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Worried about losing on grounds of failure to provide due process, the Department of Health and Human Services replaced OSI with the Office of Research Integrity (ORI) (See Part 6 of this series on Scientific Misconduct in the March, 1993 issue of EMB Magazine at page 132). One of the due process avenues in ORI is the right to appeal misconduct findings to the Health and Human Services Departmental Appeals Board (HHSDAB), where the convicted scientist can introduce his own evidence and witnesses, and cross-examine ORI investigators and their witnesses.

In the year and a half before HHSDAB was created, the government won 16 misconduct cases against scientists. Since then, every scientist who appealed has won, or ORI has dropped the charges.

A few journalists have exploited the situation with sensational headlines such as "SCIENCE AND LAW CLASH OVER FRAUD-CASE APPEALS" and "WHEN SCIENTISTS, LAWYERS ARGUE, JUSTICE IS THE LOSER." By pitting scientists against lawyers, rather than focusing on issues such as the fairness of OSI/ORI misconduct findings and ORI's attack on the HHSDAB opinions reversing them, such articles leave the public with the impression that lawyers are somehow undermining scientific research in a "clash of cultures, in which legal standards of ethics and scientific standards of ethics have collided." (See article by Phillip J. Hilts on page 10B of the Final Late Edition of the November 8, 1993 edition of the New York Times).

Are the lawyers helping the desperados or the innocents?

To answer this question, one needs to look at the facts that led to the four ORI convictions that were reversed by HHSDAB or dismissed by ORI before HHSDAB could hear them. So far, there have been two full opinions issued by HHSDAB explaining reversals (of the convictions of Rameshwar Sharma and Mikulas Popovic) and two dismissals (of the convictions of Margit Hamosh and Robert Gallo). Were the reversals based on technical (procedural) grounds, or did the ORI fail to prove that there was misconduct?

The first reversal was of ORI's misconduct finding against Rameshwar Sharma for making an incorrect statement in a NIH grant application. According to an article bylined by Malcolm Gladwell on page C-1 of the November 14, 1993 final edition of the Washington Post, Dr. Sharma's application involved 2 proteins, which he referred to 130 times in the 50-page application. After programming two adjacent keys on his computer with a macro to type the names of these proteins, "ALPHA-2A" and "ALPHA-2GC," Dr. Sharma and his wife typed his application. On page 24, one of them hit the wrong key and typed "ALPHA-2GC" instead of "ALPHA-2A." Since the accompanying discussion was obviously about ALPHA-2A, the NIH peer review panel assumed that the reference to ALPHA-2GC was a typo. But ORI found Dr. Sharma guilty of misconduct, reasoning that since he had not done much work yet on ALPHA-2GC, and ALPHA-2GC was a more complex molecule than ALPHA-2A, Dr. Sharma was misrepresenting the state of his research to enhance his prospects of getting the NIH grant. Dr. Sharma had the opportunity--for the first time--to cross-examine his accusers and present his side of the story when he appeared before HHSDAB. Dr. Sharma's panel reversed his conviction because there was no evidence to suggest that this was, in fact, his motive.

Would the community of science researchers find differently from the lawyers on Dr. Sharma's review panel?

A review panel didn't have the opportunity to reverse ORI's misconduct finding against Margit Hamosh because, after a 3-year battle, ORI dropped the charges just before her appeal would have been heard. According to the Gladwell article, the misconduct finding against Dr. Hamosh was based on the first half of a sentence at the end of a 20,000-word grant application, to wit, "Last, but not least, we are presently using the newborn rabbit as an animal model for total parenteral nutrition (TPN) ...." It turns out Dr. Hamosh was poised to use the rabbit model in specific experiments, but did not actually have experiments up and running. The 3-year debate was whether "presently using" in the context used by Dr. Hamosh in her grant application meant "up and running" or "putting into service."

A panel did hear the appeal by Mikulas Popovic, the man credited with doing the experiments that made development of the AIDS blood test possible. According to the Gladwell article, the most serious charge against Dr. Popovic was that he had used the letters "ND" in a chart to indicate that he had not done experiments that he had in fact attempted to do with inconclusive results. Popovic's explanation was that his ND's were intended to mean "Not Determinable," but were incorrectly defined as "Not Done" by an English-speaking editor of his manuscript, and he didn't catch the error. The manuscript was published in 1984 when Dr. Popovic was a recent Czech emigre who didn't speak English very well. 10 days before the Gallo appeal was to be heard, Dr. Popovic's review panel reversed his conviction. According to the Gladwell article, "...in a blistering opinion, the panel completely exonerated [Dr. Popovic]. 'One might anticipate from all this evidence, after all the sound and fury, that there would be at least a residue of palpable wrongdoing,' the opinion said. 'That is not the case.'"

Would the community of science researchers find differently from the lawyers on Dr. Popovic's review panel?

After this setback, ORI dropped its charges against Robert Gallo. What was the case against Dr. Gallo? The controversy began in 1984 after Dr. Gallo and his colleagues published a series of articles--some of which are widely considered to be amongst the most important in virology--that identified and proved that a specific virus was the cause of AIDS. Shortly afterwards, Dr. Luc Montagnier and his co-workers at the Pasteur Institute claimed that the virus identified in the Gallo lab (HIV) had actually been isolated earlier in their lab in France (LAV), and that the Americans were falsely claiming credit for the discovery. The issue was supposedly settled in 1987 with agreement to recognize Drs. Gallo and Montagnier as co-discoverers of the AIDS virus and share royalties from the patent of an AIDS blood test developed in Dr. Gallo's lab with the French.

In 1989 charges were filed against Drs. Gallo and Popovic by OSI. In December, 1992, ORI found Dr. Gallo guilty of failing to give proper credit to other researchers, for restricting distribution of a cell culture, and for making a misstatement in a science publication. According to the Gladwell article, the misstatement charge came down to the meaning of a clause in a sentence in the 1984 paper explaining how the Gallo lab figured out how to mass-produce HIV--the first step in the development of the AIDS blood test. Dr. Gallo was comparing data from his lab on its strains of HIV with data published a year earlier on the virus the researchers at the Pasteur Institute called LAV. After noting that, based on the descriptions of HIV and LAV in the two papers, the viruses looked different, Dr. Gallo states, "it is possible that this is due to insufficient characterization of LAV because the virus has not yet been transmitted to a permanently growing cell line for true isolation and therefore has been difficult to obtain in quantity." According to the Washington Post article, Dr. Gallo says he meant that "the two viruses may in fact be exactly the same. The only reason the French data look different is that, since the French could not grow their virus as completely as we did, they couldn't describe it properly." However, when ORI discovered that LAV had in fact been grown in Dr. Gallo's lab, it concluded that Dr. Gallo had made a false statement in his publication to the effect that no one could grow LAV.

Now, according to an Associated Press article bylined by Paul Recer, the Pasteur Institute has hired a New York law firm to attempt to revise the 1987 agreement, so we can expect to hear more about the Gallic-Gallo dispute.

Congressman Dingell's comments in the Shattuck Lecture about Dr. Sharma's case amount to a claim that the Cleveland Clinic's "ready exoneration" of Dr. Sharma occurred because of an inadequate investigation by Dr. Bernadine Healy at the clinic. Dr. Healy, of course, subsequently became director of NIH, where, according to Congressman Dingell, "her early actions in that post were efforts to undermine the Office of Scientific Integrity and compromise its independence...." With respect to Dr. Gallo, Congressman Dingell is puzzled and troubled by "a large number of unusual circumstances that [Dr. Gallo] claims are misunderstandings and coincidences." In the Shattuck Lecture Congressman Dingell points out, for example, that Dr. Zaki Salahuddin, "one of [Dr. Gallo's] longtime laboratory scientists," was convicted of a felony in connection with "his activities at Dr. Gallo's laboratory." And that, "In short order," Dr. Prem Sarin, Dr. Gallo's deputy laboratory chief, was indicted for activities "also stemming from work at the laboratory." Commenting on the fact that OSI had found Dr. Gallo "innocent of fraud or serious misconduct," despite the Congressman's "serious questions" about such a finding, Representative Dingell wonders aloud, "We understand that the NIH itself receives millions of dollars each year in the royalties from the blood test, but that should be no impediment to its assessing the charges against Dr. Gallo objectively." Half year later ORI made the Congressman's day by finding Dr. Gallo guilty as described above.

Yes, there were communists in the state department, but the greater threat to the Republic was Joe McCarthy.




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