Is abortion in England and Wales a
crime?
Yes, according to Sections 58 and 59 of the 1861
Offences Against the Person Act, it surely is.
The 1967 Abortion Act simply protected from
prosecution a ‘registered medical practitioner’ who
performed an abortion as long as two such doctors
certified that in their opinion, formed in good faith,
the continuance of the pregnancy would involve risk,
on one or more of six grounds, greater than if the
pregnancy were terminated.
Of course, protected by the 1967 Act, UK doctors are
performing tens of thousands of abortions in the UK
every year. And every now and again, someone is
prosecuted under the 1861 Act. In fact, it is
thought that only three such prosecutions have been
brought in England and Wales during the last 160
years. Now in 2023 that number has suddenly
risen by five more.
In December 2022, the Crown Prosecution Service (CPS)
dropped the case against a 25-year-old Oxford mother
who was charged with taking misoprostol to procure her
own miscarriage while 31 weeks pregnant. The
woman was charged a year after her baby was
successfully delivered by C-section in January
2021. The CPS considered that prosecuting her
under the 1861 Act would not be in the public
interest. The judge said he was ‘flabbergasted’
that she was ever being prosecuted.
In June 2023, Carla Foster, 45, was convicted and
sentenced to 28 months imprisonment by Stoke Crown
Court. She had admitted inducing a miscarriage
during the first Covid-19 lockdown, when she was 32 to
34 weeks pregnant. At the Court of Appeal, her
sentence was cut to 14 months suspended, and she was
released from prison.
In August 2023, Bethany Cox, 22, appeared at Teesside
Crown Court accused of carrying out an illegal
abortion in July 2020. She pleaded not guilty to
charges of child destruction and unlawfully
administering poison or another noxious substance with
intent to procure her own miscarriage and is due to
stand trial in early 2024.
Sophie Harvey, 23, is due to stand trial in November
at Gloucester Crown Court, with her partner Elliot
Benham, also 23. They have pleaded not guilty to
joint charges that include illegally procuring drugs
from India to procure a miscarriage and concealing the
birth of a child. Harvey has also been charged
with inducing her own miscarriage.
In September 2023, a woman, who cannot be named for
legal reasons, appeared in court accused of procuring
‘poison’ – the abortion drugs mifepristone and
misoprostol – with intent to cause her own
miscarriage. The offence, under Section 58 of
the 1861 Offences Against the Person Act, is alleged
to have been committed in November 2020, during the
second Covid-19 lockdown.
These five cases, mostly related to the ‘pills by
post’ or ‘DIY abortion’ scandal, suggest that
prosecutors are taking a much more aggressive stand
against women with unexplained pregnancy loss, or who
are suspected of having an illegal abortion.
What’s wrong with that? The general public is
frequently asking for our laws to be upheld
properly. And what is wrong with a law that is
162 years old? Pro-abortion campaigners are
calling for the repeal of the 1861 Offences Against
the Person Act and the decriminalisation of
abortion. They recently wrote to Max Hill KC,
the director of public prosecutions (DPP) calling for,
’urgent guidance to stop the prosecution of women who
end their own pregnancies, with immediate effect.’
The battle for the lives of unborn children (and their
mothers) continues. Abortion should never be
permitted in a compassionate, civilised society.
What has changed in 162 years? The 1861 Act
protected the unborn child – the 1967 Act fails to
protect the unborn child.
Mexico decriminalises
abortion
Back in 2021, a Mexican Court ruled in favour of a
challenge to the existing abortion law in the northern
state of Coahuila. It ruled that criminal
penalties for terminating pregnancies were
unconstitutional. This new law set the abortion
juggernaut rolling.
Then in September 2023, the Supreme Court said that
denying the opportunity of a termination violated the
human rights of women. Abortion was therefore
decriminalised across all 32 Mexican states. The
head of the Supreme Court, Arturo Zaldívar stated
that, ‘In cases of rape, no girl can be forced to
become a mother – neither by the state nor by her
parents nor her guardians. Here, the violation
of her rights is more serious, not only because of her
status as a victim, but also because of her age, which
makes it necessary to analyse the issue from the
perspective of the best interests of minors.’
Mexico City was the first of the country's states to
decriminalise abortion in 2007 and a dozen others
followed suit. Now this new judgement opens the
door for the entire federal healthcare system to
provide abortions. Despite the lack of abortion
facilities, many have welcomed the move. For
example, women's rights activist Sara Lovera is
reported as saying, ‘Many women don't know that they
have this right because local governments have not
carried out publicity campaigns about it. That's
why today's decision of the Supreme Court is
important.’
Not all are happy. The new ruling is likely to
anger Mexico's more conservative politicians and the
Roman Catholic Church, in what is Latin America's
second largest Catholic nation. However, the
Church's influence has been declining in recent years
and the country's government considers itself
staunchly secular.
Latin America has seen a trend towards loosening
abortion restrictions that has been referred to as a
‘green wave’. Elective abortion is legal in
Colombia, Cuba, Uruguay and Argentina, though the
frontrunner in the campaign for Argentina's
presidential election in October, Javier Milei, wants
to ban the procedure. Some other Latin American
countries allow abortions in circumstances such as
rape or health risks, while outright bans apply in El
Salvador, Honduras, Nicaragua, Haiti and the Dominican
Republic.
These reforms in Mexico and other Latin American
countries contrast with the situation in the United
States, where a Supreme Court ruling in June 2022
overturned the landmark 1973 Roe v. Wade
decision which had previously granted the right to
abortion nationwide.
Retraction row over
abortion paper
The British Journal of Psychiatry has been
widely criticised over its decision not to retract a
research paper on abortion. It has been
referenced in US legal cases to restrict access to the
procedure. Three of the Journal’s
international board members have resigned after the Journal
and its owner, the Royal College of Psychiatrists,
ignored the advice of its own internal panel to
retract the paper.
The paper in question was published in 2011 by
Priscilla K Coleman, who was a professor of human
development and family studies at Bowling Green State
University, Ohio, between August 2002 and June
2022. Coleman has testified in at least 20
abortion-related cases, all in favour of greater
restrictions on the procedure and the paper was cited
in recent US legal cases that restricted access to
abortion and mifepristone, a drug used for medical
abortion.
The paper is entitled, ‘Abortion and mental health:
quantitative synthesis and analysis of research
published 1995-2009’ by P K Coleman and published in
the British Journal of Psychiatry (2011,
199: 180-186). This is what Coleman’s
distressing results revealed, ‘Women who had undergone
an abortion experienced an 81% increased risk of
mental health problems, and nearly 10% of the
incidence of mental health problems was shown to be
attributable to abortion.’ Moreover, in the
Discussion section of her paper, Coleman, states, ‘The
finding that abortion is associated with significantly
higher risks of mental health problems compared with
carrying a pregnancy to term is consistent with
literature demonstrating protective effects of
pregnancy delivered relative to particular mental
health outcomes.’
This is hot territory. A woman, with
international research credentials, publishes her
findings that abortion is a risk factor in women’s
mental health. That is dynamite for many
progressive academics.
In June 2022, a group of 16 researchers led by Chelsea
Polis, a senior scientist of epidemiology at the
Center for Biomedical Research at the Population
Council, a US-based research organisation, wrote to
the British Journal of Psychiatry saying that
Coleman’s paper had methodological issues that
invalidated its conclusions. Coleman disputes
the methodological criticisms and says that the
researchers are motivated by a desire to discredit her
as a researcher and an expert witness for political
reasons.
After the British Journal of Psychiatry
contacted Coleman to inform her that an ‘expression of
concern’ would be added to her paper, her lawyers sent
the Journal a letter saying that such a
notice would cause ‘serious harm and direct damage to
her reputation.’ Coleman has said that most of
the signatories of the retraction request letter have
pro-choice views or are aligned with pro-choice or
reproductive rights organisations and initiatives,
whereas she has never held membership of any pro-life
organisation. She maintains that ‘It is not
appropriate today for activists to call for a
retraction because they are uncomfortable with the
results and the study is having a major impact in
terms of informing clinical practice and policy.’
A spokesperson for the Royal College of Psychiatrists
stated that for various reasons, ‘It has been decided
to reject the request for the article to be
retracted.’ Hooray for free speech, scientific
integrity and truthfulness. The debate goes on!
IVF &
ARTs
Are you my
Dad?
From Sunday 1 October, 18-year-olds in the United
Kingdom, who were conceived with donor gametes, were
able to find out the identity of their genetic donor
parents. Is this the beginning of that
unexpected knock on the front door followed by the
even more surprising, ‘Hello, Dad’?
The UK donor anonymity law was amended in 2005 to
ensure that everyone has a right to information about
their genetic origins. This means that the
records of ova, sperm or embryo donors who donated
after 1 April 2005 will be available. Moreover,
it means that about 30 people who were conceived by
gamete and embryo donation from donors who registered
after 1 April 2005 will turn 18 in 2023, with the
first celebrating their birthdays in October.
And by the end of 2030, this number will rise to 2,406
people. The new law gives them the right to
request their donor’s full name, date of birth and
last known address from the Human Fertilisation and
Embryology Authority (HFEA).
To raise awareness of this landmark change, the HFEA
has launched its #WhoIsMyDonor campaign. There
are limitations to the scheme. For example, will
donors want to lift their previous anonymity?
Will donors bother to update their contact details
with the IVF clinic they used? Donors will be
asked only for a postal address, which is quite likely
to be outdated. And about 65% of heterosexual
couples never tell their children that they are donor
conceived. The scheme is currently invisible on
Twitter/X, Facebook and TikTok. Finally, the
#WhoIsMyDonor campaign runs only between 19 September
2023 and 31 January 2024.
Not having information about genetic origins has been
shown in a number of studies to have a significantly
negative impact on donor-conceived individuals.
According to the HFEA, over 70,000 donor-conceived
children have been born since 1991 and today, donor
conception accounts for 1 in 6 IVF births in the UK
and 1 in 170 of all UK births. By 2030, the HFEA
predicts there will be an average of one or two
donor-conceived children in every English state
primary school.
Is all this yet another dilemma that predictability
proceeds from the troubled bioethical basis of
IVF? It is ‘making’ children versus ‘normative
parenthood’. Move away from natural conception
and problems abound. Already there are
grandmothers giving birth to their
grandchildren. Children with two fathers and
three mothers. Unknown thousands of orphaned,
frozen human embryos, and so on.
And what does donating ova, sperm and embryos
do? It creates beautiful, bouncing babies, of
course. But it also adds a third person into
what is best conducted as a two-person relationship,
namely marriage. And it also strikes at the very
structure of a society, especially the foundations of
families – it deliberately produces unstable,
patchwork relationships. As ever, the warning
is, stay away from IVF and its associated practices.
Artificial ova and sperm
What might be the ultimate goal of human reproductive
scientists? Perhaps it is the creation of a
human being using artificial gametes – no natural ova
or sperm, no sexual intercourse, no love between a man
and a woman. That all sounds pretty mechanical
and bleak. But we are moving ineluctably down
that road.
Consider so-called IVG, in vitro gametogenesis, a
radical offshoot of IVF. Scientists are striving
to be the pioneers, the originators to create those
very ‘artificial’ ova and sperm from ordinary human
somatic cells. The route is three-fold – first,
take some ordinary human skin cells (simple), second,
turn them into induced pluripotent stem cells (iPSCs,
possible) and third, convert them into gametes, ova
and sperm (complex). And then what? Mix
the artificial gametes and create ‘artificial human
embryos’. For now, the chain of these three
transformations is unachievable. Yet it remains
for some an embryologist’s dream. But maybe in 5
or 10 years it will be realised. Theoretically
and technically, we are on the road.
Bioethically, morally, legally and societally we are
far, far away.
Think of some of the serious associated issues.
Think who ‘owns’ artificial gametes. Think of
the problems associated with straightforward
IVF. Think about artificial IVG embryos carrying
dangerous genetic mutations – one simple mutation
could be disastrous. IVG would allow women of
any age to conceive genetically-related
children. What would all this mean for the
family? Men and women, husbands and wives could
become redundant. There would be an unlimited
supply of genetically-matched artificial human ova,
sperm and embryos for anyone, everyone, at
anytime. Genetic scanning of these
readily-available artificial gametes and embryos would
become the norm. Deleting the unwanted would
also become the norm. Children with particular
characteristics would become part of the shopping list
of prospective parents. IVG would eventually
lead to that problematic entity – the ‘designer baby’.
No room at the freezer
IVF is full of bioethical predicaments. It is
now facing a newish problem – storage space. As
the popularity of IVF increases, and while its
standard protocol involves giving women drugs to
induce them to superovulate, producing as many as 5 to
10 ova in a typical treatment cycle, which, after
fertilisation, leads to vast numbers of supernumerary
human embryos. Yet embryologists transfer just
one, or perhaps two, embryos per cycle. What to
do with the remainder? Freeze them or destroy
them? The upshot? Frozen human embryos are
being stockpiled and storage space is at a premium.
It was in 1978 that Louise Brown became the world’s
first ‘test-tube’ baby. Now 1 in 34 babies born
in the UK is an IVF-baby. Back in 1991, when
HFEA records began, there were just 4,938 embryos in
cryostorage facilities in the UK. By the
mid-2000s, it was about 50,000 rising in 2021 to a
record high of almost 100,000. Today, an average
of 267 newly-created embryos are frozen in liquid
nitrogen at -196⁰C every day. In other words,
there are hundreds of thousands of spare human embryos
out there. And nobody knows what to do with
them. And the numbers keep on increasing.
The use of vitrification versus the old method of
‘slow freezing’ allows for a more efficient production
method. And in July 2022, the law increased the
time limit for storage from 10 to 55 years. And
of course, embryos keep on being created – in 2021, a
record 291,241 were created in the UK, 64% up on the
2001 figure. And more than 1 in 3 of these is
now frozen and stored.
Many couples cannot bear to think about, let alone
proceed to discard/destroy their hard-won, costly
embryos, even though they will never use them for a
second, third or fourth child. And so they
continue to pay for storage at perhaps up to about
£500 per year. It is all physically and
emotionally gruelling.
The typical freezing apparatus is hugely and
inefficiently bulky – its basic design has not changed
over the decades. And so for many IVF clinics,
extra space is needed. New facilities are being
built within some clinics and the use of off-site
storage will partially alleviate the problem.
The other options are to donate them to others or to
research – in 2021 in the UK only 185 were donated to
others and 675 to research. And charging higher
storage fees might nudge more couples to discard their
embryos. Nevertheless, the real answer is to
fertilise fewer ova in the first place. And
freezing ova and sperm separately might help – it is
easier to discard these mere gametes rather than
embryos.
Euthanasia
and Assisted Suicide
One-way
tickets to Dignitas
A new report, commissioned by the pro-assisted suicide
organisation, Dignity in Dying (DiD), reckons that at
least 632 Britons have ended their lives by travelling
to Swiss ‘clinics’, such as Dignitas in Zurich.
This number has been placarded as evidence for the
need of such ‘clinics’ in Britain. But what is
the source of this figure? It is not one that I
recognised. So I phoned DiD, three times, to
enquire. An email reply told me that it was
compiled, ‘by Dignity in Dying from assisted dying
organisations Dignitas and Life Circle. Not all
assisted dying organisations in Switzerland publish
data. The timeframe is from 2002 – when the
first person from Britain has an assisted death at
Dignitas – to July 2023.’ That amounts to about
30 people per year from the UK – that is a figure I do
recognise. It is less than one per week.
The Report in question is entitled, ‘TIME FOR CHOICE
The truth about the UK’s ban on assisted dying … and
how things could be better’ and it was published in
September 2023.
The Report is a heady, polemical mix of facts and
stories. For example, it found that more than
half of Britons, or 56%, would consider an assisted
death in Switzerland if terminally ill, but that less
than a third could afford it. Apparently, ‘The
average cost of travelling abroad for an assisted
death in Switzerland is £15,000. This cost has
increased by 50% in the past 5 years. 63% of
people in England and Wales cannot afford this.’
In other words, DiD concludes that the UK ban on
assisted suicide is creating a two-tier system of
dying for Britons. In addition, the Report
includes several personal stories. For instance,
there is a moving account by Lisa Boeyen, whose
husband Stephen, died at Dignitas. Lisa wrote,
‘It is not easy to lose someone dear to you.
Stephen and I had been together for 35 years.
But perhaps my account of the process helps you
understand that it was a very peaceful, calm, safe
environment for someone to end their life.’
Moreover, palliative care has never been enough for
DiD people. The Report revealed that one in
seven NHS trusts in England and Wales have had
patients receiving palliative care who take their own
lives or attempt suicide. Thirteen out of 80
Trusts, or 16%, had experienced suicides or attempts
by palliative care patients in the last five
years. DiD thinks these people would have
benefited from assistance in their suicides.
What we need urgently is to expand the provision of
proper care at the end of life, and to develop suicide
prevention strategies to support people who are
elderly, sick or disabled.
Furthermore, the Report complains that the so-called
‘blanket ban’ on assisted suicide is because of the
1961 Suicide Act Section 2(1) which stipulates that,
‘A person who aids, abets, counsels or procures the
suicide of another, or an attempt by another to commit
suicide, shall be liable on conviction on indictment
to imprisonment for a term not exceeding fourteen
years.’ Yet this law punishes those who assist,
it protects the vulnerable and it has a deterrent
effect. That is what good laws do.
Whatever figures are presented for the numbers going
to Switzerland and elsewhere, like the 632 in this
Report, they are miniscule compared with the numbers
dying naturally back home in England and Wales.
These amount to approximately 500,000 each year or
10,000 each week. Compare that weekly 10,000
with the one or so going to Switzerland each week.
So, do you think that DiD’s call for a change in UK
law that gives ‘… terminally-ill, mentally-competent
adults, the option of controlling the manner and
timing of their deaths within a robust legal framework
that protects everyone in society’, will remain
unchanged if enacted? Will there not be a
slippery slope that widens the criteria of
eligibility, drawing in more and more vulnerable
people? Ask if that has happened, for example,
in Canada, the Netherlands, Belgium and elsewhere (see
below).
We need to get a well-informed understanding of
assisted suicide. Discussion of the topic too
often descends into horror stories about the agonising
death of ‘my aunt Mary’. Assisted suicide has
become something of a niche issue governed mainly by
an elite of articulate, strong-minded, strong-willed
men and women – the sort you see on programmes about
going to Dignitas. They can tug at your
heartstrings. But understanding raw data is also
important. For example, in this Report, DiD
states that ‘British membership of Dignitas is at an
all-time high.’ Statistically that is true, but
according to the latter’s website, the latest count in
2022, put the number at a mere 1,528 paid-up Britons.
And here is something else that DiD would prefer you
not to know. In 2019, according to a DiD poll,
‘84% of the public support the choice of assisted
dying for terminally ill adults.’ However, the
more recent 2023 poll by DiD showed that this figure
has dropped to 78%.
Laws and victims of assisted suicide and euthanasia
seem to be on the increase worldwide. Soon these
issues will be coming to a place near you – are you
prepared?
MAID in Canada, the bad
exemplar
No commentary on the state of assisted suicide around
the world can exclude the dire situation in
Canada. Indeed, more people are being euthanised
in Canada than anywhere else in the world. In
the latest official report, for 2022, 10,064 people
died through what Canadians call ‘medical assistance
in dying’ (MAID). In the Netherlands in the same
year, there were 7,666 euthanasia deaths and in
Belgium there were 2,699.
Canada passed its MAID law in 2016. And if ever
there was an example of the slippery slope, Canada is
it. In 2016, the criterion was a terminal
illness. Then in 2021, the criteria included
people who were suffering from non-terminal
conditions. And as of 17 March 2024, the net
will include people suffering solely from mental
illness. Come on, you doubters of the existence
of expanding boundaries of eligibility across all
bioethical issues, the so-called slippery slopes, are
they mythological or real?
There is something seriously out of kilter here.
On the one hand, it has become de rigueur for
politicians, doctors, celebrities, gurus and even
royals to raise awareness of, and talk about, mental
health and its debilitating effects. While on
the other hand, those suffering from such mental
illness can become eligible for an assisted death
penalty, sanctioned by the State. Should not we
help vulnerable people who think they want to die, not
just help them to die?
So what is the inevitable terminus of this mad
slipperiness? Just like the calls for the
decriminalisation of abortion in the UK, so Canada
(and every other interested jurisdiction) will
sanction a free for all – kill me under any, and
every, and no circumstance. Publicise it under
the false guise of personal autonomy and freedom of
choice. And then, after a few years, logically
all human life will have become pointless, undignified
and valueless. MAID will have become the death
penalty for victims of the euthanasia juggernaut.
Do not underestimate the trajectory of the
above. Some in the UK are looking to Canada for
guidance about implementing legal assisted
suicide. For instance, a group called UK
Humanists have stated, ‘We can and should learn from
Canada to create laws that are right for the
UK.’ In March 2023, they have even approvingly
published a report entitled, ‘Canada’s Assisted Dying
Laws.’ This 12-page document concludes with this
fundamental question, ‘Does the situation in Canada
give reasons for the UK not to legalise assisted
dying? And it answers succinctly, ‘No.’
Our UK response should be, ‘Help!’
Help! indeed. Because a recent article entitled,
‘The Realities of Medical Assistance in Dying in
Canada’ by Ramona Coelho et al., and published
in Palliative and Supportive Care (2023, pp.
1-8.) by three Canadian doctors and a bioethicist
covers much of the same ground as the UK Humanist’s
report, but it comes to very different
conclusions. It states, ‘The Canadian MAID
regime is lacking the safeguards, data collection, and
oversight necessary to protect Canadians against
premature death.’ The article is an excellent
overview of the status quo in Canada before MAID for
mental illness becomes legal next March. It
identifies 9 ‘policy gaps’, such as ‘inadequate data
collection’, ‘lack of oversight’ and ‘undefined
terminology’. Let these serve as warnings to
other jurisdictions, including the UK.
Even that is not all. In March 2023, the
Canadian Government proposed new guidelines published
as ‘Model Practice Standard for Medical Assistance in
Dying (MAID).’ It is highly controversial.
For example, Section 6 declares that patients must be
informed of MAiD if ‘MAID is consistent with the
person’s values and goals of care.’ In other
words, doctors and nurse practitioners are wellnigh
required to recommend MAID to people who might
qualify. It continues, doctors ‘must not assume
all persons potentially eligible for MAID are aware
that MAID is legal and available in Canada.’ In
other words, doctors should raise the issue of a
person’s eligibility before counselling them one way
or the other. ‘Have you thought about MAID?’ is
inseparable from a discussion of how to apply for
it. Surely that amounts to a slick sales pitch
for selling the MAID package.
‘O Canada! Our home and native land!’ What
have you done? Is this the denouement of
progressive politics? Is this where
autonomy-based liberalism and false compassion
collide? ‘O Canda’, let none praise, or envy, or
follow you.
RCS England and others go
neutral
In mid-June, members and the Council of the Royal
College of Surgeons (RCS) of England voted in favour
of adopting a neutral position on assisted
suicide. In other words, the RCS dropped its
long-held opposition to the practice.
The key figures were 72% of members voted to cut their
opposition to assisted dying. 61% of members
personally support a law change. 52% say the
College should be supportive of a change in the law to
permit assisted dying.
There is a trend here. After surveying their
members, a number of medical bodies, including the
British Medical Association, the Royal College of
Physicians and the Royal College of Nursing, have,
over the past few years, all adopted a neutral stance
on the issue. However, neutrality is NOT the
same as endorsement.
Are the British Isles on the cusp of a law
change? Evidence to supply a reliable answer to
that question should come from the Commons inquiry
into assisted dying/assisted suicide, which is
currently underway, led by the Health and Social Care
Select Committee. The deadline for submissions
was 20 January 2023. Oral and written evidence
has been taken during the summer 2023. However,
the inquiry’s website states that there are ‘no
upcoming events scheduled.’ And there is no
indication of when the report of the inquiry will be
published.
In addition, proposals for law change are progressing
in Holyrood and the parliaments of Jersey and the Isle
of Man. In the Republic of Ireland, a special
Oireachtas joint committee is currently examining the
topic. And in France, President Emmanuel Macron
has announced a national debate with a view to
legalising assisted suicide by the end of 2023.
Again, laws and victims of assisted suicide and
euthanasia seem to be on the increase worldwide.
Soon these issues will be coming to a place near you –
are you prepared?
Genetic Engineering
Gene therapy for Duchenne
muscular dystrophy
The US Food and Drug Administration (FDA) has recently
approved the first gene therapy for Duchenne muscular
dystrophy (DMD). DMD is a rare, degenerative
disease that progressively robs children of muscle
function. It is caused by a mutation in the gene
that codes for the protein, dystrophin. This
protein is essential for the strengthening and
connecting of muscle fibres. DMD causes a
progressive weakening of these muscles from the age of
about three, eventually it adversely affects the
muscles of the heart and lung. It is an X-linked
recessive condition that predominantly affects boys.
The gene therapy drug is known as Elevidys
(delandistrogene moxeparvovec-rokl). It has been
approved for children between the ages of four and
five who can walk and have a confirmed mutation in the
dystrophin gene. It uses an adeno-associated
virus to deliver micro-dystrophin, a shortened version
of the dystrophin gene, into cells, which in turn
triggers production of the protein. The large
size of the original dystrophin gene prevents its
full-length version from being delivered using this
technique.
Currently treatments for DMD address only its
symptoms. They include anti-inflammatory
corticosteroid drugs, which may improve muscle
strength, and equipment, such as wheelchairs to aid
mobility. A few targeted drug therapies have
already been approved, but they require repeated
administration. By contrast, Elevidys requires
only a single intravenous infusion.
Elevidys is the first gene therapy to be approved
through an accelerated FDA route, reserved for the
most serious conditions with an unmet need. The
FDA’s decision was contentious – the panel of 14
experts approved the drug by 8 votes to 6.
Sarepta Therapeutics, a biotech company with
headquarters in Cambridge, Massachusetts, describes
itself as, ‘A global biotechnology company on an
urgent mission: to engineer precision genetic medicine
for rare diseases that devastate lives and cut futures
short.’ Currently it is conducting a Phase III
clinical trial of Elevidys involving 126 volunteer
patients – results are expected to be published by the
end of 2023.
A smaller Phase II trial was started in 2018.
However, the results have yet to be published in a
peer-reviewed journal. Each of its 41 DMD
patients, aged between four and seven, received a
single dose of either Elevidys or a placebo.
Dystrophin levels were measured at 12 weeks. It
may be that younger patients benefited the most – if
so, then this may explain the revised age-based
approval restrictions for Elevidys by the FDA.
Elevidys is not without problems. It has shown
to cause some adverse side effects, including
vomiting, nausea and worsening liver function.
Another potential drawback is that it is expected to
cost $3.2million per patient. However, this may
still prove to be cost effective compared to existing
targeted therapies because of Elevidys’ single
administration.
He and Alzheimer’s
Remember the controversial Chinese scientist, Dr He
Jiankui? In 2018, he claimed to have created the
world’s first genome-edited humans in order to make
the twin girls, known as Lulu and Nana, resistant to
HIV. That feat caused a serious uproar among the
scientific community and the general public. He
had overstepped the bioethical red line into heritable
human embryo genome editing for reproductive
purposes. In
2019, he was fired from his university job, jailed for
three years and fined three million yuan (£330,000) by
a Chinese court. The court said he had been
‘illegally carrying out human embryo gene-editing
intended for reproduction.’ He was released from
prison in April 2022.
And apparently, he is now back at the laboratory
bench. Most recently, in June 2023, He announced
that he is hoping to pioneer a cure for Alzheimer’s
disease. He proposes to again modify human
embryos, which, he claims, will help the ‘ageing
population’. He has posted on Twitter/X, ‘I am
proposing a research project “Human embryo gene
editing to protect against Alzheimer’s
disease.”’ He continued, ‘The ageing population
is of grave importance as both a socioeconomic issue
and a strain on the medical system. More than 5%
of the population above 60 years old is effected [sic]
by dementia; of these, two thirds are the result of
Alzheimer’s disease (AD). Currently, there is no
effective drug treatment for Alzheimer’s disease.’
He then explains his proposed scientific
approach. It begins, ‘The APP gene point
mutation A673T was discovered [Jonsson et al.,
2012] to decrease the incidence of this
disease.’ The central statement is, ‘We propose
to introduce the APP(A673T) mutation into embryos, and
test whether this mutation confers protection against
Alzheimer’s disease. This will be accomplished
by base editing, rather than using CRISPR-Cas9
editing, first, in mouse embryos and then in human
tripronuclear zygotes.’ Finally, He notes, ‘no
human embryo will be implanted for pregnancy in this
study.’
Scientists have variously called this proposal ‘highly
questionable’ and ‘insane’. In March 2023, more
than 200 Chinese scholars issued a statement
condemning He’s ‘… attitude and refusal to reflect on
his criminal actions of violating ethics and
regulations of gene editing.’ Furthermore, there
is a puzzling practical aspect to this proposal
because He is serving a lifetime ban of working in
reproductive technology.
Gene therapies for rare
diseases
Some gene therapies produce good results in clinical
trials, but then fail to become commercial
successes. This is for two main reasons.
First, the therapies tend to be expensive and second,
the diseases tend to be rare and so a biotech company
is unlikely to recoup its development costs, let alone
make a profit.
To illustrate this dilemma, here is the tale of
Strimvelis. It is a potent treatment for
so-called ‘bubble-boy babies’ aka ADA-SCID (adenosine
deaminase form of severe combined immunodeficiency), a
devastating immune disorder. It was one of the
first gene therapies to be approved in Europe.
In 2018, GlaxoSmithKline (GSK) sold Strimvelis to
Orchard Therapeutics. But in 2022, Orchard
dropped it – though Strimvelis was highly effective in
treating the disease, it was not turning a
profit. Its potential market was minuscule – it
affects only 1 in 200,000 live births in Europe.
Strimvelis was one of gene therapy’s greatest
successes, but one of its greatest disappointments.
However, at least for Strimvelis, all is not
lost. The Italian charity, Telethon Foundation
in Milan, has announced that it will produce
Strimvelis itself. In a statement on 12
September 2023, Francesca Pasinelli, general manager
of the Telethon Foundation said, ‘We are making a
paradigm shift. We are the first non-profit
organization to take on the commercialization of a
gene therapy.’
Indeed, it is a paradigm shift. The charity’s
scheme offers hope to scientists who have spent
decades developing gene therapies for rare disorders,
only to find that the standard way of getting those
treatments to people in need – licensing them with
for-profit companies – is unavailable.
Other routes for funding the research, development,
manufacturing and approval of gene therapies for rare
diseases are needed. But non-profit agencies do
not normally have deep pockets. How many
generous billionaires are out there?
Stem-cell
Technologies
Transplant without
immunosuppression
An eight-year-old girl has become the first patient in
the UK to receive a kidney transplant and not require
lifelong immunosuppressive medication.
Researchers and doctors from Great Ormond Street
Hospital for Children (GOSH) in London 'reprogrammed'
Aditi Shankar's immune system before performing the
kidney transplant. This reprogramming meant that
immunosuppressant drugs, to stop her body rejecting
the donated kidney, were not needed. This
success story was achieved by first transplanting
bone-marrow stem cells from her mother, Divya, who
also later donated the kidney. She has said, ‘I
was so happy to give her blood cells and a
kidney. I just feel so proud.’
Professor Jeremy Hughes from Kidney Research UK warned
that ‘Like any new treatment, it is not without risk
and in this case as stem-cell transplantation means
the patient must also undergo chemotherapy and
radiotherapy. However, for a patient to receive
a transplant and not require a lifetime of
immunosuppressant medication is a significant
breakthrough. And though the process is limited
in scope, it does open the door for further future
development that could have the potential to overcome
one of the major challenges in transplantation care.’
Transplant surgery needs immunosuppressants.
However, anyone taking such drugs is at higher risk of
an infection, among other complications. In
addition, they usually need to be taken lifelong, but
in this case, as the bone marrow stem cells and kidney
came from the same donor, Aditi was able to stop
taking immunosuppressant drugs a month after surgery.
Prior to the transplant Aditi suffered from an
extremely rare inherited condition, Schimke's
immuno-osseous dysplasia (SIOD). She was
spending significant time receiving dialysis to remove
waste products and excess fluid from the blood when
her kidneys stopped working properly. As the
disease progressed Aditi was on dialysis for 24 hours
a day. Six months following the bone-marrow
stem-cell transplant, she was well enough to receive
the kidney transplant.
According to Stephen Marks, clinical lead for renal
transplantation at GOSH, ‘She is the first patient in
the UK who has had a kidney transplant to not require
immunosuppressive medication after the surgery.
A month after the transplant, we were able to take her
off all of her immunosuppression, which means she
doesn't get the side-effects of the drugs.’
Now Aditi is a regular 8-year-old. She is off
immunosuppression and dialysis, but swimming, singing,
dancing and playing on her trampoline. Back at
school her favourite subject is science and she has
developed a keen interest in biology.
Although this is a significant breakthrough in
transplantation care, the procedure is unlikely to be
widely used, as the double-transplant carries
increased risks to the patient. Even so, chalk
it up as another success story derived from using
bioethically-acceptable adult stem cells.
Stem cells and multiple sclerosis
A new study suggests that a therapy used to treat
blood cancers could slow the progression of a common
type of multiple sclerosis (MS) known as
relapsing-remitting multiple sclerosis (RRMS).
The work was entitled ‘Haematopoietic stem cell
transplantation for treatment of relapsing-remitting
multiple sclerosis in Sweden: an observational cohort
study’ and published in the Journal of Neurology,
Neurosurgery and Psychiatry (2023, 0:
1–9) by Thomas Silfverberg, et al.
Such stem-cell transplants aim to reset the immune
system and researchers hope that this therapy might
become part of standard care for MS patients in the
future. The treatment is based on the use of
autologous haematopoietic stem-cell transplantation
(aHSCT) blood cells that are harvested from the
patient’s own bone marrow or blood and then
reintroduced following chemotherapy. The current
study aimed to assess the efficacy and safety when
aHSCT is used in routine healthcare.
Silfverberg and his colleagues assessed 174 RRMS
patients who were treated with aHSCT in Sweden between
2004 and 2020. More than half of the
participants experienced improved disability, and
approximately two-thirds displayed no evidence of
disease activity over a 10-year period. It was
calculated that a typical patient had 1.7 relapses in
the year before aHSCT treatment but would have one
relapse only every 30 years after treatment.
Moreover, because the incidence of severe adverse
events was low, and there was no record of
treatment-related mortality, it was concluded that
aHSCT is both effective and safe to use within routine
healthcare.
According to the MS Society UK, there are more than
130,000 people with the condition in the UK and nearly
7,000 have it newly diagnosed each year.
Symptoms include fatigue, muscle spasms and pain, as
well as problems with vision, mobility, thinking,
talking and swallowing.
Dr Sarah Rawling of the MS Society UK confirmed that,
‘[Treatment] on the NHS is subject to strict
eligibility criteria and can be difficult to
access. We also know [aHSCT] doesn’t work for
everyone with MS, but it has been an important
development in MS treatment and some people see
life-changing results. This study provides
further evidence as to how it can help slow
progression of symptoms.’ There are limited data
available comparing this stem-cell treatment and the
most effective therapies available in the UK, such as
Ocrelizumab, Alemtuzumab, Cladribine and
Ofatumumab. However, such a comparative trial,
called StarMS, is currently underway at several UK
sites led by the University of Sheffield.
The legacy of a stem-cell
charlatan
Not all is wonderfully well in the realm of stem-cell
technologies. Quacks and scandals do
exist. One of the greatest such disasters is
associated with the name of Paolo Macchiarini, the
65-year-old Italian surgeon. His tales of lies
and deceit have already been covered in several
editions of these Updates on Life Issues.
Macchiarini first came to notice among the general
public in 2008 when he transplanted a trachea donated
from a cadaver and colonised it with adult stem cells
from the recipient, Claudia Castillo. This novel
treatment opened up a new and exciting world of stem
cells and tissue engineering. Initially, all
seemed hunky-dory. However, surgical success
began to evade the medical showman, Macchiarini, and
he became impulsive and manipulative. He was
accused of various unethical practices as 7 of his 8
subsequent tracheal transplant patients died and as
several of his research papers were retracted.
Events are now beginning to catch up with this
charlatan. For several years he worked in
Sweden, principally at the Karolinska Institutet, from
where he was fittingly fired. On 21 June 2023,
the Court of Appeal in Stockholm concluded that
Macchiarini’s interventions on three patients, who
later died, amounted to serious assault. He was
sentenced to two and a half years in prison. He
is yet to be incarcerated because he is appealing his
sentence. And so this wily, disgraced stem-cell
surgeon is still escaping justice.
Miscellaneous
Ian Wilmut (7 July 1944 – 10 September 2023)
Professor Sir Ian Wilmut was the leader of the
scientific team that created the world’s most famous
sheep, Dolly the clone.
Ian Wilmut was born in 1944 at Hampton Lucy, a pretty
little village near Stratford-upon-Avon in
Warwickshire. He was the son of Eileen and Jack
Wilmut, a maths teacher. He grew up in Coventry
before the family moved to North Yorkshire, where he
attended Scarborough High School for Boys – his father
taught at the school.
As a teenager, Wilmut wanted to join the Royal Navy
but, because of his colour blindness, he was unable to
do so. Instead, he studied agriculture at the
University of Nottingham. He graduated in 1967
and a summer internship kindled his interest in
embryology. As a post-graduate research student
he moved to Darwin College, Cambridge where, in 1971,
he was awarded his PhD in animal genetic engineering
for his thesis entitled, Deep Freeze Preservation
of Boar Semen.
For the next two years, he worked as a post-doctoral
fellow at the Unit of Reproductive Physiology and
Biochemistry, Cambridge. In 1973, he became a
senior scientific officer at the Animal Breeding
Research Organisation (ABRO) in Roslin, near
Edinburgh. There he led the team that produced
Frostie, the first calf born from a frozen embryo.
Several years later, on 5 July 1996, while still at
the Roslin Institute, a Finn-Dorset sheep, code name
6LLS, better known as Dolly the clone, was born.
Her significance was as the first mammal to be cloned
by a technique called adult somatic cell nuclear
transfer (SCNT) that used an ordinary somatic cell
derived from the mammary gland of a six-year-old
ewe. Prior to her birth cloning was regarded as
possible only by the use of embryonic stem cells.
Overnight, Wilmut and Dolly became global
superstars. Though her conception and birth were
exceptional, Dolly went on to breed normally with a
Welsh mountain ram and to produce six healthy
lambs. After suffering from a progressive lung
disease and severe arthritis, Dolly was euthanased on
14 February 2003, aged six. She is now on
display at the National Museum of Scotland in
Edinburgh. There has been continuing discussion
whether she was prematurely prone to these diseases
because her genetic material was already six years old
when she was conceived – was she effectively 12 at her
death?
Because the Roslin team used SCNT to initiate the
pregnancy of Dolly, Wilmut was inevitably questioned
about using it to clone a human being. He
doubted it would work and he considered it would be
‘criminally irresponsible’ to try. However, he
was troubled by several surrounding bioethical issues
– for example, he recognised that every use of
embryonic stem cells involved the destruction of
embryos.
In 2005, after the excitement of Dolly, Wilmut turned
his attention to regenerative medicine and especially
the use of induced pluripotent stem cells (iPSCs) as
discovered by Shinya Yamanaka in 2006. In 2008,
Wilmut announced that he was abandoning SCNT cloning
and embryonic stem-cell research in favour of using
iPSCs. This was BIG news. It was
sufficiently ground-breaking for Wilmut to conclude
that ‘This [the use of iPSCs] is the future of
stem-cell research. I have no doubt that in the
long term, direct reprogramming will be more
productive.’ He was appointed professor of
reproductive science at the University of Edinburgh
and a year later was made director of the Centre for
Regenerative Medicine at the University.
Eventually, in 2012, Wilmut retired and just six years
later he was diagnosed with Parkinson's disease.
He had known for some time before his diagnosis that
he was ill but suffered a crisis when he suddenly
found himself unable to move while walking his
dog. He became a patron of a research programme
developing novel therapies to slow the progression of
the disease. He told The Times that he
was ‘happy to act as a guinea pig and either donate
tissue or try new treatments.’ Poor Ian, he
admitted that he struggled to come to terms with the
condition and its seemingly endless regime of
drug-taking.
He experienced moments of frustration when he wanted
‘to kick the furniture’ and his diagnosis brought him
a sense of his own mortality. He explained,
‘With these serious conditions I rather get the
impression that the first question people ask is, ‘How
long have I got?’ ‘My doctor didn’t wait for me
to ask, he said, “Ten, 15 years. It’s not
bad. You can have a lot of fun in ten or 15
years.” In the end he had only five.
Ian Wilmut was a modest and self-effacing man.
He declined to be present at the birth of Dolly and
was instead digging in his garden. He was
appointed OBE in 1999 and elected a Fellow of the
Royal Society in 2002 and knighted in 2008. He
is survived by his second wife, Sara Haddon, whom he
married in 2017. He met his first wife, Vivienne
(née Craven), while at school. She predeceased
him in 2015 after a 48-year marriage. He is also
survived by their daughters, Helen and Naomi, and a
son, Dean, who was adopted on the statistical
calculation that he and Vivienne could not know how
many more girls they might produce before they had a
boy. Slightly weird, but essentially sweet.
Sleep, balm of hurt minds
The lifestyle sections of newspapers, magazines and TV
programmes are littered with items about the
essentialness of sleep and how to get it.
Insomnia is like a modern-day plague but even in
Shakespeare’s day the benefits of a good night’s sleep
were recognised –
‘Sleep that knits up the ravell’d sleeve of care,’
The death of each day's life, sore labour's bath,
Balm of hurt minds, great nature's second course,
Chief nourisher in life's feast.’
Macbeth, Act 2, Scene 1.
Sleep has a profound impact on human health – it
improves attention, memory, emotional regulation and
work performance, and it reduces the risk of
disease. Are you getting enough? Over the
past few decades, the amount of sleep that people get
has declined substantially. A 2017 study of some
690,000 children from 20 countries found that nightly
sleep duration fell by more than an hour from 1905 to
2008. Nearly one-third of adults in the United
States sleep for less than six hours per night.
So, is it modern-living patterns, digitalization,
globalization and social media that are making people
squeeze more into their day at the expense of sleep?
Nikki Forrester, a freelance science writer and editor
based in West Virginia, has helpfully summarised our
current understanding of sleep and our need of it in
an article entitled ‘How better sleep can improve
productivity’ and published in Nature (2023, 619:
659-661).
Studying sleep, its disorders and the genetic
mechanisms that regulate it is a relatively new area
of research. It was inaugurated largely by the
discovery of very specific brainwave patterns that
occur during sleep. This discovery was made in
1929 by the German psychiatrist Hans Berger. He
used a technique called electroencephalography (EEG),
which measured electrical activity in the brain.
Eight years later, a group of scientists used the same
technique to identify and classify different stages of
sleep.
Today, most researchers describe sleep as occurring in
two main phases – rapid-eye-movement (REM) sleep and
non-REM sleep. Non-REM sleep comprises three
stages, known as N1, N2 and N3. These are
characterized by specific brainwave patterns that
reflect neural activity. These three stages of
non-REM sleep plus REM sleep comprise the sleep cycle,
and people who sleep well typically experience four to
six cycles every night.
The average adult seems to need 7 to 8 hours of sleep
per night. However, some need only 3, while
others need 12 or 14 hours. Along with
differences in sleep duration, individuals vary in
when they feel sleepy and when they feel awake.
For instance, the ‘larks’ prefer to go to bed early
and rise early, whereas the ‘owls’ like to stay up
late and sleep late.
So what is happening when we sleep? When someone
is awake, an EEG of their brain shows lots of neurons
firing, but not in a completely coordinated way.
Then, as the person starts to go into a light sleep,
or the N1 stage, the neurones slow down into a pattern
called theta waves. This stage typically lasts
for one to ten minutes.
During the second phase of sleep, N2, body temperature
drops, heart rates and breathing slow down and muscles
relax. Brainwave frequencies now oscillate
between slower waves and short bursts of neural
activity. This phase generally lasts 10 to 25
minutes during the first sleep cycle, but gets
progressively longer in later cycles, ultimately
comprising about half of a person’s sleep time each
night.
Slow-wave sleep occurs in the N3 stage, which is
characterized by slow waves called delta waves.
This 20 to 40-minute phase makes up about one-quarter
of a person’s sleep time. This is feelgood
sleep. It seems essential to restoring energy
levels, repairing and growing tissues, clearing waste
and boosting the immune system. This slow-wave
sleep also aids learning and memory consolidation.
Neural activity picks up when the body enters REM
sleep, which is when dreaming occurs. In this
phase, which comprises one quarter of sleep time each
night, the brainwaves follow a beta-wave
pattern. As the night progresses, the periods of
slow-wave sleep shorten and REM sleep increases.
REM sleep is important for cognitive functions, such
as emotional regulation, memory and creative
problem-solving.
So, we now have a decent understanding of the various
phases of sleep, but the question of what sleep does
remains largely unanswered. This is truly
fascinating – we all experience it yet we are
completely unaware of it. How busy our brains
can be, even when we are not.
Good night! I hope so.
Are human clinical trials
trustworthy?
When you are prescribed and take your medicine, do you
expect it to work or, at least, be safe? Of
course, you do. Why? Because it has been
ingeniously developed by skilled scientists and
manufactured by a responsible pharmaceutical
company. Between these two strategic pillars of
bringing a medicine to market lie human clinical
trials, typically consisting of four phases – testing
in vitro, in animals, in limited number of humans, and
in large numbers of humans. Strict rules and
regulations govern the entire series of procedures.
But are you sure? Really sure? This
recently-published article may rattle your
confidence. It is entitled, ‘Medicine is plagued
by untrustworthy clinical trials. How many
studies are faked or flawed?’ by Richard van Noorden,
a Features Editor at Nature, and it appeared
in Nature (2023, 619: 454-458).
The idea of flawed studies in science is nothing
new. Human error, accidental and deliberate, is
inevitable in all human activities. However, the
scale of untrustworthy science is quite unknown and
has been debated for eons. But interest in the
very modern phenomenon can be dated to around 2020
when John Carlisle reported a startling estimate of
its length and breadth. His paper was entitled,
‘False individual patient data and zombie randomised
controlled trials submitted to Anaesthesia’ by
J B Carlise and published in Anaesthesia
(2020, 76: 472-479).
Carlisle is an anaesthetist working for the NHS.
He has an uncanny knack of spotting suspicious data
derived from medical trials. In 2017, he decided
to scour all the manuscripts that came across his desk
as an editor of the journal Anaesthesia.
He paid particular attention to those studies that
included a randomized controlled trial (RCT), the
so-called gold standard of medical research.
Over three years, he scrutinized more than 500
studies.
Hold onto your hat. For more than 150 trials,
Carlisle got access to anonymized individual
participant data (IPD). By studying the IPD
spreadsheets, he judged that 44% of these trials
contained at least some flawed data, such as
impossible statistics, incorrect calculations or
duplicated numbers or figures. And 26% of the
papers he judged had problems that were so widespread
that the trial was impossible to trust, either because
the authors were incompetent, or because they had
faked the data.
Carlisle called these ‘zombie’ trials because they had
the semblance of real research, but closer scrutiny
showed they were actually hollow shells, masquerading
as reliable information. Even he was surprised
by their prevalence. He stated that, ‘I
anticipated maybe one in ten.’
Carlisle went further. When he did not have
access to the raw data of a trial, he studied the
aggregated information in the summary tables. He
found that just 1% of these were zombies and 2% had
flawed data. Carlise was alarmed. It
seemed that without access to the IPD, which journal
editors rarely request, and reviewers never see, even
experienced data detectives like Carlisle cannot spot
the hidden flaws.
He wrote, ‘I think journals should assume that all
submitted papers are potentially flawed and editors
should review individual patient data before
publishing randomized controlled trials.’
Carlisle rejected every research manuscript that
contained a zombie trial, but almost three years
later, most of them had been published in other
journals, sometimes with different data to those
submitted with the manuscript he had originally seen.
Do Carlisle’s findings in the field of anesthesiology
extend to other academic disciplines? For years,
a number of scientists, physicians and data detectives
have argued that fake or unreliable trials are
frighteningly widespread. They have scoured RCTs
in various medical fields, such as women’s health,
pain research, anaesthesiology, bone health and
Covid-19, and have found dozens or hundreds of trials
with seemingly statistically impossible data.
Some scientists, on the basis of their personal
experiences, say that 25% of trials regarded as
untrustworthy might be an underestimate. For
example, Ian Roberts, an epidemiologist at the London
School of Hygiene & Tropical Medicine maintains
that ‘If you search for all randomized trials on a
topic, about a third of the trials will be
fabricated.’
Does the frequency of flawed and fake research
matter? Of course! It can be dangerous
because the results from such research trials can find
their way into recommendations for drug approvals and
medical interventions. In other words, patients
can be at risk of sub-standard, or even unsafe,
treatments.
What can be done? So much depends upon the
system of manuscript reviewing by academics.
They are the crucial gatekeepers. They need a
large dose of scepticism and a fully attentive
brain. But they are often hard-pressed
scientists, who are unpaid volunteers – reviewing
manuscripts is generally not top of their
agenda. Perhaps a harsher system of reviewing is
required with penalties for those caught deliberately
cheating the system with shoddy work.
Meanwhile, keep taking the old, tried-and-tested pills
– the overwhelming majority
are safe and effective. It is the new ones that
are more likely to have slipped through the net of
recent human clinical trials.
USA
+ Elsewhere
America post-Dobbs
What has happened since the landmark judgement in the
Dobbs v. Jackson Women’s Health Organization
case that uprooted Roe v. Wade on 24 June
2022? There have been some good things and some
bad things. The abortion landscape has become
extremely fragmented and increasingly polarized.
Many states have implemented abortion restrictions or
bans making it difficult, if not impossible, for women
to access abortion clinics. Other states have
taken steps to protect so-called abortion rights and
access. There has been a myriad of new laws,
legal challenges, clinic closures, demonstrations,
threats and general unease.
It would be impossible to describe the actions and
emotions since Dobbs was handed down.
So the following is but a snapshot of what has
occurred and what is likely to occur in the near
future. Overall, post-Dobbs has left
approximately 22 million US women and girls living in
states where abortion is heavily restricted or largely
inaccessible.
So far, more than a dozen states have enacted
extremely restrictive abortion bans, with the majority
making no exceptions for rape or incest. And
many more are waiting for legal challenges to make
their way through the courts.
Consider the mid-Western territory of Indiana, the
so-called Hoosier state. Previously abortion in
Indiana was legal up to 20 weeks. In 2022, its
new abortion law, Senate Bill 1, was the first to be
passed after the US Supreme Court overturned Roe
v. Wade. Then in 2023, a near total ban
was enacted with exceptions for fatal foetal
abnormalities, to preserve the life and physical
health of the mother, or (before 10 weeks
post-fertilisation) in cases of rape or incest.
In these cases, the abortions must be performed in a
hospital.
What about Oklahoma, nicknamed the Sooner state?
In May 2022, Oklahoma’s Governor, Kevin Stitt, signed
into law the most protective abortion ban in the whole
USA at that time. The measure was a Texas-style
law, but instead of protecting the unborn after six
weeks, when their heartbeats can be detected as the
Texas law does, it starts protecting them from
conception, when their lives truly begin. The
ban went into effect immediately and Oklahoma has
since instituted a full abortion ban protecting all
unborn children.
The Oklahoma health department has published a report
showing that the May 2022 ban has been successful in
helping women and in protecting the unborn.
There were 2,160 abortions reported across Oklahoma in
2022, down by 70% from the 2021 figure of 7,287.
In addition, medical abortions dropped by 75% from
5,009 in 2021 to 1,255 in 2022. It is estimated
that the abortion rate of Oklahoma has decreased by
70% to 2.7 abortions per 1,000 women aged 15 to 44 and
that it is at its lowest point since the state started
collecting abortion data in 2002.
All this is great news for Oklahoma, Indiana, Texas
and all the other states that are striving to decrease
the numbers of abortions and to increase the provision
of care for their mothers and their babies.
What is an American
abortion?
If ever a country was divided by the abortion issue,
it must be America. The pro-abortion-pro-choice
partition is as wide and as deep as ever. Yet
some commentators are detecting a change in the old
rhetoric.
One of the best illustrations of this shift in
language is the rebranding of one of the leading
American pro-choice organisations, NARAL. It was
launched in 1969 as the National Association for the
Repeal of Abortion Laws. Then following the 1973
Supreme Court decision in Roe v. Wade, NARAL
became the National Abortion Rights Action
League. And in 2003 it was named NARAL
Pro-Choice America. Finally, in September 2023,
the organisation became known as Reproductive Freedom
for All.
Its website describes this 2023 ‘charting a new path
forward’ as, ‘For over 50 years, Reproductive Freedom
for All (formerly NARAL Pro-Choice America) has fought
to protect and advance reproductive freedom at the
federal and state levels – including access to
abortion care, birth control, pregnancy and
post-partum care, and paid family leave – for
everybody. Reproductive Freedom for All is
powered by its more than 4 million members from every
state and congressional district in the country,
representing the 8 in 10 Americans who support legal
abortion.’
That is the rhetoric, but what is really behind these
changes? Again, its website states, ‘Our
research has shown that reproductive freedom is a core
value for people across the country – across religion,
race, and age. With this change, our
organization boldly forges ahead toward a future where
reproductive freedom is a reality for everybody.'
The old NARAL’s shift from ‘choice’ to ‘freedom’ is
interesting and a significant wordplay.
Moreover, according to the Guttmacher Institute, the
foremost US pro-choice think tank, these changes merit
further discussion. A research paper entitled,
‘“Technically an abortion”: Understanding perceptions
and definitions of abortion in the United States’ by
Alicia J VandeVusse and her colleagues, mainly from
the Guttmacher Institute, was published in Social
Science & Medicine (2023, 335:
116216). Reporting on people’s reactions to
several abortion-related vignettes, such as
miscarriage, emergency contraception or abortion
pills, lead author Alicia VandeVusse concluded that,
‘Our biggest takeaway is that people do not hold a
shared standard definition of what is and isn’t an
abortion.’ ‘We found that there’s a lot of
nuance and ambiguity in how people are thinking about
these issues and understanding these issues.’
Other examples of confusion were evident. For
instance, one of the vignettes employed the phrase
‘had a surgical abortion.’ Yet 67% of
respondents said, yes, that’s an abortion, 8% said
maybe, but 25% said no.
Furthermore, there is no doubt that the word
‘abortion’ is stigmatising. This may explain
NARAL’s name change away from ‘abortion’ and
‘pro-choice’. The ‘pro-life’ community has its
challenges too. Originally the phrase was a
stroke of PR genius, as no politician wanted to be
labelled ‘anti-life’. However, while accurate,
it, too, can be problematic in public communications,
such as debates, articles and so on. Do these
two journalistic shorthand labels now communicate some
form of extremism? For instance, ‘pro-life’ can
be associated with ‘no exceptions’ and ‘pro-choice’
can mean ‘pro-abortion’ with both possessing an
undertone of hard-heartedness.
And we thought we understood the simple meaning of
pro-choice and pro-abortion, but language and
comprehension move on. Above all, what the
Guttmacher paper clearly shows is that better
education and clarity of definition are required
around the abortion issue. Or will the pro-life
camp get left behind in the epoch of new rhetoric?
Malta, the last European
pro-life outpost
This little island nation is the only country in the
EU in which abortion is still illegal under any
circumstances – it provides full protection for the
unborn child enshrined in law. And the mother is
protected too – the Maltese Criminal Code, Articles
241-243 state, ‘Should the mother’s life be in danger,
all efforts are made to save both lives, and the
double effect principle applies, such as in ectopic
pregnancy.’ However, there is a good deal of
misinformation about Maltese abortion law.
Of course, these pro-life laws are anathema to many
and they have been subjected to constant
challenges. One such challenge has become known
as the Prudente case. In June 2022, Malta came
under international pressure to review its abortion
legislation after it was claimed that Andrea Prudente,
a US citizen, who was 16 weeks pregnant and bleeding
heavily with an incomplete miscarriage, had been
denied an abortion that was needed to save her life
when she was in Malta on holiday. At the time,
much misinformation was circulated online and in other
media networks about abortion legislation in
Malta. Eventually, Andrea Prudente was
transported to the Son Espases University Hospital in
Palma de Mallorca where she apparently received
appropriate treatment including the removal of foetal
tissue because she was at risk of a life-threatening
infection.
The circulating storyline was that Malta had such
rigid laws against abortion that it was hard-hearted
and medically deficient when it came to treating
pregnant women and their unborn children.
To counter such pro-abortion propaganda, doctors in
Malta immediately released statements to clarify how
the law operates in Malta. For example,
Professor George Gregory Buttigieg, who is a professor
of obstetrics based in Malta said, ‘Maltese law and
medical precedent are absolutely clear: if a woman’s
life is at risk from her pregnancy, then it is
absolutely legal for her pregnancy to be ended by
delivering the child, even if that child has a
heartbeat, and even if the child will sadly pass
away. This would not be seen in Maltese law or
medicine as an abortion. As a Professor of
Obstetrics, I have delivered babies prematurely in
life-threatening situations and have never been
worried about legal repercussions.’ Dr Calum
Miller, an NHS GP and research associate at the
University of Oxford, summarised the situation,
‘Maltese law and medical practice clearly allow
premature delivery of the child where the woman’s life
is at risk – regardless of whether the baby is alive,
has a heartbeat, and regardless of whether it is
viable.’
And are the Maltese people happy with their pro-life
culture? Apparently, yes. A 2022 poll
showed that 97% of the population opposed unrestricted
abortion at whatever stage of pregnancy and 90% of the
population opposed unrestricted abortion being
available in the first three months of pregnancy.
Moreover, the two main political parties in Malta, the
Labour Party and the Nationalist Party, both publicly
support the current abortion legislation in
Malta. Ahead of the 2022 Maltese general
election, following a nationwide campaign run by
pro-life campaigners, both parties made public
commitments to ensure the continued legal protection
of unborn children.
Between June and November 2022, the Maltese government
was under increasing pressure locally and
internationally from pro-abortion campaigners to
change its abortion law. And so the Maltese
government, led by Prime Minister Robert Abela,
brought forward an abortion Bill in the Maltese
Parliament.
However, at its First Reading on 21 November 2022, it
became clear that the Bill went much further than
simply codifying the current practice into law.
Instead, the amendment that was proposed included
legalising abortion to protect the health of a
pregnant woman who has medical complications that
‘may’ put her ‘health in grave jeopardy’.
On 4 December 2022, Malta experienced one of the
largest demonstrations ever as thousands of Maltese
people took to the streets to protest the Bill and to
keep abortion out of Malta. The Bill’s progress
ground to a halt.
Then in early June 2023, Malta’s President, George
Vella, made it clear that he would resign if the
Government passed this Bill as it stood and therefore
introduce abortion in Malta. This was a key
political juncture. Following the mass protests,
the Labour Government backed down and made the
necessary U-turn. Pro-lifers confirmed that the
new wording in the Bill ‘does not introduce abortion
to Malta but would codify the existing life-saving
practices currently being applied in Malta, and
provide further safeguards for mothers, unborn babies,
and doctors.’
After months of silence, on 23 June 2023, six months
after it had initially proposed the abortion Bill, the
Maltese Government made an announcement that it would
be making major changes to the wording of the
Bill. Once the wording had been amended, the
Nationalist Party and the President were happy to give
their support to the Bill for the first time.
Thus Malta retained its pro-life status. Life
Network Malta issued a statement, ‘The voice of the
people of Malta has been very clear: we are a pro-life
nation, valuing every life, the mother that deserves
our utmost protection especially when in difficulty,
the unborn child that today we have saved, thanks to
this new version of the legislation, we will continue
to do this.’