the FDA’s notice and Roche’s official statement.
The real crime? This situation was completely avoidable.
From what we know so far, these 19 medical practices knowingly purchased the fake product from a non-authorized distributor. By looking for a "good deal" outside of the legitimate channel, the physicians in charge of these practices were foolish, irresponsible, and unethical. Patiens caveo. (Patients Beware.)
Read on and see if you agree.
You know those guys on Manhattan street corners, selling Rolex watches for $30? I hate to break it to you, but those are not genuine Rolex watches.
How do I know? Because the Rolex web site lists only 5 authorized Rolex dealers in New York. See for yourself. As far as I can tell, none of these 5 operate out of a car trunk.
For Avastin, there are only 4 authorized specialty distributors for U.S. physician offices—Besse Medical/Oncology Supply, BioSolutions Direct, McKesson Specialty Care Solutions, and CuraScript Specialty Distribution. Click here to see this list on a public website. I found it with one google search.
So, why were these 19 physician practices ordering instead from Volunteer Distribution of Gainesboro, TN? The FDA reports that Volunteer sold the counterfeit products of Quality Specialty Products (QSP), “a foreign supplier that may also be known as Montana Health Care Solutions”?
If the allegations are true, Volunteer and QSP are complete scum who are happy to make a buck while patients die.
But what about the buyers at these 19 medical practices? In my opinion, they are also criminals.
Someone at these practices made a “business decision” to purchase outside of the legitimate distribution system, perhaps in search of bigger margins for the practice.
They must have known that this was wrong. Counterfeit sellers require counterfeit buyers. Who will punish the 19 practices? If we find out that a patient received the fake product, then the doctors responsible should lose their medical licenses.
This incident also inadvertently highlights the fatal flaw in track-and-trace or pedigree systems. As I wrote over two years ago in Reality Check on Supply Chain Security, pedigree laws and track-and-trace technologies only work if the buyers refuse to buy outside legitimate channels and agree to authenticate (scan) an electronic tag. There's little chance that a tag would have been read because these practices wouldn't want to alert anyone to their back-alley shenanigans. “Don't ask, don't tell” is the mantra of buyers who acquire questionable product from unauthorized channels.
Let’s just hope that the damage was contained. The FDA drolly notes: "Medical practices that have obtained unapproved products from foreign sources, in particular from Volunteer Distribution and/or QSP, should stop using them and contact the FDA."
How about: "Medical practices should stop doing dumb stuff that harms patients." When will pharmaceutical buyers learn to just say no?
UPDATE: Here's the FDA's list of medical practices that purchased from Volunteer Distribution: Letters to Doctors About Purchasing Unapproved Injectable Cancer Medications.