NEWS

In Brief

AstraZeneca Pleads Guilty to Criminal Conspiracy

Pharmaceutical company AstraZeneca pleaded guilty to criminal conspiracy after a government investigation revealed pricing and marketing practices of the prostate cancer drug Zoladex (goserelin) that violated the Prescription Drug Marketing Act.

The company admitted that they provided free samples of Zoladex to physicians with the understanding that the physicians would charge their patients and insurance programs for the drug. This practice resulted in an estimated loss of $40 million, for which AstraZeneca has agreed to pay a $63 million criminal fine.

The company will pay an additional $291 million to settle civil allegations that the company provided inducements to physicians to purchase Zoladex and that they inflated the price of Zoladex reported to Medicare as the basis for reimbursement, while deeply discounting the actual price charged to physicians. According to a statement from AstraZeneca, they are settling these claims without admitting liability.

Zoladex was AstraZeneca’s top cancer drug in 2002, earning the company $794 million. The company also produces the cancer drugs Nolvadex (tamoxifen), Arimidex (anastrozole), Iressa (gefitinib), and Faslodex (fulvestrant). AstraZeneca reported sales of $17.8 billion in 2002.

Paclitaxel Combination Improves Survival From Relapsed Ovarian Cancer

A new study suggests that pairing paclitaxel (Taxol) with platinum-based chemotherapy improves survival among patients with relapsed ovarian cancer.

Women who relapse within 6 months of treatment for ovarian cancer rarely respond to additional chemotherapy. Observational studies have suggested that these patients respond when treated with platinum-based chemotherapy and paclitaxel, a drug that attacks tumors using different mechanisms of action.

To confirm these findings, investigators from Italy, England, and Germany randomly assigned 802 women from 119 centers around Europe to receive either platinum-based chemotherapy alone or in combination with paclitaxel. The women were monitored for an average of 3 1/2 years.

After 2 years, 57% of women in the combination treatment group remained alive, compared with 50% of women in the chemotherapy-only group. Women who received the combination therapy survived on average 5 months longer (29 months versus 24 months) than women treated with chemotherapy alone and survived progression-free 3 months longer than women in the chemotherapy group.

The study appeared in the June 21 issue of the Lancet.

Studies Detail Risk of Breast Cancer with HRT

Two new studies provide a more detailed analysis of the risk of breast cancer associated with use of combination hormone replacement therapy (CHRT). Last July, results from the Women’s Health Initiative trial comparing estrogen plus progestin with a placebo in 16,608 postmenopausal women showed that use of CHRT was associated with a 26% increase in incidence of breast cancer.

In a more detailed analysis of that data, Rowan T. Chlebowski, M.D., Ph.D., of the Harbor-UCLA Research and Education Institute in Torrance, Calif., and his colleagues found that breast cancers that developed in women taking CHRT were larger and at a more advanced stage than breast cancers that developed in women taking a placebo. Moreover, use of estrogen and progestin substantially increased the frequency of abnormal mammograms.

In a separate study, Christopher I. Li, M.D., of the Fred Hutchinson Cancer Research Center in Seattle, and his colleagues examined use of hormone therapy among 975 women who had invasive breast cancer. They found that use of CHRT was associated with an increased risk of specific types of breast cancer, including invasive lobular carcinoma, invasive ductal carcinoma, and hormone-receptor-positive breast cancer. The risk increases were similar whether the progestin was taken continuously or sequentially.

The studies appeared in the June 25 issue of the Journal of the American Medical Association.

See also News, Vol 95, No. 1, p. 9, "NIH Workshop Tries to Create Consensus on HRT Use," Vol. 94, No. 15, p. 1116, and "The End of an Era? Study Reveals Harms of Hormone Replacement Therapy."

Regular Aspirin Use Associated with Reduced Risk of Leukemia

A new study suggests that regular use of aspirin, but not other non-steroidal anti-inflammatory drugs (NSAIDs), is associated with a reduced incidence of adult leukemia. Use of aspirin has been shown in past studies to be associated with a reduced risk of colon cancer.

Christine M. Kasum, of the University of Minnesota School of Public Health in Minneapolis, and her colleagues conducted a prospective study of 28,224 post-menopausal women who were participating in the Iowa Women’s Health Study to examine the association between NSAID use and risk of leukemia.

After 8 years, 81 women were identified as having developed leukemia. Women who developed leukemia reported less frequent aspirin use than women who did not develop leukemia. Women who used aspirin two or more times a week were 55% less likely to develop leukemia than women who never used aspirin. There appeared to be no association between use of nonaspirin NSAIDs such as ibuprofen and decreased risk of leukemia.

The authors cannot explain why aspirin and nonaspirin NSAIDs had different effects on leukemia risk, but they point out that these compounds have different effects on the inhibition of the certain enzymes associated with the development of cancer.

The study appears in the June 13 issue of Cancer Epidemiology, Biomarkers & Prevention.

    —Linda Wang and Katherine Arnold



             
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