The vast majority of Schering employees are decent, honest, hard-working people. . . .

. . . .which is why this sort of e-mail traffic is so unfortunate — here, the Lead Medical Investigator of the ENHANCE study (Dr. Kastelein) is trying to get a meeting scheduled with Schering-Plough and Merck executives, to go through ENHANCE issues, and apparently, the ball has been dropped on scheduling the meeting — things aren’t progressing. So, one of the executives asks about the “level of priority” on the project, at the Schering-Plough Research Institute (or “SPRI”, below) — remember, this is about a year and a half after the study was completed. Profanity ensues. As ever, click to enlarge:

This sort of traffic might lead one to wonder whether SPRI executives had some “additional motivation” in not promptly following-up on these presumably-proper requests — from the study’s lead medical investigator, no less — to schedule an important meeting.

The vast majority of Schering employees are decent, honest, hard-working people. . . .

. . . .which is why this sort of e-mail traffic is so unfortunate — here, the Lead Medical Investigator of the ENHANCE study (Dr. Kastelein) is trying to get a meeting scheduled with Schering-Plough and Merck executives, to go through ENHANCE issues, and apparently, the ball has been dropped on scheduling the meeting — things aren’t progressing. So, one of the executives asks about the “level of priority” on the project, at the Schering-Plough Research Institute (or “SPRI”, below) — remember, this is about a year and a half after the study was completed. Profanity ensues. As ever, click to enlarge:

This sort of traffic might lead one to wonder whether SPRI executives had some “additional motivation” in not promptly following-up on these presumably-proper requests — from the study’s lead medical investigator, no less — to schedule an important meeting.

The vast majority of Schering employees are decent, honest, hard-working people. . . .

. . . .which is why this sort of e-mail traffic is so unfortunate — here, the Lead Medical Investigator of the ENHANCE study (Dr. Kastelein) is trying to get a meeting scheduled with Schering-Plough and Merck executives, to go through ENHANCE issues, and apparently, the ball has been dropped on scheduling the meeting — things aren’t progressing. So, one of the Merck (Schering’s partner) executives asks about the “level of priority” on the project, at the Schering-Plough Research Institute (or “SPRI”, below) — remember, this is about a year and a half after the study was completed. Profanity ensues. As ever, click to enlarge:

This sort of traffic might lead one to wonder whether SPRI executives had some “additional motivation” in not promptly following-up on these presumably-proper requests — from the study’s lead medical investigator, no less — to schedule an important meeting.

Independent ENHANCE Panel MD: "This really overstates. . . We did not vote this."

~~~~~~~~~~~
UPDATED 4.18.08
~~~~~~~~~~~

A new lawsuit has been filed tonight, April 18, 2008, against Schering and Merck, alleging RICO pattern-activity violations, various state Consumer Anti-Fraud violations, Unjust Enrichment and common-law fraud. The most note-worthy feature of this suit, though, is that it picks up, almost word for word, much of what is written below, and adds it to the factual allegations already made in other suits — to establish civil RICO enterprise racketeering pattern activities. This new federal suit is captioned “Plumbers and Pipefitters Local 572 Heatlh and Welfare Fund v. Merck & Co., Inc., Schering-Plough Corporation, and Merck/Schering-Plough Pharmaceuticals, et al.” (Case No. 2:08-cv-01894, Complaint filed April 17, 2008, US Dist. Ct. NJ).

~~~~~~~~~~~
END, UPDATED PORTION
~~~~~~~~~~~

The more I look through the 70-plus pages of the document dump from Chairman Dingell, and Subcommittee-Chairman Stupak, tonight, the more convinced I become that several of the medical professionals associated with the ENHANCE study were wondering (aloud, at times) whether much of the “re-reading“, “querying of outlier data” and “potentially choosing new primary endpoints” was simply a delay tactic, given that it looked very likely, even in the “blinded” data (see this prior post), that there would be no statistically significant “non-inferiority” of the treatment arm, over the control arm.

But we start with an alleged attempt to document (and/or overstate) the few scientific conclusions reached by the independent ENHANCE science panel, at a meeting held in November 2007. The “draft minutes” were circulated not long after Schering Plough and Merck learned that a congressional inquiry was afoot. In one document, company executives assure a science panel member that the minutes will not be a public document, but will be used solely internally, and/or with the FDA. Oops. And with Committees of Congress. And with anyone who has an internet connection. Or buys a newspaper. Or watches television. But I digress — first, the “really overstates” snippet; then the overall e-mailed summary of this independent cardiologist’s problems with the “minutes” as drafted (some of which remained, apparently, in the final document used by Schering with the FDA, and others). In each case, click to enlarge:

Before too terribly long, I‘ll‘ve posted images of the e-mail exchange in which one Schering Plough executive called another Schering Plough executive a “prick“, and told him to “go f’ off” — all because the “prick” had the temerity, on September 17, 2007, to suggest that not enough attention was being paid to getting the ENHANCE study results finalized, and ready for publication — Wow. Tremendous corporate culture, that. Anyway, that is all for another day. Cheers!

Independent ENHANCE Panel MD: "This really overstates. . . We did not vote this."

~~~~~~~~~~~
UPDATED 4.18.08
~~~~~~~~~~~

A new lawsuit has been filed tonight, April 18, 2008, against Schering and Merck, alleging RICO pattern-activity violations, various state Consumer Anti-Fraud violations, Unjust Enrichment and common-law fraud. The most note-worthy feature of this suit, though, is that it picks up, almost word for word, much of what is written below, and adds it to the factual allegations already made in other suits — to establish civil RICO enterprise racketeering pattern activities. This new federal suit is captioned “Plumbers and Pipefitters Local 572 Heatlh and Welfare Fund v. Merck & Co., Inc., Schering-Plough Corporation, and Merck/Schering-Plough Pharmaceuticals, et al.” (Case No. 2:08-cv-01894, Complaint filed April 17, 2008, US Dist. Ct. NJ).

~~~~~~~~~~~
END, UPDATED PORTION
~~~~~~~~~~~

The more I look through the 70-plus pages of the document dump from Chairman Dingell, and Subcommittee-Chairman Stupak, tonight, the more convinced I become that several of the medical professionals associated with the ENHANCE study were wondering (aloud, at times) whether much of the “re-reading“, “querying of outlier data” and “potentially choosing new primary endpoints” was simply a delay tactic, given that it looked very likely, even in the “blinded” data (see this prior post), that there would be no statistically significant “non-inferiority” of the treatment arm, over the control arm.

But we start with an alleged attempt to document (and/or overstate) the few scientific conclusions reached by the independent ENHANCE science panel, at a meeting held in November 2007. The “draft minutes” were circulated not long after Schering Plough and Merck learned that a congressional inquiry was afoot. In one document, company executives assure a science panel member that the minutes will not be a public document, but will be used solely internally, and/or with the FDA. Oops. And with Committees of Congress. And with anyone who has an internet connection. Or buys a newspaper. Or watches television. But I digress — first, the “really overstates” snippet; then the overall e-mailed summary of this independent cardiologist’s problems with the “minutes” as drafted (some of which remained, apparently, in the final document used by Schering with the FDA, and others). In each case, click to enlarge:

Before too terribly long, I‘ll‘ve posted images of the e-mail exchange in which one Schering Plough executive called another Schering Plough executive a “prick“, and told him to “go f’ off” — all because the “prick” had the temerity, on September 17, 2007, to suggest that not enough attention was being paid to getting the ENHANCE study results finalized, and ready for publication — Wow. Tremendous corporate culture, that. Anyway, that is all for another day. Cheers!

FDA Letter re Vytorin: "Please revise. . . misleading promotional materials"

It is hard to overstate the importance of a letter like the one below, to a drug like Vytorin’s market prospects. In essence, the FDA is requiring Schering to say that the drug is less effective than alternative drugs. Now, by FDA rule, that copy change must be made within 90 days of the letter (or earlier, if Schering stocks-out of an item) — so, ALL the ad copy must be changed over, by April 24, 2008 — just about two weeks from tonight. This is an image of the actual letter — it was signed, digitally, by an FDA lawyer, Joan Hankin, on January 23, 2008 — at 3:39:39 PM — precisely. This is the actual letter Reps. Dingell and Stupak referred to, this evening.

What have Schering-Plough, and Merck been doing since then, to comply with this FDA letter? And, for how long had the Joint Veture partners been discussing this concept with FDA, prior to the actual issuance of the below letter? [There is an e-mailed summary, reflecting a meeting in which Joan Hankin participated, several days prior to her letter, where the action itmes included changing Vytorin ad copy. Wow.]

This is likely to get uglier before it gets prettier. As ever, click each to enlarge:

Independent ENHANCE Panel MD: "This really overstates. . . We did not vote this."

~~~~~~~~~~~
UPDATED 4.18.08
~~~~~~~~~~~

A new lawsuit has been filed tonight, April 18, 2008, against Schering and Merck, alleging RICO pattern-activity violations, various state Consumer Anti-Fraud violations, Unjust Enrichment and common-law fraud. The most note-worthy feature of this suit, though, is that it picks up, almost word for word, much of what is written below, and adds it to the factual allegations already made in other suits — to establish civil RICO enterprise racketeering pattern activities. This new federal suit is captioned “Plumbers and Pipefitters Local 572 Heatlh and Welfare Fund v. Merck & Co., Inc., Schering-Plough Corporation, and Merck/Schering-Plough Pharmaceuticals, et al.” (Case No. 2:08-cv-01894, Complaint filed April 17, 2008, US Dist. Ct. NJ).

~~~~~~~~~~~
END, UPDATED PORTION
~~~~~~~~~~~

The more I look through the 70-plus pages of the document dump from Chairman Dingell, and Subcommittee-Chairman Stupak, tonight, the more convinced I become that several of the medical professionals associated with the ENHANCE study were wondering (aloud, at times) whether much of the “re-reading“, “querying of outlier data” and “potentially choosing new primary endpoints” was simply a delay tactic, given that it looked very likely, even in the “blinded” data (see this prior post), that there would be no statistically significant “non-inferiority” of the treatment arm, over the control arm.

But we start with an alleged attempt to document (and/or overstate) the few scientific conclusions reached by the independent ENHANCE science panel, at a meeting held in November 2007. The “draft minutes” were circulated not long after Schering Plough and Merck learned that a congressional inquiry was afoot. In one document, company executives assure a science panel member that the minutes will not be a public document, but will be used solely internally, and/or with the FDA. Oops. And with Committees of Congress. And with anyone who has an internet connection. Or buys a newspaper. Or watches television. But I digress — first, the “really overstates” snippet; then the overall e-mailed summary of this independent cardiologist’s problems with the “minutes” as drafted (some of which remained, apparently, in the final document used by Schering with the FDA, and others). In each case, click to enlarge:

Before too terribly long, I‘ll‘ve posted images of the e-mail exchange in which one Schering Plough executive called another Schering Plough executive a “prick“, and told him to “go f’ off” — all because the “prick” had the temerity, on September 17, 2007, to suggest that not enough attention was being paid to getting the ENHANCE study results finalized, and ready for publication — Wow. Tremendous corporate culture, that. Anyway, that is all for another day. Cheers!

Friday Docu-Dump! — Reps. Dingell & Stupak Drop Bombshell Documents!

UPDATED — FDA’s letter re Vytorin is now online!

I’ll have much more on all of this in the coming days, but the after-the-fact creation of highly-defensive, lawyerly, written minutes — for a meeting (a meeting at which, at least one doctor was told, there would be “no recorded minutes” — ostensibly to improve the freedom of debate) of the lately-appointed, but finally-independent science panel on the ENHANCE study — just looks pretty bad, pretty-desperate, on its face.

Adding to the embarrassment for Schering and Merck, is the fact that the U.S. House Committee has ALSO released, to the public, the various doctors’ specifically-marked proposed revisions (in bubble-commented Word-versions) of those draft minutes.

Many of the comments made by the doctors disagree vehemently with some of the re-characterizations of the tenor of the meeting. . . . They use phrases like “overstates“, “misleads“, “is contradicted by” and “mischaracterizes” — and, well — NOW, I just have to say it — you’ve got a brand new public relations crisis on your hands, at Schering-Plough. I’ll have some of those other snippets up, later. [But even that doesn't seem to be the worst of it.]

No, I’ve chosen to first put up the portion of the comments that suggest it was highly likely that — as Senator Grassley suggested — even the “blinded data” would have revealed the study’s failure, at least to a sophisticated set of medical eyes. Click to enlarge — I will have more; this is but one page from the Stupak-Dingell document dump (of more than 60 pages!), tonight:

The highlighting on the above is original [not so, on the below]. As if all of this were not tough-enough sledding for Schering, Chairman Dingell also released a letter from the FDA, dated January 23, 2008, that called Vytorin advertising “misleading“, in view of the ENHANCE results. Ouch — that will leave a mark. Now the Committee wants a bevy of answers, and additional documents, from both Schering-Plough and Merck & Co., all within two weeks’ time — that’s April 25, 2008. Take a look — again, click to enlarge — but I highlighted it, to make it easier to read:

The most important question for the moment is to figure out when Schering knew about the FDA’s concerns — as Dingell and Stupak specifically ask, above. But it may turn out, that these Congressional committees are, day-by-day, proving the cases of the 33 consumer fraud complaints, consolidated and transferred, earlier this week, to Judge Cavanaugh in New Jersey.

Wow — just when I think I won’t be terribly-surprised to learn anything more about this whole mess — I see new, and difficult, issues surface. It just keeps on churning, here. It is hard to imagine how Schering put itself this awkwardly behind the Eight-ball.

FDA Letter re Vytorin: "Please revise. . . misleading promotional materials"

It is hard to overstate the importance of a letter like the one below, to a drug like Vytorin’s market prospects. In essence, the FDA is requiring Schering to say that the drug is less effective than alternative drugs. Now, by FDA rule, that copy change must be made within 90 days of the letter (or earlier, if Schering stocks-out of an item) — so, ALL the ad copy must be changed over, by April 24, 2008 — just about two weeks from tonight. This is an image of the actual letter — it was signed, digitally, by an FDA lawyer, Joan Hankin, on January 23, 2008 — at 3:39:39 PM — precisely. This is the actual letter Reps. Dingell and Stupak referred to, this evening.

What have Schering-Plough, and Merck been doing since then, to comply with this FDA letter? And, for how long had the Joint Veture partners been discussing this concept with FDA, prior to the actual issuance of the below letter? [There is an e-mailed summary, reflecting a meeting in which Joan Hankin participated, several days prior to her letter, where the action itmes included changing Vytorin ad copy. Wow.]

This is likely to get uglier before it gets prettier. As ever, click each to enlarge: