Today the U.S. Food and Drug Administration released a safety communication to inform people with MS, doctors and others about potential risks associated with procedures and devices used to treat CCSVI (chronic cerebrospinal venous insufficiency). The communication from the FDA outlines these risks and encourages more research to provide better understanding of the relationship between CCSVI and MS and to guide possible treatment decisions by people with MS and their health care providers.
The safety communication provides specific recommendations for people with MS, health care providers, researchers and Institutional Review Boards (IRBs) – IRBs are independent committees that approve and monitor research involving people. For people with MS, the FDA communication notes that:
a definite link has not been established between MS and CCSVI;
the safety and effectiveness of using balloon angioplasty with or without stents in the internal jugular or azygos veins has not been established for any medical condition; nor has the FDA approved the use of these devices in these veins;
serious complications can occur as a result of CCSVI treatment procedures;
before considering treatment, the FDA recommends that people discuss potential risks and benefits with a neurologist who is familiar with MS and CCSVI;
before having any CCSVI procedure, the FDA recommends that people discuss with their health care provider the signs and symptoms of complications of these procedures;
people who undergo procedures to diagnose or treat CCSVI are recommended to continue following the MS treatment plan outlined by their health care providers;
anyone considering participating in a clinical trial for CCSVI is encouraged to learn as much as possible about the trial and ask questions of the health care team conducting the trial; and
anyone undergoing treatment for CCSVI who experiences a complication is encouraged to file a report with the FDA through the MedWatch, the FDA’s safety information and adverse event reporting program (http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm)
The communication outlines adverse events connected with CCSVI treatment procedures that have been reported to the agency or reported in medical journals. These include two deaths, and incidents of stroke, blood clots, cranial nerve damage and abdominal bleeding. The communication notes that the frequency of these complications is unknown. It also notes that the FDA will continue to monitor for adverse events related to medical devices commonly used in CCSVI treatment, and keep the public informed as new information becomes available.
Learn more about the FDAs safety communications policies.
More Research Encouraged
The FDA communication encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures.
Although some individuals who have MS have undergone surgical procedures for CCSVI, there has not yet been a controlled trial to determine its effectiveness in treating the symptoms or course of the disease. The Canadian Institutes of Health Research (CIHR) announced in April 2012 that a research team had been chosen to conduct a phase I/II clinical trial to determine the safety of venous angioplasty and obtain evidence on patient outcomes in people with MS. The location of the study has not yet been announced. The clinical trial is a collaborative initiative between the CIHR and the MS Society of Canada. Read more about the CIHR announcement.
The National MS Society shares in the public urgency to advance the understanding of CCSVI as quickly as possible. In collaboration with the MS Society of Canada, the Society has been at the forefront of researching the potential links between CCSVI and MS and in July 2010 launched seven research studies with a commitment of more than $2.4 million. The research teams have recruited a broad spectrum of people with MS and others to build an understanding of who may be affected by CCSVI. In addition, they have been refining CCSVI imaging methods for accuracy and consistency to reliably validate the occurrence of CCSVI and understand its implications in the MS disease process. Read the 18-month progress report.
After the research projects are completed, the studies will be analyzed and submitted for publication in one or more scientific journals. At this point it isn’t clear when full data and results will be available to the public. In the meantime, several of the investigators have already been sharing their results with other scientists at medical meetings. Results from the seven projects as well as other studies will help guide the Society’s planning for future investments in this area of research.
Frequently Asked Questions
Q: Does the National MS Society support the FDA’s safety communication?
A: The Society supports the FDA’s effort to provide the most current clarifying information to people with MS and their health care providers so that they are better equipped to make informed treatment decisions.
The Society agrees with the FDA that research is needed to evaluate the relationship between CCSVI and MS. The Society fast-tracked its support for CCSVI research in early 2010 in collaboration with the MS Society of Canada and together we are funding $2.4 million in research grants.
We appreciate the FDA’s commitment to continuing to monitor this situation and to keep the public informed as new information becomes available.
Q: Does this FDA communication ban procedures to treat CCSVI?
A: No. It provides specific guidance about questions that should be considered by individuals and their health care providers before such a procedure is undertaken. In addition, the FDA’s safety communication notes the regulatory requirements for research using medical devices in CCSVI.
The FDA has not cleared or approved any angioplasty device or stents for the treatment of CCSVI and the use of such devices in treating CCSVI would be considered off-label at this time.
Q: Does the FDA communication have implications for the availability of venoplasty treatment for CCSVI?
A: At this time we do not know the implications of this communication for the availability of venoplasty treatment for CCSVI (venoplasty is angioplasty in veins).
Q: When does the FDA issue safety communications and what prompted them to issue one regarding CCSVI?
A: We don’t know what prompted this specific safety communication at this time. To learn more about the FDA’s policies around safety communications you can visit the FDA’s site: http://www.fda.gov/MedicalDevices/Safety/default.htm
Q. Will this communication impact how my insurance company evaluates potential coverage for this procedure?
A: We don’t yet know the implications of this safety communication and whether it might impact insurance coverage.