Medday, the company developing high dose biotin for progressive MS, has told the European Medicines Agency that it wishes to withdraw its licence application for the treatment of progressive multiple sclerosis.The European Medicines Agency (EMA) has been examining data on high dose biotin (MD1003, Qizenday) since the application was accepted in September 2016. At a meeting last week, the EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the clinical data from two trials that enrolled 253 patients was not sufficient to assess the effectiveness or the safety of biotin. link
Recent research and press releases on the use of super-high dosages of biotin (300 mg a day, also known as MD1003) for progressive MS are all over the internet, after moderate improvements in MS symptoms were announced at the annual American Academy of Neurology meeting last week. MS boards and patient blogs describe how people are considering trying this therapy on their own, by securing high dosages of biotin from compounding pharmacies or health food stores. But strangely absent from this online discussion is the method of action implied for biotin, which is targeting the results of a decrease in cerebral blood flow, as well as the actual results of pilot studies. I think it's vitally important to look behind the MS research headlines, and consider the science. Especially before investing time, money and hope in a new product.
I simply do not think it's wise to take mega-doses of biotin. Although I do think it's important to deal with slowed cerebral blood flow in the MS brain. Please take 5 minutes to read this note, and I believe you might feel the same way.
I first wrote about biotin at the beginning of April, on the CCSVI in MS Facebook page, after one of our administrators posted a link to an abstract.
High doses of biotin in chronic progressive multiple sclerosis: A pilot study.
Here's what I posted below the link from Sandro:
"Biotin is also known as vitamin B7. It is found in peanuts, leafy green veggies and egg yolks. It is naturally produced by healthy intestinal bacteria. Smoking and drinking can deplete it. Thanks to Sandro for this link.
All of these ideas can be found in the Endothelial Health Program, which recommends probiotics, B vitamins, dietary increases in leafy veggies, and smoking cessation. It's not a pill, it's a lifestyle. Joan"
At that time, readers were asking for more information, so I dug a bit deeper and found the patent application for this new "drug."
"A pharma company is patenting this high dosage of biotin, to market this vitamin as a drug. Here's the patent. I suggest you read it, it is enlightening. They are also patenting this "drug" for ischemic stroke damage and hypoperfusion. Drug companies understand the vascular connection."
In fact, if you read the entire patent application, the method of action for high dosages of biotin in multiple sclerosis is explained--biotin is targeting the damage from ischemia. This vitamin addresses the results of decreased cerebral blood flow, which creates ischemia, oxidative stress and reduced ATP production in the brain's cells. From the patent application:
The major responsibility for the evolution of the ischemic penumbra is the status of local cerebral blood flow. It is assumed that a decrease in cerebral blood flow yields reduced ATP production and failure of Na+/K+ pumps, increasing extracellular glutamate and activating glutamate- mediated channels, ending in an increase of intracellular calcium that is deleterious for the cell. It is widely accepted that the ischemic penumbra is a target for neurorepair and neuroprotective therapies.
Once again, we see quite clearly that drug companies understand the fact that the MS brain is hypoperfused and suffering from ischemia. They know there is a vascular connection in MS, and that the damage to the MS brain is very similar to ischemic stroke.
The results of the biotin study were somewhat compelling, but I was surprised at how many people were ready to take high doses of a vitamin, without understanding the mechanism of action, or the fact that this treatment was created for a very specific type of MS--mainly optic neuropathy. In fact, the major improvements in patients in the trial were not in motor abilities, but in vision. The changes is EDSS were incredibly minor. All of this information is very specifically addressed in the patent application.
I've often said that it is much easier to placebo control one compound, one drug, one treatment modality at a time, rather than an entire lifestyle. Because of this fact, drug companies are able to test high dosages of biotin in the gold standard method, against placebo, and publish results. But this does not mean that the best method of addressing the damage of a hypoperfused brain is high dosages of biotin.
There are side effects noted with high dosages of biotin, and serious interactions with other drugs.
Interactions. Biotin negatively interacts with anti-seizure medications and medications that help lower cholesterol, causing these medications to work less effectively. While biotin is helpful in regulating your metabolism and blood sugar levels, it can have a distinct effect on the overall blood glucose level in your body. If you are taking medications like cholesterol medication or anticonvulsants or treating a condition like diabetes, taking biotin can have an impact on your symptoms.
Best results are found in a complete lifestyle approach, with cardiovascular exercise, physical therapy, whole food nutrition full of leafy greens and phytonutrients from plants, stress reduction, probiotics, UV ray therapy, vitamin D supplementation, vitamin B supplementation, smoking cessation, hydration, adequate sleep, and addressing venous malformations which may be impacting cerebral blood flow.
There is no one miracle pill or supplement or drug which can replicate the results of a complete lifestyle.
Here's the complete program I created for Jeff, which takes all of this into account. It was created to deal with oxidative stress, hypoperfusion and energy depletion in the brain.
The Endothelial Health Program was created to increase cerebral blood flow, via healthier blood vessels and cardiovascular function. All of the steps are proven, scientifically, to increase cerebral blood flow and oxygenation of the brain. It is preventative and reparative medicine. And it works. Jeff's going strong, now 8 years past his MS diagnosis, with no MS progression and a reversal of brain atrophy on MRI. He's still jogging and working full days. Always consult with your own physician before beginning a new lifestyle program. Jeff works with our GP, to make sure all of his blood numbers are good, and that he is doing well on his program.
Be well, be hopeful, but understand that there is not one pill or compound or vitamin that will ever replace a multi-modal, systems approach to healing.