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Thursday, 14 November 1974
Page: 2384


The CHAIRMAN - Is leave granted? There being no objection, leave is granted.


Senator WHEELDON - Thank you, Mr Chairman. On 12 November during the debate on this Bill 2 matters were raised by Senator Baume referring to the estimates for the Department of Health. I undertook to obtain some information from the Minister for Health (Dr Everingham) concerning these matters and to make a statement to the Committee on them. I now have the information from the Minister. The first matter concerns Rauwolfia and breast cancer. The statement reads:

The association between Rauwolfia derivatives and breast cancer was first drawn to the Committee's attention late in September 1974 following publication in the 'Lancet'- 21 September issue- of the results of 3 epidemiological studies, one based on United States hospital admissions, another on Finnish data, and the third on United Kingdom data. The stated risk of breast cancer in women taking Rauwolfia derivatives ranged between about two to four times that for women not taking those agents.

Australian medical practitioners were advised of this association by circular letter on 8 October and the matter was discussed in detail by the Adverse Drug Reactions Advisory Committee (a sub-committee of the Australian Drug Evaluation Committee) on 1 1 October 1974. Doctors were advised by circular letter dated 25 October of the Committee's decision. In summary, it was felt that while there was some evidence of an association between taking these drugs and developing breast cancer, the validity of the methodology of all 3 studies was not yet verified.

The Committee accordingly agreed that a long term prospective study would be required to substantiate the claims of the 3 groups of researchers before regulatory action was warranted. A positive correlation such as this did not necessarily indicate a cause and effect relationship. Doctors were asked to review the need in their hypertensive patients for continued use of rauwolfia derivatives in the light of availability of suitable alternatives. The Committee's investigations are continuing. The results of further overseas studies are being awaited, particularly those of the FDA expert panel. As rauwolfia and its derivatives are available in this country only on a doctor's prescription, there seems little risk of a patient inadvertently taking the drug without adequate supervision by a doctor who has been pre-warned of the risk.

The other document refers to the Dalkon shield. It states:

The Australian Drug Evaluation Committee discussed the matter of septic abortion alleged to be associated with the Dalkon shield at its 59th meeting on 2 August 1 974. At that time the Committee had no reports of septic abortion following the use of intra-uterine contraceptive devices in Australia. Accordingly, it was agreed to seek details in Australia of any similar cases to those reported in the US but to broaden the survey to include reactions to the various types of intra-uterine contraceptive devices available in Australia. During its examination of the available data the Committee noted:

(i)   the Dalkon shield is one of a number of intra-uterine contraceptive devices which have been available in Australia for several years;

(ii)   mortality rate for the Dalkon shield is claimed by the company marketing the products to be 0.5 per 100,000 woman years c.f. 1 .5 to 3.9 for oral contraceptives;

(iii)   other intra-uterine contraceptive devices had been implicated in septic abortion.

The Committee agreed that if the problem proved to be device specific, the product should be withdrawn since other effective intra-uterine contraceptive devices were available. It was further agreed that temporary market suspension of the Dalkon shield was not warranted on the present evidence and that the company had acted responsibly in advising Australian doctors of the situation.

A circular letter from the Australian Drug Evaluation Committee, dispatched to all doctors on 25 October 1974, advised them of the specific problem with Dalkon shield and requested information on the use of all intra-uterine contraceptive devices and possible association of septic abortion and/or death.

The response to the request for details of cases so far has been nearly 40 reports on reactions to various types of intrauterine contraceptive devices used in Australia. Of these 40 reports, there has been no instance of death from complications following the use of the Dalkon shield. It is understood that the Dalkon shield is likely to be reintroduced onto the US market in the near future.







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