Thanks for this excellent reminder of the importance of ALL study results, especially negative results. The current system meets the definition of ‘’cherry picking” positive results to gain funding and support. Clearly fraught with danger and distortion of efficacy and risk. But profitable in any case.
But this quote is the most frightening issue: “FDA has limited resources, and we encourage voluntary compliance." A bipartisan consensus has led to regulatory gutting by austerity. Politely and quietly strangling critical agencies. The second part is the sentinel indicator of regulatory capture by industry. The feeling that the industries with massive fortunes at stake are ‘nice guys’ who can be ‘trusted’ to do the right thing ‘if we ask them nicely’ is the kiss of death for regulatory vigilance needed to protect the public from harms while focusing on facilitating approvals based on ‘good enough’ science. The next step on this path is just getting direct payments to rubber stamp and approve anything the industry wants to profit from regardless of (uncounted or reported) harms.
It is unfortunate that the US does not have a political party that seriously believes in and adequately funds a functional government that can actually protect the people from harms by pharmaceuticals and medical technology. Once upon a time it seemed to actually try.
Thanks for this excellent reminder of the importance of ALL study results, especially negative results. The current system meets the definition of ‘’cherry picking” positive results to gain funding and support. Clearly fraught with danger and distortion of efficacy and risk. But profitable in any case.
But this quote is the most frightening issue: “FDA has limited resources, and we encourage voluntary compliance." A bipartisan consensus has led to regulatory gutting by austerity. Politely and quietly strangling critical agencies. The second part is the sentinel indicator of regulatory capture by industry. The feeling that the industries with massive fortunes at stake are ‘nice guys’ who can be ‘trusted’ to do the right thing ‘if we ask them nicely’ is the kiss of death for regulatory vigilance needed to protect the public from harms while focusing on facilitating approvals based on ‘good enough’ science. The next step on this path is just getting direct payments to rubber stamp and approve anything the industry wants to profit from regardless of (uncounted or reported) harms.
It is unfortunate that the US does not have a political party that seriously believes in and adequately funds a functional government that can actually protect the people from harms by pharmaceuticals and medical technology. Once upon a time it seemed to actually try.