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Preventing an epidemic of psychopharmacology lawsuits

April 20, 2012
by H. Steven Moffic, MD
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You’ve probably by now heard of, or read, Robert Whitaker’s book “Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America” (Broadway Paperbacks, 2010). Or, maybe not, since it appears that the book has received much more attention in the lay media than the psychiatric. We at Behavioral Healthcare can have some pride that some responses to the book were covered over July-October, 2011.

What I still doubt that we know, however, is how many lawyers have read the book. I can just see some of them salivating over the prospects. I wouldn’t even be surprised if some “ambulance chasers” out there are already finding patients who may have been damaged, or at least a case could be made, by long-term psychiatric medications.

Therefore, it may pay to be proactive. Ignoring this controversy poses at least two potential problems. One is that the medications may have longer long-term risks to the brain and body that we knew before. The other is that patients who stop medications suddenly, as they often do, may have severe withdrawal symptoms and/or a return of their symptoms with even more intensity.

Now, the jury is still out about these long-term risks. In fact, corrective studies may take a generation or be impossible with our current technology. In the meanwhile, our key tool to avoid lawsuits and help our patients to the best of our ability is in informed consent, as tricky as that can be with psychiatric patients. And, that must change somewhat, as it often does after new knowledge or concerns.

In the past, it was very common for patients to ask or wonder if the psychiatric medications were safe to take long-term. Usually, I would answer – and instruct my students to answer—that for many of our medications that were around for many years, “yes, they seem to be quite safe”. An ongoing exception would be lithium, known to often cause kidney or thyroid damage over the years. Or, the antipsychotics needed some caution, too.

The old ones could cause Tardive Dyskinesia many years later, and the new ones (“atypical”), we belatedly found out often have severe metabolic effects. Now we have to suspect that most all of them may have some  sort of long range risk or another, in addition to all the acute side effect possibilities.

So, here’s how I might respond post-Whitaker’s book, and even tell the patient if they don’t ask, all the meanwhile being careful not to scare them away from taking the medication when they really need it. (Of course, I would not say this all in one breath, or without breaks to discuss different points).

“I would recommend that you try this medication for this problem, but only for as long as necessary. At some point of time, we might want to try you off of it, but when we do so, taper the dose very slowly. Please do not stop the medication all at once on your own, because your body and brain will not have time to readjust. In addition, sometimes there is a so-called placebo effect when first starting medication.

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Steve:

I hadn't thought much about liabilities with regard to these meds until your post, though I know that some who receive them swear by them and others don't much like them.

From my perspective, the biggest responses to Whitaker's book--at least within the field of mental health, are that:

1. There's been a surge of interest in the "recovery" movement, which is slowly but surely moving toward becoming a mainstream, instead of radical, concept in psychiatry. Whitaker's work certainly seemed to put the nail in the coffin the simplistic "chemical imbalance" theories used to market things like antidepressants. While it's clear that there are chemical interactions going on, the latest from "medical" folks like NIMH Director Tom Insel--is that the roots of mental disorders are found in "complex circuit disorders of the brain." (See http://www.behavioral.net/article/transforming-our-understanding-causes-and-treatment-mental-disorders).

2. A still-new foundation, the Foundation for Excellence in Mental Health Care (femhc.org) is seeking to raise $250 million in funding so that it can make grants to fund research into "optimizing" the use of pharmocological medications as part of effective treatment plans that combine meds with cognitive therapies, psychotherapy, wellness programs, and other interventions. Did some reporting on this foundation last year (http://www.behavioral.net/article/group-seeks-250-million-drive-recovery-research) and saw them at a recent presentation at a Community Psychiatry Conference in early March 2012.

The thought that medications, which in many circles are considered a primary or "standard of care" treatment for many disorders today, could become the subject of lawsuits is a chilling thought. But that prospect seems far away, as you noted, given the long-term variables that would almost certainly be involved.

I think that the work envisioned by FEMHC holds a lot of promise. Pending success in attracting funds, of course, this work could go a long way toward validating situations when meds work best, identifying approaches when non-medication treatments are best, and explaining tapering/withdrawal strategies for those not benefiting from medication therapy.

I think that either way, a new generation of research seems likely to be needed if these questions are to be settled.

In the near term, I believe that the "epidemic" of autism--and the intensive research going on in that area--is already spawning a lot of lawsuits. However, these aren't directed at pharma companies, but rather at legislators and insurers. There's a lot of emotion around that issue as well.

Even if lawsuits may be far away, Dennis, and I wonder about that, the need to improve informed consent is now. We have to reflect our uncertainty about the long-term effects of the medications for both legal protection and patient choice for recovery.

I'm not sure how "complex circuit disorders of the brain" are any clearer or more accurate than "chemical imbalance", except it is harder to understand what that really means! Actually, I think it means we are not much closer to understanding how our medications may work. The Foundation for Excellence in Mental Health Care sounds promising, if it is objective enough, but it sounds like its recommendations may be a ways off.

Thanks so much for the comments and links.

I would like to think that most conscientious practitioners DO try to keep their patients well-informed, not in fear of liability but to provide appropriate care. I am not sure that doctors ought to be held wholly responsible in any potential liability suit.

Many doctors are under tremendous pressure to prescribe dangerous drugs and many, if asked, could not tell you the specific ways that, for example, Abilify works on dopamine and serotonin receptors or what physiological processes create the conditions in which side effects manifest. Nor could they tell you what additional factors may impact the efficacy/risk of the drug.

In many cases, doctors have not been supported in keeping themselves well-informed and are simply handed a box of free samples that, as in the setting I work within, are provided to consumers who are often reassured by the colorful packaging and the possibility of relief. Often this transaction occurs within a 1/2 hour "med check" - a ritual that leaves little time to discuss the details of the powerful medication that is being prescribed. I do not believe that most doctors intend, in any way, to provide their patients with medication that can be harmful.

People do experience significant states of psychiatric distress and it is a shame that our systems of care do not allow many resources for non-pharmacological intervention.

I believe that pharmaceutical companies should be held accountable, should be held responsible, for promoting products they know to be harmful and for lobbying legislation/policy and treament protocol that support their profit interest at all costs. I actually think that doctors, at this point, have fair reason to sue pharmaceutical corporations, and certainly many patients do.

It is sad that a psychiatrist could, if faced with a patient experiencing significant symptoms that could affect safety, actually be in big trouble themselves if they did not offer therapeutic intervention and that, in many cases, the only intervention available is pharmacological. That's not a nice position to be in.

I do not understand why more psychiatrists do not widely support crisis alternatives such as Peer Respite and preventative modalities such as WRAP.

This brings us to Jim Gottstein's question, "Are psychiatrists fooled or complicit?" It's a good question. I think that there needs to be an additional option. "Are psychiatrists themselves coerced?" I think that, in the culture and practice of modern psychopharmacological psychiatry, they are.

As an aside, I do not think that "complex circuitry disorders" are remotely difficult to explain or make sense of. Considering states of distress and disorientation as a cause-and-effect process, involving neurological conditions (for example, stress hormones and serotonin levels) that are associated with particular modes of conscious experience, with distinct cognitive and emotional states that manifest as disordered.

I told my students the other day, "They call it a disorder because, in very real ways, things do become disordered. If you experience a traumatic event, your brain and body are affected by a flood of stress hormones. Over time, exposure to these chemicals can actually affect the structure of your brain. As an example, consider the hippocampic regions of the brain in children who grow up with chronic abuse.

What happens if someone pours a bucket of water on the Thanksgiving meal. Yeah, it gets wets, things spill and drip. The whole thing is a mess. It feels like a disaster."

I draw a lot of arrows on the classroom board, to show how particular stimuli trigger specific neurological events (such as a release of cortisol when one becomes angry) and how, because of the way the brain processes and organizes information, there can be corresponding events within the emotional sectors of our brains and these then are associated/interpreted cognitively, often in the form of distressing and pervasive thoughts that are themselves traumatizing and serve to reinforce the disordered state.

I think that makes much more sense than "Your chemicals are out of balance." It seems to offer people much hope that there is a rhyme and there is a reason, and - using basic principles of neuroplasticity - there is the possibility of healing distressed frameworks and learning new ways of experiencing the world.

Thank you for the opportunity to articulate this. As a Peer, I find these approaches to be live-saving. They certainly saved my life, and did so in ways far more profound than simply staying alive. The students I referred to above are adults in recovery from mental health and addiction challenges. I work in a semi-rural community in western North Carolina and the students at the Recovery Education Center, by and large, have minimal schooling and many of them carry PTSD diagnoses in addition to their Axis 1 diagnoses. They understand when I speak about cause+effect=experience and their eyes light up when they are validated in the fact that, when bad things happen to us, we get hurt in some very fundamental ways that affect the way we process our experience of the world.

As for the Thanksgiving meal and the bucket of water...you clean it up, bit by bit. You learn to appreciate the way the water-warped wood looks like a wave. You learn to tell the story in a way that makes you smile and helps you to appreciate all your peaceful meals.

Or you just throw a heavy blanket over it so you can't see the mess and you try to keep dining as if everything is all taken care of. Clearly, given the lumps and stains and drips, it is not all taken care of.

If poor people in depressed mountain towns can understand how we come to experience things in the way we do, why can't people who went to medical school?

Best Regards,
Faith Rhyne
Asheville, NC

What a wonderful and helpful commentary, Faith (and what an appropriate name you have!).

Sorry I got to it so late, but I've been away.

Dr. Moffic

Given the now widely recognized defects in psychiatry’s research base due to 20 years of meddling by commercial interests, is not remediating patient safety psychiatry’s top ethical responsibility?

That defective research is what clinicians base treatment upon, and it's why Dr. Moffic can't answer crucial questions about long-term safety. It's not a new issue. By this time, many patients have been taking medication for many years.

What exactly is psychiatry doing to gather post-marketing data for the improvement of outcomes and patient safety?

Shouldn't concerned doctors be calling for the APA and NIMH to improve patient safety and outcomes in psychiatric treatment?

In the meantime, rather than some tortured version of "I don't know" as a basis for informed consent, I would expect those concerned doctors to minimize the prescription of psychiatric drugs, minimize dosages, minimize drug combinations, and minimize the length of time patients are on medication.

If not out of ethical concern for patients themselves, I'd hope doctors would do this to save their own skins from an "epidemic of psychopharmacology lawsuits," which looks like maybe the only way to get medicine to take notice of an absence of valid risk data for psychiatric medications.

Thoughtful post and wise, measured (hypothetical) advice to patients. To this I'd add that we know even less about the long-term effects of psychotropics on developing brains. Children and teens deserve detailed and age-appropriate explanations of this phenomenon, especially given that teens have especially low rates of adherence to psychiatric meds. Even if they aren't the ones technically giving consent to treatment, young patients deserve to know what they are getting into - and to know, too, just how little doctors know about the long-term effects of certain meds, especially on cognitive and emotional development. In my book about young people's experiences of medications, Dosed: The Medication Generation Grows Up, doctors' and parents' insufficient or inadequate explanations of why meds were prescribed and how they were to be taken created a host of problems, with non-adherence and lack of trust in the clinician being just the beginning. Not understanding the ongoing need for medication, and not having frank, periodic conversations about it with the prescribing doctor left many young people confused, not only about the nature of their disorder and their symptoms, but also about their very identity.-Kaitlin Bell Barnett

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H. Steven Moffic

H. Steven Moffic

H. Steven Moffic, M.D. retired from the clinical practice of psychiatry and his tenured...