Comments on: First Geneva, Now Helsinki: The FDA’s Slide To The Inhuman http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/ Firedoglake weblog Wed, 25 Nov 2009 19:49:20 -0600 http://wordpress.org/?v=2.8.6 hourly 1 By: babybrie http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452689 babybrie Mon, 19 May 2008 22:11:31 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452689 <p>The PharmaCos design their own studies, especially for pre-marketed products. They can also sponsor “IIRs” investigator-initiated research, in other words, studies that are designed by the investigator. </p> <p>It should be noted that the big PharmaCos have to abide by other regulatory bodies, in the EU especially, but also elsewhere in the world, to have drugs approved in those countries. I haven’t had time to read all this material, or the sources, but I can tell you that the EU has been developing very strong directives regarding human subjects. I’m not sure how this FDA decision will affect how PharmaCos operate, given the other bodies to whom they must answer. It’s still appalling, another blot on the US’s reputation in the world.</p> The PharmaCos design their own studies, especially for pre-marketed products. They can also sponsor “IIRs” investigator-initiated research, in other words, studies that are designed by the investigator.

It should be noted that the big PharmaCos have to abide by other regulatory bodies, in the EU especially, but also elsewhere in the world, to have drugs approved in those countries. I haven’t had time to read all this material, or the sources, but I can tell you that the EU has been developing very strong directives regarding human subjects. I’m not sure how this FDA decision will affect how PharmaCos operate, given the other bodies to whom they must answer. It’s still appalling, another blot on the US’s reputation in the world.

]]> By: cbl2 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452607 cbl2 Mon, 19 May 2008 21:05:43 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452607 <p>ps - no one from the front page or mod squad <em>ever</em> owes me an explanation</p> ps – no one from the front page or mod squad ever owes me an explanation

]]> By: rwcole http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452606 rwcole Mon, 19 May 2008 21:05:26 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452606 <p>Doesn’t the title of the new thread show up on everyone’s screen? It does on mine.</p> Doesn’t the title of the new thread show up on everyone’s screen? It does on mine.

]]> By: cbl2 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452605 cbl2 Mon, 19 May 2008 21:04:34 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452605 <p>oh my googdness dakine - so glad you’re here - my remark was in no way aimed at you or others attempting to move the conversation along</p> oh my googdness dakine – so glad you’re here – my remark was in no way aimed at you or others attempting to move the conversation along

]]> By: dakine01 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452602 dakine01 Mon, 19 May 2008 20:57:55 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452602 <p>I think folks got used to receiving the notification that was popping up automatically and that seems to have disappeared in the last week or so (since I think there were server problems a few days ago).</p> <p>We just need to take it upon ourselves to remember the “old days” when the person who captured the zed was expected to announce things downstairs. Some slight re-fresher training if you will. :})</p> I think folks got used to receiving the notification that was popping up automatically and that seems to have disappeared in the last week or so (since I think there were server problems a few days ago).

We just need to take it upon ourselves to remember the “old days” when the person who captured the zed was expected to announce things downstairs. Some slight re-fresher training if you will. :})

]]> By: cbl2 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452601 cbl2 Mon, 19 May 2008 20:55:09 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452601 <p>of course you are right - although this very thing was discussed twice last week - forgive me my impatience and harsh tone</p> of course you are right – although this very thing was discussed twice last week – forgive me my impatience and harsh tone

]]> By: earlofhuntingdon http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452600 earlofhuntingdon Mon, 19 May 2008 20:54:33 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452600 <p>I guess we need minders to tell us the gas gauge in the car is on empty, too. Or has the tyranny of low expectations infected progressive blogs as well as the White House?</p> I guess we need minders to tell us the gas gauge in the car is on empty, too. Or has the tyranny of low expectations infected progressive blogs as well as the White House?

]]> By: egregious http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452597 egregious Mon, 19 May 2008 20:50:31 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452597 <p>If a delay of 6 minutes between the new post and notification is ”rude and inconsiderate,” perhaps we need to encourage more pups to be involved in sharing the news sooner. There is no “someone,” only the community.</p> If a delay of 6 minutes between the new post and notification is ”rude and inconsiderate,” perhaps we need to encourage more pups to be involved in sharing the news sooner. There is no “someone,” only the community.

]]> By: LS http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452596 LS Mon, 19 May 2008 20:49:05 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452596 <p>Could be.</p> <p>Personally, I think they attempted their slow coup starting in 2000…I don’t think they can sustain it because of the mistakes they’ve made and the fact that the people are against them at this point in time, but I don’t think they will leave without a fight….I’m glad to hear what Spook thinks…that makes me feel a little better!</p> Could be.

Personally, I think they attempted their slow coup starting in 2000…I don’t think they can sustain it because of the mistakes they’ve made and the fact that the people are against them at this point in time, but I don’t think they will leave without a fight….I’m glad to hear what Spook thinks…that makes me feel a little better!

]]> By: earlofhuntingdon http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452594 earlofhuntingdon Mon, 19 May 2008 20:45:56 +0000 http://firedoglake.com/2008/05/19/first-geneva-now-helsinki-the-fdas-slide-to-the-inhuman/#comment-1452594 <p>Allowing the use of placebos as the standard for comparison, rather than the current standard drug treatment, seems both faster and cheaper and potentially fraudulent. </p> <p>Placebos cost virtually nothing (but then that’s close to the actual production costs of some pharmaceuticals) and their use in place of the current standard treatment avoids tracking the continued effectiveness of that standard treatment in the test environment, with test subjects. </p> <p>More importantly, this new test protocol seems to compare the potentially new with the zero, ie, no treatment at all. Aspirin might perform wonderfully in that fixed arena. It would also seem to make it harder to compare these test results with the performance of existing drugs developed using older test protocols. Giving us only oranges to compare with apples, and giving new drugs a new, lower standard to beat. The net effect seems to make these “new” products, sometimes only mild variations of current products, look effective when they may not be as effective as even current treatments. </p> <p>In the ever more competitive world of patented pharmaceuticals, anything seems to be fair game, including patients’ health. Testing drugs offshore (or on) should not descend into some John le Carre novel’s universe, where mega-companies and drug empires make their own rules, which governments dutifully follow and for which they provide cover, and which make Cold War spies’ behavior look ethical and blameless. But rest assured; our friendly pharmaceutical companies will regulate themselves and their profits in our best interest.</p> Allowing the use of placebos as the standard for comparison, rather than the current standard drug treatment, seems both faster and cheaper and potentially fraudulent.

Placebos cost virtually nothing (but then that’s close to the actual production costs of some pharmaceuticals) and their use in place of the current standard treatment avoids tracking the continued effectiveness of that standard treatment in the test environment, with test subjects.

More importantly, this new test protocol seems to compare the potentially new with the zero, ie, no treatment at all. Aspirin might perform wonderfully in that fixed arena. It would also seem to make it harder to compare these test results with the performance of existing drugs developed using older test protocols. Giving us only oranges to compare with apples, and giving new drugs a new, lower standard to beat. The net effect seems to make these “new” products, sometimes only mild variations of current products, look effective when they may not be as effective as even current treatments.

In the ever more competitive world of patented pharmaceuticals, anything seems to be fair game, including patients’ health. Testing drugs offshore (or on) should not descend into some John le Carre novel’s universe, where mega-companies and drug empires make their own rules, which governments dutifully follow and for which they provide cover, and which make Cold War spies’ behavior look ethical and blameless. But rest assured; our friendly pharmaceutical companies will regulate themselves and their profits in our best interest.

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