


Cece wrote:The Hoag hospital, from the article on the other page with the doctor claiming credit for getting the FDA involved, is in Newport Beach, where a high volume CCSVI clinic is, and two patients treated at the clinic ended up in the ER at the Hoag hospital. They're the two listed in the FDA alert. The Hoag hospital has seen the two patients who'd had a stroke or a subdural hematoma after the procedure, with one of those patients dying and one facing a tough recovery, and they haven't seen the thousands of patients who have benefitted from the procedure.
When I first learned about CCSVI, it was a few weeks after radeck's stent migration to the heart and a few months after Holly's passing. It was clear to me that even though this was an outpatient procedure, there were some risks involved, as there would be in any surgical procedure.
Lamb released Clarke's medical records, which include examination notes. Hoag neurosurgeon Dr. Richard B. Kim says the cause "of the subdural hematoma remains unclear, but seems temporally and physiologically related to the internal jugular vein dilation procedure." An autopsy was not performed.
http://www.healthimaging.com/index.php? ... -patients-“The studies that have been reported to date, including the studies reported at the SIR meeting, have been single center retrospective series which have highlighted the potential for this treatment to improve the quality of life in patients with MS. These are the types of studies which must first be performed and reported on in order to build an initial understanding of the procedure and the entity being treated. These initial studies are also able to highlight the potential safety issues that may be encountered with these procedures. Most of the studies published or presented to date have seen little risk for significant complications in association with this procedure. However, scattered significant complications have been reported and we agree that patients should be made aware of these risks when considering this procedure,” Hicks noted.
The final presenter was Fred Fox, president of BioMed Institutional Review, the company which has granted the Hubbard’s their registry approval. I was very interested to hear Mr. Fox’s take on the FDA warning letter and press announcement on CCSVI treatment.
The term “off label” comes from the pamphlet-like label on the bottle of prescription medication or a medical device...this pamphlet states how this medicine or device can be used and in what applications. If a treatment is not “on the label” it is considered an off label usage. This is how the FDA views the use of stents or balloons in the veins of pwMS. They were created for arteries, and veins are not on the label. Doctors are allowed to treat off label---it’s a personal decision between you and your doctor. This happens everyday.
However, If the doctor promotes off label usage it is illegal.
When did off label use cross the line in CCSVI treatment? When this treatment became promoted and advertised to patients.
Cece wrote:The term “off label” comes from the pamphlet-like label on the bottle of prescription medication or a medical device...this pamphlet states how this medicine or device can be used and in what applications. If a treatment is not “on the label” it is considered an off label usage. This is how the FDA views the use of stents or balloons in the veins of pwMS. They were created for arteries, and veins are not on the label. Doctors are allowed to treat off label---it’s a personal decision between you and your doctor. This happens everyday.
However, If the doctor promotes off label usage it is illegal.
When did off label use cross the line in CCSVI treatment? When this treatment became promoted and advertised to patients.
The FDA regulates drugs and devices in the US. It doesn't control individual physicians. Attempts to go after an individual doctor by complaining to the FDA will not impact an individual doctor.
Rather the entire CCSVI movement will be hurt by theses acts of selfishness. In particular, research efforts will be limited and far more difficult. Personally, I will strive to move CCSVI forward. No matter who or what obstacles arise. The truth is CCSVI treatment works and there's no stopping the truth.
http://www.facebook.com/Dr.Arata/posts/312827728794974FDA warning is just that. A warning that adverse events could happen when undergoing CCSVI treatment. It is something we all need to keep in mind. It also means that CCSVI is on their radar. That is fantastic news. I look forward to sharing my CCSVI experience with the leaders of the FDA.
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