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Phar-men-ceuticals and the story of Viagra

Since hitting the markets in 1998, Viagra, the world’s leading erectile dysfunction pill, has been synonymous with vigorous growth. It is so influential that the US Military allocates approximately $41.6 million for it in their annual budget and almost 8 million prescriptions are written for it each year.

But were the researchers searching for a cure all to erectile dysfunction when they conducted their trials? Nope.

Sildenafil, the active chemical in Viagra, was originally supposed to be a drug targeting high blood pressure and cardiovascular disease. During the animal trials, the drug seemed to work well with no major negative side effects. So, Sildenafil moved on to the human trial phase. Things were running smoothly; however, the nurses working the trials noticed something strange…

Almost every test subject laid on their stomachs when the nurses came in to check on them and document their symptoms. With the end of the story already spoiled, we know it is due to the massive erection they had and their obvious embarrassment about it. But the interesting part isn’t the erection – it is the beginning of the first sentence of this paragraph: “Almost every test subject.”

The test subjects were primarily men.

Unfortunately, this is extremely common in the pharmaceutical industry; men dominate the number of subjects in clinical trials. Without the overwhelming number of male subjects, Viagra would not have been "discovered" at all. But how come women are so underrepresented in clinical trials?

Women’s bodies are seen as “too complex, variable and costly” for drug trials due to the varying hormones throughout women’s cycles.

In fact, if women are even included in a study at all, it is primarily during the first stage of the female cycle. When a woman's body is most like a man’s, so to speak. Even when it comes to animal trials, the majority of the animals tested on are male.

You would think this would be corrected already. Especially when the FDA list “simply not working” as the second most reason for an adverse drug response in women (even though the same drug clearly has the intended effect on men). But still today, women are strongly underrepresented as subjects in clinical trials. A public Evaluation Report of the European Medicines Agency (EMA) stated that half of the new medicines approved in 2018 and 2019 were tested on groups with less than 50% of women.

Time is way overdue to have more women included in clinical trials and to have these drugs working for us too. At the Femacy we strive to close this gender health gap together and want to raise awareness for the bias and inequality women and everyone who identifies as female face today.

* Oh, BTW: When there was an attempt to test the Viagra on women to find out whether it is effective as a drug against high blood pressure and cardiovascular diseases, the money simply ran out. Thanks for nothing!

 

Sources:

“Invisible women. Exposing data bias in a world designed for men.” By Caroline Criado Perez, 2019

“The Rise of Viagra: How the Little Blue Pill Changed Sex in America” By Meika Loe, 2004

“FDA approves Viagra” HISTORY.com Editors, 2009

Foley, Katherine Ellen. “Viagra Famously Surprising Origin Story Is Actually a Pretty Common Way to Find New Drugs.” Quartz, Quartz

Miller, Korin. “​You Won't Believe How Much the U.S. Military Spends Each Year on Viagra.” Men's Health, Men's Health, 25 Feb. 2019

Spektrum, “Die Medizin muss weiblicher werden”, 2020

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