Women Kept Out Of Clinical Trials For Long: What Are The Dangers Of It?

In recent times, we have started to understand that many women might go undiagnosed for a cardiac event like a heart attack because they don’t fit the stereotypical symptoms such as the classic pain in the chest. They might instead experience extreme fatigue or a feeling of having bad acid reflux. If men and women might show differences in the expression of diseases, they might also differ in how medicines might react to their bodies.

Reportedly, as per studies, alcohol affects men and women differently so it is very much possible that medicines might do the same. However, there is a social issue which is far less discussed and it might be the cause behind many women receiving a wrong diagnosis in the first place. The problem is that for long, clinical trials or drug trials have kept women out of their scope. As per experts, this means that it can result in women having more side effects from drugs due to the biological differences that many drug trials might have missed to observe.

Why they have been kept out of drug trials?

While the exact reason why drug trials have kept women excluded from these trials is still not very clear, experts believe hormonal causes might be involved. As per reports, in 1977, the US Food and Drug Administration (FDA) recommended that women of childbearing age might not become a part of the drug trial for safety reasons. Another reason could be that a woman’s menstrual cycle keeps her on a roller coaster ride of hormones that keep fluctuating. Hence, this could increase the element of variability in the experiment, demanding more ways to exercise control and thus adding to the overall cost.

As per quoted experts, there are drugs that are much like alcohol might show higher blood concentration and might take more time to get out of the system in women. As per quoted experts, men and women might metabolize drugs differently. Many factors might play a role in it like higher body fat composition, lower body weight and slower kidney function. Hence, including women in the drug development process might be the need of the hour to get a comprehensive efficacy of the medicine.

Conditions that often go overlooked

Since most of the medical literature has been written from a male perspective, anything or any symptom that might fall beyond the stereotypical expression of the disease might lead to misdiagnosis among women. For instance, as to studies, autoimmune diseases are more common in females than in men. Women are at least twice as likely to suffer chronic pain conditions such as fibromyalgia, and chronic fatigue and there exists a medicine bias around it. As a result of which conditions like endometriosis might see delayed diagnosis or misdiagnosis. As per studies, on average, women are diagnosed with heart disease after five or seven years more than men.

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