Cancer Drugs Info Full of Gaps – Regulatory Action Needed

Drug manufacturers are not able to provide Europeans with the required information to gauge the benefits and defects of oncology medicines. This is as per the findings published in The BMJ, which demonstrate that the patient information leaflets consistently lack information that could help make informed decisions.

The research looked at the numerous summaries of product characteristics (from here on referred to as SMPCs), patient information leaflets (PILs) as well as public summaries across 29 cancer drugs that went on to receive their first marketing authorization across Europe from 2017 to 2019. By way of assessing the three sources when it comes to regulated information and comparing them to European public assessment reports, the researchers looked out to take into account the gaps in the information that manufacturers share with clinicians, patients, and the general public.

Although nearly all the SMPCs exchange the entire information when it comes to the number and design of the main studies, none of the PILs communicate any kind of information to patients on how the drugs happened to be studied. Likewise, 72% of the SMPCs reported if the drug extended survival, but again, none of the PILs reported any information on the benefits of the drugs that the patient might expect. Apparently, the authors of the paper see these gaps as a challenge.

The authors opined that the research highlights the requirement to enhance the communication of drug benefits as well as related uncertainties when it comes to the regulated prescription drug details in Europe. The provision of high-quality information on drug benefits is very important for those patients who have time-limiting conditions like advanced cancer.

As per the authors, when patients have not so realistic expectations of the benefits of the treatment as well as misplaced confidence in the treatment’s strength, there is a lot of undermining of informed decision-making.

The research also found out that the scientific issues on the reliability of drug benefit evidence that came out during the assessment of almost all the drugs were not regularly communicated among clinicians or even patients.

Besides, the reporting of the study design as well as its findings remained inconsistent at times with the data that was provided in the European public assessment report and was also pretty misleading.

Post identification of the problems, the authors gave potential solutions, thereby acknowledging the fact that the regulators cannot force the companies to include data on drug benefits as well as evidence as far as uncertainties of benefits in patient package leaflets is concerned. The authors further noted that the action statement mechanisms may be misconstrued as a statement pertaining to effectiveness, which may further be at odds with legal requirements for data related to patient leaflets to be clear, non-misleading, and that they be non-promotional.

The authors, as per the research, also suggest that the regulators focus more on making sure that relevant, sturdy, accurate, and also useful content is available online for the public.

By way of revising the templates when it comes to public summaries, which according to authors may happen without legislation, medicine benefit details can be presented as part of a drug fact box that happens to be specific to cancer therapies and made available online.