FDA needs more sophisticated approach to drug safety
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《英国医生杂志》
A much more sophisticated approach is needed on drug safety if the recent debacle concerning rofecoxib (Vioxx) is not to be repeated. This is the view of one of the doctors who first raised fears about the cyclo-oxygenase-2 (COX 2) inhibitor.
Dr Garret FitzGerald, director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania, told a conference in Edinburgh that the problems surrounding rofecoxib could well happen again in a different guise. He blamed the problem on the "absence of science" and the failure to act on emerging evidence of risk.
Rofecoxib was withdrawn by Merck in September when the company acknowledged that the drug carried "serious cardiovascular risks" ( BMJ 2004;329: 816).
Dr FitzGerald told the conference, organised by the Royal College of Physicians of Edinburgh, that his team was reporting plausible biological evidence of a cardiovascular risk as early as 1998, at the time this group of drugs was being launched. Instead of acting on the concerns and conducting further studies, the drug companies sought to dismiss the research.
He called for more rigorous studies to be conducted into the safety of new medicines that would integrate the findings of biochemical, pharmocological, and epidemiologcal research to produce a much clearer picture of their safety profile. That, he said, was more important than introducing organisational changes, such as separating the licensing and drug safety functions of regulatory bodies such as the US Food and Drug Administration. "It is about raising the sophistication of people with drug safety rather than whether or not they sit in different rooms," he said.
Dr FitzGerald was also critical of direct to consumer advertising in the United States, which resulted in millions of people abandoning more traditional non-steroidal anti-inflammatory drugs (NSAIDs) in favour of heavily marketed COX 2 inhibitors.
He said COX 2 inhibitors were originally designed for people with gastrointestinal intolerance but were then marketed to everyone. However, he said it would be difficult either to restrict or to police such advertising in the United States.
Clear lessons can be learned from this experience, and Dr FitzGerald is hopeful that improvements will follow. He said drug safety issues are now being given priority, and the rofecoxib experience may result in a move away from "block-buster" drugs to a much more individual approach. "This is the first move towards individualised medicine. We have to get much more personal in defining benefit and defining risk," he said.(Bryan Christie)
Dr Garret FitzGerald, director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania, told a conference in Edinburgh that the problems surrounding rofecoxib could well happen again in a different guise. He blamed the problem on the "absence of science" and the failure to act on emerging evidence of risk.
Rofecoxib was withdrawn by Merck in September when the company acknowledged that the drug carried "serious cardiovascular risks" ( BMJ 2004;329: 816).
Dr FitzGerald told the conference, organised by the Royal College of Physicians of Edinburgh, that his team was reporting plausible biological evidence of a cardiovascular risk as early as 1998, at the time this group of drugs was being launched. Instead of acting on the concerns and conducting further studies, the drug companies sought to dismiss the research.
He called for more rigorous studies to be conducted into the safety of new medicines that would integrate the findings of biochemical, pharmocological, and epidemiologcal research to produce a much clearer picture of their safety profile. That, he said, was more important than introducing organisational changes, such as separating the licensing and drug safety functions of regulatory bodies such as the US Food and Drug Administration. "It is about raising the sophistication of people with drug safety rather than whether or not they sit in different rooms," he said.
Dr FitzGerald was also critical of direct to consumer advertising in the United States, which resulted in millions of people abandoning more traditional non-steroidal anti-inflammatory drugs (NSAIDs) in favour of heavily marketed COX 2 inhibitors.
He said COX 2 inhibitors were originally designed for people with gastrointestinal intolerance but were then marketed to everyone. However, he said it would be difficult either to restrict or to police such advertising in the United States.
Clear lessons can be learned from this experience, and Dr FitzGerald is hopeful that improvements will follow. He said drug safety issues are now being given priority, and the rofecoxib experience may result in a move away from "block-buster" drugs to a much more individual approach. "This is the first move towards individualised medicine. We have to get much more personal in defining benefit and defining risk," he said.(Bryan Christie)