reasonable to believe

[borislvin]

March 28, 2020

<...>

I have concluded that the emergency use of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19 when administered as described in the Scope of Authorization (section II) meet the criteria for issuance of an authorization under Section 564(c) of the Act, because:

1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate when used to treat COVID-19 outweigh the known and potential risks of such products; and

3. There is no adequate, approved, and available alternative to the emergency use of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID19.

<...>

Denise M. Hinton
Chief Scientist
Food and Drug Administration

https://www.fda.gov/media/136534/download

Comments

упоминание некоего totality of scientific evidence

[mgar.livejournal.com]

Эта отсылка, как и "no adequate, approved, and available alternative" - это цитата из закона. Это просто чек-лист, который показывает, что условия закона соблюдены.

Вот текст Section 564(c) of the Act, данный список из трех пунктов просто почти дословно отвечает "да" на данную секцию:

(c) CRITERIA FOR ISSUANCE OF AUTHORIZATION.—The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances described in subsection (b)(1)), the Secretary concludes—
(1) that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or
condition;
(2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well controlled clinical trials, if available, it is reasonable to believe that—
(A) the product may be effective in diagnosing, treating, or preventing—
(i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a product authorized under this section,
approved or cleared under this Act, or licensed under section 351 of the Public Health Service Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable;
(3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;
(4) in the case of a determination described in subsection
(b)(1)(B)(ii), that the request for emergency use is made by the
Secretary of Defense; and
(5) that such other criteria as the Secretary may by regulation prescribe are satisfied.

(4) и (5) нерелевантны.
Я выделил части, которые были процитированы в обосновательной части документа
(Я выделил italic то, что не вошло в обоснование)

> тоталити реально существует и может быть предъявлено, если спросят

Oснова scientific evidence available to the Secretary указана в этом письме - "limited in-vitro and anecdotal clinical data in case series".

RE: упоминание некоего totality of scientific evidence

[bbb.livejournal.com]

Понятно, что слова про "тоталити и т.д." придумала не она, а юристы. Но ее могут спросить, в чем эта тоталити заключается. Про лимитед ин-витро я уже написал выше и не буду повторяться - эти слова в бумаге относятся к совершенно другому сюжету, они не перечивляются в качестве содержания тоталити.