COMPANIES TICKLE DEPRESSING TRIAL RESULTS
January 23rd 2008 23:58
Biotech Daily
Wednesday January 23
Daily news on ASX-listed biotechnology companies
Wednesday January 23
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS REBOUND: NEUREN UP 23%, AGENIX DOWN 15%
* FDA GRANTS ORPHAN STATUS TO NOVOGEN CANCER DRUG
* PSIVIDA TO RELEASE PHASE IIa CANCER RESULTS AT US CONFERENCE
* COMMENT AND ANALYSIS: TICKLING DEPRESSING TRIAL RESULTS
* HOWARD FLOREY: GENE-ENVIRONMENT INTERACTIONS IMPACT BRAIN
* BIOSIGNAL COMPOUND BEATS OIL, GAS INDUSTRY STANDARD
* FERMISCAN RESULTS PUBLISHED IN CANCER JOURNAL
* FDA APPROVES SIRTEX US PRODUCTION FACILITY
* ASPERMONT TO HOLD APRIL BIOTECH INVESTMENT EVENT
THE MARKET
Twenty-six of the Biotech Daily Top 40 stocks recovered, eight fell, five traded unchanged and one was untraded.
Neuren was best, up three cents or 23.08 percent to 16 cents with 10,000 shares traded, followed by Psivida up 18.18 percent, Mesoblast up 18.0 percent and Progen up 15.17 percent.
Heartware, Living Cell, Novogen and Pharmaxis were up 12 percent or more; Polartechnics climbed 10 percent; Arana, Bionomics, Clinuvel and Genetic Technologies were up more than seven percent; Acrux, Alchemia, Avexa and Sirtex rose more than six percent; with Benitec, Chemgenex, CSL and Ventracor up more than five percent.
Agenix led the falls, down two cents or 14.81 percent to 11.5 cents with 838,625 shares traded, followed by Optiscan down 11.9 percent to 18.5 cents, Cathrx down 8.33 percent to $2.20 and Antisense and Cellestis falling more than five percent.
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TICKLING DEPRESSING TRIAL RESULTS
A meta-analysis by US researchers, published in the New England Journal of Medicine, says that negative trial results on anti-depressants tend not to be published.
The article entitled ‘Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy’ by Dr Erick Turner, Dr Annette Matthews, Eftihia Linardatos, Robert Tell and Dr Robert Rosenthal was published in the Journal (2008; volume 358: pp252-60) on January 17, 2008.
It said that selective publication of clinical trials and the outcomes of those trials can lead to unrealistic estimates of drug effectiveness and alter the apparent risk to benefit ratio.
The authors obtained reviews from the US Food and Drug Administration for studies of 12 antidepressant agents involving 12,564 patients.
They identified matching publications and for trials that were reported in the literature, they compared the published outcomes with the FDA outcomes.
The authors further compared the “effect size” derived from the published reports with the “effect size” derived from the entire FDA data set.
One definition says effect size is a name given to a family of indices that measure the magnitude of a treatment effect, independent of sample size.
Of 74 FDA-registered studies, 31 percent (accounting for 3449 study participants) were not published.
“Whether and how the studies were published were associated with the study outcome,” the New England Journal of Medicine,” authors said.
A total of 37 studies viewed by the FDA as having positive results were published; one study viewed as positive was not published.
“Studies viewed by the FDA as having negative or questionable results were, with three exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies),” the authors said.
“According to the published literature, it appeared that 94 percent of the trials conducted were positive. By contrast, the FDA analysis showed that 51 percent were positive”. Separate meta-analyses of the FDA and journal data sets showed that the increase in “effect size” ranged from 11 to 69 percent for individual drugs and was 32 percent overall.
“We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients,” the authors said.
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