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Lemtrada – Sanofi’s Request for a new MS Drug

The FDA is considering the approval of Lemtrada (alemtuzumab), a redesigned version of Sanofi’s drug CAMPATH, which has been used for over 10 years in treating a certain form of Leukemia.  The word on the web is the FDA committee doing this review , and are holding hearings this week to complete their recommendation,  is poised to deny this application. A health advocacy group reached out to a number of us who are active in the Multiple Sclerosis community and asked for our opinions and  I was asked what comments I might share with the FDA committee. The following is the message I would deliver –

I have MS and I am currently on Tysabri, an every 28 day infusion drug that has a known risk profile of the very serious side effect of progressive multifocal leukoencephalopathy or PML, an infection of the brain.  Tysabri is a black box drug- it has a warning that this drug has the potential to cause death or serious irreversible disability – but I take it as my disease modifying therapy anyway.  Why?  Because I am able to have an informed discussion with my neurologist about the risks vs benefits of Tysabri and a number of safety nets have been constructed by the manufacturer, Biogen Idec, for people on Tysabri to identify and intervene if PML becomes an issue.

I have been vocal about my displeasure as to how the MS market is manipulated for profits, especially in the case of Sanofi and their dispensing alemtuzumab under the name of Campath for free to leukemia patients while we can anticipate another high price point, most probably in the $60,000 range, if Lemtrada is approved for use in MS. I find this practice ethically distasteful and is just another example of what is wrong with our pharmaceutical industry.  This leaves me conflicted about the approval of Lemtrada .

I personally know a woman who was prescribed Campath off label, and was refused shipment of the drug from the manufacturer right at the time Genzyme Sanofi removed it from the commercial market in the US.  Her physician and her insurance had approved its use but she got caught in the time when the pharmaceutical company and the FDA began this approval process.  It angers me that she was denied the opportunity to try this treatment while leukemia patients were given it for free while this approval makes its way through FDA approval.

Scientific evidence bears out that there is no single drug that works for people with MS and we are fortunate to have a growing list of therapy choices to try until we find the right one for us. Part of our decision process in selecting which drug to try, out of the ten FDA approved therapies or why we would leave one to try another, is largely guided by the risk/benefit consideration.

That choice of risk versus benefit should always come from a discussion between the patient and their neurologist, with the patient ultimately deciding.  Many people with MS are facing continuing decline in function and are willing to try most anything to slow or halt the advance of the disease.  It should be left up to us to determine what risk we are willing to take on in an attempt to halt our Multiple Sclerosis.

It must be articulated to the person with MS that alemtuzumab, once in the system, has no known way of being removed  –  this means if there is a problem with the person tolerating the drug treatment, they are stuck with the consequences. Many people with Multiple Sclerosis are in a desperate enough situation and rapid, uncontrolled physical decline, to be willing to take on this risk if it means the possibility of improvement.  An almost certain life in a wheelchair,  and  needing 24 hour nursing care,  might be  a worse option for someone  than the possibility of cancer or the other documented possible side effects from Lemtrada. That treatment decision is not up to me nor should it be one the FDA regulators make.  Patient centered care, where the patient is making the choices,  is the optimum model of care and should be applied to this treatment option.

I also foresee that many people with MS will see this treatment regimen as an easy fix for their disease and that should be a major concern – who wouldn’t like to take a five day treatment and then do nothing for a year and have another three day round of drugs and then walk away from treatment completely? From what we know about the efficacy and safety of this drug as Lemtrada, it should be offered to people only after they have failed all other options or have such rapidly advancing MS, it would be a last-ditch attempt at slowing this progress.

The dangers of alemtuzumab must be documented and clearly communicated with people considering it as a therapy option, much like the dangers associated with Tysabri are presented.  A more intensive patient education and consent program should be developed for Lemtrada to assist the person with MS to make the informed  decision.

Despite my concerns, I would like to see Lemtrada made available as an additional treatment option – and it seems reasonable to require the manufacturer to develop a program that educates physicians and patients of the serious risks associated with Lemtrada.  For those of us living with MS and facing the accumulative effects of disability, we should be given the option of choosing our own treatment in hopes that we find that right one that works for us.

What do you think?

Wishing you well,

Laura

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The MultipleSclerosis.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

Comments

  • schroederra
    6 years ago

    I think the advisory report is more positive than is being reported:
    http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM374188.pdf

    Got to page 21 to read the conclusions.

  • rmdanielsom
    6 years ago

    Laura,

    I agree with nearly all that you, and the others, have said. I have fired two neurologists because of their outdated concepts of appropriate MS care. I too have extremely bad reactions, or no reaction, to a wide range of drugs. Add to that, that I am PPMS; that means that currently there are no MS drugs for me other than baclofen which doesn’t work and tizanadine, which is losing its efficacy. Lemtrada is the only drug that is currently being evaluated for PPMS. I have no other options. I would like to at least be able to have the discussion with my doctors. This is not a disease that I live with; I live in spite of this disease.

  • ciara
    6 years ago

    I could not agree more with approving Lematrada as another weapon patients and neurologists can use. When I read about Lemtrada months ago, I thought that perhaps the scientists/doctors? are actually realizing that there are so many other medications out there dealing with other autoimmune diseases that could help not only MS but others as well. I am on Tysabri as well and have been for 6 years after not responding to other treatments. As in your article, all drugs for MS patients must be discussed with the neurologist but also with family; because MS affects the family too.

  • lori
    6 years ago

    I’d like to be added to the list of volunteers as all other treatments have failed miserably for me, resulting on infections and bad side effects….I hope they find one that will work for me someday….I’d like to give it a chance…How do I find out how?

  • ciara
    6 years ago

    On the MS society web site you can find clinical trials for different things from exercise, diet, and medicines.

  • Mojosmom
    6 years ago

    I completely agree! We, the PATIENTS, are best at making our care choices. Some would rather leave it up to their docs, and that is their choice; as long as they’re willing to take the consequences of their choice (not necessarily true in the US). If a patient WANTS to have a more active role in his/her care they MUST be willing to doctor-shop. Just like ANY financial transaction, the doctor-patient relationship is one that should be beneficial to both parties. If your doctor is not working WITH you, get another.

  • Sonya
    6 years ago

    Another very informative article. I always enjoy reading your articles & the viewpoint you share.
    This journey, with all its twists & turns, is made easier when we are able to discuss & listen to other viewpoints. I appreciate all you do to get this information to us my friend.
    I wish you peace.
    Sonya

  • Sandra Boe
    6 years ago

    I am very supportive of your repeated statements in your blog that the decision about any treatment for our MS lies with us, the MS patient. I have experienced bullying by neurologists to follow their recommended course of therapy when I was uncomfortable with their choice, I quit therapies that were not good for me and have had to leave a doctor because of his insistence that I take tysabri when I believed it to be a bad decision for me after repeatedly having serious side effects from other medications. I have a history of responding negatively with drugs of many kinds — I am not a good candidate for drug therapy. I have finally been able to find a neurologist who will discuss openly with me what is best for me — as it turns out — none of the new pharmaceutical MS drugs are appropriate for me. I have been stable for a long time. I do have relapses, but they are short-lived, and I am not disabled. I follow a strict diet and treatment recommended by my naturopath which my neurologist supports. We work together as a team. If my MS should become more aggressive and I start to have more relapses, then we can reconsider. In the meantime, I cannot say enough about the important of people making decisions that work best for them, with a supportive medical team backing them up. Don’t be pressured into anything. You decide. It’s your body and your life.

  • Laura Kolaczkowski author
    6 years ago

    Sandra, patient centered care should be at the center of everything that is recommended to us. I am always happy to hear from people who are doing what you are – directing their own care and not just following the doctor’s orders.

  • Dave87
    6 years ago

    Amen!!!

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