Assessment of the Right-to-Try Law: The Pros and the Cons

Brown, Brandon; Camerin, Ortiz,; Dubé, Karine

doi:10.2967/jnumed.118.216945

Cited by 9 publications

(9 citation statements)

References 15 publications

(20 reference statements)

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“…It retains gases and most metallic fission products below 1600 C. It has long been known, however, that silver exhibits relatively high release from intact SiC-coated TRISO fuel particles if they are maintained at sufficiently high temperatures for sufficiently long times [15][16][17][18][19][20][21][22][23]. The release of radioactive 110m Ag in particular is of considerable concern since this strong ray emitter (half-life of 249.8 days) can plate out on the various helium-wetted surfaces in the primary circuit of direct-cycle HTGRs and thus significantly complicate plant operations and maintenance [24][25].…”

Section: Triso-coated Particle Fuelmentioning

confidence: 99%

“…Extrapolation of their data to 1500 C yields approximately 6.0  As a final note in this section, it seems also appropriate to compare the silver diffusivity in zirconium carbide with that in silicon carbide since ZrC is a candidate to replace SiC as a coating material in TRISO fuel particles. However, a direct comparison of these two types of diffusion coefficients is not possible because the published values with SiC exhibit significant scatter up to greater than six orders of magnitude; they vary from virtually zero ( 5  10 -21 m 2 /s) to about 4  10 -15 m 2 /s at 1500 C [45][46][47][48][49][50][51][52][53][54][55][56][57][58][59]. Detailed reviews can also be found in Malherbe [72] and Kim et al [73].…”

Section: Ag Diffusivitymentioning

confidence: 99%

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The measurement of silver diffusivity in zirconium carbide to study the release behavior of 110mAg in the ZrC TRISO-coated nuclear fuel particle

Yang

Allen

2016

Journal of Nuclear Materials

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The tri-structural isotropic (TRISO) coated particle fuel has been developed and used for high temperature gas-cooled reactors (HTGRs). It provides a unique robustness of the first barrier for the fission products. The TRISO fuel particle has typically consisted of a UO 2 or UCO kernel, surrounded by successive layers of porous carbon, dense inner pyrocarbon, silicon carbide, and dense outer pyrocarbon. During operation, however, the SiC layer has been known to release radioactive silver 110m Ag which makes maintenance more difficult and thus costly.Zirconium carbide has been considered as a promising alternative to the SiC fission product barrier. ZrC exhibits high temperature stability and possibly possesses superior Pd resistance, while the retention properties especially for silver have not been adequately studied.To help elucidate the diffusive behavior of silver in the ZrC coating of the TRISO-coated particle, a new diffusion experimental technique, called the encapsulating source method, has been developed by constructing a constant source diffusion couple between ZrC and Ag gas originated from Zr-Ag solid solution. SEM, WDS, EBSD Scanning electron microscopy (SEM), wavelength-dispersive X-ray spectroscopy (WDS), electron backscatter diffraction (EBSD) and optical methods were used to analyze the diffusion couple annealed at 1500 C. The resultant diffusion coefficient of Ag in single-crystalline ZrC 0.84 at 1500 C was experimentally determined to be about 2.8 (± 1.2) × 10 -17 m 2 /s.

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Section: Triso-coated Particle Fuelmentioning

confidence: 99%

Section: Ag Diffusivitymentioning

confidence: 99%

The measurement of silver diffusivity in zirconium carbide to study the release behavior of 110mAg in the ZrC TRISO-coated nuclear fuel particle

Yang

Allen

2016

Journal of Nuclear Materials

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“…When designing our framework we considered the current legal regulations of expanded access of the USA [ 11 ], the EU [ 12 – 15 ], Canada [ 16 ], Australia [ 17 , 18 ], and the Right-to-Try law [ 8 ]. Moreover, we refer to the Declaration of Helsinki (DH) by the World Medical Association (WMA).…”

Section: Main Textmentioning

confidence: 99%

“…Expanded access requests are reviewed by regulatory agencies; in addition, in some countries approval by an institutional review board (IRB) is required [ 3 , 7 ]. Recently, in the USA the Right-to-Try Act was signed into law, thereby creating an alternative to expanded access regulations at the federal level [ 8 ]. This law allows patients with life-threatening diseases to request access to investigational treatments which have completed Phase 1 clinical trials without any oversight by the Food and Drug Administration (FDA).…”

Section: Introductionmentioning

confidence: 99%

“…This law allows patients with life-threatening diseases to request access to investigational treatments which have completed Phase 1 clinical trials without any oversight by the Food and Drug Administration (FDA). However, as is the case with expanded access, this pathway is dedicated for patients who exhausted all approved treatment options and are not eligible for participation in a clinical trial [ 8 ]. Note that the term ‘treatment use of IDs’ that will be used throughout this article refers to any use of those drugs outside of clinical trials including both expanded access and treatment under the Right-to-Try law.…”

Section: Introductionmentioning

confidence: 99%

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Ethics framework for treatment use of investigational drugs

Borysowski

Górski

2020

BMC Med Ethics

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Background Expanded access is the use of investigational drugs (IDs) outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs. Legal regulations of expanded access to IDs have been introduced among others in the USA, the European Union (EU), Canada and Australia. In addition, in the USA an alternative to expanded access is treatment under the Right-to-Try law. However, the treatment use of IDs is inherently associated with a number of ethically relevant problems. Main text The objective of this article is to present a coherent framework made up of eight requirements which have to be met for any treatment use of an ID to be ethical. These include a justified need for the use of an ID, no threat to clinical development of the ID, adequate scientific evidence to support the treatment, patient’s benefit as the primary goal of the use of an ID, informed decision of a patient, fair access of patients to IDs, independent review, as well as the dissemination of treatment results. Conclusions While this framework is essentially consistent with the legal regulations of expanded access of the USA, the EU, Canada and Australia, it is substantially wider in scope because it addresses some important issues that are not covered by the regulations. Overall, the framework that we developed minimizes the risks and threats, and maximizes potential benefits to each of the four key stakeholders involved in the treatment use of IDs including patients, doctors, drug manufacturers, and society at large.

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2019

Clinical Thyroidology

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Assessment of the Right-to-Try Law: The Pros and the Cons

Cited by 9 publications

References 15 publications

The measurement of silver diffusivity in zirconium carbide to study the release behavior of 110mAg in the ZrC TRISO-coated nuclear fuel particle

The measurement of silver diffusivity in zirconium carbide to study the release behavior of 110mAg in the ZrC TRISO-coated nuclear fuel particle

Ethics framework for treatment use of investigational drugs

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