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06/03/2008
Laws To Be Tightened After Drugs Ruling
Government ministers have today promised they will tighten laws which require pharmaceutical companies to disclose data from clinical trials.
Public Health Minister, Dawn Primarolo announced the news after pharmaceutical heavyweights GlaxoSmithKline (GSK) was found to have withheld information on a controversial drug.
GSK heard today it would not face criminal proceedings over claims they did not raise the alarm quickly enough on the risk of suicidal behaviour associated with the antidepressant Seroxat in the under-18s.
The move comes as a result of a four-year investigatory report compiled by the Medicines and Healthcare Regulatory Authority (MHRA). The Authority had received information from the trials dating back to 2003 which showed patients under the age of 18 had a higher risk of suicidal behaviour if they were treated with the drug, compared to a placebo. Data also revealed Seroxat was not effective for treating depression in children and adolescents.
Health Minister Dawn Primarolo said the government would be taking steps to ensure a 'strengthening' of the law would be introduced throughout the UK and Europe.
She added that she wanted it made clear to all pharmaceutical companies, that "notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health".
While GSK rejected claims it had improperly withheld trial information regarding the drug, MHRA Chief Executive Kent Woods said it was "disappointed" that the company had not given the agency information earlier, adding drug companies had an "ethical responsibility" to do so.
He continued: "I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients and should report any adverse data signals to us as soon as they discover them.
"The investigation has revealed important weaknesses in the drug safety legislation in force at the time."
The Mental Health Foundation's Chief Executive, Andrew McCullough, highlighted concern for the failure to inform the authorities promptly of the risk, saying: "The pharmaceutical industry has played a significant role in the treatment of people with mental health problems over the years – it has a duty to be transparent and rigorous; otherwise it is in danger of losing the public's trust."
(JM/KMcA)
Public Health Minister, Dawn Primarolo announced the news after pharmaceutical heavyweights GlaxoSmithKline (GSK) was found to have withheld information on a controversial drug.
GSK heard today it would not face criminal proceedings over claims they did not raise the alarm quickly enough on the risk of suicidal behaviour associated with the antidepressant Seroxat in the under-18s.
The move comes as a result of a four-year investigatory report compiled by the Medicines and Healthcare Regulatory Authority (MHRA). The Authority had received information from the trials dating back to 2003 which showed patients under the age of 18 had a higher risk of suicidal behaviour if they were treated with the drug, compared to a placebo. Data also revealed Seroxat was not effective for treating depression in children and adolescents.
Health Minister Dawn Primarolo said the government would be taking steps to ensure a 'strengthening' of the law would be introduced throughout the UK and Europe.
She added that she wanted it made clear to all pharmaceutical companies, that "notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health".
While GSK rejected claims it had improperly withheld trial information regarding the drug, MHRA Chief Executive Kent Woods said it was "disappointed" that the company had not given the agency information earlier, adding drug companies had an "ethical responsibility" to do so.
He continued: "I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients and should report any adverse data signals to us as soon as they discover them.
"The investigation has revealed important weaknesses in the drug safety legislation in force at the time."
The Mental Health Foundation's Chief Executive, Andrew McCullough, highlighted concern for the failure to inform the authorities promptly of the risk, saying: "The pharmaceutical industry has played a significant role in the treatment of people with mental health problems over the years – it has a duty to be transparent and rigorous; otherwise it is in danger of losing the public's trust."
(JM/KMcA)
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Northern Ireland WeatherToday:Dry, bright start this morning with best of sunshine in the west. Thickening cloud over Down and Antrim this morning with a few showers, extending westwards this afternoon. Lighter winds. Maximum temperature 16 °C.Tonight:Rather cloudy and mainly dry at first, then showery outbreaks of rain extending westwards to most places during the night, turning heavier towards morning. Light winds. Minimum temperature 8 °C.
