Drug companies and Schizophrenia:
Loren R. Mosher, Richard Gosden and
Citation: Loren R. Mosher, Richard Gosden and Sharon Beder, 'Drug companies and Schizophrenia: Unbridled Capitalism meets Madness', in Models of Madness: Psychological, Social and Biological Approaches to Schizophrenia edited by John Read, Loren Mosher and Richard Bentall, Brunner-Routledge, New York, 2004, pp. 115-130.
This is a final version submitted for publication.
The major thrust of this volume is an examination of the psychosocial origins and approaches to dealing with the problem labeled as “schizophrenia.” However, it needs also to provide a historical context and examine critically how the current complete domination of schizophrenia’s “treatment” by the neuroleptic drugs (we’ll use this term and anti-psychotic interchangeably) came to be. Not only do they dictate practice but they also buttress the biomedical theorizing that dominates thinking about the problem.
Chlorpromazine (“Thorazine”), the first neuroleptic, arrived on the psychiatric scene in the early 1950’s. It received Food and Drug Administration (FDA) approval in 1955. By 1958 it was in almost universal use in American mental hospitals for the treatment of “schizophrenia” and “related conditions”. Such rapid adoption of a new treatment was previously unheard of in psychiatry. How did this occur? In 1956 Smith Klein and French (“SKF”), Thorazine’s manufacturer, assembled its American drug “detailers”(salesperson’s) to instruct them to behave as “assault troops”(Johnson, 1990) in their efforts to convince psychiatrists to use their new “magic bullet”. This represents the first massive public relations foray by a pharmaceutical company into a previously small market-institutional psychiatry. In its first year on the market the drug made $75 million for SKF (Healy, 2002a). The rest, as they say, is history-Thorazine and it successors, despite their adverse effects, are widely viewed as the only “real” treatment for “schizophrenia”. The basic elements of this aggressive sales campaign, refined and expanded (detailed below), would be used time and again sell new drugs to the psychiatric market. The introduction of chlorpromazine was such a defining moment in American Psychiatry that it has, over the years, generated a number of unsupportable beliefs about what these drugs actually did.
While these are so firmly held they may warrant an attribution of being “delusions” Mosher and Burti (1994) have charitably divided the beliefs into “known” and “mythological”. The tables below are modified from page 52 of their 1994 volume.
Neuroleptic Drugs: Proven Effects
Reduce the “positive”(externally expressed) symptoms of “schizophrenia”
Neuroleptic Drugs: Mythological Effects
Responsible for depopulation of psychiatric hospitals -“deinstitutionalization”
With this background the current context of the influence of the pharmaceutical industry (capitalism) and psychopharmacology on psychiatry and “schizophrenia”(madness) in particular can be examined.
II. Some Facts, Figures and Opinions:
It is abundantly clear to any thoughtful observer of the psychiatric scene that drug company influence is pervasive and expanding. A few facts are illustrative: between 1993 and 2001 prescription drug spending tripled in the U.S. — from $50 billion to 150 billion or more (Szegely-Marzak, 2001). For the third consecutive year (2001) prescription drug prices rose in double digits (17%)-in contrast to overall inflation-which remained in the 2-3% range (Public Citizen, 2001). In 2000, psychotropic drug sales in the U.S totaled $23 billion and are expected to rise to $42 billion by 2005. Of the $23 billion, over $10 billion was spent on anti-depressants. Between 1990 and 2000 spending on anti-depressant drugs rose 800% (Tanouy, 2001), due principally to the introduction of the Selective Serotonin Reuptake Inhibitors (“SSRI’s”). Over the same period, the availability of the new “atypical” anti-psychotic drugs caused spending on neuroleptics to rise 600 percent, to 4 billion dollars in 2001 (Moukheiber, 2001). The successful selling of “atypical” anti-psychotics-the reason for this 600% rise- to replace the older, no longer patented neuroleptics- will be the major focus of this chapter. One indication of the success of the selling of the “atypicals” is the increase in use of antipsychotic drugs in youth (under 18) in the last decade: 50,000 outpatients received them in 1992; by 2002 the figure had reached 530,000 (Thomas, 2002)!
The large pharmaceutical companies averaged between 30-40% of revenues spent on marketing and administration, 15-20% profit and 12-15% on research and development. In the U.S they paid an average of 16% of revenues in taxes whereas all other industries averaged 27% (Angell and Relman, 2001). They have 625 paid lobbyists in Washington, D.C.-one per congressperson (Public Citizen, 2001)! They spent nearly $ 2.7 billion on direct-to-consumer (“DTC”) (TV and non-medical magazine) advertising in 2001. Until 1997, DTC advertising had been forbidden-and still is in the rest of the Western Industrialized World. Roughly a third of the American Psychiatric Association’s (“APA”) budget is derived from various drug sources (Psychiatric News 15/8/97). APA meetings are dominated by drug-company sponsored exhibits and symposia that provide attendees with a variety of enticements — music, food, drink, disc players etc.
Drug companies provide substantial support to nearly all of the mental health advocacy organizations like the National Alliance for the Mentally Ill (“NAMI”), the National Mental Health Association (“NMHA”), the National Alliance for Research on Schizophrenia and Affective Disorders (“NARSAD”), National Depressive Disorder Screening Day, the Anxiety Disorders Association etc. (O’Harrow, 2000). The only groups Big Pharma doesn’t support are the true consumer advocacy organizations like the Support Coalition International (SCI), the National Empowerment Center (NEC), and the National Association for Rights Protection and Advocacy (NARPA).
Perhaps the industry’s most successful marketing tool is direct personal contact with doctors by their “detailers”, recently reframed as “sales representatives”. These representatives are portrayed as “conduits of information”. Actually, they supply physicians well sanitized information, promotional materials and samples of their company’s latest products. In 2001 there were, industry wide, 83,000 such persons — twice the 1996 number. These “conduits of information” cost about $8 billion a year and their samples an equivalent amount (Angell and Relman, 2001).
The drug industry supports clinical trial research at universities to the extent that it is doubtful that many departments of psychiatry could survive without it. The pharmaceutical industry owns the data from clinical trials it supports, decides which studies will be published, chooses authors, ghost writes articles and revises them to present the best possible interpretation of the data (Angell, 2000).
John le Carre, In Place of Nations, an essay appearing in The Nation(2001) said the following about the pharmaceutical industry from the perspective of a non-scientist:
In “Is Academic Medicine for Sale?” New England Journal of Medicine (2000) editor Marcia Angell catalogued from her professional point of view the many ways that drug money flowed to academic doctors:
“The ties between clinical researchers and industry include not only grant support, but also a host of other financial arrangements. Researchers also serve as consultants to companies whoseproducts they are studying, join advisory boards and speakers’ bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company sponsored symposiums and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies.”Psychiatrists Joanna Moncrieff and Phil Thomas wrote (March 2002) to the British Medical Journal:
A Primer for Understanding “Big Pharma’s” Market Tactics
The strategies, tactics and techniques used by the industry to market its products are legion. We will present them in outline form to give readers a basic understanding.
1. The approval process:
The American process will be described but it is roughly similar in all western European countries. For a new drug two studies must be submitted to the Food and Drug Administration (“FDA”) that indicate the drug is better than placebo and is without serious adverse effects for condition “X”. The drug need not be more effective than ones already available for condition “X”. Data from “failed studies”-those showing no significant drug placebo differences- are not supplied to the FDA. If approved, the drug can be marketed for condition “X”. The companies can later apply, by submitting new studies or new analyses from old studies for the drug’s indications to be extended to new conditions or new populations (e.g., youth, the elderly). This opens a new market. The “new indications” technique has proved to be a highly successful with the SSRI’s: first approved only for depression but now approved for obsessive compulsive disorder (“OCD”), post traumatic stress disorder, and various anxiety disorders.
Of great importance is the fact that once a drug is on the market an individual doctor can legally prescribe it for “off label”(unapproved) indications. Because doctors are often given a variety of drug company “perks”, beginning while still in training, they are “open” to listening to the detailers and may in fact be rewarded with more goodies if they prescribe enough (the companies track prescribing practices) of a new “silver bullet”(Wazana, 2000).
2. Sales campaigns:
For example, the NY Times (9/4/02) published a report by Peterson and Abelson titled “Companies Reduce Roles in Lobby Group for Generics”. In summary, it reported that two members of a lobbying coalition for generic drugs (“Business for Affordable Medicine”) had left the group or reduced their roles after big drug makers, Eli Lilly and Wyeth, threatened to end contracts with Georgia Pacific Paper and Verizon Communications, who had been supporting this lobbying effort.
IV. Conflict of Interest-Is the fox watching the chicken coop?
A special problem is that it has become nearly impossible for the American drug regulatory agency, the Food and Drug Administration (“FDA”) to convene advisory groups that do not contain members with conflicts of interest in the discussion of drugs under consideration. USA Today (9/25/00) analyzed the financial conflicts at 159 FDA advisory committee meetings from January 1, 1998 through June 30, 2000. They found that at 92% of the meetings, at least one member had a financial conflict of interest. At 55% of the meetings, half or more of the FDA advisors had conflicts of interest. Conflicts of interest were most frequent at the 57 meetings when broader issues were discussed; 92% of members had conflicts. At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict. In addition about half of the FDA’s budget is derived from drug company fees. Is the fox watching the chicken coop?
V. A Current Example: Selling the Atypical Anti-Psychotic Drugs
1. Good Drug / Bad Drug
Although the drug companies made handsome profits early on from their neuroleptic drugs their sales of this class of drugs stopped growing when the indications for their use were fairly clearly confined to psychosis because of their dangers. Also, the increasing number of “me-to” anti-psychotic (17 by 1980) drugs split the profit pie into many modest size pieces. Finally, by the mid-1980’s nearly all of these agents had run out their patent lives and cheaper generic versions had become available. This meant that spending on these agents was basically flat, at about 400 million dollars a year, from 1980 until the approval of clozapine in 1990-the first of the so- called “atypical anti-psychotic” drugs to be used in the USA. However, it was not until risperidone’s (“Risperdal”) approval in 1994 that this new class of drugs became a realistic option to the older ones. Clozapine is a complicated and dangerous drug to administer with limited indications-hence it was approached with caution. Three additional atypical agents were not far behind risperidone (olazapine-“Zyprexa”, quietapine-“Seroquel”, and ziprasidone-“Geodon”) in the FDA approval process. So, the task of Big Pharma was to have its new, patented, far more expensive drugs replace the older ones. With four to chose from they had to be concerned both about market share and market penetration.
Not unexpectedly, the older drugs-made by the very same pharmaceutical companies-were suddenly not very good-especially when compared with the new ones. It was as if the deficiences and toxicity’s of the older agents (e.g. chlorpromazine, haloperidol, fluphenazine etc.) had been suddenly discovered. They were ineffective in 30-40% of cases, had very high rates of unpleasant side effects and caused, over the longer term, the now “terrible” iatrogenic diseases of tardive dyskinesia, tardive dementia and neuroleptic induced deficiency syndrome (NIDS) (Healy, 2002a). Before the pricey new patented drugs arrived these problems were never sufficient to warrant questioning their use. Suddenly they became intolerable. All stops were pulled out as Big Pharma used its tried and true PR methods-perfected with the selling of the SSRI’s to replace the older tricyclic anti-depressants.
However, in introducing the new drugs the pharmaceutical companies were confronted by two difficult public relations problems: (a) the new drugs are many times more expensive than the older drugs and, (b) according to critics, they are not any more effective or safer than the old drugs they replace. (Breggin and Cohen, 1999, pp. 76-82, the FDA and Geddes et. al. 2000). In its final letter of approval to Janssen, the FDA made explicit its conclusions about the relative merits of risperidone and haloperidol. Robert Temple, director of the FDA’s Office of Drug Evaluation, told Janssen:
“We would consider any advertisement or promotion labeling for RISPERDAL false, misleading, or lacking fair balance under section 502 (a) and 502 (n) of the ACT if there is presentation of data that conveys the impression that risperidone is superior to haloperidol or any other marketed antipsychotic drug product with regard to safety or effectiveness.”(Whitaker, 2002, p. 277).”
Geddes et. al. (2000) reviewed results from fifty-two studies, involving 12,649 patients, and concluded, “there is no clear evidence that atypical antipsychotics are more effective or are better tolerated than conventional antipsychotics.”
2. Setting the Agenda:
The pharmaceutical companies wanted to maximize their profits in what appeared to be a potentially critical environment and a tight market. They decided the best approach would be to find ways to expand the size of the market. Hitherto the market for schizophrenia drugs had been restricted by diagnostic conventions, on the one hand, and civil liberties protections on the other. Until recently diagnostic conventions generally limited the recognition of schizophrenia, and therefore the application of neuroleptic drug treatment, to persons with active clinical symptoms indicative of psychosis. The drug company agenda setters determined to expand the market by breaking this convention and promoting the concept of an additional pre-psychotic phase of schizophrenia that requires preventive treatment with their new drugs. To further expand the market they also participated in campaigns to weaken civil liberties protections and thereby increase the number of people who could be treated involuntarily. Finally, as they did to promote the SSRI’s, they expanded the prescriber base to primary care physicians, gerontologists and pediatricians. This was accomplished by sending sales representatives to these physician’s offices to promote the “safety, effectiveness and well tolerated” mantra-this time about the atypical anti-psychotics as compared with the “problematic” older neuroleptics. So, the impression was left that these newer agents would be safe to use in youth, non-psychotic persons and the elderly. The previously noted (p. x) ten-fold increase in use of antipsychotic drugs in the 18 and under population in the last decade is stark testimony to the success of this effort.
The overall solution was the development of a two-fold public relations campaign: The first part involves harnessing support groups for relatives of people suffering from schizophrenia as the driving force for an advocacy coalition (see NAMI’s contribution to the media hype below). This has been achieved by carefully focussed funding of these organizations. (Gosden, 2001, pp. 94-97). Once they were made dependent on drug company ‘sponsorship’ they could then be used as public relations front-groups to assist with planting stories in the media about the efficacy and safety of the new drugs. They also supported claims that schizophrenia has supposedly been scientifically proven to be a brain disease requiring urgent drug treatment at the earliest signs. A ready example of this practice can found at Schizophrenia.com (Schizophrenia.com, 2001a) which purports to be “A Not-for-Profit Information, Support and Education Center” representing consumers. However, Schizophrenia.com acknowledges on its web site that it is funded by Janssen Pharmaceuticals. (Schizophrenia.com, 2001b). The slant on schizophrenia being promoted by drug company-funded organizations like Schizophrenia.com is intended to impact on governments as expressions of public interest advocacy and to position the new drugs as preferred methods of treatment by government mental health services.
3. Media Hype
Another part of their strategy involved a media hype by “experts”. Some examples follow:
This new drug (risperidone), the Washington Post reported (2/16/93) “represents a glimmer of hope for a disease that until recently had been considered hopeless.” George Simpson, a prominent psychopharmacologist (and long term drug company “consultant” “adviser” “investigator”) at the Medical College of Pennsylvania, told the Post “The data is very convincing. It is a new hope, and at this moment it appears, like clozapine, to be different from all existing drugs.” The New York Times (1/15/92) quoting Richard Meibach, Janssen’s clinical research director (no conflict of interest here for sure), reported that “no major side effects” hadappeared in any of the 2,000 - plus patients who had been in the clinical trials.
Olanzapine, the Wall Street Journal (10/04/96) announced has “substantial advantages” over other current therapies. “Zyprexa is a wonderful drug for psychotic patients,” said John Zajecka, at Rush Medical College in Chicago. Stanford University Psychiatrist Alan Schatzberg, meanwhile confessed to the New York Times (4/14/98) “It’s a potential breakthrough of tremendous magnitude.”(Whitaker, 2001, p.260-61). Endorsements for specific drugs like these, from academic psychiatrists, usually indicate drug company sponsorship.
Or as the Los Angeles Times (1/30/98) put it: “It used to be that schizophrenics were given no hope of improving. But now, thanks to new drugs and commitment, they’re moving back into society like never before.”(Whitaker, 2001, p. 259).
Laurie Flynn, then Executive Director of the National Alliance for the Mentally Ill (“NAMI”), put an exclamation point on it all: “These new drugs truly are a breakthrough. They mean we should finally be able to keep people out of the hospital, and it means that the long-term disability of schizophrenia can come to an end.”
Money, glowing press – this was a good new story all around, and finally the NAMI put it together into its full mythic glory. In 1999, it copyrighted “Breakthroughs in Antipsychotic Medications”, by Weiden et. al. Inside the front cover were framed, color photos of the new wonder pills. The NAMI authors wrote: “Conventional antipsychotics all do about the same job in the brain. They all correct brain chemistry by working on the dopamine systems in the brain…the newer medications seem to do a better job of balancing all of the brain chemicals, including dopamine and serotonin…just give the new medication plenty of time to a good job!” (Weiden et al, 1999)(from Whitaker, 2001, p. 283). This glowing set of endorsements shouldbe contrasted with the views of the FDA, Breggin and Cohen and Geddes et. al noted above.
4. A Question of Ethics
An aspect of the campaign involves funding selected psychiatric researchers to promote the doubtful belief that schizophrenia must be detected and treated in a pre-psychotic stage to avoid brain deterioration. (Gosden, 2001, pp. 224-247). This line of argument has the potential to vastly expand the market for schizophrenia drugs and has already led to the development in Australia of government-sponsored preventive treatment programs for schizophrenia, that utilize the new drugs. Treating “at risk” adolescents with these very powerful agents raises serious ethical issues that the drug companies and their researchers’ fail to attend to in any meaningful way. The risk of serious adverse effects, treating large numbers of “false positive” youth with these powerful drugs, the potential for stigmatization and the creation of a self –fulfilling prophecies are given scant consideration in this “damn the torpedoes, full speed ahead” endeavor. A project studying “pre-psychotic at risk” youth at Yale University has already been criticized for its failure to provide an accurate informed consent document. Mysteriously, it did not mention the possible consequences of treatment with olanzapine! Most recently, the Institute of Psychiatry at the Maudsley Hospital in London has approved a controversial protocol to treat “at risk” youngsters with an atypical psychotic drug (the Guardian, 8/25/02).
5. Let the Force Be With You:
A key element of the PR strategy involves funding from the drug company Eli Lilly being channeled through both the World Psychiatric Association (Rosen et al. 2000) and NAMI (Silverstein, 1999; Oaks, 2000, p. 14) to mount an anti-stigma campaign. The thrust of the anti-stigma campaign is to advocate for the elimination of discrimination against people diagnosed with schizophrenia, so long as they are taking medication- by force if necessary.
Meanwhile, in what appears to be a coordinated strategy, the Treatment Advocacy Center (TAC), which was originally established as branch of NAMI, has been feeding a very different, but complimentary, line to the media and the public about the dangerousness of untreated schizophrenia. This line involves associating untreated schizophrenia with news stories about violent behavior (Torrey & Zdanowicz, 1999, p. 27A) and promoting wild hyperbole about the murderous intentions of untreated schizophrenics: “Violent episodes by individuals with untreated schizophrenia and bipolar disorder have risen dramatically, now accounting for an estimated 1,000 homicides annually in the United States” (Treatment Advocacy Center, 2001). This approach is intended to send an agenda setting spin in the opposite direction by scaring the public and impacting on governments as a law and order imperative. The policy intention with this counter spin is to weaken civil liberties protections in mental health laws in order to increase the number of people eligible for involuntary treatment.
Involuntary treatment is an essential part of the market for schizophrenia drugs. Without involuntary treatment there would be a smaller market because many people diagnosed with schizophrenia initially have to be force-treated with neuroleptic drugs. A central objective of this hyper-stigmatizing, law and order part of the campaign is the introduction of community treatment orders, or outpatients’ commitment. Outpatients’ commitment involves a court order that allows the forced treatment of people living in their own homes. Until the introduction of outpatients’ commitment people could only be force-treated if they were in-patients in hospitals. This limited the number of involuntary patients at any one time to the number of beds available. However, considering the doubtful nature of diagnostic methods used for identifying schizophrenia, outpatient commitment promises to provide an open-ended expansion of the market for the new schizophrenia drugs. Outpatients’ commitment is already well established in most states of Australia and is being progressively introduced, state by state, in the United States.
6. By the Numbers
In the middle 1990s, as a number of the new schizophrenia drugs were passing through their final stages of approval, and these public relations campaigns were gaining momentum, one analyst of the pharmaceutical market argued that the $1 billion a year US market for schizophrenia drugs could be expanded to $4.5 billion a year. Annual sales of Eli Lilly’s drug Zyprexa alone were projected “at $1 billion after five years on the market”. But the analyst argued that the market expansion depended on the removal of two barriers. The first barrier was that currently only half of the 2.5 million Americans with schizophrenic symptoms were then receiving treatment. The implication was that ways would have to be found to ensure treatment reached this other half of the schizophrenic population. The second barrier was that a cheap generic drug was then dominating the market (Reuters Information Service, 1996).
As things have turned out this analyst under-estimated of the potential for a PR-driven expansion of the market for schizophrenia drugs. A Wall Street Journal report in May 2001 describes the market for schizophrenia drugs as a “fast-growing, $5 billion-a-year market” in which Eli Lilly’s Zyprexa has already gained a $2.35 billion share and is “on course to surpass $2.5 billion this year”(Hensley and Burton, 2001). Using a sales figure of 4 billion dollars for “atypical” anti-psychotic drugs in the USA in 2001 the profit realized by Big Pharma is about 740 million dollars! In addition, the atypicals had achieved a market penetration of nearly 90% in the US. In Europe, probably because of national health care systems, their penetration has been around 40%(personal communication, Nina Schooler, Ph.D. April, 2002). So, Big Pharma succeeded in every respect-high profitability and full market penetration for the “atypicals.” Their patents likely will have expired before we really know their serious adverse effects.
VI Policy Implications
Analysts of public policy often dissect the strategies and techniques of vested interests like Big Pharma by using agenda setting theory. Cobb et al (1976) propose three models of agenda building; an outside-initiative model where citizens groups gain broad public support and get an issue onto the formal agenda; a second model where the issues are initiatives that come from government and may need to be placed on the public agenda for successful implementation; and an inside-access model where the policy proposals come from policy communities with easy access to government, usually with support from particular interest groups, but little public involvement.
It is clear that the types of campaigns that have been run by public relations consultants to set the mental health agenda for the pharmaceutical industry utilize all three of these models. They run coordinated campaigns that involve funding consumer advocacy groups to simulate outside-initiatives; they plant stories in the media that are designed to gain public acceptance of policies that are already on the government agenda; and they use the insider-access model when they utilize pharmaceutical industry lobbying organizations to gain easy access to government. This access is facilitated by the millions of dollars pharmaceuticals companies and associations donate to politicians and political parties. (See for example, Mintz, 2000, Public Citizen, 2000).
The use of sophisticated public relations techniques for setting political agendas has become a standard practice in most advanced democracies. The consequences are slowly becoming apparent. The system of representative democracy is being reshaped into a new kind of “managed corporatocracy” in which public opinion and government policy are custom-made products that can be shaped, packaged and sold by skilled public relations experts. This example of a successful campaign to sell a very expensive product-the atypical antipsychotic drugs- is chilling testimony to the power of Big Pharma to have its way with us.
The cynical way in which this shaping, packaging and selling has been carried out in regard to mental health policy-making over the last couple of decades should serve as a warning to anyone who believes that the public good should come before corporate profits. Policies tailored to this commercial purpose are not necessarily beneficial either for patients or the society at large
The acute vulnerability of mental patients to exploitation, and the existence of mental health laws that provide for involuntary detention and treatment of certain classes of mentally disordered people, creates conditions that require vigilant protection of civil liberties and human rights. To do so in the face of the power of a $ 150 billion a year industry (in the U.S.) that has only the “bottom line” to guide its activities is a formidable, and perhaps impossible, task without assertive governmental regulatory intervention. Given the current American political climate it appears that such intervention is unlikely in the foreseeable future.
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Professor Sharon Beder is an honorary professorial fellow at the University of Wollongong.
Sharon Beder's Publications can be found at http://www.uow.edu.au/~sharonb