Wednesday, August 7, 2013

Counterfeit Drugs in Clinical Trials?

This morning I ran across a bit of a coffee-spitter: in the middle of an otherwise opaquely underinformative press release fromTranscelerate Biopharma about the launch of their
Counterfeits flooding
the market? Really?
"Comparator Network" - which will perhaps streamline member companies' ability to obtain drugs from each other for clinical trials using active comparator arms -  the CEO of the consortium, Dalvir Gill, drops a rather remarkable quote:

"Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information we need, doesn't always happen efficiently. This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs.  With the activation of our Comparator Network the participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and totally mitigate the risk of counterfeit drugs in that clinical trial."

[Emphasis added.]

I have to admit to being a little floored by the idea that there is any sort of risk, in industry-run clinical trials, of counterfeit medication "infiltration".

Does Gill know something that the rest of us don't? Or is this just an awkward slap at perceived competition – innuendo against the companies that currently manage clinical trial comparator drug supply? Or an attempt at depicting the trials of non-Transcelerate members as risky and prone to fraud?

Either way, it could use some explaining. Thinking I might have missed something, I did do a quick literature search to see if I could come across any references to counterfeits in trials. Google Scholar and PubMed produced no useful results, but Wikipedia helpfully noted in its entry on counterfeit medications:

Counterfeit drugs have even been known to have been involved in clinical drug trials.[citation needed]

And on that point, I think we can agree: Citation needed. I hope the folks at Transcelerate will oblige.


Anonymous said...

So you think that if a company chooses to run a clinical trial as "site sourced" trial rather than a "central supply" in a country that may not have a great supply chain that this couldn't happen? Just a few months ago there was counterfeit Avastin was being sold to doctors in the US. What this isn't happening in less regulated countries? While I will say that maybe this company is capitalizing on a slice of fear, I don't see how this really should be a total surprise...

Paul Ivsin said...

Thanks for the comment. I think there are a couple things to consider here:

1. I don't think that any of the companies that are part of Transcelerate currently source their comparator drugs at the site level. There are experienced companies that handle clinical trial drug supply, and big pharma – as far as I can tell – uses those companies. That's why Gill's reference to problems in the retail drug supply is, to me, entirely disingenuous.

2. The fact that something might happen does not make it a real candidate for risk management. If Transcelerate had announced that their members would no longer utilize clinical trial sites in California “to totally mitigate the risk of clinical trial participants dying in earthquakes,” wouldn’t that merit a raised eyebrow?

So, to me, it appears that Transcelerate is either trying to take credit for solving a problem that doesn't really exist, or is casting aspersions on comparator sourcing companies, or both.