A study led by researchers Ian Liu, Aaron Kesselheim, and Edward Shaffer Cliff has uncovered some interesting findings about the drugs approved for cancer treatment through an accelerated procedure between 2013 and 2017. The study found that out of the 46 drugs that received approval during this time period, only 63 percent were given permanent approval by the FDA. However, only 43 percent of these drugs demonstrated clinical effectiveness, with just 20 out of the 46 showing significant results.
Dr. Ido Wolff, director of the oncology department at Ichilov Hospital and head of Tel Aviv University School of Medicine, explains that drugs receiving temporary approval are usually for advanced or terminal diseases with no other treatment options. The FDA sometimes grants conditional approval based on promising initial results, pending further examination of the drug’s effectiveness. Dr. Wolff emphasizes the need for proper monitoring and control of subsequent studies after temporary approval, as well as transparency in marketing the drug’s status.
In Israel, separate registration procedures exist and drugs must undergo rigorous evaluation before being included in the medicine basket for use. Despite these measures, Dr. Wolff acknowledges that marketing efforts sometimes influence the use of drugs with unproven effectiveness. He stresses the importance of doctors clearly communicating with patients about a drug’s status and potential benefits before prescribing it outside of their medicine basket.
The study highlights a need for caution when considering costly treatments outside of a country’s medicine basket without fully understanding their status and potential benefits to patients.
Overall, it is crucial for doctors to be transparent with patients when considering costly treatments outside their medicine basket to ensure they make informed decisions about their health care options.
It is important to note that while comprehensive clinical studies can take several years, preliminary findings are often available sooner than expected. This means that doctors should not rely solely on initial results but also conduct further research before prescribing any new drug to patients.
Moreover, there is a need for transparency in marketing medications’ status to avoid misleading patients into believing that they are receiving effective treatment when they are not.
Overall, while accelerated procedures can help bring new cancer treatments to market quickly, it is essential to carefully monitor and evaluate these treatments before granting permanent approval or including them in a country’s medicine basket for use.
