by Ron Powers
Merck had claimed revenue of $2.5 billion in 2003. That was big money in those days.
In September 2009, Pfizer settled with the government for $2.3 billion in a similar deal. This one involved Pfizer’s painkiller Bextra, which is no longer on the market. One of the plaintiffs in the case, a former Pfizer sales representative named John Kopchinski, told the New York Times, “The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player.”
In 2010, another subsidiary of Johnson & Johnson* agreed to a settlement of more than $81 million in civil and criminal penalties to resolve allegations in a federal suit that involved its drug Topamax. Once again, the charge was “off-label” marketing. Once again, the specific wrongdoings were more impersonally amoral than legal language can communicate, and once again, the prey of the predators were the nation’s mentally ill. The FDA had approved Topamax as an anticonvulsant drug. The Department of Justice charged that the makers illegally went beyond that by promoting Topamax for psychiatric problems.17
May of 2012 saw another stunning outlay. GlaxoSmithKline, spawn of the company that had stumbled onto Thorazine more than half a century earlier, agreed to pay $3 billion in criminal penalties for illegal promotion of its antidepressants Paxil and Wellbutrin and the diabetes drug Avandia. The FDA found that GSK had not warned that children and adolescents taking Paxil showed increased tendencies toward suicide, and that pregnant women taking Paxil were more likely to have autistic babies. Wellbutrin, approved for depressive disorder, was promoted off-label for remedies such as weight loss, the treatment of sexual dysfunction, substance addictions, and attention-deficit/hyperactivity disorder (ADHD), among other off-label uses. As for Avandia, FDA clinical studies showed that it increased the risk of heart attack by 43 percent—and double that after a year of treatment.18
That same year, Abbott Laboratories drew $1.5 billion in criminal and civil fines after pleading guilty to misbranding Depakote, approved by the FDA to combat epileptic seizures and bipolar mania. Abbott admitted to recruiting a specialized sales force to peddle the drug to nursing homes as a control for agitation among the demented patients, and as a companion drug with antipsychotics to combat schizophrenia. Neither use had been shown to work in clinical tests; each was accompanied by side effects.19
In November 2013, Johnson & Johnson paid the federal piper for its fraudulent and dangerous marketing of Risperdal (one of Kevin’s medications). The price was $2.2 billion in criminal and civil fines. The charges against J&J replicated the earlier ones raised by the states and added one or two new ones; for instance: In its original review of Risperdal, the FDA had withheld approval for Janssen, a subsidiary of Johnson & Johnson, to market the drug for children. Janssen did so anyway. In fact, Johnson & Johnson, it was alleged in court, directed its sales force to promote Risperdal to children’s doctors. Parents of male children who used the drug began reporting cases of gynecomastia, a swelling of breast tissue caused by imbalances of estrogen and testosterone.
These federal court victories over Big Pharma and its depredations might not have been possible without substantial impetus from that figure of dubious reputation in popular opinion, the whistle-blower. These were not malcontented cranks, as the stereotype has it, but educated professionals, men and women who typically had held high positions within the pharmaceutical industry. John Kopchinski had been a sales representative for Pfizer. They took risks—perhaps not life-threatening, yet scary enough for people unused to cloak-and-dagger intrigue. Most of them wore hidden recorders—wires—to company meetings to capture incriminating policy conversations. The resulting transcripts proved devastating. But the potential rewards—ahh, the rewards! The rewards offer another glimpse into the surreal levels of money flowing into Big Pharma from around the world.
John Kopchinski was awarded more than $50 million in whistle-blower fees for his role in exposing Pfizer. The six former employees who testified against Johnson & Johnson and its companies shared $102 million from the Department of Justice settlement.
The whistle-blower rewards, of course, paled before the largesse that poured into federal coffers from these cases. The Department of Justice announced in 2015 that it had realized more than $3.5 billion in settlements and judgments in the fiscal year ending September 30. This marked the fourth consecutive year that the department had exceeded that figure, and it brought recoveries since 2009 to a total of $26.4 billion.20
It does not seem to have mattered. Not a penny. Not a word.
Not even, to give a specific example, the announcement in 2010 by the reformist group Public Citizen that Big Pharma had become the biggest defrauder of the federal government, surpassing the defense industry. This did not generate national media discussion. Certainly not on the level of vitriol aimed at the evils of Obamacare.
None of it seems to matter to Big Pharma’s CEOs. Their names rarely appear in the press or on television, unless they are being honored as humanitarians by some myopic or bought civic organization. Their names appear even more rarely in news of the big settlements: corporate individuals are almost never held liable for even the worst company crimes. And the largest penalties, the ones reaching into the billions, scarcely match the value of a few weeks’ revenues.
“It’s just a cost of doing business,” one pharmaceutical analyst remarked of the cash penalties, and added, “until a pharmaceutical executive does a perp walk.”21
Looking back at it all from nearly forty years as a doctor and medical researcher, and, before that, a marketing manager in the pharmaceutical industry, the Danish author Peter Gotzsche voiced the inevitable analogy. “Much of what the drug industry does fulfills the criteria for organized crime in U.S. law,” Dr. Gotzsche observed. “And they behave in many ways like the mafia does; they corrupt everyone they can corrupt, they have bought every type of person, even including ministers of health in some countries.”22
The perp walk will not likely happen soon. Nor are drug barons likely to burst into tears of epiphany at being compared to dangerous criminals. They and their companies have long since risen to take their place above the clouds of true accountability, alongside the banks and financial institutions, the firearm manufacturers, the tobacco industry, and the other global denizens of Too Big to Fail, Too Big to Nail.
And why should they not? No one cares about crazy people.
16
“Something Unexplainable”
The first signs of Kevin’s descent into schizophrenia came to light in January 2002, when he was seventeen and beginning his final semester at Interlochen. Kevin himself alerted us to his situation in a frantic telephone call one evening not long after he and Dean had returned to their schools from the holiday break. Based on what he told us, his mental state seemed to have been affected by his drug use. I emailed to Dean a digest of what Kevin had told us, or what I’d understood of it from the jumbled conversation:
Dean,
On Monday, Kevin admitted to us that he has a serious substance-abuse problem and wants help. His problem pretty much covers the gamut of available substances, and his craving for them is severe, and it has led to blackouts and other extreme results.
Nearly all of Kevin’s specific information turned out to be wrong or exaggerated. His use had covered no gamut. He’d been caught using chewing tobacco. But what the call did reveal, unfathomable to us then, was far worse. It was a symptom. He was hallucinating.
Honoree and I agreed that one or both of us must go to him. In the meantime, we reached the dean of students at the arts academy, who was aware of Kevin’s psychic disorientation and already had begun working with him. The school did not intend to expel him, as I wrote to our elder son, “but the dean made it clear to us that she feels Kevin should take a medical and emotional leave of absence.”
As a condition for allowing Kevin to remain enrolled, the dean of students asked us to place our son in a psychiatric hospital or clinic somewhere for a minimum of two weeks
of inpatient therapy. Symptomatic of the chronic shortage of psychiatric beds in the country, we could find nothing for our son. The Interlochen administrators proved accommodating, and we reached a backup agreement: Kevin would stay on as a day student under Honoree’s supervision. She would rent living space for the two of them in a residency hotel, drive him to and from the campus, and then to daily consultations with a therapist in Traverse City. Honoree drove straight to Michigan the next day.
How and why did Kevin develop his addictive urges? Or Dean?
The past thirty years or so have seen a flourishing of research into “comorbidity”—the possible correlation between the use of illicit drugs, even some prescription ones, and the emergence of schizophrenia. This field of study has generated hundreds of papers from physicians, psychiatrists, and PhDs around the world, which have tended to be at once inconclusive and highly suggestive. They typically report a high correlation between substance abuse and bipolar disorder and schizophrenia, at least among those genetically predisposed to the affliction.1 A paper published in 2003 by three French neuroresearchers is typical:
The use of psychoactive substances usually leads to a general deterioration of the patients’ condition. Pharmacodependent schizophrenic patients relapse more often, they are more frequently hospitalized, they show more violent behaviors, and they are more frequently homeless. In particular, the positive symptoms [hallucinations, delusions, confused thought] of these patients are generally exacerbated by the [illicit] psychoactive drugs.2
The team named “psychostimulants” such as cocaine and amphetamines, “anesthesic dissociatives” (PCP, ketamine), and hallucinogens (cannabis, LSD) as prominent in exerting “psychotomimetic” effects, and also listed amphetamines, cocaine, ecstasy, and heroin as causative substances.
The French psychiatric researcher P. Batel, reviewing the leading hypotheses for the high comorbidity in 2000, is among those drawn to the theory of “self-medication,” which suggests that “schizophrenics may be attempting to counter the deficit linked to their disorders by using the substances they take… to cope with their emotional problems.” Among the high-correlating features he lists are “very high nicotine and alcohol dependence, with a very poor prognosis.”3 There has yet been no consensus on whether the drugs enhanced the illness or the illness led to higher drug use. But there has been growing evidence that both may be true.
Batel published his paper at a time when “substances” were not generally believed to cause psychosis; their use was seen as a result of it. By around 2007, research had further focused the comorbidity searchlight. It now shone on cannabis: marijuana. In July of that year, the prestigious British medical journal Lancet published the results of a survey of thirty-five studies from nearly five thousand references. The evidence, its authors asserted,
is consistent with the view that cannabis increases risk of psychotic outcomes… although evidence for affective outcomes is less strong. The uncertainty about whether cannabis causes psychosis is unlikely to be resolved by further longitudinal studies such as those reviewed here. However… there is now sufficient evidence to warn young people that using cannabis could increase their risk of developing a psychotic illness later in life.4
Seven years later, another study appeared that made the Lancet piece sound waffling. In 2014 three widely published psychiatric investigators produced “Gone to Pot: A Review of the Association Between Cannabis and Psychosis,” which concluded: “At the present time, the evidence indicates that cannabis may be a component cause in the emergence of psychosis, and this warrants serious consideration from the point of view of public health policy.”5
Noting that cannabis is the most commonly used illicit drug in the world, with an estimated five million daily users, the three cited evidence suggesting many associations between the substance and disorders that included schizophrenia. “The relationship between cannabis and schizophrenia,” they assert, “fulfills many but not all of the standard criteria for causality, including temporality, biological gradient, biological plausibility, experimental evidence, consistency, and coherence.”6 One of the three, Samuel T. Wilkinson of the Yale School of Medicine, went so far as to unequivocally affirm a comorbid connection. In a 2013 Wall Street Journal essay that protested legalization of marijuana, Wilkinson cited articles in Lancet and the British Journal of Psychiatry to substantiate his conclusion: “As research accumulates, the emerging picture is that marijuana precipitates schizophrenia or related psychotic disorders in people whose brains are inherently vulnerable to psychosis.”7
These studies appeared too late to trigger warnings in the Powers household that cannabis could induce mental illness, though we tried, without success, to keep our sons from using it anyway. The world at large has remained equally, willfully clueless. As of June 2015, twenty-three states and the District of Columbia had enacted laws legalizing marijuana in some form and with varying limits.8 In Vermont, of course, cannabis is practically the unofficial state flower. The countercultural migration here in the 1970s enshrined it as the puff of choice. Organic, backyard-grown weed was a social amenity that cut across class lines. Once again, legislation on an issue with profound and toxic implications for the mentally ill was spreading across the country without attention paid to the interests of the mentally ill.
Kevin’s two weeks of intensive therapy and Honoree’s maternal companionship produced their desired effects. He finished out his final semester at Interlochen without further crises to blemish his three years of achievement. He began building his dreams for the life beyond the school. His dreams seemed at once fantastical and attainable. Kevin would continue his guitar training at the Berklee College of Music, a haven of contemporary music instruction and performance inside a deceptively drab brick-front on Boylston Street in Boston. Berklee’s alumni includes Quincy Jones, Branford Marsalis, John Mayer, Melissa Etheridge, Donald Fagen of Steely Dan, Brad Whitford of Aerosmith, and others. His bassist comrade Peter would pursue the classical double bass at the Boston Conservatory, an elite academy that accepted fewer than 250 undergraduate students. The two of them would be studying within a five-minute walk of each other in the historic Fenway neighborhood.
Kevin’s letter of application to Berklee is one of the treasures of our family memorabilia. Unembellished, humble, almost unconscious-seeming, it stands in my mind as the purest, most revelatory composition my son ever wrote, in any genre. Though he surely did not intend it as such, it is a verbal jazz piece, simple and demotic at its outset, establishing the theme, then opening up into rich, spontaneous passages of color and passion before returning to the main line for its quiet close. It is all of Kevin’s music, compressed. It is all of Kevin.
Kevin Powers
Musical Experience
As a musician, one of the most profound events I experienced was getting my first Pat Metheny CD. I was in eighth grade and the CD was “Like Minds,” a Christmas present from my dad. It featured Gary Burton, Chick Corea, Roy Haynes and Dave Holland. This was my first exposure to the jazz art form. Hearing that CD made me want to play jazz guitar.
From the first chord of the first song, something unexplainable made me listen more intently than I ever dreamed I would to a jazz recording. Gary Burton’s solo was intense. His playing was classy and smooth but not cheesy, his melodic runs and progressive energy were all there. When Pat started his solo, this was the first time I decided to give a new player a chance. I was, up until then, a die-hard for the rock scene. I had never heard someone play jazz in a way that inspired me to. That all changed with Pat’s playing.
His solo was begun in a manner that made him sound like he was in my room talking to me, telling me all the great things the guitar could offer. He started a little behind the beat with a short concise phrase and much as the title of the song would suggest, “Question and Answer,” the second phrase followed the first one perfectly. It was so lyrical and melodic. I had always enjoyed Joe Pass; however, I appreciate the two for different reas
ons now. I had never heard improvisation that was in a sense a melody itself. Pat was doing this. I had heard over and over again from camps that I attended that “space” was important, that one’s solo needs to “breathe.” Now it became clear to me why. It was happening here.
As soon as I was at the next record store, I bought a Pat Metheny Group CD. I realized that what I had heard on “Like Minds” was probably a small pixel in the larger scope of this guy. For a period of about a full year, each successive CD of his that I bought was more interesting than the last. Pat’s compositional ability is hard to comprehend. His songs are so expressive and the forms are so intricate. The most memorable experience I will have is attending the National Guitar Summer Workshop in New Milford, CT, where Pat came and spoke to us. It was three hours with the words from the man himself about what he has been doing, does and will be doing in the future. He is one of my biggest inspirations and I am very lucky to have been able to hear his music and see him.
Kevin and Peter would head for Boston almost immediately after graduation, where Peter had lined up summer jobs for them as waiters at a club. They would share an apartment in Roxbury before starting classes at their academies.
We applauded Kevin as he directed a guitar ensemble on the Corson stage during Festival Week leading up to graduation in June 2002. A day or two later we applauded him again as he walked across the stage of Kresge Auditorium on the shore of Green Lake to receive his Interlochen diploma. And then we packed his belongings into the van, resting his black Martin guitar on top of his bags and boxes, between protective pillows. We said our good-byes to faculty members near the spot where three years earlier I had watched my son begin to make new friends. Then we drove home to Middlebury, the Interlochen years already a memory, one that would grow, and then recede.