FDA Approves the Walking Pill for Multiple Sclerosis
As of Friday afternoon, a long awaited addition to our arsenal of MS symptomatic drugs has been approved.
We had a conversation about Ampyra which is a timed-release version of the drug 4-Aminopyridine (and formerly known as Fampridine SR), last May. At that time the drug was being resubmitted to the FDA for approval (rejected, originally, due to “formatting issues” during the application process).
This drug is thought to increase signal conduction by blocking tiny pore-like potassium channels on nerves of the central nervous system (CNS).
The time-released part of the drug is what is new, for those of you who have been getting 4-Aminopyridine from compound pharmacies.
Phase III clinical trials suggest that some 34-43 percent of people taking Ampyra had positive results in the areas of leg strength and walking speed. An average of 25 percent increase in walking speed!
No drug, of course, is without risk. Potential side effects include back pain, dizziness, headache, insomnia, urinary tract infection (UTI), fatigue, nausea, balance disorder and falls (which may or may not have been increased by subjects trying to walk without their assistive devices). There were also enough cases of seizure that anyone who has a history of seizure disorder are warned NOT to take Ampyra.
Patients with moderate or severe renal disorder (kidney issues) are also warned against taking Ampyra as this could lead to an unsafe level of the drug in the body.
The drug is administered in capsule form and, in clinical trials, was dosed every twelve hours.
The price of prescription Ampyra has yet to be announced, but many in the MS world are expecting a net cost around $10,000 per annum and will likely be ready to dispense in March of this year.
When we last discussed this drug, several of you commented about your use of the compounded version of the drug. I’d be interested to hear more from you, as well as those of you who may consider Ampyra in your treatment regime… or not.
Wishing you and your family the best of health.
Showing posts with label MS. Show all posts
Showing posts with label MS. Show all posts
Wednesday, January 27, 2010
Tuesday, May 12, 2009
Breakthrough of Hope
Breakthroughs Offer Hope to MS Patients
By Dennis Thompson, HealthDay Reporter
SUNDAY, July 6 (HealthDay News) -- There's no one single way to suffer from multiple sclerosis.
Every patient exhibits different symptoms as the disease gnaws away at the nerve endings in the brain, the spinal cord and even the eyes.
Doctors aren't even sure what causes MS, or what makes one person more likely to get it than another.
"I have a patient who is 6 years old," said Dr. Daniel Kantor, director of the Comprehensive Multiple Sclerosis Center at the University of Florida. "I have a patient who is 71 years old. I have patients from all walks of life, all ages."
But, the recent discovery of a second gene linked to multiple sclerosis -- hailed as a major breakthrough -- is giving researchers hope that they are zeroing in on useful treatments -- and, ultimately, a cure.
In what is considered the most significant genetic breakthrough in MS research in three decades, scientists last year announced they had found a gene that increases the risk of developing the disease by 30 percent.
"This discovery is very significant, because it is hopefully the first of many, and after more than 30 years of finding nothing," said Dr. Jennie Q. Lou, professor of public health and internal medicine at Nova Southeastern University in Fort Lauderdale, Fla.
"We will expect to find many more of these genes over the next few years. Either these genes, or genes related to them, may be an excellent target that researchers can use to develop treatments and cures for MS," she added.
The symptoms of multiple sclerosis are many and varied, as the disease attacks different parts of the nervous system.
One MS patient may have trouble walking, while another is wheelchair-bound. One person may experience terrible fatigue, while another might struggle with blurred or double vision. Still another might have slurred speech, tremors, stiffness and bladder problems, according to the National Multiple Sclerosis Society.
"A lot of the symptoms are invisible symptoms to an outsider," Kantor said. "Pain, extreme fatigue, memory problems -- these are problems you just can't see."
Multiple sclerosis is considered an autoimmune disease, because it attacks the central nervous system.
The nerve fibers of the central nervous system are surrounded and protected by a fatty tissue called myelin, which helps the fibers conduct electrical impulses. With MS, myelin is lost in multiple areas, leaving scar tissue called sclerosis. Sometimes, the fiber itself is harmed.
When myelin or the nerve fiber is destroyed or damaged, the ability of the nerves to conduct electrical impulses to and from the brain is disrupted, producing the various symptoms of MS.
Most people with MS are diagnosed between the ages of 20 and 50, and twice as many women as men have the disease. About 400,000 Americans are known to have MS, and every week about 200 new cases are diagnosed. Worldwide, the MS toll may run as high as 2.5 million people, according to the National Multiple Sclerosis Society.
The exact cause of MS is unknown, but doctors suspect it comes from some combination of genetic and environmental factors, Kantor said.
"There's a genetic predisposition and then something happens, they are exposed to something, and it makes the body's defense system attack itself versus attacking a foreign invader," he said.
That's why the discovery of the second gene is so important. Researchers now know they have to cast a wider net.
"We've been looking at one gene the whole time, and we thought that was going to be the answer to understanding MS," Kantor said. "This is just telling us there's another part of the immune system that is important as well. It's made things more complicated, but if it's true, it's true."
The gene discovery is one of a number of advances that are occurring at a rapid pace.
Lou noted that new research has successfully used stem cells to help replace myelin in the brains of mice. "This discovery has shed light on the great potential of using stem cells in MS treatment," she said.
And last year, researchers proved that an experimental DNA vaccine to fight multiple sclerosis is safe and stands a good chance of being effective. The vaccine works by thwarting the immune system's attack on the myelin sheaths protecting nerve fibers.
Other advances noted by Lou include:
- Better and earlier diagnosis owing to advances in imaging technology.
- Improved drugs to reduce the frequency and severity of symptoms, and the accumulation of lesions in the brain and spinal cord.
- More aggressive rehabilitation programs developed specifically for MS patients.
"Every time we get our Journal of Neurology, more than half of it is about MS and how we can treat MS," Kantor said. "The MS of today is not the MS of even 15 years ago. We are learning more about it at a rapid rate."
More information
To learn more, visit the National Multiple Sclerosis Society.
SOURCES: Daniel Kantor, M.D., assistant professor, neurology, and director, Comprehensive Multiple Sclerosis Center, University of Florida, Jacksonville; Jennie Q. Lou, M.D., MSc, professor, public health and internal medicine, Nova Southeastern University, Fort Lauderdale, Fla.; National Multiple Sclerosis Society
Copyright © 2008 ScoutNews, LLC. All rights reserved.
Friday, March 6, 2009
Obama Stem Cell Shift Will Speed Hunt for Cures, Scientists Say
By Rob Waters
March 7 (Bloomberg) -- President Barack Obama’s expected reversal of an 8-year-old restriction on U.S. funding for embryonic stem cell research has excited scientists and health advocates who say the action will accelerate the search for cures to major illness.
Obama plans to lift the funding ban, imposed by former President George W. Bush, in a March 9 signing ceremony, said two government officials, who spoke yesterday on condition of anonymity. Bush objected to the use of the tissue because the process caused the destruction of human embryos.
The change will free federally backed scientists to work with hundreds of newer cell colonies that have been off-limits under Bush’s order, including some that carry genetic mutations causing diseases such as juvenile diabetes and Huntington’s. If scientists can study these cells using U.S. government funding, it will speed research into those conditions, said Larry Soler, executive vice president of the Juvenile Diabetes Research Foundation.
The expected shift will “update the current policy, which has been frozen in place since 2001 and allow broad use of new technologies discovered over the last eight years,” Soler said yesterday in a telephone interview. “For 30 million Americans with some form of diabetes, stem cell research offers a possibility to develop new treatments.”
Repairing Damaged Organs
Stem cells derived from days-old human embryos have the potential to form any of the body’s 200 or so cell types and to repair or replace damaged tissue or organs. Those that contain mutations may reveal how illness develops and identify targets for prevention or treatment.
Opponents of the research consider embryos to be human life and research that destroys them to be immoral. They say stem cells from adult tissue and umbilical cord blood are available without harming embryos and already in clinical use, while treatments from embryonic cells are years off.
Bush allowed government support only for cell colonies made from embryos before August 9, 2001. Just 21 such colonies are available today to researchers, while hundreds of newer lines can be used only by researchers funded from private sources.
House Republican Leader John Boehner of Ohio said research advances allowing adult skin cells to be turned into so-called pluripotent stem cells with powers similar to those from embryos makes federal support for embryonic cells unnecessary.
‘Precious Human Life’
“Republicans enthusiastically support adult, cord blood, and pluripotent stem cell research that have shown so much promise in recent years,” he said in an e-mailed statement. “The question is whether taxpayer dollars should be used to subsidize the destruction of precious human life. Millions of Americans strongly oppose that, and rightfully so.”
Obama’s policy will encourage investment into stem cell companies, said Michael West, the founder and former chief executive of Geron Corp., the first company to use human embryonic stem cells after they were discovered in 1996.
“As the entrepreneur who was out there trying to move the industry forward, the Bush policy massively impacted the willingness of investors to put up money,” West said in a telephone interview yesterday. “Many of us hope this will spawn the new era of regenerative medicine we’ve been waiting for all these years. What a sigh of relief.”
West’s current company, Biotime Inc., based in Berkeley, California, is selling 88 cell lines carrying genetic diseases, including muscular dystrophy, Huntington’s disease and multiple sclerosis. The cells were created by a Chicago fertility center from embryos left over from in-vitro fertilization treatments.
Campaign Pledge
As a presidential candidate, Obama had pledged to overturn the Bush policy and many observers had expected him to act sooner.
“Indeed, that Obama has waited seven weeks into his presidency to sign this executive order is the only surprising aspect, said Rogan Kersh, associate dean of New York University’s Wagner School of Public Service, in an e-mail yesterday. “Amid so much policy turmoil, reversing the Bush ban won’t be as big a story as it normally might, but will arouse opposition from religious groups and other social conservatives opposed to this research on embryos.”
Reports that Obama would reverse the ban began circulating after the close of regular trading yesterday, with the first headlines coming from the Washington Post and ABC News.
The news sent shares of the stem cell companies higher. Geron, based in Menlo Park, California, gained $1.51, or 39 percent, to $5.38 and StemCells Inc. of Palo Alto, California, rose 91 cents, or 66 percent, to $1.38 in extended trading on the Nasdaq Stock Market.
The timing of Obama’s announcement couldn’t be better, said Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine at the University of California, San Francisco. It comes just days after the National Institutes of Health began requesting proposals for research projects using some of the $10 billion it was awarded from the from the economic stimulus package passed by Congress, Kriegstein said.
March 7 (Bloomberg) -- President Barack Obama’s expected reversal of an 8-year-old restriction on U.S. funding for embryonic stem cell research has excited scientists and health advocates who say the action will accelerate the search for cures to major illness.
Obama plans to lift the funding ban, imposed by former President George W. Bush, in a March 9 signing ceremony, said two government officials, who spoke yesterday on condition of anonymity. Bush objected to the use of the tissue because the process caused the destruction of human embryos.
The change will free federally backed scientists to work with hundreds of newer cell colonies that have been off-limits under Bush’s order, including some that carry genetic mutations causing diseases such as juvenile diabetes and Huntington’s. If scientists can study these cells using U.S. government funding, it will speed research into those conditions, said Larry Soler, executive vice president of the Juvenile Diabetes Research Foundation.
The expected shift will “update the current policy, which has been frozen in place since 2001 and allow broad use of new technologies discovered over the last eight years,” Soler said yesterday in a telephone interview. “For 30 million Americans with some form of diabetes, stem cell research offers a possibility to develop new treatments.”
Repairing Damaged Organs
Stem cells derived from days-old human embryos have the potential to form any of the body’s 200 or so cell types and to repair or replace damaged tissue or organs. Those that contain mutations may reveal how illness develops and identify targets for prevention or treatment.
Opponents of the research consider embryos to be human life and research that destroys them to be immoral. They say stem cells from adult tissue and umbilical cord blood are available without harming embryos and already in clinical use, while treatments from embryonic cells are years off.
Bush allowed government support only for cell colonies made from embryos before August 9, 2001. Just 21 such colonies are available today to researchers, while hundreds of newer lines can be used only by researchers funded from private sources.
House Republican Leader John Boehner of Ohio said research advances allowing adult skin cells to be turned into so-called pluripotent stem cells with powers similar to those from embryos makes federal support for embryonic cells unnecessary.
‘Precious Human Life’
“Republicans enthusiastically support adult, cord blood, and pluripotent stem cell research that have shown so much promise in recent years,” he said in an e-mailed statement. “The question is whether taxpayer dollars should be used to subsidize the destruction of precious human life. Millions of Americans strongly oppose that, and rightfully so.”
Obama’s policy will encourage investment into stem cell companies, said Michael West, the founder and former chief executive of Geron Corp., the first company to use human embryonic stem cells after they were discovered in 1996.
“As the entrepreneur who was out there trying to move the industry forward, the Bush policy massively impacted the willingness of investors to put up money,” West said in a telephone interview yesterday. “Many of us hope this will spawn the new era of regenerative medicine we’ve been waiting for all these years. What a sigh of relief.”
West’s current company, Biotime Inc., based in Berkeley, California, is selling 88 cell lines carrying genetic diseases, including muscular dystrophy, Huntington’s disease and multiple sclerosis. The cells were created by a Chicago fertility center from embryos left over from in-vitro fertilization treatments.
Campaign Pledge
As a presidential candidate, Obama had pledged to overturn the Bush policy and many observers had expected him to act sooner.
“Indeed, that Obama has waited seven weeks into his presidency to sign this executive order is the only surprising aspect, said Rogan Kersh, associate dean of New York University’s Wagner School of Public Service, in an e-mail yesterday. “Amid so much policy turmoil, reversing the Bush ban won’t be as big a story as it normally might, but will arouse opposition from religious groups and other social conservatives opposed to this research on embryos.”
Reports that Obama would reverse the ban began circulating after the close of regular trading yesterday, with the first headlines coming from the Washington Post and ABC News.
The news sent shares of the stem cell companies higher. Geron, based in Menlo Park, California, gained $1.51, or 39 percent, to $5.38 and StemCells Inc. of Palo Alto, California, rose 91 cents, or 66 percent, to $1.38 in extended trading on the Nasdaq Stock Market.
The timing of Obama’s announcement couldn’t be better, said Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine at the University of California, San Francisco. It comes just days after the National Institutes of Health began requesting proposals for research projects using some of the $10 billion it was awarded from the from the economic stimulus package passed by Congress, Kriegstein said.
Tuesday, March 4, 2008
Complaint dismissed in social host ordinance arrest - due to MS
By John A. Williams
Staff Writer
For the first time since its inception 13 months ago, a complaint against a person arrested for violating Edmond's social host ordinance has been dismissed.
Elizabeth Ellen Duncan, 53, and her son Timothy Donald Duncan, 18, were arrested Jan. 26 on the complaint of allowing underage drinking in their home.
Before the Duncans' arraignment hearing Thursday, City Attorney Paul Lakin said he made the decision to dismiss the complaint against Elizabeth Duncan based on medical information and because Duncan's son took full responsibility for the party.
"Had she been the one who set up the party, ran it, knew about it, that would have been the situation,” Lakin said.
Duncan's attorney, Pattye High, said the woman had no idea that there was a party going on in her house.
"She was upstairs asleep,” High said. "Ms. Duncan has multiple sclerosis, so when she came to the door, yes, she was unsteady on her feet, and yes, her speech is slurred, and no, she was absolutely not intoxicated. It was the result of her disability.”
According to an Edmond police report, 15 to 20 people were seen leaving the residence, several of them minors. High said police officers assumed that Duncan was intoxicated and arrested her.
"She was attempting to tell them that she had multiple sclerosis and there was no listening,” High said.
Duncan and her son posted $544 bail each, which also counts as the fine and court costs. Lakin said the money will be returned to Elizabeth Duncan.
Edmond's social host ordinance holds adults responsible when minors drink alcohol in their homes, but High said the wording of the ordinance makes it clear that a person must "knowingly permit” a gathering to be in violation.
"You can't be held criminally responsible for something if you have no knowledge about it going on,” she said. "This poor woman had no idea.”
Edmond City Attorney Stephen Murdock said he doesn't see that as a problem with the ordinance.
"We don't think it's a loophole at all,” he said.
Staff Writer
For the first time since its inception 13 months ago, a complaint against a person arrested for violating Edmond's social host ordinance has been dismissed.
Elizabeth Ellen Duncan, 53, and her son Timothy Donald Duncan, 18, were arrested Jan. 26 on the complaint of allowing underage drinking in their home.
Before the Duncans' arraignment hearing Thursday, City Attorney Paul Lakin said he made the decision to dismiss the complaint against Elizabeth Duncan based on medical information and because Duncan's son took full responsibility for the party.
"Had she been the one who set up the party, ran it, knew about it, that would have been the situation,” Lakin said.
Duncan's attorney, Pattye High, said the woman had no idea that there was a party going on in her house.
"She was upstairs asleep,” High said. "Ms. Duncan has multiple sclerosis, so when she came to the door, yes, she was unsteady on her feet, and yes, her speech is slurred, and no, she was absolutely not intoxicated. It was the result of her disability.”
According to an Edmond police report, 15 to 20 people were seen leaving the residence, several of them minors. High said police officers assumed that Duncan was intoxicated and arrested her.
"She was attempting to tell them that she had multiple sclerosis and there was no listening,” High said.
Duncan and her son posted $544 bail each, which also counts as the fine and court costs. Lakin said the money will be returned to Elizabeth Duncan.
Edmond's social host ordinance holds adults responsible when minors drink alcohol in their homes, but High said the wording of the ordinance makes it clear that a person must "knowingly permit” a gathering to be in violation.
"You can't be held criminally responsible for something if you have no knowledge about it going on,” she said. "This poor woman had no idea.”
Edmond City Attorney Stephen Murdock said he doesn't see that as a problem with the ordinance.
"We don't think it's a loophole at all,” he said.
Friday, January 4, 2008
Sten Cells without Killing Fetus
Published: November 21, 2007
Two teams of scientists reported yesterday that they had turned human skin cells into what appear to be embryonic stem cells without having to make or destroy an embryo — a feat that could quell the ethical debate troubling the field.
All they had to do, the scientists said, was add four genes. The genes reprogrammed the chromosomes of the skin cells, making the cells into blank slates that should be able to turn into any of the 220 cell types of the human body, be it heart, brain, blood or bone. Until now, the only way to get such human universal cells was to pluck them from a human embryo several days after fertilization, destroying the embryo in the process.
The need to destroy embryos has made stem cell research one of the most divisive issues in American politics, pitting President Bush against prominent Republicans like Nancy Reagan, and patient advocates who hoped that stem cells could cure diseases like Alzheimer's. The new studies could defuse the issue as a presidential election nears.
Two teams of scientists reported yesterday that they had turned human skin cells into what appear to be embryonic stem cells without having to make or destroy an embryo — a feat that could quell the ethical debate troubling the field.
All they had to do, the scientists said, was add four genes. The genes reprogrammed the chromosomes of the skin cells, making the cells into blank slates that should be able to turn into any of the 220 cell types of the human body, be it heart, brain, blood or bone. Until now, the only way to get such human universal cells was to pluck them from a human embryo several days after fertilization, destroying the embryo in the process.
The need to destroy embryos has made stem cell research one of the most divisive issues in American politics, pitting President Bush against prominent Republicans like Nancy Reagan, and patient advocates who hoped that stem cells could cure diseases like Alzheimer's. The new studies could defuse the issue as a presidential election nears.
Monday, April 30, 2007
MS and Inigo Mantoya
Mandy Patinkin participated in a 75 to 150 mile bike ride for charity to support the National Multiple Sclerosis Society with cast mates from Criminal Minds, including Thomas Gibson & Shermar Moore! Go CM team! "Mandy likes to convince you that he's an old geezer. He's not." - Moore
Thanks to everyone, especially you, Graham, for putting their hearts, money, and bodies on the line for this cause!
Thanks to everyone, especially you, Graham, for putting their hearts, money, and bodies on the line for this cause!
Tuesday, April 3, 2007
Way to Go!
Linda Chance, Oklahoma City, OK
The idea for an MS awareness ribbon was a no-brainer for Linda Chance: If so many other diseases had ribbons, why shouldn’t MS?
With newfound time on her hands due to the necessity of an early retirement, Linda decided to take action. Using a hot glue gun, she constructed more than 1,000 ribbons made from prism fabric to distribute at MS walks, runs and rides. She selected the prism design because the changing colors signified MS as an ever-changing and unpredictable disease. She also authored a brochure and created display boards to showcase the ribbons.
With her Betaseron® Champions of CourageSM grant, Linda will be able to manufacture more MS awareness ribbons and travel to other cities to promote the concept.
"My goal is to display the ribbon at as many events and locations as possible so that more people will be aware of MS and its devastating effects," says Linda. "My hope is that increased awareness will result in more funding to find an end to this disease."
With her Champions of Courage grant, Linda assembled ribbon kits which were distributed through the Oklahoma chapter of the National MS Society as well as by Linda herself!
Linda’s hard work to benefit people with MS did not gone unnoticed by her community. For her outstanding volunteer service, Linda received the 2000 Oklahoma Citian With a Disability of the Year award at the city’s Mayor’s Conference on People with Disabilities, and also was honored by her chapter of the National Multiple Sclerosis Society.
The idea for an MS awareness ribbon was a no-brainer for Linda Chance: If so many other diseases had ribbons, why shouldn’t MS?
With newfound time on her hands due to the necessity of an early retirement, Linda decided to take action. Using a hot glue gun, she constructed more than 1,000 ribbons made from prism fabric to distribute at MS walks, runs and rides. She selected the prism design because the changing colors signified MS as an ever-changing and unpredictable disease. She also authored a brochure and created display boards to showcase the ribbons.
With her Betaseron® Champions of CourageSM grant, Linda will be able to manufacture more MS awareness ribbons and travel to other cities to promote the concept.
"My goal is to display the ribbon at as many events and locations as possible so that more people will be aware of MS and its devastating effects," says Linda. "My hope is that increased awareness will result in more funding to find an end to this disease."
With her Champions of Courage grant, Linda assembled ribbon kits which were distributed through the Oklahoma chapter of the National MS Society as well as by Linda herself!
Linda’s hard work to benefit people with MS did not gone unnoticed by her community. For her outstanding volunteer service, Linda received the 2000 Oklahoma Citian With a Disability of the Year award at the city’s Mayor’s Conference on People with Disabilities, and also was honored by her chapter of the National Multiple Sclerosis Society.
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