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Multiple Sclerosis Treatment Warning Issued By FDA

multiple sclerosis ccsvi

A risky, experimental multiple sclerosis treatment has been warned against by the Food and Drug Administration (FDA) after incidents including serious side effects and death have been reported.

The multiple sclerosis treatment implicated by the severe warning is called liberation therapy, and focuses on chronic cerebrospinal venous insufficiency (CCSVI), which is a narrowing of venous structures in the neck and head. However, the treatment that uses stents or balloon angioplasties to open up veins between the head and heart has been linked to two deaths, as well as paralysis, strokes and nerve damage in some patients.

Worse yet, the risky multiple sclerosis treatment demonstrates no evidence of conferring any benefit to MS patients. So far, no devices have been approved by the FDA for this sort of treatment, and Reuters obtained a quote from the agency regarding their position on the risky treatment and its potential outcome for multiple sclerosis sufferers:

“Our position is that the evidence is simply insufficient to determine whether there’s a link,” said Dr. William Maisel, deputy director and chief scientist of the FDA’s devices division. “We want patients to be aware this treatment (with stents or balloon angioplasty) is unproven, that there are significant risks associated with the treatment, (and) the benefits are uncertain.”

However, some multiple sclerosis patients who have experienced the treatment report some improvement that they believe is linked to CCSVI. Sharon Richardson is an MS sufferer and head of the CCSVI Alliance, and she explains:

“I had my original procedure in June of 2009. I had a back pain for approximately eight years, and that pain was gone the day after I had the procedure and it has not come back since.”

Richardson acknowledges some eventual backsliding with multiple sclerosis symptoms, symptoms she reports disappeared after undergoing CCSVI a second time.

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4 Responses to “Multiple Sclerosis Treatment Warning Issued By FDA”

  1. Michele Findlay

    Much is made of two aspects of CCSVI treatment, the first being the risks attached to the procedure and secondly the scientific evidence required.
    Let me address risk as it is the one most commonly used to frighten people… The figures of complications and deaths compare most favourably with deaths and complications from MS prescribed drugs. There have been 5x less deaths as a result of angioplasty for CCSVI than there have been from Tysabri caused PML. To be generous to Tysabri/PML 1 in 2000 have died, whereas with CCSVI treatment only 1 in 10,000 have died. Additionally in terms of benefits the surgical treatment is at least as successful as Tysabri. Very little research reveals that Tysabri is not universally effective. (see risk sharing schemes).
    Secondly, let us examine the need for scientific proof. Only about 20% of currently prescribed treatment is the result of scientific proof. The fact is that medicine is not a precise science. Things work for some and not for others… I do believe that there is a rule of thirds in medicine: 1 third get better, 1 third will get some benefit and one third will not benefit at all and may get worse. The value of clinical trials in respect to this treatment in MS is uncertain being that people with MS symptoms get worse in time and at an unpredictable rate. So let us use a bit of common sense here and assess, treat, review, record patients and the outcomes of a procedure considered safe for the general population and treat people with MS for venous insufficiency without all the hype and bunkum which is flung about with great abandon by people who ought to know better.

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  3. Eileen Curras

    It is sad that the fear tactic comes from the blessing of the FDA. The label of a risky, experimental multiple sclerosis treatment has been taken out of proportion. Science has rikks. Let the patients make the decisions. The multiple sclerosis treatment implicated the liberation therapy. However, the treatment that uses stents brought hope to patients. Their position that the evidence is simply insufficient to determine whether there’s just clumsyness. They only want to instill fear.