JCV and BG-12

Discuss Tecfidera (BG-12, dimethyl fumarate) as an oral treatment for multiple sclerosis.

Re: JCV and BG-12

Postby savvymavi » Sun Jun 16, 2013 10:16 am

I was prescribed Tecfidera as soon as it was available, and have been on the full dose for about 3 weeks now. I have had no side effects at all, which is a new experience for me. I have tried Copaxone, Avonex 3x, Gilenya, and Extavia since being diagnosed in 2010. Due to different problems with each med I have been off meds for months at a time in between. Each time I am off meds I have minor relapses. My neuro had me on her priority list for BG-12 upon FDA approval.

I saw my neuro this week, and she is very concerned about the possibility of PML with Tecfidera. I am JCV positive, which prevented me from trying Tysabri. She says that they are concerned that PML cases may arise after longer term use with Tecfidera, similar to what happened when Tysabri was first introduced. She is now recommending that I try Rituxan instead.

The posts on this thread illustrate the difficulty of making these decisions. I try to be as well-informed as I can, but with teaching full time and raising two young children I don't have the physical time needed to do the needed research. I take my neuro's advice, but try not to blindly follow what she recommends. I feel I am stuck at an important crossroads, take the risk of continuing Tecfidera, or try Rituxan which sounds really scary to me. Any advice on how you all decide at these times?
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Re: JCV and BG-12

Postby Ladymac » Sun Jun 16, 2013 11:22 am

How's your white blood cell count, your lymphocytes? Did your Dr. check that before starting Tecfidera? The drug company advised a CBC before starting. With regards to the PML, I just saw my specialist last week and they have done and are continuing to do clinical trials at the center and he does not have concern for PML. The clinical trials were very controlled over many years at many locations throughout the world since 2004 is what I can find and they have not had any cases of PML reported anywhere. It's a issue with wrong information about the difference between the chemical properties that is being toted by competitors of Biogen because they are going to lose market share. It's always a personal decision and we all have to live with the consequences of our decisions good or bad with whatever we take for our bodies.
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Re: JCV and BG-12

Postby savvymavi » Sun Jun 16, 2013 1:21 pm

Hi Ladymac,

My neuro did a big panel of bloodwork before I started Tecfidra, and everything was in the "perfect" range. Because she is paranoid of PML, she has ordered a monthly standing order for bloodwork. She said she is mainly concerned because the clinical trials were only 2 years, and PML didn't start with Tysabri until after that point. She did say that the European PML cases reported were with a different compunded version of the drug, which is different than the controlled version we are getting with Tecfidera.

I know that she has an overlord at Kaiser who questions when she prescribes me expensive meds, and I have to wonder if this doesn't impact her decision making. I know it's paranoid to think that way, but you have to wonder.
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Re: JCV and BG-12

Postby Ladymac » Mon Jun 17, 2013 6:24 am

OH NO!!!!!! The clinical trials started in 2004! Please go to clinicaltrials.gov and search on Tecfidera.

The PML in Tysabri was known before is my understanding, just they only had 1 person I think and then the moving out to the public when it did there was more research they came in and in fact still research about the JCV virus and PML. None of this is with Tecfidera.

She is absolutely correct that the European cases of PML were with a totally different compounded version of a part of the drug and all 4 patients already had serious issues. 2 had AIDS and 1 cancer and 1 Lymphodema or one of those and they were also taking a ridiculously high amount.

There is a lot of competition for information between drug companies and research groups. None of these other drug companies want the companies that have produced pills to succeed. It is a business issue. I REVISED this paragraph because I am overwhelmed with the amount of information and counter-research and research out in the internet world. It is difficult to know as the average "Joe" what is factual and based on solid science and what isn't.

Is your Neurologist from an MS Center here in the US? It may be time for you to get a look over and second opinion from an actual MS Center here in the US and they can hook you up with good support, information, support groups, and you still may be able to work with your local doctor, however, it will take the pressure off by having the once-a-year full MRI and appointment at the MS Center with the plans to have the Neurologist at the MS Center work with your local doctor and provide them with more support and accuracy on what is going on.

Just a thought. If you give me what STATE your are in and what 2 major cities are near you I can check and see which ones have an actual MS Center and let you know. You can PM (private message me) with that info so it is not on the board.

Blessings,
Last edited by Ladymac on Fri Jun 21, 2013 4:02 am, edited 1 time in total.
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Re: JCV and BG-12

Postby Cece » Tue Jun 18, 2013 2:25 pm

CureOrBust wrote:
MrsMomTo6 wrote:I also learned that the people who had complications with this drug also had some issues with their lymphocytes. Interestingly, I too, had some abnormalities with my lymphocytes a year ago, and no one even discussed that with me before eagerly putting me on BG12.
Have you saved any links to a description of what these "abnormalities" are or could be or how they are tested for?

I think it's the lymphopenia or abnormally low white blood cells that some percentage of people develop on BG-12. Wheelchair Kamikaze suggested that getting a blood test every other month is a good idea and it wasn't clear why that's not a requirement with BG-12.
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Re: JCV and BG-12

Postby NHE » Thu Jun 20, 2013 5:42 am

savvymavi wrote:I know that she has an overlord at Kaiser who questions when she prescribes me expensive meds, and I have to wonder if this doesn't impact her decision making.


Ladymac wrote:Kaiser is a competitor to Biogen Idec. So is Teva Pharmaceuticals. None of these other drug companies want the companies that have produced pills to succeed. It is a business issue.


I'm guessing that Savvymavi was referring to Kaiser Permanente which is not a Biogen competitor.

https://healthy.kaiserpermanente.org/ht ... ndex.shtml
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Re: JCV and BG-12

Postby NHE » Thu Jun 20, 2013 5:58 am

Cece wrote:I think it's the lymphopenia or abnormally low white blood cells that some percentage of people develop on BG-12. Wheelchair Kamikaze suggested that getting a blood test every other month is a good idea and it wasn't clear why that's not a requirement with BG-12.


A regular blood test seems like a reasonable idea.

From...

Ingredient in New MS Drug Linked to Serious Brain Disease
http://www.nlm.nih.gov/medlineplus/news ... 36220.html

"The main reason why our [psoriasis] patient developed PML after three years of treatment with Fumaderm is prolonged lymphocytopenia [low white blood cell counts]," Schulz said. "In both BG-12 trials published in the New England Journal of Medicine in 2012, 4 percent to 5 percent of patients developed this kind of severe lymphocytopenia and are in my view at risk to also develop PML."


Ladymac wrote:She is absolutely correct that the European cases of PML were with a totally different compounded version of a part of the drug


Perhaps the active metabolites of Tecfidera and Fumaderm aren't so different...

Dr. Jorg Schulz, a neurologist at Rheinisch-Westfaelische Technische Hochschule Aachen, a research university in Aachen, said the two drugs are virtually identical once they are broken down in the body.
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Re: JCV and BG-12

Postby xpsychiatricmd » Thu Jun 20, 2013 1:59 pm

A lesson to take home, is to be proactive with any new drug. Having a CBC monthly is reasonable to avert the development of lymphopenia, which can be a risk factor for PML.
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Re: JCV and BG-12

Postby Ladymac » Fri Jun 21, 2013 4:08 am

NHE wrote:
savvymavi wrote:I know that she has an overlord at Kaiser who questions when she prescribes me expensive meds, and I have to wonder if this doesn't impact her decision making.


Ladymac wrote:Kaiser is a competitor to Biogen Idec. So is Teva Pharmaceuticals. None of these other drug companies want the companies that have produced pills to succeed. It is a business decision.


I'm guessing that Savvymavi was referring to Kaiser Permanente which is not a Biogen competitor.

https://healthy.kaiserpermanente.org/ht ... ndex.shtml


I revised my post. There are too many strongly opposing entities that publish on the internet. It is going to take some more time for things to sort out as more people get on Tecfidera. I incorrectly expressed my point. I apologize. We need to get our information from responsible parties, and I hope no one gets stuck in the mire of the "I heard this" or "that" and don't get the accurate information. Mia Culpa.
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Re: JCV and BG-12

Postby Jimpsull » Mon Jul 08, 2013 11:30 pm

I agree that BG-12's PML risk is a lot of twisted hype (in part instigated by TEVA to protect Copaxone market share. However, it is not fair to lump MS diets, in particular the research of doctor Swank, with cooked up Internet hype.

The measurable for most disease modifying therapies is relapse rate. There is little evidence that they affect progression. Copaxone kept me free of relapses for a number years, but it didn't prevent progression. By contrast, the Swank diet kept the majority of patients that adhered to it walking for 34 years. Those that couldn't abide by the diet were dead or bedridden over the same time frame.
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Re: JCV and BG-12

Postby Ladymac » Tue Jul 09, 2013 5:31 am

Jimpsull,

I agree, not lumping everything together. What I have enjoyed about having the ability to research on the Internet has been to be able to look at bonifide research and know that I have to take everything I see with an open mind, but look to cooberating evidence.

You are absolutely right about the Swank diet too and it's positive outcomes for many patients over the years.

Blessings,
Blessings,

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Re: JCV and BG-12

Postby Jimpsull » Tue Jul 09, 2013 11:44 pm

BTW - I hear a lot of talk about BG-12 side effects but very little about people's perception of its effectiveness. I have been on Copaxone 10+ years with only minor relapses (if at all). However, I have seen some significant decline in balance and stamina over the past 18 months. Neurologist has suggested switching to BG-12. Thoughts?
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Re: JCV and BG-12

Postby Ladymac » Wed Jul 10, 2013 11:12 am

Jimpsull,

GO FOR IT!!!! OMG, my family, friends, Church family, everyone has noticed a huge difference in me on this medication. I am feeling much better. In fact, it has been a PITA (pain in the) I feel like doing more and am soooooo out of shape that I need to work on getting back some strength in my legs and back because I end up over-doing....the brain is there but the body isn't.

Huge positive difference in balance. From cane to no cane.Stamina improvement, working on that part with better planning. I am up early and am good until about 2 - 3pm then I a tired, but that is a whole lot better than before.

I am having an MRI in August. Can't wait to see how things are.
Blessings,

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Re: JCV and BG-12

Postby Jimpsull » Wed Jul 10, 2013 8:20 pm

Ladymac,

Than you so much for your enthusiastic reply!! That is very encouraging.
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Re: JCV and BG-12

Postby centenarian100 » Wed Jul 24, 2013 10:30 am

Ladymac wrote:Don't we already have enough to worry about without having people pushing CUCKOO JUICE, VITAMINS, CRAZYY DIETS, or other theories on us?


Haha. You crack me up.

The suggestion of testing JC virus prior to starting tecfidera is silly as it would preclude 55% of good candidates from taking the medication, and the risk of dying of PML while on tecfidera is surely several fold lower than dying in a traffic accident during the treatment period. Three of the four cases of PML with dimethyl-fumarate containing substances had clear extenuating circumstances.

By the way, my cuckoo juice cures MS and improves sexual performance in one dose, and I'm selling it for only $19.99...limited time offer :-D
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