Today I got frustrated and sent this off to the Executive Secretary for the Commissioner of the FDA. If anyone wants the contact info for them, PM me.
I understand that Commissioner Hamburg is extremely busy, but was hoping you could see fit to pass this along to her:
My name is Jason Parker, and I have suffered from cluster headaches for over 2 decades. I am currently going through an episode, which is why I am contacting you. I am a husband, father of 3 wonderful children, and the sole source of income in our household. This disease has been devistating to my entire family as well as to myself (personally, finacially, and emotionally), and there seems to be no end in sight. Most nights, I am afraid to go to sleep, because I know that within 1 hour, I will be up and in excruciating pain.
Under the adcice and guidance of several physicians, I have been administered approximately 80% of the currently available drugs that are used today in treating this desease. I am told that the other 20% are of similar strains or "family" of drugs and would achieve no appriciable difference in result. None of the drugs I have taken work consistently, and most of which have adverse side effects. The majority of the medications currently used to treat cluster headaches is medication formulated for migraines, and not specifically cluster headaches, in another words, "hand-me-down" medication has been relied upon to stop what some doctors call "the worst pain known to medical science" (I would tend to agree with that). I have even gone through medical procedures (painful in their own right) that have only given me up to 3 or 4 days of relief.
I have recently been made aware of research performed by John Halpern, MD, of McLean Hospital and Harvard Medical School. This ground breaking research pertains to Cluster Headaches and BOL-148 (a non-psychedelic form of LSD). I believe we are ready for medication that is showing great promise while containing little to no proven side effects. No other medication or medical procedure has shown an effective rate comparable to that observed by Dr. Halpern with BOL-148. 80% of cases were completely successful and the remaining 20% showed a vast amount of improvement. That is an effective rate of 100%!
I urge you to please consider BOL-148 for orphan drug status, or to allow compassionate use administered by qualified doctors to serve as research. As you may be aware, many of us are willing to try anything that may help our condition.
It is unfortunate that the drug companies will not even consider helping with this, as there is absolutely no return-on-investment for them or their share holders.
This debilitating condition has driven many of its victims to suicide, hence the label of "suicide headache". For many of us, this is a life or death situation. We need your support.
Again, I urge you to please help with BOL-148. I thank you for you time and consideration.