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Chinese farmer victims question traumatizing Harvard projects
( 2003-10-07 16:01) (Xinhua)

Eight years since Zhang Daniu's narrow escape from death after having the first and only "physical checkup" in his life, he still keeps asking when he can get his free treatment as promised by the "checkup" organizer, a Harvard institution sponsoring human genetic research projects.

The 55-year-old farmer of Zongyang County, Anhui Province in east China, said his illness worsens in the rainy season, and he has trouble sleeping.

Zongyang, under jurisdiction of Anqing City, was a site for Harvard genetic projects, including one on asthma co-funded by the United States' National Institutes of Health (NIH) and Millennium Pharmaceuticals, a biopharmaceutical company based in Cambridge, Massachusetts.

Zhang Daniu, an asthma sufferer for well over 20 years, had a clear memory of what happened in the "checkup."

He recalled being out of breath and losing consciousness after he was told to inhale a spray of a "fog-like" agent, "contained in a plastic bottle that looked like a mosquito killer sprayer."

Both illiterate, Zhang and his wife, a full witness of the entire "checkup," never saw or heard of any "informed consent agreement," nor did they sign any document.

They were not told that their blood samples were to be used in the Harvard project. This malpractice was inconsistent with the ethical principles the Harvard institutions commit themselves to observing.

In "multiple project assurances" submitted to the US government to secure research funding, the project managers pledged to follow the same principles regarding all research involving humans as subjects.

These include, "to provide a copy of the IRB-approved (IRB - the institutional review board) and signed informed consent document to each subject at the time of consent," and "promptly report to the IRB any injuries or other un-anticipated problems involving risks to subjects and others."

Harvard President Lawrence Summers admitted at Beijing University in May 2002 that the Harvard genetic projects in China "were wrong" and "badly wrong." Yet a year later, he claimed to be "gratified" to learn that "the inquiry revealed no substantive harms done in our study and that all procedural concerns raised have been fully addressed."

Ironically, Zhang Daniu's collapse and unconsciousness for at least eight hours after inhaling chemicals for the Harvard asthma genetics study has never been reported, let alone "promptly" or " fully addressed."

Asthma is only one of more than a dozen projects drawing the Harvard research team to sample Chinese farmers' blood for genetic screening to find hereditary links to disease including hypertension, obesity, diabetes and osteoporosis.

All this was unknown to the Chinese who received the so-called "checkup." None of them has benefited in any way from their participation, not even from the "medical advice" that Xu Xiping, associate professor of the Harvard School of Public Health (HSPH) and the principal investigator, promised to offer in his application to the government.

Zhang Funian, a village medic in Lianhu township near the county seat of Zongyang, was ordered in the 1995 "checkup" program to produce a list of asthmatic patients and their family members in the village and take them to the county station for epidemic prevention and control "one day around the time the early rice came out in 1995."

"We were told the checkup would benefit them, and free medical treatment would be offered," recalled the 52-year-old medic.

"None of the farmers was told of the procedures and results of the checkup, or saw an informed consent form," said Zhang, who began offering medical services in the village since 1969 after some basic medical training.

After the Harvard projects were challenged for their ethical problems, the US government began to investigate in 1999. The investigations did find a"breadth and seriousness of violations" of ethical principles in the Harvard Anhui projects.

Under standing rules of the US Public Health Service, materials and samples for research shall be obtained only after the human subject volunteer receives "full and complete disclosure of risks associated with the applicable procedure and benefits derived."

But neither Zhang Daniu the farmer nor Zhang Funian the village medic in Zongyang County could recall ever being told of anything about the required informed consent. Xu Xiping and his Harvard collaborators explained the research purposes and procedures in far greater detail to the US investigators than to the Chinese farmers.

However so far no remedial measures have been offered to Zhang and other Anhui farmers who were unknowingly victimized in the projects. Questions remain as the US government investigation relied on field trips made by Harvard faculty members. The latest of such trips was made by Troyen Brennan, head of the HSPH's IRB, who is a leading physician at the Harvard-affiliated Brigham and Women's Hospital, in addition to his teaching and administrative responsibilities at HSPH.

But does Troyen Brennan speak Chinese? Did he communicate directly with the Chinese farmers involved in the research in their mother tongue? If not, who served as his interpreter? Who arranged his visits and interviews in China? Which sites did he go to? How did he confirm that the consent forms were signed by the research subjects? These questions passed to this physician and lawyer by email, however, were all passed to Robin Herman, HSPH's communications director.

No answer came from Brennan, and Herman cites nothing more than an official statement her school released after OHRP (the Office for Human Research Protections) concluded its inquiries to the Harvard projects on May 30, which does not address any of the above questions.

The OHRP conclusion came in a letter dated May 2, 2003, which " acknowledges" all the Harvard's "corrective actions" that have never been made known to the Chinese farmers and claimed "there should be no need for further involvement of OHRP in this matter."

Despite Zhang Daniu and his countrymen's testimony of their ignorance of the Harvard projects, the HSPH statement claimed that "participants gave voluntary, informed consent." Despite Zhang Daniu's collapse, HSPH Dean Barry R. Bloom is quoted as saying, " Harvard seeks to ensure the highest level of protection of human subjects in all its work" and "no individual participant had been harmed and no willful violations of human subjects procedures took place."

Zhang Daniu still looks forward to the promised medicine, while many questions linger on in the mind of the village medic Zhang Funian. "I know no reply to them," he said. "I wish I had studied in Harvard for the answer.

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