FDA formally approves Hubbard Registry to treat jugular and azygos vein abnormalities in MS patients.
The Hubbard Registry–History and Moving Forward
December 14, 2013 at 2:32pm
This week, the FDA formally approved the Hubbard Registry to treat and follow MS patients with abnormalities of their internal jugular and azygos veins. It has taken a year and a half of back and forth dialogue between the Hubbard Foundation and the FDA to reach this study approval.
Prior to May 2012, the Hubbard Registry was nationally collecting data from participating physicians, using an Internal Review Board (IRB) approval. Interventional radiologists and vascular diagnosticians were allowed to diagnose and treat venous abnormalities under the umbrella of this program. They compiled data on their procedures, which was collected by the Hubbard Foundation.
In May 2012, the FDA stopped all CCSVI research and treatment. They stated that treating physicians needed their approval for an “investigational device exemption” (IDE). Medical devices, such as catheters, balloons and stents, fall under the regulation of the FDA. Because the devices used in venoplasties were originally created for use in arteries, not veins, this off-label usage created further complications and necessitated the IDE approval process. Adverse effects in patients, such as death, stroke and thrombosis, also caused the FDA to halt treatment.
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
Now that the exemption is FDA is approved- cathethers, balloons, stents and other devices used in angiopasty may be used in venoplasty of the jugular and azygous veins, as part of a clinical study of CCSVI treatment in people with MS.
The next step for the Hubbard Foundation is submission of the FDA documentation to the internal review boards for each treating interventional radiologist. This process will take several weeks. Once this information is compiled, the participating sites will be listed on the Hubbard Foundation– www.hubbardfoundation.org
According to the Hubbard Foundation, the FDA has allowed only 662 MS patients to participate, and only 10 interventional radiologists to treat. It has also added restrictions and safeguards. Unfortunately, the Hubbard registry is not a funded clinical trial, and participating patients will have to pay for the treatment. However, it is not a double-blind study, all patients will be treated for their venous abnormalities. The Hubbard Foundation will post the informed consent and other forms on their website.
We hope this clarifies the issues surrounding the FDA approval process, and what is ahead for this very important research. We will keep you posted with any new developments. Our thanks and appreciation to Dr. David and Arlene Hubbard, for continuing the dialogue with the FDA, and following through on their commitment to people with MS.