9 No. 4
Drugs and Money
Pharmaceutical companies, academic medicine, and the flow of funds and favors
Reviewing conflict-of-interest policies
Funds flowing in
"We accept money because we need to do clinical trials, and that's where the rubber meets the road in this conflict-of-interest business."
"I'm not under any illusion that [drug companies] give money for the sake of neuroscience. They won't do a study if the potential is there for the outcome to have a negative impact on marketing."
THE INTELLECTUAL COMMUNITY
Bringing the Big Questions to the Community
Re-imagining the Gustafson Seminar
Multiversity or University?
Pursuing competing goods simultaneously
On the failure of roots and the strength of weak ties
Academic Exchange: Summarize your ongoing legal adventures related to your research on the anti-acne drug Accutane.
Doug Bremner: In 1997, Liam Grant’s son, an Irish student, hanged himself. Grant filed a lawsuit in Ireland against Roche, which makes Accutane, charging that the drug led to the suicide. He also started a foundation to support research. There have been several other cases in which the drug was associated with suicide. Around the time of Grant’s suicide, France issued a warning to that effect, before the U.S. warning came out. Grant [senior] contacted me and asked if I could do some research. I said I would need money for the brain scans, and he agreed to fund them; he also funded a rat study done elsewhere. Both studies showed that Accutane affected the limbic area of the brain, which affects emotion. Accutane inhibits nerve growth in the hippocampus, which in animal models causes depression. It’s not a subtle thing. In 2000, the son of Congressman Bart Stupak, who was taking Accutane, shot himself and died. Stupak put pressure on the FDA, which concluded there was good evidence that the drug caused suicides. That’s why my study and the rat study were such big deals. In the Grant case, the defense counsel subpoenaed Emory to get my study data, and I’ve been named as an expert witness in most of the lawsuits that are going on. We’re doing additional studies, and the manufacturer is trying to subpoena those records even before they’re done. They’ve already deposed me to try and find out what I’m doing, but I refused to tell them. It’s now up to a judge to say whether he wants to compel me to reveal that information.
AE: Has Roche charged you with bias because your work is sponsored by the plaintiff?
DB: Drug companies are really good at propaganda and spin control. They’ll throw up balloons that are distracting and give you a piece of the information. In Ireland, there are relatively low limits on product liability awards, so Liam Grant’s not doing this for financial gain. I don’t communicate with Grant anymore, because every time I do the emails get subpoenaed. I’ve never even met him. His donation was given as an unrestricted grant to Emory, and my time was never compensated. The day after my study came out, Roche attempted to settle with him and offered to pay all legal costs and for the research he’d paid for, which totaled several million dollars. He refused. Roche’s line has been that there’s no association between Accutane and depression, and that depression is really common in teenagers. Most of these cases involve teenagers. The fact is that teens have one of the lowest suicide rates, so that’s another piece of propaganda they’ve effectively spun, and it’s just not true. Another line is that Accutane can’t enter the brain because it’s a skin medication. It does go into the brain. In fact it exists naturally in the body. We make Accutane, which has the same chemical structure as the active form of vitamin A, which has all sorts of functions in the brain.
AE: You’ve strongly criticized the methods employed by drug companies.
DB: I’ve done studies funded by drug companies, and now I know what it’s like to be on the “wrong” side of the aisle. I’m not under any illusion that [drug companies] give money for the sake of neuroscience. They won’t do a study if the potential is there for the outcome to have a negative impact on marketing. The Vioxx study was pure marketing that backfired because it eventually came out that the drug increased the risk for cardiovascular disease. The manufacturer tried to fudge the results of some of the case reports, but even then it was obvious that something was wrong. Drug companies will do these huge studies and find tons of physicians—I think the Vioxx study listed something like a thousand authors—because they know the doctors are more likely to prescribe the drug. Contracts between drug companies and researchers, even the ones I sign, give them the right to review the results before a researcher submits the paper to a journal. Many times drug companies have tried to stop publication when they don’t like the results. It’s led to litigation. With my Accutane study, they’ve looked for data entry errors and tried to trash it. They’ll look for one piece of paper I might have missed, then claim I’m not cooperating. It becomes an absurd process. It’s intimidation. I know of cases in which a drug company hired private investigators to go out to school playgrounds to find friends of kids who have killed themselves to try to uncover something like whether the suicide victim smoked pot. I wouldn’t be surprised if they did the same thing in my case.