Study Shows Antidepressant Ineffective and Potentially Harmful
October 13, 2010 by admin
Filed under News Stories
October 13, 2010
Daily Telegraph
Stephen Adams
They discovered that reboxetine, marketed as Edronax by Pfizer, was no more effective at countering major depression than a placebo sugar pill, after studying all available data on the drug.
In the study, published in the British Medical Journal today (WED), the German researchers found that some trials which failed to show reboxetine worked well were not submitted for publication by academic journals.
This, they said, was “a striking example of publication bias” – where academics or drug companies decide not to publish unfavourable results in peer-reviewed journals.
Overall, data on nearly three in four patients who took the drug went unpublished, claimed the researchers, working for the German Institute for Quality and Efficiency in Health Care.
“Data on 74 per cent of the patients included in our analysis was unpublished, indicating that the published evidence on reboxetine so far has been severely affected by publication bias,” they wrote.
If all the studies were taken into account – both published and unpublished – then the evidence showed that the risks of taking the drug outweighed the benefits.
Their analysis found that those who took reboxetine were more likely to have “at least one adverse event” than those given a placebo. However, there was no significant difference in the rate of suicide attempts between the two groups.
They noted that guidance issued by Britain’s National Institute for Clinical Excellence (Nice), that “reboxetine is superior to placebo and as effective as other antidepressants” was in their opinion, a conclusion that “can no longer be upheld”.
A spokesman for Pfizer said: “Pfizer discloses the results of its clinical trials to regulatory authorities all around the world. These regulatory authorities carefully balance the risks and benefits of each medication, and reflect all important safety and efficacy information in the approved product labelling.
“Pfizer will review the meta-analysis relating to reboxetine published in the British Medical Journal on 13th October 2010 in detail and will provide further comment after completing the review.”
Doctors & Patients Misled Over Drug Trials
October 13, 2010 by admin
Filed under News Stories
October 13, 2010
BBC News
Michelle Roberts
Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.
Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings.
The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light.
Pfizer maintains its drug is effective.
But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.
This is not the first time a large drug company has come under fire about its published drug trial data.
Trial informationPharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.
GSK rejected claims that it improperly withheld drug trial information.
But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes.
Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer’s antidepressant reboxetine that should be made public because it could change views about the drug.
Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.
They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.
Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.
Biased pictureThe researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.
“Our findings underline the urgent need for mandatory publication of trial data,” they say in the BMJ.
They warn that the lack of all information means policy makers are unable to make informed decisions.
In the US, it is already a requirement that all data – both positive and negative – is published. The UK is also striving to achieve this.
The UK’s regulator, the MHRA, said: “There is a European initiative to provide public access to the results of clinical trials. The currently planned timeline is that this information could become available in late 2011/early 2012.”
A spokeswoman for Pfizer said: “In the UK, Pfizer’s reboxetine is licensed for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment.
“This medicine presents an effective treatment option to clinicians for the use in patients suffering from these conditions.
“Pfizer discloses the results of its clinical trials to regulatory authorities all around the world. These regulatory authorities carefully balance the risks and benefits of each medication, and reflect all important safety and efficacy information in the approved product labelling.
“Pfizer will review the meta-analysis relating to reboxetine published in the British Medical Journal on 13th October 2010 in detail and will provide further comment after completing the review.”
Others lay at least some of the blame with the medical journals that publish drug trial data.
In response, the BMJ has promised to devote an entire issue to the topic next year.
BMJ Editors Dr Fiona Godlee and Dr Elizabeth Loder said: “It is time to demonstrate a shared commitment to set the record straight.”
