Benjamin Ashford|Families scramble to find growth hormone drug as shortage drags on

Eddie held up Bryan the Lion,Benjamin Ashford a stuffed animal with its very own tiny plush injector pen and little blue stars stitched onto its fuzzy body.

"The stars are where we do the shots," his dad said, prompting his 4-year-old son to chime in.

"Yeah! Um, this is the pen," Eddie said, as he gave the lion a few faux shots. The toy was a gift from Novo Nordisk, the Danish pharmaceutical company that makes Norditropin, an injectable human growth hormone drug for kids like Eddie whose bodies don't make enough of the hormone they need to grow.

A few minutes later, it was time for Eddie's dad to give him the real shot. The Norditropin injector's needle makes the tiniest thwip as it goes into Eddie's backside exactly where one of the stars on Bryan the Lion is located. Eddie's dad counts,"1, 2, 3, 4, 5, 6."

"Left butt today!" Eddie said, unfazed.

Eddie has a twin brother, Harry, who doesn't have the condition and has always measured average for his age. He's about a head taller than Eddie and waits for his brother to return to the runway they've made out of blocks but populated with plastic dinosaurs instead of airplanes.

The daily injections have been a routine part of Eddie's life since age 3, after he was diagnosed with Albright hereditary osteodystrophy, a rare disorder, and severe early onset scoliosis.

But the routine was threatened by shortages of the drug that began around Thanksgiving. Eddie doesn't know that his dad, Edward Garnett, has spent hours on the phone trying to get his hands on Norditropin pens in the last few months.

Early on, Novo Nordisk said the supply would be restored by February. Then, the estimate stretched to June. Now, the shortage is expected to last the rest of the year.

"Unfortunately, unforeseen circumstances have resulted in longer than expected ramp-up time to expand capacity at our new production facility and meet the ever-increasing global demand for Norditropin," Novo Nordisk spokesperson Allison Schneider told NPR in an email. "These manufacturing delays mean that in the US there will continue to be intermittent product availability with periods of stockouts of all Norditropin dose strengths until the end of 2023."

She said the company is increasing manufacturing capacity and expects the supply to "stabilize" in 2024. "We understand how frustrating this situation is for the communities we serve and are doing everything we can to minimize the impact for everyone affected."

The company didn't elaborate on the "unforeseen circumstances" and hasn't publicly disclosed many details about reasons for the ongoing shortage.

For families, many questions and few answers

Parents are anxious. For children lacking growth hormone, every day they miss an injection puts a limit on how tall they'll grow.

On social media, parents have wondered if the shortage is a prelude to the drug being discontinued. Does the shortage have something to do with Novo Nordisk's latest blockbuster drug Ozempic, a diabetes drug that is used widely to help people lose weight? They had no idea.

Garnett, whose family lives in Washington, D.C., ran into trouble filling Eddie's Norditropin prescription last December. Then he and his wife went to a Facebook group for kids with rare conditions like Eddie's, and found out that lots of families were having the same problem.

"We've been told it's a manufacturing issue," Garnett told NPR, but Novo Nordisk case workers said there was nothing else they could tell him. "I was like, OK, that's not super helpful."

He said the cold shoulder was in stark contrast to how the company pitched the Garnetts to choose Norditropin for Eddie over another brand. Novo Nordisk dispatched a nurse to their house to make the case and sent Bryan the Lion in the mail.

Meanwhile, Eddie's mom, Julia, noticed a lot of talk about Ozempic while scrolling through Instagram to unwind after the kids went to bed. There were viral stories of celebrities using the diabetes drug to lose weight and reports of soaring off-label demand that left patients with diabetes scrambling to find their medicine.

Then, she saw the Ozempic injector pen on an episode of 60 Minutes in January. To her – and a lot of other stressed-out Norditropin parents confiding in one another on social media – it looked just like the Norditropin pen. And both were made by Novo Nordisk.

"I [saw] the pen and I was like, 'That is the same exact pen,' " Julia said. Without much information from the company, it has become a popular theory: Maybe Novo Nordisk, struggling to meet surging demand for Ozempic, diverted plastic pens away from Norditropin to use them for Ozempic.

Can't rule it out

According to public records maintained by the National Library of Medicine and information from Novo Nordisk, Norditropin doesn't share drug manufacturing sites with Ozempic. However, manufacturers of component parts, which could include plastic injector pens, do not have to be listed in these records.

Novo Nordisk's Schneider said parents' suspicions that Norditropin pens are being diverted to Ozempic are incorrect. She also said Norditropin isn't made at the same factories as the company's diabetes and weight-loss drugs — and that their production hasn't affected the supply of Norditropin. She did not answer whether Ozempic and Norditropin share injector pens or pen manufacturing sites by deadline.

It's difficult to verify independently. "These things are very complicated," said Yali Friedman, founder and president of DrugPatentWatch.com. "And even if two pens look the same, it doesn't mean that they are the same. You never know what's going on, on the inside."

After taking a look at the patents, he said the drugs' pens share some components but probably aren't the same.

Still, he said he also couldn't rule the possibility out.

Waiting for relief

Dr. Bradley Miller, a pediatric endocrinologist and professor at the University of Minnesota Medical School, isn't Eddie's doctor, but he has plenty of patients who depend on Norditropin. He said it's not the first time he's heard the Ozempic pen theory from a parent. It's clear to him that families are stressed.

"We've had families who have filed complaints against me, against my staff, against my hospital for not hiring additional people to help deal with the shortage," he said, adding that his patients have run the gamut during the shortage. "I've had patients off of growth hormone for three months and I've had patients who, for whatever reason, have not missed a single dose."

For most kids, a missed shot is a missed opportunity to grow and reach the same size as other kids their age. For some very young children, missing growth hormone can have more serious consequences, Miller said, including dangerous hypoglycemia or low blood sugar. But in his practice of between 500 and 600 children, only about five of them are at risk for this, he said.

Although it's possible to switch to another company's growth hormone, like Eli Lilly's Humatrope or Pfizer's Genotropin, insurance companies often declined to cover the competing drugs until recently, Miller said. And once some patients started switching, some of the other medicines went into shortage, too.

Miller, who doesn't speak on behalf of Novo Nordisk, but has consulted for it and other pharmaceutical companies that make growth hormone products, said he learned last year from company contacts that Norditropin production was being switched from one factory to another.

The switch took longer than expected. "They recognized that the short term was going to be much longer," Miller said. In January, Novo Nordisk sent a letter to health care providers explaining there would be no new Norditropin entering the U.S. for a few months. The letter cited "manufacturing delays."

A letter sent in February said some shipments to U.S. wholesalers would resume but availability would remain intermittent until June. Meanwhile, there wouldn't be enough Norditropin to meet demand through the company's patient assistance programs, including one that provides the drug for free to patients who qualify. Norditropin is expensive: The list price for the most commonly used pen is $1,535.70, and a typical month's supply costs more than $6,000, according to GoodRx, a website that helps patients get discounts on drugs.

"The hardest hit are those on the patient assistance program," Miller said in an email to NPR after receiving an update from Novo Nordisk about how the shortage would last through the end of the year. "Some of them have been out of medication for months."

Part of the problem was that increased demand was exacerbating the manufacturing delays, the company said.

When NPR sought to independently verify this with prescription claims data from Definitive Healthcare, it couldn't quite confirm an increase in demand. In fact, monthly claims had decreased in five of the 10 months prior to the start of the shortage.

'Sometimes that's all we get.'

While companies need to notify the Food and Drug Administration about shortages as they emerge, they aren't required to publicly disclose the reason something is in short supply.

"[Pharmaceutical companies] basically have the ability to control what information gets out and what doesn't," said Michael Ganio, senior director of pharmacy practice and quality with the American Society of Health System Pharmacists, which maintains its own drug shortages database. "What we can also do is sometimes try to put pieces of the puzzle together. When you look at things like FDA inspection reports or FDA warning letters, sometimes that helps us get a little bit more insight into the cause of a shortage."

Ganio said the Norditropin shortage lacked a lot of information beyond an increase in demand and manufacturing delays. "That's extremely vague," he said. "But sometimes that's all we get."

Asked why the shortage's resolution seems to get further and further away, Novo Nordisk spokesperson Schneider told NPR the company has had problems in filling enough vials with the drug and "additional unanticipated downtime."

"We understand how frustrating this situation is for the communities we serve," she said. "We remain committed to this community and are doing everything we can to stabilize supply and share timely and transparent information."

When NPR contacted Garnett to update him on the shortage with information from Schnieder at Novo Nordisk, he had mixed feelings. He was glad to learn the drug wasn't being discontinued, as some parents have feared, but wasn't expecting the shortage to last so much longer. The lack of answers is grating, too. "It's intellectually pretty frustrating just to not really understand why," he says.

"We've been able to get our prescriptions filled. I just did it today, actually. It's super, super stressful every month."

Edited by Scott Hensley for broadcast and Shots.