http://www.nytimes.com/aponline/national/AP-Hopkins-Drug-Trial.html
|
November 12, 2001 Johns Hopkins Sanctions Scientist
By THE ASSOCIATED PRESS
Filed at 2:38 p.m. ET BALTIMORE (AP) -- Johns Hopkins University sanctioned a researcher who
tested experimental cancer drugs on patients in India without the approval of
a university review board, the school announced Monday. The sanctions, the latest in a series of embarrassments for the university
involving human subjects, were based on the findings of a faculty committee
appointed in July. It investigated a study by Ru Chih C. Huang, a biology
professor in the Krieger School of Arts and Sciences, which is separate from
the medical school. The committee did not find any evidence that patients were harmed. It also
found that Huang did not conduct adequate preliminary tests of the cancer
drugs on animals. The university said it has barred Huang from serving as lead investigator
on future research involving human subjects and mandated that a senior
faculty member supervise her if she participates in any studies on humans led
by other researchers. The committee's report was not made public, university spokesman Dennis
O'Shea said, and Huang was not named in university statements due to a
confidentiality policy. Huang's study was conducted with collaborators at the Regional Cancer
Centre in the southern India state of Kerala. The study, involving 26 oral
cancer patients, ran from November 1999 to April 2000. Researchers tested
whether a chemical derived from the creosote plant could stop the growth of
oral cancer. In July 2001, reports appeared in Indian news media of complaints by
physicians that the trial had been improperly conducted. The doctors reportedly questioned whether researchers had received proper
permission from patients, whether surgery or other treatments were delayed,
and whether the drug had been screened for toxicity. Huang said all the patients consented, and blamed the dispute on confusion
between the chemical used, M4N, and NDGA, a toxic derivative of the creosote
plant. M4N is not toxic, Huang said. She said she did not submit her study to a Hopkins review board because
the research was approved by a similar RCC panel. She said she was not aware
that Hopkins requires internal approval for studies conducted abroad. Huang, a faculty member since 1965, can appeal the decision. In July, federal regulators shut down most human research at the
university for five days after a healthy 24-year-old volunteer died after
participating in an asthma study. In August, Maryland's highest court
criticized a study conducted by the Kennedy Krieger Institute on poor
children exposed to lead-based paint. On Friday, the federal Office of Human Research Protection said the
university's medical school and affiliated institutions should be commended
for changes made since the volunteer's death, but criticized two other
studies. In one study, the regulators said a researcher failed to warn parents
about serious side effects of hormones used in a study on children. In the
other, researchers were criticized for giving cocaine addicts up to $700 to
get them to participate. ^------ On the Net: The Johns Hopkins University: Regional Cancer Centre in Kerala, India: |
||||
|
|
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.