This Is MS Multiple Sclerosis Community: Knowledge & Support

Has anyone heard rumblings about problems with Biogen's BG12 oral? Supposedly in the trials there are high infection rates with even some cases of PML. Have been unable to confirm this.

Harry

Hi Harry,

I'm still new to MS and to this board, but I've looked very closely at this question.

The only thing I have found is the news about Teva's letter to the FDA requesting further safety testing of Biogen's BG12, based on possible kidney issues.
http://www.bloomberg.com/news/2013-01-1 ... views.html

I've looked at most of the academic articles I found on BG12 because I was seriously considering trying to take it on approval. I hate needles.
The most serious thing that concerns me is that the duration of fumaric ester treatment for psoriasis does not seem to extend beyond a year usually. So the decades of safety information from use for psoriasis in Germany on many thousands of patients are short term only and are not equivalent to long term MS use. I'm still thinking about taking it, but might wait a year or so, to see if problems emerge.

I don't know if you are familiar with the term 'FUD' in marketing and PR? It stands for Fear, Uncertainty, Doubt, and is part of the standard competitive technique of the people who make their living by shaping public opinion.
http://en.wikipedia.org/wiki/Fear,_unce ... _and_doubt

We represent a multi-billion dollar revenue stream to these companies. That fact represents my biggest temptation to just take nothing and deny them the profit from my disease. However, I'm so far resigning myself to being an informed and cynical consumer of both mainstream meds and alternative therapies.

But when companies are faced with a major shift in MS drug use, I'm not surprised that there are unsubstantiated rumors of very bad outcomes. If there really is PML from BG12, I would very much like to know.

Hi CaliReader,

It's not surprising that the letter from Teva to the FDA was published by Bloomberg news. They have a bit of a history in reporting Biogen's actions.

I have said for many years that the MS world of medicine is a big financial game played out by about 4 different big pharma companies. The money they make off MS patients is HUGE and like you said, a slight shift in the market share can end up meaning millions and millions of dollars of either lost or gained revenue.

Biogen has one of the best marketing/sales departments going and they can spin information like nobody else. Before you make a final decision on using BG12, please become well informed.

Harry

I tried a search for PML and BG12 in Google. All I could find was references in post on other forums and where natalizumab / Tysabri are referred to in the same news article. ie no confirmation of any PML specifically for bg12 as far as I can see. It may just be people misreading online articles in haste; or just a well kept secret.

BG 12 FDA approval has been stalled- at least until the spring.
One concern which has been brought up by pharmaceutical industry specialist David Cavalla is that there is not a specific method of action on the immune system for this drug. It appears the drug is modulating the immune system somehow...but Biogen is not clear how. The Nrf 2 pathway activation thru glutathione depletion is the only known. And as Cure would tell you, you might as well use Curcumin (or Protandim) for that, and save some money.


http://numedicus.co.uk/blog/

The Teva petition is really worth a read---- here it is online, in toto.
http://freepdfhosting.com/efaf2ebf45.pdf

Look specifically on pages 7-9, where it discusses the side effects of BG 12 in long-term animal studies...including adverse renal effects and proteinuria. (The only references to PML were made in terms of Tysabri) The problem in comparing BG 12 to fungiderm, is that fungiderm (the form of DMF approved for psoraisis) is only prescribed for short term use--like 6 months. We have no idea how long term oral use of this molecule will effect humans. And that's a problem-
For those on Facebook who want to learn more, I wrote up a pretty detailed note.
https://www.facebook.com/notes/ccsvi-in ... 4812867211
cheer

_________________
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

Some component of the benefit in psoriasis could be due to simple immune suppression...
bg-12-dimethyl-fumarate-f52/topic20845.html#p198425

Keep in mind Teva has a lot to lose when BG 12 is approved.

Now there's the Biogen I've come to know and distrust!!

Harry

Thanks for the now-defunct product name of BG-12, Panoplin, Harry.
That led me to the PML info, which is related to depletion of lymphocyte counts in Fumaderm usage. NHE is right about lymphopenia. This was in the footnotes of the TEVA letter I linked above, and is now being discussed on Cafe Pharma (a truly entertaining site!) The Panoplin site has been taken down.


http://www.cafepharma.com/boards/showth ... ?p=4618846

From Timothy Vollmer's presentation on BG-12--page 44
Fumaderm: 3 PML cases, Karposi's Sarcoma-2 cases, and gastric cancer in rodents.
http://www.ucdenver.edu/academics/colle ... ollmer.pdf


Again, the issue may simply be that fumaderm is never used long-term. Usage goes from a couple of weeks, to a couple months, max. We just do not know what the consequences of long term use of this medication will be in people who already have a compromised blood brain barrier.
cheer

_________________
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

Hi Cheer,

I rest my case

Some people accuse me of having an agenda against Biogen. Not an agenda...I just don't like the company and after reading these recent posts, my opinion of them won't change any time soon.

Harry

Appears to be 4 cases of PML and Fumaderm---here's more from Dr. Giovannoni from Barts and the London MS blog--



http://multiple-sclerosis-research.blog ... rates.html

cheer

_________________
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

In regards to the mechanism of action of BG 12 being largely unknown, keep in mind that the mechanism of action of the interferon drugs, when used to treat MS, remains an unknown. They are thought to be immunomodulators, but is it merely coincidental that they are powerful antivirals as well? Given that human endogenous retroviruses are appearing to figure more and more prominently in the MS pathogenesis picture, antiviral action could very well explain some of the interferons limited effectiveness.

As for the effects of the long-term use of BG 12 being an unknown, the long-term use of all of the new generation MS drugs, starting with Tysabri, is a huge unknown. Typically, clinical trials run for about two years, followed by drug approval if the trials are deemed successful. The drugs are then marketed to patients who are expected to be on them indefinitely. Having said that, Tysabri has so improved the quality of life of many patients who take it that they are loathe to stop the drug even when they test positive for the JC virus. On MS Internet forums throughout the web, I see patients who go into panic mode when told they must stop their Tysabri treatments because the drug has had such a positive influence on their day-to-day existence.

Bottom line, MS is a dreadful disease, and in some cases it seems the evil unknown is better than the evil known…

_________________
Marc
www.wheelchairkamikaze.com

Marc,

My biggest fear is that Biogen will introduce this drug the same way they handled Tysabri...damn the torpedoes, full speed ahead!! They are great at marketing and selling and line the pockets of the docs to entice them to prescribe their products. They also go the edge of ethics when advertising them and have been known to get their hands slapped by the FDA for false advertising. Unfortunately, it's all about the money for big pharma and collateral damage along the way is only a nuisance.

Harry

Hi Marc--
For some, agreed, the new drugs can provide a port in an horrific storm. The lack of an MOA in BG 12 issue was brought up by David Cavalla, a pharmaceutical reporter. I copy and paste. The PML issue is just surfacing.

My concern is that some neurologists, not all, do not disclose potential side effects of the newer drugs. Jeff was given the hard sale for tysabri by his neuro at his yearly appointment a couple years ago--even though he had no inflammation, no progression, no new lesions or disabilities and his gray matter looked normal on MRI. She said, "you are a man, you will progress--trust me, you want to do all you can." He told her his concerns with the drug, said he was doing well. Thanks, but no thanks. And she relented. The most recent appointment, he's still well, she told him to keep doing what he's doing. I hear from patients all over the internet who have been given this same story. Take this, to prevent future damage. And to those who do not know all the facts--taking the "most effective" drug, even though they're doing OK, seems like preventative medicine. We all want "the best." Whether it's the most prestigious neuro, highly regarded MS center, or effective drug. But it's not that simple. What happens if they become JC positive? The washout period for Tysabri (and potentially BG 12) can cause more inflammation and progression. The subdued immune system roars back to life. http://ms.about.com/b/2011/02/09/the-ty ... effect.htm I feel it's important for patients to be fully informed about all the options.
Especially now that Tysabri is applying for use as a first line medication.....this truly worries me. I share Harry's concern.

http://www.reuters.com/article/2013/01/ ... J720130116
cheer

_________________
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

This study compares BG12 to other Nrf2 activators in terms of oligodentrocyte protection from oxidative challenge:
http://registration.akm.ch/einsicht.php ... KEN_ID=900