Are Psychiatrists Betraying Their Patients?

PT Controversy

PSYCHIATRIST LOREN MOSHER RECENTLY RESIGNED IN DISGUST FROM THE
American Psychiatric Association, claiming that some of his colleagues
are too quick to hand out drugs in what he terms an "unholy alliance"
between psychiatrists and drug companies. A substantial number of cases
of misdiagnosis and fraud support his view that patient care may be in
jeopardy

But not everyone agrees. Frederick Goodwin, M.D., host of radio's
The Infinite Mind and a former director of the National Institute of
Mental Health, counters that volumes of research and thousands of
real-life stories long ago confirmed the value of prescription drugs for
psychological problems. And he has the establishment behind him.
Providing testimony are the American Psychiatric Association, the
principle professional association of psychiatrists in the country; the
National Institute of Mental Health, the federal government's policy and
research organization; and the National Alliance for the Mentally Ill,
the nation's largest advocacy group for the mentally ill.

"I Want No Part of It Anymore"

The trouble began in the late 1970s when I conducted a
controversial study: I opened a program--Soteria House--where newly
diagnosed schizophrenic patients lived medication-free with a young,
nonprofessional staff trained to listen to and understand them and
provide companionship. The idea was that schizophrenia can often be
overcome with the help of meaningful relationships, rather than with
drugs, and that such treatment would eventually lead to unquestionably
healthier lives.

The experiment worked better than expected. Over the initial six
weeks, patients recovered as quickly as those treated with medication in
hospitals.

The results of the study were published in scores of psychiatric
journals, nursing journals and books, but the project lost its funding
and the facility was closed. Amid the storm of controversy that followed,
control of the research project was taken out of my hands. I also faced
an investigation into my behavior as chief of the National Institute of
Mental Health's Center for Studies of Schizophrenia and was excluded from
prestigious academic events. By 1980, I was removed from my post
altogether. All of this occurred because of my strong stand against the
overuse of medication and disregard for drug-free, psychological
interventions to treat psychological disorders.

I soon found a less politically sensitive position at the Uniformed
Services University of the Health Sciences in Maryland. Eight years
later, I re-entered the political arena as the head of the public mental
health system in Montgomery County, Md., but not without a fight from
friends of the drug industry. The Maryland Psychiatric Society asked that
a state pharmacy committee review my credentials and prescribing
practices to make sure that Montgomery County patients would receive
proper--read: drug--treatments. In addition, a pro-drug family advocacy
organization arranged for more than 250 furious letters to be sent to the
elected county executive who had hired me. Fortunately, my employers were
not drug-industry-dominated, so I kept my position.

Why does the world of psychiatry find me so threatening? Because
drug companies pour millions of dollars into the pockets of psychiatrists
around the country, making them reluctant to recognize that drugs may not
always be in the best interest of their patients. They are too busy
enjoying drug company perks: consultant gigs, research grants, fine wine
and fancy meals.

Pharmaceutical companies pay through the nose to get their message
across to psychiatrists across the country. They finance major symposia
at the two predominant annual psychiatric conventions, offer yummy treats
and music to conventioneers, and pay $1,000-$2,000 per speaker to hock
their wares. It is estimated that, in total, drug companies spend an
average of $10,000 per physician, per year, on education.

And, of course, the doctors-for-hire tell only half the story. How
widely is it known, for example, that Prozac and its successor
antidepressants cause sexual dysfunction in as many as 70% of people
taking them?

What's even scarier is the greed that is directing a good deal of
drug testing today. It is estimated that drug manufacturers have, on
average, 12 years to recoup costs and make profits on a given medication
before a generic form can be made. So pressure to test new drugs mounts.
In the field of psychiatric drug testing, organizations make a profit of
as much as $40,000 for every patient who successfully completes a trial.
And university psychiatry departments, private research clinics and some
individual doctors live on this money.

The good news is that the press is catching on. The New York Times,
Dallas News, Milwaukee Journal Sentinel and New York Post have recently
run articles or series on how pharmaceutical companies use cash
incentives to encourage doctors to prescribe their drugs.

This spring, the New York Post revealed that Columbia University
has been cashing in. Its Office of Clinical Trials generates about $10
million a year testing new medications--much of which is granted to the
Columbia Psychiatric Institute for implementing these tests. The director
of the institute was being paid $140,000 a year by various drug companies
to tour the country promoting their drugs. He also received payments of
nearly $12,000 from a drug manufacturer to head up a study on panic
disorders. How could he rate these drugs fairly when his livelihood was
dependent on the success of the drug manufacturer? The director resigned
in the aftermath of the article's publication.

At least one drug company, Wyeth-Ayerst Research, has spoken out
against offering cash bonuses and other incentives to researchers. But
company representatives admit it's difficult to stay competitive when
other groups so eagerly violate ethical concerns.

The APA Connection

The American Psychiatric Association--representing the majority of
psychiatrists in America, with about 40,000 members--is also unduly
influenced by pharmaceutical dollars. The association:

o receives substantial rent from drug companies for huge symposia
spaces at national conventions.

o derives an enormous percentage of its income from drug
companies--30% of its total budget is from drug company advertising in
its many publications.

o accepts a large number of unrestricted educational grants from
drug companies.

This relationship is dangerous because researchers and
psychiatrists then feel indebted to the drug companies, remain biased in
favor of drug cures, downplay side effects and seldom try other types of
interventions. And they know they have the unspoken blessing of the APA
to do so.

Collectively, these practices aggressively promote reliance on
prescription drug use-so much so that many people think drugs should be
forced on those who refuse to take them. The APA supports the National
Alliance for the Mentally Ill, which believes that mentally ill patients
should be coerced to take medication. I am appalled by this level of
social control. Mentally ill people should be given a choice to have
their illness treated in alternative ways.

Over the last decade, ! have written a number of letters bringing
my concerns to the APA's attention but have received no response. The
association claims that what it's doing is in the "best interest of
patients," but its strong ties to the drug industry suggest
otherwise.

Recently, it was dues-paying time for the APA, and I sat there
looking at the form. I thought about the unholy alliance between the
association and the drug industry. I thought about how consumers are
being affected by this alliance, about the overuse of medication, about
side effects and about alternative treatments. I thought about how
irresponsibly some of my colleagues are acting toward the general public
and the mentally ill. And I realized, I want no part of it
anymore.

Loren R. Mosher, M.D.

The Other Side

"Safe and Effective Drugs Have Improved the Lives of
Millions"

Dr. Mosher has seized onto the recent press interest in the
relationship between the pharmaceutical industry and biomedical
professionals as an opportunity to re-open a 25-year-old argument--one
that has long been settled by a mass of scientific evidence and by the
testimony of hundreds of thousands of patients, their families and their
caregivers. The availability of safe and effective psychoactive drugs has
dramatically improved the lives of millions of individuals with major
mental disorders such as schizophrenia, bipolar illness, clinical
depression, obsessive-compulsive disorder and panic disorder.

While Mosher apparently still sees the issue as a choice between
medications and psychological treatment (he says, "Schizophrenia can
often be overcome with the help of meaningful relationships rather than
with drugs"), the overwhelming majority of mental health professionals
now know that for the seriously mentally ill effective medication makes
it possible for psychosocial interventions to work. And work they do.
Many well-controlled studies have shown that psychosocial treatments
combined with medication can produce substantially better results than
medication alone.

It is now so well-established that illnesses such as schizophrenia
and bipolar disorder generally require medication, that many countries no
longer allow a placebo group in clinical trials with these disorders.
Incidentally, Mosher's 1970s "study" purporting to compare "meaningful
relationships" with medication was no such thing. A true scientific
inquiry would have required a single pool of patients randomly assigned
to either psychotherapy or drug groups. The report was simply an
interesting description of their experience with a group of patients who,
at least in the short run, did not seem to require medication.

Mosher would have us believe that the very broad consensus about
the importance of medications is somehow the result of drug company
money.

Tell that to the parents of a schizophrenic son who, following
treatment with a new, atypical neuroleptic drug, is able to hold a job
for the first time, to form meaningful relationships, in short, to
reconnect to life.

Tell that to the patients who run the National Depressive and
Manic-Depressive Association, for whom medication, often combined with
psychotherapy, has made the difference between a shadow-like existence on
the margins of life and the high-level functioning necessary to sustain a
successful organization.

Tell that to the thousands of social workers, psychologists and
psychiatrists who work with the seriously mentally ill every day and who
know from their own experience that without medications, their patients
could not engage with them in the difficult psychological work of
recovery.

Don't forget that before the psychopharmacology revolution, our
state hospitals were filled with hundreds of thousands of individuals
trapped in their psychosis, the victims of what modern research has
clearly shown to be brain disorders. Today only the tiniest fraction of
the mentally ill still require involuntary hospitalization. Why ?
Primarily because of modern medications. Throughout the long history of
psychiatry and psychology during the pre-drug era, countless heroic
efforts to treat severe mental illness with psychotherapy alone ended in
frustration, a frustration keenly felt by patients, families and
caregivers alike.

Mosher suggests that the pharmaceutical industry is a monolithic
force. In reality, a variety of drug companies compete with one another
for market share, and clinicians seem to be able to sift through
competing claims and counterclaims.

While our ability to treat these disorders has improved
dramatically over the last 30 years, there is still much to be done. The
development of novel drugs will continue to be essential to improving
treatment options. Pharmaceutical innovation depends on lively
competition in the industry, adequate capitalization of what is a
high-risk business and, most importantly, a close working relationship
between industry, government and academia. The procedures and safeguards
needed to ensure the integrity of this process require continued
discussion. But it needs to be conducted seriously.

A Response By Frederick K. Goodwin

"We Advocate For the Patient and For Quality Treatment"

Dr. Mosher raises an issue of great concern for all of medicine:
the commercial influence on medical education. The APA supports the
rigorous stands taken by both the American Medical Association and the
Accreditation Council for Continuing Medical Education (ACCME) in this
area, and has instituted a careful review and monitoring process,
ensuring that sessions supported by the pharmaceutical industry at our
meetings present solid scientific information in an unbiased
manner.

We control all aspects of this process: We choose the topics and
the speakers, and we control the logistics and evaluation.

These sponsored sessions represent only a small percentage of the
program and are routinely well-attended and highly rated for scientific
content and lack of bias. Companies are charged a fee (though not "rent,"
as the writer indicates), much of which covers the cost of reviewing and
monitoring the presentations.

No advertising is permitted and the company's name is mentioned as
required by the ACCME guidelines. It would be pointless to exclude
industry from our meetings altogether because this would empower them;
they would set up independent symposia at the time and location of our
meetings, but outside of our control.

In addition, throughout APA programs and publications,
nonpharmaceutical treatments for mental disorders are explored,
emphasized and, in many cases, recommended.

A major APA commission focuses on the application and efficacy of
psychotherapy. Our practice guidelines--prepared with no commercial
support whatsoever--include recommendations on psychotherapy and other
nonmedication-based treatments, and we continue to recommend
psychotherapy training for residents. As with any medical specialty, our
members have varying attitudes about treatment modalities, but the APA
supports the use of a wide variety of therapeutic options geared toward
the needs of the particular patient and continues, above all, to advocate
for the patient and for quality treatment.

A Response By the American Psychiatric Association

"The Time for Helplessness And Bitterness Is Past"

It would be tragic if Dr. Mosher's personal history prevented
anyone with mental illness from obtaining effective treatment. In the
years since Mosher has been active in research, a revolution has
occurred. In place of medications with questionable efficacy and major
negative side effects, or unproven and expensive psychotherapies, we now
have a variety of safe and effective medications and psychotherapies for
most mental illnesses.

The National Institute of Mental Health, with public funds, has
overseen this quiet revolution and has funded its own studies to make
sure that the new mood stabilizers, antidepressants and antipsychotics
work for Americans with mental illness. While much remains to be done,
the time for helplessness and bitterness is past.

A Response by the National Institute of Mental Health

"All People Should Have The Right to Make Their Own
Decisions"

For the record, the National Alliance for the Mentally Ill (NAMI)
focuses primarily on ensuring access to adequate, appropriate treatment
within the American health care system. As a matter of policy, it does
not endorse any particular treatment or services for brain disorders.
NAMI believes that all people should have the right to make their own
decisions about medical treatment, but is aware that some individuals
with brain disorders such as schizophrenia and bipolar disorder may at
times, due to their illness, lack insight or good judgment about their
need for medical treatment. Involuntary treatment of any kind should be
used only as a last resort and only when it is believed to be in the best
interest of the individual, following a court hearing in which due
process has been provided. Outpatient treatment also should be considered
the most beneficial, least restrictive and least costly treatment
alternative.

A Response by the National Alliance for the Mentally III

A History of Drug Trials Gone Bad

Late 1980s: After a century of conducting drug trials within the
confines of academia, the industry began to privatize.

1996: Richard Borison, M.D.,: serving 15 years in prison for theft
and racketeering after conducting drug trials without the required
approval of the Medical College of Georgia. Bruce Diamond: serving five
years in prison for theft and bribery. From 1989 to 1996, the pair earned
$10 million from conducting fraudulent drug trials: They used
"attractive" women to lure patients into the studies (the women later
testified they were paid thousands--one received a Honda Accord). The
women met with mentally ill stable community members and offered them
$150 to check into the hospital. Other in-patients received cigarettes
for their participation.

July 1998: Faruk Abuzzahab, the onetime chairman of the Ethics
Board at the Minnesota Psychiatric Society, had his medical license
suspended when he admitted to the board that he had entered "disturbed
and vulnerable patients" into drug studies even though they didn't meet
the eligibility criteria.

October 1998: Joseph Santana, 36, a patient at the state-run Bronx
Psychiatric Center, died during a drug trial from a lethal combination of
antipsychotic drugs. Santana's screams for help went unheeded because he
was considered a delusional mental patient. Hoechst Marion Roussel, the
maker of one of the experimental drugs found in Santana's system, had
paid researchers at the state facility to conduct clinical trials on its
product, M.100907. Though the state claims the money from the experiments
went to a nonprofit research group, in reality, the state controls that
group through its Office of Mental Health.

November 1998: The Office of Protection from Research Risk, a
government watchdog designed to protect research subjects, revealed that
researchers at the University of Maryland, the University of California
at Los Angeles and the National Institute of Mental Health in Maryland
had violated federal regulations in their drug trials: They failed to get
the required proper consent from patients before conducting psychiatric
research. Patients said they were intentionally taken off schizophrenia
medications that were improving their condition and were not informed of
the risks involved. As a result of the investigation, the institutions
changed their practices.

1991-1994: The U.S. Department of Justice imposed a fine of $369
million on the Psychiatric Institutes of America (PIA), a chain of
private psychiatric hospitals. Law enforcement officials had accused many
of PIA's 73 hospitals in four states--Alabama, Florida, New Jersey and
Texas--of admitting patients who did not need hospitalization, keeping
patients against their will, employing "bounty hunters" to find patients,
fabricating patient diagnoses and cutting patients off when their
insurance coverage ran out.

September 1997: Robert Fiddes, M.D., was convicted of fraudulent
acts he committed while at the helm of the Southern California Research
Institute, a pharmaceutical testing facility, and sentenced to 15 months
in jail. Fiddes falsified data, invented fictitious patients and often
pressured patients to participate in experiments against their will. A
number of Fiddes' patients needed hospitalization, possibly because of
conditions that worsened after they were given the experimental
drugs.

March 1999: As a result of a series of New York Post articles
exposing the close relationship of Columbia University's drug trial
center with the pharmaceutical industry, Dr. Jack Gorman, deputy director
of the New York State Psychiatric Institute (an affiliate of Columbia
University), resigned. Gorman received $140,000 from pharmaceutical
manufacturers in the last year alone, more than any other NYSPI
researcher.

September 1999: Only a decade after private clinics began
conducting drug trials, they have moved aggressively, motivated by
profit, to assume seventy-five percent of the drug research
industry.

--Amanda Druckman

By Loren R. Mosher, M.D.; Frederick K. Goodwin, M.D.; James
Thompson, M.D.; Steven E. Hyman, M.D. and William Emmet

Adapted by M.D. , M.D. , M.D. and M.D.

Loren R. Mosher, M.D., is the director of Soteria Associates in San
Diego, Calif

Frederick K. Goodwin, M.D., is a professor of psychiatry at the
George Washington University Medical Center and former director of the
National Institute of Mental Health

James Thompson, M.D., is the deputy medical director of the Office
of Education at the American Psychiatric Association

Steven E. Hyman, M.D., is the director of the National Institute of
Mental Health

William Emmet is the chief operating officer of the National
Alliance for the Mentally Ill.