VOA健康报道2023--Drug Trials Often Do Not Include Overweight People

Drug Trials Often Do Not Include Overweight People

More than 40 percent of American adults are considered obese¹, or medically overweight. But the medications many of these individuals take are rarely tested in bigger bodies.

Obese people are currently not required to be included in drug studies. Often, they are purposefully left out.

This is a problem because the amount of drugs an obese person should take to be safe is unknown, says Christina Chow. She is a researcher who has sought to bring attention to the need to include obese people in drug development and testing. "There's no real emphasis for them to be studied at all," Chow told The Associated Press.

Medications can work differently in people who are obese, but exactly how and at what amount is not clear. Research suggests this includes antibiotics² and antifungal drugs, medications used to treat serious infections. It even includes ibuprofen, a commonly used painkiller³ that can be bought without a doctor's orders.

The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are the agencies that control and provide money for drug testing. At a gathering⁴ last year, FDA Commissioner⁵ Dr. Robert Califf noted⁶ a "deficit⁷ of evidence" about how medicines act in patients who are obese. The NIH now asks researchers to think about the results of not including obese people in their studies, an agency spokesperson said.

At a recent medical conference, Chow presented a review of more than 200 studies for new drugs in the U.S. last year. Nearly two-thirds of the studies failed to include weight or body mass index, a numerical value noting if a person is obese.

Historically, some populations have not been included in drug testing to avoid harm, including pregnant women and children. In the past, women, racial and ethnic⁸ minorities and aged⁹ people have also not been included.

Dr. Caroline Apovian is a researcher at Brigham and Women's Hospital in Boston. She is the co-author of Chow's study. Apovian told the AP there are many reasons people who are obese are not included in drug tests.

She noted that people who volunteer for trials are often thin and healthy and this does not effectively represent the general population. Obese individuals can have many health difficulties, and researchers often worry this will affect results of their work.

"Sometimes patients with obesity¹⁰ have many more comorbidities than others. They'll have more diabetes¹¹, more heart disease, more strokes," Apovian said.

But if drugs are not studied in a condition that affects 42 percent of the U.S. population, the real-world effects can be dire¹², experts say.

Some drugs remain in the body longer in obese people. That could result in harmful drug interactions if another medication is added too soon. There can also be less medication in the blood, leading to undertreatment, Apovian said.

Rexulti is a drug often used to treat people with schizophrenia or depression, Chow noted. Research has shown that in obese patients it may take much longer to reach the amount of Rexulti needed to be effective. As a result, many patients and their doctors may stop treatment too early or believe the drug does not work.

"Not treating or undertreating schizophrenia may be dangerous to themselves and the people around them," Chow said.

Even a drug as common as ibuprofen may not reduce pain in people at higher weights when taken as directed, research shows.

But without testing and clear directions, doctors won't know the amount of medicine needed for obese people, said Dr. Colleen Tenan. She is a board member of the Association of Clinical Research Professionals. Tenan said it is very hard to be a doctor and direct patients to take amounts of medication that have not been tested.

Change is coming, but progress is slow, said Dr. Alison Edelman. She is an obstetrician and researcher at Oregon Health & Science University. She told the AP that in 2019, the FDA suggested that researchers permit obese women in studies on birth control. Even though the suggestions are not required, they have already changed how she and other researchers structure their studies.

"Because unless we see representation in our study population, we don't end up with treatments that work well for individuals," Edelman said.

Apovian, from Brigham and Women's Hospital, said patients can ask their doctors about whether the usual amount of a medication is acceptable for their weight. Even if the doctors do not know, the question could start an important discussion about the most effective treatments.

"This is a big issue," Apovian said. "It can be important for patients to speak up."

Words in This Story

emphasis –n. special importance

comorbidities - n. two or more diseases or medical conditions in a patient

dire – adj. extremely serious or urgent

schizophrenia – n. a disease that affects the way the brain processes information and causes a loss of touch with reality

1 obese   

adj.过度肥胖的，肥大的

参考例句：

• The old man is really obese,it can't be healthy.那位老人确实过于肥胖了，不能算是健康。
• Being obese and lazy is dangerous to health.又胖又懒危害健康。

2 antibiotics   

n.（用作复数）抗生素；（用作单数）抗生物质的研究；抗生素，抗菌素( antibiotic的名词复数 )

参考例句：

• the discovery of antibiotics in the 20th century 20世纪抗生素的发现
• The doctor gave me a prescription for antibiotics. 医生给我开了抗生素。

3 painkiller   

n.止痛药

参考例句：

• I shall persuade him to take the painkiller.我将说服他把药吃下去。
• The painkiller only provides him a short respite from his pain.止痛药仅仅让他在疼痛中有短暂的疏解。

4 gathering   

n.集会，聚会，聚集

参考例句：

• He called on Mr. White to speak at the gathering.他请怀特先生在集会上讲话。
• He is on the wing gathering material for his novels.他正忙于为他的小说收集资料。

5 commissioner   

n.（政府厅、局、处等部门）专员，长官，委员

参考例句：

• The commissioner has issued a warrant for her arrest.专员发出了对她的逮捕令。
• He was tapped for police commissioner.他被任命为警务处长。

6 noted   

adj.著名的，知名的

参考例句：

• The local hotel is noted for its good table.当地的那家酒店以餐食精美而著称。
• Jim is noted for arriving late for work.吉姆上班迟到出了名。

7 deficit   

n.亏空，亏损；赤字，逆差

参考例句：

• The directors have reported a deficit of 2.5 million dollars.董事们报告赤字为250万美元。
• We have a great deficit this year.我们今年有很大亏损。

8 ethnic   

adj.人种的，种族的，异教徒的

参考例句：

• This music would sound more ethnic if you played it in steel drums.如果你用钢鼓演奏，这首乐曲将更具民族特色。
• The plan is likely only to aggravate ethnic frictions.这一方案很有可能只会加剧种族冲突。

9 aged   

adj.年老的，陈年的

参考例句：

• He had put on weight and aged a little.他胖了，也老点了。
• He is aged,but his memory is still good.他已年老，然而记忆力还好。

10 obesity   

n.肥胖，肥大

参考例句：

• One effect of overeating may be obesity.吃得过多能导致肥胖。
• Sugar and fat can more easily lead to obesity than some other foods.糖和脂肪比其他食物更容易导致肥胖。

11 diabetes   

n.糖尿病

参考例句：

• In case of diabetes, physicians advise against the use of sugar.对于糖尿病患者，医生告诫他们不要吃糖。
• Diabetes is caused by a fault in the insulin production of the body.糖尿病是由体內胰岛素分泌失调引起的。

12 dire   

adj.可怕的，悲惨的，阴惨的，极端的

参考例句：

• There were dire warnings about the dangers of watching too much TV.曾经有人就看电视太多的危害性提出严重警告。
• We were indeed in dire straits.But we pulled through.那时我们的困难真是大极了，但是我们渡过了困难。