A study led by researchers Ian Liu, Aaron Kesselheim, and Edward Shaffer Cliff revealed that out of 46 cancer treatment drugs approved through an accelerated procedure from 2013-2017, only 63% received permanent approval from the FDA. However, only 43% of the drugs showed clinical effectiveness, with only 20 out of the 46 drugs proving to be effective. This raises concerns about the effectiveness of these drugs and how they are being marketed to patients.
Prof. Ido Wolff explains that the FDA grants temporary approval to drugs with promising initial results, giving patients hope in dire situations. Clinical studies can take years to fully examine a drug’s effectiveness, while preliminary studies are published within a year or two. However, the lack of proper control and examination of subsequent clinical studies after temporary approval can lead to unforeseen issues, and marketers may misrepresent temporary approvals as permanent to promote the drug.
To address this issue, Prof. Wolff stresses the importance of transparency in informing patients about the effectiveness of drugs, especially if they are costly and not fully proven. Patients should be given all the information they need to make informed decisions about their treatment options.
In Israel, separate registration processes ensure that not all FDA-approved drugs are automatically approved, and a rigorous process determines which drugs enter the medicine basket for public use. Despite these measures, unproven drugs may still be promoted by marketers. This highlights the need for better regulation and oversight in order to protect patients from being misled by false claims about drug effectiveness.
Overall, it is important for healthcare providers and patients alike to be aware of
