Ethics and Drug Testing in Human Beings

1987 ◽  
Vol 22 ◽  
pp. 199-211
Author(s):  
Joseph Mahon

In late May 1984, Irish citizens were perturbed to hear that a thirty-one year old man died while participating, as a paid volunteer, in a clinical drug trial at the Institute of Clinical Pharmacology in Dublin. At the inquest, held in September 1984, the State Pathologist, Dr John Harbison, affirmed that the cause of death was the reaction of the trial drug Eproxindine 4/0091 with a major tranquillizer which had been given less than fifteen hours earlier as part of regular treatment for a psychiatric disorder. The mixture of the two drugs, he went on to say, increased their effect by between twenty and thirty times their normal strength, and the volunteer had died of cardiac depression.

1987 ◽  
Vol 22 ◽  
pp. 199-211
Author(s):  
Joseph Mahon

In late May 1984, Irish citizens were perturbed to hear that a thirty-one year old man died while participating, as a paid volunteer, in a clinical drug trial at the Institute of Clinical Pharmacology in Dublin. At the inquest, held in September 1984, the State Pathologist, Dr John Harbison, affirmed that the cause of death was the reaction of the trial drug Eproxindine 4/0091 with a major tranquillizer which had been given less than fifteen hours earlier as part of regular treatment for a psychiatric disorder. The mixture of the two drugs, he went on to say, increased their effect by between twenty and thirty times their normal strength, and the volunteer had died of cardiac depression.


2006 ◽  
Vol 36 (8) ◽  
pp. 86
Author(s):  
MARY ELLEN SCHNEIDER

2012 ◽  
Vol 46 (3) ◽  
pp. 113-116
Author(s):  
Roosy Aulakh ◽  
Chander Shekhar Gautam ◽  
Prabhjot Singh Cheema

ABSTRACT Health care law is totally localized in its nature, but research for the development of new drugs has crossed man-made geographical limits. Weaker legal sanctions, poverty, illiteracy and inaccessibility to legal system have all contributed to make India a favored hub for contact research organizations. Many recent clinical drug trials in India have sparked controversy. However, in India today, we are more bothered about animal protection, but show little concern for volunteers in human trials. It is gradually becoming difficult to conduct research on animals; however, research on human beings is far easier. Sanctions against violation of rights of human volunteers in clinical trials are often only a perceived phenomenon. They are not protected as they should be. Regulatory framework needs thorough introspection, debate, reconsideration and strict implementation. These guidelines should not only be recommendatory but mandatory in nature and those who indulge in violations, shall be punished as per the law of the land effectively. How to cite this article Gautam CS, Aulakh R, Cheema PS. Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection? J Postgrad Med Edu Res 2012;46(3):113-116.


2021 ◽  
Vol 17 (30) ◽  
pp. 37
Author(s):  
Barbara Cappuzzo

Health is a common issue for all human beings. As a consequence, everyone in the world has in some way to cope with the language of medicine. This is true now more than ever due to the global health crisis caused by the current COVID-19 pandemic, which has introduced a great amount of terms, previously mostly used by epidemiologists and statisticians, but which now have entered the daily lexicon of many languages. As the medium of international scientific communication, English is the language of worldwide information about the pandemic, and the main source of terms and expressions for other languages. The impact of the COVID-19 pandemic on English lexicon has been so deep that the Oxford English Dictionary Online (OED) released special updates in 2020 to fulfil the need to document the phenomenon. However, previous studies (Khan et al. 2020; Deang and Salazar 2021) have highlighted the important question concerning the existence of several ethnic minorities who have Limited English Proficiency (LEP) and therefore do not receive sufficient and appropriate information to defend themselves adequately against SARS-CoV-2, the virus we have all been fighting for more than one year now. The aim of this study is to highlight the importance of language and translation as essential components to provide all demographic groups/communities with access to COVID-19-related information in languages other than English and enable them to follow official health key rules. The main websites of Italian governmental and nongovernmental institutions were investigated, and the analysis focused on the availability and type of content of the multilingual material, as well as on information accessibility and clarity. The results showed important differences in the number of available languages and, even more, in the level of intelligibility of COVID-19 material in the English language. In this respect, this study intends to foster the use of plain English in the dissemination material provided by the websites of the main healthcare public institutions in Italy, a country with an ever-increasing number of registered foreigners, the majority born in non-EU countries.


1915 ◽  
Vol 21 (6) ◽  
pp. 539-570 ◽  
Author(s):  
Hideyo Noguchi

Vaccine virus freed from all associated bacteria by means of suitable disinfecting agents can be propagated in a pure state in the testicles of rabbits and bulls. The virus cultivated in this manner is not only devoid of all bacteria, but appears capable of indefinite transfer from one animal to another. Sixty passages in rabbits of a pure strain have been made within one year. Several transfers from testicle to testicle are required to bring about accurate adaptation of the virus to the testicular parenchyma, so that continued propagation in this way can be certainly secured. During the first transfers from testicle to testicle the activity of the virus may be less than the original skin specimen from which the pure strain was derived; but as the transfers proceed the activity rises until, when the adaptation is complete, the activity of the testicular equals that of the skin strain. The multiplication of the virus within the testicle is maximum on the fourth or fifth day after inoculation; the quantity of virus remains about stationary until the eighth day, when diminution begins. At the expiration of five weeks no more virus could be detected in the testicle. The vaccinal processes in the skin, cornea, and testicle of rabbits are practically identical whether the virus employed for the inoculation has been the original skin strain or the pure testicular strain; and the skin lesions produced in the calf with the two strains are also identical. In conformity with the finding mentioned in the last paragraph it has been found that human beings react to the pure testicular strain of vaccine virus in an entirely typical manner. In the case both of original vaccination and revaccination the vaccinal effects cannot be distinguished from those arising from uncomplicated skin virus. Pure strains of testicular virus are readily produced, and once secured they may be propagated in a pure state by the method described in rabbits or bulls without difficulty and with economy. The pure strains thus obtained should supply an ideal form of virus for employment in the vaccination of human beings.


1962 ◽  
Vol 17 (01) ◽  
pp. 48-63
Author(s):  
H. W. Haycocks

I first became interested in economics round about 1931 when I started studying for the Fellowship. None of you have experienced what it is like to live through a severe depression. In Liverpool unemployment was some 25% to 30% of the insured population. My brother and two cousins lost their jobs and were out of work for a long period. It was extremely demoralizing for them and the character of one was adversely affected for the rest of his life. This situation influenced me very much and made me an ardent radical. It seemed to me ridiculous that an economy should be working at full capacity one year and at 75% to 50% the next. Something was clearly wrong with the way we organized things. The mistakes were those of human beings and not those of God. (At that time many people did think that such things as trade cycles and rates of interest were natural phenomena.) To my young and simple mind an economic plan seemed a simple scheme to construct and I felt that it was only the obstruction of vested interests and the ignorance of the general public that prevented enlightened people putting into operation a plan that would preserve full employment and a reasonable standard of living for everybody. The experience of recent years suggests that there is much truth in this.


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