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
Tel 914 271 5644
Member Foreign Press
Fax 914 271 6188
