Our next speaker is Mr. Joseph Friend and his statement has also been circulated.

I thank you, Mr. Friend, for joining us.

MR. FRIEND: See I want to start with a statement that I am speaking for myself and I want to start to say that I very heartily support research because with research on human subjects my son has medication available to him today that has made him in better shape than he has been for many years.

I am a retired naval officer and later I worked for the State of Maryland. In between I worked in social programs in the innercity, an HMO Medicaid program, and have had extensive experience in the participation of the communities in the processes that they are involved in.

I know that there are many good people in research but I know that research is a bureaucratic institution and bureaucratic institutions have a way of manipulating situations that are not the intentions of those people that work in them.

Now I want to tell you my son's story because I think it does fit in with what you are trying to do. My son is currently 34 years old. He has had psychiatric problems since he was six years old but he has had excellent care in Army, Navy and Air Force medical facilities. So we grew with a trust for the medical establishment.

When he was a junior in high school he had a full blown manic depression episode. He refused treatment but finally agreed to it and so in the summer between his junior and senior year he was stabilized and put on lithium.

Things went along fine. He went into college in the Maryland Institute of Art and he started deteriorating. He then went to Europe to join a program with the agreement of his psychiatrist called "Youth with a Mission." There he went off his medication, was found wandering in the airport in Amsterdam, and I had to go and pick him -- when I got there he was actually in a catatonic state and I got him to Wiesbaden and he was air evac-ed to this country.

He was in the hospital for four months. When he was released we got him into a local program in our community and then my wife and I looked at his background and we talked with him and thought that his situation might be helpful in research in order to help him and other people like him. So we approached the Walnut Street Clinic, which is the outpatient clinic of the University of Maryland Psychiatric Research Center at Crownsville State Hospital.

Part of the protocol is they said, "Well, he had to have a baseline condition," which frankly means a washout. They said, "We will monitor him," and he stayed at home. In the third week -- he was supposed to be off for four weeks. In the third week he went -- the day after he had one of his visits he went completely psychotic. We called the institute and we were supposed to bring him in the next day but during that night we were watching him and trying to watch him. Finally my wife came to me when I was taking a rest and said, "He is laying in the street in front of our house."

I got him back in and I just happened to notice there was a bottle of about 200 aspirins that was almost empty. I called the Poison Control Center. They said, "Get him to the hospital." We were four minutes from the hospital. I do not know if you know what death by aspirin overdose is but it is internal bleeding and it is supposed to be very painful.

Needless to say we withdrew him from the program. But my point is, is that I would hope this commission would recommend and mandate that washouts, because I understand there are other ways of doing it, be eliminated from any research protocol. It is dangerous to our relatives.

Now the next thing is I talk about my experience in government. There are things called Institutional Review Boards, IRB's. I want to say that these boards are the stealth weapon of the research bureaucracy. No one knows who is on them and even the New York Times wrote an editorial saying, "Many times they are rubber stamped." I would hope that this commission would recommend that at least 40 percent of each IRB would be composed of consumers and families.

The family movement has gotten millions of dollars into research but it is as though the researchers say, "Hey, we want the money but just trust us." If this happened it would mean that research protocols would have to be written with a sensitivity towards families and they would have to be written in nontechnical language so everybody understand what was really going to be done and all the implications would have to be spelled out. Now there would still probably be mistakes but the thing is that is a type of participation that would bring accountability into the research system.

Thank you.

DR. : Thank you, Mr. Friend, and thank you for connecting some recommendations to this important story.

Alta, do you have a comment?

MS. CHARO: Yes. In some ways actually I actually would like to say something to you as well, Mr. Friend. But as a follow-up to Ms. Becker I felt one thing that got omitted is that although this commission does not investigate specific instances we try to draw lessons from them. It is important to say for the record what specific instances can generate.

I think that they need to generate a complaint to the Office for Protection from Research Risks and I think for all of these kinds of stories that we are hearing people should know there is a place to go. The Director of the Office for Protection of Research Risks is in the room today. There is a phone number that they can start with to start the ball rolling and find out how to file a complaint, which would be 301-496 -- that is the old number. What is the new number? 301-496-7005.

And the second thing is that when there is evidence of criminal activity it is important, as Alex had kind of implied, to take advantage of local authorities, both the local DA and the attorney general as a follow up when it is possible for you to do that.

But I would not want to leave people with the impression here that because we do not investigations we also are not concerned about the specific incidents we are hearing about.

Mr. Friend, specifically from the testimony that you gave and your suggestion about the composition of IRB's, do you believe that the kinds of suggestions you are making are those that are particular to people who are being enrolled in trials that have to do with psychiatric medication or are these kinds of suggestions ones you would say are generally applicable to people that are going through cancer trials or trials of, you know, headache remedies and antihistamines? I am trying to get a sense of whether you are looking for special procedures for people with psychiatric illness or a more general recommendation.

MR. FRIEND: Well, my specific recommendation, of course, was related to human subjects of psychiatric research. But in the broader sense I think any Institutional Review Board should have community participation because it does put a better sense of accountability into it.

MS. CHARO: Thank you.

DR. CHILDRESS: Other questions?

Thank you very much, Mr. Friend.