Big business is watching you

February 6, 1998

US scientists doing industry-sponsored work have found that unwelcome results can elicit an intimidating response from their paymasters. Tim Cornwell reports

Oprah Winfrey was on trial in a Texas court this month, sued by cattlemen for slandering beef. The libel case against Winfrey sought compensation after a food safety activist on her show raised the spectre of mad cow disease attacking US herds, allegedly sending prices into a tailspin. Now some scientists say the same story is happening in academia. Researchers whose work impugns commercial interests can find themselves tossed into a political, legal and personal tempest.

JoAnn Burkholder, of North Carolina State University, became a celebrity last year after the "cell from hell" that she discovered and identified, pfiesteria piscicida, was linked to fish dying in Chesapeake Bay, near Washington DC. But for five years, Burkholder's work linking diseased fish in North Carolina's waterways to agricultural drainage made her many prominent enemies in the state's tourism, fishing and farming industries. She complained of her work being slighted while she was pilloried in leaked government memos and got death threats on the phone.

Variations on the same theme appeared last year in four other cases cited in the New England Journal of Medicine and the Journal of the American Medical Association. There are warnings that, with growing public and media interest in health hazards and research, the use of pressure tactics against scientists "may become more frequent and acrimonious", and may already be wider than some realise.

In 1997, the JAMA published the results of work concluded in 1990 by the University of California researcher Betty Dong, along with an editorial saying that "an academic principle of the highest priority was at stake". Dong was paid $250,000 in a grant from Boots Pharmaceuticals for a study comparing Boots' thyroid replacement drug Synthroid with other generic drugs on the market. She concluded, unexpectedly, that the cheaper drugs were "bio-equivalent" to the Boots brand, and was prepared to publish in January 1995. But Boots Pharmaceuticals, subsequently merged with Knoll Pharmaceuticals, insisted the study was flawed. And Dong had signed a contract containing a clause which forbade publication of her research without written consent.

Next week, a panel at the annual meeting of the American Association for the Advancement of Science will debate the issue generally, under the provocative title "Manipulation of Science by Vested Interests: Money and Power versus Public Health". Speakers will include health scientists who have tangled with the tobacco industry, pharmaceutical firms, and other powerful lobbies, from inside as well as from without. They include Dr Burkholder, and the celebrated tobacco company scientist and whistle-blower, Victor DeNoble.

President Bill Clinton in his State of the Union speech last month promised the biggest funding increase in history for the National Institutes of Health and other US government science agencies, calling for "a revolution in our fight against all deadly diseases". But an increasing proportion of US research is funded by or linked to private firms, with laws enacted in 1980 to give NIH scientists more chance of profiting financially from their brains.

US scientific opinion makers stress that corporations are not the enemy. But some are calling for new guidelines to protect freedom of speech and scientific endeavour amid the increasingly intricate relations between corporate or government sponsors and scientists, their universities, and professional associations and journals. It is suggested that:

* universities need to weigh in quickly against specific cases of apparent intimidation, or allegedly vengeful budget or grant cuts against departments or individuals;

* peer-reviewed journals need to ensure that reviewers do not have their own conflicts of interests as consultants to large firms;

* contracts must be vetted for clauses that would allow the suppression of discomforting results.

The AAAS panel was the idea of Esther Sternberg, a section chief with the National Institutes of Mental Health in Maryland. Sternberg was a leading government researcher whose work linked a dietary supplement, L-tryptophan,to an outbreak of Eosinophilia-Myalgia Syndrome in 1989-90 in which about 30 people died. As a result, the Japanese petrochemical giant Showa Denko, the manufacturer, was sued for $2 billion. Showa Denko`s response was in part a demand for details of Sternberg's work. The demand "crossed the line from legitimate inquiry to intimidation", as the journal Nature put it.

The company filed requests under the Freedom of Information Act demanding voluminous pre-publication data. Lawyers called Sternberg's boss and tried to get Sternberg to meet them. In a recent letter to the New England Journal of Medicine, Sternberg refuted rumours that scientists' findings could not be reproduced in peer-reviewed studies, when in fact they were.

In an interview, Sternberg described how a scientist whose work can threaten millions, or billions of dollars in commercial profit can suddenly find themselves "in the middle of a tempest". "It's like being Alice in Wonderland on this huge chessboard, and if you are part of this chessboard, you don't recognise what's happening around you: it is confusing and isolating. That was certainly my experience."

The current publicity, she hopes, may open scientists' eyes, air the problems, and let those under pressure know they are not alone.

But Sternberg says that the aim is not "name-calling" but to replace "destructive tactics" with "constructive dialogue". "We don't want to imply that all industry does this, or all government does this," she said. "It should be in the interests of industry that wants to fund research to have research which is as unbiased as possible."

Likewise, a co-organiser of the AAAS panel, Floyd Bloom, of the Scripps Institute in San Diego, notes that his own experience with the pharmaceutical industry has been steadily "cordial and constructive". Bloom has been a consultant for Johnson and Johnson and other companies, and while he concedes that pressure can be brought to bear on scientists: "I don't want anyone to think that this is the standard way in which academic-corporate relationships take place," he said.

JoAnn Burkholder's experience moved far beyond pure science. She was profiled in places like the glitzy People magazine, usually reserved for the likes of Michael Jackson. Her dramatic story involved her own exposure to the pfiesteria microbe collected in a laboratory aquarium; for eight days, she recalled, she felt as though her brain had stopped working. A colleague was infected with skin sores, excruciating headaches and the same "mental fogginess"; subsequent research found the same symptoms among exposed fishermen. But the suggestion that pfiesteria could not only kill fish, but also make people seriously ill, was not one that endeared Burkholder to state officials who provided her grant, nor to the hog farms whose drainage she implicated in the problem.

A memo from a state toxicologist leaked to the press portrayed the 44-year-old scientist as "very shaky on the phone" and "not normal by any standard". It ended with what the local press described as an unprecedented public apology to Burkholder by North Carolina's chief of the Department of Environment, Health and Natural Resources. "I am sorry to find that some DEHNR staff may have disparaged your work," he wrote. In a strange reversal, Burkholder is now working with several state governments, though a university spokesman says she is still the target of whispering campaigns and threatening phone messages.

Drummond Rennie, the west coast editor of JAMA, who oversaw the decision to publish Dong's work, will also speak at the AAAS panel. The public's reaction to the issue, said Rennie, is sometimes akin to "who me? I couldn't care less. I'm going down to the pub". But it should concern people if "more and more research which bears on their health is done, or controlled by people who stand to make money as to which way the research goes. "

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