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
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