"It is clear that the sponsors had a heavy influence on the trial's conduct," Krumholz declared. "What transpired behind closed doors is not yet known, but delay was certainly in the companies' interest. And it is not clear whether publication of the study could have and should have been timelier than it was."
Krumholz has taken a stand against one of the trial's sponsors in the past. He served as a consultant to plaintiffs in Vioxx lawsuits against Merck. Schering-Plough calls that a conflict of interest.
Kastelein, ENHANCE's lead investigator, has seen other drugs fail as well. Just one year before delivering the ENHANCE results, he stood before the ACC as a lead investigator with bad news about
Pfizer's (PFE Quote - Cramer on PFE - Stock Picks) torcetrapib.
Pfizer, the maker of Lipitor, had hoped that torcetrapib would become its next blockbuster cholesterol drug. But Pfizer abandoned the drug, which was designed to raise so-called "good" cholesterol, after it was linked to patient deaths.
Damaged Goods?
By then, Pfizer had given up on another opportunity as well.
Just one week before shelving torcetrapib, the company ended a long-term partnership with Organon after studies of asenapine, Organon's new treatment for schizophrenia and bipolar disorder, delivered mixed results.
At the time, one analyst suggested that Pfizer had abandoned Organon because the company didn't think that asenapine was "a good enough product to be competitive in the marketplace." Organon itself admitted that this was "partly the truth."
But Schering-Plough later downplayed Pfizer's move as a "commercial" decision. In fact, when announcing its buyout plans last year, Schering-Plough portrayed asenapine as one of Organon's two most promising drugs.
Schering-Plough also highlighted sugammadex, a new agent that reverses powerful muscle relaxers, as the other likely winner. Experts have heralded sugammadex as a rare breakthrough in the anesthesia world.
Schering-Plough may have welcomed that distraction. After all, the company was supposed to be generating its own headlines with the results of ENHANCE. But the spring ACC meeting passed with the company missing another deadline instead.
This year, Schering-Plough again relied on sugammadex for some well-timed positive news. Last month, as it prepared to deal with the fallout from ENHANCE, Schering-Plough announced that expert advisers had recommended sugammadex for approval on the U.S. market. Analysts now estimate that sugammadex could generate more than $400 million in annual sales.
But Schering-Plough scored that much -- and then some -- from Vytorin and Zetia in its last quarter alone. Therefore, the company has rushed to protect that precious franchise.
Already, Grassley claims, Schering-Plough has invested millions in a so-called "49 Plan" designed to bolster Vytorin sales. For that six-week marketing program, he says, Schering-Plough budgeted $3.5 million so that sales representatives could "wine and dine" physicians who might be swayed to prescribe the popular drug.
Sales of Vytorin and Zetia fell regardless. After five years of soaring popularity -- which pushed their estimated market share from 0.1% to 15% and beyond -- the drugs are now on the decline.
Schering-Plough's stock no longer reflects any value for the cholesterol franchise at all. Down almost 40% so far this year, the stock fetches around the same price that it did when Hassan first arrived in 2003 as the company's turnaround CEO.
Back then, Schering-Plough faced gigantic challenges posed by generic competition to its flagship allergy drug. At the time, Hassan promised to rebuild Schering-Plough and diversify the company "so that we are not reliant on any single large product" again.
But history seems to be repeating itself, anyway. Once again, Schering-Plough is announcing massive layoffs as it grapples with falling sales of its most popular drug. To its credit, however, the company boasts a stronger pipeline this time around.
Clearly, Schering-Plough needed Organon after all.
Know What You Own: SGP operates in the drug manufacturers industry, and some of the other stocks in its field include
Abbott Laboratories(ABT Quote - Cramer on ABT - Stock Picks),
Bristol-Myers Squibb(BMY Quote - Cramer on BMY - Stock Picks),
Sanofi-Aventis(SNY Quote - Cramer on SNY - Stock Picks),
Eli Lilly(LLY Quote - Cramer on LLY - Stock Picks) and
Pfizer(PFE Quote - Cramer on PFE - Stock Picks). These stocks were recently trading at $53.67, -0.61%, $21.43, -1.88%, $38.18, -0.81%, $51.70, -1.15% and $20.80, -0.98% respectively. For more on the value of knowing what you own, visit TheStreet.com's
Investing A-to-Z section.
Melissa Davis
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