M Baum

ATAC, a randomized, double-blind trial compared T (20 mg) with anastrozole (A, 1 mg) (‘Arimidex’) alone, and the combination of A plus T (C), as adjuvant endocrine treatment (AET) for PM patients (pts) with EBC. It included pts with operable invasive breast cancer (BC) who had completed primary therapy and were eligible to receive AET. Main endpoints were disease-free survival (DFS) and tolerability. Other endpoints included time to recurrence (TTR: censoring non-BC deaths before recurrence) and the incidence of contralateral (CL) BC. 9366 pts were recruited (N=3125, 3116 and 3125 for A, T and C, respectively). Median duration of therapy was 30.7 months and median follow-up was 33.3 months. Total event numbers were 317, 379 and 383 for A, T and C, respectively. 84% of pts were known to be oestrogen receptor positive (ER+) and/or progesterone receptor positive (PR+). DFS was significantly improved in the overall population (pop) for A vs T (HR=0.81, 95% CI [0.71–0.96], p=0.013). A showed improved TTR compared with T (HR=0.79, [0.67–0.94], p=0.008), which improved even further in the ER+ and/or PR+ subgroup (HR=0.73, [0.59–0.90], p=0.003). An initial exploratory subgroup analysis suggested a potential interaction between A and T for prior chemotherapy use compared with no previous chemotherapy. Possible explanations for this observation, including chance, are being investigated. Longer follow-up is required before any meaningful conclusions can be made. The incidences of hot flushes, thromboembolic events, ischaemic cerebrovascular events, vaginal bleeding/discharge and endometrial cancer were significantly reduced with A compared with T (p<0.03 for all). Musculoskeletal disorders and fractures were significantly reduced in patients receiving T compared with those on A (p<0.03 for both). No increase in hip fractures was seen for A vs T (11 vs 13, respectively). To conclude, A showed superior efficacy to T for DFS, TTR and CL BC. These early findings show A as an effective and well-tolerated endocrine option for the treatment of PM pts with EBC. For the first time a choice now exists for AET for PM women with hormone responsive tumours. Longer follow-up will enable a more definitive benefit/risk assessment to be made.

# Declaration of Helsinki should be strengthened {#article-title-2} The World Medical Association is now debating the next revision of the Declaration of Helsinki. Kenneth Rothman and Karin Michels argue that critics of the declaration, notably the US Food and Drug Administration, are trying to give scientists greater latitude than the declaration allows. In particular, Rothman and Michels dispute the morality of performing placebo controlled trials when there is an existing accepted treatment, and they offer other suggestions to strengthen the protection of patients who participate in medical experiments. Michael Baum argues against their absolutism on this issue and against what he considers their anti-science stance # For {#article-title-3} Actions that penalise some for the good of others are defended under the utilitarian banner of doing the greatest good for the greatest number. For this reason we justify imposing quarantine to prevent the spread of infectious illness. In the same spirit some scientists and regulators would ask patients who participate in medical research to make sacrifices for the greater good. Their position puts them at odds with the Declaration of Helsinki, which does not mince words in choosing between the greatest good for the greatest number and the rights of the individual patient: “In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject.”1 This ethical choice of the patient's rights over the good of society in general is now up for re-examination as the World Medical Association deliberates the next revision of the declaration. Why would the World Medical Association consider stepping back from its strong support for the rights of the patient? It is under pressure to do so from several critics, 2 3 notably the United States Food and Drug Administration. The Food and Drug Administration mandates many human experiments as part of the approval …