Compassionate use of experimental therapies: who should decide?
Abstract In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy‐based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to...
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| Format: | Article |
| Language: | English |
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Springer Nature
2015-07-01
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| Series: | EMBO Molecular Medicine |
| Online Access: | https://doi.org/10.15252/emmm.201505262 |
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| _version_ | 1849761752199200768 |
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| author | Patricia J Zettler |
| author_facet | Patricia J Zettler |
| author_sort | Patricia J Zettler |
| collection | DOAJ |
| description | Abstract In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy‐based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include more specific criteria for authorizing compassionate use. But even where regulatory agencies make decisions based on clear rules, difficult questions will arise. |
| format | Article |
| id | doaj-art-36ce2f65ff474c44b64ece7d4ae8e6e2 |
| institution | DOAJ |
| issn | 1757-4676 1757-4684 |
| language | English |
| publishDate | 2015-07-01 |
| publisher | Springer Nature |
| record_format | Article |
| series | EMBO Molecular Medicine |
| spelling | doaj-art-36ce2f65ff474c44b64ece7d4ae8e6e22025-08-20T03:05:55ZengSpringer NatureEMBO Molecular Medicine1757-46761757-46842015-07-017101248125010.15252/emmm.201505262Compassionate use of experimental therapies: who should decide?Patricia J Zettler0Center for Law, Health & Society, Georgia State University College of LawAbstract In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy‐based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include more specific criteria for authorizing compassionate use. But even where regulatory agencies make decisions based on clear rules, difficult questions will arise.https://doi.org/10.15252/emmm.201505262 |
| spellingShingle | Patricia J Zettler Compassionate use of experimental therapies: who should decide? EMBO Molecular Medicine |
| title | Compassionate use of experimental therapies: who should decide? |
| title_full | Compassionate use of experimental therapies: who should decide? |
| title_fullStr | Compassionate use of experimental therapies: who should decide? |
| title_full_unstemmed | Compassionate use of experimental therapies: who should decide? |
| title_short | Compassionate use of experimental therapies: who should decide? |
| title_sort | compassionate use of experimental therapies who should decide |
| url | https://doi.org/10.15252/emmm.201505262 |
| work_keys_str_mv | AT patriciajzettler compassionateuseofexperimentaltherapieswhoshoulddecide |