By 1970, exposure of the Tuskegee experiment and improve the clinical trials system, United States legislation experimental ethics human trials must be performed by the Committee (hereinafter referred to as IRB) review, review test plans from a multiple perspective, avoiding subjects suffered injuries. In theory. Who is eligible for patient choice?
"No guess patients were assigned to the group that ... ... Survival rate of nearly 90% of the new group, only half of the older group...... "
Transplantation medicine until the 1970 's are still dark, kidney transplant survival rate of less than 50% in North America, dream of anti-rejection drugs is still not known where. 1976 agents (Agents Actions) periodical, published an article by the yuehan·bolieer (Jean-Fran ç OIS Borel)-led study, the report described a new drug extracted from fungi-cyclosporin (Cyclosporine), can effectively inhibit lymphocyte, improve the success rate of animal skin grafts.
Research team on both sides of the Atlantic have seen this potential, in the summer of 1980, United States Shi Dace physician topped his Cyclosporine + steroid cocktail for kidney transplantation in 22 cases, only one death (died of a heart attack, speculation and not related to transplantation). From the physician in the eyes, that Holy Grail of drug has been born!
"Unfair system is a majority of groups, imposed on those minority of disunity on the yoke. "-Martin Luther King (Martin Luther King, Jr.)
Despite leading the experiment to show the superiority of the new treatment, patient survival rate is almost twice times the older therapies, but I still can't shake the FDA maintains a large randomized clinical trial decision. In the design, half of the patients will use the new treatment, while the remaining patients, only using the older therapies. Such a decision strongly rebound by the patients and staff, the majority of doctors believe is unfair use of randomized clinical trials in transplant, because the patient, using the effect of poor old therapy costs were too great, treatment failure cost could be death! Finally, the FDA decision delegated to the hospital, carried out by the members of the IRB to decide the need for randomized trials. IRB review will be the 1979 Belmont report as the Supreme guidance, within the three principles are: respect for people, and benefits to patients, as well as fair.
United States Government Decree issued in 1976, Yan was born out of the IRB review mechanism, Shi Dace doctors believe IRB did avoid the inhumane experiments such as the Tuskegee Syphilis experiment, but a huge amount of documents composed of administrative systems and bureaucrat, is distorting the doctor-patient relationship, depriving patients of the authority? Shi Dace physician serving on the University of Pittsburgh hospital IRB believes that there is a need for randomized clinical trials. A year later, organ survival rates approaching 90% of new treatments, the old therapy only about 50%. Shi Dace physician wrote in his autobiography: "randomized clinical trials did not prove anything, only proved that the unexpected tragedy. 」
We are not trying to criticize the rigid legal system, in fact, the evolution of modern society system, are designed to let people can follow a clear path for the future, designed to create a better future. In the medical field, simplify and discussion of the issue would have to go through a long period of evolution, for example, "whose organs can be donated? "This issue was discussed for decades, becomes development until the appearance of this.
Whose organs can be donated? The institutionalization
In 1963, Moore at Harvard hospital doctors boarded the times (Times) the cover of a magazine, first write punchy slogan: "if they want to operate, then you are lucky so and so (If they can operate, you're lucky.)", organ transplant fame to the top, as if this medicine has been walking on Hong Chong Road. In fact, the science is still in its infancy, when very few success stories in the world. The development of media technology, always appears to be too optimistic or too panic, both ancient and modern.
Transplantation medicine at that time faced with two problems, one is the survival rate is still too low, low to more like art, rather than treating this problem really be resolved until Cyclosporine appear; while the other is more difficult, is the legitimacy of organ donation.
In 1954, the history of the first successful transplant surgery in the United States at Harvard hospital, just to congratulate the Moore medical teams around the world (see "history of science" – organ transplantation (b)) when the Massachusetts courts in the adjudication of the practice is illegal (declared illegal, then just let go and watch the patient die ...? O_o)。
Results are in, the Court found that the twin transplant, although donors had lost a kidney, but feelings between the brothers, far more than the value of a kidney. Final judgment the operation legitimate, this case makes organ donation law sources basis, accelerated throughout the study. Almost at the same time, a new concept in France the medical community took shape, the conceptual impact of the religious, legal, as well as the medical profession.
Redefinition of "death"
Knowledge in medicine, heart-stopping people who are dead, until, with the coming of "beyond the coma (coma pass é d é)", which describes the concept of brain stem death so far. In 1929, and cardiac catheterization-fosiman physician, father of the first experiment in the same year, Germany scientists Hansi·boge (Hans Berger) first found and recorded neural activity in the brain, which is today called the "brain wave". The scientific community began to find that the brain death and cardiac arrest would seem to be separated, when EEG wave patterns show the brain has no nerve activity, on behalf of brain tissue is dead, and no reply is possible. With the spread of information, fuzzy brain death concept gradually spread in academic circles. In January 1959, the French medical publishing house (La Presse m é dicale) journal wrote off a nervous system described the death of paper, the authors believe that brain death is tantamount to loss of heart and lung function. In July, the French neurological review (Revue neurologique) journal also appeared in a paper, text describes the symptoms of brain death (no breathing, reflection, etc), author and presents "beyond the coma", the concept of scientific consensus about the definition of brain death gradually.
Soul of man there?
Brain died concept of appeared, on transplant medical very important, due to at of regulations only accept heartbeat stop, so must to until big love who heart stop Hou to announced death, and disappeared of blood cycle may will on organ produced many bad effect (as: thrombosis, and organization hypoxia necrosis or other drug of effect), led to donation organ of quality declined, then effect transplant surgery of success rate.
This concept, not only in France doctors, religious leaders pushed a hand!
Catholic Pope Pius 12 (Pius x II) advocated the human soul in the brain, brain dead, the body is the soul does not exist. This idea across the sea after the United States accepted in 1968 at Harvard Medical school doctors United States Medical Association (The Journal of the American Medical Association, JAMA) published a joint report-"can not reply in a coma (a Definition of Irreversible Coma)", stated the definition of brain death, and urged State Governments to include standards and regulations. Since then, brain death in medicine, law, have a clear definition of transplantation medicine began to stride.
But in reality, we will still encounter even a moment of science and law are at a loss, for example, when father and son wanted the same kidney ... ... In addition to the scientific and legal
In national law, would avoid the occurrence of organ trading, so expressly provided for in the law in our country, living organ that can only donate five different close relatives within. But there are so many stories, cannot be solved by scientific and legal.
In 1987, National Taiwan University Hospital, Chu Shu-hsun doctors is preparing to perform a heart transplant, just when you open the patient's chest, Vice-President of the command passed to the operation room: "file has not been reported to the Department of health, immediately stop operation! 」。 Shouting the bloody cases, silly eye ... ... In 2003, the brother of a woman needing a liver transplant surgery, luckily famous strangers paired successfully, for the sake of compliance with women to divorce and remarry to the stranger. Chang Gung Memorial Hospital finds moral flaws, report asked whether the Department of health agreed to surgery? If you are the first example of shouting, or Director of health in the second case, in the decision making necessary for life, what would you do?
These cases have made it difficult to decide, but then completely detached scientific and legal scope. Early in transplantation medicine, have observed blood transplant will have the best effect. But the family's feelings are so good? Shi Dace doctors see several embarrassing situations, family exclusion are reluctant to give up organs as a whole family or families are forced to donate organs to foot and he did not love. In China, there have been more cases of overwhelming.
Wang Guangce of Henan Medical College hospital physician said a 18 years old girl, kidney necrosis in kidney dialysis life only. 50-year old mother and her two kidneys, one good, the other having kidney stones. Mother insisted to his healthy kidney to her daughter and said: "I have up to fate of the year, just to save my daughter......." Girls refused and held out two people. And another example was the opposite: 30 strong men, dialysis alone life, its 55-year old father of two kidneys, one good, the other a long Cyst (benign), after the inspection, the kidney function is completely normal. Fathers will have a cyst but functioning kidneys donated, but his son indicated that just want good kidney, father and son deadlock ... ...
Back in 1987, shouting "out, King may not be! "Faith defiance, Vice President of operations. The surgery has become Taiwan's first successful heart transplant surgery, and from that day on, heart transplants in Taiwan brought in hundreds of patients. Shouting after cutting the Department of health fined 120,000 yuan, declined public cash in hand sent the National Taiwan University, named for the shouting to pay a fine, were deeply moved by shouting.
The above two cases in Henan, China, fortunately, the last successfully completed surgery, doctors removed the mother has kidney stones, after clearing the stones into her daughter's body and son finally took the cyst of kidney, surgery, King said: "track 2 years after surgery, each of the families of perfection, harmony." Well, the outcome is beautiful like a Grimm's fairy tales, I guess.
Write in the end
Regulations always have to follow the science behind the development and formulation of regulations does not have "predictability", regardless of the perfect system, there will always be unforeseen events occur. Maybe next time we denounced the Government, "why not think of that? "When I thought" this is again probably think, than anything ", so will be able to settle down to, and then design a better system, and build a better future.
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