Fake drugs, real worries
High prices and the Internet are making U.S. patients easy prey
One evening last year, Paul Dumas, 57, an attorney in Mexico, Maine, was watching the local television news when he heard something about Lipitor, the drug he takes to lower his cholesterol. The news report warned customers to return unused Lipitor to their local pharmacies, including any purchased from the drug counter in the supermarket where Dumas and his wife, Cindy, fill their prescriptions. But the report was vague about the reasons.
Cindy Dumas, who also takes Lipitor, returned their drugs. Paul Dumas had already taken about 60 pills of his 90-pill supply. The supermarket pharmacy merely exchanged the remaining 30 pills for 30 new ones. "I never got a letter or a recall notice," says Dumas. "My wife asked at the drugstore what was happening, but they wouldn't say. We had no idea, really, until I got on the FDA website and found out: The Lipitor was counterfeit. To this day, I don't know what was in the drugs I took."
Paul and Cindy Dumas were not the only ones swallowing hard about swallowing mystery drugs. The recalls of fake "Lipitor" that began in May 2003 eventually involved more than 18 million "Lipitor" tablets. The sheer size of this counterfeiting operation, according to the real Lipitor manufacturer, Pfizer, meant that more than 600,000 U.S. consumers may have received "Lipitor" from pharmacies, health plans, in the mail, or over the Internet.
Holes in the safety net. Long considered impenetrable to the average fake pill pusher, the U.S. drug supply system is in a potentially dangerous transition. For over 65 years, selling medications to the public has been governed, above all else, by the need to provide safety. But today, every part of the system is increasingly preoccupied with price. As a result, the once tightly controlled, $216.4 billion U.S. drug market is being internationalized, and its safety net is increasingly full of holes. Americans are buying drugs freely and more cheaply over the Internet, often from foreign sources, but this brave new pharmaceutical world is exposing them to the dangers of unapproved and counterfeit medicines, the greed of unscrupulous doctors and pharmacists, and a shadowy world of small "secondary" drug wholesalers, "street brokers," drug "repackagers," and experienced criminals who see more profit in prescriptions than in pushing pot.
Americans pay more for drugs than residents of many other developed countries: They pay 60 percent more than the British or the Swiss for the same drugs, according to testimony before the Senate Committee on Government Affairs, and two thirds more than Canadians. It's well known that senior citizens, underinsured or uninsured individuals, and some states and local governments are turning to the Internet and foreign pharmacies, particularly what they believe to be safe, reputable Canadian pharmacies, to find less costly medications. What many don't realize, however, is that Internet pharmacies, even licensed ones in Canada, are increasingly buying from foreign sources themselves to meet American demand.
Drug imports to Canada increased 22 percent in the first eight months of 2003, including some from countries like Iran and Ecuador, where Canada has no agreement that the country's drug makers will abide by good manufacturing practices. CanadaRX, a large Canadian Internet site that buys drugs from other pharmacies, recently sent letters notifying customers that their drug shipments originated from the Bahamas, where one of the main brick-and-mortar pharmacies that supplies CanadaRX had opened a branch. The letters also indicated that recent restrictions imposed by drug manufacturers on the amount of medicine they send to Canada meant that to fill American orders, CanadaRX would have to obtain medications in New Zealand, Australia, the United Kingdom, and other European nations. It urged customers not to be alarmed by new drug names, packaging, or labels pasted over labels on their drug packages.
Other pharmacies are doing similar deals. A Hollywood, Fla., man was informed by the Medicine Shoppe in Vancouver that the Lipitor he had ordered for his wife would take a little longer to ship: It was coming from Fiji. Small wonder the enterprising Qualtrade Pharmacies of Karachi, Pakistan, faxed this message to Internet pharmacies in Canada known to fill lots of U.S. scripts: "We have the pleasure to advice [ sic ] you that we are in a position to supply the drugs and medicine attached herewith of well known branded companies like Abbot [ sic ], Ely [ sic ] Lilly. . . . "
No one knows how many other Internet sites sell prescription drugs. One New York City investigative firm estimated that there are more than 1,400 Internet pharmacy sites. A consultant for Federal Express found 650,310 sites in a Web search where the FedEx brand was used on the same page as a list of the top 22 drug names. The Drug Enforcement Administration says there are 537 sites selling controlled substances. Many offer narcotics without a prescription by charging from $49 to nearly $200 for a "medical consultation fee," to have a doctor write a script for hydrocodone, Valium, or some other controlled substance.
False advertising. What is clear is that no matter how often Internet sites claim they will supply FDA-approved, Canadian, or any other type of drugs, there are no guarantees that the sites will deliver on their advertising claims. In July, for example, FDA investigators purchased drugs from a website advertising "Canadian Generics" that displayed a Canadian flag and offered "generic" Lipitor, Viagra, and Ambien, three brand-name products that have no generic equivalents. After ordering and analyzing them, the FDA found the drugs to be counterfeits. The registered owners of the websites were not in Canada but in China and Belize.
The sheer volume of drug packages entering the United States as a result of Internet ordering is crippling the FDA's ability to prevent unsafe or unapproved drugs from reaching consumers. "Before the price issue became so important," says William Hubbard, associate commissioner of policy and planning for the FDA, "people were buying mostly lifestyle drugs over the Internet, like Viagra. There was a much smaller number of packages. But in recent years the number of shipments has skyrocketed."
Drug parcels arriving at international mail facilities in the United States have been estimated at 10 million annually. But the number may be even higher, according to a study on prescription drug imports done for the Pharmaceutical Research and Manufacturers of America by Giuliani Partners, a consulting firm led by former New York City Mayor Rudolph Giuliani. At the mail center at JFK International Airport in New York, U.S. Customs officials told Giuliani that in March 2004, they received about 40,000 packages of suspected drug shipments for inspection each day. That adds up to 10.4 million per year at this facility alone--and the country has 13 others. Customs officials at the mail center in Miami told congressional investigators when they visited in March 2003 that the center routinely receives about 30,000 pharmaceutical shipments each day, or more than 7 million annually.
Overwhelmed inspectors. In one of the larger mail facilities, in one week, customs collected 16 large bins of about 3,000 packages suspected to contain counterfeit or unapproved drugs for the FDA to inspect. FDA officials, however, estimated that it would take them a week to open and fully inspect about 140 of those packages. The FDA has fewer than 100 investigators to deal with drug importation issues nationwide. So the agency employs a "risk assessment" approach and tries to target particular countries, export companies, or packages suspected to contain certain drugs. The rest the FDA releases back to customs, which sends them on to the addressee "even though the products contained in these parcels may violate the Food, Drug, and Cosmetic Act and may pose a health risk to consumers," the FDA's Hubbard told a House committee last year. "We acknowledge that this is not an optimal public-health outcome . . . ."
As far as what's really in those packages, analyses by customs, the General Accountability Office, and FDA inspectors offer some disturbing snapshots. The customs lab analysis showed that of 180 drug samples, the majority, 67 percent, either were never approved by the FDA or had been withdrawn from the U.S. market for safety reasons. Five percent contained no active ingredients at all. And 28 percent contained controlled substances prohibited from importation.
Despite the limitations, the FDA, customs, DEA, and local law enforcement agencies working together have cleaned up a number of major counterfeit scams. In February 2004, the FDA shut down an Internet site called www.rxpharmacy for selling counterfeit contraceptive patches to unsuspecting women. The patches appeared to be Ortho Evra, a transdermal contraceptive made by Ortho-McNeil Pharmaceuticals. A week later three sites offering "FDA-approved drugs" were shut down for shipping unapproved products.
In Florida, where a grand jury was impaneled to investigate the avalanche of counterfeit and unapproved drugs moving through the state's healthcare system, FDA and local officials uncovered a scheme to sell millions in fake HIV and cancer drugs. By relabeling 110,000 bottles of a lower-strength medicine as high-strength Procrit, the counterfeiters passed the "Procrit" through four states and a variety of wholesalers until investigators located 800 boxes of the stuff in the warehouse of a large Texas wholesaler. Fewer than 10 percent were left. It's estimated that counterfeiters made about $46 million selling the "Procrit" to unsuspecting patients.
Paul and Cindy Dumas still don't know how they got the fake Lipitor, but the FDA arrested a counterfeiter in the case last summer. A Costa Rican man imported the "Lipitor" to the United States in bottles listed as destined for export to another country. Once here, the bottles were emptied of the fake "Lipitor," filled with another product, and exported. The "Lipitor" was sold to brokers, small wholesalers, and various "repackagers" before it was distributed to licensed retail and Internet pharmacies. Authorities continue to follow the trail, and Dumas is angry that he still doesn't know what he took for two months. He did find out shortly after the fake-drug incident that his cholesterol had gone up.
In exchange for the safety of drugs most Americans take for granted, some may be able to buy more of the medications they need at prices they can afford. It's too soon to tell if the trade-off will be worth it.
A checkup for web pharmacies
There are two programs set up to evaluate Internet pharmacies. One, the Verified Internet Pharmacy Practice Sites, run by the National of Boards of Pharmacy, certifies pharmacies that meet licensing and inspection requirements for their state, as well as for each state to which they dispense pharmaceuticals. Only 13 Internet sites qualify. PharmacyChecker.com, the other program, is a free service that allows consumers to compare drug prices at a variety of Internet sites. It has rated 44 online pharmacies in the United States, Canada, Mexico, Israel, and elsewhere.
Gabriel Levitt, director of research and operations for PharmacyChecker.com, offers these tips for choosing a reliable online pharmacy:
Licenses count: A pharmacy site licensed by a government authority is likely to protect its license by using good pharmaceutical practices.
Provide a script: Internet sites that require prescriptions signed by doctors are more reliable.
Get an address: If the online pharmacy discloses no address or phone number, surf on. -Amanda Spake
This story appears in the September 20, 2004 print edition of U.S. News & World Report.