Gender Equity in lab rats: is it a procurement problem?
In collaboration with Siddhartha Shaurabh, Lead Analyst (Chemistry & Research Model Services)
Gender biases are a reality of life! We continually argue about how to bridge the gender gap in offices, educational institutions, politics and so on with no clear conclusion whatsoever. In fact, gender divide is so entrenched in our societies such that even the animals used in pharma research are not spared!
Lab testing of animals is an important precursor to clinical trials of new drugs. For example, a drug could first be tested out on lab rats before moving onto human beings. However, a little known fact is that researchers predominantly use only male animals to test out their new drugs.
This "male preference" has led to criticism among activists of various stripes. Meanwhile, the academic as well as scientific circles are of the opinion that this practice should stop.
About 21 years ago the U.S. Congress required the National Institute of Health (NIH), the government's medical research agency, to include women in research it funded that involved human subjects. Prior to that rule, certain types of drug testing had excluded women, leading to findings that failed to account for important sex differences.
But the law did not mandate the inclusion of both sexes in the basic research involving lab animals that paves the way for human trials. Experts say an existing bias toward male lab animals, tissue and cells can lead to flawed findings.
|
Research Area/Therapy |
Male : Female Ratio |
|
Neuroscience |
5.5:1 |
|
Pharmacology |
5:1 |
|
Physiology |
3.7:1 |
|
Behavior |
1.4:1 |
|
Behavioral physiology |
1.5:1 |
|
Reproduction |
1:1.6 |
|
Immunology |
1:2.2 |
Source: Sex Bias in Neuroscience and Biomedical Research: Beery & Zucker, Neurosci Biobehav Rev. Jan 2011; 35(3): 565-572.
From the above table, it is clear that male models were preferred more than the female models in various therapeutic areas. Why is that? Single sex is generally adopted in the animal studies to reduce the cost of experiments or in hopes of lowering the deviation of results (McCarthy et al., 2002). Researchers may avoid using female animals because hormone levels, which fluctuate throughout the estrous cycle, can interact with experimental outcomes (Becker et al., 2005; Wizemann et al., 2001).
On the contrary, the higher number of male research models used at early pre-clinical research stage leads to skewed clinical outcome compromising research efforts. The idea is based on premise that male and female individuals are different, hence research findings made on male research models may not hold good for females.
Gender Equity in lab rats is it a procurement problem. For example, the blood brain barrier in females is significantly different from males, thus neurological drug responses varies between the genders. A 65-year-old woman has a greater risk of Alzheimer's disease compared to a man, as they have higher rates of depression, lower rates of exercise, greater risk due to the predominant genetic and sex-specific risk factors. (Women and Alzheimer's Disease - Pauline M. Maki, Ph.D, Research Director, Center for Research on Women & Gender University of Illinois at Chicago).
In order to bring about gender equity in research experiments, the NIH had earlier announced that beginning Oct. 1 researchers seeking NIH grants must report their plans for balancing male and female cells and animals in the preclinical studies, with only "rigorously defined exceptions."
What sort of benefits would such a rule bring about? Scientific results have shown that gender related differences could impact metabolism, pharmacokinetic, toxicokinetic profiles and therefore, impact dosage and delivery routes of drug. Hence, equal participation of male and female research models at early drug discovery stage would go a long way in addressing such factors.
THE PROCUREMENT IMPACT
So far we have discussed the science behind the preference of male animals over that of their gender counterpart. Come October, what will be the procurement impact of NIH's decision to bring about equity?
It needs to be said that procurement has no say over type of animals that need to be supplied for lab tests. Instead, procurement teams would readily procure whatever the research teams ask for.
But would category managers face shortages of female cells and animals in the marketplace once companies begin to work towards ending the gender divide?
There is no reason to worry. The lab animal market is highly consolidated with top suppliers like Charles River, Covance, Jackson Lab, Huntingdon Life Science, Taconic and so on holding about 80-90% of the market.
The usage of lab animals in pharma research is primarily regulatory driven and suppliers follow the stringent regulation for animal breeding and handling. The suppliers today not only breed customized research models and perform in vivo services, but also transport and deliver it to desired location. The suppliers in this space are hence equipped to accommodate the surge once the regulatory mandate in favor of equal participation of male and female models comes in to practice.
Hence the procurement teams won't be adversely affected when the regulatory mandate sets in.
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