A federal judge is expected to rule within a month whether NCI and other HHS agencies violated the rights of the clinical trialist Bernard Fisher by placing “scientific misconduct” labels on the abstracts of his articles in the CancerLit and Medline databases.
At a hearing Wednesday before Judge Ricardo Urbina of the US District Court for the District of Columbia, attorneys for Fisher maintained that the government had violated the federal law which requires government agencies to maintain accurate “systems of records” on individuals.
While Fisher’s side has prepared a voluminous case based on depositions and documents obtained through discovery, the government presented a case based entirely on legal arguments, contending that the literature databases do not fit under the definition of records in the Privacy Act.
“We believe the Privacy Act does not apply to the databases,” Richard Friedman, an attorney with the HHS Office of General Counsel said at the hearing. “Our argument is that the pieces of information [in the databases] are not about the plaintiff.”
Rather than referring to an individual, the database entries refer to the materials they annotate, he said. Even the address on each entry is not used as the author’s address, Friedman said. “It’s an address to get more information on the article.”
Last spring, Urbina granted a preliminary injunction sought by Fisher, ordering the removal of flags from the databases (The Cancer Letter, March 24, 1995). Now, Fisher seeks a permanent injunction, a public apology and an assurance that similar flagging would not occur in the future. If Urbina grants these motions, a separate proceeding would determine the damages due to Fisher (The Cancer Letter, Oct. 20, 1995).
“Their argument is that a database entry is not a record on Dr. Fisher,” said Stuart Newberger, an attorney with Crowell & Moring, the Washington firm that represents Fisher. “What they are saying is that as a matter of law they can do it again.”
Newberger said HHS and NIH officials decided to blame Fisher for the scandal involving fraudulent data submitted by a Montreal surgeon to a breast cancer trial run by Fisher’s cooperative group. To accomplish this, the government launched a scientific misconduct investigation of Fisher and proceeded to flag his publications in the databases, Newberger said.
Rules that generally apply were ignored in the Fisher case, his lawyers contend. Thus, the start of a scientific misconduct investigation—always a confidential matter—was announced by Philip Lee, HHS Undersecretary for Health, in an interview with The New York Times. Similarly, then-NCI Director Samuel Broder announced the misconduct investigation at a meeting of the National Surgical Breast & Bowel Project, the group Fisher ran until the start of the scandal.
When NIH officials proceeded with the annotation of Fisher’s articles, they placed labels on the basis of the titles of the articles, without reading the text. Thus, articles that included editorials and award speeches by Fisher were flagged “scientific misconduct,” Newberger said.
“[The databases] are created to help people find out about a scientist’s work,” Newberger said. “And they contain an address, so Dr. Fisher could be contacted.”
Newberger said many of Fisher’s co-authors could have Privacy Act claims against the government. “I am not trying to drum up a class action case, but many people may have an action here,” he said.
HHS: Flags Not Meant To Point To Fisher
Responding to Newberger, HHS attorney Friedman defended virtually every aspect of the flagging.
“The words `scientific misconduct’ [in the flags] were never meant to communicate that Dr. Fisher himself committed scientific misconduct,” Friedman said.
In fact, the flags were not intended to identify the perpetrator. According to Friedman, the flags were to be interpreted in the following manner: “Somebody’s scientific misconduct has affected this article. We are reanalyzing the data. Watch this space.
“It was still a statement about the article,” Friedman said. “There is no evidence that anyone has read it any other way.” Friedman acknowledged one error on the part of an official of the HHS Office of Research Integrity who placed a “scientific misconduct” flag on a paper by Fisher that included no data from the trials in question.
Friedman said Dorothy Macfarlane, the ORI official responsible for deciding which papers to flag, read only the titles of the papers in question.
“Perhaps she should have done more and read the articles themselves,” he said. However, Friedman said Macfarlane did not act arbitrarily. “The titles in medical literature are generally more informative than the titles of legal articles,” he said.
Defending Macfarlane’s decision to flag several of Fisher’s speeches and editorials, Friedman said, “Any general piece by Dr. Fisher is based on the totality of the NSABP product.”
The opinions set forth by Fisher could have been based on fraudulent entries submitted by Roger Poisson, a surgeon at St. Luc Hospital in Montreal.
“There is a linkage here,” Friedman said of Macfarlane’s decision to flag. “It’s a judgment call.”
Friedman further argued that HHS Undersecretary Lee and NCI Director Broder did not violate the Privacy Act when they stated publicly that ORI had begun a misconduct investigation of Fisher.
Fisher’s lawyers have not demonstrated that Lee and Broder had revealed information obtained from ORI records, Friedman said. “Information that is lodged in an employee’s mind does not refer to a disclosure from a system of records,” Friedman said. “There has to be a retrieval from the system.”
A series of papers published in the New England Journal of Medicine last month reaffirmed the results of the NSABP trial comparing mastectomy with lumpectomy, with and without radiation (The Cancer Letter, Dec. 8, 1995). The controversy over the fraudulent data submitted to that trial led to Fisher’s removal as chairman of NSABP.
