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Thursday, 27 May 1993
Page: 1487

Senator RICHARDSON —Yesterday in Question Time, Senator Herron referred to an answer that I had given in respect of the drug Zoladex. He went on to extend an allegation of gender bias in the listing of another drug, Rocaltrol, which is the brand name for the drug Calcitriol. He was wrong again. I seek to answer the points that he made.

  The allegation of gender bias is absurd. It is all very well for Senator Herron to raise the issue of drugs that treat medical conditions that affect one sex, but the fact is that this does not reflect any sexual discrimination on the part of the Government. Further, I strongly object to the inference that the Australian Drug Evaluation Committee, the Pharmaceutical Benefits Advisory Committee and the Government seek to favour males or females or vice versa.

  Drugs are recommended for listing on the pharmaceutical benefits scheme by the Pharmaceutical Benefits Advisory Committee. I have a list of the membership of these committees. It represents some of the who's who of Senator Herron's colleagues—people he would regard very highly. Drugs are recommended by them on the basis of the conditions for which they have marketing approval, not on the basis of the sex they treat. It is purely academic that a drug may be used for one sex.

Senator Herron —You have missed the point.

Senator RICHARDSON —Senator Herron has missed the point and he is going to get it now.

  Calcitriol, as it was raised yesterday, is listed for a number of uses in the pharmaceutical benefits scheme, including `the treatment of post-menopausal osteoporosis'. The product was first listed in the scheme in 1981. The Australian Drug Evaluation Committee recommended an extension of its uses in November 1985 and approved general marketing to include the treatment of post-menopausal osteoporosis. This did not include prophylactic use—that is, use to prevent osteoporosis.

  Calcitriol was approved for marketing for the treatment of established post-menopausal osteoporosis on 6 June 1986. An application to extend the pharmaceutical benefits scheme availability to include the treatment of osteoporosis was considered by the Pharmaceutical Benefits Advisory Committee in October 1986. The committee sought advice from two experts and the chairman of the endocrinology subcommittee of the Australian Drug Evaluation Committee, who did not support the drug's listing in the pharmaceutical benefits scheme for osteoporosis.

  The application was rejected by the Pharmaceutical Benefits Advisory Committee in October 1987. The advisory committee rejected another application in February 1988 because of the lack of evidence for the need for the product in the pharmaceutical benefits scheme.

  The company applied again in June 1991, supported by data including a New Zealand clinical study. Based on this information, the Pharmaceutical Benefits Advisory Committee recommended listing for the treatment of post-menopausal osteoporosis in accord with the marketing approval.

  The fact is that data was supplied to support the treatment of osteoporosis in post-menopausal women. No data was supplied to support the use of the drug for osteoporosis in males nor for its use as a preventive treatment for either males or females. If the manufacturer can supply data indicating that the drug is cost-effective in males, the expert committees to which I have referred will reconsider extending the uses of the drug. But to attempt to suggest bias in processing drug applications in the listing of the pharmaceutical benefits scheme just is not right.

  Senator Herron also raised the matter of Zoladex, which I dealt with yesterday. All I can say about that is the fact that only men have prostate problems does not mean that the drug should not have been put on the bottom of the pile for listing so that the Government does not get accused of gender bias.

  It is legitimate to raise the issue of the marketing of a particular drug or its listing, but to sensationalise the issue of gender bias in a press release, as Senator Herron did, is ridiculous. He referred to the use of Zoladex for endometriosis. ADEC will consider an application to extend the marketing approval of Zoladex to cover this condition at its June 1993 meeting. The fact is that ADEC cannot approve a drug for a particular medical indication without data to support it. The crux of this argument is: no data, no approval. There obviously could never be approval.

  The fact that the Government has never rejected one recommendation from that expert body suggests that we take seriously its recommendations. We accept them every time; we have not changed one. Therefore, to accuse that body of any kind of gender bias is over the top, even for Senator Herron.