Seeking evidence of disability
I had some other topics I was planning to write about today but I caught something on the news tonight regarding another drug receiving FDA approval for the treatment of fibromyalgia so I thought I would concentrate on a timely subject by writing about my participation in two clinical trials.
Participating in clinical trials for new or existing drugs vying for FDA approval as a claimed treatment for a medical condition is most definitely a unique experience - but not necessarily easy to qualify for.
During the pre-qualification telephone interview, some participating clinics will reject you on the simple fact (and don't tell them) that you have filed for Social Security Disability for the illness that the trial is doing testing to treat. Their logic is, what if you get the active drug in the double-blind placebo study and you, not only show miraculous improvement (which might destroy your disability case), but leave knowing how to play the violin as well? Okay, that may be a stretch.
Besides what business is it of theirs anyway? When I heard on the TV or the radio that a clinical research study was taking place to test a new drug for the treatment of fibromyalgia, the first thought in my mind was that hopefully it would work and maybe I could fully function again. There was also no guarantee that I would be getting the actual drug - I might get the placebo.
I have participated in two clinical trials for drugs seeking FDA approval for the treatment of fibromyalgia. Both drugs were already on the market as treatment for other medical conditions but were not "officially" FDA approved as a proven fibro-treatment drug. The doctors may have known it helped their patients and may have prescribed it for pain but they could not say it was a treatment for fibromyalgia . They could say they had fibro patients who were taking it for other conditions and reported it helped with their pain.
It's like this - take Avon's Skin-So-Soft bath oil for instance. Everyone has known (since what seems like Biblical times) that Skin-So-Soft repelled mosquitoes but, without spending millions of dollars in some government approved scientific lab for years of testing thus jacking up the price, Avon legally could not make the claim. Now they can.
Anyway, back to the subject of my clinical trial participation...
My first clinical trial was for FDA approval of Xyrem as a medication for the sleep disorder associated with fibromyalgia. The study period was 16 weeks and included four medical exams (of the tender points) by a rheumatologist and four overnight sleep studies.
I had to sign for the "drug" because Xyrem was considered a controlled substance. I also had to assure the clinician (in writing) that I would keep it secured to prevent theft in case my apartment was broken into. So now it was more than a medical problem I was trying to get help for - I could be faced with charges by the DEA for misuse, loss, etc. Clinical trials for drugs are always a federal matter.
As I said, there was no guarantee that I would be receiving the actual drug or placebo. This was a double-blind placebo vs actual drug trial. In a double-blind study, neither the clinician or patient know whether or not the "drug" is the placebo or the actual drug.
Also, there are two parts in the drug testing in the trial.
On your initial visit to the clinic - if you are accepted into the clinical trial you - are given a Palm Pilot. The Palm Pilot beeps indiscriminately signally you that it is time to answer the questionnaires. It can beep once a day or several times a day and you have to take it with you everywhere you go. In the evening you have to send the transmission of the questionnaires to the pharmaceutical company or clinic via the fax modem included with the Palm Pilot.
The "drug" comes sealed in a box with instructions but on plain unlabeled bottles. Each box and bottle have a serial number on them which the clinician records beside your name on your chart. Then you have to sign for the "drug" proving that you have received it. Each time you return to the clinic you are required to bring the "drug" with you in the box and bag you received it plus the Palm Pilot. The clinician checks the bottle to be sure you have followed all instructions and taken the required dosages. If it is the end of the first phase of the trial, you turn in the first package with "drug" and, after close inspection by the clinician, you are given another box with another bottle of the "drug". Still neither you or the clinician knows if it contains the placebo or actual drug. Each visit to the clinic includes a medical exam including blood tests, more questionnaires to fill out or interview with questions. Each visit to the clinic can last between one to two hours.
The four sleep studies included in the Xyrem clinical trial was the main reason I wanted to participate. It is a known fact that there is a sleep disorder associated with fibromyalgia, but due to the cost, most doctors feel that a sleep study is an unnecessary expense that undoubtedly can offer proof of disability. This was documentation I needed for my Social Security Disability claim.
Anyway, at the end of the clinical trial it was discovered that (both times) I was given the placebo. Of the participants who were given the placebo, I was the only one who showed no improvement in sleep. as documented in all four sleep studies. There is no way anyone can bluff their way during sleep monitoring.
The other participants who received the placebo showed improvement giving validation of the placebo effect claim of mind over matter.
I knew I had the placebo both times. Xyrem was used as one of the "date rape" drugs. It did not make me drowsy or disoriented. Many times, in the middle of the night, an hour after taking it, I would walk to CVS and shop. I'm sensitive to meds and haven't been able to drink alcohol in years.
And the results of the sleep study the night of May 18, 2004: Delta stage 3 sleep was 3.8% and stage 4 was 0.8%. Normal for each stage is 10% . I had 2 REM episodes for 18.5 minutes which was 20%, normal is 25%.
I had three other abnormal but worse sleep studies in this trial, all of which I submitted to Social Security in my initial filing for disability in August of 2004. Despite FOUR abnormal sleep studies, I received two denials by the Social Security Administration resulting in homelessness in 2005.
By the way, I was paid a total of $3500.00 for participation.
In 2006, I also had THREE abnormal sleep studies from Metro Hospital in Cleveland and a CPAP was ordered.
Also, in 2006, I participated in another double-blind placebo clinical trial for FDA approval of the drug Milnacipran. I had to leave this trial due to dizziness so severe that I ended up in the emergency room then the Cardiac Ward for three days. It is not known whether or not I had a reaction from the "drug" but I wasn't going to take any more chances. It was discovered by the facility where I was participating in the trial that I was receiving the actual drug. Milnacipran was approved for the treatment of fibromyalgia pain in 2009. Despite the scary side effect, it did relieve my pain. No sleep study was involved by the physical exam, monitoring of the drug and usage of the Palm Pilot to monitor my progress was part of the study. Payment for participation wasn't very lucrative. I received $150.00 for the time I was in the 12 week program.
I was awarded SSDI in August 2007 by an administrative law judge for the myriad of symptoms associated with fibromyalgia - sleep disorder, pain, anxiety, depression; chronic fatigue immune dysfunction syndrome (CFIDS), degenerative discs in my spine, osteoarthritis, etc.
Today on the news there was a segment of another drug approved by the FDA for the treatment of fibromyalgia pain symptoms. I used my "cool camera" to video the segment. I apologize for the sound quality midway and to the end. I must have had my thumb over the mic.
I had some other topics I was planning to write about today but I caught something on the news tonight regarding another drug receiving FDA approval for the treatment of fibromyalgia so I thought I would concentrate on a timely subject by writing about my participation in two clinical trials.
Participating in clinical trials for new or existing drugs vying for FDA approval as a claimed treatment for a medical condition is most definitely a unique experience - but not necessarily easy to qualify for.
During the pre-qualification telephone interview, some participating clinics will reject you on the simple fact (and don't tell them) that you have filed for Social Security Disability for the illness that the trial is doing testing to treat. Their logic is, what if you get the active drug in the double-blind placebo study and you, not only show miraculous improvement (which might destroy your disability case), but leave knowing how to play the violin as well? Okay, that may be a stretch.
Besides what business is it of theirs anyway? When I heard on the TV or the radio that a clinical research study was taking place to test a new drug for the treatment of fibromyalgia, the first thought in my mind was that hopefully it would work and maybe I could fully function again. There was also no guarantee that I would be getting the actual drug - I might get the placebo.
I have participated in two clinical trials for drugs seeking FDA approval for the treatment of fibromyalgia. Both drugs were already on the market as treatment for other medical conditions but were not "officially" FDA approved as a proven fibro-treatment drug. The doctors may have known it helped their patients and may have prescribed it for pain but they could not say it was a treatment for fibromyalgia . They could say they had fibro patients who were taking it for other conditions and reported it helped with their pain.
It's like this - take Avon's Skin-So-Soft bath oil for instance. Everyone has known (since what seems like Biblical times) that Skin-So-Soft repelled mosquitoes but, without spending millions of dollars in some government approved scientific lab for years of testing thus jacking up the price, Avon legally could not make the claim. Now they can.
Anyway, back to the subject of my clinical trial participation...
My first clinical trial was for FDA approval of Xyrem as a medication for the sleep disorder associated with fibromyalgia. The study period was 16 weeks and included four medical exams (of the tender points) by a rheumatologist and four overnight sleep studies.
I had to sign for the "drug" because Xyrem was considered a controlled substance. I also had to assure the clinician (in writing) that I would keep it secured to prevent theft in case my apartment was broken into. So now it was more than a medical problem I was trying to get help for - I could be faced with charges by the DEA for misuse, loss, etc. Clinical trials for drugs are always a federal matter.
As I said, there was no guarantee that I would be receiving the actual drug or placebo. This was a double-blind placebo vs actual drug trial. In a double-blind study, neither the clinician or patient know whether or not the "drug" is the placebo or the actual drug.
Also, there are two parts in the drug testing in the trial.
On your initial visit to the clinic - if you are accepted into the clinical trial you - are given a Palm Pilot. The Palm Pilot beeps indiscriminately signally you that it is time to answer the questionnaires. It can beep once a day or several times a day and you have to take it with you everywhere you go. In the evening you have to send the transmission of the questionnaires to the pharmaceutical company or clinic via the fax modem included with the Palm Pilot.
The "drug" comes sealed in a box with instructions but on plain unlabeled bottles. Each box and bottle have a serial number on them which the clinician records beside your name on your chart. Then you have to sign for the "drug" proving that you have received it. Each time you return to the clinic you are required to bring the "drug" with you in the box and bag you received it plus the Palm Pilot. The clinician checks the bottle to be sure you have followed all instructions and taken the required dosages. If it is the end of the first phase of the trial, you turn in the first package with "drug" and, after close inspection by the clinician, you are given another box with another bottle of the "drug". Still neither you or the clinician knows if it contains the placebo or actual drug. Each visit to the clinic includes a medical exam including blood tests, more questionnaires to fill out or interview with questions. Each visit to the clinic can last between one to two hours.
The four sleep studies included in the Xyrem clinical trial was the main reason I wanted to participate. It is a known fact that there is a sleep disorder associated with fibromyalgia, but due to the cost, most doctors feel that a sleep study is an unnecessary expense that undoubtedly can offer proof of disability. This was documentation I needed for my Social Security Disability claim.
Anyway, at the end of the clinical trial it was discovered that (both times) I was given the placebo. Of the participants who were given the placebo, I was the only one who showed no improvement in sleep. as documented in all four sleep studies. There is no way anyone can bluff their way during sleep monitoring.
The other participants who received the placebo showed improvement giving validation of the placebo effect claim of mind over matter.
I knew I had the placebo both times. Xyrem was used as one of the "date rape" drugs. It did not make me drowsy or disoriented. Many times, in the middle of the night, an hour after taking it, I would walk to CVS and shop. I'm sensitive to meds and haven't been able to drink alcohol in years.
And the results of the sleep study the night of May 18, 2004: Delta stage 3 sleep was 3.8% and stage 4 was 0.8%. Normal for each stage is 10% . I had 2 REM episodes for 18.5 minutes which was 20%, normal is 25%.
I had three other abnormal but worse sleep studies in this trial, all of which I submitted to Social Security in my initial filing for disability in August of 2004. Despite FOUR abnormal sleep studies, I received two denials by the Social Security Administration resulting in homelessness in 2005.
By the way, I was paid a total of $3500.00 for participation.
In 2006, I also had THREE abnormal sleep studies from Metro Hospital in Cleveland and a CPAP was ordered.
Also, in 2006, I participated in another double-blind placebo clinical trial for FDA approval of the drug Milnacipran. I had to leave this trial due to dizziness so severe that I ended up in the emergency room then the Cardiac Ward for three days. It is not known whether or not I had a reaction from the "drug" but I wasn't going to take any more chances. It was discovered by the facility where I was participating in the trial that I was receiving the actual drug. Milnacipran was approved for the treatment of fibromyalgia pain in 2009. Despite the scary side effect, it did relieve my pain. No sleep study was involved by the physical exam, monitoring of the drug and usage of the Palm Pilot to monitor my progress was part of the study. Payment for participation wasn't very lucrative. I received $150.00 for the time I was in the 12 week program.
I was awarded SSDI in August 2007 by an administrative law judge for the myriad of symptoms associated with fibromyalgia - sleep disorder, pain, anxiety, depression; chronic fatigue immune dysfunction syndrome (CFIDS), degenerative discs in my spine, osteoarthritis, etc.
Today on the news there was a segment of another drug approved by the FDA for the treatment of fibromyalgia pain symptoms. I used my "cool camera" to video the segment. I apologize for the sound quality midway and to the end. I must have had my thumb over the mic.
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