WASHINGTON -- Dr. Marc J. Straus, a cancer researcher barred from getting federal funds after acknowledging false reports were submitted in a study under his name, asserts innocence and says he has 'never been a party' to fraud.
The Health and Human Services Department, saying Straus had signed an agreement saying 'serious deficiencies' occurred in studies he supervised, moved Wednesday to bar him from getting federal funds or experimental drugs.
'I have never been a party to any data frauds or manipulations, and nothing in the settlement with the government indicates that I was such a party,' Straus said in a telephone interview Thurday from his office in White Plains, N.Y.
'I have settled with the government only after becoming convinced that this legal outcome was unavoidable since the government's regulations impose these penalties on a principal investigator even when he did not know of any wrongdoing.'
HHS said Straus 'acknowledges that false reports were submitted ... that some ineligible patients were used in the studies, and that some patients received drug dosages that deviated from the plan of the study.'
HHS said in a statement Straus conceded some study plans had not been reviewed in compliance with informed consent regulations. There was no allegation patients had not signed informed consent forms.
The irregularities occurred in 1976-78 studies while Straus was at Boston University Medical Center doing work under sponsorship of the National Institutes of Health. He resigned in 1978 and is now at New York Medical College. United Press International quoted an HHS spokesman Wednesday who mistakenly said Straus had resigned from the medical college.
Straus said the study involved in the HHS action was unrelated to work he did on small cell lung cancer, which he said 'has never been questioned.' Contrary to a UPI dispatch based on Boston Globe reports, he said, 'There have never been allegations that treatments reported were never done and there were never allegations that a tumor was invented,' he said.
Straus said the government does not accuse him of knowing about the false reports, and he faulted government regulations that do not allow him a review by his peers.
'I have spent four frustrating years fighting for a fair and complete peer review of my work which has been consistently denied to me,' Straus said. 'I intend to restrict my efforts to a lawsuit against those who made allegations against me. My vindication will come in an unbiased judicial setting.'
Straus has filed suit against five junior staff members who raised the charges.
Dr. Ruth Moran, co-chairman of 'Scientists Supporting the Rights of Marc J. Straus,' a group of 78 doctors and scientists urging that he be allowed a peer review, said the controversy 'exemplifies the failure of the NIH and FDA (Food and Drug Administration) to safeguard academic freedom.'
'The committee is alarmed that under current federal regulations a principal investigator is penalized even in situations where data alterations occurred without his knowledge,' she said, noting the agreement he signed gives 'no suggestion that he was personally involved in any impropriety.'
She said Dr. Straus is 'widely regarded as a dedicated, compassionate physician' who has made many contributions in the fight against cancer.