Safety in numbers

摘要

"The dose makes the poi-son," was the advice of Paracelsus, one of medicine's most famous practitioners. In other words, anything powerful enough to help also has the power to harm. It is a rule which applies equally to prescription drugs, and to government regulation of drugmakers. America has, in recent years, been a far friendlier place for drug firms than Europe, with its penny-pinching price controls, restrictions on direct-to-consumer advertising and other curbs on the market in medicines. But now American politicians, from state capitals to Capitol Hill, are clamouring for more control over drugs-especially when it comes to safety and pricing. Last month, yet another new product-Tysabri for multiple sclerosis-fell by the wayside. And in September, Merck withdrew Vioxx, its new anti-inflammatory medicine, because of potentially lethal cardiovascular complications. This event prompted a heated debate over the value, not just of Vioxx and its COX-2 inhibitor cousins, but of America's drug-regulatory system as a whole.