[SSRI-Research] DBS--Absent legal restraints, medical experiments cross ethical

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[sSRI-Research] DBS--Absent legal restraints, medical

experiments cross ethical boundaries

 

 

 

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

Critics are raising concerns that the latest electrical brain

stimulation

technologies--vagus nerve stimulation (VNS) and deep brain stimulation

(DBS)-which appear indistinguishable from the electric neuro-

stimulation

technologies that had been largely abandoned in the 1970s, might once

again

be used as harmful behavior control technologies. [see excerpt below]

 

These radical invasive experimental surgical implants are driven

primarily

by commercial interests. Indeed, FDA's approval of VNS for depression

was

over the objections of all FDA safety officers. [1] See:

http://finance.senate.gov/press/Gpress/02_2006%20report.pdf:

 

Psychiatry's return to psychosurgical treatment modalities for

depression is

a tacit acknowledgement of its failed therapeutic armamentarium. It

confirms

psychiatry's predilection for exposing mental patients to risks of

harm in

highly speculative, radical, invasive, experimental surgical

procedures: " a

1999 poll of American Psychiatric Association members shows that

psychiatrists are becoming more open to this physically invasive

treatment

model: 74 percent said they would consider neurosurgery for their

patients. "

[Danielle Egan, 2005]

See: http://www.thismagazine.ca/issues/2005/01/magicalmystery.php

 

DBS has been used to treat patients with Parkinson's Disease, a

neurological

movement disorder associated with bradykinesia, tremor, rigidity, and

postural instability. Clinical trials in patients with obsessive

compulsive

disorder were disappointing. Nevertheless, DBS promoters who are

commercially driven, now want to apply this surgical technology to

patients

with depression without an agreed physical pathology in which to

intervene.

 

Those who promote surgical interventions for complex psychological

disorders

demonstrate ignorance about depression-its causes, its highly

individualized, variable course of illness, and patients' equally

individualized, variable response to treatment. As acknowledged on the

Columbia University's Depression Evaluation Service website:

 

" depression is neither a unitary illness, nor is it singly

determined. there

are several or many different illnesses, all of which we currently

call

depression, not one illness. These same variations occur in people

who are

in treatment, since just because they are being treated does not mean

necessarily that it is the treatment that caused their depression to

go

away. "

See: http://depression-nyc.org/

 

DBS is being promoted much as lobotomy and electroshock had been,

with the

fervor of evangelical salesmen, not doctors or scientists:

neurosurgery, they claim is the " dawn of a new age of

neurotechnology. "

See: http://www.loc.gov/today/cyberlc/feature_wdesc.php?rec=715

 

During the heyday of prefrontal lobotomy, researchers consistently

reported

" impressive " findings. So too, ECT practitioners sing its praises:

the

problem is the patients don't.

 

Canadian journalist, Danielle Egan, who has written several articles

about

DBS quotes Dr. David Roy, founder and director of the Montreal-based

Centre

for Bioethics, who calls DBS an " ethical minefield. "

" There's high enthusiasm for neurostimulation for mental disorders

among a

number of professionals, " he says, " but the same thing happened with

prefrontal lobotomies and early electrical stimulation experiments

[in the

1970s], to disastrous effect. We need to be extraordinarily careful

that

these trials don't lead to runaway applications and that digging

around in

an organ as complex and fragile as the brain doesn't harm

individuals. At

this point, there's very little scientific evidence around the

benefits and

risks. " [2]

 

Indeed, she notes, that while tools and technologies have evolved

over the

years, " the premise of severing pathways in order to treat psychiatric

illnesses remains the same as it was back in the early days of

lobotomy. "

" Nobody has a clue why DBS works or doesn't work in different

individuals

and whether it actually inhibits or excites specific brain areas. " [2]

 

Medicine without public restraints has a history of descent into

barbarism.

 

What about the risks?

The proponents of psychosurgery claim the adverse effects

are " transient

confusion and memory loss " which specialists report that these

effects are

" usually temporary and resolve themselves within a week. "

 

Danielle Egan, writing in This Magazine in 2005, reported: " patients

have

reported a variety of long-term effects, ranging from cognitive

deficits to

extreme fatigue to aggression. As a result, these surgeries aimed at

treating dysfunctional minds are often as controversial now as they

were in

the heyday of lobotomy in the 1940s when it is estimated that tens of

thousands of lobotomies were performed globally, and later in the

1970s. "

http://www.thismagazine.ca/issues/2005/01/magicalmystery.php

 

In an update article (May 2006) she writes:

" Recent long-term DBS Parkinson's studies have documented serious

side-effects including hypomania, aggression, hypersexuality, criminal

behaviour and suicide. A European group doing DBS for obsessive-

compulsive

disorder found that it was curbed in four of their first six

patients, but

only at such a high setting-about 10 volts-that some patients

exhibited

frontal lobe damage. At this high voltage, batteries wore out within

as

little as three months, necessitating additional surgery to refresh

the

battery pack. Patients also had to be put on antipsychotic

medications

post-op, with the two non-responding patients being given non-

reversible

neurosurgeries. " [2]

 

Psychiatrists, who know even less about the mechanism of action of

these

invasive technologies than they do about the drugs, are exploiting the

currently deregulated environment to explore the workings of the

brain in

living human subjects. Once again, psychiatrists are turning their

patients

to neurosurgeons to serve as human guinea pigs in radical experiments

that

explore unknown territory, using hit or miss methods that carry a high

degree of risk.

 

Despite the absence of scientific evidence to validate psychiatry's

diagnoses, and despite the fact that its treatment outcomes show that

more

people who are treated become chronically disabled-mostly due to the

debilitating adverse effects of psychiatry's preferred treatments,

psychiatry's cowboys are galloping toward the latest technological

gimmick.-without waiting for scientific validation.

 

Is there evidence that electric stimulation actually works?

On the basis of two reported uncontrolled clinical trials involving

exactly

six human subjects in each, DBS promoters promise relief from chronic

depression. Although no abnormalities in the brain of depressed

patients

have ever been shown, speculations abound about one or another over

or under

active area of the brain. Neuroscientists at the Cleveland Clinic

report

that their surgical experiment on 6 patients in whose brains they

inserted

two electrodes " to block abnormal activity in the brain, "

was " impressive. "

[see below]

 

" Overall, preliminary results indicate that bilateral DBS of the

anterior

limb of the internal capsule holds promise for the treatment of

intractable

major depression, " stated the lead investigator, Dr. Ali Rezai. A

similarly

optimistic pronouncement-based on no science-was made by Dr. Andres

Lozano

(University of Toronto) who conducted a DBS experiment on 6 depressed

patients, four of whom, he claims, had a good outcome. [3]

 

These forays into neurosurgical technology smack of financial

opportunism:

the surgery carries a price tag of $50,000. So, for the doctors and

hospitals surgery promises to be even more lucrative than drugs.

 

Given that there are no national databases tracking human

experiments, it is

difficult to know how many psychiatric DBS operations have been

performed;

guesstimates range between 50 and 300. But public disclosure

reflects only

12 patients with depression in two clinical trials: one at the

University of

Toronto [3], the other Cleveland Clinic (below).

 

The known institutions carrying out DBS clinical trials to treat

obsessive

compulsive disorder and depression include:

the Cleveland Clinic Foundation; University of Toronto; University of

British Columbia (Vancouver General Hospital); Harvard Medical

School (at

Massachusetts General Hospital); Brown University (Butler Hospital

and Rhode

Island Hospital); the Karolinska Institute in Stockholm, Sweden; seven

centers in Europe ; the Montreal Neurological Institute .

 

At a May 2005 symposium on ethics in neuroscience at the Library of

Congress

sponsored by the Harvard University Dana Foundation, Columbia

University,

and the National Institute of Mental Health proponents of DBS said

neuroscience technology " is beginning to pay off. "

 

No one raised a hint of skepticism about the scientific and validity

and

ethical justification of conducting speculative experiments that may

damage

the brain of vulnerable incapacitated humans. Not the neurosurgeons,

the

business entrepreneurs, nor the bioethicists. All were essentially

tantalized by the prospective " pay off. "

See video: http://www.loc.gov/today/cyberlc/feature_wdesc.php?

rec=715

 

See also: Psychiatry's " Desperate Cures? " Electric Switches for

Depression?

http://www.ahrp.org/cms/content/view/129/28/

 

 

References:

 

1. See Senate Finance Committee Report prepared by Senator Chuck

Grassley:

http://finance.senate.gov/press/Gpress/02_2006%20report.pdf:

 

2. Danielle Egan, New Brave Mood, Vancouver, May, 2006 (available upon

request)

 

3. Mayberg HS, Lozano AM, Voon V, McNeely HE, Seminowicz D, Hamani C,

Schwalb JM, Kennedy SH. Deep brain stimulation for treatment-resistant

depression. Neuron, 2005 Mar 3;45(5):651-60

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

~~~~~~~~~~~~~~~~

 

<http://health.msn.com/centers/depression/default.aspx>

 

Surgical Technique Shows Promise Against Major Depression

 

Deep brain stimulation eased symptoms in study of six patients

 

By Meryl Hyman Harris, HealthDay Reporter

 

Inserting two tiny " pacemakers " into the base of the brain of people

suffering from major depression improved symptoms of the sometimes

intractable disease, a small study found.

 

The treatment, called deep brain stimulation, utilizes tiny pulses of

electrical stimulation to block abnormal activity in the brain, the

researchers said.

 

" It was interesting and impressive to see how their lives changed over

time, " said study author Dr. Ali R. Rezai, head of Stereotactic and

Functional Neurosurgery at the Cleveland Clinic Foundation. " They

went from

being withdrawn and not interacting to going back to work, and showed

marked

improvement in self care and social function. They are living their

lives

much more fully than they were when they were stuck in the grip of

depression. "

 

The researchers inserted pairs of the tiny electrodes into six

patients who

had failed to benefit from other forms of treatment, such as

medication,

psychotherapy, and electroconvulsive therapy. Over the course of a

year,

two-thirds of the patients showed marked improvement, said the

researchers,

from the Cleveland Clinic and Brown University's Butler Hospital.

 

A similar successful study was reported last year in the journal

Neuron.

 

Rezai was to present the findings at the American Association of

Neurological Surgeons annual meeting, in San Francisco.

 

The six patients -- four women and two men, with an average age of

48 -- had

bilateral deep-brain stimulation leads implanted in a part of the

brain

called the ventral anterior internal capsule. They underwent

standardized

and detailed psychiatric, quality-of-life, and neuropsychological

tests on a

regular schedule, the researchers said.

 

Six months after surgery, four of the six patients showed a 50

percent or

greater improvement on the Montgomery-Asberg Depression Rating Scale.

Measurements of quality-of-life improved, too, the researchers said.

 

Deep brain stimulation surgery has proved successful in the past for

patients suffering from obsessive-compulsive disorder, epilepsy and

Parkinson's disease, Rezai said.

 

Exactly why the treatment works is not yet understood, but it appears

to

help the brain resume normal electrical and chemical function.

 

The surgery is reversible, Rezai said, and the electrodes can be

adjusted

without further invading the brain. It is performed under a local

anesthetic, and, in some cases, the change in the patients " could be

seen

almost instantly, " he said.

 

" As we were testing the pacemakers [during the surgery], we could see

immediate change in their moods, " he said, adding that people who

hadn't

smiled in years, smiled.

 

" But, " he cautioned, " this is for people with no other hope. These

poor

patients had failed everything. I am encouraged by the results, but

we need

to do more long-term and larger studies. "

 

Dr. Michael Blumenfield, Sidney E. Frank distinguished professor of

psychiatry and behavioral sciences at New York Medical College in

Valhalla,

N.Y., said he had not seen the study. But he said that he's skeptical

of

invasive treatments that can potentially do more harm than good,

particularly when there are effective treatments already available.

 

While it's good to look for more and better ways to treat major

depression,

too often it is improperly diagnosed, he said.

 

" Sometimes one thinks one has a simple depression when it is a bipolar

depression that needs a mood stabilizer, " Blumenfield

said. " Sometimes the

underlying problem is substance abuse, and sometimes when one has

resistant

depression, the issue has psychological roots, and there is a need for

psychotherapy. "

 

All of the patients in the study were resistant to other treatments,

including medication, psychotherapy and electroconvulsive therapy,

Rezai

said.

 

An estimated 9.5 percent of the adult U.S. population -- about 18.8

million

people -- suffers from a depressive disorder each year. The price tag

to the

American workplace alone is as much as $40 billion annually. And

depression

is a global health-care concern, with the World Health Organization

rating

major depression the top cause of disability worldwide, the

researchers

said.

 

More information

 

The National Alliance on Mental Illness

<http://www.nami.org/Template.cfm?

Section==By_Illness & template==/ContentManage

ment/ContentDisplay.cfm & ContentID=w25> has more on major depression.

 

SOURCES: Ali R. Rezai, M.D., head, Section of Stereotactic and

Functional

Neurosurgery, the Cleveland Clinic Foundation; Michael Blumenfield,

M.D.,

Sidney E. Frank distinguished professor of psychiatry and behavioral

sciences, New York Medical College, Valhalla, N.Y.;

April 25, 2006, presentation, American Association of Neurological

Surgeons

annual meeting, San Francisco

 

Copyright C 2006 ScoutNews, LLC <http://www.healthday.com/> . All

rights

reserved.

 

~~~~~~~~~~~~~~~

 

Brave New Mood by Danielle Eegan

Vancouver Magazine, 2006

Excerpt:

 

A SHOCKING PAST

 

ELECTRICAL BRAIN STIMULATION (EBS ) techniques started in the

late 1800s with animal experiments in Germany. By the turn of the

century,

researchers began focussing on the brains of conscious humans

test-stimulated during routine surgeries. By the 1930s, renowned

Montreal

neurosurgeon Wilder Penfield started using EBS to treat epileptics

and map brain regions; he surreptitiously found it elicited all sorts

of

unpredictable behavioural changes, since the pathways between parts

of the brain were highly organized and incredibly complex.

 

Researchers doing EBS on rats and monkeys found that rage and

aggression

could sometimes be checked through EBS; with other stimulated brain

parts, thought to be involved in pleasure and reward, animals liked

being

zapped and would self-stimulate round-the-clock.

 

Clockwork Orange-style human experiments began at Yale in the

1940s when Jose Delgado conducted remote-control EBS on psychiatric

patients with everything from aggressiveness to schizophrenia. He

believed that " man does not have the right to develop his own mind, "

and bragged that EBS would " conquer the mind " and create " a less

cruel,

happier and better man. "

 

But EBS was also used to cause Manchurian Candidate-style

dissociative

personality disorders, like depersonalization and psychotic breaks.

Tulane

University researchers, backed by the CIA and the U.S. military, did

deep-brain

EBS experiments on psychiatric patients and prisoners from the '50s

through

the

'70s and reported that some patients " brightened " and

experienced " warm and

pleasant " sensations.

 

Others were driven to suicide. Their most infamous experiment

involved supposedly changing a homosexual man's sexual orientation by

rigging him up to electrodes and stimulating areas implicated with

pleasure

while he had sex with a prostitute.

 

Most media reports on EBS were extremely positive until the '70s, but

when U.S. researchers discussed using it on violent criminals,

ethicists

were outraged and EBS research was generally halted along with

psychiatric

neurosurgeries-though neither mind-modification technique disappeared

altogether.

 

Various groups have since tested neuro-stimulation on people with

eating disorders and on aggressive mentally handicapped patients.

Harvard-based Canadian neurosurgeon Dr. Rees Cosgrove was recently

invited to a U.S. President's Council on Bioethics meeting on

behaviour

control with DBS. Cosgrove said that when he asks neurosurgeons

whether they're interested in DBS for behaviour modification, " The

hands go up-about 75 percent of them. That, to me, is scary. "

 

 

 

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