PARLIAMENTARY DEBATES - United Kingdom Parliament

441WH
Fetal Anti-convulsant Syndrome
26 MARCH 2013
Fetal Anti-convulsant Syndrome
442WH
preliminary diagnosis of fetal valproate syndrome, another
name for fetal anti-convulsant syndrome. He was then
given a firm diagnosis by a geneticist at Glasgow’s
Yorkhill children’s hospital.
In 2002, my constituent started primary school and
was given a special educational needs teacher. The same
year, he was admitted to hospital for surgery on his
tonsils and adenoids and had grommets inserted. In
2003, he was admitted to hospital with problems going
to the bathroom that required surgery. He was diagnosed
with pneumonia again, and with primary ciliary dyskinesia,
a genetic disorder affecting the respiratory tract. He
was put on a repeat prescription of antibiotics to prevent
chest infections and given physiotherapy three times
aday.
In 2004, my constituent was seen by occupational,
educational and speech therapists due to his communication
problems and inability to mix with peers. In 2006, he
was sent back to occupational therapy and sent for a
CT scan on his chest that showed fibrosis on the lower
left lobe of his left lung, which was found to be smaller
than his right. Between 2007 and 2009, he was diagnosed
several times with pneumonia and severe chest infections
requiring intense physiotherapy and antibiotics. In 2010,
he was diagnosed with pneumonia again and, after
admission to hospital, with hypoplasia of the left pulmonary
artery, which had failed to develop.
As shocking as that story is, it is only one case, and
there are many worse. I was informed of a family in
which two children have been on disability living allowance
since the ages of five and eight. Anyone hearing those
stories can only be saddened by the personal circumstances.
It is incumbent on Members from all political parties,
whether in government or opposition, to ensure that we
work together to get justice for those families and
provide them with any necessary support.
The anti-convulsant that my constituent’s mother
was given during her pregnancy was sodium valproate,
otherwise known as Epilim, taken twice daily. It is clear
that both the Government and the pharmaceutical
companies, particularly Sanofi, could have done more
and taken further action to protect the public. It was
Sanofi’s duty to keep up to date with known medical
knowledge, conduct further research and pass on that
information to patients via the patient information
leaflet. It was the MHRA’s duty to ensure that Sanofi
investigated the medical research claims of birth defects
caused by their products. Delays by both have resulted
in thousands of women becoming pregnant without
being given the necessary information on the levels of
risk associated with the treatment.
Is the Minister aware that an estimated 40% of
children exposed to sodium valproate during pregnancy
are affected by neuro-developmental problems, autistic
spectrum disorders and physical malformations, and
that approximately 20,000 have been so affected since
1973? Does she think that that is acceptable? I know
that her answer will be, “Of course not.” Is she also
aware that this year, sodium valproate will have been
licensed for 40 years, and that it is now being prescribed
for other conditions, such as bipolar disorder and migraine
headaches, and as pain relief? Does she think that that
is appropriate, given the significant concerns raised by
medical research about the drug’s use?
Mr Hollobone, you will be shocked to hear that
80 families claiming damages against Sanofi-Aventis
lost their legal aid in 2010 after six years of pre-trial
preparation. Their legal aid was withdrawn after assessments
ruled that the group’s prospects of winning had fallen
and a judicial review failed. It was a devastating blow to
families who had been struggling to deal with the condition
without knowing what the problem was, and without
any proper support. Their lawyer, David Body, summed
up the tragedy when he said that
“our case against the manufacturers of Epilim must be discontinued,
not because we have lost our fight in court but because continuing
without legal aid funding would place our clients at too great a
financial risk.”
I know that the Minister cannot reinstate the legal
aid funding, but there are other things that she can do.
As an aside, we should never allow thousands of families
to be affected by the malpractice of a medical company
and a failure of the state, and then not give them the
support that they need to find justice for their families.
We should never allow a situation in which people,
through no fault of their own, cannot pursue justice
due to the barriers put in their way by the system. No
one who believes in the principle of fairness would
think that that was just. We all have a responsibility to
ensure that we support those families in bringing their
action, so they can get some justice. It will not be the
justice that they want, which is to have fit, healthy
children, but it will be some kind of justice.
Given that successive Governments and regulators
have failed to address the issue, will the Minister consider
launching a public inquiry to investigate why sodium
valproate and other anti-convulsants have been allowed
to cause so much damage over such a long period? At
the moment, there are pregnant women taking sodium
valproate who are unaware of the dangers, because they
did not receive pre-conception counselling. Can she
confirm that she will ensure that that is corrected in
future? Will she commit to working with the Independent
Fetal Anti-Convulsant Trust to raise awareness of the
condition? As a minimum, will she assure me that new
guidelines will be issued to ensure that children exposed
to anti-convulsant drugs in utero, particularly sodium
valproate, are monitored closely during early childhood
to allow for early intervention, diagnosis and support,
should it be required? Lastly, is she or one of her
colleagues prepared to meet me, my constituent and
representatives of the Independent Fetal Anti-Convulsant
Trust to discuss how we can support people affected by
the condition, and help protect others from it in the
future?
Inaction is not an option. These families have suffered
for long enough, and it is incumbent on all of us to
work together to find a fair deal for them, so they can
get the necessary compensation, and so that we can ensure
that not a single family suffers in future.
11.16 am
The Parliamentary Under-Secretary of State for Health
(Anna Soubry): It is, as ever, a pleasure to serve under
your chairmanship, Mr Hollobone. I thank the hon.
Member for Glasgow Central (Anas Sarwar) for bringing
this matter to the House and for his speech, which was
clearly based on careful consideration of a number of
matters that have, properly, been brought to his attention
by his constituents and by the action group to which he
has referred.