UCLA Researcher Violated Federal Rules_LAT

Thu, 17 Apr 2003

The Los Angeles Times reports (below) that a UCLA research oversight board (a.k.a. IRB) found that a microbiology professor had violated federal regulations and UCLA policy for the protection of human subjects by evaluating data and biological samples brought to the university by a Chinese scientist, without seeking the board’s approval.

The controversial, unapproved experiment sought to find out if injecting malaria-infected blood into AIDS patients in China will cure AIDS. This speculative, high risk experiment was initiated by Dr. Henry Heimlich (of Heimlich maneuver fame). It has been criticized by the Center for Disease Control, the Food and Drug Administrating and has been characterized by scientists as a medical “atrocity.”

The risks of harm–compounding the effects of one debilitating disease with another–are not speculative. The speculated benefits have no scientific basis.

Although UCLA took pains to describe Dr. John Fahey’s involvement as “indirect,” Dr. Heimlich’s website credits UCLA for its support of the research, and the Cincinnati Enquirer reported that Dr. Fahey met with the Chinese scientist who conducted the experiment in China. See: https://ahrp.org/infomail/0203/17.php

UCLA’s efforts to distance the university from a controversial human experiment that fails to meet medical ethics standards, and would not have been approved by UCLA’s IRB, is understandable. However, the university cannot simply brush off its institutional responsibility. That responsibility includes ensuring that the university culture does not encourage its faculty to provide direct or indirect assistance to those who conduct unethical human experiments.

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http://www.latimes.com/la-me-malaria16apr16,0,650344.story
Researcher Violated Rules, UCLA Says

By Rebecca Trounson and Charles Ornstein
Times Staff Writers

April 16, 2003

A UCLA medical oversight board has found that a researcher violated federal rules by taking part in controversial medical studies in which AIDS patients in China were injected with malaria-infected blood.

The university said Tuesday that the oversight board has determined that microbiology professor John L. Fahey was indirectly involved with the experiments, which seek to use the immune reaction induced by malaria as a possible treatment for AIDS.

The research effort was sponsored by Dr. Henry Heimlich, founder of the Heimlich Institute and creator of the anti-choking maneuver that bears his name. The malaria studies are regarded with skepticism by many AIDS researchers, who said the therapy could harm already ill patients by infecting them with another potentially deadly disease.

A statement issued by UCLA’s institutional review board, which reviews medical experiments involving human subjects, found that Fahey did not participate directly in the controversial trials, but did, without requisite permission from the board, evaluate data and biological samples brought to the university by a Chinese scientist.

University administrators will review the findings to determine whether discipline is required, UCLA spokesman Max Benavidez said.

A second UCLA researcher, Najib Aziz, who was included in the board’s investigation, was not found to have broken any rules, Benavidez said. Aziz was working “under Dr. Fahey’s purview,” the spokesman said.

In a statement Tuesday, Fahey said he “regrets the misunderstanding this matter has caused.” He said he became indirectly involved in the so-called malariotherapy research in 1997, when he was training a Chinese scientist, Xiao Ping Chen, during a three-month program at UCLA. At that time, Chen was testing blood serum that was collected several years earlier from patients he had treated in China with malariotherapy.

Fahey said that was “the only time specimens from malariotherapy patients were at UCLA.”

Heimlich, however, appeared undeterred by the controversy. He recently announced that he is working with doctors to begin human tests of the therapy in five African nations.

In a statement e-mailed to The Times on Tuesday, he said that available data “indicates that malariotherapy offers a safe, promising and inexpensive way to help the millions of people suffering from AIDS throughout the underdeveloped world.”

He said he was “not aware if Dr. Fahey followed the proper procedures” in his work at UCLA. “That is between Dr. Fahey and UCLA,” Heimlich said.

On his institute’s Web site, Heimlich has credited UCLA for its support of the research.

Chen participated in 1997 in the UCLA/Fogarty AIDS international training and research program, which provides training in AIDS control to visiting scholars from developing countries. Fahey then visited Chen and other Fogarty scholars in China in 1998, but did not participate in their research, UCLA officials have said.

That November, according to e-mails obtained by the Cincinnati Enquirer and first reported in February, Fahey wrote to Chen to thank the Chinese researcher for sharing his data during the visit.

In the announcement Tuesday, UCLA’s review board said Fahey had violated federal regulations and UCLA policy for the protection of human subjects by not seeking approval from the university before allowing Chen to conduct research at UCLA.

“The feeling here is that Dr. Fahey made an honest mistake,” said Steven Peckman, UCLA’s associate director for human subjects research.

“He has provided substantial assurances of his compliance in the future,” Peckman said.

In the statement Tuesday, the university reiterated that UCLA “has never approved any research pertaining to malariotherapy studies for HIV,” the virus that causes AIDS.

Copyright 2003 Los Angeles Times

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