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Monday, May 21, 2012 3:51 PM | CCSVI Alliance Volg link

Since its inception, CCSVI Alliance has been dedicated to educating patients with research based information about CCSVI.  Our website provides the tools for patients to advocate for themselves. 

  • We established a research database of peer reviewed, published articles on CCSVI (both positive and negative)  here  
  • our science writer summarizes the current research in a meta-analysis here
  • the “Helping Yourself” section provides the necessary information to seek CCSVI treatment here
  • and an “Aftercare Program” here
  • treatment and efficacy are discussed here  
  • treatment risks are discussed here
  • informative interviews with medical professionals from the endovascular and neurological communities here  and on the “Home Page”  here

Our website and educational programs encourage patients to discuss the potential risks and benefits of CCSVI treatment with doctors who are familiar with MS and the procedure, and the FDA safety alert issued last week makes similar points.  

 

The FDA alert has increased public awareness of CCSVI, and CCSVI Alliance was encouraged to see the responses to the alert from the various societies including the Society of Interventional Radiology here  the National Multiple Sclerosis Society here  and medical professionals including Dr. Barry Katzen here  and Dr. Robert Fox here  

In order for the research to realize its full potential, doctors and scientists need to embrace the open exchange of knowledge.  It only makes sense that further investigations be a collaborative, multi-disciplinary effort.  As Scott Johnson, president and founder of the Myelin Repair Foundation, has said, “Medical research experts, like top scientists in all areas of high technology, must focus narrowly.  But this kind of ‘siloing’ is a distinct disadvantage when it comes to complex diseases like MS.  To solve multifaceted problems requires coordination among the most accomplished specialists in multiple disciplines.”

 

During the past week, the Alliance was offered the opportunity to open a dialogue with the FDA.  We are especially grateful to know that they consider our website an informative resource for the MS patient wanting to learn about CCSVI.  CCSVI Alliance concurs with the FDA’s objectives of promoting patient safety and further research into CCSVI.  

 

As stated in the FDA alert, investigators of clinical trials involving “off-label” use of devices will need to obtain the FDA’s Investigational Device Exemption (IDE).  If a device is not involved, FDA approval is not required (i.e. registries and/or diagnostic clinical trials). The FDA has oversight over device manufacturers and prohibits them from advertising any “off-label” use of devices.  The FDA does not have the same jurisdiction over physicians.  The general rule is that when physicians advertise their service, they must adequately and accurately describe the risks and benefits of a procedure in the advertisement.   The FDA encourages patients to make informed decisions by being alerted to the risks and benefits of medical procedures and pharmaceutical drugs.   

 

The Alliance will continue to advocate for the MS patient by supporting collaborative research and consensus as it relates to CCSVI.

 

Sharon Richardson, President