Select committee angry over absence of drug regulator from session
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《英国医生杂志》
Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom抯 drug regulatory authority at a session last week looking into the influence of the drug industry.
Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency抯 executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency抯 predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division.
MPs wanted to question Dr Hudson about the company抯 drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.
Committee members were told that Dr Hudson could not attend the session because he was at a London meeting as a representative of the Committee for Medicinal Products for Human Use, a part of the European Medicines Evaluation Agency.
"It would have been useful if Dr Hudson had been here, as he was at SmithKline Beecham and his department was responsible ," said Mr John Austin (Labour MP for Erith and Thamesmead).
The agency抯 chairman, Alasdair Breckenridge, told MPs he had been a member of the scientific committee of SmithKline Beecham from 1992 to 1997, when he resigned. He fiercely defended his involvement with the committee and denied any knowledge of the issue of the safety and efficacy of paroxetine.
The agency抯 chief executive, Kent Woods, also giving evidence to the committee, said that Dr Hudson had assured him he had no direct personal involvement in this safety issue. "However, because of his role in the company he doesn抰 get involved ," said Professor Woods.
Speaking after the meeting, the committee抯 chairman, David Hinchliffe, who was clearly angry at the committee抯 inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend.
However, Professor Woods, also speaking afterwards, said that some discussion with the committee secretariat about who would attend had taken place and that the agency had received a clear statement from the committee about whom it wanted to see, which did not include Dr Hudson.
Professor Woods and Professor Breckenridge also sought to reassure the committee that measures were now being taken by the agency to monitor new drugs more closely. Both reiterated the views of earlier witnesses that the public needed a better understanding of the risks and benefits of all drugs.
Professor Breckenridge admitted that the agency had "suffered from not being professional enough" in its communications. "We are determined to change that," he said, explaining that the agency has just appointed a communications director.(London Lynn Eaton)
Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency抯 executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency抯 predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division.
MPs wanted to question Dr Hudson about the company抯 drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.
Committee members were told that Dr Hudson could not attend the session because he was at a London meeting as a representative of the Committee for Medicinal Products for Human Use, a part of the European Medicines Evaluation Agency.
"It would have been useful if Dr Hudson had been here, as he was at SmithKline Beecham and his department was responsible ," said Mr John Austin (Labour MP for Erith and Thamesmead).
The agency抯 chairman, Alasdair Breckenridge, told MPs he had been a member of the scientific committee of SmithKline Beecham from 1992 to 1997, when he resigned. He fiercely defended his involvement with the committee and denied any knowledge of the issue of the safety and efficacy of paroxetine.
The agency抯 chief executive, Kent Woods, also giving evidence to the committee, said that Dr Hudson had assured him he had no direct personal involvement in this safety issue. "However, because of his role in the company he doesn抰 get involved ," said Professor Woods.
Speaking after the meeting, the committee抯 chairman, David Hinchliffe, who was clearly angry at the committee抯 inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend.
However, Professor Woods, also speaking afterwards, said that some discussion with the committee secretariat about who would attend had taken place and that the agency had received a clear statement from the committee about whom it wanted to see, which did not include Dr Hudson.
Professor Woods and Professor Breckenridge also sought to reassure the committee that measures were now being taken by the agency to monitor new drugs more closely. Both reiterated the views of earlier witnesses that the public needed a better understanding of the risks and benefits of all drugs.
Professor Breckenridge admitted that the agency had "suffered from not being professional enough" in its communications. "We are determined to change that," he said, explaining that the agency has just appointed a communications director.(London Lynn Eaton)