Men, Breast Cancer and Clinical Trial Fairness

Suddenly men’s breast cancer is all over the place – The FDA is demanding that men be added to breast cancer trials and now a study about mortality rates for breast cancer being worse for men than for women. 

Breast cancer is a devastating diagnosis and my heart goes out to any person and their family suffering. But…really? Men represent 1% of breast cancer patients. 1%!

For generations seniors, women, pregnant women, ethnic minorities and children have lived with titrated prescriptions based on studies comprised of men. That means that virtually all the medical studies for all the medicines we take now are based on studying men. 

  • Do I need to list how many diseases and medical episodes present and happen differently in women as compared to men? For example, Ambien lasts much longer in women’s bodies than in men’s. So much so that the recommended dosing for women is half that of men. 
  • How children’s bodies are not miniature adults so you can’t just adjust the amount by weight. For example, tetracyclines only stain developing enamel, not adult enamel. 
  • How differing ethnic groups may also respond differently. A study of Londoners found that in the white population acetaminophen left the body much more quickly than in the Indian population. 
  • Seniors’ slowing metabolism make common meds dangerous, Benedryl for example. Here’s a link to the Beers Criteria, a list of typical needs that become a threat as you age.  
  • And to harm two for the price of one — pregnant women. Nearly every medicine taken by pregnant women is a guess as to how her stressed body will handle it and what that drug will do to the fetus. A simple reminder of thalidomide which dramatically harmed the fetus, causing shortened or missing limbs, and that Mother’s were perfectly fine. 

We desperately need more information about how everyday drugs affect people differently. 

I will grudgingly admit that some more women (not a representative amount) are being added to trials. I must argue that every single dollar spent adding and evaluating data relating to men and breast cancer is an affront, an insult to those who have and continue to be left out of trials and research.

 

More information:

https://www.regulations.gov/document?D=FDA-2019-D-2966-0001

https://jamanetwork.com/journals/jamaoncology/article-abstract/2751525 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1884865/ 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2594139/?page=22 https://www.healthinaging.org/medications-older-adults/medications-older-adults-should-avoid


Suzanne B. Robotti

Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.


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