The Times - UK (2022-01-24)

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14 Monday January 24 2022 | the times


News


Pregnant women should not be exclud-
ed from research that could lead to life-
saving drugs for them and their babies,
experts have said.
A global campaign backed by the Bill
and Melinda Gates Foundation aims to
accelerate the development of treat-
ment for pregnancy-specific conditions
and end the “stigma” of conducting
trials involving pregnant women by
putting them at the centre of research.
Areas targeted include early labour,
pre-eclampsia, impaired foetal growth
and postbirth hemorrhage, all of which
can be fatal to mothers and babies. The


Experts back drug trials during pregnancy


Katie Gibbons Accelerating Innovation for Mothers
(AIM) initiative has been welcomed by
the UK’s medical community, where
some experts have called for an end to
“a cultural approach in medicine that
intrinsically expects maternal sacri-
fice” for the sake of the foetus.
In the past 30 years there has been
only one medication developed and
registered for pregnancy-specific con-
ditions, bringing the total number of
drugs in this category to two.
Other drugs for common conditions
such as diabetes, epilepsy and auto-
immune conditions have not been test-
ed on pregnant women, leaving many
women with no clear treatment plan


once they conceive. Many drugs carry
warnings against use during pregnancy
but often this is not because the drug is
harmful but because no research into
its safety has been carried out.
The team behind AIM have identi-
fied a shortlist of drugs in production
that could be used for conditions affect-
ing pregnant women, and are working
with pharmaceutical companies to
fund and insure clinical trials involving
pregnant women. They aim to have
four projects under way this year.
Clare Murphy, chief executive of the
British Pregnancy Advisory Service,
said: “There is a cultural focus on the
foetus that pervades everything. We

need to get to a point where we recog-
nise that foetal health and impact on
the foetus cannot be the only consider-
ation. Women’s health is also absolutely
critical, both to herself and for the
healthy continuation of pregnancy.”
Of the 2,173,810 women who gave
birth in Britain in 2017-19, a total of 191
died during pregnancy or up to six
weeks afterwards, and 495 during or up
to one year after their pregnancy. Heart
disease remains the largest single cause
of all maternal deaths during pregnan-
cy or up to six weeks after.
Causes such as epilepsy and stroke,
which can require complex treatment
plans, are the second most common
cause of maternal death, followed by
sepsis and blood clots.
However, the potential risks of invol-
ving pregnant women and their unborn
babies in clinical research has caused
concern among some. Thorrun
Govind, chairwoman of the Royal
Pharmaceutical Society, said the
present situation, where certain medi-
cations are prescribed “off label” to

pregnant women under expert clinical
guidance, worked well. She said:
“Involving pregnant women in clinical
research is always a balance as there is
somebody else involved in that who
isn’t consenting. As healthcare profes-
sionals we very much err on the side of
caution.
“Of course we want innovations for
women and we need to move with the
times. If pregnant women want to be
involved in clinical trials then it is their
right to do so. But it is a balance.”
Launched in November last year,
AIM is working with experts across the
world, including professors at Kings’
College, University College London
and the World Health Organisation, to
establish a research consortium.
Metin Gülmezoglu, executive direc-
tor of the Concept Foundation, which is
behind the campaign, said: “The stigma
surrounding the inclusion of pregnant
women in medicines research has con-
tributed to the devastating reality of
thousands of preventable maternal
deaths globally.”

Test to find


melanoma a


year earlier


A trial for a blood test that could pick up
signs of melanoma up to a year before
scans has enrolled a 72-year-old man as
its first patient.
Paul Smith, from Bury, Greater Man-
chester, has had a skin cancer behind
his ear removed but experts want to see
if they can see signs of the disease re-
turning before it would cause problems.
The final-stage clinical trial, run by
the Christie NHS Foundation Trust in
Manchester and the Cancer Research
UK Manchester Institute, will involve
1,050 patients in the UK and Australia.
Scientists will take blood samples
from people with early-stage melano-
ma and look for tiny fragments known
to be shed by tumours into the blood.
The hope is that if these fragments
are detected early, patients can be given
immunotherapy drugs which offer
some people with recurrent melanoma
the chance of a cure.
Smith, who underwent surgery at
Salford Royal Hospital last July and had
further surgery at The Christie in
October, said: “I asked if there were any
clinical trials I could participate in as a
way of saying thank you and
fortunately the detection trial had just
opened and was ready to recruit. To be
the first patient recruited on to this
clinical trial is amazing.
“I’m aware melanoma is a type of
cancer that can easily recur so it’s reas-
suring that anything could be picked up
by the blood test sooner than the scan.”
About 80 per cent of people with
early-stage melanoma need no further
treatment after surgery but in some
patients, tumours will go on to develop
in other parts of their body.
The blood test should be able to pre-
dict with high accuracy those patients
who are at risk of the cancer coming
back. Oncologists at The Christie will
compare patients having the test with
those whose new tumours are picked
up during a routine scan.
Professor Paul Lorigan, consultant
medical oncologist at The Christie, who
is leading the trial, said: “If our hypo-
thesis is proved to be correct, this will
undoubtedly be a step-change in how
we treat patients in the future.
“This study focuses on patients with
melanoma but potentially the blood
test could be used for other cancers, in
particular lung and kidney as they also
respond well to immunotherapy.”

Lung cancer


signs written


off as Covid


Kat Lay Health Editor

Urgent action is needed to encourage
people with lung cancer symptoms to
come forward, Cancer Research UK
has said, with numbers seeing special-
ists 10 per cent lower than expected.
The pandemic has worsened what
was already poor performance in find-
ing and treating the cancer, the charity
said, with a target for 85 per cent of
patients to start treatment within two
months of GP referral met only twice
since 2009.
Its analysis of NHS England data
suggests 560 fewer people were seen by
a specialist following an urgent sus-
pected lung cancer referral in England
in November 2021, about 10 per cent
less than expected.
Polling of 1,001 GPs for the charity in
November found many were con-
cerned patients were failing to come
forward because of the pandemic.
Many lung cancer symptoms — such as
coughing, fatigue and shortness of
breath — overlap with those of Covid-
19.
Of those family doctors who felt the
pandemic had led to lung cancer
diagnosis delays, 74 per cent believed
this was due to patients not presenting
to primary care.
Others highlighted patients being
reluctant to go into hospitals for diag-
nostic tests, longer diagnostic turn-
around times, and difficulties identify-
ing symptoms in remote consultations.
“This pandemic has really made
things challenging,” said Dr Jodie
Moffat, Cancer Research UK’s head of
early diagnosis. “But we were really
quite off track before the pandemic hit.”
Some 85 per cent of people should
start treatment within 72 days of an
urgent GP referral for suspected
cancer, but in November the figure was
59 per cent, the third worst perform-
ance on record. The standard has been
met only twice since 2009. The charity
said this meant about 13,700 lung
cancer patients had experienced
delayed treatment.
Moffat said that while delays were a
concern for many cancers, lung cancer
required fast action. “For lung cancer in
particular it does seem to be one of
those cancers where for some people,
delays of days and weeks really could
make a difference,” she said.
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