Knockoffs on the Pharmacy Shelf
Counterfeit drugs are coming to America
It was a mystery. Over several weeks last winter, Massachusetts-based drug maker Serono Inc. received about a dozen calls from concerned patients using its AIDS drug Serostim. They complained of unusual reactions: itching, swelling, and rashes by the injection sites. The patients mailed their vials to the company for inspection, and soon after, Serono scientists discovered the cause of the ill effects: The drugs, which patients had bought at local pharmacies, were not Serostim at all, but fakes.
Counterfeit drugs have plagued underdeveloped countries for years. More than 7 percent of the world's pharmaceuticals are bogus, according to the World Health Organization; in Colombia, up to 40 percent of medications are believed to be fake. But until recently, a tightly controlled regulatory system has made it extraordinarily difficult for counterfeiters to slip suspect medications into the United States. Now, however, that system is straining under an explosion of Internet drug sales from overseas and increasingly sophisticated counterfeiting techniques.
Last month, vials of three counterfeit drugs made their way to pharmacy shelves in at least eight states. The drugs copied were Neupogen, an anti-infective manufactured by Amgen; Nutropin AQ, a human growth hormone made by Genentech; and a second batch of Serostim. This week, a New York drug wholesaler will be sentenced for distributing $4.1 million of other counterfeit medications, including the expensive fertility drugs Pergonal and Metrodin, as well as Eldepryl, a drug used to treat Parkinson's disease. According to the WHO, 16 percent of counterfeit drugs have the wrong ingredients, 17 percent have incorrect amounts of ingredients, and 60 percent have no active ingredients at all.
No one has yet quantified the counterfeit problem in the United States, but public-health officials consider it a growing threat. Pharmaceutical companies, loath to discuss the problem for fear of alarming the public or depressing sales, have quietly ratcheted up security. The Food and Drug Administration and U.S. Customs Service are stepping up enforcement. And a House oversight subcommittee will hold hearings this week. "Eventually," says one congressional investigator, "you are going to have an epidemic here that is going to kill people."
In fact, U.S. patients have already died from taking counterfeit drugs. And the tragedies highlight some flaws in a regulatory system designed to prevent them. In 1996 the FDA attributed several dozen deaths to a suspected counterfeit version of the popular antibiotic gentamicin sulfate.
Customs and FDA officials tracked the counterfeit to a New Jersey wholesaler called Flavine International. Company officials were convicted of importing counterfeit drugs from a pharmaceutical company in China and repackaging them to appear as though they had come from a manufacturer approved by the FDA.
Bad reaction. Two years later, gentamicin from the FDA-approved manufacturer caused six patients in a Denver hospital to suffer toxic reactions. Congressional investigators, who believe the drug was counterfeit, fault the FDA for not properly monitoring the manufacturer under its watch. Dr. Michael Earnest, a physician at the Denver Health Medical Center, who worked with FDA investigators, blames the agency for not alerting him to its findings. "I just assumed it was a manufacturing problem," Earnest said. "I did not know this [could have been] counterfeit." At the same time, health officials in other states say the FDA has failed to inform them of critical details of counterfeiting cases. And others fault the agency for not ordering a full recall of Eldepryl after that drug was counterfeited.
The FDA is overwhelmed by the sheer number of medications flooding into America from abroad.
In 1999, according to Forrester Research, Americans bought $158 million in drugs over the Internet, a convenience that is clearly accompanied by risks. In investigations at Washington Dulles International Airport in Virginia and Oakland International Airport in California, customs and FDA officials found that about 10 percent of the drugs they analyzed--including medications to treat Parkinson's disease, asthma, and osteoporosis--contained no active ingredients. In other cases, counterfeits have included dangerous, even life-threatening, ingredients: The fake Nutropin AQ, for instance, contained human insulin.
Controlling a problem of this scope has so far eluded both customs and the FDA. Agents who recently conducted an inspection at a mail facility in Los Angeles were faced with 16,000 parcels of pharmaceuticals in just one month. Of those, FDA inspectors were able to examine only 721 parcels, and because of budget and manpower restraints, they were not able to chemically analyze any of the drugs. This was true even though most of the 721 parcels contained controlled substances, lacked a prescription, were outdated, or were suspected of being counterfeit. "[T]he system is inadequate and incapable of protecting the public from potentially adulterated and unsafe medicines," Congress warned the FDA in a letter in March.
Profit potential. Experts fear that counterfeit drugs will proliferate as drug prices continue to soar. The most recent counterfeit cases have focused on highly expensive drugs: Serostim costs $21,000 for a 12-week dose, and Neupogen, used by chemotherapy patients, costs between $150 and $250 per vial. "If someone was to produce a truckload of this stuff," says Amgen spokesman David Kaye, "it could be quite lucrative." Indeed, the industry estimates that it loses $2 billion each year to counterfeiting.
With so much at stake, drug makers routinely check wholesalers and others to ensure that the products they supply are genuine. "These people are screened upside down and every which way," says Ken Allard, director of pharmacy development at Rite Aid. "There is no way we would buy anything that was even suspect." But the technology used to counterfeit drugs has become so sophisticated that it is often hard to distinguish the genuine medication from the fakes.
In February, Los Angeles authorities arrested three people for running a counterfeit Viagra operation so sophisticated that a Pfizer analysis of the product ranked it a nine out of a possible 10. "They had the lot numbers, the package inserts, the packaging," says Monette Cuevas, the Los Angeles County Department of Health Services pharmacist who examined the drugs. "You could not tell the difference."
In an attempt to curb the counterfeit problem, some drug companies have put chemical tags into their medications so they can check a vial with equipment resembling a home pregnancy test. And the FDA has recently provided its field inspectors with an electronic database to help them visually compare genuine medications against suspected counterfeits. In the meantime, consumers are wise to buy their drugs from familiar domestic pharmacies--and to inspect packages carefully.
Warning signs
Counterfeits are hard to detect, as shown below with real and fake vials of Genentech's Nutropin AQ.
Neupogen (Filgrastim) 300 mcg
Amgen Inc. (800) 772-6436
Use: Helps stimulate white blood cell production to fight infection.
What to look for: Lot numbers P000948 and P000890. Counterfeit versions have no boxes around the drawings in the patient insert.
Serostim (Somatropin) 6 mg
Serono Inc. (888) 275-7376
Use: Prevents HIV-related weight loss.
What to look for: Lot numbers MNH605A and MNK612A. One counterfeit version has a dark-blue label affixed to the carton.
Nutropin AQ (Somatropin) 10 mg
Genentech Inc. (800) 551-2231
Use: Alleviates growth hormone deficiency.
What to look for: Lot numbers L9101A4, L9504A2, and L9404A3. The fakes use rounded fonts for lot numbers. The real drug uses squared lettering.
This story appears in the June 11, 2001 print edition of U.S. News & World Report.