is respected whilst still enabling people to access services to which they have a legal right. 

In this case there are at least three alternatives available to the GPhC.

First would be to leave the current guidance, which grants a right to refer, unchanged. Whilst this does not give full freedom, as many would regard referral as involving a degree of complicity, it does in practice give enough wiggle room for pharmacists who have a conscientious objection to dispensing certain drugs to avoid direct involvement. It has served the profession well up until now.

Second, the GPhC could follow the example of the GMC, the doctors’ regulator. GMC guidance (para 8) permits doctors to ‘opt out of providing a particular procedure because of [your] personal beliefs and values, as long as this does not result in direct or indirect discrimination against, or harassment of, individual patients or groups of patients’. In such situations, a doctor must ensure the patient understands her right to see another practitioner and has the necessary information to exercise that right.

Third, the GPhC could follow the example of the pharmacists’ professional body, the Royal Pharmaceutical Society (RPS), in a policy statement they drew up in 2013 to preserve freedom of conscience in the event of assisted suicide being legalised. This required pharmacists to ‘opt in’ by placing their names on a register of those willing to dispense barbiturates for assisted suicide. What is to stop a similar opt-in system operating for the practices I have mentioned above, rather than making a blanket imposition on all pharmacists?

If instead the GPhC ignores these solutions and presses ahead with imposing a ‘duty to dispense’ it will not only be running roughshod over the professional status of pharmacists, but could also be opening itself up to a legal challenge.

There is already a substantial body on law on conscience protection in British and European Law.

Article 9(1) of the European Convention of Human Rights (ECHR) provides a right to freedom of ‘thought, conscience and religion’. Whilst this is not absolute, and needs to be balanced against other democratic rights, any intervention must be shown to be both necessary and proportionate. It is hard to see how this move by the GPhC fulfils either of these requirements.

The Grand Chamber of the European Court of Human Rights has affirmed rights of conscience for sincerely held religious and moral beliefs as falling within the gambit of Article 9 (ECHR, Bayatan v. Armenia [GC], (2012) 54 E.H.R.R. 15.) They base their reasoning on the premise that a refusal to allow conscientious objection fails to strike a proper balance between the interests of society as a whole and the fundamental rights of the individual; providing rights of conscience ensures a cohesive and stable pluralism and promotes religious harmony and tolerance in society (Id.at § 124, 126).

The British Equality Act 2010, which is the sole legal precedent that the GPhC quotes in their consultation document in support of their proposal, lists nine protected characteristics, one of which is ‘religion and belief’.

It is therefore almost inconceivable that this draconian draft proposal will not be challenged in court by an aggrieved individual or organisation. 

But it should not come to that. It is just not worth the time, energy and expense and can be avoided.

There is little real evidence of widespread complaints by clients denied access to drugs under the current regulations. GPhC council meeting notes from 12 April 2012 specifically state that no data is collected and mention that only ‘a small number of complaints’ relating to 'fitness to practice' are received annually. We would expect complaints specifically about FOC to make up only a tiny subset of these.

The regulator, it seems, is using a sledgehammer to crack a walnut.

The GPhC’s proposal to remove pharmacists’ conscience rights is disproportionate, unethical, unnecessary and quite possibly illegal.

For the sake of professional freedom and reasonable accommodation, essential in a pluralist multi-faith democracy, let’s hope that they chose instead a more flexible, tolerant, respectful and eminently sensible path.

New study confirms that making morning-after pill free without prescription increases sexually transmitted infections and fails to reduce pregnancy rates

Half of all pregnancies in the United States are unintended.

One might therefore assume that making the morning-after pill (MAP) more widely accessible would cut the unplanned pregnancy rate.

Not so.

A new recent US study is the first to estimate the impact of making the morning-after pill available over the counter without prescription on abortions and risky sexual behaviour as measured by sexually transmitted infection (STI) rates.

Dr Karen Mulligan, associate professor of economics and finance at Middle Tennessee State University, found that providing individuals with over-the-counter access to emergency contraception (EC) leads to increased STI rates and has no effect on abortion rates.

Moreover, risky sexual behaviour such as engaging in unprotected sex and number of sexual encounters increases as a result of over-the-counter access to EC.

Mulligan’s analysis estimated that over the counter access increases STI rates by approximately 12% for women aged 15-44 and 9% for teenagers; these numbers are also consistent with the 12-17% increase in gonorrhea rates found in Washington as a result of expanded access.

She concluded that switching EC to over the counter status has three main effects on behaviour: individuals are more likely to have sex, they have a higher number of sexual encounters, and are less likely to use condoms.

The FDA approved access to emergency contraception, or Plan B (equivalent to Levonelle in the UK), through US pharmacies without a prescription in 2012 nationally. This followed pilot programmes in several states starting with Washington in 1998. 

But the US’s persistence with this unproven strategy is apparently driven more by ideology than evidence.

In the light of Mulligan’s research, Dr David Paton, professor of industrial economics at Nottingham University Business School, today called on local and national governments in the UK to review their current policy of aggressive promotion of emergency contraception (EC) to young people in schools, pharmacies and sexual health centres.

‘It is very interesting to see further confirmation that access to emergency birth control (EBC) does not seem to reduce abortions but leads to higher rates of STIs. This paper is one of the first to explore the mechanisms whereby EBC affects STIs, finding that both rates of 'unprotected' sex and numbers of partners increase in response to over-the-counter EBC. Although this paper uses US data, it is consistent with evidence from the UK’, he said.

A previous 2012 American study showed that making emergency contraception available free over the counter without prescription leads to an increase in rates of sexually transmitted infections and does not decrease pregnancy or abortion rates. 

Christine Durrance, Assistant Professor of Public Policy at the University of North Carolina, Chapel Hill, used county-level data as well as specific timing of changes in pharmacy access to consider the intended and unintended consequences of pharmacy access to emergency contraception in Washington. 

The results were almost identical to those of a British study published in the Journal of Health Economics (full text) in December 2010 and reported in the Daily Telegraph in January 2011.

This research, by professors Sourafel  Girma and David Paton of Nottingham University, compared areas of England where the scheme was introduced with others that declined to provide emergency contraception free from chemists (See my previous blogs on this here and here).

The academics found that rates of pregnancy among girls under 16 remained the same, but that rates of sexually transmitted infections increased by 12%.

In fact, in a systematic review published in 2007, twenty-three studies published between 1998 and 2006, and analyzed by James Trussell’s team at Princeton University, measured the effect of increased EC access on EC use, unintended pregnancy, and abortion. Not a single study among the 23 found a reduction in unintended pregnancies or abortions following increased access to emergency contraception (see also fact sheet here).

The phenomenon whereby applying a prevention measure results in an increase in the very thing it is trying to prevent is known as ‘risk compensation’.

The term has been applied to the fact that the wearing of seatbelts does not decrease the level of some forms of road traffic injuries since drivers are thereby encouraged to drive more recklessly.

In the same way it has been argued that making condoms readily available actually increases rather than decreases rates of pregnancy and sexually transmitted infections because condoms encourage teenagers to take more sexual risks in the false belief that they will not suffer harm.

Whilst condoms offer some protection against sexually transmitted infections the morning-after pill offers none.

Britain has the highest rate of teenage pregnancy in Western Europe.  But international research has consistently failed to find any evidence that emergency birth control schemes achieve a reduction in teenage conception and abortion rates.

Now there is growing evidence showing that not only are such schemes failing to do any good, but they may in fact be doing harm.

Making the emergency contraceptive pill available over the counter free, without prescription, is sadly an ill-conceived knee-jerk response to Britain’s spiralling epidemic of unplanned pregnancy, abortion and sexually transmitted disease amongst teenagers. It is also not evidence-based.

The best way to counter the epidemic of unplanned pregnancy and sexually transmitted disease is to promote real behaviour change. The government would be well advised to enter into dialogue with leaders of communities in Britain where rates of sexually transmitted diseases and unplanned pregnancy are low, especially Christian faith communities, to learn about what actually works.

Doctors should not be forced to provide emergency contraception if they have an ethical objection to it

The Independent has run the story of a ‘Christian-run NHS GP surgery’ which has apparently ‘attracted criticism for posting a notice warning that some of its doctors refuse to prescribe the morning-after pill to patients on grounds of conscience’.

The message on the door of The Links Medical Practice in Mottingham, south London advises patients that if ‘a consenting doctor is not available’ to prescribe contraception they should contact a local clinic or chemist.

One of the practice’s patients was apparently so outraged by this that she opted to leave the practice and Audrey Simpson, chief executive of the Family Planning Association, has said that other women should also think about leaving the surgery in response to the notice.

She is reported as saying: ‘Leaving will send out a message to them that women have the right to access emergency contraception.’

Women can of course legally access ‘emergency contraception’ in the UK and can buy the ‘morning-after pill’ levonelle over the counter without prescription from most pharmacies as well as accessing it free on prescription, from sexual health clinics and from NHS walk in centres.

But according to General Medical Council guidelines published just recently (see my full review of them here), doctors can also refuse to prescribe certain treatments as a matter of conscience.

The Guidance ‘Personal Beliefs and Medical Practice’ states:

‘You may choose to opt out of providing a particular procedure because of your personal beliefs and values, as long as this does not result in direct or indirect discrimination against, or harassment of, individual patients or groups of patients.’

It goes on to describe how this is to be done:

‘If, having taken account of your legal and ethical obligations, you wish to exercise a conscientious objection to particular services or procedures, you must do your best to make sure that patients who may consult you about it are aware of your objection in advance. You can do this by making sure that any printed material about your practice and the services you provide explains if there are any services you will not normally provide because of a conscientious objection.’

This seems to be exactly what these doctors have done.

The guidance adds that doctors who do not provide a certain treatment should ‘tell the patient’, tell them ‘that they have a right to discuss their condition and the options for treatment with another practitioner’ and ‘make sure that the patient has enough information to arrange to see another doctor who does not hold the same objection as you’.

Why might doctors have an objection to prescribing ‘emergency contraception’?

There are three main reasons.

Some doctors may have an objection to prescribing contraception in principle. Many Catholics take this view.

Some doctors object to prescribing a drug which might in some circumstances act by preventing an early embryo from implanting in the womb as they see this as an early form of abortion. Although there is not firm proof that levonelle acts in this way there is at very least a degree of uncertainty and no absolute proof that it does not (more on this here – note levonelle in the UK is the same drug as Plan B in the US).

Finally some object because they are unconvinced that levonelle is an effective intervention. Its success rate is relatively low (95% within 24 hours of sexual intercourse, 85% from 25-48 hours and 58% from 49-72 hours).  Also in clinical trials its ready availability has been shown not to reduce pregnancy rates in a population and actually to raise rates of sexually transmitted diseases. 

This is thought to be due to the phenomenon of ‘risk compensation’ – people taking more risks because they believe there is a safety net.

But regardless of the reasons for a given doctor’s objection to prescribing ‘emergency contraception’, the fact that a patient can legally access it does not mean that every doctor thereby has a legal or ethical duty to supply it.

Doctors should not be forced to provide treatments or interventions that they believe are unethical, ineffective or inappropriate. To force them to do so would be to undermine their professional integrity. They are not simply rubber stamps.

Instead reasonable accommodation should be made. And thankfully both the law and the GMC guidance currently allow for that. 

As the recent CMF File on the doctor's conscience concludes: 

The right of conscientious objection is not a minor or peripheral issue. It goes to the heart of medical practice as a moral activity....  The right of conscience helps to preserve the moral integrity of the individual clinician, preserves the distinctive characteristics and reputation of medicine as a profession, acts as a safeguard against coercive state power, and provides protection from discrimination for those with minority ethical beliefs.

(Listen to my BBC London Interview with Vanessa Phelps here)

BPAS plan to sell morning-after pill to teenagers online this Christmas will lead to more sexually transmitted disease and no less unplanned pregnancy

A British Pregnancy Advisory Service (BPAS) campaign, launched today, encourages women to stockpile emergency contraceptive pills over the Christmas period.

According to the Daily Telegraph a poster for the scheme, featuring the word ‘sex’ in fairy lights, asks: ‘Getting “turned on” this Christmas?’ And a dedicated website for the service is titled, rather bawdily, santacomes.org.

Women wanting to obtain the morning after pill, Levonelle One Step, will have to register their details on the website. They will then be phoned by a nurse for a 15-minute consultation intended to weed out young teenagers and assess suitability before being posted the pills.

However, BPAS has admitted that under-age girls will almost certainly obtain pills through the scheme by lying to them. Some children ‘will not be completely honest about their age’, a spokesman said. Under-16s would usually need a prescription to prevent a possible pregnancy in this way.

Andrew Lansley, the Health Secretary, said last night that he would prefer the pills to be issued after a face-to-face consultation but stopped short of saying he would intervene.

Not suprisingly critics have reacted sharply.

Michaela Aston, spokesman for the pro-life charity, Life, said the new service made getting the pills as easy as ordering a pizza. She said: ‘There are absolutely no guarantees that under-age girls won’t be given this pill, as there are no checks on their age carried out by BPAS.’

Norman Wells, director of the Family Education Trust, said: ‘When the morning after pill was first approved for use in the UK, assurances were given that it would be used only in exceptional circumstances and would remain a prescription-only drug under the control of doctors. Not only is it now being marketed as a “just-in-case” drug and supplied free of charge, but BPAS’s telephone service will inevitably lead to underage girls lying about their age in order to access it.’

Josephine Quintavalle, founder of the Pro-life Alliance, said: ‘BPAS won’t have any idea about what is really going on with the caller. She could be having underage sex. She could sell it to a friend.’

The risk of underage girls accessing the morning after pill is of course a key objection to the scheme.

But there is a more fundamental reason why this scheme is dangerous: Morning-after pills don’t actually cut teen pregnancy rates and actually increase the incidence of sexually transmitted infections.

Research findings demonstrating this earlier this year (published in the Journal of Health Economics (full text) just last December and reported in the Daily Telegraph in January) were the final nails in the coffin of the Labour government’s teenage pregnancy strategy, dreamt up by the now defunct Teenage Pregnancy Independent Advisory Group (TPIAG) which was set up in 2000 to advise the government on how to cut teenage pregnancy.

Part of its strategy was to make morning-after pills free over the counter to teenagers.

The research, by professors Sourafel Girma and David Paton of Nottingham University, compared areas of England where the scheme was introduced with others that declined to provide the morning-after pill free from chemists.

The academics found that rates of pregnancy among girls under 16 remained the same, but that rates of sexually transmitted infections increased by 12%.

Britain has the highest rate of teenage pregnancy in Western Europe. In 2008, the latest year for which figures are available, more than 7,500 girls in England and Wales became pregnant. Nearly two thirds of these pregnancies ended in abortion.

Rates of sexually transmitted diseases are also rising. In 2009 there were 12,000 more cases than the previous year, when 470,701 cases were reported. The number of infections in 16-to 19 year-olds seen at genito-urinary medicine clinics rose from 46,856 in 2003 to 58,133 in 2007.

International research has consistently failed to find any evidence that emergency birth control schemes achieve a reduction in teenage conception and abortion rates. But now we have evidence showing that not only are such schemes failing to do any good, but they may in fact be doing harm.

The phenomenon whereby applying a prevention measure results in an increase in the very thing it is trying to prevent is known as ‘risk compensation’.

The term has been applied to the fact that the wearing of seatbelts does not decrease the level of some forms of road traffic injuries since drivers are thereby encouraged to drive more recklessly.

In the same way it has been argued that making condoms readily available actually increases rather than decreases rates of pregnancy and sexually transmitted infections because condoms encourage teenagers to take more sexual risks in the false belief that they will not suffer harm.

Whilst condoms offer some protection against sexually transmitted infections the morning-after pill offers none.

They are the very last thing we need to foist on vulnerable drunken teenagers during the festive season and will simply encourage them to take more risks by giving them a false sense of security.

This latest BPAS strategy is underpinned by the dangerous assumption that there is no right or wrong in teenage sexual activity - just choice. This assumption has led to a values-free framework in which the rate of unplanned pregnancies and sexually transmitted disease amongst teenagers is the highest in Europe.

Its prime effect, apart from further inflating BPAS’s already inflated coffers with more taxpayers money, will be to lead to more reckless behaviour, more sexually transmitted disease and no decrease in unplanned pregnancy and abortion.

The best way to counter the epidemic of unplanned pregnancy and sexually transmitted disease is to promote real behaviour change through such programmes as Love for Life (Northern Ireland), Love2last (Sheffield), Challenge Team, Romance Academy or Lovewise (Newcastle). These are just the sorts of initiative that the government should be encouraging and their message of abstinence and caution is the one they should be giving.

This latest BPAS move is sadly yet another unfortunate, ill-conceived opportunistic knee-jerk response to Britain’s spiraling epidemic of unplanned pregnancy, abortion and sexually transmitted disease amongst teenagers and will only make matters worse. It is most unfortunate that the government is actually funding it through them.

Instead of pursuing these tired flawed ‘ambulance at the bottom of the cliff’ policies we should be focusing on evidence-based strategies aimed at bringing about real behaviour change.

Christian pharmacists under threat from new guidelines on morning-after pill provision

Christian pharmacists who object to dispensing the morning-after pill are facing pressure from their professional regulator to recommend other outlets to customers.

Many pharmacists – not just Christians – have moral objections to the morning-after pill because the drug may in some cases act after fertilisation by preventing the implantation of an early embryo. It is thereby technically abortifacient. There is also strong evidence that its ready availability over the counter without prescription does nothing to decreases the number of unplanned pregnancies in a community and actually increases the level of sexually transmitted disease.

Those with moral objections argue there is little difference between being forced to recommend another outlet for the pill and being forced to sell it themselves.

The regulator, the General Pharmaceutical Council (GPhC), has issued ‘non mandatory’ guidance on the matter which they say the guidance will be open to review after one year. ‘Our guidance is advice for pharmacy professionals and explains how our standards might be met, or provide additional suggestions for practice,’ a spokeswoman said.

According to the Daily Telegraph, the guidance was circulated last week. However the latest guidelines on the GPhC website, ‘Guidance on the provision of pharmacy services affected by religious and moral beliefs’, are dated September 2010. They state:

‘If you do not supply Emergency Hormonal Contraception (EHC), (either over the counter or against a prescription) women should be referred to an alternative appropriate source of supply available within the time limits for EHC to be effective.’

The guidance adds that pharmacists should also phone ahead to check that the product is in stock. It also says that conscientious objection on religious grounds must take second place to contractual demands of employers, like the NHS.

As human rights lawyer Neil Addison points out, ‘What many people do not seem to grasp is the fact that if you are refusing to do something because it is morally objectionable you cannot be obliged to recommend someone else’.

And Anna Sweeting-Hempsall a pharmacist in Sunderland said the new guidance ‘forces pharmacists to act against their consciences’ and would cause legal conflicts between staff and employers.

The Telegraph reports her as saying: ‘Now the employers have the right to impose any contractual obligations that take precedence over the right of conscience. The need to notify people beforehand makes you virtually unemployable. Anybody who values the sanctity of life from the moment of conception will be forced from the profession.’

The controversial General Medical Council Guidance, ‘Personal Beliefs and Medical Practice’ leaves doctors with a similar obligation to refer for practices to which they have a conscientious objection:

‘Patients may ask you to perform, advise on, or refer them for a treatment or procedure which is not prohibited by law or statutory code of practice in the country where you work, but to which you have a conscientious objection. In such cases you must tell patients of their right to see another doctor with whom they can discuss their situation and ensure that they have sufficient information to exercise that right. In deciding whether the patient has sufficient information, you must explore with the patient what information they might already have, or need. If the patient cannot readily make their own arrangements to see another doctor you must ensure that arrangements are made, without delay, for another doctor to take over their care.’

These cases rarely come to court and so often the legal precedents are not clear. Although emergency contraception is technically abortifacient, its provision is not covered by the conscientious objection clause in the Abortion Act 1967.

However it may be that equality law might have a bearing on cases like this. In a very recent case a hospital backed down from forcing two Christian nurses to participate in abortion after it received a letter from a lawyer saying that in so doing they could be in breach of the Equality Act 2010.

Evidence shows Welsh move to make morning-after pill available free over the counter to teenagers will badly backfire

I recently blogged on the fact, surprising to some, that morning-after pills don’t actually cut teen pregnancy rates and instead increase the incidence of sexually transmitted infections.

This morning we learnt that so-called ‘emergency contraception’ can now be obtained without charge from pharmacies across Wales, while still costing about £25 in the rest of the UK.

Community pharmacists in Wales can also give the ‘morning-after pill’ to under-16s, if ‘clinically appropriate’.

Health minister Edwina Hart (pictured) announced the move last November, saying she wanted professional advice available without appointment and ‘easily accessible within the 72-hour time span necessary for emergency contraception to be most effective’.

The morning-after pill is already free to women across the UK if it is prescribed by a GP or family planning clinic, but Wales is the first nation to offer emergency contraception without charge on the high street.

Many people (including many in government) mistakenly think that morning-after pills being made more freely available will actually help Britain’s growing problem of unplanned pregnancy.

So why do I think it is such a bad idea?

First, it is strategy based on no evidence at all. In fact the very latest research in Britain, published in the Journal of Health Economics (full text) just last December and reported in the Daily Telegraph in January, showed that morning-after pills don’t cut teen pregnancy and actually increase the risk of sexually transmitted disease.

I blogged at the time that these findings were the latest nails in the coffin of the Labour government’s teenage pregnancy strategy, dreamt up by the now defunct Teenage Pregnancy Independent Advisory Group (TPIAG) which was set up in 2000 to advise the government on how to cut teenage pregnancy. Part of its (failed) strategy was ironically to make morning-after pills free over the counter to teenagers.

The new research, by professors Sourafel Girma and David Paton of Nottingham University, compared areas of England where the scheme was introduced with others that declined to provide the morning-after pill free from chemists.

The academics found that rates of pregnancy among girls under 16 remained the same (ie that the morning after pill did nothing to improve things), but that rates of sexually transmitted infections actually increased by 12%.

The phenomenon whereby applying a prevention measure results in an increase in the very thing it is trying to prevent is known as ‘risk compensation’.

The term has been applied to the fact that the wearing of seatbelts does not decrease the level of some forms of road traffic injuries since drivers, feeling more secure, are thereby encouraged to drive more recklessly. In the same way making morning-after pills widely available encourages more sexual risk-taking and more sexually transmitted disease as a result. Any effect on decreasing pregnancy rates is cancelled out by rising levels of promiscuity.

But in addition to the fact that this strategy will simply not work as a solution I have other problems with it.

Second, this policy removes prescription of the pill from the safety of the doctor patient relationship. The pharmacy, school or supermarket, is the wrong context for a young distressed girl to make such a request and to receive counselling and care.
Exchange of essential medical and social information needs time and sensitivity. Issues include side effects (nausea and/or vomiting in 25%), what to do if the girl vomits within three hours of taking the tablet, and the ‘failure’ rate of perhaps 15% of all potential pregnancies. A discussion of the social context is equally essential (eg. Recognizing coercion by an older man, other abusive sexual relationships, concomitant alcohol and drug use).

Third, these arrangements remove all accountability of the child to the parents and other health professionals in the discredited belief that this has a negative effect on teenage conception rates. The evidence suggests otherwise. Accountability to parents, it seems, is not only a disincentive to pharmacy attendance but also to sexual activity! There are many communities in Britain (both ethnic groups and faith communities) where rates of teenage sexual activity are very low indeed. The government needs to be studying these communities and learning from them.

Fourth, the MAP can potentially work as an abortifacient. The Levonelle-2 preparation used in this initiative is a progesterone-only MAP whose makers acknowledge sometimes works by preventing implantation of the early embryo. At very least teenagers have a right to be properly informed about the pill’s mode of action.

Finally, this government strategy is underpinned by the dangerous assumption that there is no right or wrong in teenage sexual activity - just choice. This assumption has led to a values-free framework in which the rate of unplanned pregnancies and sexually transmitted disease amongst teenagers is the highest in Europe.

The best way to counter the epidemic of unplanned pregnancy and sexually transmitted disease is to promote real behaviour change through such programmes as Love for Life (Northern Ireland), Love2last (Sheffield), Challenge Team, Romance Academy or Lovewise (Newcastle). These are just the sorts of initiative that the government should be encouraging.

This latest move is sadly yet another unfortunate, ill-thought out knee-jerk government response to Britain’s spiraling epidemic of unplanned pregnancy, abortion and sexually transmitted disease amongst teenagers and will only make matters worse.

The latest UK evidence, as outlined above, shows that making the morning-after pill available in this way will result in no fall in unplanned pregnancy and will increase levels of sexually transmitted disease.

Instead of pursuing these tired flawed ‘ambulance at the bottom of the cliff’ policies the government should be focusing on evidence-based strategies aimed at bringing about real behaviour change.

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.