Possible stop to Multiple Sclerosis could be just one trial away, however, pharmaceutical companies not interested
MS MRIA Utah woman is about to begin a medical journey that she hopes will save her life. Michelle Colledge has Multiple Sclerosis, a disease that causes paralysis, blindness, and sometimes death. Johns Hopkins is testing a new treatment for this debilitating disease that so far, is dramatically effective. Michelle Colledge has been accepted as part of the study of this new and very aggressive treatment.
Michelle was diagnosed on Valentines Day 2007. She says, “The only way to describe those first couple of months was absolute terror, and crying at night for several hours, and just thinking my life was over.” The young mother developed lesions on her brain and spine, her own immune system, charged with protecting her, had turned against her and become the enemy. Dr. Adam Kaplin, M.D. from Johns Hopkins explains; “What these people have, are these periods of time where their brains, spinal cords and their optic nerves are under attack .” He says no one knows why it happens, but doctors believe the immune system is tricked in reaction exposure to bacteria, viruses, or even a vitamin D deficiency.
Michelle can’t pinpoint a trigger for her MS, but she says each attack takes away the ability to live a normal life. “When I say attacks, I am not talking about, oh, I woke up and I wasn’t feeling well. I lost something. I would stop being able to walk, or I would lose my eyesight.” She has regained those abilities, but the MS has taken its toll on her balance, she has lost feeling in her hands, and they shake, making it difficult to hold objects, or her own daughter. “My daughter is four years old and I don’t know if she will ever know who her mom is. She may just see what the disease has left behind.”
But because Michelle’s MS is progressing so rapidly, there is new hope. She has been selected for a clinical trial of HiCy-Copaxone that could dramatically change her life, and the lives of everyone battling Multiple Sclerosis. Johns Hopkins has found a way to erase a faulty immune system. Dr. Kaplin says it’s a little like what you do to a computer. “It resets the immune system. We think of it as kind of the control, alt, delete of the immune system.”
Michelle will undergo intense chemotherapy using a strong drug developed decades ago (HiCy). Dr. Kaplin says “We use it at 14 thousand milligrams, in one treatment, over the course of four days.” And when it’s over Michelle’s old immune system will be gone, and so will her MS. “You watch the patients white blood cell count go to zero, and then something amazing happens, which is their cells start to repopulate and eventually the white blood cells come back to normal.”
Patients are given an additional medication, Copaxone, that along with the chemo, puts them into long term remission. So far, out of 40 patients who have participated in the study, 90 percent have shown no signs of the disease one to three years after their treatment. For some, the symptoms of MS have also disappeared. “We had one individual who needed a walker to get around and he now runs five miles every morning.”
Michelle is nervous to begin the journey to living MS free, but she’s excited about what it will mean to her and her family, as well as others who battle the disease. “This is a chance for me and it should not stop with me.”
Unfortunately, it could. Michelle believes she is the last patient accepted into the second of Johns Hopkins clinical trials, and it may be the last. Dr. Kaplin says that although the first two trials were exceedingly promising, and no side effects were reported, outside of the usual reactions associated with Chemotherapy, there may be no more opportunity to test what could prove to be the cure for MS and other autoimmune disorders. “We need to do a randomized clinical trial, a much larger trial ,between 150 and 300 patients. It’s a very expensive process. We need 15 million dollars to get this done.”
Without the trial, there can be no FDA approval, and insurance companies will not cover the cost of the treatment. “We have gone to three different pharmaceutical companies and we have showed them the data, and asked them if they would be willing to get involved in this. We’ve had the same response from all of them. They all said it’s an amazing treatment, we have seen nothing like it, this might one day lead to a cure for MS, if we could refine it. They say its fabulous, but we don’t think we could recoup our investment, so it’s not for us.”
The problem Dr. Kaplin explains, is the drugs used in combination in this new treatment are decades old, cheap, and the patents have expired. This means, it is difficult for pharmaceutical companies to make a profit.
Johns Hopkins has started a grass roots campaign to try to raise the money.
Source: ABC 4 News Copyright 2009 Newport Television LLC & MSRC (16/11/09)
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