＂New and improved. "These words are put in so many marketing campaigns that we tend to accept them as linked. But many new drugs aren't an improvement over the best existing drug for a given condition, and the fast drug-approval processes in recent years have added to the uncertainty about their advantages.
A recent report in the British Medical Journal, "New Drugs; Where Did We Go Wrong and What We Do Better?" analyzed the issue, The authors looked at 216 drugs approved between 2011 and 2017; 152 were newly developed, and 64 were existing medicine approved for new uses. Only 25% offered a major advantage over the established treatment, and fully 58% had no confirmed added benefit to reduce symptoms or improve health-related quality of life.
＂This doesn't mean there's no added benefit, "lead author Wieseler said. "It just means we have no positive proof Either we have no studies or have studies not good enough.”Wieseler and her co-authors work for a German agency which evaluates new treatments and advises on whether the country's health care system should pay a premium(补贴）for them. If payers think a new drug isn't better than an existing drug, these agencies will require that hospitals try the cheaper drug first.
Germany's HTA demands trials to prove that a new treatment beats the existing standard. This isn't always practical. For one thing, such studies can be expensive and time-consuming, with no guarantee of success. Secondly, it can discourage companies from attempting to develop new alternatives. This is already happening. Drug developers are increasingly focused on areas where there are no good treatments to compete with, such as rare diseases.
This lack of meaningful data to guide patients is a major point of Wieseler's paper. With accelerated approval, there are more products approved, with a greater amount of uncertainty about risks and benefits. But there are other solutions besides drug trials. One idea is to require postmarket studies to track the effectiveness of newly approved drugs-a step too often neglected.
