InfoMail for April 10a, 2002

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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

April 10a, 2002

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

FYI

Harvard University is not the only one exploiting China’spoor population for medical experiments. Violations of human rights in clinicalresearch are being brought to public attention by the press.  Below, TheWall Street Journal reports from Beijing that U.S. biotech start-upcompanies are conducting cheap "preliminary studies" using Chinesepeople like trial balloons: "Before we invest $20 million we want to makesure it works," says NexMed Chief Executive Joseph Mo, who estimates that apreliminary study that costs $20,000 in China might run as much as $4 million inthe U.S. "For a big company it’s nothing," he says, "but for usit’s a lot of money."

SCIENCE reports additional facts from the ongoing federalinvestigation by the Office of Human Research Protection (OHRP). Science reportsthat OHRP found discrepancies between the number of subjects approved byHarvard’s  review board  (IRB) and the number of subjects reported byHarvard’s investigators in published articles.  While universityofficials attempt to brush off the violations cited by OHRP claiming they have"already tightened their procedures", OHRP officials say the caseremains open.

We don’t believe that human rights violations should be trivialized bypretending 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 rightsof  subjects," says Vera Hassner Sharav, director of the New YorkCity-based Alliance of Human Research Protection, a private activist group thathas followed the  issue closely."

Dr. Gwendolyn Zahner, a former Harvardresearcher who brought the original complaint, told SCIENCE she ishappy that OHRP has examined her allegations but chides it for not looking "beyond [the] paperwork." Dr. Zhaner said, "investigators need tovisit 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 otherU.S. institutions to task for their handling  of research studies involvingrural Chinese subjects. University officials insist they have already tightenedtheir procedures, but the
U.S. Department of Health and Human Services has asked for more information onwhether researchers failed to obtain informed  consent in advance,backdated documents, and misled investigators about the number of peopleinvolved in the studies.

The department’s Office for Human Research Protections (OHRP) began its inquiryin 1999 after a Harvard School of Public  Health researcher filed acomplaint alleging that two occupational epidemiologists at the school, XipingXu and David Christiani,  had taken advantage of Chinese subjects in ruralAnhui Province, where they conducted a variety of genetic and environmentalstudies. The department’s first public comment about its continuing probeappeared in the form of letters to Harvard, Brigham  and Women’s Hospital,and Massachusetts Mental Health Center, dated 28 March, that outline thegovernment’s concerns and  ask for more information.

The letter to Harvard does not draw any conclusions but questions whether somesubjects were enrolled in investigations before they signed informed consentdocuments. It also notes that "the handwriting for the dates next to thesubject’s signatures appear to be identical," indicating that either thesubjects–even those who  could write–did not do the dating or that thedocuments may have been backdated. The letter also cites a large discrepancybetween a report to OHRP and a  journal article on the number of womenenrolled in one particular study. Harvard has until 10 May to respond.

OHRP notes that the institutions have made strides in correcting the apparentproblems, and Xu says the investigation has "improved our protection ofhuman  subjects in China." A Harvard statement points to the"complex and difficult … ethical and cross-cultural issues" ininternational research, adding that the university  has beefed up itsmonitoring staff. It has also formally reprimanded Xu and Christiani and placedtheir work under greater scrutiny.

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

Harvard officials insist that OHRP has accepted its action plan and that thematter is largely laid to rest. But OHRP officials say the case remains open.Former  Harvard researcher Gwendolyn Zahner, who brought the originalcomplaint, says she is happy that OHRP has examined her allegations but chidesit for not looking  "beyond [the] paperwork." Investigators needto 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 totest new drugs, drawn by increasing local expertise, lower costs and anabundance of patients among a huge population that has never been treated f! ormany illnesses.

In July, NexMed Inc., a start-up based in Robbinsville, N.J., launched trials inChina 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 affordabilityof conducting research trials on large numbers of patients in China. The companyis using the findings from its studies to help shape research on the productback in the U.S., where testing is still going on.

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

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