Do Patients Understand the Risks?
The US Food and Drug Administration's (FDA) accelerated approval program aims to provide early access to promising cancer drugs. However, a new study raises concerns about whether these drugs actually improve or extend patients' lives.
Researchers found that most cancer drugs granted accelerated approval between 2013 and 2017 did not demonstrate clinical benefit within five years. This raises questions about whether patients fully understand the risks and uncertainties associated with these drugs.
Dr. Edward Cliff, a study co-author from Harvard Medical School, emphasizes the importance of informing patients about the limitations of accelerated approval drugs. He highlights the need for doctors to carefully explain the evidence and avoid overpromising potential benefits.
Dr. Jennifer Litton of MD Anderson Cancer Center emphasizes the importance of providing patients with accurate information about the drug's effects, even if it means explaining less definitive outcomes like tumor shrinkage or stability.
The FDA has recently updated the program to give them more authority to withdraw drugs when companies don't meet their commitments. This update aims to ensure that patients have access to effective treatments and protect them from potentially harmful drugs.
While the accelerated approval program offers early access to promising drugs, it's crucial to ensure that patients understand the potential risks and uncertainties associated with these drugs. Open communication between doctors and patients is essential to ensure informed decision-making and optimal patient care.