When Maxine Blount of St. Louis, Missouri traveled to her local pharmacy, she planned on purchasing her weekly vial of Procrit, a chemotherapy drug that restores a patient’s energy and strength. Blount, a breast cancer victim, doled out $500 a week for the Procrit, and took the drug intravenously through her doctor. It worked wonders.
Then, it stopped working.
It was not until Blount began feeling ill again that she had the medicine tested—a shocking discovery was made. She had been receiving counterfeit medication with a fraction of the vital active ingredient.
In a Dateline special on pharmaceutical counterfeiting that appeared last June, Blount said it was impossible to know the contents of the medication. “It could be full of water. You wouldn’t know the difference. We had no idea that what we were getting and having administered wasn’t the good stuff. How? How could we know?” she said.
Blount happened to be one of the lucky ones. “The ultimate consequence of counterfeit drug consumption is death, liver and kidney failure, and serious illness,” said Dr. Maria Sullivan, of Lakeshore Primary Care in Hamburg. Howard Zucker, Assistant Director General for Health Technology and Pharmaceuticals at the World Health Organization, echoed those grave thoughts, stating, “People don’t die from carrying a fake handbag or wearing a fake T-shirt. They die from taking counterfeit medicine.”
Worldwide drug counterfeiting is a $32 billion business. According to the FDA, it is estimated that upwards of ten percent of drugs worldwide are counterfeit, and in Nigeria and Pakistan, more than 50 percent of the drug supply is made up of counterfeit pharmaceuticals. A recent New York Times article claimed that counterfeiting accounts for up to 200,000 deaths a year. Other countries affected by drug counterfeiting include India, China, parts of Latin America, and the United States.
Blount is like many users of pharmaceuticals in that she was unaware of the potential danger and widespread effect of counterfeit medication. At the moment, few measures are in place to protect patients. Pharmaceutical companies across the country, including Pfizer, the nation’s largest, say they do not have any standard testing in effect. According to a June 10, 2006 New York Times article, federal rules were to be put into effect that year that would require pharmaceutical wholesalers to track prescription drugs from the factory floor to the pharmacy. But, according to an October 15, 2006 Buffalo News article, the U.S. FDA has confirmed that only a handful of major pharmaceutical companies currently use the proposed tagging system on their products, and in those cases the technology has not moved beyond the pilot program. As the drugs move closer to patients, the instances of checks and tests only decreases.
Tracy Eichelberger, a pharmacist at Walgreens on Abbott Road in Buffalo, sees no problem with the current pharmaceutical circuit. She feels secure in the fact that her pharmacy only deals with an approved Walgreens pharmaceutical distributor that ships directly to the 30,000 Walgreens locations across the country. She did state, however, that there is no testing at her pharmacy and that she is unsure of where exactly her pharmacy’s drugs are produced. “I’ve never heard of any testing at a local pharmacy,” she stated. She continued by asserting that “there’s no need to, the manufacturer ships the product right to us. There’s no middle man.”
Rose Burgholzer, a pharmacist at a CVS pharmacy on Main St., says testing is not a top priority in pharmacies. “Right now, there is no testing in pharmacies to decipher if drugs are counterfeit or not,” she said. Burgholzer sees this as a potential danger, though. “When drugs are being shipped from location to location, packages intended for certain pharmacies can be re-routed to another location. With this, it’s difficult to even keep track of what packages belong where. This is how the counterfeiters seize their product.”
When asked if there was testing for counterfeit medications at his company, DIT Health Care, a national pharmaceutical distributor in Cincinnati, Ohio, the Vice-President of Sales simply answered, “No.” Dan McCarthy, another DIT employee, was more candid. “Listen, there isn’t a small pharmaceutical distributor, like mine, in the nation that does more than $200 million in sales,” he said. “The bigger companies do billions in sales. If anything, it should be their responsibility.”
One such bigger company is Pfizer, manufacturer of Zoloft, Viagra, and Lipitor. Pfizer only tests drugs when they are suspected to be fraudulent. Bryant Haskins, a Pfizer spokesperson, stated, “We have a lot of things we do to test products,” but continued, “only when the products are suspected to be counterfeit.”
Prescription drugs, such as Lipitor, Neupogen (an anti-cancer drug) and AIDS pharmaceuticals, are among the myriad of counterfeit products sold by counterfeiters to Internet pharmacies and pharmaceutical distributors. Counterfeiting is not selective. These counterfeit organizations, operating without approval from the FDA, leak products onto the Internet and to wholesale distributors across the nation through the use of identical packaging, labeling, and seals.
In addition to the fact that packaging and labeling can be easily manufactured by counterfeiters to resemble legitimate products, new studies have discovered that counterfeiters are replicating the chemical composition of pharmaceuticals as well. For example, counterfeiters use glue, paper, chalk, or any other adaptable product in proper proportions to create something that, even to the trained eye, looks legit.
Both pharmaceutical distributors and pharmacists themselves have participated in the sale of counterfeit drugs, often reaping significant financial gains before being caught years later. For instance, in February 2002, Robert Courtney, a Kansas City pharmacist, pleaded guilty to diluting cancer drugs. He later admitted to diluting at least 98,000 prescriptions over the course of a decade.
The incentives are high for those like Courtney when it comes to delving in to the counterfeit industry. Take Serostim, a drug used by AIDS patients in order to prevent rapid and drastic weight loss. A 12-week dosage of this drug costs around $21,000. Counterfeiters who can find a way to push a fake version of this product onto the market stand to make a big profit.
José Grillo of Miami was found to be manufacturing counterfeit medications in a small facility for almost a year. He had made about $28 million by selling his products to Internet pharmacies and pharmaceutical distributors. According to Dateline reports, drugs from his batch were bought and sold by a series of drug wholesalers and distributors in Texas, Arizona, Tennessee, Florida, and New York. As the drugs were in transit, someone slipped in the counterfeits.
There are efforts to stem the tide of fake pharmaceuticals. For one, pending technologies, like radio frequency chips, have the ability to identify legitimate pharmaceutical products through radio waves by assigning individual serial numbers to each product. By putting radio tags on medicine bottles sent to drug stores, officials think they will be able to detect fake drugs that aren’t moving through usual supply chains.
Another technology in the works is that of a laser identification system, which would analyze the actual composition of the products within packaging. The three million dollar project to test the new technologies includes drug makers such as Johnson & Johnson, distributors like Cardinal Health, Inc., and retailers such as CVS Corp., to name a few.
But, as McCarthy from DIT states, there is only “a certain level of concern for consumers.” He continues, “I know that there is concern on behalf of the statewide prosecutors and the FDA.” It seems as if each company in the hierarchy of drug distribution relies on the other to take proper action and responsibility. In the end, whom can patients rely on?
Haskins, when asked to discuss the future of combating counterfeit prescriptions, simply stated, “It’s an awfully tall order.”
