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:

The 33 Consumer-Fraud Actions have been Consolidated in New Jersey. . . .

UPDATED: The Congressional committees are making huge gifts to the plaintiffs’ causes here — releasing loads of pretty significant evidence to the public internet.

This morning, Regan H. Crotty, of Dechert LLP (Schering’s counsel in these matters) filed a notice that the Multi-District Panel (or “MDL”) has decided to consolidate some 33 separate cases, and have them handled by Judge Cavanaugh, in the United States District Court for the District of New Jersey. The consolidated consumer-fraud cases will be henceforth found under a single docket number, there — MDL No. 1938.

In a footnote, the MDL Panel’s order indicates there are now at least 100 separate lawsuits pending, some alleging securities fraud, some alleging RICO violations, and some alleging ERISA violations, as well as these consumer fraud claims. Eventually, I’ll have summaries of each of the sorts of allegations up here, by links. Click it to enlarge:

I’ll be back later, to I’ve just summarized some of these consumer fraud suits’ allegations.

Why won’t Schering-Plough follow Eli Lilly & Co.’s Lead?

Eli Lilly has agreed to disclose its grant practices, and payments. Merck & Co. is presently preparing to do so, according to published reports.

But Schering-Plough Corporation? “No way!”, they say. Wouldn’t such a disclosure put to bed the claims that SGP buys its recommendations from doctors?

“. . . .Schering-Plough Corp., however, told the senator what he didn’t want to hear: “We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us. . . .”

“. . . .A dozen of the nation’s leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company’s Web sites.

Watchdog groups say the companies are trying to head off legislation that would require public disclosure of their giving. . . .”

[Emphasis supplied.]

It is interesting that Schering’s spokespeople are taking a hard line, here, when they MUST know that Sen. Grassley’s March 31, 2008 letter requires even more-detailed disclosures — about influencing doctors to use Vytorin/Zetia, pre- and post-ENHANCE — and all that data is due to the Senator this Monday – in three days’ time. Else, his Committee will simply issue a subpoena, compelling the delivery of the documents about the so-called “49 Plan” — some $3.5 million worth. . . . That approach — stalling — will earn Schering nothing, except more lawsuits and headaches, in my opinion.

Moreover, Merck & Co., Schering’s partner in the Vytorin/Zetia Joint Venture, has indicated it will make many of these payments public, now. That means Merck will likely disclose grants/payments made to the Vytorin/Zetia “Medical Opinion Leaders”.

How venial and small will Schering appear, if the only way the world finds out about those payments is through Merck & Co.’s voluntary disclosures — while Schering-Plough in essense stone-walls, and forces Sen. Grassley to authorize the issuance of a Congressional Suboena Duces Tecum, from the Senate Finance Committee? Odd Public Relations strategy, that.

Such an approach makes absolutely no sense — for a company in the middle of a publicity fire-storm — especially one that purports to have nothing to hide.

We’ll see.

Why won’t Schering-Plough follow Eli Lilly & Co.’s Lead?

Eli Lilly has agreed to disclose its grant practices, and payments. Merck & Co. is presently preparing to do so, according to published reports.

But Schering-Plough Corporation? “No way!”, they say. Wouldn’t such a disclosure put to bed the claims that SGP buys its recommendations from doctors?

“. . . .Schering-Plough Corp., however, told the senator what he didn’t want to hear: “We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us. . . .”

“. . . .A dozen of the nation’s leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company’s Web sites.

Watchdog groups say the companies are trying to head off legislation that would require public disclosure of their giving. . . .”

[Emphasis supplied.]

It is interesting that Schering’s spokespeople are taking a hard line, here, when they MUST know that Sen. Grassley’s March 31, 2008 letter requires even more-detailed disclosures — about influencing doctors to use Vytorin/Zetia, pre- and post-ENHANCE — and all that data is due to the Senator this Monday – in three days’ time. Else, his Committee will simply issue a subpoena, compelling the delivery of the documents about the so-called “49 Plan” — some $3.5 million worth. . . . That approach — stalling — will earn Schering nothing, except more lawsuits and headaches, in my opinion.

Moreover, Merck & Co., Schering’s partner in the Vytorin/Zetia Joint Venture, has indicated it will make many of these payments public, now. That means Merck will likely disclose grants/payments made to the Vytorin/Zetia “Medical Opinion Leaders”.

How venial and small will Schering appear, if the only way the world finds out about those payments is through Merck & Co.’s voluntary disclosures — while Schering-Plough in essense stone-walls, and forces Sen. Grassley to authorize the issuance of a Congressional Suboena Duces Tecum, from the Senate Finance Committee? Odd Public Relations strategy, that.

Such an approach makes absolutely no sense — for a company in the middle of a publicity fire-storm — especially one that purports to have nothing to hide.

We’ll see.

Why won’t Schering-Plough follow Eli Lilly & Co.’s Lead?

Eli Lilly has agreed to disclose its grant practices, and payments. Merck & Co. is presently preparing to do so, according to published reports.

But Schering-Plough Corporation? “No way!”, they say. Wouldn’t such a disclosure put to bed the claims that SGP buys its recommendations from doctors?

“. . . .Schering-Plough Corp., however, told the senator what he didn’t want to hear: “We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us. . . .”

“. . . .A dozen of the nation’s leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company’s Web sites.

Watchdog groups say the companies are trying to head off legislation that would require public disclosure of their giving. . . .”

[Emphasis supplied.]

It is interesting that Schering’s spokespeople are taking a hard line, here, when they MUST know that Sen. Grassley’s March 31, 2008 letter requires even more-detailed disclosures — about influencing doctors to use Vytorin/Zetia, pre- and post-ENHANCE — and all that data is due to the Senator this Monday – in three days’ time. Else, his Committee will simply issue a subpoena, compelling the delivery of the documents about the so-called “49 Plan” — some $3.5 million worth. . . . That approach — stalling — will earn Schering nothing, except more lawsuits and headaches, in my opinion.

Moreover, Merck & Co., Schering’s partner in the Vytorin/Zetia Joint Venture, has indicated it will make many of these payments public, now. That means Merck will likely disclose grants/payments made to the Vytorin/Zetia “Medical Opinion Leaders”.

How venial and small will Schering appear, if the only way the world finds out about those payments is through Merck & Co.’s voluntary disclosures — while Schering-Plough in essense stone-walls, and forces Sen. Grassley to authorize the issuance of a Congressional Suboena Duces Tecum, from the Senate Finance Committee? Odd Public Relations strategy, that.

Such an approach makes absolutely no sense — for a company in the middle of a publicity fire-storm — especially one that purports to have nothing to hide.

We’ll see.

Why won’t Schering-Plough follow Eli Lilly & Co.’s Lead?

Eli Lilly has agreed to disclose its grant practices, and payments. Merck & Co. is presently preparing to do so, according to published reports.

But Schering-Plough Corporation? “No way!”, they say. Wouldn’t such a disclosure put to bed the claims that SGP buys its recommendations from doctors?

“. . . .Schering-Plough Corp., however, told the senator what he didn’t want to hear: “We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us. . . .”

“. . . .A dozen of the nation’s leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company’s Web sites.

Watchdog groups say the companies are trying to head off legislation that would require public disclosure of their giving. . . .”

[Emphasis supplied.]

It is interesting that Schering’s spokespeople are taking a hard line, here, when they MUST know that Sen. Grassley’s March 31, 2008 letter requires even more-detailed disclosures — about influencing doctors to use Vytorin/Zetia, pre- and post-ENHANCE — and all that data is due to the Senator this Monday – in three days’ time. Else, his Committee will simply issue a subpoena, compelling the delivery of the documents about the so-called “49 Plan” — some $3.5 million worth. . . . That approach — stalling — will earn Schering nothing, except more lawsuits and headaches, in my opinion.

Moreover, Merck & Co., Schering’s partner in the Vytorin/Zetia Joint Venture, has indicated it will make many of these payments public, now. That means Merck will likely disclose grants/payments made to the Vytorin/Zetia “Medical Opinion Leaders”.

How venial and small will Schering appear, if the only way the world finds out about those payments is through Merck & Co.’s voluntary disclosures — while Schering-Plough in essense stone-walls, and forces Sen. Grassley to authorize the issuance of a Congressional Suboena Duces Tecum, from the Senate Finance Committee? Odd Public Relations strategy, that.

Such an approach makes absolutely no sense — for a company in the middle of a publicity fire-storm — especially one that purports to have nothing to hide.

We’ll see.

Why won’t Schering-Plough follow Eli Lilly & Co.’s Lead?

Eli Lilly has agreed to disclose its grant practices, and payments. Merck & Co. is presently preparing to do so, according to published reports.

But Schering-Plough Corporation? “No way!”, they say. Wouldn’t such a disclosure put to bed the claims that SGP buys its recommendations from doctors?

“. . . .Schering-Plough Corp., however, told the senator what he didn’t want to hear: “We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us. . . .”

“. . . .A dozen of the nation’s leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company’s Web sites.

Watchdog groups say the companies are trying to head off legislation that would require public disclosure of their giving. . . .”

[Emphasis supplied.]

It is interesting that Schering’s spokespeople are taking a hard line, here, when they MUST know that Sen. Grassley’s March 31, 2008 letter requires even more-detailed disclosures — about influencing doctors to use Vytorin/Zetia, pre- and post-ENHANCE — and all that data is due to the Senator this Monday – in three days’ time. Else, his Committee will simply issue a subpoena, compelling the delivery of the documents about the so-called “49 Plan” — some $3.5 million worth. . . . That approach — stalling — will earn Schering nothing, except more lawsuits and headaches, in my opinion.

Moreover, Merck & Co., Schering’s partner in the Vytorin/Zetia Joint Venture, has indicated it will make many of these payments public, now. That means Merck will likely disclose grants/payments made to the Vytorin/Zetia “Medical Opinion Leaders”.

How venial and small will Schering appear, if the only way the world finds out about those payments is through Merck & Co.’s voluntary disclosures — while Schering-Plough in essense stone-walls, and forces Sen. Grassley to authorize the issuance of a Congressional Suboena Duces Tecum, from the Senate Finance Committee? Odd Public Relations strategy, that.

Such an approach makes absolutely no sense — for a company in the middle of a publicity fire-storm — especially one that purports to have nothing to hide.

We’ll see.

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.

The 33 Consumer-Fraud Actions have been Consolidated in New Jersey. . . .

UPDATED: The Congressional committees are making huge gifts to the plaintiffs’ causes here — releasing loads of pretty significant evidence to the public internet.

This morning, Regan H. Crotty, of Dechert LLP (Schering’s counsel in these matters) filed a notice that the Multi-District Panel (or “MDL”) has decided to consolidate some 33 separate cases, and have them handled by Judge Cavanaugh, in the United States District Court for the District of New Jersey. The consolidated consumer-fraud cases will be henceforth found under a single docket number, there — MDL No. 1938.

In a footnote, the MDL Panel’s order indicates there are now at least 100 separate lawsuits pending, some alleging securities fraud, some alleging RICO violations, and some alleging ERISA violations, as well as these consumer fraud claims. Eventually, I’ll have summaries of each of the sorts of allegations up here, by links. Click it to enlarge:

I’ll be back later, to I’ve just summarized some of these consumer fraud suits’ allegations.