Wednesday, December 29, 2010

Where we are and where we might be heading



It appears that all or at least most of the attention in the past has gone to arteries and precious little time has been spent studying veins. This past year has had the pendulum swing back and veins are now getting some long overdue attention.

Right now, attention is being given to the clogging of veins and the application of stents to keep them open in some patients. It is clear, listening to some CCSVI doctors on UTube, that size of the stents and the balloons is important - something that was truly guesswork a year ago. It is very possible that correctly sized stents are indeed the answer for some people and is the answer without fear of them moving anywhere and causing any ill effects.  I rather expect that the sizing will become just another automatic part of this procedure, though I do not think it has reached that point yet. I am no doctor or scientist but this seems to fall more under logic than science.

Perhaps the materials used in making balloons and stents can be improved upon?

Perhaps the day will come when the location of clogged veins will be more apparent. Perhaps there is a correlation between specific symptoms and specific veins. Or between specific degrees of disability and size of the clog. Clearly, looking at   Linda’s
results, the answer to keeping the dragon in retreat, is to keep the veins open.

One would hope that someone, somewhere, will find a way to prevent veins clogging altogether – perhaps there is a mineral missing in our diets or maybe it is too much of something in our diet that causes this. This could have the happy result of stopping our seniors from getting that very delicate skin where they are constantly becoming bruised at the slightest touch. Perhaps it will end up also being an answer for people with other conditions who are presently in the same limbo we are just emerging from.

I do have hope that our up and coming scientists are more open minded than this past group. Some old things are best left where they are but the old way of approaching disease – pre 1950, pre TV and pre mass marketing, was good. Cures and preventions happened more often then than they do now. Mass marketing is great for things like batteries and cleaners and like that; it enforces progress in those products. It is absolutely the worst thing that ever happened to medicine and drug companies; it impedes growth, encourages greed and deceipt..

Friday, December 24, 2010

Happiness is......................

December 24, 2010



Happiness is......................

Vascular Angioplasty !

Well it's not here in Canada yet but it is available to those who can afford to leave the country to get it, and I really and truly think it will be here soon. This has been the most interesting and hope filled year in a good many for me and I am sure for a good many other MSers.

There were days when there was not much point in even getting up but since CTVs W-5 show last year with Dr. Zamboni I have had the best motivation to get up - the need to fight and get this made available here in Canada. In the meantime I have learned a lot about the condition and about the treatments, both good, bad and indifferent. I have found enzyme therapy for myself that is working for me and I rather think that a combination of angioplasty and enzyme therapy might end up a good working combination. But enzymes do not need to be fought for - they are out there. Vascular angioplasty, unfortunately does need to be fought for.

Serracor-NK!

I started taking these about a month ago. And I had a side effect I could live without – an over active sinus! I sneezed 24/7 and I dripped enough to launch the Queen Mary!  SO……………………..I wrote the company about my side effect - it is rare according to them and in fact, no one I know who has tried them - 3 people so far, have not had this problem. So I am back on them taking a antihistamine at the same time and doing fine. I am going out tomorrow (to a friends for Christmas) without my walker - just taking my cane which I am bringing out of retirement. My energy level must be higher - I have gotten a good deal more done than I used to. Energy level is perhaps harder to notice until after you have done something. I do not feel energetic but I also do not feel so worn out so fast either.
 It has been years since I have said, "I'm starving".  I am never hungry and eat because it is the polite thing to do when visiting or once a day because if I don't I will starve to death. Today when I got up I was starving like in the good old days. Another of those things I never really gave much thought to.

I had most of my nose removed when I had cancer there. After the operation I figured I could not smell because they had removed all the smell sensors. Lately, I find myself noticing smells - like I got on an elevator after someone who was wearing Old Spice and I could smell it. Amazing and totally unassociated with MS. Perhaps if I can smell food cooking again, I will be hungry more often??

I have been self catheterizing for over a year because I could not squeeze  even a drop. Now I am getting back to normal with my bladder. Not there yet but getting there and do not catheterize as often any more.

About 15 years ago I was diagnosed with irritable bowel syndrome. Then I was told it wasn't that - it was MS. Doesn't matter what it was because "was" is the right tense to be using. That is all working absolutely normally again. THANK GOD!

The cog fog is still showing it's ugly face - some days worse than others. I still get headaches but no where near as many. The balance is still off but definitely getting better at least for short jaunts. I still dare not turn around in a hurry or I end up face down on the ground. The fatigue is still around but no where near as bad a it has been. I feel the blood flowing through my useless right hand and it is now warm to the touch instead of icy cold all the time. Unfortunately, I still cannot feel what I am holding so still drop tings when my concentration is broken.

 It is too bad that it is impossible to get an ultrasound on my vascular system - I wonder if I have blocked veins and if I do, are these enzymes are helping clear them up? Perhaps they could replace the blood thinners being given to angioplasty patients. Perhaps angioplasty can be reserved for only the worst cases of blocked veins? Perhaps if they are taken post angioplasty, they would cut down or maybe cut out the need for redoing the procedure? I guess we'll never know cause I can't get the ultrasound.

 Anyway, I have been on them only about a month and I am quite happy with the results. This in itself is quite a statement to be reading from me - I was a bit of a skeptic when I first got them!

 Tomorrow is Christmas so I wish everyone here a very Merry Christmas and a Happy New Year!!


P.S. Want to read more Adventures of 21st Century MSers?

http://www.facebook.com/notes/arlene-pellar-hubbard/year-end-thanks...

http://ccsvi-ms.ning.com/profiles/blogs/the-liberation-hymn


http://ccsvi-ms.ning.com/profiles/blogs/christmas-came-early-for-me




Have a Happy!!
Karen - MS dragon Slayer

Monday, December 20, 2010

We Expect Our Women in Politics to Roar, not Mewl

December 20, 2010




           My Letter to Ministers of Health, Ontario and Federal - it went out today.

Until 1929 women were not legally recognized as “persons” in Canada. We, women, fought long and hard for that distinction. We, women,  followed that battle with one that allowed us to vote and then another to allow us to have seats in Parliament. One would think that having fought so hard, we would work even harder to convince everyone that we deserved it because we were, after all, capable of reasonable thought. And furthermore we could now use that status to help other Canadians in ways that only other women know are important. You know - women as nurturers.

Well that was the idea until you two ladies showed up and proved that theory wrong.

More women than men suffer from MS. We need help. Help is out there. But instead of acting like women and having us hear your roar, we are instead subjected to drivel that comes straight out of the mouths of self serving men such as Mark Freedman, Alain Beaudet and Yves Savoie but it is served up by two women, who should be our champions.

But champions for women and men with MS you are definitely Not! How do I know? Well aside from the fact that you parrot three men who have their own agendas, you can't be bothered to respond to anyone who writes you; the odd time you do it is a form letter and clearly the wording on cigarette packages is more worthy of your time than the 76,000 Canadians with MS.

Well the cigarette thing is getting old and stale. It is sometimes downright idiotic - eg  Vogue's package warns that it causes impotency. Here is a wee history lesson. After WWII, hoards of people were smoking, including women who would not have dreamed of smoking before the war. After the war we had a baby boom. Correct me if I am wrong but if smoking causes impotency, how the sam hell did a baby boom come about.  It is not even logical. Do not mistake this for a pro smoking statement - it isn't. But I fail to see how packaging of anything is more important than people suffering from MS.

Form letters are insulting.

And those three men are the last men on earth you want to rely on. Read the drivel from Alain Beaudet at December 7th's Parliamentary Subcommittee on Neurological Disease. Listen to Mark Freedman on CTVs w-5 show or go and read all the misrepresentations on the MS Society site that Yves Savoie obviously approves of.

When are you going to start thinking................like women who care. When are you going to cast aside those props and start acting based on logic and compassion? When are you going to start listening to the Canadian people - 75%, according to Angus Reid,  who think vascular angiopathy should be allowed in Canada.

When, ladies?

Sincerely

Karen Copeland

Saturday, December 18, 2010

December 18, 2010



Dr. Ashton Embry posted this on Facebook and CCSVI Locator. I  copy it here. If you are Canadian and care even a tiny bit about people with MS, Please remember the double cheap double talk you are about to read in the next Federal election.  It is time to put the Conservatives right back where they were in  1993.

Subcommittee on Neurological Disease – CCSVI Evidence from Alain Beaudet - December 7, 2010

 Dr. Ashton Embry: 

Below is the transcript of the recent meeting of the Parliamentary Subcommittee on Neurological Disease at which Alain Beaudet ( the head of CIHR who rigged the August meeting on CCSVI to ensure no worthwhile research would be undertaken) was questioned regarding the latest developments on CCSVI.

Beaudet continued his classic doublespeak and outright false statements on such topics as the unknown assocation of CCSVI with MS, the lack of safety of the procedure, and the claim that everyone is receiving good aftercare.

Kirsty Duncan asked some excellent, penetrating questions which Beaudet either ignored or dodged around.

I found it most interesting that the Conservative MP on the Subcommittee, Colin Carrie (MP, Oshawa), is clearly anti-CCSVI and his questions were simply fat pitches to allow Beaudet to expound on various nonsense issues such as how we have no clue if CCSVI is associated with MS (12,000 + procedures have decided this issue beyond all doubt).

Sadly it appears that CCSVI has become a political football with the Conservatives doing what they can to prevent any research and progress on CCSVI and the Liberals and NDP trying to get to government to do what is best for persons with MS. Anyone with MS or anyone who cares about persons with MS has to do some serious reflection if they support the Conservative party.
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Subcommittee on Neurological Disease of the Standing Committee on Health
–  CCSVI Evidence from Alain Beaudet

Tuesday, December 7, 2010



The Chair (Mrs. Joy Smith (Kildonan—St. Paul, CPC)):

     Good morning, everybody, and welcome. Everybody looks wide awake, so this is a good sign.

    Pursuant to Standing Order 108(2), we are doing our study on neurological diseases.

    Dr. Beaudet, we want to welcome you.

    Dr. Beaudet, as you all know, is from the Canadian Institutes of Health Research.

    Doctor, I will give you as long as you need to make your presentation this morning.



Dr. Alain Beaudet (President, Canadian Institutes of Health Research):

    Thank you, Madam Chair.

    I'm pleased to appear before you today in my role as president of the Canadian Institutes of Health Research to provide you with an update on recent activities related to multiple sclerosis research in Canada. This devastating disease affects, as you know, thousands of Canadians. CIHR is committed to fund research that will alleviate the suffering of Canadians with MS and their loved ones.

    First, I would like to share with you what CIHR has been doing on the issue of chronic cerebrospinal venous insufficiency and MS during the last three months.

    As you may remember, in early September 2010, the Honourable Leona Aglukkaq, Minister of Health, accepted my recommendation that this issue be investigated in a standard scientific step-wise manner, first by determining whether or not there is an increased prevalence of venous malformations and impaired brain venous drainage in patients with MS as compared with healthy controls, and second, should this association be proven to exist, by proceeding with a clinical trial to evaluate the safety and efficacy of Dr. Zamboni's procedure. This position was endorsed by all provincial and territorial ministers at their September meeting in St. John's.

    Already, seven studies sponsored by the Canadian and U.S. MS societies have been launched to determine whether there's a link between chronic cerebrospinal venous insufficiency and MS. To monitor the results from these studies, as well as from related studies from around the world on venous anatomy and MS, CIHR has set up a scientific expert working group.

    This group is made up of the principal investigators of the seven MS Society-sponsored studies, the scientific leadership of CIHR and U.S., Canadian, and Italian MS societies, and a representative from the provinces and territories. The working group held its first meeting on November 23 in Toronto.

    At this meeting, members of the Working Group reported on the progress they were making on their initiative, funding for which was provided in June 2010. Six of seven studies have been approved by the ethics committee and the seventh is in the approval stage.

    The patient selection process for the trials is going very well, with two studies having already met their patient quota. Judging from the reports I have received, Madam Chair, I can say that stringent protocols are being followed and committee members can be assured of the quality and serious nature of the studies now under way. I am confident that these studies will determine whether or not there is a link between cerebrospinal venous insufficiency and MS and thus help us to decide if clinical trials on the procedure itself should be funded.

    The experts did stress, however, that it was important to give researchers all the time they needed to conduct these trials, without putting any undue pressure on them. The Working Group also noted that Dr. Zamboni's proposed treatment wasn't without risk, as evidenced by the growing number of complications reported by Canadian patients after they were treated abroad and following the recent tragic death of one such patient.

    Consequently, the experts recommend that all future therapeutic clinical trials include a treatment safety assessment.

     The seven projects are progressing at an appropriate pace to meet their targets. The members of the working group agreed to meet next June to review preliminary results, and the MS Society of Canada will be posting summaries of these seven research projects on its website in the new year.

    In the meantime, CIHR will continue to work closely with the MS Society of Canada and other stakeholders, such as physician associations, to share research evidence as it becomes available to build greater understanding of this devastating disease.

    Patients should be discouraged, however, from seeking treatment abroad until more is known on the safety and efficacy of this treatment. But they should also be made aware that no physician will refuse to see and treat them for complications of a treatment received abroad.

    I would also like to inform your committee that I will be providing an update of the working group's first meeting to provincial and territorial deputy ministers of health at their meeting on Thursday of this week in Toronto. This meeting will be a good opportunity for all participants to share information on any new developments with regard to this issue.

    In conclusion, I would like to highlight the fact that CIHR is currently funding numerous research projects aimed at better understanding and at eventually developing a treatment for MS. In fact, CIHR has funded approximately $49 million in MS-related research since its inception.

    Madam Chair, in closing, let me assure you that CIHR and all researchers involved are working as fast as possible to investigate this issue and provide the best science-based advice possible to patients and their families.

    I will be pleased to keep the members of this committee apprised of our progress.

    Thank you.



The Chair:

    Thank you, Dr. Beaudet.

    Now we'll go into our seven-minute Q and A, beginning with Dr. Duncan.



Ms. Kirsty Duncan (Etobicoke North, Lib.):

    Thank you, Madam Chair.

    Thank you for coming, Dr. Beaudet.

    Thank you for clarifying that no patient will go without follow-up in this country, because they have been going without. I'm aware of one patient who was denied treatment by four different specialists. So thank you for that reassurance.

    Before I begin, could I ask you to table with the committee an agenda from the August 26 meeting, all the papers reviewed and any presentation or notes from it? Thank you.

    Could I also ask that you table with the committee the work plan from the expert working group, who the panellists are, the mandate, schedule of meetings, timeline, what evidence will be reviewed to reach a decision about clinical trials—hopefully, a registry—and how much evidence will be necessary to reach a decision to proceed with clinical trials?



Dr. Alain Beaudet:

    These are very good questions. Actually, they're all the questions that were discussed at the inaugural meeting that was held in November.

    Certainly, I will be pleased to post the documents regarding the composition of the committee and a summary of the discussions at our meeting.

    It's a very unusual situation. As you know, usually when researchers receive a grant, they do the research, and they're very silent about their progress because there's intellectual property involved, as you know, and there's also competition involved. Don't try to imagine that there's no competition between these groups. They publish the results, and it's only when the results are published that they start talking about it.

    We're doing things very differently this time--very differently. We're asking them to share their results at every step along the way and to be totally open about them. I must say, the response has been fantastic. At the end of the meeting, they all agreed that they were a tad reluctant to proceed in that way, but it had been a fantastic day because they actually learned and shared and got ideas that will allow them to go faster.

    They also agreed that they would—after what was, as you can imagine, a very long discussion—reveal their results in six months. Why six months? Why not faster? It was because they all felt that there would be so few results before the end of June that it could be misleading. But they felt that at the end of June they'd have a sufficient amount of preliminary data that it will be meaningful.

    Now, we're talking about blinded studies that they will agree to “unblind”, so they can share. It's a very unusual situation, and we won't be able to share those results with the external world, for intellectual property reasons that you can understand.



The Chair:

     The time is limited.



Ms. Kirsty Duncan:

    I'm also concerned that the new expert panel website has been down for a week, and I'm wondering when it will be up and running again.



Dr. Alain Beaudet:

    I wasn't aware of that. I'll make sure that--



Ms. Kirsty Duncan:

    Thank you.



Dr. Alain Beaudet:

    It went up yesterday, I'm told.



Ms. Kirsty Duncan:

    It didn't, because I checked at about midnight last night.

    I would like to know who the Canadian neurologists are on that website, please.

    Dr. Alain Beaudet:

    The Canadian neurologists are basically the researchers who received a grant from the MS Society.



Ms. Kirsty Duncan:

    Is Dr. Freedman on that list?



Dr. Alain Beaudet:

    Dr. Brenda Banwell is on that list. She's one of the recipients. They're all the grant recipients.



Ms. Kirsty Duncan:

    Is Dr. Freedman on the list?



Dr. Alain Beaudet:

    There's no Dr. Freedman on the list.



Ms. Kirsty Duncan:

    Thank you.

    I am wondering if you will require every member of the new expert panel to declare their conflicts of interest.



Dr. Alain Beaudet:

    That's a good point. It has been asked and it will be done.



Ms. Kirsty Duncan:

    That's good, because just as ECTRIMS does, it eliminates the possibility of real or perceived conflicts of interest.



Dr. Alain Beaudet:

    You're absolutely right. It's an issue that was discussed, and we agreed they would all sign such a declaration of conflict.



Ms. Kirsty Duncan:

    I really appreciate that.

    At the third international scientific conference on CCSVI that I attended—I've attended three of the four, and I didn't attend the fourth because it was a week after the third—we learned that neurologists are admitting that their patients are improving. This is the fundamental question we have.

    I'd like to know if you can table with the committee whether we have heard from these neurologists. Have they followed their patients? How have they responded? What if any improvements have they tracked on EDSS scores?

    A prominent Canadian neurologist has written that the veins of MS patients are no different from those of anyone else. I would like to know how Dr. Beaudet responds to this, when Dr. Mark Haacke of the U.S. has identified 48 different venous abnormalities of the chest, neck, and spine.



Dr. Alain Beaudet:

    That's the issue we're facing. There's a lot of anecdotal evidence.



Ms. Kirsty Duncan:

    No, I've seen the MRI images.



Dr. Alain Beaudet:

    There's also a neurologist who last week asked me, “What do I tell my patient who says he's really feeling better after the procedure? I've actually seen the EDS score and the NMR, and both have worsened. It's going to be heartbreaking if I tell the patient the truth. What do I do?”

    We have to be very careful about the subjective “feeling better” and the objective way.

    But let's come back to the veins. The problem is exactly that. On the one hand you have people who say there's a huge difference between patients with MS and healthy subjects. On the other hand you have people who say they're exactly the same and there's no prevalence in MS patients. That's exactly what we're trying to solve. That's what we need to solve.



The Chair:

    Thank you, Dr. Beaudet.

    We'll now go to Mrs. Hughes.



Mrs. Carol Hughes (Algoma—Manitoulin—Kapuskasing, NDP):

    I'm sorry I missed the beginning of your speech. I would like to have heard a bit more of it. If I'm asking you to repeat, I apologize for that.



Dr. Alain Beaudet:

    There's no problem.



Mrs. Carol Hughes:

    You indicate that no one goes without treatment. I'm wondering how you're getting the message out there in the medical field. We want to make sure the message is out there, and we don't want to hear of another case where someone was refused.

    My view is that if you're not feeling well, no matter what the reason that may have brought you there.... We could talk about someone who was a drug addict and may have taken drugs. Does it mean that because they took drugs we shouldn't even go there?

    How is that message being put out there? Is it something that will be repeated?



Dr. Alain Beaudet:

     It's an important message. I'm communicating with the heads of the various professional associations and colleges to ensure that the message is sent or transmitted.

    It's very interesting that in the working group, most of these researchers are also physicians. They all see patients, they all see patients with MS, and most of the these researchers are linked to major MS clinics in Canada. They're the ones who noted that something had been carried in the press to the effect that they were not seeing patients who were coming back, that they were refusing to see them, and that they didn't treat patients with complications. It's absolutely false. Among these physicians and their colleagues certainly, they haven't heard of anyone refusing to treat a patient.

    What has happened, however, and I think we have to be clear about this, is that in some cases patients have come to a doctor and asked for a specific test, by saying, for instance, they believe they have a restenosis and need a venogram to demonstrate it. If the doctor doesn't feel a venogram is warranted, he won't order a venogram and the patient will sometimes complain they didn't get treatment—which wasn't the case. So it's very hard to tell, because it's a “he said, I said” situation.

    But it was very clear that these physicians in the working group were very concerned about this issue and asked us to make sure that the message was sent out that there's no patient who will not be seen by a physician, even if they had treatment abroad.

    That's what I'm trying to do today, to send this message back to you.

    I think it's a very important message.

  Mrs. Carol Hughes:

    Just on that note, are you, or is there a group, working with the provinces on this as well?



Dr. Alain Beaudet:

    I will inform the deputy ministers of this message on Thursday when I meet with them to debrief them about the working group, because I think it's a key message.

    It's one of the key messages. The other one is that it is not a very safe procedure, as we are starting to realize. It's been claimed to be totally safe. It's not as safe as we thought it was, so we have to be careful.



Mrs. Carol Hughes:

    When you're talking about it not being as safe as you thought it was, which procedure are you talking about?



Dr. Alain Beaudet:

    The opening of the veins and either the angioplasty or the insertion of a stent.



Mrs. Carol Hughes:

    So you're saying it's both of them?



Dr. Alain Beaudet:

    Yes.



Mrs. Carol Hughes:

    How much has been invested so far in the research?



Dr. Alain Beaudet:

    At CIHR—and we're certainly not the sole investors in MS research—we've invested $49 million in the past 10 years in MS-related research.



Mrs. Carol Hughes:

    I understand that, but I'm talking about research on this specific procedure so far.



Dr. Alain Beaudet:

    Right now, $2.4 million has been the total amount invested by the Canadian and U.S. MS societies in the seven projects looking at the association.



Mrs. Carol Hughes:

    What is the breakdown of dollars on that? I'm trying to figure out if all of that is administrative or—



Dr. Alain Beaudet:

    No, no, it's actually to do the research. That money is actually to do the research.



Mrs. Carol Hughes:

    Are there any patients involved at this point?



Dr. Alain Beaudet:

    Oh, yes, they're all clinical trials.



Mrs. Carol Hughes:

    How many?



Dr. Alain Beaudet:

    There are seven clinical trials going on.



Mrs. Carol Hughes:

    But how many patients are the trials working with?



Dr. Alain Beaudet:

    It all depends. We're talking of several hundred patients altogether, for sure. The number of patients varies between the studies.

    I couldn't tell you the exact number of patients.



Mrs. Carol Hughes:

    Have any of those undergone the procedure?



Dr. Alain Beaudet:

    Let me remind you that the seven studies are meant to demonstrate whether there is an association between venous malformations and venous blood flow in the veins of the neck and MS, that is, whether there is an increased prevalence of that in patients with MS as compared to healthy controls. Basically, with some variations—some are in kids and some are in adults, and there are some variations in the protocols—all of these studies compare a group of MS patients with a group of healthy subjects. They look at the anatomy of the veins and at the blood flow to see whether there is a blockage of the blood flow. It's all done in a blind fashion, so they don't know whether the patient has MS or not. When the study is unblinded, they'll see whether there's a difference in the incidence of the malformations and blood flow in the two groups. That's the principle.



Mrs. Carol Hughes:

    So no procedure has been done?

Dr. Alain Beaudet:

     There's a procedure. The procedure is a diagnostic procedure, and that's a very important one because it's another major issue. We really don't know what the best approach is to diagnose this condition. Is it, as Dr. Zamboni claims, ultrasound imaging? Is it venography? Is it nuclear magnetic resonance imaging?

    What these projects are doing is comparing the various techniques. Most of them use, as a baseline, the ultrasound approach done by Dr. Zamboni to try to at least reproduce these results. Most of them, actually, have sent their technicians to Buffalo to get the proper training to read these Dopplers in the same way as Zamboni did, and that's their baseline. They're comparing that with venographic studies, and in some cases NMR studies.

    We want to establish the best possible approach to diagnose the condition, so when there's a trial in phase two we know exactly what the perfect, true inclusion criterion is and what the standard used in terms of diagnosis will be.

  The Chair:

    Thank you, Dr. Beaudet.



Dr. Alain Beaudet:

    Sorry, it's a bit technical.



The Chair:

    That's okay. Don't apologize. This is what you're here for. Thank you so much.

    Dr. Carrie.



Mr. Colin Carrie (Oshawa, CPC):

    Thank you very much, Madam Chair.

    Thank you very much, Dr. Beaudet, for being here today.

    As you know, in another life I actually treated people who had MS, and for me and so many people it's about real people, real families. I was wondering if you could take a moment and discuss the importance of ensuring that the science is sound before moving ahead with these clinical trials, and maybe explain to people who might be listening or might read this what the risks are of not waiting for the signs.



Dr. Alain Beaudet:

    It's very clear. The risk of not waiting for the signs is subjecting patients to a treatment that is not innocuous--and we have proof of this--and that could have a number of complications, without having the proof that we're actually improving their condition. Some of these complications could be serious.

    We're talking about blood clotting. We're talking about internal bleeding, because in most of these patients there are thinning agents that are used as drugs before the procedure and after the procedure. In the case of a stent insertion, indeed the safety is probably even less because stents, as you know, are meant for arteries. The wall of the vein is really thinner, and the danger, of course, is that the blood flow is not as rapid and there's a danger of clotting.

    All of these things are serious, and we don't have a real appreciation because it's not very common to do angioplasty of veins and to put stents into veins. We don't have a good idea of the incidence of complications and negative events. There's no question that a good clinical trial will have to include, either as a phase one or into the trial, a measurement of the safety component.



Mr. Colin Carrie:

    All right.

    You also mentioned the research associations in your opening statement--and you've been in touch and in good communication with the different associations. I was wondering if you could let the committee know what the positions of the different physician associations, the MS associations, and other stakeholders is on the need.... You mentioned that you're working to try to demonstrate the link between CCSVI and MS before conducting these clinical trials.

    What are the experts saying in these different associations?



Dr. Alain Beaudet:

    By and large, it's really the position of most MS societies. And it is certainly the position of the U.S. and the Canadian MS society. The German MS society had a very harsh statement. On the other hand, the international MS society had a more balanced statement, stating the importance of furthering clinical trials, clinical research, to establish the validity of the procedure.

    I think it's important to note that in Italy the MS society is sponsoring a very large study on several thousands of patients, involving a large number of sites in the country, to do exactly what the seven studies are attempting to do here. It's association studies to try to demonstrate whether there's a link between patients with MS and this entity called CCSVI. So we're in contact, and we'll be monitoring the results of that very large study, as we're monitoring the ones from the studies carried out in Canada and the U.S.



Mr. Colin Carrie:

     Because you mentioned Italy, I was just curious. Dr. Zamboni came up with this procedure, so has he received authorization to proceed with it? If he has not, why hasn't he?



Dr. Alain Beaudet:

    I think this is an important point. First of all, Dr. Zamboni was originally part of the very large association studies that involved I think around 20 sites in Italy, and he withdrew from the study. The scientific director of the Italian MS Society told us that he withdrew because he asked that all the images from all the sites be vetted by his own laboratory, which obviously the committee didn't feel was appropriate. Dr. Zamboni, however, is also applying for a therapeutic trial, a trial this time to investigate the treatment. As far as I know, the study doesn't have all the funds necessary to be fully carried out. He did receive a bit of money from the province where his lab is, but I don't know about the status of the ethical approval of this study. He was supposed to receive ethical approval at the beginning of December. I don't know whether he did receive it.

     Do you know? We don't know.

    The last time we spoke to Dr. Battaglia, the scientific director of the Italian MS Society, Dr. Zamboni still hadn't received the ethical approval for his studies. It was pending, and we were told the beginning of December. What we know, however, is that right now the funding from the province that he's receiving for that study is not sufficient to carry out the type of study that would be necessary to prove or disprove the efficacy of the treatment.

  Mr. Colin Carrie:

    Do I have time for a little more here?



The Chair:

    Yes, you do.



Mr. Colin Carrie:

    I believe there was a study done in Sweden, and I was wondering if you were familiar with that and are able to elaborate on the process there and the results of that study.



Dr. Alain Beaudet:

    Yes, there were studies in Sweden and Germany that actually showed very different--as, Kirsty, you know--results from those of Dr. Zamboni. Actually, essentially, they found no difference between the venous anatomy of patients with MS and that of normal controls.



Mr. Colin Carrie:

    How many people did they do that study on? Do you remember, off the top of your head?



Dr. Alain Beaudet:

    I don't remember. I don't want to venture a number. I'm not good at remembering numbers. I can't remember my phone number, so I won't go there.

    But that's why we're doing these studies. When you have a controversy like this, and you have one group finding one thing and another group finding the other thing, you have to try to devise a very strict protocol. What's really great about these studies is the use of several diagnostic approaches that will be compared to determine whether (a) there's a problem with the anatomy, and (b) there's a problem with the blood flow, and trying to associate that with MS.



The Chair:

    Thank you, Dr. Beaudet.

    We'll now go into our five-minute rounds of questions and answers, beginning with Dr. Duncan.



Ms. Kirsty Duncan:

     Thank you, Madam Chair.

    And thank you to Dr. Beaudet for coming.

    I want to pick up on a couple of things. There really has been follow-up missing. I gave one example; I can give many examples of where patient appointments have been cancelled and then they were told they would no longer have their specialist. There have been tests that are repeated every six months for drugs that have been cancelled, and people who have had clotting issues are being refused treatment.

    I want to pick up on the expert panel that was talked about for the August 26 decision. If you're going to have an expert panel, I would like to see people who've actually been involved in the imaging and done the procedure be involved. I know there was fear of biasing the sample. Having said that, there were people on that panel who had actively spoken out against the procedure for over six months. We absolutely must have evidence-based medicine here in Canada. We have to. We do need to establish protocols around imaging, whether it's ultrasound, whether it's MRI. We need to know if we are going to be using stents. We need to establish these protocols.

    As you know, I have concerns because I do think we're doing replication work, work that's been done elsewhere. If people had gone to the international conferences...Bulgaria, Canada, Italy, Kuwait, and the United States are all presenting the same data. That data is as follows: 87% to 90% of MS patients show one or more venous problems if ultrasound or MRI is used. Now the outlier to that was in Buffalo, and you have to look at those results. How was the study undertaken? Did you have someone who was trained in the operations? They also looked at first-degree relatives, and we know that venous problems may run in families. So there were issues.

    Dr. Carrie brought up the Doepp and the Sundström papers. You have to look at the history of that. Those papers were published in six weeks. That's highly unusual in science. Dr. Simka's work out of Poland has done angioplasty on 381 patients, which people would describe as the gold standard; 97.1% showed one or more venous problems.

     I'm going to hand that over.

  Dr. Alain Beaudet:

    There are several elements to your questions. I'll try to go through them rapidly.

    First, I want to tell you how important it is that MPs care and how important is your statement about the need for evidence-based practice.



Ms. Kirsty Duncan:

    We have to.



Dr. Alain Beaudet:

    It's the basis of our medical practice in this country, and at times it's tough to follow. You feel for those patients who have very few options right now. Quite frankly, the last thing I want to do is blame the patients, because I understand that. We have a role to explain to them why we believe they shouldn't go abroad at this point to get a treatment.

    I really do believe that the majority of physicians will never refuse to see a patient who is sick and wants to see them, whether they've been—



Ms. Kirsty Duncan:

    I can give you case after case after case.



Dr. Alain Beaudet:

    You may well be right, but I can tell you that it's not acceptable; we will not condone it, and we'll try to, as I said, by working with the professional associations and colleges, impress upon these groups the importance that patients are seen and are treated. The only thing I can tell you is that the working group—as I said, most of them were actually physicians—said they would never refuse to see patients, and a lot of their patients had actually undergone treatment abroad. But it's an issue. We don't accept it. We have to try to change that, and there's a message that must be sent.

    The other thing is the composition of the August working group. I don't really want to go back to that, but since you bring it up again, our criterion was very simple. We invited physician scientists that were funded either by CIHR or by the U.S. NIH. That was simple, clear. They're all—



The Chair:

     Thank you, Dr. Beaudet.

    We'll now go to Dr. Carrie.



Mr. Colin Carrie:

    There has been a lot of attention given to chronic cerebrospinal venous insufficiency. I was reading in the paper today--I get up really early, and I'm one of those strange people who actually reads the paper before I get to work--that there is a new drug out, and I believe it's called RXR-gamma.

    Could you bring us up to date on what else is going on in MS research around the world?

Dr. Alain Beaudet:

    Actually, there are several.... An article came out yesterday about another breakthrough study by a British group using stem cells to regenerate myelin on the demyelinated fascicles. There are several drugs in the pipeline. One was recently accepted by Health Canada. We learned at the August conference that there are several others in the pipeline that are being investigated. You never know before the trial is completed whether it will work or not, or how good it will be. But it's not as though there is nothing coming.

    So there are two avenues: the pharmacological avenue, on the one hand, and the stem cell avenue. Splendid work on stem cells is done here in Canada by Sam Weiss at the University of Alberta.



Mr. Colin Carrie:

    I remember that in anatomy class we did a lot of work on the venous system, especially at the base of the skull and the upper part of the spine. What I was told was that there was a lot of “normal variance”. I look around this room, and if everyone in this room had these tests....

    What's the difference between a normal variant and an abnormality? Do you know?

  Dr. Alain Beaudet:

    That's one of the huge issues.

    There are two problems. We didn't worry a lot about the variation in the anatomy of neck veins until this happened. That's one thing. And why didn't we worry? It was because there is a huge redundancy in the number of veins and capacity for drainage, and it's normal. The veins have to be able to drain whether you're sitting, whether you're upside down, or whether you're standing. So the neck vein system has often been referred to as the “delta of the Nile”. You can block a number of rivulets, but in the end it drains perfectly. And that's one of the big issues.

    So even if there are a number of anatomical differences in patients, we'll have to ensure (a) that these differences are truly, systematically, more numerous than in controls, and (b) that they truly impair drainage. That's why some of the techniques that are going to be used in these seven studies that I keep referring to should give us some information regarding blood flow and the anatomy.

    There are also two groups that are doing post-mortem studies on patients to look at the vein anatomy in much greater detail than we've done so far. They will do this by moulding, by injecting silicone into the venous system, by being able to make very accurate measurements. They will be comparing--I can't say healthy controls because it's post-mortem, but comparing normal individuals with people who died from MS.



Mr. Colin Carrie:

    You mentioned the process you've put in place. Actually, it sounds very impressive. You mentioned how you're getting the researchers together, and you said, “They've learned, they've shared, and they've revealed.”

    I was wondering, with this new process, this unprecedented research process, how is it going to benefit the MS research community and MS patients?



Dr. Alain Beaudet:

    It's certainly going to benefit patients. The work is going to go faster as they benefit from one another's experience. I would say that it's a microcosm of what's going on more and more in science. There is always a mix of collaboration and competition, but there is more collaboration as we realize that we're dealing with complex issues, and that we are way better equipped to deal with them if we work together instead of against each other.



The Chair:

    I'm sorry, we will have to end it there.

    Dr. Beaudet, I have to say that it's an honour to have you here on our committee.

Dr. Alain Beaudet:

     Thank you very much.



The Chair:

    You know what struck me? It's that the very important work of the subcommittee has brought awareness and is bringing some very good dialogue. It's great to see the different countries doing different studies. Because this is a collaborative medical community or a scientific community, we can actually get the answers that we want rather than the political debates about it.

     I think that's what's so important, and I think that's what this committee wants. There are very good questions this morning.

Sunday, December 12, 2010

Letter to Ministers of Health for Canada and for Ontario

December 12, 2010



Letter sent today to Ms. Aglukkaq, Federal Minister of Health and Ms. Matthews, Minister of Health for Ontario


On Friday, December 10th, the CBC carried an item about Thelin – depending on what news source you read, it is a blood pressure or a lung drug.


The reason for pulling it was because it causes liver disease. My question to the Health Ministries is why was it out there in the first place if all the required tests were not conducted? Clearly the drug companies are either lying to you or you make subjective decisions about what can be done and what can’t be done. The MS Liberation treatment is one you have emphatically refused to allow in Canada, even though Angioplasty has been used in Canada for other things for years. Of course, your experts make no money from the treatment. They do from prescribing the hoard of MS drugs presently on the market even though they have never been proven to work and have not had one result that could begin to compare with some of the good results of the treatment. Are you aware that patients have quit some of these C.R.A.B. drugs cold turkey after taking them for more than a decade and have experienced no difference in the behavior of their affliction?


Frankly, from a strictly financial view, I am not sure why you would ok these drugs. They  don’t work and they cost the taxpayer, either directly or indirectly, a small fortune that would be better spent on treatments for other conditions or even treatments for this condition that work. The Liberation treatment, if done in Canada, would cost about half the price. Right now, Canadians who can afford it or who fundraise for themselves, are going elsewhere and having it done for $15-20,000. Do you really think so many people would fork out that kind of money on what Dr. Freedman has called a hoax?  If you do I think you need to give your head a shake and clear the cobwebs out.

I will grant you some of these folks are independently wealthy but most are not. They come from every province and territory, are not related to each other – they don’t even know each other usually. They have no reason to say they can walk when they can’t – that would be one of the easier ways of recognizing a lie. And those that it has not helped have been quite open about it not working for them. If you understood the vast array of symptoms that are lumped together and called MS, you would not find that all that surprising.

Every time $3000 comes out of the tax account to pay for a C.R.A.B. drug that doesn’t work, it isn’t going to someone who needs something that we already knows works. You continually talk about lack of funds but you blatantly waste the funds you have. And I have no doubt, you will want to spend even more money come election time, telling people to vote you back in because you have done such an outstanding job?? I don’t think so – not my vote anyway. I think I have already mentioned to you both that if the press did not include your names with your press releases, I couldn’t tell which of you was speaking. That could be because you are both taking advice from people paid to tell you what to think. I cannot believe either of you is quite that dense if left to your own devices.

CBC did an Insight program this past week about how the various governments have so trivialized politics that the average citizen has lost all interest. They are right. On the subject of MS at least, can one of you, or preferably both of you, not start making your own decisions instead of the ones the drug companies via “experts” such as Dr. Mark Freedman tell you to take?  Who runs the health ministries in this country anyway? You or the drug companies? You want to talk to an expert on MS? It can be arranged to put you in touch with a patient who knows more about MS than Dr. Freedman et al will ever know. Or a relative of a patient – again, they know more than Dr. Freedman et al.

There are 75,000 people who are known to have MS in Canada. Dr. Freedman’s staff have decided I have had it for over 20 years but it was only diagnosed recently – MRI was not always available. How many other undiagnosed/misdiagnosed  folks are out there? Add to that all the other forms of autoimmune conditions that neurologists and drug companies have not, in fact, been able to help and you have a lot of sick Canadians. You might think you, yourself are immune but you aren’t. Do you want to be treated this way should MS land on your plate? Or Alzheimer’s? Or any other autoimmune disease? And if those two arguments do not make a dent, is this the way you want to remembered in history – as the two female Health Ministers who were puppets for the drug companies? Cause, ladies, that is how you are coming across to me and to many Canadians.

Finally, (and this is directed mostly to Ms. Aglukkaq because Ms Matthews did respond once) could you please do something totally unusual and respond. I am from the old school that says a response from your representatives in government is not only good manners, it is good politics.

Sincerely

Karen Copeland

Friday, December 10, 2010

December 10, 2010


Fighting the Powers-that-be

It has come to my attention that some frustrated MSers have taken to writing hate mail to the MS doctors and neurologists that are speaking out against the involvement of CCSVI in MS and the treatment of angioplasty to alleviate some or all of it's symptoms.

Hate mail is a very unwise course of action. It is illegal. . You could find yourself on the wrong side of a court room if you do it. So Please do not do it! The Powers-that-be can be fought and we can win but not by following that particular course of action.

If you  are a fan of any of the popular crime series such as NCIS, you know that tracing emails is very possible. It takes, in fact, more time than in the shows, but it is relatively easy to do. There are people behind bars today thanks to the technology that makes tracing calls so easy for law enforcement - even when you think you have covered your tracks. Here in Canada and in a good many other countries, we want the laws to change in our favour. We want doctors with a vested interest in keeping this treatment out, brought up before the courts and made to pay for putting our health and for some people, our lives at risk so they can make the big bucks and live high on the hog! Hate mail is not going to do it!!!!

What will do it is a concerted effort to educate the public about MS and CCSVI and to get them on our side. When we spend our time in MS group rooms at Facebook and sites like CCSVI Locator - http://ccsvi-ms.ning.com/ - we learn a lot about others situations but we tend to forget that most people know nothing about the subject. So we need to find ways to spread the word about the condition, the treatments available, the results of these treatments, our own experiences about living with MS etc etc etc.

If you write well - send letters to the editors of the papers that service your area - big and small. Keep them factual - making up stories or exaggerating reality is not necessary. One good way is to ask the reader to close her eyes and try to imagine her own life with one of your symptoms.  eg. I cannot pee without catheterizing myself. This is a good deal more complicated than pulling down my briefs and plunking my butt on the john! Ask your reader to envision having to carry a catheter in her purse everywhere she goes; inserting it in her bladder when she needs to go - doing this takes some getting used to and doing it wrong is easy even for us old hands at it; finding a way to aim the urine into the john without getting it all over yourself or the floor. It's not as easy as it might sound. It is , in fact, a royal pain. It can also lead to horrid bladder infections and very often does. This problem for men is even worse - they are most often fitted with a Foley Catheter that requires medical attention to put in and to keep clean.and a bag that needs emptying periodically. I do not know one man who would do that if they could find  a better way. In fact, on this score I am very grateful to be a woman.

If you see articles written about MS or CCSVI, write in response - to either congratulate the writer on an article well written or to correct errors in fact that you see or just to give you opinion. Keep the curse words out. Saying them might make you feel better but letters containing curse words are usually deleted by the editors. If you are sending hard copy letters, know that yours may not get printed. But know also that the editors look at the numbers of letters they get on a subject to determine whether they should assign a journalist to continue writing about the subject. So whether they get printed or not, your letters have a value. Do not discount that value. Do not stop writing.

Write your member of Parliament. Chances are they will not respond. Write them anyway. Write the guy in your riding; write the minister of health, both federally and provincially. If the tone of your letter leans on the legal aspects, write the minister in charge of that. Write your city councilmen.

Do you know a local businessman who has influence in your neighbourhood?  Have a lunch with him and try to get him on your side.

Is there evidence that the people in power are abusing that power; are taking money from drug companies ; are themselves threatening MS patients - get in touch with the RCMP if you are Canadian, or the FBI if you are American or the MI division that deals with that in the UK. Be sure to have some reasonable documentation when you do this though. As they used to say on "Dragnet", "The facts, ma'am. Only the facts!"

Above all else - stay cool. I often write letters filled with the anger I have for the unfairness being leveled at us. It is good for the soul to call that guy a nasty name. But I do not send it right then. Later, when I am in a calmer frame of mind I go back and clean it up and send it after reading and rereading to make sure it says what I want. This is also a good way to make sure the spelling is correct, the tenses are correct and the grammar is correct. Letters filled with spelling errors are often dismissed - there is a spell check on my computer - it's great. My fingers have MS related problems and I depend on the spell check to help me write well. Some words like There and Their you just have to know - spell check does not correct them for you.

So go out there and calmly get us all the good attention you can!
Here's one thing you can do to help get us the notice we need for this cause:

Please vote for 'Saskatchewan's Top News Story of the Year'

 Please vote for 'Saskatchewan takes lead in plan to offer Clinical Trials for MS Liberation Therapy'.


You can place your vote at http://www.newstalk650.com/poll/20101206/which-top-saskatchewan-news-story-year  

And please! No hate letters!

Wednesday, December 8, 2010

December 8, 2010



As you may or may not know, Ottawa's Dr. Mark Freedman sent a blueberry message to one of his patients.
As this was a copy of a Facebook and CCSVI post and inasmuch as they have found it well advised to remove the letter from Dr. Freedman to his patient, I have removed it from here as well.  The response from Dr. Embry to it remains.
Karen Copeland


~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 

One of the people he mentions is a PhD. named Ashton Embry who has a son who suffers from MS. Dr. Embry has written an open letter to Dr. Freedman in reply.  I am happy to be able to put this here for you to read also.

Different Approaches to the Application of Science to Understanding and Treating Multiple Sclerosis – An Open Letter to Mark Freedman

Dear Mark,

I was recently forwarded a copy of an email which you had sent to one of your patients regarding the CCSVI issue. I was not surprised by your unwavering belief that CCSVI is nonsense but was slightly taken aback by your over-the-top view that all those who think that CCSVI treatment may be of value are nothing more than frenzied, cult members. I was also somewhat surprised that you mentioned me but was glad you asked an important question ”who am I to question the word of the many self-acclaimed experts who feed this frenzy like the rock doctor Embry whose lifelong study of lifeless objects has given him the wisdom to comment on such complex issues?”

You are correct that my primary scientific research activity for the past 42 years has revolved around inanimate rocks, mainly those in the Canadian Arctic Archipelago. I’ll be glad to send you some of my published geological papers if you have an interest in such things.

I must point out that it has not been my geological studies which have “given me the wisdom” to comment on complex issues associated with multiple sclerosis. My knowledge on MS comes from reading thousands of scientific papers and countless abstracts on MS and related subjects (e.g. nutrition, autoimmunity in general, and more recently vascular issues). My pursuit of scientific knowledge in regards to MS has been driven by a desire to ensure my son is doing everything he can to prevent the progression of his MS.

I would emphasize that I try hard to make sure any written comments I make on MS, especially recommendations on how to help control disease progression, are backed by solid science, including both empirical data and critical, rational reasoning. I suppose you could say that many years of geological research have instilled this hard-core, scientific approach so perhaps you are not entirely wrong with your statement that the source of my MS “wisdom” is my geological research.

I thought it might be useful if I discussed how we sharply differ on three important scientific issues which dominate decisions regarding the treatment of MS. These issues are CCSVI, vitamin D and the CRAB drugs. These differences show how we significantly vary when it comes to doing science and to using science to guide actions. Following this, I will wrap-up with a few possibilities on why such differences between us exist, despite the fact we both would claim we are scientists wanting to understand MS so as to allow us to make recommendations on how to treat it.

CCSVI

The first topic is CCSVI which continues to divide the MS community. As a scientist, I try to stay up to date on the literature but it wasn’t until July, 2009 that I came upon Dr Zamboni’s work, 4 months after he had published his watershed paper on CCSVI. After reading that paper, I immediately read all the available papers on CCSVI as well as major past references on vascular issues in MS. Once I had completed my literature research, which included carefully going through the Zamboni papers up to three times each, it was apparent that either impaired venous drainage was very likely an important factor in MS or that Dr Zamboni and his associates were incompetent or frauds. There basically was no middle ground given the apparent robustness of the Zamboni research.

A review of the extensive scientific contributions of Dr Zamboni and his colleagues over the past 25 years removed any doubt as to their impeccable scientific credentials and their solid competency when it comes to vascular research. Thus, their impressive clinical and theoretical studies on CCSVI, combined with past studies on vascular issues associated with MS, and the fact that CCSVI nicely explained some previously inexplicable features of MS (e.g. venocentricity of lesions, associated iron deposits, continued disease progression despite the complete destruction of the immune system), gave me no choice but to accept the proposition that it was very likely that CCSVI was an important factor in MS. This in turn led me to facilitate and encourage the dissemination of CCSVI information and to call for extensive research into CCSVI and MS in August 2009.

Since my initial immersion into the CCSVI literature, I have closely followed CCSVI research and this has included visiting with some of the researchers themselves. I have been most impressed with the CCSVI research being done at the University of Buffalo and their work, involving 500 subjects, has robustly confirmed the high association of CCSVI with MS. Such a high association, the plausible biological mechanisms which link CCSVI to the MS disease process, and the established nature of the venous problems associated with CCSVI, establish beyond a reasonable scientific doubt that CCSVI plays a role in the MS disease process.

I have also kept a close watch on the results of worldwide CCSVI treatments because such results, due to their high numbers, are important scientific data that cannot be ignored. Currently, there are at least 75 centres worldwide doing CCSVI treatment and between 100 and 200 procedures are now being done each day. These treatments involve the use of venography which is the gold standard for the identification of CCSVI and, of the 12,000+ patients treated so far, over 90% have had undoubted CCSVI. Furthermore, there have been thousands of well documented cases of substantial improvement of a variety of MS symptoms following CCSVI treatment.

As a scientist, I cannot ignore the CCSVI treatment data and to do so would be bordering on scientific incompetence/fraud. To sum up, the published scientific data on CCSVI and the many thousands of clinical procedures which have identified and treated CCSVI leave no reasonable doubt as to the existence of CCSVI and that it plays a role in the MS disease process.

I would contrast my objective, scientific appraisal of CCSVI with your emotional and non-scientific approach. I assume the first time you were exposed to the science of CCSVI was through the CTV documentary and that you had failed to read the papers which had been published on this topic before that time. Your public response to a group of MS patients that the Zamboni work was a hoax before you had read his papers, reveals a complete lack of scientific method and objectivity by you on this subject. Furthermore, your insistence on ignoring the results of many thousands of CCSVI procedures also underscores your inability to take an unbiased, scientific approach when it comes to CCSVI. I will discuss possible reasons for such a failure later.

The bottom line is that you have not spent time with the CCSVI researchers, you have not read most of the 200+ scientific papers which bear directly on the CCSVI question, and you have not taken the time to evaluate the results of the huge number of CCSVI procedures which have been done. Any claim that your comments regarding CCSVI are science-based is not supportable. Thus, when it comes to CCSVI my comments on the subject are given much more weight than yours simply because I know far more about the subject than you do and most importantly, I have taken an objective, scientific approach to CCSVI and MS, not an emotional, highly prejudiced one like you have. I can only encourage you to try to be more objective and scientific when it comes to CCSVI.

Vitamin D

The next topic is the role of vitamin D in MS. When I began my studies of the MS literature, my main goal was to identify environmental factors involved in MS. It seemed this would be the best approach for devising potential therapies for treating the disease. By 1999 there was enough solid and diverse scientific data to indicate that vitamin D deficiency was involved in MS. Given this, I advocated for the use of vitamin D supplements both as a strategy to prevent MS in the first place and to treat it. This was a classic case of a scientifically-backed therapy which offered nothing to lose (vitamin D is extremely low cost and completely safe) and all to gain in terms of prevention and treatment. At this time I also published a short note in Annals of Neurology on vitamin D and lesion formation (with a recommendation for a 4000 IU supplement) and I made available on the internet a comprehensive document on the science of vitamin D and MS.

Notably over the past 10 years there have been scores of studies on vitamin D and MS, all of which have supported and confirmed what we knew back in 1999 – there is a good chance adequate vitamin D will prevent MS in many cases and that it will have therapeutic value for those with MS. I would say that I have read at least 750 papers on vitamin D with at least 250 of those directly related to vitamin D and MS. Given that my scientific abilities and literature research allowed me to identify vitamin D as a useful therapy for MS in 1999, the question becomes what did your scientific approach achieve for you regarding vitamin D and MS.

You may recall in November,2006 we both attended an AAN MS Guideline meeting in Boston. I gave a presentation on vitamin D and MS and the potential value of developing a guideline on such a topic. Following my talk, you made light of the concept of vitamin D for MS calling it alternative medicine that had no place in the meeting. It was very obvious you had not read any of the vitamin D literature or you would not have made such an unsupportable and revealing statement.

I have also learned that you do not recommend adequate vitamin D (enough to raise one’s 25D level to between 125-175 nmol/l) to your MS patients and you do not let your patients know that there is a reasonable chance that adequate vitamin D from birth onwards will prevent MS. It is clear that you have not taken a scientific approach when it comes to vitamin D and MS and your patient care has consequently suffered. Again, I can only suggest you take some time to review all the vitamin D and MS literature in an objective and comprehensive fashion.

CRAB drugs

The CRAB drugs (Copaxone, Rebif, Avonex, Betaseron) is one topic I am sure you know lots about given your involvement in clinical trials and your very strong and lucrative financial ties to the drug companies that manufacture these drugs. I also have a great interest in these drugs because they represent a potential therapy for my son.

When it comes to such drugs, the key question is whether or not they affect the progression of the disease or not. If they do, then they would be a reasonable therapeutic option despite their high cost and adverse side effects. However, if they do not slow progression, then I would say they are possibly worse than useless. So the obvious scientific question, which we both are interested in, is whether or not any of the CRAB drugs slow MS progression.

Given that you prescribe such drugs to your newly diagnosed patients and give talks (often for money) advocating the use of such drugs, I can only presume that you firmly believe that the drugs do slow disease progression. I am not sure what you base such a belief on but I have to assume it is mainly based on the clinical trials which tested the effect of the drugs using frequency of MS relapse and number of new MS lesions as proxies for determining if a given drug affected progression or not. You and I both know that there have been no clinical trials which have lasted long enough to directly determine if any of the CRAB drugs actually do slow MS progression or not.

From a scientific perspective, it became essential to determine if frequency of MS relapse and new lesion formation correlated to MS disease progression and were thus valid proxies in clinical trials. I have read most studies connected with the MS drugs and over the last few years have been impressed with the studies which have shown that those two proxies do NOT correlate with disease progression. In fact it was found those with fewer attacks progressed faster and farther!

To emphasize this critical point I have to quote Dr George Ebers, one of the premier MS researchers in the world on this. Dr Ebers states “Clinical trials of multiple sclerosis have been uniform in utilising invalidated outcome measures. This has occurred to a degree to which it is difficult to find parallels in medicine in general. It is quite clear from natural history studies that relapses have very little if anything to do with long term outcome. Similarly, MRI measures have been thoroughly evaluated within large datasets and found to be similarly non-predictive for meaningful outcomes.” These are conclusions from hard science and have to be respected and used when it comes to actions regarding the CRAB drugs.

I assume you have read the key papers which demonstrate that relapse rate and MS lesion formation cannot be used to determine if a given drug is of value for slowing MS. I trust you will agree that currently we have no good scientific evidence that the CRAB drugs slow MS progression. In fact, we now have a three long term studies which indicate that the drugs do not slow MS progression by showing that those on the drugs reached the same EDSS end points in the same time as those not on the drugs (Boggild et al, 2009; Veugelers et al, 2009; Ebers et al, 2010).

Given the above scientific evidence and reasoning, I have advised my son not to use a CRAB drug and I also advise others not to use a CRAB drug which provides no benefit and which has adverse side effects such as flu-like symptoms and painful injection site reactions. It is somewhat bothersome that you claim to be a scientist and to follow the dictates of evidence-based medicine but continue to prescribe drugs for which we have no reliable scientific evidence that they do any good. In fact, the current data indicate they do not work.

I have to again quote George Ebers on the problem of “widespread embracing of dubious and poorly validated outcomes by some MS investigators, often in contexts where there are egregious conflicts of interest, threaten academic credibility not to mention long term professional autonomy.” There is no doubt that many neurologists are prescribing the CRAB drugs, not because the science says they work, but because it is financially advantageous to do so. Given your “egregious conflicts of interest” when it comes to the CRAB drugs and your disregard for the science concerning these drug, I assume you can understand why you have no credibility on this subject.

Summary

I have pointed out three main differences between us when it comes to various factors and MS. I objectively follow the available science which tells us that:

1) CCSVI is highly associated with MS and is very likely an important part of the disease process,

2) Vitamin D deficiency is an important factor in the onset and progression of MS.

3) The CRAB drugs do not have any effect on MS disease progression.

These science-based conclusions have led me to the following science-based recommendations that anyone with MS:

1) Be tested and, if need be, treated for CCSVI.

2) Take an adequate vitamin D supplement and ensure any first degree relative also takes such a supplement.

3) Do not use any of the CRAB drugs.

On the other hand you ignore much of the current science and, on the basis of blind faith rather than scientific analysis, tell your patients that:

1) CCSVI does not exist and persons with MS who see potential value in CCSVI treatment are frenzied cult members.

2) Vitamin D supplementation represents alternative medicine and has no place in MS treatment or prevention.

3) The CRAB drugs are of value and should be used by persons with RRMS.

Finally we are left with the question of why I have chosen an unbiased scientific path whereas you have gone in the opposite direction. My only hypothesis to explain this is that your financial ties to the drug companies have prejudiced you against any non-drug therapy such as adequate vitamin D and CCSVI treatment and made you blind to the robust data which demonstrate the drugs do not slow MS progression. On the other hand, with my son having MS, I have all to lose and nothing to gain by not ensuring that I carefully examine all scientific hypotheses for MS in a rigorous and unbiased manner. Perhaps also the fact I was trained as a scientist (PhD) whereas you were trained as an MD (ie engineer) might also come into play when it comes to the great difference in our application of science for helping persons with MS.

I hope this answers your question of why persons with MS trust what I have to say about various proposed therapies for MS far more than they trust you. They can tell the difference between an objective, science-based analysis and a self-serving, unscientific opinion every time.

Ashton Embry

Friday, December 3, 2010

Letter to Deb Matthews, Minister of Health for Ontario

December 3, 2010



Dear Ms. Matthews

Thank you for responding to my letter to yours re MS.

Ms must be a bigger problem than it appears on the surface – nearly everyone I have spoken to in government has or had a relative with MS. This makes me wonder even more why so little is being done about it.

I also wonder at your claim – and others in government make the exact same claim – to do all that you can “as quickly as we can to determine if it (Angioplasty) is effective and safe for treating MS. Specifically, I wonder why this was not your objective in all these years past when you were approving the drugs that are being doled out ad nausium to MS patients. Drugs such as Copaxone, Rebif, Avonex and Betaseron. I have been unable to find one solitary patient who claims anything good about them and many who claim negative effects.  And then there is TYSABRI – apparently responsible for a number of deaths but still being pushed as a “safe” drug treatment. I, myself, was prescribed Gabapentin which left me with a good deal less balance and a good deal more MS misery. I do not take it anymore. In spite of the less than useful, often detrimental effects of these drugs, there was no hue and cry from any government agency about needing to look out for our safety with them. So why all of a sudden, now that we have found an often effective and a good deal less unsafe treatment, is the government messing in something they clearly do not understand or know anything about?

You claim Dr. Zamboni’s treatment is experimental. True enough. But it is helping a lot of people. The above named drugs cost the taxpayer, either personally or by way of his taxes a good deal of wasted money over the years they have been being prescribed. There has been no outcry about wasting taxpayers money when it was definitely being wasted, so why now? Now that it is apparent that the odds are more in favour of it being a better risk for the tax payer?  It appears that drugs, both legal and illegal are running this country, not logic or usefulness.

You say angioplasty is an approved treatment in Ontario – just not for CCSVI. Isn’t that what we taxpayers pay you to do – approve useful treatments? This one is useful and a good deal more useful that the drugs you have previously approved. There is no logic to your argument! And there is less logic to forcing Canadians to leave the country for a little relief from this condition and refusing them post operative care when they return. It looks a lot more like spitefulness than good politics. And it appears that there are more personal agendas than public ones at play here. (See attachment)

I am well aware that my government is watching the developments.  This however is not a spectator sport. It is a debilitating condition that affects a lot of Canadians and specifically, Ontarioans.

Asking neurologists to review these developments amounts to asking a floor sweeper to do the books or the Taliban to lead Canadians soldiers in Afghanistan.  It is not at all swift! Dr. Alain Beaudet is a neurologist. That makes him one of those who have foisted all these useless and sometimes dangerous drugs off on us and one of those who, in all the years they have been at it, still knows nothing useful about MS. Sorry but their interests are not the interests of MS patients.  They have made it abundantly clear that their interests lie in getting headlines, and pushing drugs. If it were otherwise, they would have shown some interest in this treatment. They didn’t. They came out immediately and labeled it a hoax. That, Ms. Matthrews, is what is called a closed mind.

You and the Federal government have committed yourselves to speed up the development?? You call vague referrals to ‘years‘ of study speeding it up??  What we want are immediate trials with a 6 month limit for the first report, followed by yearly reports. There are a lot of over 50 (years old) people with MS. We have been misdiagnosed, treated like mental patients, used as guinea pigs and other less than decent treatments from both medical practitioners and politicians for a very long time. First of all, we do not have time for your 10 year studies. I am already turning 65 years old next week. Secondly, we are fed up with being treated like second class citizens in our own country.

I have come to expect closed minds from the Conservatives. I am disgusted and dismayed that it is, it seems, a condition that applies to all politicians. I expected more from you than politics as usual.

Sincerely

Karen Copeland

Sunday, November 21, 2010

Neither American nor Canadian governments are leading the way. But you can! Will you?

November 21, 2010

Even the unlucky among us can find someone who is a lot more unlucky than we are.  I did not have to go further than my favourite other blog to find lots of  'someones'.

Lori is a member of an MS Community group where I hang out a lot. She is in need of some relief from her MS - she is in a lot more need than some of us. Below is Lori's plight as told by her son. Give it some thought, folks. Then, if you can spare even a few dollars, please go to this site and drop it off.


a letter my son sent to local newsman--I am sitting here crying thinking about the letter my son sent to a local news agency

 

I am sitting here crying thinking about the letter my son sent to a local news agency in an attempt to help me. I love him so much.

Well, a few years ago my mother was diagnosed with Multiple Sclerosis after she went to the doctor for what she thought was nothing, the tip
of her finger going numb. It's been like.. five years and since then she
has gradually gotten worse and worse with each year. Today it takes all
her strength to get up in the morning and get my little brother up for
school. She makes like, one dollar too much to qualify for disability,
and she's planning on trying to make it until the first of the year to
quit her job, leaving her with the uncertainty of if disability will be
enough to support us. It's her, my twelve year old brother and I. We
live in a single-wide trailer in the community she manages, Ontario
Place, on Ontario Road here in Niles.

She's been on so many different medications to try and slow the spread of MS. She is on baclofen for her neuropathy and circulatory
problems, methylphenate for the narcoleptic bouts, lortabs for the pain
and they don't even touch it anymore, and takes at least ten different
vitamins every day. She took a shot every other night of this stuff
called Rebif, an interferon injection that supposedly slowed the MS from
attacking her immune system. She took it for the last three years until
her body began to reject the shots and knots formed all over her body
until she ran out of injection points. She tries to be strong but at
least two or three times a week she breaks down from it all and I have
to console her like she used to do for me.

I have taken upon myself all the "motherly" tasks. Every day I wake up and make coffee for her, I mop, I scrub, I cook, I clean, I do all
the laundry, I vacuum, I help my brother study, I make sure that she's
doing as decently as she can and do everything I possibly can for her.
We barely scrape by. I'm a college student at Southwestern Michigan
College, and I'm pursuing my BA in Information Technology/Help Desk. I
don't know how we stay alive but we do, mostly because I get my strength
from watching my mother fight these battles every day. I and my brother
have healthcare through my dad and his new wife, but my mom has no
healthcare insurance and doesn't qualify for any of it or can't afford
any of the options out there.

Every day she sits up at her computer, on Facebook, playing Farmville. My friends poke fun at Farmville players but I see it as my
mom's only escape from the prison that is her body. When she isn't
playing Farmville she's researching MS therapies and treatments, and
that's why I have come to you. There is a treatment that has been
popping up all over the world called CCSVI. To my understanding from her
and how she has a hard time speaking the thoughts in her head, it's the
theory that the difficulties brought on by MS are due to a lack of
blood flow to the brain, and the treatment is essentially opening up the
main artery to the brain and putting a stent in it to increase the
blood flow. She has spoken with hundreds of people that have had it or
know someone who has had it, and while the process doesn't always
alleviate the symptoms, most of the time it does.

So she has been asking them how they find the money. A majority of them are Canadian and the Canadian government has banned the procedure
until more research can be done. Every day people with MS are marching
up to parliament about it until they revoke it, meanwhile going to the
US or Mexico or even as far off to India to pay out of pocket for the
procedure. Fundraisers have been suggested, and we've all seen the gas
station "Save my daughter who has been diagnosed with leukemia" change
jars with 43 cents in them. But one story stood out. A woman went to her
local news stations and told them her story, and one of them picked it
up as a public relations/human interest story.

All I can really ask you is what she asked me to type up and send to you. This is our story, and if you could pass it along to someone at
WSBT who might take interest in it, we would like to ask if WSBT could
fund this procedure, in return we will give you the right to tell our
story, come into our home and see who we are, the battle she fights
every day. Film the procedure and her progress, let the world know about
this new treatment that millions of suffering people around the world
are coming together to call MS Liberation. I know it's a lot to ask, but
I figure I could either give it a shot or just sit here and watch her
suffer
If you want to read more about the situation MS patients are suffering through, the welcome mat is out at