Sample letter to:
Steven D. Silverman
Director, Center for Devices and Radiological Health, FDA, HHS
10903 New Hampshire Avenue, WO Bldg 66 Rm 3408
Silver Spring, MD 20993
fax ?301-847-8136
Dear Mr. Silverman,
I am writing to thank you for the alert issued by the FDA on May 10, 2012, on Chronic Cerebrospinal Venous Insufficiency (CCSVI) and multiple sclerosis (MS). I was treated and had some improvement in my symptoms and quality of life. I have some concerns that I hope you will consider as you continue to regulate this procedure.
1) Your warning did not reference the four safety studies on CCSVI by Zamboni, Petrov, Simka, and Mandato. It was therefore biased in favor of the pharmaceutical approach to this mysterious disease. Judging from the medical news reports following your warning, it seems that FDA fostered a misunderstanding in the medical community about CCSVI that will needlessly delay research. To be more balanced and accurate, your warning should consider:
- The autoimmune model that is the foundation of current drug therapy is also “scientifically unproven.” A significant and increasing number of mainstream MS neuropathologists believe that degenerative changes occur first and that inflammation is a secondary event. (1,2,3,4,5)
- EAE mouse model used to test MS drugs is not MS. MS is not transmissible where EAE is, and EAE mice do not have atrophy of brain tissue as in human MS. (6,7)
2) Asking us to speak to our neurologists about CCSVI, as you have, is unlikely to result in a useful discussion because they are not trained in vascular disease. Likewise it is not likely that my interventional radiologist (IR) is an expert in MS. Please edit your patient alert to recommend speaking to vascular experts about CCSVI and neurologists about MS.
I am concerned that patient protection is being used as a cover to protect investments and careers that may be threatened by this new scientific discovery. The loudest critics often have commercial or reputational conflicts of interest. The MS wars are nothing new. (8)
The original theory of MS was of a venous origin because the MS plaque is always found around the venules. Dr. Paolo Zamboni, is a world renowned expert in venous insufficiency. He used his expertise in ultrasound to find the evidence that had been lacking for over 100 years. He studied over 750 MS patients before his peer-reviewed papers were published in 2008.
The MS brain lesions have the characteristic markers of venous insufficiency that are found elsewhere in the body. Turbulent blood flow is known to alter the endothelium in blood vessels. Similar changes are found in the blood brain barrier of people with MS. Zamboni’s model of MS merits rigorous study and an opportunity to be validated with evenhanded guidance from the FDA. CCSVI is not the cure for MS, but neither is it a “hoax” nor “faith healing”, as the detractors claim in their many published opinion pieces. It is an anatomical problem causing restricted blood flow that needs a durable treatment. It is also a source of real hope and welcome good news.
3) Of course adverse events should be reported to FDA and patients should be warned of risks by informed consent. The MedWatch reporting program it seems, typically collects negative anecdotal reports as part of your post-market consumer protection. Considering that CCSVI treatment is currently investigational, all treatment results, positive and negative should be collected to avoid bias. Creating a scientifically valid registry to prospectively collect all outcomes would offer real consumer protection.
Sincerely,
Person with MS
family member, friend (edit the signature lines prior to sending and delete all purple text)
include your address 100 Main Street Anywhere USA 10001
“The great enemy of the truth is very often not the lie -- deliberate, contrived and dishonest, but the myth, persistent, persuasive, and unrealistic. Belief in myths allows the comfort of opinion without the discomfort of thought.” J F Kennedy
Refrences
1. Barnett M, Sutton I. 2006. “The pathology of multiple sclerosis: a paradigm shift.” Curr Opin Neurol. Jun;19:242-47. PMID:16702829
2.Barnett M, Prineas J. 2004. “Relapsing and remitting multiple sclerosis: pathology of the newly forming lesion.” Ann Neurol. Apr;55(4):458-68. PMID:15048884
3.Behan P, Chaudhuri A. 2005. “Looking beyond autoimmunity.” J R Soc Med. Jul;98(7):303-6. PMID:15994589
4.Roach E. 2004. “Is multiple sclerosis an autoimmune disorder?” Arch Neurol. Oct;61(10):1615-6. PMID:15477522
5.Tsutsui S, Stys P. 2009. “Degeneration versus autoimmunity in MS.” Comment in Ann Neurol. Dec;66(6):712. PMID:20033985
6.Sriram S, Steiner I. 2005. Experimental allergic encephalomyelitis: a misleading model of MS”. Ann Neurol. Dec;58(6):939-945. PMID:16315280
7. Steinman L, Zamvil S. 2005. "The virtues and pitfalls of EAE for the development of therapies for multiple sclerosis." Trends Immunol. Nov;26(11): 565-71. PMID:16153891
8. Nicolson and Mclaughlin. 1987. “Social constructionism and medical sociology: a study of the vascular theory of MS” Soc of Health Illness. Available online: http://onlinelibrary.wiley.com/doi/10.1111/1467-9566.ep11340153/pdf (Accessed Aug. 17, 2010)