Here we go again. First it was pet food from China contaminated with melamine. Then it was Chinese-made toothpaste containing diethylene glycol, an ingredient found in some antifreeze.
Another scandal erupted earlier this year when patients developed severe allergic reactions to the blood thinner heparin. More than a dozen people died. The investigation that followed found that some Chinese suppliers apparently added a cheap, dangerous compound to the raw ingredient.
Now thousands of Chinese babies are sick because melamine, the same chemical that killed cats and dogs, was added to milk to disguise dilution. Other dairy products, including yogurt and ice cream, may also have been contaminated.
All these incidents suggest that food and drug quality control is lax in China. Few Americans realize that raw ingredients for many of our medications are sourced from China.
Generic drug companies undersell brand name products in part because they buy their raw ingredients for less. How else could a discount drug chain offer a cholesterol-lowering drug like pravastatin at $10 to $12 for a three-month’s supply? The brand name Pravachol goes for over $300 for the same amount.
We do not know where discount drugstores buy their low cost medicines. One possible source is India. The FDA recently banned importation of 30 generic drugs (including pravastatin) from Ranbaxy Labs, India’s largest pharmaceutical firm. The agency cited lapses in manufacturing process and quality control. The U.S. Department of Justice is pursuing separate action alleging that Ranbaxy distributed adulterated and misbranded products.
Unfortunately it is impossible for pharmacists or patients to identify the source of their medication. For the last several years we have been hearing from readers and visitors to our Web site (www.peoplespharmacy.com) about problems with certain generic drugs. That is why we have become critical of FDA oversight.
We were recently taken to task by a Houston Chronicle reader who wrote, “The Graedons have been anti-generic drugs for years. They never miss an opportunity to denigrate generics. I wonder which companies’ stock they own.”
Just for the record, for 25 years we were strong advocates for generic drugs. Even when physicians and pharmacists questioned quality, we encouraged patients to insist on generics. We believed the FDA that generics were always identical to brand name drugs. We are no longer confident that is true for all generics. We own no stock in any pharmaceutical company, brand or generic.
We think the FDA needs to take a far more active role in monitoring foreign and domestic drug manufacturing. Currently, many companies are on the honor system: FDA checks paperwork and does little if any analysis of actual medications off pharmacy shelves to make sure they meet quality standards.
The events in China and India suggest that the honor system is no longer adequate. To keep Americans safe, our federal watchdogs need more resources and willingness to safeguard our drug supply.