Pfizer Blows Statin Smoke

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Panic 2008... Profit 2009!

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Desperate times call for desperate measures.

Over the past couple of years, Pfizer (NYSE: PFE) has been getting a small preview of what it's going to feel like when Lipitor, which fights high cholesterol, goes off patent in November 2011. Sales in the U.S. have been sinking since Merck's (NYSE: MRK) Zocor, a similar statin, lost patent protection in the middle of 2006 and generics flooded the market.

 

2006

2007

2008 through September

Lipitor U.S. sales (millions)

$7,849

$7,195

$4,717

Year-over-year increase (decrease)

6%

(8%)

(12%)*

Source: Company earnings releases.
* Compared with the same period of 2007.

To try to get some of those sales to cheaper generics back, the company ran a study comparing Lipitor with generic versions of Zocor.

But this wasn't a controlled head-to-head clinical trial -- no, that would cost way too much. Instead, the company used data collected by WellPoint's (NYSE: WLP) health outcomes research subsidiary to observe whether patients who took the drugs had differences in their chances of having a cardiac event, such as a heart attack, a stroke, or needing a bypass. 

Lo and behold, the group that took Lipitor had a 13% reduction in the relative risk of a cardiac event.

The only problem -- and it's a biggie -- is that these observational studies aren't very controlled. The scientists compiling the data try to factor the differences in, but it's somewhat out of their control. For instance, the patients taking Lipitor were on the drug for nine months on average, compared with just seven months for the patients taking generic Zocor. Pfizer even warns us that the study isn't testing a hypothesis, but rather generating one. How could anyone take the conclusions seriously?

And yet, I'm not sure that Pfizer wasted investors' money. The study probably wasn't all that expensive to compile, and enough doctors won't bother to read the fine print, so it might help gain a few sales that would have gone to generic Merck or perhaps even AstraZeneca's (NYSE: AZN) Crestor or Merck and Schering-Plough's (NYSE: SGP) Vytorin.

Investors should think of this study as an elaborate advertisement. It won't create a windfall, but it might slow the slide toward the cliff a little.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is also a Motley Fool Income Investor pick, and the Fool owns shares of it. The Fool has a disclosure policy.

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  • Report this Comment On December 05, 2008, at 10:45 AM, quiact wrote:

    With statins as a class of medications:

    A.E.s are thought to occur more often than they are reported- with high dose statins in particular, yet with the type of statin administered possibly having a correlation with A.E.s as well, according to others..

    Statins used with macrolide antibiotics can cause a higher incidence of myopathy, it is believed.

    Additionally, there is no reduction in mortality or increase in the lifespan if one is on statin therapy, according to many. So caution should perhaps be considered if one chooses to prescribe such a drug for a patient. In other words, the health care provider should be assured that statin therapy for their patients is reasonable and necessary, of course, and possibly after dietary controls have failed.

    Several risk factors should determine if one is placed on statin therapy, and not just one. High cholesterol is the apex of such therapy, yet other risk factors of the patient should be examined and evaluated as well by their health care provider, perhaps- depending on the patient’s cardiovascular history.

    Statins do decrease CV events and CV risks significantly, it is believed. This may be due to the fact that statins increase endothelial function, stabilize coronary plaque, and decrease thrombus formation. For hyperlipidemia patients, maximum reduction in LDL can be determined after about a month of statin therapy, others have said.

    There is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP) with patients on statin therapy, those with dementia or Parkinson's disease, and some forms of Cancer and cataracts, according to studies that have been conducted in the past. Yet these other roles for statin therapy have only been minimally explored.

    It appears those statins that are produced specifically by fermentation, such as Zocor and Pravachol, have less incidences of myopathy than the other synthetic statins that exist. This may possibly due to fermented statins are believed to be much more hydrophyllic, which may optimize safety for a patient on a statin medication.

    Yet overall, the existing cholesterol lowering recommendations should be re-evaluated, as they may be over-exaggerated, if one chooses to compare these guidelines with others in the past, there are possibly unreasonable and unnecessary goals to achieve presently.

    Finally, a focus on children and their lifestyles should be amplified so their arteries do not become those of one who is middle-aged, and prevent them from being candidates for statin therapy,

    Dan Abshear

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