FDA DRUG APPROVAL – TIMING IS EVERYTHING

In Today’s Wallstreet Journal, our local paper, and on the AP – “Late approval of Drugs linked to safety issues.”

Hardly a week goes by without new research reflecting certain medications have unknown, serious side effects…At least three major drugs have been pulled from pharmacy shelves in the last four years (Vioxx, Baycol, amd Rexulin) because of unsafe side effects. And what do they all have in common?

According to the AP reports, “Looking at drugs yanked off the market, Harvard researchers found a disturbing pattern: Medicines approved right on deadline by the Food and Drug Administration are more likely to cause safety problems later than those cleared with more time to spare.”

“The Harvard analysis of decades of drug approvals, published in Thursday’s New England Journal of Medicine, provides the first scientific evidence supporting some of those complaints.
The FDA challenged the findings with its own statistics. Still, the study sparked calls to re-examine the balance between speed and safety.
“The article is a wake-up call,” said Dr. Steven Nissen, the Cleveland Clinic’s influential cardiology chief who helped sound the alarm on the risks of some of those ultimately doomed drugs
“It puts the FDA in a very difficult situation when they’re trying to make complex decisions under these very, very tight deadlines,” he added. “We’ve got to reevaluate now whether that’s good public policy.”

“Amid concern about risky drugs, Harvard professor Daniel Carpenter took a closer look at the impact. First, he 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Drugs approved in that just-before-deadline period had a four- to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster – presumably slam-dunks – or those that miss the deadline, Carpenter concluded.
The FDA argued the findings weren’t accurate, rushing out its own statistics that showed somewhat more withdrawals among drugs approved just before the deadline but not enough to be statistically significant.
“FDA won’t approve a drug if we are not ready,” said drug chief Dr. Janet Woodcock. “And we have the option of denying approval altogether if there is any question about safety.”
But the Harvard researchers in turn rechecked their statistics, which had passed review by the medical journal, and informed FDA they were standing by the findings.
Among on-the-brink approvals that later caused problems: The painkiller Vioxx, pulled off the market in 2004 for increasing the risk of heart attacks and strokes; its competitor Bextra, gone in 2005; the diabetes drug Rezulin, withdrawn in 2000 for liver problems; and cholesterol-lowering Baycol pulled in 2001 for muscle damage.
More recently, the diabetes blockbuster Avandia was linked to heart risks last year, getting a strict new warning label.”

Scary stuff – read more at www.ap.com
And please, remember, no medication is without complication.

Lauren Ellerman

Lauren Ellerman

In 2011, Lauren Ellerman was named "Young Lawyer of the Year" by the Roanoke Bar Association for her work in the community. To speak with Lauren about your personal injury case, contact her at lellerman@frithlawfirm.com.