
Reply: Campath (Lemtrada)
Off-label use of alemtuzumab in MS has always been at the discretion of individual...
Posted by Rory26312
Off-label use of alemtuzumab in MS has always been at the discretion of individual clinicians without reference to the company.""In the UK, our price for Lemtrada and the value it brings to patients will be subject to the usual health economic evaluation by the National Institute for Health and Clinical Excellence."
Doug Brown, Head of Biomedical Research at the Multiple Sclerosis Society, said: "Alemtuzumab shows real promise as a potentially new medicine for many people with relapsing-remitting MS. There is no good reason why people with MS who have been allowed to benefit from the treatment should now be denied it.
"Genzyme need to come up with a scheme, quickly, that makes their product available to all those people currently being treated and, if it's licensed, price the drug reasonably so it is deemed cost effective on the NHS."
A Department of Health spokesperson said: "We know how important this drug is for some MS sufferers and are working closely with the company and the NHS to help make sure these patients can still access it."
Case study: 'I have seen the way my mother is suffering'
Oritse Williams, 25, of the platinum-selling boyband JLS, knows the suffering caused by multiple sclerosis since his mother, Sonia, 54, was diagnosed over a decade ago. He and his brother pledged when in their teens that they would do all they could to help her.
"We decided that when we grew up, my brother would become a scientist and I would try to make money from my music. That way we would have both the means and the ability to find a cure." Williams cared for his mother through his childhood and until he appeared in the final of The X Factor in 2008.
The drugs company: Sanofi
Sanofi, based in Paris, is the world's fourth-largest pharmaceutical company, employing 113,000 people worldwide.
Last year the company made a profit of almost "0AC6bn on revenue of "0AC33b. Its products include Clomid, for female infertility, the anti-clotting agent Plavix and the cancer drug Taxotere.
The company is the world's largest producer of vaccines through its subsidiary Sanofi Pasteur. It acquired Genzyme, a US biotech company based in Cambridge, Massachusetts, in 2011.
In 2010 Sanofi sacked 1,700 US employees citing growing competition from non-branded generic manufacturers. It denied the action was related to its purchase of Genzyme.
Last week, the Paris-based company announced plans to cut almost 1,000 jobs in France despite protests condemning the move.
Source: The Independent © independent.co.uk (15/10/12)
Not sure what all this means in terms of treatment but it makes me think that big pharm is trying to take advantage . It's not like the have big research and development costs on this one.
RoryView Thread
Posted byRory26312
Doug Brown, Head of Biomedical Research at the Multiple Sclerosis Society, said: "Alemtuzumab shows real promise as a potentially new medicine for many people with relapsing-remitting MS. There is no good reason why people with MS who have been allowed to benefit from the treatment should now be denied it.
"Genzyme need to come up with a scheme, quickly, that makes their product available to all those people currently being treated and, if it's licensed, price the drug reasonably so it is deemed cost effective on the NHS."
A Department of Health spokesperson said: "We know how important this drug is for some MS sufferers and are working closely with the company and the NHS to help make sure these patients can still access it."
Case study: 'I have seen the way my mother is suffering'
Oritse Williams, 25, of the platinum-selling boyband JLS, knows the suffering caused by multiple sclerosis since his mother, Sonia, 54, was diagnosed over a decade ago. He and his brother pledged when in their teens that they would do all they could to help her.
"We decided that when we grew up, my brother would become a scientist and I would try to make money from my music. That way we would have both the means and the ability to find a cure." Williams cared for his mother through his childhood and until he appeared in the final of The X Factor in 2008.
The drugs company: Sanofi
Sanofi, based in Paris, is the world's fourth-largest pharmaceutical company, employing 113,000 people worldwide.
Last year the company made a profit of almost "0AC6bn on revenue of "0AC33b. Its products include Clomid, for female infertility, the anti-clotting agent Plavix and the cancer drug Taxotere.
The company is the world's largest producer of vaccines through its subsidiary Sanofi Pasteur. It acquired Genzyme, a US biotech company based in Cambridge, Massachusetts, in 2011.
In 2010 Sanofi sacked 1,700 US employees citing growing competition from non-branded generic manufacturers. It denied the action was related to its purchase of Genzyme.
Last week, the Paris-based company announced plans to cut almost 1,000 jobs in France despite protests condemning the move.
Source: The Independent © independent.co.uk (15/10/12)
Not sure what all this means in terms of treatment but it makes me think that big pharm is trying to take advantage . It's not like the have big research and development costs on this one.
RoryView Thread
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Reply: Campath (Lemtrada)
This is from www.msrc.co.uk
Pharmaceutical giant Sanofi withdraws (campath I think)
existing treatment to boost profits with rebranded Lemtrada.
A pharmaceutical company stands accused of putting profit before patients after withdrawing a drug used in the treatment of a chronic debilitating disease — ahead of relaunching it at a price predicted to be up to 20 times higher.
Three of Britain's leading neurologists have written to the Health Secretary, Jeremy Hunt, to protest at Genzyme, part of the multinational drug company Sanofi, halting supplies of the drug alemtuzumab for multiple sclerosis.
The drug is currently licensed for the treatment of leukaemia. But it has been known for 20 years also to be effective in MS patients suffering from an aggressive form of the disease.
Neurologists have used the drug in these patients "off label" — prescribing it on their own initiative even though it was not licensed for multiple sclerosis — following encouraging results from a large placebo-controlled trial published in the New England Journal of Medicine in 1998. Alemtuzumab, which is given in two courses a year apart, costs markedly less than other drugs for multiple sclerosis to which it is thought to be superior — around £2,500.
Genzyme has now applied for a licence for the drug in multiple sclerosis to regulators in Europe and the US and is expected to relaunch it under the trade name, Lemtrada, at what could be many times its current price. In the meantime the company has withdrawn the drug from MS patients' off-label treatment, pending the granting of the licence, on the grounds that "any adverse event outside a clinical trial "026 may complicate the regulatory process".
In the neurologists' letter to the Health Secretary, professors Neil Scolding of the University of Bristol, Neil Robertson of the University Hospital of Wales and John Zajicek of the University of Plymouth say that Genzyme's decision has "serious implications for vulnerable UK patients with MS". They say patients who have already started treatment will "not be able to get their vital second course", and new patients may "miss their window of therapeutic opportunity" putting them at risk of "progressive, severe disability".
When licensed, they say, the drug's price is expected to be "15 to 20 times greater", and its withdrawal sets an "inappropriate precedent". They add: "It shows little regard for patients whose opportunity to alter the course of their disease is time-limited, and may represent an over-enthusiastic attempt by the parent company to profit from the current situation."
Professor Zajicek said he had personally treated about 150 patients with the drug, and 400 to 500 had received it across the UK. "Many of us think it is the best drug for patients with aggressive MS in the early stages of the disease. It's the greedy behaviour of the drug company that upsets me. They are just trying to rebrand it and put the price up. It is morally corrupt."
A spokesperson for Genzyme said: "Our goal is to ensure that Lemtrada is approved by regulatory authorities and made available to multiple sclerosis patients as quickly as possible. Until approved risk-management programmes are established, the use of Lemtrada for MS should occur only in clinical trials.
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Posted byRory26312
This is from www.msrc.co.uk Pharmaceutical giant Sanofi withdraws (campath I...
Posted by Rory26312
This is from www.msrc.co.uk
Pharmaceutical giant Sanofi withdraws (campath I think)
existing treatment to boost profits with rebranded Lemtrada.
A pharmaceutical company stands accused of putting profit before patients after withdrawing a drug used in the treatment of a chronic debilitating disease — ahead of relaunching it at a price predicted to be up to 20 times higher.
Three of Britain's leading neurologists have written to the Health Secretary, Jeremy Hunt, to protest at Genzyme, part of the multinational drug company Sanofi, halting supplies of the drug alemtuzumab for multiple sclerosis.
The drug is currently licensed for the treatment of leukaemia. But it has been known for 20 years also to be effective in MS patients suffering from an aggressive form of the disease.
Neurologists have used the drug in these patients "off label" — prescribing it on their own initiative even though it was not licensed for multiple sclerosis — following encouraging results from a large placebo-controlled trial published in the New England Journal of Medicine in 1998. Alemtuzumab, which is given in two courses a year apart, costs markedly less than other drugs for multiple sclerosis to which it is thought to be superior — around £2,500.
Genzyme has now applied for a licence for the drug in multiple sclerosis to regulators in Europe and the US and is expected to relaunch it under the trade name, Lemtrada, at what could be many times its current price. In the meantime the company has withdrawn the drug from MS patients' off-label treatment, pending the granting of the licence, on the grounds that "any adverse event outside a clinical trial "026 may complicate the regulatory process".
In the neurologists' letter to the Health Secretary, professors Neil Scolding of the University of Bristol, Neil Robertson of the University Hospital of Wales and John Zajicek of the University of Plymouth say that Genzyme's decision has "serious implications for vulnerable UK patients with MS". They say patients who have already started treatment will "not be able to get their vital second course", and new patients may "miss their window of therapeutic opportunity" putting them at risk of "progressive, severe disability".
When licensed, they say, the drug's price is expected to be "15 to 20 times greater", and its withdrawal sets an "inappropriate precedent". They add: "It shows little regard for patients whose opportunity to alter the course of their disease is time-limited, and may represent an over-enthusiastic attempt by the parent company to profit from the current situation."
Professor Zajicek said he had personally treated about 150 patients with the drug, and 400 to 500 had received it across the UK. "Many of us think it is the best drug for patients with aggressive MS in the early stages of the disease. It's the greedy behaviour of the drug company that upsets me. They are just trying to rebrand it and put the price up. It is morally corrupt."
A spokesperson for Genzyme said: "Our goal is to ensure that Lemtrada is approved by regulatory authorities and made available to multiple sclerosis patients as quickly as possible. Until approved risk-management programmes are established, the use of Lemtrada for MS should occur only in clinical trials.
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Reply: Avonex pen anyone?
Hi Suzanne and mykidsarespecial Well that was quick and easy no trouble at all . I...
Posted by Rory26312
Hi Suzanne and mykidsarespecial
Well that was quick and easy no trouble at all . I guess I have been lucky over the years in that I have never been afraid of needles so I never dreaded shot night , also I never have had a really hard time with side effects.
Suzanne have you ever found that you woke up a few hours after the shot and could not get back to sleep but otherwise felt fine. This started with me about two years ago (I am now ten years on Avonex). It is mildly annoying but not something that causes fatigue or any other sort of disability, just curious and thought I would ask.
Based on last night I recomend the pen to anyone on Avonex
RoryView Thread
Posted byRory26312
Well that was quick and easy no trouble at all . I guess I have been lucky over the years in that I have never been afraid of needles so I never dreaded shot night , also I never have had a really hard time with side effects.
Suzanne have you ever found that you woke up a few hours after the shot and could not get back to sleep but otherwise felt fine. This started with me about two years ago (I am now ten years on Avonex). It is mildly annoying but not something that causes fatigue or any other sort of disability, just curious and thought I would ask.
Based on last night I recomend the pen to anyone on Avonex
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Reply: Avonex pen anyone?
Yes and yes allthough you have to have a training session on how to use it. I done mine...
Posted by Rory26312
Yes and yes allthough you have to have a training session on how to use it. I done mine in neuro's office in five minutes so no big deal on that. My insurance covered it with same Co-pay. My first one tonight so will let you know tomorrow.
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Reply: Avonex pen anyone?
Just filled the script and got instruction so next shot will be the first one Rory
Posted by Rory26312
Just filled the script and got instruction so next shot will be the first one
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Reply: Newly diagnosed
HI again Dottie I mis-spelt that by "pushing through" I mean trying to keep going when...
Posted by Rory26312
HI again Dottie
I mis-spelt that by "pushing through" I mean trying to keep going when we know we should take a break or have a nap. We all do it once in awhile but it can cause promblems in the long run. I know this will not be easy with a three year old in the family.
As to treatments the more establised ones are what we call the CRAB's .All are injections so the can seem scary. Copoxane Rebif Avonex and Betaseron the have been around for fifteen plus years and there track record is pretty well establised .
Of these Copaxone is the best tolerated with fewest side effects but it an every day injection under the skin.
Rebif and Betaseron are from a class of drug called an interferon
each is an every other day injection under the skin.
Avonex is another interferon injected once a week into a muscle so there is a longer needle needed allthough the have a new system just launched which hopefully will be easier to handle.
All the interferons come with side effects including flu like symptoms after the shot and severe depression and possibly liver damge so the have to be monitered very carefully. Many people here say the cannot give up a day of the week to the flu like symptoms when the have a small child.
Avonex is the one I am on since my diagnosis ten years ago and I have been very lucky in that I have no promblems with side effects.
There is a once a month infusion called Tysabri and there has been an pill called Gilenya released recently with more to come . I do not know much about these so hopefully your neuro or someone else on here will explain more.
Remember this choice is yours to make or if you choose not to treat at all and do not let anyone bully you into taking a treatment that does not suit you.
Sorry so long
RoryView Thread
Posted byRory26312
I mis-spelt that by "pushing through" I mean trying to keep going when we know we should take a break or have a nap. We all do it once in awhile but it can cause promblems in the long run. I know this will not be easy with a three year old in the family.
As to treatments the more establised ones are what we call the CRAB's .All are injections so the can seem scary. Copoxane Rebif Avonex and Betaseron the have been around for fifteen plus years and there track record is pretty well establised .
Of these Copaxone is the best tolerated with fewest side effects but it an every day injection under the skin.
Rebif and Betaseron are from a class of drug called an interferon
each is an every other day injection under the skin.
Avonex is another interferon injected once a week into a muscle so there is a longer needle needed allthough the have a new system just launched which hopefully will be easier to handle.
All the interferons come with side effects including flu like symptoms after the shot and severe depression and possibly liver damge so the have to be monitered very carefully. Many people here say the cannot give up a day of the week to the flu like symptoms when the have a small child.
Avonex is the one I am on since my diagnosis ten years ago and I have been very lucky in that I have no promblems with side effects.
There is a once a month infusion called Tysabri and there has been an pill called Gilenya released recently with more to come . I do not know much about these so hopefully your neuro or someone else on here will explain more.
Remember this choice is yours to make or if you choose not to treat at all and do not let anyone bully you into taking a treatment that does not suit you.
Sorry so long
RoryView Thread
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Reply: Newly diagnosed
Hi Dottie Welcome to our little group but sorry you need to be here. Your Ha-Ha moment...
Posted by Rory26312
Hi Dottie
Welcome to our little group but sorry you need to be here. Your Ha-Ha moment is not unusual after diagnosis. A lot of people actually feel relieve because the diagnostic process can take so long.
The most important thing right now is to find a neuro or MS care center that will work with you on a second opinion and then on a treatment plan .Once that has been establised then you can take a deep breath and assess where you are.
As you say yourself take it day by day for now, do not be afraid to ask for help as "pushing trough" can cause more promblems in the long run.
Come back and let us know how you are doing fell free to ask,vent tell a funny story or joke.
Hug that young fellow and "breath"
RoryView Thread
Posted byRory26312
Welcome to our little group but sorry you need to be here. Your Ha-Ha moment is not unusual after diagnosis. A lot of people actually feel relieve because the diagnostic process can take so long.
The most important thing right now is to find a neuro or MS care center that will work with you on a second opinion and then on a treatment plan .Once that has been establised then you can take a deep breath and assess where you are.
As you say yourself take it day by day for now, do not be afraid to ask for help as "pushing trough" can cause more promblems in the long run.
Come back and let us know how you are doing fell free to ask,vent tell a funny story or joke.
Hug that young fellow and "breath"
RoryView Thread
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Reply: Weakness in legs
Hi Freckles My neuro usually does a five day course and I insist on the taper as I done...
Posted by Rory26312
Hi Freckles
My neuro usually does a five day course and I insist on the taper as I done it cold turkey once and it was not good.
The need to watch blood pressure and sugar levels but unless there is a pre-existing condition it is not normally a promblem.
I always get a metallic taste so bring gum just in case. I never had a headache but you need to let them know if it persists.
Be better
RoryView Thread
Posted byRory26312
My neuro usually does a five day course and I insist on the taper as I done it cold turkey once and it was not good.
The need to watch blood pressure and sugar levels but unless there is a pre-existing condition it is not normally a promblem.
I always get a metallic taste so bring gum just in case. I never had a headache but you need to let them know if it persists.
Be better
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Reply: Undiagnosed and unsure
HI Lodad The short answers are yes . Find a neuro who specialises in MS or an MS care...
Posted by Rory26312
HI Lodad
The short answers are yes . Find a neuro who specialises in MS or an MS care center andget a second opinion.
Kim has outlined the testing the should follow if the know there stuff and run if the say it is all in your head.
RoryView Thread
Posted byRory26312
The short answers are yes . Find a neuro who specialises in MS or an MS care center andget a second opinion.
Kim has outlined the testing the should follow if the know there stuff and run if the say it is all in your head.
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Reply: Do I have MS or what else could it be?
Hi Honestly I cann't read most of your first post but I am sure Kim gave you good...
Posted by Rory26312
Hi
Honestly I cann't read most of your first post but I am sure Kim gave you good advice.
On a different note there have been several Vet's on here and the all tell the same story about the VA ,it is adisgrace the way you guys are treated.
BTW the reason I am having troubles is because of the big block ,if you hit enter twice every few lines it will it will break it up,
RoryView Thread
Posted byRory26312
Honestly I cann't read most of your first post but I am sure Kim gave you good advice.
On a different note there have been several Vet's on here and the all tell the same story about the VA ,it is adisgrace the way you guys are treated.
BTW the reason I am having troubles is because of the big block ,if you hit enter twice every few lines it will it will break it up,
RoryView Thread
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