More than 40% of American adults are considered obese. But the medicines many people take are rarely tested on larger bodies.
That’s because it doesn’t need to be included in drug studies. And often they are clearly separated.
Clinical trials and dosing recommendations do not always guarantee that a drug will be safe and effective for obese patients, said Christina Chou, a drug researcher who reports on the challenges of determining obesity in 2010. Drug development said There is no real emphasis for them to study at all.
Many over-the-counter and over-the-counter medications work differently in people who are obese. But it is often not clear exactly how and in what quantities. Research suggests it may include antibiotics and antifungal drugs used to treat serious infections. Synthetic hormones used in emergency contraception, Plan B, and even ibuprofen which is a common pain reliever sold as Advil
The U.S. Food and Drug Administration and the National Institutes of Health agency that regulates and funds drug testing are highlighting new research gaps. At a workshop last year, FDA Commissioner Dr. Robert Califf acknowledged “the lack of evidence about how to use the drug in obese patients. NIH is now encouraging researchers to consider the results.” Impact of excluding obese people from their studies, spokesperson said
At a recent medical conference, Chow presented a review of more than 200 studies of new drugs in the U.S. last year. Of those, nearly two-thirds did not mention weight or body mass index, which assess disease. Generally fat This means that they do not guarantee that people who are obese are included in this group.
said Chow, who works for Emerald Lake Safety, a California-based company that investigates severe drug reactions. Weight-based studies are often used to exclude people who are obese from participating in programs. People with a body mass index or BMI of 30 or higher are considered obese.
Historically, certain populations have been excluded from testing due to fear of harm. Including pregnant women and children, women, and racial and ethnic minorities. And the elderly are underrepresented. This was before the recent efforts to promote diversity.
Dr. Caroline Apovian, a researcher at Brigham and Women’s Hospital in Boston and co-author of Chow’s study, said the reasons for screening people out for obesity are long and diverse.
Participants willing to enroll tend to be smaller in number and do not reflect the general population. she remarked And researchers often worry that the health complications that come with obesity will cloud their results.
Sometimes obese patients may have more comorbidities than others. She said they will have more diabetes. more heart disease and more cerebrovascular disease
But what if the drug isn’t studied in a condition that affects 42% of the U.S. population? The real-world consequences can be dire. experts say
Some medicines may be concentrated in fatty tissue and not in the bloodstream. That means there will be less medicine in the blood. That leads to inadequate treatment, Apovian said.
Other drugs remain in the body longer in obese people. That can result in dangerous drug interactions if other drugs are added too quickly.
An antipsychotic drug called Rexulti is often prescribed for people with schizophrenia or depression, Chow said. Research has found that in obese patients it can take much longer to reach the concentration of Rexulti needed to be effective. As a result, many patients and doctors may stop treatment too soon or conclude that the drug is ineffective.
Not treating or undertreating schizophrenia can be dangerous to yourself and those around you, Chow said.
Emergency contraception, Plan B1Step, is another example. Studies suggest that levonorgestrel which is an active drug, may not be effective in people who are obese This can lead to medication failure and pregnancy, said Dr. Alison Edelman, an OB-GYN and researcher at Oregon Health. & University of Science studies birth control and obesity, but the FDA says the data is limited and conflicting. Therefore, there is insufficient evidence to require a warning label.
Even generic drugs like ibuprofen sold as Advil may not relieve pain in people with a higher body weight when taken as directed.
But without proper testing and clear instructions Doctors simply won’t know how to adjust doses for obesity, said Dr. Colleen Tenan, a board member of the Association of Clinical Research Professionals.
It’s very difficult to be a doctor and say I’m going to prescribe more than normal, she said.
Change is coming. But progress has been slow, Edelman said. In 2019, the FDA issued draft guidance on hormonal birth control that asked study sponsors to remove restrictions on body mass index. And this includes women who are obese. The advice isn’t final, though. But it has already changed the way she and some researchers structure their studies, she said.
It’s just something we have to let go of because it’s so important,” she said, because if we don’t see representation in our study population. We do not end up with a treatment that is tailored to each individual.
In the meantime, Apovian said patients can ask their doctor if the standard dose is appropriate for their weight. The doctor may not know. But it can start an important conversation about effective treatments.
This is a big problem, she said. It is important for patients to speak up.
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The Associated Press Science and Health Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. The AP is solely responsible for all content.
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