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Alka Amin and Facts & Comparisons- eAnswers for Somatropin Injection

These results are from a study of growth hormone deficient children who began treatment on the growth hormone Omnitrope after 9 months and 15 months of treatment.   

Human growth hormone a life-changer for growth deficient children

by Kevin Danna and Jacob Peklo
Dec 02, 2010


Alka Amin and Facts & Comparisons- eAnswers for Somatropin Injection

This was a study of 97 (83 male, 14 female) pubertal patients with growth hormone deficiency.  All patients began with a dosage of 0.3 mg/kg/week, and 48 of them (41 male, 7 female) were randomly chosen to begin taking a dosage of 0.7 mg/kg/week, while the other 49 stayed on the same dosage.  Results are after a mean duration of 2.7 years. 

Jennifer Chambers

Calli Chambers has gained 11 inches and 19 pounds after more than 3 years on growth hormone treatment.  The 5-year-old started kindergarten in September.

Five-year-old Calli Chambers is in the 10th percentile for height and 25th percentile for weight. She would be much smaller if it weren’t for the growth hormone she takes every day.

Her pituitary gland secretes an inadequate amount of growth hormone, and she has been diagnosed with growth hormone deficiency. About one in 3,000 short children have growth hormone deficiency, said Deanna Aftab Guy, a pediatric endocrinologist at Vanderbilt University in Nashville, Tenn.

Before beginning growth hormone treatment, Calli was five inches below the zero percentile mark on her pediatrician’s height chart.

“Without growth hormone, I don’t even know if Calli would hit three feet.  She was like 22 pounds for almost a year,” said her mother Jennifer Chambers, a division consultant for growth hormone deficiency in children for the MAGIC Foundation, a non-profit organization dedicated to providing information to families with children afflicted by growth disorders. “She was really, really stuck and she was very, very little.”

Calli has grown 11 inches and gained 19 pounds since beginning treatment more than three years ago. She lives in Maryland with her family, including an older sister of normal height.

Many people, especially sports fans, think of human growth hormone as an illegal substance athletes abuse to gain an edge. Major League Baseball star Manny Ramirez, who was suspended after testing positive for female fertility drugs and growth hormone, isn’t much of a poster child for the treatment, either.

But for families with growth-impaired children, human growth hormone treatment is a life-changer. Since 1985, growth hormone has been synthesized in a lab and has been widely available to those in need. Before that, the hormone was taken from cadavers.

“Honestly, parents with short children are happy to hear that there is something to make their children taller,” said Barbara Burton, a professor of pediatrics and clinical geneticist at the Feinberg School of Medicine at Northwestern University.

With growth hormones, patients can reach their full height potential as if they had no deficiency.

“If you treat a growth hormone deficient patient with growth hormone and they are able to get started before they hit school age, they are going to be the height they would have been without being growth hormone deficient,” Burton said. “That could be anywhere from 5 feet tall to 6 and a half feet.” 

Hormone treatments are given as injections rather than intravenously, said Alka Amin, a pharmacist in Wheaton. The drugs are more effective because they are absorbed more slowly. 

Also, injection by the parent is much simpler than administering an IV in a hospital. Aftab Guy said either the physician’s office staff or growth hormone company providing the treatment to the family will train parents how to inject their child.

Jami Josefson, a pediatric endocrinologist at Northwestern University, said injections could be given to patients in the thighs, backs of arms, abdomen or buttocks.

Chambers gives her daughter an injection six nights a week as part of her bedtime routine, with Saturday nights being the lone exception. That seems like a lot, but everyday injections are a reality for children on growth hormone treatment.

“Essentially, you get better growth if you treat on a daily basis.  No one seriously treats three times a week anymore,” said Richard Levy, a pediatric endocrinologist at Rush-Presbyterian St. Luke’s Medical Center. “You can have patients that really don’t want to take growth hormone any longer who end up taking it only three times a week, or even less, and they basically aren’t on growth hormone treatment.”

Chambers said her daughter has not experienced many side effects with the exception of a bruise or a slight spot of blood on the injection site. Side effects are usually minor, but Aftab Guy said the three most closely monitored are severe headaches, scoliosis (curving of the spine) and hip pain. 

Josefson said really high doses of human growth hormone can induce diabetes in people who are already predisposed to the condition.

Some people mistakenly believe that human growth hormone treatment cannot be administered until a child reaches two or three years of age. Many don’t start until they are five or six, when their parents take them to school for the first time and see how much smaller their children are, Aftab Guy said.

But according to Josefson, some children could be given the treatment shortly after birth. Children born with a condition known as congenital hypopituitarism may secrete no growth hormone. In these cases, patients need growth hormone early due to their low blood sugar. “In toddlers or young children, it manifests as growth hormone deficiency and causes significant short stature,” she said. “Patients are only going to be treated right away if the condition is identified.”

What about short patients who are in their 20s or 30s who are interested in growth hormone treatment to make them taller?

“You have to tell them ‘no’,” said Richard Bowen, a biomedical sciences professor at Colorado State University in Fort Collins, Colo.

Though some adults are on a growth hormone regimen, it’s only used for very specific cases to replace natural hormone levels lacking in the body, according to Josefson.

One of the main reasons for adults not to take human growth hormone is the potential for a condition called acromegaly, a tumor on the pituitary gland that comes from an excess of growth hormone. It is an overproduction of hormones from the pituitary gland after the growth plates of the bones are fused, usually when a person is 19 or 20, according to Bowen. People with acromegaly have coarser features and cardiovascular abnormalities, he added.

“If you remember Andre the Giant, who had growth hormone excess, these people will have overgrowth of the brow, and their hands and feet will be overgrown as well,” Burton said.

However, treatments come with a price tag-- $20,000 a year on average. “With most of the very expensive drugs, $20,000-$40,000 a year is not that expensive. We might prescribe drugs that are $150,000 to $200,000,” Burton said. “It’s expensive, but it’s nowhere near the top of rare disease pharmaceuticals.”

Some insurance companies are reluctant to pick up the tab. According to Josefson, insurance typically covers only  treatment for patients with growth hormone deficiency, even though it could be used for other purposes.  

Aftab Guy said she is having increasing difficulties getting a treatment approved by insurance companies, and even if they do approve it, the companies still have the final word.

“I never used to have to even choose my growth hormone from a list; I could pick what I wanted,” she said. “Now insurance companies will pick one brand we have to use if the companies choose to cover it.”

Generally, insurance companies will cover most of the costs for patients. It may just take time, although Chambers reported having no trouble.

“My daughter has a great doctor, and our insurance covers it,” she said. “We have paid for the last three years like $150 every three months.” The dose she is on now would cost about $1,000 to $1,500 out of pocket each month.

According to Josefson, there is no real need to taper off the medication. Usually children are on the treatment until they finish puberty. “In true growth hormone deficiency, such as congenital growth hormone deficiency or following brain tumor treatment, life-long replacement is recommended,” she said. 

But for those who are using it for short-term therapy, there won’t be side effects such as withdrawal symptoms when stopping treatment. “Once the long bones are stimulated, then they can cycle off of it,” Bowen said. Long bones, those in the arms, legs, hands and feet, have growth plates on either end of the bone and assist with the growth process.

Chambers said her daughter may be on growth hormone treatment longer than most.

“She will be on growth hormone until she is at least 16,” she said. “She was very deficient and started therapy when she was very young, so she may need it as an adult.”