Home » clinical practice guidelines (CPG)
Category Archives: clinical practice guidelines (CPG)
Book Review: Robert Whitaker and Lisa Cosgrove. (2015). Psychiatry Under the Influence: Institutional Corruption, Social Injury, and Prescriptions for Reform. New York and the UK: Palgrave Macmillan. 241 pp. [$33.81 – less if digital]
This is an important book that deserves to be better know, since the consequences of the
self-dealing and conflicts of interest that it documents have not been reversed. This book points powerfully to a post-psychiatry future for individual psychiatric practitioners of integrity, navigating a way carefully between anti-psychiatry and a problematic institutional framework which has failed patients and most providers alike. The authors, Robert Whitaker and Lisa Cosgrove, spent a year at the Harvard Edmund J. Safra Center for Ethics. This work on the American Psychiatric Association (APA) is the result.
Though psychiatric “thought leaders,” principal investigators, researchers, and fellow travellers are now required to disclose the financial fees they receive from pharmaceutical corporations as the result of reforms, the consequences of several decades of self-dealing and conflicts of interests have been embedded in clinical practice guidelines (CPG). Fast forward the five years since this book was originally published and, not withstanding enhanced transparency, the band plays on.
As of this writing (Q1 2020), the APA is still going forward with significant momentum and merely modestly diminished revenues – and, therefore, merely modestly diminished economics of influence and conflicts of interest. The lack of action on the part of health care consumers, insurers, governmental regulators and legislators, indicates that Whitaker and Cosgrove are either being not believed or simply ignored.
My take on it? Whitaker and Cosgrove have a good chance of being prophets like Cassandra, the Trojan visionary and seer. Remember Cassandra was the seer whose curse was to always see and tell the truth but not be believed. Her partners threw a spear against the side of the Trojan Horse – a gift from the Greeks – and it rang hollow – thump – because the bad guys were hiding inside the hollow horse. Cassandra tried to warn her countrymen about Greeks bearing “gifts,” but Cassandra was not believed; and, in the story, a large snake ate her partners [I’m not making this up], so the trick of the Trojan Horse worked; the Greeks breached the impregnable walls of Troy; and Troy was burned to the ground.
I find it hard to accept that anyone who reads Whitaker and Cosgrove’s book would not be persuaded by the detailed marshaling of facts and figures. Therefore, the suspicion is that it is not being read. It is being overlooked. It is not too late to turn that situation around. Hence, this review.
If one were to summarize Whitaker and Cosgrove’s work in a single sentence, it would be: Whitaker and Cosgrove document institutional self-dealing in the form of conflicts of interest and the influence of big money from big pharma, which have decisively and irreversibly compromise the ability of the American Psychiatric Association (APA) to support and promote the health and well-being of patients. (Not to put to fine a point on it, the self-dealing and conflicts of interest are the definition of “corruption.”)
Whitaker and Cosgrove emphasize contextual and systematic explanations rather than bad actors, bad characters, or bad guys. As they say, it is not a matter of bad apples, but the barrel itself has gone bad.
I have searched to see if any of the targets of institutional corruption have tried to answer the charges, which, frankly, I found well-documented, compelling, a source of indignation, and, upon reflection, deeply distressing.
I found only one attempt to answer Whitaker and Cosgrove from D. J. Jaffe who claims the defects of the DSM-5 are widely known and discounted, the errors of the past have been (or are being) corrected, and Whitaker and Cosgrove are distorting and sensationalizing: “For example, the authors spend multiple pages examining the efficacy of a particular class of depression medicines, SSRIs, and find them wanting. But buried in the text is the line it “was only for severely depressed patients…that the SSRIs had provided a benefit.’” (For Jaffe’s review see: https://tinyurl.com/u7jvrmm.)
The quotation Whitaker and Cosgrove is accurate as far as it goes, but Jaffe is not accurate on the use of this data point. It is not ”buried”; but called out multiple times. Nor are the other defects and errors of the past been reversed, though they have been called out a number of times. The ineffectiveness of such denunciations and the anti-psychiatry movement leads Whitaker and Cosgrove to suspect that the problem is not one of a few (or even many) “bad apples.” The problem is an institutional one and must be addressed at that level.
Whitaker and Cosgrove’s point (contra Jaffe) is that the APA, Big Pharma, and selected researchers consulting to them have undertaken a largely successful marketing campaign: the science of medicine now knows the cause of depression (and other mental illnesses) and has a cure.
Most patients still comes in saying, “I feel depressed – I think I have a chemical imbalance – help me.” The doctor is, of course, helpful – with her or his prescription pad. Yet one theory after another has been exposed as “not proven” – the caricature of the Freudian unconscious, inflammatory cytokines, and the chemical imbalance theory.
The prescription for an antidepressant, mood stabilizer, antipsychotic, or anxiolytic, is going to work in far fewer instances – see below about major mental illness – than patients, front line MDs, and most residents in psychiatry have been led to believe. And this is 5 years after the publication. People are not reading this book, though, I submit, they may usefully do so.
The APA – and those who align with the educational (i.e., marketing) program – are not just “over sold.” They are engaging in ethically problematic practices. It is not just a bad apple, the barrel itself has a problem – the barrel itself is bad. After Whitaker and Cosgrove work, the debate is not about whether institutional corruption has occurred – the documentation is both boring and overwhelming – the debate is about what to do about it. No easy answers here.
When Whitaker and Cosgrove write about the “guild interests” of the American Psychiatric Association (APA), I was taken aback. Are the authors making matters sound like the Teamster’s back in the day when Jimmie Hoffa was running the organization? Hmmm. Whitaker and Cosgrove are surgically austere in their citing of facts and figures – which principal psychiatric investigators were also “thought leaders” working for Big Pharma.
Though Whitaker and Cosgrove are not explicit about this, an argument can be made that the APA gives the Teamsters a bad name. The latter has been required to “clean up its act,” thanks to criminal investigations by large governmental organizations. In contrast, most health care consumer remains relatively uninformed (excepts for this book (and a few others like it)) that the APA would expand diagnostic boundaries in a way that served commercial interests. This is called the APA’s “guild interest,” making money for psychiatrists independent of conflicts with the commitment unconditionally to promote patient health and well-being.
This is a particularly tangled issue in the case of psychiatry – as opposed to other medical specialties – in that psychiatry does not have biological markers such as blood tests (and so on) to identify the diseases and disorders it treats.
“In most other medical specialties, diagnoses are bounded by biological markers, and thus outcomes can be more easily quantified. Does a treatment reduce the size of a tumor? Lower blood pressure? Reduce cholesterol? Reduce or eliminate a virus? And so forth. However, in psychiatry, there are no biological markers that separate a patient with a “disease” from someone without, which renders psychiatry more vulnerable to bias, since it relies more heavily on subjective judgments for making diagnoses and assessing symptoms” (p. 139).
This leaves psychiatry vulnerable to commercial influences when making decisions about diagnoses, treatments, and professional relations (p. 115).
Yes, there is a molecular process hypothesized to exist for every disease entity, we just have no determinate, firm scientific idea what it is in the case of schizophrenia, depression, substance abuse, obsession, personality disorders, and so on. Yes, science is expanding our knowledge of brain processes, endocrinology, and biochemistry at an encouraging rate. But we know the cause of diabetes – lack of insulin. We know the cause of tuberculosis – the specific pathogen. Not so with mental illness, though a biological component looms large along with adverse childhood experiences, trauma, issues of poverty, social justice, domestic violence, access (or lack thereof) to education, jobs, housing, and recreation.
Science speculates and hypothesizes that depression (and so on) is determined in important ways by an imbalance of certain neurotransmitters such as serotonin, dopamine, and norepinephrine. Chemicals up, chemicals down – the influence on behavior, symptoms, and reports of human suffering are such that we are still trying to connect the dots. Human beings have different ways of expressing their suffering the symptoms of which have been collected in the Diagnostic and Statistically Manual, now in its 5th edition. That leaves a lot of wiggle room for human beings to be human beings and game the system.
The example I find most telling – and use with my third year medical students – is as follows: medical treatment can cure person if they have pneumonia and are unconscious in a coma; but that is not the case with substance abuse disorder. “Curing” substance abuse is a matter of body and mind. The patient must be conscious and participate like a commitment in the process. (For those who may have been living in a cave, substance abuse is now considered a disease, thus eliminating the stigma of a moral failing and opening the way to an unbiased, evidence-based approach to treatment.)
Another data point that was eye opening and needs to be better known:
“The NIMH [National Institute for Mental Health] also funded a trial that compared Zoloft to Zoloft plus exercise and to exercise alone, and at the end of ten months, 70 percent in the exercise-alone group were well, compared to fewer than 50 percent in either of the groups treated with Zoloft.19 At least in this study, Zoloft appeared to detract from the benefits of exercise” (p. 122).
Gone are the days when, if I feel the need to work out, I will lie down until it passes.
All of the psychiatrists that I know – and I know quite a few because of my empathy consulting – are dedicated, committed and hard working. No exceptions. The challenge arises when the marketing myth that mental illness is caused by a chemical imbalance gets embedded in the clinical practice guidelines (CPG).
Even though many psychiatrists are properly skeptical from an evidence-based perspective about the universality of this narrative, there are perceived medical risks in deviating from the CPG if treatment goes off the rails for unrelated reasons. It is truly a rock and a hard place scenario.
In addition, marginally informed prospective patients come in and say, “Hey, give me the medicine.” They have a sufficiently compelling narrative, sometimes gleaned from searching the diagnostic criteria on Google to validate the checklist. Rarely do they say, “I want to do the hard work it takes to change my life step-by-step, one conversation at a time, one bullet on my resume at a time, one relationship at a time.” It is deeply cynical and elitist but trending, “Show the people the light, and they will follow it anywhere!”
Here “the light” looks like: “It is just a chemical imbalance.” Millions of dollars, heck, maybe billions when the indirect expenses are included, were invested by the APA, Big Pharma, and their fellow travellers, to embed the idea: “It is just a chemical imbalance.”
One cannot just reduce ties with Big Pharma by rules about disclosing financial payments (which still occur) and expect the idea of mental illness as a chemical imbalance spontaneously to evaporate from the community at large where it is well-entrenched.
One needs a equally extensive educational program to challenge, root out, and transform the inaccuracies – but this time actual education, not marketing – to inform people of the complexity, nuances, and values involved. I see no such program in the offing, though it would be useful to require one perhaps as tobacco companies were required to advertise the consequence of smoking. The black box warning on Paxil (paroxetine) and selected other medications that it may induce suicidal ideation in children under 18 years of age is a start, but hardly a solution to the institutional issues documented here.
In section after section, I come away saying the medical literature, press releases, and marketing collateral are just flat out making stuff up. It is fake news before fake news was invented or at least became a top of mind consideration. It was marketing, not science. A sample is useful:
“[…][T]he FDA has assessed the merits of 31 studies for these four drugs [Celexa, Paxil, Prozac, and Zoloft], and even with the FDA’s charitable standards for determining that a study was ‘positive’ – it would often allow the company to sort through the data in a post-hoc analysis, to find a positive outcome – only 14 were positive. There were 14 others that were negative, and three more that were questionable. However, the published literature related to those 31 studies told of 19 positive outcomes and two negative ones” (p. 76)
“The medical literature simply didn’t reflect, in any meaningful way, what clinical trials had revealed about the efficacy of the four drugs, and this was just the tip of the iceberg. Ghostwritten papers from post-marketing studies also filled psychiatric journals, with these repots regularly telling of the drug’s efficacy, and this ghostwriting practice became so accepted that SmithKline Meacham, as it marketed Paxil, organized a campaign called “Case-Study Publications for Peer Review,” which it wittily dubbed CASPPER, mindful of television’s friendly ghost” (p. 76).
Once again, great marketing, but more than a tad short of scientific validity.
The authors go through a similar drill for other classes of medicines – attention deficit medicine, mood stabilizers, and antipsychotics. Though the details are different, the bottom line is similar.
The assessment of the authors? “Within the conceptual framework of institutional corruption, the pharmaceutical industry could be said to have ‘captured’ academic psychiatry and the APA as it tested and marketed the SSI antidepressants” (p. 77).
What was supposed to have been the Gold Standard in determining the efficacy of antidepressant medications produced disappointing results. But these sometimes negative results got embedded in complex statistical tables without explanations. A favorable spin was put on the outcomes using data mining and 20-20 hindsight.
Since this was a National Institute of Mental Health the STAR-D (Sequenced Treatment of Alternatives to Relieve Depression, psychologist Ed Pigott was able to file a “freedom of information” request to get the raw data. Some in the profession suggest this is widely known, but most consumers of psychiatric services do not know it, nor are they informed by their medical doctors (many of whom also do not know it). The results were different than those emphasized in the publications:
“[…] [I]f the protocol had been followed, 38 percent (1,192 out of 3,110) would habe been reported as remitted [free of symptoms] during this acute phase of the study (after all four rounds of treatment) [….] [A]nd if the readers got out their calculators they could discover that 568 of the 1,518 patients who entered the follow-up phase in remission had relapsed. This indicated that 950 patients – or 63 percent – had remained well” (p. 126)
Now we can debate how these data are sliced and diced, but nothing like a 6.3 % long term “cure” rate is EVERdiscussed with patients by providers contemplating SSRIs when quoting this study. That is not because providers are withholding data; it is because the providers do not know about it. It is buried.
John Rush, MD, psychiatrist at Texas Southwestern Medical Center in Dallas, reported his results: “Only 26 percent of the real-world patients responded to the antidepressant during the first year of treatment (meaning their symptoms decreased by at lest 50 percent on a rating scale), and only half of that group had a “sustained response.” Even more dispiriting, only 6 percent of the patients saw their depression fully remit and stay away during the year-long study. These ‘findings reveal remarkably low response and remission rates,’ Rush concluded” (p. 122).
Whitaker and Cosgrove make the case that the APA has been demonstrably unable to self-regulate – “police” itself – over the past three decades. The conclusion is that, therefore, others will have to provide the external regulation that has been missing internally.
The APA is not suddenly going to see the light and start urging its members to clear the schedule and engage in talk therapy with their light or moderately depressed patients instead of summarily reaching for the prescription pad as the default and acting in the face of evidence-based research, the opposite of which, however, has been built into “evidence-based” practices – this time in scare quotes – thanks to an intricate tangle of self-dealing and conflicts of interest spanning decades. It boggles my mind how this mess was created; and it is hard to see any way out, much less an easy one, which is precisely what the APA is counting on.
Thus, I believe that Whitaker and Cosgrove have “given up” on institutional psychiatry (the APA) and with cause:
“[…][T]he APA is already taking steps to ‘re-engage with pharma,’ and is doing so with little apparent appreciation that psychiatry was compromised in a significant way by its close ties to industry. Nor is there any evidence that the APA and academic psychiatry are aware that guild influence have proven to be so corrupting” (p. 199).
Here “guild influences” refer to commitment to expanding the population of diagnosable people – shyness is now “social anxiety,” boisterous kids being kids have “attention deficit,” normal sadness due to life setbacks is “major depression,” more forgetful senior citizens dealing with “mild” neurocognitive disorder, having a diagnosis for every medicine and a medicine for every diagnosis. These issues are supposedly well-know and are being addressed. I have not seen any evidence that is so. It is “baked into” the clinical practice guidelines to offer medications as first line treatments.
Since this is not a softball review, you see the issue. This stuff is dry as dirt and it takes significant effort to disentangle the details. Of course, Whitaker and Cosgrove do that, but it raises the bar on engaging the average health care consumer to expect her or him to follow the argument.
Whitaker’s earlier debunking was equally well documented in its time (see Mad in America), but criticized for being sensational. It was. But it was also accurate. I hasten to add that “sensational” is different than “sensationalism.” Here the conclusions are sensational, too, and they are well-argued, thoroughly documented, and, therefore, all the more dramatic for being understated.
Here the writing is toned-down and befits the neutral, mostly emotionless language of a scientific journal – or the Harvard Edmund J. Safra Center for Ethics. And so the authors get “dinked” with being “boring.” It is truly a case of “no good deed goes unpunished.”
No individual psychiatrist can fix this mess. Having psychiatrists transparently declaring their financial ties to funding organizations as the APA has agreed to do just does not fix the problem, though it does make clear the depth of the influences. Why not? People (and psychiatrists are people) have blind spots and conclude that most other people have a conflict of interest, but the money does not bias me (the psychiatrist in question). Cognitive dissonance causes the individual to make exceptions for themselves.
This is highly ironic because psychiatry was the discipline that promoted the notion in the 1950s through 1980s of the Freudian unconscious as a motivated blind spot. Indeed, even today, if a person takes an implicit bias test as required by many corporate diversity and inclusion programs, virtually everyone is found to have biases – biases against smokers, overweight people, bald people, old people, young people, poor people, rich people, political people, as well as more stereotypical racial and ethnic prejudices. Blind spots are pervasive among human beings as a species. Yet psychiatrists do not have blind spots when it comes to favoring funders who give them money? Hmmm.
Whitaker and Cosgrove conclude that individuals within organized psychiatry are in principle unaware that their behavior has been ethically compromised because such behaviors have become normative – required – within the institution.
Still, there is one instance in which disclosure does work: if it provides the individuals with incentive to free themselves from such ties because of the perceived devaluing cost to one’s societal and professional standing. Don’t hold your breath.
The postpsychiatry future moves beyond the psychiatry versus anti-psychiatry debate. The future belongs to postpsychiatry. Whitaker and Cosgrove conclude that a paradigm shift is required. Take seriously the bio-psycho-social model of the mind and body. Physicians have an important role to play, since biology is involved. We are neurons “all the way down.” However, the neurons then generate consciousness, language, and community.
It is also necessary to include in the team psychologists, social workers, philosophers of mind, and ethicists, that address the kind of life issues that drive people crazy. It is not a conclusion that a medical doctor would be in charge of such a team, outside the biological component of such a group. And that is the conclusion likely to raise hackles and not only at the APA. Ultimately the individual consumer of services is in charge of her- or his own life and well-being. The informed consumer of services – whether medical services, life transformational services, emotional guidance, and so on – needs to be in charge of the team. But in the meantime, as philosopher kings are still in short supply, any adult able to provide grown up supervision will do.
(c) Lou Agosta, PhD and the Chicago Empathy Project