Approving medicines shouldn’t be a rush job

What do Americans get in addition to paying the highest prices in the world for prescription drugs?

The real possibility that if the expensive prescription drug was approved on deadline, it just may cause safety problems down the line.

Like what happened with the drugs Vioxx, Bextra, Rezulin and Baycol — all taken off the market.

Harvard researchers recently found that medicines approved right on deadline by the FDA are more likely to cause safety problems than those given the OK with time to spare.

Their study was published in the New England Journal of Medicine. The FDA disputes the findings.

“The article is a wake-up call,” said Dr. Steven Nissen, the Cleveland Clinic’s influential cardiology chief. “It puts the FDA in a very difficult situation when they’re trying to make complex decisions under these very, very tight deadlines,” he told the Associated Press. “We’ve got to re-evaluate now whether that’s good public policy.”

Well, our quick re-evaluation says no, it’s not good public policy to rush drugs to market, for the sake of profit, with patients as guinea pigs.

According to the AP, deadlines were first imposed on the FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, the FDA had to either approve or reject 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was six months for drugs so novel or potentially lifesaving to be classified high-priority.

Congress tightened the deadline for most drugs to 10 months in 1997.

The Harvard researchers found approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any other time. Drugs approved in that just-before-deadline period had a four- to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster — presumably slam-dunks — or those that miss the deadline, Harvard professor Daniel Carpenter concluded.

The researchers rechecked their numbers after the FDA objected, and stood by their findings.

It takes big-time side effects to get a drug pulled: Vioxx was taken off the market in 2004 for increasing the risk of heart attacks and strokes. The diabetes drug Rezulin was withdrawn in 2000 for causing liver problems.

The Harvard researchers clearly show that our hurry-up-and-make-money system for approving new drugs can put Americans’ health at risk. It’s a policy that makes no sense, medically or morally.

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