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

First, the more important of the 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 2, 2008 – by agreement of the parties.

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.

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 her/his 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 promise no individual will ever be identified — similarly, I will never disclose whether someone inside (or outside) the FDA posted any particular comment.

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 to this post, 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.

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.