The first testing of a drug to be approved in Canada, or in the US by the FDA, or for the EU's drug agency, requires giving the drug at various doses to healthy persons. We often are taught that these are very much volunteers, who participate for only good reasons.
If there are bad side effects or even dangerous consequences to new drugs, then these factors must be known or clinical trials on sick persons might cause great harm. Yet, we seem to experience the removal of some drugs from the market long after their approved use causes some severe adverse effects. The adverse effects signal tends to take a couple of years or more before it becomes apparent that the drug should never have been approved because of its severe side effects. How can this be missed in Phase-I?
While drug companies will publically make it sound like this first testing is done by healthy humans who volunteer to contribute to science, the reality about Phase-1 safety testing is not that way at all. It could be, but the way volunteers are recruited and how they are paid has created a system that does not work as advertised.
You can check out the trailer for the new documentary "Bodies for Rent", produced by Habiba Nosheen in collaboration with the Investigative Journalism Bureau, Dalla Lana School of Public Health Sciences, at the University of Toronto.
You can learn more about this issue by listening to this recent radio broadcast from The Current show on CBC Radio. "The human ‘guinea pigs’ testing drugs for a living"
https://www.cbc.ca/player/play/audio/9.6518056
The reality in both the United States and Canada is that people are paid to do clinical trials and most of those persons are people who come from the lower income levels of our society and who are struggling to pay their rent, buy food, clothing, and transportation. Those from our society, who are desperate for income to survive.
Furthermore, these human guinea pigs, are often people who do this many times for many drugs. If they complain about side effects they are removed from the safety trial and will not get the full pay for their efforts. So, these "volunteers" learn to NOT report if they have side effects. They endure them. There are even social networking groups of people who survive economically off this work and who share advice on how to avoid being dropped from a Phase-1 trial to avoid losing their pay. So, if you are at week 9 of a 12-week trial, and note to the investigators the severe headache that you are having, they drop you from the trial. However, they do not pay you for 9/12 weeks of your time. You can see the problem in this process without me spelling it out. It also means that you often do not tell them about your headache so you get to 12 weeks and get your pay. You then become a data point of a person who experienced no side effects.
Of course, this means that drug companies get final safety test data that LOOKS like there are no side effects. Can you imagine the problems with this process?
This is the situation in 2024 in the United States and Canada. Patients, physicians, bioscientists, medical students, governments, and pharma companies need to be aware of this and do something about it.
KPM