No matter how you say it, prescription drug counterfeiting is international health care terrorism

(And so much for certain politicians who claim that Europe has no problem with counterfeiting)

An increasing amount of fake drugs is being sold over the Internet in Europe, the European Union warned. The European Commission said a recent survey conducted by E.U. member states identified 170 fake medicines that were being distributed illegally, mostly through Websites offering fake or unauthorized lifestyle drugs, growth hormones and sleeping drugs … ‘I am alarmed at the ever increasing number of counterfeit medicines sold via the Internet. This represents a real danger to the health of patients,’ said E.U. Enterprise Commissioner Guenther Verheugen. Lifestyle drugs, such as Viagra, and essential medicines such as antibiotics and insulin are particularly popular with counterfeiters, but there’s also an increasing number of fake contact lenses and even materials such as surgical mesh. Experts warned buying health products over the Internet can be a major health risk.

I’m sorry, did somebody say that counterfeit drugs are a “red herring” of the global pharmaceutical industry? The only comment I can make is, WHO’s on first.

LONDON - Worldwide, the WHO believes counterfeits make up between 5 and 8 percent of the $550 billion of medicines sold each year. But WHO spokeswoman Daniela Bagozzi said this was based on incomplete information and the actual amount could be higher.

“It represents a huge number of people who are suffering and in some case dying,” she said. “A lot of deaths could be avoided if the drugs being taken were not substandard counterfeits.”

The Associated Press reports that most US states have implemented “drug recycling” programs or are considering doing so. The basic idea is to accept donations of unused drugs and re-dispense them to people in need. It sounds like a good idea on the surface. After all, why should the drugs go to waste when there are people who can’t afford their prescriptions?

I’m sure that some people are helped by such programs and that the people running them have the best of intentions. Still, I have some concerns:

• Donations aren’t likely to be particularly steady, so I don’t see how chronically ill patients will be able to count on gaining access to a specific drug and dose over a long period of time
• Although there are some restrictions on who can donate and what can be donated, there will definitely be concerns over the integrity of the supply chain. I’m worried more about drugs being stored in poor conditions (e.g., heat, humidity) than tampering
• Inventory management will be hard. The donation centers want products six months or more before expiration, but will be a challenge to manage stock. It’s expensive to do it well
• The administrative costs of these programs will be large relative to the volume of drugs. Even the larger programs seem to be dispensing only hundreds of thousands of dollars per year worth of products (though of course that could increase)
• Widespread drug recycling would undermine the software licensing model I’d like to see implemented for chronic medications. Rather than charging per vial or per pill or per prescription, drugs could be licensed to patients per year or per episode of treatment. This would work because drugs are basically an expression of intellectual property. The production cost is negligible compared with the development cost and price. Making it work, though, will require robust tracking through the supply chain to prevent diversion of products. (Think of it as DRM for drugs.)

There are better, more cost-effective ways to get products into the hands of patients who can’t afford them:

• Patient Assistance Programs run by drug manufacturers. States and/or private agencies could put their resources into publicizing the existence of these programs rather than scrounging for donations of unwanted products
• Increased generic utilization. Generic drugs are generally cheap. (Take $4 Wal-Mart generics for example.) I’m sure the drug recycling programs spend more than $4 per prescription even though they get the drugs for free