The number one question that I always have when wanting access to life saving drugs is: What is the price of a human life? Think about it. What are you worth as an individual and should you be provided access to potential life saving drugs. The Food and Drug Administration (FDA) rejected a drug for multiple sclerosis that its sister agencies in Europe, Canada, Mexico and Australia had approved. Doctors and patients who want access to the drug Lemtrada can’t do so in the US. Doctors say that Lemtrada is an important tool in their fight against a disease that can be disabling and deadly.
Multiple sclerosis is an autoimmune disease that strikes young, healthy people, usually in their 20s, 30s or 40s. MS is a chronic disease that damages the nerves in the spinal cord by eating away at the coating that allows nerve cells to quickly transmit messages. Sclerosis means scarring, and people with MS develop multiple areas of scar tissue in response to the nerve damage. MS can lead to awkward movements, walking difficulties and mental gaps. and brain, as well as the optic nerves. For some, the symptoms come and go, though each relapse leaves the person worse off. It can be fatal over time. Currently there is no cure for MS. Living a normal life is hard among those who have MS for a long time. In addition, home care is needed as the disease progresses.
Lemtrada, made by Genzyme, seems to slow or even stop the progression in those with advanced disease. Patients were half as likely to have relapses on Lemtrada compared with a leading drug. The FDA cited the way Genzyme’s phase III trial was designed and the measure used to determine a patient’s progress as for the reasons it was declined. The FDA wanted the drug being tested to be compared to a placebo. This is fair but the problem lies in the side effects. The drug has characteristic side effects and the patients would have known they were getting a placebo instead of Lemtrada. Keep in mind that the same measure has been used in many other multiple sclerosis trials.
Lemtrada Side Effects
Lemtrada does have potentially dangerous side effects, including thyroid problems, rare platelet malfunctions and even rarer autoimmune issues. There was even a case of a patient dying in the early trial. To compensate for this, blood tests are performed monthly to prevent any deaths. If the FDA continues to block Lemtrada, Americans will simply travel to Canada or Europe to get the drug — but may not get the same kind of careful monitoring. This will lead to more deaths.
This drug is not a cure. It is a prescription drug that prolongs the ability for patients to lead normal lives like walking the dog, food shopping and maintaining their professional careers. It is not like there are a million options to choose from for MS treatment. One does have to wonder what is the price for independence from this debilitating disease.
What price is your health worth?