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Medical Tests Skewed, Study Finds

Commercial ties are tainting the outcome of research at universities, Yale investigators say.

January 22, 2003|Robert Lee Hotz | Times Staff Writer

NEW YORK -- The scramble for profit warps the way scientists and universities conduct medical experiments, undermining the integrity of research, said Yale University investigators who studied the impact of commercial funding on science.

One-quarter of the biomedical researchers at universities had commercial ties serious enough to raise questions of financial conflict, the analysts found. In many cases, it was enough to skew their research.

Moreover, the universities expected to police the integrity and ethics of faculty scientists have their own commercial research interests and financial conflicts. At least two-thirds of the universities also were involved in commercial ventures, holding equity shares in start-up companies whose research they were also expected to monitor. Twenty-seven universities had equity in 10 or more start-up companies, the researchers said.

The result can be slanted science.

Industry-sponsored research is 3.6 times more likely to produce results favorable to the company that helped pay for it, the Yale researchers determined in a university-funded study published today in the Journal of the American Medical Assn.

"Medical research is a matter of life and death," said Yale University medical analyst Justin Bekelman, who led the study team. "The guidance patients receive from their doctors relies on valid scientific research."

In all, the Yale researchers assembled and analyzed data from 37 previously published peer-reviewed studies -- covering hundreds of research projects, thousands of scientists, and more than 1,000 peer-reviewed scientific papers -- on the extent, impact and management of financial conflicts.

They named no scientists or schools involved, nor did they reveal the names of any firms. Conducting the most extensive study of commercialism and science so far, they did identify a troubling trend across the realm of biomedical research.

Their review covered the decades from 1980 to 2000, a period during which the share of commercial funding grew to 62% of all U.S. spending on biomedical research. Even as public spending on biomedical research doubled in the last five years, the financial ties between academic scientists, universities and industry became more common and more likely than ever to influence research findings.

"Financial conflicts were even more prevalent among institutions than among individuals," said Yale research analyst Cary Gross. "How workable is oversight and the policing of financial conflicts by institutions if they themselves have conflicts?"

By necessity, the public looks for reliable medical guidance almost every day.

Public health warnings, medical claims and policy pronouncements come draped in the cloak of scientific authority, usually backed by a bible of published research findings. But along the frontier of science and business, the line between research and marketing can be hard to find.

Every day seemingly brings a blizzard of new assertions: Roller coasters are safer than bunk beds. Wine and walnuts improve your health. This vaccine is harmless. That drug works better than a placebo or competitor.

Who among the chorus of experts should the public believe?

"It is getting harder and harder to find someone who can conduct the research or evaluate the research who does not have a financial interest in a particular product or particular company or a particular outcome," said Stanford University biomedical ethicist Mildred Cho.

This financial tangle is the consequence of a basic change in the way biomedical research is conducted in the United States, several experts said.

Commercial funding, once anathema to ivory-tower academics, has become the lifeblood of biomedical research, fostered by federal laws and regulatory changes since 1980 that give scientists and schools more freedom to profit from work once considered in the public domain.

At most universities and medical centers, researchers are obliged to tell people whom they want to enroll in an experiment that the researchers have a financial stake in the drug or treatment on trial. Many medical journals, which publish new research, also have rules requiring scientists to reveal any financial stake they may have in the work.

Such disclosure policies are meant to alert the public to the possibility of bias in published research, but they are honored more in the breach than in practice, medical research analysts at Stanford and Tufts universities said.

When researchers checked 47 of the most influential biomedical journals, fewer than half had disclosure policies. When Richard Smith, editor of the British Medical Journal, checked 3,642 articles published in the five leading medical journals, only 52 declared the authors' financial stake in the works.

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