This is part of an occasional series that will recall some of the stories reported 10 years ago in the News section of the Journal.
Science has changed in the past 10 years not only in terms of research and discovery, but also in the way its work is monitored.
The News reported in its June 7, 1989, issue that the House Energy and Commerce Subcommittee on Oversight and Investigations convened in 1989 to re-investigate allegations of scientific misconduct and fraud. Rep. John D. Dingell (D-Mich.) presided as chairman over the hearing, whose other key players included former Massachusetts Institute of Technology researchers David Baltimore, Ph.D., a Nobel laureate, Thereza Imanishi-Kari, M.D., and Margot O'Toole, Ph.D., who set the investigation in motion in 1986.
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The result of the Congressional hearing: a judgment of fraud on the part of Imanishi-Kari; a call for changes in the system of scientific misconduct review; and damage to the careers of the three scientific researchers. Imanishi-Kari was branded as guilty of scientific misconduct. Baltimore's steadfast defense of his colleague forced him to resign as president of Rockefeller University. And O'Toole lost her position at MIT and spoke vehemently about lack of support for whistleblowers.
In retrospect, the Baltimore case as it became known did spark changes to the process of misconduct review. In 1992, the Department of Health and Human Services formed the Office of Research Integrity. ORI is "responsible for overseeing the collaborative system for promoting research integrity in Public Health System-supported research programs." With the creation of this office came the opportunity for all scientists formally charged with misconduct to have a hearing a hearing among researchers, not lawmakers who may have limited scientific knowledge.
Perhaps the most significant change, however, has been the move to have institutions be primarily responsible for responding to allegations of scientific misconduct within their own walls. Specifically, institutions that receive financial support from the Public Health Service are now required to have policies in place for responding to allegations, and ORI ensures that those administrative policies comply with federal regulations. Policies must include protection for both the accused and the accuser.
ORI thus functions more as a reviewer or overseer in order to ensure the integrity of the research it supports, although it can conduct investigations if necessary. While the names of accused scientists are not released during the inquiry or investigation, the results of ORI hearings are public and can be read online through the ORI website (http://ori.dhhs.gov).
One document available through that website is the 1996 decision of a Research Integrity Appeals Board, which exonerated Imanishi-Kari from charges of scientific misconduct. A decade after the House convened on this matter, Imanishi-Kari is an assistant professor at Tufts University, Boston. Baltimore is now president of the California Institute of Technology, Pasadena, and O'Toole is a researcher at the Genetics Institute in Cambridge, Mass.
Oral Contraceptives
Ten years ago, researchers grappled with the question: Does the use of oral contraceptives increase a woman's breast cancer risk?
Although a great deal of research had already been done, an article in the Feb. 15 News in 1989 found that study results were inconsistent and there was no definitive answer. Conclusions ranged from no increased risk associated with oral contraceptive use to a three-fold increase in risk.
A decade later, there is considerably more data and more insight, as well as more questions.
The most comprehensive report on oral contraceptives to date, analyzing the results of 54 studies involving over 50,000 women with breast cancer and 100,000 women without, showed strong evidence of two main conclusions: women using oral contraceptives have a small increase in breast cancer risk for 10 years after taking them; and women who stop taking oral contraceptives have little or no increased breast cancer risk 10 years after cessation regardless of other known behavioral or environmental risk factors.
Several encouraging aspects of this report might assuage users of oral contraceptives, however. The cancers diagnosed in women who had used oral contraceptives were less advanced clinically and more treatable than cancers diagnosed in women who had never used oral contraceptives. Scientists also stated that the slight increased risk in both current users and women who stopped less than 10 years ago may not be due to the contraceptive per se, but rather to promotion of tumors that have already been initiated.
Today, it is reliably established that breast cancer risk is not increased 10 years or more after cessation, although information is still somewhat limited.
Researchers mirror the sentiment expressed in 1989: not enough time has elapsed since the emergence of oral contraceptive use in the 1960s to determine long-term effects. This means reexamination is needed in the coming decade, especially for those women who initiated usage in their teen years.
Not Just Fish Oil?
Seafood fatty acids may lower one's risk of certain cancers, the News reported on Oct. 18, 1989.
Scientists had shown in both epidemiological data and treatment studies of women at high risk for breast cancer that intake of omega-3 fatty acids found in quantity in certain types of seafood was associated with decreased cancer risk. Animal models of breast, colon, and pancreatic cancers demonstrating inhibition of carcinogenic processes corroborated this link. Investigators in 1989 questioned the significance of the statistical associations and called for further research.
In tabulating their results, researchers knew that there was a statistically significant difference between the two forms of polyunsaturated fatty acids the omega-6 class, found in corn and safflower oils, and the omega-3 class, found in fish oil. Omega-6 fatty acids are necessary for tumor cell proliferation, while omega-3 fatty acids tend to counteract tumor growth.
Scientists in recent years have continued to study the effect of fatty acids on cancer risk. With new results has come interest in the relative significance of both polyunsaturated fatty acids, as well as concern about the method of determining fatty acid composition.
Since the body is unable to synthesize polyunsaturated fatty acids on its own, adipose tissue sampling has come into use as a method to determine intake replacing the use of memory or food logs, long questioned for accuracy. A study in 1998 by Neal Simonsen, Ph.D., and his colleagues at the University of North Carolina, Chapel Hill, examined the fatty acid content of gluteal adipose tissues in postmenopausal breast cancer cases and controls. Reporting in the American Journal of Epidemiology, the researchers found evidence that it is the ratio of omega-3 and omega-6 fatty acids that plays a role in breast cancer, not the total fat of each.
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The fact that gluteal, not breast, adipose tissue was used in Simonsen's study of breast cancer is also a potential concern. Dilprit Bagga, M.D., et al., of the University of California, Los Angeles, published an article in 1997 in the Journal of the National Cancer Institute concluding that "gluteal fat is an imperfect surrogate for breast fat, especially for intervention studies."
The various studies underscore the necessity for further investigation. Scientists say that future research could clarify the importance of the balance between fatty acids in the diet to possible cancer sites, as well as the use of tissue stores as determinants of cancer risk.
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