Cancer drugs approved via accelerated procedures years ago lack proven effectiveness

The 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, 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. According to Prof. Ido Wolff, drugs that receive temporary approval are often intended for terminal diseases with no other treatment options available.

Prof. 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.

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. 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.