Drug safety crisis hits home

The Baltimore Sun

Not long ago, the global crisis in tainted and counterfeit drugs hit home for me. My cousin Laura - high-octane teacher, wife and mom - was rushed to her local emergency room. Six weeks earlier, she had had surgery for a broken tibia and fibula. Now a vein in her leg had clotted, and she needed immediate, high-dose anticoagulation.

Physically and psychologically, Laura's first hospital stay had been bad enough. Unfortunately, after the surgery, no one had told her to stop taking her birth control pills because of the risk of clotting. Now, with oxygen in her nose and terms such as "deep vein thrombosis," "emergency lung scan" and "pulmonary embolus" wafting past her ears, my relative got downright nervous. Then came the final blow. As soon as a nurse started her anticoagulant drip, Laura thought she was dying.

"I never felt so terrible in my life," she later recalled. Sweaty and breathless, her chest and bowels heaving, she pressed her call button and yelled for help.

After a hurried, late-night discussion, Laura's doctors finally stopped her intravenous heparin and began a different blood-thinner - at which point my exhausted cousin felt better and fell asleep.

Did Laura dodge a bullet? We'll never know for sure, but it seems likely. Just weeks before her bizarre reaction to the popular blood-thinner, a tainted batch of heparin containing a raw ingredient from China - a man-made chemical that mimics heparin but is far cheaper to make - had started to flood American hospitals. The only problem was then, no one knew. Another two months would pass before the U.S. Food and Drug Administration, responding to hundreds of serious reactions and deaths, broadcast the news and ordered a massive recall of the life-endangering product.

Since then, the circle of victims has grown wider and the facts of the case uglier. Currently, patients in 10 other countries (Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands and New Zealand) are known to have received the adulterated compound. Most likely, the substitution of oversulfated chondroitin sulfate for genuine heparin - an expensive biologic normally harvested from pig intestines - was an act of economic fraud. Or, you might say, manslaughter.

This latest chapter in the global trade of fake or altered pharmaceuticals should send shivers down many spines. For years, even jaded medical consumers assumed that drugs prescribed to the sickest of the sick carried some seal of potency and purity. Guess again. Today, the $650 billion international pharmaceutical industry is quick to purchase ingredients and produce drugs wherever costs are low, opening the door to periodic disasters in every corner of health care, including hospitals.

The developing world is less naive, of course. People there have witnessed deaths because of shoddy or fake pharmaceuticals for years. Take malaria - a disease that still claims at least 1 million lives every year. The World Health Organization estimates that one in five malaria deaths would be prevented if all the drugs taken for the mosquito-borne blight were genuine. In many parts of Africa, as well as certain Asian and Latin American countries, up to 30 percent of all medicines are counterfeit.

In such settings, the problem touches everyone. One positive result is a new wave of powerful, home-grown reformers. In Nigeria, for example, Dorothy "Dora" Akunyili, who heads her country's equivalent of the FDA, became a fierce crusader after a fake insulin injection killed her diabetic sister. For years, Mrs. Akunyili has waged a war against counterfeit drugs that has pitted her against some of her wealthiest countrymen. In December 2003, she survived an assassination attempt.

The weak and economically powerless of the world will always be vulnerable to pharmaceutical mayhem - and we should never forget their plight. But casualties are no longer simply "over there." We need more oversight and reform within our own system, and that means ponying up for more FDA inspectors and better drug-testing assays.

Better labeling wouldn't hurt, either. Why can't package inserts state the origin of raw materials found in prescription drugs - or where in the world the drugs were manufactured? American consumers know more about the pedigree of a bag of chips than about the medicines that are supposed to save their lives.

Finally, the latest heparin scare reminds us that no one is immune to tainted drugs, including patients in the finest U.S. hospitals. If you're lying in one now, or will be soon, and suspect that one of your medications may be harming you, don't be shy about pulling that bell cord and asking pointed questions. And if you don't get a satisfactory answer from a doctor or nurse, you should demand to speak to a hospital pharmacist or someone from risk management.

Which brings me back to my cousin. I'm glad she's no shrinking violet. Her quick thinking and powerful lungs may have saved her life.

Claire Panosian Dunavan is president of the American Society of Tropical Medicine and Hygiene and co-founder of the Program in Global Health at the David Geffen School of Medicine at UCLA. Her e-mail is cpanosian@mednet.ucla.edu.

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