The biotin trial results are out

Biotin is an emerging therapy for the treatment of secondary progressive MS.
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cheerleader
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Re: The biotin trial results are out

Post by cheerleader » Tue Apr 28, 2015 2:55 pm

Important question to ask before putting money down. What is biotin doing, and how?

I found the patent online. It is being patented not only for MS, but also ischemic stroke. It's all about the damage caused by slowed cerebral blood flow, also known as hypoperfusion.
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.

for more info, and link to patent:
http://ccsviinms.blogspot.com/2015/04/b ... ve-ms.html

cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com

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Re: The biotin trial results are out

Post by Jimpsull » Tue Apr 28, 2015 5:30 pm

Of the biotins I had been using, only two were specifically d-biotin.

Details here:

http://enhancedbiotintrial.blogspot.com ... s.html?m=1

I read the patent and their is data on both optic neuritis and gait improvements. Why are people willing to ingest high quantities of a supplement before all the red tape has been cut through? My decision was based on reward / risk ratio. I see the risk as small and the potential upside as significant.

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Re: The biotin trial results are out

Post by CureOrBust » Tue Apr 28, 2015 5:49 pm

cheerleader wrote:Important question to ask before putting money down. What is biotin doing, and how?
I found the patent online. It is being patented not only for MS, but also ischemic stroke. It's all about the damage caused by slowed cerebral blood flow, also known as hypoperfusion.
There is more than one theory on the answer to this question, and a published study gets trumps over a patent in my books. Also, how many people truly understand the mechanism of Gylenya; apart from the generic "it keeps lymphocytes in ya lymph nodes". I think it was after I started taking it I read somewhere that it also makes permanent changes to the immune system even after you stop taking it. If someone found a non-toxic cure for MS but they had no idea how it worked, there would be a queue around the corner, and I would be in the front!
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.
Progression in PPMS and SPMS is pretty much a guarantee. The possibility of stopping the run-away train is very tempting. As for it being only for ON, the trials PRIMARY endpoint was "Mean EDSS change improved at 12 Months". I think their next Phase III trial is ON specific. As for the dose of Vitamin, it was well tolerated, and there would of also been a Phase I trial specifically for that also. It does raise the question as to the difference between Biotin and MD1003. However, most references say that biotin has low toxicity at high doses (i did find some references to blood sugar)

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Re: The biotin trial results are out

Post by tzootsi » Tue Apr 28, 2015 6:06 pm

If anyone is looking for d-biotin at a reasonable price, Puritan's Pride seems to offer the best deal.
http://www.puritan.com/biotin-421/bioti ... mcg-051463

Cheer, I hear where you are coming from, but for folks with PPMS, a fairly safe, inexpensive over the counter vitamin that may help them is pretty hard to ignore.

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Re: The biotin trial results are out

Post by Jimpsull » Tue Apr 28, 2015 8:21 pm

Thanks for the heads up tzootsi - looks like that works out to about $60 / month at my dosing regimen (20 doses per day). Not bad.

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Re: The biotin trial results are out

Post by cheerleader » Wed Apr 29, 2015 9:07 am

CoQ10
Protandim
ECGC
NAC
vitamin D
and now biotin.

For those of us who have been following the research for any length of time, we recognize the supplement names and remember the excitement. You can search this forum for any of those names of dietary supplements listed above, and see the history. Lots of megadosing and money spent.

It is easier to placebo control one supplement or drug at a time. That's why drug companies hold all research to the "gold standard." Because if you compare any healthy nutritional component to placebo, you're bound to get something that looks good.

But that doesn't mean that any one supplement will be a "cure" or the complete answer.
That's my concern. It takes a whole new lifestyle, filled with whole foods and phytonutrients, daily exercise, stress reduction, cigarette smoking cessation, better sleep habits, UV ray therapy, transfat, glucose and junk food removal. B vitamins, like biotin, are hugely important, because they provide energy to our cells. That's why vitamin B12 deficiency is a differential diagnosis for MS.
http://www.direct-ms.org/pdf/NutritionM ... d%20MS.pdf

it's really tough to placebo control a complete lifestyle or vascular intervention (ask Dr. Wahls, Dr. Swank, Dr. Jelinek, Dr. Embry, Dr. Zamboni) but that doesn't mean that a systems approach to healing doesn't work. Make sense?
cheer
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dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com

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Re: The biotin trial results are out

Post by Simvic » Wed Apr 29, 2015 6:21 pm

What is the next step for MD 1003? Does anyone know the timeline till MD 1003 is available to PPMS and SPMS? Are they going for FDA approval or is there going to be another trial before they can apply for FDA approval?

Thanks
Simvic

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Re: The biotin trial results are out

Post by Jimpsull » Wed Apr 29, 2015 7:42 pm

Agreed that biotin is not a cure-all. I have added it to my regimen:

- swank diet
- vitamin d3
- Padma
- cod liver oil
- exercise
- b12
- biotin (http://enhancedbiotintrial.blogspot.com/?m=1)
- NUCCA chiropractic

Jim

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Re: The biotin trial results are out

Post by 1eye » Thu Apr 30, 2015 5:18 am

I think the price of biotin in its bulk form will show the world a) whether the drug companies can get away with it b) whether the French company that produces the biotin-based treatment has any more scruples than Teva, Biogen, Serono, and their ilk. While we're at it, we might as well give them the brand recognition they deserve.

Big Pharma knows that in MS it is a race between time and money, and with chronic diseases, there is no time to lose.

================================================================================================
Drug prices to treat multiple sclerosis soar, point to larger problem

Oregon State University

PORTLAND, Ore. - A new study released today found that drugs used to treat multiple sclerosis have soared in price in the past two decades, in some cases more than 700 percent, even though newer drugs have come to the market - a process that normally should have stabilized or reduced the cost of at least the older medications.

There are no multiple sclerosis drugs now available in the United States with a list price below $50,000 a year, which is two to three times more than the price in Canada, Australia or the United Kingdom. The group of drugs available to treat this disease is rising in price at five to seven times the normal rate of drug inflation in the U.S.

The findings of this research also point to a systemic problem in the U.S. pharmaceutical industry, with relevance to more than just drugs for multiple sclerosis, according to the authors of the study, which was supported by the Oregon State University College of Pharmacy.

Enormous, uncontrolled and rapidly increasing prices for some types of drugs, they say, may be linked to non-transparent drug pricing policies, a dysfunctional market and the lack of a national healthcare system to negotiate prices more aggressively and directly with pharmaceutical companies.

The end result, they say in the report, may be another industry "too big to fail."

This research was published today in Neurology, the medical journal of the American Academy of Neurology, by scientists at the Oregon State University/Oregon Health & Science University College of Pharmacy, the Oregon Health & Science University, and the Veterans Affairs Medical Center in Portland, Ore.

"The issue of astronomical drug costs, especially for newer drugs or rare conditions, is more and more common," said Daniel Hartung, lead author of the study and an associate professor in the Oregon State University/Oregon Health & Science University College of Pharmacy.

"There are often several drugs in a class available to treat a disease or condition, and 'economics 101' would suggest that competition should lower prices," Hartung said. "In the pharmaceutical industry we often don't see that. Many professionals now believe that it's time to push back, to say enough is enough."

Escalating costs for specialty pharmaceuticals, for conditions such as multiple sclerosis, cancer, and hepatitis C, have been a growing concern among many in the health care industry, the authors wrote in their study, raising questions about the ethics of our current approach, exorbitant pricing and increased burdens on "our already stressed healthcare system."

"Pricing in the pharmaceutical industry increasingly is a case of whatever the market will bear," Hartung said. "We used to think that any drug with $1 billion in sales was a blockbuster, but last year a drug for hepatitis C had 10 times that, or $10 billion in sales. This does not necessarily mean that drug research and innovation will be 10 times better."

In the specific case of multiple sclerosis, the research looked at first-generation drugs which became available in the 1990s at prices ranging from $8,000 to $10,000 a year. More competition from other drugs then entered the field. But instead of the price of the original drugs staying about the same or going down, as classic economic theory might dictate, their price soared. One drug that originally cost $8,700 now costs $62,400 a year.

The cause for escalation in the cost of these older drugs is unexplained and "alarming," the researchers said. It most likely was not attributable to a rise in manufacturing costs, and general and prescription drug inflation was only about 3-5 percent a year over the same period.

"The simplest explanation is that pharmaceutical companies raise prices of new and old MS disease modifying therapies in the United States to increase profits, and our healthcare system puts no limits on these increases," the researchers wrote in their report. "The U.S. Medicare program, the largest single-payer healthcare system in the U.S., is legally prohibited from negotiating drug prices directly with the pharmaceutical industry."

There's some evidence that generic drug growth might slow the rising drug costs in the U.S., the researchers said, but so far most multiple sclerosis drugs are not exposed to price competition from generics.

For the patient, the soaring costs of these drugs threaten access to them, the study indicated. Initial denials of insurance coverage for multiple sclerosis drugs, for both new and established patients, occur much more often now than in the past, the study reported, often requiring multiple approval steps for patients and their neurologists.

"As a doctor, I'm deeply concerned about making sure these life-changing drugs are within reach for patients," said Dr. Ruth H. Whitham, co-author of the study, a professor of neurology in the OHSU School of Medicine, and co-founder of the Multiple Sclerosis Center at OHSU. "The driving force behind this study was our experience that the high cost of MS drugs interferes with our ability to take good care of our patients.

"We decided to shine a light on this growing problem so that those of us who care for patients with chronic illness can work together and advocate for changes to drug pricing mechanisms," she said.

Hartung suggested that, lacking other major changes in the health care system, public awareness and involvement may be an important first step.

"The court of public opinion is pretty powerful," he said. "We need to shed some light on this issue and do something about it."

Authors of the study concluded that "it is time for neurologists to begin a national conversation about unsustainable and suffocating drug costs for people with MS - otherwise we are failing our patients and society."

================================================================================================
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MSbro
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Re: The biotin trial results are out

Post by MSbro » Thu Apr 30, 2015 8:26 am

And someone asked me in another thread that I started why I was concerned about my brother stating to take any of the DMD drugs. After reading the cost increases of these drugs in the US over the past number of years, how can you not be disturbed by such an article. I'm starting to wonder if the drug companies in the US view MS as their cash cow!

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Re: The biotin trial results are out

Post by centenarian100 » Thu Apr 30, 2015 1:27 pm

Does anyone have the actual article by any chance? I'm not too interested in press releases. Lets see the data and methodology. I doubt there is any downside to taking megadoses of biotin though.

"I'm starting to wonder if the drug companies in the US view MS as their cash cow!"

Of course they do. Chronic disease + desperate patients + moral hazard equals huge profits.

-Cent

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Re: The biotin trial results are out

Post by Sharon » Thu Apr 30, 2015 4:11 pm

MedDay Pharmaceuticals hosted a webcast on Tuesday, April 28 -- this was a follow-up to their presentation at the AAN Conference. Many of you have questions .. if you would like to listen to the answers direct from the Principal Investigator and the MedDay CEO, please listen to the replay of the webcast. Unfortunately, the informative slides are not on the replay -- but, the presenters were excellent with their verbal explanantions.

https://webconnect.webex.com/webconnect ... bf6c885e49

MedDay will be at the European Academy of Neurology conference June 20, 2015 Berlin, Germany where they will present addtional data on othe symptomatic improvements.

Sharon

p.s. I forgot to mention, a Facebook (closed) group has been formed BiotinForProgressiveMS@groups.facebook.com

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Re: The biotin trial results are out

Post by ribeye » Thu Apr 30, 2015 6:36 pm

Yeah, I will give this a go since the calcitriol route may not be possible at the moment. And yes, the cost of MS drugs is sickening. Maybe we MS folks should be allowed an inside stock deal so we could at least be able to pay for our treatments, and become wealthy at the same time. Just kidding, well kinda.

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Re: The biotin trial results are out

Post by ElliotB » Fri May 01, 2015 2:20 am

This explanation may help to explain why biotin seems to help those with progressive MS:

An excerpt from this website: http://www.emaxhealth.com/1275/progress ... nds-biotin


"This vitamin is a coenzyme for carboxylases, enzymes that play a critical role in energy metabolism and the production of fatty acids. In particular, biotin activates acetylCoA carboxylase, which is involved in the synthesis of myelin. Therefore, it is proposed that biotin may help to slow, stop, or even reverse the progression of disability associated with demyelination. "


This explanation makes a lot of sense as to why energy levels are improved. Dr. Terry Wahls had similar results with her diet. Since I started on a high good fat diet and an intense vitamin/supplement regimin almost a year ago, my energy level is up too and I am feeling somewhat 'better' although not symptom free . To me, this reinforces the fact that the body needs proper vitamin and EFA (essential fatty acids) intake/balance a for good health and self healing. It is certainly possible that biotin/Vitamin H can help aid the body what it needs to help repair damaged mylin. And by converting fat (proper fat in food (high in Omega 3) into energy the body can use more efficiently, the body will have more energy. It all makes sense!

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Re: The biotin trial results are out

Post by 1eye » Fri May 01, 2015 5:28 am

It not only makes sense but it's very emotionally uplifting:

http://www.thisisms.com/forum/chronic-c ... ml#p234093
http://www.thisisms.com/forum/chronic-c ... ml#p234098

You may find it so also.
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