Tuesday April 26, 2011
Sativex is a drug that contains two main compounds derived from marijuana, the cannabinoids cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC). It controls involuntary muscle movements in people with multiple sclerosis (MS). It also has been shown to help with MS-related pain, spasticity and bladder dysfunction. It is sprayed into the mouth.
Sativex is currently in a Phase III trial in the US for treatment of cancer pain, which is a necessary step for receiving FDA approval. Once FDA approval is received for Sativex, it can be used off-label to help people with MS. (For more information on how this works, read What is "off-label" use of drugs and is it legal?)
Sativex is currently approved in the UK, Spain, Czech Republic, Canada and New Zealand as a treatment of multiple sclerosis spasticity.
The US license to Sativex is held by Otsuka Pharmaceutical Co. Ltd in the United States and to Bayer HealthCare AG in the UK and Canada. GW Pharmaceuticals has signed a deal to have Novartis (makers of Gilenya) market Sativex in parts of Asia, the Middle East, Australia, New Zealand and Africa, so is moving ahead in those markets.
Tuesday April 26, 2011
Since Biogen brought Tysabri back to the market in 2005, the FDA has put the risk of progressive multifocal leukoencephalopathy (PML) at 1 case of PML per 1000 people on Tysabri.
However, there was little data about what happened after 2 years, and there were vague warnings that the risk seemed to increase after 24 infusions (which equals 2 years of monthly infusions). Now the FDA has formally quantified the risk of PML by time, as follows:
- Months 1-24 (first 2 years) - risk is .3 per 1000 patients treated with Tysabri.
- Months 25-36 (3rd year of treatment) - risk of PML is 1.5 per 1000
- After 3 years - risk of PML is a little lower, at .9 per 1000
To read the full announcement from the FDA, read FDA Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
Tuesday April 26, 2011
The sensation that I had a couple of days ago wasn't "normal" back pain - it felt distinctly like a symptom of multiple sclerosis, but I haven't been able to find any info about such a symptom. The pain was in my lower back, at the base of my spine. Don't get me wrong - it did hurt, but more in a buzzy, "electrical" way than a dull, throbbing way. I knew that taking an Advil or Tylenol wouldn't relieve it, for instance. I have suffered from sciatica in the past, and it wasn't like that, either.
The tingly pain did radiate down my legs like sciatica did, ending at my feet, which also felt like they were being bitten by ants. This made walking a challenge, but I as long as I concentrated on where I placed my feet, I could overcome the interference with proprioception. This painful burning also affected my pelvic area, making me feel like I needed to urinate constantly, as if bladder dysfunction had woken up with a vengeance.
Although I spent an hour or so plagued by these sensations, it was late at night when this came upon me. I decided not to allow myself to go down the "this just has to be a relapse" path until I had the symptom for 24 hours. Sure enough, by morning, the back pain and burning was gone.
The medical literature doesn't really address the issue of back pain in MS per se. There is some mention of back pain being more prevalent in people with limited mobility, which makes sense - time in a wheelchair could cause pain. An uneven gait that is caused by spasticity or weakness in one or both legs could also "tweak" the lower back. However, neither of these apply to me at the moment, so I guess I'll just chalk it up to being a paroxysmal symptom, that comes and goes without signaling a bigger problem.
What about you? Have you experienced lower back pain of this nature? How long did it last? What did you do for it (and did anything help it)? Can you think of anything that triggered it? Tell us about your experience in the comment section below.
Read more about pain and MS: Overview of Pain as a Symptom of Multiple Sclerosis
Saturday April 16, 2011
The treatment for cerebrospinal venous insuffienciency (CCSVI) in people with multiple sclerosis (MS) is usually balloon angioplasty - the procedure is often called "Liberation Therapy."
The doctors who typically perform this procedure are interventional radiologists (IRs), doctors who do surgery or diagnose disorders using radiological images. The whole idea is that the images will help the doctors diagnose or treat in the least invasive way - instead of cutting patients open to find out what is going on and then fix it, IRs use images to show them a picture of the problem and allow them to get to the exact spot to correct it with tiny instruments, such as needles and catheters.
A group of IRs who have been treating people with CCSVI presented data from 231 MS patients who have received treatment. The data, presented at the Society of Interventional Radiology's 26th Annual Scientific Meeting, was compelling.
A total of 247 angioplasties (both with and without stent placement) were performed on 147 female and 84 male patients, who ranged in age from 25 to 70 years. In 99.2% of cases, the people were discharged within 3 hours of the procedure. The most significant "side effect" noted was sustained cardiac arrhythmia in 3 of the patients during the procedure, leading to the recommendation that cardiac monitoring be used during surgery. In addition, 8.5% of people experienced headache and 18.5% of people mentioned neck pain.
It was stressed by the IRs that even though the procedure appears to be extremely safe in people with MS, there are still many questions to be answered, including how to select patients and the relationship of CCSVI and MS.
For additional information about CCSVI and MS:
Source: Society of Interventional Radiology (SIR) 36th Annual Scientific Meeting: Abstract 3. Presented March 28, 2011.
