In recent months, medical research has been rocked by scandal. There was the uproar over undisclosed deadly side effects of arthritis drugs and the debacle involving falsified data by a medical professor at the University of Vermont. According to this article from The Chronicle, these controversies have prompted researchers to ask the highly loaded question:

Can academic medical researchers stay objective when companies fund their projects?

In particular, many academic scientists in the occupational and environmental health field--which delves into the dangers confronting the public from the workplace and the environment--say that business interests are wielding too much influence on research agendas and results.

And the consequences are considerable as researchers giving conflicting expert analyses can deadlock multi-million-dollar lawsuits by residents against industrial sites.

"In this country over the last 20 years, the proportion of research studies that have been funded publicly has dropped substantially, and the proportion of privately funded has gone up," says Michael A. Silverstein, a clinical professor of environmental and occupational health sciences at the University of Washington, to The Chronicle. "It may be even more true in the area of environmental and occupational health," because the federal agencies that provide funds in this field get significantly less money than many other institutes do.

According to The Chronicle piece, "What critics see as a crisis in occupational- and environmental-health research is driven by two fundamental realities in the field: the lack of available money from the government, and researchers' dependence on industry for information." In short, researchers in this field often have to turn to industry for both funding and crucial data.

While some researchers believe that any level of industry involvement compromises scientific integrity, others contend that objectivity can and does thrive in this environment.

Yes, Objectivity is Alive and Well

• There's no reason that research findings should lean one way over another in the first place. "To say academic expertise should only be on one side is kind of wrong on its face," argues Marc B. Schenker, a professor and chairman of the department of public-health sciences at the University of California at Davis, who spearheaded a major industry-sponsored semiconductor manufacturing study 10 years ago that concluded that women who worked in the fabrication room at 14 semiconductor manufacturers had a slightly increased risk of spontaneous abortion.

• No reason to bias findings since researchers stand to gain no money. Schenker points out that he does not profit through his corporate-sponsored research studies or through his litigation services (he's testified on behalf of both plaintiffs and defendants). Any money he is paid for providing expert testimony goes to the university, he tells The Chronicle.

• Researchers and sponsors can come to an agreement before any work commences. According to Schenker, the sponsors of the semiconductor study did no meddling whatsoever. He was assured the right to publish his results, regardless of what they implied for his sponsors' bottom line. Similarly, Patricia A. Buffler, a professor of epidemiology and dean emerita of the School of Public Health at the University of California at Berkeley, says she requires a written guarantee from any company that she agrees to work with that it will not try to interfere with her findings in any way.

• Researchers hold their work to their peers' and their own high standards. "I believe I behave with a very high ethical threshold," says Buffler. "The way to achieve the best public-health goals is to have a strong science base and not to get carried away with poorly based advocacy...Shoddy science won't stand up to rigorous scrutiny." According to California Superior Court documents, Buffler has been paid $450 an hour as a consultant for Lockheed Martin Corporation, which is being sued by Redlands, Calif. residents who claim a Lockheed rocket-testing facility contaminated their groundwater and caused cancer and other illnesses. Perchlorate, one of the purported pollutants, is known to interfere with thyroid function. Buffler and other scientists conducted a Lockheed Martin-funded study that concluded that area residents did not experience higher risk of thyroid problems than other people did.

No, Industry's Influence is Too Insidious

• Despite written agreements, there's still pressure to come up with results that are favorable to the sponsor. "Even under the best of circumstances, there's some understanding that future funding depends at least in part on the results you find this time," comments Anthony Robbins, a professor of public health and family medicine at Tufts University, who is a former director of the National Institute for Occupational Safety and Health. Others go even further, The Chronicle reports. Daniel T. Teitelbaum, a doctor in Denver whose expertise is in medical toxicology and occupational epidemiology, says: "Industry doesn't give you money to do research. Industry gives you money to do research that favors them." Additionally, this recent study on scientific misconduct seems to support the point that many researchers cave in to pressure from funding sources.

• Research that could be damaging to industry has a way of disappearing. "There's a systematic failure to publish positive findings when they happen to conflict with the sponsor's interest," says Sander Greenland, a professor of epidemiology and statistics at the University of California at Los Angeles. Greenland supports the creation of a national registry that would list all studies. This could be a hard sell, however, as some journals in occupational and environmental health don't even require authors to disclose their financial sources or any other potential conflicts of interest, The Chronicle piece says.

• By challenging the validity of findings, industry can compel researchers to redo their work, thus stalling proposed regulations or court cases. This, reports The Chronicle, is what happened to Beate R. Ritz, an associate professor of epidemiology and environmental health at UCLA, who did a study on some 55,000 people who had worked at a facility that tested rockets and nuclear reactors between 1950 and 1993. The facility was run by Rocketdyne, a firm that became part of the Boeing Company in 1996. With funding from the U.S. Department of Energy, Dr. Ritz found that workers who had had high exposures to radiation were more likely than their colleagues to die of leukemia, and that workers exposed to the rocket fuel hydrazine had a slightly higher risk of dying of lung cancer. Even though her studies had passed peer review and been published in leading journals, Rocketdyne attacked her work. In response, Dr. Ritz performed a follow-up study, which included several more years' worth of deaths. Again, she documented an increased risk of death from cancer for exposed workers. She recalls of the company: "These people were so antagonistic."

• This antagonism is not rare. Such attacks get researchers to redo or increase the scope of their studies, says David Ozonoff, a professor of environmental health at Boston University, "to dispel the doubt that industry has created." He himself has firsthand experience: he's been forced to "keep doing studies over and over again" on perchloroethylene, the solvent most often used in dry cleaning--and a known groundwater contaminant--because an industry association keeps questioning his results. Dr. Robbins of Tufts sees this tactic used often: "Industry has found it worthwhile to challenge all of the studies that suggest there might be a link between some exposure and some kind of disease or illness... Industry is in the business of manufacturing uncertainty."

A Solution?

Fortunately, there is a middle ground, some believe, and it's exemplified by the Health Effects Institute, an organization that researchers say conducts independent studies while depending on industry money. "They do high-quality work, and it's very transparent," comments David M. Michaels, a professor of environmental and occupational health and of epidemiology at George Washington University, to The Chronicle. "They are very careful about doing it right."

The nonprofit institute funds studies and conducts analyses of existing findings on air pollution and health. The Environmental Protection Agency and a consortium of car-and-truck manufacturers provide joint and equal support. The institute issues a list of research priorities every five years, and based on this list, the EPA and the manufacturers give five-year financial allotments, which currently amount to some $4-million annually. "No matter what we say with any particular study we publish, people can't just pull out," notes Daniel S. Greenbaum, the institute's president.

Unfortunately, the Health Effects Institute is a rarity. "We're all human," says Colin L. Soskolne, a professor of epidemiology at the University of Alberta, in Canada. "We tend to respond in ways that will ensure that we are secure in our careers. Unfortunately, in my view, this does not always--perhaps ever--serve science well or the public interest well."

Source:

Occupational Hazards
Lila Guterman
The Chronicle of Higher Education, June 24, 2005
chronicle.com/free/v51/i42/42a01501.htm