Holden is one of these kids whose parents are brave enough to take a risk both for his own benefit and for the children outside of clinical trials who nevertheless might need the drug in development.

Holden is fighting Crohn’s disease – a kind of inflammatory bowel disease, which causes abdominal pain, severe, sometimes bloody diarrhea, weight loss, and malnutrition. The inflammation can involve any part of the digestive tract depending on the person but one thing is never a variable – the stigma.

We first got acquainted with Holden’s story on the National Institutes of Health website and were immediately touched by his and his mother’s bravery. Some time ago we talked about children in clinical trials – all of the risks and questions going through a parent’s mind, as well as all of the benefits both for the small patient undergoing treatment and for other children not taking part in any clinical trial.

The FindMeCure blog takes part in the ongoing discussion about representation in medical research: in the case of children and clinical trials, like women and medicine, the main concern is that medication is tested on a different group of people than the one it’s later given to. In other words, children are often given “grown-up” medicine because there’s not enough child participation in trials.

Like many parents, Holden’s mother had to make the final decision for her child to participate in a trial. Taking into account all of the risks and whether the benefits truly outweigh the possible side effects, Holden’s mother, Anne, took the path less traveled.  

Crohn’s disease is especially embarrassing for a child, Anne, explains. When you’re growing up and your self-esteem is still hugely dependent on your peers’ perception of you, it’s difficult to articulate what it’s like living with a chronic illness.

It’s very difficult for children to explain to their friends why they have to go to the bathroom 10 times a day, so he has become much more private, very scared to let others in his life.

Initially, Anne, like a lot of people contemplating clinical trials as an option, was concerned about her son becoming a “guinea pig” – one of the many myths about medical research studies. But after thinking through the risks and options, and finally making her decision, Anne says what many patients or relatives of patients involved in clinical trials already know – it’s a completely different level of care.

Not only does Holden receive care and regular check-ups from the same medical specialists every time, but he’s also one of the patients whose condition significantly improved after entering a trial.

Holden is part of the Humira clinical trial. Humira, also known as Adalimumab, is a biologic, which blocks tumor necrosis factor-alpha (TNFα) from binding to TNFα receptors in order to reduce the inflammatory response. Humira, which is an anti-inflammatory drug, is also used for treating rheumatoid and psoriatic arthritis and ulcerative colitis among a number of other inflammation-related diseases.  

An injection every two weeks in Holden’s case meant the difference between a reclusive life and one where school and even soccer practice are within reach. “(…)I think it’s given him the confidence to go to school, it’s given him the confidence to be able to participate in the sports. My son is a very avid soccer player, it’s his passion in life, and when he’s saying he can’t go to soccer, I know something’s really wrong.”, Anne says.

And though biologics are linked to some side effects ranging from unpleasant to dangerous, the medical field is putting great hope into their development and it seems that in Holden’s case they delivered on all the hype.

Humira is now only given to patients with extreme caution – the FDA issued a black box warning which is the strongest warning it can require, signifying that a drug is associated with serious potentially life-threatening adverse effects and patients prescribed the drug need to be closely monitored.

Whether the risk is worth it is always up to you and your primary physician. But if you consider joining a clinical trial, you have all the choice in the world as to what kinds of drugs and treatments you’re ok with. After all, clinical trials aim for the development of treatments with less severe, less prominent side effects, which allow for a more fulfilling everyday life.

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