New Merck Names "The Fosamax Guy" As Its New Chief Medical Officer

The man apparently led a development efforts on Fosamax (a drug a theme of over 900 lawsuits alleging jaw line bone death, as a side effect of receiving it, longer term). Let's hope his instincts have softened given then. we trust he is better than which would suggest -- here is his before life, in summary fashion:
. . . .Dr. Rosenblatt has served as Dean of Tufts University School of Medicine given 2003. Prior to Tufts University, Dr. Rosenblatt hold a appointment of George R. Minot Professor of Medicine during Harvard Medical School as well as Chief of a Division of Bone as well as Mineral Metabolism Research during Beth Israel Deaconess Medical Center (BIDMC). He served as a President of BIDMC from 1999-2001. Previously, he was a Harvard Faculty Dean as well as Senior Vice President for Academic Programs during CareGroup as well as BIDMC as well as a owner of a Carl J. Shapiro Institute for Education as well as Research during Harvard Medical School as well as BIDMC.

Prior to that, he served as Director of a Harvard-MIT Division of Health Sciences as well as Technology. And earlier, he was Senior Vice President for Research during Merck Sharp & Dohme Research Laboratories where he co-led a worldwide development team for alendronate (FOSAMAX), Merck's bisphosphonate for osteoporosis as well as bone disorders. In leading most of Merck's international research efforts, he determined two vital simple research institutes. He also headed Merck Research's worldwide University as well as Industry Relations Department.

Dr. Rosenblatt is a target of a Fuller Albright Award for his work on parathyroid hormone as well as a Vincent du Vigneaud Award in peptide chemistry as well as biology, as well as a Chairmans Award from Merck. Dr. Rosenblatt perceived his undergraduate degree summa cum laude from Columbia as well as his M.D. magna cum laude from Harvard. His internship, residency, as well as endocrinology precision were all during a Massachusetts General Hospital. . . .
Well, we theory Merck just found a permanent consultant declare for the defense of these cases -- as well as probably cheaper (all-in) than his day-rate, too.

Pharmalot Has a Great Vioxx/Zetia Perspective Piece Up

Ed Silverman has it all, on his glossy brand new Pharmalot site -- do go read it there, though here is the tiny taste (it covers both Vioxx, as well as Zetia):
. . . .The debate over conflicts of seductiveness is receiving the turn as the former Merck executive and the medical biography are teaming up to lash out at doctors who have criticized drugmaker behavior in published studies, as well as have also served as expert witnesses in product-liability litigation. . . .
Do go read it all, together with comments -- such as this one:
By: Casper the Friendly Ghost
December 15th, 2009 @ 11:11 am

I support anything created (or not) by Laurence Hirsch. . . .
Hilarious!

Fosamax "Bellweather Case" Trials: Updated Scheduling Orders

Judge Keenan will incidentally name an particular Fosamax box -- to add to his hearing calendar -- upon Feb 1, 2010, as a deputy "bellweather" case, given a Fleming box was dismissed. He has additionally scheduled a new hearing date in a "Runaway Jury"/previous mistrial of a Boles Fosamax box for June 2, 2010.
. . . .The hearing of Louise H. Maley v. Merck & Co., Inc., No. 1:06-cv-04110-JFK remains scheduled to embark upon April 19, 2010.

The retrial of Shirley Boles v Merck & Co., Inc., No. 1:06-cv-09455-JFK will embark upon June 2, 2010. Counsel for Merck as well as a Plaintiffs Steering Committee are destined to appear during a discussion in Courtroom 20-C upon Feb 1, 2010, during 11:00 a.m.

The box selected by a Court at random from a hearing pool during a Feb 1 discussion will replace a recently-dismissed Flemings action as an early trial.

Conference set for 2/1/2010 during 11:00 AM in Courtroom 20C, 500 Pearl Street, New York, NY 10007 prior to Judge John F. Keenan.

Signed by Judge John F. Keenan upon 12/7/09

Filed In Associated Cases: 1:06-md-01789-JFK-JCF, 1:06-cv-04110-JFK, 1:06-cv-09455-JFK. . . .
As ever, I'll keep you posted. we consider there is another bellweather Fosamax box scheduled for hearing prior to a very-able Judge Keenan, in mid-January 2010.

A Pretty Comprehensive "Forward-Look" -- At New Merck

Slightly too boosterish, in my opinion, though a satisfactory demeanour at almost all of a risks as great as upsides New Merck will expected face, by 2012 -- in a very prolonged web-press-release (do go read it all):
. . . .With a brand brand new expansion formula in place, a complimentary product portfolio as great as larger geographical reach, it will be a uninformed begin for a brand brand new Merck in a New Year. Merck, which has a clever balance piece with cash as great as investments of about $8 billion, has already hinted which it is not going to be restored about acquisitions as great as which it will be eyeing tube possibilities with a greatest probability of success as great as licensing opportunities. This might be a great formula to solidify a company's position at a forefront of innovation as great as enhance its systematic as great as technological leadership. . . .
We shall see.

FDA Advisory Committee -- Solo Slide

And, here it is:



Ahem -- Yawn. Background, here.

Vertex Closes $442.8 Million Secondary Stock Offering

At a very heady price per share, to boot:
. . . .Vertex Pharmaceuticals today closed upon the agreement to sell 11,500,000 shares of the common stock in a firmly-committed underwritten charity during a price to a public of $38.50 per share, which resulted in total gross proceeds of $442.8 million. . . . Goldman, Sachs & Co. acted as a sole book-running manager for a offering, in an charity underneath which BofA Merrill Lynch, J.P. Morgan Securities Inc., as well as Morgan Stanley & Co. Incorporated acted as co-managers. . . .
Regular readers will stop that Vertex is leading New Merck (as successor to Schering-Plough's investigate in this area) in a race for next-gen Hep C treatments. This nearby half billion will give (the rather small) Vertex one more coherence to accelerate the outlay upon the Phase III efforts, as well as expected correspondingly digest the time to approval during FDA.

Sunday Evening: Food For Thought -- From TruthOut.Org

The excellent websites called TruthOut.org (most famous for their being campaigns -- against smoking) are carrying the timely-blog entry/op ed, introspective health caring reform, as well as directions it ought to take. The writer is Dr. Philip Caper, M.D. -- do go review it all -- but this much caught my eye, as well as imagination:

. . . .Prior to about the mid-1970's, American health caring institutions, like those in alternative developed countries, were overwhelmingly nonprofit, locally tranquil entities driven by their mission (not money) -- comforting the sick, curing seizure as well as promoting healing. . . .

Pharmaceutical companies were. . . mostly driven by George Merck's ethic: "If we develop medicines which cure disease, the money will take caring of itself."

By the mid-1970's, leaders in American health caring fell in love with business. They began to hold which government could be improved as well as costs tranquil by the stiff dose of great aged American commercial operation know-how. As the result, initial MBAs, as well as then full-fledged corporatism, began to overflow as well as renovate healing care. Hospital administrators became CEOs, services became product lines, patients became market share as well as so on. . . .

Insurance companies combined opposite state lines, as well as ownership was eliminated from nonprofit local corporations to for-profit multistate as well as inhabitant corporations. As pharmaceuticals became the incomparable part of healing care, curative companies grew, became more essential as well as merged, eventually creating outrageous multinational conglomerates. Ownership was eliminated from in isolation (often family) hands, to apart shareholders by lucrative open offerings. . . .
A worthy Sunday evening read, indeed.

Pediatric Vytorin/Zetia Will Open Tuesday's FDA Advisory Committee Meeting

The span will receive an shortened open overview, upon a singular slide -- commencement during 8:15 AM EST upon December 8, 2009 -- as FDA staff believes these drug are not at large prescribed in pediatric settings. To be clear, a full science, safety as well as efficacy reviews have been/will be undertaken by a committee -- though a open display apportionment will be condensed, according to a FDA staff's cover letter, sent with a applicable background materials. [Click image during right to perspective full-size.]

In any event, here -- we think -- is a section of a pediatric Vytorin label copy under review, for intensity changes:
. . . .From a begin of a hearing to a finish of Week 33, discontinuations due to an inauspicious greeting occurred in 7 (6%) patients in a ezetimibe coadministered with simvastatin organisation as well as in 2 (2%) patients in a simvastatin monotherapy group.

During a trial, hepatic transaminase elevations (two uninterrupted measurements for ALT and/or AST >3 X ULN) occurred in 4 (3%) people in a ezetimibe coadministered with simvastatin organisation as well as in dual (2%) people in a simvastatin monotherapy group. Elevations of CPK (>10 X ULN) occurred in dual (2%) people in a ezetimibe coadministered with simvastatin organisation as well as in zero people in a simvastatin monotherapy group.

In this limited controlled study, there was no poignant effect upon expansion or sexual maturation in a adolescent boys or girls, or upon menstrual cycle length in girls.

Coadministration of ezetimibe with simvastatin during doses greater than 40 mg/day has not been complicated in adolescents. Also, VYTORIN has not been complicated in patients younger than 10 years of age or in premenarchal girls. . . .
I'll be upon a craft Tuesday morning, so watch a wires for news. I'll post -- if something surprising transpires -- later in a day Tuesday.

Pediatric Vytorin FDA Packet -- Working Thread -- FDA Label Changes?

Here is a FDA's outrageous Friday data-dump -- what do you see?

Interestingly -- are there FDA-mandated label changes in a functions for Vytorin, as well? It seems a file has been pulled from FDA's website (for now) -- I'll keep checking:
. . . .Content Server Request Failed

Unable to download 'UCM192102'. Unable to find latest expelled revision of 'UCM192102'. . . .
I'll keep checking a link.

On The "Gardasil Girls" Article, In The Cape Cod Times

While a overall suit of thousands (perhaps over 3,000) of potentially Gardasil-related inauspicious events, compared to a total of 26 million doses delivered expected still reflects a tolerable risk-to-benefit ratio, it is my growing perspective which a Gardasil vaccine should not be as involuntary a preference for differently abstinent, full of illness immature girls in a United States as some might suggest. This preference certainly deserves clever consideration, as well as a prolonged as well as contemplative discussion with one's illness care providers, we think.

Do go review a entire, longish essay published online this morning, as well as cruise this snippet, from a Cape Cod Times:
. . . .A growing series of immature women have been joining a ranks of "Gardasil Girls," immature women who hold they have been harmed by a Merck vaccine which was approved in 2006 as well as has been heavily marketed as a surety for cervical cancer.

On Oct. 15, a Cape Cod Times ran a story about 3 teens, all of whom developed a rash as well as other symptoms in a single case, partial paralysis after their vaccinations.

One of O'Brien's neighbors, meaningful she was frustrated about Annie's rash as well as Brianna's lingering illness issues, showed her a article, O'Brien says.

Barbara Loe Fisher of a nonprofit National Vaccine Information Center says there have been sufficient inauspicious reactions to a Gardasil vaccine to aver a sovereign investigation.

Fisher, who is a owner of a vaccine watchdog group, has asked Congress as well as sovereign illness agencies to look in to VAERS reports which more than 3,000 immature women have been harmed by a vaccine as well as 48 have died.

So far, a Centers for Disease Control as well as Prevention as well as a FDA say a vaccine since in 3 separate shots is safe as well as effective, with side goods including pain at a injection site, risk of fainting as well as blood clots.

A CDC vaccine report, final updated Nov. 5, says 26 million doses of Gardasil were distributed in a United States as of Sept. 1. The agency says that, formed on the stating systems, it continues to suggest Gardasil vaccination. . . .
Food for thought, no doubt.

Vertex To Use Goldman, Sachs To Raise At Least An Additional $390 Million Of Equity In Secondary Offering

As explanation that many denizens of Wall Street are firm believers in a bright prospects for a next-generation Hep C drug candidate, telaprevir, securing FDA approval, Vertex has left to a equity well twice in as many years. This time a indicated lift is in between you estimate $390 as well as $450 million, depending upon either Goldman exercises a supposed Green Shoe option-in-full, as well as presumption that Vertex common holds a current level, during around $39 per share -- tonight's NYSE closing price.

Here's a bit of a AP report:
. . . .Vertex Pharmaceuticals Inc. said Wednesday it plans to sell 10 million shares of batch to a open to lift cash.

The underwriters will have an choice to buy another 1.5 million shares, Vertex said. Goldman Sachs will be a book-running manager for a offering. . . .
Of course, Merck has inherited a Schering-Plough "me too" boceprevir drug candidate, in this space -- a development of that Leerink Swann analysts predicted earlier today might be scaled back, by Merck, in 2010 as well as over -- presumably based upon a increasingly large lead telaprevir is sporting, here. As ever, you shall see.

Phase III Result Favors Roche's Diabetes Drug Candidate Over Januvia

Per a Wall Street Journal, just right away -- a snippet, upon Januvia (sitagliptin), from a longer article (do go review it all, there):
. . . .Roche Holding AG said Wednesday an experimental once-weekly diagnosis under development works improved in treating a type of diabetes than Merck's Januvia, according to a clinical study.

The Basel-based drug company is comparing taspoglutide to Januvia as well as to a remedy in Phase-III studies upon Type 2 diabetes, as well as said a drug met primary endpoints as well as was well-tolerated by patients taking it. . . .
For its part, Merck has already released a statement reaffirming its idea in Januvia. This as well should infer interesting -- since a prior FDA notice upon pancreatitis risks -- associated with Januvia.

Bloomberg's -- And Tony Mauro's -- Takes On The "Kentucky Windage" From The Supremes

we said yesterday I'd post it, when accessible -- here it is, as reprinted in The Boston Globe online. we think this story appeared upon Bloomberg about twenty minutes after we detailed a potential for a majority line-up bearing a plaintiffs (on an additional board) -- based solely upon what we saw as a doubt evinced in a Justices' lines of questioning. In any event, a snippet:
. . . .Most of a nine justices referred to they are prepared to let shareholders sue Merck for purported dishonesty about a risks posed by Vioxx, which a association pulled from a market in 2004 because of links to heart attacks and strokes. . . .
In addition, Tony Mauro, essay for The National Law Journal, as posted over during law.com, ran a story last night, regulating a rather off-beat turn of phrase to describe tools of a fit (which turn of pharase appeared word for word in mine), about three hours after we ran cave (phrase bolded, below):
. . . .Merck. . . argued which there was sufficient justification of possible rascal in his client's statements about a anti-inflammatory drug in a public domain by September 2001. . . .

[Ed. Note: Tony went upon to comply thus:]

. . . .Justice Ruth Bader Ginsburg, noting which Merck initially insisted there were other explanations for a increasing risk, said, "How would a most committed plaintiffs have gone about finding out whether Merck really had no good-faith belief" in those alternate theories. . . .

Justice Antonin Scalia additionally referred to which in a early stages there was "simply substantial justification of inaccuracy," not of a kind of rascal needed to trigger a bonds suit. . . .
My take? Ex-CEO Fred Hassan is starting to need which refurbished Newark-branch Warburg Pincus office/janitors' closet to be fully-operational by Christmas. Heh.