In Agendas: hidden and not-so, Allen Coukell asks: “If you were an uninsured patient unable to afford medication in the US, would you rather get your prescription filled in a Canadian pharmacy or go without?”

If those are the only choices, you should go without.  Primum non nocere. (“First, do no harm.”)

Judging by his biography, Allen appears to be a Canadian pharmacist by training.  So he should know that many so-called Canadian pharmacies are not actually in Canada, many drugs sold by “online pharmacies” are counterfeit, and we really don’t know where Canadian pharmacies are going to source enough products to meet U.S. demand. 

Still not convinced of the danger?  Read this Drug Channels post about a father-son duo who supplied counterfeits to online spammers.  How about the guilty plea of pharmaceutical distributor that sold counterfeit drugs to U.S. pharmacies?  Or this 2005 report from Giuliani Partners about the loopholes that could endanger us?  

I could go on and on.

People will buy drugs online from unscrupulous sellers to “save money.”  Organized criminals, drug traffickers and terrorists could (and probably do) exploit gaps in our drug distribution system.  I wish it were only fear-mongering, but unfortunately we are talking about legitimate issues. 

The last time I checked, “terrorism” was defined, more or less, as the unlawful use of violence to achieve a political objective. So it is silly to describe drug counterfeiting as “international health care terrorism” (see “Flipping the Bird,” below).

Counterfeiting is a crime, certainly, but a crime most likely motivated by economics and not politics. For this reason, it is also important to distinguish between the deliberate sale of substandard product and inadvertent contamination or production problems. The former will never be amenable to inspections and standards. The latter may be.

Yesterday, the FDA issued a press release about the recall of two lots of antibiotic:

[The company] Medicis today announced that it is voluntarily recalling two lots of the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release Tablets. Medicis has received a report that one bottle contains AZASAN® (azathioprine tablets) instead of SOLODYN® … AZASAN® is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis.

Whether this happened in China or in a US plant, it just ain’t terrorism. It isn’t counterfeiting either.  Let’s maintain the useful distinction.

On Friday I offered “public comment” to the concept of placing a 1-800 number is all DTC television ads.  While to many this idea sounds like a no-brainer — it ain’t so easy.  Some things to consider:

* The use of the terms “adverse event” and “side effect” being used inter-changeably.  Just what do consumers think they mean?  The committee seemed to think that the FDA should look into this.

* How can poly-pharmacy patients report an adverse event when they can’t be sure what’s caused it?

* Will an 800 number (presented via a super, audio, or both) cause a “power of suggestion” situation, thus producing a kind of adverse event “placebo effect.”

These general themes led the committee to worry (and rightfully so) that information reported via an 800 number would likely provide the FDA with data of questionable quality and utility.  A serious “signal-to-noise” issue. Of particular worry was how the FDA would then use this information relative to communicating “early safety signals.”  Talk about unintended consequences!