Dr. Lex Lee is the principal at Biovirx Inc. an advisory in technology transfer from US to Asia. He had successfully transfered a nitroxylation drug discover platform, a bioartificial liver device, and rotavirus vaccine to Taiwan.

Dr. Lee had worked in Barlow Hospital, Los Angeles, CA (a USC Medical School Affiliate) as staff pharmacist. Other position includes on site clinical preceptor for USC Pharmacy School. His managerial experience began with Osco Drug, a national drug chain, as Chief Pharmacist Manager in Los Angeles, CA. and in 1989 was honored with the best margin pharmcy in the district.

Dr. Lee has a B.S. degree from University of California at Los Angeles, then a Doctorate of Pharmacy from the University of Southern California, and attended Exec.JD program at the Concord Law School. He has Professional Licensure from the State of California and Nevada State Boards of Pharmacy and has served as Secretary General of the Cross Strait Pharmacology Society of China where he helped build extensive contacts in the global life science sectors.

Viruses, bacteria and parasites are mutating faster than our immune system can adapt to them. The swine flu (H1N1) is a very recent example. It is a “new” mutated virus to which humans have no immunity. Therefore, the whole world is at risk to this new disease threat. Seasonal flu also generates new strains almost every year. Antibiotic-resistant bacteria are another example of evolution resulting in the rapid progression of life threatening diseases around the world. As disease pathogens mutate and new threats emerge (e.g. Swine flu/H1N1), there is a need to have ethical goals for public health emergency preparedness and response. Pandemic threat during this period was highly publicized throughout the media. While the Taiwan’s Dept of Health and CDC rapidly addressed these threats in an effective response, many ethical issues remain unanswered. The ancient medical Hippocratic Oath “DO NO HARM” is a reminder for public officials in Taiwan in directing the recent Swine flu/H1N1 vaccination policy in fall of 2009. The oath reminds us “ ..the physician must have two special objects in view with regard to disease namely, to do good or to do no harm” (Bk. 1,sec 5, trans. Adams,).

The risk of product liability claims, product recalls and associated adverse publicity is inherent in the testing, manufacturing, market¬ing and sale of vaccines especially in a new flu vaccine. The issue in Taiwan was whether the government acted openly, ethically and respected the dignity of all persons during the health response. In the beginning of the vaccination program, 2 vaccines were readily available from 2 different manufacturers. One is imported while the other is a local maker unfamiliar to most people. As weeks passed by, the public was told that due to lack of supply from the importer, there was only one available, which is from the local maker. Children from schools were handed consent form requiring signature from parent in agreeing to the vaccination program. Public announcement continue to flood the media in maintaining the necessity of a broad base vaccination program. Many questions regarding the quality of the local manufacturer was not disclosed thus the public has to blindly accept it and trust the government. The next phase of the program using the local maker, created mass hysteria as side effects from the vaccine suggests a need for a thorough recourse and a relief from the schedule. Hourly TV news reported alarming rise in side effects, but from the vaccine, such symptoms would not have occurred such as peripheral paralysis, neurological side effects, facial palsy, and death beginning to shock the public. The public officials continue to defend the health policy alleging far more death would occur if vaccination rate were not achieved. Everyday, there were more and more public outcry regarding the questionable safety of its vaccine manufacturer. While defending a sound policy, the government was paternalistically endorsing a product indirectly that the public did not want. Little was disclosed whether the vaccine has passed the critical clinical trial for all ages, especially children, that is required for all medical product and whether the manufacturer had experience in producing such a virulent strain. Many officials were defending the product and not defending for its citizen. Only in Taiwan, a president would endorse a mass gathering vaccination program giving out cabbages, toothpastes and noodle for the endorsement of its decision.[see pictures]

高市衛生局準備1000多顆高麗菜致贈給接種民眾。 （中央社）

Mr. President, the public is not questioning the policy, but concern with the safety of the vaccine product! The public is seeking compassion and not cabbage; transparency and not toothpaste; do no harm and not noodle. The objective of the vaccination was successfully achieved at the end of Dec 2009 with a drop in H1N1 flu cases, however the vaccination rate was also dropping dramatically. Globally, all cases of H1N1 were also dropping dramatically. To address this issue, by Feb 2010, the Dept of Health then announced that the public could choose 2 vaccines, importer vs domestic. Again, more questions rose whether the government withheld some supplies from the importer to endorse the local maker otherwise, where did all the extra supply come from. At this time public distrust was apparent, assessing such measure as another devised scheme from the government officials.

The finale of this saga is the death of boy Liu (劉小弟), a 9 year old from Tai Chung. After receiving the vaccine, boy Liu died within a month on Dec 21st , right before Christmas. The public was shocked in the fact that the boy’s father is a physician, who reasonably should have known the risk in agreeing to accept the local vaccine. Autopsy report revealed non-conclusive evidence linking cause of the death to the vaccine, however the family cannot and does not accept the finding. Emotional outcry from the boy’s elementary school during the church ceremony was haunting in that it could have happen to anyone in the school receiving the vaccine. Setting a price on human life is not a pleasant task, but it is one that courts are required to do now. Because the primary measure of damages in a wrongful death action is pecuniary (financial) loss, the death of a child or an elderly person may raise difficulties in arriving at an adequate damage award. When an adult dies, the pecuniary loss to the family is readily quantifiable. When a parent dies, a child may seek damages for loss of the parent's care, income, nurturing, and guidance. When a child dies, the parents' recovery is limited to their pecuniary loss, which is usually quite small. Boy Liu created emotional scar not only for the family but the whole society; it is far more expensive than any pecuniary loss, which can be accounted for.

Hypothetically, people are usually reluctant to harm people in order to help others, even when the harm is more, resulting from not acting. Likewise, most would resist a vaccine that reduced overall mortaliy in one group but increased deaths from side effects in another group. Fairness to different groups and DO NO HARM principle may be a better consequence to justify. Perhaps, it is this pricincple that is at work in Taiwan during the past flu season. Whether such principle is understandable by the public is not the issue, but the bioethical principle is more important to everyone. It is far more acceptable for a child’s death resulting from infectious disease than a wronful death cause from a questionable vaccine. In the aftermath of this past flu season, it would serve the government policy well, if there were an ethical body to “watch the guradians”. Such ethical watch dog can adapt ethical goals in dealing with public health emergency as suggested by Hasting Center:

1. Harm reduction and benefit that protect public safety, health and well-being.
2. Equal liberty and human rights-respect the equal liberty, autonomy, and dignity of all.
3. Distributive justice.-ensure benefits and burdens imposed are shared uniformly and fairly.
4. Public accountability-decision making processes are inclusive and transparent and sustain public trust.
5. Development of strong and safe communities
6. Responsible civic response- promote a sense of personal responsibility and citizenship.

Finally, public trust is key to success of any policy. Deliberative planning from the top down may work in other country, but for Taiwan, a meaningful two-way communication is vital for all citizens to participate. Although the government seemingly avoided a pandemic flu episode, it howevers must prepare itself for a next generation preparedness in future health challenges. An ethical fabric woven into its planning is far more precious than unduly burdensome promotion practice of its policy. May God help us remember boy Liu and his sacrifices that his family has made.