Month: May 2022

The current shortage of semaglutide (Ozempic), an important diabetes drug, has an unusual origin: too many people without diabetes are taking it. Here’s how that happened, and how we might course-correct to help ensure that those with the greatest need for this medicine can get it.

A diabetes drug with an important side effect: Weight loss

Semaglutide (Ozempic) was first approved by the FDA in 2017 to help people with type 2 diabetes keep blood sugar under control. But during pre-approval studies, researchers noticed a remarkable side effect: people lost weight. For example, in one pivotal study, average losses for those receiving one milligram a week of semaglutide were:

• nearly 10 pounds lost over 30 weeks
• nearly 5% overall body weight lost
• waist size shrank 1.6 inches.

This side effect helped people with type 2 diabetes because excess weight is a major risk factor for the condition. Among other health benefits, weight loss can lower blood sugar and blood pressure, and reduce the need for other diabetes medications.

Turning a side effect into a selling point

Unintended weight loss would usually be listed as a side effect for a study medication. But ads for Ozempic didn’t list it with the other possible side effects; instead, it was featured as a benefit. The Ozempic “Tri-Zone” (a phrase concocted by marketers, not medical experts) promised improved blood sugar control, lower cardiovascular risk, and weight loss.

At the bottom of the ad, fine print that’s easy to miss states: “Ozempic is not a weight loss drug.” Talk about mixed messages!

The makers of Ozempic saw the potential of semaglutide as a weight loss drug for people without diabetes. Sure enough, clinical trials confirmed that overweight and obese people taking semaglutide also lost substantial weight. Semaglutide received FDA approval in 2021 for people with obesity (BMI of 30 or greater), or who were overweight (with a BMI of 27 to 29.9) and had a medical problem related to excess weight, such as high blood pressure or high cholesterol. As a weight loss drug, it was rebranded as Wegovy.

The only difference between the two drugs? The maximum approved dose of semaglutide is a bit higher with Wegovy than Ozempic.

How social media fueled the Ozempic shortage

Soon after the approval of Wegovy, celebrities and social media influencers began taking it and sharing glowing weight loss experiences. What’s more, medicines approved for specific uses in the US can be prescribed off-label for any use: up to 38% of all prescriptions written in the US are off-label (note: automatic PDF download). So, it’s likely some of the viral run on Wegovy was fueled by people who wanted to lose weight but had no medical reason to take it.

After high demand put Wegovy in short supply, many turned to Ozempic to lose weight. And that contributed to a shortage of Ozempic, threatening the health of people with type 2 diabetes who rely on the drug.

Readjust priorities and limit irresponsible prescribing

This situation couldn’t have happened without physicians or other health care professionals willing to write Ozempic prescriptions for people who did not have diabetes or another medical reason to use semaglutide. And that suggests an obvious solution: limit prescriptions for Ozempic to people with diabetes. For many drugs, a prior authorization process requires certain conditions be met before a prescription can be filled. This could be done for Ozempic.

And of course, we should encourage people who don’t have diabetes not to request a prescription for Ozempic. While that message is unlikely to show up in a drug ad, public service announcements could do the trick.

The bottom line

Drug ads often urge you to ask your doctor if a treatment is right for you. But we already know a key piece of the answer for Ozempic: if you don’t have diabetes, don’t ask for a diabetes medicine to help with weight loss. There are better ways to get the help you need to reach a healthy weight if you are overweight or obese. Talk to your doctor about a full range of treatment options. And if your weight is already in a healthy range, it’s not a good idea to take a medication to become thinner.

Finally, to keep vitally important medicines available for those who need them most, health care professionals must prescribe them responsibly. Responsible requests by their patients could help.

About the Author

Robert H. Shmerling, MD,

Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing

Dr. Robert H. Shmerling is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center (BIDMC), and is a current member of the corresponding faculty in medicine at Harvard Medical School. … See Full Bio View all posts by Robert H. Shmerling, MD

A simple word we all hear often — exercise — makes many people cringe. Unhappy childhood memories of school sports or gym classes, flat-out physical discomfort, guilty reluctance, or trouble finding time or pleasurable activities may help explain this. Additionally, for some people with obesity, fear of falling or injury is a high barrier to activity, recent research suggests.

That finding has important implications for health and well-being. So, how can we make movement safe and joyful for people of all weights?

Why be active?

As you may know, being physically active helps combat anxiety and depression. It prevents bone from thinning and tones muscle, helps you sleep better, lowers your blood pressure and blood sugar, and improves your cholesterol levels. It would take numerous medications to do all that routine physical activity can do for you.

Weight loss programs often incorporate exercise. Research shows that exercise helps with weight maintenance and may help with weight loss. Beyond burning calories, regular exercise also builds muscle mass. This matters because muscles are metabolically active, releasing proteins that play a role in decreasing appetite and food intake.

What does this study tell us?

The study found that many people with obesity fear injury and falling, which interferes with willingness to exercise. It followed 292 participants enrolled in an eight-week medical weight loss program in Sydney, Australia. All met criteria for obesity or severe obesity. The average age was 49; one-third of participants were male and two-thirds were female.

At the beginning of the study, participants filled out a 12-question injury perception survey. The majority reported fear of injury or falling, and believed their weight made injury more likely to occur. One-third said that their fear stopped them from exercising. The researchers also recorded weight, height, and waist circumference, and administered strength tests during the first, fourth, and last sessions.

When the study ended, the researchers found that the participants most concerned about getting injured hadn’t lost as much weight as those who did not express this fear. Those who hadn't lost as much weight also tended to have the highest scores of depression, anxiety, and sleepiness.

Fear of injury fuels a dangerous cycle

As noted, exercise is healthy at every weight: it protects your heart, lowers your blood sugar, boosts your mood, and tamps down anxiety. It also builds balance. Weight-bearing exercise such as walking prevents bone thinning.

If worries about injury or falls cause people to avoid exercise, they miss out on the balance-building, muscle-and-bone-strengthening, and mood-enhancing benefits of regular activity. They may be more likely to fall — and possibly more likely to experience fractures if they do.

Find a blend of activities that will work for you

Everyone, at every weight, needs to find ways to exercise safely, confidently, and joyfully.

• Start low and go slow. If you’re not currently active, start by simply sitting less and standing more. Try walking for two minutes every half hour. If you’re afraid of falling, try walking in place or alongside a friend or loved one who can provide security and comfort.
• Ask for guidance. Consider joining a YMCA where you can engage in supervised activities, or ask your doctor for a prescription to physical therapy to help you improve your balance and build your confidence.
• Try different activities to see what works for you. Walking is a simple, healthful activity, but it’s not the only form of activity you can try. You might enjoy swimming or water aerobics. Try pedaling a seated bike or an arm bike (upper body ergometer) that allows you to stay seated while you propel pedals with your arms instead of your feet. Adaptive activities and sports designed for people with physical limitations and disabilities are an option, too. Depending on your fitness level and interests, you might also consider dancing, biking, or anything else that gets you moving more often.

Lastly, keep in mind that many people suffer from anxiety, and a fear of falling is not insurmountable. If you’re really struggling, talk to your doctor or a mental health professional.

About the Author

Elizabeth Pegg Frates, MD, FACLM, DipABLM,

Contributor

Dr. Beth Frates is a trained physiatrist and a health and wellness coach, with expertise in lifestyle medicine. She is an award-winning teacher at Harvard Medical School, where she is an assistant clinical professor. Dr. Frates … See Full Bio View all posts by Elizabeth Pegg Frates, MD, FACLM, DipABLM

We all want our child to have friends. We want them to be happy, and to build the social skills and connections that will help them now and in the future.

Sometimes, and for some children, making friends isn’t easy. This is particularly true after the COVID-19 pandemic. Because of isolation and remote school, many children either didn’t learn the skills they need to make friends — or those skills got rusty.

Here are some ways parents can help.

Start at home: Learning relationship skills

Making and keeping friends involves skills that are best learned at home with your family. Some of them include:

• Empathy. Make sure that everyone in the family treats each other fairly and with kindness. Sometimes we turn a blind eye to sibling fights, or feel justified in snapping at our partner when we have had a long day. No matter what we say, our children pay attention to what we do.
• Curiosity about others. Make a family habit of asking each other about their day, their interests, their thoughts.
• Communication skills. These days, devices endanger the development of those skills. Shut off the devices. Have family dinners. Talk with each other.
• Cooperation. Do projects, play games, and do chores as a family. Work together. Help your child learn about taking turns and valuing the input of others.
• Regulating emotions. It’s normal to have strong feelings. When your child does, help them find ways to understand big emotions and manage them.
• Knowing when and how to apologize — and forgive. This really comes under empathy, but teach your child how to apologize for their mistakes, make amends, and forgive the mistakes of others.

All of these apply also to how you and your partner talk about — or with — other people in front of your children, too!

Be a good role model outside the home, too

When you are outside your home, be friendly! Strike up conversations, ask questions of people around you. Help your child learn confidence and strategies for talking to people they don’t know.

Make interactions easier

Conversations and interactions can be easier if they are organized around a common interest or activity. Here are some ways parents can help:

• Sign your child up for sports or other activities that involve their peers. Make sure it’s something they have at least some interest in doing.
• Get to know the parents of some of your child’s peers — and invite them all to an outing or meal. It could allow the children to get to know each other while taking some of the pressure off.
• When planning playdates, think about fun, cooperative activities — like baking cookies, or going to a park or museum.

Keep an eye on your child — but don’t hover

Ultimately, your child needs to learn to do this — and you don’t want to embarrass them, either. The two exceptions might be:

• If the children aren’t interacting at all, you might want to suggest some options for activities. Facilitate as necessary, and step back out again.
• If there is fighting or meanness on either side, you should step in and make it clear that such behavior isn’t okay.

Keep an open line of communication, and be supportive

Talk with your child regularly about their day, about their interactions, and how things made them feel. Listen more than you talk. Be positive and supportive. Remember that part of being supportive is understanding your child’s personality and seeing the world from their eyes. You can’t make your child someone they are not.

If your child keeps struggling with making friends, talk to your doctor

All parents need help sometimes — and sometimes there is more to the problem than meets the eye. This is particularly true if your child has ADHD or another diagnosis that could make interactions more challenging.

For information on supporting friendships at different ages, check out the advice from the American Academy of Pediatrics.

Follow me on Twitter @drClaire

About the Author

Claire McCarthy, MD, Senior Faculty Editor, Harvard Health Publishing

Claire McCarthy, MD, is a primary care pediatrician at Boston Children’s Hospital, and an assistant professor of pediatrics at Harvard Medical School. In addition to being a senior faculty editor for Harvard Health Publishing, Dr. McCarthy … See Full Bio View all posts by Claire McCarthy, MD