Following the misleading headline in the New Zealand Herald ‘Anti-depressants don’t work – study’ I am surprised that the following findings of the MHRA’s 4 year investigation of drug company GalxoSmithKline haven’t yet made headlines here.
The MHRA [UK regulator for medicines] recently completed an investigation accusing GSK for hiding adverse test results for the drug Paroxetine commonly known as Aropax.After looking at nine undisclosed studies performed by GSK, they found that the drug was ineffective in treating depression in youths under 18 and increased the risk of self-harm and suicidal thoughts in adolescents. Currently pharmaceutical companies have to provide all research, both positive and negative when applying to licence a drug for use. However, they do not have to disclose all studies on drugs if they’re not applying for a license.
In this case, studies that investigated the negative impact of using Aropax with adolescents were withheld from the MHRA and consequently from the medial profession and the general public.The regulator (MEDSAFE in New Zealand) is there to regulate the pharmaceutical companies, not the medical profession. A licence enables the drug companies to market the drug to medical professionals, in other words, allowing the drug companies to advertise the drugs to doctors.
A licence is not a restriction on what the drug can be prescribed for or to whom – including adolescents. Medical professionals use their own discretion whether or not they choose to do so, based on available research performed either by the drug companies or by independent studies.
Ultimately this is where the issue lies. How can doctors make an informed decision about prescribing patients—specifically adolescents—when studies remain undisclosed?
Whether this recent development makes its way in to the Herald tomorrow is yet to be seen, though if it does I’m almost certain that it will be lacking the sensation that the Feb. 27 headline was granted.
Just something I’m interested to see unfold.
27-02-2008 Anti-depressants don’t work – study
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