BioMed
Katherine Eban investigates staged factory inspections and falsified test data in the global generic-drug trade, tracing the risks of weak oversight.
Some drug makers adjust their standards to the buyer: their best products go to countries with the most vigilant regulators, and their worst, made with cheaper ingredients and looser testing, go to countries with the weakest review. The same named medicine can therefore differ in quality depending on where it is sold.
When inspectors give factories advance notice, sometimes as much as two months, the factory can stage the visit so it no longer reflects real conditions. Counting how many inspections happen says little if no one asks how good they were.
To cut costs, companies can manipulate tests to get passing results, then hide or alter data to cover their tracks. The paperwork shows compliance while the reality behind it is something else, and executives may be confident inspectors will be fooled.
Wealthy countries now rely on distant factories for much of their medicine, with most active ingredients made in just two countries, yet they can see little of how these drugs are made. A regulator's attention cannot keep up when most of the plants it oversees are abroad.
Where workplaces are strictly top-down and leave no room to question superiors, problems that staff can see go unreported. Defects and falsified records can survive simply because no one feels able to speak up.
Visible carelessness hints at unseen neglect, as with a stained tray table that makes you wonder about the plane's engine. In drug making, sterile, document-heavy factories set among visible disorder can be an early warning about what the records will not show.
Substandard medicines do more than fail the person who takes them. Weak doses that don't fully kill an infection help germs become resistant, so poor-quality drugs feed a danger to whole populations.
Low-cost generic drugs have saved millions of lives in poorer countries by making treatment affordable. The same cost pressure that makes them cheap can also push makers into fraud, so the public-health breakthrough and its abuse grow together.
A drug maker can win approval and then quietly change a product's ingredients in the lab without telling the regulator. Approval only certifies what was shown at the time, not what is shipped later.