Potential conflicts of interest among academic scientists funded by the pharmaceutical industry are hardly new. As industry increasingly supports basic research and clinical trialsperhaps as much as 70% of clinical trial funding in this country comes from industry (and not the National Institutes of Health, the traditional source)opportunities for potential conflicts will only grow.
Yet the question remains, how much of a problem is conflict of interest? Does a cozy relationship between academic researcher X and company Y, with the researchers laboratory virtually dependent on company support to conduct its research on a potential anticancer agent, for example, compromise the ability to do objective research? Will the scientist be just a bit more likely to report favorable results and ignore the unfavorable? Can the findings be discussed with colleagues? Can results be published without delay?
Thanks to the Bayh-Dole Act of 1980, academic institutions are encouraged to patent and commercialize their work, establishing new academe-industry relationshipsand more situations for potential conflicts of interest.
"The potential for these relationships between investigators and industry to result in some bias in interpretation and reporting of research results is an issue that we in the investigator community need to be aware of and guard against," said Richard Schilsky, M.D., associate dean for clinical research at the University of Chicago and chair of Cancer and Leukemia Group B, a National Cancer Institute-sponsored cooperative group conducting cancer clinical trials.
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"Objectivity lies at the heart of science, and must not be compromised in any way," Ruth L. Kirschstein, M.D., acting director of NIH, said at the opening of the conference. "We need to listen, and we need to make sure that our ethics and our science are equally strong."
William F. Raub, Ph.D., deputy assistant secretary for science policy at DHHS and chair of the conference, said that NIH, the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the Office of the Secretary will work together to develop new guidance on conflict of interest based on opinions that were expressed at the meeting.
IndustryAcademe Collaborations
No one argues with the fact that without pharmaceutical company funding, a good percentage of cancer drug development would grind to a halt. Ten or 15 years ago nearly all investigational drugs came from NCI. Now, most come from industry, which has invested huge amounts of money in drug discovery, pre-clinical testing, and in some cases, early clinical testing.
To many academic cancer researchers, working with industry is simply a necessary fact of research life, conflict of interest issues aside.
"If the NIH could generate compounds at the rate that pharmaceutical companies can, we wouldnt have a problem," said Nicholas Vogelzang, M.D., Fred C. Buffett Professor of Medicine and director of the University of Chicago Cancer Research Center. "The realities of trying to bring cancer products from the laboratory to the bedside dictate that you work with pharmaceutical companies."
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Industry also needs academe for ideas. "There are a lot of good ideas for potential drug products and a lot of creative energy in academe which then get into industry for development," pointed out clinical pharmacologist Neal L. Benowitz, M.D., professor of medicine at the University of California at San Francisco.
Such marriages are usually win-win situations. "More often than not, companies get an interesting agent and after initial testing, want to know if it should be further developed," explained Jeffrey Crawford, M.D., professor of medicine and director of clinical research at the Duke Comprehensive Cancer Center in Durham, N.C.
Academic researchers tend not to be as interested in industry-directed research, where a company has done early drug testing, written the protocol, and simply needs access to patients for trials, he noted.
Similarly, basic scientists want to collaborate to attempt to answer fundamental questions. Metastasis researcher Dan Welch, Ph.D., associate professor of pathology at the Penn State University College of Medicine in Hershey, Pa., used to work for Upjohn and Glaxo. "Usually, in industry, we tried to find scientists interested in what we were interested in and arrange a mutually beneficial relationship with a product and a scientifically interesting question to answer as goals," said Welch, who currently collaborates with Genzyme and Pharmacia.
Potential Conflicts Abound
Since 1995, academic institutions receiving public funding from the Public Health Service and the National Science Foundation have been required to have conflict of interest rules in place.
Pat Harsche, vice president of business development, planning, and regulatory affairs at Fox Chase Cancer Center in Philadelphia, thinks institutional policies for the most part work fine. Most institutions have routine contractual arrangements with pharmaceutical companies dealing with details on issues such as intellectual property rights, reporting data at meetings, and publishing in peer-reviewed journals. Investigators are asked to disclose their relationships such as stock options, honoraria, and research grants. Peer-reviewed journals and meetings also require this.
"Most rules are in place to prevent the appearance of something wrong," said Mildred Cho, Ph.D., a senior research scholar at Stanford University who studies institutional conflict-of-interest policies. An investigation into the death of an 18-year-old in a gene therapy trial at the University of Pennsylvania last September, for example, revealed that the lead scientist had financial ties to the company supporting the trial. "Suddenly the attention is focused on the fact that the lead investigator had significant financial interest in the company backing the trial and producing the main viral reagents. People want to make connections between the tragic results and his financial interest. But you cant tell if there is a connection. The reason for having rules is because you cant tell if there is an effect."
Schilsky and others contend that cases in which conflicts of interest actually result in some change or bias in reporting research results are extremely rare. "Scientists need to build certain rules into the relationship with a company," he said. "There have been occasions that the sponsor doesnt want negative trial results reported. The investigator has to insist on the freedom to do this. I dont see these as actual problems in the cancer community, but more as perceived problems."
But Schilsky still cautions against investigators owning equity in companies sponsoring their research. "That can be an uncomfortable position to be in," he said. "If you own stock and the research results cause an increase in stock, you personally profit. An investigator should avoid that situation. Disclosure is very important because when people look at results, they can put those results in the proper perspective."
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