May 13, 2011

Something splashy, something new, nothing borrowed, nothing trashy…

In 2009 alone 26 new drugs were approved by the FDA in the US. Ranging from anti-depressants to diabetes medicines to diet pills. However, it’s a drug withdrawal that usually makes the news. Meridia is one such drug. The diet pill has now been taken off the market in the US, after a study by the FDA that followed 10,000 patients on the pill for six years found a 16% increased risk of heart attacks, strokes, and deaths. It has also been withdrawn in Europe and Australia, but remains on the market in many other countries. This is becoming more and more the norm.

Experiencing drug withdrawal symptoms is common among people who do not gradually quit using prescription drugs or any substance they have been using for a long time. More frequently, drug companies are coming under fire for misleading drug trials. Glaxo-Smithkline came under a lot of fire for not making known the risks of suicidal behaviour associated with the antidepressant Seroxat. Leading to parliamentary ministers in the UK to push for tighter regulations on drug trials and what is disclosed. Reboxetine, an anti-depressant drug used in the treatment of clinical depression, produced by Pfizer, was recently scrutinized for its effectiveness by a team from Germany. They found the drug to perform no better than a placebo in most trials; leading to suggestions that the drug company had intentionally withheld some data and only publishing the positive results for the drug.

Instances such as these are becoming more common. Such negative data rarely comes to the forefront. Simply because that’s not in the sphere of how data is published. No effect results and negative findings often get left on the pile. Or worse, are subject to a publication bias. Hiding data to make results seem more profound is one thing. But what is also common is reviewer positive bias. Something that is very common and that seems evident. Of course a “wow” scientific story gets noticed more than something bland. No-difference results will always lead to a “so what?-shrug-of-the-shoulders” response. Some researchers sought to determine whether positive-outcome bias is present during peer review by testing whether peer reviewers would recommend publication of a "positive" version of a fabricated manuscript over an otherwise identical "no-difference" version. And, surprise surprise... they did.

The researchers also had a further hypothesis that reviewer scrutiny of the paper would be different depending on the positive outcome or no-difference outcome of the paper. Identical errors were placed in both versions of the fabricated manuscript. Both versions of the manuscript should have received equal scores from reviewers who rated the manuscripts for methodological validity. In the end more errors were found in the no-difference version of the paper as compared to the positive version. They concluded that “Positive-outcome bias was present during peer review. A fabricated manuscript with a positive outcome was more likely to be recommended for publication than was an otherwise identical no-difference manuscript.”

So it seems that this positive bias exists in all steps of the process and, in the case of pharmaceuticals, eventually impacts patient care.

Written by Dr. Charles Ebikeme for The All Results Journals.

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