DR. CHILDRESS: Before we turn to the last person who is on the list that you received let me just note that I have in addition to Ms. Vera Sharav, Dr. Guha, Dr. Buchov and Mr. Brownstein and parents. If I omitted anyone who had given a name to the staff please let Pat Norris know.

Pat Norris has just informed me that those are interested in getting copies of the testimony please sign up on the sheet outside and copies will be available tomorrow afternoon.

All right. Ms. Vera Sharav?

MR. CAPRON: By testimony you mean just submitted statements?

DR. CHILDRESS: Yes. Thank you.

MR. CAPRON: Not the actual testimony.

DR. CHILDRESS: Not the oral testimony, right.

MR. CAPRON: Which will not be transcribed for a week.

DR. CHILDRESS: That is right. Thank you for the clarification.

MS. SHARAV: My name is Vera Hassner Sharav. I am cofounder and director of Citizens for Responsible Care in Psychiatry and Research. It is an independent network of concerned citizens, families and patients.

The speaker before me admitted that she was an anomaly of what the correct procedures for using a human subject ought to be in psychiatric research. I am here to discuss the vast majority.

The families, in fact, that we have brought before you are victims of therapeutic neglect, betrayal of trust, and institutional deception. Their children and countless others who remain silent became unwitting martyrs for science in experiments which caused them profound harm. They went to research because they had been cast out of the health care system. They have very few options and so they looked to research instead.

Overall, neglect and poor treatment outcomes are, in fact, the norm in psychiatric treatment and in research. The two go hand in hand. But when information about the risks of relapse are withheld from patients and their families the consents obtained from them are anything but informed.

In a court deposition a senior researcher at a major VA hospital in New York stated, and I quote, "I have had occasion to review many consent forms for psychiatric studies during the late '70s and '80s. I can state that I have seen not one single consent form during that period of time that discussed any risks associated with the drug free period or the withdrawal of medication. It was the norm and practice of researchers and IRB's not to discuss any such risk in consent forms even though the risk of increased symptomatology is a possibility."

Thousands of uncomprehending patients, who lack protections, are recruited into pharmaceutical sponsored drug trials in which their welfare is sacrificed to speed up the testing process. Abrupt washouts are a way of speeding up the process. They do not have to be done that way.

They are also fair game for speculative experiments which deliberately provoke paranoid delusions, hallucinations, violent mania, disorganized thinking. University physicians are actually injecting schizophrenia patients with amphetamine, L-dopa, cocaine, apomorphine and PCP, especially at VA hospitals. They are deliberately inducing relapses so that their symptoms could be recorded. I do not know of another medical condition in which that kind of experimentation takes place.

In two recent experiments at the Maryland Psychiatric Research Center fourteen patients were subjected to PCP induced relapses. It is in a published document which you have a reference to. We believe that such experiments are inhumane and unethical.

Chimpanzees are protected from such experimental abuse but disabled human beings are not. The researchers' rationale for doing these kind of studies often defies logic as well as moral responsibility.

"Because of the psychotic like symptoms shown by depressed patients during treatment with L-dopa as well as reports of such symptoms in patients with Parkinson's we decided to try the drug in schizophrenics."

We come to you to tell you that human experimentation on mentally disabled patient is out of control. There are no limits. No independent oversight. No accountability for the human casualties.

Government agencies that are entrusted to be our guardians are authorizing experiments that deliberately exacerbate incapacitating illnesses. The FDA, NIMH and Institutional Review Boards are failing to meet their public responsibility. Instead they are serving the interest of the drug industry.

Let's talk about money. No one has mentioned this in the entire morning. U.S. sales for psychotropic drugs has doubled in five years. It is now $7 billion dollars. More than 10,000 clinical testing sites are competing for human subjects. There is a race to test new drugs. Academic centers provide what industry calls a credibility bridge, prestige.

The fact is that conflicts of interest have compromised patient care and clinical practice. Psychiatrists have become partners with industry receiving thousands of dollars per patient to seed the market, that is called prescribing a drug, and to conduct drug trial studies. Academic researchers affiliated with state and VA hospitals earn as much as $20 to $30,000 per human subject in a drug trial study for Alzheimer's and schizophrenia.

Physicians are also setting up clinics and recruiting a stable of human guinea pigs whom they use repeatedly in drug trials. The FDA accepts unethically obtained data even when the human subjects are abused. They do not consider that a factor in how the data was obtained for premarketing.

The absence of protections has led to widespread violations. These are not isolated incidents. We need a national human subject welfare act that will provide all Americans with at least the protections mandated for chimpanzees. Those who profit from the drug industry claim that by providing safeguards for human subjects important research and scientific advancement will come to a halt. Well, that is nonsense. It will motivate research and industry to modify studies and the designs of the studies so that the welfare of the human subjects is not sacrificed for expediency.

Just as the Animal Welfare Act and its independent on site monitoring and oversight system did not stop genuine scientific investigation with animals neither will such scientific endeavors impede research where humans get equal protections. There would be enormous financial incentives. This enterprise is not going to come to an end.

Citizens for Responsible Care in Psychiatry and Research call for an immediate moratorium on nontherapeutic, high risk experimentation with mentally disabled persons who may be unable to comprehend or evaluate the likely or potential risks but who would suffer the consequences. Experiments which deliberately exacerbate psychotic symptoms should be absolutely prohibited.

DR. CHILDRESS: Thank you for your presentation.

Questions or comments from the commission?

MS. CHARO: You are obviously very educated about the range of regulatory protections that currently exist for human subjects and that would apply in the case of trials that are involving new drugs that the FDA is going to approve or taking place at VA centers. Yet despite those protections that are in place you are documenting problems that you have seen as unacceptable. I would like to understand more specifically exactly what kinds of changes you would advocate.

If I understood correctly, one is that you would advocate an absolute ban on research that is not expected to be a direct benefit to the particular subjects regardless of whether it has got a prospect for revealing information that will be useful for people in the future; is that correct?

MS. SHARAV: When you are dealing with a group that by definition cannot truly comprehend and evaluate risks, yes.

MS. CHARO: And for those situations in which direct benefit is anticipated but which also has significant risks, okay, for which we currently have mechanisms like IRB's, are you suggesting a change in the composition of those IRB's or a change in the degree of authority that the IRB's have with additional authority granted to additional people? I would like to understand there what kind of suggestions you have.

MS. SHARAV: One of the things I would suggest, actually one of our positions is, is that we really would like to see a comprehensive investigation of current and previous practices to be conducted either by the Justice Department or the GAO. An independent evaluation so that what I have documented for you, you get the larger picture. You are aware of a GAO very preliminary report and even in that preliminary report they said, "There is no on site inspection." That is basic in animal research.

So the composition of IRB's, which you are asking about, sure if IRB's are to function and serve the public interest and protect the individual the composition has to change. The problem is there currently is no mechanism for accountability. You can have all sorts of written regulations, if nobody actually enforces them and if people who violate it or institutions who violate it are not held accountable they do not have much relevance.

What I am suggesting really, and I am sure you have been reading the press, and I have given you also an industry newsletter, this is where you find out that the pace is accelerated. The New York Court, which you are going to be talking about, the Appellate Division decision at the very end states exactly that. They recognize that this group is particularly in danger with this race to test because they are the ones who are available and no one is protecting them.

Others of us have means to ask questions, to get other opinions, to take that protocol to three other doctors and say, "Do you think this is worthwhile for me?" These patients have no option. They are being recruited in emergency rooms where they are in complete psychotic state. They will sign anything and it is being taken advantage of.

Indeed, some researchers are even regarding it as their moral obligation because they are not helping. Their moral obligation to become research subjects for society. Well, that is not what America is supposed to be about.

DR. CHILDRESS: Thank you very much. We appreciate your presentation and the discussion.

MR. CAPRON: Could I ask a question?

DR. CHILDRESS: Very quickly because, Alex, we have got others to get in this morning.

MR. CAPRON: I understand your answer. I just wanted to have a clarification of your answer to the first question Ms. Charo asked.

You said it was because these patients, potential subjects, are unable to evaluate. Were you saying, in effect, those subjects who are unable should be governed by these across the board rules? Are you saying all subjects per se in all psychiatric research are unable?

MS. SHARAV: No. Ideally, and that is what we are really promoting, is a national act that would protect all human beings. The point is though the Americans with Disability Act requires making accommodations for a person's disability. Shouldn't the same be true here?

MR. CAPRON: Yes. I am not --

MS. SHARAV: In other words, the --

MR. CAPRON: There are people with types of cancer today who have no alternative treatment. They are sometimes asked to be in research which might have a potential benefit for them. They are sometimes asked to be in research which candidly holds no benefit for them where they are being asked to help scientists understand the tumor or the process, or something so that future patients might benefit.

They have the ability to consent to that.

MS. SHARAV: That is the difference.

MR. CAPRON: But that is my question. I mean, certainly to me some of the greatest tragedies we have heard about today were people who were successfully being treated with antipsychotic medications or other psychotropic drugs who at the time they went into the study it would seem to me were able to make the same kinds of decisions that the people who were talking -- my example of a woman or a man facing a cancer might make.

And I now understand your statement to be that you would say as to all those people, not just those who are in psychosis in an emergency room or those who are institutionalized and by a result of already being in the institution have constraints on their freedom to make choices, but these outpatient people who are, according to you, being recruited by psychiatrists in the community as a stable of people to be in their studies, none of them should be allowed to make choices? That we should have standards which we say, you know, this can be done or it cannot be done but you cannot consent to it even if you were willing.

MS. SHARAV: Part of the problem is that there is no true disclosure on the informed consent.

MR. CAPRON: There is no problem --

MS. SHARAV: Without that you do not even --

MR. CAPRON: You misunderstand. I am not arguing about consent. I just want you to clarify if you are saying that all psychiatric -- the recommendation of your group, I am trying to understand what we are hearing today, the recommendation of your group is that in all psychiatric research the subject is not capable of giving consent?

MS. SHARAV: No, not all psychiatric. The scope of psychiatric patients is vast. We are talking about those who are schizophrenic or are in a bipolar episode. We are talking about people whose cognitive faculties are impaired in a major way. We are not talking about someone who let's say has depression and is on Prozac and can evaluate and is, in fact, leading a normal life and has access to the expertise and to the institutions that you and I do. We are talking about people who do not have access and who are being recruited.

DR. CHILDRESS: Thank you again.