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.

A post below raises the prospect that discussion of prescription drug counterfeiting might be “just another scare tactic of Big Pharma.”  That could be true, if such a discussion served mainly as a trojan horse argument against the reimportation of medicines from countries with highly developed health systems. Readers can make up their own minds whether that’s what is going on here.

But ask yourself this. 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? Me too.

And, as long as we are talking about scare tactics, I’m sure it won’t escape anyone’s notice that this blog is sponsored by a company that is in the business of supply chain management and product security.

That isn’t to say there aren’t real issues. Phony drugs in the developing world are a big problem. And as the US supply chain moves increasingly to some of these same countries, Americans, too, should be concerned. But they should also be wary of anyone who benefits from ginning up a drug scare.

We don’t know the prevalence of counterfeit or substandard drugs (more on the distinction in a later post). The recent deaths caused by the Baxter brand of heparin illustrate the potential risks of adulterated product. But is that case the tip of the iceberg or an exception to the rule… the rule of a safe, well-controlled supply chain?

The high rates of counterfeit pharmaceuticals in developing countries have been well documented. Phony anti-malarials alone undoubtedly cause untold deaths. But a widely cited estimate that the counterfeit industry will be worth $75 billion by 2010 comes from a report by the Center for Medicines in the Public Interest. The report (which CMPI was kind enough to send) provides little information on how this extrapolation was derived, other than to say it was based on the “author’s calculations.” Nor does break down the number between wealthy countries with well-controlled drug supplies and countries with endemic counterfeiting and poor health infrastructure. So what is the situation in the US and similar nations? The authors of a PLoS Medicine article suggest that pharmaceutical manufacturers in the US and the UK deliberately fail to report incidences of counterfeiting. As a first step toward understanding the extent of this problem, an international and publicly accessible registry should be established to track counterfeit products. Governments should mandate that industry report all known or suspected cases.

Members of the Senate HELP Committee yesterday called for more resources for the FDA to protect Americans from unsafe products.

The hearing was a response to the Baxter/heparin debacle.

The BNA (subscription required) reports that Senator Kennedy, the committee chair, said that

drug companies should be required to know more about the suppliers from which they obtain their ingredients and use better tests to detect impurities and contaminants, he said. “FDA obviously needs greater authority and significant additional resources to enforce these requirements, especially with respect to ingredients manufactured overseas.”

Senator Sherrod Brown (D-OH) called for more oversight of imported medical devices too.

But ranking member Senator Michael Enzi (R-WY) said “we cannot inspect our way to safety.” He called for closer cooperation between industry, stakeholders and the FDA.

It was the Elixir Sulfanilamide disaster of 1937 that led to the passage of the Food, Drug and Cosmetic Act, which first required Agency oversight of safety tests. Nothing since suggests that the industry is likely to solve this problem without a strong push from government.