Scientific Symbiosis

Let's put ourselves in the chair of the chief executive officer of pharmaceutical company 'ABC,'" says Dr. Charles Hicks, associate director of the Duke AIDS Research and Treatment Center. "The [Food and Drug Administration] says if you demonstrate your particular drug works, then you can start making back money in the market, but if it doesn't work out right, it's back to the drawing board and $500 million down the drain."

This hypothetical situation is a high-stakes reality for corporate players in fields as diverse as virology, information technology and biophotonics--and one solution is for ABC to collaborate with academic institutions to research the drug's efficacy. To many researchers on the campus side of these partnerships, the importance and benefits of industry-university interactions are great, but so are the potential conflicts of interest and other ethical concerns.

Although there seem to be two major varieties of commercial collaboration--characterized by medical and technological research--both types of relationships are generally guided by one primary concern: product development.

"[Companies] are looking at least through the proof of concept point," says Richard Lucic, who often deals with corporations as director of external relations for the computer science department. "[If a project] is ready to be commercialized, they take it and bring it to the stage where it's ready to be manufactured."

In medicine, companies typically approach academic medical centers to conduct the extensive clinical trials needed for FDA approval of new drugs. Overall, industry interest in research with product potential usually leaves more fundamental and far-ranging investigations to campus laboratories and private or government grants.

"Some companies say these fundamental issues are not worth investing in in their own laboratories because they're not directly related to product development," says David Brady, director of the new Fitzpatrick Center for Photonics and Communication Systems.

But whether or not individual researchers' interests mesh exactly with those of their sponsoring corporations, many investigators agree that the partnerships are important.

Even though collaboration with companies is sometimes a controversial point in medical research fields, Kevin Weinfurt, deputy director of the Center for Clinical and Genetic Economics, argues, "If you have a good professional relationship with a pharmaceutical company, the process of obtaining funding from that company is less risky and less time-consuming than the process of getting funding from government sources."

The concerns related to commercializing research include dealing with potential conflicts of interest, obtaining complete data access and publication rights and--particularly in the case of clinical trials--maintaining integrity with patient participation and care.

In the last case, Schulman says, the direct purpose of all clinical research must be clarified among the industry sponsor, the academic research center and the participating patients.

"[Research participants] may have a vested interest in seeing results get shared among researchers... because they want to help others with their disease," says study co-author Lauren Dame, associate director of the Center for Genome Ethics, Law and Policy and a senior lecturing fellow of law.

Therefore, it becomes an issue of ethical importance to inform patients about how research data will be used. For example, companies may retain data amassed from multiple clinical testing sites, leaving investigators with only site-level data and without access to the complete research results, which are never released to the general public.

"More and more clinical research for drug development is being sponsored by private industry, and you have to be concerned that if a drug company is paying for research, what happens if the research findings indicate the drug is no good?" Dame says. "Someone who has no financial interest in the outcome [can say], 'I'll publish the results no matter what happens.' Are there provisions that results get published no matter what they show?"

On the other hand, Weinfurt, another co-author of the study, says companies are often too eager to hype favorable results in manuscripts for publication. "When it is a positive result, they want you to come to the conclusion that God Himself would take this drug," he says. "People at the company are motivated to make the scientific paper read like an advertisement, and it's our job to ensure that the text of the article at every statement has scientific integrity."

This conflict of interest can arise if companies under the pressure of the bottom line--as much as $500 million for pharmaceutical projects--have different priorities than those of investigators with lower financial stakes, Hicks says.

"The company wants to look at [the raw data] as closely as it can and, without falsifying, wants to present it in the most favorable way it can for its product," he adds. "The investigator may think the best way to report this data may be quite different, but the investigator just got $40,000, so he doesn't want to rock the boat too much."

At the same time, Hicks says, investigators' reputations are dependent on their ability to be forthright and unbiased in presenting information.

"If you have a good conflict of interest policy it can work with academic investigators staying in academia and following the rules--making sure the rules are right," says Dani Bolognesi, James B. Duke professor of surgery and chief executive officer of Trimeris, Inc., a biopharmaceutical company.

Trimeris represents one of the latest success stories in collaborations between the corporate and academic worlds. Its premier anti-HIV drug FUZEON, which has received FDA approval and is projected to launch in early 2003, is based on fusion inhibitor research that began at Duke in the late 1980s. The work's principal investigator, associate research professor of experimental surgery Tom Matthews, co-founded Trimeris with Bolognesi in 1993. The two investigators became full-time officers--with Matthews as senior vice president of research and development--in 1999.

"From the time Trimeris was founded in '93 to '99, we had what was a connection between investigators that were still academics at Duke--which was myself, Tom and others--and people who were here on the development side of the equation, trying to develop [FUZEON, also known as T-20] as a therapeutic," Bolognesi says.

Although not all corporate collaborations involve individuals working on both sides of the coin, many academic officials say the University's system of coordinating contracts--facilitated through the Office of Science and Technology--has been fairly effective at preventing problems.

"It's not that [conflicts] have never happened--no matter how good your system is, some things can fly under the radar," Lucic says, noting that all faculty must pass through a peer review committee as part of the process of establishing a commercial collaboration. "In general, Duke has done a pretty good job of keeping its house in order."

To address ethical concerns across institutions, Schulman says, schools must create universal contract standards in bargaining with companies. "Academic centers reported to [the study authors] they felt powerless with negotiations, and they felt if they asked sponsors for more rights, sponsors would merely go to others for their research," he explains.

Weinfurt agrees that academic centers must unify to avoid being played against one another and that individual investigators do not have enough leverage. "The best individuals can do is make sure the contract looks the way they want it to, but the company can say, 'We're glad you're happy with it; we're not, good-bye,'" he says.

Overall, many academics and executives agree collaboration in general is crucial to transform laboratory research into practical applications, where new drugs and technologies can be used to affect "real life."

"How can you be able to use the information that you have... for the benefit of mankind?" Bolognesi asks, encouraging academic institutions to educate their researchers in being more aware of their work's product potential.

"It's important for us to try to build a diverse and robust set of supporters to give the school maximal freedom in pursuing research," Brady says. "We want to have the resources to do things because they're a good idea and not because they're dominated by any particular class of research support."