Curing Financial Conflicts of Interest in Psychiatric Professional Organizations
Abstract and Keywords
Most of the attention to the problem of financial conflicts of interest (FCOI) in psychiatry has centered on the actions of individuals. But what if the problem is much larger, and has infected entire organizations? Using the conceptual, and normative framework of “institutional corruption,” we describe how organized psychiatry has developed values, norms, and practices that have undermined its public health mission. Specifically, we argue that institutionalized FCOI have distorted the evidence base upon which psychiatric research, diagnosis, and treatment depends. We argue that current strategies such as simple transparency of commercial ties and “managing” FCOI are insufficient and vulnerable to gamesmanship. Following the IOM’s most recent (2011) recommendations for preventing bias when there are academic–industry relationships, we offer ideas for responding to the ethical and intellectual crisis in psychiatry, and emphasize the importance of training practitioners to think critically when assessing the evidence base of industry-sponsored research.
It is common to hear patients, families, and the public (as well as practitioners) express strong concerns about the reliability of the evidence base in clinical psychiatry. Certainly, part of the problem is the complexity of psychiatry itself and the limitations of using a natural science paradigm for understanding lived experience and dynamic social interactions. However, the most preventable and reversible sources of unreliability in our evidence arise from academic–industry relationships and from systemic practices that undermine the development of trustworthy diagnostic and treatment guidelines. In addition to these conflicts of interest biasing clinical judgment itself, they also undermine the public’s trust in the profession of psychiatry and the confidence and trust of professionals in psychiatry in the sources of knowledge upon which they base their practice.
These problems are not unique to psychiatry; the entire field of biomedicine has come under scrutiny because of concerns about its improper dependence on industry. But psychiatry has been particularly troubled. Some say it is experiencing a crisis of credibility (Fava 2007). For example, newspapers have spotlighted prominent academic psychiatrists who failed to disclose millions of dollars they received from the pharmaceutical industry (e.g., Harris and Carey 2008). Additionally, there have been widely publicized cases of suspected academic misconduct. Unfortunately, the focus on individual cases actually deflects the psychiatry profession’s attention from the roots of its ethical crisis. Some have begun to use the analytic framework of “institutional corruption” to shift attention from individuals to larger systemic, usually legal, practices that bring an institution off-course and undermine its mission and effectiveness. Ironically, these practices are often widely accepted and defended, ultimately leading to weakened public trust in the institution itself (Lessig 2011).
Some caveats are in order. Academic psychiatrists’ mere association with industry does not imply that they will engage in scientific misconduct. Nor does it imply they will make design or data choices that favor industry interests over the health of patients. We review studies that attempt to go past mere association and examine the influences between industry and academia. Second, we use the term “financial conflicts of interest” (FCOI) within the framework of institutional corruption to focus attention on larger patterns damaging the profession’s credibility. Our use of FCOI contrasts with version that focuses only on individuals, framing industrial ties as a “purely individual problem—that an individual has a conflict and [the psychiatrists] need to manage [them]” (Elliot 2010, p. 161).
One example of these larger patterns is the “funding effect.” Peer-reviewed studies have documented how academic–industry relationships influence medical research and practice. In a 2005 study of 162 clinical trials that were funded by industry, it was found that among these studies, those that reported FCOI were 4.9 more likely to report positive results for pharmaceutical drugs than those that did not report FCOI (Perlis et al. 2005). Researchers studying the impact of pharmaceutical interactions—gifts, lunch rounds, educational funding, etc.—found that these interactions were associated with a negative impact on the knowledge and behavior of residents and physicians. Specifically, after such interactions, individuals were less able to identify correct information about a medication, and began to prescribe more expensive, new medications that held no actual important clinical advantages (Wazana 2000).
In addition to the ways FCOI may bias research, such conflicts also have the potential to undermine the validity and trustworthiness of diagnostic and therapeutic guidelines disseminated by professional psychiatric organizations. In this chapter, we will review some of the ways in which academic–industry relationships may have an undue influence and even a biasing effect on psychiatric practice. We examine and discuss the implications of industry ties on guideline development and patient advocacy groups, and organizations that educate psychiatrists, all of which exert an enormous influence on psychiatric practice. It is important to go beyond examining individual members with financial ties, and look at the institutionalized influence of industry, such as organizational funding, FCOI policy, content and structure of guidelines, and financial ties to boards as a whole. We examine the extent, regulation, and influence of industry ties at the institutional level of organized psychiatry. In addition, we provide recommendations on how these FCOI can be prevented in the future, including the use of checks and balances on the decision-making process, a practice also used in other professions such as government and law, but which has not yet been implemented in medicine.
An additional focus of this chapter is to offer suggestions for ethical reform, and the first step is to recognize that there is a problem, that even if a particular practice is not unethical, it does carry with it a moral risk. The point is not to vilify organized psychiatry (or pharmaceutical companies for that matter, since CEOs have a fiduciary duty to their shareholders) or to condemn individual psychiatrists. Rather, we need to see organized psychiatry as being comprised of individual actors who behave according to well-established professional and guild practices and economies of influence. In terms of the development and revision of the DSM, these practices and economies of influence may incentivize organized psychiatry to accept kappa scores (measures of inter-rater agreement) below standard thresholds of acceptability (see, e.g., Spitzer 2012; Frances 2012) and thus widen diagnostic boundaries of mental disorders. Similarly, in terms of the development of treatment guidelines, these practices and economic dependencies may incentivize organized psychiatry to overemphasize the efficacy of psychotropic medications and discount (and underrepresent) concerns about side effects and safety. Such situations create “ethical blind spots” (Bazerman and Tenbrunsel 2012).
As Sah and Fugh-Burman (2013) astutely note, all physicians are vulnerable to bias and thus are motivated to use rationalizations to deny that financial relationships with pharmaceutical companies could affect their decision-making. For example, although the APA took an important first step in addressing the issue of public trust when they instituted a disclosure policy in 2008, the leadership of the organization publicly maintained that such ties would not exert any influence. In a 2009 interview in USA Today, Darrel Regier, co-chair of the DSM-5 Task Force, stated, “There’s this assumption that a tie with industry is evidence of bias, but these people [APA panel members] can be objective” (Elias, 2009). To deny that such ties carry a moral risk increases the chances that a potential bias will become an actual bias. Thus, Namenwirth’s (1986, p. 29) point is well taken: “scientists firmly believe that as long as they are not conscious of any bias or political agenda, they are neutral and objective, when in fact they are only unconscious.” Decades of research into the nature of interpersonal and organizational biases have demonstrated that a substantial degree of bias is actually implicit and unconscious (Greenwald and Banaji 2013).
Existing Financial Conflicts of Interest in Psychiatric Professional Organizations
In this section, we discuss current arenas ripe with FCOI among psychiatric professional organizations—diagnostic and clinical guidelines, patient advocacy, and continuing medical education—and the existing state of research examining FCOI within them. By “psychiatric professional organizations” we mean entities such as the American Psychiatric Association, which produces Clinical Practice Guidelines (CPGs) and the DSM-5, patient advocacy groups such as the National Alliance on Mental Illness (NAMI), and various groups that produce continuing medical education (CME) programs for psychiatrists.
The APA instituted a conflict of interest policy requiring all panel members on the DSM-5 to file financial disclosure statements. This policy resulted in some changes in work group composition; compared to DSM-IV, some DSM-5 work groups had fewer individuals with industry ties. Elsewhere we reported that this new APA requirement rendered the DSM’s disclosure policy more congruent with most leading medical journals and federal policies on FCOI (Cosgrove and Krimsky 2012). Although the APA’s increased transparency was an important step forward in responding to the issue of FCOI, it is well documented that transparency alone is an insufficient solution to preventing either the appearance or reality of bias. In 2010, the APA issued an official policy document, approved by the Board of Trustees, in which the organization publically declared:
We affirm our support of the Institute of Medicine report
[Conflict of Interest in Medical Research, Education, and Practice]. Members involved in clinical practice, education, research, and administration must be diligent and aware in identifying, minimizing, and appropriately managing secondary (personal) interests (financial, contractual, career-centered) that may inhibit, distract, or unduly influence their judgment or behavior in a manner that detracts from or subordinates the primary interest of patients and may be perceived by some as undermining public trust.
Diagnostic and Clinical Practice Guidelines
Clinical practice guidelines (CPGs) are intended to enhance the practice of evidence-based medicine by streamlining health care delivery and improving the process and outcomes of patient care (Shackelton et al. 2009). CPGs have become increasingly influential to health care providers (Choudhry, Stelfox, and Detsky 2002) because they are a “primary mechanism for communicating clinical aspects of emerging therapies and ‘standard of care’ expectations to practicing physicians” (Genuis 2005, p. 419). Following the recommendations of the CPGs is seen as an essential component of evidence-based medicine because CPGs are assumed to be trustworthy, unbiased, and empirically derived.
Recently, however, critics have raised concerns about the potential for bias when industry-funded researchers develop treatment recommendations included in CPGs (Als-Nielson et al. 2003; Choudhry, Stelfox, and Detsky 2002; Genuis 2005; Grilli et al. 2000; Shackelton et al. 2009; Cosgrove and Shaughnessy, 2011; Cosgrove et al., 2012). Thus, a necessary first step in improving the delivery of health care services is to ensure that CPGs are developed with an absolute minimum of biases, especially those caused by industry’s influence, and are based on correctly interpreted, sound scientific evidence (Boyd and Bero 2006; Mendelson et al. 2011). Bias in CPGs creates the potential to expose patients to harm from unnecessary treatment or from treatment that is not evidence-based. Preventing bias and developing valid and trustworthy CPGs in psychiatry are particularly important issues because many non-psychiatrist physicians prescribe psychotropic medications. For example, in the USA 80 percent of prescriptions for antidepressants are written by non-psychiatrist physicians (Cascade, Kalali, and Halbreich 2008) who turn to the APA’s CPG as a trusted resource.
Although disclosure of any FCOIs was thought to be a robust solution to prevent bias, transparency alone is an insufficient response. Disclosure of FCOI in guideline development groups (GDGs) neither eliminates potential biases nor ensures objectivity and high-quality CPGs. One recent study found that 90 percent of the authors of three major CPGs in psychiatry had financial ties to companies that manufacture drugs that were explicitly or implicitly identified in the guidelines as recommended therapies for their respective mental illnesses (Cosgrove et al. 2009). While ties to industry do not necessarily imply bias in guidelines, the high level of industry ties is remarkable and dampens public trust in CPGs. Critics have become concerned that trends for CPGs becoming “marketing and opinion-based pieces” (Shaneyfelt and Centor 2009, p. 868) have escalated. In response to these concerns, the Institute of Medicine (IOM) recently recommended that, whenever possible guideline developers should avoid a financial conflict of interest, and that, at minimum, those with a conflict should comprise a minority of the GDG (IOM 2011).
In terms of diagnostic guidelines, a comparison of DSM-IV and DSM-5 panel members showed that despite the increased transparency, direct commercial ties meant that, ultimately, FCOI remained strong. Sixty-nine percent of the DSM-5 Task Force members reported financial ties to industry, a 21 percent increase over the DSM-IV Task Force. The persistence of these ties, despite the APA’s disclosure policy, shows that transparency and attempts to “manage” FCOI are not sufficient to prevent at least the appearance—if not the reality—of bias in clinical decision-making. In addition, three-fourths of the Task Force’s work groups continued to have a majority of members with ties to drug firms, and it is noteworthy that, as for DSM-IV, the most conflicted panels for DSM-5 were those for which pharmacological treatment is the first-line intervention (that is, the recommended course of action). For example, 67 percent of the panel for mood disorders, 83 percent of the panel for psychotic disorders, and 100 percent of the panel for sleep/wake disorders (which now includes “Restless Leg Syndrome”) have ties to the pharmaceutical companies that manufacture the medications used to treat these disorders or to companies that service the pharmaceutical industry (Cosgrove and Krimsky 2012). The extent of conflicts of interest among these work groups reveals how important it is to examine and reform the institutional practices that allow for these conflicts and that reinforce them as everyday practice.
Other studies have shown that FCOI, through ties to industry, can widen definitions of psychiatric disorders, potentially resulting in unnecessarily greater pharmaceutical usage in the general public. A 2013 study examined proposals to expand definitions for common disorders in the DSM. Between 2000 and 2013, 10 panels advocated for widened definitions of conditions, which would allow for greater numbers of diagnoses and pre-disease diagnoses, in effect increasing the pool of people eligible for treatments. Five panels made proposals with unclear effects on these definitions, and only one panel called for narrowing definitions; none reported analyses of potential harms of widening definitions (Moynihan et al. 2013). Approximately 75 percent of guideline panel members were found to have financial ties to industry. Among this percentage, the average number of ties per panel member was seven. The authors suggest further study to examine whether the existence of FCOI among guideline development committee members is associated with widening definitions of conditions and lower diagnostic thresholds—which can make diagnosing and therefore prescribing easier and more frequent (Moynihan et al. 2013). In effect, ties to the pharmaceutical industry might lead to pro-industry habits of thought (Lexchin and O’Donovan 2010); individuals with strong and long-term ties may be more likely to favor the creation of new disorders despite a lack of evidence for their validity. These widening definitions should be of concern to the medical and public community and must be a focus of future study. Pathologizing normal human experiences (e.g., grief) not only creates a “false positive” problem but may also have the unintended effect of distracting attention and resources from serious major mental illness.
Industry may also exert an undue influence on patient advocacy groups. These organizations provide support for individuals with certain health conditions, while they also raise awareness, lobby the government for increased research funding, and sometimes provide direct research support themselves (Rose 2013). These groups have a strong and far-reaching impact on patient health education, research, professional development, and health policy. Because of their influence in these domains, the extent and management of FCOI in patient advocacy organizations is a critical public health issue.
Some argue that organizations should be able to receive financial support from industry so long as the organization prioritizes its primary duty to patients (Rose 2013). However, this boundary is unclear, as donations from pharmaceutical companies primarily go toward organizations and areas of interest within organizations that will provide the most return for the donor company, which ties such donations to certain expectations (Rose 2013; Markman 2008; Dresser 2011; Rothman et al. 2011). In 2006–2008, the National Alliance on Mental Illness (NAMI) was shown to have received over $23 million in donations from industry. The donors included companies that manufacture the drugs that NAMI promoted, thus making NAMI serve the pharmaceutical company’s marketing interests. NAMI did not disclose these financial ties until they were investigated (Rose 2013). By investing in patient advocacy organizations through donations, thus creating a significant financial dependence on industry, pharmaceutical companies are able to conceal their influence when patient advocacy organizations lobby the government and provide public education (Rose 2013). Such covert industry penetration of even patient advocacy organizations breeds foreseeable public distrust that will unfortunately limit their effectiveness.
Continuing Medical Education
Some organizations are almost entirely dependent on industry funding. Due to its influence on practice and dependence on industry, continuing medical education (CME) is a crucial site for the rigorous study of FCOI. CME programs are either required or optional educational opportunities for health professionals to remain up to date and knowledgeable about their particular field. Faculty experts, in an academic setting, often teach these courses.
Carl Elliott (2004) provides an in-depth look at how FCOI operates within the CME context in his article “Pharma goes to the laundry: public relations and the business of medical education.” Since their beginnings, CME programs have been regularly funded by a grant from a pharmaceutical company. Historically, industry has funded over 60 percent of CME in the USA (Elliott 2004). In 2006, industry funding for accredited CME programs amounted to $1.2 billion dollars (Steinbrook 2008). The pharmaceutical company then works with for-profit medical education and communications companies (MECCs), who create the specifics of the program. Finally, the MECC pays academic physicians to teach their program. Given CME’s roots in the pharmaceutical industry, Elliot (2004) hypothesizes that these programs are created to influence medical practitioners to favor the sponsoring pharmaceutical company’s products. Indeed, companies spend billions annually to educate doctors, nurses, and health care workers, often offering courses that are free or highly subsidized (Steinbrook 2008; Cosgrove and Bursztajn 2010b). This “third-party” strategy—in which pharmaceutical companies work behind the scenes with MECCs and universities—gives FCOI a concealing veneer of objectivity in delivering medical education. It nearly conceals the pharmaceutical company altogether, and industry’s widespread influence on CME.
Consequentially, CME programs funded by industry can result in the emphasis of drugs rather than preventative and non-pharmaceutical treatment measures (Fugh-Berman 2006). Pharmaceutical firms have been shown to influence the content of CME through hired speakers and ghostwritten presentations (Rodwin 2013). Even though these programs may still contain useful information, they may selectively highlight perceptions about diseases that can predictably lead to increased prescriptions, conveying that particular diseases are epidemic just before providing details on available drug treatments (Fugh-Berman 2006). The programs can promote branded products over less expensive generic products (Rodwin 2013). In 2004, Verispan conducted a survey of 4600 physicians to find that CME seminars were deemed the most effective sales tactics (Fugh-Berman 2006). The educational and promotional activities are funded by the marketing and administration budgets of pharmaceutical companies, which comprise 30–35 percent of these companies’ total revenues (Brodkey 2005). Out of these marketing tactics, 86 percent is targeted to physicians (Brodkey 2005). Substantial but subtle influence may be exerted not only explicitly, such as by controlling content, but also more indirectly by controlling the order of presentation whereby first impressions become last impressions. Although some physicians still do not recognize the influence that financial dependence on industry may have on their judgment (De Freitas et al. 2013), pharmaceutical companies are cognizant of the fact that influencing medical education is an effective means to increase sales.
Gaps in Current Solutions
In this section, we discuss current solutions to FCOI, and the gaps that have yet to be resolved within them. We discuss each of the areas already covered in turn—disclosure policies for clinical guidelines, patient advocacy groups, and continuing medical education.
COI Policies and Disclosure
In response to growing concerns about FCOI in professional organizations, institutions across biomedical fields have worked to increase disclosure by amending their conflict of interest (COI) policies. In 2008, for instance, the APA instituted a disclosure policy for the DSM-5 (APA 2009). There is a general consensus that this is an important first step, but there is increasing evidence that disclosure alone is an insufficient solution—and may have its own iatrogenic or counterproductive effects.
A major gap in COI policies is that they do not address indirect sources of financial influence. For example, pharmaceutical companies may give hundreds of thousands of dollars to departments or academic medical centers in the form of “educational grants” or research funding. These monies are then used to pay the salaries of the researchers investigating the medications manufactured by the company. Thus, although the money is not given directly to the individual, and he/she is not required to disclose this information, a dependency still exists. Similarly, a pharmaceutical company may be a major funding source of an organization of which a researcher or guideline panelist is a member. Organizations are not required to disclose industry ties under current policies.
Additional areas of vulnerability include the fact that many FCOI policies—including those of the APA, only require a temporary hiatus so that, for example, as soon as tenure on DSM is over, one can resume lucrative industry relationships or can leverage being a panel member into new industry relationships. Another lacuna is that there are arbitrary limits set on the amount of money that can be received from industry—for example, the APA allowed panel members to have up to $50,000 in industry stocks while serving on DSM-5, and receive $10,000 a year in any form. Although we applaud the approach of setting limits on amounts of money that can be received as having practical benefits of showing that regulators are serious about the issue of FCOI, even small gifts like free lunches can bias physician decision-making, all the more so when tens of thousands of dollars of investments and gifts are involved (Wazana 2000). The effects that are observed at individual-level behavior when physicians are influenced by investments and gifts (e.g., Wazana 2000) are also seen when analyzing the effects of monetary incentives on group processes and organizational decision-making, as reflected in studies of APA CPGs and the DSM-5 (Moynihan et al. 2013; Cosgrove and Krimsky 2012; Cosgrove et al. 2009; Als-Nielson et al. 2003; Choudhry, Stelfox, and Detsky 2002; Genuis 2005; Grilli et al. 2000; Shackelton et al. 2009). For example, we have analyzed in detail the quality of the medical evidence (i.e., of randomized controlled trials (RCTs) and meta-analyses) used to support the recommendations in the APA’s most recent CPG for depression (Cosgrove et al. 2012), and have examined the possible effect of industry influence on those recommendations.
Beyond Disclosure: Zero Tolerance for FCOI and Checks and Balances
Some research points to the inherent limitations of disclosure policies in reducing bias, and thereby to the need to move beyond disclosure as the sole means for ensuring trustworthiness in the development of guidelines, in clinical research and practice, and in the dissemination of information from patient advocacy groups. Two areas of research illuminate the limited effectiveness of disclosure and its unintended effects. First, there is evidence that even if organizations required both indirect and direct disclosure, bias could still exist within clinical guidelines and medical information (Cosgrove and Bursztajn 2010b; IOM 2011). As a result, disclosure requirements may not deter industry from influencing organizations or clinicians from holding FCOIs. Moreover, current COI policies do not require disclosure of the amount of money granted to an individual, even though it is well documented that even small gifts can significantly influence physician behavior (Wazana 2000).
Second, disclosure can even worsen bias, a counterproductive effect of COI policies. Dana and Loewenstein (2003) have argued that disclosure assumes that the recipients of advice will know how conflicts of interest influence the advisor and will be able to adjust their judgment accordingly. However, recipients of advice, such as patients, tend to believe that advisors, such as doctors, would not mislead them, even when advisors disclose COI. In addition, patients often do not have ready access to these COI disclosures in routine interactions with caregivers. Social scientists have shown that disclosure may actually worsen bias because the individual’s disclosure grants them a “moral license” that can lessen their feelings of guilt (Loewenstein, Sah and Cain 2012). Therefore a disclosure of FCOI can sometimes make the effect of FCOI increase. Another concern with disclosure policies alone has been raised that if an expert in a field has numerous financial ties with different pharmaceutical companies, this individual may justify their FCOI by arguing that the relationships “cancel out” their bias (Relman 2008). Ultimately, we need to be aware of how disclosure may absolve individuals from their responsibility to manage their COI and still permit bias, albeit transparent bias (Krimsky 2010; PLoS Medicine Editors 2013).
For these reasons, scholars have looked beyond disclosure and toward complete prohibition of FCOI. There are obvious difficulties with implementing such proposals. A potential alternative, as noted below, is to have panels of industry-tied and industry-free experts to balance each other out and complement industry-free critics. In 2008, the AMA’s Council on Ethical and Judicial Affairs (CEJA) recommended that physicians and medical institutions should not accept industry funding for education. The CEJA stated that more non-commercial funding of CME is needed. Scholars, however, have argued that organizations do not follow the CEJA’s recommendations because these organizations lack alternative funding sources. In other words, they are highly dependent on industry (Relman 2008).
Until FCOI within GDGs are prohibited (see, for example, the IOM’s most recent 2011 standards) and industries are held accountable for their influence, clinicians must also bear a greater responsibility in terms of ensuring genuine informed consent. Adhering to biased CPG advice undermines the informed consent process. Specifically, clinicians must exercise caution when using CPGs produced by specialty organizations, especially when those organizations do not adhere to the IOM’s standards for ensuring valid and trustworthy CPGs. Informed consent is one way in which clinicians can communicate knowledge about the risks and benefits of medications to patients. Informed consent relative to the limitations of CPGs needs to be a process in which patients are informed of the potential uncertainties and biases regarding their treatment—even if their treatment is in keeping with a CPG (Bursztajn et al. 1990). In addition to the problem of trustworthiness of CPGs, there is little discussion or medical training about how clinicians can communicate the risks and benefits of different medications, when to discontinue medications, or how to monitor patients for withdrawal symptoms. There is the concern that informed consent is seen as only as pro forma documentation rather than a standard-of-care process vital to treating patients in a longitudinal fashion (Coletsos and Bursztajn 2011).
Moving Forward: Recommendations
In response to the challenges discussed above, we must implement comprehensive and strict COI policies that will effectively stop industry influence on psychiatric organizations that impact education, research, policy, and clinical practice. Based on our review and analysis of the literature, we can offer the following recommendations.
COI Policies for Clinical Guidelines
A number of recommendations address disclosure guidelines for the committees that develop clinical guidelines. First, it is important to address indirect ties by enforcing additional disclosure requirements. Second, there should be required independent panelists—individuals without any industry ties—to be a part of all GDGs. Third, following the IOM’s most recent (2011) standards, GDGs must include a broader array of experts and stakeholders; furthermore, GDGs should be “multidisciplinary and balanced, comprising a variety of methodological experts and clinicians, and populations expected to be affected by the CPG” (recommendation 3.1, p. 93). Organizations charged with the responsibility of developing clinical care guidelines must also refrain from “panel stacking” and instead diversify their panel with members of different schools of thought (Lenzer 2013a, 2013b). The APA could take a leadership role in making their GDGs more congruent with the IOM’s policy recommendations for more interdisciplinary perspectives and methodologies, and independent review processes.
Little attention has been given to ways to address FCOI within patient advocacy organizations (PAOs). Rose (2013) recommends limiting the amount of industry funding to these organizations where possible, although this acknowledges the difficulty for organizations that provide services for free. The literature argues for the separation of fundraisers and policymakers within the organizations to prevent subconscious bias toward the financial interests of funding sources. For the most part, there is consensus that donors from industry should not be given a position to influence the way their donations are spent within the organization. Scholars have not fully addressed how to create and implement such firewalls.
In addition, just as observers urge research and clinical guideline panels to develop mechanisms to evaluate their FCOI (for example, the AAMC has proposed that academic institutions implement independent COI review committees), PAOs are recommended to do the same (Rose 2013). PAOs should implement COI policies to require complete disclosure of FCOI that is reinforced, not simply recommended. The disclosure of FCOI should be easy to interpret to the public as only the first step toward allowing patients to be informed and make their own valid judgments (Rose 2013).
Continuing Medical Education
CME programs and universities have recognized the ethical problems that come with depending on industry funding. Some experts have proposed completely to end this relationship as the Mahatma Gandhi Institute of Medical Sciences did in rural India (Fugh-Berman 2006). However, if CME programs were to remove industry funding, how would they be funded? One proposal is to require salaried university hospital faculty to teach CME programs. Universities and not pharmaceutical companies would sponsor these CME programs. Relman (2008) argues that this proposal would be one of the least expensive and most effective alternatives. Fugh-Berman (2006) notes that physicians have the highest median income of workers and therefore should themselves pay for their CME participation, which would be tax-deductible. Rodwin (2013) proposes that Congress should create a tax on pharmaceutical firms, which will serve to fund independent, government-certified, not-for-profit institutions that would develop CME programs. Organizations beyond CME developers can play a leadership role by establishing a policy that only allows non-commercially funded CMEs to fulfill license renewal for psychiatrists (Cosgrove et al. 2013; Cosgrove and Bursztajn, 2009; Cosgrove and Bursztajn, 2010b; Cosgrove and Bursztajn, 2010c). Furthermore, in discussing the process of CME reforms, Relman argues that pharmaceutical representatives should be excluded entirely, to prevent any possibilities of bias (Relman 2008).
Educating the Public
While we must make institutional reforms in the medical sphere, we should also equip both the general public and the broader community of medical professionals to be aware of FCOI and its potential effects. Researchers as well as policy makers and bioethicists have argued that we must educate the public on the effects of FCOI on medical care and how FCOI may bias the practitioners who interpret guidelines and other kinds of medical information.
Education can also help medical professionals and administrators become aware of the larger systemic impact their seemingly small decisions to accept industry funding can make. Elliot sums this point up well:
The academic researcher says: what’s the harm if I take money for signing onto a MECC-produced editorial as long as I agree with everything that it in it? The doctor says: what’s the harm in attending an industry-funded symposium in Boca Raton as long as I look at the presentations with a skeptical eye? The department head says: what’s wrong with taking money from Janssen or Merck to fund our Grand Rounds program if it means we can bring in more high-profile speakers?…. But it is only when all these cogs click together that the machinery is put into motion.
(Elliott 2004, p.22)
In other words, FCOI is a systemic rather than an individual problem. Education can help doctors, researchers, and department heads understand their role in this system. Pharmaceutical companies cannot influence the quality of medical care if everyday decision-makers refuse to participate. But more than mere refusal is needed. Organizations need to engage vigorously in self-criticism, and to invite organizational critics to the table. Journalists have been and must continue to be a central part of this process, and an admirable example has been the work of Pro Publica, an independent and non-profit news organization that explicitly focuses on the public interest. Moreover, critical thinking needs to become a standard part of psychiatric training and continuing education. For example, physicians should understand that even strict adherence to scientific method does not preclude susceptibility to bias in diagnosis and treatment. Physicians should understand their own and their patients’ vulnerabilities to misinformation due to industry influence, such as through online marketing (e.g., Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation) (De Freitas et al. 2013, 2014).
Although much attention has been given to the problems created by individuals who have financial associations with industry, less attention has been given to the systemic and institutionalized practices that create an “economy of influence” (Lessig 2011). These economies of influence—organized psychiatry’s dependence on the pharmaceutical industry and guild interests—distort the evidence base upon which psychiatric research and practice rests. Additionally, there is a lack of focus on reform. The purpose of this chapter is also to identify areas of improvement in order to regain public trust of psychiatry and to restore the integrity of psychiatric practice.
Experts recognize that the effect of one individual’s financial ties is unclear and difficult to measure. However, researchers have shown that FCOI within whole institutions raise legitimate concerns because of the large influence these organizations collectively have on clinical practice. The research and recommendations reviewed in this chapter seek to ensure that psychiatric information has built-in checks and balances for CPG committees, advocacy organizations, and CMEs. These recommendations have ranged from increasing disclosure of indirect and anticipatory ties, hiring members who can counterbalance industry-influenced members on guideline committees, creating a truly evidence-based, valid, and reliable diagnostic manual, and locating alternative sources to industry funding by encouraging more universities to take more responsibility for CME.
When our representatives to governmental office have financial conflicts of interest, the public and legislators respond quickly to these with a sense of outrage, sometimes even finding grounds for impeachment or stepping down from office. With leaders in business, we consider financial conflicts of interest ground for imprisonment. Yet with medicine, and psychiatry in particular, our moral intuitions have stagnated, and we accept practices that in any other contexts would be unthinkable. But the irony is that what is at stake is our individual and collective health and well-being, something much less controversial than anything debated in politics and business. Ultimately, as in business and government, in medicine and psychiatry, a zero-tolerance policy towards financial conflict of interest is the only sustainable way forward.
Summary of Recommendations
There exists extensive literature and discussion on FCOI in research and clinical practice, but, until very recently, the FCOI in organized psychiatry has been widely overlooked. This oversight includes organizations such as the APA, which oversees the creation of the DSM, panels that oversee the creation of CPGs, CME programs, and PAOs. We have collected the current literature on FCOI in these areas and provide a summary of recommendations here.
Most recommendations suggest ways to improve COI policies within organizations. We recommend that COI policies require disclosure of indirect ties, and that independent groups are created to monitor the FCOI of various organizations. These policies should also extend to apply not only to the creation of clinical guidelines, but also to philanthropic organizations that influence research and public education.
Differing opinions have been voiced regarding the percentage of panel members that should be allowed to hold financial ties. Some argue that we should mandate a certain percentage to hold zero ties. Others argue that we can “balance” the FCOI within panels by actively recruiting critics of industry. However, these recommendations both assume an ambivalent position regarding the importance and impact of FCOI by still allowing for some members of these panels to hold financial ties. Some experts argue that one would never balance senators with FCOI on a US financial regulatory committee with senators without FCOI. This is why these experts recommend that panel members should be prohibited from holding financial ties entirely. In keeping with the IOM’s (2011) most recent standards for developing valid and trustworthy CPGs, we recommend that the chair be free of all ties and that there should be a rebuttable presumption that all diagnostic and clinical care GDGs should be free of FCOI. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult for the GDG, but they would not have decision-making or voting authority.
Regarding the content of CPGs and the DSM, it is clear that we need to take measures to better highlight the side effects of medications in a more conspicuous manner, and to provide more evidence of the efficacy of medications by requiring industry-independent clinical trials of longer duration and vigorous post-marketing monitoring for both long-term efficacy and side effects. Additionally, a reconsideration of the current process by which the DSM’s diagnostic categories are formulated, with a greater emphasis on the natural history of mental disorders and levels of suffering and impairment they engender, is needed. For chronic mental illness this calls for a move from an overemphasis on diagnosis to a focus on a dynamic formulation in understanding the person’s condition, suffering, and impairment over time. Such a move will likely make the 12-weeks-in-duration psychotropic pharmacological studies, on which industry-tied clinicians rely, and which the current structure of the DSM enables, far less likely to be unduly influential for treatment and research purposes.
Lastly, CME programs should decrease dependency on pharmaceutical industries for funding. Instead, some experts propose that industry-independent faculty should be responsible for providing continuing education to physicians. For this to occur it, will mean rethinking funding for education. What will be needed is industry-independent funding, be it more public funding for educational programs through public institutions such as the National Institute of Mental Health, the Federal Drug and Alcohol Administration, or industry independent private foundations.
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