A study conducted by researchers Ian Liu, Aaron Kesselheim, and Edward Shaffer Cliff found that out of 46 cancer treatment drugs approved through an accelerated procedure between 2013-2017, only 43 percent demonstrated clinical effectiveness. However, 63 percent of these drugs received permanent approval from the FDA. 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.
Prof. Wolff notes that while comprehensive clinical studies can take several years, preliminary findings are often available sooner. He 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 also undergo rigorous evaluation before being included in the medicine basket for use.
Despite these measures, Prof. Wolff acknowledges that marketing efforts sometimes influence the use of drugs with unproven effectiveness. It’s crucial for doctors to communicate clearly with patients, especially when considering costly treatments outside the medicine basket. Patients should be fully informed about the drug’s status and potential benefits.
Prof. Wolff underscores the importance of providing patients with all relevant information and supporting their decisions regarding treatment options. He emphasizes that doctors should be transparent about any risks associated with a particular treatment option and provide patients with clear information about its potential side effects.
In conclusion, while temporary approval can be helpful for patients facing advanced or terminal illnesses without other treatment options, it’s essential to ensure proper monitoring and control of subsequent studies after approval is granted. Transparency in marketing a drug’s status is also critical to prevent misleading information from influencing patient decisions.
Overall, it’s important for doctors to work closely with patients to make informed decisions about their healthcare options based on accurate information and evidence-based research. By doing so, we can help ensure better outcomes for patients and improve healthcare overall.
