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Commentary by Vera Hassner Sharav

April 10a, 2002

U.S. Bio-Tech Start-ups Conducting Cheap Preliminary Studies in China

FYI

Harvard University is not the only one exploiting China's poor population for medical experiments. Violations of human rights in clinical research are being brought to public attention by the press. Below, The Wall Street Journal reports from Beijing that U.S. biotech start-up companies are conducting cheap "preliminary studies" using Chinese people like trial balloons: "Before we invest $20 million we want to make sure it works," says NexMed Chief Executive Joseph Mo, who estimates that a preliminary study that costs $20,000 in China might run as much as $4 million in the U.S. "For a big company it's nothing," he says, "but for us it's a lot of money."

SCIENCE reports additional facts from the ongoing federal investigation by the Office of Human Research Protection (OHRP). Science reports that OHRP found discrepancies between the number of subjects approved by Harvard's review board (IRB) and the number of subjects reported by Harvard's investigators in published articles. While university officials attempt to brush off the violations cited by OHRP claiming they have "already tightened their procedures", OHRP officials say the case remains open.

We don't believe that human rights violations should be trivialized by pretending it's only a matter of record keeping. As we told SCIENCE: "the problems with the research involve more than lax record-keeping. "This is a blatant and massive institutional violation of the human rights of subjects," says Vera Hassner Sharav, director of the New York City-based Alliance of Human Research Protection, a private activist group that has followed the issue closely."

Dr. Gwendolyn Zahner, a former Harvard researcher who brought the original complaint, told SCIENCE she is happy that OHRP has examined her allegations but chides it for not looking "beyond [the] paperwork." Dr. Zhaner said, "investigators need to visit China to find out what really happened."

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www.sciencemag.org
SCIENCE
April 5, 2002 vol.296, p.26

BIOETHICS:
U.S. Questions Harvard Research in China

Andrew Lawler

BOSTON--Government investigators last week took Harvard University and two other U.S. institutions to task for their handling of research studies involving rural Chinese subjects. University officials insist they have already tightened their procedures, but the
U.S. Department of Health and Human Services has asked for more information on whether researchers failed to obtain informed consent in advance, backdated documents, and misled investigators about the number of people involved in the studies.

The department's Office for Human Research Protections (OHRP) began its inquiry in 1999 after a Harvard School of Public Health researcher filed a complaint alleging that two occupational epidemiologists at the school, Xiping Xu and David Christiani, had taken advantage of Chinese subjects in rural Anhui Province, where they conducted a variety of genetic and environmental studies. The department's first public comment about its continuing probe appeared in the form of letters to Harvard, Brigham and Women's Hospital, and Massachusetts Mental Health Center, dated 28 March, that outline the government's concerns and ask for more information.

The letter to Harvard does not draw any conclusions but questions whether some subjects were enrolled in investigations before they signed informed consent documents. It also notes that "the handwriting for the dates next to the subject's signatures appear to be identical," indicating that either the subjects--even those who could write--did not do the dating or that the documents may have been backdated. The letter also cites a large discrepancy between a report to OHRP and a journal article on the number of women enrolled in one particular study. Harvard has until 10 May to respond.

OHRP notes that the institutions have made strides in correcting the apparent problems, and Xu says the investigation has "improved our protection of human subjects in China." A Harvard statement points to the "complex and difficult ... ethical and cross-cultural issues" in international research, adding that the university has beefed up its monitoring staff. It has also formally reprimanded Xu and Christiani and placed their work under greater scrutiny.

But others say the problems with the research involve more than lax record-keeping. "This is a blatant and massive institutional violation of the human rights of subjects," says Vera Hassner Sharav, director of the New York City-based Alliance of Human Research Protection, a private activist group that has followed the issue closely.

Harvard officials insist that OHRP has accepted its action plan and that the matter is largely laid to rest. But OHRP officials say the case remains open. Former Harvard researcher Gwendolyn Zahner, who brought the original complaint, says she is happy that OHRP has examined her allegations but chides it for not looking "beyond [the] paperwork." Investigators need to visit China, she says, to find out what really happened.

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China's Pool of Patients Lures Start-Ups Doing Clinical Trials

Wall Street Journal; New York, N.Y.; Apr 9, 2002;
By Leslie Chang

Edition: Eastern edition; Start Page: D12; ISSN: 00999660

Full Text: Copyright Dow Jones & Company Inc Apr 9, 2002

BEIJING -- A growing number of pharmaceutical start-ups are coming to China to test new drugs, drawn by increasing local expertise, lower costs and an abundance of patients among a huge population that has never been treated f! or many illnesses.

In July, NexMed Inc., a start-up based in Robbinsville, N.J., launched trials in China for a cream to treat impotence. The appeal wasn't the China market itself -- whose total sales are a sliver of the global market -- but the affordability of conducting research trials on large numbers of patients in China. The company is using the findings from its studies to help shape research on the product back in the U.S., where testing is still going on.

"Before we invest $20 million we want to make sure it works," says NexMed Chief Executive Joseph Mo, who estimates that a preliminary study that costs $20,000 in China might run as much as $4 million in the U.S. "For a big company it's nothing," he says, "but for us it's a lot of money."

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