-----Original
Message-----
Sent: Wednesday, April 10, 2002 4:46 AM
To: veracare@erols.com
Subject:
Dear Vera:
I just read the article in SCIENCE (April 5, page 28) and found your name in the website. Congratulations for what you have done in trying to protect the basic human right in biomedical science research, which I started to be interested in 2 years ago.
I am totally convinced and not surprised that the Harvard study in China may seriously violate the ethic guideline for medical research. The only reason for my belief is that the same thing happened in Taiwan all these years. This is also why I am devoted to doing something right. Namely, to disclose all the scandalous misconduct in clinical trials in Taiwan, in order to educate the public. Of course, it is not a easy job. One of the major barriers for the investigation of violation of ethic guideline in Taiwan is the bureaucracy of the system. Namely, the doctors who themselves violated the ethics play important roles (positions) in IRBs and administration in hospitals. Therefore, all the mess they can easily cover up. The patients always fail to protect their own right.
The most interesting part of the misconduct of clinical study in Taiwan is as follows:
1) Most the Taiwanese patients were not informed at all. Some patients indeed signed the consent, but were not adequately or honestly explained the whole project. Namely, most patients were not aware what was going on from the beginning to the end. Above all, most patients were not informed what other options of treatment they could have. Most patients were even afraid of their doctors. They were treated very rudely if the patients were uncooperative in the clinical study.
2) Most of data from clinical studies later were published in the medical journals in States or Europe. Apparently most editorial boards appreciate those human data which are not easy to obtain in their own countries. Some experimental drugs or devices are not approved by FDA or DOH in Taiwan. In the published papers, the authors falsified the statement " informed consent was obtained and approved by IRB. " Some data were even inflated and manipulated. No system can monitor all the process.
3) Some papers of misconducted clinical studies are involved with foreign researchers as co-authors (international project). The editorial board members of certain leading journals are even invited to Taiwan as guests and that is why some of them apparently deliberately ignored the scandal that might happen here.
I still believe that the unethical human study is the major and common issues in China and in Taiwan during these years. This is only because of the evil nature of medical doctors. For example, recently we still performed cadavar organ transplantations from the death penalty prisoners (two in this month in our hospital). Although there was some voice against this kind of scandal, the government just ignored it. Same thing happened in another medical center in Taipei this month.
A number of patients got endomyocardial infection or sepsis after receiving cardiac intervention therapy. And it turns out that the cardiologists used the re-used catheter which supposed to be disposable in the procedure in order to save money. It was only headline in the local media for one day and then disappeared. Our patients just do not know their rights!!
Fortunately, there is a surveillance organization such as yours exists in the society and can convey some message to the public.
Sincerely yours
[Name Withheld]