A few weeks ago, SmithKline Beecham’s Worthing West Sussex, U.K., site received an FDA warning letter related to, primarily, alleged failure to ensure microbiological contamination of products manufactured there. The site was inspected last March, and in April the Agency said that GSK's response to initial concerns lacked sufficient corrective actions.

From 'On Pharma'

The 60 Minutes interview with GSK whistleblower Cheryl Eckard is now available online here, after airing on CBS last night. Eckard primarily discusses the mixup of drugs at the Cidra, Puerto Rico facility and her efforts to not only stop outgoing shipments but to have the plant shut down.

From 'On Pharma'

A growing number of pharma CEOs are now dealing with the consequences of failing to care about workplace realities and what Toyota called the gemba, or place where truth will be found.

If the idea of reading a book on ethics or philosophy is too off-putting....after all, it has been a rough week....why not simply listen to The Clash's hit song "Should I Stay or Should I Go?" The answer's right there. "If I go there will be trouble, and if I stay it will be double."  
From 'On Pharma'

Yesterday, I wrote on PharmaQbD.com about a new Morgan Stanley report which suggests that small-molecule drug manufacturers (and to a lesser degree biologics manufacturers) have very little financial incentive to perform their own research and development activities. The old arguments about keeping certain core competencies in-house and managing risks don't hold water anymore, the report says.

From 'On Pharma'

Emil Ciurczak reports on Tuesday at IFPAC 2010 in Baltimore:

The talks started in earnest today, with five concurrent sessions. Most were dedicated to pharmaceutical applications, so it was “interesting” to try to cover many of them. One session, in particular, caught my attention: "New Directions and Modeling". Since it made numerous references to chemometrics/multivariate modeling, I had to check it out. In the interest of brevity, I will merely highlight a few of the better talks throughout the day.

From 'On Pharma'

With global economies struggling it only gives drug manufacturers with sizable investment dollars more leverage to pit local and national governments against each other to see who can offer up the sweetest packages to earn the right to that money. GSK is playing tough with the UK over how it will invest going forward, demanding better tax incentives, patent support, etc. If not, GSK's Andrew Witty hints that Ireland, Belgium, Singapore and other locales are only more than happy to oblige.

From 'On Pharma'

A few weeks back we posted a list of the companies that were manufacturing H1N1 vaccines, and since that time many of them have been approved, either in the U.S. or abroad. Here's an update:

From 'On Pharma'

It's a matter of weeks now until we begin to see: a) to what degree the H1N1 pandemic will again ramp up; b) which manufacturers will have developed vaccines in time to address the need; and c) if those vaccines will work against the dominant strain that develops.

From 'On Pharma'

If you put credence in Swiss firm Covalence's annual ethics rankings, yes, GSK, BMS, and J&J are the most ethical companies in the Pharmaceuticals and Biotech sector. The list looks like this:

1. GSK

2. BMS

3. J&J

4. Abbott

5. Novartis

6. Roche

7. Boehringer Ingelheim

8. Astra Zeneca

9. Pfizer

From 'On Pharma'

Have been away from the epicenter of political corruption for a while.  New York is quite a bit tamer on that score than Chicago.  Not so its tabloid headline writing (especially at the New York Post), which is as brilliant as it is uncivilized.  I was shocked to hear about New York governor Spitzer's recent problems; so, too, were the non-dyslexic headline writers at the Post, who reacted with the trashy but memorable, HO NO!  (It's challenging to come up with headlines that succinct. ) New York Daily News' "Pay for Luv Guv" wasn't even in the same league. 

Had to wonder whether anyone at GSK, the company that Spitzer had pursued so vigorously, might be quietly savoring this moment.  Especially since the U.K. recently dismissed charges that the company had intentionally hidden safety information about its anti-depressant, Paxil/Seroxat. 

The Financial Times recently published an interesting analysis (Read here) calling for more transparency.  The U.K. case, which lasted for for years, has helped raise the bar for clinical data transparency, the FT reports although it acknowledges that loopholes remain. 

But Spitzer had fired the first shot in calling for data transparency here in the U.S., through a civil lawsuit filed in 2004 (for reportage from the Washington Post, click here)  requiring that more clinical trial results be made openly available to the public.  The case was settled for $2.5 million. He had also pursued GSK for filing frivolous IP infringement claims to prevent generic versions of Paxil from reaching the market.  That case was settled for $14 million).

Spitzer, when he was state Attorney General, also heard from the second Wyeth Prevnar whistleblower, Anthony Sokol, who had alleged manufacturing and quality issues, and claimed the company had violated consent decree requirements. 

The Wall Street Journal Health Blog reported recently (click here to read) that Sokol's, the second such case involving Prevnar manufacturing, was filed late in 2006, and only recently disclosed by the company, and that the first whistleblower, Mark Livingston, has appealed the decision that had been made in his case.

AMS

From 'On Pharma'