PHARMACY

Study suggests Tomoxifen may decrease mania symptoms

BY Drew Buono

IZMIR, Turkey According to a new study, the breast cancer drug tamoxifen has been shown to decrease symptoms of mania in patients with bipolar disorder.

Tamoxifen was shown to restrain the actions of a family of enzymes known as protein kinase C. Abnormal levels of activity by these enzymes have been associated with bipolar disorder.

Mania is an abnormally elevated mood that features impulsive behavior, higher energy and activity levels, and disconnected thoughts in patients with bipolar disorder. Ayegul Yildiz, of the Dokuz Eylul University Medical School, and colleagues conducted a clinical trial with 66 patients age 18 to 60, all of whom were diagnosed with bipolar disorder and were currently in a manic state or a mixed state that included mania. Participants were randomly assigned to take tamoxifen 40 mg to 80 mg per day or placebo tablets twice daily for up to three weeks.

A total of 50 patients, 29 assigned to take tamoxifen and 21 assigned to take placebo, completed the 21-day trial. Patients in the tamoxifen group had significantly lower scores on tests used to measure the severity of mania at the end of the three-week period, while those in the placebo group had scores that slightly increased. Almost half (48 percent) of patients taking tamoxifen responded to the drug compared with 5 percent of those taking the placebo, and 28 percent vs. 0 achieved cutoff scores for mania remission.

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Von Eschenbach, Leavitt visit Dr. Reddy’s facility in India

BY DSN STAFF

HYDERABAD, India In January 2008 Food and Drug Administration Commissioner Andrew von Eschenbach and Secretary of Health and Human Services Michael Leavitt visited a Dr. Reddy’s facility near the pharmaceutical manufacturer’s headquarters here.

Leavitt was focused on assuring the quality of the products as well as creating collaborations beyond borders while von Eschenbach, also concerned with the safety and quality of products, focused on the transparency of the manufacturing process.

Dr. Reddy’s was the only facility in India the two visited as part of a multi-national effort to ensure the safety of the pharmaceutical supply chain.

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Congressional report estimates CMS changes would cost states $50 billion in federal aid

BY Drew Buono

WASHINGTON According to a congressional report prepared by the Democratic staff on the House Committee on Oversight and Government Reform, proposed changes to Medicaid would cost states about $50 billion in federal aid over the next five years, the Associated Press reported.

“As the economy tips into recession, the last thing we should be doing is taking federal funds from states, especially funds that are supposed to help people with their health and medical expenses,” said committee chairman, Rep. Henry Waxman, D-Calif.

Federal officials, though, are arguing that the changes are designed to ensure that providers don’t bill the program for more than costs of providing care and also say that the states pay their fare share of the program.

Tthe proposed new rules include limiting Medicaid public hostpital reimbursement to no more than the cost of providing a particular service. Another would prohibit billing Medicaid for the costs of medical interns and residents.

Overall, the federal government will spend more than $1.2 trillion on Medicaid over the next five years. The administration projects that if all the changes it seeks were enacted, the federal government would save about $13 billion over those five years.

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