contd. from

Profitable Research

Criticism of industry-funded research is growing. But drug companies dismiss claims of conflicts of interest, saying industry needs experts and has long turned to them for clinical trials. Moreover, says Brashear of Novartis, "when the results of the trial are published or presented, there is transparency about the physician's involvement."

But conflicts can clearly arise, especially with something so controversial and hard-to-define as ADHD.

Dr. Russ Barkely, considered by some to be the world's leading ADHD expert, says he has taken money from drug companies and that problems can occur when financial connections run too deep. "Whenever there is a financial arrangement between people or organizations, there always exists the potential for a conflict of interest and to influence the outcome of that arrangement," he says. "That is just human nature. It does not mean that one always does exist or that the products of such arrangements are always biased adversely in some way."

Barkely recognizes potential conflict of interest can arise when findings from the study don't merge perfectly with the commercial interest of the drug company. But many researchers, he says, insist on "unrestricted" grants that give researchers a green light to conduct the study and promote the results in ways that don't just advance the company's financial interest.

"Nevertheless, if the researcher wants subsequent grants from a drug company, there may be an indirect conflict of interest for researchers here," says Barkely. "But so long as consumers want drug companies to produce state-of-the-art, safe, and well-tested drugs for disorders, you cannot then restrict drug companies from having access to the world's leading researchers to help them in providing such products."

For Barkely, the real test is a matter of degree, that is the percentage of a researcher's income that's directly derived from grants or consulting arrangements, not simply whether or not such an arrangement exists.

"I consult for four or five drug companies a year, yet I derive less than 10 percent of my income from such consultations and speaking engagements for them," he says. "It is the degree of support that can raise the specter of a conflict of interest and not just the existence of a relationship. And we especially want to know if the researcher has stock options, royalties, or other financial arrangements with the company such that results which are favorable to the drug in a research project result in a proportionate and direct financial advancement of the researcher."

Most scientific journals, Barkely points out, require researchers to say in their articles what, if any, financial arrangements they have with a commercial interest that supported the research or may be mentioned in the article.

"The results from drug company-funded research are not essentially different from federal studies," says Eugene Arnold, an ADHD expert and Ohio State University researcher who has taken money from drug companies. "Much of the new research funding surge has been for development of better products, such as longer-lasting delivery formulations. In order to obtain FDA approval, the companies have to sponsor research to demonstrate efficacy and safety. Naturally, they turn to experts in the disorder and its treatment to help do that research."

Arnold says that all researchers heavily involved in new product research take money from drug companies. But he points out that research supporting efficacy of MPH, amphetamine, and other FDA-approved drugs for ADHD was originally done in the 1930s, '40s, and '50s without drug company support and even now some studies are done solely with federal funding.

Sam Goldstein, a clinical neurologist and member of the faculty at the University of Utah who has in the past served as a general consultant for drug companies and authored educational materials for them, says the profit motive can hurt research in other ways. "The nature of our capitalist system is such that if there is a profit to be made it is much more likely a treatment will be investigated," he says. "There are many good psychosocial treatments that with sufficient research would probably benefit children with ADHD. No one is going to fund them because there is no profit to be made. I don't think this is a bad thing. It is just the way the system works."

Goldstein notes that the system of industry funding has produced medications that have dramatically in a positive way altered the lives of millions of people.

"For me the issue is not so much ethics but the fact that only those treatments that stand to lead to profit are funded for research," he says.

Kelly Hearn is a correspondent for The Christian Science Monitor and a former science and technology writer for UPI.

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Reviewed: 02/2006