A local neurologist is making a plea to the Food and Drug Administration to reconsider its denial of an investigational treatment for multiple sclerosis, noting the drug trials have been successful and patients are in remission.
Patients like Darlene Colton joined the study 11 years ago, and for her, it has stopped the progression of the neurological condition that affects nearly 400,000 people and has no cure.
"They thought I'd be in a wheelchair within three to four years after I was first diagnosed because of the number of lesions I had," Colton said.
Instead, she and her husband -- both square dancers -- are still active and show no signs of the condition.
Learning the drug treatment that has saved her independence was denied approval saddens her.
She said she entered the trial to make sure that her grandchildren will have a good treatment if they too develop MS.
"If we can fix someone, they deserve this chance, said Colton.
Lemtrada began as a locally developed treatment in San Antonio, and the Neurology Center of San Antonio was the first clinic to offer it to patients in the investigation.
It was tested against another drug, one that doctors knew was effective. That's the crux of the FDA’s reasoning in the denial. It preferred a placebo test.
Dr. Ann Bass is one of the lead investigators of Lemtrada.
"It's been approved in Colombia, it's been approved in Mexico, it's been approved in Canada, it's been approved in Australia, some European Countries (but) not the U.S.," she said.
She said the study didn’t want to put patients on placebo because that would be unethical.
Without any drug treatment, MS progresses.
"With MS, whatever is lost cannot be regained, so if you lose any type of neurologic function, you can't get it back. So if we wait that time and we put you on nothing, then we can really do a lot of harm to those patients in five or 10 years from now," she said.
She says the FDA’s approval process is antiquated and is doing an injustice to those who are suffering and could be benefiting from drugs like Lemtrada.
Now that the government agency has denied Lemtrada, Bass and others are appealing.