A former deputy US Food and Drug Administration Commissioner has branded plans to install a UK-based drug appraisal process in the States as flawed.
Scott Gottlieb, now Resident Fellow at the American Enterprise Institute, has written in the Wall Street Journal claiming, “the House plan isn’t really about filling evidence gaps – it’s about controlling costs”.
The new Obama Administration is advocating the creation of a “comparative effectiveness” entity researching drugs and medical devices. While there is no desire to be based exactly on the UK National Institute for Health and Clinical Excellence and its appraisal system, the idea is to use $1.1 billion to compare different drugs and devices under the remit of saving lives and money.
However, Gottlieb says in his WSJ column that the biggest flaws in the plan “aren’t just political, they’re scientific”.
Gottlieb notes drug usage is not based solely on “bare comparisons” between similar treatments and claims comparative research will be more expensive that expected.
“This is one reason why the Congressional Budget Office says that government-run comparative effectiveness studies won’t actually save much money. Despite this warning, the House still wants to conduct this research and, worse, to do the studies cheaply by adopting less rigorous research methods than what’s commonly accepted,” Gottlieb says.
He adds: “The risk is that the conclusion will be flawed and still used to restrict coverage decisions, especially by Medicare.”
Gottlieb believes “there are better ways to generate this information without Washington calling the shots”. He also recommends that private companies take the lead in conducting the studies and great transparency be adopted.
