Moral: Don’t Piss-Off Congressional Committee Chairmen — I’d Fairly Guess That These Two Are “Related”. . . .

September 4, 2008 · Leave a Comment


Just this evening, the U.S. House Committee on Energy and Commerce, chaired by Rep. John Dingell, released the PDF file of Sir Richard Peto’s purportedly-full SEAS report (it is a decidedly paltry, seven-page affair) as to why he sees no plausible link between Vytorin, and the elevated incidence rates of cancer seen in patients treated with Vytorin — when compared to those given a mere placebo. In fact, here is one of Peto’s own charts, from that report, cleaned up for the web [Click to enlarge]:


Just a few hours ago, Schering confirmed it would not meet today’s deadline for delivering the first batch of written responses to the Committee.

How’s that “I’m just gonna’ thumb my nose at ‘em” strategy workin’ for ya’, now, Mr. Hassan?

Do tell.

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Moral: Don’t Piss-Off Congressional Committee Chairmen — I’d Fairly Guess That These Two Are "Related". . . .

September 4, 2008 · Leave a Comment

Just this evening, the U.S. House Committee on Energy and Commerce, chaired by Rep. John Dingell, released the PDF file of Sir Richard Peto’s purportedly-full SEAS report (it is a decidedly paltry, seven-page affair) as to why he sees no plausible link between Vytorin, and the elevated incidence rates of cancer seen in patients treated with Vytorin — when compared to those given a mere placebo. In fact, here is one of Peto’s own charts, from that report, cleaned up for the web [Click to enlarge]:


Just a few hours ago, Schering confirmed it would not meet today’s deadline for delivering the first batch of written responses to the Committee.

How’s that “I’m just gonna’ thumb my nose at ‘em” strategy workin’ for ya’, now, Mr. Hassan?

Do tell.

Categories: Richard Peto report PDF SEAS Vytorin Cancer Incidence F

Schering-Plough Spokesperson Confirms Schering Will Miss Deadline Set by US House Committees

September 4, 2008 · Leave a Comment


The AP is moving a story — released just a few minutes ago — that indicates, among other matters, that Rosemarie Yancosek, a spokeswoman for Schering-Plough, wrote in a reply e-mail, to an AP reporter’s several questions, that Schering-Plough has not yet complied with the U.S. House Committee’s August 2008 information request, but is preparing answers and will respond soon. [See that request, right here, in full-text.]

By its terms, that written response — to the Committee’s earlier letter, dated August 21, 2008, from Chairmen Dingell and Stupak — was due by close of business todaySeptember 4, 2008. It asked for much additional detail on the SEAS trial’s travails.

I confess — I am baffled by this (apparently intentional) approach — the Chairmen just wrote another, more-sharply-pointed request for information, not even 48 hours ago – is it Schering-Plough’s intention to “jab a stick in the eye” of this giant?

If so, it is high time that someone sat Mr. Hassan down, and patiently explained to him — in single-syllable words, and short sentences – that this Committee has concurrent jurisdiction over his company’s businesses, in the United States, at least (Schering still generates well-over half of its annual income right here — in these markets).

Thumbing one’s nose at Congressional Committee Chairs — by repeatedly missing response deadlines — is decidedly bad form, Mr. Hassan. This is clearly not the right time to be rankling these particular regulators. It is, afterall, an election year. On the other hand, perhaps Mr. Hassan wants Schering to be seen as the poster child for Big-Pharma’s arrogance. Me?

I. just. don’t. get. it.

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Schering-Plough Spokesperson Confirms Schering Will Miss Deadline Set by US House Committees

September 4, 2008 · 2 Comments

The AP is moving a story — released just a few minutes ago — that indicates, among other matters, that Rosemarie Yancosek, a spokeswoman for Schering-Plough, wrote in a reply e-mail, to an AP reporter’s several questions, that Schering-Plough has not yet complied with the U.S. House Committee’s August 2008 information request, but is preparing answers and will respond soon. [See that request, right here, in full-text.]

By its terms, that written response — to the Committee’s earlier letter, dated August 21, 2008, from Chairmen Dingell and Stupak — was due by close of business todaySeptember 4, 2008. It asked for much additional detail on the SEAS trial’s travails.

I confess — I am baffled by this (apparently intentional) approach — the Chairmen just wrote another, more-sharply-pointed request for information, not even 48 hours ago – is it Schering-Plough’s intention to “jab a stick in the eye” of this giant?

If so, it is high time that someone sat Mr. Hassan down, and patiently explained to him — in single-syllable words, and short sentences – that this Committee has concurrent jurisdiction over his company’s businesses, in the United States, at least (Schering still generates well-over half of its annual income right here — in these markets).

Thumbing one’s nose at Congressional Committee Chairs — by repeatedly missing response deadlines — is decidedly bad form, Mr. Hassan. This is clearly not the right time to be rankling these particular regulators. It is, afterall, an election year. On the other hand, perhaps Mr. Hassan wants Schering to be seen as the poster child for Big-Pharma’s arrogance. Me?

I. just. don’t. get. it.

Categories: Stupak Dingell AP Johnson Hassan FDA Vytorin SEAS cance

Was VYCTOR a “seeding” study — in Mexico?

September 4, 2008 · Leave a Comment


As I indicated — in response to commenters’ questions, yesterday, a very smart friend of the blog has suggested that VYCTOR may have been intended as a “seeding” study, or promotional trial — ostensibly to influence doctors in Mexico (no small market, that).

This morning, also quite smartly, Matt Herper points out that it is not likely that Merck suppressed VYCTOR. As I indicated yesterday, I agree.

All of which is a long-winded way of thanking Matt for the link to this blog (see his second paragraph).

I have updated my original item on this topic to reflect these developments.

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Was VYCTOR a "seeding" study — in Mexico?

September 4, 2008 · Leave a Comment

As I indicated — in response to commenters’ questions, yesterday, a very smart friend of the blog has suggested that VYCTOR may have been intended as a “seeding” study, or promotional trial — ostensibly to influence doctors in Mexico (no small market, that).

This morning, also quite smartly, Matt Herper points out that it is not likely that Merck suppressed VYCTOR. As I indicated yesterday, I agree.

All of which is a long-winded way of thanking Matt for the link to this blog (see his second paragraph).

I have updated my original item on this topic to reflect these developments.

Categories: Herper Forbes VYCTOR ClinicalTrials.gov Merck Schering