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.

harish kalyan said...
This comment has been removed by the author.
bosqqpro said...

An impressive share, I given this onto a colleague who has been doing a small analysis for this. And hubby in truth bought me breakfast due to the fact I uncovered it for him.. smile. So ok, i’ll reword that: Thnx to the treat! But yeah Thnkx for spending plenty of time to discuss this, Personally i think strongly regarding it and adore reading more on this topic. Whenever possible, as you grow expertise, could you mind updating your website with additional details? It is highly ideal for me. Big thumb up just for this article! Marijuana News

bosqqpro said...

As far as me being a member here, I didnt even know that I was a member here. When the article was published I received a username and password, so that I could participate in Comments, That would explain me stumbuling upon this post. But we’re certainly all members in the world of ideas.

bosqqpro said...

An fascinating dialogue is value comment. I think that you should write more on this subject, it may not be a taboo subject but typically people are not sufficient to talk on such topics. To the next. Cheers

sasi said...

This was an excellent post and very good information provided, Thanks for sharing.
Python Training in Chennai
Python training in Bangalore
Python Training in Coimbatore
Python course in Chennai
Big Data Training in Bangalore
python training in hyderabad
python course in bangalore
Python Classes in coimbatore

mtom said...

?MrNewbieVideo? New News: With Five New Apps, Zoho Is Now The Largest Developer On The Google Apps Mar Enail Kit

saim said...

A few things i don’t understood is at truth how you are now not necessarily really a lot more neatly-favored as compared to you may be right now. You might be so smart. You already know thus considerably concerning this matter, taught me to be separately consider it from the large amount of different sides. It’s just like people are certainly not intrigued until it is something to accomplish along with Girl coo! Your individual stuffs outstanding. All the time look after up! smart buds can

saim said...

A powerful share, I just given this onto a colleague who was doing slightly evaluation on this. And he in fact bought me breakfast because I found it for him.. smile. So let me reword that: Thnx for the treat! However yeah Thnkx for spending the time to debate this, I feel strongly about it and love studying more on this topic. If possible, as you change into experience, would you mind updating your weblog with extra details? It’s highly helpful for me. Massive thumb up for this weblog put up!

Gregory smith said...

buy backwoods
dankwoods for sale
There are so many valuable and high potential benefits of cannabis th upat a greater quater of the globe is still to discover yet,at medical cannabis bud shop we make sure every customer shopping from us gets the best in terms of quality of cannabis products purchased with 100% discreet shipment and deliveries.
thc blunts for sale
juicy jay cones

buy backlinks cheap said...

There is noticeably a bundle to learn about this. I assume you made certain good points in features also. Silkroad

123456789 said...

True willpower, but, is about getting to know the way to make aware choices. Addictions stick like glue to all people who needs to overcome them. They are the 'ghosts of reminiscence' who stay in our subconscious and pa up whenever the addictive substance is in sight or is imagined.Sewer Leak Testing

Retaile Ecaper said...
This comment has been removed by the author.
Retaile Ecaper said...

I am often to blogging and i also really appreciate your content regularly. Your content has really peaks my interest. I am about to bookmark your site and maintain checking for first time data. Red wine for sale