Regulations and Animals

We were lucky enough to host Dr. Lynne Boxer, Veterinary Medical Officer with the FDA, in our class this week, and we heard from Dr. MA McCrackin last week. We also got to have a bit of reflection on Tuesday.

Class participants can choose one of the prompts to follow this week (or you can weave both together):

1) How would you explain to a non-expert the ways in which animals and products/devices for animals are treated or used in the context of regenerative medicine? How do you explain the regulatory bodies, concerns about animal welfare, and the distinctions between species and types of animals? (You can talk specifically about one type of animal if that simplifies this question into something answerable in comment-format.)

2) What has you thinking from this week or last? We’ve learned a bit more about the realities of working with animals in research and practice in terms of regulation. Have you considered what experiments are feasible or not? Have you thought about how different regulations for different species works out?  I heard some of you start to voice these thoughts on Tuesday before technical difficulties derailed things, and I wanted to open some space for you to keep exploring.

5 comments:

  1. The FDA classifies regenerative medicine products into three groups depending on if the stem cells came from the animal to be treated or not, and how the cells will be used. To date in veterinary medicine, although the FDA has classified cellular therapies as a drug, there has been no active enforcement of the FDA approval process prior to use of the majority of veterinary stem cell therapies. In this way, the veterinary scene differs markedly from the human scene. No human stem cell therapies for non homologous use have been approved, human stem cell therapies need to go a rigorous process of clinical trails and staged approvals prior to hitting the market. Even if the veterinary FDA approval process was enforced, the veterinary approval process is “simpler” and failures do not need to be made publicly available. The differences in the veterinary approval process perhaps both enhances and detriments animal welfare… On one hand, increased ease or decreased enforcement by the FDA leads to more knowledge obtained about experimental treatments and allows drugs to be developed for the less lucrative veterinary market. On the other hand, detrimental effects of a therapy may not be realized until a large number of pets have already been treated. From a human health point of view, it is beneficial to have less regulation in the veterinary field due to the contribution that this field may have to the discovery of new therapies for humans.

    The FDA classifies species into food animals and pet animals, with different regulations governing drug use in each. The basis of classification of animals into either class is cultural and should have the ability to change with society. For example, most people would expect cattle, pigs and chickens to be in the food animal category because these are available at the local Kroger. In comparison, horses, which are commonly used as a human food source in Europe are not in the USA. As with most regulation, the FDA needs to be able to make broad simplification for animal classes. This may need to change over time as more farm animals are kept as pets, such as tea-cup pigs. There is also an unspoken classification of animals that may come into existence when more stem cell products are produced and seek FDA approval. This classification is wanted or unwanted animals. Pet owners are currently able to have kidneys transplanted to their dog or cat if they adopt the donor of the kidney. While there are no laws surrounding this, it is what veterinary hospitals have deemed the most ethical process. If allogeneic stem cell therapy becomes common place what animals will the donor population? Will they be dogs and cats kept by companies to donate tissue as needed, will they be privately owned, or will they be animals that are being euthanized in shelters anyway? What will happen if stem cell therapy demand overcomes the amount of healthy donors? So far there are no guidelines on these issues, relying on veterinarians to maintain their moral compass. I think that ultimately relying on an individual’s moral compass for these decisions lacks objectivity and consistency… What do you think?

  2. Our discussions this week and last have had me thinking about all the regulations and how, especially from reviewing the slides from last Thursday, no drug/device/product can be thoroughly tested to ensure no adverse reactions when used. I don’t think the public realizes the risks they are taking when they try new drugs on the market or new therapies/devices. There is the assumption that if a product made it through all these regulations that it is 100% safe. When, in fact, there is no such thing as 100% safe and no foolproof way to determine what effect a product will have in a given individual, particularly there is little research as to cumulative effect of a product long term (such as over an entire person’s life) or how that product interacts with other therapies long term to determine a person’s overall health and changes in aging. Similarly, clients tend to be aghast if their pet or livestock reacts to a vet’s treatment and blame the vet, not understanding that individual variation does occur and cannot be easily predicted in most cases. It really just lends more strength to the argument that our health and our animal’s health should be more of a discussion between patient/doctor and client/veterinarian and less of a one size fits all prescription.

  3. Over the last week, I have been thinking about some of the differences between the regulatory mechanisms for animal research/medicine and work in human medicine. In some ways, regulations for animal research are much more rigorous than regulations for human research (as was mentioned in our class discussion about IRB a few weeks ago). However, animal medicine seems to be less regulated (at least at the governmental level) than human medicine. I found it especially surprising that the CVM cannot publicize information about new animal drugs prior to approval, in contrast to the easy availability of information about human drugs before they ever approach the market. This was a bit disturbing to me as an animal owner with a veterinary focus–I think animal owners and caretakers should have more access to the data about the drugs they might give their animals. The different regulations for different species are also interesting and very involved. I liked how Dr. McCrackin broke down regulatory bodies by species and ownership to clarify which agencies are concerned with different species. Researchers who want to use animals need to comply with a variety of different guidelines based on what they are working with and their funding source, and I want to be able to understand these guidelines as I move forward in my own animal research. As we mentioned in the class discussion, some experiments may not even be practical in certain facilities based on the regulations governing animal use (for example, using a wild species of animal vs one bred for research). I appreciated the chance to learn about these issues from people who know the field well—regulations surrounding animal research and medicine can get complicated, and I think the best way to comply with them and take the best care of my animals is to learn from those who already have experience in this area.

  4. Reflecting off of some very interesting perspectives, in terms of experimental medicine in the veterinary community, a certain amount of regulation can be incorporated at the clinic level. If veterinarians communicate effectively the scope of experimental therapies, clients will be better informed and willing to consent to the recommended course of treatment.
    With the number of innovative therapies today waiting on the FDA to approve pre-clinical trials, such as with the induced pluripotent cells in the US, the veterinary community as Sophie mentioned significantly contributes to medical advancement, ofcorse at the cost of inferior outcomes in some cases. However, we must consider demographics. Researchers are extremely benefited from animal research within the country, rather than having to migrate and set up shop in countries where certain technologies are less regulated in humans. To reiterate, animals may wrongly serve as guinea pigs for experimental medicine in the US, however said therapies may be closer to commercialization in country “X”, thereby providing incentives to scientists to migrate.
    In such a scenario, would it be wrong to deem animal research as a neutralizing agent of extremely strictly enforced research policies?

  5. I am always a little astonished by what is and what is not regulated and by who(m). The conglomeration of agencies and their different foci (that took someone intimately familiar with their workings over a decade to represent well) are almost guaranteed to trip scientists up, never mind the effect on the public understanding. There is already confusion over what the FDA can and cannot approve (see: techniques, supplements), now add in all of these competing agencies and their different bailiwicks, and one imagines that scientists can throw a few regulatory acronyms (I had never even heard of IACUC before this week) out there and it will be easily assumed that everything is above board. And yet, even with all of these agencies, and the social interest in the ethical treatment of animals, we still have very few regulations regarding mice and invertebrates and others.

    Perhaps the negotiation of this arcane and disjointed labyrinth is necessary to ensure fair treatment of animals, and of “good” science, but I wonder how it might be different. The separation between agencies looking out for the owners of the animals and the researchers seems necessary (much like patient advocates and friends of the court are necessarily separate from medical, prosecutorial, and judicial professionals), but the further breakdown by agricultural animals (as if an animal can be only for agricultural “use’), and who is housing the animals seems so obtuse as to be a hinderance.

    Again, I wonder if it can be done another way, though I honestly have no idea what that way might look like.

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