In her book, Dangerous Doses, Katherine Eban tells the frighteningly real story of the discovery of counterfeit drugs in the legal American drug supply: how the discovery was made, how the counterfeiters build their businesses and make their money, and how law enforcement can – and can’t – corral the problem.
Like most Americans, I believed counterfeit drugs were those that people ordered through the Internet from pharmacies overseas. They got what they paid for. Since I've never ordered drugs from out of the country, then it wasn't my problem.
I was so wrong! As Ms. Eban's book drew me into the intrigue and the cleverness of crooks among us -- neighbors and friends who are dealing in legal drugs that have been altered or stolen -- my sense of trust in America's drug supply was rocked to the core.
Since the book was first published in 2005, there have been some changes in the system. I caught up to Ms. Eban to ask her what progress has been made in the war against counterfeit drugs since then.
Q. Your book ends with many loose ends in the war on these counterfeit drugs – answers that just weren’t available. What has been done to improve the situation since then?
A. Almost 20 years ago, the FDA moved to implement the Prescription Drug Marketing Act which requires a pedigree for every drug as it moves though the system. The wholesalers protested saying it was too burdensome and costly. For almost two decades the wholesalers were able to suppress the implementation of that rule.
After my book was published, the FDA moved to lift the stay on that regulation and require an audit trail for every drug. The wholesalers moved to block the action in court, where it is currently stalled.
The FDA has also tried to encourage the industry to implement an electronic pedigree -- but it’s really the states that have been the principle drivers of that initiative. They individually have passed very strong legislation requiring pedigrees.
Q. Tell me about the wholesalers and distributors. How many of these wholesalers and distributors are there?
A. Thousands of them. From companies worth billions of dollars, to scammers who operate out of coolers in their basements whose value we don't know. Some are quite reputable and trustworthy. Others, not at all.
Q. That seems like an awful lot of companies to handle our drug supply. How many do we really need?
A. We only need a few dozen. Certainly not thousands. Further, there are problems with the system of "authorized distributors."
Wholesalers become a pharmaceutical company’s authorized distributor after considerable due diligence. Once the wholesaler is considered "authorized" it means they don’t have to supply a pedigree because it’s assumed they purchase their drugs from the manufacturer. However, they don’t necessarily make the purchase that way, and without the pedigree, it can obscure the origin of the drug.
Q. Is there anything at all being done to clean up this mess?
A. There is a lot of activity at the state level. A number of states have passed new and stringent legislation restricting applicants for wholesale licenses. They require more stringent record keeping and pedigrees. California is leading the way in requiring electronic pedigrees and is driving the rest of the country in that direction, too.
The National Association of Boards of Pharmacies is also a driver. It's providing assistance to the states.
Q. Do you think the drug supply is safer today than it was when your book was published?
A. Yes and no. Since the book came out, the big three wholesalers have announced they will no longer purchase drugs from the secondary market. CVS pharmacy has announced that it will not purchase drugs from any wholesaler who buys from the secondary market. So there is somewhat less secondary product in the primary market.
But no -- because so many drugs are now being manufactured overseas with little oversight. The FDA can't keep up. We have little way of knowing those drugs being manufactured overseas are, or aren't safe.
Q. If you could wave a magic wand, how would you fix the system?
A. The drug supply needs to be transparent. We need a verifiable way to know where our drugs have been, who’s handled them and how many hands they have passed through. We need much stronger regulation, more funding for the FDA, stricter criminal penalties for falsifying a pedigree or adulterating a drug. Under the current laws, narcotics traffickers will continue to view pharmaceuticals as a safer line of work.
Q. What's next then? And how can we patients get involved?
A. Patients can follow the tips from my book to make sure they don't become victims -- well, at least to stay as safe as they are able. Further, they can support efforts on the parts of their governments to enact legislation to keep the counterfeiters at bay in their states.
Making others aware of the dangers is also helpful. Just like you did, many people dismiss the idea of counterfeiting, assuming it's something it isn't. Awareness is always useful when it comes to making important changes.
In addition you can:
- Learn more about Katherine Eban's book, Dangerous Doses.
- Read an overview of the problem of counterfeit drugs and how they may affect you.
- Find Ms. Eban’s list of tips for staying safe from counterfeit drugs.
- Talk about counterfeit and adulterated drugs in the Patient Empowerment Forum.
