Validity of drug trials

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Validity of drug trials

Postby sou » Fri Mar 04, 2011 4:49 am

My apologies if this issue has been discussed before.

MS drugs, just like any other drug, must undergo clinical trials. In double blind controlled trials, the participants are divided in at least 2 groups: 1 placebo group, 1 group receiving the drug. The selection criteria of patients are quite strict. In general, they must not suffer from other chronic diseases, but the one trialed.

How valid are all MS drug trials to date, since the participants were never checked whether they suffered from chronic venous insufficiency or not? This would render the trial results void.

Only MS patients without CCSVI should be eligible for drug trials, or else the results will be inconclusive. I think that all drug trials to date should be performed again from scratch, because they have been performed on non-qualifying participants.

PS: I understand that finding MS patients without CCSVI is quite difficult, but this is definitely not my problem. Science is a bitch. I propose screening patients with MS and create 2 separate groups: MS/CCSVI and MS/no-CCSVI so as to know whether the drug is safe an effective for all of them.

In addition, until the trials are over, the drugs should not be given to MS patients with or without CCSVI because they have not been adequately tested in proper trials.
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Postby Cece » Fri Mar 04, 2011 7:07 am

I agree, if CCSVI is a comorbidity of MS, to keep the data clean you'd want to find patients without the CCSVI to be in the trial. (What, there are none? ;) )
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Postby 1eye » Fri Mar 04, 2011 12:38 pm

Anybody volunteer to tell the FDA their approval of a lot of 'MS' drugs is based on studies with participants who should have been excluded? Shouldn't they take them off the market?
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Postby gauchito » Sat Mar 05, 2011 8:17 pm

If this were to occur it would be fantastic. It would be lethal for the official world system of MS that prevents science from looking for new solutions to a long standing problem. Just imagine for a while if CRAB´s were suspended until new valid trials are performed. What would be the world like? Immediate event would be interruption of $12 billion revenue stream that the 4 big pharma get annually (figures obtained from respective financial reports to NYSE). Then, the official system of MS would fall to pieces in a matter of months and new approaches to the truth might show up freely.
Just dreaming......
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Postby sou » Sun Mar 06, 2011 3:47 am

I see 2 options here:

1. If they accept that MS is CCSVI, thus the trials are valid, they have just admitted that MS is CCSVI....

2. If they don't accept that every patient with MS have CCSVI, they have to perform the trials from scratch because they included patients with more than one chronic conditions..

Both options lose...
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Re: Validity of drug trials

Postby frodo » Sun Mar 06, 2011 5:29 am

sou wrote: In general, they must not suffer from other chronic diseases, but the one trialed.


This is great!! Using their own logic, all published trials are invalid for people with CCSVI. What will neuros say now? this idea should be posted to "Direct-MS", "Angioplasty for all" and any other fighting organization.
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Re: Validity of drug trials

Postby sou » Sun Mar 06, 2011 6:12 am

Could be, but we should first find the documentation of the exact trials that led to approval and, if possible, the hundred thousands pages of the approval applications (BLAs).
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Postby scorpion » Sun Mar 06, 2011 7:22 am

sou wrote:I see 2 options here:

1. If they accept that MS [b]is CCSVI, thus the trials are valid, they have just admitted that MS is CCSVI..[/b]..

2. If they don't accept that every patient with MS have CCSVI, they have to perform the trials from scratch because they included patients with more than one chronic conditions..




Both options lose...



Besides internet bloggers, I have not heard ANY of the researchers involved with CCSVI make such claims as the two above; especially that MS is CCSVI. If I am wrong please link me to the the researcher/scientist who made this statement.
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Postby Lyon » Sun Mar 06, 2011 8:16 am

..
Last edited by Lyon on Thu Jun 23, 2011 6:13 pm, edited 1 time in total.
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Postby jimmylegs » Sun Mar 06, 2011 8:59 am

...
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Postby sou » Sun Mar 06, 2011 11:39 am

Jut a clarification: Perhaps "accept" is not the correct word, but English is not a native language for me. I meant "based their defence on". I talk hypothetically. For me CCSVI and MS are different conditions, but CCSVI does exist. I hope my opinion is clear and makes sense.

Lyon, they will have to prove how common are problems in the IJV/VV/azugos/hemiazygos veins, since there is nothing in the bibliography for healthy people but the ones having found statistical significance in MS groups. Until then, the studies should be considered incomplete. It is a clinical trial, meaning that the environment and variables must be 100% controlled.

In addition, you can't perform such a study without having taken into account the perfusion of the participants' brains. Did they measure it? Did they drop out participants with less than normal perfusion? They only assumed it was normal, not measured. You can't approve drugs based on incomplete data, can you?

PS: These are just thoughts. I don't know whether they make sense or not. I am just thinking out loudly. I haven't read the full text of the approval studies (they are not offered for free).
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Postby Cece » Sun Mar 06, 2011 11:54 am

Lyon wrote:Considering that it's never been effectively shown that venous "abnormalities" aren't common in the general populations, it remains that "Option" number 3 might well be that no one has perfect veins and that there really is no such thing as venous "insufficiency" at all (therefore no damage caused by it).

Lyon, did you have a chance to read what I posted recently about permissive lesions? Option #4 is that the abnormal veins tip people over into having MS when a secondary factor is involved (a multitude of abnormal veins? a hyperactive immune system?). Treatment is to treat the permissive lesion(s).
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Postby jimmylegs » Sun Mar 06, 2011 12:12 pm

sou, you make sense although i'm not sure it's productive to set up dichotomies. http://en.wikipedia.org/wiki/False_dilemma

neither is it productive to inject further hyperbole, or 'trichotomies' for that matter ;)

i prefer to think of cases occupying points along a spectrum, but even that idea is too linear... maybe an escher-esque 3D spectrum :)

as for the credibility of research, i remember hearing some kind of statistic about the amount of past scientific literature that has proved to be wrong. here is a single result from a very quick search, but:
Dr. John Ioannidis .. "charges that as much as 90 percent of the published medical information that doctors rely on is flawed."

no matter the research subject, we're all trying to navigate our way through a mire of biases, our own and those of others!
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my approach: no meds so far - just nutrient-dense anti-inflammatory whole foods, and supplements where needed
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Postby 1eye » Sun Mar 06, 2011 12:40 pm

jimmylegs wrote:no matter the research subject, we're all trying to navigate our way through a mire of biases, our own and those of others!


Not speaking for me, are you? My own! Well I never. ;-)

Anyway I agree this is one for the journalists & lawyers. It casts even more doubt on a lot of research used to justify billions of $ of spending by insurance companies and governments on already doubtful drugs.
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Postby jimmylegs » Sun Mar 06, 2011 12:43 pm

sorry i forgot 1eye, you got the get out of bias free card ;P
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