The Problem of Experimentation on “Decisionally Incapacitated” Humans


Dorothy Guellec

Five

of the world’s 10 leading causes of disability are psychiatric

depression, alcohol abuse, bipolar mood disorder, schizophrenia, and

obsessive-compulsive disorder. These disorders have genetic

determinants and physical correlates. In the past 40 years, great

advances in medication have taken place. But there is concern now for

the ethical aspects of psychiatric research and the abuse of power

when dealing with vulnerable patients. One of the most vexing ethical

problems concerns the mentally ill and those with Alzheimer’s

dementia. These people are in danger because of their diminished

capacity to consent to the participation in research. The Nuremberg

Code, formulated in 1947 as a result of the trial of Nazi physicians

who had experimented on unwilling subjects, stated, "the

voluntary consent of the human subject is absolutely essential."

Because of the domination of pharmaceutical interests in this country

financial incentives are great, and there is an inherent conflict of

interest as scientists make their livelihood from research protocols.

The

system now in place for the protection of subjects only applies to

research that is federally funded. This protection is "based on a

succession, or chain, of judgments made by people in the context of

federal regulations." It is called the Common Rule and directs a

research institution to assure the federal government that it will

provide and enforce protection for human subjects. Central to the

process of insuring that the rights and well-being of human subjects

are protected are institutional review boards (IRBs). The main problem

as I see it when dealing with human beings is the problem of informed

consent. Henry Beecher, a pioneer of research ethics, wrote in 1959

that this principle would "effectively cripple if not eliminate

most research in the field of mental disease." He was talking

about the restrictions as outlined in the Nuremberg Code. There is

agreement that research on humans requires informed consent but that,

"at the same time we must learn as much as possible in order to

improve the care of those who suffer from the diseases that impair

their capacity to provide informed consent." How do we proceed

given this conflict? In 1964, the Declaration of Helsinki softened the

absolute ban of the Nuremberg Code by including legal guardians to

provide consent, at least for "therapeutic" research. In

1974, the National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research, which was created after the

revelation of the exploitation of subjects in the Tuskegee study of

syphilis, discussed the special problem of the use and abuse of

vulnerable groups as research subjects.

The

commission suggested special regulations to govern research on

"persons institutionalized as mentally infirm," but these

regulations were viewed as "overly burdensome and were never

adopted. However, the commission’s general comments paved the way for

the so-called common rule". The common rule recognizes the

problems of "vulnerable populations", including the mentally

disabled. It requires that institutional review boards (IRBs) include

additional safeguards to protect the rights of such groups but

provides no specific guidelines.

The

National Bioethics Advisory Commission (NBAC) is the latest federal

panel to address the issue. Its 17 members were appointed by Clinton

in 1995 to advise the government on bioethical issues, and especially

to "consider the problem of the rights and welfare of human

research subjects." Its report was released in 1998. With respect

to informed consent Dr. Eric J. Cassell, M.D. testified on Dec.9, 1999

that the "NBAC recommends that no person who has the capacity for

consent may be enrolled in a study without his or her informed

consent."

Yet

there have been two proposed bills in Maryland (the first one ended

negatively in committee) that would allow research on "decisionally

incapacitated "humans without their informed consent. A proxy

will make the decision for them. As for who would be experimented on,

this would include a broad spectrum of Americans with disabilities

including those diagnosed with Alzheimer’s, psychiatric disorders,

mental handicaps-any claimed brain ailment that impairs a person’s

ability to give informed consent.

As

you might have realized there is big money in all of this. In a recent

breakthrough, scientists at Elan Corporation’s research facility in

San Francisco believe they have developed what could possibly become a

treatment or potential vaccine against Alzheimer’s disease. Elan’s

researchers reported in the scientific journal Nature, on their

discovery of AN-1792, a form of the same beta amyloid peptide that

scientists believe causes Alzheimer’s. The corporation’s next move is

to apply to the FDA for human clinical trials, which could begin by

the end of 1999. Zaven Khachaturian a leading Alzheimer researcher

recently said the following on the program "Frontiers of

Medicine". "Preferably one would want to have the dementia

set in an hour before they die. Or, if an hour is not possible, maybe

ten days before. Or, if not, a year before. But clearly we cannot

afford to have a society whose population – forty to fifty percent in

their 80′s – have dementia and are going to be demented or disabled

for twenty to thirty years". There will be a big push to test

this substance on humans because mice do not have a memory as far as

we know. The government offers large financial grants for "high

risk"/ "high impact" research, while pharmaceutical

companies award large unrestricted grants to neuroscience centers

across the U.S. Great financial gain can be made as one newly

legitimized drug can bring up to a billion dollars of yearly revenue.

Mentally

ill persons with impaired decision-making capacity do not have one

problem regarding research ethics, they have two. Dr. Michels M.D.

Cornell University Medical College states in the New England Journal

of Medicine’s " Sounding Board" in May that "The focus

of the NBAC report (1998) is that the inability of such persons to

provide full informed consent may leave them vulnerable to

exploitation. The greater problem is that too little research is

conducted on their behalf. Psychiatric research is burdened by a long

history of public fear of mental illness, prejudice against the

mentally ill, and distrust of those who treat or study them."

Some of this distrust is legitimate given the history of abuses.

A

1996 court case documents experiments on thousands of indigent

pregnant women in Florida without their informed consent. Currently

tens of thousands of Americans labeled mentally ill are involved in

washout studies, where they are suddenly off their medicines, inducing

painful withdrawal symptoms and greatly increasing chances for

relapse. Any new drug will have serious side effects and these cannot

be anticipated. By an "Orwellian twist of phrase, experimental

research is now termed therapeutic research." By its very nature

any research that is experimental, especially on the fragile organ on

the brain, constitutes a major risk. For example, drugs used in

psychiatric research, were held by the New York Appellate Court to

constitute a major risk of death and injury. Hence the rush to have a

Maryland bill that would allow research on this very group.

And

through all this maze of government regulations, confusion, hovers the

constant leitmotif of greed, undisclosed failures, profits, etc. In

the recent death of Jessie Geslinger a Senate sub-committee is now

investigating the consent form he and his family dealt with. A lot was

not disclosed; least of all the conflict of interest when former

University PhD’s establish Bioresearch companies, sometimes with

federal monies, whilst pursuing brand new breakthrough therapies

without following the guidelines. Someone called this "NASDQ

medicine" because of all the new IPO’s and stock options for

those involved in the companies. Jessie’s death then, was it just

"a pot hole on the road to gene therapy?"

 

Dorothy

Guellec

[email protected]

Tel 914 271 5644

Member Foreign Press

Fax 914 271 6188

 

 

 

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