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Sunday
MS community shocked by FDA's rejection of drug Lemtrada
Harold Johnson was going downhill fast. The medication he injected three times a week for his multiple sclerosis was making him feel like a zombie, and it wasn’t helping. His vision was getting worse, and he would choke when eating or drinking, and would
“The day that bothered me the most was when I went to my mom and dad’s house on Mother’s Day. I had to use a cane to walk in front of my mom,” said Johnson, 43, of Swansea. “That affected me.” Things dramatically changed about four years ago, after Johnson began taking part in a study of the experimental drug Lemtrada.The canes and walker he sometimes used are collecting dust in his hallway. He can ride his bike, play in the park with his dog, build robots in his basement and work full time as a computer technician at Southwestern Illinois College. Imaging of his brain shows no new damage. “Within three weeks, I felt like Superman,” Johnson said. He even got married.
Many with the debilitating neurological disease have stories like Johnson’s. A study of nearly 1,400 patients with progressive forms of multiple sclerosis showed those taking Lemtrada had nearly 50 percent fewer new attacks than those taking the current best medication. New brain lesions were also significantly reduced. The findings have already led Canada, Australia, Mexico and the European Union to approve the drug for treatment of multiple sclerosis.
However, in late December, the U.S. Food and Drug Administration ruled the drug was not ready for approval, surprising and disappointing doctors, patients and advocates...HOW TO CONTACT THE FDA
“The data was highly impressive to neurologists involved in treating MS,” said Dr. Barry Singer, director of the MS Center for Innovations in Care at Missouri Baptist Hospital and who is involved in the clinical studies of the drug. “It frankly came as a shock that the medication did not get approved.”
Multiple sclerosis is an unpredictable and disabling disease where the immune system attacks the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis. About 2.3 million people worldwide have MS, including 400,000 in the U.S.
FUTURE OF THERAPIES
Medical professionals are worried that the decision not only reduces much-needed treatment options but could have ramifications for future MS research. Doctors and nurses recently joined forces with advocates to send a letter to the FDA outlining their concerns.
“We’re trying through advocacy to have a fresh review of the results and a potential reversal of the decision,” Singer said.
The drugmaker, Genzyme, is appealing the ruling; and patients, friends and family members are urging citizens to sign an online petition asking the FDA to reverse its decision.
It has gotten about 2,600 signatures so far.
Damage from multiple sclerosis varies by patient, and patients also respond differently to medication. Many with relapses have no available treatments that will work for them.
“This (FDA ruling) is disappointing news, given the need for more therapeutic options for people with MS living in the United States,” said Timothy Coetzee, chief advocacy and research officer at the National MS Society. The ruling has prompted the society of nationwide advocacy chapters to work with the FDA on establishing a clear regulatory pathway for the approval of future MS therapies.
A month before the ruling, an advisory panel to the FDA had recommended that Lemtrada be approved. Johnson and eight other patients from across the country traveled to Washington to testify before the panel about how the drug helped them. Panel members, however, expressed concerns over safety and how the study was conducted.
The FDA can’t comment on unapproved drug applications, but Genzyme reported it was told the company had not used “adequate and well-controlled studies” to show that the drug’s benefits outweigh its serious side effects.
STUDY DIFFICULTIES
Lemtrada — also known as Alemtuzumab — is used today to treat a form of leukemia. The drug suppresses misdirected immune cells that are attacking one’s own body. Side effects include thyroid problems, flulike symptoms, infections and serious bleeding disorders.
Genzyme officials said that the main issue was the study design, which was not “double-blind.”
Most rigorous studies compare an investigational treatment and a placebo, a treatment that appears similar but is fake. Neither the treating physicians nor the patients know who is receiving which. However, that was difficult in the Lemtrada study because of the drugs’ differences in side effects and how they are administered. Lemtrada is given intravenously once-a-year over five days the first year and three days the next, and most patients taking it develop a widespread rash.
The study instead was “rater-blinded,” where doctors reviewing data and evaluating brain images did not know who was receiving which drug. This form of study has also been used in past MS research.
Dr. David Meeker, president of Genzyme, based in the Boston area, said demonstrating how Lemtrada compared to another drug instead of a placebo “provides robust evidence of efficacy.” The French pharmaceutical company Sanofi bought Genzyme for $20.1 billion in 2011 partly because of high hopes for Lemtrada.
In their letter to the FDA, the coalition of medical professionals and advocates wrote that many patients without options are willing to take greater risks, and they should be allowed the choice. They pointed out that a “rater-blinded” design was used in studies of the MS drug Rebif, which the FDA approved. More stringent requirements could have implications on future studies, as well.
UNINTENDED CONSEQUENCES
The letter brought up the concern about the potential for “medical tourism” — patients traveling to other countries for treatment, making it hard to monitor safety and side effects.
The FDA released this statement to the Post-Dispatch in response to the coalition’s letter: “Patients and their health care providers count on the FDA to assure that the treatments they choose have demonstrated acceptable safety and efficacy for their intended use through rigorous, objective, scientific testing. Although we have approved a number of new drugs for multiple sclerosis during the past few years, we recognize that the disease is far from cured, and there remains a need for new therapies that are safe and effective. We are working diligently and collaboratively with drug companies to determine what type of data is needed to support approvals.
http://www.stltoday.com/lifestyles/health-med-fit/medical/ms-community-shocked-by-fda-s-rejection-of-drug/article_a19397ce-9d82-568c-8737-00bb04eb4e03.html
HOW TO CONTACT THE FDA
Those who want to express their views about the FDA's refusal to approve Lemtrada to treat MS can send an email to druginfo@fda.hhs.gov. Copies can also be sent to your congressional representatives.
To sign a petition seeking the FDA to reverse it's decision, go to petitions.moveon.org/sign/thousands-of-multiple.
 |
| Harold Johnson, 43, shows off his agility and balance during his daily walk in the Melvin Price Memorial Park near his home in Swansea on Sunday, Feb. 16, 2014, while still holding on to his dog, |
Many with the debilitating neurological disease have stories like Johnson’s. A study of nearly 1,400 patients with progressive forms of multiple sclerosis showed those taking Lemtrada had nearly 50 percent fewer new attacks than those taking the current best medication. New brain lesions were also significantly reduced. The findings have already led Canada, Australia, Mexico and the European Union to approve the drug for treatment of multiple sclerosis.
However, in late December, the U.S. Food and Drug Administration ruled the drug was not ready for approval, surprising and disappointing doctors, patients and advocates...HOW TO CONTACT THE FDA
“The data was highly impressive to neurologists involved in treating MS,” said Dr. Barry Singer, director of the MS Center for Innovations in Care at Missouri Baptist Hospital and who is involved in the clinical studies of the drug. “It frankly came as a shock that the medication did not get approved.”
Multiple sclerosis is an unpredictable and disabling disease where the immune system attacks the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis. About 2.3 million people worldwide have MS, including 400,000 in the U.S.
FUTURE OF THERAPIES
Medical professionals are worried that the decision not only reduces much-needed treatment options but could have ramifications for future MS research. Doctors and nurses recently joined forces with advocates to send a letter to the FDA outlining their concerns.
“We’re trying through advocacy to have a fresh review of the results and a potential reversal of the decision,” Singer said.
The drugmaker, Genzyme, is appealing the ruling; and patients, friends and family members are urging citizens to sign an online petition asking the FDA to reverse its decision.
It has gotten about 2,600 signatures so far.
Damage from multiple sclerosis varies by patient, and patients also respond differently to medication. Many with relapses have no available treatments that will work for them.
“This (FDA ruling) is disappointing news, given the need for more therapeutic options for people with MS living in the United States,” said Timothy Coetzee, chief advocacy and research officer at the National MS Society. The ruling has prompted the society of nationwide advocacy chapters to work with the FDA on establishing a clear regulatory pathway for the approval of future MS therapies.
A month before the ruling, an advisory panel to the FDA had recommended that Lemtrada be approved. Johnson and eight other patients from across the country traveled to Washington to testify before the panel about how the drug helped them. Panel members, however, expressed concerns over safety and how the study was conducted.
The FDA can’t comment on unapproved drug applications, but Genzyme reported it was told the company had not used “adequate and well-controlled studies” to show that the drug’s benefits outweigh its serious side effects.
STUDY DIFFICULTIES
Lemtrada — also known as Alemtuzumab — is used today to treat a form of leukemia. The drug suppresses misdirected immune cells that are attacking one’s own body. Side effects include thyroid problems, flulike symptoms, infections and serious bleeding disorders.
Genzyme officials said that the main issue was the study design, which was not “double-blind.”
Most rigorous studies compare an investigational treatment and a placebo, a treatment that appears similar but is fake. Neither the treating physicians nor the patients know who is receiving which. However, that was difficult in the Lemtrada study because of the drugs’ differences in side effects and how they are administered. Lemtrada is given intravenously once-a-year over five days the first year and three days the next, and most patients taking it develop a widespread rash.
The study instead was “rater-blinded,” where doctors reviewing data and evaluating brain images did not know who was receiving which drug. This form of study has also been used in past MS research.
Dr. David Meeker, president of Genzyme, based in the Boston area, said demonstrating how Lemtrada compared to another drug instead of a placebo “provides robust evidence of efficacy.” The French pharmaceutical company Sanofi bought Genzyme for $20.1 billion in 2011 partly because of high hopes for Lemtrada.
In their letter to the FDA, the coalition of medical professionals and advocates wrote that many patients without options are willing to take greater risks, and they should be allowed the choice. They pointed out that a “rater-blinded” design was used in studies of the MS drug Rebif, which the FDA approved. More stringent requirements could have implications on future studies, as well.
UNINTENDED CONSEQUENCES
The letter brought up the concern about the potential for “medical tourism” — patients traveling to other countries for treatment, making it hard to monitor safety and side effects.
The FDA released this statement to the Post-Dispatch in response to the coalition’s letter: “Patients and their health care providers count on the FDA to assure that the treatments they choose have demonstrated acceptable safety and efficacy for their intended use through rigorous, objective, scientific testing. Although we have approved a number of new drugs for multiple sclerosis during the past few years, we recognize that the disease is far from cured, and there remains a need for new therapies that are safe and effective. We are working diligently and collaboratively with drug companies to determine what type of data is needed to support approvals.
http://www.stltoday.com/lifestyles/health-med-fit/medical/ms-community-shocked-by-fda-s-rejection-of-drug/article_a19397ce-9d82-568c-8737-00bb04eb4e03.html
HOW TO CONTACT THE FDA
Those who want to express their views about the FDA's refusal to approve Lemtrada to treat MS can send an email to druginfo@fda.hhs.gov. Copies can also be sent to your congressional representatives.
To sign a petition seeking the FDA to reverse it's decision, go to petitions.moveon.org/sign/thousands-of-multiple.
Labels: Lemtrada
