Tighter legal controls on federally funded biomedical research -- including rules prohibiting scientists from having a financial stake in products that result from their research -- are needed to prevent misconduct, according to a congressional report to be released Monday.
The report by the House Government Operations Committee cites 10 recent cases of alleged misconduct to support its conclusions that universities and the National Institutes of Health are doing an inadequate job of investigating and punishing scientists who make up data, misrepresent findings or otherwise fail to live up to accepted research standards.
Much of the 73-page report deals with the problems of public safety and understanding posed by scientists whose research could be biased by their financial stake in that research, an increasingly contentious issue in the research community. Last December, bowing to strong opposition from scientific groups and the biotechnology industry, the Health and Human Services Department discarded a set of proposed guidelines that would have strictly limited the financial interests permitted scientists who receive government grants.
HHS Secretary Louis W. Sullivan said at that time that he intended to propose formal conflict-of-interest regulations. Public Health Service (PHS) officials said in a statement last week they are working on those rules.
But Rep. Ted Weiss (D-N.Y.), in an addendum to the report -- prepared by the subcommittee on human resources and intergovernmental relations that he chairs -- said the draft regulations are much weaker than the guidelines that were withdrawn.
"If the PHS fails to meet this responsibility, then Congress should enact legislation to achieve that goal," the report said.
In their statement, PHS officials declined to comment on the report's specific findings.
The statement said recent changes in federal regulations and procedures for investigating alleged misconduct had improved the government's ability to work with universities to monitor scientific research.
Robert Rosenzweig, president of the Association of American Universities, which represents major research institutions, said universities are taking steps to deal with scientific misconduct and conflicts of interest, and that additional laws would only hamper research.
The House committee report concluded that universities almost never find their faculty members guilty of intentional misconduct unless a researcher admits to fabricating data. It said "whistle-blowers" often suffer retribution, and that university investigations are frequently slow and inadequate. It said there should be laws to protect whistle-blowers.
The report found the National Institutes of Health reluctant to question the findings of university investigations or to enforce its own rules requiring government-funded scientists to disclose private sources of funding.
The most effective steps to prevent misconduct and protect the public's interest in high-quality research have been taken by scientific and medical journals, according to the report. Many journals require authors to sign a statement taking responsibility for the report's accuracy, and to provide to other scientists on request the detailed data on which their conclusions are based. Some require authors to disclose financial relationships that might pose a conflict of interest.
Cases detailed in the report include notorious examples of scientific fraud as well as those involving plagiarism, "massaging" of data to produce a desired result and federally funded scientists who also accept stock, consulting fees or research funding from companies whose products they are studying.
For instance, in a set of NIH-funded studies comparing the effectiveness of the drugs t-PA and streptokinase in dissolving blood clots in heart attack victims, at least 13 researchers owned stock or held stock options in Genentech, the maker of t-PA, according to the report. A 1985 study from the research concluded that t-PA was superior, but failed to mention that both drugs performed equally on some measures, and that both could cause potentially fatal bleeding.
In 1990, an Italian study of 20,000 patients found that streptokinase, which costs one-tenth as much as t-PA, was equally effective. The report accuses NIH of "standing by quietly" while a controversy developed over the possible influence of the researchers' stock holdings on their scientific objectivity.
In another case, Erdem Cantekin of the University of Pittsburgh Medical School accused a colleague, Charles Bluestone, of failing to report corporate funding of his research to the NIH and of publishing articles claiming that various antibiotics cured ear infections when his data indicated that they did not. The report said that Bluestone had received more than $18 million in government grants for research on ear infections in the last decade, and more than $3.5 million in grants from drug companies.
The report concluded that a university investigation wrongly dismissed the charges against Bluestone, and that university officials retaliated against Cantekin, including filing misconduct charges against him and trying to discourage a medical journal from publishing his analysis of Bluestone's data. It said that the NIH failed to adequately investigate the charges against Bluestone.
A spokeswoman for the University of Pittsburgh Medical School declined to comment.