One from the Dundee Courier days
By Mark McLaughlin
The Courier
7th March 2007
A DUNDEE MP is calling for the controversial anti-depressant Seroxat to be suspended for all new patients in the light of growing evidence linking the drug to suicidal tendencies.
Dundee East MP Stewart Hosie met the medicines trade body, the Association of British Pharmaceutical Industries, to outline his concerns about the drug.
A recent US Food and Drug Administration report found a six-fold increase in the risk of suicidal thoughts and acts in children and a three-fold increase in adults after Seroxat treatment.
It is the latest in a long line of damning reports over the drug’s dangerous effect on an unacceptably high number of adults and children, and Mr Hosie has criticised ministers for “dragging their heels over the strong evidence regarding Seroxat.”
He has also joined a growing number of cross-party MPs in criticising the body responsible for licensing the drug, the Medicines and Healthcare products Regulatory Agency (MHRA), for being too close to the pharmaceutical industry.
Speaking after his meeting with the pharmaceutical industries association, Mr Hosie said, “From what I have heard during the meeting, it is my understanding that many people within the pharmaceutical industry share my concerns about the apparent close relationship between the MHRA and the companies it regulates.
“The MHRA is currently funded by industry fees but I feel that it is important for the government to set up some kind of positive mechanism outside the industry to create a perceptible distance.”
However, the MHRA said that a working relationship with the industry was vital, and that appropriate safeguards were in place to ensure industry funding did not impede its regulatory independence.
A spokesperson added, “The funding of MHRA is a political decision, taken by ministers of successive governments. The current Government policy is that they have no plans to change the current system.”
The concern over industry links at the MHRA is inexorably linked to the debate over continued licensing of Seroxat.
MPs and campaigners have misgivings about certain members of the company’s executive board being too close to the company which manufacturers the drug—pharmaceutical giant GlaxoSmithKline (GSK).
MHRA chairman Professor Alistair Breckenridge once sat on the scientific advisory committee of GSK subsidiary SmithKline Beecham, while MHRA head of licensing Dr Ian Hudson was formerly director of safety at the firm.
On a public declaration of interests submitted to the European Medicines Agency (EMEA), Dr Hudson admits that he previously had “significant involvement in a number of SB products—especially Avanda, Hycamtin and Paroxetine (aka Seroxat).”
The MHRA claims that Dr Hudson holds no current financial interests in GSK. It has also confirmed that Professor Breckenridge did sit on its scientific advisory board at one time, but was never directly employed by GSK or its subsidiaries and has never held any shares in the company.
The MHRA says that its working relationship with the industry does not inhibit the scientific and regulatory independence of the agency. Furthermore, it claims that industry representatives do not participate in any of the management, executive, or advisory bodies in the agency.
However, Mr Hosie has joined forces with a growing number of MPs and pressure groups in calling for greater scrutiny of the MHRA’s links to industry in general, and the perceived conflict of interest with GSK over Seroxat in particular.
Last year, Mr Hosie submitted a petition to parliament on behalf of Derek Scott, a Dundee East constituent and the founder of the Online Seroxat Support Group, calling on the Commons select committee on health to carry out an investigation into the drug and its possible side-effects.
He is adamant that the Government should place a moratorium on new prescriptions until a review of the evidence has been carried out. However, he has stopped short of calling for an all-out ban because of the devastating effects that it could have on the patients who are dependent on the drug.
He said, “I have a seen a list of side-effects that can be brought on when patients are taken off Seroxat and I’m certain an all-out withdrawal would be extremely dangerous. Furthermore, Seroxat does have beneficial effects for a great number of people.”
Seroxat belongs to a class of anti-depressants known as selective serotonin reuptake inhibitors (SSRIs).
The MHRA has confirmed that there are no plans to restrict the use of Seroxat for new patients, despite key findings of its expert working group which showed a “modest increase” in the risk of suicidal thoughts and self-harm for SSRIs compared with a placebo.
A spokesman added, “The US Food and Drug Administration has now completed a meta-analysis of all adult clinical trials for all SSRIs and related anti-depressants examining the risk of suicidal thoughts and behaviour.
“The FDA analysis does not suggest an increased risk of suicidal behaviour in the adult population as a whole. However, when young adults (aged 18-24 years) are looked at in isolation, there does appear to be an increased risk.”
The MHRA has therefore recommended a close monitoring of patients, particularly young adults, and a greater warning of its potential side-effects upon prescription.
GlaxoSmithKline was asked whether it would endorse Mr Hosie’s request for a suspension of the drug to all new patients.
In response, a spokes-man said, “As with all medicines, SSRI anti- depressants can cause side-effects in some people.
“Information about these is provided to doctors and patients and is updated as we learn more from clinical trials and the monitoring of patients worldwide.
“Reviews by both the MHRA and the EMEA have reaffirmed the positive safety profile and effectiveness of paroxetine in adults.”
No comments:
Post a Comment