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Week 46: Antimicrobial resistance concerns on the rise, while the discussion of discontinuing the use animals for testing gets some new insight

Posted on November 23, 2018 in Uncategorized

Antimicrobial Resistance Concerns Continue to Rise

Last week was World Antibiotic Awareness Week, to help increase global awareness and education surrounding antimicrobial resistance (AMR). With concerns growing that current antibiotics available will be rendered useless against bacterial infections, the pressure is on to improve available treatments and increase education around proper use of antibiotics in both humans and animals.

Due to significant drops in the price of life-saving antidotes, the prices of certain antibiotics that can combat some of these resistant bacteria have become drastically low. Because of it, manufacturers like Novartis and AstraZeneca have stepped out of producing these drugs due to minimal returns, explained Lucas Wiarda at DMS Sinochem Pharmaceuticals in an interview by in-pharmatechnologist.com.

3D printed brain organelle first of its kind

Celprogen has produced a 3D printed brain organelle created through using human brain stem cells reports outsourcing-pharma.com. The model will be used to help study neurological diseases and potential treatments at a near in-vivo level to be closer to the patient’s brain physiological level.

A challenge to eliminate any use of animal studies has driven the design as the industry advises animal studies have poor design and results, in addition to critical brain physiological differences that can impact overall results. This push has been adopted by other companies in this space, including Emulate, and continues to gain steam based on changing societal opinions about animal health.

Atrial Fibrillation and silent brain injuries

A recent GEN report highlights what researchers believe to be a link between Atrial Fibrillation (AF) and cerebral injury. After analyzing specific markers within blood plasma, Dr. Oxana Galenko, a molecular biologist at the Intermountain Medical Center Heart Institute, found four biomarkers circulating within the body that may indicate cerebral injury believed to be attributed to AF and the impact it has on blood circulation.

This study yielded similar results to a Swiss study, which referenced MRI results that indicated silent brain injury in a percentage of patients.

Researchers are concerned that AF can lead other conditions such as depression or other neurodegeneration caused by an altered blood flow within the body, including to and from the brain.

“Hemophilia the Musical” has hit New York

The production, sponsored by Bio-Marin and featured in FiercePharma, is a musical produced and performed by teens who suffer from rare, chronic illnesses.

The six-song performance was inspired by students and their daily struggles, including those of loneliness with the overarching message on how the arts can help overcome those struggles and find who they are.

UC Davis Health issues request for government to remove use of certain pesticides

The organization has requested that the use of organophosphates, a common pesticide used, to be limited due to potential health risks on future generations. The request cites evidence that prenatal exposure to the substance can cause a lower IQ and developmental disorders.

This class of chemicals were originally developed as nerve agents and gases in war, but today are used as insecticides for places such as golf courses and around shopping malls, exposing a large number of residents in the US.

There are current regulations in place to limit the use of organophosphates, but researchers say that isn’t enough, based on studies conducted in animals and cell cultures that show there are still potential developmental implications at these ‘safe’ levels.

The full recommendations made by UC Davis Health to help eliminate the use and subsequent exposure to organophosphates is documented by Manufacturing.net.

Studies indicate that obesity may lead to increased tumor growth

It has been demonstrated, and highlighted by GEN, that obesity lowers immunity and can cause an increased risk of certain cancers and growth of tumors. However, UC Davis has shown a paradoxical impact of obesity, demonstrating in animal models and certain human patients that although obesity can increase tumor growth, it can also increase responsiveness to certain cancer treatments. The link between the two is not exactly clear, however.

Obesity is reaching ‘pandemic’ levels, accounting for as high as 20% of annual healthcare expenditure in the US. While researchers state that it is unclear whether obesity impacts overall survival rate, more studies should be conducted to look at other factors, including gender, and diet type.

Will animal testing be a thing of the past?

FDA released a statement indicating they are looking to remove the need for testing in animals.

According to the statement, this movement would be especially important within the animal health drug development industry. The model will help collect data that researchers can consult when developing potential drugs, in the hope to eliminate the use of testing in animals.

With a fair amount of studies, the animals end up being euthanized at the conclusion. The proposed change will help eliminate this need, resulting in any animals being used to study getting adopted when the study is finished.

The method being proposed is the use blood samples, recording any blood levels to be referenced in the instance of orally-administered drugs. This is in hopes to create an informatics system to be referenced when future drug development is in process.

The two types of oral drugs being looked at either act locally within a specified area, (i.e. the gastrointestinal tract) or act systemically, circulating in the bloodstream.

With studies looking at locally acting drugs, they are usually terminal in nature meaning subject are artificially infected with a parasite and at the end of the study, in order to look at the overall physical impact a drug or potential parasite in question has made, subjects are euthanized.

The collection of adequate blood samples is important for the success of this model. In order to get the best blood results, the dogs need to be calm when blood samples are taken. In order to achieve this, the plan is to have dogs be well exposed to veterinary care by receiving vaccinations and routine care as well as being socialized, with this exposure getting implemented two months prior to the start of the study. This exposure is also intended to set up the dogs for a well-adjusted transition into life as a pet at the end of the study, where socialization and exposure to proper vet care are essential.

In addition to this, the FDA implemented other councils and working groups to help ensure the welfare of animals is maintained and improved upon, the first being started in January 2018.

“While we understand that in certain situations the use of animals in research is needed, we are committed to exploring ways to help FDA scientists and product developers reduce reliance on this practice. This proposed study is a big part of that effort.”

Another argument in the case of eliminating animal studies comes from the human health side, with an argument that not only do animal studies not accurately represent a safe application into human health, but that it has negative financial implications as well, covered by Outsourcing-Pharma.com.

Lisa Kramer, Ph.D. and professor of finance at University of Toronto stated that failure of drug development can be seen at every stage, with two main reasons for these failures being efficacy and safety.

“The practice of collecting non-human animal model data prior to advancing to human clinical trials has been shown to both allow harmful drugs to advance to market and to prevent safe and effective products from advancing.”

Kramer also noted that the efficacy of animal studies being able to predict human results is almost as effective as “flipping a coin” and that if human patients were fully aware of the risks associated with these trials, they might not elect to participate.

However, another model for animal testing with human applications has been suggested in the form of canine cancer, detailed in this report from Outsourcing-Pharma.com.

Jonathan Mochel, from Iowa State University, presented at AAPS PharmSci 360 earlier this month, stating a need to bridge the gap between drug development created in mice or rats and the transition to human treatments. His argument is to use data gathered from dog models who have diseases that are almost identical to that of humans: Crohn’s disease, cancer, and Alzheimer’s.

This would also take into consideration any environmental factors or roles played in the developments of these diseases, seeing as pet dogs live in the same environment as their human counterparts, theoretically being exposed to the same carcinogens.

With dogs having a shorter lifespan than humans, their cancer progresses at a faster rate. This can help researchers determine a drug’s efficacy at a faster rate. Coupled with dogs being viewed as members of the family, there is the potential for learning in both species on how to treat naturally occurring cancers.

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