Prescription For Disaster

Miss Aruba 2007, Carolina Raven, poses for photographers on the runway clad in traditional dress on Reforma Avenue in Mexico City, Sunday, May 20, 2007. Raven will compete for the title of Miss Universe 2007 during the 56th annual Miss Universe competition in Mexico City, on Monday, May 28, 2007.
The nationwide alert was set off from a South Carolina strip mall, where drugs made by Urgent Care Pharmacy in a make-shift lab and shipped to clinics around the country were found contaminated with a deadly fungus.

Mary Scyster wrenched her back playing golf and died from fungal meningitis after a pain shot made by Urgent Care.

"I have never seen anyone suffer that much," says her husband David. "She was never at peace."

Many others fell ill. Cancer patient Jim Hickman was nearly comatose after his injection.

"You need to do a better job of regulating these medications," says Hickman. "They need some kind of quality control to see that this could never happen again."

But it's happening more and more, due to a little-known practice called compounding - pharmacists mixing drugs from scratch. In recent years, compounded drugs have killed three people in California, another in Michigan, blinded two in Pennsylvania and hospitalized many others in other states.

The most infamous case involved Kansas City pharmacist Robert Courtney, who put more than 4,000 lives at risk with watered down cancer drugs. It's hard to believe. But while big pharmaceutical companies are tightly regulated by the Food and Drug Administration, if you call yourself a compounder, oversight is minimal.

"It's outrageous," says attorney Kim Wilson.

Wilson calls it a prescription for disaster. Her Raleigh, N.C. firm filed a class-action suit against Urgent Care.

"They don't answer to the FDA, they minimally answer to their state pharmaceutical boards, and they're basically allowed to get by with making drugs and selling drugs that aren't regulated or tested by anyone," she says.

Why? Because compounding has a long, revered tradition: local pharmacists mixing drugs for individuals with special needs. Most pharmacists learn it in school. But now an unscrupulous few are exploiting the loophole; calling themselves small compounders, while making drugs on a huge scale, with cheaper, little regulated, possibly dangerous ingredients.

"We see pharmacies which are manufacturing thousands of injections," says FDA consultant Sarah Sellers. "It affords great profits to pharmacists and pharmacies engaged in the practice."

Most states are unaware or unprepared to handle large-scale compounders, like Urgent Care. The Supreme Court recently ruled the FDA can't regulate them. So, it can issue an alert, but not a recall, leaving survivors like Dave Scyster and Jim Hickman, who's joined the class action suit, to seek a legal cure for bad medicine.