6 posts tagged with clinicaltrials. (View popular tags)
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Falling STAR*D?: It is common practice for psychiatrists to switch depressive patients between different antidepressants if their current drug does not evince a symptomatic response. Despite clinical wisdom supporting this, little empirical, controlled evidence exists to direct “switching” protocols (e.g. if a patient with Z characteristics is on drug X, is it usually better to switch to drug A, B, or C? Will switching help at all?) in the psychopharmacological treatment of depression. The NIMH-funded STAR*D (Sequenced Alternatives to Relieve Depression) study aimed to address these questions of treatment direction in a very large (n>4000), “real-world” sample using a multi-phase treatment plan with different drugs (and cognitive therapy) at every step to maximize chances of eventual remission. Overall, the NIMH reported that about 67% of patients eventually achieved remission, with few differences in effectiveness between different types of treatment at each step. However, researchers and commentators have raised concerns regarding inconsistent reporting of outcomes, after-the-fact changes in study design and analysis, and other issues that may have inflated, partially invalidated, or misrepresented widely reported treatment outcomes. These inequities may also have implications for the secondary moderator analyses (i.e. does trait A predict switching to X or Y is better?) that were a major reason for the study. [more inside]
posted by Keter on Jan 14, 2012 - 12 comments

In 2004, Minnesota student Dan Markingson committed suicide while participating in a clinical drug trial for various mood disorders. Trial sponsors the University of Minnesota and AstraZeneca were cleared of blame by the FDA in 2005. Last week, a group of faculty members at the university wrote an open letter to the university's Board of Regents requesting further investigation due to "troubling questions" that remain unanswered and a concern over "conflicts of interest" in the Academic Health Center.
posted by modernnomad on Dec 6, 2010 - 21 comments

Should we start doing medical research on pregnant women? In the wake of the H1N1 epidemic, in which pregnant women had a disproportionately higher risk of death, the question of including pregnant women in clinical trials has begun to be tentatively breached. [more inside]
posted by KathrynT on Jun 21, 2010 - 22 comments

Dying for Lifesaving Drugs: Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments?Reason Magazine
posted by BrotherCaine on Jul 26, 2007 - 43 comments

No pain, no gain, they say, and when it comes to real pain, the inverse is true as well. "We now have research indicating there's a memory of chronic pain," said Dr. Doris K. Cope, director of chronic and cancer pain for the University of Pittsburgh Medical Center. It changes the genic code sometimes, it changes the biochemistry, and it causes new proteins to be formed." Or in other words, the more pain you have, the more pain you have. (More on this.) It's no wonder, then, that more money is spent on pain relief than any other medical problem, and that there has been so much pain research and so many clinical trials revealing such painful facts as redheads feel more pain, men feel less pain, and that there's a genetic difference between tough guys and wimps. (Much more pain inside.)

posted by taz on Sep 20, 2004 - 31 comments

When drug companies hide data.

"The attorney general's civil suit accuses the drug giant GlaxoSmithKline of committing fraud by concealing negative information about Paxil, a drug used to treat depression. The suit says that the company conducted five clinical trials of Paxil in adolescents and children, yet published only one study whose mixed results it deemed positive. The company sat on two major studies for up to four years, although the results of one were divulged by a whistle-blower at a medical conference in 1999 and all of the studies were submitted to the Food and Drug Administration in 2002 when the company sought approval for new uses of Paxil. At that time it became apparent that Paxil was no more effective than a placebo in treating adolescent depression and might even provoke suicidal thoughts.

My Dad was on Paxil until 26 days ago..... that's when he shot himself.
posted by Lusy P Hur on Jun 6, 2004 - 47 comments

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