The following post is on the importance of informed consent and medical ethics using examples from the history of gynecology and a more recent example: Gardasil
Today, we all are aware of Margaret Atwood’s ‘The Handmaid’s Tale’. Did you know that there was a time when slaves were used similarly for reproduction and reproductive studies by the ‘Father of Modern Gynecology’?
Don’t believe me?
Read this article which is published by the Journal of Medical Ethics in 2006. The journal article details why the slave women would have had to give some amount of consent as ether anesthesia was not established as a practice during the vesicovaginal fistula operations conducted on these women. This journal article below is a scathing review on Sims’ practice and alleges that he knowingly did not use anesthesia and did not ask for permission from these women. The other two articles are by History.com and the Washington Post on why Sims’ statues have been removed/under attack.
While the two journal articles provide some context, it is still hindsight. So instead imagine this:
If you were kidnapped, stripped of all of your rights as a citizen, and as a human being. You had to do as told, and if this was your entire world and you knew of no other existence. If your captors sold you off to a doctor who promises to take care of you, would you not have gone through with it?
Besides the fact that these women and children were slaves, were not given rights, were illiterate and did not know enough about medical practices, how are we to be positive that they were aware and consented to the gory practices they were subject to?
You might be thinking, sure this sort of nonsense only happened eons ago, it won’t happen today.
Think again!
Below is an example of problematic Informed Consent with the HPV Vaccine Gardasil.
(sources from Nature.com and Sciencemag.org)
Gardasil – the HPV vaccine clinical trials were held in India by US based pharmaceutical companies. Despite having clear obligations and responsibilities outlined for clinical trials have had a lot of issues, including:
- Failure in obtaining clear, informed consent. (many participants were illiterate and little was done to ensure an adequate provision of explanation).
- No control group. (Any clinical trial worth its salt will have a control group to support the efficacy claims. Otherwise the claims of success might as well be assigned to random chance, a 50-50% possibility of not getting cervical cancer).
- No mechanism for reporting adverse effects (this is what lead to many people and news/media outlets claiming that deaths were caused by use of this vaccine).
After the inquiry and media outburst, steps were taken to remedy the issues. The underlying problem although is that these issues should never have occurred, there are clear rules that each clinical trial must adhere to. Please click here to learn about Institutional Review Boards and their function in clinical trials in protecting human rights.
To be clear: The vaccine HAS NOT caused the death of children or women.
Here is an article debunking the entire claim:
I have been a benefactor of this vaccine. I had the opportunity to get the vaccine, and I took it (I didn’t know about the trials at the time and did not have a scientific background to assess the trial information either). I received an education in science from 2012 onward. Death by cervical cancer is horrendous and any chance to lessen that should be taken.
The point of this article is not to degrade the value of vaccines or any medical solution to health problems. The point is, to increase awareness of medical ethics and informed consent.
Gardasil was approved by the FDA in 2006 and has shown good efficacy against cervical cancer (which it does, I do not disagree with that part one bit). I found this awesome blog post by SkepticalRaptor on the facts and debunking nonsense regarding Gardasil.