scientific misconduct: us. joins research fraud suit
TRANSCRIPT
NEWS OF THE WEEK
SCIENTIFIC MISCONDUCT: US. joins research fraud suit
In an action with far-reaching implications for scientific research institutions, the Department of Justice has intervened in a fraud case brought by a whis t leb lower against his former research supervisor and two universities.
The suit alleges Ph.D. immunolo-gist John L. Ninnemann, currently associate professor of biology at Adams State University in Alamosa, Colo., submitted fraudulent research results in his applications for federal grants. It seeks damages and penalties totaling three times the $1.2 million in National Institutes of Health grant money paid to Ninnemann's former employers, the University of Utah and the University of California, San Diego.
J. Thomas Condie, Ninnemann's former laboratory technician at Utah, brought the suit under a Civil War-era law called the False Claims Act. As amended in 1986, the law al
lows individuals to sue on behalf of the government and to keep at least 15% of the damages. These so-called whist leblower suits—technically known as "qui tarn" actions for a Latin phrase meaning "he who sues on behalf of the state as well as himself"—have primarily been used in the defense industry.
The current case represents the first time the government, which must choose whether to join any given action under the False Claims Act, has decided to enter into a case of scientific research fraud. "The government's action in assuming responsibility for the case reflects our insistence that scientific research, especially when federally funded, be truthfully reported," said Stuart M. Gerson, assistant attorney general for the Justice Department's civil division, in announcing the government's decision. "The government will not tolerate the falsification of
Whistleblowers lawyer is whistleblower himself
Eugene Dong, the Palo Alto, Calif., attorney who Is representing whistle-blower J. Thomas Condie in what Dong hopes will be a precedent-setting case, is both a lawyer and a physician. As a faculty member in Stanford University's department of cardiovascular surgery, he has published more than 100 papers on heart research and has been a principal investigator on grants funded by the National Institutes of Health.
Dong himself has been the whistle-blower in an instance of alleged scientific misconduct. Like others who have brought cases of irregularities to light, he found the research establishment shunned him as if he were the guilty party. His frustrating experience helped motivate him to attend law school.
"I am supposedly full time at Stan
ford's cardiac surgery department," Dong says. "In 1972, I ran into a problem. Since then I've been a whistle-blower stuck off in the corner."
Ironically, the scientist accused of misconduct in the current case, John L. Ninnemann, was peripherally involved as a young researcher in another notorious instance of. scientific fraud. In 1974, Ninnemann was a research fellow at New York's Sloan-Kettering Institute for Cancer Research. It was there that William T. Summerlin colored black patches on white mice with a felMip pen when his experiments on suppression of rejection of skin grafts failed. Ninnemann was one of the researchers who had been unable to reproduce the successful results Sum-merlin had reported earlier.
scientific data in support of research grants."
But the action threatens to disrupt the federal policy for dealing with misconduct in research, which has been painfully evolving over the past few years. Under intense scrutiny from Congress, both NIH and the National Science Foundation have enacted rules that give research institutions the responsibility for preventing and investigating unethical behavior.
'The federal scheme for dealing with scientific misconduct is based on the notion that allegations will be evaluated by individuals with scientific expertise—first at the universities and then at the funding agencies if necessary/' says attorney Robert Charrow of Crowell & Mor-ing. "When such cases are thrown into court under the False Claims Act, a jury is going to be making the determination. Whether the jury members are competent to do so is a question." Charrow, formerly with the Department of Health & Human Services, often handles science cases involving NIH.
"I don't think using the False Claims Act is a progressive or productive approach to these issues," says Gregory C. Simon, staff director of the House Committee on Science, Space & Technology's Subcommittee on Investigations & Oversight. Under chairman Robert A. Roe (D.-N.J.) the House Science Committee has been working for institutional review of scientific misconduct cases.
"Now the Justice Department is creating a new investment opportunity for those who want to make money from scientific misconduct," Simon says. "I don't think it's productive to treat universities like defense contractors. The university is a victim in most cases, not a coconspirator. I have to say, however, that
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it is true that whistleblowers have not been treated very well."
However, whistleblower Condie's attorney, Eugene Dong, says the False Claims Act is the proper vehicle for addressing scientific fraud, because it bypasses the institutions that too often overlook or conceal such misconduct and recovers money for the federal government. In this specific case, he alleges both Utah and UC San Diego received grant money under false pretenses after they had been notified of problems with Ninnemann's work.
"Institutional investigations are inherently fraught with conflict-of-interest/ ' Dong says. 'They don't work. The professors serving on the committees that investigate either have a working relationship with the accused or, if they don't, they are not experts in the field."
"What's most important is that the institutions are liable," Dong continues. "If any fruit that arises out of the research accrues to the universities, so do the liabilities. If they do take action against one of their own, they say: 'He's the bad guy, but don't look at us.' "
In the early 1980s, Condie was head laboratory technician under Ninnemann in Utah's department of surgery where they conducted research into the cause of immune system suppression after burn injuries. According to Dong, in 1983 Condie found discrepancies between the laboratory records of the research and how it was reported by Ninnemann in publications and at meetings.
When Condie brought his suspicions to the attention of the department, he was told to resign, Dong says. Ninnemann eventually received a reprimand from Utah and in 1984 transferred to UC San Diego, according to Dong. San Diego and NIH became aware of the allegations of misconduct when Ninnemann applied to NIH to have his grants transferred from Utah to San Diego. Utah has carried out three investigations of the case and San Diego and NIH one each, Dong says.
Whatever the outcome of this landmark law suit, the very fact that it was filed reveals that normal professional procedures and mores within the sciences have not been able to address the issues of scientif
ic misconduct swiftly and yet deal fairly with all the parties involved, says Marcel LaFollette, associate research professor of science and technology policy at George Washington University. And the potential for the whistleblower to profit financially from a False Claims Act suit introduces yet another complication and inflames the si tuation, she points out. "Whatever the motives of the whistleblower, the very existence of this case indicates the failure of the system," she says.
Pamela Zurer
Report alleges agent orange coverup The House Committee on Government Operations has issued a highly critical report of the government's efforts to measure agent orange exposure in Vietnam veterans. However, some of the committee's members accuse the authors of the report, which alleges a secret 1984 White House strategy to deny federal responsibility for toxic exposures, of playing politics rather than clarifying scientific issues.
The House study was conducted by the Subcommittee on Human Resources & International Relations, chaired by Rep. Ted Weiss (D.-N.Y.). "While the Reagan Administration defended the Vietnam conflict as an honorable war, it worked behind the scenes to deny benefits to the very people who sacrificed their health for their country," Weiss says.
Most of the issues raised by the 14-month investigation had been raised before by veterans' organizations during the long history of the agent orange debate. The major issue involves a Centers for Disease Control study, mandated by Congress in 1982, on U.S. troops' exposure to agent orange. After spending $43 million, CDC said determining exposures was impossible and canceled the study in 1987. The new House report says CDC ignored valid Defense Department data on troop positions when CDC claimed such data were inadequate for exposure estimates.
Weiss' subcommittee also cites extensively a 1983 memo from the Of-
Weiss: veterans denied benefits
fice of Management & Budget that says the government's assumption of liability for alleged agent orange illnesses (and other veterans' disabilities) could cost the government billions of dollars. The report says at that point the Administration began a conspiracy to avoid any such liability. Many of the same points the subcommittee raised are included in a review of the issue by Adm. Elmo R. Zumwalt Jr. (retired). Zumwalt had done the study at the request of Veterans Department Secretary Edward J: Derwinski (C&EN, May 28, page 7).
David Hanson
ACS and Dialog clash over antitrust suit After several relatively quiet weeks, the legal confrontation between the American Chemical Society and Dialog Information Services is heating up again. Attorneys for the two sides clashed last week over several issues. And ACS's top elected officials again denounced Dialog's claims and "steady misrepresentation of the facts."
Dialog, a Knight-Ridder subsidiary that has been licensed since 1974 to provide on-line access to several Chemical Abstracts Service databases, filed an antitrust suit against ACS in U.S. District Court in Washington, D.C., on June 7 (C&EN,
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