Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Recent Communication with the FDA and CHOP
If you have kept up with our previous articles on MiraLAX, or follow the issue in general, you may have noted the ongoing delay in the Children's Hospital of Philadelphia (CHOP) PEG 3350 study and the lack of information from both CHOP and the FDA on the matter. Refer to our earlier article, “Efforts to Advance MiraLAX Studies and Innovations to Inform the Population”, to grab some details of the study.
Now it appears the same problem is occurring. Those who advocate for and investigate the MiraLAX issue have been in communication with CHOP and the FDA, urging both to provide some sort of an answer as to what is going on with the CHOP study. Ultimately, why children still are not even enrolled when the study was supposed to be completed in 2018.
The FDA’s press has said, “assays required to analyze the data that will be gathered raise novel scientific issues and will be challenging to develop...the FDA is providing additional assistance with this... we have asked CHOP to give more frequent updates”
Meanwhile, a representative from CHOP has said they are, “actively working with the FDA to finalize methods of this study and an announcement will be made once we start enrolling patients”
FAERS and OpenFDA Inconsistencies
It has come to our attention that running MiraLAX and polyethylene glycol (PEG) 3350 on the FDA Adverse Event Reporting System (FAERS) and OpenFDA gives very different results. FAERS shows the total cases for MiraLAX at 24,413 and PEG 3350 at 26,924. On the other hand, OpenFDA shows the total reports in its database for MiraLAX at 43,340 and PEG 3350 at 64,125.
This huge data discrepancy was sent to the Center for Drug Evaluation and Research as an inquiry. The response was that, “All data in FAERS public dashboard is based on FAERS data. We are not familiar with the source for OpenFDA reports. FAERS public dashboard shows ONLY suspects [sic] drugs. That could be one of the reasons for the discrepancy since OpenFDA could show both suspect and concomitant [drugs].”
Film for Thought
An upcoming film, "My Kid is Not Crazy", takes an interesting perspective on the issue of neuro-psychiatric problems in young children.
Dr. Susan Swedo with the National Institute of Health dedicated her time to researching, understanding, and finding the cure for the condition she calls “Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)” You can visit the film’s website to learn more about what PANDAS is.
It appears the main takeaway that the audience will get from this film is that children who develop the symptoms of PANDAS may often be diagnosed with a mental illness. As a result, they may be given medications or other treatments to combat their “neuropsychiatric issue”. Doctors are quick to settle on such a diagnosis and pharmaceutical companies are happy to make money off of the medications.
To understand how this film relates to the MiraLAX issue, you can read the May 2017 article of ours, “Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX”. Both PANDAS and MiraLAX present the same sort of issue in the behavior of young children.
We will continue to monitor the MiraLAX issue, including new developments and study updates. As always, we are open to any relevant information parents and medical researchers may have and intend to keep the public as informed as we are.
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