by Alison Bass
The social worker shared what she had found on the disk with several co-workers. A few weeks later, she received a call from the inspector general's office of the Health and Human Services Department: they wanted to talk to her about the disk she had discovered. Shortly after that, the social worker transferred to another department at Brown, and Howard lost touch with her. In January 1996, Keller acknowledged in an interview with me that the National Institute of Mental Health was investigating the lithium bipolar study. The NIMH inquiry was in response to a letter from a Brown employee (not Howard) alleging the falsification of data in Keller's application to the federal institute for the renewal of his department's $188,000 annual contract for the lithium study. (A NIMH spokeswoman later confirmed that the institute had indeed sent an auditor to Brown. The auditor found the department's "books" on the lithium grant and two other NIMH-funded studies were in order, she said.)
Three years later, in the summer of 1999, Howard herself was contacted by an agent from the HHS inspector general's office. He wasn't as nice as the two agents who had visited her home in January 1996. "He implied that I could come and talk friendly-like or he would subpoena me," she recalled. Howard met the man, whom she would describe as "a sixtyish professional bureaucrat," at a Providence hotel and spent an anxious hour in the hotel cafe answering his questions. She never heard from him again, and no federal charges were filed against Brown or its chief of psychiatry, according to a spokeswoman for HHS.
At the time, what bothered Howard most about the lithium study was her sense that participants were not being adequately informed about the risks involved. She had also come across what she considered blatant conflicts of interest in the recruitment process. One homeless, manic eighteen-year-old girl had been recruited for the study by the same psychiatrist who was treating her at a public clinic in Fall River, Massachusetts. According to Howard and the psychiatrist who treated and recruited the girl, Keller had hired him as a paid consultant to do "subject recruitment" for the lithium study. Who, Howard wondered, was looking out for this girl's best interest?
Sheldon Krimsky, the Tufts University medical ethicist, expressed the same concern. "There's a general, widely accepted agreement you shouldn't get paid for recruiting your own patients," he said. "That would be a deep conflict of interest." Receiving financial remuneration (to the tune of $25,000, in this particular case) for recruiting a vulnerable teenager could easily clash with the best interests of the patient, Krimsky said. (When interviewed for this book, the psychiatrist who was paid for recruiting the girl said he saw no such conflict.)
Years later, Donna Howard would point to such issues as one reason she never enrolled her own daughter in a clinical trial at Brown or its affiliate hospitals. Fortunately, by the fall of 2002, Howard's daughter was doing much better. Maria had recently earned a general equivalency diploma (GED) and was now enrolled in Bristol Community College in Fall River, about twenty-two miles away. She continued to live at home, and Howard drove her to campus on her way to work every morning. When classes were finished for the day, Maria would wait for her mother to pick her up. Howard felt as if all those years of struggle, of trying to keep Maria safe and sane within the confines of her illness, were finally paying off. She was intensely proud of her daughter for having the courage to insist on a normal life.
In the COBY study Keller was recruiting for that autumn, the aim was to follow adolescents with bipolar disorder over the long term and see how they did on various medications and measures of psychosocial functioning. The COBY study was not a randomized clinical trial, where patients were blindly assigned to either a group taking the active drug or a group taking a placebo. No matter. Howard felt strongly that she couldn't allow teenagers already in deep trouble to be recruited for a study run by researchers she didn't trust. She was also still upset over what had happened at an earlier lecture, when another Brown-affiliated hospital had distributed literature without authorization, disrupting the discussion. So she politely but firmly told the Butler emissary that it was against NAMI's policy to allow advertising or recruitment at a lecture intended for educational purposes only.
Within a few days, someone from Butler called Howard's boss to ask for clarification of NAMI Rhode Island's policy on recruiting at educational events. To Howard's relief, Nicki Sahlin backed her up. As the executive director herself recalled, she agreed that it was not a good idea to allow recruiting among vulnerable families who had come to an educational event desperate for information on how to deal with a bipolar child.
Howard had hoped that would be the end of it. But now, listening in on Sahlin's conversation with Jim McNulty, she could tell it wasn't over, not by a long shot. As president of the National Alliance's board of directors, McNulty was a powerful presence in Rhode Island. He himself had been treated for bipolar disorder and was now a patient advocate. He sat on key advisory committees to the National Institute of Mental Health that made important decisions about what kind of research the institute should fund. At the same time, McNulty was also, to use Howard's term, a "professional patient spokesman" for the drug industry. According to Howard, Sahlin, and McNulty himself, he received money from GlaxoSmithKline, Eli Lilly, Pfizer, and other pharmaceutical companies to travel to and speak at various company-sponsored events. In an arrangement that medical ethicists say is highly questionable, McNulty would process the "grants" through NAMI Rhode Island.
The scheme worked like this: McNulty's pharmaceutical sponsors would give NAMI Rhode Island a check usually several thousand dollars- and then Sahlin would write a check to McNulty as compensation for his speaking engagements on behalf of whichever drug company was paying him. In interviews with me, both Sahlin and McNulty acknowledged this arrangement.
"Jim didn't have a job for many years, and he was singing for his supper," Sahlin said. "He didn't have an employer; he was not a nonprofit unto himself, so it would go through NAMI Rhode Island." When I asked McNulty why he had been paid that way, he said, "Paperwork: it was simpler that way."
Sahlin knew the check-processing scheme was improper, according to Howard. But Sahlin couldn't bring herself to speak out against McNulty; he was, after all, her uberboss.
Several ethicists say this kind of arrangement is patently unethical because, as McNulty acknowledged, he did not disclose to the audiences at his various speaking engagements, or to NAMI's membership, that he was being paid by the pharmaceutical industry. "Here is someone who's acting like a citizen advocate, and he's getting paid by the pharmaceutical companies and not disclosing it," said Sheldon Krimsky. "Most people would question whether he's truly a citizen advocate after that"
McNulty said that if he had similar speaking engagements today, he would disclose who was paying his way. "Where people are today is very different from where they were in 2002," he said.
Over the years, the National Alliance for the Mentally Ill has itself accepted millions of dollars in corporate donations from the pharmaceutical industry. In 2002 and 2003, the years that McNulty served as president of the national organization's board of directors, corporate contributions to the national nonprofit totaled more than $4 million each year, almost half of the nonprofit's annual revenues, according to NAMI's posted annual reports. And that didn't include the millions of dollars in corporate donations to the organization's Anti-Stigma Foundation. The list of NAMI's corporate "partners" on its annual report for 2002 and 2003 includes every major pharmaceutical company in the world, including Abbott Labs, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Forest Labs, G1axoSmithKline, Novartis, Pfizer, and Wyeth. (NAMI continues to receive millions of dollars from drugmakers, but its annual reports no longer break out the amount of money given by corporations as opposed to individual donors. The organization merely provides a list of its corporate partners which continues to be a roll call of every company making psychoactive drugs.)
On this particular day in October 2002, it was clear from the strain in Nicki Sahlin's voice that McNulty was insisting that
she allow Brown recruiters into the November 13 lecture. Listening in the next cubicle, Howard frowned. This wasn't the first time she had run afoul of the NAMI board president. In December 1999, a year after she was hired by NAMI, the news broke that Brown University had agreed to repay the Commonwealth of Massachusetts for the thousands of dollars in research funding it had received from the state's Department of Mental Health. After a long investigation, the Massachusetts attorney general's office had determined that Brown had "improperly collected" a total of $300,170-a sum even greater than the amount Howard had dug up. As part of the settlement with Brown, Massachusetts officials agreed to drop the lawsuit they had filed against the Ivy League institution in Suffolk Superior Court. At the time, I quoted Howard in the Boston Globe having said, "I'm glad the Commonwealth stuck in there against Brown's formidable efforts to deny and cover the matter up"
Upon seeing that article, McNulty had thrown a fit. Sahlin, of course, knew all about Howard's whistleblowing at Brown and had hired her in spite of it (or, as Howard liked to think, because of it). In time, Sahlin managed to calm McNulty down.
But now, as Howard listened in on her boss's conversation with McNulty, she feared that Sahlin would cave and allow the Brown recruiters to come to the lecture. Howard was fond of Sahlin, a well-meaning woman in her fifties, but she knew the former executive director was an emotionally fragile woman who often wilted under pressure. How long would it be before she buckled under this time?
Much to Howard's surprise, she heard Sahlin say, "We're going to support Donna on this."
Her joy proved premature, however. Within the hour, Sahlin received another call, this time from someone high up at Butler. As Howard was later to learn, the Butler official was offering to expedite the hospital's annual donation to NAMI Rhode Island's yearly conference in exchange for the opportunity to pass out COBY literature at the November 13 lecture.
Howard didn't hear that particular conversation, but from that day forward, she felt as if her boss was trying to change her mind about the recruitment drive.
"I really think it wouldn't be a bad idea to allow the Brown researchers to pass out these flyers," Sahlin said one afternoon a few days before the November 13 lecture. Brown was doing an important study to find out what the course of bipolar disorder looked like in adolescents, she added. "This is research"
At this point, Howard had already printed up and distributed flyers for the event. She herself was the guest speaker, and she was especially proud of the title for her lecture: "Injured Bird in the Cat Cage: Understanding the Family Impact of Childhood Onset Bipolar Disorder." The words had come from an essay written by Maria.
"If you allow this, I'm not going to do the lecture," Howard said flatly. "I'll just cancel it."
Nicki's face folded up into itself.
"Okay, Donna, this is your show," she said, and walked away.
THE NIGHT OF THE lecture was overcast with the kind of brisk November wind that chills right through to the bones. The leafless limbs of the trees surrounding the Butler campus looked stark and lonely in the reflected lights of the cars driving up to park. In the brightly lit Ray Conference Center, seats were rapidly filling with people. Howard and Sahlin were busy greeting parents and guests and preparing the podium. The plan was for Sahlin to introduce Howard as the guest speaker. As Howard passed by the table near the entrance where NAMI placed its education literature, she noticed a stack of lime green brochures that hadn't been there before. She looked closer: they were the COBY brochures.
Howard couldn't breathe. It felt as if someone had just punched her in the gut. In the shock of that moment, she realized that Sahlin had taken the money from Butler as a quid pro quo after all and hadn't had the courage to admit it. After a few seconds, Howard straightened up and grabbed the stack of brochures from the table. She looked around. Someone from Brown was also passing out the flyers to families as they entered the auditorium. Howard strode over to two NAMI volunteers setting up floor microphones nearby.
"Would you do me a favor?" she asked them in a casual voice. "These flyers aren't supposed to be distributed tonight; someone made a mistake. Would you go around and scoop up as many of them as you can?"
"Sure." The women were happy to be of assistance. "What do you want us to do with them?"
"Just give them to me," she said.
IN A TELEPHONE interview with me, Nicki Sahlin, by then retired from NAMI, acknowledged that the Rhode Island chapter had received "something like one thousand dollars" from Butler toward its annual educational conference. Sahlin admitted that the check had been contingent on her allowing Brown researchers to pass out flyers advertising the COBY study.
"We wouldn't have gotten the money unless we cooperated with them fully. What do you think?" Sahlin said with exasperation in her voice. But then she immediately became defensive, insisting, "That wasn't a sufficient payoff to corrupt anyone."
During our phone conversation, Sahlin tried several times to warn me off doing a book about the drug industry and detailing what happened that night at Butler, even if the account was "factually accurate" "This is not a book you should be writing," she cautioned. "The reactionit could ruin you."
As DONNA HOWARD remembers it, the rest of the evening went remarkably well. In the end, more than 150 people showed up and listened intently as she spoke about the difficult family dynamics of living with a child with bipolar disorder the loneliness, the stress of dealing with an unpredictable roller coaster of mood swings, reckless mania one minute, abject depression the next. She had culled case examples from her own experience and from the stories that many people had shared with her over the years. When she finished, the audience applauded warmly.
Afterward, one of Howard's friends, a mental health professional who had come to give her moral support, offered to walk her out to her car.
"That's not necessary," she said. "This is Butler -I know my way around."
"That's precisely why I should," he said, and then grinned. "You never know: Marty could be hiding in the bushes."
Howard laughed uneasily. Marty Keller and his unwelcome presence in her life was an inside joke between the two of them. But after that night's escapade, it didn't seem so funny anymore. NAMI Rhode Island needed the money that Brown and Butler could shovel its way, and Howard knew that her boss had been caught in the middle. The fact that Sahlin had caved in and allowed Brown researchers to pass out flyers over her assistant director's objections made it clear to Howard that her days at NAMI were numbered.
hen Rose Firestein found out that she had landed a job with the New York State attorney general's office in June 2002, she couldn't believe her luck. Eliot Spitzer was just beginning to grab national attention for his investigation of the financial conflicts between Wall Street analysts and the huge investment banks they worked for. The month before, Merrill Lynch had agreed to settle for $100 million Spitzer's charges that it had pressured its own stock analysts into misleading investors about start-up companies that were clients of its banking arm. This was the first time a state prosecutor had taken on Wall Street traditionally the preserve of the federal Securities and Exchange Commission-and New York's powerful business community was furious. The conservative editorial pages of the Wall Street Journal attacked Spitzer as a deluded publicity seeker. The incoming flak only intensified Rose Firestein's desire to join his team.
Even though her eyesight had stabilized-she had no vision in her left eye but could still see things up close with her right-she knew it was time to find a job with a more forgiving travel schedule than she had at Children's Rights. So when she heard about the opening at 120 Broadway, she jumped at it. At this particular juncture in her life, Firestein wanted nothing more than to be part of a large, high-powered team, all rowing in the same direction under the orders of a granitejawed coxswain who seemed to know exactly where he was going.
Had Firestein known what lay in store for her those first few months, she might have felt differently. Almost as soon as
she walked in the door at 120 Broadway, she found herself buried in an enormously complicated case involving the way the pharmaceutical industry priced its products for sale.
"I won't pretend this is a simple case," Joe Baker said when he sketched the assignment for Firestein her very first week on the job. Baker had come to the AG's office by way of the Medicare Rights Center, a national patient rights consumer advocacy group, and the Gay Men's Health Crisis. The forty-two-year-old Philadelphia native favored pink shirts and was open about the fact that he was gay. Although Baker was head of the Health Care Bureau and had an imposing corner office on the twenty-fifth floor (near Eliot Spitzer's), he had developed a good working relationship with Tom Conway and his consumer team on the third floor.
"In fact, this case is incredibly complicated. I don't really understand all the ins and outs myself," said Baker, sitting around the conference table with Firestein, Conway, and Stark. "It's going to involve a lot of research and drilling down into the facts." At the core, however, was a simple premise: that the drug companies were wildly inflating the average wholesale price (AWP) of their drugs so that Medicare, Medicaid, and private insurers would reimburse doctors for the drugs at a higher price than they actually paid. Drugmakers employed the AWP scheme, Baker explained, as a way of essentially bribing doctors and pharmacies to use their products.
"That's what we think is going on here, anyway," Baker said. "Rose, we need you to pull together enough evidence to build a case with. This is a good way to get your feet wet. You up for it?"
Firestein nodded with a lot more confidence than she felt.
"You're really putting me to work here, aren't you?" she said in a joking tone of voice. Everyone around the table laughed with relief. This was a huge undertaking, particularly for someone so new to the AG's office. Baker, for one, appreciated Firestein's can-do attitude.
