When I first started thinking about experimental drug therapies my initial thoughts went to patients with life-threatening diseases. A family friend of mine has been diagnosed with Multiple Sclerosis (MS). Briefly speaking, MS is a chronic neurological disease that affects the central nervous system. The CNS is made up of brain, spinal cord and optic nerves, and the disease causes symptoms that vary from person to person. My friend has had the disease for several years and is now so debilitated that he is now on disability. His main symptoms include things like severe migraines and dizziness. Some days he feels very active and others he can’t even get out of bed. He is taking a drug called Tysabri that had a very short clinical trial time and has been removed from the market once already.
Tysabri works as a monoclonal antibody and it has been made to attach to lymphocytes (white blood cells) and then prevent them from entering the brain. Typically with MS the lymphocytes cause damage to the brain and thus creates the symptoms of MS. The problem with this drug is that is has had several cases where it developes a degenerative brain infection called progressive multifocal leukoencephalopathy (PML) and it is often fatal. This is why it was taken off the market the first time.
When talking to my friend about this, he told me that having good quality of life, even for a short period of time was more important to him than having a pro-longed miserable life. That is why the risk is worth it for him. He also said that when he began the drug his chances for getting the brain infection was 1:24,000 and now after 39 infusions (one infusion every month), not only does he have the record for greatest amount of infusions, but also his chances are now 1: 1,000.
Obviously, the FDA had problems with the drug the first round, so why was it allowed to be put back on the market? The FDA’s idea is that the consumer should decide if the risks outweigh the benefits and whether or not they want to be involved with it. The problem with this thinking is that the whole purpose of the FDA is to make sure that it is safe for the general population. That is why we have experimental drug trails and why the FDA exists at all. If a drug isn’t safe it shouldn’t be let out of trials…right? For my friend, his actions say no. He wants to try anything. I guess it is up to the rest of us to decide for ourselves.
By Stacie Guinn
Additional Resources:
Sources:
Edelson, E., (2005). FDA Approves Tysabri for Multiple Sclerosis Treatment. Retrieved from http://www.medicalnewstoday.com/articles/16942.php
Medical News Today. (2004). With Tysabri decision, the FDA decalares no drug is too dangerous to be FDA approved. Retrieved from http://www.naturalnews.com/019331.html
National Multiple Sclerosis Society. (2009). What is Multiple Sclerosis?. Retrieved from
http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/index.aspx
I agree with your friend. I think that there are a lot of other experimental drugs that have been pulled off the market to protect the public when it should be up to the individual whether they should be protected. Why should the government get to choose this for us? What might be right for one person may not be right for another. My mother, who was a nurse like myself would come home and tell me about patients that she had and say "there are a lot worse things than death." If there is something that improves your quality of life, I say "Go for it."
The government should step in only if the person is incapible of making decisions for themselves...and only then if there isn't any family to speak for the patient.
I have been on drugs that were pulled off the market. I have severe psoriasis, an autoimmune disorder that affects the skin and causes premature and immature reproduction of the skin cells. The result is a miseralbe, itchy, flakey existance. When the FDA pulled a over-the-counter drug off the market, I was devastated because it had made such a life-changing improvement for me. I am now on Humira, a twice monthly self injectable medication. If the FDA were to decide this was unsafe, my life would be miserable. A part of me says, "Let the patient decide! It's his/her life!" but then, I would have Dr. Kevorkian practicing medicine...what do I know except that sometimes the risks are worth it.