TCS Daily


First, Do No Harm

By Conrad F. Meier - September 5, 2003 12:00 AM

Americans are assuming a major risk buying prescription drugs from so-called drug stores over the Internet. Canada, where government mandated price controls lower drug costs, constitutes the bulk of these sales.

Still, Americans are buying record quantity drugs via the Internet from 25 other countries including Mexico, Israel, Austria, Ireland, Italy and China -- to name a few.

The Food and Drug Administration (FDA) warns re-imported drugs raise serious safety concerns since they could be counterfeit, contaminated, expired, or mislabeled. They won't vouch for the quality of re-imported foreign drugs or those sold over the Internet since there is no way to tell the origin of the drugs, their quality, their effectiveness, or if they endanger our health.

No one disputes the fact that legitimate sales of high quality prescription drugs sold in America are expensive consequences of the massive investment in research and development. But, while other nations piggyback off our pharmaceutical innovations we are distracted from the real issue here: The risks counterfeit medications pose to American's.

The real threat to the nation's drug supply is not cost, but health. Consider these grave examples:

  • Turkey 1993: the police arrest a pharmacist attempting to sell baking powder as genuine prescription drug.
  • Haiti 1996: at least 88 children die after taking counterfeit antipyretic syrup.
  • Lebanon 1998: Interpol, the international police agency, says a giant factory in the Bekaa Valley may be the world's largest producer of counterfeit medication, including Viagra. An Israeli Health Ministry's spokesperson told the Jerusalem Post, "According to experts 80% of the Viagra sold world-wide on the black-market is not the real drug. What is ironic is that the black-market pills cost twice the price of Viagra gotten by prescription."
  • Kansas City 2002: Authorities arrest a local pharmacist for diluting cancer drugs to hundreds of patients and selling the medication at full price.
  • Florida 2003: Concerns about the safety of drugs surfaced after prosecutors announced a grand jury indicted 19 people on charges of watering down or selling fake prescription drugs to businesses selling prescription medications to consumers. The drugs are often prescribed for AIDS and cancer patients.
  • Nebraska 2003: A counterfeit version of Pfizer's Lipitor, the world's top selling cholesterol-lowering medication was recently discovered after pharmacists and patients complained their medication tasted unusually bitter and dissolved too quickly. At least six lots of 90-count bottles containing 10 mg or 20 mg tablets have been recalled because they may contain counterfeit medication. The suspect bottles are labeled "Repackaged by: MED-PRO, INC. Lexington, NE 68850."

    Hank McKinnell, chairman and CEO of Pfizer said, "While the evidence available suggests that the counterfeit Lipitor is in limited distribution, American consumers need absolute certainty that the pharmaceutical distribution system will protect them from counterfeit products."

  • New Jersey 2003: As part of the Food and Drug Administration's (FDA) efforts to investigate rapidly growing counterfeiting activities, FDA's Office of Criminal Investigation uncovered the existence of contaminated Procrit, a drug used to stimulate the production of red blood cells in humans with severe anemia.

    As a result of investigative review and laboratory testing performed by FDA, and in cooperation with Ortho Biotech Products, L.P., Bridgewater, New Jersey, medical professionals and consumers are being alerted to the existence of three lots of the counterfeit product labeled as Procrit (epoetin alfa); P007645 - 40,000 units/mL, Expiration 10-2004; P004677 - 40,000 units/mL, Expiration 02-2004; P004839 - 40,000 units/mL, Expiration 02-2004.

    The firm issued a warning by letter and posted on its website http://www.procrit.com/counterfeit/letter.html because counterfeit Procrit has been found to be contaminated with harmful bacteria. FDA testing also demonstrated some of the counterfeit product contains no active ingredient at all.

In light of the evidence that numerous counterfeit drug operations have been disclosed and shut down is no guarantee that the bogus drug is out of the distribution pipeline.

In March of 2000, the FDA announced that Janssen Pharmaceutica, a wholly owned subsidiary of Johnson & Johnson, would discontinue the sale of Propulsid (cisapride) in the United States. The use of the drug has been associated with 341 heart rhythm abnormalities including 80 deaths. The drug was used as treatment for severe nighttime heartburn in adult patients with gastro-esophageal reflux disease.

Even though lawsuits have been filed against Janssen and Johnson & Johnson, the drug is still available for sale, often without prescription, on Internet drugstore websites.

Consumers need to be concerned about buying prescription drugs across borders or over the borderless Internet with no one assuring them they are safe or even that they are getting the exact drug their doctor prescribed. No foreign source of prescription drugs accepts responsibility for any harmful effects or deaths from re-imported drugs.

The author is Senior Fellow in Health Policy, The Heartland Institute, and Managing Editor, Health Care News.

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