News

How Clinical Trials Are Failing Women

by Chris Tognotti

Sometimes, you can't trust everything your doctor and WebMD tells you — because the medical community at large could be ignoring medical differences between the sexes in clinical trials. A report released Monday by the Connors Center for Women's Health at Brigham and Women’s Hospital in Boston found that many medical studies fail to do so: Test subjects are predominantly male, the report points out, and studies just don't differentiate between the sexes for a finer understanding of the research.

Let's take one big example: Women's heart health. Many more women die from heart attacks than men, and heart disease is the number-one killer of women in America. Yet, clinical trials designed to analyze and combat heart ailments mostly feature male subjects — men make up about two-thirds of that trial population.

Worse yet, the report finds only one-third of those tests actually draw a distinction between men and women in their outcome statistics, despite the fact that women's hearts grow weak and struggle in different ways than men's do.

For example, a very standard test for clogged arteries, in which dye is injected through the heart to visually demonstrate areas of diminished blood flow and blockage, is less useful for women than it is for men. This is because arterial plaque formation inside women's hearts tends to be more diffuse and less concentrated than in that of a man's — a distinction extremely important to female patients, and for men as well.

Unfortunately, according to the report, the medical community just isn't recognizing the distinction.

Paula Johnson, executive director of the Connors Center, told Bloomberg Businessweek that this is an issue fundamental to women's health.

We’ve got to do the work and change the way science is done and translated to clinical care. Until we do that, we are putting women’s health at risk. ... We do have the technology to go into the artery with a small ultrasound probe, or measure the flow across the artery, [though doctors] have to be thinking about, and have knowledge that these sex differences do occur.

More bad news: As it happens, not all flawed studies are just falling short of a well-intentioned goal. Sometimes, you can run into a scientific study that has no merit or basis whatsoever — just a products of a random algorithm.

Don't believe us? Just ask the 30-plus different science publications which were forced to eliminate entirely nonsensical studies from their archives. Why? Because they were made by an online generator explicitly designed to create fake studies — the description of the generator, created by MIT students in 2005, states it plainly: "Our aim here is to maximize amusement, rather than coherence."

Oh. Oh dear.

Prioritizing amusement over coherence is a dangerous game, at least when fraudulent medical studies are involved — but at least it draws attention to another dangerous issue: Failing to ensure a paper is factual before it hits medical journals.

And possibly even more harmful is not considering the unique health differences faced by women in clinical trials. Which all goes to show, whether by nefarious design or by simple negligence, it's often worth digging a little deeper into the data.