Category Archives: Merck Form 10-Q disclosures September 30 2008 Novemebr

Merck Tells the WHOLE Vytorin Truth — in its Q3 Form 10-Q — Schering? Not so much.

Compare the below, to what Schering swore was true — that “media reactioncaused the 2008 declines in the Cholesterol Management Joint Venture’s equity income.

SEC Forms 10-Q are essentially sworn statements, by the CEO, CFO and Controller — sworn to, before the SEC — an agency of the federal government. Statements to which civil and criminal liability for fraud attaches. This Merck well-understands — so, it chose to tell the WHOLE truth about Vytorin/Zetia equity income trend-lines (on Form 10-Q, page 38):

. . . .The decrease in equity income from the Merck/Schering-Plough joint venture is a result of lower revenues of Zetia and Vytorin related to the ENHANCE and SEAS clinical trial results. . . .

[Wmphasis supplied, above — Now, quoting from the top of Page 40 — regarding SEAS results:]

. . . .There also was no significant difference in the key secondary end point of aortic valve events; however, there was a reduction in the group of patients taking Vytorin compared to placebo in the key secondary end point of ischemic cardiovascular events. Vytorin is not indicated for the treatment of aortic stenosis. Vytorin contains two active ingredients: ezetimibe and simvastatin. No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. In the study, patients in the group who took Vytorin 10/40 mg had a higher incidence of cancer than the group who took placebo. There was also a nonsignificant increase in deaths from cancer in patients in the group who took Vytorin versus those who took placebo. Cancer and cancer deaths were distributed across all major organ systems. The Company believes the cancer finding in SEAS is likely to be an anomaly that, taken in light of all the available data, does not support an association with Vytorin. The Company, through the MSP Partnership, is committed to working with regulatory agencies to further evaluate the available data and interpretations of those data; however, the Company does not believe that changes in the clinical use of Vytorin are warranted. . . .

[And — more on this, in a later post — a potential block-buster: ENTIRELY UNDISCLOSED BY SCHERING! — on Page 21 (filed on September 10 — so well before Schering filed its Form 10-Q!) — we now learn that the DoJ is formally investigating potential violations of the federal False Claims Act, related to the sale of Vytorin and Zetia:]

. . . .Finally, on September 10, 2008, the Company received a letter from the Civil Division of the U.S. Department of Justice informing it that the DOJ is investigating whether the companies’ conduct relating to the promotion of Vytorin caused false claims to be submitted to federal health care programs. The Company is cooperating with these investigations and working with Schering-Plough to respond to the inquiries. In addition, since mid-January 2008, the Company has become aware of or been served with approximately 140 civil class action lawsuits alleging common law and state consumer fraud claims in connection with the MSP Partnership’s sale and promotion of Vytorin and Zetia. Certain of those lawsuits allege personal injuries and/or seek medical monitoring. . . .

In my opinion — Schering’s officers did not tell the whole truth, when each signed, and filed Schering’s Form 10-Q, here.

Both companies witnessed the exact same events — yet one attributed it to “study results” — while the other attributed it to the “media reaction” to those same study results.

Yes — I do see this as tantamount to ’34 Act fraud, Messrs. Hassan, Bertolini and Sabatino.

[A sincere hat tip to PM, for alerting me to the fact the Merck had filed its 2008 Q3 SEC Form 10-Q, overnight.]