Results 85 to 96 of 102
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02-01-2012, 03:43 PM #85
Re: Anyone Else Depressed Over this Week?
The number of patients and their demographics are outlined in a clinical study. You have no basis for your statement that they tend to find ways to manipulate the results and that has been a rare occurence.
The methodology and results are scrutinized and investigators follow an agreed upon protocol.
A study is peer reviewed before it is published in a reputable journal. If a study is done at Johns Hopkins it is reviewed by a panel of experts before it is published in the New England Journal of Medicine.
When a drug is up for approval it is reviewed by a panel of experts who make recommendations to the FDA. The FDA experts then take over. In most cases they will ask for additional data that might require more studies.
I worked on a drug that was highly recommended by the expert panel. FDA submitted 75 pages of questions that they had constructed.
Three patients out of 8,000 had what appeared to be allergic reactions. FDA required another year of study before approval. There are no short cuts.
It now costs close to a billion dollars to bring a new drug to market from the day the patent is filed. The 17 year patent life starts that day.Last edited by DkBlue; 02-01-2012 at 04:29 PM.
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02-01-2012, 03:53 PM #86
Re: Anyone Else Depressed Over this Week?
Depression is thought to be caused by low serotonin, a neurotransmitter in the brain. Anti-depressants stimulate
serotonin. It is a complex mechanism and does not work the same for all patients. Anti-depressants "wear out."
The body will sense an overoad of serotonin and downregulate itself so there are less receptors available.
Usually the patient is changed to a new drug with a different mechanism.
Not every drug works in every patient.
Side effects are part of the mechanism. Once you are altering neurotransmitters the brain chemistry goes through a lot of changes. Neurotransmitters are powerful chemicals and can cause many side effects.
The receptors control other functions in the body such as sexual desire and nausea. These are not the receptors targeted but they are impacted.
It all goes back to the premise that efficacy can be demonstrated for a certain percentage of patients and the incidence of side effects can be discerned. It is not possible however to say what will happen with any indvidual.
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02-01-2012, 03:58 PM #87
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02-01-2012, 04:37 PM #88
Re: Anyone Else Depressed Over this Week?
I was on the company end as a project director. The medical people rarely make mistakes and it usually consists of allowing patients into the study with pre-existing conditions that may skew the results.
There are study monitors who work with the researchers that monitor everything and also the ethics committee at the hospital has to approve all studies or any changes.
Drugs are initially studied in healthy volunteers, usually med students or interns to determine does range, toxicity, and all the basics. Once you get sick people into a study things can change. Drugs act differently in different age groups and also differently in different ethnic groups.
Studies are often discontinued if something adverse comes up and on the other side of the coin, they are shortened if the results are so good they want to make it available to patients.
Bottom line is drugs are not as exact as the public might think. Some are not well understood. Aspirin for example could not get on the market under today's FDA. Not a chance.
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02-01-2012, 06:11 PM #89Legendary RSR Poster
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Re: Anyone Else Depressed Over this Week?
Might have to move this soon, but since it's the off season (ugh) I suppose we can let this go for a while ....
So let me get this straight. Some of you feel that the science of creating medicine assisting the brains function is all a sham even though that same science has been producing medications that assist the function of the body's other organs?
And you really want to be taken seriously on this?
Oprah has a couch y'all can jump up and down on.
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02-01-2012, 06:16 PM #91Legendary RSR Poster
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Re: Anyone Else Depressed Over this Week?
The brain malfunctions just like every other organ. The brain, among other things, regulates your mood.
Regardless of the reams of evidence that's out there, common sense should tell everyone all they need to know.
Now one thing I will say, it's over diagnosed big time. Same as ADD and ADHD. But that does not diminish the science behind the discovery of the affliction.
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02-01-2012, 06:21 PM #93Legendary RSR Poster
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Re: Anyone Else Depressed Over this Week?
Okay. I've looked and I can't find anything on a resounding yes (and that's what I am looking for).
I've even looked for how to measure for a chemical imbalance, as I would think if someone comes in and says there depressed and doesn't know why, that would be the first step.
I know Google is not the end all be all, but it is not finding me anything when I look for info on it...
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02-01-2012, 07:11 PM #95
Re: Anyone Else Depressed Over this Week?
Twenty years of Cheers.
Thanks Baltimore Ravens Fans - You're the Best!
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02-01-2012, 07:12 PM #96
Re: Anyone Else Depressed Over this Week?
And so once again the clever Steeler troll is allowed to hijack a thread - cause ya'll gave him the fuel to do so!
Twenty years of Cheers.
Thanks Baltimore Ravens Fans - You're the Best!
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