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Psychology Today ; 10-01-1999
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"
Loren R. Mosher, M.D.
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: - receives substantial rent from drug companies for huge symposia spaces at national conventions. - derives an enormous percentage of its income from drug companies--30% of its total budget is from drug company advertising in its many publications. - 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, I 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., is the director of Soteria Associates in San Diego, Calif.
The Other Side
"Safe and Effective Drugs Have Improved the Lives of Millions"
A Response By Frederick K. Goodwin, M.D.
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.
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.
"We Advocate For the Patient and For Quality Treatment"
A Response By the American Psychiatric Association
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 (thought 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.
James Thompson, M.D., is the deputy medical director of the Office of Education at the American Psychiatric Association.
"The Time for Helplessness And Bitterness Is Past"
A Response by the National Institute of Mental Health
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.
Steven E. Hyman, M.D., is the director of the National Institute of Mental Health.
"All People Should Have The Right to Make Their Own Decisions"
A Response by the National Alliance for the Mentally Ill
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.
William Emmet is the chief operating officer of the National Alliance for the Mentally Ill.
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 anti-psychotic 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