“Patients are being prescribed pricey new medications that have not been tested as rigorously … The large majority of newly approved drugs offer modest benefits over existing therapies.”
Who needs testing when eager patients are waiting to pop the latest pill?
HealthDay News – New drugs are being approved by the U.S. Food and Drug Administration for patients based on less and less solid evidence, thanks to incentive programs that have been created to promote drug development, a new study shows.
Researchers report that more than 8 out of 10 new drugs in 2018 benefited from at least one special program that streamlines the approval process.
The result is that patients are being prescribed pricey new medications that have not been tested as rigorously, said lead researcher Jonathan Darrow, an assistant professor at Harvard Medical School.
“The evidence standards have changed, but it’s not clear that physicians, let alone patients, understand either the basic FDA approval standard or that requirements have become increasingly flexible over the past 40 years.”
The share of new drugs supported by two strong clinical trials, rather than just one, decreased from 81 percent to 53 percent between the 1990s and the 2010s, researchers found.
The time that the FDA spent reviewing each new drug dropped during the same period, from 2.8 years in the late 1980s to about 7.6 months in 2018, Darrow added.
This might be good news if highly effective new drugs were reaching the market quicker, but other research has found that the large majority of newly approved drugs offer modest benefits over existing therapies, he said.
“In many cases, you can get almost all of the benefit of the new drugs by taking older drugs,” such as generics, Darrow said.
The programs also haven’t really improved the number of new drugs approved each year, either.
“Even with that flexibility, there has been no strong upward trend in the number of drug approvals, which on average has remained about 30 new drugs approved per year since the 1980s,” Darrow said … Read more.