Tuesday, April 12, 2005

Dream Team

Can you guess what a torcetrapib is? Maybe the name of a dinosaur? Or perhaps a remote village in the Himalayas? An odd, tongue-twisting word like that could only be one thing: a new drug. Actually, torcetrapib is the "active ingredient" name of the drug. And someday, if everything goes as planned, it will have a snappy, easy-to-pronounce brand name. And you'll hear about it. Oh, believe me, you'll hear all about it. Because the pharmaceutical giant Pfizer is betting hundreds of millions of dollars that torcetrapib is going to be the Next Big Thing. And it probably will be. But there's a catch. There always is with these guys. Torcetrapib has already been shown to raise HDL cholesterol levels. Obviously that's a good thing. Contrary to the stubborn mainstream mindset of the past 15 years, recent research has demonstrated that low LDL is not the key to cholesterol health. An optimal cholesterol profile requires HDL to be elevated while LDL is reduced. So going to extremes simply to drive down LDL as far as it will possibly go is; A) not healthy, and B) like savagely beating one horse in a two-horse team. That's why executives at Pfizer (makers of the superstar LDL-lowering drug Lipitor) are developing a product that will combine Lipitor and torcetrapib. And you've got to admit it looks good on paper: Take a wildly successful drug that lowers LDL and package it with an effective HDL elevating drug and - ka-ching! - back up the money truck! But besides adverse side effects (don't worry - I'll get to that in a moment), there's just one problem with this beautiful marriage: It's a violation of U.S. antitrust laws that forbid the bundling of products so that one can't be purchased without buying another. But guess what? According to a report in the New York Times, the FDA provides a neat little loophole to this law. If Pfizer researchers can demonstrate that their Lipitor/torcetrapib Dream Team can actually reduce heart disease risk only when used together, the drug will almost certainly get FDA approval, which would override that pesky antitrust law. So, how much do Pfizer execs want this new drug to succeed? The Times article estimates that the company will devote more than $800 million to Lipitor/torcetrapib research over the next two years. In other words: They want it really bad. If Pfizer executives can pull this one off it will be like winning three Super Bowls in a row. Here's why: The patent on Lipitor is due to run out in 2010. And as soon as generic Lipitor hits the streets, Lipitor sales will drop dramatically. That's an unsettling prospect for Pfizer. According to the Times, 2003 sales of Lipitor came in at just under $11 billion, accounting for about half of Pfizer's profits. But the patent on Lipitor could easily be extended because of its new design, bundled with torcetrapib. Then, when the patent on Lipitor/torcetrapib eventually runs out, torcetrapib could possibly go on to have a patent of its own. By that time most people won't even remember what the heck LDL is because we'll all be "re-educated" to an HDL mindset, with people in commercials crowing, "I boosted my HDL!" And without question, boosting your HDL is a good thing. But is it worth the risk of developing high blood pressure? That's a fair question because preliminary trials suggest there may be hypertension concerns with higher doses of torcetrapib. Incredible, isn't it? A drug designed to prevent heart disease may prompt a condition that raises the risk of heart attack and stroke. The most refreshing feature of the Times report on torcetrapib was a quote from Allen J. Taylor, M.D., who is a cardiologist at the Walter Reed Army Medical Center. Dr. Taylor pointed out that there's already a "proven" way to dramatically raise HDL: take niacin. The importance of niacin is well known to our readers. In previous alerts, we've told you how niacin (vitamin B-3) may offer a double bonus by lowering triglycerides while raising HDL. Jonathan V. Wright, M.D., has also noted that niacin is effective against degenerative arthritis, anxiety, and type 1 diabetes. Of course, there are two key things that niacin doesn't do: It doesn't raise blood pressure, and it doesn't raise drug company profits.

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