GAO Details Perils of Internet Drug Buying
Americans can easily buy many prescription drug products, including addictive narcotic pain medications, without a prescription over the Internet from U.S. and foreign pharmacies, government investigators stated in a June 17 report.
But, the researchers found, Canadian Internet pharmacies are stricter and more reliable than many of those operating in other foreign countries or the United States.
From January to June 2004, the Government Accountability Office (GAO)—the watchdog of Congress—examined the extent to which certain drugs can be purchased over the Internet without a prescription, how medications were shipped, whether drugs obtained were approved by FDA, and the business practices of Internet pharmacies.
Investigators placed orders for 10 samples of 13 different types of drug products each from a different Web site in the United States, Canada, Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey.
GAO obtained 68 samples of 11 different types of prescription drugs: 29 from the United States, 18 from Canada, and 21 from the other countries.
The majority of U.S. and none of the foreign Internet pharmacies outside of Canada where drugs were obtained sought a prescription, researchers found. But all Internet pharmacies in Canada where investigators purchased drugs required prescriptions from a patient's physician.
At a June 17 Senate hearing, Senator Carl Levin (D-Michigan), ranking member on the Governmental Affairs Permanent Subcommittee on Investigations, argued that while Internet purchases of illegal pharmaceuticals are "out of control," GAO's report shows that "medicines purchased from Canada are as safe, or safer, than those purchased in the United States."
Stricter laws needed. Subcommittee Chairman Senator Norm Coleman (R-Minnesota) urged members of Congress to take action by passing legislation that would bar Internet sites from selling or dispensing prescription drugs to consumers without a prescription.
California resident Francine Haight, whose 18-year-old son died of an overdose of a narcotic he purchased without a prescription over the Internet, told the subcommittee that there is a need for tougher regulations enforced with severe punishments.
"Internet pharmacies should be required to identify their business, pharmacist, and physicians," she said.
Narcotics easy to buy. Some of the Internet pharmacies where GAO obtained drugs without a prescription, including narcotics, asked purchasers to complete an online questionnaire but did not require any type of an examination by a physician, Robert J. Cramer, GAO's managing director of special investigations, testified before the subcommittee.
Researchers obtained hydrocodone from eight U.S. Internet pharmacies without a prescription, Cramer reported.
Even though orders for all eight purchases of hydrocodone were placed on separate U.S. Web sites, six of the orders were dispensed by the same Southeast pharmacy, he noted.
GAO provided its findings about the pharmacy to federal and state law enforcement agencies for further investigation, Cramer added.
Marcia Crosse, director of GAO's health care team, testified that investigators purchased a drug purported to be Purdue Pharma's OxyContin—a Schedule II controlled substance—from one foreign Web site without a prescription by paying a membership fee and joining an Internet pharmacy "drug club."
Appearances can be deceiving. The product, which was later determined to be counterfeit, was shipped in a plastic compact-disk case wrapped in brown packing tape with no other labels or instructions included, Crosse said.
"Some of the samples we received from these [non-Canadian] foreign pharmacies arrived in unconventional packaging, in some instances with the apparent intention of concealing the actual contents of the package," she explained.
A manufacturer's container labeled as 180 capsules of 400-mg Crixivan, Merck's indinavir sulfate product used to treat patients with HIV infection, was shipped inside a sealed pop-top aluminum can enclosed in a box, which was labeled as a free promotional sample of "Gold Dye and Stain Remover Wax," Crosse told members of Congress.
The box's label described the contents as a "well mixture of oil solvents and antioxidants" made in Istanbul, Turkey.
Additional orders from non-Canadian foreign Web sites for Crixivan—a moisture-sensitive drug—arrived in punctured blister packs, Crosse stated.
Three orders from non-Canadian foreign Web sites for Eli Lilly's Humulin N—an insulin product that must be stored and shipped in temperature-controlled and insulated conditions—arrived in envelopes without insulation, she noted.
Elizabeth Carr, a California resident whose husband died of an overdose of propoxyphene hydrochloride, a narcotic drug that he purchased without a prescription over the Internet from a foreign pharmacy, testified that a package of the drug delivered to her home was labeled as "sweets."
According to the Drug Enforcement Administration (DEA), it is illegal for consumers to import controlled substances into the United States.
Many of the products delivered to Carr's husband from foreign Internet pharmacies lacked pharmacy labels and instructions, she asserted.
An order placed by GAO investigators at a foreign Internet pharmacy for Roche's Accutane arrived with instructions and warnings in Spanish only, Crosse said.
Are they fake? Manufacturers who tested the drugs for GAO reported that all but two of the samples from the non-Canadian foreign pharmacies were unapproved for the U.S. market, she said.
But, she added, the manufacturers reported that the chemical composition of all but four of the foreign samples was comparable to the products investigators had ordered.
Four samples of drugs purporting to be Accutane, OxyContin, and Pfizer's Viagra ordered from non-Canadian foreign Web sites were found to be counterfeit.
Most of the samples ordered from Canada were also unapproved for the U.S. market, Crosse said, but the manufacturers determined that the chemical composition of all of the Canadian samples was comparable to the products GAO had ordered.
Of the purchases investigators received from U.S. and Canadian Internet pharmacies, all included pharmacy labels, almost all included warning information, and none displayed evidence of mishandling, Crosse testified.
Unpredictable. Some Internet pharmacies, mostly non-Canadian foreign pharmacies, were unreliable, she told the subcommittee.
"We did not receive six of the orders we placed and paid for, five of which were placed with other foreign Internet pharmacies and one of which was placed with a pharmacy location that could not be determined," she said. "Also, we found that several of the drug samples were sent from locations that raised questions, such as private residences. We also observed Internet pharmacies that obscured details about the drugs sold, such as other foreign pharmacies in which we ordered brand name drugs but then received a generic or foreign version of the drug."
About 21% of the Internet pharmacies from which investigators received drugs are under investigation by DEA or FDA, Crosse revealed. Nine of the online pharmacies under investigation were located in the United States, one in Canada, and four in other foreign countries.
Reasons for the investigations, she added, included allegations of selling adulterated, misbranded, or counterfeit drugs and providing prescription drugs where no valid physician-patient relationship exists.
Google it. Crosse said that GAO selected Web sites for its purchases from a list of 1,400 provided by FDA and through Internet searches conducted by investigators using various search engines, including Yahoo and Google.
During the hearing, Senator Mark Pryor (D-Arkansas) asked GAO officials if investigators were able to determine the percentage of Internet pharmacy Web sites that are safe and honest.
But, Crosse reported, because the Internet is "changing constantly," it would be difficult to identify all online pharmacies that are operating legitimately.
She noted that the National Association of Boards of Pharmacy has only 14 online pharmacies listed as certified with its voluntary Verified Internet Pharmacy Practice Sites program.
"However, that alone is not a signal of whether or not they are dealing honestly and meeting requirements," she said. "I'm sure there are other pharmacies out there who just have not sought certification who could meet those requirements."
The Internet and Mailorder Pharmacy Accreditation Commission—a Vermont-based professional organization of Canadian, Mexican, and American physicians and pharmacists—has only three pharmacies listed as "accredited" on its Web site.
An unprotected border. At a time when the United States is attempting to secure its borders to protect Americans from terrorist attacks, said Rudolph W. Giuliani, former New York City mayor and chairman and chief executive officer of Giuliani Partners LLC, the Internet is "an area where our borders are wide open."
Only 10% of packages that enter the United States from foreign countries are inspected, he testified before the subcommittee.
"A great deal more must be invested so that a lot more inspections can be done," he said.
Giuliani provided the subcommittee with preliminary findings from a study his company is conducting for the Pharmaceutical Research and Manufacturers of America.
Before taking any legislative action, he urged, lawmakers should wait until the Department of Health and Human Services Task Force on Drug Importation completes its comprehensive study on importation, which was mandated by Congress under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
Risking health for low prices. When he was attorney general for Arkansas, Pryor said, he encouraged residents to purchase drugs from their local pharmacist "because they are dealing with a licensed professional. They're dealing with someone that if there's a problem they know who to go to."
But given the high prices of prescription drugs in the United States, he maintained, "certainly there's a lot of incentive for people to get online and go elsewhere, and that industry, online pharmacies, [is] now a reality."
Americans looking for cheaper drugs online, especially from pharmacies abroad, are gambling with their health, said Senator Frank Lautenberg (D-New Jersey).
But, he added, "if it is a choice that is desperately motivated, people take risks in those conditions."
Congress needs to investigate online pharmacies, he said, but it also needs to consider the underlying issue of what is driving consumers to risk their health by purchasing drugs from unfamiliar sources.
"The answer is obvious: the lower price that they can get these products for is very appealing," Lautenberg declared. "We've got to protect consumers from fake drugs and unscrupulous online pharmacies, but we also must recognize that consumers, particularly those that are elderly and modest-income families, are flocking to the Internet because it is the only way they can afford to buy these essential products.
"Today we are looking at ways to regulate online pharmacies to protect consumers more effectively, but we can't ignore the real problem, which is that prescription drugs in many cases are way too expensive. And ultimately, we've got to find ways to lower prescription drug costs for all Americans."
Lautenberg said he has "invited" the pharmaceutical industry to come forward and offer their ideas about how to modify prescription prices and equalize them "whether or not they're purchased in Canada or purchased here."
"Yes, we want to avoid price fixing as is done in Canada," he said. "But the fact of the matter is, when the difference can be as much as 50%, you are talking about sums of money that are really very tough for the people to provide."