Are Your Drugs Safe?
Shoddy and fraudulent pharmacy products pose a growing threat
Warning: The contents of your medicine cabinet may not be what they seem.
Just 10 of the 21 multivitamins tested met the quality claims on the label, ConsumerLab.com of White Plains, N.Y., reported in January. Several had significantly more or less of the active ingredients than promised; one was contaminated with lead.
Last fall, more than 1 million counterfeit OneTouch diabetes test strips flooded the United States and went on sale in 700 pharmacies in 35 states.
And in December, metal poisoning took the life of a 58-year-old woman who lived on Vancouver Island, Canada. Prescription medications she had purchased from an Internet pharmacy contained toxic amounts of aluminum.
"How is anybody supposed to know the difference?" asks Arthur Soclof, an allergist in Livonia, Mich. He discovered that the Lipitor he'd bought at his local pharmacy was fake only because the pills wouldn't break the way they had in the past. "If I wasn't splitting pills I wouldn't have thought twice about it," says Soclof, 50.
Gone are the days when Americans could unquestioningly trust in the quality and authenticity of their pharmaceuticals. So far, no American deaths have been linked to shoddy or fraudulent medications. But a surge in hazards discovered at home and abroad has cast new doubts on the safety of prescription and over-the-counter drugs, supplements, and other medical products. Americans "should be quite concerned," says Roger Williams, CEO of US Pharmacopeia, a private organization that creates the nation's official quality standards for drugs.
Americans still have the best pharmaceutical products in the world, says Williams. But the safety net is getting frayed. Recent problems with other goods imported from China, such as the melamine that tainted pet food and killed dozens of dogs and cats, and toothpaste made with diethylene glycol, have sparked worry that the pharmaceutical industry's rapid migration to manufacturing plants in China and other Asian countries is increasing the risk of similar problems with medicines.
Explosion of imports. In the past five years, Chinese pharmaceutical imports into the United States have more than doubled, to $698 million. Already, half of the aspirin used worldwide comes from China, as do 35 percent of the painkiller acetaminophen and almost all synthetic vitamin C. India's pharmaceutical imports into this country increased 2,400 percent, to $789 million, from 1996 to 2006, making it the fastest-growing drug importer. Last year, Indian firms won Food and Drug Administration approval to import more than 100 generic drugs, including a version of the anti-HIV drug Retrovir. India and China make about 20 percent of generic and over-the-counter drugs sold in the United States and at least half of the "active pharmaceutical ingredients" for pills made within the United States. "Ten years ago, the Chinese and Indian API market was nonexistent, and now they're dominant," says Lynne Jones Batshon, executive director of the Bulk Pharmaceuticals Task Force, a group of ingredient manufacturers. Price is a key driver of that shift, Batshon says, and complying with American regulatory requirements is expensive.
At the moment, consumers have no way of knowing where their drugs are produced or assembled, because there are no requirements for country-of-origin labeling of drugs. The counterfeit diabetes test strips were traced to a firm in Shanghai. And when at least 56 people died in Panama last fall after taking cough and allergy medicines, it was discovered that the drugs had been spiked with toxic diethylene glycol sold as harmless glycerin by a Chinese firm. Raw ingredients and finished products can move through a half-dozen countries before landing on a pharmacy shelf. Pharmacies buy from manufacturers or from wholesalers who are licensed by the states. "Our mantra is, the more often a product changes hands, the more likely a counterfeit can be introduced into the supply chain," says Rubie Mages, a former district attorney who is a director of global security for Pfizer, which makes Lipitor and Viagra, probably the world's most counterfeited drug.
The FDA gained the authority to order tainted drugs off the market in 1938, after more than 100 people died in the States from taking medicine made with diethylene glycol. The federal regulatory system now requires manufacturers to test drugs for safety and efficacy before they are marketed, and also to quality-test the raw ingredients they use and the finished product. The FDA sends inspectors to domestic production facilities about every two years to make sure that they're in compliance; the inspections can take months. But the agency's enforcement division doesn't have the resources to inspect more than a tiny fraction of manufacturers overseas. Between 2,000 and 3,000 overseas pharmaceutical manufacturers that sell to the United States are registered with the FDA. Some of those have not been inspected in eight to 10 years, an FDA official told a congressional committee last month. And the suppliers of ingredients to those importers never get a look-over. "The FDA doesn't have the people who can go to these countries and inspect," says William Hubbard, a former associate commissioner for policy and planning at the agency. "The enforcement side has been cut drastically."
The public uproar over the pet deaths from melamine, as well as tainted toothpaste, got the government's attention. Congress has introduced several bills that would require country-of-origin labeling on pharmaceuticals, as well as fees on drug imports to pay for more inspections at the borders. An import-safety task force held hearings in Washington, D.C., last week, with the aim of preparing a report on possible solutions later this fall. And the Department of Health and Human Services is in the midst of negotiations with its Chinese counterpart over how to improve that country's food and drug safety programs. The top priority: the chemicals from which drugs are made. "We're very interested in oversight of the API industry in China," says Murray Lumpkin, deputy commissioner of the FDA's Office of International and Special Programs. In the past year, the standards-setting organization us Pharmacopeia opened offices in India and China, its first outside the United States. Some manufacturers in those countries have courted USP in an effort to prove they meet international standards.
People who rely on generic drugs may have to worry about more than the active ingredients, says Joe Graedon, a longtime champion of generics and coauthor of the 2006 book Best Choices From the People's Pharmacy. Since 2004, when the FDA fast-tracked the approval process for new generic drugs, more and more people have told him they've experienced side effects with a generic that they didn't have with the brand name, or the generic is failing to work at all. He wonders if differences in inactive ingredients or formulations could account for the treatment failures; when a company seeks FDA approval for a new generic, it must prove only that the active ingredient is the same. ConsumerLab.com is testing for differences between some generics and brand names; results are expected later this month.
Spotting phonies. Even brand-name drugs you buy at the local pharmacy may pose dangers. Counterfeiting, says Hubbard, is extremely profitable and "a lot easier than selling narcotics. And you don't have to deal with a Colombian drug lord." The World Health Organization estimates that 10 percent of pharmaceuticals worldwide are counterfeit.
Sometimes, perceptive citizens must do their own detective work. Soclof, the Michigan allergist, had been taking half a pill of Lipitor daily to lower his cholesterol. In 2003, he picked up a refill and found that the pills wouldn't crack, no matter how hard he tried. "It used to break in half very easily," he says. He thought the sudden change was "really odd." A few days later he happened to see a newspaper article about counterfeit Lipitor being sold in pharmacies. Soclof called Pfizer, which manufactures Lipitor, and the FDA and was sent a FedEx envelope to return the suspect pills for testing. They were fake.
Like Soclof, customers are at a disadvantage when it comes to figuring out if the medications they get from their pharmacist or mail-order benefit plan are fakes. In many cases, counterfeiters imitate packaging of the legitimate company, as in the case of the fake OneTouch test strips. The fraud was discovered only because alert users clued in LifeScan Inc. of Milpitas, Calif., the company selling the strips, that they were getting odd results. At other times, counterfeiters mix real pills with fake (as in the case of the counterfeit Lipitor) or "uplabel," substituting 10-mg pills, say, for 40-mg ones.
Experts in counterfeiting suggest that patients examine pills and packaging when they get a new prescription and note if the medicine tastes different, dissolves differently, or appears to have different effects. "We're big advocates of going back to the pharmacy" where the prescription was filled if something looks off, says Ilisa Bernstein, director of pharmacy affairs for the FDA. A pharmacist can help answer questions: Often a pharmacy will switch a patient from one generic to another, and the difference in the pills' appearance can spark needless worry. If in doubt, Bernstein says, take the medicine back to the pharmacy, or call the manufacturer.
For years, federal agencies have warned Internet shoppers of the risks of getting bogus or substandard medication. Yet the Internet drug trade is still booming. In May, the FDA announced that patients who had bought Xenical, a weight-loss drug, over the Internet received pills that looked identical to the Roche product but contained talc and starch. Other pills contained Meridia, a different weight-loss drug. In a June survey by MarkMonitor, a San Francisco-based firm that keeps tabs on online sales and marketing abuses, 38 percent of spam E-mail hawking Internet drugs came from China; 24 percent came from the Russian Federation; and just 2 percent came from sites actually in Canada, though many others claimed to be based there. An online pharmacy that falsely claimed to be in Canada sold the tainted drugs that killed Marcia Bergeron, the Vancouver Island woman. The MarkMonitor survey found that just four of the 3,160 pharmacies surveyed were certified by the National Association of Boards of Pharmacy, which vets online drugstores.
Suspect supplements. If there are troubling gaps in the regulation of imported pharmaceuticals, the oversight of nutritional supplements has yawning cavities. More than 150 million Americans take vitamin and mineral supplements regularly, but those tablets don't always contain all of the active ingredient claimed. In June, the FDA issued rules defining good manufacturing practices for supplements. But manufacturers still aren't required to prove dietary supplements are safe and effective by testing them before they enter the marketplace, as they are with prescription drugs.
Thus consumers tend to learn of safety and quality issues only after supplements are on the market. In August, for instance, the FDA warned people not to take red yeast rice supplements sold by Swanson Healthcare Products Inc. or Sunburst Biorganics because they contained lovastatin, a prescription drug used to treat high cholesterol. And in September, the agency recalled Axcil and Desirin, herbal supplements made by twc Global of Mountain View, Calif., because the pills contained sildenafil, the active ingredient in Viagra. That drug can interact with nitrates taken for heart problems and may dangerously lower blood pressure.
In September, new ConsumerLab.com tests found that three of the 10 tested B-vitamin supplements had less folic acid than claimed. That may be because folic acid degrades if it's not stored properly, says President Tod Cooperman. Supplement purchasers concerned about quality and safety should be particularly careful about herbals, he says, because they are more likely to be of poor quality or contaminated. He suggests checking out independent laboratories that test supplements, including US Pharmacopeia and his company, ConsumerLab.com, which charges $29.95 a year for access to test data. Simplest of all, buy two different brands of multivitamins and switch daily. That way, he says, if one is subpar, at least the other may measure up.
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