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,
How many specialists did you see before finding "The One"?