I came across an article today on Disability Scoop about the FDA issuing a warning to consumers regarding the use of hyperbaric oxygen therapy for Autism and Cerebral Palsy.
Here is the concern stated by Nayan Patel of the FDA:
“Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by the FDA, which may cause them to delay or forgo proven medical therapies,” said Nayan Patel, a biomedical engineer at the FDA’s anesthesiology devices branch. “In doing so, they may experience a lack of improvement and/or worsening of their existing conditions.”
I am a firm proponent of research based treatment for many reasons. I believe society needs a grounding point for gauging safety risks and efficacy of treatments. Following protocols to move treatments into the main stream and working to have them covered by insurance will also make them accessible to the broader population.
Here is the rub. The CP community doesn’t have robust funding for research. What is currently considered conventional treatment for CP doesn’t even have a clear body of research evidence behind it that proves its efficacy. During the CP Alliance webinar on stem cells back in May of 2013 Dr. Iona Novak stated that current therapies for CP have an estimated 4-10% gain or improvement for the individual. So, we don’t really have much at our fingertips to help our children, or for adults to help themselves. Parents of children with cerebral palsy are often forced to make difficult decisions and I propose many try unproven treatments based on empirical evidence and word of mouth. The alternative is often to stand by feeling helpless and hopeless.
If the FDA is so critically concerned about the use of alternative treatments, they might consider that at least when it comes to cerebral palsy, that most everything is “alternative” and/or “off-label use” for this community. I agree this needs to change.
This is why I am working to bring support and attention to cerebral palsy. We need funding for research to explore new treatments and discover what is safe, effective, and possible. CP doesn’t have to be a maintenance condition, nor should parents and adults with CP feel compelled to put their children or themselves at risk physically and perhaps financially trying to find ways of improving this disorder. The real issue for CP is that the advocacy and financial support for research hasn’t been there and we need to change this. We also need agencies such as the FDA to connect with other agencies and organizations to understand and work toward making these changes.
Parents and individuals will often explore alternative treatments and possibilities when they don’t see the answers or possibilities emerging to help them in the way they expect. It’s happened since the beginning of time. All researched and proven treatments once started out as a notion, idea, or possibility and usually involved people taking risks upon themselves to see what possibilities or potentials were out there that may help them. Have we tried alternative therapies with Maya? Yes, we have. And evaluating alternative options and their potential risks is stressful, confusing, and one of the greatest challenges we have faced in trying to help our daughter.
I believe and will work toward building support for this community and bringing awareness to larger issues such as what I present here. Potential treatments need to be studied and evaluated formally in our population (and it’s categories) so that scientists can determine with as much clarity as possible what we know, what we don’t know, and how we know it. Over time more focus and support on the cerebral palsy community will hopefully lessen the intellectual and often financial burden facing many parents and adults with CP today who continue to wander through unchartered territory looking for a way to make a better life for their child or themselves.
BTW, isn’t interesting how they don’t mention cerebral palsy in the title of this article?
-Michele, CP Daily Living