Wednesday, March 31, 2010

Merck's Controller Named CFO At Gates Foundation


Per this Reuters report:

. . . .Richard Henriques, who has been senior vice president of finance and corporate controller at pharmaceutical giant Merck since 2006, takes up his job at the Seattle-based foundation on April 19.

The Gates Foundation, which has an endowment worth $34 billion, works with a number of drugs companies as it fights malaria, AIDS, tuberculosis and other diseases in developing countries. It also funds a range of infrastructure and education projects. . . .

Interesting. Was he feeling "capped off", at New Merck? Clearly this is a promotion to more responsibilty, and a higher profile seat. Merck will miss his considerable talents, no doubt.

नमस्ते

More Detail On Merck's Cozaar® "Shenanigans" -- Attempt To Stiff Teva Fails


This one failed -- as reported by Lexology (summarizing a McDermott Will lawyer's report) -- and Teva will have its 180 days' exclusivity on generic versions of Merck's Cozaar® (as earlier reported, here):

. . . .Teva had filed Paragraph IV certifications against one patent listed in the Orange Book for Merck’s Cozaar® and Hyzaar® products. Rather than suing, Merck asked the FDA to delist the challenged patent. Already faced with two unrelated prior FDA rulings ordering forfeiture of the 180-day marketing exclusivity based on patent delisting, Teva challenged the FDA’s interpretation when it learned that Merck’s patent had been delisted. The district court granted summary judgment upholding the FDA’s interpretation.

On appeal, Teva argued that the declaratory judgment provisions added by the 2003 MMA amendments should be the only scenario in which the FDA may delist a challenged patent. Teva reasoned that nothing in the 2003 MMA amendments altered the essential incentive structure that Congress had set forth in the Hatch-Waxman statute. The court rejected Teva’s argument that declaratory judgment delistings are the only delistings permitted under the Hatch-Waxman Act. However, in ultimately ruling for Teva, the court read the statute as a whole, stating that all of the other forfeiture provisions required some participation by the generic drug maker and, therefore, the 2003 MMA amendments must not be read to mean that brand companies "should be newly able to delist challenged patents, thereby triggering a forfeiture event that deprives generic companies of the period of marketing exclusivity they otherwise deserve. . . ."

This sort of attempted gamesmanship seems beneath the dignity of the mission -- the mission is to save lives. Long ago, Merck made many times its investment back, on Cozaar/Hyzaar. And now, patients are overpaying for this medication -- millions of dollars, in the aggregate, for every day that Merck delays. That is simply wrong. Full-stop.

Tuesday, March 30, 2010

Legacy Schering-Plough Paid "Kickbacks" In Vietnam -- For PegIntron® 'Scrips?


Online versions of various newspapers in Sàigòn are reporting that the Vietnamese Prime Minister has ordered a formal penalty-assessment inquiry today, against the local Schering-Plough subsidiary, and several hepatologists.

The papers report that "commissions" of between 10 percent and 30 percent of the per treatment selling-price of PegIntron®, in country, were offered -- and paid -- to various Vietnamese liver doctors.

This one could be immensely toxic to New Merck's business reputation in Southeast Asia -- and well beyond the actual size of the "commissions" offered (and apparently, paid) in Vietnam. Do go read the whole article:

. . . .Leaders of the city’s Medical University and its hospital held a press conference. . . to discuss the controversy as related to staff here. . . .

Co-deputy Director of the hospital Dr. Nguyen Hoang Bac said he had ordered the facility’s Pharmaceutical Faculty to investigate all drug prescriptions written recently, especially those for Schering-Plough’s Pegintron 50 mcg and Pegintron 80 mcg used to treat liver disease.

It would then be decided if doctors had prescribed the medicines inappropriately to receive commissions.

Dr. Le Quan Nghiem, deputy head of the Medical University-turned-head of the Pharmaceutical Faculty, said the school has also suspended Dr. Nguyen Duc Tuan after rumors surfaced that he was working as a marketing director for Schering-Plough.

The US pharmaceutical company merged with US-based Merck. . . in 2009 and Ton That Luong Nguyen was appointed chief representative in Vietnam.

Mr. Nguyen reportedly secured high commissions for doctors of 10-30 percent of the cost of the drugs if they prescribed Pegintron 50 mcg and Pegintron 80 mcg for patients. . . .

Deeply disconcerting -- and when the inevitable "other shoe" drops, I'll have it -- right here. Once again, we've seen that Mr. Hassan sold some sows' ears, as silk purses. And Mr. Clark bought them -- paying silk-purse prices.

Kids 1; Insurance Lawyers 0


A couple nights ago, I mentioned (with scorn) what a terrible PR position some lawyers for health insurance companies had put their clients in, by suggesting they'd quibble and whine -- whine that an arcane "inside-baseball" definitional phrase had not been employed as clearly as it could have been, by Congress -- when drafting and passing the reform package. I think the CEOs just got the message: they will NOW cover kids with pre-existing conditions this year.

The New York Times reporting, here:

. . . ."Health plans recognize the significant hardship that a family faces when they are unable to obtain coverage for a child with a pre-existing condition," said Karen M. Ignagni, president of America’s Health Insurance Plans, a trade group. Accordingly, she said, "we await and will fully comply with" the rules.

Ms. Ignagni made the commitment in a letter to Kathleen Sebelius, the secretary of health and human services, who had said she feared that some insurers might exploit a possible ambiguity in the new health care law to deny coverage to some sick children. . . .

In a Twitter message, Robert Gibbs, the White House press secretary, scored the tug of war as "Kids 1, Insurance Cos 0". . . .

Indeed. Surprising, I suppose -- only insofar as it took a few news cycles to reach the right result, here.

Monday, March 29, 2010

"The FOIA Packet": FDA's Nasonex® Briefing Materials Now Online


To its enduring credit, FDA's transparency initiative is paying dividends -- in the form of online access to pre-1998 review packets, for several of the most-widely prescribed drugs in the US -- ones for which, until now, electronic versions of the original records were rather scarce (due to the FDA approval having predated the more internet-friendly FDA approval process, and no funding for "backward" digitizing of the archived approvals). Click here to see the full 630 page PDF file on Nasonex®.

FDA has been placing the background materials, and public portions of the approval files online, and the ones thus far available are listed, and linked, in this FDA Transparency blog posting, posted on St. Patrick's Day, 2010.

. . . .The posted records are from the agency’s historical file of information that was previously disclosed under the Freedom of Information Act. The records are posted as is and have not been previously posted due to the quality of some of the records. The best available copies have been posted. . . .

Here's a peek -- at what lies, within (page 341 of 630) -- click it to biggify:



Just think -- this is, even after all these years -- a $164 million per year franchise. Wow.

There's No Doubt "New" Merck Still Faces A Patent Cliff


And this UK report proves it -- right out of an MSD senior executive's mouth. Thanks go to Ed Silverman, at Pharmalot.com, for the heads' up:

. . . .Speaking at the BioFinance and BioInnovate Europe meeting in London at the end of last week, Margaret Beer, head of licensing and external research in Europe for Merck Sharp & Dohme, noted that the newly-expanded company, fresh from its acquistion of Schering-Plough, is still very much in the market for other partnerships. She said the merger means that “Merck is now a bigger beast to feed”. . . .

As for technologies, they do not have to be new, she said, they just need to be “faster, better and cheaper than what we already have”. Dr Beer concluded by noting that “we rarely come across an opportunity that’s unique” but partnerships are vital; last year 63% of Merck’s 2009 sales were attributable to alliance products and patents. . . .

So, read this as sheer size is not always an advantage -- especially when Wall Street expects a high, and steady rate of percentage growth -- on an already gargantuan base of revenue and EPS. And that steady growth is increasingly hard to come by, when one's pipeline is slowly, but surely, drying up.

This Ought To Make You Laugh Out Loud.


Here's a rap all about being quarantined "in hospital", for TB, in Australia -- but I promise he'll make you laugh:



Quoth the artist, ChristiaanVanVuuren:
. . . . was eventually let out of hospital on the 2nd Jan, but then brought back in on the 18th Jan and diagnosed with a more serious form of TB... As a result, I have been back in quarantine since the 18th Jan, and all up now I have spent 55 days on the inside of a single room in hospital... This is starting to take it's toll on my mental stability, and this song is about the impact (or lack thereof) it has had so far. . . .

Seriously. Party-on.

Sunday, March 28, 2010

Some Health Insurers Seek To Catch The "Train To Hades" -- Express-Style!


So, apparently some lawyers for some health insurers are suggesting that -- despite what the Senate and House said was their collective intent, in passing the reform package -- the insurers may decide to argue they are not required to cover children with pre-existing conditions, this year. They would argue that they are allowed to drop the entire family, to avoid covering the sick child. They would argue that they would not be required to cover the sick child until 2014.

Here is what The New York Times is reporting, tonight -- as to legislative intent:

. . . .The authors of the law say they meant to ban all forms of discrimination against children with pre-existing conditions like asthma, diabetes, birth defects, orthopedic problems, leukemia, cystic fibrosis and sickle cell disease. The goal, they say, was to provide those youngsters with access to insurance and to a full range of benefits once they are in a health plan. . . .

The first place the courts will look, in deciding such a denial of coverage/dropped coverage case, will be the "plain language" of the statute. The next place the courts will look -- if the language is deemed ambiguous (which is what the insurance company lawyers are arguing), will be to seek out legislative intent. On that score, the isurers are likely to lose, given the above -- and given the about two-dozen speeches made by Congressional leaders, this past week, alone.

But just to be certain, a spokesperson for the White House now indicates that the Obama Administration plans to issue regulations setting forth its view that "the term 'pre-existing' applies to both a child’s access to a plan and his or her benefits once he or she is in a plan."

That ought to seal it -- except for that little matter of handing out an Express Pass to Hades to the insurers with the temerity to argue that they ought to be able to wriggle out of a clear intent to regulate/mandate coverage -- under a new federal legal scheme -- to stiff sick children, despite the intent of the legislative branch. Outrageous. Note that the insurers are not arguing the law is unconstitutional -- just that a term of art in arcane insurance industry practice wasn't expressly employed by Congress, to refer to these children.

If this is not the best evidence that reform is desperately needed, I don't know what is. Holy cow.

Fred Hassan's Myopic "Deal Goggles": Back On, At B+L?


The "Heard on the Street" column of The Wall Street Journal ran this, on Friday:

. . . .Bausch & Lomb has its deal goggles back on. Under new leadership, the restructuring eye-care specialist is looking for bolt-on deals priced in the hundreds of millions of dollars to revive its prospects. According to someone familiar with the thinking of new Chairman Fred Hassan and Chief Executive Brent Saunders, deal making is likely to be concentrated in core areas such as lenses and solutions, eye surgery and pharmaceutical treatments for conditions like glaucoma. Nothing like staying focused. . . .

That last bit gets it exactly right -- this is "nothing like" staying focused. If Mr. Hassan follows his recent proclivities, now freed up by the cloak of B+L's private company status -- these "deal goggles" will simply be vehicles to take charges, lay off employees and ultimately bust-up old B+L. I don't think I'll bother to watch -- as I saw this particular rerun, last summer.

Why Was A Saphris® Study -- Complete In 2007 -- Just Now Mentioned?


ClinicalTrials.gov lists this study of Saphris® (asenapine) as completed in December 2007. It is now almost April 2010. The study showed no difference -- over a placebo -- at 52 weeks. It was never published, until this past week, in Munich, apparently. Background here, from Salmon. As you can readily see, no study results are indicated as published, at ClinicalTrials.gov, for this study -- as I type this:

. . . .No Study Results Posted on ClinicalTrials.gov for this Study. . . .

Why is that? And why is it that the report out, in Munich last week, unduly highlighted only three week data (offering the misleading impression that the study turned out favorably, for asenapine), despite the title of the study indicating a "12 weeks, plus 40 weeks" duration? Per Salmon:
. . . .In summary there was an initial study that looked at efficacy at three weeks in patients who were taking Lithium or valproate (possibly relapsed). The responders were then continued to 12 weeks and then 52 weeks (12 + 40). [There was efficacy shown at three weeks, at just the duration for which FDA has approved asenapine. . . .] However, beyond three weeks, it appears there is likely no efficacy. All of this, in spite of the primary endpoint being at three weeks Merck titles the abstract "[Presentation title: Asenapine as Adjunctive Treatment for Bipolar Mania: A Placebo-Controlled 12-Week Study and 40-Week Extension. Abstract PW01-28]". . . .

-- Salmon
March 25, 2010 @ 11:57 AM

Odd.

We should start asking after these questions. Do the press people sitting in Whitehouse Station have answers? The study involved fewer than 170 patients -- how on Earth did it take almost two and one-half years to make public mention of the data?

[ENHANCE much, anyone? Anyone. . . . anyone?]

Saturday, March 27, 2010

The Dénouement Of A Now-Dead Deal: A GTx-Merck Close-Out Sale


Dénouement Alert: GTx had to strike a hard-luck (highly dilutive) deal, once its collaboration with Merck came to an end, according to InVivo Blog's "Deals of the Week" column:

. . . .In need of non-dilutive financing after its selective androgen receptor modulator deal with Merck came to an end three weeks ago, GTx this week revised an existing collaboration with Ipsen. It calls for Ipsen to pay GTx $58 million pegged to Phase III trial milestones for toremifene, which is being tested to reduce fractures in prostate cancer patients receiving androgen deprivation therapy. The money will certainly come in handy, but GTx is paying a heavy price. The Memphis firm will forgo some longer-term payments that Ipsen would have owed had toremifene suceeded, as well as right of first negotiation to the Phase II prostate cancer drug, GTx-758. . . .

[T]oremifene in November garnered a complete response letter from FDA that requested a second Phase III trial to demonstrate efficacy. With just $49 million in the bank and no more money coming from Merck, GTx calculated near-term cash was more important than downstream financial rewards. It's yet another example of the new math being practiced by cash-strapped biotechs. . . .

Indeed. A few weeks back, the then-dying deal was disclosed in a highly-irregular fashion, given its impact on GTx's fortunes (GTx being geometrically smaller than Merck -- yet it appeared, in almost-footnote fashion, in Merck's annual disclosures, long before GTx officially admitted what had happened). Some background on the story here; follow-up story here.

To be clear, this latest Ipsen deal is dilutive to GTx's "intellectual property portfolio equity", not its common share equity, directly. But it will likely be felt there, just the same. Tough market conditions, indeed.

Friday, March 26, 2010

What The Health Care Reform Laws Will ACTUALLY Do -- THIS Year


I don't know about you, but I am bone-weary of the lies being told, and sold, on Fox News about what this law does -- and doesn't -- do. Here's at least some of the the truth -- in a three minute package:



Indeed.

Thursday, March 25, 2010

Saphris®/Asenapine: Did Merck's Researchers "Cherry-Pick" A 3-Week Data Point?


Salmon has provided (in comments, below) an excellent new piece of the asenapine (now branded as Saphris®, by legacy Schering-Plough/New Merck) puzzle. On March 1, 2010, in Munich, Germany, researchers hired by Merck presented some new study results, from an asenapine study designed to measure efficacy at a therapy duration of 12 weeks.

Oddly, the study's PI (or "principal investigator") reported out the data from week 3 (even though the study actually ran for 52 weeks), apparently. Do go read it all (at the link), but here is an interesting snippet:

. . . .Joseph Calabrese, MD, PhD, Mood Disorders Program, Case Western University School of Medicine, Cleveland, Ohio, and colleagues determined the efficacy of asenapine co-treatment with lithium or valproate in a 12-week primary study and a blinded extension study that followed for 40 weeks.

The primary-study endpoint was to evaluate the efficacy, safety, and tolerability of adjunctive asenapine for acute manic or mixed episodes in patients with bipolar disorder who incompletely responded to lithium or valproate monotherapy. The extension study had the same endpoints in addition to determining the maintenance of efficacy of adjunctive asenapine treatment.

The primary study was a randomised, double-blind, placebo-controlled trial wherein patients who had incompletely responded to treatment with a mood stabiliser received sublingual flexible-dose adjunctive asenapine 5 or 10 mg BID (n = 155) or placebo (n = 163). The 40-week blinded extension included 38 patients from the asenapine group and 33 from the placebo group. . . .

The incidence of treatment-emergent adverse events with asenapine and placebo was 73% and 69% in the core study and 78% and 69% in the extension. . . .

Is Salmon right, here (as he so often is) -- is this the use of the classic early effect magnification version of "cherry-picking" a study's results?

Quoth Salmon:
. . . .Plus, at 52 weeks PLACEBO BEAT ASENAPINE.

Now of course the author could have it wrong. Initial 3 week evaluations are more common with acute mania with extensions to 12 and 52 weeks. But if the message is supposed to be that asenapine is useful for extension beyond three weeks then I don't see it. Besides I've discussed other reports of extension studies here before and they also had major problems.

All in all so far everything I've seen so far does argues against any extended use beyond three weeks. . . .

I'll do some more digging -- but I doubt the study is registered at ClinicalTrials.gov. We'll see. Great find, Salmon!

Wednesday, March 24, 2010

Two Three Random Science Developments -- But I Liked 'Em. . . .


The first (video, below) because one of the Mars rovers is now using a newly-installed software pacakge, to "self-navigate, and self-select" destinations, across the Martian surface -- the first extra-planetary vehicle ever to do so:



[When we go "off-topic" for this blog -- we go way off -- ("nothing exceeds, like excess," eh?) -- off the planet, even.]

Next, because I eat a banana a day -- and the last because I'd like to live for 150 years -- the much longer linked article, from which these snippets were culled:
. . . .Banana Lectin an HIV Fighter?

A potent new inhibitor of HIV, derived from bananas, may open the door to new treatments to prevent sexual transmission of HIV, according to a University of Michigan Medical School study.

The interest is centered around lectins, naturally occurring chemicals in plants, because of their ability to halt the chain of reaction that leads to a variety of infections. In laboratory tests, BanLec, the lectin found in bananas, was as potent as two current anti-HIV drugs. Based on the findings published in the March 19, 2010 issue of the Journal of Biological Chemistry, BanLec may become a less expensive new component of applied vaginal microbicides, researchers said.

The new study described the complex actions of lectins and their ability to outsmart the HIV virus. Lectins are sugar-binding proteins that can identify foreign invaders, like a virus, and attach themselves to the pathogen. The U-M team discovered that Ban Lec can inhibit HIV infection by binding to the sugar-rich HIV-1 envelope protein, gp120, and block its entry to the body.

Regeneration Gene Identified

Scientists have identified a gene that may regulate regeneration in mammals. The absence of this single gene, called p21, confers a healing potential in mice long thought to have been lost through evolution and reserved for creatures like flatworms, sponges and some species of salamander.

In a report published in the Proceedings of the National Academy of Sciences, researchers from the Wistar Institute demonstrated that mice lacking the p21 gene gain the ability to regenerate lost or damaged tissue. Unlike typical mammals, which heal wounds by forming a scar, those mice begin by forming a blastema, a structure associated with rapid cell growth and de-differentiation as seen in amphibians.

According to the researchers, the loss of p21 causes the cells of the mice to behave more like embryonic stem cells than adult mammalian cells, and their findings provided evidence to link tissue regeneration to the control of cell division. . . .

Carry-on, folks -- NCAA Sweet Sixteen games to handicap. . . .

NEJM: New Study Results -- Of Fosamax®, and Fracture Risks


UPDATED: 03.24.10 @ 8:40 pm EDT -- The New York Times is just out with a story on the below, and it's a good one. Do go read it, for more background.

Because the study was conducted, in part, by employees of Merck (and funded in part by it, as well), the maker of Fosamax® (and funded by other makers of these osteoporosis drugs), we should look very carefully at the power claimed, for the conclusions offered. However, I think the independent editor writing for the New England Journal of Medicine may safely be trusted when she intones, thus:

. . . .This new report has important strengths. The investigators evaluated studies that were randomized and placebo-controlled, involving 14,195 women and 55,000 person-years of observation. The degree of exposure to bisphosphonates is known, providing a denominator that was lacking in previous reports. The alendronate extension data that compared 5 years and 10 years of alendronate use provide some reassurance regarding reported associations between subtrochanteric or diaphyseal fracture and long-term bisphosphonate treatment.

However, several important limitations in the study by Black, et al., diminish our ability to draw definitive conclusions. In most cases, radiographs were not available to evaluate features of atypia. Only a minority of women received more than 3 to 4 years of bisphosphonate treatment, and some received a lower dose of alendronate (5 mg) than is commonly prescribed. Most important, as the authors acknowledge, because of the rarity of atypical femoral fractures, the study's statistical power was extremely low, which underscores the difficulty in detecting rare complications, even in very large clinical trials. The experience with bisphosphonates highlights the importance of postmarketing surveillance studies to detect the emergence of rare side effects of drugs that are widely used for very common chronic diseases. . . .

Although detailed recommendations are beyond the scope of this editorial, it is reasonable to consider drug holidays with careful observation for most patients with osteoporosis who are receiving long-term therapy, particularly those whose bone-turnover markers indicate substantially reduced levels. However, we must also balance evidence of persistent antifracture efficacy after discontinuation with data showing that the use of alendronate for 10 years, as compared with 5 years, was associated with significantly fewer new vertebral fractures and nonvertebral fractures in patients with a bone mineral density T score of –2.5 or below.

Because subtrochanteric fractures are so rare, many questions remain unanswered. Research is needed to address the true incidence of such fractures, the pathogenetic importance of bisphosphonate use and other risk factors, the detection of incipient fractures, and appropriate medical and surgical management. . . .

As ever, more to come -- the FDA is likewise undertaking a review, the results of which may be available by late June 2010.

PegIntron® Challenger Zalbin® Advances In Trials


Per Reuters' reporting, this morning -- HGSI's next generation of Hep C treatments, ones that will compete with legacy Schering-Plough's PegIntron® product -- have shown promise in mid-stage trials:

. . . .Human Genome Sciences Inc said interim data from a mid-stage study testing a monthly-dosing version of its experimental hepatitis C treatment, Zalbin®, showed the drug's efficacy was comparable with the current standard of care.

Human Genome and its partner Novartis AG have already submitted an application to the U.S. health regulators for a version of Zalbin dosed every two weeks and received a review date of October 4, 2010. . . .

The two current leading interferons, Pegasys and Merck's Pegintron are taken intravenously [sic; Ed. Note (per comment below) -- in fact, these medicines are self-injected, not "dripped" by IV bag] once a week for up to 48 weeks in combination with the antiviral pill ribavirin, while Zalbin is injected [only once] every two weeks.

Human Genome shares were up 1 percent to $32.55 in premerket trade. They had closed at $32.10 Tuesday on NASDAQ. . . .

Interesting.

Merck's Januvia®: Just Approved in China, But How Much Is That Worth?


I am not sure that most diabetic patients in China will be able to afford the likely price point, in country (or more precisely, that the Chinese government will be able/willing to reimburse at an acceptable price), for Januvia®, and there remains the concern about elevated risk of pancreatitis -- but this is still good news for Merck, on balance:

. . . .Januvia (sitagliptin), a new oral diabetes drug, has been approved by China's State Food and Drug Administration (SFDA) for distribution in the Chinese market. . . .

China has about 41 million diabetics, mostly Type 2 - second only to India - struggling to get their blood sugar under control. More than 70 percent of China's diabetics fail to achieve normal blood glucose levels through existing oral medications.

Pan notes that many patients are unable to stick with their treatment of either oral medications or insulin therapy, in part because the drugs cause hypoglycemia, stomach problems and weight gain. . . .

We'll see if it moves global Januvia sales figures (translated back into US dollar volumes) much -- on the Q2 2010 conference call.

Tuesday, March 23, 2010

The Truth Has Been Spoken -- To Power: Reform Is The Law Of The Land


As I type this, the President is signing the Senate/House version of the Reform bill, proper. [The Senate is debating the "fixes" this afternoon, but they too will pass shortly, and the President will sign them.]

He's just said that he is doing so, to remember his mother (who fought insurance companies to try to get treatment for the cancer that finally took her life), for Ted Kennedy, for Ryan Smith (a small business owner), for 11-year old Marcellus Owens (who lost his mom to an illness -- because she couldn't keep her job, and thus lost her health care insurance -- all due to the illness), and hundreds and hundreds of others. . . .

By the way, any Republican claim that this package is unconstitutional is burdened, then, with proving that the federal income tax is. . . likewise unconstitutional.

That's right, the GOP has been reduced to agreeing with the "nut-job" tax protesters who have lost. . . and lost. . . and lost, in their claims that the federal government does not possess the power to tax the people. It is simply an untenable position. The provisions complained of are tax provisions, not takings provisions -- plain and simple.

This hopeless GOP obstruction (filing of dubious lawsuits) is also a[nother] waste of tax-payers' money -- to pursue that specious argument in the courts.

[LIVE VIDEO, now, here -- on C-SPAN.org.]

Now, we speak truth. And we speak power. We now open a new era -- an era of a fairer America.

AdWeek: IPG Wins Merck's $600 Million/Year Ad Account


Here's the AdWeek story -- but I have to believe Merck will be looking to reduce the overall spend, wringing some "synergy value" out of the now-combined New Merck-Legacy Schering-Plough current level of annual spending:

. . . .Merck has awarded media planning and buying duties on its nearly $600 million advertising account to a team of Interpublic Group agencies led by Initiative and Draftfcb following a review, according to sources. . . .

This is a follow-up to the original story I posted in February. So at this spend level, it is about $1,100 per minute, 24 hours a day, seven days a week, 52 weeks a year. Wow -- another $1,100 in the time it took me to type that sentence.

March MAD-ness -- CNBC Has A Stock-Tourney -- By .Txts, and Tweets(!)


The would-be stock-pickers over at CNBC are conducting an NCAA-sytle "Sweet Sixteen" of stock picking (well, not even close, actually). Silly, I know. Especially since the first round bracket pitted a pharma against. . . a chain of burger restaurants. But, underdog Mickey-Dees just "upset" No. 3 Ranked Merck, thus:

. . . .McDonalds (14) beat Merck (3) in a blowout with 76% of the vote favoring Mickey D. . . .

How will it play out? You decide. Text the word MADNESS to 26221 to start playing (message and data rates may apply). . . .

Okay. I admit it. I am apparently way, way short on actually newsworthy material this morning. I do apologize. Something better, very soon.

Monday, March 22, 2010

Ex-Schering-Plough General Counsel -- To United Airlines' HoldCo.


Amazing. His first day on the job is next Monday, March 29, 2010.

There is little more to say. I'll update this item, with his compensation, and full employment agreement, when it is available, via an SEC Form 8-K filing:

. . . .Chicago, March 22, 2010 (Business Wire) -- UAL Corporation, the holding company whose primary subsidiary is United Airlines, today named Thomas J. Sabatino Jr. senior vice president, general counsel and corporate secretary.

Sabatino joins United from Schering Plough where he served as executive vice president and general counsel, and oversaw the company's global law department. . . .

I am put in mind of at least a thousand jokes. I'll offer. . . none of them.

All 5.5 Million Pages Of Merck Documents -- In the Plaintiffs' Hands, Now




Starting today, March 22, 2010, the plaintiffs' lawyers will also see the so-called "privilege logs" -- the listing of all documents held-back, on a claim of attorney client privilege. Those will come on a rolling basis -- but the pages held back from the first 1.1 million pages -- will arrive at the plaintiffs' lawyers offices, this evening.

That is often more important that the pages delivered -- as the log indicates what the document is, what its subject matter is, and why it is exempt from discovery. More background on these consolidated Vytorin/ENHANCE federal cases, here.

[Click each image, above and below, to "biggify". Or, just go read the whole three page letter (as a PDF file).]


. . . .A journey of 1,000 miles begins with the first step. . . .

President Obama -- On US House Passage Of Reform


Webstreaming video -- from very late last night (early this morning, actually):


A snippet:
. . . .Most importantly, today’s vote answers the prayers of every American who has hoped deeply for something to be done about a health care system that works for insurance companies, but not for ordinary people. For most Americans, this debate has never been about abstractions, the fight between right and left, Republican and Democrat -- it’s always been about something far more personal. It’s about every American who knows the shock of opening an envelope to see that their premiums just shot up again when times are already tough enough. It’s about every parent who knows the desperation of trying to cover a child with a chronic illness only to be told “no” again and again and again. It’s about every small business owner forced to choose between insuring employees and staying open for business. They are why we committed ourselves to this cause.

Tonight’s vote is not a victory for any one party -- it's a victory for them. It's a victory for the American people. And it's a victory for common sense. . . .

In the end, what this day represents is another stone firmly laid in the foundation of the American Dream. Tonight, we answered the call of history as so many generations of Americans have before us. When faced with crisis, we did not shrink from our challenge -- we overcame it. We did not avoid our responsibility -- we embraced it. We did not fear our future -- we shaped it. . . .

Sunday, March 21, 2010

ONE PM, EDT, March 21, 2010 -- US House: What's Next?




After midnight on Saturday night, the House Rules Committee finished its work -- there will be debate tomorrow, and likely two votes, up or down -- both on the House floor. One vote will be on the Senate version of the package; the other on "reconciliation" measures, to amend the Senate version, to harmonize it with the House's current thinking -- and thus send it back to the Senate, where the Senate is poised to adopt the changes in reconciliation. It is likely the President will sign the original House-Senate version, probably even before the reconciliation bill is finished in the Senate, on Monday or Tuesday.

The New York Times' Prescriptions blog, has the run-down:
. . . .Under the rule approved by the committee shortly before midnight, the House will spend two hours debating both the Senate health bill and a budget reconciliation measure that includes revisions to the Senate bill.

Once that debate is completed, the House will vote on the Senate bill — a step that some Democrats have been reluctant to take because they dislike aspects of the Senate bill and will not support it without changes.

If the Senate bill is approved, the House would then vote on the budget reconciliation measure. The terms of debate restrict the ability of Republicans to derail the legislation, but there are still a number of parliamentary weapons at their disposal and they have vowed to use all of them.

The committee did give Democrats an escape hatch, allowing for the proceedings to be postponed at the discretion of the speaker. . . .

C-SPAN will cover it all, beginning at 1 pm, EDT -- streaming video, right here. I may live-blog it, depending on my other commitments. The below image will show "Live" -- if I am going to do so, tomorrow. G'night.

UPDATE -- 03.21.10 @ Noon:




Δ 11:47 pm EDT -- US Health Care Reform package draws 219 "Aye" votes -- it passes; Reconciliation package draws 220 "Ayes" -- it passes. On to the Senate. The President of the United States will be televised, speaking on this topic, in about 20 minutes' time. G'night -- I'll watch that video, tomorrow. Well-played, indeed.

Δ 4:07 pm EDT -- Rep. Stupak speaking now -- on C-SPAN.org -- And in view of the agreed Executive Order, Rep. Stupak WILL VOTE IN FAVOR OF THE PACKAGE.

Δ 3:51 pm EDT -- Rep. Stupak will hold a C-SPAN press conference at 4 pm today. No need to do that, unless he is going to support it. If he were going to oppose it, he would need to be on the floor of the House. He won't be. Game over. It passes.

Δ 12:45 pm EDT -- Rep. Stupak has switched -- "Yes" according to MSNBC, per C-SPAN feed.

Δ 12:17 pm EDT -- Rep. Kaptur has switched into the "Yes" column. Ms. Kaptur had been concerned that the legislation did not contain sufficient restrictions on the use of federal money for insurance coverage of abortions, but had been negotiating with the White House about a potential executive order to clarify federal policy.

Her switch to the “yes” column suggests that Democrats are on the brink of securing the 216 votes that will be needed to pass the health care legislation. . . .



Saturday, March 20, 2010

Reprinted WaPo Article -- US Atty. Loucks' Reform Endorsement -- To Continue Prosecuting Pharma Fraud


UPDATE 03.21.10: PharmaConduct also has a piece along these lines -- do go read it.

Tomorrow's Washington Post will run a slightly updated version of an award-winning story on the ways in which some executives -- even the very largest pharmaceutical behemoths on the planet -- still commit fraud. They do it by minimizing risks of side-effects, and pushing doctors to use a drug for unapproved purposes -- all to amp sales. If only required to pay out, say 10 percent of the amount they rake in -- in criminal and civil fines. . . they will keep doing it.

I simply must point out (once again, for the sake of making sure all the names are named, here!) that, according to multiple now public record documents -- mostly discovered in the ensuing investigations, Ex-CEO Fred Hassan, and his lieutenant, Carrie S. Cox -- were deeply involved in the launch planning -- and marketing strategies -- for Bextra®, while they ran Pharmacia & Upjohn, from early 2000 through 2003.

Do go read it all, but here's a snippet, from page 5 of the story:

. . . .Pfizer bought Pharmacia & Upjohn in April 2003. From 2001 through 2003, P&U, first as an independent company and then as a unit of Pfizer, paid doctors more than $5 million in cash to lure them to resorts, where salespeople illegally pitched off-label uses for Bextra, P&U admitted.

In her guilty plea, Holloway said her team had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn't mention the increased risk of heart attacks in their marketing.
They told doctors that side effects were no worse than those of a sugar pill, Holloway said.

In 2003, Holloway reported her unit's off-label promotions of Bextra up the corporate ladder at Pfizer, according to a presentencing memo to the judge written by Robert Ullmann, Holloway's attorney. Top managers didn't attempt to halt the illegal conduct, the memo said. . . .

On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra -- a drug approved only for the relief of arthritis and menstrual discomfort -- for treatment of acute pain of all kinds.

For this new felony, Pfizer paid the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the United States and 49 states.

"At the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct in 2004, Pfizer was itself in its other operations violating those very same laws," Loucks, 54, says. "They've repeatedly marketed drugs for things they knew they couldn't demonstrate efficacy for. That's clearly criminal."

The penalties Pfizer paid for promoting Bextra off-label were the latest chapter in the drug's benighted history. The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005. . . .

Indeed. This is another powerful reason to get behind the reform bill. [Here is the earlier piece I wrote on Mr. Loucks' appeal to pass health care reform -- and to continue funding of the US Attorneys' taskforces on health care fraud.] A sincere Hat Tip to Jack (the "Insider") Friday -- at PharmaGossip.

President Obama At George Mason, Yesterday -- Vote Tomorrow: Turning Point Arrives


Without any additional ado, the President (see full video-stream here, or just click the play button below), speaking at George Mason University, yesterday:

. . . .AUDIENCE: Yes we can! Yes we can! Yes we can! Yes we can!

PRESIDENT OBAMA: Thank you, everybody. It’s good to be back with some real Patriots. I want to thank Dr. Alan Merten, the President of George Mason University, and his family. Dr. Shirley Travis, who’s here -- thank you. And Coach Larranaga, we were just talking a little bit about -- (Applause) -- looking forward to picking George Mason in my bracket next year. . . .

Okay. . . . here’s what I do know. I do know that this bill, this legislation, is going to be enormously important for America’s future. I do know the impact it will have on the millions of Americans who need our help, and the millions more who may not need help right now but a year from now or five years from now or 10 years from now, if they have some bad luck; if, heaven forbid, they get sick; if they’ve got a preexisting condition; if their child has a preexisting condition; if they lose their job; if they want to start a company -- I know the impact it will have on them. . . .



And in just a few days, a century-long struggle will culminate in a historic vote. We’ve had historic votes before. We had a historic vote to put Social Security in place to make sure that our elderly did not live out their golden years in poverty. We had a historic vote in civil rights to make sure that everybody was equal under the law. As messy as this process is, as frustrating as this process is, as ugly as this process can be, when we have faced such decisions in our past, this nation, time and time again, has chosen to extend its promise to more of its people. . . .

You know, the naysayers said that Social Security would lead to socialism. (Laughter.) But the men and women of Congress stood fast and created that program that lifted millions out of poverty.

There were cynics that warned that Medicare would lead to a government takeover of our entire health care system, and that it didn’t have much support in the polls. But Democrats and Republicans refused to back down, and they made sure that our seniors had the health care that they needed and could have some basic peace of mind.

So previous generations, those who came before us, made the decision that our seniors and our poor, through Medicaid, should not be forced to go without health care just because they couldn’t afford it. Today it falls to this generation to decide whether we will make that same promise to hardworking middle-class families and small businesses all across America, and to young Americans like yourselves who are just starting out. . . .

We must not delay. We must act now for 33 million fellow Americans.

Friday, March 19, 2010

Salmon Rises (Again!) -- On Merck's Zocor® "Muscle-Pain-to-Renal-Failure" Continuim


This story comes to us (do go read it all) from the ever-vigilant Salmon, via our comment box, below:

. . . .There's a story in today's Los Angeles Times regarding rhabdomyolysis and renal failure with high doses of Zocor® and higher risk in those of Chinese descent.

This is consistent with what I have been saying here and elsewhere for a long time.

Many lethal drug reactions are due to issues related to drug metabolites or drug metabolism.

Increased risk for some of these reactions can be predicted by knowledge of drug metabolism and in some cases pharmacogenetics.

Knowledge of an individual's pharmacogenetics is not necessary for communicating risk information. Instead knowledge of the individual's ethnic background is often sufficient to indicate a higher probability of risk.

Companies and the FDA have known of this for years (in some cases nearly 20 years) and have been remiss in not including such information in labeling.

Failure to include such information in labeling in my opinion means the drug is misbranded.

-- Salmon

March 19, 2010 @ 2:06 PM. . . .

Indeed. However (post 2008), it is the rather unusual patient who ends up on such a high dose of statins, that this becomes a truly-vexing issue -- excepting of course, where genetic factors (as Salmon mentions) elevate the cholesterol markedly, and ethnic (again, other genetic) factors then magnify the statin-risk presented. All of that said, one-sixth of the planet faces the genetic marker problem, as Merck seeks to expand beyond the US and Western Europe, with Zocor.

For some learned background on just how little we really know about all of this, take a look here.

Good stuff, Salmon!

NPR Wins Scripps Howard Award -- For Its "Deep Dive" -- On Merck's Fosamax®


As I indicated right before Christmas 2009, the NPR business journalists who looked into the way Merck marketed Fosamax® did a superb job of demystifying the complicated science surrounding the controversy.

Such an outstanding job, in fact, that the prestigious Scripps Howard Foundation has just this morning bestowed the Jack R. Howard Award upon Alix Spiegel, the NPR radio journalist who put it all together (snippet from businessjournalism.org):

. . . .This is the story of how pills for osteopenia ended up in [Katie] Benghauser’s medicine cabinet, and in the medicine cabinets of millions of women like her all over the United States. But more broadly, it’s the story of how the definition of what constitutes a disease evolves, and the role that drug companies can play in that evolution. . . .

As noted in the story, Merck pushed to create a machine that would allow more doctors’ offices to scan bones [in order to sell more Fosamax, to women who might only marginally be candidates to take the powerful drug]. . . .

Quite-so. Well-done.

Thursday, March 18, 2010

Green Light From CBO; Pay/Delay Measure In A Later Sidecar Bill


BREAKING -- a vote could come by Sunday, March 21, 2010 -- (via the New York Times early story) more soon:

. . . .Democrats' new health care reform bill is estimated to cost $940 billion over the next decade without adding to the deficit, sources said.

Sources said the estimates show the updated bill would save $130 billion over the first 10 years and save $1.2 trillion over the second decade. . . .

Ed Silverman, over at Pharmalot, points out that Sen. Herb Kohl has let it be known that the strongest version of a measure to curtail "Pay For Delay" deals has been moved to a sidecar process, as it did not quite as clearly meet the CBO numbers crunchers' formulae.

This means any bill curtailing "pay for delay" deals will itself be. . . um, delayed -- probably into late 2010, or early 2011. Disappointing for US consumers, but yet another tough compromise needed to get overall reform package through expeditiously.

The sidecar bill will ultimately pass, though. There will be just too great a populist (and righteous) groundswell to avoid doing this, any longer -- these anti-competitive deals to stretch the delay of generics, as replacements for branded drugs -- cost millions of limited income US seniors something like $30 billion, every year. That is essentially a wealth transfer, from all of us, as US taxpayers, to big pharma, as more than half of the actual payment from limited income US seniors comes through Medicare -- which we all, collectively, fund with federal budgetary allocations.