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On Bias in Pharmaceutical Studies

Recently, many psychologists, psychiatrists, the general public, and the media have been becoming more aware of bias in pharmaceutical research.  The most recent work found that researchers design the study in order to favor the medication that is sponsored by the funding source.  In this post, I will talk about some of the problems with pharaceutical study research design.

The Placebo Washout Phase

Nearly all studies of pharmaceuticals, at least psychotropics, include an initial phase in which people who respond (read benefit) from a sugar pill are excluded from the study.  So, if in the initial phase, they get better on placebo, they are excluded from the study.  Purportedly, this is to remove an unimportant variable.  But what this does is amplify the effects of the medication in the actual study.  So, the drugs end up looking like they have a greater effect than they actually have.  You end up with a group of folks who purportedly do not respond well to placebo taking an active drug versus a sugar pill.  If you are going to run this type of study, the results need to state, "For people who are poor responders to placebo, the drug proved to be moderately efficacious."  That would be a more honest way to present the results, but I have never seen this occur.  The exclusion of 'placebo responders' amplifies the effect of the 'drug.' 

Use of Percentages in Results

I have seen a number of popular drugs tested against placebo and the only statistics you find in the article to be "percent who achieved remission."  You read the whole article and the only thing presented is percentages and statistics to tell you if the percentages who fall into certain groups differ.  This is also done so that the drug looks better than placebo.  As an example, please see my previous analysis of on a study of antidepressants (Prozac) in children.

The Double Blind is not Blind

The double-blind research design is considered to be the 'gold standard' in pharmaceutical research.  It is purported to be the most objective and best way of determining whether or not a drug has efficacy.  The double-blind experiment is accurately described on Wikipedia:

Double-blind describes an especially stringent way of conducting an experiment, usually on human subjects, in an attempt to eliminate subjective bias on the part of both experimental subjects and the experimenters. In most cases, double-blind experiments are held to achieve a higher standard of scientific rigour.

So, the assumption is that the researchers do not know which group the study participants have been assigned, and the participants do not know which group they have been assigned to.  Ah....but there's a problem here.  Previous research with antidepressant medication, reveals that both patients and doctors are pretty good at figuring out which group they are in, most likely because of side effects.

Some Solutions to the Problem

If you are reading pharmaceutical research that does not include a check to see if the blinding actually worked (in other words ask the researchers or physicians what group they think the participant is in and ask the participant what group they think they are in), uses a placebo washout phase, and only uses percentages or stats to tell if the percentages differ, be very skeptical of this research.  Irving Kirsch has proposed a model for research that includes an 'active placebo,' in other words a drug that produces side effects, but in theory does not act in the same way as the drug.  This should help to actually insure the 'blind' of the study.  Finally, when research is funded by a pharmaceutical company, you need to be very skeptical of the results.  If researchers are going to receive pharmaceutical industry funding, they need to be blind to the 'who' is funding them.

16 Jul

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A glimse

This is Day 4 of detox cold turkey from my effexor after 3 years of taking them. Right now I am feeling like I am wearing Magneto Helmet.  My head feels so darn heavy and it is like my vision is blocked.  My eyes feel so heavy and like there is pressure coming both from the inside and the outside.

This morning I completely freaked out; my whole body was in pain; my whole skin was feeling like it was crawling with god knows what.  I almost scratch myself to the blood.  Jackson prepared me  bath and stayed with me.  He kept on talking, reassuring me that everything is going to be alright and that it is my mind playing tricks on me because of the detox.

But a least I think I can somewhat start to see a glimse of the light in all this.  It is not clear, I can't grasp it, but i've felt it.  I can't really write right now because of how I feel but I know it's going to be ok. I can believe it.  I think I can almost remember who I am truly.  I think I can go back to being myself.

15 Jul

Antidepressants ‘’Don´t Work'’

“Prozac, used by 40m people, does not work say scientists” reads the headline in The Guardian today. This newspaper and others report that a study which pooled all available data comparing Prozac and similar antidepressants with inactive “dummy” pills found that placebo was just as effective as the drugs. The study’s authors say that antidepressants proved more effective among severely depressed patients. However, the scientists add that this could be due to a reduction in the effect of placebo rather than because the drugs worked better, according to The Times.

The scientists told The Independent that “given these results, there seems to be little reason to prescribe antidepressant medication to any but the most severely depressed patients, unless alternative treatments have failed".

Continue Reading »

15 Jul

Put on your red shoes and dance

Been miserable and depressed as hell the last few days, but where's the fun in talking about that? Had a therapist appointment yesterday and a shrink appointment on Thursday, therapist called shrink and shrink called in a zoloft Rx since the lithium doesn't seem to be doing it by itself, hopefully things will be better soon.

What is fun to talk about is Gavin dancing around (and getting me to dance with him) to this "muskick" this morning. I started reading my friend Jeff's blog, and found myself at the Davey Dance Blog. It's like this:

Davey Dance-BLOG. A project started while traveling Europe during Spring 2007. Armed only with an ipod and a Canon PowerShot, Davey picks a location and a pop song. Then Davey records an improvised dance.

The most recent one is in front of Cinderella Castle at the Magic Kingdom. This guy is hilarious, and I love how random people come join him in his dance. Bear in mind that the other people can't hear any music, and it's just classic. Check out the little boy dancing in the background, and you'll get an idea of how Gav was while listening. Go on to the rest of his blog and see everything else we listened to -- and danced to -- this morning.

[vodpod id=ExternalVideo.633355&w=425&h=350&fv=clip_id%3D1334655%26server%3Dwww.vimeo.com%26autoplay%3D0%26fullscreen%3D1%26md5%3D%26show_portrait%3D0%26show_title%3D0%26show_byline%3D0%26context%3D%26context_id%3D]

more about "Davey Dance Blog -50- ORLANDO - The B...", posted with vodpod

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