Even if you've been living in Germany or England and pay as much attention to pharmaceutical minutiae as I do, odds are the drug reboxetine would be Greek to you.
The Pfizer antidepressant, never approved in the U.S., has been available in many European countries since 1997. Even so, the medicine, which zeroes in on the chemical norepinephrine in the brain, hasn't been a big hit.
Now we're getting a deeper look from German researchers at why that may be. An analysis just published by BMJ, the British Medical Journal, pans reboxetine, calling it "an ineffective and potentially harmful antidepressant."
Perhaps the most disturbing part of the report is that three-quarters of the clinical test data the German researchers examined had never been published. Pfizer made the data available only after "massive public pressure," said the researchers, affiliated with the nonprofit Institute for Quality and Efficiency in Health Care.
After the previously unseen data on more than 3,000 patients were added to the mix, the researchers found reboxetine wasn't effective for treating major depression and had more side effects than a placebo or Prozac.
In a statement, the German group said, "when the results concealed up to now were included, the effect of reboxetine (marketed under the trade name Edronax) became so small that patients did not benefit from the drug, meaning that it is useless." The researchers say their experience with reboxetine underscores the need for mandatory public reporting of the results from clinical tests of pharmaceuticals.
Pfizer stands behind reboxetine. A company statement said it's "an effective treatment option" for patients with depressive illness/major depression. Furthermore, the company said it discloses the results of its clinical trials to regulators. In time, Pfizer said it would provide more detailed comments on the BMJ review.
Update: I asked Dr. P Murali Doraiswamy, a professor of psychiatry at Duke who's written before about reboxetine, to take a look at the BMJ paper. Here's what he had to say:
This is a very thorough and insightful analyses. A decade ago, reboxetine seemed to herald the potential of tapping into the noradrenaline brain system but with experience we realize now that pure noradrenergic drugs don't seem as robust for treating depression as serotonergic or mixed serotonin/noradrenergic drugs. Plus, there were problematic side effects such as high blood pressure and urinary blockage.
For a researcher or doctor, unpublished negative clinical trial data was tough to find in the past. One reason is that companies didn't have to include negative efficacy data in their package inserts (they only had to include negative safety data) and skeletons could often be tucked away in a closet under the misnomer "failed" trials. Even today, in package inserts, positive trials are highlighted with pretty graphs whereas negative efficacy data is never highlighted.
What we really need is a common public site, run by an independant entity, which posts complete results of all trials (whether positive or negative) in a timely manner and in a format that is balanced and easily accessible to all.