Archive for March, 2010

03 Mar

Congress’ Remedy for Post-marketing

When the Food and Drug Administration (FDA) approved Merck’s quadrivalent human papillomavirus vaccine (Gardasil) on June 8, 2006, the agency extracted some post-approval commitments from the company, as it frequently does when it “green-lights” an important new drug around which questions still revolve. Those commitments involved additional testing of Gardasil after it went on the [...]

02 Mar

Gastric Acid Suppression by Proton Pump Inhibitors: DISCUSSION

In studies evaluating PPIs as a risk factor for CDAD, results have been mixed. This relationship has been somewhat ambiguous, and the exact mechanism of action is only speculative. C. difficile is a gram-positive, spore-forming anaerobic bacillus. The spores are acid-resistant, and they are not affected by the gastric pH. By contrast, a vegetative inoculum [...]

01 Mar

Gastric Acid Suppression by Proton Pump Inhibitors: RESULTS

Primary Outcome The difference in the rate of exposure to a PPI in the case and control groups was not statistically significant. Thirty-four case subjects and 37 controls were exposed to a PPI (P = 0.442). In a separate analysis, we examined each of the criteria for PPI exposure independently and found no statistical difference [...]

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