From VOA Learning English, this is the Health & Lifestyle report.
In 2021, the U.S. food and drug agency approved the drug Wegovy for weight loss. Now, the Food and Drug Administration (or, FDA) says the drug can reduce the risk of death from stroke or heart attack in adults who have cardiovascular disease or are overweight.
The FDA approved a usage change requested by drugmaker Novo Nordisk. The change expands the use of semaglutide, the general or generic name of the drug. Wegovy is the brand name given by the company that sells it.
The FDA based its decision on the results of a study that found Wegovy cut the risk of serious heart problems. The study also found that overweight patients with heart disease but not diabetes were 20 percent less likely to experience those problems. Researchers compared the results of patients who took the drug with those who took a placebo, or inactive injections.
Wegovy is the first medication approved to help prevent possibly life-threatening disease in overweight people, the agency said.
Dr. John Sharretts directs the FDA’s Division of Diabetes, Lipid Disorders, and Obesity. He said, “Providing a treatment option that is proven to lower this cardiovascular risk” is good for public health.
Dr. Martha Gulati said the decision will change the way many heart patients are treated. Gulati is a cardiologist at Cedars-Sinai Medical Center in Los Angeles. The research also confirms that the new class of obesity medications are useful for improving health, not just losing weight.
“The hope is that insurers will start understanding that this is not a vanity drug,” Gulati said. So-called vanity drugs are drugs that serve no medical purpose. Some researchers call them “lifestyle” drugs. Gulati estimates that nearly 70 percent of her heart patients could be eligible for treatment.
Wegovy is a high-dose version of the drug Ozempic. Ozempic is a diabetes treatment. The FDA approved the drug to cut the risk of serious heart problems in people with disease. The weight-loss drug costs about $1,300 a month.
Novo Nordisk has also asked European Union officials to expand the use of the drug for heart problems.
The FDA warned that Wegovy carries the risk of serious side effects. These included thyroid tumors and certain cancers. Other possible side effects can include low blood sugar. Organs in the body can be affected such as the pancreas, gallbladder, kidney, or eye. Another possible side effect is suicidal behavior or thinking.
The clinical trial, which resulted in the drug’s approval, involved more than 17,600 people. About one third of them reported serious side effects. About 17 percent of the group that took Wegovy and about eight percent of those who received a placebo left the study because of reported side effects.
The new approval could mean that Medicare might increase coverage to the drug. Medicare is the federal health coverage program for retirement-aged citizens. U.S. law bars Medicare from covering drugs for weight loss alone. Recent estimates say nearly $3 billion was spent in 2021 covering Ozempic to treat diabetes.
Tricia Neuman is a Medicare expert at KFF, a nonprofit organization based in San Francisco that researches health policy. She said the change “… will open the door to allow more people on Medicare to gain access to Wegovy.”
A spokesperson for the industry group America’s Health Insurance Plans said private health coverage companies will consider the new guidance for Wegovy.
Drugmakers and activists for lower obesity rates have been pushing for expanded coverage. This includes legislation that would require Medicare to pay for the obesity drug. The cost of the drug needs to be balanced by reduced spending on medical care related to obesity and heart disease.
Another problem is a limited supply of the drug. The FDA said there has been a shortage for more than a year. Novo Nordisk officials said they are aiming to increase production.
For Gulati, the heart specialist, wider use cannot come soon enough.
“Everybody (is) waiting to get this medication,” she said. “Lower the cost, do (not) be greedy and make sure the drug is available for use.”
And that’s the Health & Lifestyle report. I’m Anna Matteo.
Jonel Aleccia reported this story for the Associate Press. Anna Matteo adapted it for VOA Learning English.
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Words in This Story
cardiovascular –adj. related to the circulatory system including the heart
generic –adj. a class of product that is not sold under a brand name because its production and sale is no longer restricted by government patent protections
placebo –n. an amount of an inactive substance whose effect is compared to that of a drug that is being tested
option –n. a choice among several that can be made
vanity –n. the feeling of mainly paying attention to your own appearance, feelings and comfort
dose –n. the amount of a medicine needed to be effective
tumor –n. an abnormal growth that can be linked to cancer
eligible –adj. able to do or to receive a treatment
clinical trial –n. a medical test done on real patients
obesity –n. the condition of being severely overweight
greedy –adj. wanting more for yourself than is fair or right