Pages Menu
TwitterRssFacebook
Categories Menu

Posted by on Aug 17, 2016 in Health | 9 comments

The Gender Gap in Health Care

Health care is something that should, by its very definition, care equally for both genders. Men and women both get sick, though they can be affected very differently by the same diseases or conditions.

In spite of the perceived illusion of equality that presents itself whenever health care is discussed, there is an enormous gender gap when it comes to research and the development of treatment plans. These treatments, which could be used to save lives, are being overlooked in favor of other more visible diseases that often garner more funding.

All The Cells

Before any sort of drug, treatment or procedure can be tested on humans, it’s tested in a petri dish, on small clumps of targeted cells. This style of testing is most common when dealing with cancer treatments and other procedures that are designed to target a specific type of cell.

What does this have to do with the gender gap that is currently manifesting in the health care industry? Simple – these cells are not categorized by gender, age, nationality, genetic profile or any other modifier. Instead, they’re just sampled and tested. While this doesn’t generally limit the efficacy of this stage of testing, it can create an incomplete set of data that could potentially change the overall outcome of the trials.

The Phases of Clinical Trials

Once a drug or procedure reaches the human clinical trials stage, it then has four phases that it has to pass through before it can be considered safe. Phases one through three take place before the drug is marketed to the public, and phase four takes place after the drug has been released.

The first phase determines how safe the drug, device or treatment is. These small trials usually consist of less than 100 participants and are designed to determine the effects of the drug, how it is metabolized and absorbed by the body, etc. It also allows the researchers to observe any side effects that might affect patients in the future.

The second phase is designed so researchers can determine how effective the drug actually is. Yes, you did read that right – whether or not the drug is effective in treating its targeted disease or disorder is actually less important than whether or not the drug is safe. This is a good thing. These studies take infinitely longer than the first-phase studies, lasting anywhere from a few months to two years, and allow researchers to find out things like which dosages work the best and how well the drug actually functions in the real world.

The third phase is a rehash of the second, just on a much larger scale. This provides both drug companies and the FDA a large data pool from which to pull, and these studies often last years and involve thousands of participants. Once a drug has passed this phase, it can be marketed to the public.

The fourth phase can last for as long as the drug is actually on the market and being prescribed. This stage is designed to compare the drug to other similar drugs that are already being used, as well as continue the long-term studies that were started in phases two and three. Any major problems found during the phase four studies can cause the drug to be pulled off the market.

Missing: Women in Clinical Trials

One of the most heavily studied conditions in the United States right now is cardiovascular disease. This disease affects both men and women, though the disease and its symptoms manifest differently in both genders. Why is it, then, that less than one-third of clinical trial participants for cardiovascular disease treatments are women?

The NIH (National Institutes of Health) Revitalization Act of 1993 required that women and minorities be included in clinical research and trials, but as it stands, the female half of the species is still vastly underrepresented in the world of clinical research.

Why is it so important to include more women in clinical trials? Well, if you exclude the fact that they make up 50.8 percent of the population of the United States, the simple fact is that men and women are different, and we don’t mean that in the we’ve-got-different-dressing-rooms kind of way. Women metabolize drugs differently than men do, and even that changes during their lives due to the dramatic shifts in the endocrine system during puberty, birth and menopause.

You can’t run a clinical trial with only male participants and expect to get an accurate data pool for the entire population. That’s Biology 101.

Men Are Missing Out Too

Women aren’t the only one getting the short end of the stick when it comes to clinical trials and medical research.

For example, some cancers that are generally considered female-only, like breast and ovarian cancer, are receiving the majority of funding while other fast-growing cancers, such as lung and esophageal cancer, are receiving little to no funding.

Going back to the breast cancer example, contrary to popular belief, this is not a female-only disease: Men can get breast cancer too. When it comes to clinical trials, this is one of the major places that men are getting the short end of that same stick.

Only about half of the clinical trials available for breast cancer treatments are open to male patients, and most studies that are done in regard to male breast cancer are only epidemiological in nature, not even branching off into the realm of clinical trials.

This is just one example of the many single-sided clinical trials that are not actively excluding the other half of the population, but tend to ignore them just the same.

Benefits of Clinical Trials

Why are these human clinical trials so important when it comes to developing new drugs and treatments? Because you won’t know what effects the medications or treatments have until they’ve been tested on a human being. Sure, researchers have access to an enormous variety of tissue samples and test animals ranging in size from a small mouse to a rhesus monkey, but none of those test results will provide an accurate picture of how a new drug or medication will affect the human body, both in short- and long-term applications.

Why are they so important?

In a word – curiosity. We don’t have all the answers and without the proper tools, including clinical trials, we will never get them.

There is still a lot we don’t know about how the human body works, but with observation and clinical trials, we’re that much closer to finding the best way to treat all the things that break down in the human body.

Click here for reuse options!
Copyright 2016 The Moderate Voice
  • “these cells are not categorized by…”
    Many cells, particularly cell lines, are not properly characterized at all…or falsely characterized. This is a giant ball of crap that scientists are trying to correct.

    This article is close to home for me… I am trying to raise venture capital investment for a phase 1 clinical trial for a heart attack therapy. Phase 1 in my world is more like 10 patients, but I am still looking at raising 6 million dollars/euros….which is a side the author doesnt mention…cost!

    • KP

      Rock On, mate.

      Exciting stuff.

      • Thanks…I was once told that entrepreneurship is “cool”.
        “Frustrating” would be a better word.

    • Bob Munck

      Many cells, particularly cell lines, are not properly characterized at all…

      HeLa cells are. Would they be used in this kind of thing?

      I strongly recommend the book The Immortal Life of Henrietta Lacks by Rebecca Skloot. I found it quite mind-boggling.

      • HeLa is good.. almost too good. There is a big problem with that cell line contaminating other cells lines. I dont work with them luckily. We work with a lot of patient cells.

  • dduck

    Thanks Holly.

  • KP

    Holly, important issue(s).

    Top shelf post.

  • In answer (I used to test clinical samples for Johnson and Johnson occasionally):

    Men do not tend to have plasma changes going from soup to nuts depending on the time of the month in their reproductive cycle.

    Testing (chemically) the samples from volunteer test subjects is tricky business. All sorts of globs and such can get in the way of extracting the same amount of plasma. Creating the test methods for these does NOT usually include using plasma from volunteers who include women. This makes it very difficult to be certain that a test method is robust (if women are in the sample pool).

    I am not suggesting that women should NOT be in clinical trials. I am suggesting that women in clinical trials do not represent a single category. Women who are ovulating, women who have already ovulated, women during menstruation, women who have not ovulated yet–these are, chemically speaking, different groups.

    In theory, women who have finished (not reached, but finished) menopause would likely be a homogeneous group. Little girls might also be a homogeneous group. However, given the higher likelihood of disease in both groups, that would also make any tests extremely difficult to conduct.

    So, in short, the reason that men are chosen twice as often as women for clinical trials is that it is easier (and thus cheaper) to test the samples.

    • Great point RPC. One of the more difficult and important parts of performing a clinical trial is how to properly categorize your patient cohorts.

Twitter Auto Publish Powered By : XYZScripts.com