Merck CEO Dick Clark — Lobbying at White House — in March and May 2009

July 22, 2009 · Leave a Comment


In response to public pressure from CREW, a citizens’-advocacy group, President Obama’s White House Counsel has just released a letter (the full-text full PDF file), listing March 24, 2009 and May 11, 2009 visits by Merck CEO Dick Clark. CREW, for its part, reiterated tonight that it will continue to seek the full-text of all White House (and Vice Presidential residence) visitor logs on the topic.

The letter released tonight also lists all of Billy Tauzin’s [imaged, at right] visits, as President of PhRMA, and his in-person contacts — at the White House, presumably all on health care reform initiatives, per Sharon Theimer, for the AP Newswires:

. . . .lobbyist Billy Tauzin, a former Louisiana congressman who heads the drug industry lobby, the Pharmaceutical Research and Manufacturers of America [PhRMA]. . . . went to the White House on March 5, the day of a summit on health care, and again on May 11, 19, June 2 and June 24, 2009. . . .

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Current Hep C Regimens — Either Current Drug Will Do — Except, Of Course, If You’re Black. . . .

July 22, 2009 · Leave a Comment


Even though Schering funded the IDEAL study (reported tonight in The NEJM), it turns out that neither the Schering-Plough currently approved drug, nor the Roche Holding AG one differ much — in treating Hep C. Sadly, neither drug does a very good job in treating people of color — for reasons (as yet) unknown.

The IDEAL results must be at least a mild disappointment to Kenilworth, as they also appear to suggest that using less of either drug still causes a significant decrease in viral loads.

Finally, this study says nothing about the so-called next-generation of Hep C candidates — those still awaiting FDA filings and apporvals. The lead in that next gen race clearly belongs to Vertex’s teleprevir. It is theirs to lose. Perhaps teleprevir will show improved efficiacy in people of color — where the current regimens are doing a particularly poor job. In fact, I’ll try to go track down some information on that, for a future post — it would be a very-welcome development.

I suppose I am, personally, very frustrated about the racial disparity in treatment success — as it has been widely known, and widely-reported, in The Wall Street Journal, even, going back to at least 1991. African Americans — although only about 13 percent of the United States population — are disproportionately hard-hit by this disease.

And yet — here we sit — almost two full decades later, with very little in the way of any actual data, or even operating assumptions — as to what might work for them, as a group — or even, why this sad state of affairs continues to exist.

Perhaps this would change, if there were a greater financial incentive (i.e., health care coverage for all) — given that a disproportionate number of people of color tend to be under-, or un-insured – and given that Hep C disproportionately presents, hand in hand, with poverty, more generally.

Unfortunate, in the extreme. From the NEJM synopsis, then:

. . . .Consistent with previous observations14,15,16,17,18,19,20 a sustained virologic response was less frequent among blacks. . . .

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

[Click to read some of the prior findings, depicted above.]

. . . .14. Muir AJ, Bornstein JD, Killenberg PG. Peginterferon alfa-2b and ribavirin for the treatment of chronic hepatitis C in blacks and non-Hispanic whites. N Engl J Med 2004;350:2265-2271.

15. Myers RP, Patel K, Pianko S, Poynard T, McHutchison JG. The rate of fibrosis progression is an independent predictor of the response to antiviral therapy in chronic hepatitis C. J Viral Hepat 2003;10:16-22.

16. Soresi M, Tripi S, Franco V, et al. Impact of liver steatosis on the antiviral response in the hepatitis C virus-associated chronic hepatitis. Liver Int 2006;26:1119-1125.

17. Reddy KR, Govindarajan S, Marcellin P, et al. Hepatic steatosis in chronic hepatitis C: baseline host and viral characteristics and influence on response to therapy with peginterferon alpha-2a plus ribavirin. J Viral Hepat 2008;15:129-136.

18. Bronowicki JP, Ouzan D, Asselah T, et al. Effect of ribavirin in genotype 1 patients with hepatitis C responding to pegylated interferon alfa-2a plus ribavirin. Gastroenterology 2006;131:1040-1048.

19. Moucari R, Ripault MP, Oulès V, et al. High predictive value of early viral kinetics in retreatment with peginterferon and ribavirin of chronic hepatitis C patients non-responders to standard combination therapy. J Hepatol 2007;46:596-604.

20. Yu ML, Dai CY, Huang JF, et al. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology 2008;47:1884-1893. . . .

Yep — at least six prior studies observed the same thing (per the numbered footnotes, above). Yet here we sit.

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Additional Thoughts — Non-GAAP EPS Figures (and Unicorns!) — Especially Pre-Merger. . . .

July 22, 2009 · Leave a Comment


I think a large portion of Schering-Plough’s NYSE stock price-performance, of yesterday, was simply Merck tugging it along, via the coming exchange-ratio.

Some of it was also, in fairness, the Street’s reaction to Schering-Plough’s non-GAAP EPS figures. But these non-GAAP figures should be viewed with an earnestly-questioning eye — especially in the quarters right before a “bust-up/wipe-out” merger is slated to close. These EPS figures are a little like reports of unicorn sightings: they should be viewed with significant skepticism.

In this regard, note particularly Merck CEO Clark’s new disclosure, of yesterday — that even Consumer Health Care may “need a partner“. That’s financial/accounting Pig Latin for Merck may need to take a lot of charges in that business franchise, once it assumes control. And in those charges are where the non-GAAP EPS measures hide, and/or later find, their “unicorns“. [It is no mere coincidence than CEO Hassan doesn't want the merger-execution-process to cross any fiscal year-end. But to be abundantly clear, here -- I am accusing no one of fraud. Each of these matters involves the exercise of a significant amount of professional judgment, along with business accumen. That said, if nothing else has been established over the last two years at Schering-Plough, it is that the judgment of many executives and professionals employed by Schering-Plough (especially at the highest levels) is questionable, at best.]

And so, any talk of “beating” such Non-GAAP EPS estimates sounds decidedly like talking about those “unicorns, out there, in the woods“. Perhaps sales revenue is the only truly verifiable number, in these settings.

Consider that Schering-Plough will likely no longer exist, at all (by late 2010): so CEO Fred Hassan may, fairly safely, post any non-GAAP number he thinks Merck CEO Dick Clark will be able to reasonably swallow, into a series of merger reserves and charge-offs, post close. Moreover, as to the various “canopic jars” for these coming charges — it is certain that either Intervet, or Merial will be gone from the Animal Health franchises (and, perhaps most of both!): Charge 1; it is (after yesterday) likely that Consumer Health Care will be decimated, or sold off: Charge 2; and it is likely that a good chunk of the profit on Remicade/Simponi will revert back to Centocor/J&J’s control: Charge 3. And then, there is the more-general “costs of merger” canopic-jar: Charge 4. I forgot — there is probably still at least some open reserve/charge amount related to the Organon acquisition, of 2007: Charge 5.

Good luck finding where any “variances” went, after allocation, re-allocation, among these four five canopic-jars.

Unfortunate — but likely, more than a little truth resides there.

Now — in an alternate Universe (one not driven solely by greed, nor awash in such unicorns!) — let’s just suppose, for a moment, that CEO Hassan hadn’t promised Wall Street “the moon — and a herd of unicorns, to boot!” during the period 2003, to 2007 — regarding Schering’s coming fortunes.

Suppose he had said “we will run the company for slower, but sustainable, earnings growth“. Suppose he had said we will focus on good science, not quick marketing kills. Suppose he had said that he would put science, and human health first. Oh, wait — he did say all of those things. He Just. Didn’t. Do. Any. Of. Them.

Instead, he lined his pockets (and the pockets of his top five, and fellow EMT members), drove what will end up being perhaps 30,000 people out of their jobs, and careers — and caused a 120 year-old company to wink out of existence, entirely. Did that benefit the American economy, net-net? No. Did it even benefit most long-term shareholders? Again, no.

It only benefitted CEO Hassan, and his close-and-craven executive team.

So, I ask — was it really a good idea — in the larger, macro-economic, sense — for Hassan to extract perhaps $300 million, personally, all-in, over these last six or seven years, to simply kill this once-proud company? Why does our system reward that sort of behavior? Isn’t such a system broken, in a fundamental sense?

And just to forestall the obvious retort, here — I don’t agree, by the way, that Schering-Plough “was going to die, anyway, one way or another“. It could have continued on independently, albeit in a smaller form, doing good — where it could. But it was an easy mark for the Hassan/Cox “shell game” — the same one they allegedly played at Pharmacia — only super-sized, this time.

I am really interested in an intelligent response to why we as a body-politic think, collectively, this was a good idea. I, for one, remain puzzled about that.

[Discuss among yourselves, over at Whitehouse Station, and Kenilworth.]

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