Scam artists have stepped up the smuggling of medicines because of drug shortages in the United States while brazenly counterfeiting others, profiting on people with cancer and other medical conditions.
Last month, the U.S. Food and Drug Administration alerted pharmacies and physicians that questionable versions of two leading cancer drugs had entered the pharmaceutical supply chain.
The breast cancer drug Faslodex and the lymphoma medication Rituxan have recently made their way through unknown sources into U.S. cancer clinics, officials said.
But those pharmaceuticals are just two of a vast array of medications smuggled into the country from foreign pharmacies or counterfeited - made from scratch - in clandestine labs.
"This is the worst possible kind of crime when you think about the patients," said James Abberton, pharmacy director at Long Island Jewish Medical Center in New Hyde Park.
Counterfeit, stolen and smuggled medicines are a $75 billion global enterprise, according to the World Health Organization, which estimates that one in every four medications sold worldwide is from a questionable source. These drugs have been blamed for hundreds of thousands of deaths annually, mostly in Africa, Asia and South America.
Carmen Catizone, executive director of the National Association of Boards of Pharmacy, estimates 5 percent of the 4.5 billion prescription medications used in the United States are counterfeits, generally purchased by consumers online.
"That's our best estimate because there's no hard science behind it," he said.
Fake medications are becoming an even bigger problem in the wake of ongoing medication shortages caused by production delays and other problems at major pharmaceutical companies, experts and officials said.
"You can't be too careful," said Marcelle Levy-Santoro, pharmacy director of Nassau University Medical Center. "It's like the wild, wild West out there. And [illegal] distributors can get their hands on almost anything."
Shortages of injectable cancer medications may be inviting "unscrupulous individuals to introduce unapproved products into the drug supply," the FDA said, raising the risk that patients may be exposed to potentially deadly doses.
Nearly 200 medicines, according to FDA statistics, are in short supply and span a wide range, from injectable medications to anesthetics and painkillers.
Thousands of bogus medications are routinely seized at Kennedy Airport, a major point of entry for rogue medications made in China, Pakistan and India, officials said. Questionable medicines of all kinds account for the largest number of items confiscated by federal authorities, the U.S. Customs and Border Patrol said last week.
To prevent counterfeit medications from reaching the public, pharmacies and others need to know who they are buying from, experts said.
For example, the North Shore-Long Island Jewish Health System, Abberton said, only buys medications from known wholesalers that deal directly with pharmaceutical manufacturers. Working through reputable wholesalers allows the health system to trace each drug's chain of custody from production to delivery, Abberton said.
Levy-Santoro said her center's medication purchases also are made only through major wholesalers.
The FDA learned last month that the two cancer drugs were being peddled directly to physicians via distributors who remain at large.
"The FDA was made aware that clinics were purchasing unapproved medications as a cost-savings measure," said agency spokeswoman Shelly Burgess, who did not reveal how the agency found out about the smuggled cancer drugs or where the drugs were sent.
Burgess said tests revealed the cancer drugs are versions approved in other countries and are similar to the FDA-approved medications in this country.
There have been no reports of harm caused by the drugs, the FDA said.
Internet pharmacies' role
The National Crime Prevention Council, which cites counterfeit medications as a growing health threat, reports the most commonly bootlegged medications are aimed at patients with serious or chronic health conditions: high cholesterol, hypertension, HIV infection and cancer. Erectile dysfunction drugs are the most widely counterfeited drugs, experts say.
Skyrocketing medication costs have been driving consumers to search for deals online, according to the council, and attractive pricing is a deceptive lure.
Catizone said about 80 percent of the Internet pharmacies on his pharmacy organization's "not recommended" list do not require a valid prescription.
And virtually all of the so-called Canadian pharmacies online, Catizone said, are not licensed to sell drugs in the United States.
"Only two Canadian pharmacies are registered in the United States, and they're registered in Nevada and not in any other state," he said. "So they're operating illegally in the rest of the country because a pharmacy has to be registered in each state that it operates."
Rep. Steve Israel (D-Dix Hills) is in the process of retooling a measure that strengthens consumer protections against purveyors of bogus medicine. Israel plans to reintroduce his bill during the current session of Congress, spokeswoman Samantha Slater said.
Israel first introduced legislation in 2003 after Tim Fagan, a Dix Hills teenager at the time, nearly died after receiving an injection of the immune-booster Epogen following a liver transplant.
Fagan's parents purchased the medication at a Dix Hills CVS outlet. The altered drug was the product of a Florida counterfeiter who removed the labels of a lower-dose version of Epogen and placed his own on the bottles, claiming it as the higher dose. The medication, which was never maintained at the proper temperature, was then sold back into the supply chain at an elevated price.
The counterfeiter was indicted in 2003 on racketeering charges and sentenced to 12 years in prison.
Fake pills seized Today, most of the world's medication traffickers are in China, Pakistan and India, said Tom Kubic, president of the Pharmaceutical Security Institute, a consortium of drug-security officers for major pharmaceutical companies.
The institute investigates reports of fake or foreign medicines that have infiltrated the United States or other countries and works in conjunction with the FDA and customs officials, Kubic said.
"At JFK . . . you see the customs guys working with the FDA inspectors, taking package after package off the line. Most are small quantities of about 90 tablets," Kubic said.
In 2010, the most recent year for complete statistics, Kubic's organization investigated 2,054 cases of stolen, counterfeited and diverted medications worldwide involving 593 specific types of medicine. Diverted medications, he said, are genuine pharmaceutical products approved and intended for sale in one country, but illegally intercepted and sold in another.
Last year, customs agents found 20,000 counterfeit erectile dysfunction pills at Kennedy in cargo from Hong Kong, according to a U.S. Customs and Border Patrol report. The shipment, valued at $220,000, contained fake Viagra, Cialis and Levitra. "Counterfeiters generally do not want to kill their customers," Kubic said. "Whether these customers get better, they don't care."
Some bogus medications have seriously sickened unwitting patients. A Texas emergency room doctor last year suffered a stroke after taking a counterfeit version of the popular over-the-counter weight-loss drug Alli. The doctor bought the fake drug on eBay.
The counterfeit, according to the FDA, contained sibutramine, a compound legally found in other types of weight-loss medicines but included at three times the usual daily dosage. The genuine product contains no sibutramine.
FDA investigators last year also reported fake versions of drugs for insomnia, depression and anxiety. The bootlegged Ambien, Xanax, Lexapro and Ativan all contained the potent antipsychotic drug Haldol, which caused people to suffer serious breathing problems.
"Fake drugs are often made in unsanitary conditions. They can contain lead or talc or rat poison," said Dr. Jed Kaminetsky, a urologist at NYU Medical Center. He now warns his patients about fake erectile dysfunction drugs after some of them bought bogus pills online.
Kaminetsky spares no details. "A lab can be anything," he said, "a filthy kitchen or somebody's bathroom."
Tips to prevent buying counterfeit medications
Tell your doctor if you're undergoing cancer therapy outside a major cancer center, and make certain your physician knows the provenance of the medications being administered.
Online buyer beware: Avoid online pharmacies that sell medications without a prescription. These operations are major sources of bogus medications
Look for the seal: Trust online pharmacies that carry the VIPP seal for Verified Internet Pharmacy Practice site, certification they have been accredited by the National Association of Boards of Pharmacy
Get a listing: Consult the National Association of Boards of Pharmacy website for a list of accredited online pharmacies at www.nabp.net
Other signs: If using an online pharmacy, also make sure it has a legitimate street address and is registered in New York to dispense medications in the state.
Sources: Nassau University Medical Center; National Association of Boards of Pharmacy; U.S. Food and Drug Administration