Additional
comments
Senator Gary Humphries
Senator Guy Barnett
Senator Steve Fielding
Senator Helen Polley
Senator Barnaby Joyce
1.
The nature of the
Chair’s Report is to provide a description of “the approval processes in
question and the pharmacological properties of RU486” along with “an outline of
the issues and arguments raised in evidence by those groups and individuals
supporting the Bill and those opposing the Bill.”
2.
These additional
comments go further. As full or participating members of the Committee who have
considered all the evidence in the 4788 submissions and correspondence received
and given at the public hearings we would like to state our conclusions.
3.
The central claim
of the supporters of the Bill is that RU486 is simply another drug, not essentially
different from any other drug, and that therefore there is no justification for
the ‘restricted goods’ provisions in the existing legislation.
4.
After considering
all the evidence we conclude that this central claim is without foundation
because it ignores the fundamental fact that RU486 is a drug intended to cause
abortion.
5.
It is used as the
first drug in a two drug regimen administered during the first 9 weeks of
pregnancy for the purpose of ending the life of the developing child and
bringing about its expulsion from the mother’s body. RU486 has also been used
in abortions up to 20 weeks gestation. Even if the TGA approved it solely for
abortions up to 9 weeks once it was registered there would be nothing to
prevent its off-label use for mid-trimester abortions.
6.
This use does not
correspond to any of the meanings of “therapeutic use” given in Section 3 of
the Therapeutic Goods Act 1989.
7.
Opinions in the
community on abortion are divided and conflicted. Recent opinion polls indicate
that Australians think there are too many abortions and that they disapprove of
abortion for financial and social reasons.
8.
Supporters of the
Bill argued that, given that the States and Territories are responsible for the
legal status of abortion in their jurisdictions, the Federal Parliament has no
right to retain legislation that can be construed as limiting the methods of
abortion available in Australia. We strongly reject this argument. The Federal
Parliament has constitutional responsibility for imports and other matters
reflected in the very existence of the Therapeutic Goods Act 1989. In voting on
the provisions dealing with abortifacients as “restricted goods” Senators and
Members are necessarily voting on the question of abortion. To vote to treat
that class of drugs intended for use in abortion as simply equivalent to
genuinely therapeutic drugs would be to state that these drugs do not raise any
particular ethical or social issues connected with abortion itself.
9.
The Therapeutic
Goods Administration is empowered by the Act to consider the safety, quality
and efficacy of a drug. It has no power or competence to consider the broader
social and ethical impact that may follow if a drug is registered for import
and use in Australia. Under the existing ‘restricted goods’ provisions the
Minister can consider the social and ethical impact of an abortifacient drug.
If this Bill is passed, and these provisions are removed, then the social and
ethical implications of introducing RU486 to Australia cannot be taken into
consideration. We hold that allowing the abortion drug RU486 into Australia is
a major social policy change that therefore should only be able to be made by a
Minister accountable to the Parliament and the people.
10. We believe that
there is strong evidence of serious risk to women associated with the use of
RU486 in abortions, evidence which could properly be assessed by the TGA in
considering the safety and efficacy of the drug.
11. Given the
requirements of close consultation with the administration of RU486 and the difficulties
in many regional areas with an appropriate level of access to medical
facilities and supervision we have grave concerns for the health and lives of
women in regional areas and specific disadvantaged groups who would use the
drug.
12. Supporters of the
Bill were of one voice in claiming the safety of RU486. Many claimed that a
medical abortion was as safe or safer than a surgical abortion. Several claimed
that RU486 had a higher adverse event rate than the over the counter allergy
drug Claratyne ® . These comparisons are demonstrably false. Medical abortion
carries with it a ten fold higher mortality rate than surgical abortion. RU486
is certainly far more dangerous than Claratyne ® .
13.
Many supporters
of the Bill were also distressingly cavalier in their attitude to the eleven
deaths of women officially acknowledged to have occurred in association with
RU486 abortions. One witness stated that the difference between 10 women out of
100,000 dying from an RU486 abortion compared to 1 woman per 100,000 dying from
surgical abortion at the same gestational stage was like the difference between
10 grains of sand and one grain of sand – imperceptible to the human eye. As
Senators entrusted with making laws for the peace, order and good government of
this Commonwealth of Australia we utterly reject this cavalier approach to the
lives of Australia women. We cannot support any diminution of the checks
currently in place before a drug which may take the lives of healthy young
Australian women is allowed into this country.
14. There have been a
total of 11 known deaths associated with RU486 abortions. Three British women
have died, five women have died in the United States, one in Canada, one in
Sweden and one in France. In August 2001 a 26 year old, previously healthy
woman was admitted to Sherbrooke University Hospital in Quebec, Canada with
abdominal pain, vomiting and foul-smelling vaginal discharge. Seven days
earlier she had had abortion medically induced by RU-486 and misoprostol.
Despite treatment in the intensive care unit the woman died within 3 days of
admission. Her uterus was found to be infected with a bacteria Clostridium sordellii and she was found
to have died of toxic shock. As a result of this tragic death the trial of
RU486 in which the woman had participated was halted and RU496 has never been
approved in Canada.
15. Four American
women, all otherwise healthy before submitting to an RU486/misoprostol
abortion, have also died from toxic shock syndrome caused by Clostridium sordellii infection. These
women were Holly Patterson (18), who died September 17, 2003; Hoa Thuy Tran
(21), who died 29 December 2003; Chanelle Bryant (22), who died 14 January 2004
and Oriane Shevin (34), mother of two, who died 14 June 2005. According to
Professor Ralph Miech, MD, Ph.D., the abortion drug triggers a bacterial infection in a woman's cervical canal that doesn't
normally occur. The bacteria thrive
on the decaying tissue from the dying unborn child and impairs the woman's
ability to fight off the infection. Officials from the Food and Drug
Administration and the Centers for Disease Control and Prevention have decided
to convene a scientific meeting early 2006 to discuss this medical mystery,
according to two drug agency officials who spoke on the condition of anonymity
because of the sensitivity of the topic.
16. The death of 16
year old Swedish girl Rebecca Tell Berg on 3 June 2003 after an RU486 abortion
resulted from blood loss six days after taking misoprostol to complete the
abortion process. She was found by her boyfriend having bled to death in her
shower.
17.
An analysis of
adverse events following RU486 abortions demonstrates that for every woman who
dies in association with an RU486 abortion there are seventy women who suffer
life-threatening complications, including severe haemorrhage, sepsis and
ruptured ectopic pregnancy. Sixty eight American women have required blood
transfusions after RU486 abortions with 42 of these cases classified as life
threatening. Up to 8% of women who are
undergo an RU486 abortion fail to abort. They may undergo a second surgical
abortion further increasing the overall health risks. If the woman chooses not
to have this second abortion and carries the pregnancy to term the risk of
fetal malformation is 23%.
18. Governments and
legislators in several other jurisdictions have taken steps to prevent or cease
the use of RU486 for abortion. The Italian Government has just announced a ban
on any general import of RU486 into Italy. This follows the suspension of a
trial of RU486 in Turin last September after serious health concerns. The
United States Congress has before it the RU486 Suspension and Review Act (also
known as Holly’s Law after Holly Patterson, an 18 year old woman who died after
an RU486 abortion). This Act would suspend all sales of RU486 while the comptroller
general investigates the Food and Drug Administration’s handling of the
approval process for RU486. A Congressional Subcommittee is also investigating
the handling of the approval process for RU486 by the FDA, as well as its
response to the five deaths and other adverse events related to RU486
abortions.RU486 remains unlicensed in Canada after the suspension of a trial
following the death from toxic shock syndrome of a 26 year old woman on 1
September 2001.
19. Given these moves
in other jurisdictions, the serious health risks to Australian women, and above
all the necessity to consider the social and ethical implications of a drug
intended to produce abortion, we conclude that the ‘restricted goods’
provisions for abortifacient drugs should remain in place and the Bill be
rejected.
Senator Gary Humphries
LP,
Australian Capital Territory
Senator Guy Barnett
LP,
Tasmania
Senator Steve Fielding
FFP,
Victoria
Senator Helen Polley
ALP,
Tasmania
Senator Barnaby Joyce
NATS,
Queensland
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