Eight years ago, I wrote a cover story for the Sunday magazine of the San Francisco Chronicle. It began with the story of a teenage girl I called Angela Reich who became depressed after enduring months of grueling chemotherapy for leukemia. She resisted suggestions that she try antidepressants and saw a therapist for a while but her sadness and despair didn’t lift. So she relented and saw a psychiatrist, who started her on Paxil, an antidepressant made by the British pharmaceutical company GlaxoSmithKline.
The doctor increased the dose a little at a time, even after Reich told him she was feeling strange in her body and worse than she had before. She became increasingly anxious and jittery, with a relentless discomfort inside her body that caused her to constantly shake her leg. Finally, one morning, she attempted suicide by trying to swallow multiple doses of Ativan, Paxil and other medications she found around her house. Her father broke down the door of the bathroom, interrupting her pill-binge and rushed her to the hospital. His action may have saved her life.
As I looked into the story at the time, several things became clear: GlaxoSmithKline was promoting the drug for use by teenagers even though it had never been cleared by the FDA for anyone under 18. The company also knew—but hadn’t revealed to doctors and patients—that, in some children, Paxil seemed to magnify their distress and increase their risk of thinking about or attempting suicide. GSK also seemed to be manipulating data from its clinical trials to minimize the number of suicides or attempts that might be blamed on its pills—“cooking the books,” in the words of a former Navy lawyer who took on the British pharma giant.
Last week, the U.S. Department of Justice announced that GlaxoSmithKline had agreed to pay $3 billion in criminal and civil fines for its misdeeds in inappropriately marketing Paxil and another antidepressant, Wellbutrin; for withholding information on the cardiovascular risks of Avandia, a diabetes drug that has been shown to cause heart attacks; and for promoting Advair, an inhaled lung drug, to patients with mild asthma even though it wasn’t approved or appropriate for them. The fine was the largest ever imposed by the U.S. on a pharmaceutical company and settled both civil and criminal charges.
The settlement agreement and the attached documents were full of juicy details that have now been widely reported: How GSK orchestrated the publication of a “misleading,” ghost-written study purporting to show that Paxil helped children when evidence suggested the opposite. How the company paid doctors, including “Dr. Drew” Pinsky, to promote Wellbutrin and how sales reps pitched Wellbutrin to doctors as the “happy, horny, skinny drug,” claiming it was also good for obesity and sexual dysfunction although it was approved only for depression.
As I read through company documents released by government lawyers, I began thinking about some of the victims I’ve interviewed during two decades of reporting on the pharmaceutical industry and its marketing of flawed, sometimes dangerous drugs—people like Angela Reich and the anguished parents of other children who died. I also thought about the statements made by Sir Andrew Witty, Glaxo’s chief executive officer, who expressed “regret,” said the company had learned from “the mistakes that were made” and asserted that under his leadership the company was now “putting patients first, acting transparently…and displaying integrity in everything we do.”
I wanted to talk to some of the people who had been harmed by taking GlaxoSmithKline’s drugs and the lawyers who represented them to see how they felt about the company’s admission of guilt and its $3 billion fine. First, I connected with Angela Reich, who was back in the Bay Area from an eastern school where she is now pursuing a PhD in literature. (She again asked that her name be changed, as it was when I first wrote about her in 2004.)
She recalled her Paxil experience and her subsequent effort to wean herself from the drug as a nightmare, and was outraged that the company failed to warn patients about the dangers.
“I think it’s despicable what they did and I think a $3 billion fine is pathetic,” when the company’s earnings are considered, she told me. “No specific individual executive has been prosecuted or punished or fined; there’s nothing to take away the incentives for huge drug companies to commit fraud. I’m infuriated.”
In fact, Glaxo’s legal and financial liability goes beyond the DOJ settlement. The company has been hit with jury verdicts and settled thousands of cases alleging that Paxil caused suicides, addiction and birth defects in babies whose mothers using the drug during pregnancy. A couple of years ago, my former colleagues at Bloomberg News estimated that Glaxo had paid out about $1 billion to settle Paxil-related cases. That was before a raft of birth-defect cases had been settled or tried.