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What Has the Vioxx Debacle Taught Us?
Medical journal editors, physicians and medical researchers are all rethinking how results of clinical trials are presented in the scientific literature. Maybe the bar needs to be raised. It's easy to criticize a pharmaceutical company-sponsored clinical trial on the grounds that the desire to present the science in a way that is most favorable to the product being tested outweighs scientific rigor.
That's not really fair, though. True, a company such as Merck is anxious to see favorable data published. But articles in scientific journals are not simply advertisements. They aren't even considered for publication unless they've met several criteria.
First, the article must address a significant question. An example of such a question would be whether or not a new drug is safe and more effective than existing medications for an important condition such as arthritis.
Second, strong methodology must be used in the study. An appropriately large number of participants, good statistics and careful controls all contribute to the legitimacy of a clinical trial's design.
Third, the findings of the study should clearly lead to a conclusion that means something. Less-than-conclusive findings are not very publishable.
Finally, the study design, analysis and presentation must be deemed acceptable by reviewers who examine the article with expert eyes. Only the most significant findings made from well-designed studies are published in top peer-reviewed journals such as the New England Journal of Medicine.
Those articles that are published should be reliable beyond any reasonable doubt. Scientists, physicians and patients should be able to count on the validity of the published results absolutely. And that's exactly the reception the article on Vioxx published in 2000 was given. The fact that the NEJM retracted the article late last year shows that the reliance placed on the integrity of these particular published results was in fact misplaced.
Hopefully, it doesn't happen all that often. But, in this case, it looks like several of the checks and balances which usually prevent less-than-solid findings from being published failed. The authors of the article failed. The reviewers failed. And the NEJM editors only 'succeeded' when they took the unusual step of retracting the article four years after its publication.
We need to do better. Next time - what questions to ask about preliminary results if you're considering participating in a clinical trial.
-Joe
Related Topics: Lawmakers: Doctors Misled on Vixx Safety, Timeline of Pain Reliever Controversy
That's not really fair, though. True, a company such as Merck is anxious to see favorable data published. But articles in scientific journals are not simply advertisements. They aren't even considered for publication unless they've met several criteria.
First, the article must address a significant question. An example of such a question would be whether or not a new drug is safe and more effective than existing medications for an important condition such as arthritis.
Second, strong methodology must be used in the study. An appropriately large number of participants, good statistics and careful controls all contribute to the legitimacy of a clinical trial's design.
Third, the findings of the study should clearly lead to a conclusion that means something. Less-than-conclusive findings are not very publishable.
Finally, the study design, analysis and presentation must be deemed acceptable by reviewers who examine the article with expert eyes. Only the most significant findings made from well-designed studies are published in top peer-reviewed journals such as the New England Journal of Medicine.
Those articles that are published should be reliable beyond any reasonable doubt. Scientists, physicians and patients should be able to count on the validity of the published results absolutely. And that's exactly the reception the article on Vioxx published in 2000 was given. The fact that the NEJM retracted the article late last year shows that the reliance placed on the integrity of these particular published results was in fact misplaced.
Hopefully, it doesn't happen all that often. But, in this case, it looks like several of the checks and balances which usually prevent less-than-solid findings from being published failed. The authors of the article failed. The reviewers failed. And the NEJM editors only 'succeeded' when they took the unusual step of retracting the article four years after its publication.
We need to do better. Next time - what questions to ask about preliminary results if you're considering participating in a clinical trial.
-Joe
Related Topics: Lawmakers: Doctors Misled on Vixx Safety, Timeline of Pain Reliever Controversy
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