Before authorising any new drug for public consumption, these must go through many steps. When researchers develop new drugs, the first tests are called pre-clinical studies. Often this starts with a positive result on a cell, tissue samples, then test on mice, followed by tests on large animals and then on humans. These drugs are not tested directly on humans because the risks of mortality are unfortunately too high. I am not saying that animal life is worthless but only explaining how most pharmaceutical testing work.
Every year, Health Canada received numerous clinical trial applications for testing new drugs on humans. What we understand is that clinical trials studies are supposed to find out whether the drug is safe and effective for people. What we didn’t know is that clinical trials are often done with young men. Pharmacology is therefore poorly adapted to women’s metabolism. For many years, it was accepted that women did not differ from men except where their reproductive organs were concerned. It was therefore assumed that data obtained from male subjects could simply be extrapolated to women and there was, therefore, no need to include women in clinical trials.
Some medications (Seldane, Cisapride) that were deemed perfectly fine after testing on young men turned out to be associated with potentially fatal cardiac arrhythmias in women.
In the 1960s, all drugs were developed from male animal models. The situation has improved since then.
Since the 1997’s, Pharmaceutical companies are encouraged, but not obligated to include women in clinical trials. So before this time, it didn’t occur to researchers and government leaders that women may have a different drug efficacy or side effect profile than men. Since 2010, Ethical Conduct for Research Involving Humans guidelines states that women shall not be inappropriately excluded from clinical testing. That was only 7 years ago! Am I the only one to find this information ridiculous? These are still guidelines and recommendation, not obligations.
Even today, information on potentially serious side effects in women are not available. Health Canada should require pharmaceutical companies to share this information.
Individuals who volunteer for clinical trials ar warned of possible side effects. Unfortunately, there is usually limited information about the safety and efficacy of the drug being studied at that time. These trials give Canadians a chance to take part in research that could improve their health.
Canada does have a set of good clinical practices that pharmaceuticals must follow, such as protecting the health of the people in the trial, that the trial is conducted by trained professionals, that the result is monitored adequately and any potential side effects are reported to Health Canada.
It was recently found that the use of antipsychotics can be dangerous for men. Quebec has already put in place an initiative to reduce the use of antipsychotics. Although I am happy that the province is acting quickly to help reduce the danger associated with antipsychotics, I find it deplorable that they once again move much faster when it comes to men’s health than women’s health.
- Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences – Health Canada – May 29, 2013
- Equal but not the same
- Gender Bias in Research – Journal of the Royal Society of Medicine.
- In Canada’s Healthcare system, female can have deadly consequences
- Medicine’s deadly gender gap – Maclean’s