Cancer drug leaflets for patients in Europe omit important facts | Research against cancer

Cancer drug information leaflets for patients in Europe frequently omit important facts, while some are “potentially misleading” about treatment benefits and associated uncertainties, researchers have found.

Cancer is the biggest killer in Europe after heart disease, with more than 3.7 million new cases and 1.9 million deaths each year, according to the World Health Organization.

Medicines are a vital weapon against disease. But critical facts about them are often missing from official sources of information provided to patients, clinicians and the public, according to a study by researchers from King’s College London, Harvard Medical School and the University of Sydney, among others.

“Regulated cancer drug information sources in Europe are failing to meet patients’ information needs,” the study authors wrote in the journal BMJ. “If patients don’t have access to this information, clinical decisions may not match their preferences and needs.”

To receive and participate in medical care, patients need quality information about treatments, tests and services, including information about the benefits and risks of prescription drugs. But existing research on the issue is limited.

To address this issue, researchers assessed the extent to which cancer drug information is communicated to patients, doctors and the public in Europe.

They looked at official written and electronic information for clinicians, patient information leaflets and public summaries of 29 new cancer medicines approved by the European Medicines Agency between 2017 and 2019.

They then compared the drug benefit information in these sources with the data available in regulatory review documents, which contain everything required for drug approval.

Vital information about the benefits and uncertainties of drugs was often not reported, the researchers found. There have been instances where reporting of drug research was “inconsistent” and “potentially misleading” compared to what was reported in regulatory review documents.

Significant gaps and uncertainties in the evidence base were also rarely reported, especially those that might be relevant or helpful to patients, such as whether a drug prolonged survival or improved quality of life.

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The study also found that scientific concerns about the reliability of evidence on drug benefits were rarely communicated to clinicians, patients or the public.

The striking findings “highlight the need for improved communication of the benefits and associated uncertainties of cancer drugs in regulated information sources in Europe to support evidence-based decision-making by patients and their clinicians,” said concluded the authors.

In a linked editorial, BMJ editors said the study raises questions about whether this lack of knowledge interferes with shared decision-making and whether new ways of presenting information, such as visual representation of data on benefits and harms, could be applied to other types of drugs.


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