Our next speaker will be Mr. Brownstein who will have five minutes and then his parents will have two to three minutes to add some comments.

MR. A. BROWNSTEIN: Good morning. My name is Andy Brownstein. I am representing myself. I have no recommendations. I have no answers. I just can speak about my own experience as a research patient.

What does it mean to be a research patient? I had no clue when I came to the NIH in September of '94. I have a pretty clear picture now. I really did not understand when I was desperate for help and came here and auditioned in front of a room filled with doctors and nurses and qualified and met the criteria to be a patient at the National Institute of Mental Health in the Biological Psychiatry Branch. I spent 13 months as an inpatient.

During my intake interview where my parents were present I was told I would spend three to six months here. After admission my nurse told me, "Three to six months? No way. The average stay was 12 months."

After spending a short amount of time on the unit I learned from patient colleagues that no one was there less than 12 months. Most were there at least a year-and-a-half to two years. My roommate was discharged after 26 months. My next door neighbor left after three years. My roommate said to me, "Deciding to come here was a very difficult and personal decision, and you will be sicker here than you have ever been before."

Somehow these lengthy stays were a secret at NIH. I met NIMH secretaries who were totally unaware that anyone spent that amount of time as an inpatient. When my three months came up I asked about discharge. When a shrug and a smile the doc was not sure. After six months I received the same response. Eventually I learned that I was, along with the others, in what they called an omnibus protocol.

As long as there was something of interest to the researchers that they could study and observe and as long as I was desperate and hopeful and willing to be poked and prodded, PET scanned, MRI, lumbar punctured, as long as there were fluids that they could collect I would be, as Kay Redfield Jamison of Johns Hopkins University said to me, "One of Bob Post's guinea pigs." Kay Jamison is a professor of psychiatry and she is a researcher at Johns Hopkins and a colleague of Dr. Post's who was the chief of the branch that I was in.

What does it mean to be a research patient? Someone who is vulnerable. Someone who, like me, was desperate to find a cure. Someone whose community doc raises his hands in the air and says, "I do not know what else to do."

What is informed consent? Was I really informed when I signed all those long and complicated consent forms? I was very sick when I was admitted to NIMH. As a person with bipolar disorder refractory case, a case of ultra rapid cycling, out of control, depression so black I could not think or concentrate, often the smallest tasks, counting change, selecting items off the grocery store shelf, reading a map or a menu, making decisions was extraordinarily difficult.

On my first day in the unit the doc produced a black notebook filled three or four inches thick. It was filled with protocol consent forms. I was given no opportunity to read them, take them to my room, talk to my nurse about them, or consider them. The doc turned pages and I signed and I dated in triplicate.

At one point the doc said excitedly, "Oh, this one is really cool." Well, maybe not to patients. Other consents were signed en masse during group meetings. Minimal explanation was given. We signed, dated and the nurse would witness and sign. All of these without regard to our condition at the time or our ability to concentrate and read, and no opportunity to read and consider them. Consents were often signed months before a final version of the protocol would be approved by the IRB.

We were all blind to the protocols we were involved in or whether we were or were not on meds. From day one all of our pills were pink, active agents or placebo. You were unable to tell the difference between them. I signed this protocol October 31, 1994. A three-tiered protocol, two active drugs, and a placebo. The protocol I learned at my blind breaking began sometime in March of '95.

I was given a revised version of the protocol and had it signed on June 5, 1995. This was a three-tiered protocol. I was given the consent form for the second drug, I began this protocol in March, I was given the protocol for the second drug on June 5th, 1995. The protocol I was already in was three months -- I was already in it for three months.

The protocol was to be three arms of eight weeks each, March through July, and should have ended, and I should have been discharged. The protocol lasted eight months. I was discharged October 25, '95.

At my blind breaking I was shown pictures of my PET scans. My doc was excited to show me the difference between depressed periods and times when there was greater activation in my brain. He told me the images of those depressions were during the lengthy period when I was not receiving an active agent.

The placebo periods were horrible. All of the patients were apprehensive and scared knowing placebo periods were built into the protocols. During my 13 months I was in placebo phases a total of 14 weeks. No effort was made by NIMH to assist me in finding a doc on the outside in the Philadelphia area where I live who could or would take on a complicated case like mine with a cocktail of meds that included drugs that were not approved by the FDA for the treatment of bipolar disorder.

It was very difficult finding a doc in a city with five medical schools especially after knowing I had been a patient at NIMH. No follow-up, no phone calls, a cold discharge.

At my last group meeting the docs, nurses, patients, my good-bye, I was told by my doc with a smile, and he was laughing, and he was excited, I had broken the record for the number of procedures done to patients on that unit during my time at NIH.

On the day of discharge I met Bob Post, my branch chief, on the sidewalk in front of building 10. He was waiting for a bus. He said, "Thanks for your time and for all the body fluids you have provided us. Good luck. Oh, by the way, what are you going to be doing?"

I learned a lot while I was at NIH. I had a respect for research but I would not recommend it to anybody. Research is cold and research subjects are treated with much less respect than so-called healthy normal volunteers. I still get nervous when I exit 495 and drive down Wisconsin Avenue towards NIH.

Thank you.

DR. CHILDRESS: Thank you for your powerful story. Could you just add a couple of minutes? The Brownsteins have also indicated they will provide written testimony. They were not aware that was an option and they will later provide written testimony for us.