Thursday, July 31, 2008

Wall St. J.: FDA on SEAS Cancer concerns for Vytorin -- Rep. Dingell's Latest Letter to FDA


More in a tick, but the Wall Street Journal is moving an important update on the two Congressional Committees investigating Schering's Vytorin, generally, and now, the SEAS study -- rather specifically -- and pointedly. Do go read it.

It seems Chairman Dingell and Chairman Stupak want Dr. (Sir) Richard Peto's work -- now in FDA hands, but not available to the public -- regarding his analysis of the cancer incidence data in SEAS. Some, including Dr. Harlan Krumholz, have wondered about the conclusions reached thus far largely dismissing the cancer incidence data seen in SEAS -- at least, insofar as the public documents are -- at the moment -- not complete enough to reach the conclusions mentioned by Dr. Peto, with adequate certainty, where something as momentous as a potentially-elevated risk of cancer is suspected.

All of this means FDA will need to turn over all of Schering's Vytorin/SEAS documents that mention the cancer incidence data -- in under two weeks' time. There is no doubt that these Committees have jurisdiction over FDA, in this matter. Take a look -- as ever, click it to enlarge:



Quoth the Journal:

. . . .A report called the SEAS study stunned investors and the medical community in late July, because researchers looking at Vytorin's efficacy in reducing cholesterol had unexpectedly found an increased risk of cancer and deaths from cancer in patients taking Vytorin, compared with those given a placebo.

Vytorin is made by a joint venture of Merck & Co. and Schering-Plough Inc. The companies delayed their earnings announcement on July 22 to inform investors about the SEAS findings. . . .

It seems all those people in the blogosphere, rightly complaining about the incomplete -- and thus potentially confusing -- disclosures of only selected SEAS study papers have found a friendly ear -- and so, it seems, we will all soon see most of those documents, right here.

Tuesday, July 29, 2008

EU Approval of Bridion® (sugammadex) -- about 2.4 cents ONE PENNY per share of 2008 EPS -- in the "Very Best" Case.


~~~~~~~~~~~
U P D A T E D
08.01.08 @ 8 AM EDT:

~~~~~~~~~~~


FDA declares the drug "non-approvable". Ouch! So much for that $600 million. Said another way, the about 2.4 cents I posited below in 2008 Schering EPS, just became about one single little penny, in added EPS -- for the foreseeable future at Schering. How much has been spent, thus far, to garner that one shiny penny? I dunno. Yikes.

~~~~~~~~~~~


This afternoon, Schering announced that it had received EU approval for sugammadex, its new anesthesia drug. That is good news for the besmirched pharma-company. It just won't amount to much, any time soon, in my analysis. Here is something I just wrote, albeit for another purpose. I'll clean it up a little, later -- but you'll get the gist of it, right now:

The fact is today's EU approval of Bridion®, or sugammadex, won't be enough -- enough to cover the 2008 hole Vytorin has created.

Last year, in June of 2007, pre-acquisition Organon had this to say -- putting its very best face on sugammadex's market potential (press release), to lure Schering to pay-up, on acquisition:
". . . .Organon said the global market for the drug is estimated at 400 million euros ($537 million) and could be higher. . . ."

So, Global sales of let's call it $600 million (we see a weaker dollar now) -- and, let's say it has a 30 percent margin (probably a little too generous, but so what?), then its gross WORLDWIDE contribution to pre-tax earnings (and ultimately, after-tax EPS) will be around $180 million.

But wait! -- suggamadex is not approved in the United States -- and may not be, until 2009 (if one reads the FDA tea-leaves carefully), so. . . .

Let us also assume that Europe will be about 30 percent of the gobal market (again, very generously!) -- then the gross contribution of sugmamadex will be around $54 million, max, in 2008.

Spread that $54 million over 1.637 billion common shares outstanding (last SEC Form 10-Q), and the pretax EPS is 3.3 cents a share -- after tax (assuming a 28 percent tax rate) it would be. . . .

2.4 cents per share of 2008 EPS -- the 2008 Vytorin "hole in earnings" or EPS, is something like 42 cents a share of 2008 EPS (doing the math, here, from Merck's Q1 2008 projection of $700 million of Equity Income fall-off due "solely" to the Cholesterol Joint Venture's mishaps).

So, my best guess is that sugammadex (while a nice little pick-up) will not really matter -- it won't "move the needle much" even when the US approval ultimately comes -- it won't be nearly enough to "right the good ship Schering-Plough". QED.

~~~~~~~~~~~~~
U P D A T E D
07.30.08 AM
~~~~~~~~~~~~~


Financial Analysis/Math is an acquired skill-set, folks. At a 12 times Schering-Plough P/E Multiple, then, that 2.5 cents yields 25 cents in share price increase (today's open) -- but then we must net that, against over $4.80 ($0.42 times a P/E Multiple of 12) "in the hole" [mostly owing to the uncertainties -- still to come], due to ENHANCE-Vytorin fallout. And this stock skids sideways, rather than climbs (like now). But what do I know?

Officials of Suffolk County, New York Allege Schering-Plough Committed "Indictable" Acts Under RICO -- Newly-filed Civil Suit


[UPDATED -- 07.29.08 4 PM EDT: Ed, over at Pharmalot, has featured this post! Cool!

11 PM EDT: Dr. Peter Rost has also linked, and featured the graphics from this one. Perfect! Thanks!

Later, Still: The Insider, across the pond, at PharmaGossip has linked this one, as well! Geez -- I guess that's a trifecta, of sorts!

07.31.08 AM-- Chris Truelove, at the Pharma Blog Review has run a teaser on this story, at the end of his, this week. Cool.

07.31.08 PM-- Adventures in Autism has captioned her link, to mine the "Merck Mafia(!?)" -- Ouch!]

The county government of Suffolk County, New York has filed a new civil suit against Schering-Plough (and the Joint Venture, and Merck, among others), overnight, in the federal district courts sitting in Newark, New Jersey. It makes some Consumer Protection Act/False Advertising allegations, but it also takes important new strides in alleging RICO pattern activity -- calling Schering's and Merck's conduct here "indictable".

"Now, that's gonna' leave a mark!" Take a look -- click to enlarge -- see the yellow bubble, and the red underlining, here on page 25 of the complaint:



Suffolk County, New York -- a governmental entity, now -- is alleging that Schering has engaged in what it sees as indictable predicate acts, under the RICO statutes.

There are already other RICO putative class action cases pending against Schering-Plough and Merck, but this is quite significant, in my experienced-estimation -- as at a minimum, it represents a new level of gravitas in the ENHANCE litigation malestrom now beseiging Schering-Plough and its executive leadership: a local-governmental agency is now effectively swearing that Schering has committed "RICO-indictable pattern racketeering" -- in (allegedly) concealing the ENHANCE results for almost two years -- while the good people of Suffolk County, New York were forced to pay greatly-inflated prices for a drug that was no more effective than those much cheaper statins.

For those keeping score at home, the suit is captioned Suffolk County, NY v. Merck Schering-Plough, et al., (Case No. 08-3711, Complaint filed July 28, 2008, DCM-MF, U.S. Dist. Ct., NJ).

I'll keep an eye on this one, for the readership. You may count on it.

Monday, July 28, 2008

Of Rough SEAS -- And McLuhan's "You know nothing of my work. . . ." scene


[UPDATED -- 07.29.08 @ Noon EDT: The Insider, over at PharmaGossip, has named this blog (presumably, on the strength of the below-post), a "hot blog"! Cool!]

This feels a little like the scene in the movie "Annie Hall" -- where Woody Allen pulls Marshall McLuhan, almost bodily, from behind a cut-out [A Real-audio stream of that moment!], to suggest that a near-by bloviating know-it-all, in the ticket-line at the movies -- really. . . . doesn't -- Ahh, but "What the heck?", here goes:



Slide it forward, to the 2:05 mark in the clip! He~He!


You'll need to read my post quoting Dr. Harlan Krumholz (the noted-cardiovascular authority, of Yale University Medical School), of this past-Friday, for this to make the most sense -- but on those SEAS-related cancer incidence observations, the following took place, in the comment-box connected to that post, over the weekend. I think it deserves a much wider audience -- so I re-print it now, as its own post.
Anonymous said...

Krumholtz [sic], although respected and distinguished does not reflect the entire population of opinion. He and Nissen have always been critical of more than just Vytorin and Zetia. There are many who listen to them and do the opposite, for they have created their own political storm for themselves. For Balance, refer to Thomas Dayspring who says the news is FANTASTIC. (HE SUPPLIED HIS OWN EMPHASIS.) His newsletter, Lipidaholics is up to date and his credentials are as good if not better than Krumholtz [sic].

Remember, this population has no Tx except surgery so a Tx that offers 22% decline in events is not a bad thing. Whether the decline is due to the statin or to zetia is a good question but does not change the usefulness of this new information. The cancer incidence has been dealt with quite nicely by the experts from Oxford so I am not concerned and believe it to be unrelated to the Vytorin.

Be careful to take a completely negative opinion of SEAS. Take it in context with all other studies and advance your knowledge, not limit it. This will result in better Tx for pts and a better discussion.

July 26, 2008 4:35 PM


~~~~~~~~~~~~~~~

Harlan Krumholz said...

I appreciate being called respected and accomplished -- I do not know Dayspring and whether he is a speaker and consultant for the companies, but I take your word that he is a good source. The people in London were also the stars of the medical world and they discounted the risk. There is controversy and people of substance on different sides of this discussion. From my perspective SEAS provided no evidence to support ezetimibe (the study was negative -- but statin trials of AS have also been -- it did have a 22% reduction in risk but that is not more than what we would have expected from simva alone -- but that is an indirect comparison -- so all we can say is no supportive evidence) -- and then a question of a cancer risk -- that was strong in SEAS but unexpected -- and then there also exists an excess risk for cancer death in IMPROVE-IT/SHARP (the P value is somewhere around 0.05 and whether it is above or below may depend on what analysis you do -- but essentially it is close to 0.05). Now there is other info that would lead one to doubt the association -- but, in my opinion, it is hard to dismiss it completely. The findings from these studies would seem to reinforce the message that people should be on statins if they can take them and get to target. And for people who cannot, many will consider ezetimibe as an option but patients and doctors should know that the safety and effectiveness has not yet been established in clinical trials.

SEAS has raised a safety issue -- many are uncertain about it, were surprised by it, and have some concern about it (that is, we do not believe the evidence from IMPROVE-IT/SHARP can dismiss it). We hope it is not a true adverse effect as 3 million people worldwide are reportedly on the drug. But patients should be aware that the issue will not be settled until more data become available.

July 26, 2008 5:47 PM


~~~~~~~~~~~~~~~

Anonymous said...

Thomas Dayspring, MD, F.A.C.P. has disclosed that he is on the Speaker's Bureau for Astra Zeneca, Reliant, Abbott, Merck, Schering Plough and Sanofi-Aventis and is a consultant for Abbott and Reliant.

July 26, 2008 6:08 PM

~~~~~~~~~~~~~~~

Marilyn said...

Great article by Matt Herper on differences between statins and ezetimibe.

July 27, 2008 7:40 AM


~~~~~~~~~~~~~~~

Anonymous said...

The webcast of the SEAS trial can be viewed at clients.mediaondemand.net/Pederson with Tedje Pederson, chairman of the SEAS study, Sir Richard Peto and Rory Collins from Oxford, Eugene Brown from Harvard, Robert Califf - Duke University.

An additional worthwhile review can be seen at the National Lipid Association - www.lipid.org where ENHANCE is reviewed in a virtual roundtable discussion, "An Examination of the ENHANCE Trial - proceedings of an expert roundtable discussion webcast" www.lipid.org/news/lipid_insight_enhance.pdf

July 27, 2008 8:04 AM


~~~~~~~~~~~~~~~

On ENHANCE:

On theheart.org, you can see "Surrogate End Points on Trial: ENHANCE and Other Controversies"

Also, on MedPage Today:

Researchers Debate Ezetimibe/Simvastatin (Vytorin) ENHANCE Trial, Parts 1, 2 and 3:








Indeed. Do follow the links.

Friday, July 25, 2008

The more-rigorous reviews of SEAS are beginning to appear. . . .


And, the ever-on-point PM, over at Gooznews, has done a stellar job of synthesizing them -- do go read that one, top-to-bottom, but here is one money quote:

. . . ."This drug [Vytorin] does not have sufficient evidence for it to be used as a front-line agent," [Dr. Harlan Krumholz, of Yale University Medical School] said. "Statins are the drugs of choice. The evidence is not even strong enough to say that people who cannot tolerate statins should go on it. It is an option. Right now using it is based on an assumption that you know what IMPROVE-IT will find. . . ."

[Emphasis supplied.]

Gooz, himself, had written on the cancer concerns, driven by the SEAS data release, earlier in the week. Do go read it, as well.

UPDATED -- 07.26.08 @ 10 AM EDT: Ed, at Pharmalot, has also put up a similar review -- with additional, exclusive Krumholz quotes.

Also a very worthy read on the topic.

Three Two smallish Schering-Plough litigation scheduling updates. . . .


First, the most important of the three two -- in Cain v. Hassan, et al., the putative shareholders' derivative suit, the newly-extended due date for motions in response to Schering's motion to dismiss the action is September 22 2, 2008 -- by agreement of the parties. Defendants' replies will then be due by October 15, 2008.

Second, but falling earlier on the calendar -- for those keep score at home -- is in the Clarinex® patent litigation, captioned In Re Descloratadine Patent Litigation (litigation in which Schering is the plaintiff), Orchid Pharmaceuticals' (the Defendant's) written answers, or other responsive pleadings -- to Schering's Complaint, will now be due -- on August 6, 2008 -- again, by agreement of the parties.

Finally, in the putative Securities Class Action -- Schering-Plough ENHANCE Litigation, Mason v. Schering-Plough, et al., (Case No. 08-397) the Lead Plaintiffs now have until September 15, 2008 to file an amended, Consolidated Complaint -- yes, again, by agreement of the parties.

Each of these matters is now pending in the federal district courts in Newark, New Jersey.

Dechert LLP's Philly office: A Very-Active Reader. . . .


Not a huge surprise, but perhaps the specific path is of interest -- the visit spans over six hours -- just on this one detour. Dechert, of course, represents Schering-Plough in several of the pieces of litigation that have emerged from the ENHANCE fiasco. Most recently, Dechert lost a motion to stay the Plaintiffs' discovery efforts -- in the ENHANCE/Vytorin Marketing, Sales Practices and Product Liability litigation. Might the below-visit be in preparation for defending these early, and accelerating, discovery efforts? I don't know.

There have been hundreds of others from Dechert computers. So this is but one recent example:

204.155.226.2 (Dechert LLP) [Label IP Address]

Pennsylvania, Philadelphia, United States

24th July 2008 09:53:55 AM www.fiercepharma.com/story/vytorin-news-buried-in-merck-report/2008-04-22

shearlingsplowed.blogspot.com/2008/04/new-civil-rico-suit-alleging-stein-e.html

24th July 2008 09:54:39 AM shearlingsplowed.blogspot.com/2008/04/new-civil-rico-suit-alleging-stein-e.html

shearlingsplowed.blogspot.com/2008/04/independent-enhance-panel-md-this.html

24th July 2008 09:55:25 AM shearlingsplowed.blogspot.com/2008/04/independent-enhance-panel-md-this.html

shearlingsplowed.blogspot.com/2008/04/vast-majority-of-schering-employees-are.html



24th July 2008 09:56:37 AM shearlingsplowed.blogspot.com/2008/04/independent-enhance-panel-md-this.html



shearlingsplowed.blogspot.com/2008/04/vast-majority-of-schering-employees-are.html

24th July 2008 09:57:17 AM shearlingsplowed.blogspot.com/2008/04/new-civil-rico-suit-alleging-stein-e.html



shearlingsplowed.blogspot.com/2008/04/independent-enhance-panel-md-this.html

24th July 2008 09:58:36 AM shearlingsplowed.blogspot.com/2008/04/new-civil-rico-suit-alleging-stein-e.html

shearlingsplowed.blogspot.com/2008/04/independent-enhance-panel-md-this.html

24th July 2008 09:58:43 AM shearlingsplowed.blogspot.com/2008/04/new-civil-rico-suit-alleging-stein-e.html

shearlingsplowed.blogspot.com/2008/04/independent-enhance-panel-md-this.html

24th July 2008 09:58:45 AM www.fiercepharma.com/story/vytorin-news-buried-in-merck-report/2008-04-22

shearlingsplowed.blogspot.com/2008/04/new-civil-rico-suit-alleging-stein-e.html

24th July 2008 09:59:25 AM www.fiercepharma.com/story/vytorin-news-buried-in-merck-report/2008-04-22

shearlingsplowed.blogspot.com/2008/04/new-civil-rico-suit-alleging-stein-e.html

24th July 2008 03:11:51 PM No referring link

shearlingsplowed.blogspot.com/2008/07/seas-comical-farce-in-three-acts.html

24th July 2008 03:11:53 PM No referring link

shearlingsplowed.blogspot.com/2008/07/seas-comical-farce-in-three-acts.html

24th July 2008 03:11:59 PM No referring link

shearlingsplowed.blogspot.com/2008/07/seas-comical-farce-in-three-acts.html

24th July 2008 08:02:50 PM No referring link

shearlingsplowed.blogspot.com/2008/07/seas-comical-farce-in-three-acts.html

Fascinating.

Once More -- Awaiting CafePharma Queue Moderation. . . .


This won't make sense, unless you've read the original CafePharma thread to which it relates -- but here goes:

I don't know who the Condor is, but I can sure tell you that I know the industry, worked in it for decades, and even worked for SP for a while. If the Condor needs assistance and facts about this cesspool known as Schering Plough, there are many, many like me who will offer the info gratis. I would revel in your company's demise. You are bad for the industry, but most importantly, you are bad for patients and their medical care providers.

~~~~~~~~~~~~

To be clear -- I was "yanking the chain" of the decidely-dim-witted anonymous poster (way above) who seems to complain about me 24 by 7, around here. That's all jake by me, though -- that is his/her right, after-all -- it is a marketplace of ideas, here.

It is odd, isn't it, though, that s/he doesn't complain AT ALL about the PRIMARY actors -- at Schering. Are the messengers really to blame? I don't think so.

I don't need to write a book. It is writing itself -- day by day, in the national newspapers -- and on various blogs. [BTW, the alluded-to "SeekingAlpha piece" is actually a syndication feed (reprint) of something originally written by a VERY pro-Schering guy (Derek's an ex-Schering science guy, in fact!) -- at Corante/Pipeline. Google it for yourself -- get "the truth. It is out there." AND, BTW -- Derek said Schering "couldn't have done more damage" to ITSELF (re SEAS), if it "had hired Professional Saboteurs". Heh.

That line made me kinda' warm and fuzzy, inside. But I digress.]

That said, I welcome the above-offer (in green).

More of Salmon's Cogent Observations -- on the SEAS/Cancer Issue "Dear Doctor" Letter


This also appears in the comment-box for the original "Dear Doctor" letter post. I felt it (like the CafePharma post itself) deserved a wider audience -- so here is our exchange -- in full:

In the US any written material provided by a companay relating to an approved drug including advertising is 'labeling'.

This is what the Food Drug and Cosmetics Act has to say about labeling:
Food, Drug & Cosmetics Act

SEC. 502. [21 USC 352] Misbranded Drugs and Devices

A drug or device shall be deemed to be misbranded. . . .

(a) False or misleading label. If its labeling is false or misleading in any particular. . . .

(j) Health-endangering when used as prescribed. If it is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.

Now if Vytorin is paid for by Medicaid or Medicare the following is something else to consider.
18 USC § 371. Conspiracy to commit offense or to defraud United States

If two or more persons conspire either to commit any offense against the United States, or to defraud the United States, or any agency thereof in any manner or for any purpose, and one or more of such persons do any act to effect the object of the conspiracy, each shall be fined under this title or imprisoned not more than five years, or both.

If, however, the offense, the commission of which is the object of the conspiracy, is a misdemeanor only, the punishment for such conspiracy shall not exceed the maximum punishment provided for such misdemeanor. . . .

Salmon

July 25, 2008 4:35 AM

Quick correction. Not only advertising but printed materials are considered labeling for determination of misbranding.
See FD&CA SEC. 201:
. . . .(m) The term "labeling" means all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual. . . .

So if they only give out a letter about Cancer if requested, is this failure to reveal material facts? What about all the other clauses and the fact that it's illegal to introduce into interstate commerce a drug that's misbranded?

Discuss among yourselves.

Salmon

July 25, 2008 4:52 AM

~~~~~~~~~~~~~~~

Condor said...

Salmon -- you've just gone where I was headed, next -- swimming up the very same river, it seems -- I'll likely highlight yours, in a new post, later today, and with it, predict that in perhaps only a few days' time, the FDA will "give Schering a call" about less than complete transparency -- i.e., reticence on material saftey information. . . .

Perhaps I'll caption it:

"How to help an ordinary train-wreck. . . catch fire, and explode, to boot!"

But make no mistake about it -- this looks to fit the Hassan-led Schering pattern, to a tee -- torture a very-dubious position until it is barely recognizable as attempted compliance with the applicable law -- and thus, put Schering into an even deeper hole, as opposed to digging Schering out of one.

Great post -- thanks for the research materials, Salmon!

July 25, 2008 6:32 AM

Feel free to chime in, any and or all of you wise FDA-heads looking in from Potomac, Maryland -- Host: wallwhale-pub.fda.gov -- ISP: Parklawn Computer Center / Dimes Hq. Seriously -- I welcome your observations. This seems right up the Agency's alley, doesn't it?

I would also welcome anonymous (or attributed) comments on any or all of this from the wise folks in Frederick, Maryland, at the National Institutes of Health (NIH) -- Host: fernwood-arbiter-a.net.nih.gov -- ISP: National Institutes Of Health. . . .

I promise no individual's identity will ever be revealed -- similarly, I will never disclose whether someone inside (or outside) these groups posted any particular comment.

Thursday, July 24, 2008

An Anonymous CafePharma post that deserves to be seen. . . .


UPDATED: 07.25.08 @ 8:30 AM EDT -- That fine gent -- at PharmaGossip -- has linked this, and made a poignant reference to the fantastic Joseph Heller novel "Catch 22". Do go see his!

I have also set the comments, and some observations on them, as a new post, here.

~~~~~~~~~~~

Schering has prepared a "Dear Doctor" letter related to the cancer issue in its SEAS study. Here is one purported salesperson's incredulity -- given that Schering will only provide the letter to doctors who ask for it -- I thought I'd link the letter, and quote the salesperson's reaction:

Today, 01:14 PM Anonymous

Re: Is this what you were trying to show with SEAS?

~~~~~~~~~~~~

Quote:
Originally Posted by Anonymous

One word summary..CANCER

~~~~~~~~~~~~

I just had a Physician ask me for the letter explaining the Cancer concern coming out of SEAS. He saw it on the internet. Beautiful. It actually states that we will not be automatically sending letters to all Docs, instead we will hand them a letter if they ask about it. God I have to get out of this company quick. Again SP is doing the bare minimum to inform our customers. Personally, I am going to make copies and hand one to every doctor and nurse in my territory. This shell game bullshit is another SP manipulation of our credibility and I told my DM on the phone that this is what I plan to do. Nothing but silence on the other end. I don't think she had a clue about this. . . .

Jaw-slacking. Simply jaw-slacking.

Hindsight is always 20-20 -- but why wasn't Schering-Plough's NYSE trading halted on Monday morning, when it delayed its Q2 Earnings Release?


First off -- I do recognize, from extensive experience, that no one really knows how any particular event to going to affect trading in a listed security, until the event is announced -- but the better advisors and counsellors usually have "Kentucky-windage" as to which way it will break -- before it breaks.

That is -- of course -- the main reason for NYSE Listed Company Manual Section 202.06(B), discussed last night: To seek, and receive, the considered wisdom of the NYSE (that deals in such matters daily -- as opposed to once in a blue moon, for most public companies) -- before an unwarranted trading-trainwreck ensues.

Now, I have set to thinking -- after looking at the trading on the morning of July 21, 2008 -- and knowing that Schering had chosen to delay its Second Quarter Earnings Release to post-market close (presumably for tactical advantage), from pre-market open, some time during the night/early morning on July 20-21 -- why on Earth didn't Schering ask the NYSE for a halt in trading -- until the 1 PM EDT conference on SEAS could be held -- if, in fact, there was no possibility of moving the timing of the SEAS disclosure web-cast? Why?

I am curious. Look now at the Monday morning trading -- shaded red -- click it to enlarge (graphic derived from a rather-flat Yahoo! screen-shot):



Might a lot of that awful morning's carnage been avoided if, in the wise words of NYSE Manual Section 202.06, time had been allowed for a "period of calm for public evaluation" of the SEAS news -- during a trading-halt? And, wouldn't all the buyers between 1:15 PM and 1:20 PM, EDT on Monday (at a plainly-artificially-high price) have had a chance to avoid all the losses they are now suffering (shaded in lemon-lime, above)?

I think so, in both cases.

Remember, over 108 million shares changed hands that day -- there were perhaps 7 million shares bought at the higher (1 PM) prices.

Finally, Schering specifically chose to arrange all the elements -- and the chronological sequence of those elements -- that resulted in Monday's debacle, depicted, and on-going, above. For ease of reference, here is Section 202.07 -- on NYSE Trading Halts:

202.07 Trading Halt Procedures

Whenever the Exchange determines that trading in a listed security should be halted or delayed pending the release of a material news announcement:

* Implementation of the halt or delay will be announced and the reason for the halt or delay will be stated "news pending";

* Thereafter, the Exchange will monitor the situation closely and will commence the opening or reopening of trading in the listed security in accordance with its normal procedures as soon as the material news announcement has been made. If the announcement is not made within a reasonable time after the halt or delay is implemented, trading in the listed security may be opened or reopened in the interests of providing a liquid market. While the time period may vary from case to case as a result of the particular circumstances involved, normally if the announcement is not made within approximately 30 minutes after the delay or halt is implemented, the Exchange may commence the opening or reopening of trading in the listed security. Such action will be preceded by an announcement to the effect that trading is resuming even though the material news announcement has not been released. . . .

No one really likes trading halts -- they are scary. Unnerving to the market-makers, afterall. But, the above may be a text-book example of why a halt should occassionally issue from the NYSE. It may have been something Schering's advisors should have requested from the NYSE -- given that Schering knew what the SEAS Update foretold.

Wednesday, July 23, 2008

Did Schering-Plough comply with the terms of the NYSE Listed Company Manual when it released SEAS?


UPDATED 08.24.08 @ 2 PM EDT: The Case FOR NYSE Trading Halts -- Schering's SEAS Announcement: a Textbook Example. Obviously, I continue to be troubled by Schering's Monday NYSE trading rip-tide. Do go see why.

Earlier, PharmaLive pointed to, and linked this post! Cool! -- Thanks!

~~~~~~~~~~~~

I broadly hinted at my concern about this, early on Monday morning, but I wonder whether Schering made the required "pre-event" phone call to the NYSE Department of Stock List, to solicit the opinion of the Listed Company Representative assigned to Schering -- about whether the timing of the SEAS study release (from Europe) was appropriate -- and was the best way to handle news of such gravity.

I really wonder, given the wrenching volitility the stock suffered before -- and after -- the 1 PM EDT (Mid-Trading-Day) web-cast. That was evening in Europe, by the way. What was the magic about that time? I do wonder.

Let's read from the NYSE Listed Company Manual -- these are the standards that govern NYSE-listed public companies -- like Schering-Plough (and Merck):

202.06 Procedure for Public Release of Information. . . .

. . . .(B) Telephone Alert to the Exchange

When the announcement of news of a material event or a statement dealing with a rumor which calls for immediate release is made shortly before the opening or during market hours (presently 9:30 A.M. to 5:00 P.M., New York time)*, it is recommended that the company's Exchange representative be notified by telephone at least ten minutes prior to release of the announcement to the news media. If the Exchange receives such notification in time, it will be in a position to consider whether, in the opinion of the Exchange, trading in the security should be temporarily halted. A delay in trading after the appearance of the news on the Dow Jones, Reuters or Bloomberg news wires provides a period of calm for public evaluation of the announcement. The halt also allows customers to revise the terms of limit orders on the specialist's book in view of the news announcement. Even if limit orders are not canceled or changed during the halt, the fact that trading is halted results in the reopening being considered a new opening, thereby enabling limit orders to participate at the new opening price regardless of the previously entered limit. A longer delay in trading may be necessary if there is an unusual influx of orders. The Exchange attempts to keep such interruptions in the continuous auction market to a minimum. However, where events transpire during market hours, the overall importance of fairness to all those participating in the market demands that these procedures be followed.

* Effective June 13, 1991 the New York Stock Exchange off-hours trading sessions became operational. The facility offers the opportunity to trade at NYSE closing prices after the NYSE's 4:00 P.M. close until 5:00 P.M.

(C) Release to Newspapers and News Wire Services

News which ought to be the subject of immediate publicity must be released by the fastest available means. The fastest available means may vary in individual cases and according to the time of day. Ordinarily, this requires a release to the public press by telephone, facsimile, or hand delivery, or some combination of such methods. Transmittal of such a release to the press solely by mail is not considered satisfactory. Similarly, release of such news exclusively to local press would not be sufficient for adequate and prompt disclosure to the investing public. . . .

It seemed rather strange to me, back then (and more so, now, that I have gone back to refresh my memory of the NYSE Listed Company Manual's terms), that the SEAS study presenters -- in Europe -- waited until something like 7 PM (local time in Europe) to conduct the web-cast. Why was that time chosen? Was the NYSE pre-notified?

Did Schering actually believe the results would be "immaterial", and thus did not call the NYSE -- to pre-notify, under Section 202.06(B)? That approach would have been "at variance" with the pro-offered reason for moving the time of the Q2 Earnings Conference Calls. Did Schering think it material, or not so? I do wonder.

Certainly, the SEAS release web-cast could have also been held prior to market open on Monday -- say 11 AM, local Europe time, and still have held both the Merck and Schering conference calls at the originally-scheduled time -- avoiding perhaps a half-day of market turmoil.

Tuesday, July 22, 2008

The Most Ominous Line -- for Schering -- in Merck's Q2 Press Release, tonight?


UPDATED -- 11 AM EDT: Though clearly not fully-intending to do so, the generally very-pro-Schering-Plough web site "In the Pipeline" (Derek is an ex-Schering science guy) -- seems to be throwing in the towel on the Cholesterol Joint Venture. He adds detailed credence to the thesis that the Joint Venture is coming to an end -- albeit not directly.

He writes of SEAS ". . . .put out press releases that your compound, even though it failed to work again, isn't actually a cancer risk. You really couldn't do worse; a gang of saboteurs couldn't have done worse. Of course, there's no such gang: the companies themselves authorized these trials, thinking that there were home runs to be hit. But all these sidelines -- familial hypercholesteremia, aortic stenosis -- have only sown fear, confusion, and doubt. . . . ."

[Emphasis supplied.]

~~~~~~~~~~~~~~~~~

From CEO Dick Clark's first full paragraph after the first two tables [emphasis supplied; link to the full release]:

". . . .Earlier today, data for the SEAS study was presented by the primary investigator," he said. "We are moving quickly to fully assess the potential implications of the data for our cholesterol joint venture. . . ."

The bolded bit could be read to suggest one possible "implication" for the Joint Venture. . . . would be its end.

Am I reading too much into his statement, here? Let me know.

Revised -- Schering-Plough: A Greek Tragedy, in Three Acts.


An update, to this one, proclaiming it all a "comical farce", also in three acts -- I sincerely apologize. That was entirely premature:


Act I


March 31 -- April 1, 2008: ACC ENHANCE Panel Discussion in Chicago -- Schering stock goes from $19.87, to $14.41 per share [Meanwhile earlier, off-stage, left, SEAS study launches -- to compare Vytorin to a placebo (i.e., stack the deck-chairs)].


Act II


Slowly recover -- to around $22 -- by late last week. . . . Then, delay Schering and Merck Q2 earnings conference calls -- to after market-close, on July 21, 2008 -- for "an important update" on SEAS: Vytorin to a placebo results*.


Act III


Fail the primary endpoint on a Vytorin study -- [Again!]

But flog an (underpowered) secondary SEAS endpoint, while ignoring some data on cancer incidence-spikes. Point to your successes in rearranging those pesky deckchairs -- dutifully ignore that icberg. Vytorin/Zetia is still more than 50 percent of all of Schering's 2008 full-year profitability -- at least before this evening, it was. . . .

Tune in tomorrow, for all [the rest] of the carnage. James Cameron is now under contract -- to direct. Shorter Condor [channeling PharmaGossip's excellent turn of phrase!]: Heavy SEAS, ahead!

~~~~~~~~~~~

* A more detailed plot synopsis, then: I just walked off my plane from the West Coast, and I am still digesting how this topsy-turvy Schering-Plough trading day ended. . . .

Over 108 million shares changing hands -- off another 3 percent in the NASDAQ after-hours session -- on about a million shares changing hands, after hours.

Yep. I think it safe to say -- "Look out below."

Add to this that Merck refused to update its full-year 2008 guidance, tonight -- CEO Clark is still studying the SEAS fallout. So, will Schering close below $18 tomorrow?

$17?

$16?

$15?

I honestly need to do some math -- but all of these are at least possibilities "in play", at the moment. [Had the analysts really taken all of the 2008 Vytorin profits out of their models, before last Friday? I doubt it.]

I am genuinely saddened -- for the Schering rank and file -- to have been so terribly right, over the last few weeks. That $22 was truly a suckers' rally.

So, it would seem SEAS missed the primary end-point (bad enough), but wait! There's more! The big "C" -- However, since no similar cancer incidence results have been seen in IMPROVE-IT (thus far, apparently) -- this should "only" mean that Vytorin is largely ineffective at improving cardiac outcomes -- not "inherently a dangerous drug", per se.

And, while it is also true that the secondary result (flogged by CEO Hassan, tonight) was a "positive", that positive is underpowered possibly the result of a confusing variable -- the statin's presence in the compound. [Edit: Thanks to the loyal fanbase, MM, for the edit -- I did misuse the term of art: "underpowered"!] That is, it should have been significantly better than it was, if it was NOT (quite likely) an artifact.

So, tomorrow we will know -- by the close of the market -- whether Wall Street's analysts had really factored Vytorin sales to be near zero by mid-2009. If so, Schering should be flat, to slightly rising, tomorrow. I. don't. think. so.

I expect it will be off sharply, and on very heavy volume, again. I cannot see how there is a significant market for a combo pill that costs at least triple what a plain statin does -- but can't beat a placebo. Sell me that one, please.

Where is the [revised] business model for this drug? I say this fully-aware that I am simply ignoring the cancer-incidence data. (Will your family doctor do the same?) And -- still, I genuinely ask -- what is the "value proposition" this drug now offers? At any price. What?

I don't see it. I don't think Wall Street will, either.

Monday, July 21, 2008

SEAS -- A Comical Farce, in Three Acts. . . . Sponsored by the Odd Folks at Schering-Plough


[UPDATED 08.24.08 @ 2 PM EDT: The Case FOR NYSE Trading Halts -- Schering's SEAS Announcement: a Textbook Example.]

Act I:

Compare Vytorin to a placebo (i.e., stack the deck).

Act II:

Schedule Schering and Merck Second Quarter 2008 Earnings Calls for pre-market-open on July 21, 2008.

Act III:

Delay both calls -- to after market-close, on July 21, 2008 -- for "an important update" on SEAS: Vytorin to placebo.

H I L A R I O U S L Y. . . . bad theatre! Why?

Well, what is missing from the above plot-synopsis is this: According to paragraph two of Schering-Plough's press release, the SEAS update will be published around 1 PM EDT today -- during the trading day.

Were this "Norway Update" truly material, it would not be published during the trading day, as at a minimum (and more fully-discussed here), an NYSE Halt-Trading process would be invoked -- with a "News-Pending" flag on the stock's ticker symbol. If Schering opens (at all) this morning -- on the NYSE -- in about 20 minutes' time, then this is all a stunt.

My prediction, then: There will be no Earth-shatteringly-positive actual news from the SEAS update -- out of Sweden.

You read it here, first.

~~~~~~~~~~~
UPDATED 9:28 PM EDT
~~~~~~~~~~~


I was mistaken. A Greek tragedy, in three acts. . . .

PharmaGossip, and PharmaLaw each featured this post, earlier today -- while I was off the grid. PharmaGossip apparently even shoved a link to it, onto the WSJ's Healthcare Blog! Wow! -- Thanks!

1 PM EDT -- LIVESTREAM of SEAS UPDATE WEB-CAST




▲ Schering-Plough's common stock has opened very-badly on the NYSE — off 5.7 percent in the first few minutes of trading — falling through $20.20 now.

▲ Half a million shares in the first ten trades.

▲ I’d say that the market has sniffed-out a pig, despite its lipstick. Strictly "Bread and Circus" stuff, out of Kenilworth these days. . . .

▲ Now falling through $19.65 (Down 8.68 percent). Heavy volumes. Gee this looks to have been a real swell idea, Mr. Hassan.

▲ Now $19.54 (Down 8.86 percent) 2.86 million shares changing hands in the first 40 minutes.

▲ Now $19.34 (Down 9.8 percent) 3.4 million shares changing hands in the first 50 minutes.

▲ Just fell through $19 support floor: $18.73 (Down 12.3 percent) 4.4 million shares changing hands in the first 58 minutes.

▲ Now it's a 13 percent "down bubble". And still diving:
Ensign: "Approaching crush depth, Captain Hassan."

Chief of the Boat: "Orders, sir?"

Captain Hassan: "Grant me more stock options (at $18.85) -- only that will right the ship, men!"

▲ I've got to jet. Good luck, folks.

You did read it here, above, first.

Sunday, July 20, 2008

Once again -- while I wait for CafePharma's moderation que. . . .


I posted this, over at a Cafepharma discussion -- and it is still awaitng moderation, so I set it forth, in full here:

I think this has slowly-evolved into a well-intentioned (if occasionally spirited) discussion -- one that finally focuses on Schering-Plough -- and not so much on me. And, that is a good thing.

So, if I might -- I, too, believe the vast majority of Schering's rank-and-file (like the rank and file, anywhere) are very decent, hard-working and honest people. I have been on record -- for more than three months -- with that sentiment: "The Vast-Majority of Schering employees are honest hard-working. . . ."

That is why the (lack of ethical) "tone at the top" is so unfortunate -- it tars all employees with the bad-choices of a very-few, highly-placed, influential actors. But to suggest we should look the other way, simply because lower-level employees will "lose their jobs" if/when all that was hidden -- is revealed -- is simply illogical. If you don't face the sunshine, you are an agent of the darkness.

So, lose your job -- or wear an orange suit -- as a "co-conspirator", if you choose to "be a good corporate loyalist" and help cover-up the misdeeds?

You get to decide. That is the beauty of this moment in Schering's history.

I'll vanish again now -- for a while -- I'm largely off-the-grid, here on the West Coast (on other business) -- until the Merck and Schering earnings calls, tomorrow morning, of course.

Be well.

Friday, July 18, 2008

Dechert LLP loses -- Plaintiffs get "Early Discovery" win from Magistrate Mark Falk -- in Polk v. Schering-Plough, et al.: July 18, 2008


Well, we'll have to wait and see what, exactly, this early "limited" discovery order will actually allow, but as I predicted just a few days ago, the Dechert LLP letter -- filed in MDL 1938, the Vytorin/Zetia Marketing, Sales Practices, and Products Liability consolidated litigation -- seeking a stay of discovery -- has not carried the day. I did not "pop-over" to Newark, to hear the arguments on this motion (now I wish I had!), so I don't yet know how much early discovery will occur, but I do know that this is very bad news for Schering. . . .

Such bad news, in fact, that Dechert LLP may well move for reconsideration before Judge Cavanaugh. Dechert might even appeal any adverse ruling there (should one be entered by the judge) to the Court of Appeals. But that strategem risks "poisoning the well" with the very people who will ultimately be called upon to try one's case -- and, after-all, if Schering really has "nothing to hide," it should want depos to be taken sooner, rather than later, so that its executives' memories will still be very current, right? R-i-i-i-I-i-ight.

Note that what has been granted here is a very important "early-look": at least for some purposes, factual discovery -- perhaps including depositions of officers and directors -- may begin very shortly. Take a look at the image of the order -- do click it, to enlarge:



Things are going to start poppin' -- on all of this -- pretty quickly, now. . . .

Note that the Magistrate has ordered Schering's lawyers to meet, and confer to start working out the schedules for sharing documents [and the taking of depositions(?)]. . . .

So, were I one Hans Becherer, I'd take my vacation (in Europe?), in the next two weeks -- after that, it may be back-to-back for quite a while, defending all those compensation decisions -- in depositions, day-after-agonizing-day. . . .

Oh, and, "Buckle-up," Mr. Hassan -- Monday's earnings call may get very "interesting".

Monday, July 21, 2008 will be a busy day for various developments at Schering-Plough -- including Clarinex®


I'll be out-of-pocket -- in Northern California, for a quick in-and-out, on various meetings -- but (owing to the time differences), I intend to live-blog highlights of the Merck, and the Schering Q2 calls, on Monday morning, from my hotel. We should learn quite a bit more from Merck's call, as Merck will likely need to update its projection of $700 million in lost 2008 profits, solely from the Vytorin Joint Venture with Schering, due to these latest Schering-provided, IMS-generated, monthly scrips disclosures.

Will Merck CEO Dick Clark simply ante-up, and re-set it at a nice, round $1 billion? We'll know a lot more -- on Monday.

[An aside -- today Citigroup initiated coverage on Schering. And, before you ask -- the answer is "Yes". Yes, yes, yes -- Citi-controlled entities had over $860 million at stake in the August and September 2007 Schering public offerings it helped co-lead -- offerings priced at $27.50 -- Hmmmmm. . . just how independent is that coverage? I wonder. You should, too. But I digress. . . .] UPDATING, here: I just noticed that Citi initiated at "Hold" -- that is a very-ominous sign -- it would suggest that Citi sees almost no upside from here. It would suggest Citi thinks Schering is now fully- to over-, valued. Wow. And this, from a bank already showing a $5.50 per share (albeit unrealized) loss on its clients' earlier purchases in the Schering public offerings, in Q3 2007.

I'll have much more on what it will all mean for Schering, proper, on Monday, but now the real reason I foresee a log-jam of events:

I have been (quietly) watching the numerous pieces of Descloratadine (marketed as Clarinex® tablets) patent litigation (particularly Case No. 06-04715 against Zydus) that Schering brought against various would-be generic manufacturers of Clarinex®-equivalent tablets -- back in 2007, and in some cases, back as far as 2006. These have now progressed to an important series of deadlines -- many of which also fall on this Monday morning. Odd convergence, eh?

On Monday, the Briefs in Opposition -- to Watson Laboratories, Inc.'s and Watson Pharmaceuticals, Inc.'s Motions to Dismiss chunks of Schering's patent infringement suit -- are due, from Schering's Counsel, McCarter and English. Also on Monday, responsive pleadings and motions -- as to other defendants in these Schering-intitiated lawsuits (now consolidated with the suits against Orchid, Sun, Barr, Sandoz, Watson and other would-be generic manufacturers -- in the face of Schering's claims about the broad coverage, and applicability of its so-called "Patent No. '274"), will be filed.

[Oh, and fascinatingly, Winston and Strawn has beefed up its defense team, adding lawyers from its Chicago office (on behalf of Sun, one of the other generic companies sued by Schering) to its roster, last night -- which often suggests an imminent, and large, filing -- authored by one (or more) of those newly-added lawyers. We'll see.]

Finally, the decision of the federal District Court, in Newark, New Jersey -- from United States Magistrate Judge Tonianne J. Bongiovanni, on Schering's attempt to hide from public inspection most of its substantive papers in these consolidated actions -- actions Schering, itself, brought -- was earlier-scheduled for Monday, as well, but will now be held over until September 2, 2008, thus:

". . . .Motion to Seal certain materials submitted in Opposition to Defendants Watson Laboratories, Inc.'s and Watson Pharmaceuticals, Inc.'s Motion to Dismiss for Lack of Subject Matter Jurisdiction.

Motion Hearing set for September 2, 2008 before Magistrate Judge Tonianne J. Bongiovanni. . . .
"


We may decide to file some sort of amici materials, on this issue -- these are public documents [the federal courts are presumtively open to all, regardless of some usually-remote potential for business advantage, or dis-advantage -- the Clarinex® (descloratadine) patents at issue, here, are likewise entirely public documents -- as are the formulae by under which Schering (and the generic companies) make the tablets] and, except for the relatively-few paragraphs that might contain core Clarinex® trade secrets, there is little legal basis for Schering-Plough to seal papers in a suit it made a conscious-choice to bring.

I may not get to a lot of this until I return, on Tuesday-evening, July 22, 2008.

But I can confidently predict there will be a lot of new information on whether Orchid Pharmaceuticals (based in India) will be in a position to attempt an "at-risk", late-2008, launch of its generic version of Clarinex® tablets. If nothing else, it should all be rather droll -- entertaining fare -- assuming the court orders at least the non-trade-secret portions of these presumptively-public documents to appear in the electronic court files -- and soon.

At the moment, one of Schering's heftiest briefs is visible only as a summary -- the actual brief (or statements of, and arguments on, the laws -- entirely public laws) is now sealed, temporarily, from the public's prying eyes (and iPhone®-G3's). Heh.

Thursday, July 17, 2008

June 2008 IMS scrips -- Bottom line: Vytorin/Zetia STILL losing share -- in a "shrinking" US Market. . . .


These are moderate declines, compared to two motnhs ago (still, close to a 5 percent, month-over-month sequential decline), but it is an especially ominous sign that the overall "cholesterol market" in the U.S. is "shrinking" -- in this economy, that might well-mean that the under-, and un-insured have stopped taking their meds, altogether.

Or, it could mean that people are being counseled to adopt healthier lifestyles before trying any drug -- statin or other -- at all.

Overall, a 26.6 percent decline since the start of the year. Wow. [Click to enlarge.]



This is not good news. Meanwhile, 1.09 million shares traded -- essentially flat, after-hours -- on the NASDAQ, thus far.

Kaiser CEO testimony today, before Congress -- George C. Halvorson. . . .


The entire PDF is well-worth reading, but here are some highlights:

. . . .I am sad to say that health care in America is a disorganized, weakly coordinated, inadequately linked, $2.3 trillion care infrastructure that is currently our country’s fastest growing industry. . . .



It is an industry that will not be reformed without intervention by public policymakers and purchasers. . . .

. . . .Major studies show huge inconsistencies in care delivery across this country. For example, diabetics consume over 32 percent of the total costs of Medicare, and reliable studies show that the U.S. health care infrastructure provides the right care for diabetics less than 10 percent of the time. . . .

We are missing critical linkages among clinicians and we are missing systematic, patient-focused care. One key element of the solution is to have vertically linked clinicians functioning in teams to deliver care, supported by a secure electronic medical record (EMR) that gives each clinician the relevant information about each patient in real time at the point of care. . . .

Another key element of the solution is to have special computer systems –- care registries –- that analyze data from the electronic medical record and give doctors and other clinicians reminders and prompts to recommend what the best scientific evidence and expert opinion would agree is necessary and optimal care for each patient. . . . Only a few places in this country will be able to achieve the full electronic medical record supported by an up-to-date care registry in the immediate future. . . .

What Kaiser Permanente and other multi-specialty groups such as Group Health Cooperative, Intermountain Healthcare and Geisinger can accomplish is to set the gold standard with a sophisticated electronic medical record and a fully integrated system. But the rest of the health care system is not vertically integrated and does not have appropriately aligned financial incentives. However, as a country, we can decide to move towards virtual integration and to create payment structures that reward good care, rather than the quantity of services delivered.

Most American patients will need another pathway to computer supported care. That second pathway is possible. We don’t need algorithms for hundreds of diseases in order to transform care. We do need algorithms and support systems for the five chronic conditions (congestive heart failure, asthma, diabetes, coronary artery disease, and depression) and for the five percent of the total population who drive 50 percent of the care costs in this country. . . .

If we want care to get better for those patients, we need to insist that all chronic care patients with serious co-morbidities have their care supported by electronic care registries –- and that clinicians who choose not to interact with those registries should be financially affected by their decision.

What happens when care is fully supported by electronic panel support tools? The outcome improvements can be huge. We should set a national goal to decrease hospitalization for asthma patients by 50 percent. We should also reduce congestive heart failure crisis by 50 percent. We should reduce kidney failure by 50 percent.

The electronic medical record alone does not do the work. EMR is a great thing, but an EMR all by itself is not enough. The EMR must be supported by panel management tools that scan the data and give advice to clinicians about needed care. . . .

My advice for you today is this: Our nation’s current non-system -- depending on siloed and separate paper medical records and providing perverse financial incentives that directly reward sub-optimal care and discourage efficiency –- will never reform itself. It will also never magically become a “system.”

We need to focus on the areas of the greatest potential - and we need to put computerized support systems in place as soon as that work can be done. . . .


[Emphasis supplied.]

LIVE VIDEO! -- July 17, 2008 -- Yet Another Health-Care Reform-themed Hearing -- Senate Finance Committee


~~~~~~~~~~~~
FLOATED: 07.17.08 AM
EACH WITNESS' STATEMENT
IS NOW LINKED TO HIS OR
HER NAME, BELOW. . . .


[Originally posted: 07.15.08 PM]
~~~~~~~~~~~~


I'll have a archived live, streaming video feed in an embedded window, here, of the entire hearing -- the feed will go "live" at about 9:50 AM EDT, on Thursday July 17, 2008. Be sure to check back at this space, then. Here are the hearing particulars:



"The Right Care at the Right Time:
Leveraging Innovation to Improve
Health Care Quality for All Americans
"


July 17, 2008, at 10:00 a.m.,
in 215 Dirksen Senate Office Building

Member Statements:

Max Baucus, MT

Charles Grassley, IA


Witness Statements:

Peter Orszag, Director, Congressional Budget Office, Washington, DC

Richard Hillestad, Ph.D., Principal Researcher; Professor, RAND Graduate School, Santa Monica, CA

George C. Halvorson, Chairman and CEO, Kaiser Foundation Health Plan, Inc., Oakland, CA

Gail R. Wilensky, Ph.D., Senior Fellow, Project Hope, Bethesda, MD

I'll also have links to all testimony, anchored to the witnesses' names, above, a few days after the hearing (most-likely as PDF files).

If this one really starts rockin', I may live blog it, below:



See you Thursday, bright and early!

Wednesday, July 16, 2008

Dechert LLP's latest -- in the Sales Practices consolidated suit -- comes up "a day late, and [more than a] dollar short". . . .


Overnight, Dechert LLP, on behalf of Schering-Plough, filed a letter in MDL 1938, the Vytorin/Zetia Marketing, Sales Practices, and Products Liability consolidated litigation, arguing essentially that no discovery should occur in that case, until the motions to dismiss now pending in the securities action, and any other related action (could that possibly mean the Organon Qui Tam action?), are decided.

[This all becomes very interesting since Arent Fox has effectively given all these various bunches of plaintiffs an avenue to take early discovery in the Organon Qui Tam case -- as I earlier noted -- a week or so before Lowenstein, Sandler replaced Arent, Fox as Schering's counsel of record in the Organon matter.]

In doing so, Dechert quotes cases interpreting the Private Securities Litigation Reform Act for the proposition that ERISA case discovery may be stayed while a pending securities law motion to dismiss is pending -- as well as any discovery based on a state law claim or theory, in order to effectuate the intent of Congress in enacting the PSLRA, and the subsequent amendments to it. Take a look at this, from Dechert's letter, at Page 5 (click to enlarge):



Now, what Dechert LLP wholly-fails to mention, in its letter to United States Magistrate Mark Falk, is that the express language of the PSLRA, at 15 U.S.C. § 78z-1(b)(1), provides that "in any private action arising under this subchapter, all discovery and other proceedings shall be stayed during the pendency of any motion to dismiss, unless the court finds, upon the motion of any party, that particularized discovery is necessary to preserve evidence or to prevent undue prejudice to that party. . . ."

In short, unless Dechert demonstrates that the current litigation was filed to thwart the stay provisions of the PSLRA, discovery in the MDL Case No. 1938 may well move forward.

ANOTHER fact Dechert fails to mention is that Cain v. Hassan, et al. is pending. It is a purported shareholders' derivative suit, and the express terms of PSLRA, at 15 U.S.C. § 15 U.S.C. § 77p(f)(2)(B) specifically exempt shareholders' derivative actions from these automatic stay provisions.

So, it would seem that, in order to "preserve evidence" -- chiefly, the now-fading memories of the involved officers, directors and underwriters -- the Magistrate Falk, or the court itself -- in the person of Judge Cavanaugh -- ought to find Dechert's letter unpersuasive. But don't trust me -- read the cases, and you'll agree. Quoting from Romero v. Career Education Corporation, Civil Action No. 793-N (Delware 2005), a memorandum opinion, now:

. . . .At the motion to dismiss stage where all inferences must be drawn in plaintiff's favor, I am not convinced that [plaintiff]'s purpose is to circumvent the PSLRA's proscriptions. The purposes identified in support of [plaintiff]'s May 26 Demand, for example, include investigating whether the [defendant] Board or officers breached their fiduciary duties by "actively participating in, or failing to make a good faith effort to detect, investigate, prevent and correct, violations of the Ethics Codes." It is certainly conceivable that any resulting claim for violation of fiduciary duties under Delaware law would be entirely different from the pending federal claims against [defendant] or its agents. . . .

~~~~~~~~~~~~

Footnote 16: 15 U.S.C. § 77p(f)(2)(B); City of Austin Police Ret. Sys. v. ITT Educ. Serv., Inc., 2005 WL 280345, slip op. at *10 & n.2 (S.D. Ind. Feb. 2, 2005) ("[T]he PSLRA and SLUSA were not intended to protect corporate management from shareholder derivative claims. Those are left to state law."). . . .

So, the-above letter, from Dechert, seems to have earned the sharholders. . . nothing, inasmuch as all the money Schering-Plough spent to have it researched, and drafted will lead no effect whatsoever.

And as I said yesterday -- that is also a waste of scarce judicial resources. Unfortunate.

An aside -- from CNBC's Mike Huckman -- on Schering's Levitra. . . .


Well, we all know that Schering-Plough earns some decent revenue from Levitra -- which, in the words of the above Mr. Huckman, is "an also-ran, me-too ED drug. . . ." Truer words were never typed.

It is what follows the-above comment, though, in his post, that most interested me:

". . . .But I do know one new Levitra convert. A certain co-worker, who will remain unnamed, recently told me he spent more than 300 bucks to fill a Levitra prescription his neighbor wrote for him. Mr. Anonymous said he'd grown frustrated with his primary care physician who would only write him tiny, apparently insufficient, prescriptions for Viagra. . . ."

Wow -- that seems like a dangerous recipe -- at least if it's all for one man -- perhaps his co-worker is looking to be an "off-license distributor" of erectile dysfunction (or, "ED", for short) drugs. Heh.

Let us (fairly) assume he isn't. A dosing at that sort of size might have profound cardio-vascular implications -- even for an otherwise-very-healthy young[er] man.

Now, what if the "anonymous co-worker" is a 40-something "weekend-warrior", whose primary care physician knows about a history of heart-disease in the family, or in the co-worker, himself?

No doubt this is a dangerous thing -- even if the "neighbor-Doc" admonished him to stay at the low-end of the daily-dosing on the label. Wow. What a sad "pill-poppin' public" story that makes.

Thanks for the candor, just the same, Mr. Huckman. This sort of thing needs more sunshine, not less. Seriously. Thanks.

Senate Finance Committee Testimony of Stanford Law Professor John H. Barton, Yesterday, on Pharma IP. . . .


John H. Barton, the George E. Osborne Professor of Law, Emeritus, Stanford Law School, testified before Congress on a broad array of global intellectual property (or "IP", for short) issues, yesterday. [Ed. Note: for a far more detailed look at the issues he discussed yesterday, do also read this 2005 JAMA article he authored.]

I found his remarks on global pharma IP to be quite enlightening -- as he set the very-legitimate question of protecting property rights into the broader framework of whether there is a moral -- if not legal -- duty to provide life-saving medical developments across economic, and continental divides -- at something other than the highest possible price -- especially in the case of HIV meds -- where it is literally the choice between a death-sentence, or life-saving "commutation", if you will, hanging in the balance. I'll leave you with the most intriguing of his, below, but do go read it all -- quoting the professor's testimony (PDF File), then [emphasis supplied]:

. . . .The area of current political tension is in the middle income nations. These nations are the growth pharmaceutical markets of the future, so that patent protection is of great importance to the future of the pharmaceutical industry’s business model. At the same time, these nations still have many poor people and thus view themselves as reasonably benefiting from the Doha Declaration. South Asia, for example, has more very poor people than Sub-Sahara Africa. Moreover, several, including Brazil and Thailand, have undertaken public programs to supply antiretrovirals to their HIV-affected populations, an expensive task whose overall cost depends heavily on the price of the drugs.

I believe that we must attempt new approaches in dealing with these nations. It is in our national interest to facilitate their growth in health. That may call for low, i.e., generic prices for at least some drugs for some people. This might be an exception for a limited time. In another approach, GSK is developing mechanisms for differential pricing within poorer countries based on charging a generic price to certain public or nonprofit distribution channels while charging a higher research-reimbursing price to others. Might the approach be extended?

But there will need to be reforms beyond prices. For example, in a number of nations, including China, much medical care is effectively financed through pharmaceutical sales by doctors and hospitals -– a process that certainly creates terrible incentives toward price markup to patients and toward overprescription. In India, the poor are not effectively served by the medical system. And some of these nations are pharmaceutical exporters at the same time that they have many needy citizens. Compromise seems reasonable; it will necessarily be more complex than a pure IP arrangement.

In approaching such a compromise, it is worth noting that price controls are likely to be the key topic for future international negotiations with developed nations in the pharmaceutical area. The importance of such controls is exemplified by the current European disputes over Roche’s anticancer drug, Avastin, as well as by the inclusion of price-related provisions in the 2004 U.S.-Australia Free Trade Agreement and the great attention paid to the issue in the 2008 USTR Special 301 Report. Moreover, at some point, price controls will almost certainly be an issue in our own country -– health care reform may increase the role of the government in purchasing pharmaceuticals, and it is hard to envision continued significant government purchasing of pharmaceuticals without pressure toward price controls. Unless the price controls are applied thoughtfully, the result will be to decrease incentives for research. Such harm may already have occurred in the U.S. childhood vaccine industry. In approaching health care reform and international trade both, we will need to define effective decision-making standards and procedures to maintain optimal incentives for research in medical technology. These various trends suggest to me that it is important to moderate our IP focus and to recognize that IP is only part of a broader package of pharmaceutical trade goals.

All nations want greater access to health care; all want to contain the cost of that health care; all want more advanced technologies. These are goals that have to be balanced; and the details of the balance may reasonably be different for nations at different income levels. . . .

Indeed. Hopefully the folks in Kenilworth are watching CSPAN.org.

Tuesday, July 15, 2008

Despite Presidential Veto, Medicare Improvements Act becomes law


The United States Senate and House of Representatives have overridden a Presidential veto to improve Medicare for seniors, soldiers and low-income Americans.

All the details are here -- but it is time for pharma to get out in front of this, and "stop sticking its collective head in the sand. . . ."

Just for the record, that italicized pull-quote, immediately above, was offered the other day by Billy Tauzin [yes, that Billy Tauzin], the President of the most influential U.S. pharmaceutical trade group -- PhRMA. Gee, now where have I previously quoted language like that, before? Oh. Yes. Right. Quite-so. The Chairman of the Fed.

Shearman and Sterling LLP to defend Schering's Ex-Cadre of Securities Underwriters, jointly. . . .


This morning, the New York office of Shearman & Sterling LLP entered its appearance (through Sills Cummis & Gross, locally in New Jersey), to represent all of the various securities underwriter-defendants from the August and September 2007 public offerings of Schering-Plough securities (by each severally, but not jointly). These public offerings, which delivered over $3.8 billion to Schering (at $27.50 per share, used to partially-fund the Organon acquisition) are in issue in In Re Schering Plough Corporation/ENHANCE Securities Litigation. All similar such cases are presently "travelling" under a single Lead Case No. 08-397, before Judge Cavanaugh.

Nominally, the filing was placed in the electronic court file for the Arkansas Teachers' matter. Do take a look -- click to enlarge:



This could very-well suggest that the interests of Schering, and its officers and directors, on the one hand, and its various underwriters (named above), on the other, are not nearly-as-tightly-aligned as might have once been presumed by traders on Wall Street.

Hmmmmm.

UPDATED: 07.16.08 @ 11 AM EDT -- Via an agreed order, the plaintiffs in this consolidated securities action will now have until September 15, 2008 to file the amended, consolidated complaint. The old deadline was August 1, 2008. A very long, cold summer indeed.

Monday, July 14, 2008

A Review of Schering's Motion to Dismiss Cain v. Hassan, et al., shareholder derviative action -- Lowenstein Sandler PC, and Mayer Brown, LLP


Ordinarily, a motion of the above-sort reveals a fair bit about the defendants' strategy and tactical advantages/disadvantages -- in a shareholders' derivative action. This time?

"Not. so. much."

These two firms, representing essentially Schering-Plough's whole board, and several
officers of Schering, in Cain v. Hassan, et al., take about 32 pages, proper (and well-over 120 pages, if one includes exhibits) to essentially ask "a big nothing" of the lawyers for Ms. Cain -- other than that they send a simple demand-letter to the board. A demand letter like this one, one on the very-same predicate facts, that the board admits it had received back in early-February of 2008. Click image, at right, to enlarge. [Also, remember to vote in the new poll on this, at left!]

I say so because, despite Schering's lawyers' positioning the filing made today as a "Motion to Dismiss" -- it would seem rather unlikely that it would achieve anything more than a few months' delay in the Cain v. Hassan derivative action, or some substantially identical one (as yet unfiled, by Roy L. Jacobs, on behalf of Steven Waldman -- see at right) -- moving forward.

While so-called "demand futility" is an important concept in the law here applicable, it can hardly be said that Schering's directors would have been "taken by surprise" when Ms. Cain filed her action in the federal court-house in New Jersey. Indeed, counsel for Schering admits that Schering's board had, by the time the Amended Complaint in Cain was filed, apparently formed an allegedly independent special committee to investigate Mr. Jacobs' letter, above. Note that (in orange highlighting, at top) Fred Hassan's office, or Mr. Hassan himself, routed it to legal ("SW" is undoubtedly Schering Corporate Secretary Susan Ellen Wolf) with a handwritten note, and it was stamped "received" by some assistant in his office February 7, 2008. Where a special committee was already meeting on this topic (by the time of the amended Cain complaint filed), it should come as no surprise that Ms. Cain's lawyers might want to know about these developments -- especially if Schering, in good faith, was in fact seeking a reasonable resolution of the Cain matter. Yet only now -- Mid-July 2008, as part of a Motion to Dismiss, does Schering make this fact known. To be clear, that course of conduct is clearly permissible -- it just seems rather inefficient -- if the overarching goal here is to conserve the shareholders' resources (and reduce the associated legal fees).

If, on the other hand, the goal is actually only to protect the directors. . . . then, I think the futility of demand is evident from this little thumbnail of a chronology.

I just checked, and as of this afternoon, Mr. Jacobs had not filed a derivative action, at least not in the New York or New Jersey federal court-houses -- despite having asked for a 60-day turnaround on his letter -- which would fairly suggest that he is in negotiations with Schering-Plough about whether he will have to file such a suit, or whether he will have his demands met without having to do so. [He -- Jacobs -- is one of the lawyers listed on the Grand Theft Auto videogame securities litigation matters.]

In any event, it would seem highly likely that someone's derivative action will move forward, in a few months, in the federal District Courts sitting in Newark, New Jersey. Said another way, is it likely that Schering's directors and officers will personally return to the company all these losses? -- that is over $10 billion of market-capitalization. No, that's not likely to happen, voluntarily.

And so -- this simply looks a bit like 120-plus pages of delay, at least to my experienced eye.

Your mileage may vary, but I'd bet the plaintiffs' firm in Cain v. Hassan will solve this purported "problem" by sending a letter, like the one Mr. Jacobs sent.

Should Judge Cavanaugh grant the motion filed today, he almost certainly would do so only in part -- only insofar as he would grant Cain leave to make a specific demand, and further leave to re-file the action, should that demand actually prove to be futile.

Sheesh. what a waste of time -- judicial resources -- energy and talent, here.

Thursday, July 10, 2008

Far be it from me -- to suggest these two are related -- BUT. . . .


. . . .I could not help noticing that, as of this morning (filed July 10, 2008), in a consent dated yesterday, July 9, 2008 by Defendants' counsels -- Lowenstein, Sandler has taken the reins from Arent Fox, in US v. Organon, Inc. (Case No. 07-2690, US Dist. Ct. NJ), the Organon Qui Tam/False Claims litigation matter.

Click it -- to enlarge (and, in such a pretty color, too)!



It is unclear why this "mid-stream horse-switch" was undertaken, but I would not be terribly surprised to learn that it had something to do with the throw-away due diligence argument Arent Fox offered, and I highlighted in a discussion, toward the end of last month.

A bit of a pickle that one created, no?

Of course, it could be completely unrelated -- and it could be as simple as "it makes sense to keep all our defense counsel well-coordinated, so why not consolidate at one firm?"

Which, of course, is to admit that I was (mostly) right -- as "better coordination" could have avoided that particular gaffe.

I'm jes' sayin, that's all. . . .

Vytorin/Zetia Marketing, Sales Practices, and Products Liability case hearing in Newark -- July 18, 2008


Udating an earlier item, here -- the previously-scheduled judicially-supervised teleconference has just been ordered to be handled as an "in person" hearing on the record, in open court -- the court rooms open to the public, at large. That is a very good thing, for this blog, and perhaps, for Pharmalot (hint-hint), too.

Re: In Re Vytorin/Zetia Marketing,
Sales Practices, and Products
Liability Litigation
, Civil
Action No. 08-285 (DMC); MDL No. 1938

Dear Counsel:

Kindly be advised that the telephone conference scheduled for Thursday, July 17, 2008 at 10:00 a.m. has been converted into an in-person conference on Friday, July 18, 2008 at 10:00 a.m. Should this change present an unavoidable conflict for counsel involved, the Court will be amenable to further rescheduling.

SO ORDERED.

/s/ Mark Falk

United States
Magistrate Judge

Well, this could be a very entertaining day in the federal District Courthouse -- in Newark, New Jersey.

Maybe I'll pop-in. We'll see.

Of the "Generally-Goofy" Thoughts of Tim Anderson on SEAS. . . .


As I first hinted here, yesterday afternoon, with my first link, some analysts -- Tim Anderson at Sanford Bernstein, most notably -- are suggesting that a small study due out in the Fall of 2008, called SEAS, will provide some vindication for Schering's Vytorin.

I. think. not. Here's why:

SEAS is a study not at all designed to measure Vytorin v. statins, or other actual therapies. No, it is a superiority non-inferiority study [Thanks go to commenter Marilyn, below!].

In fact, all SEAS "measures" is the effectiveness of the combo-pill, Vytorin, against a placebo. In other words, it seeks to provide the data that Vytorin should have shown, in order to be approved by the FDA, in the first place, as to effectiveness [but that, lax FDA approval processes, 2001-2004, is a topic for another day].

So, when all is said and done -- if SEAS returns a "positive" -- all we will know is that Schering's Vytorin does better than nothin' at all.

There will be no statistical way to tease out how much of the effect was due to the statin portion of the pill, and how much was due to the ezetimibe portion. [This point was very-cogently first made by one Marilyn Mann at Pharmalot's joint, yesterday.]

In fact, it might be fairly argued -- if we accept Tim Anderson's rather non-lucid analysis, and original premise -- that a "win" on SEAS simply declares that a statin -- the portion of the pill-combo that has been around forever, and been proven to work in improving outcomes -- was responsible.

So, IMO, this line of analysis is really clutching at straws.

~~~~~~~~~~~~~~~~

Confidential Sidebar: Isn't it possible that Schering has (once again!) acheived a "functional unblinding," (this is a superiority non-inferiority study, after-all) and "pre-"determined that Vytorin will show a positive outcome? I think so. Why else are we hearing about this, now?

Note -- IF Vytorin shows anything less than a VERY STRONG improvement over the PLACEBO -- it has NO BUSINESS being an approved drug -- none. It should be pulled by FDA, if it can't beat a placebo. This is especially true, if one considers that such a failure would mean that ezetimibe somehow dampens the known-effectiveness of statins. Wow.

To be clear -- I think Vytorin will show an improvement over "nothin' at all" -- but that is very cold comfort, for such a pricey drug.

Wednesday, July 9, 2008

Matt Herper has a nicely balanced piece in Forbes today. . . .


But first, do go read this -- it is related, and perfectly put!

At the end of the day, it would seem that the Pfizer/Lipitor non-result in CASHMERE really means. . . nothing to Vytorin/Zetia.

It comes out as a zero. Nada. Zip.

Do go read it, it is quite well-sourced and fairly-balanced.

~~~~~~~~~~~~

[I do wonder whether my own Fourth of July round-up was the germ of Matt Herper's idea for today's Forbes story. Yes, I do wonder -- someone from Forbes spent time reading the July 4, 2008 entry on July 5 and again, on July 6. Interesting.]

Tuesday, July 8, 2008

Lowenstein Sandler may one day wish it hadn't (so-firmly) staked out THIS position. . . .


Lowenstein, Sandler represents many of the defendants in the Schering ENHANCE Securities Fraud putative class action. That firm also represents many of the same defendants -- in an earlier iteration of a Schering Securities Fraud class action -- the one involving manufacturing problems related to the Clarinex launch in 2001. That older piece of litigation has progressed a bit in the intervening years, leading to motions for summary judgment, filed by the Lowenstein firm.

Read the below, from one of those filings -- click it to enlarge.



". . . .unless such silence renders an affirmative [truthful, but incomplete] statement misleading. . . ."


Now, consider that Sen. Grassley, and many of the plaintiffs, are beginning to focus upon the idea of "functional unblinding". It was apparently one of the more important events on the plaintiffs' ENHANCE securities fraud timeline -- the "functional unblinding" of ENHANCE, as early as January 2007 -- a full year before Schering presently admits it had formally-unblinded results from ENHANCE.

If this functional unblinding theory is established by competent evidence, then every statement filed with the SEC about the Cholesterol Franchise was arguably "misleading" -- in that it ommitted what Schering already well-knew: ENHANCE had failed. That is the sort of "silence" that has been held to be misleading enough to sound in securities fraud.

That would make the highlighted statement, toward the end of the letter, above, very troublesome for Schering, Messrs. Hassan and Becherer, et al., and Lowenstein.

We'll know far more on August 1, 2008.

Monday, July 7, 2008

Some (nearly) real-time analysis of whether Schering-Plough's preferred is fairly priced at $190 per share, today with its common at about $19.80


Last week, a kindly anonymous commenter (below) here, asked after the wisdom of buying Schering-Plough's 6% preferred stock, due August 2010, to collect the $3.75 (per quarter, or $15 annual) dividend. I think that's a sucker's bet, and below I'll explain why -- but first, let's re-read the commenter's questions:

Anonymous said. . . .

Do examine the dividend per share that has been announced for owners of Schering common stock - $.06 and contrast it with the preferred dividend of - +-$3.75.

Am I wrong or should I run right out and buy some Schering common so I can get my $.06, while the few can get their $3.75? The preferred likely meets legal requirements for advertising but who really knows about it except the top execs? My understanding is that the price is expensive but contains a guaranteed rate of return. Is this all on the up and up?Many at the top own this preferred and are cleaning up at the rests' expense. NO?

July 1, 2008 10:51 PM

Now, my rather longish answers -- parts of the below were prepared for answers to other boards' questioners -- so this may be overly-inclusive. The background will likely be useful, though. Note also that Schering's common dividend per quarter is actually 6.5 cents, not a flat 6 cents. And rememeber, I am not giving investment advice. Use your own advisor -- make your own decisions -- after doing your own due diligence:

In a word -- No.

[A preliminary note: In this discussion, I've assumed the investor buys the preferred at close to recent prices -- say, around $190 per preferred Schering-Plough share.]

I'd not buy the preferred. It is a suckers' bet. And here's why:

The preferred -- trading now at around $190 a share -- will automatically covert into a variable number [bracketed by buckets] of shares of Schering common stock in August 2010 (at an implied price of no less than $27.50 per common Schering share). That single fact is why the preferred trades a fair amount like Schering equity (common), and not so much like debt.

Now, if Schering's common is below $27.50, in August 2010, then Schering's issuance of the shares will be dilutive -- Schering will have to pay out $27.50 worth of value when the market is pricing the stock below that. That's a bad thing, for Schering, and a good thing for the preferred holder.

Between the Schering common prices of $27.50 and $33.69, in August 2010, it will be a straight exchange/convert. (That's a generally-neutral thing.)

If Schering common shares are above $33.69 in August 2010, the issuance will be non-dilutive to common-holders. And that would be a good thing, to Schering, all other things being equal, and a bad thing (absent some special tax situation, unique to a given holder) to the preferred holder.



But, from where I sit -- there is almost no chance of this stock being north of $33 by August 2010. I think it most likely will be nearer $16 to $22 by then. So, let's look now at some more-likely scenarios, given this.

At August 2010, the original $250 invested, by the first person who purchased the Schering-Plough preferred, is supposed to be returned by Schering-Plough to the person then holding the preferred (sorta' like the principal on a debt, with a balloon payment at the end). Remember though, that Schering-Plough common was trading at $27.50, back in August 2007 -- so, you are taking some very real "principal" risk, by buying the preferred when you know that the underlying Schering-Plough common has declined by 35 percent since August 2007. [A good chunk of that particular loss -- for people who bought in the new issue market -- may be unavoidable, if they hold to maturity.]

So, regardless of what you originally paid for the preferred, be it $190, or $220 or $150 or even $250 -- at August 2010, assuming that Schering-Plough common is trading at anything less than $27.50, then for every preferred share, the holder will get 9.0909 shares of Schering-Plough common. [$250 divided by 9.0909 = $27.50]. With me so far?

So, if you paid $190 for it (about today's price), you'll get 9.0909 Schering-Plough common shares. And, that seems a little too risky, to me, for these perils (the issuer-specific risks Schering-Plough now faces).

The key question is whether, on that day, in August of 2010, Schering-Plough common is trading at $25, $22, $20 or $15.

If Schering-Plough common is trading at $20, you can sell those new 9.0909 common shares to get $181 (before calculating your periodic return on the dividends, and before paying your capital gains tax). If you bought the preferred at $190, then you "lost" $9 of principal value. Importantly, though, you will have collected dividends (and paid the higher ordinary income tax rates on those dividends) for the period from today to August 2010 -- about $30 (pre ordinary income tax on the dividends paid) -- as there are now just about two years left on the preferred.

So, your all in net after tax gain might be $11 -- if you are in the 33 percent tax bracket [Your $30 of dividends, less taxes of $9.90, equals $20.10 of income, less the $9 capital loss you suffered in August 2010 by receiving $181 worth of common, for a preferred you paid $190 to acquire, at today's prices -- leaves $11.]

If you bought the preferred at $190 (say, last week), then "all in, you made" $11. So your two-year rate of actual return was 5.78 percent, or your annual rate of return was 2.89 percent. Rather anemic for these risks, I'd say. Again, throughout this example I assume a purchase of the preferred at near today's preferred market prices, and a August 2010 common price of around $20, or up 5 percent from today's Schering common prices.

If you buy the preferred at anything over $200, you'll very-likely "lose" on this bet. But notice -- if you originally bought in at $250 (the intial public offering price, in August of 2007), you are already sitting on an unrealized 30 percent loss (on the underlying decline in common stock). Yikes -- so, much of the "loss" in that case already existed prior to today, in 2008.

To further complicate matters, if Schering-Plough common is trading at $18 in August of 2010, then again, you lose "principal" -- unless you bought the preferred at less than $174. Who knows where Schering-Plough common will be in August 2010? No one. Make your own guesses, here -- and work it out.

So, it all depends on where you bought into the preferred, and where Schering-Plough common is, at August 2010.

Now -- and of the most interest to me -- personally, if Schering-Plough common is below $27.50 at August 2010, the new common shares will dilute the older Schering-Plough common holders. And they won't like that one bit. It will cost the company, in both money, and reputation.

Given all of the above, you can work out what happens at the high end -- above $33.69 (using a fixed convert of 7.4206 common shares for each preferred). Make your own guesses about what Schering-Plough preferred will trade at, in 2010, and what Schering-Plough common will be then -- [just over the fix-spot, at] $34, or way over at $40, or up huge at $45.

However -- Remember that if Schering-Plough common trades above $50.53 for a period of time, the company may force the preferred out of your hands, and convert it, at the fixed 7.4206 rate, into Schering-Plough common.

Whew -- so, there are very-few absolute statements that may be made about Schering-Plough's -- or any Fortune 200 company's -- mandatory convertible preferred stock issuances. I do think the deck is stacked, at the moment, against Schering-Plough preferred being a worthy risk-to-return investment.

Now, more on the Schering-Plough (dilution) side:

These instruments are generally touted by the company's bankers, to the company, as being low-cost financing vehicles (from the company's point of view). This argument runs along the lines that, as Schering-Plough common rises, the company will likely be able to force conversion early, and produce exactly the savings you point out (lower dividend, mostly).

What Schering-Plough seemed to overlook, back in August of 2007, was that, if its common stock fell significantly, it would have to issue a lot of shares in August 2010 -- over 104.5 million shares of common (11.5 million shares of preferred issued at August 2007, times 9.0909 equals 104.54 million shares of common), and it must cover those new Schering-Plough common shares with earnings sufficient to meet Schering-Plough's expected EPS numbers in 2010, and every year thereafter. . . else, the per share of Schering-Plough common will fall, even more. So, one man's "well, that's only 5.6 percent dilution" is another man's "can't get there, from here" on the expected 2010 Earnings Per (Common) Share line.

But it is true that the running cost of the dividends line -- for Schering -- decreases, "all in" upon conversion -- when the conversion ultimately comes, at the start of the third quarter of 2010.

I might suggest that a more meaningful comparison (v. the dividend-rate differences) might be to look at what would have been the August 2007 Schering-Plough "pure debt interest rate" -- the rate at which Schering-Plough could have sold straight-vanilla unsecured debt.

I suspect that number was well-south of 6 percent. So, given the ENHANCE disclosure, the preferred looks like a bad deal, even for Schering-Plough, from where I sit.

Now as to this suggestion of yours: ". . . .Second, isn't there a one time gain since Schering-Plough booked the sale at a value of 2.500M (assuming a conversion of $27.50) and if they convert at any price under that figure, Schering-Plough could buy the common back and book a one time profit on the difference?. . . ."

In a word, no. This would likely be a "manipulative practice", generally prohibited by the federal securities laws, and rules promulgated thereunder.

There are some very complicated SEC rules about when and whether Schering-Plough may repurchase its own common shares during a so-called "tender period" -- a period of time governed by the Williams Act's rules on not manipulating the market for one's own securities.

See, when the forced conversion comes, Schering-Plough will need to be out of the market of its own common (generally speaking -- there are some largely-esoteric exceptions) for a period of time.

So Schering-Plough can't just plan, with any degree of certainty, on buying back Schering-Plough common to fund the preferred/forced conversion issuance of common.

Moreover, it is my experience, that in low interest rate environments (like this one), and in situations where the underlying common is trading at low values, relative to recent history (again, like this situation) -- and where that is due to real uncertainty about future results (like here). . .

that a preferred will be more volatile (show wilder price swings) than the underlying common -- it just has so much futher to fall -- so, I'd shy away from it. I don't think a yield of 7.8 percent will adequately compensate you for the real probability of "loss of principal" I've alluded to above.

But you may feel differently. Obviously, if a capital loss of this kind has tax-appeal for your personal situation, that might make a difference on your risk/return calculus hare, too.

So, if I were convinced that Schering-Plough common was a reasonable purchase, at this price (~$19.60), I'd go buy the common, book the dividend on it (it is bigger, as a percentage, at these lower common prices), and leave the risky-volatile preferred for others to chew on.

But I am not convinced that Schering-Plough is a good buy at these levels, so you should probably seek advice elsewhere, as I cannot see the preferred as offering any real kind of hedge.

These opinions are all a function of time and tide. Time and tide. Yours may differ.

Sunday, July 6, 2008

Tomorrow's WSJ -- Glaxo, Novartis CEOs Evince "Vision", by asking Euro-Regulators about Priorities for Approvals. . . .


Tomorrow's print Wall Street Journal will carry a very interesting counter-point to Fred Hassan's recent lament -- also aired on the front page of the Wall Street Journal, just a week ago -- that Hassan just doesn't know what it takes to get a drug approved at FDA, anymore. Ah, the poor dear.

In contrast to Mr. Hassan's proffered befuddlement, UK-based-GlaxoSmithKline PLC CEO Andrew Witty did the apparently-truly-remarkable:

He asked -- asked UK, French, Italian and Spanish regulators. Whoa. Novel concept.

Quoth The Wall Street Journal:

. . . .British pharmaceutical giant GlaxoSmithKline PLC is taking the unusual step of giving government health-care systems a say in deciding which drugs advance in its research pipeline, a move it hopes will result in more products these customers will pay for.

Glaxo's new chief executive, Andrew Witty, said the effort is part of his drive to help the world's second-largest drug maker adapt to a tough pharmaceutical market. In recent years, soaring health-care costs have led insurers, governments and other drug buyers to tighten their belts.

"I'm going to deal with the pharmaceutical realities of the next 10 years, and they're very different from those of the 1990s," Mr. Witty said in an interview at a company townhouse. . . .

The current Novartis CEO also drew approving ink in the article for consulting with European regulators over pipeline priorities.

Confidential Note to Fred Hassan: This -- the above -- is just a thought. Feel free to ignore it. I mean, it is pretty far "out of the box" thinking to ask some of your most-important payors -- and key regulators -- what each might be most-inclined to approve, and "pay" for, respectively.

But really -- you, and Schering have no need for nutty, stake-holder/customer-focused ideas like these. I mean, you are sitting perfectly "pretty" right where you are, now, right? Right.

It is just so much easier to hold that last, long, wailing note, seemingly-forever, on your lament: "We just don't know what to do with the FDA-a-a-a-a-a--a-a-a-A-A-A-a. . . ."

Once again, A Picture's Worth 1,000 1,000,000 Words. . . .


NOTE: AND, once again, thanks to PM for the heads-up on all of this (Gooz's her latest, on the benefits and costs of Avastin, the very-pricey Genentech cancer drug, is very-well-laid-out -- do go read it) and do go read this, on preventible inpatient death rates, by PM. . . .

UPDATED -- 07.06.08 @ 7:00 PM EDT: The Insider, at Pharmagossip is on the case -- and has featured my derivative graphics, at right. Brilliant!

Now, the graphic at left (a part of this longer editorital) was originally derived from the data presented in this NEJM paper. What I want the readers to notice is that -- at every subgrouping -- ezetimibe did not outperform the statin-regimen in any statistically-significant fashion.

Perhaps even more importantly, in the sub-groupings in which ezetimibe performed worse -- it did much worse. Note how "right weighted" those dots are (click the image to enlarge it). Only three of 25 sub-groups were fully-over the "zero-line", and into the "left side -- ezetimibe better" result -- and all of those three were just barely better.

Now, let's hear from Dr. Taylor, himself (do go read all of his, though):

. . . .[Earlier] in this issue of the Cleveland Clinic Journal of Medicine, Dr. Michael Davidson, a respected lipid expert but one invested in ezetimibe’s development, assures us that all is in order and that the results of ENHANCE can be explained away by several arguments, most notably that most of the trial’s participants had previously received lipid-lowering treatment, which obscured the effects of ezetimibe.

Moreover, he argues that ezetimibe’s mechanism of action is well understood and that the drug is safe and well tolerated and thus should remain a first-line treatment for hyperlipidemia.

These arguments may eventually prove to be correct, but as of now they are merely wishful post hoc hypotheses awaiting more data apart from ENHANCE. Negative clinical trials do occur as a matter of chance, but we should be cautious in any attempts to explain away a trial that was designed, executed, and reported as conceived simply because the results do not match our expectations.

Confronted with ENHANCE, the astute clinician should ask three questions: Do we really understand ezetimibe’s mechanism of action? Do other lines of evidence indicate the drug is beneficial? And how reliable is the arterial thickness as a surrogate end point?. . . .

That is exactly right -- the bottom line?

There can be no lipstick red enough for this pig -- the pig called ENHANCE.

UPDATED: I think Dr. Davidson's opposing conclusion -- in the vein of "the lady doth protest too greatly" -- tells me all I need to know about his biases:
. . . .Enormous challenges are on the horizon for the pharmaceutical industry, with a shrinking pipeline of potential new drugs, increasing regulatory hurdles, greater liability risk, political pressure for price controls, enhanced scrutiny of sales practices, and a growing media bias. As a cardiologist and clinical researcher [appeal to emotion omitted]. . . . I am concerned that, unless change occurs, a vibrant pharmaceutical industry with the financial and intellectual capital to find and develop new, more effective treatments will cease to exist. . . .

With all due respect, Dr. Davidson, that is a conclusion not remotely supported by the actual data. This silly mantra of the "death of US Pharma" [as Samuel Clemens, in 1897, sort of intoned -- "is greatly exaggerated. . . ." and] -- simply must stop. It is beneath the abilities of the people offering it. It suggests there is little else, of worth, to write in defense of the failed study. Perhaps that is the case.

Perhaps that is the object lesson, here.

[In the interest of being complete, here is the introduction of this Journal's editor -- Dr. Brian F. Mandell -- to the above point-counterpoint debate, found in this month's Cleveland Clinic Journal of Medicine. All of the pieces are PDF files -- emphasis here supplied.]

Saturday, July 5, 2008

An important judicial teleconference -- on discovery issues, and scheduling -- on one "peninsula" of Schering-Plough's "continent" of litigation. . .


Last month, Judge Cavanaugh encouraged the plaintiffs' lawyers in the consolidated actions now captioned In Re Vytorin/Zetia Marketing, Sales Practices, and Products Liability Litigation (Civil Action No. 08-285 (DMC); MDL No. 1938, US Dist. Ct. NJ), to meet with the defendants' lawyers and try to work out some of their differences. One of the more important remaining differences is now scheduled to be the subject of a July 17, 2008 judicially-supervised teleconference. Quoting from the Magistrate's letter order, just filed July 3, and entered as of July 4, 2008, then:

". . . .Please be advised that this matter has been scheduled for a telephone conference on Thursday, July 17, 2008 at 10:00 a.m. The parties should be prepared to address the discovery scheduling issue raised in plaintiffs’ letter of June 19, 2008 to District Judge Cavanaugh (docket no. 61). Plaintiffs’ co-liaison counsel are responsible for arranging and initiating the conference call. . . ."

/s/ Mark Falk
United States
Magistrate Judge

The issue to be discussed on this call is whether the plaintiffs will be allowed to begin "discovery" -- that is, start reviewing Schering documents (including Schering's "due diligence" files), and potentially taking depositions -- before the court rules on the pending Schering-Plough motion to dismiss these consolidated actions.

It may take several months -- into early 2009 -- before the court will be fully-briefed on the issues that will drive its decision on the pending motion to dismiss. So, quite sensibly, the plaintiffs do not want this to be a period of "lost time", in terms of moving the litigation forward, should the judge deny Schering's motion to dismiss (given the considerable amount of potential evidence of alleged negligence, if not outright malfeasance, and the variety of the plaintiffs' theories for recovery, I personally doubt that Schering has much of a chance of winning on its motion to dismiss -- I'll explain why some other time).

So -- here's "what's-up" for July 17: whether the plaintiffs may begin to force Schering to turn over that potential evidence, essentially immediately, perhaps entirely mooting the pending motion to dismiss.

While I think it likely that Magistrate Judge Falk (for District Court Judge Cavanaugh), is likely to allow immediate discovery -- it is a certainty that Schering will seek to have the judge -- Judge Cavanaugh -- reconsider the Magistrate's decision -- in the event that the Magistrate allows immediate discovery. Delay, in these situations, is usually the ally of the defendants -- that is, the longer Schering can hold-out, and avoid offering up its internal files for review, the greater the chance that various peoples' memories will have faded, or clouded-over, and sharp recall of details will have been "lost" -- such that no clear trail of wrong-doing (or exoneration!) will appear from any of the documents (and the depositions of witnesses, as they are quizzed about the relevance, meaning and import of the documents).

So -- I'll predict that Magistrate Judge Falk will allow essentially immediate discovery (an important "first-step" toward victory for the plaintiffs); Schering will file a motion for reconsideration -- and, if Judge Cavanaugh (after a Schering motion to reconsider) then allows discovery to proceed immediately, Schering's lawyers will take an immediate appeal of that order "upstairs" -- to the Court of Appeals.

However, there are ways in which Judge Cavanaugh's ultimate order may be crafted to minimize the chance that Schering could acheive additional delay (by filing that appeal). For example, Judge Cavanaugh could enter his order (allowing immediate discovery against Schering) as a "non-final", or conditional, order -- it could be an interim order allowing discovery to proceed, subject to his ruling on the motion to dismiss. That would leave Schering with almost no basis to appeal, as only "final orders" are generally appealable, under the federal rules. If non-final, the order would be non-appealable -- but might be vacated, if, at some future point, as briefing on the motion to dismiss evolves, Judge Cavanaugh sees the motion for dismissal as being more meritorious than it now would appear to be.

So -- and the reason for all this circumlocution, here -- if this July 17 conference call goes well for the plaintiffs, internal Schering documents could begin to emerge as early as late-August, 2008. More likely, it will be late-September 2008, but soon enough, Schering will have to begin to make those diligence files available. And there will very-likely be a treasure trove of evidence there.

Evidence that radiates well-beyond these consumer fraud cases -- to the derivative actions, to the ERISA cases, to the RICO actions and, of course, to the securities fraud claims -- and, very-little of it likely helpful to Schering's defenses. Remember, you read it here, first.

Friday, July 4, 2008

Pharmalot and Herper; on Nissen -- then Lipitor's CASHMERE data. . . .


I've been out of pocket most of the day, but saw this one by Matt Herper -- and Ed Silverman's cogent remarks on the same topics, earlier -- thanks to PM (her latest, on reducing preventable inpatient death-rates, is great -- do go see it, BTW!).

Sort of as a tangent off of those few -- there is also, tonight, a budding CafePharma thread -- in which the Schering-Plough Joint Venture faithful see CASHMERE [a small Pfizer/Lipitor study that came out inconclusively, using CIMT (carotid intima-media thickness) as a proxy-measure] as some vindication of Vytorin.

My take? "Well -- that's. just. Odd. . . ."

I am all for vigorous scientific debate -- but to paint CASHMERE as vindicating Vytorin is simply wishful-thinking. I am sure someone will immediately correct me if I am wrong, here, but Vytorin has no "outcomes data" in its favor. Lipitor plainly does -- tons of it.

So -- I'd allow that a smallish study involving Lipitor came out inconclusively -- and the use of CIMT as a measurement is now suspect. That is all relatively-fair.

It is a horse of a completely different color, though, to suggest that this means Vytorin should be, in any way, elevated to be on a par with Lipitor -- as to outcomes data. That is rubbish. Simply rubbish.

Vytorin simply has no data to back that claim. None.

Lipitor now has one inconclusive study, to add to its several larger favorable outcomes studies. Doesn't that say it all?

Have a safe and happy Fourth, one and all!

Thursday, July 3, 2008

44 days later. . . . on DTC -- and Merck and Pfizer have YET to respond?


The Schering-Plough "immediate" response to US House of Representatives Engergy & Commerce Committee Chairman Dingell's written requests -- for industry's assurances about some of the ethical issues involved in so-called "Direct to Consumer" (or DTC) advertising of FDA-regulated pharmaceuticals -- is now available (PDF file) on the web.

It was 44 days ago that the Chairman asked for an "immediate written response" from these four companies. Smartly, J&J hand-delivered its response to the Chairman on May 30, 2008. [Those apple-polishers(!) -- click the image, at right.]

Though CEO Fred Hassan's letter on behalf of Schering is also dated as of May 30, 2008 -- it would seem highly-unlikely that it was delivered to the Committee at the same time as CEO William C. Weldon's, on bhalf of Johnson & Johnson. Why? Well, because the Committee's website has featured a link to the J&J letter of response for over a month, now -- and the Schering link appeared sometime during the afternoon, yesterday -- on July 2, 2008.

Note also that the PDF file shows a series of hand-written "routing" notes on the upper right portion of the first page (or, click on the image, below). That would suggest that the letter was dumped into the "ordinary" U.S. Postal Service Congressional Mail-bins (note that the Committee's Room Number is hand-written at the far upper-right) -- and so, at a minimum, it took a few weeks to arrive on the Chairman's desk. Not so smart, Mr. Hassan:



Seriously -- how much does hand-delivery cost? Or FedEx, signature required?

And, what are we to make of Pfizer? And of Merck? No letter -- in 44 days? Wow.

Wednesday, July 2, 2008

Miscellaneous Schering-Plough Putative Class Actions -- Litigation Updates, here. . . .


Rather than set each of these up separately, I'll consolidate these few litigation developments -- as each one, individually, is relatively minor:

(1) The plaintiffs will have until September 22, 2008 to file their amended, consolidated complaint in In Re: Vytorin/Zetia Marketing, Sales Practices and Products Liability Litigation (MDL Case No. 1938, original lead case captioned Polk v. Schering-Plough et al., Case No. 08-285) -- and, I bet some version of this Complaint Paragraph 72 will be featured, then and there. Heh!

(2) As earlier mentioned, the consolidated amended securities fraud complaint is at the moment due on August 1, 2008 -- it too will likely feature some version of the above-mentioned Complaint Paragraph 72.

(3) Dr. Jeffery Feldstein's attorneys -- in USA v. Organon, et al. (Case No. 07-2690), the Qui Tam/False Claims Act case, are seeking an unspecified additional chunk of time to respond to, or otherwise move against the Schering Motion to Dismiss, filed by Arent Fox -- Judge Cavanaugh hasn't yet ruled on this rather customary request for an extension, but if nothing else happens, the response to motion will be returnable (due) on July 21, 2008. July 21, 2008, of course, is also the morning on which Schering will announce its second quarter financial results -- a webcast, with a conference call.

I'd suspect Dr. Feldstein's lawyers are thinking "there are so, so many grounds upon which to oppose -- and so very little time(!)". . . .

Said another way, I'd expect that response, when it comes, to lay the issue of "due diligence" directly at the feet of Schering-Plough, and its various investment bankers and securities underwriters.

(4) As earlier mentioned, Judge Cavanaugh consolidated two civil ERISA actions Gradone v. Schering-Plough, et al. (Case No. 08-1432 (DMC), U.S. Dist. Ct. N.J.) and Oettinger v. Schering-Plough, et al. (Case No. 08-2436 (WJM), U.S. Dist. Ct. N.J.), for all purposes and appointed interim class counsel. The now-consolidated cases have been re-named In re Schering-Plough Corp. ENHANCE ERISA Litigation (Case No. 08-1432 (DMC), U.S. Dist. Ct. N.J.).

Have a safe and happy Fourth!

Tuesday, July 1, 2008

From a Friend of the Blog -- Forbes' Herper -- on the "Statin Showdown" Comparing Statins v. Ezetimibe


[Headline Revised, per the below: "Comparing and Contrasting Statins v. Ezetimibe". . . .]

An occasional guest blogger at Gooznews -- one PM alerted us to the mobile edition (fancy!) of last night's Forbes piece updating the state of the play on statins. Do go read it. It is delivered sans graphics and ads. Nice.

UPDATED -- 07.01.08 @ 6:00 PM EDT: Several developments lead me to float this to the top of the blog.

First, read this reaction, posted over at CafePharma, to the Herper story being pasted-in there by someone:

Forbes article on ezetimibe v. statins

~~~~~~~~~~~~

What's very interesting about this article is I distinctly remember, as do several of my counterparts, a particular cardiologist asking the same thing about Zetia. However, the conversation occurred years ago when I launched Vytorin. In fact, he was my very first call when I began launching the product. I was happy to be launching this new product and was terribly disheartened after my first call in the field with Vytorin. He questioned me about the effect Zetia could have on inflamation and suggested that Zetia could have a negative effect. We had a very long discussion as the cardiologist carefully outlined his concern over lack of data for the Zetia component of Vytorin. Interestingly, I discussed with my manager that this cardiologist was concerned and would not use the product until we have proof that Zetia did NOT have a negative effect on inflamation. In typical manager fashion the eyes rolled and the rant began about how this guy was an idiot and we need to find a way to convince him to use it. Another interesting parallel is the fact that Cordaptive was not approved based on lack of evidence of one component of the combo. HMMMM, makes me question what I do in the field each day. . . .

Well, that war-story is entirely fascinating. Shove the drug into the docs' bags -- don't listen to actual feedback on mechanism of action. "Don't confuse me with any actual facts -- my mind is already made up -- we're positively going to flog this new product -- it's the best thing since sliced bread! -- so that's that. . . ."

Now the second reason, and perhaps more importantly, the real reason for floating, as well as updating, here, is that I have revised -- at PM's astute suggestion -- the title of this post. PM writes:
. . . .The headline to [the Forbes] article doesn't really fit the content of the article. The intent of the piece is to point out that statins have pleiotropic effects, i.e., beneficial effects unrelated to cholesterol lowering. Ezetimibe appears not to have these effects, due to its different mechanism of action. So I was wondering if you could revise your post so it is clear that the article contrasts ezetimibe with statins. . . .

Done. I originally read it -- looking for new information on the marketing of Vytorin -- and saw none. Clearly, PM's eyes are more discerning than mine. Have a safe and happy 4th, one and all! May be light blogging through the weekend, here. . . .

Now, that's what I'm TALKING about. . . .


[UPDATED -- 07.02.08 @ 10:00 PM EDT: A gent named Random John (who really isn't -- all that "random", that is), at Realizations in Biostatistics, has also weighed in on this topic -- the likely irrelevance of "blinding/unbliding" in non-inferiority studies, where non-inferiority does NOT result -- and, he linked my post. Thanks!

07.01.08 @ 11:00 PM EDT: That gentleman across the pond, the Insider -- at PharmaGossip, has linked this story, and featured its graphics! Thanks a ton!

Apparently, Dr. Peter Rost at The PharmaLaw Blog has also linked this, freely-liberating the graphics -- COOL! (that's what they are here for, folks!) -- while adding significant additional detail about the possible origins of Sen. Grassley's scientific understanding of "non-inferiority" studies -- studies like ENHANCE. Did the Senator's staffers "go to school" on all of this via The Insider and Dr. Rost? Read the above two links, and decide for yourself!]

I missed this earlier in June, but it would seem that the first case reciting Sen. Grassley's theory of the irrelevance, from a scientific/statistical and legal point of view, of the blinded v. unblinded ENHANCE data-sets -- has now been filed. This will likely become a central theory advanced in the yet-to-be amended securities fraud complaints, the shareholders' derivative action, and all the others, due to be filed later this summer.

This particular case is a consumer fraud case, filed June 13, 2008, by a health-care plan in Minnesota, captioned Electrical Workers 242 Health and Welfare Fund, et al. v. Merck & Co., Inc, et al. (Case No. 2:08-cv-03025-DMC, Complaint filed June 13, 2008, US Dist. Ct. NJ).

This is the legal theory I think I was the first to really outline, and then amplify, back in early April 2008, after reading Sen. Grassley's February letter, referenced in the below paragraph. As ever, click the image to enlarge it.



Cool.

[Late-night edits: the original PDF of the complaint, as well as my original .jpg of this portion, above, contained a typo: "unblended" where "unblinded" was plainly intended -- I've fixed it, in three places, just now. Also, "not" was used once where "no" was intended. Even though the original at the federal district courthouse in Newark still contains these typos -- this one will be fully-correct. In this way, it will make a better model -- for all of the other plaintiffs' lawyers, likely to graft it into their respective complaints.]

Senator Grassley -- on the Unaccounted-for "Billions of Dollars Spent on Medicaid/Medicare Supplemental Payments"


Yesterday, the Senator's office released the following statement:



June 30, 2008

M E M O R A N D U M


TO: Reporters and Editors
FR: Jill Kozeny, 202/224-1308
for U.S. Senator Chuck Grassley of Iowa

RE: GAO report on supplemental payments to hospitals

Senator Chuck Grassley is urging the Centers for Medicare and Medicaid Services to implement recommendations issued today in a new report of the Government Accountability Office payments of disproportionate share (DSH) funds to hospitals. The report, GAO-08-614 [Full-text of PDF file at link], is titled MEDICAID CMS Needs More Information on the Billions of Dollars Spent on Supplemental Payments. . . . Senator Grassley also said he will continue to study the practices of non-profit hospitals to confirm that they are providing a public benefit commensurate with the public subsidies they receive. . . .

Hospitals in America, particularly non-profit hospitals, receive numerous forms of support from federal, states, and local governments. The Medicare and Medicaid programs provide disproportionate share (DSH) funds to hospitals that provide care to a significant caseload of uninsured patients. The Medicaid payment system for hospitals allows states to pay hospitals up to an Upper Payment Limit (UPL) which is greater than their costs under the state Medicaid program. In addition to not paying income taxes, non-profit hospitals receive tax-deductible contributions, issue tax-exempt bonds and receive exemptions from state and local property and sales taxes.

Hospitals were granted special status back at the turn of the last century when hospitals were the only places where the poor could go when they were sick. The enactment of Medicare in 1965 and the explosion of the insurance market since then has resulted in incentives for hospitals to treat only paying patients. The current environment is no different than where we were over a hundred years ago. Back then, people with money had private physicians who made home visits. The poor received treatment at alms houses supported by philanthropy. The only difference now is that many of those former alms houses have become rich institutions that believe they no longer need to serve the poor to reap all the benefits of their tax-exempt status.

In my investigation of non-profit hospitals, I have found disturbing evidence that some hospitals are not delivering the services that they should in exchange for the benefits they receive. Some hospitals lack charity care policies, or don't make them known to the public. They bill the uninsured or underinsured chargemaster rates, which are significantly higher than what insurance companies and Medicare actually pay. They engage in questionable collections practices. They pursue payments from the poor and near-poor uninsured without consideration of the DSH funds that they receive from states or the funds they hold in endowments. On June 10, 2008, the Finance Committee heard testimony from Lisa Kelly, who was required to come up with a cashiers check for tens of thousands of dollars before receiving treatment for cancer at the MD Anderson Center. An institution with an endowment of more than a half billion dollars required an underinsured woman with cancer to come up with tens of thousands of dollars before they would treat her.

We need to know that the public appropriately benefits from these numerous federal subsidies. We need to know that federal funds are being properly spent. In 2003, Congress passed a provision in the Medicare Modernization Act (MMA) to require states to submit annual audits of their DSH payments to CMS. Almost five years have passed, and CMS has still not implemented the final rule for the MMA provision. The GAO report I am releasing today shows how critical it is CMS issue the final rule.

CMS doesn't know where DSH funds are being used.

That simply cannot continue.





United States Senator
Ranking Member,
Committee on Finance


[Emphasis supplied.]