Oh, Donna!
Price, David Andrew
David Andrew Price Oh, Donna! Evidence is emerging that the Secretary of Health and Human Services lied about allegations of science fraud and stolen research during her tenure as chancellor of...
...Also, it was peculiar that the DeLuca team never used the process on any subsequent occasion until receiving the Barton-Hesse manuscript three weeks later...
...S halala's role in the DeLuca case came to light shortly after President-elect Clinton named her as his choice to run HHS...
...Cohen said that to complete the investigation, as federal law required, the university would appoint another panel...
...Senators Grassley and Cohen have arranged for the DeLuca case and the reassignment to be examined by the Comptroller General's Office of Special Investigations, which handles inquiries into possible criminal misconduct...
...In particular, OSI wanted to follow up on a crucial question of the case—the authenticity of the notebook entry for the January 29, 1973 experiment—using forensic tests that could establish when the entry had been written...
...Evidence is emerging that the Secretary of Health and Human Services lied about allegations of science fraud and stolen research during her tenure as chancellor of the University of Wisconsin...
...Shalala appeared on January 14 before the Finance Committee and on the 15th before the Labor and Human Resources Committee...
...The agency impounded their files of correspondence and data on fifteen misconduct cases—including the Madison affair...
...a member of the Madison faculty, Professor Emeritus David Berman...
...I had to cut her off and set the record straight...
...There was no evidence that DeLuca's group ever tested any of the material that it sent out...
...32 The American Spectator January 1994 missing from the carbon copy of the entry...
...The evidence also suggested that DeLuca had obtained pharmaceuticals manufactured only for use in animals, sent them to doctors for testing in humans, and lied to the doctors and the FDA about where the material came from...
...DeLuca's Madison group did produce 1-alphaHCC, but with a different method...
...The Wisconsin Alumni Research Foundation (wARF) obtained a patent on this breakthrough process and The American Spectator January 1994 31 on 1-alpha-HCC itself...
...The panel heard no testimony from six of the seven disinterested scientists (one of them Howard Rasmussen) who had served as witnesses against DeLuca in the patent litigation, nor did the panel receive the affidavits they had submitted in the litigation...
...When Moynihan later described the incident, he said acidly, "She tried to lie to me...
...A Grassley staffer reports, "Their cooperation has been very limited, and in terms of essential documents we've requested, we've gotten next to nothing...
...Hence, Clyde Watkins of OSI wrote Shalala on April 17, 1990, to request the notebook...
...If those substances could be synthesized, they were expected to have important, and lucrative, uses in the treatment of osteoporosis and other conditions...
...Grassley and Cohen have also been seeking answers directly from HHS...
...Senator Moynihan, a committee member and a proponent of the act, interrupted her and quoted CDF testimony opposing it...
...The two scientists, Walter Stewart and Ned Feder, had received excellent performance ratings up to then...
...On April 9, only weeks after Shalala's confirmation, two NIH scientists who had accused DeLuca of misconduct and who had criticized Madison's handling of the case were suddenly ordered to discontinue their research on science fraud and were reassigned to other duties...
...C3 The American Spectator January 1994 33...
...by coincidence or otherwise, they first used it at roughly the same time that DeLuca received a manuscript from a journal for peer review—a manuscript in which the Barton-Hesse team presented a similar process...
...Senate Republicans Trent Lott, Charles Grassley, and William Cohen have investigations into the Madison affair underway...
...As DeLuca intended, the investigators provided the material to human patients...
...Madison's troubles began when another group of researchers sued WARF in 1985 for the invalidation of the DeLuca patent on the ground that it had been obtained fraudulently...
...In fact, she had at first flatly refused to provide the notebook at all, and continued for the duration of the case to deflect all efforts by OSI to obtain the notebook for analysis...
...The university lead-ership rejected the panel's initial report, and told the panel it was authorized only to recommend further investigation or to dismiss the charges...
...So far, HHS has refused to cooperate...
...If it was authentic, then his group had used the process before receiving the manuscript...
...As for her refusal to turn over the notebook, Shalala explained that "there was never any attempt on our part not to make the documents available, but we felt very strongly that if they were going to be original documents, we would simplysend someone along...
...Shalala, of course, now directs the entire federal medical establishment, and the enactment of Clinton's health plan would expand her authority even further...
...but with little success...
...Now it is clear that a Clinton cabinet secretary—Health and Human Services secretary Donna Shalala—committed the same offense...
...In 1973, DeLuca claimed that his research group had discovered a process for making a vitamin D derivative called 1-alpha-HCC...
...it gave up on trying to analyze the notebook and closed the case without either accepting or rejecting the panel's findings...
...Finally, in August, the university told OSI it would comply if one of its representatives could accompany the document at all times...
...T his striking turnabout piqued the interest of the Office of Scientific Integrity, the NIH office responsible for investigating misconduct in federally funded research...
...The three panel members (professors of biochemistry, chemistry, and medicine at other schools) took their assignment seriously—too seriously, in fact: The panel concluded that DeLuca had misused information in the Barton-Hesse manuscript and had improperly taken credit for the process...
...Finally, the charges threatened wARF's worldwide patents on 1-alpha-HCC, still worth millions a year...
...The allegations against the researchers were presented by a local attorney hired by Madison...
...David Andrew Price is a writer living in Washington, D. C S halala's role in the story began in January of 1988, just as she was starting her chancellorship...
...The indictment, although later dismissed, was the ideal means for the Democrats to beat back Republican attacks on Clinton's character, and the Clinton camp exploited the charge relentlessly...
...Circumstantial evidence suggested that DeLuca and his team had pirated the work of a rival research team and obtained lucrative patents based on falsified experimental results...
...Regarding the first review panel, Shalala explained that it was supposed to do no more than "identify areas for further investigation...
...WARF also distributed a share to DeLuca and those who worked with him...
...The deputy director of OSI, Suzanne Hadley, continued to press Shalala and vice chancellor Melany Newby for access to the notebook...
...Because the second panel had accepted the researchers' testimony as to when they had received the manuscript, and had accepted the technician's testimony as to his intentions in drawing the diagram, Shalala said she considered the original notebook irrelevant and refused to turn it over...
...But the written notes on the page were arguably inconsistent with the diagram...
...also, OSI's access would be for inspection only—not forensic analysis, which the university said was "for further discussion...
...Howard Rasmussen, a Yale biochemistry professor and a former member of the Madison faculty, wrote Shalala to call her attention to the case of professor Hector DeLuca, a Madison biochemist...
...T his, then, was the situation when Donna Shalala became Madison's chancellor in 1988...
...WARF and the Barton-Hesse group ultimately settled out of court for an undisclosed sum, but further evidence of misconduct by the Madison team emerged during the litigation, including evidence that DeLuca had knowingly sent inadequately tested 1-alpha-HCC material to clinical investigators for human trials...
...T he more recent Senate inquiries into the DeLuca matter were triggered by an unusual personnel action at NIH...
...The situation that Rasmussen described had grown out of a race among research teams to discover and synthesize certain chemical derivatives of vitamin D. DeLuca and his colleagues had determined in the mid-1960s that the human body converted vitamin D into other substances...
...The report also stated that "the Committee cannot exclude the possibility that some 1-alpha-HCC synthesized by Upjohn was also sent to clinical investigators for use in humans," and that a lack of records left the panel unable to determine "whether there was any deliberate serious violation of protocol," In announcing the report, Shalala's vice chancellor for academic affairs, Bernard Cohen, claimed that the reason the panel merely recommended further investigation, instead of reaching a judgment itself, was that it was "unable to resolve" the charges...
...DeLuca's defense was based largely on that notebook entry, which showed a diagram for the disputed process...
...In addition, she may have deceived the Senate as to her role in a possible whitewash of the misconduct charges, which threatened to deprive the university of millions annually in revenues from patents and grants...
...On her second day of hearings, in response to a slow-pitch question from Senator Kennedy, she maintained that "we handled [the DeLuca case] very rigorously...
...The technician who wrote the notebook had testified that he moved a piece of carbon paper through his notebook as he progressed from page to page, thus recording all his notes in duplicate...
...Shalala told the Finance Committee that the Children's Defense Fund, under her chairmanship, had backed the 1988 Family Support Act, a welfare reform measure...
...Although DeLuca told the Food and Drug Administration of his intention to supply clinicians with 1-alpha-HCC that his group would synthesize and test at Madison, lab records showed that DeLuca sent investigators across the country 1-alpha-HCC produced by Upjohn Laboratories—made for animal studies and marked "Not for human use...
...OSI replied that it regarded the negotiations as futile...
...Stranger still, the diagram was Shalala lied about her actions in thwarting a federal investigation of scientific misconduct at the University of Wisconsin at Madison, where she served as chancellor before joining the Clinton administration...
...Virtually all of the communications' from Madison to OSI during this period were either sent by Shalala herself or were sent by Newby with a cc to Shalala...
...HHS has given the senators conflicting explanations of who was responsible for the reassignment and when Shalala knew of it...
...The two were also forbidden, while on official time, from discussing their government-sponsored work of the past ten years...
...In 1989, the university assembled a second panel, consisting of a federal judge on senior status, John Reynolds...
...The episode was a legitimate, and indeed highly relevant, subject for her confirmation hearings: If confirmed, Shalala would not only be responsible for the largest budget of any Cabinet agency, but would also have jurisdiction over NIH, including its investigations of science fraud...
...WARF would eventually receive more than $25 million in royalties on the patent during the 1980s...
...Evidently, someone had turned back to that page on a later date and written in the diagram without remembering to move the carbon paper...
...Accordingly, the panel's final report of November 1988 merely recommended further investigation of the two charges on which it had previously found misconduct...
...The agency insists that no internal documents on the reassignment even exist, an explanation that moved a Lott staffer to remark, "This is the first bureaucracy I've encountered that doesn't keep any paper...
...In mid-April, the university convened a panel of outside scientists to examine the charges...
...The general counsel's office of the agency has refused to comply, except to confirm that the files are still locked away...
...Senator Kassebaum then questioned her more closely about the charges of a cover-up...
...Nor, incidentally, is this the first time Shalala has been said to have prevaricated during her confirmation hearings...
...To be exact, during her Senate confirmation hearings, Shalala lied about her actions in thwarting a federal investigation of scientific misconduct at the University of Wisconsin at Madison, where she served as chancellor before joining the Clinton administration...
...and two outside scientists, Robert Hill of the Duke biochemistry department and John Wiseman of the University of Michigan chemistry department...
...After she finishes that job, she has the right under a special arrangement to return as a tenured professor to Madison...
...In November, the second panel unanimously found the researchers innocent of all charges...
...The_ episode came to the attention of Senator Lott, who wrote Shalala on June 23 to demand that she turn over information and documents about her involvement in the reassignment decision, her involvement in the handling of the DeLuca case when she was at Madison, and the whereabouts of the confiscated files...
...Over the next three months, OSI and Madison played an epistolary cat-and-mouse game over the terms of access to the notebook...
...In our society," she wrote, "the duty and responsibility to determine credibility is with the initial fact-finder, not with those who later dissect the written record for their own purposes...
...WARF paid most of the revenues from the patent to DeLuca's department and to the university...
...A t the eleventh hour of the 1992 presidential campaign, Independent Counsel Lawrence Walsh obtained an indictment against Caspar Weinberger for making false statements to Congress on the Iran-contra affair...
...The charges jeopardized not only the reputation of the department, a longtime leader in vitamin D research, but also DeLuca's eligibility for federal grants, which brought in hundreds of thousands of dollars annually, and a portion of which went directly to the university...
...On May 7, 1990, in a scathing reply, Shalala all but told OSI to drop dead...
...The other research team, led by Sir Derek Barton, a Nobel laureate from Britain, and Robert Hesse, an American, contended that the Madison group had actually never succeeded in producing 1-alpha-HCC with the patented process...
...Under civil-service laws, they cannot be fired outright...
Vol. 27 • January 1994 • No. 1
