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April 15, 2008     Cape Gazette
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April 15, 2008

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CAPE GAZETTE - Tuesday, April 15 - Thursday, April 17, 2008 - 25 FDA on the hot seat o00er heparin horror Americans have been repeated- ly told that we have the safest medicines in the world. That's because the Food and Drug Administration has the reputation for policing our drug supply con- scientiously. The recent scandal over the anticoagulant heparin, however, has many people wondering just how safe our drugs really are. During the past several weeks, investigators have begun to piece together the puzzle. It all started when patients experienced severe allergic reactions to this injectable blood thinner: abdominal pain, nausea, vomiting, diarrhea, fever and low blood pressure. More than a dozen people have died. Eventually, the problem was traced to China, where the raw ingredients for heparin are pro- duced from pig intestines. Early speculation attributed the problem to unsanitary manufacturing con- ditions or sick pigs. Recent revelationsi however, suggest that a contaminant was intentionally added to fool testers into thinking there was more heparin than was the case. This compound has been identified as oversulfated chondroitin sulfate. Even though it is hard to distin- guish from heparin ,with basic tests, it has no anticoagulant activ- ity. This should ring some bells with alert readers who remember the pet-food scandal from last year. Chinese suppliers added melamine to wheat gluten bought by American pet-food manufac- turers. Melamine was added to make the gluten appear to have more protein in it, so it could com- mand a higher price. Dogs and cats died as a result of this adulter- ation. Toxic toothpaste from China also had to be pulled off the mar- ket last year. It contained the poi- sonous antifreeze diethylene gly- col, which had been substituted for the more expensive ingredient glycerin. The heparin incident now looks like another instance of Chinese PEOPLE'S PHARMACY Joe and Teresa Graedon manufacturers charging more for less. The fact that the Food and Drug Administration (Fl inspected the wrong Chin adds to the calamity. These incidents may b of a giant iceberg. More factories in China exp, ingredients or finished pi )A) had se plant the tip Ihan 500 )rt drug ls to the United States. Last year, he FDA inspected 13. ] Because of cutthroat 9ompeti- tion, especially for generic drug ingredients, China and Irldia have emerged as major suppliers. There is no system in place to ensure these products icontain what they claim and othing more. The heparin example demonstrates how vulnerable we are to counterfeit or adulterated / medication. Readers have reported failures and adverse effects from many generic drugs. Some may be related to imported ingredients. Others may be traced to shortfalls in the FDA's generic drug approval and monitoring process. We recently warned about the special problems associated with some generic forms of the antide- pressant Wellbutrin XL 300 and the heart and blood pressure pill Toprol XL. You can read more about this at www.peoplesphar- Anyone who has had a problem with a generic drug can report it to us or directly to the FDA at Physicians, pharmacists, insur- ance companies and hospitals have relied upon the FDA to guar- antee that American medications are reliable and safe. They have assumed that the agency was capable of monitoring the drug supply chain. Perhaps it is time to reevaluate that assumption. Editor's note: Joe Graedon is a pharmacologist, and Teresa Graedon is a medical anthropolo- gist. Write to them in care of King Features Syndicate, 888 Seventh Ave., New York, NY 10019, or via their website at www.peoplespharmacy, com. Mzheimer's Association to host tning The Alzheimer's Association Delaware Valley chapter spon- sors the Family Caregiver Education Series four times per year in each of Delaware's three Counties. The training session will be from 8:30 a,m. to 4:30 p.m., Thursday, May 1, at Cadbury of Lewes. The program includes a medical overview and addresses legal and financial issues, challenging symptoms, dally care issues and how care- givers can get the help they need. This training for family care- givers is free, and Cadhury of Lewes will provide lunch. Preregistration is required by Wednesday, April 23. To register, call Jamie Magee, branch office coordinator, at 854-9788. (Toll-Free) Free expert counseling by phone Or work with a counselor in person Use workbooks on your own You could qualify for free nicotine patches and gum For Delaware residents 18 and older QUETNET DELAWILRE HEALTH AND SOC/AL SERVICES Oivt o Put I-lealth Free online hq i Talk online wi Get quitting t counselors Create your For Delaware residq lp to quit smoking th people who are quitting ps and hints from expert wn stop-smoking plan nts 13 and older TOba=  am  Program