How do you turn a traumatic event into strength and growth to do something that helps others? I’ve been stuck in an infinity loop going through the various stages of grief. There are times I pretend nothing is wrong with me and I’ve completely recovered from my reaction to Humira. “It’s all up to me now!” There are times when I’m just depressed and doing anything at all is so difficult. I don’t even have the energy to get angry. Then I get angry again. I’m angry a lot. “Why did so many doctors miss the Humira reaction?” “My doctor never even said I’m sorry!!” “I hate doctors!” The anger lingers more often that I would like and that’s when I try to pull myself out of the fiery pit of anger and do something positive. I accept that I have permanent damage and all the doctors and other medical professionals just missed my problem in the midst of a once in a lifetime pandemic. This is when I start trying to do whatever I can to ensure this never happens to anyone else. No one deserves to spend 19 months in severe pain, unable to live their lives, and suffering from depression and loss. This is why I submitted a FOIA request to the FDA for more information on the Adverse Reaction Database and the approval of Humira. I admit the past few years have been difficult for me to understand. I’ve spent a considerable amount of time trying to read medical journal articles and track various symptoms and medications with nothing behind me other than an exercise science class in undergraduate school. To say it’s time consuming is an understatement. I don’t know when I’ll finish reading all of the information about the approval of Humira but I do know what to do with the processes and procedures around the FDA’s Adverse Reaction Database. I know business. I know organizational effectiveness and how to optimize work standardization and work flow. The FDA needs this expertise, badly. If you’ve ever been to the Adverse Reaction database, you know it’s a nightmare. It lacks standardization, naming conventions, and structure. Prescribing physicians are not required to report reactions to medications so one can assume, this is just a compilation of patients reporting their personal experience with a drug without any medical training to better understand how to describe their symptoms. It gets worse. The FDA does compile a quarterly report but it’s almost impossible to access. This report is in an Xml or Ascii file that is so large, it’s almost impossible to open on your home computer. The report is not user friendly and uses codes that require a key and a complicated structure. Any prescribing doctor, medical staff, or patient should be able to quickly pull these quarterly reports to look for any emerging trends in reactions and there should be a synopsis up front with an analysis of the information from that quarter for the drug reactions reported. Anyone should also be able to check this for specific drugs. Has the FDA ever heard of a strategic communications plan? There is nothing transparent about the FDA’s reaction database and it’s almost impossible to track reactions post-approval. No wonder so many doctors aren’t familiar with a relatively common drug reaction. Just wait, it gets worse. Congress already knows about these issues. I also found a GAO report dated December 2015, 4 years before I started having my reaction, that outlines many of these same issues. The title of the report puts it up front, “Data for Post approval Oversight Need Improvement”. Why has Congress done nothing in 7 years? No one deserves to experience what I did. No one deserves the hardship that comes with 19 months without a diagnosis and another 2 years of rehab. What will it take to get Congress to finally act? How many people need to suffer…or die? Congress, fix the FDA and make post approval oversight more efficient and reported reactions more transparent.
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