Perhaps no other drug over the past several years epitomized the controversy over antidepressants and suicidal side effects than Glaxo’s Paxil. The drug has become a sort of poster child for the debate over hidden clinical data, ghostwriting and failed FDA oversight. As a reporter at The Boston Globe during the 1990’s, Alison Bass began delving into pieces of the tale and returned to the topic several years later to write a fact-filled, yet breezy book that is being published this week: ‘Side Effects: A Prosecutor, A Whistleblower and A Best-Selling Antidepressant on Trial.’ We chatted with Alison about the Paxil scandal…

Pharmalot: What prompted you to write the book?
Bass: When I heard about the New York Attorney General’s investigation, which was in 2004, I realized a source of mine had told me about Brown University and Martin Keller, a professor who ran Paxil studies, and how the studies were coded incorrectly. At the time (the source conveyed this information), I didn’t understand the significance, but then the investigation began. And I realized there was a very interesting and important story to tell. It was eye opening.

Pharmalot: There have been many troubled drugs, though. Why tell this story?
Bass: They’re all worth telling. I’m not saying this one is more important than another. I happened to have written about some of this while at the Globe. But I wanted to tell a story about people whose lives were affected by the extent to which some companies would go to boost sales of their products. Most people have no idea about the connections between some doctors and drug companies. This is largely out of sight and there’s very little oversight, in fact, of these sorts of things. And I believe there’s a need for reform, but the FDA still isn’t doing its job.

Pharmalot: What would you say is different about the Paxil tale?
Bass: Well, to some extent, it’s the people. Take Marty Teicher (a researcher at McLean Hospital), who was the first to speak out against Prozac. Here was someone who tried to make a difference and speak his mind, and he saw his reputation smeared. He was the first psychiatrist and researcher to publish findings of an increase in suicidal risk in Prozac. And most psychiatrists at the time thought Prozac was a magic bullet and a great improvement over older antidepressants. All he wanted to do was alert doctors to side effects in some people and that’s precisely what drugmakers didn’t want him to do.

And there was Rose Firestein, who’s legally blind. Because of her work for Children’s Rights (a nonprofit that works on behalf of foster children) and the way she saw drugs used in a vulnerable population, when she got to the New York Attorney General, she had a unique perspective and wanted to look at off-label use. But she came up with novel idea of using the New York State consumer fraud statute to go after drug companies. No one had ever done that before. And she had the goods and the evidence. So they were such interesting people who were involved in all this and they believed in a greater good.

But this is just one example of a bigger problem that has continued in a long line through Vioxx and Vytorin. Drug companies know the side-effect profiles of their drugs and hide something. In the case of antidepressants, these drugs do a lot of good for a lot of people, but for a small population, doctors didn’t know these drugs had (suicidal) side effects and, as a result, didn’t monitor patients as closely as they should have. But they didn’t have the information, because Glaxo didn’t publish its negative findings.

Pharmalot: What was the most surprising info you came across while researching the book?
Bass: What I found most surprising was they doctored the research on the Paxil study. When I looked back at memos I received from the Institutional Review Board from Brown, teenagers were withdrawn from the study and called non-complaint when they were in suicidal as a result from Paxil and should’ve been counted in the study as adverse effects. If these had been appropriately coded, there would have been an even greater risk of suicidal effects from Paxil. That was really amazing. There were many indications this Paxil study, it was called study 329, was doctored. But because it was published in a prestigious medical journal, Journal of the American Academy of Child & Adolescent Psychiatry in 2001, doctors paid attention.

Pharmalot: In reading the book, you don’t get much of Glaxo’s voice. Did the company not cooperate?
Bass: They didn’t respond to my requests. I spoke with Wick (Joseph Sollers, an attorney with King & Spalding, which represented Glaxo) on the phone a few times. I asked if I could interview some of their top officials, but they wouldn’t grant the requests. I did speak with the spokeswoman several times, as you could tell. But there were a lot of unseen documents from lawsuits. That’s how I got the smoking gun memo saying not to publish negative studies.

Pharmalot: What lesson can be learned from all this?
Bass: A few things. There has to be full disclosure of clinical trial data. And doctors have to acknowledge when they have conflicts of interest. Major academic centers should have requirements that doctors aren’t allowed to earn more than ‘X’ amount from a drug company. As I wrote in my blog recently, Marty Keller, the principal Paxil investigator at Brown University for the 329 study, acknowledged receiving consulting fees from Glaxo, but never reported them on his tax return. Researchers who are getting lucrative personal payments should be prohibited from studying these drugs if they’re making more than whatever minimum is established by the institution. But you know, these studies are a great source of income for these institutions.

Pharmalot: Have industry practices not changed since the Paxil scandal? That was a few years ago already, yes?
Bass: They’re still paying lucrative payments to doctors and researchers, and still misleading patients by not telling the full story about the risks, whether it’s in the advertising or the medical journals. The practices are still going on. Some companies are more ethical than others, but the business model is to develop blockbuster drugs. And the people in charge are marketers, not scientists. Which brings us to the FDA, which I don’t think has provided suffiicent oversight. Again, the drugs can help some people, but hurt others, and the oversight hasn’t been working.