An Experimental Drug Was Helping A Girl With Dravet Syndrome. Will She Lose Access After the Trial?

According to a recent story from CityNews Toronto, Alara Ozkose’s Dravet syndrome was preventing her from being able to live a life that was even close to normal. She was constantly plagued by multiple seizures on a daily basis, and they could happen at any time. As a result, she was at risk of falling and severely injuring herself if she had a seizure in a public place. Dravet syndrome is a type of epilepsy that is characterized by frequent seizures that can easily be triggered by fevers or hot temperatures. These seizures are often accompanied by other symptoms such as behavioral problems, cognitive impairment, and problems sleeping. Click here to learn more about Dravet syndrome.
Alara’s situation was dramatically improve when she registered for a clinical trial that is testing the effects of cannabidiol (CBD) on Dravet syndrome. CBD is a substance derived from the cannabis plant. Although, the high strength CBD oil used in the trial has some side effects, such as drowsiness and weight gain, the treatment was able to bring her seizures to a complete halt. The severity and frequency of seizures get progressively worse over time with Dravet syndrome, and Alara was having nearly a hundred a day before she began to start the trial.

Unfortunately, the trial is slated to end in a couple of months, and after the trial ends, her mother Arzu has been told that she will have to pay for the drug if she wants her daughter to continue to use it. Unfortunately, this would be prohibitively expensive for the Ozkose family, as the oil costs $1,800 per month. Arzu is convinced that the drug has saved her daughter’s life.

The manufacturer has stated that it will offer a discount for patients that responded well to the drug, but the situation highlights a significant ethical quandary for the clinical trials process: if the drug is offering potentially life saving benefit, should the drug company be legally obligated to continue supplying the drug?

The general standard is that companies will usually offer some assistance to patients if a drug works well for them in trials, but this is still left up to the company, and they can determine the extent of this assistance. Perhaps in the future more regulation will help spell out more clearly what drug companies are obligated to do so that families like the Ozkose’s do not have to worry about getting access to treatment in the future.

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