Secrecy Is Often the Price of Medical Research Funding

When Dr. Nancy Olivieri at the University of Toronto wanted to warn patients about toxic side effects of a drug she was testing, the company supporting her research tried to quash her findings, citing a nondisclosure agreement.

When she alerted her patients anyway, the company suspended the clinical trial and canceled her research contract. Even so, she published her misgivings in the New England Journal of Medicine. The Hospital for Sick Children, where she worked, sided with the company and dismissed her, triggering an international protest earlier this year.

Only after sustained pressure by faculty groups and leading health experts was she reinstated.

“I will never ever again accept drug company money that is not clearly and completely free of any secrecy clauses whatsoever,” Olivieri said.

Nature, scientists like to say, has no secrets. Yet many researchers increasingly find themselves ensnared in a web of secrecy spun by the people who pay for their experiments.

For these researchers, the struggle for scientific truth also has become a market struggle for commercial advantage--a contest played under different rules, with different incentives and penalties than those of traditional science.

It is a world in which intellectual property rights, material transfer agreements and nondisclosure forms can trump professional ethics and academic freedom. Although scientists certainly keep some things to themselves, they bridle at the imposition of such restrictions by outsiders.

“The commercialization of science has led to a new regimen of secrecy that is of great concern to the scientific community . . . secrecy of an entirely new scope and scale,” said physicist Irving A. Lerch, who is spearheading an effort by the American Assn. for the Advancement of Science to combat the trend.

“It is very troubling,” Lerch said.

Cases of Lung Disease

When Dr. David Kern, an occupational health expert at Brown University, discovered eight cases of a new, deadly lung disease among workers at a Rhode Island nylon-flocking plant two years ago, the company sought to suppress his findings, citing a trade secrecy agreement.

Nonetheless, Kern spoke out about the disease at an international medical conference in San Francisco. He also alerted the U.S. Centers for Disease Control. Hospital officials announced that they would let his contract lapse. His occupational health program was closed. His place on the medical school faculty was eliminated.

On June 30, when his contract officially expires, Kern will be out of a job.

In the meantime, at a recent medical meeting in San Diego, he reported five more cases of the disease.

And when pharmacologist Dr. Betty J. Dong at UC San Francisco discovered evidence that called into question the effectiveness of a thyroid medication taken daily by 6 million Americans, she too found herself blocked from revealing her results by the company that funded the $250,000 study. She had signed a nondisclosure agreement.

“It made me nervous,” she said. “But evidently, a lot of people signed these clauses.”

Not until 1997--seven years after her discovery--did her research reach the public through publication in the Journal of the American Medical Assn.

Spurred by such incidents, many universities today are trying to find the proper balance between the commercial secrecy their corporate donors demand and the traditional openness of the academic research community.

USC, for instance, receives more corporate research funding than any other school in California and ranks among the top 15 nationally, according to an analysis of funding reports filed with the National Science Foundation.

Like most universities, USC ordinarily allows private sponsors to delay publication of research only long enough to secure patent rights--usually no more than 30 days and in a few instances up to 60 days, said Cornelius W. Sullivan, the university’s vice president for research.

But when the grant is large enough, the rules are negotiable. When USC recently accepted a $100-million donation from biomedical industrialist Alfred E. Mann, university officials agreed to delay publication of research results for six months or more--three times longer than federal National Institutes of Health guidelines would allow for publicly funded research.

Last fall, plant geneticists at UC Berkeley signed a five-year, $25-million research contract with a Swiss-based life sciences company called Novartis. Under the terms of that agreement, the company has 30 days to review any research publications to ensure that none of its own commercial secrets are leaked. If a patent application is filed, research can be kept secret for up to 90 days.

Even so, university officials said that only the school has the right to make any final decision about the timing or content of faculty publications.

Patrons’ Rules Usually Honored

Science has always depended on ground rules set by its patrons, ranging from private foundations and industrialists to the federal agencies that have integrated science into virtually every aspect of national life.

As pharmaceutical companies and other biomedical endeavors assume an ever-increasing share of university research budgets, however, commercial secrecy is becoming more pervasive on campuses, several experts said.

“Secrecy is not always bad,” said John Deutch, a former director of the CIA. Certainly, the recent furor over the theft of nuclear weapons technology at Los Alamos National Laboratory has underscored the importance of military secrecy to national security. “But it is a major threat to science when it arises and it is antithetical to the purposes of a university,” Deutch said.

Companies often want to withhold research findings, experimental materials like cell lines or genetically engineered lab animals, and research methods they underwrite. Their motivation is to wring maximum advantage from their investment, protect a market share, or simply to deny information to a potential competitor.

“Nothing should unreasonably delay the publication of scientific research,” said Sullivan at USC, which had $68 million in private research funding and $194 million in federal research grants last year.

Although Sullivan acknowledged some restrictions on the disclosure of privately funded research, he would not discuss other provisions of the Mann agreement, such as patents, royalty shares or licensing provisions, saying they were confidential.

In some cases, researchers may find themselves caught between conflicting university and hospital policies over what restrictions are permissible.

Olivieri said her nondisclosure agreement was permissible under the guidelines of the hospital where she treated her patients, but not under those of the University of Toronto, where she teaches.

In Dong’s case, she said she was not aware of the University of California guidelines that would have prohibited the nondisclosure agreement she signed.

And Kern still insists that, as a company consultant, he never signed an agreement.

Even conscientious scientists can sign research contracts without understanding all the ramifications of the fine print, in which companies may guarantee the right to publish any findings in one paragraph and then take it away in another by retaining the right to approve all research publications.

“The problem these days is that commercial organizations try to attach very severe restrictions on our ability to function in an open manner,” said Nobel laureate David Baltimore, president of Caltech.

“If the laboratory ever lost its sense of openness, we would lose one of the core values that lead to great science,” Baltimore said.

“Openness is a necessity.”

Scientific Secrecy Is a ‘Reality’

Certainly, scientists have always kept some secrets.

“Secrecy in science sounds repugnant,’ said Charles Vest, president of the Massachusetts Institute of Technology. “Yet secrecy in science is a reality.”

Many researchers routinely keep new research to themselves, however briefly, to preserve a fleeting competitive advantage in the academic race to publish or perish, to be first to announce a new discovery, or to secure foreign patent rights.

Oil geologists keep secret their stores of data about potential petroleum reserves, just as corporate chemists guard a proprietary formula for a soft drink, an over-the-counter nostrum, or new shampoo. Medical researchers protect the privacy of their research subjects.

As bioprospectors scour rain forests for new biomedical compounds and examine isolated tribes for human genes worth patenting, some anthropologists now withhold information about the people they study to prevent the commercial exploitation of unspoiled cultures.

“Anthropology is presently vastly hampered by secrecy and self-censorship,” said UC Berkeley anthropologist Laura Nader.

“The people we study want us to protect their intellectual and genetic property,” she said. “I will--and have--destroyed data that would have given a lead to pharmaceutical companies.”

The federal government created 6,620,154 secrets in 1997, according to the most recent audit of federal security operations.

Many of those are scientific secrets, but less than 1.5% actually involved the kind of atomic secrets considered crucial to national defense, several experts said.

In addition, there are 5,002 secret inventions registered with the U.S. Patent Office--devices considered so critical to national security that their very nature must be withheld from the public.

Ironically, it is the government itself that is leading the effort to curb official secrecy. Not only has it released a flood of once-secret research since the end of the Cold War, but several times in recent years federal bureaucrats have revolutionized scientific fields by making previously secret data publicly available for the first time.

The results include the first detailed global maps of the ocean floor, the techniques of laser fusion, a trove of astronomical data on gamma ray bursters collected by spy satellites, and decades worth of information about the global biosphere and climate gathered by U.S. intelligence sensors.

Moreover, the research community is fuming over a new law that makes all federally funded scientific data--from raw instrument readings and lab notebooks to medical interviews--a matter of public record, subject to the Freedom of Information Act.

That much openness is simply too burdensome, say scientists who are fighting to narrow the law’s scope.

In many ways, conflicts concerning secrecy are as old as science itself. Decades ago, for instance, scientists banished classified military research from university campuses out of concern that secret projects were incompatible with the open conduct of an academic community.

The growing importance of private funding, however, has injected a new tension into this community. Colleagues who might otherwise be partners in the scientific enterprise have become business competitors jockeying for commercial advantage.

It is now not uncommon for some prominent researchers to maintain two independent laboratories--one for public work, the other for proprietary research.

To determine how often scientists delayed publication of their research or refused to share results with colleagues, health policy analyst David Blumenthal and his colleagues at Massachusetts General Hospital recently surveyed 3,400 scientists at the top 50 research universities that receive the most taxpayer support from the National Institutes of Health.

One researcher in five admitted delaying publication for at least six months one or more times in the past three years to protect a scientific advantage, patent a discovery or secure some other commercial advantage.

One in 10 had flatly refused to share research results with other university scientists at least once in the past three years.

“Secrecy in science has gone from government-imposed to self-imposed,” said molecular biologist Howard K. Schachman at UC Berkeley.