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: Describe the process by which researchers receive funding from drug and device manufactures.
Peter Block: Drug companies don’t write a check directly to researchers to conduct clinical trials. The contracts are much more complicated and involve the sponsor, the principal investigator, and the academic or clinical center, if necessary. The contract covers the cost of the trial and the cost of starting up the trial, as well as fringe benefit monies that may go to support an academic center in other ways.
We put that all together in the form of a budget, which is often negotiated on a per-patient cost. The investigator never gets a lump sum, though sometimes it appears that way.
AE: Explain “unrestricted grants.”
PB: The concept of unrestricted grants has come out of the conflict-of-interest issue, and I think they’re a good idea. If an investigator wants to do a project that is relatively circumscribed and thinks it may cost $25,000 but has difficulty getting it funded, he asks the company that makes the product for funding. To avoid the conflict of interest that implies, the money would be given in the form of an unrestricted grant fund controlled by the academic center. That puts at arm’s length the company’s interests and what the researcher is trying to do. Unrestricted grants can also be used for something other than a study, such as bringing in out-of-town experts to speak at Grand Rounds or supporting other programs. A drug company may suggest a use for the money, but that’s just a suggestion. There’s some level of conflict of interest, but this is one way to minimize it.
AE: What are some of your perspectives on the conflict of interest that arises between industry and academic medical centers?
PB: Strangely, I think it’s the investigators, not the companies, that vary. Many investigators will lean over backwards to avoid emphasizing any controversial data that might make a drug or device company look good. Most investigators will be quick to say that such data are not strong enough to prove any point. Others investigators may nevertheless feel they owe something to the sponsor or don’t feel as strongly about the conflict-of-interest issue, and they might be more prone to emphasize that kind of outcome. 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. An academic medical center must do trials to maintain its academic potential, otherwise it becomes just a clinical center, which is not what academic centers are about. The drug company needs to do clinical trials to keep itself going and it needs positive results, and that’s where the problem arises.
There’s also frequently an interpersonal issue in these trials that is not talked about very much but is important. There is frequently a person from the company who knows the investigator and begins the negotiation. A friendship may have formed between the investigator and that person. That’s where it gets difficult. Am I able to say I’ll walk away from that kind of help and be completely unbiased? I’d like to think that’s true, but candidly that’s difficult.
AE: How do you, as a researcher, maintain your ethical distance?
PB: The good news is that the data should speak for itself, and that is the most important point. In a trial there can’t be any coercion to make the data come out one way or another. The data are the data. There is, of course, no way to deal with a dishonest investigator who fudges data. You can’t stop that. The only saving grace is that over time the truth will come out. We’ve seen instances in clinical research when researchers who are unethical can’t win because someone will come along the next year and show that their data is false. The media would like to portray us as just sitting there hoping money will fall our way and that we’ll do anything to get it. It just isn’t the truth. Most investigators are extraordinarily careful about how they handle data because they know their academic life depends on their credibility. It’s a shadier area when it comes to researchers who are also consultants for a drug or device company. These are people who have expertise that sponsors want to tap into, and they’re also asked to be investigators, which creates a terrible tension. Sponsors need to pay them for their work, but on the other hand they can’t have a conflict. It seems to me that as long as the investigator discloses those relationships out front, then it’s up to the reader to evaluate the credibility of the data. The data should speak for itself. It keeps coming back to that.