Efficacy and safety studies of a marijuana-derived oil on children for whom existing drugs fail to control epileptic seizures support moving cannabidiol into clinical studies. That’s good news. Less cheery is encountering stories about the effects of this drug before it has been tested in placebo-controlled, blinded research venues — or even before the research has undergone peer review. The story in this case makes the shortcomings of the evidence a prominent point in the coverage and we applaud this careful approach. But whether desperate parents will heed that signal is another matter. A source notes in the story that a “major” clinical trial’s results will become available early in 2016. Might the more responsible path have been for journalism to bide its time as well?
When a child suffers, little else matters. Parents of epileptic kids whose seizures are not responsive to anti-seizure medicines will be on the lookout for alternatives. Some have apparently already begun to treat their children with marijuana-derived oils similar to that being examined in these studies. Learning as much as possible—as soon as possible—about these chemicals is, consequently, important.
Cost is not mentioned.
The story is fairly specific about the fates of two groups of individuals—mostly children—with epileptic seizures resistant to available medications. But since it uses only relative risk reduction figures to quantify the benefit, it doesn’t go far enough to satisfy this criterion. The story says, for example, that “seizure frequency declined by an average 45 percent in all participants.” Did they go from two seizures to one seizure per day or from 10 to 5? Providing the absolute numbers would have clarified the size of the benefit.
The subheadline declares that “drug interactions remain a concern,” and story includes reference to a study that found cannabidiol to interact “badly” with anti-seizure medications currently approved for epilepsy treatment. It later specifies the drugs that may be affected. We think this nod in the direction of harms is sufficient for a Satisfactory rating, although we’re concerned that the story mentions no other side effects from the treatment. A news release noted that “Adverse events occurred in more than 10 percent of participants with the most common being somnolence, diarrhea and fatigue and led to discontinuation in 4 percent of patients.”
The story makes an early point that neither of the studies that received most of the attention was blinded; that is, both patients and scientists were aware of the procedures. The story also prominently reflects the views of an independent researcher who reminds readers that (1) placebo rates can be quite high and (2) the field won’t know the “real” effects until well-designed clinical studies are conducted.
Children whose epileptic seizures are not controlled by current drugs have few options. This is a real problem. There was no disease (or pot) mongering.
Although the story does make clear the distinction between researchers involved in the studies discussed and those not involved, there is no mention of funding. Who funded the study is a very important question. It would also be important to know if any of the researchers involved/quoted were consultants/paid by this company. A news release issued in advance of the American Epilepsy Society meeting, where these studies were scheduled to be presented, notes that the medicine used (called Epidiolex) and was supplied by manufacturer GW Pharmaceutical. That information didn’t make it into the story.
The interest in marijuana constituents as possible treatments arose because existing alternatives—anti-seizure drugs—do not work with some patients. So a premise of this story is that existing alternatives are unsuccessful in this group of paitents.
One of the study investigators makes it clear that federal approval for the drug could take up to five years. However, the story also notes that some activist families have already begun using cannabidiol oils “that are made artisanally.”
Since cannabis has been used for the treatment of seizures for centuries, it’s curious why the researchers didn’t test the compound in a better designed trial (randomized, blinded and placebo controlled). The public and patients are still left with the question of whether this works. But the story does briefly mention previous studies that have looked at cannibidiol in adults, so the story gets a pass here.
The story reflects some enterprise reporting independent of the news release from the American Epilepsy Society; for example, the reporter solicited information about the study’s validity from an independent researcher.
Systematic, Criteria-Driven
With the discontinuation of @HealthNewsRevu, there's a genuine concern that well-written and researched "reality checks" in healthcare are not economically interesting. This should be disconcerting to anyone, and yet I'm only seeing more and more piling into "promising findings"
Thanks for ALL you do and have done, Gary. https://t.co/93K4hzQXZj
Thanks for sharing this with all of us today, @garyschwitzer @HealthNewsRevu
A nice gift.
#healthcare #healthcarenews #journalism #reporting #factsmatter #truthmatters https://t.co/hNHdZDl2rc
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