Cardiac RM and Animal Regulations

So glad that Dr. Jia He and Dr. MA McCrackin could present to our group this week.

Dr. He tried to convince us that the cardiac system was the most important system and explained the RM approaches to repair and recovery in heart tissues. Were there any issues or approaches that surprised you from his presentation? What considerations that he presented were new to your thinking?

Dr. McCrackin explained the ethical compliance aspects of animals research between OLAW, USDA, IACUC, and AAALAC. What are your impressions of the origins of the Animal Welfare Act of 1966 and the Health Research Extension Act in 1985 (which let to IACUC)? Do the regulatory frameworks make sense? Why or why not? What is the importance of the regulatory frameworks in the context of animal research?

7 comments:

  1. The cardiac system, while it could be seen as the most important, can still be replaced, unlike the brain. It would come down to a question of spirituality, is a brain dead person alive? Politics has already answered that question for us, by allowing the “unplugging” of those in a vegetable state.

    I was not surprised that the USDA made it a point to evade classifying lab rats, birds, and mice as under their authority. With countless professionals possibly lobbying against the protection of these species, medicinal breakthroughs would have been halted much earlier; Just as when stem cell research was outlawed.

  2. Unfortunately, I missed Dr. He’s lecture, but I had the privilege of hearing the same lecture last spring. One thing I have found very unique about his lecture is he always goes in to explain the timeline of stem cells, and I was initially surprised at how new most of the techniques are, despite the fact that stem cells have been studied since mid1900s.
    Dr. McCrakin gave a very great talk about animals and their regulatory agencies for research. I do think the process of regulating animals for research is very confusing, and it could use some work to make it more simple. What really surprised me was if you have certain animals outside of NIH, you really only need permission from their owners in order to use them for research. It made me wonder if there were places in the United States where they buy animals (and become their “owners”) and use them for their own research purposes. Sometimes controversial studies on animals can lead to huge advancements in science, so I can understand why some people might be interested in trying to fun their own research to bypass these regulations.

  3. I liked thinking about the details of how stem cell treatment works and the specific challenges of this research through Dr. He’s presentation. One fact that stood out to me was that stem cells lose the risk of tumorigenesis after differentiation. Since one of the current concerns with stem cell therapies is the risk of uncontrolled proliferation/differentiation (i.e. tumorigenesis), understanding the factors involved in controlling stem cell differentiation would be a big step forward in stem cell therapy. The different means used to evaluate effectiveness of stem cell therapy were also new to me. I was especially interested to learn that “quality of life” is often considered when evaluating a cardiac stem cell treatment, and I am curious about how life quality is assessed—a measurement of this kind seems like it would be very relevant but also subjective.
    Dr. McCrackin’s lecture was interesting and useful to me in making sense of the interactions between different regulatory agencies. The complex crossover between agencies can be confusing, but I came away with a better grasp on how species and ownership affect who regulates research animals. This is important for me to understand as a researcher who uses an animal model for research—I need to know which regulations and laws I am responsible to in order to carry out good research and to take the best care of the animals in my lab. It was a little surprising that privately-owned animals are covered by few (if any) governmental regulations. As in the class example, giving an experimental drug to a research animal requires compliance with multiple agencies and laws, while giving the same drug to a pet requires only a minimal level of approval. I agree that private owners have the right to make decisions for their animals, but it was surprising to see the different level of control between a pet animal and an animal of the same species in a research lab.

  4. Dr. He mentioned a fact that really surprised me: embryonic stem cells have too much capacity to differentiation so researchers sometimes encounter difficulty to use embryonic stem cells. This surprised me because there are many kinds of arguments or narratives about the advantages of embryonic stem cells but no one mentioned the difficulty before. It is easy to keep the sensibility to notice side effects of a therapy but it is not that easy to notice the difficulty of a promising cutting edged research target like embryonic stem cells. In this sense, IPS cells are not only the solution of ethical debate, like Dr. He mentioned, but also a possible solution of scientific research, which had not been addressed in the ethical discussion before.

    The regulatory framework also surprised me that there is no centralized institution of animal research. Instead, there are several institutions governing animals depending on animals’ ownership. I think this regulatory setting costs much than having a centralized agency but can reduce the risk of animals further by cross-monitoring some animals and referencing paper works.

  5. I thought the research Dr. He presented was compelling, but it would present a stronger case if some background research on where these injected cells stay short term and then long term as well as how they integrate or change at those locations. Without targeting moieties, researchers have found it difficult to make drugs and cell therapies stay in particular tissues, such as the vocal folds or within joints and it is then difficult to attribute improvements in patients to a therapy. To simply inject cells and then look at the macroscopic picture (i.e. the patient’s recovery) was startling to me, but then again, sometimes medicine has to use what it has without every step in between worked out to try to improve human health in the here and now.

    First of all, Dr. McCrackin has the most awesome name ever. I thought she did a great job engaging us in case studies for in a subject that can be quite dry. The way she explained how each regulatory agency follows a different aspect of animal research (i.e. NIH follows funding whereas AAALAC follows ownership) helped make things much clearer and less random as to who is involved. Having multiple levels and different agencies helps ensure that regulations are followed and no exceptions are made (favoritism) based on personal relationships. It is definitely a hassle for paperwork, but I think it is fair for the public to make using animals in research harder because they are still lives that we are using and we have an obligation to make sure their sacrifices are honored.

  6. I thought an interesting issue from Dr He’s lecture was about what stem cell dose to use. He mentioned if it was too large then the cells may contribute to occlusion of the coronary artery. There must be a balance between the number of cells needed to be efficacious that is under the amount that would cause occlusion. Looking at the landmark trails of stem cells for use in ischemic heart disease, the doses range from just below 2 million to 5 billion. The corresponding results, however, do not appear dose dependent. It is hard to see a correlation due to these results coming from different studies, but it just highlights how much we could learn about stem cell dose. The thought that the heart was the most important organ in the body was a novel way of thinking about an individual organ. He made some valid points, but I think that Jerry’s argument above about the brain is compelling.

    Regulation of research or other activities that detriment animal welfare is justified and important. Today in class we were talking about the large amount of paper work that comes with such regulation. However, I think we need to remember that this paper work ensures that appropriate processes are taken by everyone so that welfare breeches do not happen. I think that the part of this regulation that is controversial is the exclusion of certain animal groups. For example that invertebrates are not covered by any regulation, for pets the owner is ultimately responsible for deciding on study enrollment and the exclusion of rats and mice from the more stringent regulations in USDA. While this makes sense from a practical point of view, it is controversial because we know that invertebrates have nociception and just because an animal is bred for research does not justify its exclusion from well established and monitored animal welfare codes. As researchers and veterinarians it is our ethical duty to act to protect all animals to the best of our ability no matter what the species, use, or regulations that do or do not protect them.

  7. Animal research and its regulation can be sometimes exhausting but I believe for good reason. The sentiment for higher regulation for some animals relative to other was raised in class. For example, a researcher using mice may not be too concerned about the regulation of ‘Reduction’ compared to a researcher using dogs. Personally, I think one of the reasons for this is the value we humans put on different animals (non-scientific reason). Dogs are considered mans best friend in the western world and does research pertaining to them are considered relatively delicate compared to mice. What do you guys think?

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