The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug - an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
More Quotes from Peter Lurie:
I don't think that's good enough. People don't poke around in the latest issue looking for conflict-of-interest statements.Peter Lurie
The circumstances regarding this study raise troubling questions about the ability of the government to effectively issue rules protecting public health when studies are conducted, controlled and selectively published.
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In effect, it's an empty promise, ... The FDA's drug advertising division has been drastically understaffed for decades, and there's no reason to believe that will change anytime soon.
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Lead wicks are unnecessary in candles, and the industry has acted recklessly by continuing to manufacture them, ... Now the agency should complete the notice and comment necessary to complete the rule making as rapidly as possible.
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Before, you couldn't get back and forth to these countries the way you can now. You couldn't share data electronically the way you can now. Even if people had the temptation to go overseas before because of less regulation, more compliant populations or study designs that they couldn't pull off locally, logistically it was not possible until recently. That's where globalization comes in.
Peter Lurie
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