article "MS drug trial a fiasco"

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

Postby cheerleader » Sun Jun 06, 2010 9:04 am

Scorpion...unbelievable. This is a thread on the UK drug fiasco.
Let's just go back to the 1930s and EAE....the model used to create the CRAB drugs. This is when the vascular paradigm of multiple sclerosis was clarified by lab coats and science, and taken away from those crazy voodoo doctors in animal pelts.....

In the early 1930s, Thomas Rivers and colleagues provided the first evidence that immune cells can attack the brain. Their simple experiments established what is now the most well-studied model of autoimmunity—the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis.

Many versions of the EAE model now exist, which vary both in the strategies used to evoke disease and in the resulting pathology. Critics of the EAE model question whether this animal model is truly reflective of human MS, as many EAE models trigger a specific acute syndrome, whereas most human disease involves cycles of relapse and remission. Vijay Kuchroo (Harvard University) defends the EAE model, pointing out that “each model recapitulates a small piece of the human disease,” and has provided valuable insights into the human disease. Lawrence Steinman (Stanford University) seconds Kuchroo's sentiments, adding, “To say that EAE has little to do with MS would be to ignore that two approved treatments for MS [Copaxone and Tysabri] were developed as a result of experiments in the EAE model.”
The EAE model has also shaped the modern day evaluation of vaccines by contributing to the understanding of how a vaccine, independent of the organism it is intended to generate immunity against, can sometimes have devastating side effects.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2212888/

The CRABS/EAE apologetics of the last 70 years is a hall of mirrors....MS must be autoimmune because the drugs work/the drugs work because MS is like EAE, the drugs prove it in mice. What if the drugs don't work, and EAE in mice is nothing like MS? That is the question which is currently being studied by science.
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Postby Sotiris » Sun Jun 06, 2010 9:07 am

I have a difficulty getting the point of the previous messages. Maybe my english is not so good and I misunderstood something. In any case I suggest viewing the following video. Dr. Galeotti is closing his presentation on the CCSVI workshop in Sardinia (April 24).
:arrow: http://www.youtube.com/watch?v=5RzWQRe_ ... r_embedded

PS. I dont mean the one of cheerleader (it was not there)
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Postby mshusband » Sun Jun 06, 2010 9:16 am

scorpion wrote:Please take heed. Sorry for the long post but I think it is worth it. According to Robert Park PHD these are the seven warning signs of Bogus Science.

1. The discoverer pitches the claim directly to the media.

The integrity of science rests on the willingness of scientists to expose new ideas and findings to the scrutiny of other scientists. Thus, scientists expect their colleagues to reveal new findings to them initially. An attempt to bypass peer review by taking a new result directly to the media, and thence to the public, suggests that the work is unlikely to stand up to close examination by other scientists.


Some scientific claims avoid even the scrutiny of reporters by appearing in paid commercial advertisements. A health-food company marketed a dietary supplement called Vitamin O in full-page newspaper ads. Vitamin O turned out to be ordinary saltwater.
2. The discoverer says that a powerful establishment is trying to suppress his or her work.
The idea is that the establishment will presumably stop at nothing to suppress discoveries that might shift the balance of wealth and power in society. Often, the discoverer describes mainstream science as part of a larger conspiracy that includes industry and government.
3. The scientific effect involved is always at the very limit of detection.

4. Evidence for a discovery is anecdotal.

If modern science has learned anything in the past century, it is to distrust anecdotal evidence. Because anecdotes have a very strong emotional impact, they serve to keep superstitious beliefs alive in an age of science. The most important discovery of modern medicine is not vaccines or antibiotics, it is the randomized double-blind test, by means of which we know what works and what doesn't. Contrary to the saying, "data" is not the plural of "anecdote."
5. The discoverer says a belief is credible because it has endured for centuries.

There is a persistent myth that hundreds or even thousands of years ago, long before anyone knew that blood circulates throughout the body, or that germs cause disease, our ancestors possessed miraculous remedies that modern science cannot understand. Much of what is termed "alternative medicine" is part of that myth.

Ancient folk wisdom, rediscovered or repackaged, is unlikely to match the output of modern scientific laboratories.
6. The discoverer has worked in isolation.

The image of a lone genius who struggles in secrecy in an attic laboratory and ends up making a revolutionary breakthrough is a staple of Hollywood's science-fiction films, but it is hard to find examples in real life. Scientific breakthroughs nowadays are almost always syntheses of the work of many scientists.
7. The discoverer must propose new laws of nature to explain an observation.

A new law of nature, invoked to explain some extraordinary result, must not conflict with what is already known. If we must change existing laws of nature or propose new laws to account for an observation, it is almost certainly wrong.

But as I finished the list, I realized that in our increasingly technological society, spotting voodoo science is a skill that every citizen should develop.


Re:

Point 1> This may have been true in the old days or in a common disease everyone could find out about this about. But in MS (a not high population of people have) to get the word out MAYBE the media is necessary anymore. Also, Dr. Zamboni is not necessarily making MONEY off of this, I could see in cases like your Vitamin O ... this is not the same. Argument doesn't fit. So are you telling me the lung cancer drug being touted on news channels in the US (CNN/FoxNews) is junk science because its researchers put it in the media any more than CCSVI?

NOPE.

Point 2> I don't think neurologists are trying to "stop" CCSVI. I think people think that because they go to their neurologists and this isn't what they've learned for 30 years+ so they can't intelligently speak about it. Aside from that ... it is what it is. The drug companies however, have never dealt with IRs but they better get on board and prove their drugs help post-CCSVI or they might be in trouble. Again, invalid argument.

Point 3> Everything with MS is almost at the limit of detection. Can you tell me someone with MS feels pain by looking at them? Or feels numbness? Nope ... so the whole MS theory is at the limit of detection. I guess MS is junk science (it seems for the last 70 years since EAE theory came about it has been) ... again, argument invalid.

Point 4> See point 3 ... same thing. I can tell you (even though I don't have MS) today my legs hurt because I ran the other day. Go ahead test me and tell me how you can "prove" my legs hurt? And by the time you test them or figure out which test is significant in a few days (if I don't run again) ... they probably won't hurt. Again, argument against CCSVI is invalid.

Point 5> A lot of "scientists" thought the earth was round long before it was actually proved to be round. Besides your modern drugs can't prove they work or don't work. There is no true test of this anyway. The only way to tell if drugs work or not would be to have the same person cloned (test them with the drug in the clone, and don't test the drug on the non-clone at the same time doing the same things in life) ... MS is unique to each individual ... so trials are flawed in the first place. Point invalid ...

Point 6> Jonas Salk cured polio ... he worked on his own. Hmmmm ... I guess that was junk science because he worked alone (even though it's been proved years later through more research). Fine how about Louis Pasteur? Point invalid.

Point 7> There is nothing about MS that is "law", just ask any neurologist a litany of questions and see how many "we don't knows" you get. Point invalid.

Scorpion, I don't know if you and your ilk (Lyon, Concerned, PatientX and a few others) have MS or not ... but NEVER get the CCSVI treatment, and let EVERYONE ELSE GET IT ... we'll see who is better off.

Thanks for playing.
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Postby concerned » Sun Jun 06, 2010 9:41 am

I think having a bullshit detector is important, but I guess i'm just of that ilk? I imagine any scientist worthy of that title would agree.

Also, my mother has MS not me, and I'm not against anyone trying the "treatment" out in a controlled study, I just think people should wait until those studies are done before they make claims about miracle healing powers, unless, as it seems to be expressed here often, it really is just a matter of faith, in which case no further studies are needed before it goes down the memory hole.
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Postby concerned » Sun Jun 06, 2010 9:45 am

Also if your legs hurt, that would suggest pain signals in your brain in the areas which map out your leg feelings, etc. Couldn't this maybe be detectable on a fMRI?

Lesions and other hallmarks of MS are detectable in an MRI, but "CCSVI" requires special training in interpreting the images.
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Postby MrSuccess » Sun Jun 06, 2010 9:56 am

MS Husband .... good reply ... but you are suffering fools gladly . I agree with all but one on your list. I would not include PX with that group.

PX is an intelligent [ unlike Bob ] longtime contributor here at TIMS.

That said , PX ... sometimes push's the envelope ....... and I call him out when he does :twisted:

PX ... more often than not ..... produces research publications of great interest to pwMS.



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Postby Hope66 » Sun Jun 06, 2010 10:02 am

"Lesions and other hallmarks of MS are detectable in an MRI, but "CCSVI" requires special training in interpreting the images.[/quote]

I think this statement is misleading. I believe that MRI tech's are trained and skilled in reading the MRI's and that not all lesions are MS related. They too have to be trained to identify those lesions which are "suggestive" of MS.

I also think the EAE/autoimmune theory is a bit like "parking lot science" (i.e. the story of the guy who lost his keys in a far corner of a parking lot at night but looks for his keys under a lightpost in the middle of the lot because that's where the light is).

Cheers,
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Postby cheerleader » Sun Jun 06, 2010 10:02 am

This thread is not about CCSVI. It is about CRABS efficacy. There are enough threads going "debunking" CCSVI. And if these thread devolves into another "yo Momma" thread of insults and weirdness, jimmy might start putting people into corners for time outs.

Here is commentary on the fiasco from Dr. Ebers (a man in a white coat) Read his entire commentary and his references for a more complete picture.
G C Ebers, Action Research professor of clinical neurology

Many specialists thought the visually obvious spots on MRI "were the disease." As a result MRI scanning soon became indispensable for multiple sclerosis trials and individual high profile MRI centres capitalised on lucrative contracts with industry. Over the next two decades, little effort was made to validate the suppression of MRI spots against hard disease outcomes. Amid the enthusiasm for short term MRI monitoring of the impact of interferons, their lack of impact on long term disability (despite suppression of MRI spots) in patients with secondary progressive disease was ignored.

Although the drugs have been licensed for 20 years, we still have no clear evidence on long term outcome. This is because the FDA failed to tie approval of interferon to mandatory follow-up for hard outcomes in the original trial patients, as had been suggested, and did not enforce its requirement for validation of the original surrogates.9 The agency, beset by aggressive criticism from Congress, shifted the onus for gauging effectiveness onto practising physicians. Many US and EU physicians failed to perceive the added responsibility. A Cochrane review had conceded very short term efficacy only. 10 Evidence from more recent long term studies is not definitive and ascertainment is suboptimal.11 12 13

The sobering interim findings from the risk sharing scheme spotlight important broad issues about the importance of determining efficacy in chronic diseases, in particular, the methods required to do this. The scheme also emphasises the "fragility" of adopting surrogate outcomes of impact. Shortcuts are wanted and needed, but measures with face validity and formal validation remain essential.


http://www.bmj.com/cgi/content/full/340/jun03_1/c2693
Last edited by cheerleader on Sun Jun 06, 2010 10:06 am, edited 1 time in total.
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Postby concerned » Sun Jun 06, 2010 10:04 am

Can we not get into personal attacks? Or if that's the norm on this board (most people seem pleasant and polite) I guess let's just all have a free for all of name calling and flame wars!
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Postby mshusband » Sun Jun 06, 2010 10:09 am

I don't mean to call ANYBODY out ... I don't want this to become and "us" vs. "them" thing.

But those are the names I continuously being ANTI-CCSVI even when good points are brought up by doctors that show CCSVI COULD be relevant. Medical Doctors who have studied this ... yet the stance of a few is well Zamboni this or somebody else that ... it's like their mind is closed as much as anyone else's mind is open.

I've always said trials are needed for CCSVI, to which everyone agrees. But yet there are no trials going on ... let's get the trials started.

IF you're of the ANTI-CCSVI ilk, sign up now on a list that says I'll wait until all trials EVER are over to be treated. I'll let everyone else go first. Otherwise, if you can't do that then you must at least hold out some hope that CCSVI is something ... just a few people, I don't get why they post in this forum if they are so ANTI-CCSVI ... because really they bring nothing to the conversation except to say well there are no trials or irritate people and question everything with the same old lame arguments. I agree there aren't YET. There will be though ...

In the end ... there IS going to be something to CCSVI ... I don't know how they don't see that. Whether it's the be all end all stand alone ... we don't know ... but it's more of a start than any of the current CRABS drugs offer that's for sure.

Too bad betaseron isn't named petaseron ... so it could be CRAPs drugs instead (which is what they are).
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Postby sbr487 » Sun Jun 06, 2010 10:09 am

scorpion wrote:Please take heed. Sorry for the long post but I think it is worth it. According to Robert Park PHD these are the seven warning signs of Bogus Science.

1. The discoverer pitches the claim directly to the media.

The integrity of science rests on the willingness of scientists to expose new ideas and findings to the scrutiny of other scientists. Thus, scientists expect their colleagues to reveal new findings to them initially. An attempt to bypass peer review by taking a new result directly to the media, and thence to the public, suggests that the work is unlikely to stand up to close examination by other scientists.


Some scientific claims avoid even the scrutiny of reporters by appearing in paid commercial advertisements. A health-food company marketed a dietary supplement called Vitamin O in full-page newspaper ads. Vitamin O turned out to be ordinary saltwater.


Dr. Zamboni has published papers on CCSVI. It is for anyone to read. Its only the neuros who have not read it.

2. The discoverer says that a powerful establishment is trying to suppress his or her work.
The idea is that the establishment will presumably stop at nothing to suppress discoveries that might shift the balance of wealth and power in society. Often, the discoverer describes mainstream science as part of a larger conspiracy that includes industry and government.


Dr. Z has been shown real class when it comes to presenting CCSVI. Go take a look at Dr. Freedman and Dr. Khan once.

5. The discoverer says a belief is credible because it has endured for centuries.

There is a persistent myth that hundreds or even thousands of years ago, long before anyone knew that blood circulates throughout the body, or that germs cause disease, our ancestors possessed miraculous remedies that modern science cannot understand. Much of what is termed "alternative medicine" is part of that myth.

Ancient folk wisdom, rediscovered or repackaged, is unlikely to match the output of modern scientific laboratories.

Exactly, CCSVI pionners have presented papers while a neuro's (dont remember the name) argument was that MS isn't vascular was proven in 80's itself (no proof does not mean theory is incorrect). Now who is blindly using history to his credit?

6. The discoverer has worked in isolation.


Yes, thats the reason why Kuwait was able to replicate because Dr. Zamboni's results were hidden from everybody.

7. The discoverer must propose new laws of nature to explain an observation.


Thanks for letting us know that vascular and haemodynamics is a new field in medicine and is in complete contradiction with everything that modern medicine stands for. I wonder where Dr. Dake, Sclafani, Sinan got their degree (probably from Mars)

Anyway, thanks for all the hardwork you put in for the welfare of uneducated MSers like us ...
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Postby concerned » Sun Jun 06, 2010 10:15 am

Mr. Success called me a fool.

I know that this is about CRABS drugs, and i'm not sticking up for them, but it is in the CCSVI forum so there is some relation, we're not just totally off base.
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Postby cheerleader » Sun Jun 06, 2010 10:22 am

In a final attempt to keep the ball on the field, I will link to commentary by Dr. Alastair Compston, head neurologist and proponent of the scheme---he admits that the results were very disappointing.

Many who once supported the scheme now do not; others remain loyal. Probably, no one expected that the first analysis would show a worse clinical course in treated patients than controls. But the result is credible. Attempts to force drug companies to repay costs would be likely to trigger complex legal arguments given the debate over methodological issues. So should the risk sharing scheme now be closed and the financial losses written off? Not until after the second analysis, due late in 2010, that uses the new control group and aims to resolve many other ambiguities identified, has reported.

Regardless of the scheme’s outcome, it has advanced the situation for people with multiple sclerosis. Now that the principles of when and who to treat are better understood, more effective treatments can be developed. The culture and platform for prescribing and managing this difficult disease, and the specialist teams who support these patients, are also infinitely better in 2010 than they were in 2002. The risk sharing scheme has contributed to these welcome advances in the management of multiple sclerosis.


http://www.bmj.com/cgi/content/full/340/jun03_1/c2707
Let's please just read the research and comment on that, OK?
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Postby jackiejay » Sun Jun 06, 2010 10:30 am

do you think that the doctors' continuing message to patients will be to continue on your DMD if you appear to be doing well....lesser lesions, no relapses, etc. or will they change their views after this BMJ article's report that these drugs are actually ineffective.
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Postby cheerleader » Sun Jun 06, 2010 10:43 am

jackiejay wrote:do you think that the doctors' continuing message to patients will be to continue on your DMD if you appear to be doing well....lesser lesions, no relapses, etc. or will they change their views after this BMJ article's report that these drugs are actually ineffective.


I think what Dr. Compston is stating (linked above) is that this situation has given the neurologists a clearer picture of which drugs work better for whom, and when to administer them. I believe we'll be seeing more tests like the one out of Stanford, clarifying who is a better responder to interferon, and new drugs, like Campath, being introduce into the larger RRMS community. And that will take another 10-20 years of study to clarify. But I doubt we'll hear anything about this report in the US. Maybe Canada?
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