The Fight for Pharma Accountability and Psychiatric Rights: Jim Gottstein, Esq

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CONVERSATIONS IN CRITICAL PSYCHIATRY

James Barry “Jim” Gottstein is an Alaska-based lawyer and a well-known advocate for the legal rights of individuals with serious mental illness. He graduated as a lawyer from Harvard Law School in 1978. In 1982, he experienced a psychotic break due to sleep deprivation and was introduced firsthand to the mental illness system. This encounter led him to legal representation and other advocacy for individuals diagnosed with mental illness. Gottstein opened his own law office in 1985, generally focused on business matters, and is now mostly retired from the private practice of law. He cofounded the Law Project for Psychiatric Rights (PsychRights) in 2002 and currently serves as its president. Gottstein is the author of The Zyprexa Papers (Samizdat, 2021).

The Zyprexa Papers is a fascinating story of how Gottstein obtained and shared confidential documents showing that Eli Lily executives had knowingly concealed data related to metabolic risks of Zyprexa including diabetes, downplayed risks in published data, and illegally promoted off-label use in children and the elderly. These documents led to a series of front-page stories by The New York Times in 2006,¹ and Gottstein became the target of the ire of Eli Lilly’s army of lawyers. Gottstein provides a detailed account of the events in the book.

While it is no surprise, it is still disturbing to see how pharmaceutical companies engage in blatantly unethical practices and how they employ the legal shenanigans to avoid any meaningful accountability, and how we, as a society, repeatedly allow that to happen. It takes great courage—one might even say recklessness—on the part of lawyers and activists such as Gottstein to expose such wrongdoing at great personal risk. As David Healy has commented, “… everything we know about what pharma gets up to comes from legal actions in the US and a handful of lawyers like Gottstein.”² Half of the book is about Bill Bigley, whose psychiatric commitment and forced medication case enabled Gottstein (his lawyer) to subpoena the Zyprexa Papers and whose rights he defended vigorously, going all the way to the Alaska Supreme Court and resulting in landmark decisions. I left the book with a renewed sense of moral disgust directed at pharmaceutical corruption, a renewed sense of alarm at their pervasive influence and lack of meaningful public accountability, and a renewed appreciation for the legal rights of individuals with mental illness.

Aftab: Tell us more about your background and how you got involved in psychiatric legal advocacy.

Gottstein: In 1982, at age 29, after taking on too much, I got sleep deprived, became psychotic, and was hauled to the hospital in a straitjacket. Before that happened, I had no idea my mind could become unreliable. It was a complete shock. Those that believed I was a lawyer told me I would never do that again, and when I told them I had gone to Harvard Law School, that confirmed I was delusional. I was told I would have to be on psychiatric drugs for the rest of my life and the best I could hope for was to minimize my time locked up in psych wards. Luckily, my mother referred me to a wonderful psychiatrist—Robert Alberts, MD—who told me anyone who gets sleep deprived enough will become psychotic and I could learn how to prevent that from happening. In other words, I escaped having my career changed from being a lawyer to that of a mental patient. I felt lucky in so many ways and resolved to try and help others not so lucky.

There are a number of themes, as it were, in my book, The Zyprexa Papers, and one of them is to subtly bust the myth that people who get diagnosed with serious mental illness cannot recover. I do this by briefly describing a number of people who recovered after being diagnosed with serious mental illnesses and were involved in the events surrounding the release of the Zyprexa Papers.

Aftab: It is inexcusable that you and countless others have been told such things. As an early-career psychiatrist who finished training not too long ago, my perception is that there has been progress in this regard, although practice is far from optimal. I think the development of first-episode psychosis specialty programs and the recovery movement have really emphasized the diverse trajectories of psychosis in treatment approaches, and many prominent psychiatrists (such as Robin Murray, MD; Jim van Os, MD, PhD, MRCPsych; and Patrick McGorry, MD, FRCP, FRANZCP) have questioned the validity of the notion of schizophrenia and the prognostic pessimism that has historically surrounded it. We have examples of researchers with lived experience and their perspectives on recovery, such as Nev Jones, PhD, which inform our thinking. It is worth noting though that the issues that surround involuntary care are distinct from concerns pertaining to erroneously misleading narratives about recovery surrounding psychosis. The 2 are linked in your experience, but a different psychiatrist in an alternative history may very well have given you a more hopeful message during your involuntary hospitalization and may have facilitated your return to work.

Gottstein: My sense is, in the main, the "Abandon All Hope Ye Who Enter Here" message has not changed much—if at all—in the trenches.

There are some encouraging developments, and I hope they will gain traction. Personally, I am spearheading the follow-up activities for MindFreedom International and Rethinking Psychiatry to the International Peer Respite Soteria Summit held virtually on the 5 Sundays of last October. We are actively working on helping people open these types of programs and provide support for ones that are currently operating. There is huge interest around the world, with over 750 people participating from 40 countries. It may be good timing because more and more people are coming to the conclusion that we need to do things differently. On the other hand, in the United States, the scapegoating of people thought to be mentally ill is the only approach everyone can agree on as a response to mass shootings in the US, and seems likely to lead to more psychiatric confinement and psychiatric drugs, often coerced.

Aftab: What have you learned over the course of your legal career about the ways in which pharmaceutical companies misrepresent, misreport, or mis-advertise findings from clinical trials? How can we, as a society, safeguard against this, and how can they be held accountable?

Gottstein: The ways pharmaceutical companies misrepresent, misreport, and mis-advertise clinical trials are legion. I think the most important thing to keep in mind is, in order to gain regulatory approval and promote sales, clinical trials are designed to inflate benefits and hide the harms, rather than be a neutral evaluation. One of the ways they do this is through miscoding adverse events, such as suicide attempts being coded as lability. Another is by assuming adverse events are not related to the drug. Pharmaceutical companies can get away by not looking for unanticipated adverse events. Sometimes they deliberately conceal or minimize adverse effects, as they did in the case of Zyprexa. They also rig the benefit side. As I write in The Zyprexa Papers, in its clinical trials, in order to make Zyprexa look good in comparison, the so-called placebo group were people who had been abruptly withdrawn from Haldol, which is known to exacerbate or even cause severe psychiatric symptoms, and then the introduction of Zyprexa in the trial relieves some of those withdrawal symptoms, which manifests as clinical improvement compared to placebo. They went even further. While most people abruptly withdrawn from Haldol experience withdrawal psychiatric symptoms, some people do quite well, and they threw them out of the study. They hijacked the term “placebo washout” to describe this.

There are plenty of things that could be done about this, but the pharmaceutical juggernaut is difficult to stop, especially politically. For example, David Healy, MD, is on a mission to make the trial data available for review at the participant level, including being able to interview the participants. He makes the point it is outrageous the drug companies claim these data are trade secrets when volunteers risk harm for the benefit of society.

The most practical—and a very effective thing that could be done, in my view—is for prescribers to be appropriately skeptical of drug company claims for their latest and greatest drugs. The reality is the newer drugs are, in most instances, neither more effective nor safer than the older drugs. Often the opposite is true on both scores. It is amazing to me people prescribe the “latest and greatest” new drug, typically at much greater cost, based on the word of companies that are well-known to have lied to the professionals and the public. The true benefit of the newer drugs is monopoly prices can be charged because they are still on patent. As a general matter, the true benefits and harms of a drug are not known until it is off patent.

Aftab: Since The New York Times published the story on the Zyprexa Papers in 2006, there have been numerous other scandals involving pharmaceutical companies. There is much greater awareness now of the criminal role played by Purdue Pharma in creating the opioid crisis in the US. The links between the FDA and pharma continue to be a source of concern, as evident recently in the controversy surrounding the approval of aducanumab despite a manifest lack of efficacy. Do you see any reason to think that we, as a society, are any safer and wiser in our dealing with pharma than we were in 2006?

Gottstein: No.

You want me to say more? If anything, I would say it is worse. For a brief period of time after the release of the Zyprexa Papers and the accompanying New York Times articles, lawyers representing pharmaceutical victims were less willing to agree to keep the harms of drugs secret in order to achieve a settlement, but my sense is things have gone back to normal where the harms of drugs discovered during litigation are kept secret as a condition of settlement. The courts are supposed to look out for the public interest, but they, as well as the parties, are only interested in settlement. If keeping the harms secret is what it takes for the victims to get some (usually inadequate) compensation, the lawyers to get (usually exorbitant) legal fees, and to get the case off the court's docket—so be it.

The corruption of the medical literature has gotten to the point of absurdity, with a large percentage of medical journal articles ghost-written by the drug companies, the prominent “authors” being paid by the drug companies to put their name on the articles not even allowed access to the data.

Aftab: I am somewhat heartened by the developments in psychological sciences, where many of the top journals have embraced the ideals of open science and require sharing of pertinent data. Psychology has also matured from the replication crisis. Medical journals are still behind, unfortunately, when it comes to the goals of open science, although they have taken some half-measures against ghost-writing and have improved their requirements with regards to preregistration of trials, specifying primary outcomes, and spinning of results, etc. It remains the case that many academic authors who put their names on pharma-conducted RCTs do not have direct access to data and depend on whatever analyses the pharma statisticians provide. It is disappointing that litigation leading to settlements is not serving public interest by keeping harms secret. All of this speaks to the lack of systemic safeguards—both medical and legal—and resultantly, there is a disproportionate responsibility on clinicians and patients to maintain a critical attitude.

Your advocacy through the Law Project for Psychiatric Rights (aka PsychRights) has substantially altered the legal landscape in Alaska with regards to involuntary psychiatric commitment and involuntary use of medications via a series of landmark Alaska Supreme Court rulings. Can you give us an overview of what these rulings were about?

Gottstein: PsychRights has won 5 Alaska Supreme Court cases, 3 of them on constitutional grounds. For involuntary commitment, the Alaska statute allowed someone to be psychiatrically confined as gravely disabled if their previous ability to function in the community would otherwise deteriorate. In the 2007 Wetherhorn case, the Alaska Supreme Court held this unconstitutional unless construed to mean the person is “unable to survive safely in freedom.” In other words, the level of disability has to be life-threatening to justify the “massive curtailment of liberty” locking someone up is.

As to court-ordered administration of psychiatric drugs, the Alaska statute said if the person is found to be incompetent to decline the drugs, the hospital is allowed to force into the person any drugs, at any doses the hospital wants. In the 2006 Myers case, the Alaska Supreme Court held this was unconstitutional with the hospital having to also prove by clear and convincing evidence the forced administration of medication is in the person's best interest and there is no less intrusive alternative available. This was expanded upon in the 2009 Bigley case, with the Alaska Supreme Court ruling the state has to provide a constitutionally required less intrusive alternative to forced medication or discharge the patient. The continued viability of this is questionable, however, as a result of a more recent involuntary commitment decision holding the less restrictive alternative to involuntary commitment has to actually exist and be available to the person.

There are nuances to all of this, but these are the basics.

Aftab: You have argued in an article in Alaska Law Review that “lawyers representing psychiatric respondents and judges hearing these cases uncritically reflect society’s beliefs and do not engage in legitimate legal processes when conducting involuntarily commitment and forced drugging proceedings. By abandoning their core principle of zealous advocacy, lawyers representing psychiatric respondents interpose little, if any, defense and are not discovering and presenting to judges the evidence of the harm to their clients.”³ Why do you think this is the case, and what do you think the lawyers representing psychiatric respondents could be doing differently?

Gottstein: Fundamentally, lawyers are appointed to represent psychiatric respondents in order to check the box that the person had a lawyer. They are not expected—and, frankly, not allowed—to present vigorous defenses. They are assigned too many cases to mount a defense, especially within the extremely compressed time frame required in these cases. The lawyers go along with it because they believe if their clients were not mentally ill, they would know what the state wants to do to them is good for them. We have what is called the “adversary system” of litigation in the US, whereby having each side’s lawyers zealously presenting evidence and arguments for their clients’ position, the neutral decision-maker—a judge or jury—is supposed to arrive at the truth and the correct result. Without that, the legal proceedings are a farce.

Lawyers assigned to represent psychiatric respondents should treat involuntary commitment and forced medication, also known as forced drugging, as the high-stakes cases they are. The state is trying to lock their clients up and subject them to mind-numbing, life-shortening chemicals they do not want, after all. One of the other things I do in The Zyprexa Papers is show how I think and go about defending these cases in the hope lawyers representing psychiatric respondents will litigate them zealously. Whether or not psychiatrists agree, they cannot accurately predict violence or self-harm—a prerequisite to commitment—and whether or not they believe the drugs are counterproductive and harmful, psychiatric respondents are entitled to have this evidence presented in court on their behalf.

The lack of effective legal representation is very harmful. People are entitled to the least restrictive alternative with respect to psychiatric confinement and the least intrusive alternative with respect to forced medication. By not challenging the proposed involuntary commitments and forced medication, people are not being allowed more humane alternatives. If people’s rights were being honored, more of these humane alternatives would have to be provided.

Aftab: The availability of psychiatric inpatient beds is quite limited in the US, at least compared to what it was like in earlier decades, and restrictions from insurance companies have drastically reduced length of stays, even for voluntary admissions. Reliance on psychiatric commitment is directly linked to the availability of viable alternatives in the community, and the failure of US psychiatry to provide such alternatives following deinstitutionalized has directly resulted in alarmingly high rates of homelessness and incarceration of individuals with mental illness. Given the current state of US politics and the pessimism surrounding the possibility of radical social reform, many in the psychiatric community are advocating for an expansion of psychiatric commitment. We can make the legal process of involuntary commitment much more arduous, as you advocate, but that only results in a good outcome if individuals with psychiatric disabilities receive meaningful accommodations and care in the community. In the absence of that, aren’t we just making the homelessness and the incarceration problem much worse?

Gottstein: That is hardly a ringing endorsement of more involuntary commitment. I think it is silly, too. Hospitalization costs what—$2000 a day? Providing housing would be far less expensive and solve a lot of the problem. Leaving the fiscal folly of the argument aside, the dysfunction, inequality, inequity, indifference, and cruelty of our society is not a legitimate excuse to lock more people up. My biggest project right now is follow-up activities to the International Peer Respite/Soteria Summit held on the 5 Sundays of last October. We are trying to use the summit as a springboard for creating and sustaining more Peer Respites and Soteria Houses around the world instead of hospitalizing people and administering medication into them against their will.

I do want to say I know I come across as being against the use of psychiatric drugs, especially the neuroleptics, and basically, I am—or at least I think we should try to minimize them—but it is the forced drugging I am against. I know people who find even the neuroleptics helpful, and if adults want to take them, they should have access to them.

Aftab: It is silly from a systemic and social perspective. Not only is it more expensive, but it is also more ethically problematic. I certainly agree that addressing social inequities, safeguarding social needs, and providing social support and programs such as Soteria Houses will prevent many, perhaps even the majority of (though not all) involuntary admissions, and I certainly think this ought to be a priority when it comes to psychiatric funding and policy. The problem, however, is not silly or illegitimate at all from the perspective of individual psychiatric clinicians who have no power over social dysfunction or social resources, but have been given the responsibility to deal with the psychiatric aftermaths of it. Decisions to hospitalize when confronted with the risk of homelessness, incarceration, serious physical neglect, or physical harm to self or others are complex, ethical questions. I am reminded of something the psychiatrist Paul Gosney, MD, said in a debate in the British Journal of Psychiatry: “Much of modern psychiatric practice feels like we are trying to rescue people from damaged lives. If one of our tools is going to be taken away, then there needs to be a corresponding commitment from society to do better by all its members.”⁴ Honestly, I am highly sympathetic to efforts to reduce involuntary hospitalization and for there to be robust legal safeguards, as you advocate, but I am skeptical that this on its own will result in good outcomes unless there is a corresponding commitment from society to do better by individuals with psychiatric disabilities. The need for this sort of commitment is perhaps something upon which we can both strongly agree?

Gottstein: I certainly agree on the need for that sort of commitment to noncoercive, nonharmful approaches. One of the ways to achieve that is for people to have effective legal representation because no more than 10% of people involuntarily committed actually meet commitment criteria, and nonemergency involuntary medication can never meet the legal standard of being proven by clear and convincing evidence that it is in the person’s best interest and there are no less intrusive alternatives. If the system was not allowed to psychiatrically confine the 90% of people who do not meet commitment criteria and force psychiatric drugs into people against their will, society would have to find other ways to deal with people who are disturbing and thought to be mentally ill. I think of involuntary commitment and involuntary medication as the path of least resistance for the hospital, and it should be far more difficult.

I will give you an example. After the 30-day involuntary medication order I got reversed on appeal on constitutional grounds, the Myers case was a 4-month all-out legal battle, the likes of which the hospital had never seen before—and did not like. Shortly after that, I received a call from someone who had been court ordered for a psychiatric evaluation and the hospital had to file a commitment petition against him the next morning or let him go. I contacted the CEO of the hospital and told him I did not think the person met commitment criteria and would represent him if they filed a petition to commit him. Well, they tried really hard to find something else and I never got to meet my potential client because literally as I was driving up to the hospital that evening to meet with him, he was being driven away to something less restrictive and they never filed a commitment petition.

In the Myers case, Loren Mosher, MD, the former chief of schizophrenia research at the National Institute of Mental Health and the principal investigator in the Soteria-House study, testified under oath that involuntary treatment should be “difficult to implement and used only in the direst of circumstances,” and⁵:

[I]n the field of psychiatry, it is the therapeutic relationship which is the single most important thing… Now, if because of some altered state of consciousness, somebody is about to do themselves grievous harm or someone else grievous harm, well then, I would stop them in whatever way I needed to… In my career, I have never committed anyone… I make it my business to form the kind of relationship [through which the mentally ill person and I] can establish an ongoing treatment plan that is acceptable to both of us.

This is the needed approach, and patients are entitled to it.

Aftab: You say that the use of “nonemergency involuntary medication can never meet the legal standard of being proven by clear and convincing evidence that it is in the person's best interest and there are no less intrusive alternatives.” Never? That is a pretty strong claim. Can you elaborate?

Gottstein: This will be a lawyer nerd answer. First, it is important distinguish the “police power” justification for forced medication versus the “parens patriae” justification. The police power justification is to stop an immediate threat of great harm. In Alaska, it is called an emergency and has very strict requirements. It is for situations like when the tiger attacking Roy Siegfried was put down with a shot of Haldol. In contrast, the parens patriae justification is based on a judicial determination the person is incompetent to make a decision about the medication, and therefore, the government must step in in the nature of a parent and make the decision for the person in their best interest.

The legal standard for that is to prove by clear and convincing evidence it is in the person’s best interest and there are no less intrusive alternatives. I do not believe either can be proven by the clear and convincing standard which has various definitions depending on the state, but basically means “highly probable.” As an aside, in the United States Supreme Court case of Addington v. Texas, the psychiatric patient argued since the state was seeking to lock him up like a criminal, they should have to prove the right to do so beyond a reasonable doubt. The Supreme Court held psychiatrists could never prove their case beyond a reasonable doubt and since the confinement was not for a punitive purpose, they had to prove it by clear and convincing evidence instead, which is a higher bar than the more likely than not standard in other types of civil cases. This was for involuntary commitment, but it has been held the same standard applies to involuntary medication. This does vary by state, but I think it is the correct constitutional standard.

In my view, based on the evidence, the state can never prove it is highly probable that forcing psychiatric drugs into an unwilling patient is in their best interest in light of the abysmal outcomes and physical harm they cause, including early death. I also do not think it can legitimately be proven by clear and convincing evidence there is no less intrusive alternative that could be provided. I know people may disagree with me and, in fact, I tended to lose at the trial court level. I think that was because of the practical problem there was no actual less intrusive alternative to which my client could be sent. I write in The Zyprexa Papers about my last case representing Bill Bigley, where I had presented the evidence and the judge ordered Bill be drugged against his will anyway, ruling, “Even if the medication shortens Bigley’s lifespan, the court would authorize the administration of the medication because Bigley is not well now and he is getting worse.” So, I know many people disagree with me, including probably most of the people who will read this, but it is my view no legitimate determination can be made that it is highly probable forcing psychotropic medication into someone is in their best interest and there is no less intrusive alternative. It is hard for me to accept that shortening Bill Bigley’s life was in his best interest.

Aftab: I want to say for the record that, as a clinician, I am not persuaded by your stance on the involuntary use of medications, and based on my experience of working with the courts, neither are they, but I appreciate your engagement, and I am sure your arguments will give many readers much to think about. Thank you!

Dr Aftab is a psychiatrist in Cleveland, Ohio, and clinical assistant professor of psychiatry at Case Western Reserve University. He leads the interview series “Conversations in Critical Psychiatry” for Psychiatric Times™. He has been actively involved in initiatives to educate psychiatrists and trainees on the intersection of philosophy and psychiatry. He is also a member of the Psychiatric TimesTM Editorial Board. He can be reached at awaisaftab@gmail.com or on Twitter (@awaisaftab).

Dr Aftab and Mr Gottstein has no relevant financial disclosures or conflicts of interest.

References

1. Berenson A. Eli Lilly said to play down risk of top pill. The New York Times. December 17, 2006. Accessed July 20, 2022. https://www.nytimes.com/2006/12/17/business/17drug.html

2. Healy D. The Zyprexa Papers: this book had to be written. Samizdat Health. March 21, 2020. Accessed July 20, 2022. https://samizdathealth.org/zyprexa-papers/

3. Gottstein JB. Involuntary commitment and forced psychiatric drugging in the trial courts: rights violations as a matter of course. Alaska Law Review. 2008;25:51.

4. Gosney P, Bartlett P. The UK Government should withdraw from the Convention on the Rights of Persons with Disabilities. Br J Psychiatry. 2020;216(6):296-300.

5. Faith Myers v. Alaska Psychiatric Hospital. http://psychrights.org/states/alaska/caseone/30-day/3-5and10-03transcript.htm