Internet Pharmacies Rewards and risks

by David Orenstein free-lance writer

Just a few years ago, only the most motivated or desperate patients used the Internet to import cheaper prescription drugs. Now, as pharmaceutical costs continue to rise, some state and city governments are encouraging the practice, most notably Illinois this past summer. Such moves rapidly have legitimized the practice, but critics continue building their case that such thrift comes with serious risks.

“The interest in affordable prescription medication is on everybody’s radar,” says David Gonzales, senior director of public affairs for the Texas Pharmacy Association. “We keep coming to the same place. The safety of these drugs is questionable.”

The debate between savings and safety has evolved but is not new. Back in March 2001, when this column last looked at the issue, it seemed simpler: The federal government and the states were cracking down on unregulated Internet pharmacies that dispensed drugs (possibly inferior or counterfeit) without prescriptions. In those more free-wheeling days, government officials worked with seeming unanimity to steer patients away from the rampant risk of fraud.

Now many officials are more worried about drug costs and less worried about the risk of importing them. After Minnesota and Wisconsin set up Web sites to help their residents buy drugs more cheaply in Canada, Illinois announced in August a site that will help its residents buy drugs from Canada, the UK, or Ireland. Although the site might violate US law, it is hard to ignore the rationale: A three-month supply of the arthritis drug Vioxx costs $322 in the United States, but only $138 in Canada, $205 in Ireland, or $221 in the UK. Illinois estimates its residents can save $1.9 billion a year.

The Illinois program is accounting for safety. The program is limited to refilling legitimate prescriptions and would not import drugs that can spoil. Also, Canada, Ireland, and the UK are all industrialized nations with well-developed regulatory frameworks. The drugs wouldn’t come from just anywhere, would they?

They might. According to an August article in the Minneapolis Star Tribune (www.startribune.com/stories/535/4923324.html), Canadian pharmacies are caught between a surge in demand from US patients and a reduction in supply from angered US drug makers. The shortage has caused some Canadian pharmacies to import a fraction of the drugs they export to Americans. This doesn’t mean any of the drugs have been inferior or counterfeit, but the more obscure the drugs’ origins, the more regulators have become alarmed. FDA Associate Commissioner William Hubbard told the Star Tribune: “The FDA cannot assure you that what you think is Lipitor from Canada is actually Lipitor, or if it’s from Canada or Bangladesh or Timbuktu.”

It seems indisputable that some drugs from some countries indeed are inferior. Just a few weeks before the Illinois announcement and the Star Tribune article, the journal Science published an article (Vol. 305, p. 481) by researchers Michael A. Veronin and Bi-Botti C. Youan of the School of Pharmacy at Texas Tech University. The pair showed significant irregularities in some imported pills. Near-infrared spectroscopy images of Simvastatin (Zocor) tablets from Mexico, India, and Brazil showed clumping of the medicine’s active ingredient within the pills. The poor mixing, the researchers said, could pose problems for patients who split pills or could affect the pills’ dissolution rates and, therefore, the onset of their effects.

Texas has no legislation pending to do what the Upper Midwest states have done, Mr Gonzales says, but Texans with computers are free to seek savings on their own. After years of debate, patients still have a tough choice: Stay home and pay more, or browse abroad and risk opening a Pandora’s pillbox.

David Orenstein is a technology and business writer in Silicon Valley. To learn more about a technology topic in Computing Care, e-mail him at davealli@comcast.net.