4 March 2004
spokesperson John Smyth, QC
**Unlicensed Abortion Drug Caused Widespread Deaths In Government
Hospitals In The Free State
**6 Months Afterwards Minister Of Health Personally Denies All Knowledge
**3 Years Later Still No Answer From The Minister And The Drug Continues
To Be Used In Spite Of Ban
“It has come to the attention of the province that there is an inappropriate
use of Misoprostol in a number of health facilities. The inappropriate use is
so high that in every case where the over-dosage of Misoprostol was given, it
resulted in maternal death. Most of the deaths were related to severe haemorrhage.”
(Free State Provincial Government Health Circular
Oct 2000)
“During the past 2 years maternal deaths occurred
after Misoprostol over-dose in term pregnancies. All cases occurred at primary
care level and were prescribed by community service doctors within 1 year after
their intern year.”
(Letter from Free State MEC Health to Doctors For Life
3 April 2001)
“The purpose of this letter is to remind you that Cytotec (Misoprostol)
administration by any route is contraindicated in women who are pregnant because
it can cause abortion. Cytotec is not approved for the induction of labour or
abortion…….Serious adverse effects reported following off-label use
of Cytotec including maternal or fetal death.”
(Letter from manufacturers to Health Care Practitioners
dated August 23 2000).
In a letter to Doctors For Life International (DFL) dated 9 March 2001 and signed
personally by the Minister, she denied all knowledge of the Free State deaths.
In a subsequent letter of 4 May 2001 her assistant Private Secretary promised
further investigations and a further response. Nearly 3 years later we still await
her response.
In the light of the new Abortion legislation which will relax safeguards for abortion
on demand, and in view of the current debate into the safety of legal abortion
it is imperative that the tragic and scandalous deaths admitted by the Free State
be brought into the public domain and fully investigated. Accordingly DFL has
today called on the Minister to take the following immediate action (copy of our
letter to her attached to this Release)
- Provide the names of the deceased women and the details of
the Health Facilities where the deaths occurred (or where the drug was prescribed
or administered) so that we may obtain the relevant Inquest Records. (Inquests
are a statutory requirement).
- Provide details of the compensation paid to the families or
dependents of each deceased.
- Publish the Report of the Provincial Maternal Death Investigator
(prepared for the National Department of Health) referred to in a letter from
the Free State MEC for Health dated 3 April 2001 to the Public Protector and
copied to DFL.
- Set up a PUBLIC INQUIRY into the deaths of the women in the
Free State and any others caused by the use of the drug in the Republic at
large.
DFL is an organisation of more than 1000 doctors, specialists and professors
of medicine from various medical faculties across South Africa and abroad.
###
Letter to Dr. Tshabalala-Msimang:
For the immediate and personal attention of the Minister of Health Dr M Tshabalala-Msimang
Dr Tshabalala Msimang
Legal spokesperson: John Smyth,
QC
Private Bag X399
ref: Cytotec / Misoprotol Feb
‘04
PRETORIA
0001
2 March 2004
Fax: (012) 323-0093
Dear Dr Tshabalala-Msimang,
Re.: Your letters to DFL dated 9 March 2001 and 4 May 2001
Use of Misoprostol in Government Hospitals and Clinics to induce Abortion resulting
in Maternal Deaths
We continue to be very concerned about the widespread use of Misoprostol (Cytotec)
to procure abortions notwithstanding:
- The widespread deaths of women directly as a result of the misuse of the
drug for abortion purposes in the Free State Province, as admitted by the
Provincial Health Authority in a circulardated 5 October 2000 and subsequently
reiterated in a letter to Doctors For Life International (DFL) dated 3 April
2001.
- The stringent warnings given by both the manufacturers of the drug (previously
‘Searle’ now ‘Pfizer’) and the Food and Drug Administration
(FDA) in the USA against the use of the drug which is not indicated for use
as an abortifacient.
We see from our files that we have had no explanation from you whatsoever as to
the deaths in the Free State, and no report from you or the Provincial Authority
as to the outcome of the inquests required by law, in spite of your promise to
us in a letter signed by Mr Mduduzi Masuku dated 2 May 2001.
What is more your earlier letter of 9 March 2001 gives every reason to suspect
a cover-up of the very serious negligence, and perhaps culpable homicide, causing
the deaths of numerous women as admitted by the Provincial health authority. In
the light of the Provincial authority’s Primary Health Care Circular No.
14 of October 2000 and our letter to you of 15 February 2001 it is surely inconceivable
that you had not been put on notice of these unlawful deaths by 9 March 2001 when
your letter was written, and yet you deny all knowledge.
The current debate in the media about the safety of legal abortions, and the introduction
of the new Abortion legislation which relaxes the safeguards for abortion on demand,
has made it imperative for us to pursue this very serious matter.
Accordingly we respectfully call upon you to take the following action within
seven days:
- Provide us with the names of the deceased women and the details
of the Health Facilities where the deaths occurred (or where the drug was
prescribed or administered) so that we may obtain from the relevant Magistrates
Courts the Inquest Records.
- Provide us with details of the compensation paid to the families
or dependents of each deceased.
- Provide us with the Report of the Provincial Maternal Death
Investigator (prepared for the National Department of Health) referred to
in a letter from the Free State MEC for Health dated 3 April 2001 to the Public
Protector and copied to ourselves.
- Undertake publicly to set up a PUBLIC INQUIRY into the deaths
of the women in the Free State and any other deaths caused by the use of the
drug in the Republic at large.
We are sending a copy of this letter to the Public Protector who has also failed
to respond adequately to our correspondence of 2001.
Furthermore we are issuing a PRESS RELEASE with a copy of this letter attached
to it. A copy of the press release will be sent to you for your information.
Yours faithfully,
pp DR ALBU VAN EEDEN
- CEO -
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