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Internet Stores Ship Fake Drugs to U.S., Congress Unit Finds

By Kerry Dooley

June 17 (Bloomberg) -- Internet pharmacies outside the U.S. and Canada shipped fake versions of Pfizer Inc.'s Viagra impotence drug, Roche Holdings AG's Accutane acne treatment and Purdue Pharma Inc.'s OxyContin painkiller to the U.S., a test by the investigative arm of Congress showed.

Orders from 68 pharmacies in the U.S., Canada and 10 other countries also showed that 45 sold prescription drugs without requiring a prescription from a patient, and four shipped medications with improper packaging, according to a report by Congress's General Accounting Office. An unspecified number improperly sent medicines that require monitoring by a doctor, the study found.

``We observed questionable characteristics and business practices of some of the Internet pharmacies from which we received drugs,'' the GAO report said. ``Most, but not all, involved other foreign pharmacies'' outside of Canada and the U.S.

Senator Norm Coleman, a Minnesota Republican, ordered the test as part of an inquiry into the safety of imported drugs. An investigation panel he heads is to hold hearings on the issue today. Coleman supports one of three Senate proposals that would enable Americans to buy drugs legally from countries that set prices lower than in the U.S.

Washington-based AARP, the largest lobbying group for seniors, said yesterday it plans to mobilize its 36 million members aged 50 and older to overcome opposition by pharmaceutical companies to such drug imports. U.S. consumers spent more than $1 billion last year on medicines from Canada, where regulations keep prices as much as 70 percent below those in the U.S.

Wisconsin's Warning

States such as Minnesota, Wisconsin, New Hampshire, North Dakota, Iowa and Illinois are studying ways to reduce drug spending by purchasing drugs from Canada. Springfield, Massachusetts, said it saved $2.8 million in the past year by buying from Canada for its workers and pensioners.

In April, the Wisconsin Department of Health and Family Services told three Canadian Internet pharmacies that they violated terms of an agreement to ship only U.S.-approved drugs, the U.S. Food and Drug Administration said yesterday. The medicines had been approved in Canada.

Speakers at today's Senate subcommittee hearing will include Rudolph Giuliani, the former New York City mayor. His firm, Giuliani Partners LLC, has been retained by the Washington-based industry lobbying group Pharmaceutical Research and Manufacturers of America to evaluate the risks of importing medicines from Canada and other countries. GAO officials will also testify.

Not Approved for U.S.

In its report, the congressional accounting office said it found that 16 of 18 drugs that investigators bought from Canadian pharmacies weren't approved for sale in the U.S. All of them were chemically comparable, the report said.

Investigators also obtained drugs from Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand and Turkey, according to the report.

``The process of obtaining a drug from many of these pharmacies involved only selecting the desired medication and submitting the necessary billing and shipping information,'' the report said. ``It is notable that we identified these numerous problems despite the relatively small number of drugs we purchased.''

Two cases of false versions of drugs involved Viagra, the impotence medication sold by New York-based Pfizer, the world's biggest drugmaker, the GAO said. Another fake was of privately held Stamford, Connecticut-based Purdue Parma's Oxycontin pain drug. A fourth was Basel, Switzerland-based Roche's Accutane.

In addition, the inquiry found Accutane among drugs requiring special precautions that were improperly sold. Pregnant women shouldn't take Accutane because of the risk of stillbirth or deformities in their children.

FDA Wants Bigger Study

In a response included in the study, the FDA urged a larger trial. The agency's acting commissioner, Lester Crawford, said in a May 26 interview that regulators can't ensure the safety of unauthorized drug imports.

``Although the size of the study demonstrates the gravity of the situation regarding other foreign Internet sites, a much larger study that has statistical significance should be considered,'' the FDA said.

The GAO said it found that some pharmacies that advertised painkillers known to cause addiction tried to fill orders with less potent and addictive medications. One U.S. pharmacy declined to fill an order for Accutane. The FDA and Roche have a program in the U.S. to limit use of the drug to people whose doctors have informed them of its risks.

One Canadian and one U.S. pharmacy declined to fill an order for Basel, Switzerland-based Novartis AG's Clozaril schizophrenia drug, the study said. The medicine can cause a fatal blood disorder. Doctors must monitor patients with blood tests.

Last Updated: June 17, 2004 00:10 EDT