Friday, October 16, 2009
The last few days have slipped by like hours. Over the weekend we spent 3 days in Ashville,N.C. as guest of The EASTERN CHAPTER OF THE NORTH CAROLINA MS SOCIETY. We enjoyed meeting new friends involved in fund raising for The MS Walk. The 4 couples together raised over ONE QUARTER of a MILLION Dollars in the last three years for THE EASTERN CHAPTER. That is a big number, a great effort of TEAM MEMBERS, and tremendous generosity from FRIENDS, FAMILY, AND THE BUSINESS COMMUNITY. Monday involved travel to The David H.Murdoch Science and Research Campus in Kannapolis,N.C. This is was created by David H. Murdoch with $185 million dollar commitment to research for disease, one of which is MS. Most of what I learned at the conference was that there is little or nothing going on with Adult Stem Cell research. All focus seemed to be with finding more Pharma therapies that aid in treating the disease rather then finding a cure. I was concerned and disappointed that Stem Cell Research was not on the top of the list. Well the new weekend is here and I hope that all of you have a great one. My new cells are starting to grow and I am feeling great, Remember to Remember and that ATTITUDE is what determines your ALTITUDE!! Best of Health, Roger
FDA approval possible by October 22/09
Oct 14, 2009
Panel Recommends that FDA Approve Fampridine-SR (proposed name Amaya) for Symptomatic Treatment of MS -- Found to improve walking speed for all types of MS
A U.S. Food and Drug Administration advisory committee today recommended that the agency approve marketing of Fampridine-SR (Acorda Therapeutics, with a proposed name change to Amaya) for its ability to improve walking speed in people with any type of multiple sclerosis. While the FDA is not required to follow the recommendations of its advisory committees, it usually does. The agency is expected to make a final decision about whether to approve the drug for market on or before the target date of October 22, 2009.
During an all-day meeting held October 14, 2009, the FDA advisory committee considered Acorda Therapeutics’ application for approval of Fampridine-SR, reviewing data about the drug’s effectiveness and safety. The committee also heard public testimony from individuals and patient advocacy groups, including the National MS Society, which testified to the unmet need for therapies to improve walking for people with MS.
Among its discussions, the advisory committee recommended that the FDA require the sponsor to evaluate the effects of doses lower than originally studied, but that these studies would not be required to be done prior to the drug’s marketing approval. In addition, the FDA is likely to require a plan to mitigate potential risks. During its presentation to the committee, Acorda representatives outlined such a plan -- the Risk Evaluation Mitigation Strategies (REMS).
Background on Unmet Need: Problems with gait (difficulty in walking) are among the most common limitations in MS. While there are six FDA-approved disease-modifying therapies that are at least partially effective against some forms of the disease, as well as rehabilitation and symptomatic treatments for some symptoms, at present there is no pharmacologic treatment specifically available for MS-related difficulty walking. This disability has wide-ranging effects on people’s lives, even in its milder manifestations.A recent survey among more than 1,000 individuals with MS and many of their family members examined the impact of mobility issues, such as difficulty walking, on quality of life among patients with MS and their families. Some two-thirds of patients reported difficulty walking and of these, 70% reported that such difficulty was the most challenging part of their MS, and most reported that difficulty walking restricts their daily activities significantly, including their ability to travel. (Read more about survey results)
About the Drug: Fampridine-SR is a sustained-release formula of 4-aminopyridine, which blocks tiny pores, or potassium channels, on the surface of nerve fibers. This blocking ability may improve the conduction of nerve signals in nerve fibers whose insulating myelin coating has been damaged by MS. The first studies of this potassium-blocking approach in people with MS were supported by the National MS Society.
What Clinical Trials Found: Acorda Therapeutics sponsored two phase 3 clinical trials of the drug. In the first, involving 301 people with any type of MS, walking speed increased by 25%. Results of this study have been published (February 28, 2009 issue of The Lancet (2009 373;732-738), summarized here). Results from a later, second phase 3 study involving 240 people with MS confirmed the benefits seen in the first, finding that a significantly greater proportion of people on the therapy had a consistent improvement in walking speed compared to those who took placebo. Among those taking Fampridine-SR who improved in walking speed, there was a statistically significant improvement in leg strength.
In the first study, common adverse events (side effects) experienced more often by those on active treatment included back pain, dizziness, insomnia, fatigue, nausea and balance disorder. Two serious adverse events led participants to discontinue taking the drug (one case of anxiety and one seizure in a person who developed sepsis from a urinary tract infection). In the second study, additional common adverse events in those on therapy included urinary tract infection, falls, and headache.
Comment: “The clinical trial results suggest that for a substantial percentage of people with MS, Fampridine has the potential to restore some significant function and make a real difference in people’s quality of life,” said John R. Richert, MD, Executive Vice President of Research & Clinical Programs for the National MS Society. “If the FDA agrees that Fampridine is safe and effective, this would bring a welcome symptomatic therapy that has potential utility for a large number of people with different types of MS.”
Further study and clinical practice may help determine the extent to which the drug may impact other functions not measured in the clinical trials, and provide hints as to which patients are most likely to respond.
Panel Recommends that FDA Approve Fampridine-SR (proposed name Amaya) for Symptomatic Treatment of MS -- Found to improve walking speed for all types of MS
A U.S. Food and Drug Administration advisory committee today recommended that the agency approve marketing of Fampridine-SR (Acorda Therapeutics, with a proposed name change to Amaya) for its ability to improve walking speed in people with any type of multiple sclerosis. While the FDA is not required to follow the recommendations of its advisory committees, it usually does. The agency is expected to make a final decision about whether to approve the drug for market on or before the target date of October 22, 2009.
During an all-day meeting held October 14, 2009, the FDA advisory committee considered Acorda Therapeutics’ application for approval of Fampridine-SR, reviewing data about the drug’s effectiveness and safety. The committee also heard public testimony from individuals and patient advocacy groups, including the National MS Society, which testified to the unmet need for therapies to improve walking for people with MS.
Among its discussions, the advisory committee recommended that the FDA require the sponsor to evaluate the effects of doses lower than originally studied, but that these studies would not be required to be done prior to the drug’s marketing approval. In addition, the FDA is likely to require a plan to mitigate potential risks. During its presentation to the committee, Acorda representatives outlined such a plan -- the Risk Evaluation Mitigation Strategies (REMS).
Background on Unmet Need: Problems with gait (difficulty in walking) are among the most common limitations in MS. While there are six FDA-approved disease-modifying therapies that are at least partially effective against some forms of the disease, as well as rehabilitation and symptomatic treatments for some symptoms, at present there is no pharmacologic treatment specifically available for MS-related difficulty walking. This disability has wide-ranging effects on people’s lives, even in its milder manifestations.A recent survey among more than 1,000 individuals with MS and many of their family members examined the impact of mobility issues, such as difficulty walking, on quality of life among patients with MS and their families. Some two-thirds of patients reported difficulty walking and of these, 70% reported that such difficulty was the most challenging part of their MS, and most reported that difficulty walking restricts their daily activities significantly, including their ability to travel. (Read more about survey results)
About the Drug: Fampridine-SR is a sustained-release formula of 4-aminopyridine, which blocks tiny pores, or potassium channels, on the surface of nerve fibers. This blocking ability may improve the conduction of nerve signals in nerve fibers whose insulating myelin coating has been damaged by MS. The first studies of this potassium-blocking approach in people with MS were supported by the National MS Society.
What Clinical Trials Found: Acorda Therapeutics sponsored two phase 3 clinical trials of the drug. In the first, involving 301 people with any type of MS, walking speed increased by 25%. Results of this study have been published (February 28, 2009 issue of The Lancet (2009 373;732-738), summarized here). Results from a later, second phase 3 study involving 240 people with MS confirmed the benefits seen in the first, finding that a significantly greater proportion of people on the therapy had a consistent improvement in walking speed compared to those who took placebo. Among those taking Fampridine-SR who improved in walking speed, there was a statistically significant improvement in leg strength.
In the first study, common adverse events (side effects) experienced more often by those on active treatment included back pain, dizziness, insomnia, fatigue, nausea and balance disorder. Two serious adverse events led participants to discontinue taking the drug (one case of anxiety and one seizure in a person who developed sepsis from a urinary tract infection). In the second study, additional common adverse events in those on therapy included urinary tract infection, falls, and headache.
Comment: “The clinical trial results suggest that for a substantial percentage of people with MS, Fampridine has the potential to restore some significant function and make a real difference in people’s quality of life,” said John R. Richert, MD, Executive Vice President of Research & Clinical Programs for the National MS Society. “If the FDA agrees that Fampridine is safe and effective, this would bring a welcome symptomatic therapy that has potential utility for a large number of people with different types of MS.”
Further study and clinical practice may help determine the extent to which the drug may impact other functions not measured in the clinical trials, and provide hints as to which patients are most likely to respond.
Thursday, October 15, 2009
More on SCT
10/15/2009 Did the video but have not got it posted yet, have to get a friend to show me one more time how to load it to You Tube. I’m technically challenged, but stay in denial. The PHYSICAL THEREPY at the hospital was FIRST CLASS in all respect. The therapists were very specialized in dealing with MS patients. While I was in treatment I received PT 7 times at an hour each time. Totally wiped out after each session. The Doctors suggested that we exercise when we returned to our homes to encourage the NEW CELLS to start growing. The two weeks that I spent at the ICM went by quickly and when we got home on Sunday night it was like I was now starting a new journey. I have been home for 6 weeks and the report on my health (SYMPTOMS) is that I’m confused because some days the SYMPTOMS are mild and then on other days when I do too much and get very tired my SYPMTOMS seem to flare up and my balance really goes to HELL! It is very frustrating when friends tell me how good I look and I know how bad I might be feeling that particular day. My weight has gone from a too heavy 246 lb’s. Down to 192 lb’s. In the last year so there is something very positive. Anyone need 42 and 40 dress slacks like new and also men’s’ golf shorts new? Give me a call 349-9525, just come and pick them up.
October 1, 2009 Went to my chiropractor this morning, had acupuncture, tens, and an adjustment on my spine. I have 3 active lesions at my C2, C5, 6. So the adjustment really felt like it was of great benefit. Feeling good and Attitude is GREAT!! PROACTIVE, going again tomorrow. Don’t let things like the bullsh-t we have to deal with get you down, you still can control your THOUGHTS? Make them GOOD THOUGHTS and when it seems impossible, and then call out to your Savior, Jesus for strength. I Talked with Richard Humphries on Monday and he said he is feeling good and that he talked to Holly Huber. Holly has many videos posted on You Tube about her SCT at ICM in Costa Rica. Holly received her first SCT in November of 2008. Now she is back for a new dose of ADULT STEM CELLS. I will be trying to touch base with her next week. You can see her on Face Book or You Tube. If you have MS or some one you are close to, it is very informative. Here is an article that will be helpful on gaining a resource for information if you are not familiar with social networking.
What is Facebook? It is a social networking website that was created to connect people. After signing up for Facebook, which is free, individuals make a profile page, begin to connect with others ("friends"), exchange messages, join groups, and play games. Today, there are over 300 million active Facebook users.
Facebook: The Power of Social Media
Living Well with MS
With the dawn of the digital age, our means of connecting with others have changed dramatically. Today, digital mediums--especially online communities--have changed the way many of us think of communication and the act of connecting with others.
For people with MS, online communities, such as Facebook, are proving to be incredible connecting tools. This has certainly been the case for Sandi St. Clair-Vargo who, after joining Facebook, began to discover a global network of support.
"Meeting other people with MS has been amazing...there are 100 plus people I've met from all over the world through Facebook," Sandi said. She describes these people, who she only knows digitally, as "kindred spirits," because they know what she is going through.
"All these people reassure you," Sandi said. "We're all going through the same thing."
Sandi has connected with many of these "kindred spirits" through MS-specific groups--of which there are more than 500. Each group offers something different, and runs the gamut from "Fight Multiple Sclerosis" to "Tysabri: As long as my body tolerates it, I'm not scared of PML!" The groups are key in connecting people with MS, despite geographical distance.
Have you seen the Rocky Mountain MS Center on Facebook page yet?
October 1, 2009 Went to my chiropractor this morning, had acupuncture, tens, and an adjustment on my spine. I have 3 active lesions at my C2, C5, 6. So the adjustment really felt like it was of great benefit. Feeling good and Attitude is GREAT!! PROACTIVE, going again tomorrow. Don’t let things like the bullsh-t we have to deal with get you down, you still can control your THOUGHTS? Make them GOOD THOUGHTS and when it seems impossible, and then call out to your Savior, Jesus for strength. I Talked with Richard Humphries on Monday and he said he is feeling good and that he talked to Holly Huber. Holly has many videos posted on You Tube about her SCT at ICM in Costa Rica. Holly received her first SCT in November of 2008. Now she is back for a new dose of ADULT STEM CELLS. I will be trying to touch base with her next week. You can see her on Face Book or You Tube. If you have MS or some one you are close to, it is very informative. Here is an article that will be helpful on gaining a resource for information if you are not familiar with social networking.
What is Facebook? It is a social networking website that was created to connect people. After signing up for Facebook, which is free, individuals make a profile page, begin to connect with others ("friends"), exchange messages, join groups, and play games. Today, there are over 300 million active Facebook users.
Facebook: The Power of Social Media
Living Well with MS
With the dawn of the digital age, our means of connecting with others have changed dramatically. Today, digital mediums--especially online communities--have changed the way many of us think of communication and the act of connecting with others.
For people with MS, online communities, such as Facebook, are proving to be incredible connecting tools. This has certainly been the case for Sandi St. Clair-Vargo who, after joining Facebook, began to discover a global network of support.
"Meeting other people with MS has been amazing...there are 100 plus people I've met from all over the world through Facebook," Sandi said. She describes these people, who she only knows digitally, as "kindred spirits," because they know what she is going through.
"All these people reassure you," Sandi said. "We're all going through the same thing."
Sandi has connected with many of these "kindred spirits" through MS-specific groups--of which there are more than 500. Each group offers something different, and runs the gamut from "Fight Multiple Sclerosis" to "Tysabri: As long as my body tolerates it, I'm not scared of PML!" The groups are key in connecting people with MS, despite geographical distance.
Have you seen the Rocky Mountain MS Center on Facebook page yet?
Wednesday, October 14, 2009
the video is posted on You Tube and I will blog what I said on the video. Since returning from treatment’s, (MY SYMPTOMS, NUMBNESS IN MY LIMBS, WEAKNESS ON THE RIGHT SIDE, DROP FOOT , FATIGUE, AND BALANCE), all improved about 10 %. PAIN IS DOWN FROMa 9 to a 4.5. My joint pain is down even more, could be the new cells, along with the supplements I have been taking. REMEMBER IT WILL BE 3 TO 6 MONTHS FOR THE CELLS TO GROW. Even tough I am very impatient to get dramatic results. I must remain realistic and continue to put EVERY ASPECT REGARDING MY LIFE, NOT JUST MY HEALTH, IN JESUS CHRIST AND HIS FATHER.
Tuesday, October 13, 2009
my videos posted on YOU TUBE SCT treatment started on the 3rd. of August. It will have a new post tomorrow, that’s the plan. The best Nugget I can throw your way today is to be PRO ACTIVE in the management of your disease. Get some exercise everyday. It improves your ATTITUDE and also mobility and self-esteem. Get some fun in your life and chose to be around fun and funny people. Be aware to laugh at yourself. Because of our disease the goofy things like tripping, falling, forgetting, dropping stuff (you get the idea)NEED to be released and not be REACTIVE but rather being PRO ACTIVE TO WHAT EVER THE SITUATION IS. Remember,” THE SITUATION IS THE BOSS AND THE RESULTS ARE THE JUDGE”! SAY THAT OVER AND OVER IN YOUR MIND AND LET IT SINK IN, IT IS A NATUREAL LAW.
Wednesday, October 7, 2009
Here we go, everyone take their attitude adjustment tonic. The most important thing in our day is attitude, it’s everything. So, let’s play the hand we were dealt and make it as good as we can. I always have been a fun person and have looked for humor in almost every situation. While traveling to San Jose on7/31/09 fortunately I had the airlines provide an agent to wheel me to my gate in a wheelchair, I’m not on a cane or walker or wheelchair and can still walk but not that far, and both in Charlotte and San Jose, getting thru customs would have been a nightmare without it. We were met by representatives of THE INSTITUTE OF CELLULAR MEDICINE and transferred to THE CHRISTINA APTOHOTEL, about a 20 minute drive. Checked in, everything in order. The facility was perfect. Clean, convient and close to ICM headquarters and only 10 minutes by the transfer van to the hospital. That night Sarita and I enjoyed a wonderful Italian dinner at a restaurant located in the hotel. That by the way was my last glass of wine. The doctors suggest that you not drink alcohol for 6 months to help insure that the new cells will grow. Yes, I do miss an occasional glass of wine! After a good nights rest, we needed it, and hearty breakfast, it was off to the Headquarters of ICM to be interviewed and filmed about our personal MS story and what each the us expected from the treatment of the transplanted stem cells. One thing I don’t want to fail to mention is how humbling it was to meet so many other MS suffers’ that were so much worse off in their fight of this Crazy disease. Many on walkers and even one friend in a wheelchair. There were 11 others from Texas, Ohio, Tennessee, Colorado, California, Georgia, and several other states. Several were there with children with Autism. See you to morrow, I’m tired.
Tuesday, October 6, 2009
9/22/09 I’m back, pretty busy day yesterday, 5 miles on the stationary bike at the YMCA, WAS DEAD TIRED AFTER BUT AM ALWAYS HAPPY THAT I MADE MY SELF DO IT. ONCE THE FATIGUE SUBSIDES I REALLY FEEL GOOD MENTALLY. Then onto Bible study last night till 9:00 PM. A little Monday Night Football and then finally gave up around the end of the first half. Congrat’s to the Colts and Payton Manning, good start at 2/0. On with my story and my Stem Cell Transplant in Costa Rica. For 1 year I have been going on the INTERNET looking for any new information about treatments for MS. I had pretty much come to the conclusion that my Neurologist was not in a position or did he have the time to do all the research because he was busy diagnosing and prescribing. I decided to be PRO ACTIVE with regard to finding new information each and everyday. At one point I was considering going to China for treatment with SCT. I backed out and changed my mind because of cost, distance, and that my wife would not be available to accompany me. My relentless search for new information lead me to discover a You Tube a video that featured a MS patient by the name of RICHARD HUMPHRIES who had treatment (SCT) at The Institute of Cellular Medicine in San Jose, Costa Rica. After seeing RICHARDS’s video and finding out how much success and promise ADULT STEM CELLS had, I started to investigate. Then on our local TV station, W.R.A.L featured an article about a local police officer named AJ Luedtke who had just been to The Institute of Cellular Medicine. I called him and the next day we had lunch and discussed his experience and the reduction of many of his MS symptoms. This was very encouraging to say the least! Speaking with the staff at the Institute of Cellular Medicine, exploring their web site, at CELLMEDICINE.COM and communicating via e-mail with many of their MS patients that had been for SCT felt commfortable with my discisson to go for a STEM CELL TRANSPLANT. We flew to C.R on the 1st of August and I spent 2 weeks in treatment. (Good stopping point)
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