Gender Problem in Pre-Clinical Drug Research
Most drug researches and developments use male animal model, preventing women from getting the best drugs.
When I read an article about how animal model used in drug research prevents women from getting best drugs in a New Scientist website, I immediately remembered the time I did both my bachelor and master’s research in university. For both degrees’ research project, I conducted experiments to search natural herbs’ activity on the immune system.
I chose female mice as animal model for both experiments and some of my friends questioned my choice. They argued that the female hormone cycle would bias the experiments’ result. I did not counter their argument, but I thought, “What if the disease has something to do with hormonal cycle, which only happens in female? What if the drugs respond along with the hormones in female body? Isn’t it something to be searched instead of put aside?”
In researching a potential drug for a certain disease, first we have to conduct an experiment in an animal model to ensure that the chemical (both synthesized and natural) has desirable activity. It is called a pre-clinical trial phase. Most researchers prefer male animal model than female, based on the hypothesis that hormone cycle in female animal will disrupt the obtained result. Hence the result is not as objective as wanted, and cannot be further developed to human trial. They argue that by using female animal, the drug cannot be used in male patients.
In the article mentioned above, it was stated that by choosing only male animal as a model in drugs’ research presents further problem. Drugs that were later developed using only male animal model may be less effective in female. Also stated in the article, drugs that were developed using data from male animal-only model might even produce greater harm for women.
Even if researchers minimize gender-imbalance in the clinical trial phase, drug tested in clinical trial was chosen from pre-clinical trial that only uses male animal as subjects.
We must admit that there are certain differences in male and female biology. It is exactly because of that, we have to consider both of them in drugs development. This gender bias in pre-clinical research will only push aside potential drugs that work better in women, because researchers only consider pre-clinical results from male animal model to be continued in the clinical trial phase.
Gender related problem in drugs’ s researches is nothing new. It has been going on for decades. Researchers first acknowledged the problem when they found out that marketed drugs have worse adverse effects in women patients. It turned out there was a gender-imbalance in clinical trials’ samples that led to bias results of the drugs’ activity and toxicity in human. Back then, the number of female patients included in the trial was low and any adverse effect experienced by them wasn’t recorded accordingly.
Only by 1994, did the United States require all clinical trials funded by the government department to include women in their sample. But, as you see, the gender-related problem has started even before the drugs reached clinical trial phase. Even if researchers minimize gender-imbalance in the clinical trial phase, drug tested in clinical trial was chosen from pre-clinical trial that only uses male animal as subjects.
In Indonesia, despite the lack of new drugs’ development, our researchers perform a lot of experiments in examining plants’ activity as a potential drug. If you searched published scientific articles about pre-clinical drug researches, most of the experiments used male animal model. It is not caused by the unavailability of the female animal, but due to the hormone influence hypothesis.
As researchers, we should really ask ourselves several questions. If we want the best treatment we can give to the patients, shouldn’t we also prepare the best drugs for both men and women? If we are serious about promoting health and health justice, why do we set aside one gender from the drug’s development process? By considering only one gender in the development process, aren’t we, researchers, undermining the role of hormonal cycle in women’s body? By doing so, aren’t we undermining the importance of our own biological process?
