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Clinical drug trials as ‘clunky’?

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AardvarkGoodSwimmer
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15 Sep 2010, 6:08 pm

"The Deadly Corruption of Clinical Trials," Mother Jones, Sept./Oct. 2010.
http://motherjones.com/environment/2010 ... eca?page=1

“ . . . Yet the CAFE study was not without risks. It barred subjects from being taken off their assigned drug; it didn't allow them to be switched to another drug if their assigned drug was not working; and it restricted the number of additional drugs subjects could be given to manage side effects and symptoms such as depression, anxiety, or agitation. . . ”

---------------------------------------------

Now, this young man, Dan Weiss, was struggling with schizophrenia. And the article, Wow! it just blew me out of the water. The ethics were not at all what they should be. The ‘ethics’ seemed mainly to protect the institution.

And the actual practice of medicine, ‘clunky’ at best, and that’s being charitable. If a medication is clearly not working, you’re then stuck with it for a whole year?!?

Okay, and more commonly, for the treatment of depression, a number of medications, some work for some people, some for others. Offhand, I’d say 6 weeks is plenty of time to try a medication, and if it’s not working, time to start thinking about something else. (I am emphatically not a doctor. However, I am scientifically literate.)

Asperger's is part of who I am. It is not something I 'have.' It is a difference, not a disability, and should be treated with the same matter-of-fact respect as any other human difference. At the same time, a fair number of us do have issues with depression and/or anxiety, and these can sometimes be effectively treated with medication. And for that reason, we should be savvy to these issues pertaining to clinical trials.



StuartN
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18 Sep 2010, 9:56 am

AardvarkGoodSwimmer wrote:
And for that reason, we should be savvy to these issues pertaining to clinical trials.


There are so many problems with clinical trials - they are paid for by the beneficiary drug manufacturer, use their own control groups, report the data in arbitrary ways that inflate benefit, choose exclusion criteria after the trial ends, publish only positive studies, etc, etc. There are moves to register all clinical trials, with pre-defined exclusion criteria and outcome measures, to standardize the results and force dissemination of all (including negative) trials.

Ben Goldacre writes some good bits, occasionally, http://www.badscience.net/category/regulating-research/



pgd
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18 Sep 2010, 10:04 am

One way to look at neurological challenges is to look at first person accounts
written by persons who had a surprising, positive response (not a cure) to a FDA
approved medicine. For some reason, there are very few accounts written. Two
accounts which I am aware of are a Remarkable Medicine book by Jack Dreyfus
about the epilepsy medicine, Dilantin (not a cure) and a How To Cure (part of
the misunderstanding/ignorance surrounding) Hyperactivity book by C. Thomas Wild
about FDA approved medicines Tirend, NoDoz, and Bonine (not cures). In contrast
to these very rare, first person accounts, there is an almost endless array of
fictional (aka second party, third party, hearsay) accounts which come from
pharmaceutical companies, doctors, and the news media which extol the almost
unlimited benefits (continual advertising) of medicines on a daily basis. The
first person accounts can provide some understanding (not a cure) into the whole
area of what FDA medicines do/can't do and so on it seems to me. Apparently FDA
approved medicines do actually work a little for a few users - enough so that it
motivated Dreyfus and Wild to write accounts about their experiences with FDA
approved medicines.



AardvarkGoodSwimmer
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19 Sep 2010, 7:58 pm

pgd wrote:
. . . look at first person accounts
written by persons who had a surprising, positive response (not a cure) to a FDA
approved medicine. For some reason, there are very few accounts written. Two
accounts which I am aware of are a Remarkable Medicine book by Jack Dreyfus
about the epilepsy medicine, Dilantin (not a cure) and a How To Cure (part of
the misunderstanding/ignorance surrounding) Hyperactivity book by C. Thomas Wild
about FDA approved medicines Tirend, NoDoz, and Bonine (not cures). . .

I think this is an excellent point. Most studies seem to jump to the 'please check on the seven-point scale' variety of self-report, and basically do not want to hear full-bodied, descriptive accounts of what it was like for you as a human being to actually have this experience, most probably because such data is messy (I'm sorry, it's fully human, yes, it is messy!) and not easy to put into the nice, neat statistics. And obviously, good science should have both. More of the descriptive early on and more of the statistical later on. But we should never entirely abandon the descriptive.



AardvarkGoodSwimmer
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19 Sep 2010, 8:18 pm

StuartN wrote:
There are so many problems with clinical trials - they are paid for by the beneficiary drug manufacturer, use their own control groups, report the data in arbitrary ways that inflate benefit, choose exclusion criteria after the trial ends, publish only positive studies, etc, etc. There are moves to register all clinical trials, with pre-defined exclusion criteria and outcome measures, to standardize the results and force dissemination of all (including negative) trials.

Ben Goldacre writes some good bits, occasionally, http://www.badscience.net/category/regulating-research/

Yes, these are very much systemic problems and the so-called "public-private partnerships" usually seem to dance to the corporate tunes, now don't they!



Callista
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19 Sep 2010, 8:23 pm

pgd wrote:
One way to look at neurological challenges is to look at first person accounts
written by persons who had a surprising, positive response (not a cure) to a FDA
approved medicine. For some reason, there are very few accounts written. Two
accounts which I am aware of are a Remarkable Medicine book by Jack Dreyfus
about the epilepsy medicine, Dilantin (not a cure) and a How To Cure (part of
the misunderstanding/ignorance surrounding) Hyperactivity book by C. Thomas Wild
about FDA approved medicines Tirend, NoDoz, and Bonine (not cures). In contrast
to these very rare, first person accounts, there is an almost endless array of
fictional (aka second party, third party, hearsay) accounts which come from
pharmaceutical companies, doctors, and the news media which extol the almost
unlimited benefits (continual advertising) of medicines on a daily basis. The
first person accounts can provide some understanding (not a cure) into the whole
area of what FDA medicines do/can't do and so on it seems to me. Apparently FDA
approved medicines do actually work a little for a few users - enough so that it
motivated Dreyfus and Wild to write accounts about their experiences with FDA
approved medicines.
I'm very leery of depending on case studies and testimonials, but I do agree they can be useful starting points for structured research into phenomena associated with medications.


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CockneyRebel
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19 Sep 2010, 10:52 pm

I often find myself questioning Big Pharma.


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AardvarkGoodSwimmer
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11 Oct 2010, 11:56 am

Callista wrote:
I'm very leery of depending on case studies and testimonials, but I do agree they can be useful starting points for structured research into phenomena associated with medications.

My initial reaction is that there’s a big difference between case studies and testimonials. But, on thinking it over, no, not that big a difference. Both are one-shot deals. Yes, a case study is perhaps a doctor observing the patient and doing so in real time, instead of a patient exuberantly reconstructing a series of events after the fact. But still, a one shot deal. And so, for example with depression or anxiety, a person can get better or worse for a wide variety of reasons, of which the medication being taken is only one.

All the same, are we going to so quickly jump to:
‘How is your daily mood?’
7 much improved
6 somewhat improved
5 slighly improved
4 about the same
3 slighly worse
2 somewhat worse
1 much worse

For starters, some people are harder graders than others! And then, anything quirky or offbeat is immediately lost.



AardvarkGoodSwimmer
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11 Oct 2010, 12:01 pm

CockneyRebel wrote:
I often find myself questioning Big Pharma.

And you have good reason to question Big Pharma. For example . .

http://motherjones.com/environment/2010 ... eca?page=3
page 3, first paragraph:
‘ . . . The companies had simply designed the studies in a way that virtually ensured their own drugs would come out ahead—for instance, by dosing the competing drugs too low to be effective, or so high that they would produce damaging side effects. Much of this manipulation came from biased statistical analyses and rigged trial designs of such complexity that outside reviewers were unable to spot them. As Dr. Richard Smith, the former editor of the British Medical Journal, has pointed out, "The companies seem to get the results they want not by fiddling the results, which would be far too crude and possibly detectable by peer review, but rather by asking the 'right' questions." . . . ’


(Although Dan was struggling with schizophrenia, presumably many of these same ‘research’ practices are used for depression, anxiety, bipolar, etc.)



AardvarkGoodSwimmer
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11 Oct 2010, 12:08 pm

And so, if I was struggling with depression and was asked if I wished to participate in a ‘free’ study, I would not. Too big a chance I would be given an inappropriate dose of another company’s drug just so the sponsoring company’s drug would ‘win.’