Eastman's consulting was approved in November 1995 by two senior officials, including the then-director of the NIH diabetes institute.
In March 1996, Eastman signed a federal recusal, pledging to disqualify himself "to judge or otherwise act [as a federal official] on any matter or matters pertaining to" Rezulin's status in the NIH study.
However, the NIH has no procedure for verifying that officials comply with the terms of their own recusals. And Eastman continued to participate in decisions of the study's four-person executive committee regarding Rezulin, according to records and interviews.
When the inspector general of the Department of Health and Human Services inquired years later, Eastman said he had not thought he was violating his recusal, records show.
Eastman and his boss also told the inspector general that they had never seen a 1996 memo from an NIH attorney warning Eastman: "recuse yourself from all official matters" involving Warner-Lambert. Both Eastman and his boss, then the deputy director of the diabetes institute, stated that an office aide had filed away the attorney's warning before they had a chance to read it.
From 1995 through 1997, while collecting upwards of $43,000 in consulting fees and related compensation from Warner-Lambert and its affiliates, Eastman repeatedly defended Rezulin in his government capacity.
On Nov. 28, 1997, Eastman wrote to the 22 physicians around the U.S. who were carrying out the NIH's diabetes prevention study, telling them that the British distributor of Rezulin was about to pull the drug.
"This is apparently a marketing decision, rather than a regulatory one," Eastman wrote. The withdrawal was voluntary, but it was made in consultation with officials at Britain's Medicines Control Agency, who concluded that Rezulin was unsafe.
An internal Warner-Lambert document circulated about that time termed Eastman and his NIH colleagues "the strongest advocates for the safety of this drug."
On May 17, 1998, a participant in the major NIH study that Eastman supervised suffered sudden liver failure and died.
The victim was Audrey LaRue Jones, a 55-year-old high school teacher from East St. Louis, Ill. The death loomed as an indictment of Rezulin because Jones fell into liver failure despite having her liver functions monitored monthly, consistent with the product labeling. Some 580 other patients remained on the drug in the NIH study.
