Rushing medicines to market is supposed to help people in need. But relying on lower standards of evidence may ultimately cause more harm than good.
WEEKS before their due date, some women find themselves stunned, peering through glass at their baby, a tiny body covered in sensors and tubes, striving to stay in the world.
Premature birth can be terrifying. Although survival rates for babies born before 37 weeks of pregnancy have steadily improved, they are still significantly worse than those of babies born later, and the likelihood of longer-term health complications is higher.
So any medication that could reduce that risk would be gratefully received – and has been. In 2011, a drug called Makena was approved by the US Food and Drug Administration (FDA) on the basis of a small trial showing that it helped prevent preterm birth. Later, larger studies found that it didn’t. One hospital even reported higher rates of gestational diabetes among women given the drug. Then last month, a large trial found that Makena was no better than placebo; an FDA committee recommended withdrawing it from the market. The FDA has yet to decide.
It isn’t just Makena. At drug approvals agencies around the world, more and more medications are being rushed to market after limited testing. Drugs are approved based on preliminary findings, or authorised for a particular use, then widely prescribed for something else. And hanging over the process is a worrying question: are these agencies working to protect the public or to further the interests of drug companies?
We would all like to think that any treatment our doctors offer is the best option available for us, based on credible evidence. But not …