According to a pair of recent rulings by the U.K.’s Prescription Medicines Code of Practice Authority (PMCPA), Jazz Pharmaceuticals struck the wrong chord in presentations about its Epidyolex.
The cannabidiol-based med, which is known as Epidiolex in the U.S., is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex.
The first complaint to the PMCPA regarded a pair of “educational, promotional, online presentations for health professionals” about Epidyolex, while the second, filed a day later, was described only as being related to “a promotional presentation” on the drug.
In both cases, the drug marketing watchdog’s panel ultimately concluded that Jazz had breached, among others, Clause 2 of its code of practice—the most serious ruling from the group, constituting a finding that the drugmaker had brought discredit upon and reduced confidence in the pharma industry.
In the first filing, the anonymous complainant—who self-identified as a health professional—took issue with what they perceived as the omission in two promotional videos of important safety information about liver issues in Epidyolex users.
According to the complainant, the first presentation failed to advise its HCP audience that if a patient taking Epidyolex in combination with seizure treatment Valproate sees liver transaminase levels significantly increase, the medications should be reduced or discontinued until the enzyme levels return to normal.
In the second video, they wrote, the speaker discussed the importance of liver monitoring in patients taking Epidyolex, but didn’t detail the levels of liver transaminase elevation at which the drug is contraindicated.
In response, Jazz noted that the complainant’s first claim represents a misreading of Epidyolex’s summary of product characteristics (SPC), which advises doctors that a reduction or discontinuation of the drug combo “should be considered” if liver transaminase levels rise, but is not required. As for the second, Jazz argued that Epidyolex dosing information and details about required liver function monitoring were shared throughout the presentation, and viewers were directed to the full SPC for more details.
Jazz therefore refuted all the alleged breaches of the PMCPA’s code. In its ultimate ruling, however, the group’s panel largely sided with the complainant, concluding that the pharma had breached its clauses regarding making a misleading claim and failing to maintain high standards—three times over in both respects—and, in doing so, had brought discredit upon the industry.
The second ruling, which also came from an anonymous health professional, again took issue with the omission of specific information about Epidyolex contraindications linked to liver monitoring, even as the speaker discussed the importance of monitoring.
Jazz once again denied all of the alleged breaches, pointing to the speaker’s inclusion of information about liver monitoring and slides showing that increased liver enzymes are a common adverse effect of Epidyolex use, among other safety information.
But the PMCPA panel once again upheld almost all of the complainant’s contended breaches, agreeing that specific contraindication data should’ve been included in the presentation. It therefore levied on Jazz two instances of making a misleading claim and therefore failing to maintain high standards and bringing discredit on the industry.
In explaining the latter breach, the panel wrote that it had “considered that patient safety was of the utmost importance and that health professionals should be able to rely on materials produced by companies to be complete and unambiguous in this regard,” and concluded that Jazz had provided “some, but not all, of the relevant information in relation to hepatic impairment in a presentation which was intended to advise health professionals on indications and dosing when using the medicine.”
Jazz did not appeal either case, and the PMCPA said an undertaking had been received for both, referring to a written statement from an offender describing how it plans to avoid any future violations. As for additional sanctions, the PMCPA will be running advertisements (PDF) in December in the journals BMJ and the Nursing Standard describing Jazz’s breaches of the code.