Word: drugging
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There are plenty of studies about antidepressants. What makes this one so important - the results were front-page news across the U.K. on Tuesday - is that the researchers were able to track down comprehensive unpublished trial results from the drug makers themselves before the drugs were authorized for sale in the U.S., and include them in their review of the literature. The U.S. Food and Drug Administration (FDA) must receive records of all relevant pharmaceutical-company trials, both published and unpublished, before it will approve a drug. Under the Freedom of Information Act, the researchers writing in PLoS Medicine were...
...Drug companies claim the review is still flawed, however. One massive problem: there are many more recent studies than those surveyed in the article, which looked only at pre-approval trials conducted before 1999. Nicholas Francis, a U.K. spokesman for Eli Lilly and Company, which produces Prozac, says that the new study "does not take into account that today more than 12,000 patients have participated in Prozac clinical trials and thousands of scientific papers have referenced Prozac, supporting its use in the treatment of depression." Some 50 million people worldwide have taken Prozac, and in a company statement Lilly...
...There are really two issues at the heart of the controversy. One is the difference between "statistical significance" - a measure of whether the drug's effects are reliable, and that patient improvement is not just due to chance - and "clinical significance," whether those effects actually are big enough to make a difference in the life of a patient. The researchers behind this new paper did find that SSRI drugs have a statistically significant impact for most groups of patients: that is, there was some measurable impact on depression compared to the placebo effect. "But a very tiny effect...
...more troubling question concerns what kind of data is appropriate for analyzing a drug's efficacy. The companies are correct in claiming there is far more data available on SSRI drugs now than there was 10 or 20 years ago. But Kirsch maintains that the results he and colleagues reviewed make up "the only data set we have that is not biased." He points out that currently, researchers are not compelled to produce all results to an independent body once the drugs have been approved; but until they are, they must hand over all data. For that reason, while...
...Lipitor ads are only a lightning rod for a growing concern about how prescription drugs are advertised to the public. While patients cannot purchase the drugs on their own, they can - and do - approach their doctors about certain medications they see touted on television or in magazines. Seeing celebrities or other well-known figures endorsing a drug may make a medication all the more appealing. That's why Representatives John Dingell and Bart Stupak, both of Michigan, and the House Energy and Commerce Committee decided last month to investigate how truthful this celebrity-driven drug advertising is - and hope...