Cochrane report

A board to discuss the Multiple Sclerosis modifying drug Copaxone

Cochrane report

Postby HarryZ » Fri Nov 05, 2004 1:06 pm

OK...here is a revisited article on Copaxone by the Cochrane Group which is a non-profit organization.

I would imagine that Teva, the makers of Copaxone, wouldn't have the Cochrane Group on their Christmas list this year...if ever!!

Harry

http://www.pharmalive.com/News/index.cf ... eid=186200
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Postby OddDuck » Fri Nov 05, 2004 1:12 pm

:lol:

No comment, Harry! :wink:

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Suspicisions Validated

Postby coach » Fri Nov 05, 2004 2:51 pm

My suspicions validated. Posts about the pharmaceuticals industry have been interesting. Think I may send my ex-neuro a copy of this FHI (for his information)
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Postby HarryZ » Sat Nov 06, 2004 7:45 am

Deb,

Teva operates the internet MS Watch Forum in Canada and the US. The operators of the Canadian Forum and I have had some "disagreements" in the past over comments that I have made on their site. They don't like anyone giving opposite points of view against the CRAB drugs!!

I wrote them a message this morning and asked if they would object to their readers having the ability to read the Cochrane Copaxone info on the site that I posted yesterday. I already know what their answer will be but suggested they should be in a position to defend their product.

I'll let you know what happens.

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Postby OddDuck » Sat Nov 06, 2004 10:17 am

Hey, I totally agree, Harry!

Lots of "claims", but they won't even attempt to show you where or how they arrived at their conclusions, huh? (Not referring to Cochrane, but to the "forum" you mention.)

Way to go! :lol: Keep me posted.

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Postby Ptwo » Sun Nov 07, 2004 5:37 am

Harry,
I'm not sure about mswatchca but the U.S. version has discussed the Cochrane reviews at least a dozen time starting back in March when they were first released. This latest publication has been pasted in a couple of times. There has been no censorship of the threads.

Things I've wondered about the Cochrane review are, why did they exclude the mri data, and why did they include the PP study. Including a study for PP in a drug thats approved for RR can obviously skew the results.

Here is a study of the other 3 trials alone.
http://www.ncbi.nlm.nih.gov/entrez/quer ... s=12926839

Effects of glatiramer acetate on relapse rate and accumulated disability in multiple sclerosis: meta-analysis of three double-blind, randomized, placebo-controlled clinical trials.

Boneschi FM, Rovaris M, Johnson KP, Miller A, Wolinsky JS, Ladkani D, Shifroni G, Comi G, Filippi M.

Department of Neuroscience, Scientific Institute, University H San Raffaele, Milan, Italy.

Three randomized, double-blind, placebo-controlled trials have shown that glatiramer acetate (GA) is effective in reducing relapse rate in patients with relapsing-remitting (RR) multiple sclerosis (MS). Using raw data pooled from 540 patients, we performed a meta-analysis of these three trials, to investigate whether the extent of GA efficacy varies according to disease-related variables at study entry. Three regression models were developed to assess the efficacy of GA on the annualized relapse rate (primary outcome measure), on the total number of on-trial relapses and on the time to first relapse. We also explored the efficacy of GA on accumulated disability and the potential role of baseline clinical variables as predictors of relapse-rate variables and treatment efficacy. The mean adjusted annualized relapse rate on study was 1.14 in the pooled placebo-treated subjects and 0.82 in the pooled GA group (P = 0.004), indicating an average reduction in annualized relapse rate of 28%. About a one third reduction of the total number of on-trial relapses was also observed in patients receiving GA (P < 0.0001), who had a median time to the first relapse of 322 days versus a median time to the first relapse of 219 days seen in those receiving placebo (P = 0.01). A beneficial effect on accumulated disability was also found (risk ratio of 0.6; 95%; CI = 0.4-0.9; P = 0.02). The drug assignment (P = 0.004), baseline EDSS score (P = 0.02) and number of relapses during the two years prior to study entry (P = 0.002) were significant predictors of on-trial annualized relapse rate. No other demographic or clinical variable at baseline significantly influenced the treatment effect. This meta-analysis reaffirms the effectiveness of GA in reducing relapse rate and disability accumulation in RRMS, at a magnitude comparable to that of other available immunomodulating treatments. It also suggests that GA efficacy is not significantly influenced by the patients' clinical characteristics at the time of treatment initiation.

Publication Types:
Meta-Analysis

PMID: 12926839 [PubMed - indexed for MEDLINE]

--------------------------------------------------------------------------------
Even though I've been on Copax for 44 months I'm not sure that it's had any impact on my ms. I've not had a relapse, there's been no change in my mri and my EDSS score has improved during the time I've been on it, but is it the copax or my natural coarse of the disease. We may never know.

I wonder how well Prokarin or LDN would do in a Cochrane review if there was enough or any data on those drugs to warrant a review.

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Postby HarryZ » Sun Nov 07, 2004 8:12 am

Peter,

I have sent an e-mail to one of the MS Watch Canada forum administrators and asked if he would have any objection to posting the Cochrane review link. This is the same person who has written me a couple of times to warn me against posting information that goes beyond relating personal experiences with MS??!! It appears from what you have said the US site is far more liberal.

As for the Cochrane report..... from what I have read so far, these people look at clinical trials differently than do the drug companies. They are far more objective and analyze the entire picture. In as much they are MS researchers as well, they have come up with a very different perspective on Copaxone. Even the FDA supposedly admitted the initial data to gain their approval was minimally convincing and Copaxone offered very little benefit to MS patients. So here we have Teva on one side of the fence stating that Copaxone is great for MS while the Cochrane group is saying something totally opposite! Now they can't both be right and it's the MS patient in the middle who has to try and figure out who to believe!!

You mention how LDN and Prokarin would stack up to the Cochrane group.

I'm going to assume that the backers of both these drugs would love the opportunity of having the Cochrane people perform the same kind of analysis. But before that can happen you must have clinical trial data to look at. We know that LDN so far has not had any scientific trials done for its use on MS. That may change by early next year. The only data collected so far has been from surveys by people who know how to do this. The results showed the LDN users benefited to the same level as Copaxone users but again, not scientific. I suppose that if I had to make a choice based on this info only, I would choose LDN because of the cost, lack of side-effects and easy application versus Copaxone.

Now let's look at Prokarin. One pilot non- standard trial and one full, double-blind random clinical trial which was published by The MS Journal in February 2002. The Journal stated the results of Prokarin on MS fatigue were encouraging and further trials were warranted. Unfortunately, trials cost a lot of money and EDMS, the company behind Prokarin, simply doesn't have that kind of money. And the NMSS, in typical fashion, torpedoed the study ( a lot of history here) and actually tried to convince the editor of The MS Journal to recant the publication!! He refused and stated the trial was good science and done properly.

If you look at the NMSS's action on both these drugs, they have gone out of their way to cast an "evil spell" on them. They have also got help from some neurologists as well. Dr. Craig Smith, a noted MS neurologist from the Seattle area, stated at a conference in Chicago, that 20 people had died while using Prokarin!!! When challenged about his comments later on, he denied that he had said such a thing....but a number of people around him at the time stated that he did indeed make such a comment. It's amazing what some people, who are considered professionals, will say out of ignorance! I'm not sure if some docs or the NMSS feel threatened by other drugs that present a totally different direction on treating MS. We can only guess at their reasons.

The bottom line here....MS still has no known cause, certainly no cure and a variety of approved drugs that give minimal benefit to a small group of patients. And all this after 70 years of research!!! No wonder Dr. P. Behan wrote in his Pathogenesis of MS that the results of MS research to date have been simply abysmal!! And what are Teva, Biogen, Burlex and Serono doing today....conducting "head-on" trials against one another to try and prove their drug is better than the other one. Perhaps if I was the CEO of one of these companies and going after the $ 4.5 billion MS drug market, I may be doing the same thing!!! Ugh!!

Take care.

Harry
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Postby Ptwo » Sat Nov 13, 2004 5:59 am

Harry,

Hopefully you'll never end up with a chronic disease and have to make one of the toughest choices a person has to make. Do I believe big pharma and the science or go the alternative route and follow the anecdotal evidence? Until a person personally walks in those ms shoes I'm not sure they can say which way they would go.

On the Cochrane report I still have a hard time accepting their results. Somehow the inclusion of the PP study in with the RR studies in a drug approved for RR seems counterintuitive. Wouldn't you use only RR data if you were studying a drug approved for RR? It looks like an apple & oranges kind of thing to me.

The Cochrane report did say one interesting thing:" Glatiramer acetate did not show any significant effect on disease progression, measured as a sustained worsening in the Expanded Disability Status Scale (EDSS). On the other hand, a slight decrease in the mean EDSS score, driven by a major study, should be considered " Is it just me or is this a contradiction?

If LDN is as good as Copaxone and Copaxone is no good, how good is LDN?

With the caffeine in Prokarin it's not a surprise that it helps with fatigue. When I'm fighting ms fatigue a couple pots of coffee usually gets me going. I wonder how Prokarin would do in a head to head with Jolt chewing gum.

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Postby HarryZ » Sat Nov 13, 2004 9:15 am

Peter,

Hopefully you'll never end up with a chronic disease and have to make one of the toughest choices a person has to make. Do I believe big pharma and the science or go the alternative route and follow the anecdotal evidence? Until a person personally walks in those ms shoes I'm not sure they can say which way they would go.


You are absolutely right of the difficulty in making a decision in this circumstance. My wife has made the same statement to me many times and she has suffered from MS for over 30 years!

If big pharma could be trusted the decision would be easy but what we have seen in the past number of years is that they can't. One only needs to look at Warner-Lampert who are under criminal charges for their disgusting fraud with Neurontin. Another problem is that the MS patients' docs don't always properly discuss with them all of the possible treatments available. In many cases they simply tell the patient that they are going to be prescribed "this drug" and the docs don't even bother to tell them much about the drug that they are going to use.

On the Cochrane report I still have a hard time accepting their results. Somehow the inclusion of the PP study in with the RR studies in a drug approved for RR seems counterintuitive. Wouldn't you use only RR data if you were studying a drug approved for RR? It looks like an apple & oranges kind of thing to me.


The Cochrane people looked at Copaxone overall, including ALL the trials they did for its effect on all MS. From what I have read, the vast majority of the trials were for RRMS. They came up with their unbiased report and I have a tendency to believe them far more than Teva. The Cochrane people have nothing to gain, especially monetarily from this report and everything to lose because they knew what kind of reaction they would get from the established MS world of medicine. Interesting to note that the recent response from the "established MS world" centred on continued support for Copaxone and the CRAB drugs but it did not appear to challenge the technical info that the Cochrane report stated.

It certainly does leave the MS patient out in the cold as to whom to believe.

The Cochrane report did say one interesting thing:" Glatiramer acetate did not show any significant effect on disease progression, measured as a sustained worsening in the Expanded Disability Status Scale (EDSS). On the other hand, a slight decrease in the mean EDSS score, driven by a major study, should be considered " Is it just me or is this a contradiction?


I guess it all depends on what their intent was here. I think the overall bottom line is that they stated that Copaxone simply wasn't beneficial based on the data that they reviewed.

If LDN is as good as Copaxone and Copaxone is no good, how good is LDN?


You have to take this statement within the context of which it was written. That is the difficult part of understanding what a person means on the internet. The validity of LDN's anecdotal effect was questioned. I was merely quoting an internet survey that was done by a statistician who compared what info he got with LDN to that of published data on Copaxone. The results were the same. Based on this, I would prefer taking LDN which is far less expensive, has few if any side-effects and extremely easier to administer.

The LDN data was simply a survey...certainly not scientific. Copaxone's data has been challenged by the Cochrane report. If you use the lowest common denominator here and state that neither drug can show effect, I would still use LDN and avoid all the pitfalls of using Copaxone.

With the caffeine in Prokarin it's not a surprise that it helps with fatigue. When I'm fighting ms fatigue a couple pots of coffee usually gets me going. I wonder how Prokarin would do in a head to head with Jolt chewing gum.


You know, Peter, this perception about Prokarin is one of the most misunderstood parts of the medication and some docs make the same ignorant(please don't take this word in a derogatory manner) comment about it. Often they will suggest you stop at Starbucks along the way and get the same kind of reaction!!

Now let me give you the scientific information. Prokarin uses caffeine citrate in it. The drug is used solely to control the metabolism of the histamine diphoshate into your system. Otherwise, the half-life of histamine diphosphate is about 50 minutes and if allowed to break down uncontrollably, it is of little use to you. The amount of caffeine citrate in a daily dose of Prokarin would be equivalent to sipping on ONE cup of coffee over a 16 hour period. And that assumes you absorb 100% of the Prokarin and that rarely, if ever, happens. Now if that gives any MS patient a continuous buzz and avoids fatigue, then I suggest they dump all their meds and drink a lot of coffee during the day :-))

Another fact.....during the Prokarin double blind trial, the patients on placebo had a higher caffeine blood serum level than did the patients on the Prokarin. Nothing like scientific fact to destroy humorous fiction!!! THe docs that highly criticized the trial conveniently overlooked the data that was clearly written in the actual study.

Again, I never tell a MS patient what they should take...I always strongly advocate that they demand their doc to go over all the possible medications with them and allow the patient to become part of the decision making process. That, unfortunately, doesn't happen as much as it should. And I still don't trust the pharmaceutical industry when it comes to telling everything about their drugs.

Harry
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