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Questions raised about promising HIV vaccine trial results

BY Alaric DeArment

NEW YORK The excitement over data from a late-stage clinical trial of an HIV vaccine regimen may have been premature, according to published reports.

Last month, Sanofi-Aventis announced results of a trial of a vaccine regimen comprising its ALVAC HIV vaccine and VaxGen’s AIDSVAX B/E in 16,000 men in Thailand. Results showed that when combined, the two vaccines reduced the risk of HIV infection by 31.2%. That rate, while modest, was statistically significant, Sanofi said at the time.

But according to reports, a press conference showed only initial analysis of the data. Further analysis showed lower rates of protection and evidence that the results were not statistically significant, and some scientists have criticized the presentation of the data as misleading.

Nick Saraniti, CEO and director of operations of Fort Lauderdale, Fla.-based specialty pharmacy Commcare Pharmacy, is also skeptical. He noted that the results indicate patients who took the vaccine contracted HIV 31.2% less than those who didn’t, but the question remained as to whether they were also 31.2% less exposed to the virus.

“Realistically, it doesn’t put them much closer to a vaccine than they were two years ago,” Saraniti told Drug Store News. “It gives us the hope to keep trying.”

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FDA approves hereditary angioedema treatment

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a drug designed to treat symptoms associated with a rare and potentially fatal genetic disease.

The agency announced the approval of Marburg, Germany-based CSL Behring’s Berinert (C1 esterase inhibitor), for the treatment of abdominal attacks and facial swelling associated with hereditary angioedema in adolescents and adults. The drug is a protein product derived from human plasma.

“Berinert will enhance the treatment options for individuals who experience acute abdominal attacks and facial swelling associated with hereditary angioedema,” FDA Center for Biologics Evaluation and Research acting director Karen Midthun said in a statement.

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Deloitte consumer spending index up for fourth consecutive month

BY Allison Cerra

NEW YORK The Deloitte Consumer Spending Index rose again in September, hitting its highest level in two years. The index attempts to track consumer cash flow as an indicator of future consumer spending.

“The fundamentals of consumer spending continue to improve, giving households increased purchasing power,” said Carl Steidtmann, chief economist with Deloitte Research, a subsidiary of Deloitte Services LP, and author of the monthly index. “The housing market is beginning to show signs of stabilizing while initial unemployment claims have fallen significantly. Household net worth is rising and real wages are climbing at their fastest pace in 40 years. Signs of recovery got a boost from the cash for clunkers program in August, plus a gain in real spending has materialized across the board in recent months.”

Highlights of the index include:

  • Tax Burden: The tax burden continues to fall with the weakening of the economy. The tax burden is at a level only seen on a few occasions over the past 50 years during brief periods following tax rebates. Continued decline is expected.
  • Initial Unemployment Claims: Initial unemployment claims have come down sharply over the past three months which historically has been a reliable signal of economic recovery. Claims are down more than 100,000 from their recession peak.
  • Real Wages: Real wage growth continues to post solid gains due in large part to falling prices. Real wages are up 4.8 percent from a year ago as falling prices have given a big boost to consumer purchasing power.
  • Real Home Prices: The pace of decline in home prices has slowed significantly on a year over year basis. Continued efforts to forestall foreclosures coupled with a tax credit for first-time home buyers have brought some stability to the housing market. The decline in home prices has made home buying much more affordable.

“The Index suggests that many households increasingly have the means to spend, and with the worst of the downturn seemingly behind us, the retail environment may soon see signs of life,” said Stacy Janiak, vice chairman and Deloitte’s U.S. retail leader. “Retailers have tackled cost cutting and cash conservation and the next few months will likely be all about enticing the consumer to spend. Offering personalized marketing, enhancing in-store customer conversion tactics and encouraging online product reviews are just a few of the ways that retailers may be able to gain an edge this holiday season.”

For more information about Deloitte’s retail sector, please visit www.deloitte.com/us/retail.

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