Growth Hormone Treatment: Technologies to Improve Compliance

When the four-time winner of the prestigious FIFA Ballon D’Or was a young soccer player in Argentina, it certainly did not seem he could ever become a superstar. Lionel was small for his age, very small in fact. 

At the age of 13, he was not even 1.40 meters tall. However, his talent was amazing, and he had already played soccer for eight years when he was in seventh grade. Messi’s soccer skills led not only to his enrollment in FC Barcelona but also to the treatment of his stagnating growth. The soccer club bore the costs of his treatment. The master dribbler grew to a height of 1.69 meters. In combination with his rapidity, punch and consummate feel for the ball, Messi’s stature creates an ideal mix for the man who is considered by many to be the world’s best soccer player.

Growth hormone (scientific designation: somatotropin) deficiency has a long history. It affects around four out of every 10,000 people; slightly more than 200,000 people suffer from it in the EU. If the deficiency is not treated in childhood, it results in lifelong stunted growth. The condition could not be treated until the 1960s. Back then, the treatment was a compromise. Because there was no process for artificially creating the peptide hormone that is produced by the anterior pituitary gland, patients had to use hormones extracted from human anterior pituitary glands. 

As a result, there was a chronic shortage of the hormone, so the growth-impaired patients could only be treated three times a week, even though a daily dose is preferable, explains Professor Tilman Rohrer, a pediatrician at Saarland University Medical Center. Not until recombinant DNA processes were developed in the 1980s did it become possible to produce somatotropin on an industrial scale. Today, these recombinant hormones can reliably prevent patients from only growing to be 1.20 to 1.30 meters tall.

There are obstacles to effective treatment, however. Like all other therapeutic peptide hormones (the best-known example is insulin), a growth hormone cannot be taken orally. Be-cause the patient’s stomach would immediately destroy the hormone’s protein structure, somatotropin has to be injected into subcutaneous tissue. 

Nowadays, an automated drug delivery device safely changes the needle, provides the right dosage, and correctly places the needle. For EMD’s growth hormone Saizen®, this autoinjector is a high-tech system known as easypod®. The latest generation consists of the injection device itself along with a wireless transmitter and the associated software. The device not only ensures gentle and precise injections but can also document the treatment. 

As a result, it addresses the most important remaining difficulty in the treatment of impaired growth. The main problem is not side effects. As Rohrer explains, the side effects are very minor, because the recombinant hormone is identical to the natural one produced by the human body. Instead, the difficulty is in the patient’s compliance with, or adherence to, the treatment regimen. “Having to make daily injections for several years is a big challenge,” says Luis Fuente, the marketing director who is responsible for the growth hormone franchise at Merck KGaA, Darmstadt, Germany and thus also for easypod®. “Doctors, nurses, and patients have all told us repeatedly that this has to be improved.” 

In an international survey, 79 percent of the specialists involved in growth hormone treatment said that inadequate adherence was one of the main reasons why treatments were not completely successful. But with the help of the injection data stored in the easypod®, doctors and their young patients can now observe how the treatment is progressing, and, if necessary, find ways in which to ensure the daily injection is never missed. In addition, successful treatments mean cost savings for the health care system as a whole. The company aims to focus on this aspect in order to prove that this device benefits funding agencies.

Although Rohrer’s patients certainly do not try to fool him, they nevertheless tend to claim that their adherence to the regimen is better than is actually the case. They want to make a good impression and not disappoint the doctor. However, the new device depicts the true reality. 

The aim is not to monitor the patients, but to help them do something that is in their own interest. “We know from our hospital experience that children whose daily injections are monitored by their parents have more successful treatment outcomes,” says Rohrer. “But the day invariably comes when patients are at an age in which they do not want their mothers standing next to them in the bathroom.” 

One special aspect of growth hormone treatment greatly benefits the innovative easypod® system: The patients are young and belong to a generation of people for whom online technology and social media are a part of their daily lives. In addition to going to their treatment control sessions, patients can receive text messages or e-mails that remind them to make their injections. As a result, the patients are guaranteed to get the message. The technology is thus part of a trend that François Feig from EMD Serono describes as the “entry of social media tools” into medicine. “Treatments will be increasingly personalized in the future. 

Patients will greatly contribute to the success of their own treatment, and they will also want to bear this responsibility,” says Feig, who heads Global General Medicine and Endocrinology, the franchise that is responsible for growth hormones. “As a company, we have to address these needs and at the same time realize that people expect us to offer new technologies such as treatment-supporting apps, the highest levels of data security, and customized solutions.” Feig is therefore certain that the networked easy-pod® is a future-oriented step in an ongoing process of innovation.