GlaxoSmithKline has given a measured response to an eye-catching study from researchers at Hull University in the UK which suggested that antidepressants are no better than placebos for the vast majority of patients.
The company has expanded on the concerns it raised about the study published yesterday which involved a meta-analysis of both published and unpublished data from clinical trials of four blockbuster selective serotonin reuptake inhibitors – Eli Lilly’s Prozac (fluoxetine), Wyeth’s Effexor (venlafaxine), Bristol-Myers Squibb’s Serzone (nefazodone) and GSK’s Paxil/Seroxat (paroxetine). The study’s lead author, Irving Kirsch, added that the analysis “raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported”.
GSK hit back by saying it disappointed by how the study has been reported and “believe that it has caused unnecessary alarm and concern for patients”. The firm said that patients should not stop taking their medicine before discussing their situation with their doctor and added that antidepressants “remain an important option, in addition to counselling and lifestyle changes, for patients suffering from depression”.
The UK-based drugs giant went on to say that “we strongly believe that the authors’ interpretation is incorrect and is clearly at odds with the benefits of antidepressants routinely observed in actual clinical practice”. It also says it is important to emphasise that “regulatory bodies around the world have conducted extensive reviews of published and unpublished data for licensed antidepressants and have concluded that these medicines provide benefit to patients”.
Only 16 out of 170 paroxetine trials included
GSK says that “contrary to what has been reported”, the study has only examined a small subset of the total data available for antidepressants. With paroxetine for example, “this study only considers data from 16 trials out of a total database of more than 170 trials involving at least 14,000 patients”. With regards to Paxil, “.all trial data published and unpublished were submitted to regulators, at the time of registration”, GSK notes, saying that all the data related to paroxetine, “regardless of study outcome”, are available at the company’s clinical trials register on its website.
A GSK spokesperson added that the firm “rejects any suggestion that we deliberately withheld data on paroxetine” from the UK’s National Institute for Health and Clinical Excellence, which is due to review its guidance on treating depression. The spokesperson said that the firm provided both published and unpublished data as part of the development of the NICE guidelines regarding the licensed use of paroxetine in adults with depression, anxiety disorder, post traumatic stress disorder and obsessive compulsive disorder.
In addition, however, GSK responded to a request for data on the use of paroxetine in children. The spokesperson noted that the company provided a list of the studies that had either been completed or were underway, “however this was an unlicensed indication and was subject to an ongoing regulatory review by the Medicines and Healthcare products Regulatory Agency. It was therefore not appropriate to provide these data to NICE ahead of the MHRA’s conclusions.”
Despite GSK’s concerns about the study, which were shared by Lilly and Wyeth, the Hull analysis has brought the whole antidepressant argument back under the spotlight.
Alison Cobb, treatments expert at mental health group Mind, said that the study “makes a serious challenge to the predominance of drugs in treating depression”. She added that “many people find antidepressants helpful, but they certainly don’t work for everyone. One size certainly doesn’t fit all when it comes to treating depression.”
£170 million psychology therapy scheme unveiled
Her comments came on the day that UK Health Secretary Alan Johnson unveiled plans for a major new programme to train an extra 3,600 psychological therapists. The £170 million Improving Access to Psychological Therapies programme is designed to help “transform the lives of thousands of people with depression and anxiety disorders by offering them access to cognitive behavioural therapies”, the Department of Health said.
“Improving access to psychological therapies is a Government priority and evidence shows therapy is as effective as drugs in the short-term and longer lasting in the long-term”, it concluded.
