First, let me start by saying that this is an opinion piece, and definitely does not replace the medical advice given by your treating health professionals. This is more of an ethical argument than a scientific one, but I think ethics should always be considered in medicine.
I have watched the latest news regarding the FDA approval of Lemtrada this week, and it got me thinking. I have been a registered nurse for 14 years, and I cared for many cancer patients in my career, some of whom had been using Campath for various types of leukemia. Campath was the "old" brand name for the drug that has now been re-marketed as Lemtrada. The good news is, this is not a novel treatment, and we have many years of data to use to determine how safe it is. The bad news is, it has definite, serious risks.
Multiple sclerosis is a debilitating illness. It is incurable, and it can greatly diminish the quality of life of those like myself who suffer from it. It is not, however, considered a potentially fatal illness. I do not say this to diminish the seriousness of MS, and I fully recognize that MS can severely disable some patients, such as my grandmother. However, the most seriously affected patients, those with progressive forms of MS, are not going to receive Lemtrada. Lemtrada has been approved only for relapsing-remitting MS.
Bruce A. Cohen, M.D., the chair of the National Advisory Committee for the National MS Society, said about Lemtrada “Its long-lasting effects may profoundly influence the course of relapsing MS, but will require careful and sustained monitoring for side effects which people receiving the medicine must follow. Individuals with MS who are considering treatment with this medicine should thoroughly educate themselves on its potential benefits and risks,” he added.
What exactly are the serious risks associated with the drug? Serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia (a rare bleeding condition) and anti-glomerular basement membrane disease (which impacts the kidneys). It also warns about serious and life-threatening infusion reactions (reactions occurring during or more than 24 hours after the administration of the medication), increased risk of malignancies (including thyroid cancer, melanoma, and blood cancers). Autoimmune thyroid disorders occurred in 34% of people treated with Lemtrada in clinical studies. (National MS Society, 2014.)
And what about the benefits? If you have spent any time reading clinical study data, you will recall that these numbers are mathematical calculations of statistical data. These numbers are calculated based on a sample of individuals included in the study. First, you should look for the number of patients included in the study. Was it large enough to create good, accurate data? Secondly, consider the outcome. How was the study done? What other drug was this one compared to? What were the real differences proven in the study? These were the results of one of the Lemtrada trials:
"The CARE-MS II study was a two-year trial comparing Lemtrada to the standard subcutaneous dosing of Rebif. Data were evaluated for 628 people with relapsing-remitting MS who had already been treated with another MS therapy but had experienced at least one relapse on that previous therapy. After two years, the annual relapse rate for those on Lemtrada was 0.18 compared to 0.39 for those on Rebif, representing a 49% lower risk of relapses. In addition, on average fewer people on Lemtrada had an increase (worsening) in their EDSS score compared to those on Rebif (13% for Lemtrada vs. 21% for Rebif) – a 42% difference that was statistically significant. After two years, 65% of those on Lemtrada remained relapse-free compared to 47% on Rebif, which was also statistically significantly." (National MS Society, 2014.)
Keep in mind that even on Lemtrada, some patients were still having relapses, and still having worsening EDSS scores. Fewer than Rebif, but still.....not a perfect solution.
As MS patients, we have dealt with potentially life threatening risks associated with our medications for many years. I used Tysabri for many infusions, fully aware of the risk of PML. What I want to tell MS patients now is, do not allow yourself to become complacent. Do not allow yourself to march along blindly, taking these medications because they are FDA approved, without fully educating yourself about the risks and the actual benefits. We suffer from a terrifyingly unpredictable disease, but we do not need to fear imminent death from our illness the way a cancer patient might. We are fortunate in this way.
I have used almost all of the 12 different available disease modifying drugs available during my 5 years with MS. I developed allergies to several, had treatment failures with several, and I take Tecfidera at this point. I basically have no options left if my current medication fails me, but I do not think I am ready for Lemtrada. I have had to seriously ponder this issue, and I have come to the conclusion that I want to be around to see my children grow up and have children of their own. If I have to attend weddings and the births of grandchildren from a wheelchair, that is my fate. But I can't quite accept the thought of dying from my MS treatment and missing all of those things. I may change my mind, of course, depending on the course of my illness, but at this point, it is a risk I am not willing to take.
I am not advising patients to avoid Lemtrada, but rather to have a serious discussion with their health providers first. Please do as much research as you can before you decide on any pharmacological treatment. Ask questions, research online from trustworthy sites like the MS society, and get solid advice from your treating health professionals. Maybe even get a few opinions. Your life is worth the time and effort, and you will be able to choose with confidence.
I am thrilled that we have gone from having zero treatments in 1992, to having 12 options today. I am grateful for the constant, tireless research that continues every single day worldwide. I recognize that I am extremely fortunate to have any options at all, let alone 12. However, I want to advise patients to always be their own advocate. Have a thorough, lengthy discussion with your provider before you make these serious decisions about your health.