On May 10, 2012 the FDA issued a warning against CCSVI treatment for MS patients. By letter dated February 21, 2012 they had warned Dr. Mehta of the Albany Vascular Group to cease treatment without the required approval which effectively put an end to his independent practice of angioplasty.
The following quote comes from the ThisIsMs.com website from 1eye July 15, 2012 (under the entry CCSVI, MS
Fatigue, Brain Oxygen) who corrected my original FDA remarks as follows.
"The FDA has not banned patients from seeing doctors or even banned the procedure from being done by a specialist. What it has done is to withhold permission from some randomized prospective trials, that they possibly thought were being done under group and other IRB approvals, without a permission slip called an IDE or Investigational Device Exemption. The IDE allows the trial to be prospective (outcome unknown) when they are using devices such as catheters and stents. What I think that does, is to hinder research, and perpetuate the statement that the use of the catheter or stent on a vein is "Investigational" or experimental,
when the only thing under question is its effect on "MS".These pw"MS" have been saddled with fighting bureaucrats, turf-scared neurologists, the AMA, the CMA, the MS societies, judicial and quasi-judicial organizations, drug vendors, professional associations (the list goes on), to make this procedure a legal
entity for those with "MS", paid for by their paid insurance premiums.The FDA has succeeded in slowing research on the procedure to a snail's pace in the US. But they have not banned, and have no power to ban the procedure itself. Many doctors believe the FDA are acting in the interest of the patient. Unfortunately, nobody speaks for the Patient, without having a financial interest to protect."
The end result is that insurance companies and Medicare are refusing to re-imburse the procedure (which they did before this FDA action) since it is considered "investigational". Doctors refuse the procedure rather than risk legal
consequences. A recent death of a Canadian woman who was forced to go to Mexico to obtain angioplasty and was subsequently refused post-operative care "she so desperately needed" in Canada highlights the negative consequences of this ban. (Canada follows the same policy as the US.) Roxane Garland, age 37, died of an
untreated bladder infection, not CCSVI. The "effective" ban reminds me of the dark ages when abortions were illegal. The medical act itself was not dangerous. Women died because they were forced to go underground. In some way I believe she was punished by her Canadian Doctor for having gone against "established norms, beliefs or paradigms." (See the Semmelweis Reflex) She left a grieving husband and 2 children.
REVISION 13 AUGUST:
I need to clarify this post. I compared abortion and CCSVI, but only with the medical aspects intended. But in truth I think CCSVI may carry more medical risks than abortion. Apparently in the case of Roxane Garland (admittedly I don't know the circumstances first hand) she was treated with angioplasty in Mexico and enjoyed the expected recovery of lost functiuon. However, the improvements wore off as the vein in question re-stenosed. So she returned to Mexico where they did 2 interventions in one week with the result that there were no improvements and perhaps her condition worsened. Eventually she went to a clinic in California where she was told the vein was entirely blocked (?) and there was nothing they could do. She tried to get help in Canada (when I don't know) but help was refused. Her doctors seemed to take a negative attitude towards her when they learned she had gone overseas for treatment. The Califirnia clinic wanted her to get an ordinary venography (?) which is standard procedure if one has a vein problem, but is considered "investigational" if one has MS. (The Doctor in California felt it unwise for her to try to travel.) This tragic story might illustrate the idea that CCSVI should be forbidden when in fact it illustrates the gross stupidity of forcing people to go overseas for a promising treatment still in its infancy. Roxane Garland should have been able to visit a vein specialist, undergone preliminary diagnostic tests such as a doppler sonogram, been advised of potential risks before the catheter venography which is both a diagnostic and treatment procedure. That is to say, if a blockage is found, it is immediately treated. Apparently the jugular veins re-stenose 50% of the time. There is some wear and tear on the vein caused by the catheter venography which carries the risk the vein may close up even more than before treatment. I myself would recommend that one try the various self help measures I have used, massage, acupuncture, self acupressure etc to see if one can open the circulation without angioplasty since angioplasty MAY result in a worsened condition. I know that interventional radiologists want to "intervene", that they have facilitated near miraculous recoveries where a patient bound to a wheelchair gets up to walk, but sometimes one needs to let go. The other side of this "miracle" is a deterioration. And there are other, non medical ways to control the disease process. I don't see how a controlled clinical trial can account for all the variables in MS I have no doubt that Dr Zamboni has discovered the CAUSE of MS. But not THE solution, because there are numerous solutions and some do not fall into the Medical Doctor's domain.