The FDA's New Procedures for the Use of Investigational Drugs in Treatment

Young, Frank E.; Norris, John A.; Levitt, Joseph A.; Nightingale, Stuart L.

doi:10.1001/jama.1988.03720150043034

Cited by 55 publications

(6 citation statements)

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“…During the HIV/AIDS pandemic, government authorities were pressured to grant exceptions to the strict regulations for human-subject research. [22][23][24] Advocates argued that potential treatment agents should be exempt from the established requirements in order to possibly save more lives. FDA regulations were eventually modified to fast track drugs that showed promise in treating HIV.…”

Section: What Ethical Concerns Are Created By Relaxing Fdamentioning

confidence: 99%

Ethics in the Time of Coronavirus: Recommendations in the COVID-19 Pandemic

Kramer

Brown

Kopar

2020

Journal of the American College of Surgeons

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When I entered this profession, I did it because it was particularly difficult for a workman's son like myself. And then I had to see people die. I saw that I could never get hardened to it."Dr Rieux in Camus' The Plague 1Healthcare organizations across the nation are responding rapidly to the numerous medical, social, and legal challenges forced by the COVID-19 pandemic, in many cases altering what is considered standard of care in order to provide the best care to the most patients in the defining public health crisis of our time. 2 The urgency with which our practice decisions and organizational protocols are being reconfigured necessarily infuses considerable uncertainty into patient care and leads to sizeable variation in treatment. Being instructed to "just do the best you can," while understandable in the current situation, is a suboptimal alternative to carefully considered and systematically enacted guidelines for action. 3 An ethically sound framework has been outlined in the Hastings Center's 3-tiered approach to a pandemic; namely, the duty to plan, the duty to safeguard, and the duty to guide. 4 Furthermore, the landmarks proposed by the American College of Surgeons of transparency, advocacy, and commitment to support all those affected directly or indirectly clarify a way forward. 5 With these concepts in mind, we examine and provide recommendations for several of the most pressing ethical challenges of the novel coronavirus (COVID-19) pandemic.

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Section: What Ethical Concerns Are Created By Relaxing Fdamentioning

confidence: 99%

Ethics in the Time of Coronavirus: Recommendations in the COVID-19 Pandemic

Kramer

Brown

Kopar

2020

Journal of the American College of Surgeons

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“…The US Food and Drug Administration (FDA) has designated ALS as an "orphan" disease because of its prevalence of less than 200,000 individuals in the United States. The FDA also has procedures in place for the rapid development and use of orphan drugs in the treatment of serious illnesses, such as ALS [3]. Nevertheless, several stages of trials are necessary Because treatments are not yet powerful enough to reverse the symptoms of amyotrophic lateral sclerosis (ALS), randomized placebo-controlled trials remain the gold standard for testing new therapies.…”

Section: Translational Research and Trial Designmentioning

confidence: 99%

Advances in clinical trials for amyotrophic lateral sclerosis

Gordon¹

2005

Curr Neurol Neurosci Rep

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Because treatments are not yet powerful enough to reverse the symptoms of amyotrophic lateral sclerosis (ALS), randomized placebo-controlled trials remain the gold standard for testing new therapies. To date, only one drug, riluzole, has been shown to slow the course of ALS, albeit in a very modest way. Since the approval of riluzole almost 10 years ago, there have been a number of negative trials, and we still await the discovery of a medication with a truly meaningful effect. With each study, our sophistication in trial design grows, but hurdles remain, including how to use transgenic animal models optimally, which outcome measures most accurately reflect changes in the disease, and how to reduce the often high dropout rates in trials of ALS. This article is devoted to the recent evolution of clinical trials in ALS and discusses specific trials conducted during the past 5 years.

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“…Nevertheless, earlier in this section, we alluded to measures intended to protect both transfusionrecipients and blood-donors, which relate to these issues. (131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147) Apart from the usual ethical considerations which apply to all medical activities (voluntary choice, informed consent, protection of patients suffering from diminished autonomy, maximum benefit for the patient, etc), the problem with a very serious illness like AIDS is that it may seem immoral to deprive the patients of a treatment which may be beneficial to him (126).…”

Section: -Measures Intended To Protect Societymentioning

confidence: 99%

The ethical approach to AIDS: a bibliographical review.

et al. 1990

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This bibliographical study involved first the exploitation of four data-banks: Medline, CNRS, Bioethics and AIDS, with the following key words (in conjunction with AIDS): ethics, human rights, confidentiality, legislation, jurisprudence. A total of 412 references were listed between 1983 and the end of 1987. Examination of the quantitative increase of articles over these years shows that, while references to AIDS and/or HIV infection--referred to as 'AIDS' for brevity--increased by about one third per year, the number of papers treating ethical problems linked to AIDS doubled each year. This increase makes it clear that these problems are important and pressing, that they are evolving rapidly and can be given no easy solution. After reading and analysis of accessible articles in readily comprehensible languages, the different themes can be classified in two categories: 1: Measures intended to protect society (starting with the most coercive); quarantine and isolation; discriminatory measures concerning specific groups; non-respect of the confidential nature of medical information; application of the penal code; screening; obligatory declaration and registration; testing of blood given by donors; vaccination and medical innovations, therapeutic assays; information, education. 2. Measures intended to protect the individual: fundamental rights of the patient: his/her right to confidentiality, to information and to treatment; civil rights: civil liberty, right to education, right to work, etc...; rights of the healthy individual: right of those in contact with the patients, safety of hospital staff, of those receiving blood-transfusions, etc... The legislation adopted in the various countries and the main opinions to be found in these articles are listed and analysed, and for each particular theme it is possible to refer to a list of the 232 most important articles. While the debate seems to concentrate on the conflict between the right of society to protect itself against the spread of infection and the 'civil' rights of the infected minorities, our conclusion tends to reduce this antagonism, showing that, particularly as far as the confidential nature of medical information is concerned, measures intended to protect the individual also protect society.

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The FDA's New Procedures for the Use of Investigational Drugs in Treatment

Cited by 55 publications

References 0 publications

Ethics in the Time of Coronavirus: Recommendations in the COVID-19 Pandemic

Ethics in the Time of Coronavirus: Recommendations in the COVID-19 Pandemic

Advances in clinical trials for amyotrophic lateral sclerosis

The ethical approach to AIDS: a bibliographical review.

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