Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

by Alison Bass

  THE DAY AFTER her car broke down, Howard found herself standing stock-still in the middle of the file room, a bunch of loose papers gripped tightly in one hand. Realization struck her like lightning, clearing the dust ball of confusion in her mind. "I've got to tell someone about what's going on. It's wrong," she announced to the large, empty room. "I can't go on like this."

  When Alice Tangredi-Hannon drove her home that afternoon, Howard waited until the research director had swung onto Route 195 toward Fall River. And then she asked, "Do you know anything about the research Brown is doing at Corrigan Mental Health Center?" she asked.

  The administrator shot her a sharp look.

  "We don't have anything to do with Corrigan. Why?"

  Howard proceeded to tell her about the invoices she had found and her suspicions. She also mentioned her concerns about the Paxil and lithium studies. Tangredi-Hannon's hands gripped the steering wheel tightly as she listened. When Howard was finished, the administrator shook her head, mouth drawn down into a grim line.

  "Why am I not surprised? Listen, do me a favor. Photocopy some of those documents and bring them with you tomorrow. I'd like to take a look at them"

  Howard nodded, her heart racing. In one corner of her mind, she felt tremendous relief that this highly respected administrator believed her and wanted to probe further. Surely, with Alice Tangredi-Hannon asking questions, Brown wouldn't be able to sweep things under the rug. But the inquiry could cost Howard her job. Could she trust Alice? Would Keller figure out where the university's director of research administration had obtained her information? Howard lay awake for a long time that night, thinking about what she had done.

  t was dark by the time Donna Howard pulled into her driveway, but she could see the black Lincoln Continental parked on the side of the road, an anomaly in her working-class neighborhood of beat-up pickup trucks. She knew the two men sitting inside the car were federal agents because one of them had called her earlier that day at the hospital. He said he was from the U.S. Postal Service, investigating the possibility of mail fraud. Howard didn't quite know what that meant, and she was afraid to ask. The man sounded friendly enough. Could he drop by this evening to talk to her?

  Aghast that a law enforcement agent had called her at work how did he know her number, anyway?-Donna tried to quell the queasiness surging up her throat. This was the last thing she needed right now. Thinking fast, Howard told him she had to take her daughter for a doctor's appointment and wouldn't be home until after 7 p.m.

  "That's okay," the agent said. "We don't mind the late hour."

  HOWARD'S COTTAGE WAS ISOLATED, a quarter mile from the nearest neighbor. When she first saw the Continental parked on the side of the road, she had to resist an impulse to turn around and drive madly away. Instead, she took a deep breath and told Maria in as light a tone as she could muster, "We've got visitors. I was expecting them."

  As she emerged from her car, the two men got out of theirs. The older man looked to be in his fifties. He was heavyset and balding. When he introduced himself, Howard recognized his voice: he was the one who had called her. The other man, who was probably in his forties, was built like a football player, muscular, broad around the shoulders, with a crew cut. A Secret Service type, Howard thought shakily as she ushered the two men inside and invited them to sit down at her kitchen table. Her new puppy, Hudson, a spaniel-collie mix, barked excitedly and ran circles around the room. Maria, who was on a new medication and not feeling well, said she was going to bed. Howard walked her to her room and gave the puppy some food. Then she poured herself and the two agents some water and sat down at the table.

  The men wanted to know all about the accusations leveled against Martin Keller and the Brown psychiatry department in a page-one story that I had written for the Boston Globe a few weeks earlier. Headlined STATE PAID SCHOOL $218,000 ON FALSELY BILLED DMH STUDY, the January 7, 1996, article described how the Massachusetts Department of Mental Health (DMH) had been paying Brown's psychiatry department hundreds of thousands of dollars to fund research that wasn't being conducted. Moreover, it said, the psychiatry department had submitted partially fabricated invoices to the Massachusetts agency to obtain the funding. Dr. Martin Keller denied the allegations in the article; he said that the first few years of the DMH contract had been devoted to planning for research that was to take place at Corrigan. State officials, however, said they were not in the business of awarding grants for planning, just for actual research. The story's publication prompted immediate calls for an investigation by top Massachusetts officials.

  As Donna Howard wearily answered the agents' questions, she wondered, not for the first time, how she had gotten herself into this mess. She thought she had done the right thing by telling Alice TangrediHannon of her concerns.

  For weeks afterward, Howard heard nothing. Then one evening, Tangredi-Hannon called her at home. She said she had gone to the dean of the medical school with the information Donna had given her. But the dean had told her to let it go. All they had here, he insisted, was a bunch of disgruntled employees. Tangredi-Hannon told Howard that she was sorry, but there was nothing more she could do.

  Shortly after that conversation, Howard started looking in earnest for another job. She could already sense a freeze in Carolyn O'Sullivan's attitude toward her. Despite her fears that Keller was onto her, the memos and faxes that Howard had unearthed in the file room at Duncan ate away at her. She hated the thought that a prestigious academic institution might be benefiting at the expense of indigent people with mental illness. After Maria was diagnosed with bipolar disorder, Howard had become active with a group of patient advocates in southeastern Massachusetts that was working to raise public awareness about mental illness. At one point, Howard had even coordinated an interdisciplinary conference on depression in New Bedford. So she knew all about the deep cutbacks in mental health services that Governor William Weld had implemented in Massachusetts beginning in the early 1990s. It just didn't seem right to her that the research department of an Ivy League institution was collecting seemingly bogus research money at a time when services to the state's mentally ill were being slashed to the bone.

  But that wasn't the only aspect that bothered her. Howard knew by name many of the troubled teenagers enrolled in the department's Paxil and lithium trials. They came through Duncan every week for their regular checkups, and she always made time to chat with them. A good number of them were in foster care, and they reminded her, uncomfortably, of Maria.

  In mid-November, as the trees bared their limbs and the sandy beaches near her home turned cold, Howard called the Massachusetts attorney general's office. She was connected to an officer in the criminal bureau who seemed completely disinterested in what she had to say, so the day after she got word that she had been hired as a community relations coordinator by the Arbor-Fuller Hospital in Attleboro, Massachusetts, Howard steeled herself and called the city desk at the Boston Globe. Someone there took down her name and number, but no one called back. She tried again. This time the message was forwarded to me, and I returned her call. We agreed to meet at the Burger King on Route 24 outside Brockton (it was roughly halfway between Boston and Providence). There, Howard turned over a box full of incriminating documents from the Brown psychiatry department.

  Since she was still working at Brown, Howard asked that she not be identified in the initial story. In a case of pure serendipity-Howard had no way of knowing exactly when the Globe piece would run- she ended up leaving Brown on Friday, January 5, and starting her new job at Arbor-Fuller the following Monday. The front-page story that I wrote on Keller and Corrigan ran that Sunday (the seventh). Even though Howard was not identified in the piece, everyone at Brown knew she had been the primary source. The day after the piece ran, Marty Keller called a meeting of the research staff and came in person to the Duncan Building for the first time in years. At the meeting, he called Donna a "very sick individual" and angrily denounced the Globe article. He told the assembled gr
oup that he planned to rebut the allegations and warned them not to speak to reporters. Howard wished she could have been a fly on the wall at that meeting. Fortunately, one of her co-workers was considerate enough to call and tell her all about it.

  Now IT WAS LATE JANUARY, and here she was, sitting at her own kitchen table with two formidable-looking federal agents asking her the strangest questions. She felt as if she were the suspect in a gruesome murder trial.

  "So what kind of car does Dr. Keller drive?" the heavyset agent asked.

  Howard stared at him in disbelief.

  "I have no idea," she said. She explained that she worked across campus from Keller and very rarely saw him.

  "Do you know what his wife does?"

  'No"

  The agent scratched his balding head and looked at his companion. The younger man, who had been occupied tossing a drool-covered ball to Hudson, shrugged.

  "Um, Mrs. Howard, what possessed you to copy all these documents and give them to a reporter?" the older man finally asked.

  Howard told him what she had told me: that she cared deeply about the welfare of patients with mental illness and had been outraged to learn that at a time of major cutbacks in services, all this money seemed to be disappearing into the coffers of a wealthy institution.

  By the time the agents left, close to 10 p.m., they were joking about her puppy's ball-fetching skills. They thanked Howard for her time and drove away. As she watched their big black car recede into the darkness, Donna Howard hoped fervently that these were the last federal agents she would ever have the privilege of speaking to. Her wish would not be granted.

  artin Teicher had been testifying under oath for nearly six hours, and he was exhausted. This was his second day of being deposed by an attorney for Eli Lilly. The drug company was being sued by Joan Greer, a widow whose husband, a prominent attorney in Washington, D.C., had killed himself while taking Prozac. It was one of the dozens of wrongful death lawsuits that had been brought against the maker of Prozac in recent years. But it marked the first time that Teicher had agreed to become an expert witness. He had signed on to Greer v. Eli Lilly more than six years earlier, after taking a call from Allen Sandler, the deceased man's psychiatrist. Teicher had already turned down a request to testify in a case that had evolved into perhaps the most notorious Prozac trial of the 1990s: the Wesbecker writ. In 1989, a former factory worker named Joseph Wesbecker opened fire with an AK-47 in Louisville, Kentucky, killing eight people, wounding twelve, and fatally shooting himself. Wesbecker had been taking Prozac, and the families of his victims sued Eli Lilly. After reading Wesbecker's medical records, Teicher felt that there wasn't a clear enough cause-and-effect relationship between Prozac and Wesbecker's homicidal behavior for him to testify for the plaintiff. That case, which went to trial in the fall of 1994, resulted in a verdict for Lilly, which the drugmaker trumpeted as a victory "vindicating" Prozac. Only later would the judge on the case discover that Lilly, fearing it was going to lose in court, reached a secret agreement to pay the plaintiffs' attorneys and their clients a tremendous amount of money if they would throw the trial. In a 1996 book summarizing the trial and its impact, The Power to Harm: Mind, Medicine, and Murder on Trial, John Cornwell described the secret deal as "unprecedented in any Western court." A resulting investigation by the Kentucky attorney general's office confirmed the secret settlement and the "mind-boggling" sums Lilly paid to the plaintiffs' attorneys and their clients to deceive the court. After the Kentucky AG's report was issued in March 1997, the official record on the Wesbecker case was changed from a jury verdict in Lilly's favor to "dismissed ... as settled." But by then the deception had achieved its intended effect: many other Prozac users were discouraged from suing Lilly. (No charges were ever brought against any of the parties to this sordid tale.)

  Teicher strongly believed that Prozac was a factor in the death of Joan Greer's husband in 1990. The Greer lawsuit had been filed in 1991, and now, five years later, he was finally being deposed. Attorneys in civil actions routinely subpoena opposing witnesses to testify under oath in the hopes of catching them in a lie or factual discrepancy so that their testimony can be discredited should the case come to trial. Jonathan Cole, another of Greer's expert witnesses, had already been deposed. Now it was Teicher's turn.

  His deposition was taken in the glass-enclosed conference room of one of those downtown law firms with ornate offices overlooking the Boston Harbor. The lead attorney for Eli Lilly (who had borrowed the space for the occasion) was an attractive, dark-haired woman whom Teicher judged to be in her late thirties or early forties. A partner in the Philadelphia law firm of Pepper Hamilton, Nina Gussack had built a lucrative practice representing the pharmaceutical industry. Teicher found her to be a consummate professional, well-prepared and knowledgeable not only about the medical issues involved, but about other matters as well. She had certainly done her homework when it came to him. Years later, Teicher would acknowledge that if he hadn't been on the receiving end of her rapier, he might have admired her skill in disemboweling him.

  Looking back, Teicher could see that Gussack spent the first day of the deposition softening him up. She asked Teicher about his research, his private practice at McLean Hospital, and why he thought Prozac was to blame for the suicide of Michael Rosenbloom, Greer's husband. Rosenbloom had jumped off a bridge five days after starting Prozac. Gussack also wanted to know what Teicher had discussed with Andrew Greenwald over dinner at Legal Seafood the night before. Teicher was only too happy to tell her. Among the matters they talked about was his analysis of data that Lilly had submitted to the BGA (short for Bundesgesundheitsamt), the German equivalent of the FDA, when seeking approval to market fluoxetine in Germany in 1984.

  Teicher could remember exactly where he had been when he first took a close look at the BGA data: sitting in his doctor's office at Harvard Community Health Plan. As he skimmed the BGA material while waiting to go in, it suddenly dawned on him that the data Lilly had submitted to the German authorities showed an almost twofold increased risk of suicide attempts among patients taking Prozac compared to those on placebo. Here was evidence that Lilly had known all along that Prozac carried a heightened risk of suicide! Not only had the drug company lied to him and his McLean coauthors about not being aware of any such risk, but a senior Lilly scientist had omitted this data from his presentation at the pivotal 1991 FDA hearing on Prozac. No wonder the BGA had initially refused to approve the drug in Germany. Teicher jumped up from his seat in the waiting area and paced around the watercooler, aware that some of the other patients were watching him curiously. But he couldn't sit still. After taking a few sips of water, he walked back to his seat and read through the papers again, shaking his head in disbelief.

  Responding to Gussack's question that first day, Teicher had mentioned his epiphany while reading the BGA data. But his interlocutor didn't seem particularly interested. She moved on to another line of questioning, and the first day of the deposition ended pretty much on time at 5:40 p.m.

  Driving home that evening, Teicher replayed the day's exchanges over in his mind. He'd gotten off easy, he thought. Too easy, as it turned out. He was sitting down to a late dinner when the phone rang. It was his ex-wife. Bev was now a highly regarded cancer researcher at DanaFarber. Teicher knew that although Bev enjoyed her work at the Harvard teaching hospital, she felt somewhat hamstrung there in her desire to develop practical applications from her research.

  "Hey, Bud, you're not going to believe it -I just got a call from the oncology division of Eli Lilly." Bev said. "They are calling to see if I'd be interested in a position."

  "Lilly?" Teicher asked.

  "Yes, I could go in as their top research scientist in oncology. Their program needs new blood it could be a tremendous opportunity. It may be too good to refuse"

  "In Indiana?" Teicher felt the beginnings of a massive headache.

  "Yes, Lilly's labs and headquarters are there"

  Marty was having a hard tim
e wrapping his mind around her words. Was Bev seriously considering moving to Indiana? That meant taking their son, who was in his last year of high school, and their twelve-yearold daughter with her. Bev had physical custody of the children, but until now, that had posed no major problem. Their divorce six years earlier had been amicable, and Bev had made it clear that he was welcome at their house in Belmont anytime. He typically drove his daughter to school in the mornings, and he saw both children every other weekend and one or two times during the week as well.

  "They just called today?" Teicher asked.

  "Yes, out of the blue," Bev said. "They called -I didn't apply or anything."

  "Do you know how weird this is? I'm going through this horrendous deposition with their attorneys, and they just called you out of the blue about a job"

  Bev laughed and assured him it was just a coincidence. Lilly wanted to ramp up its cancer research, she said, and this would be a fantastic opportunity to help the pharmaceutical firm develop some very beneficial cancer products.

  "Yeah, okay," Teicher finally said, even though it wasn't okay. He tried to keep things light. "Just make sure you don't mention my name in the interviews," he said, only half-joking.