This Washington Post article announces approval by the U.S. Food and Drug Administration of the first drug made directly from a compound found naturally in marijuana plants. It is meant to treat rare, genetic forms of severe childhood epilepsy, and the article goes to some lengths to make clear the FDA’s view that the approval does not constitute government support for marijuana in general, or for the growing commercial availability for self-prescribed medicinal use by the public.
The news story further emphasizes that the marijuana compound — CBD — contains too little of the psychoactive part of the plant, THC, to cause the “high” associated with recreational use.
The story would have been strengthened had it included a discussion about the evidence on which the FDA based its approval. It also doesn’t address the cost of the drug or the diverse and sometimes severe side effects identified in a substantial number of patients who participated in clinical trials, which also are not mentioned. For a comparison, see this recent 5-star review of a CNN story from May that looks at one of the studies that led to the approval.
The FDA’s approval of this drug is highly newsworthy and will be of great interest not only for those seeking help for the rare seizure disorders the new drug, Epidiolex, is intended to treat, but also for other diseases and symptoms such as pain and nausea.
At the same time, the FDA has come under increasing criticism for approving risky drugs without much evidence they work, making it vital that journalists scrutinize approvals.
Some reports suggest the cost of Epidolex will be high and insurance coverage is unclear. The article should have addressed these issues.
Some would argue that FDA approval automatically means that benefits and risks of a new drug have been quantified to experts’ satisfaction. But that is not necessarily the case and readers with an interest in this drug would be better informed if some of the clinical trial evidence had been included in the story. As it stands, the article offers no information at all about reduction in seizures of those who take the drug, or a basis for which to compare its value to other treatments for severe epilepsy.
The FDA release about the agency’s approval lists the most serious side effects, many of which are common, including liver damage, depression, suicidal thinking, anorexia and insomnia. But the news story does not mention them.
As noted above, there is no description of any of the evidence used by the FDA to evaluate the new drug.
No mongering here.
There is a quote from a neurologist with the American Epilepsy Society, however he consults for drug companies and the society has received substantial donations from a subsidiary of the drugmaker manufacturing this drug. This should have been flagged for readers.
The article does note that parents are giving their affected children “unregulated” CBD formulations, and although there are also other drug treatments and (although of unproven value) some efforts at surgery to abate the seizures, these offer less than good solutions, as the article notes.
The article does not state exactly when the drug will be on the U.S. market, but generally, FDA approval coincides with market availability.
The article makes clear that this is a “milestone” FDA approval and in what way.
This did not rely solely on the FDA’s news release.