Notes From a Lab Rat

Hello folks, I just got through a clinical trial for treatment of insomnia. I thought I would put my impressions here because it may help people to understand the process of scientific investigation better. It may also help to see that medications are thoroughly and carefully screened for effectiveness and side effects. Since many parents struggle with medication issues I thought my insights into this process may help.

First impression: I was given great medical care by the investigators. I was thoroughly screened for any psychiatric or medical problem and carefully diagnosed. I had to keep a sleep diary, and wear an armband that detected my activity level. Once diagnosed as a true insomniac I was given an MRI, pet scans and a complete sleep study. They were very careful in monitoring my “before” sleep, mood and activity profile, and then my “after (treatment)” sleep, mood and activity profile.

Second impression: The investigators were almost obsessive about side effects. I swear if I mentioned I had a hangnail, they would follow up and carefully ask all about it. OK, the hangnail comment was sarcastic, but you get the idea. I mentioned I felt a tiny bit dizzy, and the man interviewing me asked me all about it. What is the dizziness like? Is it much worse than usual? He was really very, very careful to make sure he fully understood what I was going through.

Third impression: The study was very carefully controlled. The questions asked had to be the same of all participants and the same ones were asked over time. The idea was to get “good data” The idea is to compare apples to apples and oranges to oranges. These people were not careless or sloppy in the least.

Fourth impression: This was a double blind study. The doctor in charge, who I saw every week, had no idea what medication I was on. I could have been on Celexa (an antidepressent) or Ambien (a sleeping pill) or placebo. There was a doctor who did know, but I never saw him. He adjusted dosages, but did not monitor effects. So there was no bias at all. I also did not know what I was on. At the end we all guessed, the interviewer, the doctor and me. I guessed correctly that it was the Celexa. the doctor guessed incorrectly that it was placebo, and the interviewer (who is a liscenced social worker) guessed it was Ambien.

Fifth impression: All of the people involved were the most professional, intelligent and competent people I have ever worked with. They all get an A+!I was made to feel completely at ease. Any question I had was answered, any concern was met. I felt I could bring up any problem or issue, because that is exactly what they wanted me to do.

Sixth impression: you know the list of “adverse side effects” that the tv commercial rattle on in those ads? They are either extremely mild or very rare. I essentially had no adverse side effects to the medication. I reported mild dizziness and ringing in the ears. They duly noted this, even though I went to great pains to say I always have mild dizziness and ringing in my ears. I don’t think the meds caused it. It is almost as if they were looking for side effects to report. They err on the side of caution. They do not brush aside concerns or questions or problems.

Seventh impression: The Celexa did not help my insomnia. The data on my sleep (my sleep diaries and the sleep study done while on meds) is now part of a pool of data. Those who took Celexa will be compared to those who took Ambien and those who were on placebo. There will be no bias or opinion on what worked. Maybe this med does help some people sleep, maybe it doesn’t. They will find out by coolly and carefully comparing the data.

General notes: there is no risk free medication. In fact, there is no risk free life. You stand a much greater chance of seriously injuring or killing your child by driving him to school every day than by giving him one of the ADD meds. Also, these meds do not cure the problem. Nobody claimed they would “cure” my insomnia. Same goes for ADHD. Meds also may not work. The med I took certainly didn’t help me sleep better. That doesn’t mean that it won’t work for others. If it doesn’t help others to sleep better, then they will have found out valuable information, that will be reported in peer reviewed medical journals. This will help doctors to make informed decisions on how to help patients will insomnia. Obviously, this all goes for ADD meds as well.

I think to sort all this out, we need to be cool and calm. If a medication has bad side effects for you or your child, then stop the med. Take them only under a doctor’s care. If they don’t work, then stop the med. Trial and error and carefully noting the benefits/risks/ side effects are what is needed. Also, meds do not cure ADHD. There is no cure. They treat symptoms. But that is often vitally important. The child also has to learn coping skills.

My experience as a “lab rat” has left me with great respect for the medical profession, and the careful science that goes into medical studies. They are not perfect, but perfection is impossible. They do not fully understand these conditions, but I believe the human brain is irreducibly complex. Nobody will ever have the complete picture. But we can all have a better understanding.