In April of 2005, Margaret Sleeboom from the University of Amsterdam published a paper on PubMed.gov concerning a Chinese research project by Harvard University which drew international condemnation for Harvard's appalling lack of ethics in the theft of Chinese DNA. (1) (2)
Years after completion of this research, when the details were leaked to the media, Chinese authorities were furious to learn that Americans had engaged in an underhanded and secret project to collect Chinese DNA. Even though the Chinese government had previously prohibited the collection or export of any such data, Harvard eluded the prohibitions and slipped the DNA out of China.
One of the leaders of this project was a Chinese Harvard researcher Xu Xiping who, with financing from the US government (most likely the military's DNA database project) and Millennium Pharmaceuticals (3)(4)of the US, conducted this study in Anhui with Frank Speizer and Scott Weis, the latter a Harvard epidemiologist who apparently had access from an unknown source to information on about 60 million people in Anhui. Xu, who came from Anhui and still maintained contacts there, conspired with Weis and the financiers to recruit thousands of volunteers to collect the DNA and blood samples, all unknown to China's central government. Millennium was closely related to the US Defense Department and was paying millions of dollars for the study and its data.
•The Harvard University Experiment
Xu and his collaborators submitted "project assurances" to the US government to adhere to all regulations on human research, including "to provide a copy of the (Chinese) IRB approval", as well as consent documents signed by each subject, and to "promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects and others". A letter of explanation of the study was to be sent to each family, on which the consent form would be based.
Xu enlisted the cooperation of low-level local officials in Anhui Province to conduct what he termed a study of asthma prevention and control. The officials were to instruct local medics to deliver all residents to the nearest medical facility where they would receive a free medical examination and free medication to treat any conditions discovered.
This was a complex medical experiment involving exposure to a potentially lethal pathogen as well as the collection and shipment to the US of hundreds of thousands of vials of Chinese DNA, but the victims were not informed of either aspect. The revelation was from the result of an investigation in 2003 by Xiong Lei and Wen Chihua from the China Daily, who travelled to the locations in Anhui where Harvard and Xu conducted their study, and interviewed the local subjects and medics who participated. Xiong and Wen reported: (5)
"Zhang Da'niu, a 55 year-old farmer who had been an asthma sufferer for more than 20 years, told the China Daily that he was approached one day by a local official who asked him to travel to the local hospital for "a free physical check-up", claiming he was also assured that he would receive free medicine if any medical condition were discovered as a result. The man and his family attended the hospital as requested. The unidentified attending physician, who was not local, asked Zhang to open his mouth then gave him a spray of what Zhang described as "a fog-like agent" from what looked like "a mosquito killer sprayer". He immediately found himself unable to breath, lost consciousness, and entered an apparent coma for more than eight hours. His wife was certain he was dead."
The physicians apparently panicked and gave him an unidentified injection, but he claims he received no further treatment or medical assistance after he regained consciousness, and was simply told to return home in spite of being weak and obviously quite ill. The physicians promised to send medicine, but he says it never arrived, and his condition is now poor and deteriorates with the seasons. Zhang claims no one ever informed him of the results of any "check-up", nor was he told of the purpose of the blood samples taken. He says he neither saw nor signed any consent form and had no further knowledge.
"One of the village medics said he understood that the so-called check-up was part of a research project for an American university, and told China Daily he and his colleagues were told to notify any villagers with asthmatic symptoms to come to the hospital for a physical examination. He says he was told this was solely for the patient's benefit and that free medical treatment would be offered to any who needed it. He said he was "not without misgivings about the project as it involved an American institution", but says he dismissed his doubts "since it seemed to be authorized" by higher authorities. He was ordered to produce a list of asthmatic villagers and to bring them and their families to the county health station "for epidemic prevention and control". He said he did not witness any of the actual "check-ups" and has no idea if they ever occurred. He said to his best knowledge none of the farmers were informed of the procedures they would encounter, nor were they given any information as to the results of this so-called physical examination. He also claimed that he never saw any consent forms and that as far as he knew none of the farmers had seen one either, and further both Zhang and the medic stated firmly that the topic of "informed consent" or the completion of any related forms had never even been raised.
The Chinese victims interviewed by China Daily exhibited no understanding of anything in this process. Specifically, Zhang Da'niu and his wife claimed to have never either seen or heard of any 'consent agreement', nor did they ever sign or otherwise annotate any forms of any kind. Neither had any idea their blood samples would be sent to the US for use in genetic research experiments. Neither had ever heard of a University named Harvard. Neither received the 'free checkup' for which they were told to report, and neither received the 'free' medical treatment they had been offered."
Xu and Weiss claimed that a letter explaining the study was sent to each eligible family, but no evidence of such letters have ever been located and no subjects have confirmed the receipt of such a letter. Xu also claimed that each and every subject received a full explanation of the study and, based on that, had signed a voluntary consent form, but again no record of such forms has been found. Moreover, Xu and his colleagues were under ethical and US government legal compulsion to report injuries or risks to subjects, but Zhang had instantly collapsed and remained in a coma for more than eight hours after inhaling chemicals given to him, and his case was never reported at all, much less "promptly".
When Xu was questioned whether he had obtained Chinese official approval for his study, he disclaimed ownership or responsibility, claiming it was "a pilot project launched by Chinese investigators" in cooperation with China's IRB, rather than having been initiated by Harvard and Millennium Pharmaceuticals. However, according to an official Chinese police investigation, the claimed 'Chinese investigators' did not exist. Also, Xu claimed to have collaborated with, and had received permission from, the "Anqing Medical Human Subjects Committee" in Anhui, in July 1994, but no such committee had ever existed. One local health official said he had "never heard of such a thing", and another official of the local Medical Society said there was not, and had never been, any such organisation.
Xu and Weiss began conducting their human experiment and collecting DNA but when their actions became publicly condemned and their facts questioned, Xu and Weiss published a retraction, saying they "incorrectly stated" that their study began on July 1994 when it actually began in 1995 "after obtaining local Chinese IRB approval". Xu and Weiss began their study long before their fictional approval was obtained from a non-existent organisation. Other writers noted that the same issue of the same medical journal in which this admission was made, also carried similar "corrections" for seven other scientific research articles written by Xu and Weiss, all retracting the earlier dates of the actual commencement of the study and re-stating them to coincide with apparent later IRB 'approvals'.
All tangible evidence indicates, however, that Xu Xiping forged documents, backdated forms, and commenced his collection without approval, and it appears no official approval had ever existed. It seems everything he did was illegal. Some treatises have been written on this event, e.g. Pomfret & Nelson, 2000 (6) (7) (8) (9), Tao & Li, 2001, which you may wish to reference.
•What Really Happened?
It appears Xu took advantage of his experience and his position, his knowledge of China and his Anhui roots, and of the lack of sophistication of a poor and backward province, to perform an illegal and unapproved medical study, with reasonable expectation of confining knowledge of his activity to the local counties, then escaping to the US with a treasure trove of Chinese blood and DNA samples. All evidence suggests his intention was to conduct this privately, unknown to higher authorities and to China's central government. There is no evidence that the free medical examinations or medications promised to the locals were actually provided; rather, it appears he used those promises as bait to lure his victims.
The record indicates that no medication, even that which was necessary to treat victims for the potentially-lethal results of the tests, was provided to anyone. There is no indication from the facts available that any kind of actual physical check-up was ever performed or ever intended to be performed, which means the entire story was a lie.
While it is not known how Xu obtained his attending physicians who performed the tests, it appears they were testing the efficacy of one or more pathogens known to cause violent asthma attacks, with Harvard, Xu, and other US government agencies later correlating those sensitivities with Chinese blood types and DNA samples. Clearly, the purpose of the unidentified spray was to observe the immediate impact on the victim – in so far as there were no arrangements for patient follow-up - but the severity of the instant comas was apparently unexpected. The one patient identified here, received emergency treatment and did not die, but there is no easy way now to know how many similar emergencies actually occurred, nor whether any deaths resulted from the application of these pathogens to the victims - nor indeed the extent of any longer-term impact.
Given the backwardness of the area and the general lack of sophistication in rural Anhui, it is easily possible that deaths, serious injuries and chronic medical conditions occurred which were either attributed to other causes or were otherwise masked and buried. It is likely a statistical improbability that only one person would be placed into such critical distress as to immediately enter a coma state upon the administration of a pathogen, if hundreds of thousands of individuals are being tested. Further, no Chinese medical staff were located who had actually seen the tests or "examinations" administered. Given that Xu and his colleagues failed to inform the authorities about Zhang's case, we are safe in assuming that all other such cases also went unreported. And if Xu would fail to report a critical event like instant unconsciousness or a coma, he would almost certainly have better cause in failing to report more serious events. It would seem clear that if Xu weren't fully aware of the potential for death or serious injury prior to the effects on Mr. Zhang, they were certainly aware after that, and the facts available tell us that no follow-ups were ever done. This also raises a serious question about whether the tests were terminated at that point, or continued, since there are records of similar experiments conducted in Georgia, where the Russian authorities terminated the experiments after deaths occurred.
In her research paper, Margaret Sleeboom wrote that this was a perfect story of
"how an American exploited the vulnerability and gullibility of a backward population in the desolation of mountainous Anhui province", and noted that Xu's arguments were of "the project's merits to patients in wealthy countries, not to those in China".
•Denial, Lies and Cover-Up
When the news of this medical travesty became public, Xu and Harvard became the subject of criminal investigations in both the US and China. But when exposed and challenged about his activities, Xu was defiant, his first act being to reach high into the official infrastructure and demand that his critics be censored and silenced. Xu defiantly responded to the criticisms of his criminality and appalling lack of ethics by writing to officials in China's central government demanding that they censor all news reports on his genetic experiments and take official action against his critics. (10) (11)
Sleeboom wrote that Xiong Lei, a top journalist for the New China News Agency, spent a long time on the Xu Xiping case trying to stand up for 'the people' of China. Her reports became so influential that Xu saw Xiong as a threat to his research and asked the Ministry of Education to censure her reports. He also wrote other letters to officials of the Chinese Academy of Sciences, asking them to censure Xiong's criticisms of his work. It was her articles that alerted China's central government to the problem and caused them to investigate Xu and his activities. Xu admitted he had illegally taken hundreds of thousands of blood and DNA samples out of China, and that he surreptitiously avoided the laws on the export of such products. Sleeboom wrote that Xu showed "no sense of responsibility" for his actions, but instead he "blamed less enlightened people, such as local physicians".
When it became obvious that the reputations of both Harvard University and the US NIH were being seriously battered by the multiple charges of crimes and ethical lapses and the public revelation of an increasing litany of lies exposed in the cover-up, the US government became involved, but only to create a program of libel and slander to deflect attention from the criminality of Harvard, Xu and Weiss.
First, a Jewish-American woman named Gwendolyn Zahner, a psychiatric epidemiologist and former assistant professor at the Harvard School of Public Health, filed a fifteen-page complaint in 1999 with the US Office for the Protection of Human Research Participants (OHRP) alleging that two occupational epidemiologists at the school had taken advantage of the subjects in this study, and claimed the unwitting guinea pig-participants were forced into the study. OHRP launched an investigation in 1999, which lasted until early 2002, and generated damning findings, the foremost of which was that coercion was indeed used to recruit subjects for the experiments. (12)
But Zahner's claims included an attack on China’s one-child policy, which she termed "a eugenics program", and which she claimed would lead to Chinese use of the collected DNA to identify and harm undesired ethnic groups. Zahner stated (13) (14), "reviews of genetic studies hadn't adequately weighed the risks of the Chinese government misusing sensitive genetic information", suggesting Harvard and Xu confiscated the Chinese DNA samples because the Chinese government couldn't be trusted with the DNA of their own people. This slanderous attack on China's one-child policy was entirely unwarranted, with US government officials claiming to have serious concerns about "China's Eugenics laws". The intent was clearly to link Zahner's despicable inferences to a suggestion the Chinese government would, if they had the DNA, somehow use it in the extermination of their own people.
This is perhaps an aside, but Zahner was later apparently teaching graduate and undergraduate medical courses as a Foreign Expert at Peking Union Medical College and the Cancer Institute, Chinese Academy of Medical Sciences in Beijing. One needs to wonder at the recruiting process of Chinese universities when such virulently anti-Chinese individuals are placed in high positions in China's educational institutions. I have a list of many of these foreign so-called "experts" who should never have been given a visa to China and yet who are hired to contaminate the country's students. Nailene Chou Wiest is another, who was at Sun Yat-Sen University. My conclusion is that no one in China performs any investigation into the background or character of the foreign experts they so eagerly hire. Such travesties would never occur in any other country.
But because of Harvard, OHRP, Zahner and others, the important issues were thus deflected, American media attention turned from Harvard's lack of ethics and the deceit and criminality of Xu and Weis, to estimations of the probability of the Chinese government misusing genetic information on their own people, evoking all the fraudulent shades of Nazi Germany and of course the Jewish "holocaust".
The Western media quickly stated, with no supporting evidence whatever, that Chinese researchers were so eager to seek international cooperation and American funding that they themselves ignored all the ethical issues involved, "especially the issues concerning the protection of the rights of the farmers who are the subjects of the projects". But nowhere in their statements did either Harvard, the US government or the media admit to the fact that this study was done under the management of Harvard University entirely without the knowledge, approval or supervision of the Chinese government. The truth is that it was only long after the "study" had been completed that the Chinese national authorities realised it had happened, and this only from the local investigation by China Daily
Many influential Chinese demanded an international examination and review of the Millennium-Harvard DNA study and that Xu Xiping be made to accept responsibility for all that occurred, but the chance of such an examination with American participation is zero. Sleeboom wrote that Harvard's main concern was not ethics but its own reputation, and that Xu's ethical "mistakes" were dismissed as a "professional failing" rather than a moral travesty. Harvard didn't reprimand Xu for his lack of ethics or his criminality, their only action being to inform Xu to "officially disassociate himself (and Harvard) from his demands to Chinese officials for reprisals against his critics".
On October 25, 2003 the Alliance for Human Research Protection (AHRP) published an article on this Harvard study, noting that the US government has a specialised Department - the Office of Human Research Protections (OHRP), to ensure that all US Federal regulations are followed in the area of human research. The OHRP has the power to investigate any American institutions or other bodies accused of violating legal and ethical principles both within and outside the USA. The AHRP attempted to obtain information on the investigation of the OHRP in this case of Harvard University but were refused documentation, so the organisation filed a Freedom of Information request in a court to obtain the details they needed.(15) (16) (17) (18) (19) (20) (21) (22) (23) (24)
They learned primarily two things. One was that the OHRP did indeed begin an investigation of Harvard and Xu Xiping and requested from Harvard all the existing documentation on the case, including Chinese government approvals and the consent forms Xu and Harvard claimed had been completed by all the subjects in the study. The other thing they learned was that upon receipt of the request, the OHRP immediately shredded all the original documents on the pretense of "ensuring the privacy" of the test subjects. (5) (6) And, since no documentation now existed, no further investigation could be performed. The OHRP discarded its mandate and engaged in further criminality to cover up the original duplicity and crimes of Xu and Harvard. It was more than apparent their only consideration was protecting Harvard's reputation, and only after this reputation was seriously battered from the huge international public outcry did the government finally step in - to destroy all the evidence.
The Federal investigators apparently relied almost entirely on Xu and Weis and their colleagues for information about ethics violations and criminal activity. The OHRP did not send staff to China nor did it interview any of the test subjects or the local medical officials who would have had full knowledge of Harvard's study and Xu Xiping's methods, which could have uncovered all of the truth. It did not investigate the ultimate financing sources of the study, nor the illegal export from China of the blood and DNA samples. Nor did it address the issue of Harvard's data-sharing with the US military DNA storehouse(25) (26). The OHRP claimed to have performed a three-year investigation, but they merely dragged that vacant process out until public anger moderated, memories faded, and attention turned to other things. Then, they quickly concluded Harvard's halo was intact and swept the entire mess under the rug.
It is already well-known that the US Military has been collecting DNA from all Americans, but also from Russians and other ethnic groups, and that Hillary Clinton when US State Secretary issued orders to the entire Foreign Service to collect DNA and fingerprints from all foreign diplomats and leaders. But this was all being done for good purposes, in the service of humanity. (27) (28) At the same time, the US media suddenly began a flood of accusations that China was collecting DNA on its Uigurs in Xinjiang and other minority ethnic groups - for nefarious purposes, of course.(29) (30)
Halfway through the OHRP's investigation of Harvard, the top leadership at the agency was replaced, the government hiring the accused to investigate his own crime. Greg Koski, who was the former Director at Harvard responsible for overseeing Xu's and other human subject research projects, became the new head of the OHRP and personally conducted the investigation of Xu Xiping's research program. It was he who reported to Federal investigators that nobody at Harvard had misbehaved and that there was no need for any corrective action against either Xu or Harvard. Koski then left OHRP and returned to Harvard, mission accomplished, Harvard having investigated itself for crimes and declaring itself innocent.
Harvard claimed that two of its professors travelled to Xu's research sites in Anhui, to conduct "as thoroughly as possible" a fact-finding inquiry, but apparently (and very quickly) concluded that "allegations of any harm being done to individual subjects or of fraud in obtaining information consents could not be substantiated". However, I could locate no evidence that Harvard's team of professors ever went to China. Harvard claimed one of these persons was Troyen Brennan (31) (32) from a Harvard teaching hospital. Brennan apparently refused contact with investigative media and was asked - through his lawyer - whether he had traveled to China, whether he spoke Chinese, whether he actually communicated directly with any of the victims in Anhui, who was his translator, where he actually went, to whom he spoke, who arranged his visits and interviews, and how he managed to confirm that consent forms were signed" since the OHRP had shredded the originals. Reports were that Brennan refused to answer any of the questions. Given the vast duplicity in this entire affair by every American participant, it is certainly possible, if not likely, that Brennan's trip to China and his "fact-finding inquiry" were also either fraudulent or, like the consent forms, non-existent.
Harvard admitted all of Xu's DNA vials had indeed been sent to Harvard and were being stored there, but insisting that all had been done properly. Harvard's President, Lawrence Summers, claimed to be "gratified" that the inquiry "revealed no substantive harm done", and that "all procedural concerns raised have been fully addressed". In the end, Harvard University, through its damage-control PR representative Barry R. Bloom, a dean at one of Harvard's teaching hospitals, made the following statements: (19)
"We are enormously grateful to our collaborating partners in China, including Anhui Medical University and Beijing Medical University, for their patience and cooperation throughout the three and one half years of this investigation. We are grateful to members of the Chinese Human Genetics Resource Administration for their willingness to share their knowledge and experience with us in this effort. We look forward to continuing our partnerships in China."
"We have worked diligently over that time to examine every aspect of our human subjects research and to make many changes that would improve our processes. Our China studies were observational in nature, not clinical trials: No drugs, devices or procedures were being tested. There were no experimental treatments involved. As we had hoped, the inquiry found no harm to any individual participants in the studies. We believe that, in response to OHRP’s queries, the improvements put into place to sharpen our oversight of all research involving human subjects, in the end, have established the kind of professional collaboration respectful of the safety of our study populations and of the integrity of our processes that we all strive for. Harvard seeks to ensure the highest level of protection of human subjects in all its work and will continue to endeavor to meet that standard."
"Harvard seeks to ensure the highest level of protection of human subjects in all its work". "[All] participants gave voluntary, informed consent", "no individual participant had been harmed", and "no willful violations of human subjects procedures took place". "Participants gave voluntary, informed consent. They answered questionnaires and may have kept health diaries or had their blood pressure or lung function measured. They gave small blood and/or urine samples and were compensated for their travel expenses and work time missed. Again, these were observational health studies; there were no experimental treatments involved."
•The Chinese Genome
One of the main concerns is that this kind of mass DNA collection is precisely what is required to design and produce ethnically-specific bio-weapons. Sleeboom's article stated:
"Sino-American joint research projects in the 1990s used students and joint-research to steal Chinese blood and to decode the DNA of the Chinese race. This code would provide information on the Chinese immune system, which could be used to create genetic weapons."
Sleeboom noted that the Chinese genome project is of special interest due partially to its minority groups but mostly because "some of its rural populations and ethnic groups are thought to have remained static for centuries, making each region different in its pattern of genes and diseases". Numerous organisations are interested in collecting Chinese DNA, but many experts have been warning for 20 years that, as Sleeboom stated, "China faces the prospect that the genes of hundreds of millions of its people may become the priceless resources of foreign pharmaceutical companies". And this leads us to our current topic where a Big Pharma company financed a research program through Harvard University that was meant to obtain blood and DNA samples from 200 million Chinese, the results of which would reside with and be owned by American Big Pharma and the US military, with no benefit whatever to the Chinese people. Sleeboom wrote further:
". . . all Zhonghua Chinese, who stem from the Yellow River and Changjiang, share the same genes. According to the paper, the Americans thought that Anqing district, where the mobility of the population is low, the blood relations relatively stable, and the dispense of medicine relatively low, is not polluted yet. This facilitates genetic experiment on Orientals. Not only were human experiments done on the DNA of the Han and the Tibetans, but research was also done into the differences between the Eastern and Western genetic codes."
Xiong Lei, the investigative medical correspondent for the China Daily who broke open this case in China, wrote that Americans are fond of quoting the Nuremberg Code of human rights when it suits their purposes but ignore the code when they choose to violate it. She wrote that when she learned of an international conference on bioethics was to be held in Beijing, she proposed to the program committee that the subjects in the Harvard study be included in the conference so everyone could learn the truth. Her proposal was refused. The organisers from Harvard, England's Oxford University and (sadly) the Chinese Academy of Social Sciences, told her the purpose of the conference was to be "an academic meeting which will focus on the ethical issues emerging in human research", and that "We don't think it is appropriate to invite non-bioethical professionals to attend our conference". Xiong concluded that the issue of medical bio-ethics needed to be taken out of the grip of the "bioethical professionals" and put into the hands of those who would enforce their application.
She ended one article by stating that China needed to "put its own house in order", and to that I would heartily agree. She also wrote that China needed to put resources into the enforcement of ethical principles and that an international tribunal should be established to punish those who violate them. I concur, but the chance of forming such a tribunal with teeth is impossible when it is the Western governments themselves and their multinational organisations and corporations who do all the violating. The US would never agree to participate in any body that had power over it; we need only consider the International Court of Justice world or the International Criminal Court to see the truth of this. The US recognises their authority only as a political tool against its enemies, nothing more.
There have been many unethical and illegal genetic expeditions into China, all performed by Americans, the Tufts University "Golden Rice Experiment" being another such.
Larry Romanoff is a retired management consultant and businessman. He has held senior executive positions in international consulting firms, and owned an international import-export business. He has been a visiting professor at Shanghai's Fudan University, presenting case studies in international affairs to senior EMBA classes. Mr. Romanoff lives in Shanghai and is currently writing a series of ten books generally related to China and the West. He can be contacted at: email@example.com
(1) Margaret Sleeboom, Amsterdam School of Social Science Research, University of Amsterdam and International Institute for Asian Studies, University of Leiden, The Netherlands; Routlege; Taylor & Francis group; New Genetics and Society, Vol. 24, No. 1, April 2005
(32) Brennan frequently writes articles on China for the RAND corporation, who specialise in, among other things, simulating conventional and biological war games with China (as they did with Vietnam - RAND was the source of Ellsberg's 'Pentagon Papers'). The internet appears to have been expunged of his role in the Harvard investigation, though this next link may still be active: