This Is MS Multiple Sclerosis Knowledge & Support Community

cah wrote: You get the CRABs if you're willing and your Dr. recommends it, but no one can tell you if they will help you. It's also just an attempt. Take a look at the medications for cancer: Sometimes they really help, but most of the time patients just live a few days or weeks longer. They often even cost more than MS medications. It's argued if the outcome even is significant. Yet, this ATTEMPT is covered by insurance. Following your argumentation, that would be wrong...

But the big difference is that the current MS and cancer meds have clinical trial evidence of how successful they are on a group of people. BLINDED research. So, while we have no idea how successful anything will be on an individual, as a group, we have objective proof that the drugs will help.

We don't have this with CCSVI treatment. If there is a stastically significant effect directly related to treatment and the risks aren't exhorbitant in relation to the benefits then the treatment is approved and available. I want us to find that out about CCSVI treatment before our public funding pays for it. I'm aware that stats are manipulated in trials, but objective trials is the only way we have right now to impute some objectivity into this and remove bias. Not great, but it's all we have. That's the difference between current treatments and CCSVI treatment, lack of objective clinical data.

eric593 wrote:I don't know if the risks or benefits can be known at this point.

We are talking about percutaneous venoplasty, a minimally invasive procedure done under local anesthesia on an outpatient basis.

Vascular malformations are not new; they crop up elsewhere in the body, there are set procedures and specific tools to deal with them. Percutaneous venoplasty is a fairly simple procedure. Risks are known to be very low but include incision site infection, stenosis recurrence, and complications with any blood thinners used after treatment. Benefits are the restoration of healthy blood flow to nearby organs.

Insurance companies consider blood flow to be important enough that if any blood vessel in the body is occluded over 50%, they will pay for it.

Cece wrote: Insurance companies consider blood flow to be important enough that if any blood vessel in the body is occluded over 50%, they will pay for it.

Then what is the problem then?

And then why are IRB's getting involved and preventing treatment for this if it's as straightforward as that?

I don't understand. Why would IRB's consider it "experimental" and require unique specialized informed consent waivers to be signed if it was so straightforward as just another occluded blood vessel to be dilated?

eric593 wrote:But the big difference is that the current MS and cancer meds have clinical trial evidence of how successful they are on a group of people. BLINDED research. So, while we have no idea how successful anything will be on an individual, as a group, we have objective proof that the drugs will help.

But the difference is, those are meds. Usually, you don't have this Phase I - Phase II - Phase III-thing in surgeries and "physical" procedures. If there's something screwed in your body and the surgeon can fix it, he just does it. Because it's healthy to have a normal anatomy. Period.

To sum it up: The fact that one has MS indicates that his/her veins are blocked. So diagnosis is justified. And if diagnosis shows abnormal veins, it is justified to have them corrected with a procedure with minimal risks. Whatever the outcome may be.

Another analogy. Everyone has his wisdom teeth checked at some time in his life. And if they TEND to make problems in the future, you have them removed. Nobody waits until the really are a problem. Nobody can tell if they really will be. And there's a risk to this procedure, too. Mine, for example, went completely wrong...

Again. Trials are important and should be done, no question. But until they are finished, one should have the right to take the chance. And the possibility of attempt of getting healthy shouldn't be measured by the size of your wallet, cause that's what's public healthcare is all about.

I love your wisdom teeth analogy because I had mine out just to avoid potential teeth crowding since I'd already had braces. Of course that wasn't publically funded though. Nor was it "medically necessary"

But if I have an earlobe that is misshapen, public funding isn't going to fix it because there is no known problem associated with having a misshapen earlobe and no known benefit to correcting it. It's just something that developed differently when I was born, an anomaly. And our venous system is even better because if the veins have occlusions, the system develops another system to help it out and circulate the blood.

cah wrote: And the possibility of attempt of getting healthy shouldn't be measured by the size of your wallet, cause that's what's public healthcare is all about.

But that's my point, we have no objective data that these venous malformations impact our health and fixing them benefits our health. We don't know that we are UNHEALTHY because of these venous blockages! I want treatment to be shown to medically impact our health! After all, there are a fair number of people now who have been treated who have experienced NO benefit at all, at least not yet. Whether they EVER do remains to be seen. I think we should know the likelihood that we'll see some benefit to this treatment before it's funded. Because at this point, we don't even know that the venous malformations are a detriment to our health in any way much less their treatment makes us healthier in some way. People die every day and it is discovered on autopsy they had things wrong with them that they lived with without ill effect. But that doesn't mean public funding pays for full body scans every year or so to make sure that nothing has gone awry during that year and public funding pays to fix what might have gone wrong. The "wrong" has to be associated with some impact on our health before it's covered.

Re: Direct MS Statement. I think a really big player that is not mentioned in the charts are the drug companies. If you look at who has the most to lose if CCSVI takes forever it is the drug companies.
Think about it. The MS society people can find work with one of the many other chronic illnesses. There will still be work for the neurologists, though their egos will take a beating.

But who will be the biggest loser? The drug companies who make billions off CRAB Drugs that work on 30 percent of the people.

Betaseron, the first drug on the market for MSers has been around long enough that its patent will be soon up. When a generic form is available the profits will drop. So fighting CCSVI as long as possible makes financial sense to these companies.

These drug companies don't only make MS drugs. Their influence over the medical system is huge, including hospitals and doctors. So when we see a rogue doctor in Victoria,BC being blacklisted for doing one CCSVI procedure, we shouldn't be surprised.

MONEY is a big motivator. And the Drug companies are about BIG MONEY.

and.... no I don't think the drug companies have tapped my phone lines , or that the drug companies shot JFK. I don't think in terms of a "conspiracy theory". Protecting huge profits aren't part of a conspiracy theory, it is just what good businesses do.

facetspera wrote: But who will be the biggest loser? The drug companies who make billions off CRAB Drugs that work on 30 percent of the people.

All the more reason to hurry up with trials to show whether we can get OFF these meds if CCSVI treatment proves beneficial as a stand alone treatment.

Even now Zamboni and Zivadinov are advising MSer's to remain on their meds until after the research is done. So can we hurry up with the research then!

The fact remains. If a major vein is stenosied/clotted over 50%, angioplasty or anti-thrombotic treatment is covered by most insurance companies in the US. This is because it is a known medical fact that a closed vein harms the organ it drains.
It is covered in Budd-Chiari- liver disease
It is covered in CKD- kidney disease
It is covered in jugular thrombosis/menieres

As Dr. Embry and Dr. Brandes are saying, take MS out of the equation, and treat the venous stenosis. It is bad for the brain. That's what Dr. Dake told Jeff as he looked at his malformed jugulars. He's a vascular doctor, he would know.
cheer

eric593 wrote:And then why are IRB's getting involved and preventing treatment for this if it's as straightforward as that?

I have not yet heard of an IRB preventing treatment...have any, so far? As far as I know it has only been delays as studies go through the process of obtaining IRB approval...and Georgetown for one came out the other side with approval. No prevention there, just oversight. I think the fact that the m.s. population can be considered a vulnerable population contributes to the perceived need for oversight.

CCSVI is a newly discovered vascular malformation, so yes it needs research, particularly in regards to the apparent tie-in with m.s., but that does not change the fact that it is a vascular malformation and there are already long-proven methods on the table for how to treat vascular malformations.

eric593 wrote:So can we hurry up with the research then!

Amen to this!! I fear it will take much too long.

Actually, even if unproven, there are some advantages in offering it to those who want it (as an experimental attempt, not an standard, recommended procedure):

- It reduces the risks, as travelling long distances has risks on its own. (I'd say, travelling in polish traffic - I did this - is much more risky than an angioplasty ;) )

- Making it available makes shure that only approved experts offer it.

- The money paid for the procedure (either by yourself or insurance) stays within your country.

- The procedure is mainly demanded from patients not responding to standard treatments, so it will do little harm to the sales of big pharma at the moment (as long as unproven).

What in heavens name are the powers that be waiting for??? Is it that we MSers are so,so vulnerable needless to say not intelligent enough, to need the all pervasive minds of Neurologists {who crowned then KING?] to tell us how we should proceed with his disease...they've been WRONG so far. just about everything except telling us the only sure thing is progression. If approval is given for HyC protocol ,and that is incredibly dangerous,,,I did it, then what's taking so long? anD why in the first place, if, as someone so astutely said, a procedure is being performed everyday, in Med. centers all over the world, by surgeons schooled in their discipline/procedures are clinical trials called for anyway????
My Mom was part of a heart valve replacement surgery group back in the '60's. She was basically asked"Do you want to try this?" and she said "What's my alternative?" She lived a good quality of life for 15 years afterward.Clinical trials? I don't think so. And this was a completely untried, untrue procedure.
Now this surgery is done on a daily basis, successfully. Come on, guys. STOP THIS NONSENSE

Cece wrote:

eric593 wrote:And then why are IRB's getting involved and preventing treatment for this if it's as straightforward as that?

I have not yet heard of an IRB preventing treatment...have any, so far? As far as I know it has only been delays as studies go through the process of obtaining IRB approval...and Georgetown for one came out the other side with approval. No prevention there, just oversight. I think the fact that the m.s. population can be considered a vulnerable population contributes to the perceived need for oversight.

CCSVI is a newly discovered vascular malformation, so yes it needs research, particularly in regards to the apparent tie-in with m.s., but that does not change the fact that it is a vascular malformation and there are already long-proven methods on the table for how to treat vascular malformations.

eric593 wrote:So can we hurry up with the research then!

Amen to this!! I fear it will take much too long.

I've spoken to two interventional radiologists who want to do the testing and perform the procedure and they both said they can't because of their IRB's. They said it could take months or longer to get approval and that's not a guarantee. They perform the procedure every day for patients with other diseases.

MS patients aren't any more vulnerable than any other patient. People having the testing and procedure are knowledgable of the risks and that it may or may not be a cure. It's their right to make the decision as to what treatment they choose to pursue.

You're completely right, Cece. The research, on an approved treatment, just because MS is part of the equation will take years. People with progressive forms of the disease don't have time to wait. They also have nothing to lose.

Let's face facts. Nobody is listening. If they were, somebody would have fought this to the Supreme Courts of the US and Canada in about 3 weeks' time. But they ain't. In the so-called Free World, money talks, and those who have fought for and won a good income from drug sales, don't want it interfered with. Drs. Dake and Haacke and Zivadinov are still dealing with people who say there is no proven link between MS and CCSVI.

The truth takes a long time even if you're looking right at it, and "some people never see the light, 'till it shines through bullet-holes."

Never thought I'd be dealing with so many of those. Any doctors out there willing to risk insurance or their license? That's what is being held over their heads, by people who control very deep pockets. For just such an eventuality
as you, or I. See they really think they own us and that our words are irrelevant.

I can offer no refutation about the issue of their ownership. I have seen the future of MS, and this is as good as it will be allowed to get, for most sufferers. Regardless of CCSVI. We have allowed ourselves to become second and third-class citizens of these so-called democracies.

Trish317 wrote:I've spoken to two interventional radiologists who want to do the testing and perform the procedure and they both said they can't because of their IRB's.

shoot that makes a lot of sense...that the prerequisite of IRB approval is itself so much trouble that IRs would shy away from this...I hadn't thought about it from that angle.