Editor’s focus: Off-target effect from inactives?

More information about adverse effects of so-called 'inactive' ingredients could be useful, but it also could just be a ton more information that we can't do much with once we have it

Jeffrey Bouley
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Some of you might remember when eggs were considered good for you. Then they were a risk to your cholesterol. Then they were good for you again. I’m not sure where the current consensus lies on the topic. Similar controversy exists for things like red wine, various food oils, coffee…the list goes on and on.
 
It hearkens back to the oft-recycled phrase that many of us bring out when someone “helpfully” shares that something we enjoy causes cancer, and that is, “Doesn’t everything seem to cause cancer?” It’s not true, of course, but it’s true enough.
 
The fact is that nothing, no matter how generally innocuous, is a true innocent. Much like we can cause harm to people’s well-being by speaking certain words or sharing certain news that we think is fine and pleasant or at least neutral, so too can just about anything hurt someone.
 
Earlier this year, the Massachusetts Institute of Technology (MIT) sent me an email that shared research about the inactive ingredients that constitute a hefty amount of most over-the-counter and prescription drugs. They are typically necessary to stabilize the drug or aid in its absorption, and they can make up more than half of a pill’s mass.
 
While these components are usually considered benign, a recent study from MIT and Brigham and Women’s Hospital has found that nearly all pills and capsules contain some ingredients that can cause allergic reactions or irritations in certain patients. In most cases, healthcare professionals of course have no idea that these ingredients are in the pills because there are so many different formulations.
 
“For most patients, it doesn’t matter if there’s a little bit of lactose, a little bit of fructose, or some starch in there. However, there is a subpopulation of patients, currently of unknown size, that will be extremely sensitive to those and develop symptoms triggered by the inactive ingredients,” said Daniel Reker, a Swiss National Science Foundation postdoc at MIT’s Koch Institute for Integrative Cancer Research and one of the lead authors of the study.
 
The researchers hope that their study, published in the March 13 edition of Science Translational Medicine, will raise awareness of this issue among patients and healthcare providers and help to stimulate reforms that could protect patients from drugs that they don’t tolerate well.
 
“Right now there is an imbalance in the amount of information and understanding out there with respect to the inactive components of medication,” noted Giovanni Traverso, an assistant professor in MIT’s Department of Mechanical Engineering, a gastroenterologist at Brigham and Women’s Hospital and the senior author of the study.
 
I’m definitely not against more information being available, and perhaps full ingredient lists on drug, including inactive ingredients, might be one way to help physicians and other healthcare folks to pin down when a drug may be harming a patient only because of a seemingly innocuous ingredient.
 
Of course, the challenge is that people often don’t know when they are allergic to normally harmless substances. And even when they do, will we be able to pin down which drug has that substance in a form or amount that is enough to cause a problem?
 
In my family, allergies are a pretty common issue—mostly mild, but common. My co-parent has pretty serious year-round allergies but as she notes, “I can’t avoid the whole world, and it’s mostly the pollen out there that’s attacking me.”
 
Much as Randy Willis notes in his “Out of Order” commentary this month, drugs don’t always work as planned, and sometimes it’s the microbes in our bodies that make that happen. But adjusting our microbiome in response might not be the best idea. And finding a new drug that works better is often tricky.
 
And so, much like with genomics, I welcome the new insights and information. But let’s remember that sometimes, we can’t do much, even when we have lots of data and knowledge. Sometimes, things are just bad for some of us, and that cannot be helped.

Jeffrey Bouley

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