Faculty, business ties invite conflicts

ROYALTIES FOR RESEARCH

April 05, 1993|By Liz Bowie | Liz Bowie,Staff Writer

Once scientists had modest dreams; today they can be more grand.

Top scientists can now dream of uncovering the genetic basis of disease, developing a cure and seeing a drug come on the market -- all in a lifetime's work.

"A generation ago no one thought you could do that," said David Blake, senior associate dean at the Johns Hopkins University School of Medicine. Instead, a scientist could spend a career proving a single theory that might lead to a new drug in another generation.

This speeded-up process of discovery is what fills Dr. Blake's job with a host of ethical and social issues. As the dean in charge of research, the 52-year-old must tackle issues that go to the core of what a university is.

Today, the line between university research and commercial enterprise has blurred. A faculty researcher can now receive royalties on patents, be a consultant and own stock in companies that are commercializing his research.

All that has created plenty of room for conflicts of interest -- or faculty misconduct.

But Dr. Blake seems unruffled.

"It doesn't worry me as long as institutions accept the leadership" and develop clear rules over those relationships, he said. "Unless people have incentives to do things, they don't do them very well."

In the past 15 years, Hopkins has investigated 12 misconduct charges, he said, the majority for plagiarism. The concern is that when faculty have interests in a company, there is a financial incentive to skew research results.

Dr. Blake's experience at Hopkins began 20 years ago as a young researcher interested in the effect of drugs on pregnancy. He complained about the difficulty in getting research money, and the dean responded by giving him a part-time job to help solve the problem.

Soon, he gave up his research and worked full time on grants. Today, he is an administrator with responsibility over all Hopkins medical school research. While individual researchers are responsible for pulling in grants, he helps guide young faculty members.

He also has authority over the offices that handle patenting, licensing and dealing with companies.

For Dr. Blake, the conflict-of-interest issues are less complicated than the questions being raised about the influence of corporations on academic institutions. Some charge that the direction and subjects of university research are too often determined by big corporations rather than researchers' interests.

In earlier years, a university was prohibited from offering an exclusive license to a company if the inventor was using federal funds. The rule had a chilling effect on commercializing technology, because no company was willing to invest in the development of a product that did not have patent protection.

But the law changed in 1985. Now a university can patent its inventions and receive royalties from the patent even if taxpayers subsidized the research.

"We are a good barometer of the impact of that legislation. Up until that time it was infrequent that we would have a report of an invention," Dr. Blake said. But in the past year, Hopkins scientists declared an invention at a rate of two a week. They found that corporations sniffed their laboratories for hot research like baseball scouts looking for a good pitcher.

Last year, Dr. Blake and others at Hopkins developed a policy giving faculty more freedom to develop relationships with companies. Also, the policy for the first time allowed the university and faculty members to own stock in a company that was working with Hopkins research.

For pharmaceutical companies, the university research laboratories are a rich source that can be mined to develop new drugs. But as collaboration with industry increases, so do questions by universities and Congress about those relationships.

The National Institutes of Health director recently questioned whether taxpayers were, in effect, paying twice for new drugs, once by subsidizing research and a second time when they buy the drug.

Other ethical issues were raised by a series of collaborations that U.S. universities have made with foreign companies. For instance, Sandoz Pharmaceuticals Corp. has agreed to give the Scripps Research Institute in La Jolla, Calif., $300 million over a decade beginning in 1997. Sandoz would have rights to any discoveries made at Scripps.

Congress also is looking at these relationships with foreign and U.S. corporations. One bill would limit the profits that pharmaceutical companies can make on drugs that were developed from federally funded research.

The bill worries Dr. Blake, who believes that those companies would be less inclined to license research from universities knowing that profits on any drug developed would be limited.

Hopkins is particularly vulnerable because a large percentage of its research money comes from the federal government. In fact, Hopkins gets more money from the government for life sciences research than any other institution in the nation.

Dr. Blake also argues that the bill would cause U.S. pharmaceutical companies to lose their competitive edge over foreign companies because they would not invest as much money into research and development.

"I would argue that the most innovative products come out of universities," he said. Often, he said, those products are ones that save money in health care by replacing more expensive treatments.

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