Integrative Literature Review

The Journal of Psychohistory 48 (2) Fall 2020

Psychopharmacology for the Psycho-Historian: The Evils of “Big Pharma,” Lobbying, Corruption and Serious Side Effects of Medications

Doctors pour drugs of which they know little, to cure diseases of which they know less, into patients of which they know nothing.

—Moliere (1622-1673, French dramatist)

ABStrACt: Psychohistorians have an interest in understanding terrorism, gun vio- lence, suicide, homicide, war crimes and other forms of criminal activities. In some of these situations side effects of medications, often psychotropics were considered a contributing factor to the violence and aggression involved in these acts. there are cases of war criminals who claimed their medications caused them to murder innocent civilians. In several mass gun shooting, the gun industry claimed that the offender was on psychiatric medication and claimed that mental sickness and the side effect of medication caused their homicidality. In several civil cases, drug manufacturers have been sued and a number of them settled their case without a court finding and without claiming responsibility for any wrong doing. However, in other cases they were held liable resulting in million-dollar fines. We review scientific articles on the side effects of psychiatric medications and the presence of any connection to violence, suicide and criminal activities. We also explore cor- ruption in a number of pharmaceutical companies and their financial relationship with government officials and prescribers.

A PSyCHO-HISTORICAL PERSPECTIvE: TALK vS DRUGS

Telling stories and tales to share learning and provide healing has ex-isted since ancient times. The collection of Middle Eastern folk tales commonly known as the “1001 Nights” illustrated the healing effect these

JamsHid a. marvasti & claire c. olivier

101Evils of Psychopharmacology; Implications for Psycho-Historians

stories could have.1 They provided “sessions” for the listeners as they took in the lessons and integrated them as a talking remedy. The difference from the Freudian school is that through folk tale type of storytelling the doctor does the talking, sharing tales that meet the patients’ concerns. In the 1970’s and 1980’s metaphors, and fairytales were used as a therapeutic intervention by Milton Erikson, Peseschkian and Bettelheim. While hair- dressers and bartenders filled the role of amateur modern therapists listen- ing to their clients and offering life stories.2

Clinical literature indicates a replacement of talk therapy by pharmaco- therapy during the last 30-40 years. In the 1970’s, the treatments of choice were psychotherapy, behavioral therapy, and/or environmental therapy. However, it gradually changed to the point that treatment now relies heav- ily on medication. There are multiple reasons for this change. One is the pressure from the insurance companies and the managed care industry to use drugs, which are cheaper and may possibly work faster (on the sur- face).3 Because certain psychiatric symptoms are connected to neurotrans- mitters, insurance companies may encourage doctors to use medications to modify these neuromessengers to minimize symptoms.4 Yet inhibiting these neurotransmitters may not cure the patient. Researchers are trying to connect mental disorders to biochemical causes. If such connections are found, it is believed that the most effective approach would be a biochem- ical treatment. However, in our opinion, various types of therapy (psycho- therapy, somatic (body based) therapy, etc.), may also positively impact a person’s brain chemistry, without negative side effects.

PREvALENCE OF UTILIzING PSyCHIATRIC MEDICATIONS Many Americans have come to expect substances to provide instant relief. Legal substances such as coffee, tea, alcohol and marijuana (in states where it is legal) are commonplace and can help provide energy, comfort, cre- ativity, relaxation and distraction. When these methods are not enough to combat one’s mood the media is more than willing to step in and provide other suggestions. Marketing in the media and news provides a way to de- crease the unknown about medications, regardless of their veracity. Adults then become more comfortable asking doctors about medications they see on the television for them or their children.5

In regards to prevalence of medication utilization, IQVia, the compa- ny that is the best source for physician prescribing data, reported that in 2017, over 7,200,000 children under 17 were on psychiatric medication.6 The highest number of children were on ADHD medication, followed by antidepressants, then antipsychotics, and finally anti-anxiety agents.7 The

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total of people (all ages in the US) taking psychiatric medications in 2017, was over 80,200,000.8

NATURE OF SIDE EFFECTS AND FDA IMPACT ON WARNING LABELS Side effects are generally dose oriented (which means that they may in- crease if the dose increases) and time related. Time related refers to how the body can adjust to side effects over time; therefore, they may decrease gradually and some of them eventually disappear.

The range of side effects of psychiatric medications may include insig- nificant and temporary ones (e.g., dry mouth, frequent yawning, stuffy nose), those which are significant and permanent, (e.g., tardive dyskine- sia-uncontrollable jerky movements of the body), and finally, life threaten- ing disorders (e.g., serotonin syndrome, neuroleptic malignant syndrome, suicidality or aggression).9 Almost all antidepressant and antipsychotic medication may cause akathisia which is a neurological disorder charac- terized by a feeling of inner restlessness, rocking while standing or sitting, lifting the feet as if marching on the spot, and constantly crossing and un- crossing the legs while sitting. The other name for akathisia is Restless Leg Syndrome, however the restlessness may not be limited to the legs. It may transfer to the upper extremities and generally can include a feeling of “in- ner tension.” Clinical literature indicates that this kind of internal tension and severe anxiety/restlessness may result in aggression or suicidality.

Phenobarbital, which is used for the treatment of epilepsy, is associated with memory disorders, hyperactivity, irritability, aggression, inattentive- ness, learning difficulties and depressed mood.10 Benzodiazepines such as Va- lium and Ativan may cause disinhibition in children and also in adults with TBI (traumatic brain injury). They may become aggressive and hyperactive. Long term use of Lithium may cause kidney and thyroid damage which may lead to cognitive dulling, weight gain, tremors and slowed down movement.

CHANGES TO THE LABEL OF PSyCHIATRIC MEDICATION WARNING There were approximately 14,775 cases reported to the US FDA’s MedWatch system between 2004-2012, which noted that a number of psychiatric drugs had violent side effects. In 1,500 cases there was homicidal ideation/ homicide. There were over 8,000 cases of aggression and approximately 3,280 cases of developing mania.11 Drug companies have been forced to change their warning labels over time, given the severity of side effects or the discovery of new negative impacts.

In 2004, the FDA requested drug companies to change the warning la- bel of 10 popular antidepressants. Patients who were on these medications were to be closely monitored for increased depression or suicidality. Addi-

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tionally, the FDA shared that agitation, hostility, impulsivity and mania (among other side effects), had been reported by child and adult patients who were taking these antidepressants.12 Yet the Black Box label change to Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants regarding possible suicidality in 2004, only warned patients up to age 18. It was not until 2007 that the FDA extended this warning to people under age 24.13

In 2007, the FDA changed the label of the ADHD medication Desoxyn (methamphetamine), to include multiple warnings regarding potential side effects of: aggression, bipolar disorder and psychotic symptoms.

In 2009, warning labels of drugs for smoking cessation and depression (Zyban and Wellbutrin) were changed to include warnings of hostility, agi- tation, and suicidal ideation/behavior.

In 2011 in Australia, a safety update on the psycho-stimulant medica- tion Provigil stated that this drug was associated with aggressive behavior, suicidal ideation/behavior, psychosis and mania, among other warnings. In 2010 the FDA in the U.S. added “aggression,” to the warning label.14

The most frequent prescribed SSRI antidepressants are Prozac, Paxil, Zoloft, Effexor, Cymbalta, Lexapro and Celexa. Their side effects may in- clude the development of mania and psychosis which may result in poor judgment and violence. Additionally, these medications may also cause somnambulism, or sleepwalking. Dr. Ohayon conducted a sleep study poll of nearly 16,000 adults in the U.S.15 He found that people who were taking an antidepressant were twice as likely to experience sleepwalking. Despite this clinical research, sleepwalking is not listed as a side effect for most anti- depressants. Legally if someone commits a crime while sleepwalking, they are not held responsible, as the defendant, “does not have the capacity to form intent.”16

Additionally, in 2017, the FDA changed the label of ADHD medication Dyanavel XR (amphetamine) to include the warning that it may exacer- bate behavior disturbance symptoms or thought disorders for those with a history of psychotic diagnosis. More significantly, this medication could cause psychotic symptoms including hallucinations or mania for patients with no previous psychotic symptoms.17

CRIMINAL ASPECTS OF PSyCHIATRIC MEDICATIONS AND DRUG MANUFACTURERS

Case of Wesbecker Trial In 1989 Joseph Wesbecker killed 8 people and injured 12 at his workplace, before committing suicide and a case was brought against the drug man- ufacturer. Wesbecker had been taking an SSRI antidepressant (Prozac) for

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one month before committing these crimes.18 Dr. Breggin was the scientific and medical expert for the case. He was asked to evaluate for the plain- tiffs the scientific basis for the claim that the antidepressant was causing violence and suicide. Additionally, he was to evaluate the potential negli- gence of the manufacturer, Eli Lilly, in how it developed and marketed this medication, which included any possible attempts to minimize the risk of drug-induced suicide and violence.19

Initially, it appeared that Eli Lilly had won the case, as this medication was found not to be at fault. However, the judge then found out the trial had been rigged, as the manufacturing company had paid the plaintiffs to withhold damaging evidence.20 As part of the settlement in 1994, the drug manufacturer released internal documents from 1985 which showed evi- dence that the risks of this drug outweighed the benefit.

Even without knowing how much the drug was at fault in the Wesbecker case, what is still significant is the possible withholding of information by drug manufacturer. Eli Lilly conducted research on animals which demon- strated that previously friendly cats began showing aggressive behavior (such as growling and hissing) when given this medication. This response was consistent with their unpublished work on a SSRI (Sertraline).21 While Eli Lilly denied that suicidality could be caused by medications, unpub- lished reports showed healthy volunteers on this antidepressant dropping out of the clinical trials because of developing akathisia and suicidality. Yet published reports by Eli Lilly did not include material on behavioral toxic- ity. Additionally, Kaufman stated that in other clinical trial reports, it was not mentioned that this drug company had been co-prescribing Benzodi- azepines (tranquilizers) along with this SSRI antidepressant to minimize the agitation caused by this drug alone.22

Case of Donald Schell In Wyoming in 2001, Donald Schell murdered his wife, daughter and granddaughter before shooting himself under the influence of another SSRI antidepressant (Paxil). The plaintiff was awarded a multimillion-dol- lar settlement.23 As put forth by Anne Thompson, “plaintiffs’ lawyers have argued for years that the so-called miracle antidepressants have a darker side that pharmaceutical makers have hidden from the general public, oc- casionally with lethal consequences.”24 In her article Thompson reviews the legal case of Donald Schell who had been taking this drug for only 48 hours before his crimes. This was a ground-breaking case because it was the first time a jury found a pharmaceutical company liable for the homicides committed by a person taking an antidepressant. A key element of the case were internal documents by the pharmaceutical company, which showed that they were aware that a small number of people could become violent

105Evils of Psychopharmacology; Implications for Psycho-Historians

as a side effect. Despite having this information, the company did not in- clude such warnings about aggression or suicide on drug packaging.

It was not contested that Schell had been depressed. He had previous- ly been on a different antidepressant medication. Yet he had no significant marital problems and loved his daughter and granddaughter, so there was no apparent motivation for the murder. The plaintiffs’ lawyer Vickery, fo- cused the argument on whether it is, “possible for the drug to produce a violent reaction in some people.” A critical element was Vickery’s win in pre-trial when a motion by this drug company was overruled. They had wanted to exclude testimonies by two expert witnesses, Dr. Healy a psychia- trist and Dr. Maltsburger an associate clinical professor of psychiatry at Har- vard. Healy was known for his lectures and writings regarding SSRIs and how they should have warning labels. His own research illustrated that one in four healthy volunteers on this medication could develop agitation and sui- cidality. He shared that these results were supported by studies that Beecham labs had conducted at the request of the manufacturer. Within their inter- nal confidential documents, were the results of a study with 2000 healthy volunteers taking either a placebo or anti-depressant. The plaintiffs’ team shared that in these results were hundreds of volunteers who had negative side effects, like attempted suicide which Beecham physicians stated were either, “possible, probably, or definitely caused by this SSRI anti-depressant.”

The defense put forth that their medication was very effective and could have been for Schell if he had been able to take it for a longer duration. They also claimed that two pills couldn’t have caused his actions. However, the plaintiffs showed the results from their study included volunteers experienc- ing anxiety, nightmares, hallucinations and other symptoms within two days of taking this drug. Two other volunteers attempted suicide within 2-3 weeks.

Although the plaintiffs asked for $25 million, the 8-person jury award- ed $8 million. The manufacturer was found to be 80% at fault, Schell 20%. Therefore, his relatives received $6.4 million. This was a significant win as it encouraged other plaintiff lawyers to begin taking up antidepressant cases.25

Case of Stewart Dolin In 2010 in Chicago, Stewart Dolin, a 57-year-old attorney, committed sui- cide by jumping in front of a train.26 His wife sued GlaxoSmithKline (GSK), a drug manufacturer, because just days before his suicide he started taking a generic version of an SSRI anti-depressant (Paxil). The suit claimed that GSK did not sufficiently warn Dolin’s doctors, about the suicidal risk for adults using this drug. The suit held that Dolin would not have taken his life if he had not taken this medication. The Black Box warning on the medication stated that there was a suicide risk but only for children and young adults up to age 24. During the trial it was argued that the manu-

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facturer had known for 20 years that this medication could trigger suicidal behavior in a person of any age but hid the risk and ignored numerous sui- cides committed during clinical trials.

GSK had claimed no fault because they had not manufactured the ge- neric version, however the judge ruled that they were responsible for the label. However, they stated they were not responsible because the FDA did not require them to add a suicidal risk on the warning label. The 9-panel jury found this company liable in 2017 for the charges and Dolin’s widow was awarded $2 million for damages and $1million for the suffering of her husband. However, the original suit asked for $39 million in damages.27 The defense later appealed and in 2018, the verdict was overturned. GSK claimed that they had repeatedly asked the FDA to update this drug’s warn- ings to include risk of suicidality to adults. The 7th Circuit panel found that the FDA would have rejected an adult suicide warning and that this drug company was following the FDA’s mandated drug label warning.28

One wonders if the FDA could be sued for negligence if they had been provided with clinical studies which supported a known risk of older (over 24 years old) adult suicide, yet did not require this information on medica- tions’ labels. While the FDA is entrusted with ensuring the safety of all food and drug products in the United States, it is not clear how some medications are approved to be on the market despite a mix of success and failure during clinical trials. During the pre-market trials of one of the SSRI antidepressants, 16 people taking this medication attempted suicide, two successfully.29 Yet it was still FDA approved in 1987, without a warning label of possible suicidali- ty. The German version of the FDA would not allow this medication to come to their market until it included a suicide warning on the label in 2004.30

PHARMACEUTICAL COMPANIES PAyOUT Pharmaceutical companies have been in the news for years regarding claims of false advertising or promoting their medication for unapproved usage. Additionally, they are accused of being more focused on making a profit than in disclosing all significant information about their drugs and the side effects they cause. Major drug companies have had to settle hundreds of millions of dollars in government cases or are under investigation.31

In 2005, the major drug company Eli Lilly, had to pay out $690 mil- lion in a lawsuit to settle claims by 8000 plaintiffs that an antipsychotic (Zyprexa), had caused diabetic and hyperglycemic side effects. They also had to pay an additionally $500 million in 2007 for another 18,000 suits against the same medication.32

In 2009, the same company, Eli Lilly, paid a $515 million dollar fine, in addition to pleading guilty to criminal charges, that it unlawfully promot-

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ed their antipsychotic medication (Zyprexa) for uses that had not been FDA approved which included treating dementia. They settled an addi- tional federal civil investigation paying out $800 million to the federal government and various states.

In 2009, Pfizer, a major drug company, was ordered to pay $2.3 billion by the U.S. Department of Justice in criminal and civil fines. They were charged with illegal promotions to encourage doctors to use several of their products including Geodon, an antipsychotic. Additionally, to curb fur- ther similar offenses they were monitored for five years by the Department of Health and Human Services Office of Inspector General.33

In 2009, another maker of an SSRI anti-depressant GlaxoSmithKline (GSK) was found guilty of failing to adequately warn doctors of the risks of using their medication (Paxil) during pregnancy. Lyam Kilker, age 3, was born with heart defects which his mother attributed to this medication, taken during her pregnancy. He was one of the first out of approximately 600 similar cases, and his family was paid $2.5 million in damages.34

THE ISSUES OF KICKBACKS Psychiatrist, Michael Reinstein, had his license suspended for overprescrib- ing clozapine, an antipsychotic medication. In the case brought against him he was accused of submitting 140,000 false claims that involved kick- backs from drug manufacturers. Additionally, the disciplinary board stated that he did not consider alternative treatments that would have been less harmful to his patients. This antipsychotic is known for having seizures as one of its side effects. The company which makes the generic version of this anti-psychotic, had to pay over $27 million for persuading Dr. Rein- stein to overprescribe their drug.35

Case of Andrew yount Andrew Yount was a 4-year-old boy when he was prescribed an antipsy- chotic, Risperdal, for his behavioral problems and ADHD.36 Yet this drug had only been approved by the FDA for adult schizophrenia. However Johnson & Johnson, the pharmaceutical company, began to market this drug to doctors, encouraging them to prescribe it to children for a range of behavioral concerns. The FDA has specifically rejected it for the pediatric population because there was not enough data to show its safety. This an- ti-psychotic increased the hormone prolactin which promoted the growth of female breasts, and affected Yount and thousands of other boys. These boys became men with full sized breasts, a condition that is irreversible un- less they are surgically removed. Some of these men have won settlements against the manufacturer, which included Yount, who received $76 mil-

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lion. In their 2016 annual report, Johnson & Johnson stated that they have 18,500 lawsuits against them related to this medication.37

LOST COURT CASES WHEN MEDICATIONS WERE USED AS A DEFENSE Although there are multiple drug lawsuits and settlements against large drug manufacturers,38 there are also cases that claiming medications as a cause of abnormal behavior were ruled out. Following are a few of these cases:

Texting suicide case In the Commonwealth v Michelle Carter case, better known as the “texting suicide case,” Carter had been sending text messages to her boyfriend Roy, encouraging him to kill himself, which he ultimately did.39 A psychiatrist for the defense claimed that Carter’s use of antidepressants made her invol- untarily intoxicated and delusional in thinking she was helping Roy. She was later convicted of involuntary manslaughter. While it is reasonable that defense attorneys will use whatever material, they can to help their clients, psychiatrists testifying in court have an obligation to share relevant psychi- atric clinical science that illustrates the current reality of understanding.

“Ambien Excuse” Roseanne Barr, a television actress, had to face consequences for posting a racist comment on twitter. She blamed her bad behavior on her pre- scription medication Ambien in response to public outrage, however the medical community has found this excuse hard to believe. Ambien is a sedative hypnotic prescribed as a sleeping aid in patients with insomnia. Although the side effects of the psychotropic medication include con- fusion, drowsiness and muscle weakness, the drug maker tweeted that, “…racism is not a side effect of any Sanofi medication.” Ms. Barr was certainly not thinking clearly in her “Ambien blackout” when she “sleep tweeted,” but that does not excuse or explain the racist nature of her post. Ms. Barr was tried in the Court of Public Opinion and her sitcom was cancelled. Allen Frances M.D, a psychiatrist at Duke University com- mented in a STAT News article, “Allowing fake medical excuses to go un- challenged has 3 harmful consequences: encouraging more bad behavior, discouraging those who really need medications from using them, and unfairly stigmatizing the mentally ill.”40

Sleeping Pill Crime Brian Browning killed his wife while she was asleep, but blamed his ac- tions on Unisom, a sleeping pill he had been taking. Browning’s doctor had shared that this medication could trigger behavior outside of one’s normal

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character. However, the courts in Australia, where this took place, did not accept this argument and Browning was convicted. The court acknowl- edged that Browning’s judgement and emotional abilities could have been impacted, however there were other factors to consider that carried more weight. Browning had claimed that Unisom caused psychosis, yet evidence showed that psychosis is not one of the side effects, therefore this assertion was abandoned at the trial.41

U.S. SOLDIER WHO MURDERED AFGHANI CIvILIANS Some of the U.S. veterans who have been involved with war crime activ- ities have claimed that their medications contributed to their crimes.42 One such case involved Army Staff Sgt. Robert Bales, who was charged with murdering 16 Afghani civilians during his deployment in 2012, but believes that his homicidal behavior was tied to taking Lariam, a prophy- lactic antimalarial drug given to troops in endemic regions.43 This drug is controversial since it has a number of neurological and psychiatric side effects (hallucinations, anxiety, paranoia) and can cause vestibular prob- lems (inner ear functioning affecting balance, eye movement and causing vertigo). Due to its side effects profile, in 2009, the Defense Department made it a last-choice option for the U.S. military, only to be used in areas with drug-resistant strains of malaria. In 2013 the FDA placed a Black Box warning on Lariam. Bales cited a number of possible contributing factors for his war crimes, such as traumatic brain injury (TBI) which he sustained in 2009. This is significant because U.S. Military regulations stipulate that Lariam is not allowed for individuals with TBI because of its likelihood to cross the blood-brain barriers and cause psychotic, homicidal or suicid- al behavior. However, there was no documented evidence that Bales was taking Lariam, yet it is not uncommon for deployed service members to be issued this drug without it being recorded in their medical records. It is possible that Bales was experiencing hallucinations and psychosis during the massacre if he was administered Lariam in direct contradiction to the U.S. military rules.44 In order to avoid the death penalty, Bales pleaded guilty to 16 counts of murder and six counts of assault and attempted murder. He was sentenced to life in prison without the possibility of pa- role. His legal team had asked the U.S. Army Court of Criminal Appeals to review his life sentence, given that the implications of being prescribed this drug, in addition to witness information, were not part of the orig- inal investigation. His appeal was denied however, and his life sentence stands.45 If he runs out of options in the courts, Bales may seek clemency from President Trump.46

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DRUG COMPANIES AS REPEAT OFFENDERS? There are several explanations as to why major pharmaceutical companies continue to be repeat offenders. As Morgan Statt mentioned in her article, “Taking Big Pharma to Court,” one is that drug companies are permitted to provide the funding for clinical trials.47 The National Institute of Health puts a portion of its budget toward the cost of research trial however, the amount has been drastically decreased in recent years. Obviously the source of money should not dictate the result of trial. But, there are those who believe one who finances the project, possibly can shape the research to its own benefit. For example drug companies may exclude certain popula- tions (like the elderly) from the trials, (even if that population is most likely to need the medication), in order to have more positive outcomes. Addi- tionally, government investigations revealed that certain research studies regarding antipsychotics were ghostwritten by the drug companies’ market- ing department and then signed by well-known physicians. In this way the study falsely appears to be conducted independently by physicians.48 Dr. Stefan Kruszewski, a psychiatrist who previously worked as a paid speaker for multiple drug companies shared that in the beginning, he was able to speak about the drugs related to the science. Later he was told what to say, which included false data. One presentation included information about an antipsychotic drug which was promoted as having no neurological side effects. He stated, “‘They made it all up. It was never true.”’49

Lobbying The health and pharmaceutical companies are also a very powerful lob- bying group and just in the first quarter of 2017 they spent $78 million in their lobbying efforts.50 There is a concern that there is a conflict of interest between these companies and the FDA. In 1992 the Prescription Drug User Fee Act was passed (and is renewed every 5 years) which allowed the FDA to collect fees for processing medication approvals. While originally meant to offer the FDA a nominal resource, as of 2017 it accounted for over 40% of the FDA’s budget. Raising the question of how neutral the FDA can be towards these companies’ demands regarding getting certain drugs to the market. While this regulation was altered in May 2018, prescription drug user fees still have a major impact on the FDA’s overall budget. These fees accounted for 45% of the agency’s FY2018 total fundung.51

Members from the 7 largest pharmaceutical companies appeared before the Senate Finance Committee in February of 2019 to discuss high drug costs.52 The committee criticized the companies of finger pointing and greedy policies, including only cutting costs of drugs which were not draw- ing in much money. Yet it is important to note that the members of this committee also took a combined $7.9 million in campaign contributions

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from the pharmaceutical industry during the last 6-year Senate election cycle. Pharmaceutical Research and Manufacturers of American (PhRMA) alone spent $28 million on lobbying efforts in 2018 to impact federal poli- cy regarding drug pricing bills.53

New Legislation Two senators, Grassley and Klobuchar have put forth two bills to lower costs of prescription drugs. One is aimed at limiting “pay-for-delay deals,” where pharmaceutical companies are paying generic companies to delay releasing generic versions of their drugs; if there is no generic option, the public is forced to buy the more expensive name brand. The second bill would allow U.S. citizens to buy medications from Canada for lower prices.54

A HISTORICAL AND ETHICAL PERSPECTIvE There were various periods of psychopharmacology, from its conceptual be- ginnings in the 18th century, to the start of modern psychopharmacology in the 1950’s and now its present-day usage. However ethical concerns arose during each time period naming the potential dangers of these med- ications.55 One historical perspective on psychopharmacology suggests that its rise was not necessarily caused by more effectiveness in medica- tion treatment of nuanced psychiatric diseases.56 Rather, a combination of pharmaceutical marketing, advances in science, political/economic situa- tions, changes in mental health care and a desire for a quick fix, supported the success of psychopharmacology. There is an ongoing mindset/hope in Western culture that technology and science can create a magic pill which will cut through the messiness of being human and provide simple solu- tions for madness and misery. Doctors Braslow and Marder put it this way. “It is not that psychopharmacology has failed. Instead, we have failed our patients by adopting a myopia that sees only symptoms and their allevi- ation by psychoactive drugs.”57 Yet with a fragmented health care system, psychiatrists may feel these drugs are all they can offer.

In the world of medications, researchers are also exploring drugs which could target the memory processes for those suffering with PTSD like vet- erans.58 While the desire for a remedy that could disrupt dysfunctional aversive memories is warranted, it does raise the question of how is our humanity impacted? One of the significant challenges in this drug research is the ability to be selective when attempting to alter aversive memories.59 One doctor who lectures in medical ethics, Dr. Daniel Sokol, made this point, ‘‘Removing bad memories is not like removing a wart or a mole. It will change our personal identity since who we are is linked to our mem- ories.’”60 Additionally, would a drug that removed memories, also prevent those who take it from feeling remorse, or learning from their mistakes?61

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CONCLUSION We have illustrated the various types of court cases that have arisen re- garding the potential connection between psychiatric medication and vio- lence. Yet as Kaufman stated, “While manufacturers have a vested interest in exonerating their drugs, plaintiffs have an interest in blaming it, and defendants in exonerating themselves. We need careful, independent anal- ysis of existing study data.”62 However, clinical trials have demonstrated that there can be side effects from psychiatric medications which may im- pact suicidality and aggression/homicidality. Additionally, we have report- ed how various pharmaceutical companies have a history of withholding unfavorable clinical research and at times, falsely marketing medications.

There are some physicians, such as Allen Frances,63 who believe that the pattern of illegal activity committed by various pharmaceutical companies will not stop unless a few of these companies’ executives are handcuffed and sentenced to jail.

Literature has put forth various recommendations to improve the health of our nation. One idea concerns the relationship between drug company sales representatives and physicians. Doctors should not receive any kind of reward or compensation for giving patients certain medications, nor should drug companies be allowed to advertise directly to consumers. Drug companies spend billions of dollars to advertise to the public, who are then encouraged to ask their physician for a specifically advertised medication. Yet the public does not know the actual clinical trial results of this med- ication. Furthermore, when a drug company pays for a clinical trial, an independent party should review the details and results before they are submitted to the FDA. Drug companies must disclose all of their research, instead of cherry-picking favorable results.

Jamshid A. Marvasti, M.D. is a child and adult psychiatrist practicing at Prospect Manchester Hospital, Manchester, Connecticut. He is a clinical assistant professor of psychiatry at the University of New England College of Osteopathic Medicine. Dr. Marvasti has published and edited a number of articles and books including War Trauma in Veterans and Their Families (2012), and Psycho-Political Aspects of Suicide Warriors, Terrorism, and Martyrdom (2008). He can be reached at [email protected].

Claire C. Olivier, MSW Received her master’s degree from the University of Cali- fornia at Berkeley. Ms. Olivier previously wrote a chapter entitled, “The Battle Af- ter the War: Cultural Challenges for those Coming Home,” in Dr. Marvasti’s book War Trauma in Veterans and Their Families (2012), and contributed to Dr. Marvasti’s earlier book, Psycho-Political Aspects of Suicide Warriors, Terror- ism and Martyrdom (2008). She can be reached at [email protected]

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REFERENCES 1. Marvasti JA, Using Metaphors, Fairy Tales, and Storytelling in Psychotherapy with Chil-

dren, in 101 Favorite Play Therapy Techniques. Edited by Kaduson HG, Schaefer CE. New Jersey, 1997, pp 35-39.

2. Ibid 3. Marvasti JA, Wu P, Merritt R: “Psychopharmacology for Play Therapists.” Interna-

tional Journal of Play Therapy: 27:1:35-45, 2018. 4. Ibid 5. Ibid 6. Citizens Commission on Human Rights International: The Mental Health Watch-

dog. Number of Children & Adolescents Taking Psychiatric Drugs in the U.S. Avail- able at https://www.cchrint.org/psychiatric-drugs/children-on-psychiatric-drugs/. Accessed March 1, 2019

7. Ibid 8. Citizens Commission on Human Rights International: The Mental Health Watch-

dog. Total Number of People Taking Psychiatric Drugs in the United States. Avail- able at https://www.cchrint.org/psychiatric-drugs/people-taking-psychiatric-drugs/. Accessed March 1, 2019

9. Marvasti JA, Wu P, Merritt R: “Psychopharmacology for Play Therapists.” Interna- tional Journal of Play Therapy: 27:1:35-45, 2018

10. Dulcan M, Lake M: Child and Adolescent Psychiatry (4th ed.,). Washington, DC: American Psychiatric Publishing, 2012. pp 303

11. Citizens Commission on Human Rights International: The Mental Health Watch- dog. Psychiatric Drugs and Violence-The Facts. Available at https://www.cchrint.org/ psychiatric-drugs/drug_warnings_on_violence/ Accessed February 13, 2019

12. Ibid 13. Kauffman J: “Selective Serotonin Reuptake Inhibitor (SSRI) Drugs: More Risks than

Benefits?” Journal of American Physicians and Surgeons. Vol 14, Number 1, Spring 2009

14. Citizens Commission on Human Rights International: The Mental Health Watch- dog. Total Number of People Taking Psychiatric Drugs in the United States.

15. Doheny K: Sleepwalking may be more common than you think. WebMD. May 14, 2012. Available at https://www.webmd.com/sleep-disorders/news/20120514/sleep- walking-may-be-more-common-than-you-think#1 Accessed March 7, 2019

16 Healy D, Herxheimer A, Menkes D: “Antidepressants and Violence: Problems at the Interface of Medicine and Law.” Plos Medicine. September 2006; 3(9). E372.

17. U.S. Food and Drug Administration (2017) Available at https://www.accessdata.fda. gov/drugsatfda_docs/label/2017/208147s003lbl.pdf. Accessed March 1, 2019

18. Healy D, Herxheimer A, Menkes D: Antidepressants and Violence: Problems at the In- terface of Medicine and Law.

19. Breggin P: Wesbecker-Prozac Product Liability Suits. Available at https://breggin .com/wesbecker-prozac-product-liability-suits/ Accessed March 15, 2019

20. Ibid 21. Kauffman J: Selective Serotonin Reuptake Inhibitor (SSRI) Drugs: More Risks than Benefits? 22. Ibid 23. Hilts PJ: “Jury Award $6.4 Million in Killings Tied to Drug.” NY Times, June 08, 2001 24. Thompson A: Paxil Maker Held Liable in Murder/Suicide. Will $6.4 Million Verdict

Open a New Mass Tort? Baum Hedlund Aristei Goldman. July 9, 2001. Available at https://www.baumhedlundlaw.com/drug-injury-press-releases/paxil-maker-held-li- able-in-murder-suicide.php Accessed March 7, 2019

25. Ibid

114 Jamshid A. Marvasti & Claire C. Olivier

26. CBS (Chicago): Jury Awards $3M to Widow Who Sued Drug Firm Over Husband’s Suicide. April 21,2017. Available at https://chicago.cbslocal.com/2017/04/21/jury- awards-3m-to-widow-who-sued-drug-firm-over-husbands-suicide/ Accessed March 15, 2019

27. Ibid 28. Bellon T: U.S. appeals court says GSK cannot be sued over generic drug suicide. Re-

uters. August 22, 2018. Available at https://www.reuters.com/article/us-gsk-lawsuit/ u-s-appeals-court-says-gsk-cannot-be-sued-over-generic-drug-suicide-idUSKCN- 1L72D1 Accessed March 15, 2019

29. Walker A: “Take Two of These and Sue Me in the Morning; The Emergence of Litiga- tion Regarding Psychotropic Medication in the United States and Europe.” Arizona Journal of International and Comparative Law. 2002. Vol.19. No.2. Available at http:// arizonajournal.org/wp-content/uploads/2015/11/Walker.pdf Accessed March 1, 2019

30. Ibid 31. Wilson D: “Side Effects May Include Lawsuits.” The New York Times. October 2,

2010. Available at https://www.nytimes.com/2010/10/03/business/03psych.html Accessed March 9, 2019

32. Citizens Commission on Human Rights: Chronology of Sample Lawsuits about Psy- chotropic Drugs. Available at https://files.ondemandhosting.info/data/www.cchr .org/files/education/appendix/10-chronology-of-sample-lawsuits.pdf Accessed Feb- ruary 15, 2019

33. Ibid 34. The Telegraph: GSK antidepressant Paxil to blame for baby’s heart defects, U.S. jury

rules. October 15, 2009. Available at https://www.telegraph.co.uk/news/health/ news/6335822/GSK-antidepressant-Paxil-to-blame-for-babys-heart-defects-US-jury- rules.html Accessed March 12, 2019

35. Harrison P: Psychiatrist Suspended for Antipsychotic Overprescribing. Medscape. August 12, 2014. Available at https://www.medscape.com/viewarticle/829790 Accessed March 9, 2019

36. Liston B: Makers of Risperdal Sued for Breast Development in Boys. Mad in Ameri- ca. July 21, 2017. Available at https://www.madinamerica.com/2017/07/risperdal- sued-breast-development-boys/ Accessed March 17, 2019

37. Ibid 38. Saunders J: Top Eight Largest Drug Lawsuit Settlements of All Time. Saunders Walk-

er. October 23, 2017. Available at https://www.saunderslawyers.com/top-eight- largest-drug-lawsuit-settlements-time/ Accessed March 2, 2019

39. Knoll J, Annas G: “Warning: Antidepressants may cause messaging manslaughter.” Psychiatric Times. September 19, 2017. Vol 34:9. Available at http://www.psychiatric times.com/psychopharmacology/warning-antidepressants-may-cause-messaging- manslaughter Accessed March 19, 2019

40. Biscaldi L: Roseanne Barr’s “Ambien Excuse” Tried in the Court of Public Opin- ion. Medical Bag. June 6, 2018. Available at https://www.medicalbag.com/medicine/ ambien-excuse-roseanne-barr-tweets/article/771396/ Accessed March 21, 2019

41. Loughnan A: The drugs made me do it: can prescription side-effects be an excuse for crime? The Conversation. July 8, 2016. Available at http://theconversation.com/the- drugs-made-me-do-it-can-prescription-side-effects-be-an-excuse-for-crime-45821 Accessed March 29, 2019

42. Marvasti JA, Podolski J E: Forensic Aspects of Combat Trauma and PTSD: Special Vet- erans’ Court, Malingering, And Criminal Conduct, In War Trauma In Veterans And Their Families: Diagnosis And Management of PTSD, TBI and Comorbidities Of Combat Trauma. Edited by Marvasti JA. Springfield, IL: Charles Thomas Publishers, 2012, pp154-168

115Evils of Psychopharmacology; Implications for Psycho-Historians

43. Kime P: “U.S. Soldier Who Murdered Afghan Civilians Blames Malaria Drug Used By Army.” Miami Herald. August 8, 2017. Available at https://www.miamiherald.com/ news/nation-world/national/article165990147.html Accessed March 13, 2019

44. Ibid 45. Associated Press: Court upholds ex-soldier’s life Sentence In Slaying Of Afghan

Civilians. Army Times. September 28, 2017. Available at https://www.armytimes .com/news/your-army/2017/09/28/court-upholds-us-soldiers-life-sentence-in- slayings-of-afghan-civilians/ Accessed March 28, 2019

46. Kime P: Ex-soldier Who Shot Up Afghan Village May Seek Clemency From Pres- ident, Lawyer Says. McClatchy Washington Bureau. June 20, 2018. Available at https://www.mcclatchydc.com/news/nation-world/national/article213092124.html Accessed March 19, 2019

47. Statt M: Taking Big Pharma to Court: Why Lawsuits Have Little Effect on Drug Company. Mad in America. February 22, 2018. Available at https://www .madinamerica.com/2018/02/big-pharma-lawsuits-little-effect-drug-companies/ Accessed March 26, 2019

48. Wilson D: Side Effects May Include Lawsuits. October 2, 2010. 49. Ibid 50. Statt M: Taking Big Pharma to Court: Why Lawsuits Have Little Effect on Drug Company.

February 22, 2018. 51. Dabrowska A, Green V: The Food and Drug Administration (FDA) Budget: Fact

Sheet. Congressional Research Service. Updated September 12, 2018. Available at https://fas.org/sgp/crs/misc/R44576.pdf Accessed March 25, 2019

52. Evers-Hillstrom K: Senators Publicly Grill ‘Big Pharma’ Executives After Accepting Millions From Industry. Open Secrets. February 26, 2019. Available at https://www .opensecrets.org/news/2019/02/senators-grill-big-pharma-executives/ Accessed March 16, 2019

53. Ibid 54. Smith J: Senators Grill Pharma Execs Over Prescription Drug Prices. Yahoo Finance. Feb-

ruary 26, 2019. Available at https://finance.yahoo.com/news/senators-grill-pharma- execs-over-prescription-drug-prices-154953281.html Accessed March 22, 2019

55. Barbara JG: History of Psychopharmacology: From Functional Restitution to Function- al Enhancement. 2015. 489-504. 10.1007/978-94-007-4707-4_26. Available at https:// www.researchgate.net/publication/283653231_History_of_Psychopharmacology_ From_Functional_Restitution_to_Functional_Enhancement Accessed April 8, 2020

56. Braslow JT, Marder SR: History of Psychopharmacology. Annu.Rev.Clin.Psychol. 2019. 15:25–50. Available at https://www.annualreviews.org/doi/pdf/10.1146/ annurev-clinpsy-050718-095514 Accessed April 5, 2020

57. Ibid 58. Giustino TF, Fitzgerald PJ, Maren S: Revisiting propranolol and PTSD: Memory erasure

or extinction enhancement? Neurobiol Learn Mem. 2016 Apr; 130: 26–33. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4818733/ Accessed April 8, 2020

59. Ibid 60. Derbyshire D: Pill to erase bad memories: Ethical furor over drugs ‘that threaten

human identity.’ Daily Mail. February 16, 2009. Available at https://www.dailymail .co.uk/news/article-1145777/Pill-erase-bad-memories-Ethical-furore-drugs- threaten-human-identity.html Accessed April 6, 2020

61. Ibid 62. Kauffman J: Selective Serotonin Reuptake Inhibitor (SSRI) Drugs: More Risks than Bene-

fits? 2009 63. Frances A: Saving Normal. New York, NY: HarperCollins Publishers, 2013.

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