A thought-provoking (if not unbiased) article from an unexpected source, Vanity Fair.

Over the past several years, biomedical researchers and scientists from Europe and China have been holding workshops and collaborating on a project to establish an ethical framework for clinical trials and biomedical research conducted across cultures—namely, as a result of partnerships between European and Chinese life science companies. The fruits of the BIONET project are being realized this year, and the project’s final report has recently been released.

Pfizer has decided to drop two late-stage drug candidates because, according to this AP story, it sees no real market potential for them. That is, it sees no blockbuster potential. And, as the article implies, this is in direct response to the Wyeth purchase and the fact that the company is flush with new compounds to consider and prioritize.

A new report conducted by doctors at the University of California-San Francisco claims that pharmaceutical companies are still not being transparent in the reporting of their clinical trials, finding that some are up to five times more likely to report positive findings than negative.

Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis.  And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W. was reassigned from her post of Chief Medical Officer and Deputy Commissioner to head up CDER.  Using the triage imagery of the Emergency Room, running the Critical Path initiative is important, but maintaining control of CDER, drug review and inspections, is urgent.

Yesterday's announcement that Eli Lilly had sold off its Greenfield, Indiana, R&D facility to Covance is perhaps not just a big deal, but really a bellwether move that may signal a trend of Big Pharma companies not just outsourcing aspects of their R&D operations but selling them off altogether. As the above-linked article suggests, the time for companies like Lilly to assume the role of financiers who aggregate data may be closer to reality.

Your thoughts on the significance of the deal? We'll be keeping a close eye on this one, and include expert input in posts to come.

--PWT

George Laszlo has been keeping tabs on the technology offerings in his blog.  For access to this very handy list, a work-in-progress, read on.  Also note posts on open-source code (technology is ready, but is the industry ready for it, he asks) and the changing role of the Pharma CIO.

A storm, complete with hail, thunder and generous amounts of lightning, appeared to follow me through Connecticut and Rhode Island as I drove to Boston on Wednesday for the DIA meeting.  Didn't make it until almost 4 PM, only to have the storm break out in Boston at 6 PM in all its glory.  Although I'd missed the presentation on global regulatory harmonization (which included Japan's top pharma regulatory official), the few hours were very well spent.

Flagging a cab was quite difficult, with very long lines at the convention center, so we found a kindly trolley car driver who took us to one appointment, and gave us an impromptu tour of the North Side along the way. 

One highlight of the trip was a visit with two top executives with Microsoft's Life Sciences division (in order of their appearance: Les Jordan, Industry Technology Strategist and Michael Naimoli, Director) to learn more about SharePoint, its manufacturing and drug development platforms, and a new clinical trial data management platform developed by TranSenda (whose CEO, Robert Webber explains the system) but powered by Office.  For the die-hard Microsoft fans, here's a brief audio clip (which isn't on our web site yet)

AMS

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

Am starting to feel like the witch in "The Wiz" -- "Don't nobody bring me no bad news." A quick look at some headlines brought yet another story of blockbuster-challenged pharma ethics, this time involving Germany's Bayer AG.

Next Sunday, CBS' 60 Minutes will interview Dr. Dennis Mangano, a researcher whose studies reportedly had found higher rates of kidney failure in patients who took Bayer's Trasylol, which is designed to stop bleeding during heart surgery. For more read on. His research came out in January 2006; the drug was recalled last November. In the interim, Dr. Mangano claims, 22,000 patients receiving the drug may have died needlessly.

Dr. Mangano's study was the subject of an FDA advisory board panel meeting in September 2006, but Mangano says that Bayer did not disclose negative findings during that meeting, even though internal company research had confirmed the results. FDA advisory panel chair Dr. William Hiatt, reportedly told 60 Minutes he would have voted to remove Trasylol from the market had he been informed about Bayer's study.

AMS