Director Yale Psychiatric Institute concedes I don't think drugs can prevent fu

[Guest guest]

Director Yale Psychiatric Institute concedes " I don't think drugs can

prevent full-blown psychosis " _NYT

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

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

FYI

Our criticism of a high risk, speculative drug

experiment conducted on

healthy children and adolescents at Yale

University's Psychiatric Institute

was validated by a federal investigation: and our

criticism is now validated

by the principle investigator, Dr.

McGlashan. Dr. McGlashan, who now

concedes that his screening test proved

unreliable. Furthermore. he said:

" I'm more pessimistic about all this now. I don't

think the drugs can

prevent full-blown psychosis, only delay it. " He

added, " I think more than

ever we need to follow a group of prodromal

adolescents who get no drug

treatment to see more clearly what happens and

refine our understanding of

what the prodrome is. "

A profile of Dr. McGlashan, Director of Yale

Psychiatric Institute and

professor of psychiatry, was published in The New

York Times Science

section, " A Career That Has Mirrored Psychiatry's

Twisting Path. " The

profile follows a Times news report (May 1)

revealing that this

controversial (we maintain, unethical) experiment

failed. The authors

reported that " the drugs were more likely to

induce weight gain than to

produce a significant, measurable benefit. [And]

more than two-thirds of the

participants dropped out, rendering the trial

inconclusive. "

This unethical experiment was funded by Eli Lilly

and the National Institute

of Mental Health. The children (12 years old +)

did not qualify for a

diagnosis of any mental illness. Yet, they were

exposed for one year to the

severe risks and health hazards linked to Lilly's

antipsychotic drug,

Zyprexa (olanzapine) merely because the Yale

investigators presumed the

adolescents were " at risk " of

schizophrenia-without scientific evidence to

back up that presumption. See:

http://www.ahrp.org/cms/content/view/157/80/

The profile of Dr. McGlashan (below) is a

portrait of psychiatry: its

pseudo-scientific theories that are anchored in

faith and speculation, not

science. Its scientifically unsubstantiated

treatement arsenal have given

rise to a cowboy culture that readily endorses

high risk, mostly

non-therapeutic experimentation on patients. Dr.

McGlashan at first

enthusiastically embraced psychoanalysis. When it

failed to improve

patients' lives, he threw his energies into

biological, drug-centered

treatment. Benedict Carey notes that Dr.

McGlashan " has with grim delight

extinguished some of psychiatry's grandest

notions, none more ruthlessly

than his own. "

But what about the patients who have suffered

harm by being subjected to

test " psychiatry's grandest notions " that ended

in failure? Where is the

concern about the human consequences of

pseudo-scientific tinkering?

Indeed, if psychiatry's prescribed treatments

were assessed from the

perspective of patients' satisfaction-as is done

in all other medical

evaluations-the inescapable conclusion would be

that each of its failed

treatments has aggravated rather than ameliorated

suffering-often causing

chronic disability and premature death.

Psychiatry's ministrations violate

the foremost Hippocratic medical dictum: " Primum,

Non Nocere " ( " Above all,

do no harm " ).

Even as a body of irrefutable empirical evidence

has shown that psychiatry's

drug treatments induced irrevocable harm, medical

journal editors and most

of the major media have deftly avoided

questioning psychiatry's ethics and

have continued to broadcast unfounded, claimed

benefits for its harmful

treatments. FDA officials have shown reckless

disregard for the safety of

children who are exposed to toxic drugs in

unehtical experiments.

The drug prescribed for the adolescents in Dr.

McGlashan's experiment

(Zyprexa, olanzapine) is so toxic that Eli Lilly

paid $700 million to settle

lawsuits filed by 8,000 surviving patients and

families of deceased patients

who became diabetic while taking the drug.

Zyprexa's adverse effect profile

is so well-known among psychiatrists, University

of Cincinnati psychiatrist,

Dr. Henry Nasrallah, refers to the " Zyprexa

metabolic syndrome " in his

presentations. [1] And Dr. Carol Tamminga, a

leading schizophrenia

researcher and promoter of the antipsychotics

acknowledged in an editorial

in the American Journal of Psychiatry: " the side

effect outcomes are

staggering in their magnitude and extent and

demonstrate the significant

medication burden for persons with

schizophrenia.. " [2]

The Times quotes Dr. E. Hyman, Provost,

Harvard University and the

former director of the National Institute of

Mental Health: " Given the

likelihood that psychosis is delayed and not

prevented by the drugs, and

given the severe side effects of the drugs, this

is an idea that needs to be

taken with great caution. " However, a cowboy

culture fosters risk

taking- " shoot first, worry about the

consequences, later " -and ambitious

psychiatrists at powerful academic institutions

do not respect the

cautionary principle of medicine.

Furthermore, psychiatry's penchant for applying

its " grandest notions "

before they have been scientifically validated is

an abuse of power that

tramples on individual rights. Schools are being

turned into experimental

laboratories posing a threat to children and

adolescents who may be

mistakenly labeled as " mentally ill. " The Boston

Globe reported (2002) that

a " Yale research center called

Prevention through Risk Identification,

Management and Education , or PRIME,

is developing a possible student screen now,

although Dr. McGlashan,

PRIME's chief investigator, said general

screening was still some time in

the future. ''We're talking about a year from

now'' at the soonest, he said.

[3]

Dr. McGlashan now concedes that his screening

test proved unreliable, and he

no longer recommends exposing adolescents to

antipsychotics inasmuch as they

may never need them. Not so, Dr. Barbara

Cornblatt, the director of the

Recognition and Prevention Program at Zucker

Hillside Hospital of the Long

Island Jewish Medical Center (Albert Einstein

School of Medicine). Dr.

Cornblatt continues exposing children to

unjustifiable risks of harm in a

similar dubious experiment on the basis of the

following rationale: " I may

be more optimistic about early treatment than he

is at this point. "

Dr. Cornblatt's shrug of the shoulder attitude

about very serious risks of

harm for the human subjects in her speculative

experiment is a reflection of

the lack of accountability within the context of

medical research. The

adverse events suffered by the children and

adolescents in these experiments

must be accessible to public scrutiny. What did

the original consent forms

disclose about the risks to parents ?

The media's soft-peddling when one after another

of psychiatry's ambitious

experimental forays ( " grand notions " ) has ended

in disaster, has helped

perpetuate disinformation about speculative

benefits of harmful treatment

modalities such as those embraced and then

discarded by Dr. McGlashan. He

told the Times that he has turned down an

invitation to sign up for a debate

over whether high-risk adolescents should be

treated with drugs: " He wanted

me to sign up for the pro side, and I said

absolutely not. "

Whereas Dr. McGlashan has seemingly retreated

from prescribing antipsychotic

drugs for adolescents, the same toxic drugs are

currently being tested on

very young children--even toddlers--at Harvard

University affiliate,

Massachusetts General Children's Hospital. See:

http://blogs.abcnews.com/theblotter/2006/05/tots_used_as_hu.html

The outpouring of public comments about this

experiment on the ABC News

( Ross) website is an indication of public

dismay and indignation.

To our knowledge, the last comment was posted by

Dr. Marcel E. Wingate,

Professor Emeritus, University of Washington, a

clinical psychologist and

expert on speech pathology. His most recent

book, Foundation of Stuttering

(2001) set forth a rational and scientifically

defensible foundation for the

study and management of stuttering, based on the

fact that stuttering is

manifestly a disorder of speech: " Stuttering is

not a symptom of emotional

or mental problems, although it may become a

source of stress and cause

emotional difficulties. "

Commenting about the Mass General antipsychotic

drug experiment, Dr. Wingate

wrote: " These experiments are truly exploratory.

The territory is strange

and very little is known about it. Those who

invade it are truly

adventurers, reminiscent of the Conquistadores,

essentially criminal types,

looking for GOLD! "

Posted by: marcel e wingate, Ph.D.

<mailto:wingate@...> | May 25,

2006. See:

http://blogs.abcnews.com/theblotter/2006/05/tots_used_as_hu.html

Reference

1. See video slide presentation (Internet

Explorer):

http://gdp.videoarkiv.net/janssen-

cilag/20012006_JC_DK_nordic_academy/defaul

t.html

2. See: Dr. Carol Tamminga, " Practical Treatment

Information for

Schizophrenia " Editorial, AJP, April, 2006, vol.

163:563-565.

3. Ellen Barry, High school testing eyed for

schizophrenia signs, Boston

Globe May 25, 2002 page A1

<http://www.boston.com/globe/search/copyright.html>

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

THE NEW YORK TIMES

May 23, 2006

Scientist at Work | McGlashan

A Career That Has Mirrored Psychiatry's Twisting

Path

By BENEDICT CAREY

The patient, , was a deeply religious young

man, disabled by paranoia,

who had secluded himself for weeks in one of the

hospital's isolation rooms.

In daily therapy sessions he said little but was

always civil, seemingly

pleased to have company and grateful for a

cigarette and a light.

Until one spring morning, when he wrestled the

lighter from his therapist's

hand and held it to his own head - igniting his

hair.

" I grabbed him and was slapping at the flames,

and he immediately became

passive, " said Dr. H. McGlashan, the man's

therapist. " He went limp

and pulled a blanket over his head. "

He added, " That patient, that experience, changed

everything for me. "

In a career that has spanned four decades, Dr.

McGlashan, now 64 and a

professor of psychiatry at Yale, has with grim

delight extinguished some of

psychiatry's grandest notions, none more

ruthlessly than his own. He strived

for years to master psychoanalysis, only to

reject it outright after

demonstrating, in a landmark 1984 study, that the

treatment did not help

much at all in people, like , with

schizophrenia . Once placed on

antipsychotic medication, became less

paranoid and more expressive.

Without it, he quickly deteriorated.

Dr. McGlashan turned to medication and biology

for answers and in the 1990's

embarked on a highly controversial study of

antipsychotic medication to

prevent psychosis in high-risk adolescents. But

doctors' hopes for that

experiment, too, withered under the cold eye of

its lead author.

Early this month, Dr. McGlashan reported that the

drugs were more likely to

induce weight gain than to produce a significant,

measurable benefit.

Through it all, he has remained optimistic,

restless, hopeful that he is

close to understanding some of schizophrenia's

secrets. In a way, his work

mirrors the history of psychiatry itself, its

conflicts and limits, its

shift away from talk therapy to drugs and

biological explanations for

illness.

And for those who want a sense of what direction

the field will take next -

and how - Dr. McGlashan may serve as a kind of

bellwether.

" Basically, you're talking about a person who can

walk into an extremely

hostile environment and deliver bad news; I don't

know how to describe him

better than that, " said Dr. Wayne Fenton of the

National Institute of Mental

Health. He is a former colleague of Dr.

McGlashan's at Chestnut Lodge, a

psychiatric hospital in Rockville, Md., closed in

2001.

" At the lodge, he stood up and, in essence, told

all these giants of

psychotherapy that there was not a shred of

evidence that what they were

doing with schizophrenia patients was helping,

much less curing the

disorder, " Dr. Fenton said. " And the therapies

were being advertised as

cures. "

Dr. McGlashan is recognizable from a distance, a

lean figure striding across

the grounds of the medical school as if against a

strong wind, chin forward

beneath a mop of white-gray hair. On a typical

day, he visits with adult

patients at a state mental hospital in the

morning and with adolescents in a

private institute in the afternoon. He is a

deliberate presence, solemn for

long periods; but then he will remark on

something absurd and tip backward

with laughter.

This unsettling combination - gravity punctuated

by sudden levity - may help

explain his comfort with the world of psychosis.

" I thought he was the Antichrist when I first met

him; I thought all the

therapists were, " said , the patient at

Chestnut Lodge who changed Dr.

McGlashan's thinking in 1982. " But in the end I

liked his sense of humor,

and he liked mine, and I keep in touch with him. "

, who is now 47 and spoke by telephone only

on the condition that his

last name not be used, said he set his hair on

fire that day because he was

terrified that a great tribulation was at hand,

during which he would be

dragged by his hair before the devil.

" I really believed it was coming, any moment, and

there was no way to

escape, " he said. " I still believe it's coming,

but not right now; I'm not

afraid of it. " Dr. McGlashan joined the staff of

Chestnut Lodge at a time

when psychoanalysis was in ascendance in

psychiatry, nowhere more so than at

the lodge, which became known for its commitment

to treat severe mental

illness without antidepressants, antipsychotic

drugs or electroshock

therapy. It was thrilling just to be there, Dr.

McGlashan recalled, hearing

so many accomplished therapists offer seemingly

powerful ideas about what

troubled patients and why.

At the time he was treating , Dr. McGlashan

was pursuing a study for

the hospital's owner, Dr. Dexter Bullard, to

track patients years after

treatment. Their records were revealing

artifacts, detailing thousands of

interactions in which therapists, steeped in

psychoanalytic theory, tried to

interpret patients' every word and gesture.

In one account, a psychiatrist described an

outing when he bought a patient

an ice cream cone. The patient refused it

vehemently. " This was very

exasperating to me, " the therapist wrote. " She

never did accept the cone,

and I had to throw it away. I thought of it at

the time as having

represented a kind of rape situation to her. "

Yet in his analysis of 446 cases, Dr. McGlashan

found that about two-thirds

of the former patients with schizophrenia who had

been treated with

psychoanalysis were functioning poorly and

struggling in their relationships

and in their jobs, if they had them. Their lives

were no better than those

of similar patient groups who had received little

psychotherapy or none at

all.

" I felt like people at the lodge had become lost

in the process, " he said.

" We would have all these erudite conversations,

talking about

interpretations, and meanwhile the patient is

crumpled in the corner of his

or her room. "

Chestnut Lodge changed some of its policies as a

result of the study,

allowing more drug treatment, job training and

other programs.

Dr. McGlashan's intensity, and willingness to

reverse course, was evident

even in childhood. An ardently religious boy, he

grew up with two sisters

near Rochester, where his father worked at Kodak.

In middle school, the

youngster pored through the Bible, to the dismay

of his father and the

bemusement of his mother.

The devotion was isolating, Dr. McGlashan

remembers, creating a mostly

private world of mystery and awe. Then in his

first year of high school, he

met other Christian students, who belonged to a

group devoted to

proselytizing.

He was reluctant to join, and his father sensed

it. " He saved me, " Dr.

McGlashan said. " He picked me up after a meeting

and said it was O.K. to

pull back " from the group.

" He was giving me permission. "

He graduated second in his high school class and

studied chemistry at Yale.

He then entered the University of Pennsylvania's

medical school, where,

during a psychiatry rotation, he met his future.

He interviewed a

middle-aged Philadelphia businesswoman, who

described to him a tortuous plot

being hatched against her, involving family

members and the F.B.I. " I

thought, 'She can't possible believe this,' " Dr.

McGlashan said.

He was hooked. Psychosis was isolating, too, and

deeply mysterious even to

scientists who spent their lives thinking about

it. By the 1990's, most

psychiatrists believed schizophrenia to be a

genetically based brain

disorder involving developmental changes that

occurred well before the first

full-blown psychosis. No one knew precisely what

those changes were, but

studies strongly suggested that they were real.

Moreover, psychiatric clinics periodically saw

adolescents who seemed to be

experiencing mild, prepsychosis symptoms. They

were " prodromal, " in the

medical jargon, perhaps destined to develop a

full-blown psychotic episode,

perhaps not.

Dr. McGlashan and several others saw in these

converging threads a

possibility: maybe treating young people with

drugs before they became

psychotic would prevent the illness, and perhaps

even help illuminate its

cause.

Dr. McGlashan recalled patients at Chestnut Lodge

who had spent decades

receiving daily psychotherapy, to no avail,

before receiving antipsychotic

drugs and reclaiming some portion of normal life.

One woman spent 18 years

at the lodge, barefoot, unkempt, closeted in her

room. One day, he said, he

looked out a window and saw her going for a

morning walk, smartly dressed,

wearing shoes; she had recently been given

medication and began taking daily

walks.

" What right did we have denying her that? " he

asked. " Small changes in a

person's life, which I think is what we can

expect, can make a big

difference. "

The risks of using drugs to try to prevent

psychosis seemed to him moderate.

New antipsychotics were becoming available, and,

though they could have

serious side effects, they appeared to be more

tolerable than the older

generation of drugs, and to reduce the risk of

debilitating, Parkinson's

disease-like side effects. So Dr. McGlashan began

a study, financed in part

by Eli Lilly, giving medication to adolescents

considered at high risk for

developing psychosis. But almost immediately,

there were difficulties.

The test that Dr. McGlashan developed to identify

those at high risk proved

less reliable than he had hoped, meaning many

adolescents would be exposed

to drugs needlessly. Participants for the trial

were hard to recruit. Mild

psychosislike symptoms are rare in adolescents;

and some who came in chose

to continue seeing Dr. McGlashan or another

psychiatrist but did not enter

the study.

An ethical debate over the wisdom of early

treatment ensued, and not

everyone thought the potential benefit was worth

the risk.

" Given the likelihood that psychosis is delayed

and not prevented by the

drugs, and given the severe side effects of the

drugs, this is an idea that

needs to be taken with great caution, " said Dr.

E. Hyman, a professor

of neurobiology at Harvard

<http://topics.nytimes.com/top/reference/timestopics/organizations/h/h

arvard

_university/index.html?inline=nyt-org> and a

former director of the

National Institute of Mental Health.

And in 2000, Vera Sharav, a prominent

patient-protection advocate, wrote to

government officials calling the experiment

unethical, because " healthy

children - who are not capable of voluntary,

informed consent - are being

put at high risk of harm for experimental

purposes. "

Officials from the federal Office for Human

Research Protection began an

investigation. About a year later, the agency

concluded that the researchers

needed to strengthen their informed consent

documents to emphasize the side

effects of the medication.

The researchers made the required changes, and

the trial continued. But in a

paper published this month, the authors reported

that more than two-thirds

of the participants had dropped out, rendering

the trial inconclusive.

Moreover, those on medication gained an average

of about 20 pounds.

The entire process, almost 10 years in the

making, has altered Dr.

McGlashan's thinking again. " I'm more

pessimistic about all this now, " he

said. " I don't think the drugs can prevent

full-blown psychosis, only delay

it. " He added, " I think more than ever we need to

follow a group of

prodromal adolescents who get no drug treatment

to see more clearly what

happens and refine our understanding of what the

prodrome is. "

Sitting in his office on a recent Tuesday

morning, after having seen three

patients taking a total of 10 drugs, Dr.

McGlashan sighed. " I've never

written so many prescriptions in my life, " he

said.

He said he had recently gotten a call from

someone in England organizing a

debate over whether high-risk adolescents should

be treated with drugs. " He

wanted to sign me up for the pro side, and I said

absolutely not, " he said.

Now colleagues are watching the progression of

his thinking, wondering where

his drive for answers will ultimately take him.

" It's funny, he seems to be

coming full circle, " said Dr. Barbara Cornblatt,

the director of the

Recognition and Prevention Program at Zucker

Hillside Hospital in Glen Oaks,

N.Y., and an early critic of preventive drug

treatment. " I may be more

optimistic about early treatment than he is at

this point. "

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[Guest guest]

Director Yale Psychiatric Institute concedes " I don't think drugs can

prevent full-blown psychosis " _NYT

Falls a little short of conceding that psyche meds can CAUSE full-blown

psychosis.