U.S. Probe: Canadian Web Pharmacies Best-Behaved
June 19, 2004
by Amanda Gardner, HealthDay
FRIDAY, June 18 (HealthDayNews) -- Critics of the Bush administration's move to halt online prescription drug sales from Canadian pharmacies say a new U.S. government probe undermines the argument that drugs bought in Canada are unsafe.
The General Accounting Office (GAO) report "shows that Canadian pharmacies are a safe source of high-quality prescription drugs, and we all know that those drugs are cheaper. This report means there are no more excuses for inaction," Sen. Edward M. Kennedy (D-Mass.) told HealthDay Friday.
"It's high time for the congressional leaders and President Bush to pass our bipartisan drug importation bill, to allow all American consumers to order cheaper prescription drugs from Canadian pharmacies," he added.
Kennedy, along with Sen. John McCain (R-Ariz.), helped sponsor a bipartisan bill to legalize the importation of cheap prescription drugs from Canada and other countries.
The probe by the GAO, the investigative arm of Congress, found a multiplicity of problems, including drugs that weren't what they were supposed to be. But Canadian pharmacies were far from the worst offenders, according to its report, which was issued Thursday.
And the FDA did not dispute the findings, the report added.
All 18 Canadian pharmacies contacted required prescriptions before selling drugs, compared to only five of 29 in the United States that did so. The remaining American pharmacies and all 21 other foreign pharmacies contacted sold drugs without a prescription from a doctor.
"The biggest issue for Canadian pharmacies we found was that 16 of 18 samples were not approved for U.S. markets, either because of variations in labeling or facilities that were not FDA-inspected, so it was a drug intended for a foreign market," said Marcia Crosse, co-author of a new report on the subject and director of health care at the GAO. "But for all 16 of those samples, the manufacturer attested that they were chemically comparable."
In general, the main problems were not including instructions or warning information, not shipping the items properly, shipping drugs that were not for the U.S. market, selling counterfeit drugs, or not sending any drugs at all. Fourteen of the 68 Web sites were under investigation: nine U.S. sites, one Canadian, and four from other foreign countries.
"The main message is that there are some risks for consumers from some Internet sites, and it may be difficult for an individual consumer to know," Crosse said.
While the report stated that the U.S. Food and Drug Administration "generally agreed" with the findings and conclusions, an FDA official said Friday there still are problems.
"There are still a lot of concerns here that the report bears out," said William Hubbard, the agency's associate commissioner for policy and planning. "It found that [Canadian internet pharmacies] were less unsafe when compared to others. That's still a lesser standard than the very high standards set here."
Asked if there was a distinction to be made between American Internet pharmacies and Canadian ones, he replied, "Generally, we've said that if you go to a licensed American internet pharmacy, you will get the same quality as at your brick-and-mortar corner store. Those that are unlicensed or operating beyond borders may not have the same quality. It's hard for the consumer to tell the difference because Congress hasn't moved any of the bills which would require disclosure."
Also applauding the report was Sen. Judd Gregg (R-N.H.), chairman of the Senate Committee on Health, Education, Labor and Pensions.
Legislation recently introduced by Gregg and others would legalize importing prescription drugs from Canada but would also include provisions for tightening Internet security.
"The status quo is not acceptable," he said in a statement. "We would be irresponsible as legislators if we did not put better regulations and safety measures in place."
The report, titled Internet Pharmacies: Some Pose Safety Risks for Consumers, was undertaken by the GAO at the request of the permanent subcommittee on investigations of the U.S. Senate's Committee on Governmental Affairs.
The impetus for the request, of course, was the surge in Internet drug sales, itself a result of spiraling prescription drug costs in the United States.
The GAO researchers placed a total of 90 drug orders, each with a different Web pharmacy, and received 68 samples of 13 different drugs. The pharmacies were located in the United States, Canada, and several other countries, including Mexico, Pakistan and Spain.
GAO staff checked labeling, shipping, and other information, then forwarded the samples on to the manufacturers to check for authenticity.
The list of drugs included narcotics (such as OxyContin and Percocet), some with special safety restrictions (for example, Accutane), and some with special handling requirements (such as Humulin).
In general, the probe found, top-selling drugs such as Celebrex, Lipitor, Viagra, and Zoloft were easily obtained from multiple pharmacies.
Those with safety restrictions, like Accutane or Percocet, were more difficult to obtain. In fact, one order placed for Accutane, an acne medication that can cause birth defects if taken by women who are pregnant, was declined by one pharmacy.
One U.S. and one Canadian pharmacy refused to fill a prescription for Clozaril, an antipsychotic. Few pharmacies would sell narcotics without a prescription.
None of the non-Canadian foreign pharmacies included labels with instructions, and only about one-third had warning information. Four Canadian samples did not have appropriate warning information.
Some pharmacies had questionable return addresses that looked like private homes.
Some foreign pharmacies outside of Canada seemed to be offering U.S. brand-name products only to attempt to substitute an alternative drug sometime during the ordering process.
And while some products were "chemically comparable," the FDA "has concerns about whether that translates into therapeutically equivalent," Crosse said.