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Sixteen States, DOJ Join Whistle-Blower Lawsuits Alleging Wyeth Defrauded Medicaid Programs
The U.S. Department of Justice and 16 states have joined two whistle-blower lawsuits filed in federal District Court in Massachusetts alleging that Wyeth defrauded the government by not offering the same discounts on two medications to Medicaid that it offered to hospitals, the Wall Street Journal reports. The lawsuits were initiated following a grand-jury investigation by the U.S. Attorney"s Office in Massachusetts (Johnson, Wall Street Journal, 5/19). The other states included in the lawsuits are California, Delaware, Florida, Illinois, Indiana, Louisiana, New York, Michigan, Nevada, New Hampshire, Tennessee, Texas, Virginia, Wisconsin and the District of Columbia (Barrett, AP/Austin American-Statesman, 5/18).According to the lawsuits, Wyeth from 2000 to 2006 sold hospitals a bundled package called the Protonix Performance Agreement, which included its acid-reflux drugs Protonix Oral and Protonix IV. The suits allege that Wyeth gave hospitals up to a 94% discount for the oral version under the deal, with the understanding that when patients were released from hospitals they would be switched from the intravenous version of the drug to the oral version. According to the complaint, Wyeth hoped to gain an edge in a competitive market for acid-reflux pills by taking advantage of its standing as the only company offering an IV acid-reflux drug. The Journal reports that Wyeth charged hospitals $20 per vial for the IV version of Protonix and $3 for the oral version.Medicaid rules stipulate that the program is entitled to the lowest price on prescription drugs, and drugmakers are required to pay states rebates if they offer discounts to any other entities. The lawsuits state that Wyeth avoided paying hundreds of millions of dollars to state Medicaid programs because it did not offer the programs the same discounts or provide rebates (Wall Street Journal, 5/19).The lawsuits are seeking financial penalties against Wyeth of up to three times the amount lost by Medicaid. Assistant Attorney General Tony West said, "By offering massive discounts to hospitals, but then hiding that information from the Medicaid program, we believe Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have." Wyeth spokesperson Doug Petkus said that Wyeth "believes that its pricing calculations were correct and intends to defend itself vigorously in these actions" (AP/Austin American-Statesman, 5/18).
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Study Examines Gender Differences In Immune System's Response To HIV
New research showing that "a receptor molecule involved in the recognition of HIV-1 responds to the virus differently in women than in men," might "explain why HIV infection progresses faster to AIDS in women than in men with similar viral loads," the HealthDay/Greenville Daily Reflector reports. The study was conducted by researchers at the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard University and will be published in an upcoming issue of the journal Nature Medicine. Study authors also note that during the early stages of infection, women tend to have a stronger immune response to HIV than men, but then progress to AIDS more quickly. The different immune system response "then leads to differences in chronic T-cell activation, a known activator of disease progression, according to the researchers," the article states (7/13). Researcher Marcus Altfeld said the findings raise new questions about how sex hormones affect HIV in the body. "Focusing on immune activation separately from viral replication might give us new therapeutic approaches" to treating HIV, he added (AFP/Google News, 7/13).
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Pharmaceutical Company Manager Sentenced For Off-Label Marketing
A Branchburg, NJ, woman was sentenced for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.
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Is There Any Association Between COX2 And Colon Cancer?

Non-steroidal anti-inflammatory drugs (NSAIDs), which are known to reduce the risk of colon cancer, act directly on cyclooxygenase-2 (COX2) and reduce its activity. Population studies have found an association of inherited variations in the COX2 gene with colon cancer risk, but others were unable to replicate this finding. Similarly, variations in the uridine diphosphate glucuronosyltransferase 1A6 (UGT1A6) gene, which is also known to be key in the metabolism of NSAIDs, have been shown to modify the effect of NSAIDs on developing colon polyps, a precursor of colon cancer, but these modifications of NSAID effects have not been observed in risk of colon cancer. A research article published on May 14, 2009 in the World Journal of Gastroenterology addresses this problem. The research team led by Dr. Li from Case Western Reserve University examined the association of variants of the COX2 and UGT1A6 genes, and their interaction with NSAID consumption, on risk of colon cancer in attempt to more fully understand the relationship between genetic variation and the protective effect of NSAIDs on colon cancer risk. They found that no single nucleotide polymorphisms (SNPs) in either gene were individually statistically significantly associated with colon cancer, nor did they statistically significantly change the protective effect of NSAID consumption. Like others, the authors were unable to replicate the association of variants in the COX2 gene with colon cancer risk (P > 0.05), and they did not observe that these variants modify the protective effect of NSAIDs (P > 0.05). Their study does not support a role of COX2 and UGT1A6 genetic variations in the development of colon cancer. Reference: Thompson CL, Plummer SJ, Merkulova A, Cheng I, Tucker TC, Casey G, Li L. No association between cyclooxygenase-2 and uridine diphosphate glucuronosyltransferase 1A6 genetic polymorphisms and colon cancer risk. World J Gastroenterol 2009; 15(18): 2240-2244 http://www.wjgnet.com/1007-9327/15/2240.asp Correspondence to: Li Li, MD, PhD, Department of Family Medicine, Research Division, Case Western Reserve University, 11001 Cedar Ave., Suite 306, Cleveland, Ohio 44106-7136, United States. Lai-Fu Li World Journal of Gastroenterology


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