Friday, April 24, 2020

And they wonder why some people question their motives.

The Guide [Guide for the Care and Use of Laboratory Animals: Eighth Edition. Washington, DC: The National Academies Press.] is the authority on what is and isn't allowed and on what is and isn't absolutely required when dealing with animals in biomedical research funded by the NIH and other federal agencies.

Here's the germane passage from page 35:


Disaster Planning and Emergency Preparedness

Animal facilities may be subject to unexpected conditions that result in the catastrophic failure of critical systems or significant personnel absenteeism, or other unexpected events that severely compromise ongoing animal care and well-being (ILAR 2010). Facilities must therefore have a disaster plan. The plan should define the actions necessary to prevent animal pain, distress, and deaths due to loss of systems such as those that control ventilation, cooling, heating, or provision of potable water. If possible the plan should describe how the facility will preserve animals that are necessary for critical research activities or are irreplaceable. Knowledge of the geographic locale may provide guidance as to the probability of a particular type of disaster.

Disaster plans should be established in conjunction with the responsible investigator(s), taking into consideration both the priorities for triaging animal populations and the institutional needs and resources. Animals that cannot be relocated or protected from the consequences of the disaster must be humanely euthanized. The disaster plan should identify essential personnel who should be trained in advance in its implementation. Efforts should be taken to ensure personnel safety and provide access to essential personnel during or immediately after a disaster. Such plans should be approved by the institution and be part of the overall institutional disaster response plan that is coordinated by the IO or another senior-level administrator. Law enforcement and emergency personnel should be provided with a copy of the plan for comment and integration into broader, are-awide planning [my emphasis] (Vogelweid 1998).

Call me naive, but I assumed that since the Guide said that law enforcement and emergency personnel would be provided with a copy of the plan, that the plan existed, that I could ask for a copy of it. I have to laugh. I'll never learn.

From the University of Wisconsin, Madison:
Reference #P001069-040220

Dear Requester,

The university received a public records request from you on 4/2/2020. You requested the following: "the university's disaster plan (the plan specified on pg 35 of The Guide.)"

Before we can begin the search for responsive records, we need clarification from you.We estimate that your request encompasses between 1,000 and 10,000 pages of documents. Many of these documents are not exclusive to the university’s research and teaching animal program because they cover emergency response to adverse events that impact university students, staff, visitors, property, and functions as well as research and teaching animals. If it is even possible to sort out all of the emergency response documents that address research and teaching animals, it is likely to take months and much staff time simply conduct such a search. Each record would then need to be reviewed at multiple levels to determine whether you are entitled to it under Wisconsin’s Public Records Law.

What? Between 1,000 and 10,000 pages of documents? How could "Law enforcement and emergency personnel should be provided with a copy of the plan for comment" get turned into somewhere between 1,000 and 10,000 pages of documents?

They did say though, at the end of their lament, that a summary plan was available. Hello? So I wrote back and said yes, to please send me the summary plan. No idea why they just didn't send it in the first place; I'm sure it will be captivating.

Monday, April 20, 2020

Hurting animals because that's just what they do

(There are no photos from either of the projects mentioned below.)

As I write this, there is "an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19" underway. It will evaluate the use of a drug called Remdesivir as a treatment for COVID-19. "The study is a multicenter trial that will be conducted in up to approximately 75 sites globally." It is estimated that there will be about 440 patients enrolled in the study. More info here.

Remdesivir was originally developed by Gilead Pharmaceuticals to treat Ebola. It seems to have had mixed results. Monkeys were experimented on and killed during its development. Gilead is already in Phase 3 trials of Remdesivir as a treatment for COVID-19.

On April 17, 2020, I received a news release from NIH titled "Antiviral remdesivir prevents disease progression in monkeys with COVID-19." The NIH clinical trial's first patient was enrolled on February 21, 2020.

If the NIH and Gilead are already testing remdesivir in world-wide large human trials, why experiment on monkeys? Here's what the NIH says:
Early treatment with the experimental antiviral drug remdesivir significantly reduced clinical disease and damage to the lungs of rhesus macaques infected with SARS-CoV-2, the coronavirus that causes COVID-19, according to National Institutes of Health scientists.

The study was designed to follow dosing and treatment procedures used for hospitalized COVID-19 patients being administered remdesivir in a large, multi-center, clinical trial led by NIH’s National Institute of Allergy and Infectious Diseases (NIAID)... The findings are not yet peer-reviewed and should not be considered clinical advice, but are being shared to assist the public health response to COVID-19.

There doesn't appear to be a reasonable or logical reason other than the fact that they could. Experimenting on animals is just what they do.

Here's the paper: Williamson, Brandi, et al. "Clinical benefit of remdesivir in rhesus macaques infected with SARS-CoV-2." bioRxiv (2020).

This passage caught my eye: "The animals were observed twice daily for clinical signs of disease using a standardized scoring sheet as described previously(10); the same person, who was blinded to the group assignment of the animals, assessed the animals throughout the study."

The scoring sheet they referenced, slightly modified in size and layout to fit here:

The chart paints numerous possibilities for suffering. There doesn't seem to be a justification for hurting and killing these animals in light of the large global carefully monitored clinical trial underway. It's telling that the clinical trial is loaded with patient safeguards while the monkey experiment was seemingly only wanted in order to document just how sick a monkey could be.