A number of recent research studies have raised questions regarding the efficacy of many commonly prescribed psychotropic medications, including antidepressants. In some studies, these drugs do not perform better than placebo, when the placebo is selected to mimic the side effects that frequently allow participants in “double blind” randomized drug trials to tell whether or not they were given the active drug.
Now a new study adds to concerns by suggesting that antidepressant use may cause harm by significantly raising the likelihood of relapse upon cessation of medication in patients receiving them. In a meta-analysis quantitatively combing data from a number of published studies, Paul Andrews of McMaster University found that antidepressant use increased the risk of relapse from 25% among those not receiving drugs to 42% among those who received antidepressants, as described in a McMaster press release.
They [Andrews and colleagues] analyzed research on subjects who started on medications and were switched to placebos, subjects who were administered placebos throughout their treatment, and subjects who continued to take medication throughout their course of treatment.
Andrews says anti-depressants interfere with the brain’s natural self-regulation of serotonin and other neurotransmitters, and that the brain can overcorrect once medication is suspended, triggering new depression.
Andrews, an evolutionary biologist, uses these results as the basis for speculation about the nature of depression and whether it should be conceptualized as a disease or “disorder”:
“There’s a lot of debate about whether or not depression is truly a disorder, as most clinicians and the majority of the psychiatric establishment believe, or whether it’s an evolved adaptation that does something useful,” he says.
Longitudinal studies cited in the paper show that more than 40 per cent of the population may experience major depression at some point in their lives.
Most depressive episodes are triggered by traumatic events such as the death of a loved one, the end of a relationship or the loss of a job. Andrews says the brain may blunt other functions such as appetite, sex drive, sleep and social connectivity, to focus its effort on coping with the traumatic event.
Just as the body uses fever to fight infection, he believes the brain may also be using depression to fight unusual stress.
If these authors’ view that depression is, in most cases, a natural mechanism to deal with stress, then “treating” it with drugs that short circuit the healing process may be counterproductive in many ways.
As with all new research, we should be cautious about interpreting these results until they are critically examined by other researchers. Like with other research methods, there is often no consensus as to whether a meta-analysis has been properly conducted.
If this study holds up after critical examination, these new results should increase concerns that antidepressants are, at best, radically over-prescribed. Physicians, including primary care physicians who often know little about the subtleties of antidepressant use, often use these medicines as the first, and even only treatment for most depressions. Though knowledge about the danger of relapse when discontinuing these drugs has spread among thoughtful psychiatrists in recent years, this knowledge has often not spread to primary care physicians and others who do most of the prescribing of these medications.
Thus, extant evidence suggests that, these medications should be used carefully. This new study ads to evidence that these drugs should be used sparingly and that, once administered, antidepressants should not be discontinued quickly, but should be gradually tapered over a long time to give the brain’s neurotransmitter systems time to adjust.
Current patterns of antidepressant use may be causing serious harm to public health, this and other studies suggest. Thus, the mental health field should seriously reconsider whether antidepressant use should continue to be the first-line treatment for those suffering from depression. If these drugs increase relapse rates while having uncertain efficacy in many cases, they should be used sparingly and with caution.
Alternatively, first-line use of psychological treatment approaches that aid the body’s natural coping processes may avoid the problems with antidepressant use, including difficulty in withdrawing from the drugs and increased likelihood of relapse. Alas, the power of the pharmaceutical industry makes such reconsideration difficult. When there are billions of dollars at stake, science and public health often count for little.
Here is the press release from McMaster University:
Patients who use anti-depressants are more likely to suffer relapse, researcher finds
Patients who use anti-depressants are much more likely to suffer relapses of major depression than those who use no medication at all, concludes a McMaster researcher.
In a paper that is likely to ignite new controversy in the hotly debated field of depression and medication, evolutionary psychologist Paul Andrews concludes that patients who have used anti-depressant medications can be nearly twice as susceptible to future episodes of major depression.
Andrews, an assistant professor in the Department of Psychology, Neuroscience & Behaviour, is the lead author of a new paper in the journal Frontiers of Psychology.
The meta-analysis suggests that people who have not been taking any medication are at a 25 per cent risk of relapse, compared to 42 per cent or higher for those who have taken and gone off an anti-depressant.
Andrews and his colleagues studied dozens of previously published studies to compare outcomes for patients who used anti-depressants compared to those who used placebos.
They analyzed research on subjects who started on medications and were switched to placebos, subjects who were administered placebos throughout their treatment, and subjects who continued to take medication throughout their course of treatment.
Andrews says anti-depressants interfere with the brain’s natural self-regulation of serotonin and other neurotransmitters, and that the brain can overcorrect once medication is suspended, triggering new depression.
Though there are several forms of antidepressants, all of them disturb the brain’s natural regulatory mechanisms, which he compares to putting a weight on a spring. The brain, like the spring, pushes back against the weight. Going off antidepressant drugs is like removing the weight from the spring, leaving the person at increased risk of depression when the brain’s regulating mechanism, like the compressed spring, overextends before retracting to its resting state.
“We found that the more these drugs affect serotonin and other neurotransmitters in your brain – and that’s what they’re supposed to do – the greater your risk of relapse once you stop taking them,” Andrews says. “All these drugs do reduce symptoms, probably to some degree, in the short-term. The trick is what happens in the long term. Our results suggest that when you try to go off the drugs, depression will bounce back. This can leave people stuck in a cycle where they need to keep taking anti-depressants to prevent a return of symptoms.”
Andrews believes depression may actually be a natural and beneficial – though painful – state in which the brain is working to cope with stress.
“There’s a lot of debate about whether or not depression is truly a disorder, as most clinicians and the majority of the psychiatric establishment believe, or whether it’s an evolved adaptation that does something useful,” he says.
Longitudinal studies cited in the paper show that more than 40 per cent of the population may experience major depression at some point in their lives.
Most depressive episodes are triggered by traumatic events such as the death of a loved one, the end of a relationship or the loss of a job. Andrews says the brain may blunt other functions such as appetite, sex drive, sleep and social connectivity, to focus its effort on coping with the traumatic event.
Just as the body uses fever to fight infection, he believes the brain may also be using depression to fight unusual stress.
Not every case is the same, and severe cases can reach the point where they are clearly not beneficial, he emphasizes.
July 20th, 2011
By Roy Eidelson, Marc Pilisuk, and Stephen Soldz
Why is the world’s largest organization of psychologists so aggressively promoting a new, massive, and untested military program? The APA’s enthusiasm for mandatory “resilience training” for all U.S. soldiers is troubling on many counts.
The January 2011 issue of the American Psychologist, the American Psychological Association’s (APA) flagship journal, is devoted entirely to 13 articles that detail and celebrate the virtues of a new U.S. Army-APA collaboration. Built around positive psychology and with key contributions from former APA president Martin Seligman and his colleagues, Comprehensive Soldier Fitness (CSF) is a $125 million resilience training initiative designed to reduce and prevent the adverse psychological consequences of combat for our soldiers and veterans. While these are undoubtedly worthy aspirations, the special issue is nevertheless troubling in several important respects: the authors of the articles, all of whom are involved in the CSF program, offer very little discussion of conceptual and ethical considerations; the special issue does not provide a forum for any independent critical or cautionary voices whatsoever; and through this format, the APA itself has adopted a jingoistic cheerleading stance toward a research project about which many crucial questions should be posed. We discuss these and related concerns below.
At the outset, we want to be clear that we are not questioning the valuable role that talented and dedicated psychologists play in the military, nor certainly the importance of providing our soldiers and veterans with the best care possible. As long as our country has a military, our soldiers should be prepared to face the hazards and horrors they may experience. Military service is highly stressful, and psychological challenges and difficulties understandably arise frequently. These issues are created or exacerbated by a wide range of features characteristic of military life, such as separation from family, frequent relocations, and especially deployment to combat zones with ongoing threats of injury and death and exposure to acts of unspeakable violence. The stress of repeated tours of duty, including witnessing the loss of lives of comrades and civilians, can produce extensive emotional and behavioral consequences that persist long after soldiers return home. They include heightened risk of suicide, posttraumatic stress disorder (PTSD), substance abuse, and family violence.
Conceptual and Empirical Concerns
Although its advocates prefer to describe Comprehensive Soldier Fitness as a training program, it is indisputably a research project of enormous size and scope, one in which a million soldiers are required to participate. Reivich, Seligman, and McBride write in one of the special issue articles, “We hypothesize that these skills will enhance soldiers’ ability to handle adversity, prevent depression and anxiety, prevent PTSD, and enhance overall well-being and performance” (p. 26, emphasis added). This is the very core of the entire CSF program, yet it is merely a hypothesis — a tentative explanation or prediction that can only be confirmed through further research.
There seems to be reluctance and inconsistency among the CSF promoters in acknowledging that CSF is “research” and therefore should entail certain protections routinely granted to those who participate in research studies. Seligman explained to the APA’s Monitor on Psychology, “This is the largest study — 1.1 million soldiers — psychology has ever been involved in” (a “study” is a common synonym for “research project”). Butwhen asked during an NPR interview whether CSF would be “the largest-ever experiment,” Brig. Gen. Cornum, who oversees the program, responded, “Well, we’re not describing it as an experiment. We’re describing it as training.” Despite the fact that CSF is incontrovertibly a research study, standard and important questions about experimental interventions like CSF are neither asked nor answered in the special issue. This neglect is all the more troubling given that the program is so massive and expensive, and the stakes are so high.
It is highly unusual for the effectiveness of such a huge and consequential intervention program not to be convincingly demonstrated first in carefully conducted randomized controlled trials — before being rolled out under less controlled conditions. Such preliminary studies are far from a mere formality. The literature on prevention interventions is full of well-intentioned efforts that either failed to have positive effects or, even worse, had harmful consequences for those receiving them. For instance, in the 1990s the DARE (Drug Abuse Resistance Education) substance abuse prevention program was administered in thousands of elementary schools across the U.S., at a cost of many hundreds of millions of dollars. Yet evaluations of DARE rarely found the desired effects in regard to reducing young people’s later substance use (e.g., see this and this summary). In response, DARE was modified in the last decade; however, subsequent evaluation found that the revised program actually increased later alcohol and cigarette use in those who received it compared to controls.
Similarly, criminal justice researcher Joan McCord has demonstrated how well-meaning programs have caused actual harm. She conducted a 30-year follow-up of a classic delinquency prevention program. Those participants randomly selected for intervention, but not matched controls, were provided with extensive enrichment, including mentoring, counseling, and summer camp. Among the matched pairs who differed in outcomes decades later, those who received the intensive assistance were more likely to have been convicted of serious street crimes; were more frequently given a diagnosis of alcoholism, schizophrenia, or manic depression; and on average died five years younger. Other studies of criminal justice interventions have also uncovered unanticipated, deleterious effects. Given this well known record, it is especially concerning when a major intervention is rolled out for thousands — or hundreds of thousands — without careful prior examination, including an investigation of potential negative effects. The special issue of the American Psychologist gives no indication that preliminary studies of CSF were conducted.
Also problematic, the CSF program is adapted primarily from the Penn Resiliency Program (PRP) where interventions were focused on dramatically different, non-military populations. Even with these groups, a 2009 meta-analysis of 17 controlled studies reveals that the PRP program has been only modestly and inconsistently effective. PRP produced small reductions in mild self-reported depressive symptoms, but it did so only in children already identified as at high risk for depression and not for those from the general population. Nor did PRP interventions reduce symptoms more than comparison prevention programs based on other principles, raising questions as to whether PRP’s effects are related to the “resilience” theory undergirding the program. Further, like many experimental programs, PRP had better outcomes when administered by highly trained research staff than when given by staff recruited from the community. This raises doubts as to how effectively the CSF program will be administered by non-commissioned officers who are required to serve as “Master Resilience Trainers.”
Regardless of how one evaluates prior PRP research, PRP’s effects when targeting middle-school students, college students, and adult groups can hardly be considered generalizable to the challenges and experiences that routinely face our soldiers in combat, including those that regularly trigger PTSD. In an inadequate attempt to bridge this gap rhetorically, CSF proponents describe PTSD as “a nasty combination of depressive and anxiety symptoms” (Reivich, Seligman, & McBride, p. 26). In fact, PTSD involves a far more complicated cluster of severe symptoms in response to a specific traumatic event, including flashbacks, partial amnesia, difficulty sleeping, personality changes, outbursts of anger, hypervigilance, avoidance, and emotional numbing.
Ethical Concerns
We also believe that other key aspects of Comprehensive Soldier Fitness should have received explicit discussion in this special issue. It is standard practice for an independent and unbiased ethics review committee (an “institutional review board” or “IRB”) to evaluate the ethical issues arising from a research project prior to its implementation. This review and approval process may in fact have occurred for CSF, but the manner in which the principals blur “research” and “training” leads us to wish for much greater clarity here. This process is even more critical given that the soldiers apparently have no informed consent protections — they are all required to participate in the CSF program. Such research violates the Nuremberg Code developed during the post-World War II trials of Nazi doctors. That code begins by stating:
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
Disturbingly, however, this mandatory participation in a research study does not violate Section 8.05 of the APA’s own Ethics Code, which allows for the suspension of informed consent “where otherwise permitted by law or federal or institutional regulations.” Despite the APA’s stance, we should never forget that the velvet glove of authoritarian planning, no matter how well intended, is no substitute for the protected freedoms of individuals to make their own choices, mistakes, and dissenting judgments. Respect for informed consent is more, not less, important in total environments like the military where individual dissent is often severely discouraged and often punished.
More broadly, the 13 articles fail to explore potential ethical concerns related to the uncertain effects of the CSF training itself. In fact, the only question of this sort raised in the special issue — by Tedeschi and McNally in one article and by Lester, McBride, Bliese, and Adler in another — is whether it might be unethical to withholdthe CSF training from soldiers. Certainly, there are other ethical quandaries that require serious discussion if the CSF program’s effectiveness is to be appropriately evaluated. For example, might the training actually cause harm? Might soldiers who have been trained to resiliently view combat as a growth opportunity be more likely to ignore or under-estimate real dangers, thereby placing themselves, their comrades, or civilians at heightened risk of harm?
Similarly, by increasing perseverance in the face of adversity, might the CSF training lead soldiers to engage in actions that may later cause regret (e.g., the shooting of civilians at a roadblock in an ambiguous situation), thereby increasing the potential for PTSD or other post-combat psychological difficulties? Or, might the resilience training lead some to overcome, for the time, the disabling effects of traumatic episodes and thereby increase the likelihood of their redeployment to situations with further risk of serious disability? The likelihood of these eventualities, or other negative effects, is unknown. But certainly they are sufficiently plausible — as plausible as McCord’s unexpected findings, noted earlier, of intensive counseling and summer camp leading to increased crime, mental illness diagnosis, and early death among participating youth — that they cannot legitimately be ruled out a priori. These possibilities increase the ethical responsibility of those promoting CSF to conduct pilot studies, carefully monitor them for possible negative effects upon soldiers or others, submit the program to careful ethical review, and seek informed consent.
It is also important to note here two controversial aspects of the Comprehensive Soldier Fitness program that have already received attention from investigative journalists. First, Mark Benjamin has raised provocative questions, not yet fully answered, about the circumstances surrounding the huge, $31 million no-bid contract awarded to Seligman (“whose work formed the psychological underpinnings of the Bush administration’s torture program”) by the Department of Defense for his team’s CSF involvement. Benjamin notes that the government allows sole-source contracts only under very limited conditions. The Army contract documents note that “there is only one responsible source due to a unique capability provided, and no other supplies or services will satisfy agency requirements.” But as we have detailed above, public claims about the effectiveness of the Penn Resiliency Program and its superiority to alternative prevention programs are significantly overstated, casting doubt upon the rationale for awarding the sole-source contract.
Second, Jason Leopold and others have raised serious questions about the “spiritual fitness” component of the CSF program, which appears to inappropriately promote a religious worldview as an important path to greater resilience and purpose. The special issue article by Pargament and Sweeney confirms the legitimacy of this concern. It includes a range of theologically oriented terms and references, and it specifically identifies the Army’s chaplain corps as a resource “to assist individuals in their quests to develop their spirits” (p. 61).
The Limits of Positive Psychology
Comprehensive Soldier Fitness draws heavily on “positive psychology” in aiming to reduce the incidence of psychological harm resulting from combat and post-combat stress. The field of positive psychology has grown dramatically over the past decade and has many exuberant supporters and evangelists. Rather than focusing on distress and pathology, they emphasize human strengths and virtues, happiness, and the potential to derive positive meaning from stressful circumstances. Few would dispute the benefits of broadening psychology’s purview in this way. But writers such as Barbara Held, Barbara Ehrenreich, Eugene Taylor and James Coynehave offered compelling critiques of positive psychology, including its failure to sufficiently recognize the valuable functions played by “negative” emotions like anger, sorrow, and fear; its slick marketing and disregard for harsh and unforgiving societal realities like poverty; its failure to examine the depth and richness of human experience; and its growing tendency to promote claims without sufficient scientific support (e.g., the relationship between positive psychological states and health outcomes, or the mechanisms underlying “posttraumatic growth”).
These and related concerns are directly relevant to Comprehensive Soldier Fitness. As described by Cornum, Matthews, and Seligman in the special issue, the CSF program aspires “to increase the number of soldiers who derive meaning and personal growth from their combat experience” (p. 6). But in many ways the technocratic language of military training programs and the positive psychology strategies that characterize the CSF program appear inadequate for the task. Activities such as the “three blessings exercise” in which the individual reflects on what went well that day and why seem ill-suited for encouraging and supporting the deep questioning and open exploration of existential issues that often arise for soldiers facing extreme circumstances. By all indications, the program’s positive psychology orientation also fails to scrutinize those very institutions that subject recruits to potential trauma in order to create people sufficiently hardy to engage in death-defying and death-inflicting experiences.
In this regard, it is worth noting how special issue authors Peterson, Park, and Castro briefly discuss the lowertrust scores of female soldiers on the CSF program’s Global Assessment Tool (GAT), which measures psychological fitness in four domains (social, emotional, spiritual, and family). They interpret these results as suggesting “Female soldiers do not feel as fully at ease in the Army as do male soldiers,” and they recommend further research to “understand the needs and challenges of female soldiers and to help them attain the same morale as male soldiers, which perhaps would reduce attrition among them” (p. 15-16). What goes unmentioned is that the extremely high rates of sexual assault on women soldiers, condoned or covered up by others higher in rank, is clearly a source of distrust and trauma — and it calls less for building a positive, resilient outlook among the victims than for recognition of how the commonplace victimization of women in war should be vociferously prevented.
In important ways, key lessons of humanistic psychology are also regrettably overlooked in the CSF program. For many soldiers, combat awakens questions regarding the meaning of life and of its worth, which can become more persistent after returning home. Too often, our veterans face anomie, lack of community, and the replacement of caring ties with the competitive values of marketability when their military service is over. Humanistic and related perspectives more directly and fully attend to this void, the emptiness of contemporary society that increases the difficulties in recovery from trauma, than does positive psychology. Because of the limitations of quantitative psychology to date, the data for phenomena of this type are more frequently found in stories than in self-report inventories such as the GAT. Limited data encourage a limited view of the phenomenon of PTSD and of any resilience that is based upon denial. In contrast, it is through revelations such as the Winter Soldier testimonies of U.S. veterans and active duty soldiers from Afghanistan and Iraq, through studies of the phenomenology of returning soldiers by Daryl Paulson and Stanley Krippner, or accounts of soldier participants in U.S. torture as relayed by journalists Joshua Phillips and Justine Sharrock, that we are able to see how much distress comes from abuses soldiers commit either as a result of commands from superiors or due to the morally disorienting effects of ambiguous combat situations.
Indeed, among the most traumatic psychological scars that soldiers sustain are those resulting from what they have done to others. Some of the particularly intense characteristics of PTSD are found among perpetrators. AsCol. Dave Grossman and others have described, human beings have an inherent resistance to killing other human beings. As a result, waging war almost always relies upon propaganda and training designed to dehumanize the enemy and elevate one’s own cause. Psychology and psychologists have contributed to training programs aimed at increasing soldiers’ willingness to kill. Now this newest positive psychology program for resilience promises to shield soldiers from some of the debilitating consequences of their actions and, as Reivich, Seligman and McBride note, it aims to better enable soldiers to “live the Warrior Ethos — ‘I will always place the mission first. I will never accept defeat. I will never quit. I will never leave a fallen comrade’” (p. 27).
Missing, it would seem, is any meaningful CSF component devoted to helping soldiers grapple with the profound ethical dilemmas involved in their duties, including killing others in furtherance of state policy. Brett Litz and his colleagues have used the term “moral injury” to describe the exceedingly difficult challenges and consequences that soldiers face in response to “perpetrating, failing to prevent, bearing witness to, or learning about acts that transgress deeply held moral beliefs and expectations” (p. 700). These are especially troubling omissions from the CSF program when we also consider the regrettable reality that many recruits, often drawn to the military by economic necessity and deceptive marketing strategies, are never told about the types of injuries to which they will be exposed or the level of slaughter in which some of them will take part.
The U.S. Military and American Psychology
In the closing article of the special issue, Seligman and Fowler (former CEO of the APA) attempt to counter the objections they anticipate from readers who have concerns about how closely the American Psychological Association and the profession of psychology should align themselves with the agenda of the U.S. military. Certainly, such reader concerns are not entirely unfounded, especially given the tragic repercussions of the APA’s decisions post-9/11 to shape its ethics code, policies, and pronouncements to meet the perceived needsof an administration that viewed torture and other detainee abuse as legitimate components of national security practice. Unfortunately, however, Seligman and Fowler’s arguments serve only to instill greater concern about the foundations of the Comprehensive Soldier Fitness program and the role of institutional psychology in advancing it, as we explain below by responding to three statements from their article.
“It is not the military that sets the nation’s policies on war and peace. The military carries out the policies that emerge from our democratic form of government. Withholding professional and scientific support for the people who provide the nation’s defense is, we believe, simply wrong” (p. 85)
No one recommends withholding services from anyone in need. Indeed, health professionals deserve to be commended for providing such support to our soldiers and veterans. But when acting ethically, health professionals address the needs of their clients before the wishes of the institutions that hire them. Therefore, if those institutions constrain the options available for the well-being of the practitioners’ clients, these professionals have an obligation to consider remedies beyond the narrow institutionally defined interests. For example, the CSF program does not include a component whereby participants are invited to listen to fellow soldiers and veterans who have enhanced their own safety, well-being, and sense of purpose by refusing to comply with illicit orders, or by deciding, as have so many other American citizens, that the war they are fighting is unjust and immoral.
In addition, whether the U.S. military plays a role in establishing policies is not a matter to be determined by recitation of formal rules. Scholarship involves an obligation to look at the actual evidence. Generals routinely make political statements in which they advocate for the latest war. Major military contractors work closely with military officials to sell both weapons of war and war itself. Retired military officers are then often hired as lobbyists for these same corporations, and some appear as military “experts” in the media without revealing their conflicts of interest. The exorbitant budget for “perception management” services paid to professional propaganda organizations is also used by the military to spin news and promote war to government officials and the public alike. And, as recently reported by Rolling Stone, psychological operations (“psyops”) techniques were used by the military on visiting U.S. Senators to strengthen their support of the increasinglyunpopular Afghan war effort.
“The balance of good done by building the physical and mental fitness of our soldiers far outweighs any harm that might be done” (p. 86).
It is disappointing that researchers who have emphasized the purported empirical underpinnings of the CSF program would here abandon all semblance of scholarly rigor. The authors offer their cost-benefit claim as transparently true (i.e., the good outweighing the harm). But they offer no evidence in support of this crucial claim. For example, in their calculation how much weight do they give to the tragic numbers of civilian casualties in Iraq (minimally estimated in the hundreds of thousands) and Afghanistan — the dead, the injured, and the displaced? Does this harm matter at all to those promoting CSF? Have we reached the point where “do no harm,” the fundamental principle underlying the psychology profession’s ethics, has become “do no harm to Americans, unless it serves the interests of the state”? These issues deserve careful consideration, not evasion.
We should also keep in mind that every effort to support military operations is billed as “support for our troops.” Whether it is the use of drones that kill from a continent away or tapping into a soldier’s capacity to kill without a serious hangover, all are justified as for the brave troops. But the decisions to use military force are not made with the well-being of military personnel in mind, nor are they made by soldiers or even influenced by their desires. Master resilience trainers in the Army will not be urging soldiers to report violations of the rules of engagement by their superiors. They will not encourage soldiers to empathize with the humanity of the adults and children whom they may have killed as collateral damage, nor to use forms of restorative justice for apology and reconciliation that have a potential for deeper healing. And they will not encourage troops to build supportive ties with those critical of the wars they are fighting or the tactics required of them.
“We are proud to aid our military in defending and protecting our nation right now, and we will be proud to help our soldiers and their families into the peace that will follow” (p. 86).
The blind embrace of overly simple notions of “patriotism” is inappropriate for professional psychologists dedicated to the promotion of universal human health and well-being. Ideological convictions based upon mythologies of American exceptionalism are no substitute for an examination of their verity. If it is not true that the U.S. is defending its democratic foundations against ruthless adversaries, then the balance shifts dramatically toward averting the alleged harm of making healthier killers. By tying the CSF program to claims of the rightness of American military goals and actions, Seligman and Fowler are, unrecognized by them, requiring that an ethical evaluation include a comprehensive empirical evaluation of the justification for those policies.
Such an evaluation likely will find that the view of U.S. military history as being primarily “defensive” in nature, rather than one of imperial control, is false. Rather, the U.S. has a long history of intervening in other countries and overthrowing their governments when they act in ways considered to be against U.S. national interests. Where does the “defending and protecting” reality lie in regard to the war in Iraq, or the invasion of Guyana, or the support for the Venezuelan coup, or the bombing of Serbia, or military aid to dictators around the world? Sadly, history (and scholars such as retired U.S. Col. Andrew Bacevich, among many others) has shown how remarkably war-prone the United States has been in the non-defensive pursuit of its foreign policy and “national interest.” The U.S. is, in fact, at best only inconsistently a defender of democracy. Our empire-building behavior has caused great harm to our own safety and well-being — and to the principles our country purports to value. Meanwhile, the promise of peace following military victories has surely not materialized, while the case for the extent of U.S. engagement in wars that were unneeded is extensive and compelling. It is not professionally responsible to ignore these facts.
Conclusion
In addition to our deep concerns about Comprehensive Soldier Fitness, the American Psychological Association’s unrestrained enthusiasm for the program is especially worrisome for what it says about the APA, the largest organization of psychologists in the country, indeed the world. As we have demonstrated, there are many complex issues regarding the CSF program’s empirical foundations, its promotion as a massive research project absent informed consent, and the basis on which its psychologist developers justify the program. We would therefore expect a special issue of the American Psychologist, a journal edited by the APA’s CEO Norman Anderson, to encourage an extended discussion of these matters.
In contrast, guest editors Seligman and Matthews have assembled 13 articles that include no independent evaluation of the empirical claims underlying CSF. They contain no unbiased discussion of ethical issues raised by the program. They do nothing to enlighten psychologists about ethical challenges posed by consulting and research work with the military. And they most certainly offer no encouragement for questioning the foreign policy context in which our soldiers are sent into combat, to face physical and moral hazards for which even the best program can never adequately prepare them. Unfortunately, the APA’s uncritical promotion of the CSF program reveals much about the current moral challenges facing the psychology profession itself.
Psychology should maintain an ethical and critical stance distinct from and resistant to the lure of patriotic calls, which are part of each and every military undertaking — by all nations — regardless of the legitimacy of the cause. As psychologists we should tread carefully when our efforts are solely directed toward sending soldiers back into combat rather than counseling them away from participating in misguided wars. In a similar way, assessing soldiers for their potential to withstand such horrors of war and building their resilience through teaching mental toughness skills are not necessarily healthy alternatives compared to affirming and assisting them in their expressions of doubt and dissent.
Ultimately, there is a paradox that should be foremost in the minds of professional psychologists. Helping people who have already been harmed by trauma is essential. But should we be involved in helping an institution prepare to place more people in harm’s way without careful and ongoing questioning and review of the rationale for doing so? Whatever the needs for a military for national defense, or the benefits of team building, loyalty, camaraderie, and a positive outlook, militaries are, among other things, authoritarian institutions that kill, maim, deceive, and actively reduce an individual’s sense of independent agency.
The enormous toll that armed conflict exacts on soldiers, veterans, families, and communities is a key reason why we should send young men and women to war only as an absolute last resort — and we should bring them home as quickly as possible, rather than sending them back again and again. If the Comprehensive Soldier Fitness program is truly about enhancing well-being, then we should also question whether these soldiers might be helped more effectively by finding non-military ways to resolve the conflicts and concerns for which they carry such heavy burdens.
Authors
Roy Eidelson is a clinical psychologist and the president of Eidelson Consulting, where he studies, writes about, and consults on the role of psychological issues in political, organizational, and group conflict settings. He is past president of Psychologists for Social Responsibility, associate director of the Solomon Asch Center for Study of Ethnopolitical Conflict at Bryn Mawr College, and a member of the Coalition for an Ethical Psychology. Roy can be reached at reidelson@eidelsonconsulting.com.
Marc Pilisuk is Professor Emeritus, the University of California, and Professor, Saybrook Graduate School and Research Center. He is the author (with Jennifer Achord Rountree) of Who Benefits from Global Violence and War: Uncovering a Destructive System (Greenwood/Praeger, 2008), and the co-editor (with Michael Nagler) ofPeace Movements Worldwide (Praeger/ABC-CLIO, 2011). Marc can be reached at mpilisuk@saybrook.edu.
Stephen Soldz is a psychoanalyst, psychologist, public health researcher, faculty member at the Boston Graduate School of Psychoanalysis, and president of Psychologists for Social Responsibility. He has conducted extensive research on psychosocial prevention and treatment interventions. He edits the Psyche, Science, and Society blog and is a founder of the Coalition for an Ethical Psychology, one of the organizations working to change American Psychological Association policy on participation in abusive interrogations. Stephen can be reached at ssoldz@bgsp.edu.
March 26th, 2011
The New York Times has an interesting article about controversy in New York about a study on an intervention program for the homeless. Many object to the receipt of services being decided by random selection. While I’m of two minds about this, I tend to support it in a situation, like the one described, where available resources do not allow everyone eligible to receive the services. It is not necessarily more ethically problematic to use random numbers to select those getting the services rather than a system like, for example, first-come-first-served.
Further, as a program evaluator as well as social activist, I am well aware of how often the best sounding social interventions ultimately turn out to be ineffective. Studies like the one described here are among our best tools to figure out what works so that scarce resources can be used where they will be most effective.Even if more resources become available, one is faced with the question of how to use them effectively. Knowledge of which interventions actually work is still required.
Studies like this one don’t seem more ethically problematic than the standard double blind drug versus placebo trials that we rely upon to help decide which drugs actually are effective.
To Test Housing Program, Some Are Denied Aid
By Cara Buckley
It has long been the standard practice in medical testing: Give drug treatment to one group while another, the control group, goes without.
Now, New York City is applying the same methodology to assess one of its programs to prevent homelessness. Half of the test subjects — people who are behind on rent and in danger of being evicted — are being denied assistance from the program for two years, with researchers tracking them to see if they end up homeless.
The city’s Department of Homeless Services said the study was necessary to determine whether the $23 million program, called Homebase, helped the people for whom it was intended. Homebase, begun in 2004, offers job training, counseling services and emergency money to help people stay in their homes.
But some public officials and legal aid groups have denounced the study as unethical and cruel, and have called on the city to stop the study and to grant help to all the test subjects who had been denied assistance.
“They should immediately stop this experiment,” said the Manhattan borough president, Scott M. Stringer. “The city shouldn’t be making guinea pigs out of its most vulnerable.”
As controversial as the experiment has become, New York City is among a number of governments, philanthropies and research groups turning to so-called randomized controlled trials to evaluate social welfare programs.
The federal Department of Housing and Urban Development recently started an 18-month study in 10 cities and counties to track up to 3,000 families who land in homeless shelters. Families will be randomly assigned to programs that put them in homes, give them housing subsidies or allow them to stay in shelters. The goal, a HUD spokesman, Brian Sullivan, said, is to find out which approach most effectively ushered people into permanent homes.
Such trials, while not new, are becoming especially popular in developing countries. In India, for example, researchers using a controlled trial found that installing cameras in classrooms reduced teacher absenteeism at rural schools. Children given deworming treatment in Kenya ended up having better attendance at school and growing taller.
“It’s a very effective way to find out what works and what doesn’t,” said Esther Duflo, an economist at the Massachusetts Institute of Technology who has advanced the testing of social programs in the third world. “Everybody, every country, has a limited budget and wants to find out what programs are effective.”
The New York study involves monitoring 400 households that sought Homebase help between June and August. Two hundred were given the program’s services, and 200 were not. Those denied help by Homebase were given the names of other agencies — among them H.R.A. Job Centers, Housing Court Answers and Eviction Intervention Services — from which they could seek assistance.
Advocates for the homeless said they were puzzled about why the trial was necessary, since the city proclaimed the Homebase program as “highly successful” in the September 2010 Mayor’s Management Report, saying that over 90 percent of families that received help from Homebase did not end up in homeless shelters. One critic of the trial, Councilwoman Annabel Palma, is holding a General Welfare Committee hearing about the program on Thursday.
“I don’t think homeless people in our time, or in any time, should be treated like lab rats,” Ms. Palma said.
But Seth Diamond, commissioner of the Homeless Services Department, said that just because 90 percent of the families helped by Homebase stayed out of shelters did not mean it was Homebase that kept families in their homes. People who sought out Homebase might be resourceful to begin with, he said, and adept at patching together various means of housing help.
The department, Mr. Diamond added, had to cut $20 million from its budget in November, and federal stimulus money for Homebase will end in July 2012.
“This is about putting emotions aside,” he said. “When you’re making decisions about millions of dollars and thousands of people’s lives, you have to do this on data, and that is what this is about.”
The department is paying $577,000 for the study, which is being administered by the City University of New York along with the research firm Abt Associates, based in Cambridge, Mass. The firm’s institutional review board concluded that the study was ethical for several reasons, said Mary Maguire, a spokeswoman for Abt: because it was not an entitlement, meaning it was not available to everyone; because it could not serve all of the people who applied for it; and because the control group had access to other services.
The firm also believed, she said, that such tests offered the “most compelling evidence” about how well a program worked.
Dennis P. Culhane, a professor of social welfare policy at the University of Pennsylvania, said the New York test was particularly valuable because there was widespread doubt about whether eviction-prevention programs really worked.
“There’s no doubt you can find poor people in need, but there’s no evidence that people who get this program’s help would end up homeless without it,” said Professor Culhane, who is working as a consultant on both the New York and HUD studies.
Professor Culhane added that people were routinely denied Homebase help anyway, and that the study was merely reorganizing who ended up in that pool. According to the city, 5,500 households receive full Homebase help each year, and an additional 1,500 are denied case management and rental assistance because money runs out.
Still, legal aid lawyers in New York said that apart from their opposition to the study’s ethics, its timing was troubling because nowadays, there were fewer resources to go around.
Ian Davie, a lawyer with Legal Services NYC in the Bronx, said Homebase was often a family’s last resort before eviction. One of his clients, Angie Almodovar, 27, a single mother who is pregnant with her third child, ended up in the study group denied Homebase assistance. “I wanted to cry, honestly speaking,” Ms. Almodovar said. “Homebase at the time was my only hope.”
Ms. Almodovar said she was told when she sought help from Homebase that in order to apply, she had to enter a lottery that could result in her being denied assistance. She said she signed a letter indicating she understood. Five minutes after a caseworker typed her information into a computer, she learned she would not receive assistance from the program.
With Mr. Davie’s help, she cobbled together money from the Coalition for the Homeless and a public-assistance grant to stay in her apartment. But Mr. Davie wondered what would become of those less able to navigate the system. “She was the person who didn’t fall through the cracks,” Mr. Davie said of Ms. Almodovar. “It’s the people who don’t have assistance that are the ones we really worry about.”
December 11th, 2010
Earlier today I posted an article on changes in publication patterns in response to new rules by the Journal of the American Medical Association requiring independent analysis of drug company data before publication in JAMA. That article also referred to problems with the national registry of clinical trials. A friend sent me the following article on these problems, which cast serious doubt on the quality of our knowledge on drug efficacy:
Quality and completeness of medical literature questioned in two new studies
By Michael O’Riordan
New York, NY – Two recently published studies cast some unfavorable light on the current quality and completeness of medical literature, with one showing that less than half of registered studies are published in medical journals [1], and the other showing questionable discrepancies between the registered and reported clinical outcomes [2].
Dr Joseph Ross (Mount Sinai School of Medicine, New York), the lead investigator of the study showing that just 46% of studies registered on the National Institutes of Health (NIH)-funded website ClinicalTrials.gov ever make it as a published paper, told heartwire that the findings are very alarming.
“The research should send shockwaves through the research community, as it shows us that while it’s all well and good to practice evidence-based medicine, we don’t have all the evidence,” said Ross. “In terms of following guidelines and understanding the right treatment approach, we actually don’t have all the evidence at hand to make those decisions. This is a really shaky foundation. On top of that, the stuff that is being published might not even reflect the studies as they were designed.”
Dr Harlan Krumholz (Yale University School of Medicine, New Haven, CT), the senior author of the paper with Ross, commented to heartwire that the studies, in tandem, reveal significant shortcomings of the data available in the national registry of randomized trials, with the implication being that drug assessment is “hampered, even undermined” by the incomplete picture.
The study by Ross, Krumholz, and colleagues is published in the September 9, 2009 issue of PLoS Medicine, while the second study comparing the registered and published outcomes in clinical trials, which is led by Dr Sylvain Mathieu (Hôpital Bichat-Claude Bernard, Paris, France), is published in the September 2, 2009 issue of the Journal of the American Medical Association.
What’s required and optional with ClinicalTrials.gov?
In 2005, the International Committee of Medical Journal Editors (ICMJE) began a policy stating that information about a clinical trial needed to be registered before patient enrollment as a precondition for publication. ClinicalTrials.gov, a registry that has seen an average of 220 trials registered each week since 2005, requires mandatory information from investigators, with other information considered optional.
Mandatory reporting includes study title, summary, design, phase, type, conditions or focus of study, intervention, eligibility criteria, gender, minimum/maximum age, recruitment status, sponsor, facility, study official or facility contact, central contact, oversight authorities, and institutional review board approval, as well as other administrative details.
Optional information includes the primary purpose for the study, start date, completion data, enrollment target number, primary and secondary outcomes, whether the trial accepts healthy volunteers, and FDA product status.
Trial completed but never published
In the study by Ross et al, the researchers examined the reporting of registration information among a cross-section of clinical trials registered at ClinicalTrials.gov after December 31, 1999 and updated as completed by June 2007. The study looked at the trials registered and the completeness of the mandatory and optional reporting fields on the NIH website and the extent to which these registered trials were published.
Excluding phase 1 trials, the group identified 7515 completed trials over the seven-year period, and of these, nearly 100% reported information mandated by ClinicalTrials.gov, including the study intervention and sponsorship. Ross noted, however, that some trials were more complete than others, with some providing only vague or nondescript information. Optional data, however, fared worse. Just 53% of studies reported the study’s end date, only 66% reported the primary outcome, and 87% reported the trial start date.
“About half to two-thirds of the time, the information that was supposed to be there was there, or could have been there,” said Ross. “What we discovered as we looked through the second step at publication was this optional information is really important when you’re trying to figure out what’s been published and what hasn’t.”
To assess how many of the registered trials were published, the group examined 10% of the completed trials as a subsample. Of these trials, just 46% of studies were published, and of these, only 31% provided a citation in ClinicalTrials.gov of that publication. Trials sponsored by industry fared the worst, with just 40% of registered trials published, which was significantly less than the 56% of published trials not sponsored by government or industry, such as a university or foundation. Of studies sponsored by government, 47% were published.
“For the most part, everybody’s publication rates were disappointingly low,” said Ross. “It’s really hard to know why. On the one hand, it seems like zillions of papers are published every day, and it should be easy to get something published. But once a paper has been rejected a few times, it’s sort of easy to lose steam. Investigators and companies are often chasing the next grant for the next study by the time the push comes to get something published.”
Ross said the results are in line with literature showing that studies sponsored by industry are more likely to be positive. Because their publication rates are low, it is likely that many negative trials aren’t being published. He noted that it is also possible that they are conducting trials for purposes other than research, such as trying to get people to adhere to their medication, and while it is registered as a trial, it is not considered for publication.
Differing clinical end points
In the second study, by Mathieu and colleagues, the group compared the primary outcomes specified in ClinicalTrials.gov with the primary outcomes reported in 10 high-impact medical journals, including Circulation and the Journal of the American College of Cardiology.
They obtained information on 323 randomized, controlled, clinical trials in cardiology, gastroenterology, and rheumatology. Of these trials, just 45.5% were adequately registered, meaning they were registered before the end of the trial and the primary outcome was clearly specified. Among these trials registered adequately, investigators say that there were discrepancies between outcomes registered and outcomes reported in 31% of the published papers. Almost 83% of the differences in the primary outcomes favored reporting statistically significant results, according to Mathieu and colleagues.
Overall, more than one-quarter of the published studies were unregistered, 14% were registered after the study was finished, and 11% were registered with no description or an unclear description of the primary outcome.
“A main goal of trial registration is to enhance transparency of research and accountability in the planning, conduct, and reporting of clinical trials, an objective achieved by making available details about the trial,” write Mathieu and colleagues. “Therefore, adequate registration should be a safeguard against publication bias. A major step has been achieved with the ICJME initiative for trial registration, and the existence of all trials is now publicly available. However, after this first step, the quality and timing of registration still needs improvement.”
Speaking with heartwire, Ross said that he believes registries like ClinicalTrials.gov are excellent ideas and that the research profession is headed in the right direction by making the medical field more transparent. However, some changes are needed to make it more effective, including making more information mandatory, including specific details about primary and secondary end points, and better oversight.
“There aren’t a lot of resources being devoted to oversight right now,” he said. “Who’s going to be responsible for catching up with companies and investigators who are registering trials and not reporting or not filling in all the needed fields?”
************
Ross and Krumholz were previously consultants for the plaintiffs in litigation against Merck related to rofecoxib. Krumholz has research contracts with the American College of Cardiology and the Colorado Foundation for Medical Care, has served on the advisory boards of Amgen and UnitedHealthCare, and is the academic editor-in-chief of Circulation: Cardiovascular Quality and Outcomes, and Journal Watch Cardiology.
September 14th, 2009
The Chronicle of Higher Ed has an interesting article on changes in publication patterns when the Journal of the American Medical Association started requiring independent analysis of drug company data before publication in JAMA. Drug company submissions to JAMA dropped 21%, while their submissions to rival journals increased. The article also discusses problems with other approaches to drug company bias of research results, such as a clinical trials registry.
These and similar studies suggest that we face a major problem in that these sorts of biases increase concerns about the validity of much medical “knowledge” is questionable. Research is already plagued with many aspects of its social organization that bias results. For example, the tendency to be more willing to publish positive rather than negative results. As a researcher and as a frequent peer-reviewer of research, I am well aware of these problems. the various ways in which industry funding distorts research, while not the only problems in the research-publication process, significantly compound the problem.
Medical Journals See a Cost to Fighting Industry-Backed Research
By Paul Basken
The Journal of the American Medical Association saw a 21 percent drop in industry-financed research after it began requiring that data in company-sponsored medical trials be independently verified by university researchers, a study has concluded.
The study, by a team of medical researchers in England and Florida, found that two of JAMA’s competitors saw their proportions of industry-backed research grow after JAMA decided to impose the requirement in 2005 to deter companies from shading descriptions of medical-test results to favor their products.
The findings suggest JAMA could face significant financial pressure to abandon the policy, given the reliance of medical journals on corporate dollars, said one of the study’s authors, Benjamin Djulbegovic, a professor of medicine and oncology at the University of South Florida.
“Major medical journals face an inherent conflict of interest” when trying to ensure the integrity of their published findings, Dr. Djulbegovic said in presenting the findings at the International Congress on Peer Review and Biomedical Publication here, a quadrennial conference of medical-journal publishers organized by JAMA with support from several of the other journals.
The three-day conference was dominated by investigations of the ways that corporate money is believed to be misleading both the public and medical professionals who rely on the journals for impartial evaluations of the safety and effectiveness of drugs and medical procedures.
Such warnings have been common features of the JAMA-initiated conferences, which began in 1989, though the issue took center stage in Vancouver after another year of allegations of corporate distortions of medical-research findings.
In the past few months, lawyers suing drug makers alleging harmful effects of their medications have found evidence of concerted attempts by the companies to secretly influence the presentation of medical-journal articles that appeared to have been written by independent university scientists.
Dozens of universities have meanwhile seen the need to toughen requirements on their researchers to disclose details of their financial relationships with makers of pharmaceuticals and medical devices. The federal government has also formed a registry where researchers are encouraged to describe their studies in advance so that any published conclusions can be compared with the promised objective.
‘Lots of Warts’
Despite those efforts, the studies presented to the journal editors gathered here covered a range of ways in which articles in their pages may still contain inaccuracies, often resulting from a financial conflict involving a scientist or a reviewer.
Such concerns led some conference participants to question the journals’ financial models: They rely on unpaid volunteers to review article submissions and on revenue from companies that buy reprints of articles that depict their products favorably.
Conference topics included the failure of journals and their authors to disclose corporate connections, the reluctance of researchers to share their data, the use of misleading rhetoric in journal articles, and the almost uniform ability of authors rejected by one journal to get published in another.
“We still have lots of warts,” Catherine D. DeAngelis, editor of JAMA, said of her industry after listening to the presentations.
Even some areas of improvement were shown to have their limits. About 300 journals have now joined a commitment by JAMA and other leading journals to publish only research in which the authors registered their intended outcomes in advance. The system, using either the federal registry or a recognized alternative, is designed to guard against researchers’ using their studies to selectively identify data that support a drug or treatment rather than sticking to the criteria they initially promised to measure.
But studies presented in Vancouver showed that the registry system isn’t yet having a significant effect because too many researchers are making registry entries that are either vague or filled with too many measurement criteria. “Registration alone cannot improve research quality,” Deborah A. Zarin, director of the federal registry, told the conference.
Independent Data Reviews
JAMA also found its competitors still unwilling to join its commitment to publish industry-supported studies only if the data get an independent review.
Dr. Djulbegovic and his colleagues at the Committee on Publication Ethics, in Britain, compared JAMA’s experience under its 2005 policy with that of two other leading medical journals. They tallied the portions of research appearing in the journals that involve industry financing, comparing numbers from 2002 and 2008.
JAMA saw the percentage of industry-supported studies in its pages drop 21 percent, from more than 60 percent of its published trials to 47 percent. Lancet, however, saw a growth of 17 percent, and The New England Journal of Medicine had an increase of 11 percent, the group reported.
Dr. Djulbegovic called the finding “quite dramatic,” while acknowledging that his investigation had a number of limitations, including the fact that it did not demonstrate the degree to which the shift could be attributed to the 2005 policy.
The study also didn’t show whether JAMA’s policy is actually producing more reliable research, said Fiona Godlee, editor in chief of BMJ, another leading medical journal. Dr. Godlee told Dr. Djulbegovic that other journals “would be flocking to” join JAMA if anyone could show the policy produced better science.
‘Something to Hide’
Dr. DeAngelis, JAMA’s editor, followed Dr. Godlee with an impassioned pledge to stick with the policy, saying she was pushed into imposing the requirement after at least two instances in which a corporate sponsor refused to allow an outside review of its data before publication.
The policy, she said, means she will always have the ability to call a university dean and ask for an investigation any time she encounters a challenge to data published in JAMA. And while some companies may be boycotting JAMA, the journal hasn’t seen its ad revenue drop any more than its competitors have during the recession, and its “impact factor”—a measure of its authors’ influence—has grown since 2005, she said.
“Until somebody can prove that what we’re doing is wrong, we’re going to keep it.” Dr. DeAngelis told her fellow editors. “The cynic in me says, If you’re not submitting to JAMA because you have something to hide or you don’t want anybody else to look at it, so be it. ”
JAMA, meanwhile, had its own issues with data accuracy at the conference. Dr. DeAngelis and other JAMA editors presented a survey of authors conducted last year that concluded, according to the summary given to conference participants, that the prevalence of “ghostwriting”—in which university scientists sign their names to research articles that secretly originated with writers paid by companies—has grown significantly since their previous survey in 1996.
But in the actual presentation to the conference, a JAMA researcher, Joseph S. Wislar, said his subsequent analysis of the data showed no significant increase in ghostwriting during that period. Nevertheless, the prevalence of “ghost” authors in top-ranked medical journals remains a concern, Mr. Wislar said, ranging last year from 2 percent at Nature Medicine to 11 percent at The New England Journal of Medicine.
Industry Silence
The conference participants included representatives of several of the drug companies, who largely sat silently through the repeated depiction of their industry as an obstacle to the unbiased pursuit of medical research.
Many of the concerns raised at the conference appeared to reflect industry tactics that may have been practiced by some companies a decade or more ago but aren’t common now, said Fran Young, director of science publications at Shire Pharmaceuticals. “Things have changed,” Ms. Young said after watching the presentations.
“Either I have worked at the three most rigorous companies out there,” said Ms. Young, formerly with AstraZeneca and GlaxoSmithKline, “or things are not as bad as being painted in this room.”
The companies and the journals appear to share concern over some of the problems identified at the conference, Ms. Young said. Those areas include the bias, as described by some conference presenters, in favor of publishing test results that show a specific result of a medication or procedure as opposed to “negative” results that show no significant effect of the treatment. Either positive or negative findings can contain critical information, yet data presented at the conference suggest that the positive result is more likely to get published.
And any resulting bias in journal articles may not be the fault of drug companies alone. During one discussion of the reluctance of medical journals to publish negative results, Faina Linkov, a research assistant professor at the University of Pittsburgh, said it was a well-known problem.
“All of my colleagues and I,” she said, “are very much tempted to massage the data until we find some positive results.”
September 14th, 2009