Multiple Sclerosis (MS) Support Group
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Interferons for MS disappoint. How are you coping?
By Julie Stachowiak, Ph.D., About.com GuideJuly 24, 2012
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No doubt most of you have heard the news of the study published in JAMA that indicates that interferons (Betaseron, Rebif and Avonex) do not delay progression to disability for people with multiple sclerosis (MS).
For those of you who haven't read the study, here is the link to the original paper in JAMA (full-text version): Association Between Use of Interferon Beta and Progression of Disability in Patients with Relapsing-Remitting Multiple Sclerosis.
If you would like to see how mainstream media reports the study results, check out the coverage by The New York Times, TIME and CBS News. Also worth a look is the summary by the National Multiple Sclerosis Society: Study Suggests That Interferons Did Not Reduce MS Progression. There is the New York Times artricle:
http://www.nytimes.com/2012/07/18/health/research/multiple-sclerosis-drug-doesnt-stop-disability-study-finds.html
Rather than rehash the results here, I'll let you read them for yourself from your chosen source. I see some weaknesses in the study and places where the results are may not be so black and white, but I'll reserve those for a different time.
What I am most interested is how those of you on interferons are coping with this news. I found the news upsetting, to say the least, but I takeCopaxone and don't have to grapple with any interferon-related decision personally. My first thoughts were of the emotions of all of the people who have been injecting themselves for years with these drugs. Did you feel scared? Angry? Disappointed? Skeptical about the study results and confident that the meds are helping you?
Then I wondered what everyone currently taking interferons would actually do. I imagine that most people will continue taking them for the time being, but plan a visit with their neurologists to discuss options. However, there are undoubtedly some people who will never pick up a syringe containing these drugs again, despite urgings in the press to continue taking interferon-based therapies and emphasizing the fact that the study did show that the drugs were shown to prevent relapses.
We all know preventing relapses is a good thing. Relapses are terrible. But is preventing them enough motivation for the people who experience interferon side effects of flu-like symptoms? What about the people who hate injecting themselves so much that the only thing that keeps them doing it is the vision of themselves in a wheelchair?
That is why I really want to hear from all of you who are taking Avonex, Rebif or Betaseron. What are you feeling? What are you doing? How are the people around you reacting? What does your neurologist say about the study? Please share your story with us,
By Julie Stachowiak, Ph.D., About.com GuideJuly 24, 2012
\
No doubt most of you have heard the news of the study published in JAMA that indicates that interferons (Betaseron, Rebif and Avonex) do not delay progression to disability for people with multiple sclerosis (MS).
For those of you who haven't read the study, here is the link to the original paper in JAMA (full-text version): Association Between Use of Interferon Beta and Progression of Disability in Patients with Relapsing-Remitting Multiple Sclerosis.
If you would like to see how mainstream media reports the study results, check out the coverage by The New York Times, TIME and CBS News. Also worth a look is the summary by the National Multiple Sclerosis Society: Study Suggests That Interferons Did Not Reduce MS Progression. There is the New York Times artricle:
http://www.nytimes.com/2012/07/18/health/research/multiple-sclerosis-drug-doesnt-stop-disability-study-finds.html
Rather than rehash the results here, I'll let you read them for yourself from your chosen source. I see some weaknesses in the study and places where the results are may not be so black and white, but I'll reserve those for a different time.
What I am most interested is how those of you on interferons are coping with this news. I found the news upsetting, to say the least, but I takeCopaxone and don't have to grapple with any interferon-related decision personally. My first thoughts were of the emotions of all of the people who have been injecting themselves for years with these drugs. Did you feel scared? Angry? Disappointed? Skeptical about the study results and confident that the meds are helping you?
Then I wondered what everyone currently taking interferons would actually do. I imagine that most people will continue taking them for the time being, but plan a visit with their neurologists to discuss options. However, there are undoubtedly some people who will never pick up a syringe containing these drugs again, despite urgings in the press to continue taking interferon-based therapies and emphasizing the fact that the study did show that the drugs were shown to prevent relapses.
We all know preventing relapses is a good thing. Relapses are terrible. But is preventing them enough motivation for the people who experience interferon side effects of flu-like symptoms? What about the people who hate injecting themselves so much that the only thing that keeps them doing it is the vision of themselves in a wheelchair?
That is why I really want to hear from all of you who are taking Avonex, Rebif or Betaseron. What are you feeling? What are you doing? How are the people around you reacting? What does your neurologist say about the study? Please share your story with us,
My first attack left me in a wheelchair for 3 months. I learned that the wheelchair can be used as a tool to save energy for more important things or it can be seen as something horrible and therefore make you progress at a more rapid pace. It now sits in my basement gathering dust. I am no longer afraid of it. If people would see walking aids at helpful tools that can help them enjoy other things so they do not have to waste all their energy on walking...then I believe peoples quality of life would improve.
Walkers with wheels and a seat can be very helpful too. I used a walker with wheels for awhile too when I needed it.
I have found that there are very specific things that cause worsening MS...stress...over exercise...(in the form of...pushing not only into a healthy lifestyle of exercising every day..but pushing beyond your limits), heat (for those that are heat sensitive), unhealthy diet, not enough rest, inflamation, and the randomness of the disease itself.
So to fight MS, I have found that what works the best for me...(and I am no expert except over what works for my body):
rest every day
exercise every day
eating a healthy diet...(with lots of water) which for me is no sugar, little or no white flour or starchy foods, little gluten. I live on vegetables and protein, and some fruits. Like stir frys, and chef salad, and whole grains..(not a lot...because of the gluten), and I eat mostly fish and nuts and chicken for protein and small amounts.
I try to reduce stress, but during the past month I have not been able to do that due to life itself.
On Friday I go to the MS clinic and they will surely try to get me on one of the shots. I will decline. If my disease started progressing and the only thing to stop it was one of them, I may consider it then...I don't know ....it would take a lot for me to decide to do that.
I really really feel like we have a strong hand in helping keep the MS at bay.
If MS fatigue is an issue for you, please look at every aspect of what you do. There are so so many things that you can do differently to make it so you use less energy doing things that do not bring you joy and therefore have more precious energy for the very things that bring you joy.
For instance...folding laundry on your lap uses a like a quarter of the energy of folding it arms outstretched.
Standing uses so much more energy than walking..
Going to look at your flowers outside instead of reaching high in the cupboards for food or dishes is a great exchange of energy. The dishes and food and everything else that you grab daily can be placed at your level...which equals less energy used.
It's all about balance..
That's what has worked for me anyway..
Cathy
the statement: The medicine, interferon beta, does help reduce the development of brain lesions and limit the frequency of relapses, but until now there have been few well-controlled long-term studies demonstrating its effectiveness at preventing the onset of irreversible disability.
everyone with ms will experience things that they're stuck with for the rest of their lives unfortunately. interferons are not a cure, it's to stall damage, which the article says it does above.
also, a new york times article? i'd worry more if they linked multiple medical journals that proved interferon to be completely ineffective.
basically the article is saying a study proved that interferon is not a cure, so what? everyone should already know that but, if it gets more funding for ms research to publish articles like this, keep on stating the obvious lol!
I don't feel anything. No way to determine rate of progression w/wo meds. It's a mystery that I don't see anyone solving soon.
My daughter was on avonex for a year and had four new lesions. She is now on Extavia. There is no way of knowing if she had not been on avonex, how many lesions he would have had.
When they discover the agent that causes ms, then they can grade progression, severity, etc.
Till then, I just worry about controlling symptoms and enjoying whats left of me for however long God allows.
Alma
Nadine Cohen, Ph.D. Senior Vice President, Regulatory Affairs Biogen Idec 14 Cambridge Center Cambridge, MA 02142
RE: BLA # 103628
AVONEX (Interferon beta-1a) IM Injection
MA # 374
Dear Dr. Cohen:
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed Biogen Idecs (Biogen) webpages, Long Term Results and Multiple Sclerosis Treatments, which are part of a consumer website1 for AVONEX (Interferon beta1a) IM Injection (Avonex). These webpages are misleading because they overstate the efficacy of Avonex, omit material information, and present unsubstantiated superiority claims for the drug. Thus the webpages misbrand Avonex in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 352(a), (n); 321(n). See 21 CFR 202.1(e)(5)(iii); (e)(6)(i), (ii); (e)(7)(i).
link for pdf letter
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmac%20euticalCompanies/UCM296666.pdf
Larry Downey Executive Vice President, US Branded Pharmaceuticals Teva Pharmaceuticals USA c/o Teva Neuroscience, Inc. 901 East 104th Street, Suite 900 Kansas City, MO 64131
RE: NDA# 020622
COPAXONE (glatiramer acetate injection) solution for subcutaneous injection MA #762
WARNING LETTER
Dear Mr. Downey:
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed 2011 AAN Professional Exhibit Panels AAN Static Panels G double (COP112014807/110193) (2011 AAN Exhibit Panels G) for COPAXONE (glatiramer acetate injection) solution for subcutaneous injection (Copaxone), submitted by Teva Neuroscience, Inc. (Teva) under cover of Form FDA-2253, as well as the Team COPAXONE webpage (COP110006303/110312), David Kyle webpage (COP100006331/102252), and Karen Stewart webpage (COP100006324/102245) for Copaxone.1
These promotional materials are false or misleading because they overstate the efficacy, present unsubstantiated claims, broaden the indication of Copaxone, omit and minimize important risk information associated with the drug, present unsubstantiated superiority claims, and omit material facts. Thus, the 2011 AAN Professional Exhibit Panels and Team COPAXONE webpages misbrand Copaxone in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 352(a), (n); 321(n). See 21 CFR 202.1(e)(3)(i); (e)(5); (e)(6)(i), (ii), (iv), (xviii) & (e)(7)(i). These violations are concerning from a public health perspective because they suggest that Copaxone is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience.
link to pdf letter
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmac%20euticalCompanies/UCM296204.pdf
I was on Avonex for five years and had an awful time adjusting to the drug, fighting with Medicare plans to get the drug, fighting with financial assistance as not given me proper information. The whole thing was a nightmare. My feelings were bad already when the nurses of Avonex didn't recognize a serious side effect. My neurologist dismissed it. Now to hear about this well, I'm glad I had allergic reactions so I no longer have to take it and it's over. I don't take anything now except supplements, eat healthy, try to get some type of exercise and mediation. My neurologist found out I turned down Gilenya after two assistance programs out of funding and won't take anything else. See him in August.
The neuro I was going to when I was dx'd was on the pilot studies/program for Betaseron and he was pushing that drug like you would not believe.
He told me, "This drug helps one in three people that use it! Of the one and three that it helps, they have 7 instead of 10 attacks!".
I remember sitting there looking at this "doctor" and thinking to myself, BIG DEAL.
I read the studies and they were all skewed and not at all impressive, hence I said no to betaseron. I have no regrets to this day.
Since time, this neuro, deemed to be an "MS specialist" has now left the field and is practicing in another area not at all related to MS. I guess he realized the drugs he was pushing don't work and he knew about this study and the results and now he has a new field of "expertise".
What a joke. The joke is on all of us for believing these liars and yes, they knew.
Those early studies told me all I needed to know. They had few subjects, many of the subjects had left the study and there were not enough subjects in the study for the study to even be statistically valid. I happen to know all about statistics and the viability of studies and I'm sorry, 17 subjects is not enough to be valid at all and they know this and have know this.
However, most of us are not skilled in the study of statistics as I happen to be. Some have said to me, "What a shame, all of that education and nothing to show for it." Perhaps this is true, but what I learned studying the subject of statistics in college for about 10 years has served me well in life, MS or no MS.
In any event this makes me sad and angry at the same time.
I always felt like suppressing one's immune system was a poor idea at best. It seems I was right.
As for the "MS expert" of a doctor, I hope he retires soon and/or finds another cash cow to fuel his greedy needs. How is that for blunt? I do mean it as this neuro has put me through HELL because I would not use any of these damned interferons that I knew did not work.