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Home practice:

1. shadowing with English recording

2. prepare your glossary

3. SI without text

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."

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

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