The drug Lemtrada has been disapproved for patients in the us. But this is really making the spirit of those with a passion for the disease stand out. Lemtrada is one of the most potent drugs that slows or sometimes may even be able to stop the disease from getting any worse. Up t 70 doctors saw it in there hearts to do something about it. They wrote letters to the FDA encouraging them to approve the drug to be able to help out there patients more effectively. Its nice to see People sticking together through the hard times.
In November, the Food and Drug Administration 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 have launched a lobbying campaign to get the regulatory agency to change its mind.
Last week, 70 doctors involved in the drug’s clinical trials published a letter in the journal The Lancetencouraging the FDA to approve Lemtrada, which they say is an important tool in their fight against a disease that can be disabling and deadly.
Advocates say they don’t understand why the FDA rejected the drug. “Trying to get a grip on what the FDA is thinking around this is quite puzzling and frustrating,” said Timothy Coetzee, chief of advocacy, services and research for the National MS Society.
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, research showed.
“Lemtrada appears to be among our most effective, if not the most effective agent in reducing relapses,” said Aaron Miller, a professor and medical director of Corinne Goldsmith Dickinson Center for Multiple Sclerosis at the Icahn School of Medicine at Mount Sinai in New York City.
The FDA does not comment on drugs under review.
In declining Lemtrada, the agency cited the way Genzyme’s phase III trial was designed and the measure used to determine a patient’s progress. Advocates argue that the same measure has been used in many other multiple sclerosis trials, and that pitting Lemtrada against a placebo — which is what the FDA said it wanted — wouldn’t be possible. The drug has characteristic side effects, doctors and advocates said, and the patients would have known they were getting a placebo instead of Lemtrada.
“We felt the study had been properly carried out,” said Douglas Franklin, president and CEO of the Multiple Sclerosis Association of America, an advocacy group.
Lemtrada does have potentially dangerous side effects, including thyroid problems, rare platelet malfunctions and even rarer autoimmune issues, said Christopher LaGanke, a neuroimmunologist who shepherded 16 patients through Lemtrada trials, all sponsored by Genzyme. One man — not his patient — died in an early trial, but patients’ blood is now tested monthly to prevent a repeat, said LaGanke, whose own mother died of the disease.
And that’s one major concern, advocates say: 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.
“If I had a relapse, I would want to get Lemtrada,” said physician David Goldblatt, of Austin, who was headed for a wheelchair when he got the first set of infusions in 2003. He has had only one round since and is still able to walk and work full-time as a neuroradiologist, a doctor who reads brain scans.
Harold Johnson joined a Lemtrada clinical trial after brain scans showed the disease was active in 100 different spots in his brain, and his ability to walk was threatened.
“I decided to go for it, because what other choice did I have?” said Johnson, a computer technician of Swansea, Ill., whose disease activity disappeared within a few weeks of starting the drug in 2009, and hasn’t returned. “I want to stand up. I want to keep working. I want to keep walking my dog.”