s Hopkins Faults Researcher in Human Drug Trial in Kerala

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http://www.washingtonpost.com/wp-dyn/articles/A18596-2001Nov12.html.]

s Hopkins Faults Researcher in Human Drug Trial

By Shankar Vedantam

Washington Post Staff Writer

Tuesday, November 13, 2001; Page A06

A s Hopkins University researcher testing a cancer drug in India

violated safety procedures, a university investigation has concluded.

As a result, the researcher has been barred from leading any medical

studies involving human subjects in the future, officials announced

yesterday in releasing the results of its investigation.

No one is known to have been harmed by the experiment, but it was

conducted without the school's knowledge or permission and violated

both school policies and federal requirements, school officials said.

In addition, the university had been lax in not launching an

investigation before reports of irregularities appeared in the Indian

media, the report found.

" The whole study was not up to the standard of s Hopkins

University -- it fell far short, " said E. McCarty, dean of

the university's Zanvyl Krieger School of Arts and Sciences.

The researcher failed to get approval from a university panel that

must approve all research to ensure that it is safe, failed to get Food

and Drug Administration approval to export the drug being tested, and had

insufficiently tested the drug's safety by only experimenting in mice

before trying it on people, McCarty and other officials said.

McCarty said that the school had not launched an investigation

earlier because officials did not know the trial was underway.

The trial, which involved more than two dozen oral cancer patients,

was intended to establish the safety of a medicine called tetramethyl

NDGA.

The university did not name the researcher, but biologist Ru Chih

Huang had acknowledged previously that she was the scientist involved. In a

telephone interview last night, Huang defended her study and conduct and

questioned the university's decision to punish her.

Huang said she had believed that only medical school researchers had

to get approval from the university's Institutional Review Board to conduct

a trial. As a scientist who was not directly in charge of patient care,

she thought that approval from Indian authorities would suffice. She also

said the university had been aware of the trial from the start and had

even written two checks funding the trial -- one of which was sent to

India the month before the trial began.

" It's authorized by the dean's office, " she said. " He knew this

before the trial started. "

In an earlier interview, Huang said that the experimental medicine

had been thoroughly tested in dogs, rats, rabbits and mice before the human

trial.

A report by the Indian Medical Association in the state of Kerala,

where the trial was conducted, said that investigators had tracked down

eight volunteers in the trial, none of whom had suffered adverse effects.

The Indian doctors said that although some procedures had not been

followed, there was no evidence that patients had been exploited, misled or

placed at undue risk.

A statement by India's government in September said that contrary to

early reports, the drug used in the trial had not been banned. Although

there was no " violation of human rights, " the statement said " a serious view "

was being taken regarding certain regulatory and procedural lapses.

The university's report was also filed with two agencies at the

Department of Health and Human Services, whose rules may have been violated:

In addition to the FDA, the university also sent the report to the

Office for Human Research Protections, which monitors patient safety in

trials that use federal money.

A small amount of federal money might have been used in the trial,

McCarty said. Huang said she had personally funded much of the trial by

giving a gift to s Hopkins, which then wrote checks to the Indian

institution running the trial. s Hopkins owns the patent on the experimental

chemical, and both the university and Huang would benefit financially if the

chemical was found to be effective and marketed.

Vera Hassner Sharav, president of the patient advocacy group Alliance

for Human Research Protections, said the university report ignored the

institution's own role in permitting the research. She called for an

independent investigation. " Internal self-investigation and self-

regulation does not work, " she said. " The public trust will not be restored with

this kind of self-serving finding. "

Research at s Hopkins has been under heavy scrutiny since an

asthma patient died during a drug trial in June. Federal regulators put all

of the university's 2,200 trials on hold and ordered a review of each.

University officials said yesterday that they had almost completed the reviews.

© 2001 The Washington Post Company

http://www.washingtonpost.com/wp-dyn/articles/A18596-2001Nov12.html.]

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