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Harvard Cancer Unit Cited for Faulty Research

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Times Medical Writer

After reviewing a widely publicized case of apparent scientific fraud, the federal government has found evidence of “serious misrepresentations” of data and shoddy research practices at Harvard Medical School’s Dana Farber Cancer Institute.

The National Institutes of Health recommended in late January that Italian researcher Claudio Milanese be barred from receiving federal funds because he fabricated a 1986 report about a “new” immune system molecule that turned out not to exist, according to documents obtained by The Times last week under the federal Freedom of Information Act.

In addition, the federal agency and Harvard officials have issued a stern reprimand to Dr. Ellis L. Reinherz for inadequate supervision of Milanese in Reinherz’s laboratory. They have announced plans to closely monitor all research performed under Reinherz’s supervision.

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When the “discovery” of “interleukin-4A” was reported in Science magazine in March, 1986, news stories hailed the substance as a crucial missing link in the body’s ability to fight disease. The molecule appeared to be related to interleukin-2, which is being used experimentally to treat cancer patients.

After the paper was published and Milanese returned to Italy, Reinherz and other researchers continued to study the new molecule. By November, they became convinced that Milanese had made up the data, which Milanese eventually conceded. The Science paper and several others had to be retracted.

A Harvard investigating committee found that Milanese pulled off his deception because his raw data was never reviewed and because the “data” fulfilled Reinherz’s expectations about the size and shape of the non-existent molecule.

“The conviction that the (interleukin-4A) story was correct was so strong in the laboratory that it actually eliminated a climate of skepticism and led to a failure to scrutinize Milanese’s data,” the committee concluded.

Dr. James B. Wyngaarden, director of NIH, praised Reinherz for discovering the fraud, adding “we have no reservations about your integrity as a scientist.” But he underscored his concerns about “deficiencies of supervision and quality control.”

Harvard officials said Reinherz “must shoulder most of the responsibility” for allowing the results to be portrayed “as a major advance before they were adequately confirmed in the laboratory.”

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In a four-page response to the Harvard investigating committee, Reinherz acknowledged responsibility, stating, “I am truly distressed at the dishonor brought to our scientific community.”

After discovering the fraud, Reinherz said, he changed lab procedures to prevent recurrence of the problem. New procedures include better record-keeping and “assistance from outside laboratories in repeating critical experiments of key findings.”

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