Drugmakers are failing to provide Europeans with the information to understand the benefits and harms of oncology medicines. That is the headline finding of a paper published in The BMJ, which found patient information leaflets routinely lack details that could support informed decision-making.
The study looked at the summaries of product characteristics (SmPCs), patient information leaflets (PILs) and public summaries for 29 cancer drugs that received their first marketing authorization in Europe from 2017 to 2019. By assessing the three sources of regulated information, and comparing them to European public assessment reports, the researchers sought to understand the gaps in the information that companies provide to clinicians, patients and the public.
While nearly all SmPCs communicated full information about the number and design of the main studies, none of the PILs communicated information to patients about how drugs were studied. Similarly, 72% of the SmPCs reported whether a drug extended survival, but none of the PILs communicated information about the drug benefits that patients might expect based on study findings. The authors of the paper see the gaps as a problem.
“Our study highlights the need to improve the communication of drug benefits and related uncertainties in regulated prescription drug information in Europe. The provision of high-quality information on drug benefits and related uncertainties is especially important for patients with time-limiting conditions such as advanced cancer,” the authors wrote.
As the authors see things, when patients have “unrealistic expectations” of the benefits of a treatment and “misplaced confidence” in the strength of the evidence, informed decision-making is undermined.
The study found that scientific concerns about the reliability of evidence on drug benefits, which were raised during an assessment of almost all the drugs, were rarely communicated to clinicians or patients. And that reporting of the design of a study and its findings was sometimes inconsistent with information reported in European public assessment reports and “potentially misleading.”
After identifying the problems, the authors proposed potential solutions. Acknowledging that regulators “cannot compel companies to include information on drug benefits and evidence about uncertainties of benefits in patient package leaflets,” the authors note that “mechanism of action statements may be misunderstood as statements of effectiveness” and “this may be at odds with legal requirements for information in patient leaflets to be accurate, non-misleading, and non-promotional.”
The authors suggest regulators concentrate on ensuring that relevant, accurate and useful content is available in online lay summaries for the public. By revising the templates for public summaries, which the authors say could happen without legislation, details of a medicine's benefits could be presented as part of a “drug facts box” specific to cancer therapies and made available online.