With as many as 14,000 people exposed to tainted steroid injections, resulting in more than 200 infections and 15 deaths, and more expected in the coming weeks, the drug delivery system is once again coming under scrutiny and has been threatened with loss of confidence.
In the shameful steroid contamination scandal now continuing to evolve, the New England Compounding Center appears to have exploited an astonishing loophole. Compounding pharmacies are supposed to mix custom combinations of drugs from already manufactured materials when ordered by a doctor. Some compounding pharmacies will pre-mix certain recipes. They call it "anticipatory compounding." In the case of the fungus-tainted steroid, the New England Compounding Center mixed a batch of 17,000 doses. Massachusetts Gov. Deval Patrick has said that the company was operating outside the limits of its state license.
"What they were doing instead is making big batches and selling them out of state as a manufacturer would," Patrick said Wednesday at a news conference.
Every few years a major scandal revolving around patient safety brings us closer to a profound question: How can this continue to happen?
Some of the past headline pharmaceutical failures have resulted from negligence, lack of oversight or self-recognized problems. Other problems, like the current steroid tragedy and the distribution of phony heparin just a few years ago are caused by rogues.
Every industry has its offenders and rogues. The world of asset management had Bernie Madoff; Washington lobbyists and political advisors had Jack Abramoff; and football coach Jerry Sandusky is now deservedly serving 30 to 60 years in prison. Yet, even the most stringent oversight can't identify every potential problem and no government can post police at every corner to assure that rules and laws are obeyed.
Drug development and delivery is a long and tortuous process. It starts in a laboratory, where basic scientific knowledge is enhanced and ends when a pharmacist fills a prescription or a patient takes an over-the-counter medication off the drug store shelf.
Science that results in a new drug advances in steps. Building scientific knowledge is like building a brick wall. If the bricklayer has to personally inspect every brick before placing it in the wall, progress is delayed. If the bricklayer assumes all the bricks are solid but some are not, the wall could be seriously weakened or even collapse. In the pharmaceutical world, each brick in the process of developing and delivering a drug must be reliable or people's health, and potentially their lives, are in danger.
The painful reality is that there are many gaps in the reliability and accuracy of the drug development chain. Not only is the end of the chain sometimes tainted, but increasingly, so is the beginning.