[Or should that be Campi? Encampments? Camping Grounds? I dunno.]
More seriously (perhaps ominously, even), in the end, there will likely be only one world headquarters campus -- for the combined Merck/Schering-Plough. Indeed, if the pattern holds, relative to the rest of the thus-far announced reverse merger decisions -- it is likely to be in Whitehouse Station.
NJBiz.com's Evelyn Lee has a decidedly-hand-wringing, pearl-clutching story this morning, thus:
. . . .About 180 pharmaceutical companies currently occupy about 18 million square feet of office, industrial and flex space in [New Jersey], compared to some 200 firms occupying about 21.4 million square feet in 2008, according to Grubb & Ellis, a commercial real estate services firm.
“There’s just excess capacity in the industry,” with most of it in manufacturing, said Tim Bender, chair of the New Jersey chapter of CoreNet Global, a corporate real estate executive association. Greater efficiencies in the production process, as well as pharmaceutical companies producing less of the basic materials they used to make, have reduced the need for manufacturing and distribution facilities, he said.
Also, “when products go off patent, then a lot of times you have excess manufacturing, so once generics come into the market, you don’t need as much,” Bender said.
Bender, who also is director of real estate at Merck, declined to comment on the merger with Schering-Plough. . . .
But of course -- as required by SEC rules -- he so declined. But the writing is on the wall.
6 comments:
Campus
Campi
Campo
Campum
Campe
Campo
Campi
Camporum
Campis
Campos
Campi
Campis
Yep. It's Campi.
As for Whitehouse Station. Don't go knocking it. Just for you SPers who will never see it. It's beautiful. It's got its own exit off the highway, then right after the you drive past security there's a heliport with 3 landing sites. Of course we wouldn't want Fred, Carrie, and Hans to have to go through security like the riff-raff.
But once you get inside. O-boy is it something. There's rare antique tapestries from around the world on the walls and the woodwork, desks, file cabinets, and all the 9 foot doors are all matching rare tropical hardwoods. But for all you environmentalists don't worry, it's a six sided building with woods in the middle and just to show everyone how environmentally conscious Merck is they had news coverage of them moving some maple saplings from where the buildings were built to the inner courtyard area (kept wild).
The view is so serene. It's as if you're in the middle of the woods. Not like Pfizer where they have to look at a bunch of vacant lots.
But then this is the 'billion dollar building'. Of course they have to do something with all that cash (besides buy other companies and get rid of the dead weight to cover costs) so that they don't pay so much in taxes.
Salmon
missing Raplon appeals
http://www.pharmalot.com/2008/04/organon-covered-up-raplon-side-effects/
So they covered up AEs and didn't report them to FDA.
Sounds like ....
Yep you guessed it Asenapine. For those of you who forgot. In the background package
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/ucm173875.htm
pages 897 - 898 it says:
2.3.3 Recommendations re: Criminal Investigations
Per instructions from OCP management (Dr. Mehta) any recommendations (or communications)
regarding criminal investigations from this reviewer first obtain approval from the management chain of command. This constitutes a formal request to FDA management and recommends criminal investigation of individuals in various companies and organizations for failure to report deaths, attempting to mislead reviewers by various devices that are apparently intended to obfuscate and hide data required for review
and that are needed to make safety assessments that would effect approval, and potentially sales and
reimbursements. In fact the evidence suggests that there may have been an intentional design to harm, maim, and occasionally kill children so as to induce the need for purchasing other products from the sponsor or cosponsors.
Consequently this reviewer believes that the following section of federal law may have been potentially
violated:
SEC. 301. [21 USC §331] Prohibited Acts.
(ii) The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 760 or 761) or the falsification of a serious adverse event report (as defined under section 760 or 761) submitted to the Secretary, (see §3.5.1.2 and §3.5.1.6).
There are more than instance which will require more time to cite appropriately and will be communicated only to the appropriate criminal investigators.
This reviewer believes the following laws may have also been violated; these include possible violations of law by FDA personnel. (N.B. This list does not encompass all potential violations). Per instructions from Dr. Mehta this reviewer requests that these concerns be referred to the appropriate criminal investigators.
18 USC § 201
(Bribery of public officials and witnesses)
18 USC § 286
(Conspiracy to defraud the Government with respect to claims)
18 USC § 371
(Conspiracy to commit offense or to defraud United States)
18 USC § 372
(Conspiracy to impede or injure officer)
18 USC § 1001
(Statements or entries generally)
18 USC § 1002
(Possession of false papers to defraud United States)
18 USC § 1018
(Falsification of Official certificates or writings)
18 USC § 1111
(Murder)
18 USC § 1112
(Manslaughter)
18 USC § 1117
(Conspiracy to murder)
18 USC § 1343
(Fraud by wire, radio, or television)
18 USC § 1347
(Health care fraud)
18 USC § 1349
(Attempt and conspiracy for chapter 63)
18 USC § 1505
(Obstruction of proceedings before departments, agencies, and committees)
18 USC § 1512
(Tampering with a witness, victim, or an informant)
18 USC § 1518
(Obstruction of criminal investigations of health care offenses)
(Section Titles provided for clarity - not included in review).
Now let's not forget what the same reviewer said at the FDA transparency meeting.
(See the first comment at the following SGP post:
http://shearlingsplowed.blogspot.com/2009/07/fda-reviewer-on-asenapine-schering.html )
Part 2
In addition on page 986 it says:
"In addition, the sponsor’s conclusions and sponsor’s labeling proposals appear to be intentionally misleading especially with respect to subjects with mild hepatic impairment and this conclusion is
supported by analyses in the original OCP NDA review.
The sponsor’s signatory for this study is Larry Alphs, MD from Pfizer. Dr. Alphs was also one of the signatories to the request for the Drug Safety Monitoring Board that is contemporaneous with the SAE in the woman who may have died from agranulocytosis, but was not reported.
The information available leads this reviewer to believe that one or more individuals at Pfizer and
Organon as well as others at other companies intentionally mislead the FDA as to important information
regarding the safety of asenapine that would have been needed to make a decision regarding this NDA.
Based on this and Chapter 18 of the United States Code this reviewer believes that the Inspector General or another criminal investigative unit must be informed.
As this reviewer was instructed by Dr. Mehta that any such requests must obtain prior approval by FDA
management, this request will be included in the recommendations."
Well guess what. There's nothing in the approved labeling on mild hepatic impairment yet according to the review this results in misleading labeling (Drugs with misleading labeling may not be introduced into interstate commerce.)
Plus on September 30th (2 weeks ago) FDA issued class labeling for agranulocytosis for antipsychotics. Recommending monitoring early in therapy but there's no info in the sections on getting labs. Yet the plots of the potential agranulocytosis cases in the asenapine review show they occurred after 1 year and not in the first few months. Plus clozapine has info on specific patterns of cell line changes and what to do and agan may occur early but it may also occur late. But these other antipsychotics don't have any detailed info on laboratory monitoring.
Plus if you go through the asenapine reviews the medical reviewer completely dismisses the concerns about blood cell line decreases / agran / potential aplastic anemia (and from Seroquel reviews at Drugs@FDA.gov appears to be promoted the very next day).
Yet now the FDA psych division right after asenapine is approved is putting class labeling in. (Hmmm. So which one is really the worst? Remember clozapine has limited access and it had a rate of 1 in 5000 yet asenapine had 2 cases in 2400).
The new Zyprexa labeling also talks about new info re: drug interactions with lithium and valproate but gives no information about it. (This was a concern in the asenapine review with valproate and effects on metabolites.)
It also refers to the Symbyax labeling (Zyprexa and Prozac) and warns against 3rd trimester administration. (I think there was something about this in the asenapine review.)
So we have in documents that FDA has released (of course it's a crime to make false statements in official documents).
Public claims of witness tampering.
Puclic claims of going to Congress.
Public claims of Firing.
Safety Issues.
Possible Rewards for Coverups.
Where's an investigative reporter when you need one?
Back on task re: corporate campi-
Talk at the S/P headquaters in Kenilworth is that a lot of effort has been going on to 'spruce' the buildings up. Lots of people walking around with clipboards, marking off areas and physical upgrades occuring that were previously neglected.
Considering that the EMT has called for belt tightening but all this money to improve the campus-wonder if it means the property is being primed 'for sale?'
Interesting, indeed.
Great dialogue, here!
Thanks, and Namaste. . . .
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